Pharmacovigilance For Asu Drugs

PHARMACOVIGILANCE
FOR ASU DRUGS
Dr Vasavi Madurwar
PG FINAL
BMAM Nagpur
INTRODUCTION
Pharmacovigilance also called as drug safety.
Pharmakon ( in greek)------- drug
Vigilare ( in latin )------------to keep watch
Definition:
Pharmacovigilance is the scientific branch which is dedicated to reducing

the risks of the drugs related harm to the patients. It includes the
reporting system for the adverse events associated with drug use.
IMPORTANCE OF PHARMACOVIGILANCE -
PREAMBLE:
● Thalidomide tragedy (1961-62): The greatest of all drug disasters.

● Thalidomide had been introduced and welcomed as a safe hypnotic
and antiemetic. It rapidly became popular for the treatment of
nausea and vomiting in early pregnancy.
● Tragically the drug proved to be potent human teratogen that
caused major birth defects in an estimated 10,000 children.
● Phocomelia was a characteristic feature.
OTHER HISTORIC VIOLATIONS:
● Sulfanilamide tragedy: Elixir sulfanilamide was an improperly

prepared sulfanilamide medicine that caused mass poisoning in the
United States in 1937. It caused the deaths of more than 100 people.
The public outcry caused by this incident and other similar disasters
led to the passing of the 1938 Federal, Food and Drug Cosmetic act.
● The thalidomide disaster led in Europe and elsewhere to the
establishment of the drug regulatory mechanisms of today.
● These mechanisms require that new drugs shall be licensed by well
established regulatory authorities before being introduced in clinical
use.
● List of a few licensed medicines withdrawn after marketing for drug
safety reasons.
1. Secholex (polidexide) - 1975
2. Zomax - 1983
3. Halcion - 1991
4. Kava Kava - 2001 due to liver toxicity.
5. Vioxx ( rofecoxib) - 2004 due to increased cardiovascular risks.
6. Bextra ( valdecoxib) - 2005 due to Stevens Johnson Syndrome.
NEED, SCOPE, AIMS & OBJECTIVES
● Worldwide the hazards of the drugs and medical therapies are

monitored stringently to reduce the patient’s mortality or the
untoward, adverse or unwanted effects of the drugs or of
therapeutic procedures.
● It is commonly considered that as compared to the modern drugs
the Ayurvedic drugs show the less adverse effects or the toxic
effects on the human recipients.
● Due to the popularity of the ASU drugs and due to increase in a
demand of these drugs from the community the chances of
adulteration and malpractice in the manufacturing and distribution
are increasing. Commercialization of ASU drugs put forward the
issue of safety and efficacy.
● For the regulation of safety and efficacy issue the control and check
o the use of ASU drugs through the Pharmacovigilance program was
essential.
NATIONAL PHARMACOVIGILANCE PROGRAM
FOR ASU DRUGS :
● Since 2003, National Pharmacovigilance Program under the control

of Central Drug Standards Control Organization ( CDSCO) is being
functioning in India.
● In December 2007, the two days workshop and seminar was
organized in Jamnagar on Pharmacovigilance which was funded by
WHO. The need to develop the National Pharmacovigilance Centre
for ASU drugs was addressed in this seminar to monitor the program
centrally.
● This program aims to keep the data of adverse drug reactions of
herbal, mineral and metallic products.
● The glossary of terms used like adverse events, adverse effects, side
effects, adverse reactions, serious adverse reactions, unexpected
adverse reactions etc. was published under the National
Pharmacovigilance Program for ASU drugs.
1. Adverse event: Any untoward medical occurrence that may be
present during treatment with a pharmaceutical product but which
does not necessarily have a casual relationship with the treatment.
2. Adverse reaction: 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 functions.
4. Expected Adverse reactions: As opposed to “unexpected”, an event that is
in the investigation brochure or labelling ( package insert or summary of
product characteristics.
5. Unexpected adverse reactions: The nature or severity of which is not

consistent with the domestic labelling or market authorization, or expected
from the characteristics of the drugs.
6. Adverse Effects: An adverse effect is an undesirable harmful effect

resulting from a medication or other intervention such as surgery.
7. Side Effects: A side effect, is an effect, whether therapeutic or adverse that is
secondary to the one intended; although the term is predominantly employed
to describe adverse effects, it can also apply to be beneficial, but unintended,
consequences of the use of a drug.
8. Serious Adverse Reactions/ Event: An adverse reaction that results in death
, is life threatening , requires hospitalisation or prolongation of existing
hospitalisation resulting in persistent or significant disability or incapacity, or
birth defect.
Goals of the program:
1. Short term: To develop the nature of the notification.

2. Medium term: To involve the health care professionals and
professional associations in the drug monitoring and information
dissemination processes.
3. Long term: To make this program as a benchmark for the global drug
monitoring endeavors.
As per the provision of this program any health care professional may
report the suspected adverse drug event, but not from the layman or any
other person than the health care professional.
The reporting should be submitted in the prescribed format to the

Pharmacovigilance Centre. Confidentiality is assured through this
program.
THANK YOU !

Pharmacovigilance For Asu Drugs

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PHARMACOVIGILANCE

FOR ASU DRUGS

Pharmacovigilance also called as drug safety.

Pharmakon ( in greek)------- drug

Vigilare ( in latin )------------to keep watch

Pharmacovigilance is the scientiﬁc branch which is dedicated to reducing

● Thalidomide tragedy (1961-62): The greatest of all drug disasters.

● Sulfanilamide tragedy: Elixir sulfanilamide was an improperly

● Worldwide the hazards of the drugs and medical therapies are

● Since 2003, National Pharmacovigilance Program under the control

5. Unexpected adverse reactions: The nature or severity of which is not

6. Adverse Effects: An adverse effect is an undesirable harmful effect

1. Short term: To develop the nature of the notiﬁcation.

The reporting should be submitted in the prescribed format to the

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