Pharmacovigilance (abbreviated PV or PhV) 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. Generally speaking, 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 with a view to:
- Identifying new information about hazards associated with medicines
- Preventing harm to the patients.
Pharmacovigilance starts from the clinical stage and continues throughout the product life cycle of the drug, mainly divided as pharmacovigilance during pre-marketing (that is 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 etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.” 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. Postmarketing surveillance uses tools such as data mining of spontaneous reporting systems and patient registries, and investigation of case reports to identify the relationships between drugs and ADRs.
Read more about Pharmacovigilance: Risks of Medical Treatment, Terms Commonly Used in Drug Safety, Finding The Risks of Drugs, Spontaneous Reporting, Other Reporting Methods, International Collaboration, Pharmacoenvironmentology, Pharmacovigilance of Herbal Medicines, Signal Detection in Pharmacovigilance