Hospital pharmacy complete notes

Hospital Pharmacy Complete Notes 4th professional Pharm D

1. GHULAM MURTAZA HAMAD
4
TH
PROFF. EVENING
PUNJAB UNIVERSITY COLLEGE OF PHARMACY, LAHORE



HOSPITAL
PHARMACY
4
TH
PROFESSIONAL


Reference
Dr. Hamid Lectures
Dr. Furqan Lectures
Hospital Pharmacy by Nadeem Irfan Bukhari
William E. Hassan
ASHP Guidelines

2. GM Hamad

TABLE OF CONTENTS

Contents
1. Introduction
2. Hospital and Its Organization
3. Pharmacy, Its Organization and Personnel
4. Pharmacy and Therapeutic Committee
5. The Hospital Formulary
6. Dispensing to In-Patients
7. Dispensing to Ambulatory Patients
8. Distribution of Controlled Substances
9. Dispensing During Off-Hours
10. Safe Use of Medication in Hospitals
11. Manufacturing Bulk and Sterile
12. The Pharmacy, Central Sterile Supply Room
13. Aseptic Dispensing
14. Role of Pharmacist in Small Hospital, Nursing Homes, Etc.
15. Purchasing, Distribution and Control of Hospital Medicines, Medical & Surgical
Supplies
16. Nuclear Pharmacy
17. The Physical Plant and Its Equipment
18. Investigational Use of Drugs
19. Health Accessories
20. Surgical Supplies
21. Inspection of Wards with Reference to Drug Storage and Administration
22. Management of Accident & Emergency Pharmacy (A & E)

3. GM Hamad

Minimum Standards for Pharmacies in
Hospitals
PURPOSE
• Following the minimum standard guidelines are intended to serve as a basic
guide for the provision of pharmacy services in hospitals.
• These outline a minimum level of services that most hospital pharmacy
departments should consistently provide.
ELEMENTS OF CARE
(1) Practice management
(2) Medication-use policy development
(3) Optimizing medication therapy
(4) Drug product procurement and Inventory management
(5) Preparing, Packaging, and Labeling medications
(6) Medication delivery
(7) Monitoring medication use
(8) Evaluating the effectiveness of the medication-use system, and
(9) Research
ROLE OF PHARMACIST
The role of pharmacists is to help people make the best use of medications.
Therefore, pharmacists shall be concerned with not only the provision but the
outcomes of pharmacy services.
Scope of pharmacy services will vary from site to site, depending upon the needs
of patients and the hospital as well as the resources available, these core elements
are linked to successful outcomes.
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4. GM Hamad

STANDARD I. PRACTICE MANAGEMENT
Effective leadership and practice management skills are necessary for the delivery
of pharmacy services. Leadership should foster continuous improvement in patient
care outcomes.
The management of pharmacy services should focus on the pharmacist’s
responsibilities as a patient care provider and leader of the pharmacy enterprise
through the development of organizational structures that support that mission.
A. Pharmacy and Pharmacist Services
• Pharmacy Mission, Goals, and Scope of Services. The pharmacy shall have a
written mission statement that reflects both patient care and operational
responsibilities. The mission, goals, and scope of services shall be clearly
communicated to everyone.
• 24-Hour Pharmacy Services. Adequate hours of operation for the provision
of needed pharmacy services shall be maintained; 24-hour pharmacy
services should be provided when possible.
• After-Hours Pharmacy Access In the absence of 24-hour pharmacy services,
access to a limited supply of medications shall only be available to
authorized, licensed health care professionals for use in carrying out urgent
medication orders.
• Practice Standards and Guidelines The standards and regulations of all
relevant government bodies (e.g., state boards of pharmacy, departments of
health) shall be met.
B. Laws and Regulations
• Applicable provincial and federal laws and regulations shall be met, and
relevant documentation of compliance shall be maintained.
C. Policies and Procedures
• Policy and Procedures Manual There shall be a policy and procedures
manual governing pharmacy functions and all pharmacy personnel shall
follow those policies and procedures.
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• Appropriate mechanisms to ensure compliance with the policies and
procedures should be established.
• Personnel Safety
• Emergency Preparedness Facility emergency preparedness plans shall
describe the role of pharmacy staff in emergency response for providing safe
and efficient pharmacy services in case of emergencies.
• Medical Emergencies The pharmacy shall participate in hospital decisions
about emergency medication kits and trays, and the role of pharmacists in
medical emergencies.
• Immunization Programs The pharmacy shall participate in the development
of hospital policies and procedures concerning preventive and post exposure
immunization programs.
• Substance Abuse Programs The pharmacy shall assist in the development of
substance abuse education, prevention, identification and treatment
programs.
D. Human Resources
• Position Descriptions Areas of responsibility within the scope of pharmacy
services shall be clearly defined.
• Director of Pharmacy The pharmacy shall be managed by a professionally
competent, legally qualified pharmacist.
• Pharmacists The pharmacy shall employ an adequate number of competent,
legally qualified pharmacists.
• Support Personnel Sufficient support personnel (e.g. pharmacy technicians
and clerical or secretarial personnel) shall be employed to facilitate
pharmacy services.
• Education and Training All personnel shall possess the education and
training.
• Recruitment, Selection, and Retention of Personnel Personnel should be
recruited and selected by the pharmacy director on the basis of qualifications
and prior performance.
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• Orientation of Personnel There shall be an established, structured
procedure for orienting new personnel to the pharmacy.
• Work Schedules and Assignments The director of pharmacy shall ensure
these.
• Performance Evaluation There shall be procedures for regularly scheduled
evaluation of the performance of pharmacy personnel.
• Effective Communication There should be established methods for
communicating important information to staff in a timely manner.
• Ethical Conduct Standards of ethical conduct shall be established.
E. Facilities
• Pharmacy Adequate space, equipment, and supplies shall be available.
• Medication Storage and Preparation Areas
• Compounding Areas
• Patient Assessment and Consultation Area
• Office and Meeting Space
• Record Maintenance
F. Committee Involvement
• A pharmacist shall be a member of and actively participate in hospital and
health-system committees responsible for establishing and implementing
medication-related policies.
STANDARD II. MEDICATION-USE POLICY DEVELOPMENT
A. Policy Development
• All committees that make decisions concerning medication management
and use shall have at least one pharmacist as a member.
• Pharmacists shall be involved in the development, implementation, and
assessment of care plans.
B. Formulary Management
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• Formulary. A well-controlled formulary of approved medications shall be
maintained and regularly updated by the P&T committee.
• Medication Therapy Monographs. Medication therapy monographs for
medications under consideration for formulary addition or deletion shall be
made available to the P&T committee for use in the decision-making process.
• Nondrug Substances. All chemicals or biological substances whose
administration is intended for pharmacological or medical effect shall be
under the control of the pharmacy.
C. Drug Information
• Drug Information Requests The pharmacist shall provide patient-specific
drug information and information about drugs and drug therapy to health
professionals and patients as appropriate.
• Dissemination of Drug Information Pharmacists shall keep the hospital’s
staff and health care providers informed about the use of medications on an
ongoing basis through appropriate publications, presentations, and
programs.
STANDARD III. OPTIMIZING MEDICATION THERAPY
A. Creating a Relationship with the Patient
• Pharmacist Role in Direct Patient Care
• Continuity of Care
• Patient Confidentiality
B. Acquiring Essential Patient Data
• Pharmacists should obtain, prepare, or have immediate access to
comprehensive medication histories for each patient, from the patient’s
medical record or other databases (e.g., a medication profile), or both.
C. Consulting with Other Health Professionals About Medication Therapy
• Pharmacist’s Consultations Pharmacists should provide oral and written
consultations to other health professionals.
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8. GM Hamad

• Medical Record Documentation
• Medication Therapy Decisions
STANDARD IV. DRUG PRODUCT PROCUREMENT AND INVENTORY
MANAGEMENT
A. Selecting Sources of Pharmaceutical Products
• Medication Acquisition There shall be policies and procedures for managing
medication acquisition.
• Pharmaceutical Manufacturers and Suppliers Criteria for selecting drug
product manufacturers and suppliers shall be established by the pharmacy
to ensure the highest quality of and the best price for drug products.
• Pharmaceutical Manufacturers’ Representatives Representatives should
not be permitted access to patient care areas. All promotional materials and
activities shall be reviewed and approved by the pharmacy.
B. Managing Inventory
• Medication Storage Medications shall be received, stored, and prepared
under proper conditions.
• Drug Shortages The pharmacy’s inventory management system should be
designed to detect subminimum inventory levels and alert the pharmacy to
potential shortages.
• Samples Medication samples shall never be used for inpatient treatment.
• Patient Care Area Stock The proper use of automated dispensing devices
reduces the need for medications to be stored in non-pharmacy areas.
• Controlled Substances There shall be policies and procedures to ensure the
control of distribution of controlled substances.
• Patient’s Own Medications Drug products brought into the hospital by
patients shall be identified by pharmacy and documented in the patient’s
medical record if the medications are to be used during hospitalization.
C. Inspecting Storage Areas and Inventory Items
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9. GM Hamad

• All stocks of medications shall be inspected routinely to ensure the absence
of outdated, unusable, recalled, or mislabeled products.
• Storage conditions that would foster medication deterioration, storage
arrangements that might contribute to medication errors, and other safety
issues shall be assessed, documented, and corrected.
D. Returning Recalled, Expired, and Other Unusable Items
• There shall be a written procedure for the timely handling and
documentation of a drug product recall. These procedures should include an
established process for removing from use any drugs or devices subjected to
a recall.
STANDARD V. PREPARING, PACKAGING, AND LABELING MEDICATIONS
A. Preparing Medications
• Compounding Drug formulations, dosage forms, strengths, and packaging
that are not available commercially but are needed for patient care shall be
prepared by appropriately trained personnel in accordance with applicable
practice standards and regulations.
• Sterile Preparations When possible, manufactured sterile preparations
should be preferred to compounding in the pharmacy.
• Hazardous Drug Products Special precautions, equipment, and training for
preparation, handling, storage, and disposal of hazardous drug products shall
be described.
B. Packaging Medications
• Unit Dose Packaging. Whenever possible, medications shall be available for
inpatient use in single-unit packages and in a ready-to-administer form.
• Bar-Coding of Unit Dose Packaging and Point of Care Administration. Unit
dose packages should contain a bar code and that code should be used in
inventory management, dose preparation and packaging, dispensing, and
administration.
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STANDARD VI. MEDICATION DISPENSING AND DELIVERY
A. Medication Dispensing
• Prescribing. Medications shall be prescribed by individuals who have been
granted appropriate clinical privileges in the hospital and are legally
permitted to order medications.
• Diagnostic or Therapeutic Purpose. Pharmacists should have immediate
access to the patient’s diagnosis or the intended therapeutic or medical
purpose of medications.
• Medication Orders. All patient medication orders shall be contained in the
patient’s medical record.
• Review of Medication Orders. All medication orders shall be prospectively
reviewed by a pharmacist.
B. Medication Delivery and Administration
• Drug Delivery Systems, Administration Devices, and Automated
Distribution Devices The potential for medication errors associated with
such systems and devices should be thoroughly evaluated. Pharmacy
personnel shall supervise the stocking and documentation of medications in
automated dispensing devices.
• Medication Administration Only personnel who are authorized by the
hospital in accordance with applicable laws and regulations shall be
permitted to administer medications to a patient.
STANDARD VII. MONITORING MEDICATION USE
A. Reviewing Patient Responses to Medication Therapy
Medication therapy monitoring shall be conducted by pharmacists. It includes
assessment of:
• Therapeutic appropriateness of the patient’s medication regimen.
• Therapeutic duplication.
• Patient adherence to the prescribed medication regimen.
• Adverse drug reactions and other undesired effects.
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11. GM Hamad

• Drug interactions.
• Effectiveness of the patient’s medication therapy.
B. Educating and Counseling Patients and Family
• Pharmacists shall participate in patient education. Pharmacists should help
to ensure that all patients are given adequate information about the
medications they receive and encourage adherence to medication regimens.
• Patient education activities shall be coordinated with the nursing, medical,
and other clinical staff as needed.
STANDARD VIII. EVALUATING THE EFFECTIVENESS OF THE MEDICATION-
USE SYSTEM
A. Assessing Pharmacy Services and Practices
• Documentation of Pharmacist-Provided Patient Care Services and
Medication Therapy Outcomes The pharmacy shall have an ongoing process
for consistent documentation of the patient care services provided by
pharmacists and patient outcomes from medication therapy.
• Workload and Financial Performance. A process shall exist to routinely
monitor and document workload and financial performance.
B. Improving the Medication-Use Process
• Medication-Use Evaluation There shall be an ongoing program for
monitoring drug utilization and costs to ensure that medications are used
appropriately, safely, and effectively and to increase the probability of
desired patient outcomes.
• Medication Safety Pharmacists should provide leadership to and participate
in collaborative, multidisciplinary efforts to prevent, detect, and resolve
drug-related problems that can result in patient harm.
STANDARD IX. RESEARCH
• The pharmacist should initiate, participate in, and support clinical and
practice-related research appropriate to the goals, objectives, and resources
of the specific hospital.
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• Policies and Procedures The pharmacist shall ensure that policies and
procedures for the safe and proper use of investigational drugs and
medication-related devices are established and followed and that these
policies and procedures meet all applicable laws and regulations.

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HOSPITAL SYSTEM
DEFINITION
• The hospital is a complex organization and an institute which provides
health to people through complicated but specialized scientific equipment
and team of trained staff educated in the problems of modern medical
science.
• They are all coordinated together for the common goal of restoring and
maintain good health
BRIEF HISTORY
• The earliest documented institutions aiming to provide cures were ancient
Egyptian temples. In ancient Greece, temples dedicated to the healer-
god Asclepius, known as Asclepieia
• dream-like state of induced sleep known as enkoimesis
• Institutions created specifically to care for the ill also appeared early
in India.
• Fa Xian, a Chinese Buddhist monk who travelled across India ca. 400 CE,
recorded in his travelogue
• The heads of the Vaishya [merchant] families in them establish in the cities
houses for dispensing charity and medicine. All the poor and destitute in
the country, orphans, widowers, and childless men, maimed people and
cripples, and all who are diseased, go to those houses, and are provided
with every kind of help, and doctors examine their diseases.
• They get the food and medicines which their cases require and are made to
feel at ease; and when they are better, they go away of themselves.
MUSLIM ERA
• The first Muslim hospital was an asylum to contain leprosy, built in the
early eighth century, where patients were confined but, like the blind, were
given a stipend to support their families.
• The earliest general hospital was built in 805 in Baghdad by Harun Al-Rashid
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• By the tenth century, Baghdad had five more hospitals,
while Damascus had six hospitals by the 15th century.
• Many of the prominent early Islamic hospitals were founded with
assistance by Christians such as Jibrael ibn Bukhtishu from Gundeshapur.
• "Bimaristan" is a compound of “bimar” (sick or ill) and “stan” (place).
• In the medieval Islamic world, the word "bimaristan" referred to a hospital
establishment where the ill were welcomed, cared for and treated by
qualified staff.
EARLY EUROPE
• After the dissolution of the monasteries in 1540 by King Henry VIII the
church abruptly ceased to be the supporter of hospitals, and only by direct
petition from the citizens of London, were the hospitals St
Bartholomew's, St Thomas's and St Mary of Bethlehem's (Bedlam)
endowed directly by the crown; this was the first instance of secular
support being provided for medical institutions
ESTABLISHMENT OF PROPER HOSPITALS
• The voluntary hospital movement began in the early 18th century, with
hospitals being founded in London by the 1710s and 20s,
including Westminster Hospital (1719) promoted by the private bank C.
Hoare & Co and Guy's Hospital (1724) funded from the bequest of the
wealthy merchant, Thomas Guy.
• Other hospitals sprang up in London and other British cities over the
century, many paid for by private subscriptions. St. Bartholomew's in
London was rebuilt in 1730, and the London Hospital opened in 1752.
MODERN HOSPITALS
• In the mid-19th century, hospitals and the medical profession became more
professionalized, with a reorganization of hospital management along more
bureaucratic and administrative lines. The Apothecaries Act 1815 made it
compulsory for medical students to practice for at least half a year at a
hospital as part of their training
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• Florence Nightingale pioneered the modern profession of nursing during
the Crimean War when she set an example of compassion, commitment to
patient care and diligent and thoughtful hospital administration.
• The first official nurses’ training programme, the Nightingale School for
Nurses, was opened in 1860, with the mission of training nurses to work in
hospitals, to work with the poor and to teach
FUNCTIONS
• Patient Care
• Training
• Medical Research
• Public Health
• It provides diagnosis and treatment of diseases to both inpatients and
outpatients
• Provides facilities for hospitalization
• Act as immunization Centre in the prevention diseases
• Provides advices on matters like family planning, STD (sexually
transmitted drugs), AIDS for the improvement of socials aspects and
rehabilitation
• Act as training medium for medical and allied health professional
(nurses, pharmacists etc.)
• Educate the people
• By its early detection, treatment and advice, lowers the incidence of
diseases
• Provides facilities for research
• Co-ordinates various disciplines of medicines and improves the
standards of medical practice
• Take care of the community at large and contributes a lot in
prevention of diseases
TYPES OF HOSPITALS
CLINICAL ORIENTED
• Based on system of medicines
• Allopathic hospitals
• Ayurvedic hospitals
• Hikmet hospitals
• Unanih Hospitals
• Homeopathic hospitals
• Physiotherapy hospitals
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BASED ON OWNERSHIP
• Government controlled
• Central government controlled
• a) Military hospitals
• b) Railway hospitals
BASED ON DISEASES
• Tuberculosis hospitals
• Leprosy hospital
• Cancer hospitals
• Mental hospitals
• Diabetes hospitals
• Rehabilitation
BASED ON ANATOMY /PHYSIOLOGY
• ENT hospitals
• Eye hospitals
• Kidney hospitals
• Dental hospitals
• Heart hospitals
• Orthopedic hospitals
• Neurological hospitals
• Based on type of people
• Maternity hospitals
• Pediatric hospitals
• Gynecological hospitals
• General hospitals
STATE GOVERNMENT CONTROLLED
• General hospitals
• Specialized hospitals
MUNICIPALITY CORPORATION
CONTROLLED
• DHQ hospitals
• THQs hospitals
• Non-government controlled
RELIGION BODIES CONTROLLED
• Church hospitals
• Hospitals funded by religious
parties
BASED ON BED NUMBERS
• Large hospitals –more than
1,000 beds
• Medium hospitals-b/w
500&1,000 beds
• Small hospitals –b/w 100-500
beds
• Very small hospitals –less than
100 beds
BASED ON COSTS
• Costly or elite hospitals
• Low budgets hospitals
• Free hospitals
MISCELLANEOUS HOSPITALS
• Training hospitals (hospitals
attached to medical &dental
colleges)
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FIRST
Outreach and community-based
services, which focus on
immunization, sanitation, malaria
control, maternal and child health
and family planning;
Health Care Providers Specialists,
Doctors, Nurses, Paramedical Staff
SECOND
The primary care facilities include
Basic Health Units (BHUs) and Rural
Health centers (RHCs) mainly
preventive, outpatient and basic
inpatient care.
Specialists, Doctors, Nurses,
Paramedical Staff
THIRD
The Secondary health care facilities
which include Tehsil Headquarters
Hospital (THQH) and District
Headquarters Hospital (DHQH) for
outpatient, inpatient and also
specialist care.
MO,LMO, Dentist & Paramedical
Staff
FOURTH
Tertiary care hospitals located in the
major cities for more specialized
inpatient care.
Medical officer& Paramedical Staff
FOUR TIERS
OF HEALTH
CARE SYSTEM
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DISTRICT HEADQUARTER HOSPITAL (DHQ)
SERVICES OF DHQs
• All PHC activities
• Morning and evening OPD
• 24-Hour emergency care
• Special disaster services
• In-patient facility
• Specialist services (Medicine,
Surgery, Eye, ENT, Gyn & Obs.,
Pediatrics, Anesthesia,
Radiology, Pathology,
Physiotherapy.
• Referral support
• Blood transfusion services
• Diagnostic services
• Cardiology wards
• Dialysis Unit
• Radiology
• Laboratory
TERTIARY CARE
(Tertiary Level Facilities)
Primarily Curative Services
SECONDARY CARE
(Secondary Level Facilities/ First
Referral Facilities)
DHQs, THQs
Primarily Curative Services
PRIMARY CARE
(First Level Health Care Facilities)
BHQs, MCHs, RHCs and
DISPENSARIES
Primarily Preventive and Health
Promotion Services
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• Operation
theatre
• Intensive and coronary care
• Reproductive
health services
• Dental care
• Nursing care
• Pharmacy
• Training and internship services
• Ambulance services
• Hospital records and HMIS
• Kitchen and dietary services
• Hospital waste, environment and estate
management
HUMAN RESOURCE FOR DHQS

















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TEHSIL HEADQUARTER HOSPITALS (THQ)
SERVICES OF THQs
• All PHC activities
• Morning and evening OPD
• 24-hour emergency care
• Special disaster plans/services
• In-patient facility
• Specialist services (Essential: Surgery, Gyn & Obs., Pediatrics and
Anesthesia)
• Referral support
• Blood transfusion services, Diagnostic services, Radiology, Laboratory
• THQ Hospital (40-60 Bedded)
• Operation theatre
• Reproductive health services
• Dental care
• Nursing care
• Pharmacy
• Training services
• Ambulance services
• Hospital records and HMIS
• Kitchen and dietary services
• Hospital waste management
• Hospital management.
HUMAN RESOURCE FOR THQS
Cadre #
MS 1

Specialists 10
Medical Officers 12

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21. GM Hamad

Nursing Staff 15
Paramedics 24
Others 251
Beds 40-60

Population 0.5 – 1 million

RURAL HEALTH CENTRES (RHC)
SERVICES OF RHCS
• All PHC activities
• Morning and evening OPD
• 24-hour emergency care
• Special disaster plans
• In-patient facility: (Typically the RHCs have 10- 20 beds and each serves a
catchment population of about 50,000--100,000 people).
• Referral support
• Diagnostic services ú Radiology
• Laboratory
• Operation theater
• Reproductive health services
• Dental care
• Pharmacy
• Training services
• Ambulance services
• Hospital records and HMIS
• Facility waste management
• Facility management
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22. GM Hamad

FUNCTIONS OF RHCS
• Patient awareness/education
• Immunization
• Mother and childcare including growth monitoring, food and nutrition.
• Control of diarrheal diseases and ARI.
• Safe motherhood.
• Safe delivery.
• Disease surveillance and epidemic control
• Tuberculosis control
• Malaria control.
• Laboratory, radiology & diagnostic tests.
• Patient assessment, treatment & follow-up system
• Record keeping & information management.
• Human resource continuing education.
• Referral.
• Emergency care.
• Supply of essential drugs.
• In - patient admission and discharge
HUMAN RESOURCE FOR RHCS
Cadre #
SMO I/C RHC 1

Medical Officer 1
Women Medical Officers 2

Dental Surgeon 1
Nursing Staff 2
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23. GM Hamad

Paramedics 21
Others 21
Beds 10-20
Population 50,000 – 100,000
BASIC HEALTH UNITS (BUH)
SERVICES OF BHUS
• Supports; clinically, logistically and managerially to the LHWs, TBAs, MCH
Centers, Dispensaries, Sub Health Centers etc.
• Serve as a focal point, where community and the public sector health
functionaries may come together to resolve issues concerning health.
• Reproductive health services
• Pharmacy
• Training services
• Facility records and HMIS
• Linen and sterilization
• Facility waste, management
• Facility management
• Serve the children less than 5 years of age for providing them;
Immunization; and CDC (center of disease control), ARI (acute respiratory
infection), CDD (control of diarrheal disease).
• Act as referral for the high-risk pregnancies and FP cases referred by the
LHWs and TBAs (traditional birth attendants).
• Support clinically, logistically and managerially the LHWs and TBAs.
HUMAN RESOURCE FOR BHUS
Cadre #
MO 1
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24. GM Hamad

School health and nutrition supervisor 1
Lady health visitor 1
Sanitary Inspector 1
Computer operator 1
CDC supervisor 1
Dispenser 1
Midwife 1
Vaccinator 1
Others 5
Population 25,000
MATERNAL AND CHILD HEALTH (MCH) CENTRE
SERVICES OF MATERNAL AND CHILD HEALTH (MCH) CENTRE
• Reproductive health services
• Morning OPD
• Referral support
• Pharmacy
• Training services
• Facility records and HMIS
• Linen and sterilization
• Facility waste management § Facility management
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25. GM Hamad

DISPENSARIES
SERVICES OF DISPENSARIES
• Treatment of common diseases
• Morning (and may be evening) OPD.
• Referral support
• Pharmacy
• Training services
• Facility records and HMIS
• Linen and sterilization
• Facility waste, environment and estate management
• Facility management.

Private Health Care
System
Modern for
Profit
Regular
Hospitals
Nursing
Homes/Centres
Clinics
Informal
Structures
Modern for
Non-Profit
NGOs
Traditional
Ayurvedic
Unani
Homeopathic
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PUBLIC SECTOR DEPARTMENTS
INVOLVED IN HEALTH CARE
Pakistan International
Airlines Corporation
Pakistan Railways
Employee's Social Security
Benefit Organization
Water and Power
Development Authority
Pakistan Bait-ul-Mal
Others
Paksitan
Telecommunication
Fauji Foundation
Armed Forces Institutions
Allopathic
Service
Providers
Qulaified:MBBS,
Specialists
Semi-qualified:
LHVs, LHWs
Non-qualified:
Dispensers,
Peons, etc
Non Allopathic
Service
Providers
Homeopaths
Hakims
Pehlwans
Acupuncturists
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MAYO HOSPITAL
• Mayo Hospital is one of the oldest and biggest hospitals
in Lahore, Punjab, Pakistan.
• King Edward Medical University is the attached university which is
Pakistan's most prestigious and South Asia's second oldest
institution.
• The hospital was built in n 1870 and it began operating in 1871.
• The hospital is named after then Viceroy of British India, "Richard
Bourke, 6th Earl of Mayo" also locally known as Lord Mayo.
• The architecture of the hospital is Italian, designed by Pudon and
engineered by Rai Bahadur Kanahya Lal, one of the leading
architects of that time.
• The hospital buildings were built in the following order:
• Main Building of Mayo Hospital (Now inpatient department) in
1871
• AVH (Private) Block in 1891
• Outpatient Department in 1952
• Pediatrics Ward in 1974
• Institute of Ophthalmology in 1982
• Accidents & Emergency Block & Pediatric Surgery Block
(Present)in 1984
• Department of Physical Medicine and Rehabilitation in 2001
• Development is actively taking place and new buildings like the
"Surgical Tower" are being built to meet patient demand.




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CLINICAL SERVICES
• Bed Strength - Mayo Hospital has a bed Strength of 1900.
• Main Accident & Emergency Department
• Paeds Medical & Surgical Emergency
• OPD
• Medical Facilities
• Surgical Facilities
• Blood Bank Services
• Dialysis
• Lithotripsy
• Chemotherapy/Radiotherapy
• Cardiology Related Diagnostic & Interventional Procedure
• Plastic Surgery Department
• Cleft Pallet Clinic
• Child Psychiatry Department
• Addiction Ward
• Eye Department
• Special Diagnostic tests & Laser Treatment regarding Eye Diseases
• Audiometric Tests regarding Hearing Disorders
• Speech Therapy
• ELISA & PCR Diagnostic for HCV Patients
• ELISA & other Diagnostic for Dengue Patients
• Cardiology related Interventional procedure
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30. GM Hamad

OUT-PATIENT DEPARTMENT
• There are 42 out-patient departments comprising Medicine and Surgery
and other sub-specialties.
• Average patients per day in OPD: ~2000
INPATIENT DEPARTMENT
• Average surgeries performed per day: ~250
• Total Beds: ~2399
• Major Departments: 4 Internal Medicine and 4 General Surgical
Departments.
• Total patients seen per year are ~8,35,136: ~2,25,653 in the Emergency and
~6,09,483 in the Outpatient Department.
STRATEGIES
1. Improvement in the provision of Emergency services Medical and Surgical
services for the betterment of the patients
2. Free provision Medicine to the patients in Emergency/Indoor/Outdoor
Patients
3. Early preparedness for the Epidemics of Communicable & Non-
Communicable diseases
4. Better Infection Control strategies implementation
5. Better & Advanced Waste management system implementation
ORGANIZATION
• Levels allow efficient management of hospital department
• Structure helps to understand the hospital’s chain of command
• Large hospitals have complex organizational structure
• Small hospitals tend to have much simpler organizational structure
• Sometime hospital departments are grouped to efficient working
COMMON ORGANIZATIONAL GROUPING
1. Administrative Services
2. Informational Services
3. Therapeutic Services
4. Diagnostic Services
5. Support Services
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31. GM Hamad

PHARMACY, ITS ORGANIZATION AND
PERSONNEL
HOSPITAL PHARMACY
It is a department or service in a hospital under the direction of qualified
pharmacist where all medicines and related supplies are stocked, dispensed or
prescription to in or outpatient, supplied to the nursing units, manufactured in
bulk and injectables are prepared and sterilized.
PHARMACY DEPARTMENT
Pharmacy department is staffed with pharmacists and is supervised by director of
pharmacy or pharmacist-in-chief. The pharmacy department is one of the many
departments of a hospital that exerts a great deal of influence on professional
position of institution as well as upon its economics of total operational costs. It is
also due to its interrelation and inter-dependency of other services upon it. This
department offers the following services;
• Drug distribution, including floor-stock and unit dose distribution.
• Dispensing of drugs to outpatients.
• The intravenous admixture program.
• The clinical services provided from the hospital pharmacy may include
therapeutic consultation, drug information, for physicians, nurses and other
allied health personnel and for patients. Clinical pharmacy practice also
encompasses preparation of patient drug profiles, recording patient drug
history, advising physicians of possible drug-drug interactions and drug
effects on clinical laboratory test results. It also involves preparation of
patient drug use review, collection of the pharmacy- patient data base,
therapeutic monitoring, and auditing of therapeutic regimens, monitoring
of specific adverse drug reactions to decrease their incidences and
management of chronic care patients.
• Purchasing and inventory control of drug and allied items.
• Conduct and support of pharmaceutical and clinical research, respectively
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32. GM Hamad

• Education services for pharmacy personnel, medical profession, nursing
staff and for patients.
• Serving function for vital committees such as pharmacy and therapeutic
committee, infection control, research review, antibiotics ambulatory and
standardization committees.
• Special services may include the provision of radiopharmaceuticals
services, total parenteral preparation, central sterile service and poison
control center.
ORGANOGRAM FOR PHARMACY DEPARTMENT
Organogram is also charting or organizational structure of pharmacy department.
This reflects the flow of administrative authority & who is accountable to whom.
Charting is essential after selection & categorization of employees. Obviously, in
small departments, this is generally simple but in large units with more number of
personnel & subdivisions, it is complex.
Once the organogram is prepared & approved, it is posted at prominent place for
each of departmental employees to read & adhere to.
Given figure illustrates an organogram for a well segregated pharmacy
department;








IDM: interactive Database Management
STENOGRAPHY: is one of the most identifiable methods of recording the spoken
word.
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33. GM Hamad

DEPARTMENTAL ORGANIZATION IN A LARGE UNIVERSITY HOSPITAL PHARMACY
OPERATION

PHARMACEUTICAL SERVICES
A pharmacy mainstream service is the drug dispensing to inpatients & where
hospital pharmacy permits, to outpatient. Besides this activity, depending on size
of hospital, other important additional services requiring pharmacist‘s skills &
potentials can also be offered. These additional programs offer at one hand great
financial savings for hospital and on the other hand pride and prestige.
Following are various services mentioned on charting for pharmacy along with the
functions.
1. ADMINISTRATIVE SERVICES DIVISION:
• Plan & coordinate departmental activities.
• Develop policies.
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34. GM Hamad

• Schedule personals & provide supervision to professional, supportive &
office staff.
• Coordinate administrative needs of pharmacy & therapeutic
committee.
2. IN PATIENT SERVICE DIVISION
• Provide medication to all in patients of hospital on round the clock basis.
• Inspection & control of drugs in all treatment areas.
• Co-operate with medical drug research. Sometimes this is included
under research division.
3. OUTPATIENT SERVICE DIVISION
• Compound & dispense outpatient prescriptions.
• Inspect & control all clinics & emergency service medication stations.
• Maintain prescription records.
• Provide drug consultation services to staff & medical students.
4. CONTROLLING AND DISPENSING
• Control & dispense intravenous fluid.
• Control & dispense controlled substances.
• Coordinate & control all drug delivery & distribution system.
5. PURCHASING & INVENTORY CONTROL DIVISION
• Purchase all drugs.
• Receive, store & distribute drugs.
• Maintain drug inventory control.
• Interview medicated service representative
6. CENTRAL SUPPLY SERVICES DIVISION
• Preparation of sterile solution & fluids.
• Develop & coordinate distribution of medical supplies & irrigating fluids.
This service is sometimes rendered through ancillary supply division
7. MANUFACTURING & PACKAGING DIVISION
• Manufacture wide variety of items for use at the hospital.
• Operate an overall drug packaging & prepackaging program.
• Undertake program in product development.
• Maintain unit dose program.
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35. GM Hamad

8. STERILE PRODUCT DIVISION
• Produce small volume parenteral.
• Manufacture sterile ophthalmological, irrigating solutions.
• Prepare aseptic dilution of lyophilized & unstable sterile injection for
administration to patients.
9. ANCILLARY SUPPLY SERVICE
• Supplying medical, surgical laboratory supplies & ward floor stocking.
• Distribution of health accessories & parapharmaceuticals.
• Providing information on the above.
10. RADIOPHARMACEUTICAL SERVICES DIVISION
• Centralize procurement, storage & dispensing of radioisotopes.
• Labeling of radioisotopes with appropriate kit formulations.
• QA in section & QC of radiopharmaceuticals.
• Radiopharmaceutical research.
11. INTRAVENOUS ADMIXTURE DIVISION
• Centralize the preparation of IV solution admixture
• Review each I/V admixture for physiochemical incompatibilities.
• Preparation of TPN.
12. ASSAY AND QC DIVISION
• Perform analysis on products manufactured & purchased.
• Develop & revise assay procedures.
• Assist research division in special formulation.
13. DRUG INFORMATION SERVICES DIVISION
• Provide information on drugs & drug therapy to medical, pharmacy &
nursing staff & to patients.
• Maintain a drug information center.
• Prepare the hospital’s pharmacy newsletter.
• Maintain literature files.
• Help in updating of formulary.
14. POISON CONTROL CENTRE
• Provide info. on poisons, poison prevention and first aid.
• Maintain list of antidotes.
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36. GM Hamad

15. EDUCATIONAL AND TRAINING DIVISION
• Coordinate educational programs of pharmacy, medical and nursing
staff.
• Participate in hospital wide educational programs involving nurses,
doctors etc.
• Train newly employed pharmacy department personnel.
16. SERVICE MONITORING AND AUDITING
• Appraise, audit and monitor each of the pharmaceutical services for
quality assurance.
• Take corrective measures if not up to the standards.
17. PHARMACEUTICAL RESEARCH DIVISION
• Develop new formulations of drugs, especially dosage forms not
commercially available, and of research drugs.
• Improve formulations of existing products.
• Cooperate with the medical research staff of projects involving drugs.
18. AFTER HOURS PHARMACY SERVICES
• Dispensing of drugs when pharmacy is closed.
Each of the above services is coordinated and managed by head or manager who
report to chief pharmacist.
JOB DESCRIPTION AND RESPONSIBILITIES OF HOSPITAL PHARMACIST
Job description is the performance and responsibilities required for patient care.
It depends on activities of pharmacy department. Typically, responsibility of a
hospital pharmacist includes the following;
PHARMACY POLICIES
• Planning, organizing, and directing pharmacy policies and procedure in
accordance with established policies of hospital
IMPLEMENTATION OF DECISIONS
• Implementation of decisions of pharmacy and therapeutic committee
COMPOUNDING AND DISPENSING
• Compounding and dispensing of drugs, narcotics and controlled substances
according to prescriptions
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37. GM Hamad

DEVELOPING AND IMPLEMENTATION A CONTROL
• Developing and implementation a control over requisitioning and
dispensing of drugs and pharmaceutical supplies
FILLING AND LABELING
• Filling and labeling of all drug containers issued to services and indicates
the direction for use on the containers for patients
PREPARATION AND STERILIZATION
• Preparation and sterilization of injectables medication manufactured in
hospitals and manufacturing pharmaceutical
MAINTENANCE OF PERPETUAL INVENTORY
• Maintenance of perpetual inventory of drugs, narcotics and other
controlled drugs
INSPECTION
• Inspection of all pharmaceutical supplies on all services
MAINTENANCE OF AN APPROVED STOCK
• Maintenance of an approved stock of antidotes and other emergency drugs
FORMULATING SPECIFICATION
• Formulating specification for purchase of all drugs, chemical and biological
used in hospital
ESTABLISHMENT AND MAINTENANCE IN COOPERATION
• Establishment and maintenance in cooperation with accounting
department of a system of records and bookkeeping in accordance with
policies of hospital for charges to patients
PREPARATION OF PERIODIC REPORTS
• Preparation of periodic reports on progress of department
ENSURING ACCURACY
• Ensuring accuracy in use of pharmaceutical equipment for compounding
and dispensing of drugs
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38. GM Hamad

FOLLOW PRESCRIPTIONS
• Follow prescriptions in detail for any drug interaction or for any error
(called prescription intervention)
FURNISHING INFORMATION
Furnishing information concerning medications to physicians, nurses and to
patients
COOPERATION IN TEACHING COURSES
Cooperation in teaching courses to nursing and medical students
RESEARCH
• Carrying out, participation in and supporting research
PERFORM DUTIES
• Performs any professional related duties assigned other than those
mentioned here.
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39. GM Hamad

PHARMACY AND THERAPEUTIC COMMITTEE
BACKGROUND
• Inappropriate use of medicines wastes resources and seriously undermines
the quality of patient care.
• A drug and therapeutics committee (DTC) can significantly improve drug
use and reduce costs in hospitals and other health care facilities in the
following ways:
• Providing advice on all aspects of drug management
• Developing drug policies
• Evaluating and selecting drugs for the formulary list
• Developing (or adapting) and implementing standard treatment
guidelines
• Assessing drug use to identify problems
• Conducting interventions to improve drug use
• Managing adverse drug reactions and medication errors
• Informing all staff members about drug use issues, policies and
decisions.
DEFINITION
• The pharmacy and therapeutics committee are a policy framing and
recommending body to the medical staff and the administration of hospital
on matters related to therapeutic use of drugs
• One of the methods or mode of ensuring the proper rationality in the use
of drugs is that the hospital organizes and constitute.
ROLES
• The PTC has 3 major roles to play.
• These are
• Advisory
• Educational
• Drug safety and adverse drug monitoring
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40. GM Hamad

OBJECTIVES
• To develop and implement an efficient and cost-effective formulary system
which includes consistent standard treatment protocols, a formulary list
and formulary manual
• To ensure that only efficacious, safe, cost-effective and good quality
medicines are used
• To ensure the best possible drug safety through monitoring, evaluating and
thereby preventing, as far as possible, adverse drug reactions (adrs) and
medication errors
• To develop and implement interventions to improve medicine use by
prescribers’ dispensers and patients; this will require the investigation and
monitoring of medicine use.
COMPOSITION OF PTC
• Composition of PTC might vary from hospital to hospital.
• It may compose of
1. At least three physicians from the medical staff
2. A pharmacist
3. A representative of the nursing staff
4. An hospital administrator with his or her designated an ex-officio
member of the committee one of the physicians may be appointed
as the chairman of PTC.
• The pharmacist functions usually as the secretary and therefore, he is
designated as the Secretary of the committee.
PRE-REQUISITES
TRANSPARENCY AND COMMITMENT TO GOOD SERVICE
• The success of a DTC will depend upon its being active, working regularly in
a consistent direction and making sound decisions in a transparent way.
• This is especially important in medicine selection and procurement policies.
• The people involved should not be influenced by inappropriate drug
advertisements, promotional activities or personal financial interests.
TECHNICAL COMPETENCY
• A DTC must have the appropriate technical competence.
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41. GM Hamad

• Members will have different competencies and the DTC process of
discussion and appraisal of drug use issues is a good way to solve issues
ADMINISTRATIVE SUPPORT
• Administrative support is very important, as otherwise a DTC may not be
able to implement its decisions.
• Administrative support can provide the executive authority needed to gain
• the cooperation of senior medical staff.
• The administration can also provide the funds needed to undertake many
of the DTC’s activities.
MEMBERS
• Members should be selected with reference to their positions and
responsibilities and they should have defined terms of reference.
• In most hospitals, the membership includes:
• A representative clinician from each major specialty, including
surgery, obstetrics and gynecology, internal medicine, pediatrics,
infectious diseases, and general practice (to represent the
community)
• A clinical pharmacologist, if available
• A nurse, usually the senior infection control nurse, or sometimes the
matron
• A pharmacist (usually the chief or deputy chief pharmacist), or a
pharmacy technician where there is no pharmacist
• An administrator, representing the hospital administration and
finance department
• A clinical microbiologist, or a laboratory technician where there is no
microbiologist
• A member of the hospital records department.
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42. GM Hamad



