Introduction:
The
Pharmacovigilance is abbreviated PV or PhV and also known as Drug Safety. 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. In general pharmacovigilance is the
science of collecting, monitoring, researching, assessing and evaluating
information from healthcare providers and patients on the adverse effects of
medications, biologicals, herbalism and traditional medicines.
Pharmacovigilance
starts from the clinical stage and continues throughout the product life cycle
of the drug, mainly divided as pharmacovigilance during pre-marketing, the
clinical phase and post-marketing. The process of collection of such
information about a drug begins in phase I of the clinical trial, before
approval of the drug, and continues even after approval; several post-market
safety studies are conducted, with many made mandatory by drug regulatory
agencies around the world.
The word
Pharmacovigilance is derived from the Greek word pharmakon, which means drug
and the Latin word vigilare (which means keep an alert or keep wtch).
Pharmacovigilance is particularly concerned with adverse drug reactions, or
ADRs, which are officially described as “A response to a drug which is noxious
and unintended including lack of efficacy of drug and which occurs at doses
normally used… for the prophylaxis, diagnosis or therapy of disease, or for the
modification of physiological function. It also includes overdose, misuse and
abuse of drug.
Pharmacovigilance
is gaining importance for doctors and scientists as the number of stories in
the mass media of drug recalls increases. Because clinical trials involve
several thousand patients at most, less-common side effects and ADRs are often
unknown when a drug enters the market. Even very severe ADRs such as liver
damage are often undetected because study populations are small.
