What is It? Why is It important?


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Definition of Pharmacovigilance

Pharmacovigilance is defined as “All post-approval scientific and data gathering activities relating to the detection, assessment, understanding and prevention of adverse effects or any other product related problems”.

It can also be defined as “Systems and arrangements designed to detect and quantify adverse drug reactions after a medicine has been marketed, to inform prescribers and patients of possible risks“.

Health-Canada defined Pharmacovigilance as ” A clinical science whose objectives are the surveillance, evaluation and signalling of the undesirable effects of pharmaceutical products used for medical therapy and whose major sources of new information are spontaneous notification and reporting of such effects. Pharmacovigilance also includes the diffusion of this information and the regulatory measures taken to prevent future adverse drug reactions, to ensure safer use of drug products as well as the improvement in the risk:benefit ratio.”

Why Pharmacovigilance?

In clinical trials the drugs are being tested under vigilant criteria, with selected number of patients. The scenario is completely different from the real world where drug may behave differently in complicated disease conditions in poly-pharmacy kind of administration. Hence there is now potent need to study drug profile under such circumstances.

Also information often collected are incomplete or not available on:

  • Rare but serious reactions
  • Use of vulnerable groups (pregnancy, children, elderly)
  • Risks of long term repeated use, interactions

Following are the aims of Pharmacovigilance:

  • Early detection of unknown safety problems
  • Detection of increases in frequency
  • Identification of risk factors
  • Quantifying risks
  • Preventing patients from being affected unnecessarily
  • Improve patient care and safety in relation to the use of medicines
  • Improve public health and safety in relation to the use of medicines
  • Contribute to assessment of benefit, harm, effectiveness and risk of medicines encouraging their safe, rational and more effective use.
  • Promote understanding, education and clinical training in pharmacovigilance and its effective communication to public

There are differences amongst countries in the occurrence of Adverse Drug Reactions (ADRs) and other drug-related problems. This may be due to differences in disease and prescribing practices, genetics, diet, traditions of the people, drug manufacturing processes used which influence pharmaceutical quality and composition, drug distribution and use of indications, dose and availability.

The use of traditional and complimentary drugs (herbal remedies), may also pose specific toxicological problems, when used alone or in combination with other drugs. Therefore pharmacovigilance is needed for detecting ADRs and specifically to combat counterfeit and substandard quality products. Adverse drug reaction monitoring ensures that patients obtain safety and efficacious products.