OPERATION
• This committee should meet regularly at least six times in the year and also
as and when necessary.
• The committee can invite its meetings persons within or outside the
hospital who can contribute specialized or unique knowledge, skills and
judgments.
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• The agenda and the supplementary materials should be prepared by the
Secretary and furnished to the committee members well in advance so that
the members can study them properly before the meeting.
FUNCTIONS
ADVISORY COMMITTEE TO MEDICAL STAFF, ADMINISTRATION AND PHARMACY
• The DTC is a valuable resource that can provide advice to medical staff,
nurses, administration, pharmacy and other departments and groups
within the hospital.
DEVELOPMENT OF DRUG POLICIES
• The DTC is the most appropriate body to develop drug policies within a
hospital or group of health facilities, since the committee members will
have the most experience and training in drug therapy and supply.
• Criteria for inclusion of medicines on the formulary list (essential medicines
list (EML))
• Standard treatment guidelines and treatment algorithms, which should be
the basis of formulary selection
• Periodic use of medicines not on the formulary list, for example restricting
their use to specified prescribers on a named patient basis only, or only
allowing 10% of the hospital medicines budget to be spent on them
• Expensive or dangerous medicines, such as third-generation antibiotics or
oncological drugs, which are restricted to certain practitioners,
departments or patients (structured order forms may be used to
implement this policy)
• Drugs that are under investigation for safety or efficacy
• Generic substitution and therapeutic interchange
• Drug representatives and promotional literature.
EVALUATING AND SELECTING MEDICINES FOR THE FORMULARY LIST
• Perhaps the most important function of a DTC is the evaluation and
selection of medicines for the essential medicines list or formulary list.
• Drugs should be selected on the basis of the standard treatment guidelines
or protocols that have been developed or adapted for use in the hospital or
health facilities.
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• The evaluation of medicines requires significant expertise and time
commitment and a rigorous, transparent approach.
• Documented evidence for the efficacy, safety, quality and cost of all drugs
under consideration for inclusion in the formulary list must be examined.
DEVELOPING STANDARD TREATMENT GUIDELINES
• Standard treatment guidelines (stgs) or protocols are a proven way to
promote rational use of medicines provided they are:
• Developed in a participatory way involving end-users
• Easy to read and up to date
• Introduced with an official launch, training, supervision and wide
dissemination
ASSESSING MEDICINE USE TO IDENTIFY PROBLEMS
• Appropriate changes within the formulary list or other interventions may
correct a number of problems in how medicines are used.
• It is important for the DTC to identify the priority problems and make
appropriate recommendations aggregate drug consumption data review
including ABC and VEN analysis and use of
• Defined daily dose (DDD) methodology
• Monitoring indicators of medicine use, including adherence to
standard treatment guidelines
• Drug use evaluation (DUE), also known as drug utilization review
• Monitoring adverse drug reactions and medication errors
• Antimicrobial resistance surveillance
CONDUCTING EFFECTIVE INTERVENTIONS TO IMPROVE MEDICINE USE
• There is no point in a DTC collecting information on drug use problems if
nothing is done to correct the problems identified.
• The DTC is the main body within a hospital, or group of health facilities,
responsible for ensuring that drug information is provided to health staff
and also for conducting interventions to promote more rational drug use.
• Monitoring and supervision, audit and feedback, educational programmes,
in-service training, use of standard treatment guidelines, provision of
unbiased drug information, prescribing restrictions and automatic stop
orders are some important interventions
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45. GM Hamad

MANAGING ADVERSE DRUG REACTIONS
• Adverse drug reactions (ADRs) are serious in terms of patient harm
(morbidity and mortality) and avoidable economic costs.
• Adverse drug reactions may be due to the unknown effects of new (or
older) drugs, unknown drug combinations and interactions, or poor drug
quality.
MANAGING MEDICATION ERRORS
• Medication errors occur in all health-care settings, no matter how good the
health-care staff are at prescribing, dispensing and administering
medicines.
• Even if there is no error on the part of health-care staff, patients may take
drugs incorrectly.
• Causes are numerous and include lack of knowledge, tiredness of staff,
careless work attitudes, poor procedures, lack of policies, unfamiliar dosage
forms and human error
INFORMATION DISSEMINATION AND TRANSPARENCY
• The DTC must disseminate information about its activities, decisions and
recommendations to the staff who must implement the DTC’s decisions.
• This may seem obvious, but it is often forgotten.
• Inadequate dissemination of information leads to a loss of credibility.
• It is also very important that the DTC operates in such a way as to ensure
transparency of all its decisions and to avoid conflict of interest.
• Members should either have no relationship with pharmaceutical
companies or declare it openly so that conflicts of interest can be avoided.
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A MULTIDISCIPLINARY APPROACH SENSITIVE TO LOCAL POLITICS
• DTC activities will involve different cadres of health professional, who will
have different experiences, beliefs, skills, practices, motivations and status.
• Often a DTC must manage conflict arising between clinicians and the
pharmacy or administration concerning prescribing restrictions that result
from the implementation of agreed guidelines.
• Such conflicts can be reduced if staff are convinced of the need for, and
benefits of, change and there is strong institutional commitment with the
support of people in authority.
• Wide representation on the DTC and documenting and disseminating
decisions taken to correct problems in the use of medicines helps to
convince health-care workers.
• Everyone who contributes should be acknowledged.
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STEPS IN SETTING UP AND MANAGING THE DTC
• The most effective way of gaining support is through a dynamic DTC that
can formulate policy and guidelines with consensus of all parties and that is
seen to be sensitive to comments.
• Organizing the committee and selecting members
• Opinions vary regarding the optimal size and composition of the
committee.
• Smaller committees may be appropriate for smaller hospitals; larger ones
may be useful in big hospitals with wider work perspectives.
• Fewer members may allow consensus agreements to be reached more
easily.
• More members can provide greater expertise, reduce the workload for
individual members, and increase the ease of implementation of decisions.
• All committees should have sufficient members to represent all
stakeholders, including the major clinical departments, the administration
and the pharmacy.
DETERMINE THE OBJECTIVES AND FUNCTIONS OF THE COMMITTEE
• It is not possible for a DTC to do everything.
• The first thing a DTC should do is to agree its terms of reference, which
specify the DTC’s place in the organizational structure of the hospital, its
goals, objectives, scope of authority, functions and responsibilities.
• The most important objectives and roles have already been described.
• Once basic functions, such as a formulary system, are implemented, the
DTC can move on to other activities.
• Sometimes the initial functions of the DTC, during the time of organization,
depend on the prevailing clinical and pharmaceutical management
problems that must be immediately addressed.
• This is a good way of getting the support of the management and the
agreement of medical personnel.
DETERMINING HOW THE COMMITTEE WILL OPERATE
• Regular meetings of the DTC, at least quarterly and preferably monthly, are
important.
• The schedule may vary depending on needs. Special meetings can be
convened when
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48. GM Hamad

• necessary.
• The length of meetings should be limited, as clinician members of the
committee are unlikely to attend or to stay throughout if the meetings are
too long.
• Regular attendance of members at committee meetings is often a problem.
• As a solution, some institutions make it a part of the requirements for
reappointment.
• Other institutions provide some monetary incentives or serve food or
refreshment at meetings.
• The agenda, supplementary materials and minutes of the previous
meeting should be prepared by the secretary and distributed to the
members for review in sufficient time before the meeting.
• These documents should be kept as permanent records of the hospital and
should be circulated to chairpersons/directors of all clinical departments.
• All DTC recommendations should be disseminated to the medical staff and
other concerned parties and authorities in the hospital.
• Regular hospital activities such as grand ward rounds and clinical
discussions can be used as venues to discuss recommendations and to
educate the health staff on the proposed policies for implementation.
• All DTC operating guidelines, policies and decisions should be
documented. This documentation should include the decisions on actions
to be taken if the decisions, guidelines or policies are not followed.
• Relevant documentation must be made available to interested party such
as staff members and drug companies.
• Members of the committee should be responsible for disseminating the
resolutions of the DTC.
• Liaison of the DTC with other hospital committees and regional or national
committees is important, for two reasons:
— To harmonize related activities (for example, surveillance of
antimicrobial resistance (AMR) and antimicrobial use)
— To share information concerning common activities (for example,
monitoring of adverse drug reactions and educational strategies such
as continuing medical education).
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IDENTIFYING BUDGETARY SOURCES
• The DTC must be able to identify budget resources to support its own
activities (such as meetings or incentives for its members) and those
activities it recommends for implementation (for example, educational
programs, development of standard treatment protocols, drug utilization
review and supervision).
• Budgeted staff time should also be reflected in their job descriptions.
• Usually the budget requirement is not substantial and can be justified to
the hospital administration on the basis of drug cost savings that can be
realized through the DTC activities.
• The DTC should be able to demonstrate its own cost-effectiveness when
requesting a regular budget allocation from the hospital management.
• To this end, the DTC should prepare an annual action plan with
corresponding budget requirements.
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FORMING SUBCOMMITTEES TO ADDRESS SPECIFIC ISSUES
• Often there are specific areas which need a great deal of extra work and
expertise that the DTC cannot provide or give time to, for example, the use
of antimicrobials.
• Many DTCs have dealt with this issue by forming a subcommittee to work in
the specified field on behalf of the DTC and report back.
ASSESSMENT OF THE DTC’S PERFORMANCE
• Self-assessment and evaluation of the DTC are very important if
performance and impact are to be improved.
• The organizational development and performance of the DTC should be
monitored continuously and documented, especially if the DTC expects the
hospital management to provide continuing funds.
DEVELOPING AND IMPLEMENTING A FORMULARY LIST
• The hospital formulary list should be consistent with the national essential
medicines list (EML) if the latter is available.
• It is very important that an explicit and previously agreed process and
selection criteria be followed at each step-in order to increase prescriber
confidence in the validity and usefulness of the list.
CRITERIA IN MEDICINE SELECTION
• Which drugs are selected depends on many factors
• Only those medicines should be selected for which sound and adequate
data on efficacy and safety are available from clinical studies, and for which
evidence of performance in general use in a variety of medical settings has
been obtained.
• Each selected medicine must be available in a form in which adequate
quality, including bioavailability, can be assured; its stability under the
anticipated conditions of storage and use must be established.
• When two or more medicines appear to be similar in the above respects,
the choice between them should be made on the basis of a careful
evaluation of their relative efficacy, safety, quality, price and availability.
• In cost comparison between medicines, the cost of the total treatment, and
not only the unit cost of the medicine, must be considered.
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• Where drugs are not entirely similar, selection should be made on the basis
of a cost-effectiveness analysis.
• In some cases, the choice may also be influenced by other factors, such as
pharmacokinetic properties, or by local considerations such as the
availability of facilities for storage or manufacturers.
• Most essential medicines should be formulated as single compounds.
• Fixed-ratio combination products are acceptable only when the dosage of
each ingredient meets the requirements of a defined population and when
the combination has a proven advantage over single compounds
administered separately in therapeutic effect, safety or compliance.
• Drugs are specified by the international nonproprietary name (INN) or
generic name without reference to brand names or specific manufacturers.
PRIORITIZE A LIST OF COMMON PROBLEMS/DISEASES BEING TREATED IN THE
HOSPITAL AND DETERMINE THE FIRST CHOICE OF TREATMENT FOR EACH
PROBLEM
• The diseases may be ranked to identify the most common diseases being
treated in the hospital by consulting all medical departments and reviewing
the previous hospital mortality and morbidity records.
• For each disease, an appropriate first choice of treatment should be
identified using STGs – either nationally or locally developed.
• If there are no published STGs endorsed by the health ministry, publications
by WHO, unbiased professional organizations and academia can be used.
• Alternatively, an expert committee can be brought together to identify the
appropriate treatment for each of the common health problems.
• A commonly used alternative method of developing a formulary list –
easier, but not recommended – consists of reviewing the existing formulary
list of the hospital concerned or any other hospitals in the country.
DRAFT, CIRCULATE FOR COMMENT, AND FINALIZE THE FORMULARY LIST
• A draft of the list must be prepared. It is useful to identify
— The most important medicines (which are absolutely essential) and
those that are less essential
— The most expensive medicines
— Whether all the medicines that are prescribed in large volumes, or
are expensive, are essential
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DEVELOP POLICIES AND GUIDELINES FOR IMPLEMENTATION
• The formulary list will never be useful unless there are documented policies
and guidelines on how it should be used.
• These should include:
— Who should use the list (prescribers and the procurement
department should both abide by the list)
— How the list should be reviewed and updated
— A clear mechanism for adding and deleting medicines from the list
— How medical staff can request medicines that are not included on
the list in exceptional or emergency situations (for example, certain
non-formulary drugs may be prescribed by authorized senior doctors
for specified less common conditions on a named patient basis).
EDUCATE STAFF ABOUT THE FORMULARY LIST AND MONITOR IMPLEMENTATION
• All the staff in the hospital must be educated about the list.
• A common problem is that prescribers continue to request and use
medicines not on the list.
• This results in patients having to buy their medicines from pharmacies
outside the hospital, or the procurement group buying non-formulary
medicines, without the approval of the DTC.
• There should be a clear system of implementation, accountability and
enforcement including reprimands and sanctions
MAINTAINING A FORMULARY
• Routine review of different therapeutic categories is an important part of
formulary management.
• An efficient formulary management process will not passively wait for
applications to add new medicines to the formulary.
• New drugs and treatments are emerging all the time, and without
evaluation the formulary may become a collection of older, less effective
drugs.
• Therefore, the entire formulary should be reviewed every 2–3 years.
• This can be done by evaluating all the formulary medicines within each
therapeutic class in a systematic way on a regular basis and comparing
them to other new non-formulary medicines within that class.
• DTC should meet regularly to discuss and decide upon:
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• Requests for the addition of new medicines and deletion of old
medicines
• Systematic review of a therapeutic class of medicines
• Review of programmes to identify and resolve medicine use
problems.
• All decisions of the DTC should be documented.
FORMULARY MANUAL
• The formulary manual is the publication that brings all the important
summary information on medicines in the formulary list together in a
manual.
• There is no set standard on how this document is arranged or what is in the
manual.
• Normally it would contain an alphabetically and therapeutically arranged
listing of all the formulary drugs, and a section on drug usage including
doses, contraindications, side-effects, drug interactions and price.
• Ideally the manual should include a section on the medicines of choice and
alternates for treating the medical conditions of the region.
STANDARD TREATMENT GUIDELINES
• Even with an ideal formulary list, inappropriate use of formulary drugs may
occur.
• STGs or treatment protocols are a proven, effective strategy to promote
appropriate prescribing, when used in conjunction with educational
strategies to promote their use (Grimshaw and Russell 1993).
• STGs may be defined as ‘systematically developed statements to help
practitioners or prescribers make decisions about appropriate treatments
for specific clinical conditions’ (MSH 1997).
• As a minimum, they should contain information on clinical features,
diagnostic criteria, non-drug and drug treatments (first-, second-, third
line), and referral criteria.
• Contrary to what is often alleged, STGs do not constrain but advise
prescribers, who still retain their responsibility to decide upon appropriate
treatments.
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• STGs merely define the boundaries between the accepted norms in treating
a disease based on good clinical evidence, and the practice of relying purely
on clinical experience.
• STGs are very useful in
• Providing guidance to health professionals on the diagnosis and
treatment of specific clinical conditions
• Orienting new staff about accepted norms in treatment
• Providing prescribers with justification for prescribing decisions made
in accordance with stgs
• Providing a reference point by which to judge the quality of
prescribing
• Aiding efficient estimation of drug needs and setting priorities for procuring
and stocking drugs
• The problems associated with STGs include:
• A development process which is difficult, time-consuming, and
requires human and financial resources the need to update regularly
to avoid stgs becoming obsolete
• The danger of inaccurate or incomplete guidelines which provide
wrong information to prescribers, so doing more harm than good.
• Common pitfalls that need to be avoided include, for example,
including treatment choices that reflect common existing practices
rather than best practice according to the evidence
• Recommending treatment choices that do not take into account
existing expertise or infrastructure.
DEVELOPING, ADAPTING OR ADOPTING STANDARD TREATMENT GUIDELINES
• STGs can range from protocols covering diseases commonly seen in primary
health care to those seen only in major medical centers and tertiary
hospitals.
• An STG manual may contain a few or many clinical conditions.
• The DTC can develop new STGs from scratch – a very difficult and time-
consuming activity, which may be appropriate for large hospitals.
• Alternatively, the DTC may adapt existing national or institutional STGs to
form their own local version, or simply advocate the use of existing STGs
published by other groups.
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• Adaptation or adoption of existing STGs is much easier and may be
especially appropriate for small hospitals with inexperienced DTCs.
• Some guidelines are freely available on the web such as those from South
Africa (Essential Drugs Programme South Africa 1998) and Australia
(Therapeutic Guidelines Ltd 2000). Development and publication of a
hospital’s own STGs, with its own book cover, may create a sense of
ownership and acceptance of the guidelines.
• However, the DTC will need to decide whether this sense of ownership will
promote the use of the STGs sufficiently to justify the extra work involved.
STEPS IN DEVELOPING AND IMPLEMENTING STGS
• Credibility, ownership, and hence use, will be increased if the development
process uses evidence-based medicine, is participatory, is documented, and
all contributors are acknowledged.
1. IDENTIFY THE WORKING GROUP TO ADAPT/DEVELOP THE HOSPITAL STGS
• The DTC may give responsibility for drafting the guideline, searching the
literature and reporting back to the DTC on progress, to one or two DTC
members or to a working group or subcommittee.
• Whoever is chosen, it is important that staff from all departments,
including general practice, clinical pharmacy and pharmacology, be
encouraged to comment on the draft.
2. DEVELOP AN OVERALL PLAN FOR DEVELOPING AND IMPLEMENTING THE
STGS
• It is not enough merely to identify a working group and experts. The DTC
should agree and document who will be responsible for drafting the STGs,
who will review them and who will edit them.
• Other things that need to be agreed include a format, a budget, and what
kind of information will be used.
• It is useless to put a vast amount of effort into developing STGs that will not
be used by prescribers or supported by hospital management (in terms of
distribution or inclusion in pre- or in-service training), so a plan and budget
should also be made at this stage for publication, dissemination and
implementation.
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3. IDENTIFY THE DISEASES FOR WHICH STGS ARE NEEDED
• Each department should be asked to identify the most common diseases in
their specialty area, for both outpatients and inpatients.
• The list of diseases as identified by the different departments should be
consolidated and ranked based on prevalence, severity, impact on general
health of the population and the cost to the hospital of treating the
condition.
• Some diseases, such as skin diseases, contribute substantially to the
number of patients treated and the cost of drugs provided, but cause little
significant morbidity or mortality.
4. DETERMINE THE APPROPRIATE TREATMENT
• This step is critical to the development of any new STGs. Experts and clinical
specialists should consider the evidence concerning appropriate treatment
for each disease or clinical problem and reach a consensus based as far as
possible on evidence-based information sources. Consistency with national
STGs is important and recommended treatments should:
— Consider non-drug treatments
— Use the fewest medicines necessary
— Choose the most cost-effective treatments
— Use approved formulary list drugs only (although the formulary list
may need to be changed according to a review of the evidence)
— Identify first-, second- and if necessary third- line drugs
— Determine dose and duration, contraindications and side-effects for
all medicines recommended
— Take into account
— The existing level of prescribers (and their diagnostic skills)
— The hospital facilities and monitoring capacity
— The affordability and availability of the drug of choice in the market.
5. DETERMINE WHAT INFORMATION SHOULD BE INCLUDED IN THE STGS
• The decision on how much information to include must be weighed
carefully.
• A small book that fits into the prescriber’s pocket will be used more readily
than a large comprehensive textbook that is kept in the library.
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• It is always important to state clinical signs and symptoms, diagnostic
criteria, drugs and dosage, clearly and concisely, but other information may
be omitted.
• Information that may be included in hospital STGs includes the following:
— Clinical condition, its natural history and diagnostic criteria, including
signs and symptoms and laboratory tests
— Treatment objective, for example elimination of plasmodium
parasites from a blood smear, sputum negativity in a previously
sputum-positive tb patient
— Non-drug treatment
— The drug of choice for the specific disease/condition
— Alternative second- and third-line drugs, together with their
indications
— Relevant prescribing information – dose, duration, contraindications,
side-effects, warnings, toxicity and drug interactions
— Referral criteria
— What to tell the patient
— Cost of treatments, especially if alternatives are proposed.
6. DRAFT THE STGS FOR COMMENTS AND PILOT TEST
• STGs generate widely varying opinions especially among prescribers, who
are unlikely to use them unless they have been involved in the
development process and a consensus is reached during drafting.
• Thus, the draft should be circulated widely, and relevant comments
incorporated.
• In order to ensure that comments are constructive, it may be helpful to ask
for responses to be given in a structured way. For example, one may ask:
— What should be changed and how
— Why it should be changed, providing evidence and justification
7. IMPLEMENT – PUBLISH, LAUNCH, DISSEMINATE, TRAIN AND SUPERVISE
• Once the final draft is approved by the DTC, it can be published and
distributed to staff.
• Distribution should be accompanied by an official launch, some initial
training for staff on the STG, its importance and how to use it.
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• Thereafter, follow-up (in-service) training, monitoring of adherence to STGs
and supervision should be carried out.
8. UPDATE
• Treatments can change rapidly, for example with the emergence of new
drugs or new patterns of antimicrobial resistance.
• Thus, STGs must be updated regularly by reviewing the local antimicrobial
susceptibility pattern, and other sources of information from evidence-
based sources (for example reputable textbooks, drug and therapeutics
bulletins or respected medical journals).
• The various experts and clinicians within the hospital should keep abreast
of the current developments in drugs and therapeutics within their own
disciplines and inform the DTC appropriately.
CRITERIA IN MEDICINE SELECTION FOR FORMULARY
• Which drugs are selected depends on many factors, such as the pattern of
prevalent diseases, the treatment facilities, the training and experience of
available personnel, the financial resources, and genetic, demographic and
environmental factors.
WHO (1999) HAS DEVELOPED THE FOLLOWING SELECTION CRITERIA
• Only those medicines should be selected for which sound and adequate
data on efficacy and safety are available from clinical studies, and for which
evidence of performance in general use in a variety of medical settings has
been obtained.
• Each selected medicine must be available in a form in which adequate
quality, including bioavailability, can be assured; its stability under the
anticipated conditions of storage and use must be established.
• When two or more medicines appear to be similar in the above respects,
the choice between them should be made on the basis of a careful
evaluation of their relative efficacy, safety, quality, price and availability.
• In cost comparison between medicines, the cost of the total treatment, and
not only the unit cost of the medicine, must be considered. Where drugs
are not entirely similar, selection should be made on the basis of a cost-
effectiveness analysis.
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• In some cases, the choice may also be influenced by other factors, such as
pharmacokinetic properties, or by local considerations such as the
availability of facilities for storage or manufacturers.
• Most essential medicines should be formulated as single compounds.
• Fixed-ratio combination products are acceptable only when the dosage of
each ingredient meets the requirements of a defined population and when
the combination has a proven advantage over single compounds
administered separately in therapeutic effect, safety or compliance.
• Drugs are specified by the international nonproprietary name (INN) or
generic name without reference to brand names or specific manufacturers.
ONE CLASSIFICATION SCHEME FOR LEVELS OF EVIDENCE IS THAT USED BY THE
SCOTTISH INTERCOLLEGIATE GUIDELINE NETWORK (SIGN)

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ENSURING MEDICINE SAFETY AND QUALITY
THE NEED FOR ENSURING MEDICINE SAFETY AND QUALITY
• Medicine safety problems are commonly caused by medication errors, poor
quality, and certain drugs that are inherently unsafe (cytotoxic drugs, for
example).
• Such safety problems are manifested through adverse drug reactions
(ADRs), which may result in serious patient harm, extended hospital stay
and large consumption of resources.
• A drug and therapeutics committee (DTC) has a role in ensuring that all
medicines are prescribed, dispensed and administered to patients in as safe
way as possible, and that all medicines so given are, in themselves, safe and
of adequate quality.
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MONITORING AND ADDRESSING MEDICATION ERRORS
• A medication error is any preventable event where a dose of medication
that is received by a patient differs from what the prescriber has
prescribed, or from hospital policy and procedures (ASHP 1999).
• These errors may result in therapeutic failure and adverse drug reactions as
well as wasting resources.
POSSIBLE ERRORS – PRESCRIBING & DISPENSING
• Having a pharmacist or nurse, or another doctor or prescriber, review the
prescriptions before the drugs are administered can prevent some of these
errors.
— Wrong rate of administration, for example IV infusion
— Wrong time or frequency of administration
— Medicine given for the wrong duration
— Wrong preparation of a dose, for example incorrect dilution of a
dose, not shaking a suspension
— Incorrect administration technique, for example unsterile injection
technique (or incorrect installation of eye ointment
— Medicine given to a patient with a known allergy.
• Whenever an error is identified, it must be documented and the prescriber
or nurse administering the medication informed.
• All errors should be compiled, and a report presented monthly.
• It is important to do this in a non-confrontational manner without
mentioning names of the doctor, nurse or pharmacist responsible for the
errors.
PROBLEMS WITH MEDICATION ERRORS – ROLE OF DTC
COMMON UNDERLYING PROBLEMS THAT ARE ASSOCIATED WITH MEDICATION
ERRORS INCLUDE
• High staff workload and fatigue
• Inexperienced and inadequately trained staff
• Poor communication among health-care workers, including poor
handwriting and verbal orders
• Environmental factors, for example poor lighting, much noise, frequent
interruptions
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• Increased number or quantity of drugs per patient
• Frequency and complexity of calculations needed to prescribe, dispense or
administer the drug
• Large number of formulary medicines and dosage forms (such as injections)
that are associated with more errors
SOME WAYS OF PREVENTING MEDICATION ERRORS, PARTICULARLY IN HOSPITALS,
INCLUDE
• Establishing a consensus group of physicians, nurses and pharmacists to
select best practices
• Introducing a punishment-free system to collect and record information
about medication errors
• Developing written procedures with guidelines and checklists for the
administration of intravenous fluids and high-risk drugs such as insulin,
heparin and narcotics
• Developing standardized times to administer medicines and a policy to do
so only when patients are on the wards
• Requiring that a patient’s identity be confirmed before administering a drug
• Allowing verbal or telephone orders only in an emergency
• Requiring legible handwriting and complete spelling of a drug name
• Requiring the use of standardized notation
• Dose units written in one way only, for example ‘mcg’ not ‘μg’ or ‘g’ not
‘gm’
• Use of leading zeros for values less than 1 (0.2 instead of.2) and avoidance
of trailing zeros for values more than 1 (2 instead of 2.0)
• Requiring that the route of administration and the complete directions (for
example ‘daily’ not ‘od’) be written on all drug orders (prescriptions)
• Requiring that prescribers write generic and brand names for medicines
with ‘look-alike’ or ‘sound-alike’ names.
ROLE OF THE DTC IN PROCUREMENT
• Procurement practices can have a significant bearing on drug quality.
• The DTC should ensure that the practices followed by the responsible
department will ensure adequate drug quality.
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• The DTC should not spend committee time and meetings in deciding order
lists, nor should DTC members generally be on tender committees assessing
bids to supply drugs.
• However, a DTC should monitor and ensure implementation of good
procurement procedures.
• In some hospitals this may mean the DTC has to reassess and identify the
limits of its role.
• The DTC must be represented in the preparation of the annual hospital
budget, including review and allocation of the drug budget.
ROLE OF THE DTC IN MEDICINE DISTRIBUTION AND STORAGE
• The quality of medicines can be adversely affected by poor storage and
distribution.
• The DTC has a role in ensuring that the practices followed by the
responsible department are consistent with those that ensure the highest
possible drug quality.
• In some situations, this may mean that the DTC must be able to assist the
pharmacy in initiating and monitoring an adequate system for drug storage
and distribution.
MONITORING AND ANALYSING MEDICINE QUALITY PROBLEMS
• A very important role of the DTC is to monitor and analyze all reports of
inadequate medicine quality.
• The problem may present in the following ways:
— Visual deterioration of the product as reported by health staff, for
example discoloration, fragmentation, leakage, smell
— Lack of therapeutic effect
— Adrs.
• Once a problem has been reported, it should be investigated to see if the
problem is one of manufacture (including counterfeit), storage,
distribution, administration or use.
• This may involve the following steps
— Confirming the exact nature of the problem.
— Visually inspecting the product, including the expiry date, the
packaging and the labelling.
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— Eliciting information concerning the product’s procurement, storage
and distribution.
— Observing how the product is administered, for example injection
technique, dispensing process, interviewing the patient if necessary,
to check on compliance.
GOOD PROCUREMENT PRACTICES
EFFICIENT TRANSPARENT MANAGEMENT
• Divide procurement functions and responsibilities (selection, quantification,
product specification, pre-selection from suppliers and adjudication of
tenders), among different offices, committees and individuals to ensure
that no one individual is dealing with all activities and thus susceptible to
undue external influences.
• Follow explicit documented procedures for adjudicating tenders and
awarding procurement contracts.
• The procurement department should do this and should regularly report to
the DTC and senior management and undergo external audit annually.
DRUG SELECTION AND QUANTIFICATION
• The DTC should decide the formulary list and approve purchase of non-
formulary drugs.
• Select formulary drugs carefully to ensure safety and efficacy.
• This includes choosing appropriate dosage forms, preparations and
packaging and defining the specifications of the products to be purchased;
for example, theophylline elixirs for children should not contain alcohol.
• Use the method of quantification best suited to the available data –
morbidity method if morbidity data are available and standard treatment
guidelines (STGs) are followed, or consumption method if there are no
morbidity data and STGs are not followed.
• Adjustments may have to be made cautiously if there is not enough budget
to procure all the medicines needed (see point below).
• Use VEN analysis to identify the most essential medicines, especially if
there is insufficient budget to finance all medicine needs.
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FINANCING AND COMPETITION
• Buy in bulk if possible. DTCs of small hospitals can collaborate with other
hospitals and recommend that bulk procurement be done jointly to get
good value for money.
• Purchase only from the supplier who holds the current contract as decided
through the competitive tender adjudication process to ensure the lowest
possible purchase price
SUPPLIER SELECTION AND QUALITY ASSURANCE
• Procure only registered products from reliable, licensed suppliers and
manufacturers that comply with GMP and have good records of
performance, to ensure that medicines procured meet the required
standard of quality.
• Only accept medicines with the appropriate documentation, including:
— A certificate of analysis issued by the manufacturer (batch certificate)
— For imported medicines, a who-type certificates issued by the drug
regulatory authorities of the exporting country
— Detailed product specifications.
• Ensure quality through the inclusion of certain pre-tendering criteria, for
example specifying a minimum shelf-life, or insisting manufacturers have a
minimum turnover or proof of GMP compliance.
• Find out from various sources (such as regulatory bodies) whether a generic
product is bioequivalent to the brand product.
SAFETY OF MEDICINES
• The safety of medicines is critically important to health care. A DTC may
have a significant impact on preventing and managing drug safety problems
through:
— Assessing the literature on safety issues of new medicines proposed
for the formulary
— Preventing the occurrence of adrs by ensuring that patients are
carefully evaluated before medicines are prescribed and ensuring
staff are trained accordingly
— Implementing systems to monitor the occurrence of adrs, which
includes the regular review of adr reports
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— Evaluating suspected adrs
— Reporting adrs to regulatory authorities and manufacturers
— Monitoring and investigating medication errors
— Monitoring and investigating problems of medicine quality
POSSIBLE DTC ACTION AFTER ADR EVALUATION
• Possible actions will depend on what the cause of the ADR is and may
involve any or all of:
— Reporting to the national drug authority and/or manufacturer
— Implementing new prescribing procedures including restrictions
— Educating prescribers if needed
— Changing the formulary, if necessary, to obtain a drug of improved
safety; this may mean substituting a drug that is absolutely safer or
one that is easier to use by staff
— Adapting the stg or formulary manual if necessary; either in terms of
which medicines are recommended for the formulary, or what
recommendations are made concerning how and when a formulary
medicine should be used
— Educating patients if necessary
— Following up the rate of adrs after action has been taken to reduce
the adrs to ascertain whether the dtc action has been successful.

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HOSPITAL FORMULARY
DEFINITION
A formulary is a continually revised list of drug products, which reflects the current
clinical judgment of the medical staff.
WHY FORMULARY
• In the interest of better patient care the institution should have a program
of objective evaluation, selection, and use of medicinal agents in the
facility.
• This program is the basis of appropriate economical drug therapy. The
formulary concept is a method for providing such a program and has to be
utilized.
P & TC
• The P&T committee is responsible for managing the formulary system.
• It is composed of actively practicing physicians, other prescribers,
pharmacists, nurses, administrators, quality-improvement managers, and
other health care professionals and staff who participate in the medication-
use process.
• Other responsibilities of the P&T committee include medication-use
evaluation (MUE), adverse-drug event monitoring and reporting,
medication-error prevention, and development of clinical care plans and
guidelines.
• Applications for formulary additions should be initiated and completed
independently by the requesting health care provider and not by an
industry representative or vendor.
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HOSPITAL FORMULARY SYSTEM
• The formulary system is an ongoing process whereby an organization’s
pharmacy and medical staffs, working through a pharmacy and
therapeutics (P&T) committee evaluate and select the drug products that
are considered to be most useful in patient care. These products then are
routinely available for use within the organization.
TYPES OF FORMULARY
NATIONAL FORMULARY
• National formulary is a compilation of all drugs available in a country. In
Pakistan, national formulary is under preparation..
LOCAL OR PRIVATE FORMULARY
• This formulary is also called a hospital owned formulary and is a
compilation of drugs used in an institution, may be similar in appearance to
the National formulary. Local formularies contain a restricted number of
drugs and may include only some of the drugs listed in National formulary.
Advantages of Private formulary
• Prepared locally by the hospital’s own clinical staff which creates a feeling
of a sense of pride and loyalty as well as a determination to make the
system succeed.
• Contents and information are provided under each monograph according
to the local needs.
• May be published in a more convenient size and format.
SPECIALIZED FORMULARY
• A formulary prepared for and provides information on very particular
specialty products is the specialty formulary. Increasing use of enteral
nutrition products in hospitals requires specialty formulary for use of the
medical and dietetic staffed.
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OBJECTIVES OF A FORMULARY
• The primary objectives of the formulary are to provide
1. Information on the approved drug products.
2. Basic therapeutic information about each item.
3. Information on organizational policies and procedures governing the use of
drugs.
4. Special information, such as dosing guidelines and monographs,
abbreviations approved for prescribing.
ADVANTAGES OF FORMULARY SYSTEM
PROVIDES THERAPEUTIC MERITS
Under formulary system, drugs are carefully evaluated, appraised and selected
from multiple drug products in term of safety, efficacy and cost effectiveness.
PROMOTES RATIONAL PRESCRIPTION
A formulary system recommends inclusion of specific drugs while exclude others.
This coupled with the guidelines to assist prescribers in using the drugs in a
formulary and specific treatment protocols enhances the rational drug
prescription to the patients.
PROMOTES COST EFFECTIVENESS
A formulary contains selected drugs and eliminates branded duplication thus
reducing the inventory duplication, easier cash flow and the opportunity for
volume purchasing.
POSSESS EDUCATIONAL VALUE
The formulary contains various prescribing tips and drug information of
educational value thus beneficial for medical staff and nurses.
CLOSE EXPIRY MONITORING
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Formulary makes the possibility of a close drug monitoring for expiry dates as
under these system only limited and fewer products are stocked.
IMPROVES RELATIONSHIP
Formulary system establishes and improves relationship between pharmacists,
prescribers and other medical professionals since all jointly input into developing
an institutional formulary.
DEMERITS OF FORMULARY SYSTEM
• Deprives the physicians to prescribe brands of their own choices
• Permits the pharmacist to act as the sole judge of which brand of drug is to
be purchased and dispensed
• May allow to purchase of inferior quality drugs as in case of those
institution having no pharmacist.
• Unable to reduce the cost of drugs to patients. Because most of the
hospitals purchase large volume of drug at reduced price but don’t pass the
discounts to the patients.
• A continual updating of formulary requires a lot of efforts, times and
expenditure.
FORMULARY VS DRUG CATALOGUE OR LIST
• A formulary usually consists of a listing, of therapeutic agents by their
generic names followed by information on strength, dosage form, posology,
toxicology, use, and recommended quantity to be dispensed.
• Whereas a drug/List is usually consists of a record of therapeutic agents by
their generic names followed by data on strength and dosage form. There
may or may not be any additional information although some drug lists may
provide the prescriber with recommended quantities to be dispensed.
• Clearly then, the formulary is the more informational type of presentation
with educational value on drug therapy particularly.
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COMPOSITION OF TYPICAL FORMULARY
1) Title page.
2) Table of contents.
3) Information an policies and procedures concerning drugs.
4) Products accepted for use in the organization.
5) Appendix
CONTENTS OF A FORMULARY
Part 1- Information on hospital policies and procedures concerning drugs
These include
• Policies and procedures for restriction on drug use.
• Procedures for requesting that how a drug can be added in a formulary.
• Brief description of P& TC including its membership, responsibilities and
operation.
• Hospital regulations governing the procuring, dispensing and
administration of drugs.
• Pharmacy operation procedures
• Automated stop orders
• Information on using the formulary
Part 2 - Drug Products Listing
This section is the core of a formulary and comprised of one or more descriptive
entries for each formulary item along with indices to facilitate use of the
formulary. The formulary entries can be arranged in several ways:
(1) Alphabetically by generic name
(2) Alphabetically within therapeutic class
(3) A combination of the two systems whereby the bulk of the drugs are
contained (alphabetically) in a general section which is supplemented by
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several “special” sections such as ophthalmic/otic drugs, dermatological and
diagnostic agents.
The type of information to be included in each entry will vary. At a minimum,
each entry must include
• Generic name of the basic drug product; combination products may be
listed by generic, common or trade names.
• Common synonym(s) and trade name(s), there should be a note in the
'‘directions for use" section of the formulary explaining that inclusion or
omission of a given brand does not imply that it is or is not stocked by the
pharmacy.
• Dosage form(s), strength(s), packaging (s) and size(s) stocked by the
pharmacy.
• Formulation (active ingredients) of a combination product.
Some additional information may be part of the drug entries in part 2 and may
include
• Usual adult or pediatric dosage ranges, or both.
• Special cautions and notes such as: ‘do not administer ‘I/V’or ‘refrigerate’.
• Controlled substances symbol.
• Cost information is useful where therapeutic classification system is used
or, alternatively, lists of similar drugs (e.g., oral steroids) may be presented
showing relative cost data. This cost can be mentioned in variety of ways
such as actual cost, per unit cost or cost of the therapy.
Indexes to the Drug Products Listing: These are included to facilitate the use of
the formulary. They are
• Generic Name-Brand/Synonym cross index.
This index also could be integrated into drug products listing rather than being a
separate entity. The listing, in this event, must be arranged alphabetically
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• Therapeutic/Pharmacologic index.
This index is a listing of all formulary items within each therapeutic category. It is
useful in ascertaining what therapeutic alternatives exist for a given situation such
as patient allergy to a particular.
Part 3 - Special Information
The material to be included in this section is of general interest to the hospital
staff and not readily available from other sources. Examples of the type of items
often found in the special information section of hospital formularies are:
• Nutritional products list.
• Tables of equivalent dosages of similar drugs.
• List of hospital-approved abbreviations.
• Rules for calculating pediatric dosages.
• List of sugar-free drug products.
• List of items available from central supply.
• List of the contents of emergency carts
• Lists of dialyzable poisons.
• Pharmacokinetic dosing and monitoring information
• Metric conversion scales and tables.
• Examples of blank or completed hospital forms such as prescription blanks,
request for non-formulary drug forms and adverse drug reaction report
forms.
• Tables of drug interactions, drug interference with diagnostic tests and
parenteral drug incompatibilities.
• Poison control information.
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FORMULARY MANAGEMENT SYSTEMS
The formulation management system constitutes the
1) Production
2) Distribution
3) Updating of the formulary of drugs.
1) PRODUCTION
• The production of a formulary, a technical, complex and time-consuming
task can be accomplished by one or more small groups of individuals,
expert in particular fields under the advice of pharmacy and therapeutics
committee.
• A completely new formulary can be prepared from start or can be modified
from existing formularies.
• If the budget allows, a perpetual drug monograph service such as American
Hospital’s Formulary Service can be subscribed.
• The British National Formulary is another example, which can be used as a
guideline for the production of formulary.
2) DISTRIBUTION
• On the completion, the copies of drug, formulary are to be distributed
among all the prescribers, nurses, medical staff. It should be placed at each
patient care unit, including clinics and other outpatient care areas such as
the emergency room.
• The necessary steps should be taken to ensure that the nursing and medical
staffs are familiar with the formulary and know how to use it.
3) FORMULARY UPDATING
Despite of all efforts of producing of formulary and its distribution, soon after, it
goes out of dated. This is due to the:
• introduction of new drug
• Removal of existing drugs from marketplace.
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• Change in hospital policies and procedures.
• Changing data on adverse _ reaction profiles as provided by post-marketing
surveillance.
• Demand for inclusion/exclusion of new/existing drugs from.
• Evidence of efficacy of existing drugs in novel indication.
THE FORMAT
The physical appearance and structure in which the formulary is presented has an
important influence on its use.
Formulary should be
• Esthetic in appearance
• Easier to read.
• It should be such that it imparts an impression to the users that the hospital
considers the formulary as an extremely important document.
• Standard in grammar, punctuation and correct spelling.
SIZE OF FORMULARY
• A formulary that is sufficiently small and handy in size will, in all probability,
enjoy widespread acceptability and use in an institution.
• No specific size can be recommended; however, this determination can be
arrived at after careful study of the local need as well as the formularies
gathered from local hospitals or other sources.
LOOSE-LEAF VS BOUND
• A formulary can be presented in loose-leaf or bound type. A loose-leaf
formulary is unbound and thus can be kept current by inserting merely
papers having modifications. On the other hand, a bound volume is difficult
to keep up-to-date and therefore requires more frequent revision.
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• Those desiring a permanently bound volume also have many selections to
choose form ranging from paper to cardboard to plastic or its substitutes.
The controlling factor here will, in all probability, be the cost involved.
CRITERIA FOR APPROVAL / DELETING DRUGS FROM FORMULARY
The P&T committee will take into consideration
• Availability of a substitute.
• Volume of usage in hospital
• Cost effectiveness
• Inventory considerations at pharmacy
The committee will review and reprint the formulary once in two years
ESSENTIAL DRUG EVALUATION- SELECTION CRITERIA
• Essential drugs—which satisfy health care needs of majority of population.
• Available all time in adequate amount & appropriate dosage forms.
• Selection on the basis of:
• Availability of safety & efficacy data(clinical studies)
• Evidence of performance in general use.
• Choice—depends on factors like
• Pattern of prevalent diseases
• Treatment facilities
• Training and experience of available personnel
• Financial resources
• Genetic, demographic & environmental factors
QUALITY OF A SELECTED DRUG
• Adequate quality
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• Bioavailability
• Stability under the anticipated conditions of storage and use
• CHOICE AMONG SAME TYPE OF DRUGS
• If two or more drugs appear similar, choice is based upon careful
evaluation of
• Efficacy, Safety, Quality, Price & Availability
FORMULARY CHANGES
• To add a drug to the formulary drug list:
A consultant must submit a request form to pharmacy & therapeutic committee.
• To change or delete drugs:
A consultant must submit a form to P&T committee.
OFF-LABEL USE
• The use of a drug prescribed for an indication not specifically approved by
FDA is often referred to as off-label use
• Off-label use can include the use of pharmaceuticals outside of specified
populations, for different diseases or stages of diseases, or by different
routes of administration.
• Other types of off-label use involve changes to dosing or dosing schedules
or in chronology or sequence of use.
• Before considering off-label use, supporting safety and efficacy evidence
must be carefully evaluated and a risk–benefit determination made,
especially when alternatives with FDA-approved labeling are available for
the intended off-label
use.
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USE OF NON-FORMULARY DRUGS
• A formulary cannot be expected to cover all possible situations and thus a
patient can receive treatment out from a formulary's recommendations.
This is called non-formulary drug treatment
• A non-formulary drug in many institutions is dispensed only to inpatients
on a physician’s order by the use of a non-formulary' drug request form.
NON-FORMULARY MEDICATION REQUEST
To be accompanied with the copy of physician's order for a non-formulary drug
order This form is for the inpatient drug orders only
• Patient Name: -------- MR. No: -------- Room: -----
• Drug Name: -------- Manufacturer: ---------
• Reason why formulary drug is not suitable: ---------
• Dosage Schedule and Route of administration: ---------
• Number of doses required (Approximate): -----------
• Name and Signature of the house officer: ------------
• Date and time of sending this form: ----------
• Completed forms should be directed to Pharmacy Administrative officer.
• Pharmacist receiving form: -------------------
• Date and time of receipt: ==========


