Pharmacovigilance involves monitoring the effects of medications after they have been approved for use. It aims to detect, assess, understand, and prevent adverse effects. The field has grown in importance due to limitations of clinical trials and examples of drugs that caused harm after approval. Pharmacovigilance processes involve collecting adverse event reports from healthcare professionals and patients, analyzing the reports for signals of potential safety issues, and taking action if needed. India has established pharmacovigilance programs to help ensure the safe use of drugs within the country.

1. PHARMACOVIGILANCE-
An Overview
Presented By:
Dr. Pramod Kumar
Pharmaceutical Researcher

2. CONTENTS
1. Definition
2. Why Pharmacovigilance (PV)
3. Historical Background
4. Aim and Scope
5. Terminology in PV
6. PvP Process
7. Risk Management Program (RMP)
8. WHO and UMC
9. Pharmacovigilance Program in India (PvPI)

3. Definition:
Pharmakon (Greek): “drug”
Vigilare (Latin): “to keep awake or alert, to keep watch”
WHO Definition:
“The science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other drug-
related problems”.
It has been widened to include biological products, herbals, traditional
and complementary medicines
(The Importance of Pharmacovigilance, WHO 2002)
“To undergo treatment you have to be very healthy, because apart from your
sickness you have to withstand the medicine”.
Molière

4. FDA Definition:
“All scientific and data gathering activities relating to the detection,
assessment, and understanding of adverse events. This includes the
use of pharmacoepidemiologic studies. These activities are undertaken
with the goal of identifying adverse events and understanding, to the
extent possible, their nature, frequency, and potential risk factors.”

5. Why Pharmacovigilance
1. HUMANITARIAN CONCERN
 Insufficient evidence of Safety from Clinical trials, Animal Experiments and Phase
1-3 Studies prior to marketing Authorization.

6. Limitation of Clinical Trials
a. Small Numbers of patient Studied
b. Restricted Populations (Age, Sex and Ethnicity)
c. Narrow Indications (only specific Disease)
d. Short Durations of Drug Exposures
2. MEDICINES ARE SUPPOSED TO SAVE LIVES
“Dying from Disease is sometimes unavoidable;
dying from a medicine is unacceptable”
Lephakin V. Geneva, 2005

7. 3. ADR ARE EXPENSIVE
Cost of Drug related Morbidity and Mortality exceeded
177.4 Billion Dollars in 2000.
ADR related Cost to the country exceeds the cost
of medication themselves.
4. PROMOTING RATIONAL USE OF MEDICINES AND
ADHERENCE.
5. ENSURING PUBLIC CONFIDENCE
6. ETHICAL REASONS
Not reporting serious reaction is Unethical

8. Historical Background
1747: James Ling reported clinical trial showing effectiveness of lemon juice in
prevention of scurvy.
1937: Sulphanilamide disaster, where sulphonamide was dissolved in
diethyleneglycol leading to death of more than 100 people because of renal failure.
1938: The preclinical toxicity and pre-marketing clinical studies made mandatory
by FDA.
1950s: Aplastic anaemia caused due to use of chloramphenicol.
1960: The FDA started hospital based drug monitoring program.

9. 1961: Thalidomide disaster Phocomelia (congenital limb Defects)
1963: 16th world health assembly recognized importance to rapid action on ADR.
1968: Establishment of International Drug Monitoring Program by WHO.

10. 1970s: Clioquinol was found to be linked with Sub-acute-myelooptic neuropathy.
1980s and 1990s: Many drugs with serious adverse effects were recorded.
1996: India started global standard clinical trial.
1997: India joined ADR Monitoring Program.
1998: PV activity initiated in India.
2002: 67th National Pharmacovigilance Centre established in India.
2005: India started conducting structured clinical trials.
2009-2010: PV plan of India was initiated and implemented

11. Pharmacovigilance is
gaining importance as the
number of stories of drug
recalls increases

13. Examples of Licensed Drugs Withdrawn after
Marketing for Drug safety Reasons

14. AIM & SCOPE

15. SCOPE
PV is a booming concept which deals with chemical, botanical,
and biological medicines including medical devices. The
information about suspect product is collected from healthcare
providers and patients to detect and prevent abnormalities
associated with it. Therefore PV deals with adverse effects of
drug, poly-pharmacy, paradoxical reactions, and severe adverse
events. It also covers vaccination failure, irrational use, and lack
of efficacy, drug interactions, poisoning, overdose, abuse,
medication errors and misuse of drug.

16. TERMINOLOGY IN PV
1. Adverse Drug Events (ARE): Any untoward medical occurrence that may
present during treatment with a pharmaceutical product but which does not
necessarily have a causal relationship with the treatment.
2. Adverse Drug Reaction (ADR): 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
physiological function.
3. Side Effects: Any unintended effect of Pharmaceutical Products occurring at
a doses normally used by patient, which is related to the Pharmacological
properties of the drug.
4. Expected Adverse Reaction: As opposed to “unexpected”, an event that is
noted in the investigators brochure or labeling (package insert or summary
of product characteristics).
5. 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.

17. 6. Signal: Reported information on possible causal relationship between an
adverse event and a drug, the relationship being unknown or incompletely
documented previously. Usually more than one single report is required to
generate a signal depending upon the seriousness of the event and quality
of information.
7. Serious Adverse Drug Events/ Reaction: Untoward medical occurrence
that at any dose:
 Results in Death
 Requires in patient Hospitalization or prolongation of Existing
Hospitalization.
 Results in persistent or insignificant disability/incapacity.
 Is life –threatening
8. Data mining: is used to describe various automated or semi automated
techniques to generate signals from existing databases.
For each AE, the calculation of the proportion of that AE as a function of all
Aes reported for a drug is calculated and compared with the proportion of that
AE for all other drugs in the database

18. Example: liver failure for drug X was reported as 95 times out of the
1,418total AEs for drug X. The proportion is 95/1,418=0.067 and is called
“Score” or “Statistic”.
This score can be used as a comparison for other drugs in database.
For a signal to be generated the score should be >1

19. Types of ADRs
1. Type A: Augmented pharmacologic
effects (dose-dependent and predictable)
2. Type B: Bizarre effects (dose independent & unpredictable)
3. Type C: Chronic effects
4. Type D: Delayed effects
5. Type E: End-of-treatment effects
6. Type F: Failure of therapy
7. Type G: Genetic reactions

20. SEVERITY OF ADR’S

21. Pharmacovigilance Process

39. Pharmacovigilance Program in India (PvPI)

40. HISTORY
1. No formal Pharmacovigilance system initially: Sourced their safety
assesment of drugs on data derived US, Europe and Japnese Markets.
2. 1986: Formal Pharmacovigilance activity were initiated
3. 1997: India joined the adverse Drug Reaction Monitoring Program of
WHO.
4. 2004-2008: National Pharmacovigialnce Prog. (2 Zonal, 5 Regional, 24
Peripheral centers.
5. 2008: Due to some technical difficulties the NPP had to be closed.
6. 2010: It was again resurrected as the Pharmacovigilance Program of
India PvPI in 14/07/2010 at AIIMS.

41. 7. For more effective implementation of the program the centre was
shifted from AIIMS to Indian Pharmacopoeia commission,
Ghaziabad on 15/04/2011

48. Communication Under PvPI