What is it?
What is its role?
How is it helpful?
Pharmaco = Drug
Vigilance = to keep awake or alert, to
Pharmacovigilance derived from
Pharmacovigilance (abbreviated PV, PhV)
is drug safety.
Is the pharmacological science related to the
detection, collection, assessment,
understanding and prevention of
adverse effects or any other medicine
Is the study of safety of marketed drug
under the practical conditions of clinical use
in large populations.
Monitor the quality of drugs
Identify the health risks involved in administration
of certain drugs
Prevent harm to patients
Research and efficacy of drugs
Goal of Pharmacovigilance
Pharmacovigilance saves thousands of lives each
year. By monitoring the adverse effects of drugs
right from the lab to the pharmacy and then on for
Pharmacovigilance keeps track of any drastic
effects of dugs.
This gives information about the hazards caused
by the medicines.
By this way, it prevents harm to patients using
Thalidomide tragedy (1961): The greatest of all
Thalidomide had been introduced and welcomed
as a safe and effective hypnotic and antiemetic. It
rapidly became popular for the treatment of
nausea and vomiting in early pregnancy.
Tragically the drug proved to be a potent human
teratogen that caused major birth defects in an
estimated 10,000 children
Phocomelia was a characteristic feature
e start with the
The Pharmacovigilance study of drug or
products until life-cycle is not completed.
Why do we study
Whatever drug we take shows some ADRs which
were not knowing at the time of clinical trials, but
come after marketing in the large population
which show some events which are not seen at the
time of Clinical Trials.
After knowing this ADRs and ADEs
will arranged according to their severity to cause
toxicity to maintain the safety profile of the drug.
Adverse event: Any untoward medical occurrence
that may present during treatment with a
pharmaceutical product but which does not
necessarily have a causal relationship with the
Adverse reaction: WHO technical report: A
response to a drug which is noxious and
unintended and which occurs at doses normally
used in humans for the prophylaxis, diagnosis or
therapy of disease or for the modification of
Glossary of terms
Expected: As opposed to “unexpected”, an event that
is noted in the investigators brochure or labeling
(package insert or summary of product
Unexpected adverse reaction: the nature or severity
of which is not consistent with the domestic labeling
or market authorization, or expected from
characteristics of the drug.
Signal: Reported information on possible causal
relationship between an adverse event and a drug, the
relationship being unknown or incompletely
documented previously. Usually multiple report is
required to generate a signal depending upon the
seriousness of the event and quality of information.
Important organizations involved
FDA: The Food and Drug Administration (FDA or
USFDA) is an agency of the United States Department
of Health and Human Services, one of the United
States federal executive departments, responsible for
protecting and promoting public health through the
regulation and supervision of food safety, tobacco
products, dietary supplements, prescription and over-
the-counter pharmaceutical drugs (medications),
vaccines, biopharmaceuticals, blood transfusions,
medical devices, electromagnetic radiation emitting
devices (ERED), veterinary products, and cosmetics. 13
EMEA: The European Medicines Agency is a
decentralised body of the European Union located
MHLW: Ministry of Health, Labor and
CDSCO: The government of India with the
assistance of world bank has initiated the National
pharmacovigilance programme. The central drugs
standard control organization (CDSCO) is
coordinating the country wide pharmacovigilance
programme under the aegis of Ministry of health
and family welfare, DGHS New Delhi
Uppsala monitoring centre
The Uppsala monitoring centre(UMC, on behalf of
WHO) has over 3 million AE case reportes from
over 75 countries. The data are supplied by
national health authorities. Most of the data are
from the United states and supplied by the
FDA.The UMC does not review or assess the
individual cases put into database, but it does
pharmacovigilance analyses and signaling.
The science and activities relating to the detection,
evaluation, understanding and prevention of
adverse drug reactions or any other drug-related
Pharmacovigilance is used for preventing patients
from being affected unnecessarily
The work of WHO in the area of safety monitoring
of medicines is necessary if we are to achieve the
mission of EDM
Medicines should be Available, Affordable, Safe
and Properly used 16