general pharmacology

1. PHARMACOVIGILIENCE AND
ADVERSE DRUG REACTION
• INTRODUCTION:
• The etymological roots for the word
"pharmacovigilance" are: pharmakon (Greek for
drug) and vigilare(Latin for to keep watch)
• It is the study of safety of marketed drugs
examined under the practical conditions of
clinical use in large communities.
• It is used mainly in evaluation of response
generated by the body after the intake of a
particular drug or the adverse effects the drug
imparts on body.

2. DEFINITION BY WHO
• Pharmacovigilance (PV) is defined as the
science and activities relating to the detection,
assessment, understanding and prevention of
adverse effects or any other drug-related
problem.
• ADVERSE DRUG REACTION : A response to
a drug which is noxious and unintended, and
which occurs at doses normally used in man for
the prophylaxis, diagnosis, or therapy of disease,
or for the modifications of physiological
function'.

3. NEED OF PHARMACOVIGILIENCE
• The thalidomide disaster is one of the darkest
episodes in pharmaceutical research history. The
drug was marketed as a mild sleeping pill safe even
for pregnant women. However, it caused thousands
of babies worldwide to be born with malformed
limbs.
• The damage was revealed in 1962.
• Before then, every new drug was seen as beneficial.
• But the irrepairable loss of lives has changed the way
of evaluation of drugs and paved way for the
flourishing of pharmacovigilience and its importance.

4. WHY PHARMACOVIGILIENCE ?
Everyone should understand the value in reporting side
effects of medicines.
This is an important measure by which the safety of
medicines for, and treatment of patients worldwide
can be improved.
Less is further known about how reporting actually
happens, what may prevent reporting from happening
effectively and what is done with the data once
collected.
Collectively, these activities are referred to as
pharmacovigilance (PV), and we all have a role to
play in delivering effective PV.

5. AIMS OF PHARMACOVIGILIENCE
• Improve patient care and safety.
• Improve public health and safety.
• Contibute to the assessment of benefit, harm,
effectiveness and risk of medicines.
• Promote understanding, education and clinical
training in pharmacovigiliance and its effective
communication to the public.

6. HOW DOES IT WORKS
• DRAFT REGULATIONS:
The Medicine’s authority shall establish a
pharmacovigiliance system which should be
used to collect information useful in the
surveillance of medicinal products, with
particular reference to adverse reactions in
humans, and evaluate such information
scientifically.

7. MEDICINES REGULATORY UNIT (MRU)
PROJECTS IN PHARMACOVIGILINECE
1. Design Of
ADR Report
Form.
2. Launching OF
Form during
seminar for HCP
3. Setting up of
Medicines
Advisory Board.

8. Example Of An ADR Report Form

9. WHAT TO REPORT ?
• Reports on all suspected adverse reactions
known or not, serious or not, are welcome and
useful.
• Established drugs – Serious or unusual
reactions are of particular importance.
• Known and minor reactions are of less interest.
• If an increased frequency of a given reaction is
suspected this is also a reason for reporting.

10. SUMMARY OF THE
PHARMACOVIGILIENCE PLAN
1. Design of ADR Reporting Card.
2. Launching of new ADR
Reporting System.
4.Conducting Seminar’s
(NtMAHs, obligations of
MAHs, HCPs and
regulatory authority)
5. Reinforcing use of
ADR Reporting Card
along with Launching of
News Letters on Drug
Safety Issues by :
1.Targeting HCPs
2. Scientific Institutions
3. Patient groups.
3. Launching of Market
Authorisation Projects.
6. Academia : regulatory
affairs education.