Introduction of Pharmacovigilance

What is Pharmacovigilance?

Pharmacovigilance (PV or PVG) is the science associated with detection, assessment, understanding and prevention of adverse effects of drugs. According to the Pharmacovigilence definition given by WHO, it is "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Recently, its concerns have been widened to include herbals, traditional and complementary medicines, blood products, biological, medical devices and vaccines"

Pharmacovigilance System
Pharmacovigilence studies the long term and short term adverse drug reaction or simply stated- side effects of medicines.

Pharmacovigilance system involves collection, monitoring, researching upon, assessing and evaluating information received from health care workers such as doctors, dentists, pharmacists, nurses and other health professionals for understanding the adverse drug reaction.

Pharmacovigilance definition includes monitoring of all pharmaceutical drugs and also other medical products including vaccines, X-ray contrast media, traditional and herbal remedies etc. especially when the reaction is unusual, potentially serious or clinically significant.

Importance of Pharmacovigilance
When a pharmaceutical drug is introduced in the market there are still a lot of things that are unknown about the safety of the new drugs. These medicines are used by various patients for different diseases these people might be using several other drugs and must be following different traditions and diets which may adversely affect the impact of medicine in them. Also the different brands of same medicine might differ in the manner of their production and ingredients. Additionally, adverse drug reactions might also occur when drugs are taken along with traditional and herbal medicines that have also to be monitored through pharmacovigilance.

In some cases, adverse drug reaction of certain medicines might occur only in one country's or region's citizens. To prevent all undue physical, mental and financial suffering by patients, pharmacovigilance proves to be an important monitoring system for the safety of medicines in a country with the support of doctors, pharmacists, nurses and other health professionals of the country.

Pharmacovigilance in Different Countries/ Regions
All the regions of the world have their own particular pharmacovigilance system, though based on WHO guidelines.

Pharmacovigilance in Europe- Pharmacovigilance system in Europe is coordinated by the European Medicines Agency (EMA) and conducted by the National Competent Authorities (NCAs). The EMA maintains and develops the pharmacovigilance database comprising all suspected serious adverse drug reactions observed in the European region. Here, the pharmacovigilance system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions.

Pharmacovigilance in United States- Here pharmacovigilance has a multi faceted approach. Three branches of pharmacovigilance in the USA can be defined as the FDA; the pharmaceutical manufacturers; and the academic/non-profit organizations like RADAR and Public Citizen. The US Food and Drug Administration (FDA) receive reports about adverse drug reaction and takes appropriate actions for drug safety.

Pharmacovigilance in India- the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Govt. of India launched the National Pharmacovigilance Programme (NPP) in November, 2004 based on the WHO recommendations made in the document titled “Safety Monitoring of Medicinal Products – Guidelines for Setting Up and Running a Pharmacovigilance Centre”. The whole country is divided into zones and regions for operational efficiency. CDSCO, New Delhi is at the top of the hierarchy followed by two zonal pharmacovigilance centers viz, Seth GS Medical College, Mumbai and AIIMS, New Delhi.

To summarize the basic knowledge about pharmacovigilance, it can be said that the information obtained from reports about adverse drug reactions promote drug safety on a local and national level. These reports are entered into the national adverse drug reaction database and analyzed by expert reviewers justifying the whole pharmacovigilance system.