This article on the "Power of pharmacovigilance", by Mike Mentesana, was published in the
MedAd News, November 2006. Contributor authors were BJ D'Avella, Frank Depaoli and Anup Kharode.
Heightened public awareness of drug-safety issues and greater regulatory scrutiny have created unprecedented challenges for pharmaceutical companies, regulators, and elected officials. One of the most difficult of these challenges is ensuring the post-market safety of pharmaceutical products. The idea that controlled clinical trials can establish the safety and effectiveness of pharmaceutical products has been the foundation of the industry, but neither the clinical trials process nor the US Food and Drug Administration's approval procedures can provide a perfect guarantee of safety for all potential consumers under all circumstances.
Pharmacovigilance—the systematic detection, assessment, understanding, and prevention of adverse drug reactions—can build upon conventional research and development practices to reduce or even prevent costly safety-related withdrawals whilst enhancing patient safety.
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