FLICKR, E-MAGINE ART
The US Food and Drug Administration, the European Medicines Agency, and other experienced regulatory agencies have stringent pharmacovigilance programs that ensure monitoring of drug quality and usage, efficacy, adverse events, and other post-marketing concerns. These programs, supported by both government and innovator pharmaceutical funding, are essential to detect, assess, communicate, and assure “real world” drug safety and efficacy. Post-marketing drug withdrawals such as Vioxx® demonstrate post-marketing drug safety monitoring success in saving lives and preventing morbidity. Pharmacovigilance is critical for revising drug product labeling; detecting harm due to inappropriate use, counterfeit, and substandard medicines; crafting treatment guidelines; communicating new or reinforced information to medical professionals and the public; and, not least, providing advice on pharmaceutical action to clinicians.
But the scope of global pharmacovigilance programs ...
