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Pharmacovigilance is the use of scientific methods to identify, track, record and analyze over time the effects of various pharmaceutical goods in order to ensure drug quality and safety. Pharmacovigilance pertains to almost every part of the drug lifecycle, ranging from preclinical development to post-market surveillance. Pharmacovigilance programs often deal with counterfeit drugs because counterfeiting can hamper the performance of otherwise safe pharmaceuticals.

The aim of pharmacovigilance is to find possible risks and adverse effects, analyze medical information to track effects, and inform health-care professionals and the public of this information. Other goals of pharmacovigilance include the early detection of safety problems that are not revealed during clinical trials, the identification and quantification of risks, and the improvement of patient care as well as safety in relation to the use of pharmaceutical drugs.

A key aspect of pharmacovigilance is identifying which side effects are worth the risk to patients, versus how effective they are at treating a disease. For instance, chemotherapy’s serious side effects – weighed against life-threatening cancer – may be considered acceptable, given the potential to cure a patient. Yet if a drug for curing a headache caused similar side effects, the risk to the patient would outweigh the benefits.

Pharmacovigilance is a crucial function within life science companies. Businesses that develop, manufacture and commercialize drugs must adhere to strict regulations, many of which focus on patient safety and well-being – and are at the heart of pharmacovigilance.

A strong pharmacovigilance strategy requires expertise in medicine, regulatory requirements and technology. It involves strong processes, case study report capture and processing, literature screening, signal detection and assessment, risk management, periodic safety writing, regulatory expedited reporting and safety databases. 

Organizations that have pharmacovigilance programs designed to monitor drug use statistics; identify risks and adverse effects; and educate the medical, scientific and lay communities regarding drug safety include the World Health Organization, the International Society of Pharmacovigilance, the U.S. Food and Drug Administration (FDA), and the U.K.’s Medicines & Healthcare Products Regulatory Agency.

This was last updated in November 2017

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