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Pharmacovigilance: Staying Compliant is Critical

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By Joanne Ferrell and John Leavitt, Ph.D.

Originally published October, 2013

Pharmacovigilance: What is it and why is it important?

The requirements regarding post-market safety monitoring are more stringent now than ever. Numerous incidents involving marketed pharmaceuticals and over-the-counter (OTC) medicines in recent years have brought the issues of safety monitoring and risk management to the forefront of public attention and regulatory scrutiny in the United States, Europe, and elsewhere around the world.

The regulatory protocols for pharmacovigilance are significant for companies with pharmaceutical products on the market. Scientific literature surveillance requires access to multiple databases and search strategies that are comprehensive in order to find all clinical literature describing safety and efficacy, adverse events, and toxicological findings for any particular drug product. Relevant literature should be examined on an annual basis, and ideally more frequently, to determine if a clinical finding should be reported to the FDA and/or other regulatory agencies. Drug companies are required to read the full-text of potentially relevant literature, keep records of literature audits and review protocols, as well as files of relevant literature for future reference.

 

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