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DISPENSING
INTRODUCTION
• Dispensing refers to the process of preparing and giving medicine to a
named person on the basis of a prescription.
• Involves correct interpretation of the wishes of the prescriber and the
accurate preparation and labeling of medicine for use by patient.
• Public or private clinics, health center, hospital, community pharmacy
settings
• It is carried out by many different kinds of people with a variety training
and backgrounds.
• Dispensing is one of the vital elements of the rational use of drugs
DISPENSING ENVIRONMENT
• Dispensing environments must be clean → most medicinal products are for
internal use, making it important that they be hygienic and uncontaminated
• The environment must also be organized so that dispensing can be
performed accurately and efficiently
• The dispensing environment includes
– Staff (good personal hygiene)
– Physical surroundings (free of dust and dirt)
– Shelving and storage areas
– Surfaces used during work
– Equipment and packaging
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DISPENSING PERSON
• Laws mandate that the distribution of medicines and medical supplies to
the general public be carried out by professional pharmacists.
• Good reading, writing, counting and pouring skills.
• Specific additional knowledge, skills and attitudes to complete dispensing
process are required.
• Level of training needed for any particular dispensing task is determined by
the range of medicines dispensed and the extent to which calculation and
preparation are required.
• Skills include
– Knowledge about medicines being dispensed (common use, correct
dose, precautions about the method of use, common side effects,
common interactions with other drugs or food, storage needs)
– Good calculation and arithmetic skills
– Skills in assessing the quality of preparations
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– Attributes of cleanliness, accuracy and honesty
– Attitudes and skills required to communicate effectively with patients
DISPENSING PROCESS
• It covers all activities involved from receiving the prescription to issuing the
prescribed medicine to the patient.
• Development and use of written SOPs for dispensing ➔ improve the
process of dispensing
• Framework of SOPs
1. Receive and validate the prescription
2. Understand and interpret the prescription
3. Prepare and label items for issue
4. Make a final check
5. Record the action taken
6. Issue medicine to the patient with clear instructions and advice
STEP 1. RECEIVE AND VALIDATE THE PRESCRIPTION
• Confirm the name of the patient
• Cross check the name and identity of the patient at the time of issuing
medicines
STEP 2. UNDERSTAND AND INTERPRET THE PRESCRIPTION
• Read the prescription
• Correctly interpret any abbreviations used by the prescriber
• Confirm that the doses prescribed are in the normal range for the patient
• Correctly perform any calculations of dose and issue quantity
• Identify any common drug-drug interactions
STEP 3. PREPARE AND LABEL ITEMS FOR ISSUE
• Central part of the process
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• Must include procedures for self-checking or counter-checking to ensure
accuracy
• Begins after the prescription is clearly understood and the quantity has
been calculated
Select stock container or prepack → a good dispenser selects the item by
reading the label and cross matching the product name and strength against
the prescription.
• Check the stock to make sure that it has not been expired and follow the
principle of FIFO or FEFO
• Double checking the labels is good practice.
Measure or count quantity from stock containers
• Liquids must be measured in a clean vessel and should be poured from the
stock bottle with label kept upward (avoids damage to label)
• Tablets and capsules can be counted with or without the assistance of a
counting device
• Avoid direct hand contact with the medicine
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• Counting should be done using one of the following
• Clean piece of paper and clean knife or spatula
• Clean tablet-counting device
• Lid of the stock container in use
• Any other clean, dust free surface
Pack and label medicine
• Tablets or capsules → clean, dry container (bottle, plastic envelope,
cardboard box, paper envelope)
STEP 4. MAKE A FINAL CHECK
• Check against the prescription and against the stock containers used
• Valuable to have final check done by another staff member
• Final check → reading and interpreting the prescription
– Checking appropriateness of doses
– Drug interactions
– Identity of medicine dispensed
– Labels
– Countersigning the prescription
STEP 5. RECORD ACTION TAKEN
• Records of issues to patients are essential
• Helpful in verifying the stocks
• Entering patient detail and all information in the record book
STEP 6. ISSUE MEDICINE TO PATIENT WITH CLEAR INSTRUCTION AND ADVICE
• Medicine must be given to named patient or patient’s representative
• Clear instructions and advice
• Side-effects (detailed)
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• Dose, frequency, length of treatment, and route of administration.
DISPENSING TO IN-PATIENTS
INTRODUCTION
In-patients are those patients, who require hospitalization i.e. get themselves
admitted in the hospital, stay there for treatment till they are discharged.
There are four systems in general use for dispensing drugs to inpatients. They
may be classified as follows.
1. Individual prescription order
2. Complete floor stock system
3. Combination of individual & floor stock system
4. Unit dose system
1. INDIVIDUAL PRESCRIPTION ORDER SYSTEM
It is a type of prescription system where the physician writes the prescription for
individual patient who obtains the drug prescribed from any medical store or
hospital dispensary by paying own charges.
Advantages:
• All medication orders are directly reviewed by pharmacists.
• It provides the interaction of pharmacist-doctor, nurse and the patient.
• It provides clear control of inventory.
2. COMPLETE FLOOR STOCK SYSTEM
Under this system, the drugs are given to the patient through the nursing station
and the pharmacy supplies from the drug store of a hospital.
Drugs on the nursing station or ward may be divided in to.
A. Charge floor stock drugs
B. Non charge floor stock drugs.
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A. CHARGE FLOOR STOCK SYSTEM
Medicines which are stocked on the nursing station at all times and charged to
the patient’s account after they have been administered to them.
Dispensing of floor stock drugs.
• The patient is charged for every single dose administered to him.
• Selection of these drugs in various wards is decided by PTC
• Once the floor stock list is prepared, it becomes the responsibility of the
hospital pharmacist to make the drugs available
B. NON-CHARGE FLOOR STOCK DRUGS
Non charge floor stock drugs are the medicaments that are placed at the nursing
station for the use of all patients on the floor.
These drugs, there shall be no direct charge from the patients account. It is
divided in to two methods.
i. Drug basket method.
ii. Mobile dispensary unit.
i. Drug basket method
• Nurses fill a requisition form for delivery of drugs at
their floor.
• When there is an empty container, the nurse place it
in the drug basket.
• Once the basket is completed, its delivery to the floor
via messenger service.
• Alternatively, mobile dispensary can be utilized.
ii. Mobile dispensary unit
• It is specially constructed stainless steel.
• 60 inches high.
• 48 inches wide and 25 inches deep.
• It is mounted on bottom tyres.

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3. COMBINATION OF INDIVIDUAL AND FLOOR STOCK SYSTEM
This system is followed in the government and also in private hospitals who run
on the basis of no profit and no loss.
Individual prescription or medication system is followed as a major means.
Requirement of drugs or surgical items are given to the patient who purchase and
deposit these items in hospital wards or rooms under supervision of registered
nurse.
4. UNIT DOSE DISPENSING:
Those medications which are ordered, packed, handled administered and charged
in multiples of single dose units containing a predetermined amount of drug or
supply sufficient for one regular dose.
A single unit package is one which contains one complete pharmaceutical dosage
forms
Example: One tablet, capsule.







Advantages
• Better financial control.
• It prevents the loss of partially used medications.
• It does not require storage facilities at the nursing station.
Two methods of dispensing unit doses are
A. Centralized unit dose distribution / dispensing system (CUDDS)
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B. Decentralized unit dose distribution / dispensing system (DUDDS)
A. CENTRALIZED UNIT DOSE DISTRIBUTION / DISPENSING SYSTEM (CUDDS)
All in-patients are dispensed in unit doses and all the drugs are stored in central
area of the pharmacy and dispensed at the time the dose is due to be given to the
patients
Drugs are re-transferred from the pharmacy to the indoor patients by medication
cards.
B. DECENTRALIZED UNIT DOSE DISPENSING
This operates through small satellite pharmacies located on each floor of the
hospital.
Procedure:
• Patient profile card containing full date, disease, diagnosis is prepared.
• Prescriptions are sent directly to the pharmacist which are then entered in
the patient profile card.
• Pharmacist checks medication order.
• Patient profile card and prescription order is filled by pharmacy technicians.
• The nurses administer the drugs and make the entry in their records.
Advantages:
• Convenient handling for staff
• Easy accounting
• Better stability
Disadvantages:
• High cost.
• Consumes more time and doubtful.
• Will occupy more space for storing.
• Ledger posting and inventory control problem.
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DISPENSING TO AMBULATORY / OUT-
PATIENT DEPARTMENT (OPD)
OUT-PATIENT
Ambulatory refers to patients not occupying beds in hospitals or other settings,
and to care given in physician’s offices, clinics, other health centers and other
places where ambulatory patients usually go for healthcare
Outpatient load into three categories.
1. General OPD
2. Emergency OPD
3. Referred OPD
1. GENERAL OUTPATIENT
• All the patients other than emergencies who report directly to the OPD.
2. EMERGENCY OUTPATIENT
• A person given emergency or accidental care for conditions which require
immediate medical attention.
• Suffering from serious health conditions or illness.
3. REFERRED OPD
• A person referred to an outpatient department by his attending medical
practitioner for specific treatment other than an emergency treatment.
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LOCATION
• It is always preferable to have a separate outpatient pharmacy.
• When this is not possible units are combined and the services provided
from the same or separate window.
• There is no general rule regarding location of out-patient pharmacy, it
should be so located that minimum disturbance is caused to the in-patients
and routine working of the hospital and its pharmacy.
LAYOUT
• It is important because the outpatient can carry good or a bad impression
about the hospital depending on the services they get.
• Unit must have prescription receiving window & delivery window.
• Waiting area should be provided.
• This area should be elegant, clean, ventilated and provided with
comfortable seats.
• Some publications related to medicine and pharmacy as well as
newspapers, magazines can be provided.
RECEIPT & ISSUE SYSTEM
• If a visit for first time –registration is must.
• Depending on the symptoms, the patients are directed to particular
department.
• Physician prescribes prescription-name, age, registration number and
diagnosis of patient.
• Prescription is to be produced before the pharmacist at the prescription
receiving counter.
• Any clarification about prescription-contact physician.
• The compounded prescriptions should be filled in the container and labeled
to include details (name, age reg. no, and directions for use and storage)
• Call check system can employed-for delivering compounded drug.
RECOVERY AND SERVICE CHARGES
• In charitable hospitals the patients have to pay the charge for the
medication, services.
• 3 important methods of pricing are based on
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1. Fee depending on dosage form and number of doses supplied
2. A simple markup procedure depends on the cost of the drug.
3. A professional fee system.
PROFESSIONAL FEE
• It is most widely used.
• The concept is not new.
• It represents an amount that covers the cost of providing services and a
reasonable profit the for pharmacist.
• The professional fee is same for all types of prescriptions irrespective of the
cost of the ingredients.
PRESCRIPTION PRICES
• It can be calculated by
• Prescription price = Drug cost + Professional fee
• Professional fee may vary depending on the practitioner’s environment.
• Thus, PFi = CODi + PROFIT
• CODi = Professional services + Over head
• Professional fee based on operating expenses can be calculated by
• Professional fee = A+(B*C)/D+E
• A = Manager’s salary
• B = Prescription sales to total sales
• C = Expenses minus manager’s salary
• D = Total no. of prescriptions and
• E = Net profit per prescription
PREPACKING
• It is a very convenient method of improving the standard of dispensing in
hospital pharmacies.
• It can be employed for fast moving items (or) too much time for packaging.
• It requires accurate procedures, controls and records in order to trace the
identity of the drug.
• Pre-packing policy is based on
1. Demand for the product
2. Size of unit to be packaged and numbers in each unit.
3. Type of containers and closure to be used.
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4. Special labeling required, if any
5. Packaging facilities available i.e., manual or mechanical.
6. Stability of the product and expiry date, and
7. Unit cost of pre-packaging.
ADVANTAGES
• Improves standard of dispensing.
• Cuts down patient’s waiting time.
• No special equipment is necessary.
• It can be employed for both in-patient and out-patient dispensing.
• PACKAGE SIZE: In most hospitals-20 or 25 tablets considered to be pre-
package size for in-patients.
• Outpatient-depends on no. of appointments in a month.
MINIMUM STANDARD FOR AMBULATORY CARE
• Qualified pharmacist
• Appropriateness of the choice of drug and its dosage, route of
administration and amount must be verified by the pharmacist
• Maintenance of medication profiles for patients
• All medications dispensed to patients will be completely and correctly
labeled and packaged
• Proper control
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DISTRIBUTION OF CONTROLLED MEDICINES
DEFINITION OF CONTROLLED DRUGS
• By law, a controlled drug (CD) is any substance or product as specified in
Schedule 2 of the Misuse of Drugs Act 1971.
OR
• Substances, products or preparations, including certain medicines, that are
either known to be, or have the potential to be, dangerous or harmful to
human health, including being liable to misuse or cause social harm, are
subject to control under the Misuse of Drugs Acts 1977 to 2016. They are
known as “controlled drugs”.
DEFINITION
• In practice, CDs are medicines that are subject to control under several
pieces of legislation to prevent them being misused, obtained illegally, or
causing harm.
OR
• A Controlled drug may have high potential of abuse, lack of accepted safety
for use and use of which may lead to severe psychological or physiological
dependence.
LAWS OF CONTROLLED DRUGS
• DEA (The Drug Enforcement Administration) – US Law Enforcement Agency
• FDA (The Food and Drug Administration) – federal agency of the United
States Department of Health and Human Services
• CSA (The Controlled Substances Act)
• Misuse of drugs regulations 2017
CATEGORIES OF CONTROLLED DRUGS
• The Misuse of Drugs Regulations 2001 split those drugs into five schedules
(ranging from the most tightly controlled in schedule 1 to the least tightly
controlled in schedule 5).
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• The schedules correspond to the drugs' therapeutic usefulness and misuse
potential. The Home office has produced a list of the most commonly
prescribed controlled drugs.
CATEGORIES OF CONTROLLED DRUGS
• Schedule 1: High potential for abuse and has no accepted medical use in
treatment in USA (e.g. raw opium, cocoa leaf)
• Schedule 2: High potentials for abuse but accepted for medical use in USA
(e.g. morphine)
• Schedule 3 to 5: Less as compare to above potentials for abuse, accepted
for medical treatment in USA and has less physical dependence and
psychological dependence
• Schedule 3: Certain benzodiazepines and painkillers (e.g. temazepam,
Flunitrazepam, Pentazocine, Ketamine)
• Schedule 4 – Part A: Most Benzodiazepines and ‘Z-drugs’ for example,
Diazepam, Alprazolam, Clonazepam, Midazolam
• Schedule 4 – Part B: Certain Anti-Epileptics for example, Phenobarbitone
<100mg Certain MAOIs for example, Selegiline
• Schedule 5: Lower strength of painkillers (e.g. Codeine)
Apart from schedules CDs can also be categorized into three classes — A, B and C.
• Class A drugs (Schedule – I) are considered most likely to cause harm and
carry the most severe punishment for unlawful possession and supply: up
to life imprisonment.
• Class B means Schedule – II and
• Class C means Schedule III to V drugs.
HOSPITAL CONTROL PROCEDURE
Assigning responsibility of control:
1. Hospital administrator
2. Pharmacy Department
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3. Nurses
1. HOSPITAL ADMINISTRATOR
Hospital Administration responsibilities include:
A. Policies for ordering CDs
B. Prescribing
C. Dispensing
A. POLICIES FOR ORDERING OF CDS
• Preparation of orders
• Doctor’s order and signature
• Telephone orders
• Verbal orders
• Ordering non ward CDs from pharmacy
B. PRESCRIBING
• When prescribing CDs, it is important to take into account the risks and
benefits of the CD, as well as any other medicines the patient may already
be taking.
• Personal Use
• Outpatient Department
B.1. PRESCRIBERS OBLIGATIONS
• Provide a valid prescription which meets the requirements of legislation
• Be satisfied as to the identity of the person for whose treatment the
prescription is to be issued
• Follow relevant national and international prescribing guidelines
• Within reason, be available to confirm or discuss any matters related to the
prescription and the patient
• Ensure the safe keeping of prescription pads to reduce the risk of theft and
forgery
• Facilitate appropriate withdrawal of controlled drugs and follow-up and
refer as necessary
B. 2. RECOMMENDATIONS FOR PRESCRIBERS
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• The indication and regimen must be clearly documented on the patient’s
care record.
• The quantity of the CD prescribed should be sufficient to meet the patient’s
clinical need for no more than 30 days.
• However, if a larger quantity is prescribed, this should be documented in
the patient’s care record.
• It is also important to provide patients and careers with information about
the CD, including whether it affects their ability to drive or if they require
identification to collect it.
• Prescription writing requirements for controlled drugs in Schedule 2 and 3,
clinical need and the person’s values and preferences.
• Regulations of the 2001 Regulations specifies requirements for writing
prescriptions for controlled drugs.
• In addition to working within the legal framework, prescribers need to use
their clinical and professional judgment when prescribing controlled drugs
to people.
C. DISPENSING
• For home use
• Employees
• Pharmacy off hours
2. PHARMACY DEPARTMENT RESPONSIBILITIES
• System for controlled drug loss report
• Controlled delivery to nursing station
• Protocol for prevention of drug abuse or diversion
• Documentation
3. NURSES’ RESPONSIBILITIES
• Auditing of narcotic inventory
• Physical count of narcotics
• Monitoring on audit record
• Forwarding of loss report to pharmacy department
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OBTAINING AND SUPPLYING CONTROLLED DRUGS
The recommendations in this section are for all health professionals supplying
controlled drugs unless otherwise stated.
1. STANDARDS AND SAFETY CHECKS FOR SUPPLYING CONTROLLED DRUGS
• When supplying prescribed controlled drugs:
– follow relevant standards set by the professional regulator
– check with the prescriber about any safety concerns, such as whether
the prescribed dose is safe for the person.
• When supplying controlled drugs to a person or their representative, take
reasonable steps to confirm their identity before providing the controlled
drug.
• If intending to supply dispensed controlled drugs to a person in police
custody, first check whether the custody staff have adequate arrangements
and handling facilities for controlled drugs.
2. PROVIDING INFORMATION AND ADVICE TO PEOPLE RECEIVING CONTROLLED
DRUGS
• When supplying more than one formulation (e.g. immediate-release and
sustained-release) of a controlled drug, discuss the differences between the
formulations with the person, and their family members or carers if
appropriate, and check that they understand what the different
formulations are for and when to take them.
• When the total quantity of a controlled drug in Schedule 2, 3 or 4 cannot be
supplied:
– inform the person receiving the drug that only part of their supply is
available
– tell them when the rest will be available
– ask them to collect it within 28 days of the date stated on the
prescription.
• When supplying controlled drugs, advise people how to safely dispose of:
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– unwanted controlled drugs at a community pharmacy
– used controlled drugs.
3. RECORDING SUPPLIES IN THE CONTROLLED DRUG REGISTER
• When health professionals in primary care dispense controlled drugs in
Schedule 2 in advance of collection, they should document the supply in
the controlled drug register only after the drugs are collected by the person
or their representative.
• Pharmacists or dispensing doctors who are unable to supply the total
quantity of a prescribed controlled drug in Schedule 2, must make an entry
in the controlled drugs register for only the quantity of the controlled drug
supplied, in line with Regulation of the 2001 Regulations. They must then
make a further entry in the register when the balance is supplied.
4. USING REQUISITION FORMS TO OBTAIN STOCK CONTROLLED DRUGS
• When obtaining controlled drugs for use in the community, health
professionals in primary care must use the approved mandatory form for
the requisitioning of controlled drugs in Schedule 2 and 3, in line with
Regulation 14 of the 2001 Regulations and the Misuse of Drugs
(Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015.
• When obtaining stocks of controlled drugs in Schedule 2 and 3 from an
organization’s contracted external pharmacy, a requisition signed by a
doctor or dentist employed or engaged in the organization must be
provided, in line with Regulation 14 of the 2001 regulations.
5. PART SUPPLIES OF STOCK CONTROLLED DRUGS
• Pharmacists in internal pharmacies (such as hospital and prison
pharmacies) who are unable to supply the total quantity of a stock-
controlled drug requested by requisition should ensure that the recipient is
aware that:
– a part supply has been made and no further supplies will be made for
that requisition
– the quantity on the requisition has been amended to the amount
actually supplied and is initialed or signed by the supplier.
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PROCESSES AND RECORD KEEPING
As a minimum, all secondary care facilities must have a robust overarching CDs
policy in addition to risk-assessed, task-specific standard operating procedures
(SOPs). This should include SOPs for the processes listed below, although it should
be noted that this list is not exhaustive. The NICE guidelines include a useful
baseline assessment tool for organizations to assess whether they are meeting
the recommendations.
1. Storage
2. Transport
3. Destruction and Disposal of CDs
4. Stock-checking processes
5. Prescribing processes
6. Supplying and administering processes
7. Audit provision
8. Providing medicines information
9. Raising concerns and sharing learning experiences
10. Management of national medicines safety guidance
1. STORAGE (STORING OF CONTROLLED DRUGS – CONTROLLED DRUG
CUPBOARDS)
• Must meet British Standard BS2881:1989 security level 1. The Safe Custody
Regulations specify the quality, construction, method of fixing, and lock and
key for the cupboard. The controlled drugs cupboard must be:
– Secured to a wall and fixed with bolts that are not accessible from
outside the cupboard
– Fitted with a robust lock
– Made of metal with strong hinges. The walls of the room should be
of a suitable thickness and made of a suitable material, for example
bricks. This means that the cupboard must be securely fixed to a wall
– License holder should have possession of keys
– No label on outside
OTHER CONSIDERATIONS
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• You can fix the cupboard to an internal wall as long as it is secure
• You do not need to store the controlled drugs cupboard within another
cupboard
• You must restrict access to the cupboard proportionally
• The cupboard should be in a suitable location
• Store spare keys securely
• For safe practice, only use the cupboard to store controlled drugs
2. TRANSPORT
• The movement of CDs to and from the pharmacy department.
• Risk assessments should be undertaken to determine people authorized for
CD transportation.
• Assessments should also be made for actions required during temporary
and permanent ward closure.
• All movement of CDs must be fully auditable, including the return of CDs
back to pharmacy and transfer between wards.
3. DESTRUCTION AND DISPOSAL OF CDS
• For both pharmacy and clinical areas. All facilities disposing of CDs must
have a T28 waste exemption certificate issued by the Environment Agency.
• The records of and disposal of large volumes of part-used amps and
infusions should be considered carefully.
• All care must be taken to ensure that they are not open to abuse; part-used
amps/vials/infusions should have their contents withdrawn and denatured
using absorbent granules (as part of a denaturing kit or added to a sharps
bin).
• For stock-controlled drugs, when disposing of bottles containing
irretrievable amounts of liquid drugs:
– Consider rinsing the bottle and disposing of the liquid into a
pharmaceutical waste bin
– remove or obliterate labels and other identifiers from the container
– dispose of the clean, empty container into the recycling waste.
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– Disposal of irretrievable amounts of controlled drugs does not need
to be recorded.
• All destructions, whether at a clinical level or within pharmacy, need to be
witnessed; however, stock CDs no longer fit for purpose can only be
destroyed by an authorized witness (e.g. the police CD liaison officer or the
facilities authorized witness for destruction, who needs to be registered
with the Home Office and Care Quality Commission [as appropriate]).
• When a person has died in their home and controlled drugs need to be
removed for destruction and disposal in primary care, consider:
– discussing the removal of controlled drugs with a family member or
carer
– recording the action taken and details of the controlled drugs listed
in the person's medical record or notes
– having a witness to the removal
– any requirements of the coroner to keep medicines in the person's
home for a period of time
– taking the drugs to a health professional, such as a community
pharmacist who is legally allowed to possess controlled drugs, for
safe disposal at the earliest opportunity.
4. STOCK-CHECKING PROCESSES
• There should be standard operating procedures (SOPs) about how to check
stock and documentation based on a documented risk assessment of
activity. Check stocks regularly. For good practice, two staff members
should sign when:
– Receiving controlled drug stocks
– Checking stock balances
– Administering the medicines
– Disposing of these medicine stocks
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• Medicines, Ethics and Practice has the most up-to-date legal requirements
for record keeping of CD transactions.
• At minimum, a separate CD register is legally required to be kept at all
premises where CDs are stored, in which, all records of receipt and supply
of Schedule 1 and 2 CDs are made (for Sativex® [GW Pharma Ltd, Bayer], a
Schedule 4 Part 1 CD must also be recorded).
• The registers are a legal document; therefore, entries must not be
cancelled, obliterated, or altered. If amendments are made, the register
should be clearly documented to show which staff member made the
amendments, with dated marginal notes or footnotes. CD registers must be
kept for two years from the date of the last entry.
5. PRESCRIBING PROCESSES
• There should be SOPs to ensure legality of prescriptions, safe prescribing
practices, clear instructions and reduced opportunity for dependency,
overdose, and diversion.
6. SUPPLYING AND ADMINISTERING PROCESSES
• There should be SOPs to ensure requests for CDs are legal and volumes are
appropriate.
• Processes should also be in place to ensure anyone requesting CDs or
supplying or administering CDs are suitably trained and are authorized to
do so.
• All supply and administering of CDs must be witnessed.
7. AUDIT PROVISION
• There should be SOPs to monitor all operational processes, including review
of prescribing trends and high-volume prescribing.
8. PROVIDING MEDICINES INFORMATION
• There should be SOPs for how to inform patients, carers and healthcare
professionals about CDs.
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9. RAISING CONCERNS AND SHARING LEARNING EXPERIENCES
• There should be SOPs about how to raise concerns and share experiences
both inside and outside the hospital facility or organization.
10. MANAGEMENT OF NATIONAL MEDICINES SAFETY GUIDANCE
• For example, patient safety alerts to ensure alerts or new guidance and
recommendations are reviewed and acted upon within an appropriate time
frame.
MANAGEMENT OF LIQUID CD DISCREPANCIES
• Stock control of liquid CDs is extremely difficult as loss of volume is
inevitable when repeatedly manipulating a stock bottle of liquid. There is
no formal published guidance dictating the value of an ‘acceptable loss’,
although, anecdotally, many organizations adopt 5% of total volume as an
acceptable loss.
• Other measures can help ensure the loss per manipulation is reduced e.g.
– Ensuring staff have access to suitable-sized enteral syringes, so they
can use the smallest size possible to measure the volume required
more accurately
– Using bungs help reduce spillage
– Regular physical balance checks enable identification of diversion;
however, the number of checks should be limited because
introducing too many may also contribute to losses.
RATIONAL USE OF CONTROLLED DRUGS
• Generally rational drug use is judicious, appropriate, and safe use of
medicines. Rational drug use includes prescribing suitable drugs, making
them available at all times at affordable prices, ensuring their safety and
quality, dispensing them correctly, taking them in the right doses and right
interval for the right period of time.
• At this point in time, drugs with high misuse and abuse potential i.e.
controlled drugs are considered and given more emphasis. To curtail the
major problems associated with the misuse, abuse of licit psychotropic and
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narcotic drugs, interdisciplinary collaboration involving physicians,
pharmacists and other health professionals is of paramount importance.
1. Good Prescribing Practice
Physicians play a decisive role:
• In ensuring that safe and cost-effective medicines are prescribed to
patients,
• In providing sufficient information and educating patients and
• In improving the quality of patient care.
2. APPROVED DRUGS LIST
• Drugs required to treat the most prevalent diseases are included in the
approved drugs list. On the basis of constant review of the approved drugs
list and existing regulation governing pharmaceuticals, the Ministry of
Health may propose addition or deletion of products to and from this list,
as necessary. Single ingredient preparations containing controlled drugs are
recommended to be on the list of approved drugs.
• To ensure quality and safety, import of controlled drugs by various agents
from undesignated sources is not permitted and sole import by the State
Trading Organization from reputable manufacturers or their accredited
agents complying with standards of Good Manufacturing Practice (WHO)
shall be adhered.
3. STANDARD PRESCRIPTION FORMAT
• A prescription is a written instruction for the pharmacist to supply with a
specified drug(s) to a patient. Apart from this, a prescription can be a
source of information and a legal document when problems arise and
needs to be justified.
• Therefore, necessary care should be taken while writing prescriptions. A
standard prescription format is developed with a guideline to facilitate
good prescribing practice and to minimize the occurrence of forged
prescriptions and misuse of drugs with high potential for abuse.
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– The standard prescription format is printed in two copies, blue and
white colored, while the blue color (original) should be given to the
patient, the white copy should remain with the pad.
4. PRESCRIBING DURING EMERGENCIES
• Prescriptions containing controlled drugs from other prescribers are not
accepted except for medicines required for emergency situations such as
epilepsy.
• Except for treating disease conditions, prescribing controlled drugs greater
than 48 hours for known cases of drug addicts should only be done by a
consultant psychiatrist or in the his / her absence the prescribing physician
should get prior authorization from the Ministry of Health.
5. REFERRAL SYSTEM
• Known cases of patients under controlled drug therapy can be followed up
at primary and secondary level of health care, however, the examining
physician should refill the prescription or be consulted through appropriate
means of communication as regards to previous medication history of the
patient.
• Junior prescribers are allowed to prescribe a limited number of drugs in
emergency situations only for 24 - 48 hours use, any extension requires the
authorization of a physician or a specialist if applicable, else the patient
should be referred to the nearby health center or hospital.
6. REPEAT VS INSTALLMENT
• A “repeat prescription”, as defined in the Medicinal Products (Prescription
and Control of Supply) Regulations 2003, as amended, means a prescription
which may be dispensed more than once.
• Schedule 2 and schedule 3 controlled drugs cannot be repeated. Schedule 4
(part 1 and part 2) and schedule 5 controlled drugs may be repeated.
• “Instalments” allow the total quantity of the medicine prescribed to be
dispensed in smaller, specified amounts, at specified intervals.
• All controlled drugs can be legally dispensed in this manner, however, in
accordance with the Misuse of Drugs Regulations 2017, ‘the number of
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instalments and the intervals at which the instalments may be dispensed’
must be specified on prescriptions for schedule 2, schedule 3 and schedule
4 part 1 prescriptions.
7. IDENTIFYING RISK FACTORS AND HIGH-RISK PATIENTS
• As part of this collaborative relationship, pharmacists and prescribers
should, in particular, communicate and collaborate in the care of patients in
high risk groups.
• Engagement within and between the professions in the shared care of
patients in these groups is particularly important to meet patients’ care
needs. This includes shared responsibility for follow up and after-care for all
patients, and collaborative working in the implementation of appropriate
withdrawal procedures for controlled drugs.
EXAMPLES
• Pt with drug dependency issues
• Pt receiving addiction
treatment services
• Pt under the management of
multiple doctors
• Pt population who attend pain
clinics
• Pt transitioning from one place
of care to another
• Patients in residential care
settings
• Patients at risk of developing
sleep disordered breathing
• Prisoners
• Pts with poor health literacy
• Pediatric patients

• Older people
• Pregnant/breast feeding
women
• Patients with
physical/intellectual disabilities
• Patients suffering from chronic
illnesses
• Patients receiving palliative
care
• Patients with mental health
issues
• Homeless patients
• Pt with additional care
requirements


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ADMINISTRATION OF CONTROLLED DRUGS
1. STANDARDS AND SAFETY CHECKS FOR ADMINISTERING CONTROLLED DRUGS
• Follow the relevant standards set by the professional regulator when
administering controlled drugs, and when necessary check with the
prescriber about any safety concerns such as:
– whether the prescribed dose is safe for the person
– whether other formulations have already been prescribed for the
person
– whether the formulation is appropriate
– that any past doses prescribed have been taken.
2. PROVIDING INFORMATION AND ADVICE TO PEOPLE HAVING CONTROLLED
DRUGS ADMINISTERED
• Tell the person having the controlled drug the name and dose of the drug
before it is administered unless the circumstances prevent this.
• Provide advice on how different formulations of controlled drugs are
administered, and check that the person understands the advice. Ensure
that appropriate equipment is available for the correct dose to be
administered.
3. RECORDS OF ADMINISTRATION
• Ensure records of administration for controlled drugs include the following:
– name of the person having the dose administered
– date and time of the dose
– name, formulation, and strength of the controlled drug administered
– dose of the controlled drug administered
– name and signature or initials of the person who administered the
dose
– name and signature or initials of any witness to administration.
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• Ensure the record of administration of a controlled drug for inpatients and
people in the community is readily accessible to:
– ensure continuity of care
– prevent doses being missed or duplicated
– avoid treatment being delayed.
– Using continuous administration for controlled drugs
• When prescribing controlled drugs, involve the person's GP and any lead
health professionals for other care teams involved in the person's care in
decisions about whether to use a device for continuous administration.
Record the decision in the person's care record. If prescribing outside
normal working hours, tell the GP about the decision the next working day.
• Health professionals who use devices for continuous administration of
controlled drugs should:
– complete training in setting up the specific devices used by their
service and have their competence confirmed
– seek specialist advice if needed when setting up devices for
continuous administration.
4. RECORDING LEFT OVER CONTROLLED DRUGS IN THE CONTROLLED DRUG
REGISTER
• For controlled drugs that are left over after administration, record in the
controlled drugs register:
– the amount of controlled drug administered
– the amount of controlled drug to be disposed off after administration
– the signatures of the person disposing off the remaining controlled
drug and any witness to the disposal.
US PROCEDURE
• Healthcare practitioners should take proactive measures to ensure that a
narcotic regimen is being used for legitimate medical purposes.
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• DEA regulations require the pharmacist to verify that a controlled
substance prescription contains the patient name, address, drug name and
strength, quantity prescribed, and directions for use, as well as the name,
address, and DEA number of the issuing practitioner.
• The pharmacist must further verify that the prescription is dated as of, and
signed on, the date that it is issued.
• Written patient agreements with physicians and/or pharmacies help the
pharmacy monitor the legitimacy of a patient presenting for a narcotic
prescription.
• The Drug Enforcement Administration (DEA) promulgates rules to enforce
against the risk of drug diversion.
• DEA's "Office of Diversion Control" prevents, detects, and investigates the
diversion of controlled substances from legitimate sources while ensuring
an adequate and uninterrupted supply for legitimate medical needs.
• To accomplish this mission, the DEA sets forth regulations designed to
prevent any such diversion.
RISK ASSESSMENT FOR ORGANIZATIONS
• Carry out a risk assessment to determine if controlled drugs in Schedule 3,
4 and 5 should be handled in the same way as controlled drugs in Schedule
2. The risk assessment may include:
– frequency and quantities of controlled drugs used
– storage facilities available
– whether the security setting is low, medium, or high risk
– checking for discrepancies in stock balances at shift handover
– frequency of staff turnover
– staff access to controlled drugs
– any data from relevant reported incidents.
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• Ensure that standard operating procedures for administering controlled
drugs include sufficient safety measures to minimize the risk of
administration errors. Safety measures may include:
– asking for advice from other health professionals (this could be by
telephone or email)
– arranging for another health professional to carry out a second check
of dose calculations and route for administration.
• In organizations with an internal pharmacy or dispensing doctors, use a risk
assessment (see Regulation 3 of the Management of Health and Safety at
Work Regulations 1999) to determine locally the most appropriate place for
destroying controlled drugs.
• This should take into account how close the place of destruction should be
to where the drugs are used to help minimize risks of controlled
drug-related incidents.
ROLE OF PHARMACIST
IN A JOINT STATEMENT ISSUED ON 1
st
OCTOBER 2009 DHSC AND PSNC STATED
“Introduction of the responsible pharmacist requirements have been achieved
through the amendment of medicines legislation. No changes have been made to
NHS Pharmaceutical Services Regulations, including the terms of service for
community pharmacy contractors. The Department of Health and the
Pharmaceutical Services Negotiating Committee will undertake a review of the
community pharmacy contractual framework and NHS Pharmaceutical Services
Regulations in light of the responsible pharmacist changes to medicines
legislation. “
ROLE OF A PHARMACIST
• Pharmacists have a responsibility to ensure the safe and secure
management of CDs, both operationally and clinically.
• They must ensure that the necessary operational processes are regularly
process mapped, risk assessed, and embedded via a sustainable program of
audit and sharing of lessons learnt, both within and outside their
organizations.
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• Simple changes, such as reviewing CD documentation or reviewing
management of liquid CDs, can result in substantial improvements.
• With respect to a pharmacist's responsibility, the DEA regulations state that
"[a] prescription for a controlled substance to be effective must be issued
for a legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice. The responsibility for the proper
prescribing and dispensing of controlled substances is upon the prescribing
practitioner, but a corresponding responsibility rests with the pharmacist
who fills the prescription."
• As a result, a pharmacist must "carefully review all purported controlled
substance prescriptions to ensure that the prescription meets all of the
legal requirements for a valid prescription. The pharmacist has a duty to
inquire further as to any question surrounding the satisfaction of any or all
of the legal requirements for a valid prescription, depending on the
particular circumstances, including the requirement that the prescription
be issued for a legitimate medical purpose by a practitioner acting in the
usual course of professional practice."
• By undertaking due diligence in this regard, a pharmacist will help ensure
compliance with DEA requirements.
PHARMACIST’S OBLIGATIONS
• Only dispense on the basis of a legally valid prescription
• Be satisfied that the signature of the prescriber is genuine
• Prior to supply, be satisfied as to the identity of the person or bona fide
representative presenting the prescription or collecting controlled drugs
• Be vigilant for forgeries or unusual prescribing patterns
• Store controlled drugs in a safe manner, in accordance with the relevant
legislation
• Record all supplies of schedule 2 controlled drugs (CD2) in the pharmacy’s-
controlled drugs register
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• Communicate with the medical practitioner if there is any query about the
prescription, or care of the patient
• Adhere to national guidelines and facilitate appropriate withdrawal of
controlled drugs and follow-up and refer as necessary
VERIFICATION
• Additionally, DEA regulations dictate that the pharmacist must verify that a
controlled substance prescription contains the patient name, address, drug
name and strength, quantity prescribed, and directions for use, as well as
the name, address, and DEA number of the issuing practitioner. The
pharmacist must further verify that the prescription is dated as of, and
signed on, the date that it is issued.
FRAUDULENT PRESCRIPTIONS
• Legitimate prescription with alterations made by patient
• Stolen prescription pads of a legitimate prescriber but with contact changes
• Drug seekers who phone for their own prescriptions and use their own
phones for verification
• Drug abusers who use stolen pad to write prescriptions
• Individuals present themselves at emergency to obtain controlled
substance prescription to modify it later or copy for re-use
• STEPS THE PHARMACIST MUST TAKE TO ENSURE THE VALIDITY OF
PRESCRIPTIONS
1. ENSURE THAT ONLY STATE-AUTHORIZED PRESCRIBERS WRITE/ORDER
PRESCRIPTIONS.
– The DEA defines a practitioner as a physician, dentist, podiatrist,
veterinarian, state-registered practitioner.


