Monday, 11 March 2013

Pharmacovigilance & Clinical Trials


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.