PHARMACY AND THERAPEUTIC COMMITTEE

PHARMACY AND THERAPEUTIC COMMITTEE IS VERY IMPORTANT IN RECENT DAYS TO MAKE SURE DRUG FORMULARY MAINTENANCE

1. PHARMACY AND THERAPEUTIC COMMITTEE SUBMITTED BY: UNDER THE GUIDANCE OF: P.MONIKA Dr. G.RAMESH PHARM.D 15AB1T0019 DEPARTMENT OF PHARMACY PRACTICE IV PHARM.D VIGNAN PHARMACY COLLEGE (Approved by AICTE & PCI Affiliated to JNTU KAKINADA) VADLAMUDI, GUNTUR DIST-522213,ANDHRA PRADESH, INDIA.

2. Introduction : To be effective, medication-use policies must have the concurrence of individuals involved in the medication-use process. Such consensus is achieved by developing medication use policies through a properly organized and representative pharmacy and therapeutics (P&T) committee or equivalent body and ensuring that those policies are approved by the organized medical staff. The P&T committee is composed of actively participating physicians, other prescribers, pharmacists, nurses, administrators, quality-improvement managers, and other health care professionals and staff who participate in the medication-use process.

3. ORGANISATION : Composition of pharmacy and therapeutics committee (PTC) might vary from hospital to hospital. The following scheme is suggested for general adoption: The PTC may be composed of: At least three physicians from the medical staff A pharmacist A representative of the nursing staff An hospital administrator with his/her designated an exofficio member of the committee one of the physicians may be appointed as the chairman of PTC.

4. PTC Medical staff: Chairman Co-chairperson Hospital administrators : director Pharmacist : Secretory Nursing staff

5. Sub committees Neo-plastics Anti- infectives CVS DRUGS: Diuretics Hypertensives Vasodilators S pasmodics GI drugs : Autonomics laxatives CNS agents : Analgesics Anti- convulsants Endocrinology: Anti diabetic hormonal

6. GOALS The goal of a DTC is to ensure that patients are provided with the best possible cost-effective and quality of care through determining what medicines will be available, at what cost, and how they will be used. In order to achieve this goal a DTC will have the following objectives: T o develop and implement an efficient and cost-effective formulary system which includes consistent standard treatment protocols, a formulary list and formulary manual T o ensure that only efficacious, safe, cost-effective and good quality medicines are used T o ensure the best possible drug safety through monitoring, evaluating and thereby preventing, as far as possible, adverse drug reactions (ADRs) and medication errors T o develop and implement interventions to improve medicine use by prescribers, dispensers and patients; this will require the investigation and monitoring of medicine use.

7. OBJECTIVES The PTC has 3 major roles to play : 1.advisory 2.educational 3.drug safety and ADR monitoring Advisory : The committee recommends the adoption of policies or assists in the formulation of broad professional policies regarding evaluation , selection and therapeutic use of drugs in the hospital The committee serves in anadvisory capacity medical staff and hospital administration in all matters pertaining to use of drugs

8. Education : The committee recommended in formulation of function, design to meet the need of professional staff (physician, nurses, pharmacist other health care practitioner for complete current knowledge of matters related to drugs and its usage. Drug safety and monitoring : Pharmacist has an increased responsibility and also develop a moral or legal and professional functions of ensuring safety in handling and administration of drugs .

9. FUNCTIONS There are many possible functions of a DTC, and the committee must decide which to undertake as a priority; this decision may depend on local capacities and structure. Furthermore, certain functions will require liaison with other committees or teams, for example the infection control committee or the procurement team. The most important DTC functions are summarized below.

10. 1. Advisory committee to medical staff, administration and pharmacy The PTC is a valuable resource that can provide advice to medical staff, nurses, administration, pharmacy and other departments and groups within the hospital. The PTC can advise on all issues, policies and guidelines concerning the selection, distribution and use of medicines. Usually a DTC will provide advice and an executive body, usually the pharmacy or hospital management, will implement it. 2 Development of drug policies The PTC 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.

11. Drug policies may vary in different hospitals and countries, but all hospitals should have specific policies concerning: C riteria for inclusion of medicines on the formulary list (essential medicines list (EML)) S tandard treatment guidelines and treatment algorithms, which should be the basis of formulary selection P eriodic 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 E xpensive 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) D rugs that are under investigation for safety or efficacy G eneric substitution and therapeutic interchange D rug representatives and promotional literature.

12. 3. Evaluating and selecting medicines for the formulary list Perhaps the most important function of a PTC 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. The evaluation of medicines requires significant expertise and time commitment and a rigorous, transparent approach . 4.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 PTC to identify the priority problems and make appropriate recommendations

13. 5.Appropriate methods to identify drug use problems include: • 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 guideline• drug use evaluation (DUE), also known as drug utilization review • Monitoring adverse drug reactions and medication errors • Antimicrobial resistance surveillance

14. 6.Conducting effective interventions to improve medicine use There is no point in a PTC collecting information on drug use problems if nothing is done to correct the problems identified. The PTC 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.

15. 7.Managing adverse drug reactions Adverse drug reactions (ADRs) are serious in terms of patient harm (morbidity and mortality) and avoidable economic costs. One large meta-analysis estimated that ADRs cause 3-4% of all hospital admissions in the USA and that in 1994 the incidence of ADRs was 6.7% (2.2 million events) with 106 000 fatalities ( Lazarou et al. 1998). These estimates should be viewed with caution because of the heterogeneity among studies and small biases in the sample, but the data nevertheless suggest that ADRs are a large and serious problem

16. 8.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. PTCs can reduce such errors by monitoring, analysing , reporting errors and implementing corrective action

17. 9.Information dissemination and transparency The PTC must disseminate information about its activities, decisions and recommendations to the staff who must implement the PTC’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 PTC operates in such a way as to ensure transparency of all its decisions and to avoid conflict of interest. In particular, members should either have no relationship with pharmaceutical companies or declare it openly so that conflicts of interest can be avoided. The only acceptable contact with pharmaceutical companies is to ensure the flow of information about their drug products in a way that is as unbiased as possible

18. Policy Development The P&T committee formulates policies regarding evaluation, selection, diagnostic and therapeutic use, and monitoring of medications and medication-associated products and devices. The P&T committee should establish and assist in programs and procedures that ensure safe and effective medication therapy (e.g., clinical care plans, treatment guidelines, critical pathways, disease management protocols). Members of the P&T committee, or their representatives from appropriate specialties (including pharmacists), should participate in or direct the development and review of such programs or procedures, which should be kept current.

19. The P&T committee should participate in performance improvement activities related to procurement, prescribing, dispensing, administering, monitoring, and overall use of medications. The P&T committee should advise the institution, including the pharmacy department, in the implementation of effective medication distribution and control procedures, incorporating technological advances when appropriate. The P&T committee should initiate, direct, and review the results of medication-use evaluation programs to optimize medication use and routinely monitor outcomes (economic, clinical, and humanistic) of formulary decisions.

20. Communication and Education The P&T committee ensures that mechanisms are in place to communicate with health care professionals, patients, and payers about all aspects of the formulary system, including changes made to the formulary or policies and how formulary system decisions are made. The P&T committee also recommends or assists in the formulation of educational programs designed to meet the needs of professional staff, patients, families, and caregivers on matters related to medications and medication use. The P&T committee should establish or plan suitable educational programs on matters related to medication use for staff involved in the care of patients and the use of medications.