– The pharmacist must know the laws in each state/province, if
presented with a prescription from that state.
– If the pharmacist is presented with a questionable prescription, he or
she may want to use the contact information on the prescription.
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– States have the authority to determine the scope of treatment by
prescribers.
– States may restrict the ability of certain practitioners to write
prescriptions only for certain indications or specific conditions — for
example, dentists being restricted to treatments related to oral
health.
– If the pharmacist has questions regarding whether a valid prescriber-
patient relationship exists, he or she may contact the prescriber or
ask the patient when they last saw the prescriber, or ask other
general questions related to the interaction with the prescriber.
2. VERIFY PRESCRIBER REGISTRATION NUMBER.
3. PRESCRIPTION MONITORING PROGRAM (PMP)
– In US, every state has PMP - generally track every controlled
substance dispensed in the state and include patient name,
controlled substance name and quantity, date dispensed, prescriber
and pharmacy identity.
– The pharmacist must be judicious in accessing information in the
PMP.
– The pharmacist must never abuse the privilege of reviewing the
information in the database.
– The pharmacist should access information only when a prescription is
presented.
– The pharmacist must always adhere to federal and state privacy and
security laws, and act in a professional, ethical manner
4. REVIEW OF PRESCRIPTION
• The pharmacist must take the time to comprehensively review the
prescription order the patient presents. The pharmacist may conduct the
following review steps in any order:
• Review the prescription order for any changes or alterations.
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• Both handwritten and computer-generated prescriptions are subject to
alteration.
• Check if the prescription appears to be a photocopy that might indicate
duplication of the original order by the patient.
• The pharmacist should specifically examine the date of the order, the
quantity and strength; and signature on the prescription order to ensure
that the prescriber’s handwritten signature is included on the prescription
as required by the DEA.
• Any alterations must be brought to the attention of the prescriber,
• In the case of Schedule III-V medications, a pharmacist may contact the
prescriber to authorize a verbal telephone order for prescriptions.
• The pharmacist may not receive oral authorization for a Schedule II
controlled substance prescription.
5. OBTAIN TREATMENT PLAN
If customers are submitting prescriptions for large quantities of drugs
6. REVIEW THE DATE ISSUED
7. REVIEW THE MEDICATION, STRENGTH, DOSAGE FORM AND QUANTITY
8. DOCUMENT, DOCUMENT, DOCUMENT
• The pharmacist regularly hears this mantra for many actions taken in the
pharmacy, but documentation is even more important when verifying a
controlled substance prescription. The pharmacist must document the
steps they have taken to verify the prescription, including any calls to the
prescriber(s), conversations with the patient, medication history review,
and PMP access and review on the prescription itself or in the pharmacy
management system
PHARMACY CONTROLS TO ENSURE APPROPRIATE DISPENSING
• The pharmacist should take necessary actions to prevent widespread
prescription drug abuse and ensure appropriate dispensing in the
pharmacy.
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• Receive and validate prescription (print, DEA#, Date, Doctor name, License
# etc.)
• Understand and interpret prescription (patient, medicine, dose)
• Identify area prescribers who most often prescribe narcotic or dubious
prescriptions and review these prescriptions carefully
• Communication by the pharmacist to both the prescriber and patient is
necessary because it may uncover rational reasons for prescribing.
• Once the pharmacist identifies the prescribers and patients who should be
flagged, the pharmacist and pharmacy staff must ensure that all federal and
provincial laws and regulations, and other protections, are maintained
when doing so
• The pharmacist should implement a substance order management and
inventory system to closely monitor receipt and dispensing of drugs.
• Prepare and label items for issue (self-checking, double checking, counter
checking, FEFO not FIFO, read the label twice), do not select medicine
based on color or place of the container, do not open many containers at
the same time.
• Measure the tablets or capsules without touching them, use spatula, clean
white paper, or lid of the container
• Label should be kept upward while pouring medicine from container
• Make final check
• Record action taken
• The pharmacist should review logbooks, perpetual inventory, invoices,
receipts, and other pharmacy distribution records to flag excessive ordering
or dispensing by certain pharmacists or on certain shifts.
OTHER RESPONSIBILITIES OF A PHARMACIST
• The Pharmacist shall keep all controlled drugs in a locked cabinet under
his/her own direct supervision and control.
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• The Pharmacist must check validity of the prescription and identity of the
patient before dispensing
• The Pharmacist shall consult the prescribing doctor if there is any doubt
about the prescription.
• The Pharmacist shall only dispense controlled drugs if the prescription
provided by the physician is complete and valid.
• Dispensing part of a prescription is not permitted.
• The Pharmacist shall properly label and mark containers to avoid undue
intermixing that may cause harm to the patient.
• The Pharmacist shall provide complete information to the patient about the
prescribed drug he /she is dispensing including cautions, warnings, and
clear direction for use.
• Under the current regulation, the pharmacist is not permitted either to
refill or substitute a generically equivalent controlled drug unless instructed
by the physician.
• The Pharmacist shall retain prescriptions containing controlled drugs after
dispensing the medication.
• The Pharmacist shall keep retained prescriptions containing controlled
drugs in a separate file and submit these prescriptions for the Ministry of
Health.
HANDLING OF CONTROLLED DRUGS IN THE ABSENCE OF A PHARMACIST
• In institutions where there is no pharmacist / pharmacy assistant, only
drugs required to manage emergencies will be kept in stock under the
direct supervision of the physician or if not available, the in-charge of the
health institute shall be responsible to keep them in a locked cabinet with
appropriate records. However, special care should be exercised in the
selection of staff that would handle controlled drugs in any establishment.
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EDUCATING THE PATIENT AND THE PUBLIC
• In general, the physician, the pharmacist and health workers have a
responsibility to educate the patient and the public regarding the risk and
benefits of medicines prescribed and dispensed to them.
• Effective education requires a commitment to, and an understanding of the
need for, improved communication between the health care provider and
the patient.
• At large, consumers will be provided with basic health education through
appropriate media to understand better what controlled drugs are and how
they act in the body, their risks and benefits, and their impact on the
community development. In order to reduce the demand for controlled
drugs, proper counseling and more clinical psychology and social services
shall be sought.














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DISPENSING DURING OFF-HOURS
DEFINITION
The dispensing of medication when the pharmacy is closed is called Dispensing
during off hours.
INTRODUCTION
• The major criticism of small hospital was the lack of pharmaceutical service
on 24 hours.
• Two major reasons for that are:
• Shortage of trained personnel
• Prohibitive costs
MEANS OF THE HOSPITALS TO PROVIDE 24 HOUR A DAY PHARMACY
COVERAGE
1. Use of the Nursing Supervisor
2. Emergency Boxes and Night Drug Cabinets
3. Use of Physicians
4. Pharmacist-On-Call
5. Purchased Service
1. USE OF THE NURSING SUPERVISOR
It permits the evening and night nursing supervisor to enter the pharmacy and
provide limited type of services.
The first and the most widely used.
DISADVANTAGE
• Dangerous
• An illegal practice (in some areas)
However, the advocator said:
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• There exists a correlation between the nurse selecting a medicine from the
drug cabinet on the pavilion and selecting the same item from the
pharmacy.
The fallacy of this view:
• The medication in nursing station have already had the benefit of special
packaging, Handling and labeling by professionally competent.
So, it should be practiced with caution (if it is the only mean available to small
hospital)
Nursing personnel serving in this category should be:
• Specifically, prohibited form compounding a mixture
• Restricted to dispensing from the selection of pre-labeled and pre-
packaged items
2. EMERGENCY BOXES AND NIGHT DRUG CABINETS
EMERGENCY BOXES
It is necessary to expedite treatment in situations where time is of the essence.
So, the emergency box must be:
• Large enough
• Sufficiently compact (to facilitate handling items)
• Kept in a ready accessible place (known to all ward personnel)
• Ready for use at all times
In order to accomplish this goal.
• The pharmacy should’ve reserve boxes prepared so that the units may be
handled on an exchange basis to reduce the period of time without a ready
to use emergency box
If the hospital policy charge for the supplies used from emergency box, the nurse
should prepare a charge ticket and submit it to the pharmacy with the used box
“Emergency cart” or “resuscitation cart”; Mobile units have on them the same
basic supplies contained in emergency box plus:
• Facilities for the administration of oxygen
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• The application of suction
• A cardiac pacemaker
Emergency box must be checked on regular basis (monthly) by hospital
pharmacist. In order to:
• Remove outdated
• Deteriorated medications
This system requires placing an inventory and product control card in the box







The objectives of the card.
• Serves as an inventory of the emergency box
• Shows when the unit was last checked
• Provides the nursing personnel with adequate directions for replenishing
any item which may have been used.
THE NIGHT DRUG SUPPLY CABINET
An adjunct to the charge floor stock medications already on the pavilion.
Range from simple cabinets with drawers to large elaborate installations which
include narcotic vaults and refrigerate compartments.
The large cabinets are usually constructed in the wall of the pharmacy
• Serviced from within the pharmacy
• Yet is accessible from the corridor side to authorized nursing personnel
It should be stocked with:
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• Pre-packaged
• Labeled containers of the drugs
Many hospitals also store certain medical and surgical supplies. (oxidized
cellulose)
The nursing supervisor leave identified charge ticket Listing:
• The item removed
• To whom it was administered
The next morning the pharmacy personnel restock the unit and forward the
charged ticket to accounting office.
3. USE OF PHYSICIANS
It Requires the physician to enter the pharmacy and obtain any special medication
not provided through:
• The floor stocks
• Night cabinets
• Emergency box
DRAWBACKS
• A physician might waste a great deal of time searching for a product
• An unfair burden to place upon their already heavily taxed work hours.
ADVANTAGE
• The physician may be influenced to use available drug which will
accomplish the same purpose.
4. PHARMACIST ON CALL
In order to encourage this type of coverage, many administrators have
developed:
• Bonus
• Extra pay plans
• A rotational plan of on-calls will not burden single individual
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5. PURCHASED SERVICE
Contracting with local community pharmacy for
• Night
• Holiday
• Vacation
• Relief for the staff pharmacist
ADVANTAGES
• Safe and legal
• Protect the drug needs of the hospital and patient
• Safeguard the health needs of the area on a round-the-clock basis.
Where there is more than one pharmacy in the community, care should be taken
to avoid any claims of favoritism or politics
This may be accomplished by
• Develop a set of specifications and requirement concerning the desired
service
• Request the local establishments to submit their bids.
Only the retail pharmacies with adequate staff, inventory, and delivery service
can qualify to bid.
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SAFE USE OF MEDICATIONS
MEDICATION ERRORS
• Medications are offered by health services throughout the world. However,
with substantial and increasing medication use comes a growing risk of
harm.
• “To Err is Human”, however, in healthcare profession this could lead to
serious consequences and in severe cases, can lead to loss of lives also.
DEFINITION
• There is no consensus about the definition of a medication error. A
systematic literature review found 26 different terminologies employed for
a medication error.
• The United States National Coordinating Council for Medication Error
Reporting and Prevention defines a medication error as
• “any preventable event that may cause or lead to inappropriate medication
use or patient harm while the medication is in the control of the health care
professional, patient, or consumer. Such events may be related to
professional practice, health care products, procedures, and systems,
including prescribing, order communication, product labelling, packaging,
and nomenclature, compounding, dispensing, distribution, administration,
education, monitoring, and use”
• Medication Error – any preventable event that may cause or lead to
inappropriate medication use or harm to a client
• Incident or Occurrence – anything outside of normal routine or
unexpected; usually untoward
• Sentinel Event – any adverse occurrence resulting in death or serious
physical or psychological harm
CLASSIFICATION OF MEDICATION ERRORS
• There are a number of different approaches to classifying medication
errors.
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• CLASSIFICATION ON THE STAGE IN THE SEQUENCE OF MEDICATION USE
PROCESS, such as prescribing, transcribing, dispensing, administration or
monitoring.
• CLASSIFICATION BASED ON TYPES OF ERRORS OCCURRING, such as wrong
medication, dose, frequency, administration route or patient.
• CLASSIFICATION BASED ON WHETHER THEY OCCUR FROM MISTAKES
MADE WHEN PLANNING ACTIONS (knowledge-based or rule-based
mistakes) or errors in the execution of appropriately planned actions
(action-based errors, known as “slips”, or memory-based errors, known as
“lapses”).
• LEVEL OF SEVERITY
• NCC-MERP (National coordinating council for Medication Error Reporting
and Prevention) has organized medication errors into four major groupings
encompassing a total of nine categories (categories A through I):
1. NO ERROR
• Category A: Circumstances or events that have the capacity to cause
error
2. ERROR, NO HARM
• Category B: An error occurred but the error did not reach the patient
(An "error of omission" does reach the patient)
• Category C: An error occurred that reached the patient but did not
cause patient harm
• Category D: An error occurred that reached the patient and required
monitoring to confirm that it resulted in no harm to the patient
and/or required intervention to preclude harm.
3. ERROR, HARM
• Category E: An error occurred that may have contributed to or
resulted in temporary harm to the patient and required intervention
• Category F: An error occurred that may have contributed to or
resulted in temporary harm to the patient and required initial or
prolonged hospitalization
• Category G: An error occurred that may have contributed to or
resulted in permanent patient harm
• Category H: An error occurred that required intervention necessary
to sustain life
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4. ERROR, DEATH
• Category I: An error occurred that may have contributed to or
resulted in the patient’s death

RATE AND SIGNIFICANCE OF MEDICATION ERRORS
• Widely varying error prevalence rates reported in different parts of the
world.
• For example, a United Kingdom study found that 12% of all primary care
patients may be affected by a prescribing or monitoring error over the
course of a year, increasing to 38% in those 75 years and older and 30% in
patients receiving five or more drugs during a 12-month period.
• Overall, 5% of prescriptions had prescribing errors.
• A Swedish study found a medication error rate of 42%.
• However, two-thirds were related to a failure to state the purpose of the
treatment on prescriptions and only 1% of errors resulted in an incorrect
dose
• A study from Saudi Arabia reported that just under one-fifth of primary
care prescriptions contained errors, but only a small minority were
considered serious.
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• Another study in Mexico observed that 58% of prescriptions contained
errors, with dosage regimen accounting for most cases (27.6%).
UNDESIRABLE OUTCOMES DUE TO MEDICATION ERRORS
• Undesirable outcomes include adverse drug reactions, drug-drug
interactions, lack of efficacy, suboptimal patient adherence and poor
quality of life and patient experience.
• In turn, these may have significant health and economic consequences,
including the increased use of health services, preventable medication-
related hospital admissions and death
• In some countries, approximately 6-7% of hospital admissions appear to be
medication related, with over two-thirds of these considered avoidable and
thus, potentially due to errors.
• The problem is likely to be more pronounced in the elderly, because of
multiple risk factors, one of which is polypharmacy
WHY TO AVOID MEDICATION ERRORS
• Medication errors have a large impact on patient safety and on healthcare
cost.
• There are not many studies that have directly assessed the economic
impact of medication errors, but there are studies that explain the impact
of preventable adverse drug events (ADEs) which is a serious type of
medication error.
• Among these ADEs, the preventable ones are medication errors.
• At least 1.5 million preventable ADEs occur every year in the United States.
• The average additional length of stay in a hospital due to preventable ADEs
is 4.6 days in the tertiary setting and 3.15 days in community setting.
• Preventable ADEs costs over $4685 in tertiary hospitals and $3511 in
community hospitals.
• The estimated annual cost attributable to preventable ADEs in a 700-bed
teaching hospital was 2.8 million dollars.
• Bates et al studied 247 ADEs, of which 14 were life threatening, 30 were
serious and 26 were significant preventable.
• It is regrettable that preventable errors could cause such a significant
threat to patient safety.
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• Therefore, preventing medication errors is a vital necessity.
PREVALENCE
• A United Kingdom study found that 12% of all primary care patients may be
affected by a prescribing or monitoring error over the course of a year,
increasing to 38% in those 75 years and older and 30% in patients receiving
five or more drugs during a 12-month period.
• Overall, 5% of prescriptions had prescribing errors.
• A Swedish study found a medication error rate of 42%.
• However, two-thirds were related to a failure to state the purpose of the
treatment on prescriptions and only 1% of errors resulted in an incorrect
dose
• A study from Saudi Arabia reported that just under one-fifth of primary
care prescriptions contained errors, but only a small minority were
considered serious
• Another study in Mexico observed that 58% of prescriptions contained
errors, with dosage regimen accounting for most cases (27.6%)
CAUSES OF MEDICATION ERRORS
• The Commonwealth Fund International Health Policy survey compared
factors associated with patient-reported medication errors across seven
countries.
• In 11% of patients experiencing a medication error, risk factors included
poor coordination of care, cost-related barriers to medical services or
medicines, multi-morbidity and Hospitalization
• Other studies have found that medication errors are associated with
increasing number of medications, childhood and older age, and specific
medications and medications for certain disease states (e.g.,
musculoskeletal, oncology and immunosuppression, dermatology,
ophthalmology, otolaryngologic conditions, infections and cardiovascular)
FACTORS ASSOCIATED WITH HEALTH CARE PROFESSIONALS
• Lack of therapeutic training
• Inadequate drug knowledge and experience
• Inadequate knowledge of the patient
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• Inadequate perception of risk
• Overworked or fatigued health care professionals
• Physical and emotional health issues
• Poor communication between health care professional and with patients
FACTORS ASSOCIATED WITH PATIENTS
• Patient characteristics (e.g., personality, literacy and language barriers)
• Complexity of clinical case, including multiple health conditions,
polypharmacy and high-risk medications
FACTORS ASSOCIATED WITH THE WORK ENVIRONMENT
• Workload and time pressures
• Distractions and interruptions (by both primary care staff and patients)
• Lack of standardized protocols and procedures
• Insufficient resources
• Issues with the physical work environment (e.g., lighting, temperature and
ventilation)
FACTORS ASSOCIATED WITH MEDICINES
• Naming of medicines
• Labelling and packaging
FACTORS ASSOCIATED WITH TASKS
• Repetitive systems for ordering, processing and authorization
• Patient monitoring (dependent on practice, patient, other health care
settings, prescriber)
FACTORS ASSOCIATED WITH COMPUTERIZED INFORMATION SYSTEMS
• Difficult processes for generating first prescriptions (e.g. drug pick lists,
default dose regimens and missed alerts)
• Difficult processes for generating correct repeated prescriptions
• Lack of accuracy of patient records
• Inadequate design that allows for human error
STRATEGIES AND POTENTIAL SOLUTIONS
• Strategies employed include using
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• Clinical pharmacists
• Computer technology
• Educational programs - often within multifaceted interventions.
• There is also an emphasis on the elderly population.
• Some interventions have targeted specific clinical areas, such as
infectious diseases and appropriate antibiotic use
MEDICATION REVIEWS AND RECONCILIATION
• Medication review is a process of patients` medicines evaluation in order to
improve the health outcomes and mitigate the drug-related problems
• A systematic review of 38 studies of primary care interventions designed to
reduce medication related adverse events found that most successful
interventions included a medication review conducted by a pharmacist or
other clinicians, or focused on multicomponent interventions, which had a
medication review by a primary care professional as one component.
• Studies showed that pharmacist-led medication reviews reduced hospital
admissions
• Medication reconciliation is the formal process of establishing and
documenting a consistent, definitive list of medicines across transitions of
care and then rectifying any discrepancies.
• Increased medication discrepancies at discharge are associated with an
increased number of prescribed medications, underscoring the need to
address polypharmacy as a multifaceted threat to patient health
AUTOMATED INFORMATION SYSTEM
• A review of 10 randomized trials of computerized interventions found a
reduction in medication errors in half of the studies.
• COMPUTERIZED PROVIDER ORDER ENTRY (CPOE) OR COMPUTERIZED
PRACTITIONER ORDER ENTRY with decision support may be effective if
targeted at a limited number of potentially inappropriate medications and
is designed to reduce the alert burden by focusing on clinically relevant
warnings
• There is substantial evidence which supports the use of CPOE to decrease
the frequency of medication errors in the in-patient setting.
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• One study found that the likelihood of error occurrence was decreased by
48% when an order was processed via CPOE.
• However, there is additional research needed to link a decrease in
medication errors to a decrease in patient harm.
EDUCATION
• Educating health care providers is a key element to improve safety in
primary care.
• This holds true in reducing medication errors where education is often part
of multicomponent interventions
• A review of 47 studies found that educational interventions to improve the
prescription and dispensing of antibiotics may impact on clinician behavior
with improved adherence to guidelines.
• Evidence regarding medication management education targeted at patients
is lacking, but it is an important area for exploration.
• A review found some evidence that patient self-administration of
medication can be as safe or safer than usual care following appropriate
education and preparation.
MULTI-COMPONENT INTERVENTION
• Many studies include more than one intervention.
• Evidence supports the use of multifaceted approaches for improving
medication practices.
• In a review of 10 studies on improving the appropriateness of
polypharmacy in the elderly studies involved complex interventions (the
remaining one employed computer decision support).
• Overall, there were reductions in inappropriate prescribing and the number
of adverse drug events
• Among these, complex interventions employing education, provider
supervision and community case management strategies appeared to be
the most effective
DOUBLE CHECK—OR EVEN TRIPLE CHECK—PROCEDURES
• This is a process whereby another medical staff on the same shift or
an incoming shift reviews all new orders to ensure each patient’s
order is noted and transcribed correctly on the physician’s order and
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the medication administration record (MAR) or the treatment
administration record.
HAVE THE PRESCRIBER (OR ANOTHER MEDICAL STAFF) READ IT BACK
• This is a process whereby a medical staff reads back an order to the
prescribing physician to ensure the ordered medication is transcribed
correctly
CONSIDER USING A NAME ALERT
• Some institutions use name alerts to prevent similar sounding
patient names from potential medication mix up.
• Names such as Johnson and Johnston can lead to easy confusion on
the part of nursing staff.
PLACE A ZERO IN FRONT OF THE DECIMAL POINT
• A dosage of 0.25mg can easily be construed as 25mg without the
zero in front of the decimal point, and this can result in an adverse
outcome for a patient.
RECORDS AND DOCUMENTATION
• This includes proper medication labeling, legible documentation, or
proper recording of administered medication.
ENSURE PROPER STORAGE OF MEDICATIONS FOR PROPER EFFICACY
• Medications that should be refrigerated must be kept refrigerated to
maintain efficacy, and similarly, medications that should be kept at
room temperature should be stored accordingly.
• Most biologicals require refrigeration, and if a multidose vial is used,
it must be labeled to ensure it is not used beyond its expiration date
from the date it was opened.
LEARN YOUR INSTITUTION’S MEDICATION ADMINISTRATION POLICIES,
REGULATIONS, AND GUIDELINES
• This is where education comes into play whereby the institution’s
educator or education department (CME) educates medical
personnel on the content of their medication policy.
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• These policies often contain vital information regarding the
institution’s practices on medication ordering, transcription,
administration, and documentation.
CONSIDER HAVING A DRUG GUIDE AVAILABLE AT ALL TIMES
• Whether it’s print or electronic is a matter of personal (or
institutional) preference, but both are equally valuable in providing
important information on most categories of medication, including:
trade and generic names, therapeutic class, drug-to-drug
interactions, dosing, nursing considerations, side effects/adverse
reactions, and drug cautionaries such as “do not crush, or give with
meals.”
KEY ISSUES
• INJECTION USE
• Injection use may be associated with errors not applicable to oral
preparations.
• A primary concern is the risk of infectious disease transmission.
• Results from the WHO global burden of disease study estimated that
unsafe medical injections led to 340,000 human immunodeficiency
virus (HIV) infections, 15 million hepatitis B infections and three
million cases of bacteremia in 2008
• Other errors associated with injection use include mistakes in weight-
dependent dosing, incorrect reconstitution (including the wrong
concentration or inappropriate diluent), wrong route of
administration and problems with storage (e.g. inappropriate
refrigeration).
• Other issues related to injection use include the need for hepatitis B
vaccination of health workers, and adequate facilities and training for
the safe disposal of used injection equipment
PEDIATRICS
• The off-label and unlicensed use of medicines is widespread, which may
increase the risk of avoidable medication-associated harm
• A small error in dose of medication given to children has a greater risk of
harm compared to the adult population.
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• Pediatric prescribing also requires weight-related dose adjustment and
other dosing calculations, which are less commonly encountered in adult
prescribing
TYPES OF MEDICATION ERRORS
• There are basically four main types of medication errors
1. PRESCRIBING ERRORS
2. DISPENSING ERRORS
3. DRUG ADMINISTRATION ERRORS
4. MONITORING ERRORS & COMPLIANCE ERRORS
1. PRESCRIPTION ERRORS
• Most common type of medication errors.
• Account for 80% of all medication mistakes.
CONTRIBUTING FACTORS FOR PRESCRIPTION ERRORS
• Inadequate knowledge
• Calculation errors & different drug formulations available
• Uncommon dosage regimen frequencies
• Complicated dosage regimens
• Poor patient history taking Use of multiple dosage forms per dose
• Use of abbreviations
• Mental slips
• Lack of adequate resources
• Interruptions while involved in writing prescriptions or orders
• Illegible handwriting & Use of verbal orders.
• Drug name confusion (Look alike Sound alike)
• Inappropriate use of decimal points
METHODS TO MINIMIZE PRESCRIPTION ERRORS
• Ensuring up-to-date reference sources (e.g. BNFs)
• Use of computerized physician order entry.
• Ensuring knowledge of a drug before prescribing.
• Ensuring an accurate drug history is taken.
• Printing the drug name and patient details clearly on the prescription
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• Including all details of drug therapy i.e. name of drug, dose, directions,
duration of therapy
• Avoiding the use of abbreviations
• Being aware of Look-alike and sound alike products.
2. DISPENSING ERRORS
• This error occurs at any stage during the dispensing process (from the
receipt of a prescription to the supply of a dispensed product to the
patient).
• Research estimates that 5% of all prescriptions are dispensed improperly.
• Confusion occurs primarily with drugs that have a similar name or
appearance. Lasix® (frusemide) and Losec® (omeprazole) Confusion also
occurs between amiloride 5mg and amlodipine 5mg tablets.
CONTRIBUTING FACTORS FOR DISPENSING ERRORS
• Confusing the name of one drug with another.
• Two or more drugs have a similar appearance or similar name (look-a-
like/sound-a-like) Selection of the wrong strength/product.
• Lack of knowledge on new medicines.
• Use of outdated and/or incorrect references.
• Poor dispensing procedures with inadequate checking.
• Unreasonable workloads.
• Poor housekeeping standards.
• Distractions and interruptions.
• Dispensing unfamiliar products.
• Dispensing before seeing a written order.
• The use of computerized labelling, transposition and typing errors (most
common causes of dispensing error).
METHODS TO MINIMIZE DISPENSING ERRORS
• Ensuring a safe dispensing procedure.
• Using different brands or separating Look alike and Sound alike products.
• Focusing on the task in hand.
• Keeping interruptions to a minimum.
• Maintaining workload at a safe and manageable level
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• Being aware of high-risk drugs (HAM) e.g. Hypertonic Electrolytes
(Potassium chloride, Calcium chloride, Magnesium Sulphate), cytotoxic
agents, IV Insulin.
• Introducing good housekeeping practices.
3. MEDICINE ADMINISTRATION ERRORS
• Discrepancy between the drug therapy received by the patient and the
drug therapy intended by the prescriber.
• Administration errors account for 26% to 32% of total medication errors.
• Examples of Medication Administration Errors
• Extra Dose Error
• Wrong dose error
• Wrong route error
• Wrong rate error
• Wrong dosage form
• Wrong time error
• Wrong administration technique
• Administration of expired drugs
• Administration of wrong preparation
• Omission Error (e.g.: lack of stock).
CONTRIBUTING FACTORS OF ADMINISTRATION ERRORS
• Failure to check the patient’s identity prior to administration.
• Storage of look-a-like preparations side by side in the drug trolley.
• Environmental factors such as noise, interruptions and poor lighting while
undertaking the drug round.
• Calculation to determine the correct dose where more than one dose is
required.
METHODS TO MINIMIZE ADMINISTRATION ERRORS
• Checking patient’s identity.
• Having dosage calculations checked independently by another healthcare
professional before the drug is administered.
• Having the prescription, the drug and the patient in the same place so they
can be checked against one another.
• Ensuring that medication is given at the correct time.
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• Minimizing interruptions during drug rounds.
ROLE OF A PHARMACIST IN REDUCING MEDICATION ERRORS
• Pharmacist play individual as well as a team player in preventing
medication errors for improvement of patient health.
• The role of pharmacists in medication safety can be categorized in three
major areas which are given below
• Hospital
• Clinical
• Community
• There are three responsibilities of hospital pharmacist for both In and
Outpatient, those are given below
1. DISPENSING AREA’S RESPONSIBILITIES
• Ensure that established policies and procedures are being followed
• Check for accuracy in the work of supportive personnel
• Maintains professional competence
• Ensure that proper techniques are used in extemporaneous
compounding.
2. PATIENT CARE AREA’S RESPONSIBILITIES
• Inspect periodically the medication areas on the nursing unit to
ensure an adequate supply of stock drugs and their proper storage.
• Identifies drug brought into clinic.
• Assist in drug product and entity section.
3. GENERAL RESPONSIBILITIES
• Provide drug information as necessary to pharmacy, medical and
nursing staff.
• Coordinates overall pharmaceutical needs of the ambulatory
services.
• Provide adequate control.
CLINICAL PHARMACISTS PLAYS A VITAL ROLE IN THE HOSPITAL. THEIR
ROLE ARE AS FOLLOWS
• Prescription monitoring.
• Medication history-taking and medicines reconciliation.
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• Communicates patient information to the physician.
• Assist physician to select drug product, dosage form and schedules.
• Patient education and counseling.
• Monitoring the patients total therapeutic drug level, effectiveness, side
effects, toxicities, allergic drug reactions, drug interactions and
appropriate patient outcome.
• Provide drug information to the patient, medical & nursing staff
• Overseeing the ordering and safe storage of medical products and in
some cases, arranging the delivery of prescription medicines to patients.
• Keeping up to date with current pharmacy practice, new drugs and their
uses.
• Managing, supervising and training pharmacy support stuff.


HOSPITAL SIMPLY COULDN’T FUNCTION WITHOUT HIGHLY TRAINED
AND HIGHLY SKILLED PHARMACISTS.

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PHARMACISTS PRODUCE PERSONALIZED MEDICINES ALLOWING FOR
SPECIFIC AND INDIVIDUAL TREATMENT FOR EVERY PATIENT FOR
MEDICATION SAFETY.


PHARMACIST MAKE SURE THAT HOSPITAL HAS THE RIGHT MEDICINES
FOR THE RIGHT PATIENTS, AT THE RIGHT TIME AND THAT THESE ARE
ADMINISTERED IN THE RIGHT WAY FOR MEDICATION SAFETY.

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PHARMACISTS WORKS WITH THE PATIENTS, DOCTORS, NURSES & THE
PUBLIC.


Safety action What is involved Example of impact
Ensure access
to medication
Evaluate ability to
pay for
medication;
explore alternative
medications or
payment means
Finding patient assistance programs or
working with insurers to make
medication available that patients
otherwise could not afford, improving
adherence and safety
Supply
medication
information
Educate patients
and caregivers on
safe and effective
medication use
Reviewing proper dosing with patients
or providers can prevent medication
errors and adverse drug interactions
Evaluate
medication
appropriateness
Assess medication
appropriateness,
effectiveness, and
safety for each
individual patient
Individual consideration of "five rights"
in light of patient condition, medication
list, age, weight, ethnicity, diet, allergies,
and kidney and liver function can result
in recommendations for changes in
therapy or monitoring to increase
medication safety
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Improve
medication
adherence
Help patients take
medication as it is
prescribed
Reviewing how patients are using
medications can result in suggestions for
changes in medication, dosing, or
additional therapies that improve
patient adherence
Provide health
and wellness
services
Deliver direct
health and
wellness service
Blood pressure screenings can reveal
poorly controlled hypertension
Medication
management
Comprehensive
review of patient's
full medication
regimen to ensure
medications work
well together and
avoid problems
(e.g., interaction)

Pharmacist review may determine
which of several medications is causing
an adverse effect; simplify a patient's
medication regimen; identify gaps in
reaching treatment goals; or prevent
prescription of medications that have
adverse interactions
Assess health
status
Determine current
patient status and
medication
effectiveness;
provide guidance
regarding
medication
therapy
Pharmacist may detect dangerously low
or high blood pressure and recommend
changes in medication therapy and
thereby prevent harm
Coordinating
care transitions
Coordinate
medication
management
across care
transitions; assist
with care
coordination for
transitions
Pharmacist-led medication
reconciliation may identify potential
interactions or omissions from
medication list at transitions in care,
which are prone to error.

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MANUFACTURING BULK AND STERILE
INTRODUCTION
• The in-house preparation of drugs in hospital pharmacy may be categorized
into bulk compounding, preparation of nonsterile drugs and sterile
manufacturing.
• The bulk compounding programs is instituted for preparation of drugs not
commercially available and modified formulations to be used for clinical or
investigation purpose.
• Whereby sterile manufacturing is used for preparation of sterile topical
solution, small volume injectables, special sterile products for clinical and
investigational purposes, IV admixtures and total parenteral in the hospital
pharmacy.
BENEFITS OF THE MANUFACTURING BULK AND STERILE
1. Development of a close relationship between hospital pharmacist and the
physicians.
2. Promotion economy within the hospital.
3. Complementing the operation of formulary system.
4. Making drugs available, which are not commercially available.
5. Enabling physician to cope with the problem of unavailability of the drugs
for unusual illnesses.
6. Providing research clinician with the opportunity to develop new
pharmaceutical formulations to be use for clinical or experimental
purposes.
7. Enhancing the prestige of a hospital pharmacist.
IN-HOUSE MANUFACTURING
• A pharmacist must note that in-house manufacturing requires the same
principles, standards and controls as those employed in the commercial
manufacturing.
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• The control refers to testing and verification of a procedure and product
against certain standards.
• Control also means to exercise careful restraining power over various
manufacturing processes so as these processes can result into a product of
required specifications.
• The regulations of good manufacturing practice (cGMP) are useful model
for developing comprehensive control systems.
CONTROL SYSTEMS
MANUFACTURING PROCESS CONTROL
• It is responsibility of hospital pharmacist to make a product which meet
high pharmaceutical standards.
• Adequate controls over manufacturing eventuate into the products
accurate in identity, strength, purity and quality.
• Sufficient packaging and labeling controls prevent product/package/label
mix-ups.
• The good manufacturing practice regulations provide minimum
requirements for the preparation of drug product for administration to
humans with reference to the premises, environment, men, methods,
machinery, documentation, etc.
QUALITY CONTROL
• Quality of a product is its degree of possession of those characteristics
designed and manufactured into it which contribute to performance of an
intended function when it is used as directed.
• Quality control implies procedures by which decision may be made whether
a product is meeting standards established previously.
• The quality control in the pharmacy department falls into the following
categories:
1. Quality control of raw materials.
2. Quality control of instruments used.
3. Quality control of area to ensure the specified pharmaceutical
environment.
4. Quality control of the finished products.
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BUDGETARY CONTROL
• The budgetary control is employed to regulate economic aspects of hospital
pharmacy manufacturing program.
• The feasibility of a manufacturing program in hospital pharmacy depends
on the budgetary control.
• An adequate budgetary control over the manufacturing program requires
careful planning for the manufacturing requirements, raw materials
requirement, manufacturing capacity, available personnel and operating,
costs.
REQUIREMENT FOR MANUFACTURING
MANUFACTURING REQUIREMENTS
• The manufacturing requirements can be estimated in terms of rate or
production volume, batch quantity, or manufacturing frequency.
• The manufacturing requirements of any item depend on its expected
consumption rate.
• The best is to plan for the consumption rate for smaller periods, i.e.,
consumption rate for one quarter of a year.
MATERIAL REQUIREMENTS
• Materials for which the planning is done include raw materials, containers,
labels, ancillary materials.
• The estimated manufacturing requirements provide the basis for the
prediction of materials requirement for a particular manufacturing
program.
• For effective material planning, the required material can be divided into
four quarter to allow an ample time to utilize the basic principles of good
purchasing technique and at the same time ensures against over inventory
and shortage of materials in the pharmacy.
MANUFACTURING CAPACITY
• The type and size of manufacturing equipment required for manufacturing
program vary from institution to institution.
• Modern technology has made possible the availability of equipment that
meet every production needs.
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• These are automatic, semi-automatic or manual equipment and can handle
amounts that are considered to be practical volume/quantity for a
particular hospital.
MANUFACTURING STAFF
• Number of manufacturing staff constitutes pharmacist as a supervisor and
the ancillary personnel.
• The number of manufacturing staff is also a very critical factor for
economics of a bulk compounding program.
• Reduction in labor cost is the aim of an administrator but under no
circumstances should a bulk compounding program be undertaken without
services of a pharmacist.
OPERATING COSTS
• The operating costs include both direct and indirect (overhead) costs.
• The direct cost is price spent on materials and labor involved in
manufacturing.
• On the other hand, the costs of supervisory personnel, space, equipment
depreciation, maintenance, housekeeping, are the indirect or overhead
costs.
• The increase in batch size will, to a point, reduce the unit cost, though this
reduction is not geometrically with the increase in batch size.
MAINTENANCE OF MANUFACTURING EQUIPMENTS
• Maintenance of manufacturing equipment is actually a control over
equipment operation.
• A high investment on pharmaceutical manufacturing equipment and
expense associated with frequent repairs necessitate an equipment
maintenance program to ensure maximum performance with the lowest
possible repair cost.
• The development of an equipment maintenance program would be the
responsibility of a pharmacist.
STERILE MANUFACTURING
• The sterile manufacturing involves the same basic principles as required for
the bulk compounding only difference of more stringent specifications,
sterility and apyrogenicity of the products.
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• Besides various controls discussed earlier, additional environmental
controls are needed for sterile manufacturing.
• Components of sterile manufacturing program are intravenous additive
program and the intravenous additive services.
STERILE MANUFACTURING
• The sterile manufacturing involves the same basic principles as required for
the bulk compounding only difference of more stringent specifications,
sterility and apyrogenicity of the products.
• Besides various controls discussed earlier, additional environmental
controls are needed for sterile manufacturing.
• Components of sterile manufacturing program are intravenous additive
program and the intravenous additive services.
INTRAVENOUS ADDITIVE PROGRAM
• An intravenous additive program deals with policies and procedures for
both, preparation and administration of intravenous fluids to which drugs
are to be added.
• These drugs are incorporated under aseptic conditions.
• The intravenous additive service on the other hand is a part of the I/V
additive program and refers only to the preparation of product.
PREPARATION AND DISPENSING OF I/V ADDITIVE SOLUTIONS
• The pharmacist involved in the I/V preparation program should have an
understanding of parenteral feeding therapy, including knowledge of acid-
base balance, nitrogen balance, fluid and electrolyte therapy, metabolic
and mechanical complications.
• Total parenteral nutrition delivery systems, drug-nutrient and drug-
laboratory interactions.
• Good aseptic technique and experience in preparing intravenous
admixtures is essential.
• The pharmacist should also be aware of current standards and
recommendations on sterile admixtures and quality assurance.
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PARENTERAL HYPERALIMENTATION (TPN)
• Parenteral hyperalimentation is intravenous administration of sufficient
nutrients above the usual basal requirements to achieve tissue synthesis,
positive nitrogen balance and anabolism for specific patients unable to
tolerate any form of enteral feeding (i.e. nasogastric tube) for long term
basis.
• This form of therapy is also known as total parenteral nutrition (TPN).
• The Parenteral hyperalimentation is the part of total care for any patient.
• The Parenteral hyperalimentation is the part of total care for any patient.
• The preparation of parenteral hyperalimentation solutions; therefore, must
an integral part of the pharmacy department's manufacturing program
irrespective of its size.
• The procedures employed for this program are simple and do not require
extensive capital outlay for equipment.
• Most hospital pharmacists prepare these solutions under controlled
environmental conditions provided by laminar flow hoods.
• The pharmacist must have knowledge of preparation methods, stability and
compatibility, facilities, equipment and environment, required for this
program.
STABILITY AND COMPATIBILITY
• The TPN preparation incorporates various ingredients resulting in the
production of very complex pharmaceutical systems, particularly where
lipid is present.
• There is much opportunity for interactions and incompatibilities between
entities possible, leading to impaired therapeutic value of the preparation
or increase risk of its toxicity to patients.
FACILITY AND ENVIRONMENT
• As with all aseptic processes, the environment used for manufacturing can
contribute considerably to product quality and must thus be designed,
cleaned, maintained and monitored to the highest achievable standards.
PERSONNEL AND TRAINING
• Personnel having suitable training should carry out aseptic preparation of
TPN solutions. This should cover not only aseptic technique and validation
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but also theoretical aspects such as patient requirements and use of
products.
DOCUMENTATION
• A work sheet should be generated for each TPN dispensing activity for
recording materials, patient name, label details, etc. Records pertaining to
raw material testing, environmental monitoring, cleaning, operator
training, patients should all form part of the documentation packages
which are developed and retained to best fit the requirements of the
hospital environment and the standards laid down in guide to good
pharmaceutical manufacturing practice.
MANUFACTURING PROCEDURES
• Manufacturing procedures or guidelines should be drawn up jointly by
production and quality control staff depending upon the manufacturing
environment. All personnel involved in the process, updated regularly and
audited periodically should adhere these to ensure conformance. The
preparation of TNP is initiated on receipt of the request.
COLLECTION OF MATERIALS AND PREPARATION
• The first stage in this process will be the identification and collection
together of all materials required to be taken into the aseptic suite. The
components assembled are then checked against the work sheet by the
pharmacist who should initial the sheet.
FORMULATION
• Where more than one TPNs are being processed in the preparation room,
care should be taken to avoid intermixes of source materials, labels, etc. As
with all aseptic operations, materials should be placed well within the
laminar air flow cabinet making use of all the available space and organized
in a manner which will facilitate the pre-defined systematic steps in the
dispensing process and cause minimum disruption of air flow.
INSPECTION
• The completed nutrition bag should be inspected to check for integrity of
all ports, leaks, splits and particulate, for which TPN solutions should
conform to compendial criteria together with the limit test for particulate
matter.
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LABELING
• In general, the following information will be required on the label:
1. Patient name/number
2. Ward
3. Product constituents
4. Batch (dispensing number)
5. Expiry date/time
6. Storage conditions
7. Other instructions such as guidance on administration rate or
technique, limitations on further additions etc., may also be required.
STORAGE
• The compounded TPN Solutions should recommend to be stored at 2 -6°C
to protect it from microbiological and chemical degradation factors. The
bags containing lipid, should not be allowed to freeze and should not be
stored at room temperature for periods in excess of the 12 -24 hours
required for administration.
PACKAGING
• Where supplies of compounded product are to be made to hospitals
patients away from the site of manufacture, the quality of the packaging
system must be validated to comply with quality control standards and to
maintain product temperature during transit. Insulated polystyrene
containers may be useful for this purpose.
DISPENSING
• The TPNs are dispensed according to procedure mentioned above. The
hospital pharmacist may be involved in development of nursing care
guidelines with particular reference to further additions, storage, etc. It
may also be useful for the ward pharmacist to check that TPN is being
correctly administered.
CHARGING OF TPN
• A TPN compounding service within a hospital is a costly venture for the
pharmacy department. Amino acid and lipid presentations are, by their
special nature, expensive items to purchase. Pricing of the prepared TPN
requires the identification of the compounding materials cost and other,
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sometimes not so apparent, costs such as labor input, overheads,
consumables, etc.
• All these factors must be considered when developing true service costs
and deciding whether to produce in-house or obtain product from another
hospital or commercial source.
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THE PHARMACY CENTRAL STERILE SUPPLY
ROOM
DEFINITION
• The central sterile services department (CSSD), also called sterile processing
department (SPD), sterile processing, central supply department (CSD),
or central supply, is an integrated place in hospitals and other health
care facilities that performs sterilization and other actions on medical
devices, equipment and consumables; for subsequent use by health
workers in the operating theatre of the hospital and also for
other aseptic procedures, e.g. catheterization, wound stitching and
bandaging in a medical, surgical, maternity or paediatric ward.
INTRODUCTION
• The sterile supply room (SSR) is a unit dealing with furnishing of
professional sterile supplies to special departments.
• The supplies are
• Single use disposable
• Syringes
• Tubing
• Urine collection sets
• Intravenous administration sets
• Needles
• Gloves
• Blood bags
• The special department supplied with these items include nursing caring
area, physician clinics, special laboratories and operating room.
• Initially, the facility of the central sterile supply room was started as an
equipment washroom with autoclaving facilities.
• Currently a sterile room utilizes the modern production line techniques
with automatic control recording devices to ensure sterility, modern
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washing, drying and powdering equipment for surgical gloves as well as
taking an active role in development of various sterilization techniques.
MISSION OF CSSD
• Timely delivery of sterile goods
• Quality (according to European Standards – EN)
• Efficiency (line process)
ACTIVITIES OF THE CSSD
• Cleaning
• Disinfection of semi / noncritical items
• Sterilization of critical items (high risk for infection)
• Supply of sterile materials
AIM
• Centralizing the activities of receipt, cleaning, assembly, sterilization,
storage and distribution of sterilized materials from a central department
where safe sterilization is done under controlled conditions with adequate
managerial and technical supervision at an optimum cost.
• To provide an efficient, economic, continuous and quality supply of
sterilized material to various areas of the hospital to deliver quality and
infection free patient care.
• Contributes to reduction in hospital infection rate
• To reduce the burden of work of the nursing personnel, thereby enabling
them to devote more of their time to patient care.
FUNCTIONS & ACTIVITY







