PHARMACOVIGILANCE by Keshav Singh Sisodiya

Pharmacovigilance project submitted by Keshav Singh Sisodiya Bpharm 8th semester, guided by Dr. Mahendra singh ranawat sir at Bhupal nobles college of pharmacy.

1. PHARMACOVIGILANCE

BHUPAL NOBELS’ COLLEGE OF PHARMACY, B.N.
UNIVERSITY, UDAIPUR-313001 (RAJASTHAN)

Presenting by : Guided by :
Keshav singh sisodiya. Dr. M.S. Ranawat
B. pharm 8th sem

2. INTRODUCTION :
No drug which is pharmacologically effective is without hazard. Furthermore
not all hazards can be known before a drug is marketed. Pharmacovigilance,
which includes the procedures used to identify, evaluate, and minimise the
hazards connected to medications in clinical use, is widely recognised as an
essential component of public health. Most nations now have notification
mechanisms in place for reporting information on adverse medication
responses to the authorities as a direct result of the thalidomide catastrophe
in the 1960s.

3. DEFINITION USED IN PHARMACOVIGILANCE
ABUSE : Abuse is the intentional, non-therapeutic use by a patient or
consumer of a product -over-the counter or prescription -for a perceived
reward or desired non-therapeutic effect including, but not limited to, "getting
high" (euphoria).
DRUG ADDICTION : Addiction is an overwhelming desire by a patient or
consumer to take a drug for non-therapeutic purposes together with inability
to control or stop its use despite harmful consequences.
MISUSE: Misuse is the intentional use for a therapeutic purpose by a patient
or consumer of a product -over-the-counter or prescription -other than as
prescribed or not in accordance with the authorisedproduct information.

4. COMPOUNDING: Compounding refers to products that are usually made by a
pharmacist or physician. DEVICE USE ERROR: An act or omission of an act that
results in a different medical device response than intended by the
manufacturer or expected by the operator.


DISPENSING ERRORS: Dispensing errors are not limited to pharmacists.It can
include nurses and physicians.For example, physicians can dispense sample
products in their office.


PRESCRIBING ERROR: Prescribing errors may be made in the hand of
physicians or other healthcare professionals who have the prescription
authority.

5. OVERDOSE: Overdose is more than the maximum
recommended dose (in quantity and/or concentration), i.e.,
an excessive dose.

UNDERDOSE: Underdose is the administration of less
than the minimum recommended dose (in quantity and/or
concentration).

OCCUPATIONAL EXPOSURE: Occupational exposure
encompasses the “chronic" exposure to an agent including
therapeutic products) during the normal course of one's
occupation.

6. Pharmacovigilance Programme of India (PvPI):
• Launched by the MoHFW, Govt. of India in the year 2010 at AIIMS New Delhi as
National Coordinating Centre (NCC).
• The Programme transferred to IPC as NCC in April, 2011 by a Notification issued
by the MoHFW, Govt. of India.
• IPC-PvPI became the NCC for Materiovigilance Programme of India
(MvPI) from July, 2015
• IPC, NCC-PvPI became a WHO Collaborating Centre for
Pharmacovigilance in Public Health Programmes & Regulatory services from
July, 2017.

7. Pharmacovigilance in Acts & Rules:
• Pharmacy Council of India: Pharmacovigilance as one of the subjects in Pharmacy
Under Graduate curriculum

• Drugs & Cosmetic Act & Its rules 1945: establishment of Pharmacovigilance
cell in the pharmaceutical industry is mandatory. • National Health Policy:
Pharmacovigilance includes Prescription Audit inclusive of Antibiotic usage, Ministry of
Health & Family Welfare, Government of India.

8. Pharmacovigilance in India: Present Scenario and
Future Challenges :
Pharmacovigilance in India was initiated way back in 1986 with a formal
adverse drug reaction (ADR) monitoring system, under supervision of the
drug controller of India. India joined the World Health Organization (WHO)
Programme for International Drug Monitoring in 1998, but was not successful.
Later, the National Programme of Pharmacovigilance was launched in 2005,
and was renamed as the Pharmacovigilance Programme of India (PvPI) in
2010. In consideration of having a robust pharmacovigilance system in India,
steps were taken.

11. Clinical trials
Before the drug candidate can be launched into the market, it has to go
through some extensive testing in human beings. Since the drugs are meant to
be used in humans hence the test results obtained from animals cannot be
relied on completely as the physiology of animals and humans are quite
different. Hence the safety and efficacy of the drug candidate in humans
should be established. By means of clinical trials, researchers may get answer
of the questions, whether the treatment work, whether the drug has any side
effect or whether it is better than other existing drugs.

12. REFERENCES
BOOK : Fundamentals of PHARMACOVIGILANCE by Saugata Gosh
WORLD HEALTH ORGANISATION WEB PAGE:
https://www.who.int/
PHARMACOVIGILACE ROGRAM OF INDIA(PvPI) WEB PAGE :
https://www.ipc.gov.in/PvPI/pv_home.html
MINISTRY OF HEALTH AND FAMILY WELLFARE
https://www.mohfw.gov.in/