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ABSTRACT:
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention
of adverse effects, particularly long term and short term side effects of medicines.
It is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers
and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a
view to:
Identifying new information about hazards associated with medicines
Preventing harm to patients.
Phase IV of the evaluation of a drug starts when the marketing license is granted and extends over many years. It
consists of pharmacoepidemiological studies to evaluate the effectiveness, safety, and utilization of the drug in large
populations, under real-life conditions. The results confirm or disprove the effectiveness of the drug in clinical practice
(confirmation of the therapeutic effect), determine whether approved uses should be expanded or restricted, any
untoward interactions (pharmacovigilance) and pharmacoeconomics of the drugs.
INTRODUCTION:
Received on 25.10.2011
Accepted on 12.12.2011
Asian Pharma Press All Right Reserved
Asian J. Res. Pharm. Sci. 2(1): Jan.-Mar. 2012; Page 04-08
[AJPSci.]
AIMS OF PHARMACOVIGILANCE
The aims of pharmacovigilance are 4
1. The identification and quantification of previously
unrecognized adverse drug reactions (ADR).
2. The identification of sub-groups of patients at
particular risk of ADRs (the risk relating to dose, age,
gender and underlying disease).
3. The continued monitoring of the safety of a product,
throughout the duration of its use, to ensure that its
risks and benefits remain acceptable. This includes
safety monitoring following significant newly
approved indications.
4. The comparative adverse drug reaction profile of
products within the same therapeutic class.
5. The detection of inappropriate prescription and
administration.
6. The
further
elucidation
of
a
products
pharmacological/toxicological properties and the
mechanism by which it produces adverse drug
reactions.
7. The detection of significant drugdrug interactions
between new products and co therapy with agents
already established on the market, which may only be
detected during widespread use.
[AJPSci.]
PARTNERS IN PHARMACOVIGILANCE
A complex and vital relationship exists between wide
ranges of partners in the practice of drug safety monitoring.
Sustained collaboration and commitment are vital if future
challenges in pharmacovigilance are to be met in order to
develop and flourish.
Government
Industry
Health professionals7,8
Patients12,13
Consumers
Media
WHO
PHARMACOVIGILANCE IN INDIA
It is related to the surveillance of drugs once they are
released for use in the community (post marketing
surveillance) and relies on voluntary reporting, prescription
monitoring, medical records and statistical studies in the
population.
Since very few new drugs were discovered in India and
hardly any new drug was launched for the first time in India
in the past, there was no major compulsion to have a strong
Pharmacovigilance system to detect adverse reactions of
marketed drugs. The experience from the markets where the
drug was in use for several years before introduction in
India, was used by the Companies and the Regulatory
Agencies to assess the safety parameters and take corrective
actions , such as the withdrawal or banning of the drug in
question. With the Indian Companies'' capacity to develop
and market new drugs out of their own research efforts, it is
important that adequate Pharmacovigilance standards are
introduced to monitor adverse reactions of products, first
launched in India.
[AJPSci.]
[AJPSci.]
Monitoring medicines as used in everyday practice to 10. National Pharmacovigilance Protocol, Ministry of Health and
Family Welfare, Govt. of India.
identify previously
unrecognized adverse effects or changes in the patterns
of their adverse effects
Assessing the risks and benefits of medicines in order
to determine what action,
if any, is necessary to improve their safe use
Providing information to users to optimize safe and
effective use of medicines
Monitoring the impact of any action taken
CONCLUSION:
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