CSS
D
Rinsi
ng
clea
ning
Dryi
ng
chec
king
steriliz
ation
Labeli
ng
Stora
ge
Issue &
Distribu
tion
Recei
pt
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FUNCTIONS OF CSSD
• Receiving and sorting materials used in the hospital.
• Determining whether the item should be reused or discarded.
• Carry out the process of decontamination or disinfection prior to
sterilization.
• Carry out specialized cleaning of equipment and supplies.
• Inspecting and testing instruments, equipment.
• Assembling treatments trays, instrument sets, etc.
• Packing all materials for sterilization.
• Sterilizing.
• Labeling and dating materials.
• Storing and controlling inventory.
• Issuing and distributing.
ADVANTAGES
1. Bacteriological safe sterilization.
2. Less expensive.
3. Elimination of unsound practices & establishment of standard procedures.
4. Assurance of adequate supply of sterile products immediately and
constantly available for some time as well as emergency use.
5. Conservation of trained staff.
6. Better quality control
7. Better good of material flow
8. Prolonged life by proper care of equipment
PURPOSE
1. the purpose is to provide centralized system for total decontamination in
order to provide professional support.
2. To provide professional support and service for improved patient care.
3. Direct operating room supply.
4. Cleaning and sterilization of hospital items
5. Preparation, packaging and sterilization of items received from pharmacy
for this purpose, if the pharmacy and sterile service is not under one
management.
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6. Preparation of procedural trays and sets used in the care and treatment of
patients.
7. Maintain accurate and current inventory of supplies and equipment in the
department.
8. Maintain an accurate record of the effectiveness of various processes for
cleaning, disinfecting and sterilization.
ORGANIZATION AND MANAGEMENT OF SUPPLY ROOM
ADMINISTRATION SCOPE
• CENTRAL STERILE SUPPLY ROOM
• Operating not under the pharmacy control. Involved in cleaning,
storage and dispensing of specialized equipment's such as suction
pumps, dressing carts.
• In some departments is not a separate department and considered
as a sub department.
• In some other institute's this unit operates under the control of a
division of surgical care established under control of general nurse
and services. In addition to the supply room, this division also
encompasses the operating rooms, recovery rooms and intensive
surgical care unit.
MANAGEMENT CONTROL OF SUPPLY ROOM
• PHARMACIST CONTROL
• Preparation, Storage, distribution of preparation of various sterile
solution same as in pharmacy. Management of a sterile room are the
same as pharmacist undertakes in pharmacy.
• NURSE CONTROL
• Nurse in patient care ultimately use majority of sterilized items
dispensed.
• Nurse has full understanding of intended use of these products.
• PHARMACIST-NURSE DUAL CONTROL
• Has dual function such as cleaning, packaging, distribution of medical
equipment and supplies and manufacture of sterile solution.
• OPERATING SUPERVISORS CONTROL
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• In some institutions, the supply room has not accorded a full
department status and is considered as a sub-department of any
major department. Under this situation
STAFFING OF PERSONNEL IN STERILE ROOM
• Skillful and trained personnel are required, having the knowledge of:
• Sterilization
• Use of autoclave
• Identification of surgical equipment's, dissembling and assembling
the equipment's,
• Decontamination
• Bacteriology and Biological testing
• Training of these personnel by pharmacist director of sterile supply room.
• In case of unavailability of such personnel, individual with scientific
background may be recruited and given on the job training.
HOSPITAL PHARMACIST AS MANAGER OF STERILE ROOM
• Purchasing of supplies
• Receiving and sorting of supplies
• Dispensing of supplies in small lots
• Dispensing of supplies to pavilions
• Charging, inventory and accounting procedure
• Practicing the principles of standardization
• Manufacturing in bulk
• Manufacturing in small lots, both sterile and non-sterile products.
PLANNING OF CSSD DEPT








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LOCATION
• Must be located on areas frequently requiring its services. While selecting
its location, consideration must be given to easy receipt of large quantities
of linen from the laundry, surgical dressings from storeroom and large
shipments of sterile intravenous and irrigation fluids.
• If ideal central location is not possible, efficient transport systems such as
conveyor and pneumatic tube systems (or capsule pipelines Transport
are systems that propel cylindrical containers through networks of tubes by
compressed air or by partial vacuum. They are used for transporting solid
objects) can be provided.
LAYOUT DESIGNING PRINCIPLE
• There is no back tracking of sterile goods.
• One-way movement from receiving counter to issue counter.
• Sterile area should be prior to sterile storage and issue.
• The receiving counter must be away from the issue counter.
• Separate receiving and issuing counter
THERE SHOULD MINIMUM SIX BASIC DIVISION IN CSSD
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STRUCTURAL DESIGN
• The Central Unit comprises of three zones, separated by two distinct barriers.
• One collection window
• One supply window on the other end.

EQUIPMENT IN CSSD
• Cleaning and decontamination devices
• Hot air Oven for drying & heat sterilization
• Glove processing unit for surgical gloves
• Testing apparatus for emergency sterilization
• Others: trolleys, work surface, telephones
• Maintenance and repair of equipment
• Material: chemicals for washing and cleaning
• Steam Boiler
• Hot air ovens for drying instruments
• Autoclaves using dry heat, moist heat.
• Ethylene oxide sterilizers.
• Testing material to check effectiveness of sterilization.
• Sealing machine
Cleaning
Area
Drying Area
Packaging
Area
Sterilization
Area
Storage
Issue
counter
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• Ultrasonic Washer
STORAGE
• After sterilization the sterilized items are kept in different racks as per
labeling.
• Supplied as per the demand of different area.
• To ensure continuous availability of sterile supply five times of daily
requirement should be available in storage.
ROLE OF MANAGER
• Maintenance and repair of equipment
• Inventory management of supplies and consumable
• Ensure quality of sterilization
• Ensure proper distribution and transport
• Cost control measure, to analyze and reduce the number of cycles
• Record keeping and data analysis
• Optimal utilization of manpower and equipment
• Motivation of staff and training
• Inter departmental coordination
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ASEPTIC DISPENSING TECHNIQUE
INTRODUCTION
• Aseptic technique refers to a “procedure that is performed under sterile
conditions”
• Validation is especially important in the aseptic dispensing of individual
products prepared in response to a prescription for a named patient.
• All aspects of the aseptic process, including the technique of the operator,
must be fully validated to ensure that the product prepared is made to the
desired standard and will be of the required quality.
PRESCRIPTION VERIFICATION
• The first step in the aseptic dispensing of an individual product prepared in
response to a prescription for a named patient is verification of the
patient’s prescription. This is a clinical activity to ensure that the product is
appropriate for the individual patient and must therefore be undertaken by
a pharmacist.
WORK SHEET & LABEL GENERATION
• All products should be prepared in accordance with the appropriate
‘master’ worksheet to ensure that they are made consistently to the
required standard.
An individual product worksheet should be generated for each product
prepared, for accountability and traceability purposes.
• Master worksheets should contain product name, product formula,
ingredients to be used, final container to be used for the product, a sample
of the label to be affixed to the final product and step-by-step dispensing
instructions.
• Product worksheet should contain a unique identifying number, patient
information, date of preparation and expiry date of the final product.
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ASSEMBLY OF INGREDIENTS AND CONSUMABLES
• The next stage in aseptic processing is to assemble all the ingredients
and consumables required to prepare the product. The batch numbers and
expiry dates of all drugs and diluents used should be documented on the
product worksheet in accordance with local SOPs.
TRANSFER OF MATERIALS INTO THE CLEAN AIR DEVICE
• Once the ingredients and consumables have been assembled, they are
transferred from the prep room into the clean room via a transfer hatch.
• It is important to follow the correct procedure for transferring materials
into the clean air device, as this will ensure that the risk of contamination is
minimized at this stage of the process.
IN-PROCESS CHECKS
• In-process checking is an important part of GMP. Any checks that are
carried out during the dispensing process should be performed by a
pharmacist or an appropriately accredited aseptic checking technician.
These checks should be documented on the product worksheet in
accordance with local SOPs.
• Checks carried out during the dispensing process would usually include:
o Volumes of liquid used to reconstitute powders
o Volumes of solutions to be added to infusion bags.
PRODUCT RELEASE
• Products should only be approved for release by an authorized pharmacist.
• A final check should be carried out by the authorized pharmacist before
product release. All checks should be documented with a signature.
POINTS TO BE CHECKED BEFORE PRODUCT RELEASE
Before release of the product the authorized pharmacist (AP) must ensure
that:
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o The product complies with the prescription and the appropriate
product specification, transcriptions of the prescription/requisition
details onto the worksheet are correct.
o The correct ingredients, within the expiry dates, have been used.
o All batch numbers, expiry dates and names of manufacturers have
been recorded.
o All in-process checks have been completed and recorded.
o Any syringes used for the final product contain the correct volume.
o A visual inspection of the product is carried out to look for particulate
contamination, precipitation or creaming/cracking, and to ensure
integrity of the final product.
o All part-used and empty ingredient containers are reconciled
label contents are appropriate.
IV ADMIXTURE
INTRODUCTION
• These preparations consist of one or more sterile drug products added to
an IV fluid, such as dextrose, sodium chloride, lactated ringer solution etc.
etc.
• Parenteral comes from a Greek words “Para” and “enteron” = outside the
intestine, Injection medication into veins and through subcutaneous tissue.
• Hospital pharmacist have been involved with the preparation of parenteral
dosage forms for several decades. It has been estimated that 40 % of all
drugs administered in the hospital are given in the form of injection & their
use is increasing. Part of this increase in parental therapy is due to the
wider use of intravenous fluids.
ADVANTAGES
• Used to reach appropriate drug serum levels & for drugs with unreliable
gastrointestinal absorption for the patient who is:
o Unconscious
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o Un co-operative
o Can’t eat by mouth
PHARMACIST ROLE
• Pharmacist is responsible for ensuring that compounded sterile preparation
are properly
o Prepared
o Labeled
o Stored
o Dispensed
o Delivered
CHARACTERISTICS OF IV PREPARATION
• IV preparation are either solution or much less commonly, suspension.
• The body is primarily an aqueous or water containing vehicle & so most
parenteral preparation introduced into the body are made up of
ingredients placed in a sterile water medium.
• Some parenteral preparation, however may be oleaginous or oily e.g. an
emulsion containing fat may be administered in some cases to supply extra
calories to patient who cannot or will not feed themselves & who need
more calories than can be supplied by dextrose in water/or amino acids in
TPN.
• Parenteral preparation must also have chemical properties that will not
damage the vessels or blood cells or alter the chemical properties of the
blood stream.
• IV solutions must be iso-tonic & iso-tonic with the blood. The osmolality of
blood serum is approx. 285 mOsm/L. An example of isotonic solution is 0.9
% normal saline.
METHOD OF INJECTION
• Bolus or injection.
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• The injection is performed using a syringe. Many injectables come
prepackaged in the form of filled, disposable plastic syringe.
• At other times, the injectable drugs must be taken up into the syringe from
a single or multi dose glass or plastic vial or form a glass ampoule.
• In some cases, as with lyophilized powder, the solid drug in the vial has to
be reconstituted by addition of liquid (generally WFI) before use. A vial may
be colored or amber colored. The amber color protects the drug form
exposure to light.
• IV infusion administer large amount of liquid into the blood stream, over
prolonged periods of time. The route of administration is used to deliver
blood, water other fluids, nutrient such as lipids & sugars, electrolyte &
drugs.
EQUIPMENT USED IN IV PREPARATION
1. Syringes & needle
2. IV set
3. Filters
4. Catheters
5. Pump & controller
1. SYRINGE & NEEDLE
• Syringe, used for IV push & in the preparation of infusion, are made
of glass or plastic.
• Glass syringes are more expensive, & their use is limited to
medications that are absorbed by plastic.
• Plastic syringe, besides being less expensive, also have the
advantages of being disposable & they come from the manufacturer
in a sterile packaging.
• A needle consists of
o The canula or shaft.
o The hub (the part attaches to the syringe)
o Needles are made of stainless steel or aluminum.
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2. IV SET
• An IV administration set is sterile, pyrogen free disposable device
used to deliver IV fluids to patients.
• The IV container is vented or unvented glass bottle or a flexible,
vented plastic bag.
• The set may come in sterile packaging & sealed plastic wrap or it may
be sterilized before use by means of radiation or ethylene oxide.
• Sets do not carry expiration dates but do carry the following ligand:
“Federal law restricts this device to sale by or on the ordered of
physician.”
• Nurses generally have the responsibility for attaching IV tubing to the
fluid container, establishing & maintain flow rate, & overall
regulation of the system.
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IV SETS HAVE CERTAIN BASIC COMPONENTS
• SPIKE
Spike is a rigid, sharpened plastic piece used proximal to the IV fluid
container. Spike is covered with protective unit to maintain sterility &
removed only when ready for insertion into the IV container.
If an air vent is present on a set, it is located below the spike. The air vent
points downward & has a bacterial filter covering. The vent allows air to
enter the bottles as fluid flows out of it. Some bottles don’t have an air
tube. For these a vent system is necessary.
• A DRIP CHAMBER
Hollow chamber located below the set’s spike. Drops of fluid fall into the
chamber from an opening at the upper most end, closest to the spike. The
number of drops it takes to make 1mL identifies an IV set. This calibration is
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referred to as drop set. The most common IV drops sets are 10,15,20 & 60
gtt/ml.
An opening that provides 10,15 or 20 gtt/ml is used for adults, 60 gtt/ml for
pediatric patients.
Drip chamber serves to prevent air bubbles from entering the tubing.
• CONTROL CLAMP
Clamps allow for adjusting the rate of the flow & for shutting down the
flow. Clamps may be located at any position along the flexible tubing.
Three types of clamps are commonly used for IV solution
o Slide clamp
o Screw clamp
o Roller clamp
• FLEXIBLE TUBING
Tube is specially designed for our flow regulator to offer a reliable flow
regulation over time.
• NEEDLE ADAPTER
Needle adapter is usually located at the distal end of IV set, close to the
patient. A needle or catheter may be attached to the adapter.
The adapter has a standard taper to fit all needles or catheters & is covered
by a sterile cover before removal for connection.
• Y-SITES/INJECTION PORT
Y-site is an injection port found on most sets. The Y is a rigid plastic piece
with one arm terminating in a resalable port. The port, once disinfected
with alcohol, is ready for the insertion of a needle and the injection of
medications.

• IN-LINE FILTER
A set may have a built-in or in-line filter, which provides a final filtration of
the fluid before it enters the patients. Final filtration should protect the
patient against particulate matter, bacteria, air emboli.
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3. FILTERS
• Device used to remove contaminants such as glass, paints, fibers &
rubber core.
• Filters do not remove virus particles or toxin.
• Filters sizes are as follow:
o 5.0 micron
❖ Micron random path membrane filter, removes large
particulate matter
o 0.45 micron
❖ In line filter for IV suspension drug.
o 0.22 micron
❖ 0.22 micron-removes bacteria & produces a sterile
solution
4. CATHETERS
• Needle like devices.
• These are the devices that are inserted into vein for direct access to
the blood vascular system.

PERIPHERAL VENOUS CATHETER
• Inserted into veins close to the surface of the skin & used for up to 72
hours.
• Easy to insert
Catheters
Central
venous
Peripheral
venous
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• Usually inserted in the sites on the arms or hands but can also be
inserted in the feet & scalp if the nurse & physician cannot locate
“good" veins in the arm & hand.
DISADVANTAGE
• Cause pain & irritation in 20-50 % patients
• Some drugs cause vein irritation because of their drug inherent
properties.
CENTRAL VENOUS CATHETERS
• Used to dilute hypertonic solution such as TPN solution or potentially
toxic drugs such as cancer chemotherapeutic agent.
• These catheters are placed deeper in the body.
• They are more complicated to place & are inserted by a physician to
minimize the risk of infection.
• Commonly used for therapy of 1-2 week or even longer in some
cases.
• Site for insertion:
o Subclavian vein
o Jugular vein
o Femoral vein






Peripheral venous Central venous
catheters catheter

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5. PUMPS & CONTROLLERS
• Fluids & drugs are often delivered to catheters by some form of
device, including electronic devices, to control the infusion rate.
• These devices are the pumps & controllers.
• In this system fluid is run into the cylinder & the nurse can add drug
in the top of the cylinder injection port for dilution & mixing of the
drug before it is infused. Better system than syringe system because
the drug is being diluted in the cylinder & it can be infused over a
long period of time.
• Problem:
Potential drug incompatibility (a drug cannot be identified once it is
injected into the cylinder)
CONTROLLERS
• These are low-pressure devices of 2-3 pounds per square inch.
• The pressure of controller is generated by gravity.
• Flow rate is controlled by the rate of fluids drops falling through a
counting chamber. Maximum flow rate is 400 ml/hr.
• The low pressure of controllers is less likely to cause vein breakdown
of infiltration.
• Most popular devices are the infusion pump that Produce a positive
pressure of 10-25 psi & more accurate than controllers. Maximum
flow is 999ml/hr therefore providing a higher rate of infusion.
PREPARATION OF IV ADMIXTURE
• The pharmacist must be knowledgeable in preparing a form for the
combination of drugs and IV solutions that will be suitable for
administration to the patient.
• Products used in preparing the admixture must be sterile and not
contaminated.
• Proper conditions for aseptic handling can be provided by laminar-flow
hoods.
• IV push and IV infusion dose forms are prepared in the laminar-flow hoods.
• Follow proper procedures for handling sterile devices & medication
container to ensure an accurate microbial free product.
• Plunger & tip of the syringe should be sterile & must not be touched.
• Electrolytes, vitamins & minerals are commonly added to IV solution.
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• Theses medication may be packaged in vials or ampoules.
• Some products come from manufacture ready to use; Others (for stability
reason) come in dry powder that must be reconstituted before they can be
added to the IV admixture.
IV SOLUTION
• Most IV, Intrathecal, intra-arterial & intracardiac injection will be solution &
preservative free SWFI or normal saline will be used as diluents.
• A diluent is the sterile fluid to be added to a powder to reconstitute or
dissolve the medication.
• Another common diluent is BWFI which contains preservatives for multiple
uses.
• The vehicle most commonly used for IV infusion are
o Dextrose in water
o NS solution
o Dextrose in saline solution.
TWO MAIN TYPES OF IV SOLUTION
1. Small-volume parenteral (SVPs) of 50 or 100 ml
2. Large-volume parenteral (LVPs) of more than 100 ml
• SVPs are typically used for delivering medication at a controlled infusion
rate.
• LVPs are used to replenish fluids, to provide electrolytes, & to provide
nutrients such as vitamins & glucose. LVPs are commonly available in
250,500- & 1000-mL sizes.
• In some cases, a medication is preferred specifically to deliver a medication.
In other case a medication is “piggy backed” onto a running IV.
PIGGYBACK
• It involves the preparation of a small amount of solution usually 50 to 100
ml, in a mini bag or bottles.
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• Some IV piggybacks are prepared in 250 ml solution because they contain a
medication that is irritating to the veins & thus require a large volume of
solution.
• The piggyback solution is infused into the tubing of the running IV, usually
over a short time, from 30 min to 1 hour. In some cases, syringes are used
instead of piggyback containers to deliver medication into running IV.
PREPARING A LABEL FOR AN IV ADMIXTURE
• When making an IV admixture, a label must also be prepared. The label
should contain the following information:
o Patient’s name & identification no
o Room number
o Fluid & amount
o Drug name & strength
o Infusion period
o Flow rate
o Expiration date & time
o Additional information as required by the institution or federal
guidelines, including auxiliary labeling, storage requirement & device
specification information.
CYTOTOXIC DRUG DISPENSING
DEFINITION
• An agent that possesses a specific destructive action on certain cells or that
may be genotoxic, oncogenic, mutagenic, teratogenic, or hazardous to cells
in any way and includes most anti-cancer drugs.
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INTRODUCTION
• Cytotoxic drugs are potentially hazardous to Health Service Staff, who are
involved in their handling, preparation, distribution, administration, and to
patients receiving them.
ACCOUNTABLE PRACTIONERS
• Medical staff
• Pharmacist
• Nurses
TRAINING AND ASSESSMENT OF COMPETENCE
• All staff who have received training must have names entered onto a
central file - kept by Senior Pharmacist.
CYTOTOXIC DRUG PRESCRIPTION
• Must be prescribed on
a. Preprinted cytotoxic prescription charts.
b. Computerized prescription.
• The prescription must be authorized by qualified doctor i.e. consultant
designated for that patient or Senior Specialist Registrar specializing in
Hematology or Oncology according to agreed protocols.
AREAS OF SKILL NEEDED FOR PHARMACIST
• Safe handling
• Preparation areas
• Techniques and precautions
• Prevention of aerosol formation from cytotoxic vials
• Waste disposal
WORKING AREA
• Use of laminar air flow safety cabinet provides protection.
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• There are two types of laminar flow safety cabinets.
o Type A
o Type B
PREPARATION AREA
• The ventilation of area should be adequate, but doors and windows should
be closed to exclude draughts.
• Working surface should be non-porous to substances being be handled &
be easily cleaned.
• The equipment & stocks of cytotoxic drugs should be arranged in a safe and
orderly manner to avoid accidents.
• Neutralizing solutions to cope with spills should also be close to hand.
PRECAUTIONS
• Prohibiting eating, drinking, smoking and application of cosmetics in the
work area prevent ingestion.
1. Wearing of suitable
2. Protective clothing.
3. Gloves
4. Surgical face masks
5. Goggles
• Gloves should be long enough to cover wrist cuffs of the gown.
• Gloves should be changed after each procedure, or if overt contamination
or perforation occurs.
PACKAGING
• Cytotoxic agents should be packaged in a sealed, leak-proof container, with
outer bags heat-sealed where possible.
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• The container should protect the agents from breakage in transit, contain
leakage if breakage occurs and have a childproof lid.
LABELLING
• All cytotoxic agents should be labelled with purple cytotoxic warning labels.
• All labels for parenteral cytotoxic drugs should comply with national
regulations
o Contain the word “Cytotoxic” on yellow labels
o Intended route of administration
o Name of the drug
o Quantity of the drug
o Vehicle containing the drug (infusion solution as appropriate)
o Final volume
o Batch number allocated to the product
o Expiry date and time where applicable
o Storage conditions that ensure stability
o Patients name and location and hospital number
o Name and address of the cytotoxic dispensary.
• All labels for oral cytotoxic chemotherapy should
o Comply with national regulations
o Contains the word “Caution Cytotoxic”
o Intended route of administration.
TRANSPORT
• Cytotoxic agents should be transported in sealed impervious containers
resistant to breakage.
• Containers should be returned to pharmacy after use.
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• For inter hospital transport or transport to the patient's home, a contact
telephone and instructions in the event of a spill should be included.
STORAGE
• Clearly marked storage areas must be available for all cytotoxic agents.
• Safe storage areas must be designed to minimize the risk of breakage and
to contain spills.
• Cytotoxic agents must not be stored in food storage and preparation areas.
DISPENSING
• Requests for the dispensing of parenteral cytotoxic drugs must be referred
to a senior pharmacist.
THE SENIOR PHARMACIST UNDERTAKES THE FOLLOWING ACTIONS
1. Contact the Ward Manager for the area of intended administration to
assess the need for an urgent risk assessment.
2. Completion of a Trust Incident form.
3. Request a protocol/reference from prescriber.
4. Contact the Consultant responsible for prescribing the medication, checking
on familiarity with this policy.
5. Contact the Ward Pharmacist for the relevant ward.
After consideration of the above, make a decision whether to supply based on the
identified risks involved. All parenteral cytotoxic drugs should be dispensed in a
ready-to-use form by the production unit.
All dispensing of parenteral cytotoxic drug therapy must take place using an
approved worksheet.
ADMINISTRATION PROCEDURES
• Ascertain administration and management details of specific cytotoxic
agents.
• Ensure the child and family are involved in the process, encourage them to
alert staff of any problems.
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• Maintain close supervision of the patient.
ROUTES OF ADMINISTRATION OF CYTOTOXIC AGENTS
• Intravenous
• Oral
• Subcutaneous
• Intrathecal
ADMINISTRATION EQUIPMENT
THE USE OF THE FOLLOWING EQUIPMENT IS RECOMMENDED:
• Needleless administration systems
• Notable trolleys
• Disposable injection trays, dressing packs and medication cups
PATIENT CARE
• Cytotoxic agents are primarily eliminated from the patient by renal and
hepatic excretion.
• All body substances may be contaminated with either the unchanged agent
or active agent metabolites.
• The period during which body substances may be contaminated with
cytotoxic agents will differ for individual agents and patients.
PERSONAL CONTAMINATION
It may result due to:
1. Agent preparation,
2. Agent administration.
3. Handling patient waste.
4. Transport.
5. Waste disposal or spills.
HOW WE CAN AVOID SKIN CONTACT WITH CYTOTOXIC DRUGS
SKIN EXPOSURE
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181. GM Hamad

• Remove contaminated clothing.
• Wash the affected skin and flush thoroughly with running water.
EYE EXPOSURE
• Immediately flood the eye with clean water by continuous irrigation for a
period of 15 minutes.
NEEDLE STICK INJURIES
• Wash thoroughly as for skin exposure, do not administer antiseptic or
anesthetic drops or ointments.

SEMI STERILE DISPENSING
• Those products that are manufactured in class 1000 area according to the
federal standard 209 and are not intended to be directly injected into blood
stream.
• Class 1000: Particle count not to exceed a total of 1000 particles per cubic
foot of a size of 0.5 micron and larger or 10 particles per cubic foot of a size
5 micron or larger.
EXAMPLES
OPHTHALMIC PREPARATION
• Eye drops
• Eye Lotions
• Semi Solid Eye preparations
• Ophthalmic inserts
EAR PREPARATION
• Ear drops and Ear sprays
• Semi Solid Ear preparation
• Ear powders
• Ear washes

EYE DROPS
• Eye drops are sterile aqueous solutions or suspensions of drug having anti-
septic, anesthetic, anti - inflammatory, mydriatic or meiotic properties,
instilled into the conjunctiva sac with a dropper.
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182. GM Hamad

FORMULATIONS REQUIREMENT


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183. GM Hamad


205

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185. GM Hamad


STERILITY TEST
• Remove the applicator `from its package and transfer it to
a tube of culture medium so that it is completely
immersed. Incubate and interpret the results.

EAR DROPS
• Ear drops are simple solutions (alcoholic or glycerin)
used to treat or prevent ear infection, especially
infection of outer ear and ear canal (otitis externa).

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186. GM Hamad

FORMULATION OF EAR DROPS
• Antibiotics: used in combination with other solvents.
• Solvents: containing glycerin, vegetable oils, mineral oil, and PEG 300.
• Analgesics: for ear pain
• Preservatives: benzalkonium chloride.
CONTAINER
• Ear drops are dispensed in multi dose containers of glass or suitable plastic
fitted with integral dropper or rubber or plastic teats.
• Colored fluted bottles with dropper and plastic screw cap closure may be
used.
• E.g. hydrogen peroxide ear drops, and phenol ear drops
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187. GM Hamad

ROLE OF PHARMACIST IN SMALL HOSPITALS
AND NURSING HOMES
NURSING HOME
A residential facility for people with chronic illness or disability. Also known as a
convalescent home and long-term care facility.
Includes adults who suffer from chronic (long-lasting) or such illnesses as stroke
or Alzheimer’s disease.
Both medical and residential care is provided.
METHODS OF HANDLING DRUGS IN HOSPITALS WITHOUT PHARMACIST
Most extended care facilities and small hospitals do not employ full time
pharmacist, many of them contract for such services.
Medical staff rely upon community pharmacist to dispense medication from local
pharmacy and deliver the facility.
Pharmacy service in small hospital is provided by department of pharmacy of a
nearby large hospital.
EXTENDED CARE FACILITY AND PHARMACY DEPARTMENT
If extended care facility has pharmacy department, a licensed pharmacist is
employed to administrate pharmacy department.
If no pharmacy departs. Then prompt & convenient obtaining required drugs &
biologicals from community pharmacist.
If facility has only drug room where bulk drugs are stored, consultant pharmacist
is responsible for control of bulk drugs.
Consultant pharmacist dispenses drug from drug room properly labels and make
them available for nursing personnel.

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188. GM Hamad

SMALL-LARGE HOSPITAL RELATIONSHIP
Sharing of departments like
• Pharmacy
• Radiology
• Pathology
Services are provided by the pharmacist on call in large hospitals.
ROLES OF PHARMACIST IN EXTENDED CARE FACILITY (ECF)
DRUG REGIMEN REVIEW
Encompasses the clinical activities of consultant pharmacist.
Drug regimen must be reviewed at least monthly by pharmacist, any irregularity
found during review must be reported to physician and director of nursing.
Examples of irregularities include
• Use of three or more analgesics at a same time.
• Use of iron therapy without red blood cells assessment.
• Concurrent use of two or more hypnotics.
Pharmacist should check medication order. Appropriate medication order
includes:
• Drug
• Dose
• Route of administration
• Frequency
• Reason of use.

UNNECESSARY DRUG REGULATIONS
To improve the quality of care in the nursing facilities. This regulation require that
patients drug regimen should be free from unnecessary drugs.
Use of antipsychotics.
MEDICATION ERROR AND ADRS
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189. GM Hamad

The consultant pharmacist should report and document any drug irregularities,
drug interaction and clinical recommendations promptly to the attending
physician or nurse-in-charge and the nursing home administrator.
Drug interactions, including interactions between prescription drugs and over-
the-counter drugs, drugs and disease, and interactions between drugs and
nutrients.
Contraindications and precautions.
MEDICATION PASS OBSERVATION
To observe the preparation and administration of medication.
Compare medication label with med. administration sheet
• Ensure drug dose, time
• 5 RIGHTS (resident, drug, dose, time and route)
Adequate hydration when administering drug.
The consultant pharmacist should ensure the automatic stop order in case where
duration and number of doses is not specified.
The consultant pharmacist ensures that all known allergies are documented in
plain view in the patient's medical record.
Periodic inspection of nursing station medication cabinet to ensure external &
internal medicines
• Are separately placed.
• No outdated med.
• Proper record of narcotics being administered to the patient.
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190. GM Hamad

PURCHASING DISTRIBUTION AND CONTROL
OF HOSPITAL MEDICINES, MEDICAL &
SURGICAL SUPPLIES
PURCHASING
• A continuous supply of pharmaceutical essentials need to be bought to
maintain the inventory.
SIGNIFICANCE













LAW FOR CONTROLLED DRUGS
• Hospital is fully authorized to purchase medicines and allied products in
consideration with its needs and demands, However, purchasing of
controlled drugs and alcohol is regulated by Federal Government.
• This is done on the purpose to ensure rational use of these drugs, accurate
purchase and inventory control.
Purchasing is most important phase
in Successful Operation of Hospital
pharmacy
It is main stream function of
Hospital Pharmacy.
Hospital Pharmacist Is most
authorized person responsible for
proper functioning of Hospital
pharmacy.
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191. GM Hamad

AUTHORITY OF PURCHASING DRUG
• PURCHASING AGENT VS PHARMACIST
• TWO DIFFERENT SCHOOL OF THOUGHTS
o One School believes that all institutional purchasing should be
centralized under aegis of all the purchasing agent.
o The Other school believes that pharmaceutical and related items
constitute specialties which require technical skill of a formally
trained individual for their proper selection and purchase.
• ASHP defining minimum standards for pharmacies in hospital states:
o The pharmacist In charge shall be responsible for specifications both
as quality and source of purchase for all drugs, chemical, antibiotics,
biologics and pharmaceutical preparations used in treatment of
patients.
• CONCLUSION
o Considering the International Standards defined by ASHP.
o It Is thereby drawn conclusive remarks that:
Purchasing agent may have authority to purchase drugs, but he will
have to follow specifications defined by pharmacist for purchasing
pharmaceuticals and allied products.
PROCUREMENT PROCEDURES
• Hospital Pharmacist happens to be most influential personnel in hospital
pharmacy is charged with important responsibility of considering following
parameters while choosing manufacturer or source of supply:
o Price
o Terms
o Shipping Time
o Dependability
o Quality of Service
o Returned Good policy and packaging
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192. GM Hamad

PURCHASING METHODS

1. DIRECT PURCHASE
• This Is direct procurement of drugs and allied items from
manufacturer or wholesaler.
• This type of purchasing is without any discount.
• This is not usual practice.
2. BID FROM MANUFACTURER
• Pharmacist estimates drug usage and reputable manufacturers are
invited.
• Manufacturers submit their bid quotation.
• Preference is given to company with the lowest price yet with
standard quality.
• There should be some arrangement for analytical and clinical testing.
3. PURCHASE FROM LOCAL RETAIL PHARMACY
• It is costly.
• Emergency purchases only.
4. CONTRACT PURCHASE
• This system is also known as PRIME-VENDOR SYSTEM.
1.Direct
purchase from
manufacturer
or wholesaler
2. Bid from
either
manufacturer
Or wholesaler
3.Purchase
from local
retail
pharmacy
4.Contract
purchase
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193. GM Hamad

• Institution and a single supplier enter into a contract for supply of
drug products, whenever needed, for specified period of time.
• Thus, multi purchase orders are eliminated and order can be e-
mailed on a daily basis.
• Vendor provides materials to hospital for small percentage fee.
PURCHASING PROCEDURE











PURCHASE REQUEST FORM
• It contains the description, specification, quantity, price and packaging of
the drug in question.
• Pharmacist sends it to the purchasing department.
• Purchasing department sends it for the approval to the administration.
• Forwarded to the purchasing agent.
• A copy of the form is kept by each department as a record.
PURCHASE ORDER FORM
• It is prepared by the purchasing agent in accordance with the purchase
order form.
• This is then sent to the different vendors or the respective parties involved.
Specifications are defined
Fill purchase request form
Forward to administrative officer
Upon approval, forward to purchasing agent
Prepare Official purchase order
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194. GM Hamad

PURCHASE RECORD FORM
• Once the required merchandise is received, it becomes mandatory on
Pharmacist to record transaction of each item received on purchase record
form.
• This will help him in determining rate of use, cost of pharmaceuticals,
source of supply etc.
RECEIVING DRUG
• Drug must be delivered direct to the pharmacy department.
• Delivery of all the drugs must be checked against the hospital purchase
order forms.
• Expiry dates, batch number and manufacturer must be recorded.
• The Pharmacist must ensure that records and forms provide proper control
upon receipt of drugs.
• All drugs should be placed into stock promptly upon receipt.
DISCOUNTS IN PURCHASING
1. Volume Contracts
2. Deals
3. Discounts
1. VOLUME CONTRACTS
• It Includes contracts to cover total purchases of pharmaceutical
goods. i.e. tablets, parenteral solution, ampoules etc.
• At the end of contract if goal is achieved rebate check is given.
• This method is usually offered by majority of manufacturers.
2. DEALS
• Receiving certain quantities of products on bonus at no additional
cost.
For Example:
• One free with purchase of dozen.
3. DISCOUNTS
• May be given to an institution for prompt payment of its drug bills
• Other types of discounts are also available from the manufacturer
• Hospital pharmacist should immediately investigate the discount
policy of every new firm with which he deals.
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195. GM Hamad

DISTRIBUTION
DEFINITION
• The supply delivery and transitory storage of drugs at patient care areas
(Nursing Stations) other than main hospital pharmacy for subsequent
patient’s utilization is called distribution.
DISTRIBUTION PROCEDURES

DISTRIBUTION OF SURGICAL SUPPLIES
• Many items involved in ancillary categories can be routinely handled by
pharmacists and all of the following items comes under horizon of his
professional responsibilities.
o Surgical dressings.
o Operation Room Supplies.
o Sutures and Ligatures.
DISTRIBUTION OF CONTROLLED DRUGS
• Controlled drugs are distributed and dispensed with additional care to
avoid their abuse.
INDIVIDUAL
DRUG ORDER
SYSTEM
FLOOR STOCK
SYSTEM
COMBINED
INDIVIDUAL
FLOOR STOCK
SYSTEM
UNIT DOSE
DISTRIBUTION
SYSTEM
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196. GM Hamad

• Examples:
o Nicotine
o Morphine
o Cocaine
CONTROL
INTRODUCTION
• Dictionary defines Control as “to exercise, directing, guiding or retaining
power over “
• Control precisely includes all those measures which are taken in order.
o To maintain past records.
o To ensure proper storage.
o To keep checks and balances.
INVENTORY
• An inventory is a complete itemized list of goods with their estimated
worth present in the stock.
• Usually it is defined as an annual account of stock.
TYPE OF INVENTORY REASON FOR HOLDING THE
INVENTORY
1. Raw materials To reap the price advantage available
on seasonal raw materials.
2. Work in progress To balance the production flow.
3. Readymade components When the components are bought
rather than made.
4. Scraps They are disposal of in bulk.
5. Finished Goods Lying in stock rooms and waiting
dispatches
OBJECTIVES OF INVENTORY CONTROL
• Protection against fluctuations in demand.
• Better use of men, machines and material.
• Protection against fluctuations in output.
• Control of stock volume.
• Control of stock distribution.
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197. GM Hamad

INVENTORY ‘MANAGEMENT’ SPECIFIES
1. Obtaining.
2. Managing.
3. Maintaining of drugs and medical supplies in a pharmacy.
DEFINITION OF INVENTORY CONTROL
• Inventory control is the technique of maintaining the size of the inventory
at some desired level keeping in view the best economic interest of an
organization.
MAJOR ACTIVITIES OF INVENTORY CONTROL
• Planning the inventories.
• Procurement of inventories.
• Receiving and inspection of inventories.
• Storing and issuing the inventories.
• Recording the receipt and issues of inventories.
• Physical verification of inventories.
• Follow-up function.
• Material standardization and substitution.
INVENTORY DECISIONS
• Executive decide two basic issues while dealing with inventories:
o How much of an item to order when the inventory of that item is to
be replenished.
o When to replenish the inventory of that item.
INVENTORY SYSTEM
• Inventory system is a set of policies and controls which monitors and
determines the levels of inventory. Inventory conventionally include raw
materials, work-in-progress, components parts, supplies and finished
goods. Operations is a transformation process in which the inputs are raw
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198. GM Hamad

materials and output is the finished goods.

STEPS IN INVENTORY CONTROL
• Method of control through turn over
• Deciding the maximum, minimum limits of inventory.
• Determination of reorder point.
• Determination of reorder quantity.
• ABC analysis.
• Perpetual inventory control.
1. INVENTORY TURNOVER
• The Inventory turnover is a measure of the number of times
inventory is sold or used in a time period such as a year.
• COMPUTATION OF INVENTORY TURN OVER
o Computation of inventory turnover =
??????&#3627408476;&#3627408480;&#3627408481; &#3627408476;&#3627408467; &#3627408468;&#3627408476;&#3627408476;&#3627408465;&#3627408480;
????????????&#3627408466;&#3627408479;??????&#3627408468;&#3627408466; ??????&#3627408475;??????&#3627408466;&#3627408475;&#3627408481;&#3627408476;&#3627408479;??????

