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Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep ...
Serious adverse reactions are serious adverse events judged to be related to drug therapy. A SUSAR (suspected unexpected serious adverse reaction) should be reported to a drug regulatory authority under an investigational license by using the CIOMS form (or in some countries an equivalent form).
Expert Opinion on Drug Safety is an international peer-reviewed medical journal publishing review articles on all aspects of pharmacovigilance and original papers on the clinical implications of drug treatment safety issues.
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
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Black triangle. A black triangle appearing after the trade name of a British medicine (or vaccine) indicates that the medication is new to the market, or that an existing medicine (or vaccine) is being used for a new reason or by a new route of administration.
They take the shuttle bus out to the Hamptons, Lake Tahoe, Lake Michigan,” Kaplan said. “There always have been special situations.” ...