• LOW INVENTORY TURNOVER
Indicates:
o Difficulty in selling.
o Duplication of stock.
o Dead inventory.
o Large purchases of slow-moving items.
Low inventory turnover is a sign of inefficiency.
Suppliers
Raw
materials
Productio
n
work-in-
progress
Finished
good
Customers
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199. GM Hamad

• HIGH INVENTORY TURNOVER
Indicates:
o Ease of selling.
o Small purchasing volume.
A high inventory turnover is indicative of better inventory
management.
However, small volume purchases have a disadvantage of missing
out on bulk purchase discounts.
2. MAXIMUM STOCK LEVEL
• Quantity of inventory above which should not be allowed to be kept.
• This quantity is fixed keeping in view the disadvantages of
overstocking.
• Factors to be considered:
o Amount of capital available.
o Godown space available.
o Possibility of loss.
o Cost of maintaining stores.
o Likely fluctuation in prices.
o Seasonal nature of supply of material.
o Restriction imposed by govt.
o Possibility of change in fashion and habit.
3. MINIMUM STOCK LEVEL
• This represents the quantity below which stocks should not be
allowed to fall.
• The level is fixed for all items of stores and the following factors are
taken into account:
o Lead time
o Rate of consumption of the material during the lead time.
LEAD TIME
o Lead time is the “time lapse between placement of an order
and time it is received“
4. RE-ORDERING LEVEL
• It is the point at which if stock of the material in store approaches,
the storekeeper should initiate the purchase requisition for fresh
supply of material.
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200. GM Hamad

• This level is fixed somewhere between maximum and minimum level.
5. ECONOMIC ORDER QUANTITY
• It is also known as standard order quantity, optimum quantity or
economic lot size.
• By definition economic order quantity is that size of order for which
the total cost is minimum.
COMPUTATION OF EOQ
o The widely used formula is
EOQ =√
????????????????????????
????????????

Where,
R= Annual quantity to be used in units.
Cp=Cost of placing an Order.
Ch= cost of holding one unit for one year.
6. ABC ANALYSIS
• It is efficient control of stores requires greater in case of costlier items.
• On basis of their value, the drugs are classified into 3 classes: highest,
medium and low-value drugs.
ITEM QUALITY QUANTITY ORDER CHECKING
A Costlier Less
Regular system to
see that there is
no overstocking as
well as that there
is no danger of
production being
interrupted for
unwanted
material.
B Less Costly
Order may be on
review basis.
Position being
viewed in each
month
C Economical Larger
Order in large
quantity so that
cost can be
avoided
7. PERPETUAL INVENTORY SYSTEM
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201. GM Hamad

• It is a method of recording stores balances after every receipt and issue,
to facilitate regular checking and obviate closing down for stock taking.
QUALITY OF DRUGS
• Manufacturers not listed in CLASS A group.
• Qualified supplier list.
• Suppliers application form.
DRUG STORAGE
• Storage is an important aspect of total drug control and inventory system.
• Storage cost for each drug is considered before determining the EOQ.
• The cost of storage usually involves, humidity control, temperature,
ventilation, labor, segregation etc.
• While in storage the drugs can be marked with ‘shelf stripping’ or ‘floor
marking’
• The label includes the identification of the drug, receiving date, expiry date
and its price.
CONTROL OF DATED OR PERISHABLE INVENTORY
• Dated Inventory require special control to ensure potency at time of
dispensing.
• Example:
o Biological
o Antibiotics
• Each dated product is entered on record of dated pharmaceuticals.
• Which helps pharmacist to tell which product is expiring in one glance.
INVENTORY AND CLINICAL PHARMACY SERVICES
• The ultimate goal of all these processes is to optimize patient care.
• A good inventory management system ensures a continuous supply of the
right drug of the right quality to fulfill the patients’ needs.
• Inventory management also makes the patient care more cost effective by
minimizing the losses and making health care more economical for the
patients.
• A well-maintained inventory would also mean that each and every drug
consumed in the hospital would have a maximum therapeutic value with
regard to its shelf life.
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202. GM Hamad

RECORD KEEPING
• It is important to keep record of each transaction by each department.
• For example, copies of purchase request forms, purchase order forms,
receiving order forms and invoices are kept by the pharmacist, purchasing
agent, the administration of the hospital and also the vendor.
• A ‘history’ copy of each form is also kept in the hospital files.
• The records are necessary for future references, any budgeting problems or
legal matters.
• Records required are:
o Purchase and inventory records.
o Controlled substances inventory and dispensing records.
o Medication orders and their processing.
o Manufacturing and packaging production records.
DIGITALIZATION
• There is inventory management software available (e.g. WorkflowRx and
MedPortal)
• Everything from purchasing request form to purchasing order forms
become centralized in a hospital and can be done online.
• Having set the sub-minimum inventory levels, the software notifies when
there is a shortage of a certain drug, or an order needs to be placed.
• It also calculates EOQ.
SUMMARY
Shortage of a
drug
Pharmacist fills
a drug request
form
Purchasing
department
approves
Purchase order
form by the P.
agent
Inventory
management
models applied
Order to the
vendor
Receiving of
the order
Storage
Control of
dated
inventory
Distribution
Clinical
services
provided
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203. GM Hamad

NUCLEAR PHARMACY
INTRODUCTION
Nuclear pharmacy is a service to improve and to promote health through safe and
efficacious use of radiopharmaceuticals for:
• Diagnosis
• Therapy
• Palliation (Patients with terminal diseases usually need palliation. It is a
kind of care that makes you feel better, even though it can't cure you.)
Sometimes the term nuclear pharmacy is used interchangeably with
radiopharmacy. Radiopharmacy is a subspecialty of pharmacy that deals with
receiving, preparation, quality control, storage, and dispensing of
radiopharmaceuticals
The radiopharmacy also deals with disposal of radioactive wastes and
documentation of each operation. Furthermore, radiopharmacy may be engaged
in research, designing and development of new radiopharmaceuticals
HOT LABORATORY AND HOT MATERIALS
• In terms of space, the radiopharmacy is also called a hot laboratory because
of the processing of radioactive materials in it which sometimes, are
referred to as hot materials
RADIOPHARMACEUTICAL
• The term radiopharmaceutical is derived from two words, viz. radioactive
and pharmaceutical.
• It is a medicinal product containing a radionuclide as an integral part of the
main ingredients.
• The medicinal part of the radiopharmaceutical, available in a minute
quantity is not intended for pharmacological actions.
• Radiopharmaceuticals is a radioactive drug used for diagnosis or therapy in
a tracer quantity with no pharmacological effect
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204. GM Hamad

RADIOACTIVE TRACER
• Rather, it carries the radioactivity to site of action and thus called
radioactive tracer or just a tracer.
RADIONUCLIDE
• The second part of the radiopharmaceutical is a radionuclide. The
radionuclide is a species of radioactive atom with a specific atomic number,
neutron number and a defined nuclear state.
HOT LABORATORY
• Due to the use of radiopharmaceuticals, this service and the unit from
where it is provided is also called radiopharmacy or hot laboratory.
• The person who rendered this service is called a radiopharmacist. The use
of radioactive isotopes for the diagnosis, treatment and palliation is
increasing in various clinical settings such as cancer, cardiac and imaging
centers.
RADIOISOTOPE
• A version of a chemical element that has an unstable nucleus and emits
radiation during its decay. Radioisotopes have important uses in medical
diagnosis, treatment, and research.
• Radioactive isotope, also called radioisotope, radionuclide, or radioactive
nuclide, any of several species of the same chemical element with different
masses whose nuclei are unstable and dissipate excess energy by
spontaneously emitting radiation in the form of alpha, beta, and gamma
rays.
• Every chemical element has one or more radioactive isotopes. For
example, hydrogen, the lightest element, has three isotopes with mass
numbers 1, 2, and 3. Only hydrogen-3 (tritium) 3H, however, is a
radioactive isotope, the other two being stable. More than 1,000
radioactive isotopes of the various elements are known.
ISOTOPES
• Any of two or more forms of a chemical element, having the same number
of protons in the nucleus, or the same atomic number, but having different
numbers of neutrons in the nucleus, or different atomic weights.
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205. GM Hamad

• Some isotopes/nuclides are radioactive, and are therefore referred to as
radioisotopes or radionuclides, whereas others have never been observed
to decay radioactively and are referred to as stable isotopes or stable
nuclides.
• For example,
14
C is a radioactive form of carbon, whereas
12
C and
13
C are
stable isotopes.
A large number of private and government hospitals have established facilities for
radiopharmaceuticals
Pakistan Atomic Energy Commission owned hospitals are currently using
radioisotopes for diagnostic, therapeutic and research purpose
Hospital pharmacists have the potential to expand professional services rendered
by the pharmacy department
The Radiopharmacy practice is in its infancy in Pakistan particularly in private
institution making the responsibilities and challenges for a pharmacist more
exciting and of course, rewarding.
ORGANIZATION
The radiopharmaceutical service is rendered from a division of hospital pharmacy
or by a section under Nuclear Medicine department.
The nuclear medicine is a clinical specialty dealing with the application of
radionuclides
As an integral part of nuclear medicine department, radio-pharmacy functions
under management of head of nuclear medicine department who is a physician.
Medical physicist(s) for the implementation of radiation protection is his
colleague and the radiopharmacist will be the in-charge of radiopharmaceutical
administration nurse and nuclear medicine technologists
In Pharmacy department, radiopharmacy unit performs under the directions of
pharmacy director. As premises, the radiopharmacy may be located within the
pharmacy department, or in the nuclear medicine department of the institution
adjacent to radioisotope administration area.
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206. GM Hamad

PROPERTIES OF RADIOPHARMACEUTICAL
A radiopharmaceutical has the following discriminating features:
Difference between ordinary pharmaceutical and radiopharmaceuticals
PRESENCE OF RADIOACTIVITY
• Due to the presence of a radionuclide (radioactive atoms) as an integral
part of radiopharmaceutical, it is associated with emission of radiation.
Thus, requiring special precautions during handling.
SCARCITY OF PHARMACOLOGIC EFFECT
• The radiopharmaceuticals do not produce pharmacologic effects since the
quantities of active pharmaceutical ingredients range from picogram to
nanogram per kilogram of administered dose.
HAVING SHORT SHELF LIFE
• Due to the presence of radioactivity, radiopharmaceuticals have short shelf
life. Thus, a pharmacist has to keep a constant eye on expiry of a
radiopharmaceutical. This also poses constrain for quality control check
before administration of the radiopharmaceutical to patients. Administered
to patient even before the results of quality control tests.
USUAL ROUTE OF ADMINISTRATION
• Most of the radiopharmaceuticals are prepared as sterile, pyrogen-free
intravenous solutions to be administered directly to patients. Other less
common routes of administration include oral, interstitial, and inhalation
e.g., radioactive gases, aerosols.
DOSE MEASUREMENT IN TERMS OF RADIOACTIVE UNITS
• The dose of a radiopharmaceutical is measured in units of radioactivity
rather than mg, ml etc.
HALF LIFE
• The half-lives of radiopharmaceuticals taken in consideration are physical
half-life, biological half-life and effective half-life.
• THE PHYSICAL HALF LIFE
The Physical half-life of a radiopharmaceutical is time necessary for the
radioactive atoms to decay to one half of their original number.
• BIOLOGIC HALF LIFE
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207. GM Hamad

Biologic half-life is the time required for the body to eliminate one-half of
the administered doses of any radiopharmaceutical by the processes of
biologic elimination.
• EFFECTIVE HALF LIFE
Effective half-life of a radiopharmaceutical is the time required for an
administered radiopharmaceutical dose to be reduced by one-half due to
both physical decay and biological elimination.
PRACTICE REGULATIONS
• The practice of radiopharmaceuticals as well as the premises for this
practice requires NOC from Pakistan Atomic Energy Commission
RESTRICTIONS ON QUANTITY USED
• Prescribed amount can be handled per year in a clinical setting.
APPLICATION OF RADIOPHARMACEUTICALS
The radiopharmaceuticals are applied for diagnosis, treatment and palliative care.
1. DIAGNOSTIC APPLICATIONS
In diagnostic application, gamma emitting radiopharmaceuticals are used to
probe physiologic or pathophysiological functions of human body. These
radiopharmaceuticals are localized in organs of interest so as their images can be
acquired externally with gamma camera. Many radiopharmaceuticals are
available to trace one or more particular functions of human body.
For optimal detection efficiency by a gamma camera, gamma energies of between
100 keV and 200 keV are desirable. The diagnostic radiopharmaceuticals used are
• Carbon-14
• Gallium-67
• Technetium-99m
• Iodine-123
• Indium-111
• Thallium-201
229

208. GM Hamad


CARBON-14
Chemical Symbol: 14C
Diagnostic use: Detection of gastric urease as an aid in the diagnosis of H. pylori
infection in the stomach.
GALLIUM-67
Chemical Symbol: 67Ga
Chemical Form: Gallium-67 Gallium Citrate
Half-life: 3.26 days
Diagnostic use:
Useful to demonstrate the presence/extent of:
• Hodgkin’s disease
• Lymphoma
• Bronchogenic carcinoma
• Aid in detecting some acute inflammatory lesions
TECHNETIUM-99M
Technetium-99m is used in 20 million diagnostic nuclear medical procedures
every year.
Approximately 85% of diagnostic imaging procedures in nuclear medicine use this
isotope as radioactive tracer.
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Radiopharmaceuticals based on 99mTc for imaging and functional studies of
the brain, myocardium, thyroid, lungs, liver, gallbladder, kidneys, skeleton, blood,
and tumors.
Depending on the procedure, the 99mTc is tagged (or bound to) a pharmaceutical
that transports it to its required location. For example, when 99mTc is chemically
bound to exametazime (HMPAO)(chemical name of hexamethylpropyleneamine
oxime or HMPAO) the drug is able to cross the blood–brain barrier and flow
through the vessels in the brain for cerebral blood-flow imaging.
This combination is also used for labeling white blood cells to visualize sites of
infection.
99mTc sestamibi is used for myocardial perfusion imaging, which shows how well
the blood flows through the heart.
Imaging to measure renal function is done by attaching 99mTc to mercaptoacetyl
triglycine (MAG3); this procedure is known as a MAG3 scan.
Technetium-99m can be readily detected in the body by medical equipment
because it emits 140.5 keV gamma rays (these are about the same wavelength as
emitted by conventional X-ray diagnostic equipment), and its half-life for gamma
emission is six hours (meaning 94% of it decays to 99Tc in 24 hours).
BONE SCAN
The nuclear medicine technique commonly called the bone scan usually uses Tc-
99m.
The nuclear medicine technique is sensitive to areas of unusual bone rebuilding
activity, since the radiopharmaceutical is taken up by osteoblast cells which build
bone. The technique therefore is sensitive to fractures and bone reaction to bone
tumors, including metastases. For a bone scan, the patient is injected with a small
amount of radioactive material of 99mTc-medronic acid and then scanned with
a gamma camera.
MYOCARDIAL PERFUSION IMAGING
Myocardial perfusion imaging (MPI) is a form of functional cardiac imaging, used
for the diagnosis of ischemic heart disease. The underlying principle is, under
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conditions of stress, diseased myocardium receives less blood flow than normal
myocardium. MPI is one of several types of cardiac stress test.
Several radiopharmaceuticals and radionuclides may be used for this, each giving
different information. In the myocardial perfusion scans using Tc-99m, the
radiopharmaceuticals 99mTc-tetrofosmin or 99mTc-sestamibi are used.
Following this, myocardial stress is induced, either by exercise or
pharmacologically with Adenosine, dobutamine which increase the heart rate.
Scanning may then be performed with a conventional gamma camera.
CARDIAC VENTRICULOGRAPHY
In cardiac ventriculography, a radionuclide, usually 99mTc, is injected, and the
heart is imaged to evaluate the flow through it, to evaluate coronary artery
disease, valvular heart disease, congenital heart diseases, cardiomyopathy, and
other cardiac disorders.
IODINE-123
Iodine-123 (123I or I-123) is a radioactive isotope of iodine used in nuclear
medicine imaging, including single photon emission computed
tomography (SPECT) or SPECT/CT exams. The isotope's half-life is 13.22 hours.
In medical applications, the radiation is detected by a gamma camera.
The isotope is typically applied as iodide-123, the anionic form.
MEDICAL APPLICATIONS OF
123
I
123
I is the most suitable isotope of iodine for the diagnostic study
of thyroid diseases. The half-life of approximately 13.13 hours is ideal for the 24-
hour iodine uptake test and
123
I has other advantages for diagnostic imaging
thyroid tissue and thyroid cancer metastasis.
123
I is supplied as sodium iodide (NaI), sometimes in basic solution in which it has
been dissolved as the free element. This is administered to a patient in capsule
form, by intravenous injection, or (less commonly due to problems involved in a
spill) in a drink.
DIAGNOSIS OF HYPERTHYROIDISM AND HYPOTHYROIDISM
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The iodine is taken up by the thyroid gland and a gamma camera is used to
functional images of the thyroid for diagnosis.
Quantitative measurements of the thyroid can be performed to calculate the
iodine uptake (absorption) for the diagnosis of hyperthyroidism and
hypothyroidism.
INDIUM-111
Indium-111 is an isotope of indium with a radioactive half-life of 2.80 days,
making it useful as a radioactive tracer.
Among the medical applications of indium-111 are specialized diagnostic uses:
indium-111 labeled antibodies
indium-111 oxine is also useful for isotopic labeling of blood cell components,
specifically the labeling of platelets for indium-111 for thrombus detection and
indium-111 labeled leukocytes for localization of inflammation and abscesses, and
determination of leukocyte kinetics.
THALLIUM-201
Before the widespread application of technetium-99m in nuclear medicine, the
radioactive isotope thallium-201, with a half-life of 73 hours, was the main
substance for nuclear cardiography. The nuclide is still used for stress tests for risk
stratification in patients with coronary artery disease (CAD).
Radiation therapy uses high-energy radiation to shrink tumors and kill cancer
cells. X-rays, gamma rays, and charged particles are types of radiation used for
cancer treatment.
2. THERAPEUTIC APPLICATIONS
The radiation emitted from therapeutic radiopharmaceuticals cause damage
selectively to neoplastic cells within body. The radiopharmaceuticals for
therapeutic use normally contain a radionuclide that decays by emitting a ß
particle.
The energy of the ß- particles should ideally be within the range 0.5 - 1.0 MeV to
prevent widespread dissemination of radiation from the target. The half-life is
normally of the order of several days in order to provide reasonable time for
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action. Iodine
131
and phosphorous
32
are the commonly used therapeutic
radiopharmaceuticals.
HYPERTHYROIDISM
Radioiodine therapy is a nuclear medicine treatment for an overactive thyroid, a
condition called hyperthyroidism, and also may be used to treat thyroid cancer.
When a small dose of radioactive iodine
131
(an isotope of iodine that emits
radiation) is swallowed, it is absorbed into the bloodstream and concentrated by
the thyroid gland, where it begins destroying the gland's cells.
Drug therapy includes medications that reduces the symptoms of thyrotoxicosis
and decrease the synthesis and release of thyroid hormone.
The most common therapy for hyperthyroidism is to decrease the hyperactive
thyroid with an oral dose of radioactive iodine
131

In some cases, the patient is treated with antithyroid medication to return thyroid
hormone levels to normal.
GRAVE DISEASE
POLYCYTHEMIA VERA
Radioactive phosphorus is known as P
32
. It is a radioactive form of sodium
phosphate. It is a treatment for some blood disorders, including one called
polycythemia vera (PV).
POLYCYTHAEMIA VERA
Polycythemia vera means that your bone marrow makes too many red blood
cells. You might make too many platelets and white blood cells too.
Radioactive phosphorus is absorbed by the bone marrow and gives a dose of
radiation, which stops it making too many cells. Very little radiation is given to the
rest of the body.
This treatment is not commonly used because other types of treatment are
available. You might have it if you have had PV for some time.
DESCRIPTION RADIOACTIVE ISOTOPE USES
Ammonium bromide Br
82
Study of extracellular
measurement
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Calcium chloride Ca
45
Study of ca metabolism
Chromium EDTA
51
Cr Determination of
glomerular filtration rate
Colloidal Gold
198
Au Treatment of neo-plastic
conditions and general
investigation of
reticuloendothelial cells
Chromium Chloride
51
Cr Studies of GIT protein
loss in vivo labelling and
absorption studies
Human Serum Albumin
125
I Study of cardiac cavity
imaging scanning of sub-
arachnoid spaces
detection of brain
tumors
Potassium Chloride
24
Na Determination of
exchangeable potassium
Triolen
125
I Fat absorption studies
3. PALLIATIVE APPLICATIONS
The radiopharmaceuticals used to improve quality of life of a patient but cannot
eradicate a disease provide palliative care. Strontium
89
and phosphorous
32
are the
examples that are used to relieve the pains due to cancer metastasis in bone at
terminal cancer stage patients.
PLANING FOR A RADIOPHARMACY
Planning for radio-pharmacy requires following aspects and pharmacists have a
paramount role in this respect:
1. Feasibility of an isotope section operated by the hospital pharmacy.
2. Layout and design for a radioactive branch of a pharmacy department.
3. Allocation of space and equipment for isotopes laboratories, and
4. Information concerning facilities and equipment for isotope programs.
5. Types of monitoring, handling or measuring devices required.
6. Procurement procedures for radioactive materials.
7. Radiation protection measures necessary for their handling.
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8. Organization and training of the hospital staff for the utilization of
radioactive materials.
9. Licensure requirements.
10. Suggestions for special courses for hospital pharmacists in the handling of
isotopes in hospitals.
BASIC REQUIREMENTS FOR RADIOPHARMACY
A pharmacist, in order to render high quality radiopharmaceutical services must
know the legal and professional requirements for both, individuals and
institutions before instituting radioisotope program. In general, the following are
the requirements for establishment of radiopharmacy section in a hospital.
LICENSURE
The radioisotopes on one hand offering diagnostic, therapeutic and palliative
promises but on the other hand are potentially dangerous.
Therefore, their use is subjected to control and supervision of Atomic Energy
Commission, a Federal Government agency. Radioisotopes can be used only by
duly licensed individuals in premises complying with the requirements of Atomic
Energy Regulations.
As mentioned before, license restricts the use of the isotopes to those institution
listed on license. In addition, the regulations require that an institutional licensee
have a medical isotope committee to evaluate all proposals for research,
diagnostic, and therapeutic uses of isotopes within the hospital.
FACILITIES
SPACE
Nuclear pharmacy must have adequate space, matching with the scope of
services required and provided, meeting minimal space requirements for efficient
working. The nuclear pharmacy area shall be separated from the pharmacy areas
for non-radioactive drugs and shall be secured from unauthorized personnel.
A radioactive storage and product decay area must be separated from
compounding, dispensing, quality assurance and office area. Detailed Floor Plans
are to be submitted to the Atomic Energy Commission before approval of the
license.
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EQUIPMENTS
The Minimum equipment requirements for a radiopharmacy are as:
1. Isolators or laminar flow hood.
2. Fume hood for the fume generating radiopharmaceuticals.
3. Dose calibrator.
4. Refrigerator (lead-lined).
5. Class A prescription balance or balance of greater sensitivity.
6. Single or multiple channels gamma scintillation counter.
7. A radiochemical hood and filter system.
8. Other equipment's necessary for services of radiopharmaceutical.
NUCLEAR PHARMACIST
Hiring a radio pharmacist is not yet a legal requirement for a radio pharmacy in
Pakistan. However, if their abilities and knowledge are utilized, they have
excellent potentials for radiopharmaceutical services. A pharmacist intended to
become a radiopharmacist must have training in the following areas:
RADIOPHARMACY
1. Elementary aspects of structure of matter.
2. Mode of radioactive decay of radionuclide.
3. Technology and quality control.
4. Application of radiopharmaceuticals.
5. Radiopharmaceutical distribution and inventory control.
6. Research methodology.
INSTRUMENTATION
1. Principles of radiation detection and detectors.
2. Dose calibrator.
3. Gamma well counter.
4. Function QC of dose calibrators.
MATHEMATICS, STATISTICS AND COMPUTER SCIENCE
1. Fundamental concepts.
2. Compartmental analysis and
3. Mathematical models of physiologic system.
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4. Principles of radiation detection detector.
5. Dose calibrator.
6. Gamma well counters.
7. Quality control of dose calibrator.
RADIATION BIOLOGY AND RADIATION PROTECTION
1. Safe handling.
2. General principles of production.
3. Formulation.
4. Pharmacokinetics.
IN VITRO STUDIES
1. Microanalytical techniques (RIA etc.).
2. Radioassays.
3. Binding capacity studies (receptor assays).
RADIOISOTOPE COMMITTEE
Radioisotope committee is broad established for supervision and control of
hospital isotope program.
Typically, the committee made include a
• Medical physicist
• A clinical radiologist.
• Hematologist.
• A surgeon.
In addition to above it is also suggested that a representative from administration,
pharmacy and nursing service should also be included on the committee registrar.
The pharmacists may assist in the purchasing, receiving and storage of isotopes.
The administrator can contribute to the development of the entire program and
the nurses will become familiar with type of work carried out, the associated
dangers and the means whereby the patient, doctor and nurse may protect
themselves.
RESPONSIBILITIES
An institutional radioisotope committee typically has following responsibilities
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1. Review and approval of the use of isotopes within the institution.
2. Prescribe special conditions such as training of personnel, designation of
limited areas of use, disposal methods.
3. Receive reports from the radiation protection officer and the review of
records.
4. Recommend remedial (corrective) action when an individual fails to
observe protection, recommendations, rules and regulations.
5. Keep a record of actions taken in approving the use of isotopes.
UNITS OF ACTIVITY
Units of activity (the curie and the becquerel) also refer to a quantity of
radioactive atoms. Because the probability of decay is a fixed physical quantity,
for a known number of atoms of a particular radionuclide, a predictable number
will decay in a given time. The number of decays that will occur in one second in
one gram of atoms of a particular radionuclide is known as the specific activity of
that radionuclide.
The activity of a sample decreases with time because of decay.
The rules of radioactive decay may be used to convert activity to an actual
number of atoms. They state that 1 Ci of radioactive atoms would follow the
expression:
N (atoms) × λ (s−1) = 1 Ci = 3.7 × 1010 Bq
RADIOPHARMACEUTICAL OPERATION
The radiopharmaceutical operation is conditioned upon an approval from atomic
energy commission and must comply with its applicable laws and regulations. The
operations must be carried out by or under the supervision of a qualified person.
The radiopharmaceuticals are prepared complying regulations, standards of
quality assurance and nuclear pharmacy practices. Documentation of inventory
and disposition is to be maintained.
The immediate outer container of radioactive drug to be dispensed must be
labeled with:
a) Standard radiation symbol
b) Name of radionuclide
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c) Amount of radioactive material in baqural or curies.
The becquerel (symbol: Bq) is the SI derived unit of radioactivity.
The curie (symbol Ci) is a non-SI unit of radioactivity.
ENVIRONMENTAL CONTROL
MORE CRITICAL THAN ORDINARY PHARMACEUTICALS
The environmental requirements are more critical in radio- pharmacy practice
than that of the ordinary pharmaceutical practice because the short-lived
radiopharmaceuticals have to be administered without conducting quality control
tests or before their results.
NON-TERMINALLY STERILIZED RADIOPHARMACEUTICALS
The non-terminally sterilized radiopharmaceuticals (which cannot be sterilized in
their final containers) still need more critically controlled environmental
conditions so as they can be prepared aseptically and retain sterility till
administration.
UNIDIRECTIONAL AIR FLOW CABINETS
Special purpose build unidirectional air flow cabinets provide aseptic conditions
and appropriate environmental control for preparation and handling of
radiopharmaceuticals.
UV LIGHT
The ultra-violet light (UV) light, fitted in these completely sealed cabinets offers
decontamination of the worktops.
LEAD LINES GLOVES
These cabinets used in radiopharmacy, are appropriately shielded and are more
often fitted with lead lined gloves.
This arrangement completely isolates material under processing from the worker
and external environment and vice versa.
ISOLATORS
Such type of cabinet is also called isolators. The internal environment of the
isolators can be easily controlled and maintained according to the specifications.
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Special clean area is not always required. E.g. for the preparation of oral dose
does not require aseptic condition however, workers still need radiation
protection.
For the radiopharmaceutical administered orally or by inhalation. The
requirements of operator protection predominate.
Preparation is usually carried out in fume cupboard, which carries released
activity away from the operator, and discharged to the atmosphere. Suitable
shielding may also be placed inside the fume cupboard. An adequate ventilation is
also provided to keep temperature reasonably constant, usually at around 22°C.
The relative humidity should be kept at less than 80%.
The isotopes to be stored far away from the equipment and from radioisotope
storage area to keep the background activity at a low level.
ROLE OF THE PHARMACIST
Hospital pharmacist may assume the responsibility for the ordering, receiving and
storage of all isotopes current in use in hospital.
The purchasing phase of such a program is relatively simple and straightforward.
A number of commonly used radioisotopes usually purchased in pre-determined
quantities for automatic shipment on a standing order basis usually from foreign
vendors.
RECEIVING OF RADIOPHARMACEUTICALS
All packages coming to pharmacy must be stored in a lead vault and a date and
time of receipt, purchase order number, name of isotopes and quantity of
isotopes received is recorded.
MONITORING OF PHARMACY VAULT
The radiation safety officer or the radiopharmacist, depending on the local policy
of hospital monitors the pharmacy vault and the surrounding program as a part of
safety program. The radioactivity is recorded.
All records of isotope materials received are to be maintained in the pharmacy
office and are made available to the radiation safety officer and the Atomic
energy commission inspector when necessary.
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The disposal of waste products will fall under the support of the radio-pharmacist
with collaboration of the radiation safety officer.
RESPONSIBILITIES OF A RADIOPHARMACIST
The responsibilities of the pharmacists are the same as that the
radiopharmaceutical practice entails.
The radiopharmaceutical practice and responsibilities are:
1. ordering, receiving and keeping the record of all radioactive materials and
cold kits
COLD KITS (Radiopharmaceutical cold kit is the API that do not contain
radioactivity. Cold kits have been developed to produce quality
radiopharmaceuticals at the site of use when mixed with the requisite
amount of a radioisotope).
2. Elution of the generator, labeling and dispensing of kits.
3. Performing quality control tests.
4. Implementation of Good pharmaceutical and good radiopharmaceutical
practices (GRP).
5. Radiation monitoring of radiopharmacy laboratory and injection area.
6. Implementation of radiation protection and safety policy in radiopharmacy
laboratory, gamma counter room and injection area.
7. Performing of all in-vitro procedures, processing of data and providing of
the results.
8. Support research and active participation in research projects.
9. Performing of any other duty related to the clinical and assigned research
work.
10. Training to the technologists on the pharmaceuticals aspects of the nuclear
medicine, radiation biology and protection.
FORMULATION OF RADIOPHARMACEUTICALS
Some radiopharmaceuticals are available in ready to use form and not demand
any of the preparatory steps.
• Iodine-131
• Galium-67
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• Iodine131 incorporated radiopharmaceuticals, meta iodo benzyl
guanidine are the examples of such radiopharmaceuticals.
Formulation of other radiopharmaceuticals requires any of the radiolabeling
techniques whereby a radionuclide is tagged with a pharmaceutical moiety.
Technetium-99m is the most widely used radionuclide for such purpose because
of its almost ideal physical properties. It is used in the preparation of a wide
variety of radiopharmaceuticals, which have different biological fates and hence
are used for various diagnostic investigations.
The 6-hour half-life of technetium 99m is suitable for the majority of
radiopharmaceuticals investigations. It can be obtained from a technetium
generator containing its parent nuclide, molybdeynum-99m alumina column.
Molybdenum-99 decays to technetium-99m.
On passing through column, normal saline solution selectively carries only
technetium-99m as sodium pertechnetate form. This collection of technetium-
99m in a vial is called elution.
The molybdenum continues to decay to technetium-99m and after 23 hours
another technetium-99m elution with sodium chloride is possible. The process
can be repeated daily until one week when the yield of sodium pertechnetate
becomes inconveniently small due to a low levels decay of molybdenum-99.
The simplest and most widely available formulation consists of a single, sterile,
freeze dried, rubber capped vial containing necessary non-radioactive ingredients
to prepare aseptic radiopharmaceuticals.
Such vials commonly referred to as “Kits” can be obtained commercially and are
available for all technetium-99m radiopharmaceuticals in routine use for
diagnosis of various physiologic functions.
Kits can be prepared indigenously in the radiopharmacy by a radio-pharmacist.
This program however will require some more instruments like lyophilizer etc.
The preparation of radiopharmaceutical is achieved by the single step addition of
sterile sodium pertechnetate to the kit in accordance with manufacturer’s
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instructions. The activity of sodium pertechnetate injection required is calculated
and is injected into the kit vial.
An equivalent volume of gas is drawn from the space above the solution before
withdrawing the syringe from the vial.
Manufacturer’s specifications:
• The manufacturer specifies minimum and maximum range of activity that
can be added into a particular kit.
The vial is shaken to dissolve the contents.
Aseptic technique is used throughout to maintain sterility of the final product and
to ensure adequate protection of the operator from radiation.
Technetium 99mTc : possesses a relatively short half-life of 6 hours, which allows
administration of higher amounts of activity for faster and clearer images while
exposing the patient to a low radiation dose. it offers an abundance of gamma
photons for imaging.
QUALITY CONTROL
The quality control of radiopharmaceutical is the area of the pharmacist. The
radioactive material administered to the patients are medicinal products and
therefore, are expected to have the same degree of quality and safety as any
other pharmaceutical.
All ingredients and the final product itself must meet all the legal, statuary, and
quality requirements.
SHORT LIVED RADIONUCLIDE
• The majority of diagnostic investigations are performed with
radiopharmaceuticals containing short lived radionuclides which have to be
prepared and used on the same day.
The results for quality control test cannot be achieved before the administration
of radiopharmaceutical. After a long period of continuous satisfactory testing, the
radiopharmaceutical laboratory can be confident about the safety of the products
currently dispensed.
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The quality control tests are performed on retrospective basis and are done for
sterility and pyrogenicity of the products. Recently the limulus amebocyte lysate
(LAL) test is considered of merit for pyrogen testing of radiopharmaceuticals
which gives an instant result.
PHYSICAL TESTS
PH
• Ideally pH should be 7.4 and but it can vary from 2-9.
• Correct ionic strengths can be achieved by the addition of acid or Alkali.
ISOTONICITY
• Particle size
• Recognize the color and state of a radiopharmaceuticals.
• Colloidal or aggregated preparations: identify size by microscope with
hematocytometer.
• Size of particles will determine the site where the radiopharmaceuticals get
localized.
• Tc labeled albumin microspheres 10 to 100 µm
• If >100 µm cause pulmonary embolism.
• If <10 µm: deposits in the reticuloendothelial cells.
CHEMICAL TESTS
RADIONUCLIDE PURITY
• % of the total radioactivity that is present in the form of stated specified
radionuclide.
• Determine by measuring the half-lives and characteristic radiations emitted
by individual radionuclides.
• Gamma ray emission radionuclides: checked with multianalyzer
BIOLOGICAL TESTS
• Sterility
• Apyrogenicity
• Toxicity
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QUALITY ASSURANCE
Radiopharmaceuticals are generally expected to conform to specifications under
the following heading:
1. Radionuclide concentration
2. Radiochemical purity
3. Chemical purity
4. Sterility
5. Apyrogenicity
6. Absence of foreign particulate matter
7. Particle size (if appropriate)
8. pH
9. Biological distribution
GENERAL PRECAUTIONS
A radioisotope administration sheet is placed in the medical record by the isotope
administrator at the time of treatment and is to remain there permanently as an
isotope to sign at the entrance of the room or unit by the administrator.
The isotope administrator will provide a substitute who may be contacted in care
the administrator is not available.
DISPENSING OF RADIOPHARMACEUTICALS
The dispensing of radiopharmaceuticals should be safe, straightforward and
reliable.
An important factor in radiopharmaceutical dispensing has been the production
of ready to use kits or cold kits which provide individual/ multiple doses and can
be reconstituted by the addition of the radionuclide at the time of intended use.
chemical reagents are prepared in a sterile environment using apyrogenic raw
materials and dispensed into single/multiple unit dose containers. The
preparation of individual doses can be carried out rapidly and safely when
required with minimum manipulation.
The cold kit preparation should be capable of terminal sterilization preferably by
autoclaving or if not by membrane filtration for removal of microbes
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Radio pharmaceuticals never go directly to the patient they are provided to
trained health care professionals at the hospital or clinic and then administered to
the patient.
FOR THE RADIOPHARMACEUTICALS NOT REQUIRING PREPARATION
For the radiopharmaceuticals not requiring preparation can be prescribed at any
times. The physician provides necessary information regarding the dose and time
of administration.
The pharmacist then makes necessary calculations. For dispensing, calculated
radioactivity containing volume is transferred from stock container and placing it
in a paper cup within a lead container is ready for administered to patient.
Prior to dispense, a label is affixed appropriately containing the earlier mentioned
information and the material is transported to administration area.
FOR RADIOPHARMACEUTICALS REQUIRING PREPARATION
For radiopharmaceuticals requiring preparation, a list is furnished to
radiopharmacist one day prior to their administration.
This is because the fresh technetium 99m elution is available in the morning.
The physician upon deciding to prescribe radioactive material calls the pharmacist
and provides him with all of the necessary information.
STEPS
The radiopharmaceutical is prepared as mentioned above, radioactivity in vial is
measured placed in a lead container and is affixed bearing name of the
radiopharmaceutical, the total volume in the vial and the activity measured at
specified time.
Ideally, labeling is done both, on the kit vial and on lead container.
This container carrying kit is transported to the injection area and is ready for
administration.
Decay of radionuclides at different time intervals in the form of table is also
furnished along with radiopharmaceuticals particularly if the dose is prepared for
more than one patient.
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For administration by nurse the dose required for patient is calculated and the
appropriate volume is dispensed in a sterile syringe.
The activity present in the syringe is measured and recorded before it is issued for
administration to patient.
COMPOUNDING
Compounding of radio pharmaceuticals requires receipt (or anticipation) of:
• A valid prescription/drug order
• Appropriate components, supplies, and equipment
• A suitable environment, especially for sterile dosage forms
• Appropriate recordkeeping, including written procedures and lot-specific
information to ensure traceability
• Validation/verification of the compounding procedure, storage conditions,
and expiration.
DIRECTIONS WHILE COMPOUNDING
Involves reconstituting reagent kits, radio labeling, and strict aseptic technique
must be followed during compounding.
A kit involves pre-packed set of sterile ingredients. The freeze-dried kit is
reconstituted by aseptically transferring the necessary activity of sodium
pertechnetate using a sterile syringe and needle.
The reconstituted kit is aseptically subdivided to provide each patient dose with a
sufficient activity after administration. A diluent may be added to the final dose to
give the desired radioactive concentration.
RADIOPHARMACEUTICAL PRODUCTION






Cyclotron or Reactor
Nuclear reaction or
Radioisotope production
Radiochemical Grade
Product Or Active
Pharmaceutical
Ingredient -Purification,
Quality Control,
Dispensing
Radiopharmaceutical
Product -Labelling (if
required), Dispensing,
Sterilization, Quality
Control, packaging,
Shipping
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OTHER AREAS OF RADIOPHARMACEUTICALS INTEREST
Besides all concepts mentioned in earlier sections, a radiopharmacist must also
know other areas of radiopharmaceuticals practice including principle of
1. Radiation protection
2. Good Radiopharmaceutical Practice (GRP)
1. RADIATION PROTECTION
The radiation protection is safekeeping of worker from the hazards of radiation by
minimum radiation exposure of the worker to a level as low as reasonably
achievable (ALARA principle).
This can be achieved by preventing spills and spread of contamination outside the
laboratory.
Another important aspect of radiation protection is sensible use of:
1. Time
2. Distance and shielding.
3. The time spent in radiation area,
4. intensity of radioactivity
Distance from the radiation source and shielding (TDS) are the basic and critical
elements of radiation safety.
1. TIME
A radiation dose for a worker in an area having a particular radioactive dose rate
would be directly proportional to the amount of time spent.
It is thus required that all the quality control procedures and operations with
radioactive sources must be carried out as rapidly as possible consistent with
good technique and not the cost of satisfaction and safe performance of the task.
2. DISTANCE
Increasing distance has a dose reduction effect because radiation intensity
decreases by square of distance from radiation source.
A direct contact with radioactive source should be avoided by any available
means, e.g. by using long Forceps.
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3. SHIELDING
The material capable of absorbing large proportion radiation are used for
shielding.
Lead absorbs gamma rays and thus gamma emitter is shielded in lead.
The plastic, glass or aluminum effectively serves as shielding materials for beta
particulate emitting radiopharmaceuticals.
4. INTENSITY
The radiation hazard increases with the intensity of radioactive source so for
safety reasons. It is not recommended to work unnecessarily with high strength of
radioactivity.
OTHER GENERAL RULES FOR SAFETY
1. All the members of department are responsible to protect themselves and
other persons as well from the radiation hazards.
2. Know the rules, area designation and signs set for the handling of the
radioactive materials.
3. Ideally any task requiring radioactivity handling should be performed in
isolators or by keeping the radioactive sources behind the lead glass
shielding.
4. Wear the film badge and dosimeter at all time while working with
radioactive substances.
5. The fume generating radioactive materials must be handled in the isolator
fitted with fume hood.
6. Use proper safety clothing and wear gloves while working with radioactive
materials.
7. Absorbent paper shall cover work benches, trays, and other work surfaces
where radioactive material.
8. Avoid carelessness in handling materials and do not splash or spill
radioactive liquids.
9. On completion of procedure, wash the hands.
10. Avoid unnecessary movements of the radioactive materials if needed so,
transport radioactive material carefully in the trolley or in tray lined with
disposable cloth.
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Radiation protection concerning waste disposal
Guidelines for waste disposal vary depending on the types. These guidelines are
as follows:
1. DISPOSAL FOR SHORT LIVED RADIONUCLIDES
Used syringes, vials and contaminated papers have some residual activities and
are disposed of like other solids or dry wastes.
These materials are disposed of in containers provided for this purpose in
radiopharmacy section.
These containers are emptied into a central shielded waste container for disposal
where wastes are retained for their total decay.
After 10 half-lives of the materials, the waste is disposed of like ordinary
materials.
This practice eliminates high levels of radiation in radiopharmacy.
The water soluble or dispersible liquids should be poured in sink specified for this
purpose followed with copious flow of water, which is designed so that the waste
is stored for its decay.
2. DISPOSAL FOR LONG LIVED RADIONUCLIDES
The wastes of long-lived radionuclides are to be transferred to the authorized
commercial firms that bury or burn them at approved sites.
For Good radiopharmaceutical practice(GRP) each shipment of such radioactive
wastes shall properly be classified, packaged, marked, and labeled mentioning an
identity, activity and volume of the radionuclide and the names, addresses, and
telephone numbers of the sender/generator of the wastes and receiving
authority.
The vendors instruction if any must be followed for this purpose.
In Pakistan, no such system is in practice. It is therefore suggested to construct
special waste disposal room in basement of the institute with special construction
materials.
This waste room may be equipped with appropriate shielded large tanks where,
wastes of radioisotope of long half-life can be stored till their decay.
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3. DISPOSAL OF RADIOACTIVE GASSES
The radioactive gases such as Xenon
133
and Xenon
127
can be released into the
environment provided that the maximum permissible concentration does not
exceed the limits.
4. DISPOSAL OF RADIOACTIVITY CONTAINING SPECIAL PARTS
The parts of research animals and the body fluids of patients containing
radioactive materials can be incinerated.
The biological wastes containing radioactivity must not, in any case be
accumulated more than 35 days.
However, for a reason of radiation precaution, if the material is to be stored for a
longer time than specified, appropriate precautions such as spraying with
disinfectants and sealing the container tightly must be taken for the purpose of
environment protection.
DOCUMENTATION OF WASTE DISPOSAL
Whatever may be the material to be disposed off, records must be maintained for
all the material stored for decay, released to the environment, material
incinerated and material transferred to the authority with amount and activity
and date/time in a waste disposal logbook. The stored packages must also be
labeled with patient information.
2. GOOD RADIOPHARMACEUTICAL PRACTICES
Radiopharmaceuticals has to release before completion of certain quality control
tests due to its short half-life.
TERMINAL STERILIZATION
• The terminal sterilization by autoclaving is not normally performed on such
preparations because of constrains of time.
Thus, a great reliance is to be placed on aseptic technique and operators’ skills.
Furthermore, continuous assessment of effectiveness of quality assurance system
becomes very important.
This is possible by adhering with good radiopharmaceutical practice (GRP).
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The good radiopharmaceutical practices are the guidelines designed, documented
and implemented for protection of workers, patients and preparation of safe and
appropriate radiopharmaceuticals.
The GRP is concerned with:
PERSONNEL
All personnel employed in areas where radioactive products are manufactured
should be qualified and must receive additional training specific to this class of
products.
They should be given detailed information and appropriate training on
preparation, quality control and particularly on radiation protection.
PREMISES (RADIOPHARMACY) AND EQUIPMENT
The premises must be designed to fulfill the requirement of production, quality
control, and environment control.
The GRP requirements for a radio pharmacy are:
1. The design of radio pharmacy will vary from designated bench in
department of pharmacy to a purpose-built radiation laboratory.
2. The whole area should have minimal access to public and the patient in
order to safekeeping radiation hazards, proper storage capacities and
disposal system for radioactive waste.
3. Radioactive products should be stored, processed, packaged and controlled
in dedicated and self-contained facilities.
4. In order to contain the radioactive particles, it may be necessary to the air
pressure to be lowered where products are exposed than in surrounding
areas. However, it is still necessary to protect the product from
environmental contamination.
5. For sterile the working zone where products or containers may be exposed
should comply with the environmental requirements described for sterile
products.
6. Surfaces in the area should be designed to facilitate cleaning and
disinfecting.
7. A periodic sanitation program indicating cleaning procedures and cleaning
schedules should be designed and implemented.
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8. The contamination level in the room should be monitored at regular
intervals.
9. The walls floor, worktop in radiopharmacy should be so that it can
withstand repeated cleaning with water or detergent/antiseptic solutions.
10. The ventilation should be so that it could provide a clean air supply and
avoid recirculation of contaminated air out to the environment without
filtration.
There should be a system to prevent air entering the clean area through exhaust
ducts when the exhaust fan is not operating.
PREPARATION
1. Production of different radioactive products in same workstation and at the
same time should be avoided in order to minimize the risk of mix-up.
2. Process Validation, in-process controls, monitoring of process parameters
and environment assume particular importance in cases where it is
necessary to take the decision to release or reject a batch or a product
before all tests are completed.
In case of in-house preparation, the raw materials chemicals, and ligands should
be given some appropriate batch number.
Complete record of their procurement use, analysis and disposal should be
maintained.
A sufficient number of samples from each batch should be kept aside during the
lifetime of the product. These batch samples can be used to check the product
quality in case of any complaint and any reason for poor performance can be
identified.
QUALITY CONTROL
The quality control is an integral part of GRP and covers the control over material,
processes and environment. Following are the requirements:
1. when products have to be dispatched before all tests are completed, this
does not obviate (prevent) the need for a formal record decision to be
taken by the qualified person on the conformity of the batch.
In this case there should be a written procedure detailing all production
and quality control data which should be considered before the batch is
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dispatched. A procedure should also be describing the measures to be
taken by the qualified person if unsatisfactory test results are obtained
after dispatch.
2. Unless otherwise specified, reference samples of every batch should be
retained.
CODE OF GOOD RADIATION PRACTICES (GRP)
1. Strict personnel hygiene.
2. Avoidance of risk methodology.
3. Operations only in the recommended zones of the hot lab.
4. Proper techniques of distance and shielding.
5. Isolated storage, refrigeration of radionuclides and labelled compounds.
6. Trial run using dummy or inactive source.
7. Adequate washing facilities including showers.
8. Proper in-service training of qualified personnel.
9. Drawing out a manual of standardized procedures of safe handling and step
by step processing, testing and waste disposal of radioactive compounds
and animals.
10. Facilities of minimizing radiation levels, removal of surface and air borne
contaminants, calibration and maintenance of instruments for radioactivity
measurements.
11. Provision of appropriate personnel monitoring and protective devices.
12. Periodic inspection of protective devices for wear and tear and
performance.
13. Establishment of well understood emergency procedures.
14. Proper documentation system is required by law.
DISPENSING
The GRP requires a right radiopharmaceutical with right amount of radioactivity
to be administered to the right patient.
A radiopharmaceutical is prepared in a standard concentration and the decay of
the activity with the passage of time during its storage should be provided in the
form of activity table to the injection area with dispensed radiopharmaceuticals.
The radiopharmaceutical should be dispensed in lead container, lined with
absorbent paper to confine any spillage.
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An appropriate label should be affixed on the dispensed vial, which clearly reflects
the name, amount in ml, date and dispensing time, radioactivity and any
instruction for the administration.
EQUIPMENT CALIBRATION
Checks and calibration on all measuring and monitoring equipment should be
performed at least weekly. The isotope calibrators require checking against long
lived standard.
DOCUMENTATION AND RECORD KEEPING
The scope of documentation in GRP covers the records of:
1. Receiving all radiopharmaceuticals, kits and generators.
2. Various stages of preparation, dispensing of radiopharmaceuticals.
3. Maintenance of Premises.
4. Result of test procedures
5. Issue of finished preparation
6. Activity dispensed to the patient.
7. Preparation of master procedure specifications and quality control
procedure as reference.
Ideally the records of radioactive material should be reflecting life history of an
incoming radioactive material from delivery to the final disposal as waste.
The documents must be periodically revised in light of current experience and
developments in the field but after a satisfactory validation and should be
authorized by the help of head of the unit.
LABELLING
All products should be clearly identified by label which must remain permanently
attached to the containers under all storage condition.
The label on the container should show them.
1. Name of the drug product and product code.
2. The name of radio nuclide.
3. The name of manufacturer or the company.
4. The radioactivity per unit dose.
5. The route of administration.
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6. The expiry dates.
7. The amount of radioactivity at dispatch time.
8. In case of cold kits, -the direction of preparing and a statement of shelf life
of the prepared radio pharmaceutical and the radiation dose that the
patient would receive.
PRODUCTION AND DISTRIBUTION RECORDS
The processing records of regular production batches must provide a complete
account of the manufacturing history of each batch of a radio pharmaceutical,
showing that it has been manufactured, tested, dispersed into containers and
distributed in accordance.
Separate records for the recent storage, use and disposal of radioactive products
must be maintained.
Distribution records should be kept since the return of radioactive products is not
practical, the purpose of recall procedures for such products is to prevent their
use rather than actual return.
DISPENSING & DISTRIBUTION
DISPENSING
Recommends dosage levels based on patient history, age, weight, surface area,
and/or other factors
Dispenses prescriptions in conjunction with applicable pharmacy law and keeps
appropriate records
DISTRIBUTION
Complies with all applicable regulations concerning packaging, labeling, and
transportation of radioactive and other materials (e.g., biohazards),
demonstrating knowledge of:
• DOT regulations concerning packaging, labeling, and transportation of
radioactive and other materials.
• Proper procedures and use of equipment necessary to verify that package
meet DOT requirement
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THE PHYSICAL PLANT AND ITS EQUIPMENT
INTRODUCTION
• Physical plant refers to the necessary infrastructure used in support and
maintenance of a given facility.
• It refers to locations, physical space, equipment and their space allocation
and furnishings of a particular structure.
• Adequate pharmaceutical and administrative facilities is one of minimum
required standard for pharmacies
PLANNING OF PHYSICAL PLANT AND ITS EQUIPMENT
• It includes
o Equipment planning
o Architectural design
o Controlled environment design
o Other architectural aspects e.g. plumbing finishing
• Planning is done following
o Master Planning
o Functional Planning
o Architectural Planning
MASTER PLANNING
• Dictates goals and objectives
FUNCTIONAL PLANNING
• Set forth the operational demands and equipment planning
ARCHITECTURAL PLANNING
• Translates master planning and functional planning into physical space,
equipment and furnishing.
• Architects gather information on objectives and goals of pharmacy
department by attending meetings with Hospital Administrator, Pharmacy
Departmental Head, Hospital Pharmacist and Hospital Building Committee.
DEVELOPMENT OF FUNCTIONAL PROGRAM
• It includes following steps
o Determination of Pharmacy objectives and plan of operation.
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o Determination of functions to be performed.
o Determination of workflow and procedures.
o Estimation of workload.
o Determination of work areas needed.
o Determination of personnel to be accommodated in each work area.
o Determination of space, shape, furniture, equipment and service
needs of each work area.
o Determination of interrelationship b/w work areas and b/w
pharmacy and other departments.
o Arrangement of work areas to maximize the performance functions.
o Designing of schematic floor plans to meet requirements.
o Evaluation of effectiveness of each design for meeting requirements.
o Review the above steps until an optimal design emerges.
LOCATION
• Location of Pharmacy should be so as it can
o Conveniently provide services to many departments of hospital and
nursing stations.
o Easily accessible to inpatients and outpatients as well.
• Pharmacy should be located at first floor, in the center of activities.
Basement of hospital is not desirable for location of Hospital Pharmacy.
SUB PHARMACIES
SATELLITE PHARMACY
• A satellite pharmacy is defined as a pharmacy in an institution which
provides specialized services for the patients of the institution and which is
dependent upon the centrally located pharmacy for administrative control,
staffing, and drug procurement.
• Their number depends upon diversity of clinical services and distance from
main pharmacy.
ADVANTAGES
• Cut the cost on transportation.
• Being able to respond to clinical needs of pt.
• Enable the pharmacist to provide pharmaceutical services to patient,
physician and nurse.
• Pharmacist is available for taking pt. drug histories, maintaining pt. drug
policies and observing pt. for drug reactions and toxicities.
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FLOOR SPACE
• The method of space allocation to a floor is based on
o Number of beds
o Workload of outpatients
• The allocation on the basis of beds depends on basic estimates range from
10 sq feet per bed in 100 beds hospital, 6 sq. feet per bed in 200 bed
hospital and on average of 5 sq. feet per in large hospitals. Area is
measured in sq. foot or sq. inches exclusive of walls and partitions.


• With the evolution of pharmacy profession and emergence of new role of
clinical pharmacist as a center of solution to all drug related issues, varied
functions and services of current pharmacy practice are being provided
o Ranging from standard type dispensing to unit dose dispensing.
o Intravenous additives programs
o Drug information centers
o Extemporaneous compounding
• All these demand for an effective method of space allocation. The space
requirement of a hospital pharmacy is determined by following factors
o Variety and scope of the services provided
o Type of equipment used in the program
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o Expected future expansions
• The floor space is provided for following areas
o Cleanup area
o Nonsterile mixing and filling areas
o Prepackaging area
o Injection reconstitution area
o Labeling and inspection area
o Quarantine storage area
1. CLEAN UP AREAS
• In such areas cleaning and steaming of packaging materials and
utensils is done, therefore it is the demand of pharmacy involved in
compounding or manufacturing of extemporaneous preparations.it
should have pass through windows and floor area with a floor drain.
2. NON-STERILE MIXING AND FILLING ROOM
• It is nothing but a preparation area, where the formula is
compounded but not necessarily aseptic.in this area, the mixing and
filling of liquid must be separated form ointments, though both may
be in the same room
• Adequate space must be provided for storage purpose.
3. PREPACKAGING AREA
• An area in pharmacy for the packaging of oral dosage form into
containers.
4. INJECTION RECONSTITUTION AREA
• It is a place for addition of water for injection for powdered
injectable. Area must be provided with laminar air flow hoods.
5. LABELING AND INSPECTION ROOM
• The labeling and inspection room of hospital pharmacy –
manufactured products are to be located adjacent to filling areas.
• Pass through windows are used for the transfer of unlabeled
products.
• Area must be provided with labeling accessories.
6. QUARANTINE STORAGE AREA
• An area where the manufactured or filled products in the pharmacy
are detained until declared pass the chemical and biological quality
control testing.
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TEMPERATURE CONTROLLED STORAGE FACILITIES
• The drug storage temperature requirements are any of the following
o Refrigerator
o Cold place
o Cool place
o Excessive heat
1. REFRIGERATOR
o Temperature- (2°C – 8°C)
2. COLD PLACE
o Temperature- (not exceeding 8°C)
3. COOL PLACE
o Temperature- (8°C – 15°C)
4. ROOM TEMPERATURE
o Temperature- (15°C – 30°C)
5. EXCESSIVE HEAT
o Temperature- (above 40°C)
o ‘Avoid excessive heat’
• Drug storage and safety is the responsibility of a pharmacist.
• In larger hospital, the refrigerator is too small to accommodate the
inventory requiring refrigeration.
• For this purpose, a cold room is constructed.
• The cold room is artificially cooled area with a regulated temperature of 12
– 15°C.
FEATURES OF COLD ROOM
• The walls of room may be constructed of concrete, concrete blocks or
bricks.
• The door should fit tightly, no larger than necessary.
• The windows are double-paned.
• The switch controlling the light should be on the outside wall near to the
entrance.
• An electric motor-driven air-cooled Freon compressor unit is required for
refrigeration.
• The blower is mounted in the cold room.
• The room can be equipped with necessary shelving, storage binds, cabinets
and work bench.
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ENVIRONMENTAL CONTROLLED FACILITY
VENTILATION
• Air conditioning of the pharmacy is desirable for
o It provides ventilation even when doors and windows are closed.
o The use of various autoclaves, ovens and steam kettles may render
the working environment too hot.
o It permits maintenance of a temperature compatible with official
storage requirements for drugs irrespective of climate conditions.
o Adequately removes strong odors characteristic of the chemicals
used.
o Since the doors and windows can be kept closed, there can be
affected a saving in the cost of housekeeping service in the
pharmacy.
EQUIPMENT PLANNING
• The equipment planning and subsequent purchase of major equipment for
pharmacy is the joint responsibility of hospital administrator, pharmacist,
purchasing agent of the material management department and an
architect.
• The equipment planning is largely dependent on the
o Number
o Varieties
o Per day duration of services offered from the hospital pharmacy.
TYPE AND NUMBER OF EQUIPMENT
• The type & number of equipment can be evaluated on the basis of
determinants of their relative significance and rating by classifying them
into
o Deserving essential considerations.
o Requiring further study before being included or excluded and can be
included.
PARAMETERS
• The following are the parameters, which will dictate the equipment
planning
o Service options
o Choices of internal activities
o Workload and workflow
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o Automation
o Work area
o Ways of communication & transport
o Environmental control requirements
EQUIPMENT SELECTION CRITERIA
• Each equipment is carefully selected on the basis of some criteria as
mentioned below
o Efficient provision of services.
o Affordable operating cost.
o Requiring minimal maintenance.
o Offering maximum safe performance
EQUIPMENT REQUIRED
• Equipment required for the pharmacy are categorized into
o Fixed equipment
o Movable equipment
FIXED EQUIPMENT
• “The equipment requiring installation and is to be attached to the building
is called fixed equipment.”
Examples
o Cabinets
o Counters
o Sinks
o Elevators etc.
SPECIAL ATTENTION SHOULD BE GIVEN TO THE COUNTER TOPS AND THESE
MUST
1. Offer resistance to corrosion and abrasion.
2. Withstand impact without flaking or peeling.
3. No or little effect of high humidity.
4. High color retention quality if colored to resist appreciable discoloration.
5. Must have the abrasion resistant finish-coat.
6. Reagent resistant finish-coat to acids, alkalis, oils and solvents.
MOVABLE EQUIPMENT
• “Movable equipment is capable of being moved and are not intended to be
permanently affixed to the building.”
Examples
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o Carts
o Desks
o Balances
o Mixers etc.
OTHER UTILITIES
• Electric lighting and services
• Transport system
• Plumbing
• FINISHES
o Work counters
o Floors
o Walls
ELECTRIC LIGHTING AND SERVICES
• Smooth and safe functioning of any activity require the appropriate electric
lighting and sufficient number of ground outlets.
• Lighting is based on the location, operation and environment.
• For critical work areas such as prescription dispensing area, manufacturing
area, I/v admixture area.
• Ground electrical outlets should be provided in all areas in which use of
electrical equipment may be indicated.
TRANSPORT SYSTEM
• From pharmacy to various destinations in hospital.
• With the help of messenger, porter or helper is less efficient and time
consuming.
• Modern technology has made available automated means of transporting.
• Including conveyor belt and pneumatic tube system.
• These are used in all pharmaceutical manufacturing units of country but
not yet in hospital pharmacy.
• Drugs and supplies can convey through moving belts to the nursing station
and desired destination.
PLUMBING
• The system of pipeline for the supply of water to desired areas and disposal
of wastes.
• Pharmacist has to advice the architect about details and requirement of
points for hot and cold water for pharmacy and nature of material which
will be disposed off through the various waste lines.
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FINISHES
WORK COUNTERS
• The work counters in pharmacy for writing, dispensing, counting of drugs
receipt of drugs.
• It should be such material that does not show peeling, distortion, erosion or
sticking.
• For these units Formica or similar material is efficient and durable.
FLOORS
• Floor should be smooth, non-slippery, stain resistant.
• Asphalt tile, vinyl tiles, rubber tile and heavy-duty linoleum.
• Carpeting of floors gives aesthetic impact in a pharmacy.
• For manufacturing room should be supplied with covered drain system.
WALLS
• Should be painted with material that permits periodic washing without
losing its color.
• Ceramic tiles or other comparable material should be used.
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INVESTIGATIONAL USE OF DRUGS
INTRODUCTION
The investigational drug is a pharmaceutical entity that is not permitted by health
authorities, for its general distribution and use. This drug may be considered for,
but have not yet received, approval for human use. Such a drug has been
evaluated pre-clinically in appropriate animal models but its safety and efficacy is
yet to be evaluated in humans.
Research drug or experimental drug will be used in this text interchangeably with
the investigational use drug.
A research drug also encompasses a well-known drug formulated in a new
manner with different excipients, coating solvents, vehicles, or other formulation
materials resulting in pharmaceutical that has not been examined for safety and
efficacy.
Similarly, a new combination of two or more old drugs with a change in the usual
proportions in a product is considered ‘new’ if question of safety and efficacy is
introduced by alteration. The new use of an old drug, new dosage schedule or
regimen or proposed new route of administration or new dosage form also needs
new evaluation.
The generic copies, of an originally approved drug are exempted from such
testing provided these are identical to the original drug. Such drugs legally require
bearing a statement on their labels, which identifies them as a new investigational
drug as:
• Caution- limited drugs for Investigational Use only.
• Or Caution: Research Drug
The approval for marketing of a research drug requires submission of an adequate
proof of its effectiveness, which has been accomplished after carrying out clinical
investigation.
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Considering the future potentials demands and training of the pharmacists for
such clinical research, it has become necessary to give pertinent knowledge on
various aspects of clinical research, procedure, and local legislation and to define
responsibilities of a pharmacist for the use of these products.
CLINICAL EVALUATION
The evaluation of a research drug in human is conducted for a substantial
scientific evidence of safety and effectiveness in following four phases.
• Phase – I
• Phase – II
• Phase – III
• Phase - IV
PROTOCOLS OF CLINICAL INVESTIGATION
A PRIORI REVIEW AND APPROVAL
Since investigation in human subjects is potentially uncomfortable. Thus, a clinical
research on human beings must be reviewed prior to its initiation by a committee
of experts usually known as committee in human use and research. If, it is
established that the safety and the benefits of clinical investigation over way the
risk in a piori review, the committee will approve the clinical project.
INFORMED PATIENT CONSENT
Informed consent is willingly acceptance by a patient or an individual by himself
to be subjected in research after having a complete information on the aim,
protocol and procedures of research.
A person recruited for research has legal capacity to give consent and has a free
power of choice to withdraw after a fair explanation of all information concerning
administration of investigational drug, or his possible use as a control.
Ethically, the rights, privacy and welfare of human beings involved as subjects in
research are protected in each research activity.
Before the acceptance of an affirmative decision by a person the investigator
should make known to him either in written, verbally or in both:
• Nature and purpose of the study and expected benefits.
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• All inconveniences, risks, discomforts and hazards reasonably expected.
• Alternative treatments available with respective risks.
• General description of the study procedures and the expected length of
therapy.
• A statement that: a) patient may withdraw from the study at any time
without penalty, and (b) the investigator may remove patient from the
study if circumstances warrant.
• Any compensation or treatment that will be furnished in the event of
injury.
• The name of the person(s) to be contacted for answers to questions about
the study.
• A statement of whom will have access to any study records that contain the
patient’s name.
The ethics impose the condition that investigators must obtain a written consent
of such human beings or their representatives, except when:
• Consent is not feasible because of inability to communicate with patient or
his representative. Some of examples of such conditions are: patient is in a
coma or is otherwise incapable of giving informed consent, his
representative cannot be reached, and it is imperative to administer a drug
without delay.
• Consent is contrary to best interest of such human beings judged
professionally in conditions when communication of information to obtain
consent would seriously affect patient’s disease status or when patient’s
best interest would suffer if consent were sought.
The consent in Phase I and II must be in writing.
In phase III, it is the responsibility of the investigator, taking into consideration the
physical and mental state of the patient, to obtain a verbal consent and record
that fact in the medical record of the person receiving the drug. Usually an
industrial sponsor also gives handsome incentive to the patient or human subject
for their participation in research.
CONSENT FORM
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The consent form should be as detailed as is practical, minimizing the amount of
information that must be presented verbally. Information on a consent form
should be in the patient's own language when feasible or adequate interpretation
is provided.
PROXY AUTHORIZATION FROM PATIENT REPRESENTATIVE
In instance when a patient himself is not able to give consent even verbally, a
legal representative of that patient may give a proxy authorization to investigator
for such studies on appropriate form.
AUTHORIZATION OF TREATMENT INTIMATION TO THE DRUG AUTHORITIES
The clinical evaluation of a drug in human beings raises ethical and legal issues.
Thus, such research in human beings is initiated only after the intimation to the
drug authorities. It is the duty of investigator to notify drug authority before
initiating a research involving human.
Prior intimation of research to drug authority is a requirement by the Food and
Drug Administration authority of USA.
This review ensures that the protocol contains all of the necessary information
and that the patients are not exposed to unwarranted risks. The new drugs used
only for in-vitro research or in laboratory animals have been exempted from a
prior intimation and notification to drug authorities.
These must be labeled as:
• Caution - “Contains a new drug for investigational use only in laboratory
research animals. Not for use in humans”.
• Or Caution – A new drug for test in vitro. Not for use in humans
However, in-vitro research on a new drug that influences diagnosis or treatment
of a disease (i.e., selection of drug or modification of dose) in human patients
requires notified. The antibiotic discs, for instance which are used to determine
sensitivity, to antibiotics of bacteria in culture in a laboratory, or a diagnostic stick
to test sugar in urine are the example of such drugs. These drugs are used in-vitro
but may influence the selection of drug or modification of drug dose.
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Apparent ineffectiveness of an antibiotic sensitivity disc or a false negative test for
glycosuria might lead to an incorrect diagnosis and deprive the patient of
appropriate treatment.
The intimation or notification must have the following information:
• Complete composition of the drug, its source and manufacturing data, to
show that appropriate standards exist to ensure its safety.
• Results of preclinical investigations, particularly on drug’s safety, rather
than its efficacy. The data must demonstrate that there will not be
unreasonable hazard on carrying out studies in humans.
The drug authority generally requires as a minimum:
• (i) Pharmacological profile, (ii) Acute toxicity in several species of animals,
and (iii) The route of administration used in the animal trials.
• A detailed outline of the planned investigation.
• Information regarding training and experience of the investigators
• An agreement from the sponsor to notify the drug authority and all
investigators if any adverse effects arise during either the animal or human
tests.
• The investigator’s agreement to obtain the consent of the person on whom
the drug is to be tested before the test is made.
• Agreement to submit annual progress reports and commitments regarding
disposal of drug when studies are discontinued.
The purposes of notification to drug authorities before undertaking a research on
investigation drugs is to:
• Provide added safeguards for human subjects.
• Establish investigative procedures to supply substantial scientific evidence
that a drug is safe and effective.
• Improves reports by drug investigators.
• Provide ease in collection data from research. An approval, besides
intimation must also be required for research on following:
o Controlled substances.
o Toxic drugs, the use of which may be justified only under special
conditions.
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o Substances proposed for treatment of drug dependence.
o Drugs, the investigations of which have been terminated under the
law for reinstitution of research.
TERMINATION OF CLINICAL INVESTIGATION
The drug, authority may direct a sponsor to terminate investigation on drug after
failure of one chance given to the sponsor for correction at any stage under
following conditions:
1. Evidence of significant hazard.
2. Convincing evidence or drug ineffectiveness.
3. Submission of false data.
4. Omission of material information submitted to the drug authority.
5. Unsatisfactory manufacturing practices.
6. Noncompliance of submitted and approved research plan.
7. Failure to submit progress reports at specific time.
8. Failure to report serious or potentially serious adverse reactions.
9. Failure to meet requirements for patient consent.
The drug in question may not be reintroduced into clinical testing until additional
data have been submitted to drug authority and is approved for proposed
resumption of study.
CONTINUOUS MONITORING
In order to ensure continuing surveillance of the research project by the
Committee of Human Use in Research, each principal investigator should prepare
a Continuing Surveillance Report, on quarterly basis, and forward it to the
Secretary of the Committee on use of Humans in Research.
DOCUMENTATION
The record pertaining to the reports, data, results, inventory and for control
purpose is required to be kept and retained usually for two years or as required
by regulation authority. Documentation is required for: (a) drug amount received
from sponsor, (b) amount dispensed to patients, and (c) returned to sponsor.
BASIC PRINCIPLES FOR INSTITUTIONAL CLINICAL RESEARCH
The procedures in the use of investigational drugs should be based on following
basic principles and conditions:
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• Existence of clear-cut written policies and procedures for the approval,
management and control of investigational drug studies in clinical research.
• Assurance that all clinical studies contain adequate safeguards for the
institution itself, staff of the institution, the scientific integrity of the study
and, especially, for patients.
• Assurance that involved staff is fully informed about, and complies with,
these policies and procedures.
• Assurances that drug studies meet accepted ethical, legal and scientific
standards and are conducted by appropriately qualified investigators.
• All patients who participate in investigational drug studies must freely
consented, in writing, to treatment with the drugs as mentioned before.
GUIDELINES AND CONDITIONS
GENERAL GUIDELINES
EXISTENCE OF A CLINICAL RESEARCH COMMITTEE
• An institution intended to conduct a clinical research must have an
approval from institutional review committee (IRC) Any clinical study
should be reviewed and approved, in writing prior to its initiation by the
committee. This committee must also monitor approved studies to ensure
they are carried out appropriately.
PATIENT CONSENT
• A written patient consent and where not possible, a verbal or proxy
authorization from a legal representative must be obtained to participate in
the study.
SUPERVISED UNDER COMPETENT PERSONNEL
• Investigational drugs must be used only under the supervision of a
competent principal investigator.
AVAILABILITY OF RESEARCH FACILITIES
• In an institution where the investigations will be conducted, special
equipment and other research facilities must be available or provided
before initiation of the research on drugs.
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SELF-REGULATORY NATURE OF RESEARCH
• The research must be self-regulated and to be terminated on evidence of:
(a) a significant hazard, or (b) drug ineffectiveness.
STUDY RESULTS NOT TO BE USED FOR PROMOTION
• The result of a study on new drug will not be used as its promotion until the
completion of investigation and confirmation of its safety and
effectiveness. However, exchange of scientific findings in scientific
communications media is not restricted.
GUIDELINES FOR RESEARCH DRUG CONTROL SYSTEM
EXISTENCE OF AN EFFECTIVE CONTROL SYSTEM
• An effective control system must exist in institution for investigation drugs.
The institution’s drug control system must be efficient to assure surplus
availability, storage, proper packaging, labeling in accordance with
applicable standards and safe use by the nursing staff and patients
PRESCRIPTION FROM AUTHORIZED PRACTITIONER
• Ensure that only authorized practitioners will prescribe the medication and
only consented patients receive the drug
RECORD KEEPING
• After dispensing a record is to be maintained of the amounts of drug
received from the sponsor, amounts dispensed to patients and returned to
the sponsor
RECEIVING DRUG AT ANOTHER FACILITY
• If the patient is to receive the drug at another facility, suitable
arrangements for its transfer must be made. Sufficient information for safe
use of the drug, a copy of the patient’s signed consent, and study protocol
must accompany the patient. The facility to which the drug is transferred
should have written procedures governing the proper handling of
investigational drugs
GUIDELINES FOR INVESTIGATORS
COMPETENCY OF INVESTIGATOR
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• The principal investigator must have proper education, training and
experience or potentials for such studies. The training and experience
needed varies, depending upon the kind of drug and nature of the
investigation. In phase I, the investigator must be able to evaluate human
toxicology and pharmacology. In phase II, the clinicians should be familiar
with the conditions to be treated, the drugs used in these conditions and
the methods of their evaluation. In phase III, in addition to experienced
clinical investigators, physicians not regarded as specialists in any particular
field of medicine may serve as investigators. At this stage, large number of
patients may be treated by different physicians to get a broad background
of experience.
AUTHORIZATION AS CO-INVESTIGATOR
• A principle investigator can authorize another hospital staff member as co-
investigator.
PATIENT CONSENT
• The principal investigator is responsible for obtaining the written, informed
consent of the patient to participate in the study.
RECORD KEEPING
• The principal investigator is responsible for maintenance of records which
may be required by the drug sponsor, institution or drug authority for at
least two years. The records must be made available promptly to the drug
sponsor and to the drug authority when required.
REGULAR REPORTING
• Regular reporting on progress and adverse effects to sponsor is needed so
that drug authority and other investigators can be notified, and the study
stopped if the hazard warrants.
GUIDELINES FOR PHARMACISTS
DEVELOPMENT OF INVESTIGATIONAL DRUG DATA SHEETS
Using the protocol and additional information supplied by the principal
investigator, the pharmacist should prepare an ‘investigational drug data sheet’
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which concisely summarizes for the medical, nursing and pharmacy staffs, the
information pertinent to use of the drug. This form should contain minimally:
1. Drug designation and common synonyms.
2. Dosage forms and strengths available.
3. Usual dosage range, including dosage schedule and route of administration.
4. Indications.
5. Expected therapeutic effect.
6. Expected and potential untoward effects, symptoms of toxicity and their
treatment.
7. Contraindications.
8. Storage requirements.
9. Instructions for dosage preparation and administration.
10. Instructions for disposition of unused doses.
11. Names and telephone numbers of principal and authorized co-
investigators.
The drug data sheet is included with the study protocol submitted to the IRC.
Copies should be distributed to the appropriate pharmacy staff to familiarize
them and all patient care units where the drug will be used.
POSSESSION OF AN APPROVED RESEARCH COPY
• A pharmacist must have a copy of the institutional review committee -
approved research protocol in the pharmacy.
MAINTENANCE OF DRUG INVENTORY RECORD
• The pharmacist should maintain an investigational drug inventory record
where a perpetual inventory of the drug is kept. This form should contain
the following information: (a) drug’s name, (b) dosage form and strength,
(c) lot number, (f) name, address and telephone number of the sponsor,
and (g) information needed for ordering the drug, (h) amounts dispensed,
(i) names of patients receiving the drug and prescribers, and (j) and amount
currently in hand.
PATIENT EDUCATION AND MONITORING OF THERAPY
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• The patient education and monitoring of therapy are two clinical functions
which should be provided in a coordinated fashion by the pharmacy,
nursing staffs, and authorized investigator(s).
RETURNING OF UNUSED DRUGS
• At the conclusion of the study, the pharmacy should return all unused drugs
to the principal investigator or to the sponsor.
PREPARATION OF A STATISTICAL SUMMARY
• The pharmacy should prepare an annual or semiannual statistical- summary
of investigational drug use, including such information as the number of
drug studies in progress and a listing of all drugs studied during the
previous year.
COST ALLOCATION
• The drug costs and other expenses associated with investigational drug
studies such as the costs of record-keeping, drug administration should be
properly allocated.
GUIDELINES FOR NURSES
A nurse involved in administration of investigational drugs must have adequate
written information about study objectives, protocol, drug pharmacology, adverse
effects, storage requirements, dose preparation and administration, precautions,
authorized prescribers, patient monitoring guidelines and any other material
pertinent to the safe and proper use of the drugs.
After dispensing, a nurse must maintain the records of the amounts of drug
dispensed to patients and returned to the pharmacy.
ROLE OF PHARMACIST
The knowledge of pharmacology, drug formulation, stability evaluation,
biopharmaceutics, clinical pharmacokinetics, therapeutic drug monitoring, drug
analytical techniques and statistics enables a pharmacist to play a very significant
role in clinical research. A pharmacist has potential roles at various levels of
research on experimental drugs.
Direct role and Indirect role
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1. Direct role
DEVELOPMENT OF THE RESEARCH PROTOCOLS
• A pharmacist can assist in development of research protocol and
appropriate research designs. During the extended clinical trial stage of
Phase II, a pharmacist can assist in the control of a double-blind study.
• In double blind tests the administration of placebo and the actual drug is
entrusted to pharmacist to dispense according to a predetermined pattern
and to maintain an exact record of which patient received the true drug
and which received the placebo. Neither the patient nor the physician is
informed as to whether the placebo or test pharmaceutical is being tried in
any individual patient. All information for decoding of double-blind codes is
to be kept in the pharmacy.
FORMULATING PLACEBO AND NEW DOSAGE
• A hospital pharmacist can provide service to drug researcher by formulating
new dosage forms. In such case, the time constrain must not compel a
pharmacist to act nonprofessionally and always a scientifically sound
formulation meeting stringent chemical, potency and sterility criteria must
be considered.
PATIENT MONITORING AND DATA COLLECTION
• Pharmacist can render his services for the monitoring of patients and data
collection in a clinical research.
SOURCE OF INFORMATION ON DOSAGE REGIMENS
• A pharmacist can monitor blood and tissue levels of the new drugs as well
as their excretion rates and thereby advise the clinical pharmacologist
relative to the need for dosage adjustment, mode of administration or
product formulation.
DATA ANALYSIS AND CALCULATION OF RESULTS
• A pharmacist may be asked to calculate pharmacokinetic parameters based
on the obtained research data.
STATISTICAL EVALUATION
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• The statistical evaluation of the data is undertaken for meaningful
inference. Due to the knowledge of pharmacostatistics, a pharmacist can
render his valuable service in statistical evaluation of the data for a
meaningful inference.
2. INDIRECT ROLE
• Procurement and storage of investigational drugs according to the
specification.
• Labeling and proper identification of such drugs.
• Preparations of drug before use according to the manufacturer’s
instructions.
• Information regarding the administration of such drugs to the
patients/volunteers.
• Close control over for safe use of investigational drugs.
• Collection of literature describing the method of controlling such drugs.
• Dissemination of information concerning new investigational drugs to the
proper personnel.
• Documentation.
• A pharmacist may be a member of Review Committee on Human Use.
CLASSIFICATION OF DRUGS USED IN AN INSTITUTION
In order to attain a control on the investigational use drug in an institution, it is
necessary for the pharmacy and therapeutics committee to establish a drug
classification system.
Two types of classification are currently in use of their effective control. Under
one system drugs are classified into 4 classes while another, into 3 drug
categories.
One simple classification, which can be adapted to any hospital research program,
is as:
CLASS -A
• Class A are the research drugs that are in a preliminary experimental stage
and are restricted to be dispensed, only on the prescription of principal
investigator. The products in this category are to be stocked and dispensed
either by the principal investigator or from the pharmacy by a pharmacist.
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CLASS -B
• Class B consists of the investigational use drugs that have passed through
the preliminary research stage. Usually, drugs in this category are supplied
to the department of pharmacy by the principal investigator and are
dispensed only upon his written prescription or by prescription of this
nominee.
CLASS -C
• The Class C drugs are contained in any of the official compendium (such as
United States Pharmacopoeia, British Pharmacopoeia, National Formulary,
etc.), or has been approved by the country’s drug authorities for
commercial distribution. Such drugs may be used within the hospital by
obtaining consent from the Chief-Of-Services or his duly designated
alternate (usually the Chairman of the P & TC) before the product may be
obtained from the pharmacist.
• A drug of Class C may be introduced into the hospital on a six-month trial
period. For such inclusion, a request is to be submitted to the P & TC which
may then authorize the pharmacist to purchase, stock, and dispense the
said products. Pertinent data, concerning this special drug, is to be
gathered and filed in the pharmacy office. At the completion of the trial
period, the clinical experience of the drug is reviewed by the P & TC along
with the clinician. If the results are favorable, the product is accepted into
the hospital formulary for further use.
CLASS -D
• The drugs in Class D have been accepted for routine use in the hospital and
are listed in the hospital formulary. Information concerning these products
is to be kept in the general literature file in the pharmacy library. The
preparations in this class may be prescribed routinely by any licensed
physician on the hospital staff.
Another simple classification can also be adapted to any hospital pharmacy
operation that classifies drugs into three categories:
GENERAL
• An approved drug by drug authority and has been recommended as an
essential for good patient care and is with a well-established usage. Once
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this is accepted for inclusion in formulary, may be prescribed by all
members of staff physicians. This drug category is equivalent to the drug in
Class D.
CONDITIONAL
• A drug approved for a conditional period of trial. This drug has been
approved, by country’s authority for general use, but which the Committee
wishes to evaluate for a given period before final consideration. It may be
prescribed by all staff physicians. This drug corresponds to the drug in Class
C.
INVESTIGATIONAL
• A drug not approved by drug authority for use other than under controlled
clinical settings. These drugs are equivalent to the drugs in mass A and/or
B. Before use of such drug, the institutional research committees have
allowed doing so. A protocol of any study involving drugs must be
submitted to the Pharmacy.
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HEALTH ACCESSORIES
INTRODUCTION
“Health accessories are the items which improve the Patient’s Quality of Life and
provides Maximum Physical Independence.”
Recognizing the importance of health accessories in a patient’s life, currently it is
given name of “Para pharmaceuticals”
TYPES OF HEALTH ACCESSORIES
The health accessories are divided into:
1. Convalescent aid
2. Orthopedic braces
3. Home diagnostics aids
4. First aid supplies
1. CONVALESCENT AID
It includes:
a) Ambulatory aids (wheelchairs. Walker, cans)
b) Bed ridden aids
A) AMBULATORY AIDS
WHEELCHAIRS
Following factors are considered while selecting a wheelchair
• Patients disabilities
• Size
• Weight
Its major purpose is to keep patient mobile.
WALKERS
• Walkers are light weight devices that are made of metal tubing.
• It can be wheeled or non wheeled walkers
• It consist of Multi-breaking System so …. A folding walker is much more
convenient to use.
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• It provides steadier support to patient and requires reasonably good arms, wrist
and hands.
i. NON-WHEELED WALKERS
Non wheeled walker provides:
• Increased comfort
• Advanced versatility
• Attractive styling
ii. WHEELED WALKERS
• Wheeled walkers are also called a rollator
• Wheeled walkers are easier to push
• Walkers are used for individuals who do not have the
strength to lift the walker.
• Wheeled walkers are not as safe as the standard walker.
Front wheeled walkers can easily slide and tip causing the
patient to lose their balance.
CANES
Canes are very simple and light weight devices that serves two important
functions
1. Weight transfer
2. Balance
TYPES OF CANES
i. Loop cane
ii. Light weight folding cane:
iii. Quad Base Cane:
i. LOOP CANE
• Easy to use
• Lightweight and durable
• Perfect as an everyday cane
• Ergonomic handle designed for comfort
• Elliptical tubing enforces simple height adjustment
Material: Plastic handle, metal tubing, rubber
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ii. LIGHT WEIGHT FOLDING CANE
• Height adjustable
• Lightweight and durable
• Perfect for traveling,
• Lightweight Folding Cane folds down easily and is held securely together
by the included elastic wrist strap.
iii. QUAD BASE CANE
• Large base design provides more stability than
standard canes.
• Adjustable base allows left or right-handed use
• Can stand on its own when not in use
B) BEDRIDDEN AIDS
Bedside safety Bars
It prevent patient from falling out of bed.
It is made up of Aluminum or steel.
It is available as:
• Full length
• Half Length
• Or any bed type
Over Bed Trays
It is used to serve meal to patients Variety of tables are available for patient ease
and comfort.
• Provides a sturdy platform to eat, read, write or do projects
while in bed
• Tilts up to 70 degrees
• Raised edge keeps objects from falling off
• Wood grain surface is a wipes clean with a sponge or damp
cloth and It can be raised and lowered in infinite positions.
• Locks securely in place when the height adjustment handle
is released
• Chrome-plated steel with "H" base provides security and stability.
• Easy to assemble
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2. ORTHOPEDIC BRACES & SURGICAL FITTINGS
By limiting Patient movement, orthopedic braces and surgical fittings promotes
proper body alignment.
It includes:
i. Back Supports
ii. Cervical support
iii. Wrist support
iv. Knee braces
i. BACK SUPPORT
• Adjustable to increase or decrease tension and corrective
force
• Helps retrain muscles to support your back
• Aids with posture
• Small size great for children
• Helps treat Scoliosis
ii. CERVICAL SUPPORT
• Used to reduce pain due to stress, injury or muscle
spasm.
• One-inch thick foam covered with soft, breathable
fabric.
• Easily adjusted
• Easy to clean (hand washable).
iii. WRIST SUPPORT
• Lightweight for maximum comfort.
• Effectively limits wrist flexion and extension during
repetitive hand motion.
• Helping heal the effects of carpal tunnel syndrome.
• Now using power tools, typing, playing musical
instruments and other activities that cause repetitive
stress trauma to the hands.
• In tendonitis, a weak or flaccid wrist, a wrist sprain or fracture, or lateral
epicondylitis, it supports the wrist.
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iv. KNEE BRACES
• It is used for stabilization and support of knee.
• An incorporated silicone insert leaves the pressure
free and provides intermittent compression to the
soft tissue of the joint leading to increased
circulation, thus aiding in the resorption of swelling
and edema
• Conditions to use Knee Braces:
o Knee strains or sprains
o Knee instability
o Post arthroscopy
o Recurrent knee pain
o Pre- and post-operative knee inflammation
o Chondromalacia
o Adolescent knee pain
o Arthritis / osteoarthritis
3. HOME DIAGNOSTIC AIDS
It includes:
i. Thermometer
ii. Glucose test kit
iii. blood pressure monitors
iv. Pregnancy test kit
v. Dose Alerts
I. THERMOMETER
• It is an instrument used to check body temp.
• It is essential to medical practice
• Thermometers are of following types
i. Mercury thermometer
ii. Digital beeper thermometer
II. GLUCOSE TEST KIT
• It is used to monitor Glucose level in Diabetic Patients.
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• Place a drop of Blood on strip and insert it in Glucometer which gives
value of Glucose level.
III. BLOOD PRESSURE MONITOR
• Blood pressure monitors are of two types
o Mercury model
o Digital model
MERCURY MODEL
• It is more accurate
• Don’t require calibration
• Generally, more expensive
• Require stethoscope
DIGITAL MODEL
• Easy to operate
• Don’t require stethoscope
IV. PREGNANCY TEST KIT
• It detects presence of Human Chorionic Hormone in
urine.
• C is control and T is sample if T changes color
red/pink test is positive otherwise negative.
V. DOSE ALERTS
• Medication reminder and automated pill dispenser in one.
• Ideal for in home care and caregiver facilities, fitness trainers,
naturopathic physicians, dietitians or nutritionists
• Tamper-proof locking key system helps prevent
over- medication
• Easy to program
• Alerts at specified times with 1 of 3 tones and a
blinking red light
• Helps ensure medication compliance for elderly,
Alzheimer’s patients, and the mentally or visually
impaired
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• Reduces the need for personnel to distribute medication
• Great for organizing nutritional supplements or recommending
nutritional supplementation plans
• Low battery alert
4. FIRST AID SUPPLIES
These are items to provide a first aid in home before taking patient to hospital.
It includes:
i. Dressings
ii. Scissors
iii. Tweezers
iv. Applicators
v. First aid kits.
I. DRESSINGS
• A dressing is an adjunct used for application to a wound
o to promote healing
o prevent further harm.
• A dressing is designed to be in direct contact with the wound, which
makes it different from a bandage, which is primarily used to hold a
dressing in place
• Objectives of dressings
o Controlling the moisture content, so that the wound stays
moist or dry
o Protecting the wound from infection
o Removing slough, and
o Maintaining the optimum pH and temperature to encourage
healing.
II. SCISSORS
• Scissors are hand-operated cutting instruments.
• They consist of a pair of metal blades connected in such a way that
the sharpened edges slide against each other.
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• Scissors are used for cutting various thin materials, such as paper,
cardboard, metal foil, thin plastic, cloth, rope and wire.
III. TWEEZERS
• Tweezers are tools used for picking up small objects that are not
easily handled with the human hands
IV. APPLICATORS
• A device used for inserting something or for applying a substance to
a surface.
V. FIRST AID KIT
• A first aid kit is a collection of supplies and equipment for use in
giving first aid
• First aid kits may be made up of different contents depending on
who has assembled the kit and for what purpose.
• It may also vary by region due to varying advice or legislation
between governments or organizations
• Usually following items are included in first-aid kit
• First-aid manual
• Antiseptic solution
(like hydrogen
peroxide)
• Antibiotic cream
(triple-antibiotic
ointment)
• Antiseptic wipes
• Acetaminophen
and ibuprofen
• Flashlight and
extra batteries
• List of emergency
phone numbers.
sterile gauze
• Adhesive tape
• Adhesive
bandages in
several sizes
• Elastic bandage
• Soap
• Hydrocortisone
cream (1%)
• Tweezers
• Sharp scissors
• Safety pins
• Disposable instant
cold packs
• Calamine lotion
• Thermometer
• Plastic gloves (at
least 2 pairs)
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SURGICAL SUPPLIES
DEFINITION
“Surgical supply is a wide term applied to a wide range of materials used for
dressing wounds, injured and disease tissues.”
OR
“It can be defined as hand-held tools or implements used by health professionals
for the performance of surgical task.”
CATEGORIES
There are three main categories:
1. Surgical Dressings
2. Sutures and Ligatures
3. Operating Room Supplies
1. SURGICAL DRESSING
The term surgical dressing includes all materials used for dressing of wounds,
injuries or diseased tissues to provide a healing environment.
DRESSING PROVIDES
• Moist environment for desiccated wounds
• Prevention of maceration of exudative wounds
• Prevention of wounds from dehydration, mechanical or chemical damage
• Facilitates the healing by promoting autolysis, compression, homeostasis
and reducing edema and heat loss
• Provide support to the wound or injured tissues
• Reduction of pain, odor, increase patient comfort, improve functional use
of wound
• Reduce overall cost associated with wound treatment
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ADVERSE EFFECTS OF DRESSINGS
Wound dressing may cause following problems:
• Allergic contact dermatitis
• Maceration of surrounding skin
• Irritant contact dermatitis
TYPES OF DRESSINGS
Dressing selection is based on the basis of degree of exudation, presence or
likelihood of infection and presence of narcotic tissue and anatomical site. The
correct selection of a wound dressing depends not only on the type of wound but
also on the stage of repair. Functionally the dressings can be classified as:
✓ PRIMARY
• Plain Gauze
• Film Dressing
• Impregnated Gauze
✓ SECONDARY
o Surgical Cotton
▪ Absorbent Cotton
▪ Non- Absorbent Cotton
❖ Bleached Cotton
❖ Unbleached Cotton
o Surgical gauzes
▪ Filmated Gauze
▪ Non-Woven Surgical Sponges
▪ Medicated Surgical Gauze
▪ Gauze Pads or Sponges
▪ X-ray Detectable Gauze Pads
o Bandages
▪ Gauze Roller Bandage
▪ Muslin Bandage Roller
▪ Triangular Bandages
▪ Orthopedic Bandage
▪ Cast Paddings
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▪ Elastic Bandages
❖ Woven Elastic Bandages
❖ Crepe Bandages
❖ High Bulk Bandages
o Miscellaneous
▪ Dressing Combines
▪ Laparotmy Sponges
▪ Sanitary Napkins
▪ Disposable Under-Pads
▪ Disposable Cleaners
▪ Eye Pads
▪ Cotton-Tipped Applicators
✓ COMBINED
• Hydrocolloids
• Hydrogels
• Alginates
• Thrombin Solution
PRIMARY DRESSINGS
1. PLAIN GAUZE
• Used as primary dressing to reduce exudative, necrotic and
infected wounds.
• Stick to all clean and incised wounds.
• Its removal is painful as it often removes the newly formed
tissues and epithelium.
2. FILM DRESSING
• May be transparent, occlusive or semi-occlusive.
• Made up of polyurethane with acrylic or polyether adhesives.
• Applied to exuding wounds where they permit enough
evaporation and promote moist wound healing and prevent
maceration.
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• It adheres well to intact skin but has low wound-tissue adherence.
• Helps to protect area vulnerable to pressure, friction, shear and ulceration.
3. IMPREGNATED GAUZE
• Impregnated with cotton, rayon or cellulose.
• Impregnation reduces adherence to wounds.
• Usually used with secondary dressing to prevent desiccation
and entry of pathogens in the heavily exuding wounds.
SECONDARY DRESSINGS (ABSORBENTS)
1. SURGICAL COTTON
▪ ABSORBENT COTTON
• Prepared from raw cotton fiber by removal of natural waxes,
impurities and foreign particles
• It is practically pure and white cellulose fiber
• Available in form of roll, cotton balls and cotton
tipped applicators
• They absorb fluid faster and retain their shape
better than cotton balls
▪ NON-ABSORBENT COTTON
• BLEACHED COTTON
o Prepared from raw cotton by bleaching process wherein
natural oils and waxes are retained.
o Its silky feel is cognitive in nature.
o Water repellent-so does not become matted
or inelastic
o Well adaptive to packing, padding and
cushioning
o Act as non-absorbent backing on sanitary
napkins and drainage dressings
• UNBLEACHED COTTON
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o It is made up of raw cotton fiber, mechanically
cleaned of dirt and carded in layers
o Used in padding and covering of the unbroken
surfaces
o Usually used as cotton plugs in bacteriological
laboratory because of its non-absorbency
2. SURGICAL GAUZES
• Provides an absorbent material of sufficient tensile strength for
surgical dressing that is why known as “absorbent gauze”
• Prepared by raw cotton by cleaning and spinning
or twisting the cotton fiber into thread, which are
woven into an open mesh cloth that is gray in
appearance and nonabsorbent which is then
bleached white and render absorbent. Cuts into
length, folded, rolled and packaged
• Is classified according to their mesh numbers
• Closer the mesh size greater the strength and so
the protection
▪ FILMATED GAUZE
• Absorbent gauze with a thin even film of cotton
or rayon
• It fluffs and gives extensive dressing
• Possesses quick absorption and unusual softness
▪ NON-WOVEN SURGICAL SPONGES
• Alternative to cotton gauze for cleaning the
wounds, wound dressing and tissue handling
sponges
• This fabric depends on dense entanglement of
their synthetic fibers to provide fabric with an
acceptable tensile strength
• Have greater absorbent capacity than cotton gauze sponges
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▪ MEDICATED SURGICAL GAUZE
• Also known as antiseptic surgical gauze due to
presence of antibiotics and other therapeutic
agents
• Commonly used are Lodoform and Penrose
drain gauze
▪ GAUZE PADS OR SPONGES
• They are folded squares of surgical gauze so that
no cut gauze edges, or loose threads are exposed.
This prevents lose fibers from entering into the
wound
• Sterilized packages are frequently used
• Available in tamper proof packages
▪ X-RAY DETECTABLE GAUZE
• Similar to all other gauzes nut contain inert
thread with barium sulfate
• It is nontoxic, soft and nonabrasive
• They are permanently detectable because they
are not detoriated in the body.
3. BANDAGES
Bandages hold dressings in place by providing pressure or support. They
may be inelastic, elastic or become rigid after shaping for immobilization
▪ GAUZE ROLLER BANDAGE
• Prepared from absorbent gauze
• Each bandage is a continuous piece, tightly rolled
and free from loose threads and shedding material
▪ MUSLIN BANDAGE ROLLER
• They are made up of unbleached material
• They are strong and provide sufficient strength
and support as compared to gauze roller bandage
• Are used to hold splints or bulky compression
dressings in place
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▪ TRIANGULAR BANDAGES
• Also called as “Esmarch bandages”
• Made by cutting, square of bleached muslin
diagonally from corner to corner
• Used in first aid work for head dressings, binders
arm slings and as temporary splints for broken bones
▪ ORTHOPEDIC BANDAGES
• Used to provide immobilization and support in the
treatment of broken bones and joints
• Plaster of Paris impregnated gauze are available in
a wide variety of sizes
• They are made from treated plaster while other
fabricating materials, polyester and fiber glass
casting are also used
• These casts are water resistant, light weight and durable
• They are intended for specialized prosthetic uses
▪ CAST PADDING
• They are soft, absorbent, protective bandages,
applied to areas affected before application of cast
• Composed of fiber constructions which conform and
cling, absorb moisture and allow the skin to breathe
▪ ELASTIC BANDAGES
They are used to provide support, pressure, bandaging injury and
dressing stability
▪ WOVEN ELASTIC BANDAGES
o They are made up of heavy elastic webbing
containing rubber threads
o This type of rubber elastic bandages provides
good support and pressure
▪ CREPE BANDAGES
o Its elasticity is due to a special weave rather than rubber
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o Weave allows it to stretch to twice its
length even after repeated launderings
o It is serviceable in bandaging varicose veins,
injuries etc., because it conforms closely to
skin or joint surfaces, lies flat and secure,
allows limited motion and stretches in case of swelling
so that circulation is not impaired.
▪ HIGH BULK BANDAGES
o Elastic bandages made of multiple layers of crimped
cotton gauze
o The high bulk of this bandage type is designed to provide
padding protection in wound dressing applications with
absorbent capacity
4. MISCELLANEOUS
▪ DRESSING COMBINES
• Designed to provide warmth, protection and to absorb large
quantities of fluid drained from incision or
wound
• Consists of non-woven fabric covering enclosed
fiber with or without absorbent tissue
• They are also incorporated into a non-absorbent
layer in cotton, tissue, or plastic film to prevent
fluid from coming through the soil liners and bedding
▪ LAPAROTMY SPONGES
• Also called “abdominal packs, tape pads, stitched pads”
• Four layered gauze used to form a non-abrasive
wall to prevent abdominal or other organs from
escaping into the field of operation and to
maintain the body temperature
• The entire pack is cross stitched and looped tape
½ inch wide and 20-inch-long is attached to one
corner
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• An example is X-ray detectable insert
▪ SANITARY NAPKINS
• Available sanitary napkins are V-pads, obstetrical pads,
gynecological or maternity cases
• The napkins with replacement tissue on its side and back
surfaces have greater fluid holding capacity
• Packaged, sterilized napkins are also available and are used
generally to reduce cross-contamination possibilities
▪ DISPOSABLE UNDER-PADS
• Used for incontinent, maternity and other patient
with severe drainage
• They provide easy cleaning and handling and can
be easily disposed off
▪ DISPOSABLE CLEANERS
• Made up of various types of unwoven fabrics
• Offer advantages over paper of wet strength and
abrasion resistance and better ability if cleaning
• Reduces laundry expenses
▪ EYE PADS
• Made up of non-woven fabric is scientifically shaped
to fit comfortably and cover the eye completely
• Two sides of the pad are enclosed to prevent the
cotton from escaping and the pad from distorting
• May be used as pressure dressing
• Sealed in separate envelope
▪ COTTON TIPPED APPLICATORS
• They are sticks of uniform size having cotton attached
firmly
• They may be sterilized and are used to apply medications
or cleanse an area
• Available in 3- or 6-inches lengths
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COMBINED PRIMARY AND SECONDARY DRESSINGS
1. HYDROCOLLOIDS
• Composed of carboxy methyl cellulose, gelatin, pectin, elastomers
and adhesives that turn into a gel when exudate is
absorbed. This creates a warm, moist environment
that promotes debridement and healing
• Depending on the hydrocolloid dressing chosen
can be used in wounds with light to heavy
exudates, sloughing or granulating wounds
• Available in many forms (adhesive and non-
adhesive pads, paste, powder) but most commonly as self-adhesive
pad.
2. HYDROGELS
• Composed mainly of water in complex network or
fibers that keep the polymer gel intact. Water is
released to keep the wound moist
• Used for necrotic or sloughy wound beds to
rehydrate and remove dead tissue. Do not use for
moderate to heavily exudating wound
3. ALGINATES
• Composed of calcium alginate (a seaweed component). When in
contact with wound, calcium in the dressing is
exchanged with sodium from wound fluid and this
turns dressing into a gel that maintain a moist
wound environment
• Good for exudating wounds and helps in
debridement of sloughing wounds
• Do not use on low exudating wounds as this will cause dryness and
scabbing. Dressing should be changed daily.
4. COLLAGENS
• Dressings come in pads, gels or particles
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• Promote the deposit of newly formed collagen in the wound bed
• Absorb exudate and provide a moist environment.
2. SUTURES AND LIGATURES
SUTURES
A strand or fiber used to hold wound edges in opposition during healing and
the process of applying such a strand is called ligating.
LIGATURES
When such material without needle is used to stop bleeding by tying of
severed blood vessels, strand is called ligatures and this technique is called
ligaturing.
TYPES OF SUTURES AND LIGATURES
✓ ABSORBABLE SUTURES
• Natural Sutures
o Surgical catgut
o Plain surgical gut
o Treated surgical gut
• Synthetic sutures
o Polyester fibers
✓ NON-ABSORBABLE SUTURES
• Natural sutures
o Silk
o Dermal silk sutures
• Synthetic sutures
o Nylon fiber
o Polyester fiber
o Polyolefin
✓ METALLIC SUTURES
• Silver
• Stainless steel
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1. ABSORBABLE SUTURES
▪ NATURAL ABSORBABLE SUTURES
They are proteinaceous in nature and derived from collagen rich animal
tissues. Certain proteolytic enzymes are responsible for their digestion
▪ SURGICAL CATGUT
• Collagen derived from connective tissues
• Intestine from freshly killed sheep are cleaned-→ split
longitudinally in ribbons→ submucosa separated from other
mucosal layer→ separation→ stretched→ spun→ twisted→
dried→ polished→ cut→ packed→ sterilized
▪ PLAIN SURGICAL GUT
• Unable to retain its tensile strength for extended
period of time
▪ TREATED SURGICAL GUT
• Retain tensile strength for longer periods because of an increased
resistance to proteolytic substances
• Earlier, surgical guts were packed in glass tubes with the strands
immersed in xylene as high boiling tubing fluid. The exteriors of
the tube could be sterilized at hospital by autoclaving and thus
was labeled as boilable
• The production of a stiffer strand due to high temperature
sterilization and afterward soaking requirement in sterile water to
let it cool before surgeons find it pliable enough to use.
• The present method of packing provides the sutures ready for use
as removed from its packet.
• The catgut, designed non-boilable, is contained in either a foil or a
plastic packet, immersed in a pliabilizing fluid, which generally
consist of an alcohol or mixture of an alcohol with a small
percentage of water
• These are rendered sterile by ethylene oxide or by irradiation
• All foil or plastic packets are now over-wrapped in a secondary
package. Both the contents and outside of the inner packet are
rendered.
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▪ SYNTHETIC ABSORBABLE SUTURES
• Made up of polymeric polyesters
• High tensile strength
• Packages without fluid
• Sterilized with ethylene oxide
• Do not undergo the enzymatically mediated
absorption process
• Suture is broken down completely by simple hydrolysis as it
resides in tissues.
2. Non-Absorbable Sutures
Found encapsulated in a thin sheath of fibrous tissue.
▪ SILK
• Chiefly made of protein fibroin as extruded by
silkworm
• Many fibers are twisted into a single strand of
various diameters and are available in natural
color or after dying.
• Firmness and strength.
OBJECTIVES
• Minimize the rise of tissue fluid
• A degree of stiffness to improve the handling and tying
properties
• Minimize attachment of tissue cells they would cause
pain or removal of suture
• Lubrication of implantation and removal of silk
DISADVANTAGES
• Interstices of strands protect organisms from
antimicrobial agents from the bodies defense
mechanism
• Sutures knots or ends may serve as center for the
formation of concretions or for other irritating action
CAUTION
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• Not to be used in biliary or urinary tract surgery
▪ DERMAL SILK SUTURES
o Natural twisted silk encased in an insoluble coating of tanned
gelatin or other protein
▪ SYNTHETIC NON-ABSORBABLE SUTURES
o NYLON
• First modern synthetic fibers
• Monofilament used for skin or stay suture,
plastic surgery
• Multifilament is strong water resistant for all
type of suturing or ligating
o POLYESTER FIBER
• Synthetic multifilament
• Tensile strength is superior to that of braded
silk, nylon and twisted cotton
• Do not lose strength significantly when in
contact with water or body fluids so used in
installation of artificial heart valves
• Excellent known holding characteristics
o POLYOLEFIN FIBERS
• Tie more secure knots as compared to monofilaments
• Have very low order of tissue reactivity
• Because of smoothness of polypropylene sutures, they slip
through the tissue easily and because there is no tissue in
growth, they may be removed easily when necessary.
3. METALLIC SUTURES
It is now regarded as controlling consideration in the choice of substances
for implantation in tissues.
▪ SILVER
o Available readily and is alleged to have some
antiseptic actions but in some tissues is definitely
irritating.
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▪ STAINLESS STEEL
o Widely used as wire sutures, fixation plates, screws and other
items
o Proper selection of stainless-steel composition
seems to provide a material essentially inert in
tissues and free from the earlier disadvantages
o Available in both monofilament and multifilament
forms
o Employed most commonly in areas where great strength is
required, such as in the repair of sternum after chest surgery.
SURGICAL NEEDLES
Suture materials may be threaded on eyed or eyeless needles for suturing.
▪ EYE NEEDLES
• They must be made large enough to
accommodate the needle and two thickness
of suture, but with the eyeless needle, the
opening need only accommodate the
needle, slightly larger than the single which
follows.
▪ EYELESS NEEDLES
• They are attached to each individual strand.
• This needle is manufactured with an open
channel into which the suture can be placed,
and the channel is then swaged around the
strand.
• Another type known as “seamless”, has a very
delicate hole drilled in shank which is pressed
firmly about the suture to prevent pullout.
• These sutures minimize trauma, so greatly used in fine surgery
such as ophthalmic & plastic work.
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OTHER SUTURING TECHNIQUES
1. SURGICAL STAPLING DEVICE
▪ These approximate the tissues with rows of
steel staples that remain permanently
▪ Used for closing skin and anastomosing blood
vessels, for reconstructing other organs such as
stomach and intestines
2. LIGATING CLAMPS AND CLIPS
• V-shaped steel or titanium clips and used to
clamp small blood vessels
• More convenient and easy to use
• Clips have the absorbable material like
polydiaxone and lactomer
• Ligating clips made from these substances absorb
after their function is completed
ADVANTAGES OF SUTURES AND LIGATURES
• Tying of suture is more secure
• Less risk of suture fracturing, when handled with forceps
• Less tissue reaction
• Less incidence of micro abscess formation in tissue
• Absorbable sutures are not required to be removed after wound healing
STORAGE
• Freeze at -20°C
• Metal sutures at 32°C
• Protect from dampness and direct sunlight
PRECAUTION
• Do not continue using after expiry date
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3. OPERATING ROOM SUPPLIES
1. HEMOSTATIC PRODUCTS
• It accelerates hemostasis by providing a thrombogenic
surface that promotes platelet aggregation and fibrin
polymerization
• It includes collagen sponges and powder, gelatin sponge
and oxidized cellulose
• When they are applied to bleeding surface they swell up
and form a gelatinous mass that is absorbed gradually by tissue
usually within 7-12 days
• Employed in surgery for the control of moderate bleeding where
suturing or ligation is ineffective
2. THROMBIN SOLUTIONS
• Bovine origin and promote hemostasis by catalyzing
the conversion of fibrinogen to fibrin
• Used in conjunction with fibrinogen concentrates
prepared from autologous cryoprecipitate or from
pooled donor blood
3. DISPOSABLE STERILE PACKS
• These are available for operating room and for obstetrical room
• Prepared, packaged, and sterilized assemblies of
diapering and gowns units, designed to fulfill
operating room needs
• Eliminates the problems of laundering, storage,
assembly and sterilization of muslin drapes and
gowns
• Special materials are available with particular properties of porosity,
repellency to water, alcohols, blood, and other fluids
• Double packages of contamination resistant papers are available that
permit the use without compromising sterility
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4. FACE MASKS
• Available for use in operation room and where control
contamination is required
• Made of plied, fine mesh gauze, shaped to cover the
nose, mouth and chin
• Can be laundered and autoclaved.
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MANAGEMENT OF ACCIDENTAL &
EMERGENCY PHARMACY
INTRODUCTION (ED)
EMERGENCY DEPARTMENT (ED)
• “It is the medical treatment facility specializing in emergency medicines,
that is, acute care of patients who present without prior appointment.”
• ED is often found in a hospital or primary care center.
• Emergency department (ED) is also known as accident & emergency (A&E),
emergency room (ER), or casualty department.
EMERGENCY DEPARTMENTS IN HOSPITALS
• Accidental Management and
Disaster Management
• Airway management
• Ambulatory care
• Cardiology
• Critical care
• General medicine
• Psychiatry
• Infectious diseases
• Pediatrics
• Procedural sedation
• Toxicology/drugs of
abuse/overdose
• Poison Control Centre
EMERGENCY PHARMACY SERVICES (EPS)
NEED FOR EMERGENCY PHARMACY SERVICES
• The unique and complex nature of the ED.
• ED is known to be a particularly high-risk environment with.
• Frequent medication errors
• Fatal drug adverse event chances.
• EDs care for patients who experience adverse drug events and drug-drug
interactions.
• Adverse drug events that occur in the ED are a significant public health
problem and need to be reduced.
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PHARMACIST ROLE IN EMERGENCY DEPARTMENT
• Attention on Patient Safety
• Reduce Medication Mishaps
• Control Medication Errors
• Preventable Adverse Events
• Improve Quality of Care
RESPONSIBILITIES OF HOSPITAL PHARMACIST IN ED
A. Emergency Drug List
B. Pharmacy Representation
C. Pharmaceutical Care
D. Drug Distribution Support
E. Clinical Interventions
F. Investigational Drug Studies
G. Research & Teaching
H. Poisonous Management
A. EMERGENCY DRUG LIST
• Formulation of Emergency Drug List.
• Supplies of Parenteral Therapies.
• Developing a procedure for obtaining and preparing antidotes.
EMERGENCY MEDICINES
• for certain conditions, are as follows:
TO TREAT ALLERGY
• Hydrocortisone sodium succinate injection, 100mg powder for
reconstitution
• Adrenaline 1 in 1,000 (1mg/mL)
• Chlorphenamine tablets 4mg
• Chlorphenamine injection 10mg/ml
ANTIBIOTICS
• Amoxicillin capsules/co-amoxiclav tablets and suspension
• Cefuroxime injection
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• Cefalexin capsules
• Erythromycin tablets and mixture
CENTRAL NERVOUS SYSTEM
• Diazepam injection 10mg/2Ml
• Diazepam tablets 5mg
• Diazepam rectal tubes 5mg/2.5mL
• Chlorpromazine injection 50mg/2mL
• Chlorpromazine tablets 25mg
• Haloperidol injection 5mg/mL
TO REDUCE PAIN (PAINKILLERS)
• Paracetamol tablets 500mg
• Dihydrocodeine tablets 30mg
• Cyclimorph® injection
• Diclofenac 75mg/3Ml
B. PHARMACY REPRESENTATION


PHARMACIST
Pharmacy
Technician
Dispensor
Pharmacy
Assistant
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C. PHARMACEUTICAL CARE IN ED
• Medication Order Clarification.
• Documentation of Patient & Pharmacy Record.
• Monitor Drug Therapy.
• Pharmacokinetic Consultation.
• Detection & prevention of ADR & medication errors.
• Improve Quality of Care by monitoring Activities & Outcome (from
diagnosis to post discharge care).
D. Drug Distribution Support
• Distribution related issues.
• Provision of Unit Dose Packaging.
• Pyxis (automated drug dispensing machines) related issues.
• Review of Medication in ED.
E. CLINICAL INTERVENTIONS
• Promote Rational, cost effective drug therapy.
• Identify and implement drug therapy.
• Reporting of potential impact.
• Develop and conduct target drug program and medication.
• Evaluation and reporting to Pharmacy & Therapeutic committee.
F. INVESTIGATIONAL DRUG STUDIES
• Facilitation
• Co-ordination of ongoing research
• In-services for ED related investigational studies
G. RESEARCH & TEACHING
• Co-investigation (along with clinician)
• Active Participation
• Publishment
• Conducting Clinical Trials.
H. POISONOUS MANAGEMENT
• Formulation of common Antidote List.
• Formulation of Un-common Antidote List.
• Supplies management of common and un-common Antidotes.
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RESPONSIBILITIES OF CLINICAL PHARMACIST IN ED
A. Medication Histories.
B. Consult with Emergency Clinicians.
C. Medication Monitoring.
D. Narcotics Management.
E. Risk Management.
F. Counseling at Discharge.
G. Teaching other Staff
A. MEDICATION HISTORIES
• Medication History Review (if patient has any).
• (in case of no history) consult patient or his relatives and inquire about the
common drugs used by patient in order to avoid,
• Drug Interactions
• Drug Allergies
• ADR
• Medication History has an impact on decisions made by Health Care
Professionals about patient’s care
B. CONSULT WITH EMERGENCY CLINICIANS
• Discuss history with clinician so that avoiding any drug interaction or
adverse effect
• Providing drug information consultation to providers (staff).
• Ensure appropriate prescribing and administration.
• Drug Therapy Recommendation.
C. MEDICATION MONITORING
• Monitor Rational use of drugs.
• Monitor Patient compliance with recommended treatment. (about 50% of
patients don’t comply with the treatment).
• Monitoring patient responses and laboratory values.
• Monitoring patient adherence to therapy (assessment of contraindications
to therapy).
• Antimicrobial Dosing.
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D. NARCOTICS MANAGEMENT
• Monitor dose
• Adjust dose
• Suggest dose
• Monitor supply
E. RISK MANAGEMENT
• Providing Primary Care to patients with regular emergency pharmacy
services.
• Participation in CPR.
• Preventing Adverse interactions by following up the patients.
• Planning and Participation in advent of natural & intentional disaster.
F. TEACHING OTHER STAFF
• Teaching session for doctors and para-medical staffs.
• Scheduled In-service meeting.
• Public education.
• Journals
G. COUNSELING AT DISCHARGE
• Counseling patient to strict to the dose regimen therapy.
• Patient Education.
OPTIMIZATION OF THE EMERGENCY PHARMACIST ROLE IN MEDICATION
SAFETY
• Screening physician orders for accuracy in dosing, drug interactions,
contraindications, and allergies.
• Access to more patient information and clinical data.
• This model increases the pharmacists’ involvement in medication choice
decisions tailored to specific patients.
• Pharmacists, as members of an inpatient care team, reduce the number of
adverse drug events.
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EMERGENCY PHARMACIST JOB DESCRIPTION
• The Emergency Pharmacist is responsible for providing comprehensive
clinical pharmacy services for the ED and all associated areas (e.g.,
pediatrics, trauma, urgent care).
• Pharmacokinetic and Therapeutic consultation.
• Specific responsibilities include, but are not limited to:
• Involvement in direct patient care
• Visibility of the EPh
• Involvement in teaching.
• Surveillance of medication orders.
• Pharmacy review of high-risk medication orders prior to administration.
• Patient-specific medication use teaching for discharge medications when
appropriate.
• Focus on cost avoidance and cost savings due to medication use in the ED.
• Facilitate proper information transfer with regard to medication use for
patients.
• Working with other clinicians and health care providers to implement and
maintain innovative disease management programs.
• Interpret each prescription order to determine that it meets all legal
requirements.
• Keep informed of the actions, side effects, and proper use of all new drugs.
• Provide immediate information in emergency situations to Physicians,
nurses, and allied health staff regarding:
o Drug Drug Interaction (DDI)
o Adverse Drug Reactions (ADR)
o Drug Disease Interactions (DID)
o Drug Food Interactions (DIF)
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INSPECTION OF WARDS WITH REFERENCE TO
DRUG STORAGE
INTRODUCTION
• In every hospital there are a number of wards and with every ward there is
a satellite pharmacy in which medicines are stored for usage. Being
pharmacist, it is our duty to inspect wards and satellite pharmacies
regarding safe use of medication and their storage. It is also necessary to
ensure that all medication in wards and satellite pharmacies are neat,
clean, and well organized and free of all expired or deteriorated
medications.
INSPECTION
• “Act of examining something closely, in order to see if rules are being
followed or the things are in their proper conditions”
• An inspection of wards is, most generally, an organized examination or
formal evaluation exercise performed in wards with reference to drug
storage and administration.
IMPORTANCE OF INSPECTION
• The main importance of this inspection is to ensure that medications are
stored and administered in a proper way otherwise they are deteriorated
and can ultimately cause toxic or undesirable effects in patient. Proper
storage ensures safety and stability of the medicine.
ROLE OF PHARMACIST
• The director of pharmacy will maintain a list of all the wards throughout the
hospital. A pharmacist will inspect the ward and document it in ‘WARD
INSPECTION FORM’. The pharmacist shall be responsible for ensuring that
the storage and usage of medications are proper.
1. INSPECTION OF SATELLITE PHARMACY
The following parameters should be checked while doing an inspection:
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• All medicines are placed in order (Alphabetical or code no. sequence)
• Medicines are separated from disposable
• Medicines are stored in shelves or racks (not in stocked form)
• Drug storage area is neat and cleaned by proper disinfectant
• Bin cards are displayed and updated
• Proper environment control (proper temperature, light, humidity,
ventilation, sanitation)
• Cold storage area is provided
• Temperature of the room is maintained i.e. 25℃
• Temperature of refrigerator is checked regularly
• Controlled substances are stored separately in locks
• Medicines are protected from sun light and dust
• Arrangements for rodents and insects is provided
• Access to storage area is restricted or not
• Externals should be separated from internals.
2. CHECKING OF REFRIGERATORS
Refrigerators containing medications must be checked physically to ensure that
• They have a working thermometer with the alarm switch set to ‘ON’
position. The refrigerator temperature should be between 2-8℃.
• No foods, beverages, or culture media are to be stored with medications.
• All refrigerated medications should be checked manually.
• Also ensure that refrigerator is free from
o Expired medications
o Any open single-dose or multiple dose medicine
o Any unlabeled medicine
3. THE SECURITY OF MEDICINES
• Pharmacist is the responsible person for the security of all medicine which
includes
1. Medicines in the storeroom (central storage)
2. Medicines in the wards.
3. Medicines brought into hospital by patients.
• Patients may bring their current or previously used medicines with them on
admission.
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• This should be hospital policy to secure all the medicines and return to the
patient or patient agents at the time of discharge.
• If there are harms related effects of these medicines, then pharmacist
should take measures for the destruction of that medicines with the
consultation of patient agents by counseling them about the harms.
4. STORAGE OF THE PHARMACEUTICAL PRODUCTS
• It is the key responsibility of hospital pharmacist.
• Storage may be central or specific forward management.
• Generally, in hospitals, for the handling of varieties of supplies, Central
storeroom may be divided into following areas.
• Alcohol and liquids
• Capsules and tablets
• Chemicals
• Narcotics
• Biological
• Ointments
DIFFERENT STORAGE CONDITIONS
• Refrigerator 2-8℃
• Cold place 8℃
• Cool place 8-15℃
• Room temp 25℃
• Excessive Heat up to 40℃
COLD ROOMS
• In large hospitals, the refrigeration facility becomes limited. To overcome
this, cold room usually constructed. The features of room are,
• The construction of room should be of concrete.
• The doors of room should be fit tight.
• The windows should be double paned sealed.
• The light switch should be nearest to the entrance of room.
• An Electric motor driven air-cooled compressor unit is needed to
provide necessary refrigeration.
• The room should be designed with necessary shelving, storage binds,
cabinets and working bench.
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ENVIRONMENTAL CONTROLLED FACILITY
VENTILATION
• Must be appropriate to provides necessary temperature when the
windows and doors are closed.
• It permits maintenance of a temperature compatible with official
storage requirements.
5. MEDICINES SUPPLIED TO A SPECIFIC WARD
• A list of stock medicines to be held on the ward should be decided by a
pharmacist in consultation with appropriate medical staff and the
Appointed Nurse in Charge.
• Pharmacy staff should determine the amount of each stock medicine to be
held at any time from usage patterns. This amount should be stated on the
record of ward orders. This may be done automatically using computer-
controlled systems and electronic orders.
6. RECEIPT AND RECORDS
• Medicines coming on to the ward should be received by a Designated
Person who should check them against the requisition and record that a
check has been made.
• Receipt and record-keeping for Controlled Drugs should follow the agreed
local procedures that comply with the current legal framework. The senior
pharmacist should be responsible for devising such local procedures.
7. LABELING OF FLOOR STOCK DRUGS
• None of the floor stock drugs is labeled with the directions for use.
• This is due to the fact that many patients may be receiving the same drug
but under a different therapeutic regimen.
• Therefore, it is the duty of hospital pharmacist to label the packages
containing generally used floor stock medications which show the
• The name of ward
• Name of patient
• Name and strength of the preparation.
8. ADMINISTRATION OF THE MEDICINES
NURSING POLICY AND PROCEDURE FOR DRUG ADMINISTRATION
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• Although, the hospital pharmacist does not directly involve with the drug
administration to the patient, but he should be thoroughly familiar with the
procedures and policies followed by this particular institution
• Different procedures for drug administration are employed by nurses which
are decided by the medical center, during his inspection in ward pharmacist
should check out all these procedures
GENERAL REGULATIONS FOR MEDICATIONS ORDERS
• VERBAL ORDERS
Verbal orders for medications can only be accepted by a registered nurse,
from a physician only in case of emergency.
• TELEPHONIC ORDERS
It is necessary for a registered nurse to accept the telephonic order; this
order will be valid only for 24 hours.
NURSING MEDICATION ADMINISTRATION REGULATIONS
• PURPOSE
To describe the policy and procedures which guide nursing personnel in the
administration of medications within the limits imposed by state law, nurse
practice act as well as hospital policy.
GENERAL REGULATIONS FOR MEDICATIONS ADMINISTRATION
• Medications are not to be administered without a written order from the
physicians.
• The nurse must know the nature of the drug, the desired effect, the
average dose, the mathematical preparation of the dose, methods of
preparations, the toxic symptoms, and methods of administration before
administering any other medications.
• The nurse may administer only those medications he/she prepared
personally in hospital pharmacy.
• The nursing staff must be familiar with the bulletins and directives relating
to medications administration.
• During inspection of wards, hospital pharmacist should keep an eye on all
that regularities and has to play a key role in patient care.
REGULATIONS FOR SPECIFIC DRUGS
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1. NARCOTICS
• Narcotic drugs should not be administered if the patient’s respiratory rate
is below 12/min.
• Dose adjustment.
• Route of administration.
• While administering antihypertensive drugs both upper and lower limits of
blood pressure should be observed.
2. VACCINES
• Vaccines need special considerations about their administration.
3. DIGITALIS
• May not be administered if the patient’s pulse rate is below 50 without
consulting the physician.
REGULATIONS FOR VARIOUS ROUTES OF ADMINISTRATION
1. ORAL MEDICATIONS
• Only scored tablets may be divided.
• Capsules should not be opened to divide the dose.
2. PARENTERAL MEDICATIONS
• Not more than 5 ml of any drug should be administered intramuscularly
into one site at one time.
• Not more than 2ml of drug should be administered subcutaneously.
3. INTRADERMAL MEDICATIONS
• Should be given by a skilled and registered nurse only.
4. INTRA-ARTERIAL MEDICATIONS
• Should be administered by physician only.
5. RECTAL MEDICATIONS:
• Should be administered by retentions enema or by suppository.
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9. INSPECTION OF NURSING DRUG CABINET
• The key thing to check by a hospital pharmacist during ward inspection is
the drug cabinet of nursing staff.
• Pharmacist should check that all the necessary products must be present
including all parameters set by the administrator of ward with consultation
of hospital pharmacist.
• The only way to ensure the proper supply to the pavilion is the inspection
of nursing drug cabinet
• Inspection of cabinet should be done on regular basis
• There should be points in the check list, which includes:
• Mechanism of security of cabinet
• Refrigeration and lightning conditions
• Ensure the deterioration of all non-dated drugs.
• Labeling and segregation of research drugs
• Elimination of non-approved drugs, samples from drug cabinet.
• Correctness of the previous inspection’s citations.
• General inspection of drug preparation area.
• Check properly the storage and rotation of IV solutions.
10. DISPOSAL OF PHARMACEUTICAL PRODUCTS
• Out-of-date medicines and any stock no longer required should be returned
to the pharmacy with appropriate security precautions.
• The disposal of these out of date products is also responsibility of hospital
pharmacist.
CONTROLLED DRUGS
• Disposal of Controlled Drugs should follow the agreed local procedure that
complies with the current legal framework. The senior pharmacist should
be responsible for devising such local procedures.
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