Forensic pharmacovigilance and substandard or counterfeit drugs

Issue title: Forensic Pharmacovigilance

Article type: Research Article

Authors: Labadie, Jerry

Affiliations: Vaccine Safety Specialist,Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Box 1051, 751 40 Uppsala, Sweden. E-mail: jerry.labadie@who-umc.org

Abstract: Identification of harm in the form of adverse drug reactions that are caused by counterfeit or other substandard medicinal products by application of standard pharmacovigillance methods of registration, analysis and investigation could be forensic pharmacovigillance. As recent example of this type of forensic pharmacovigilance is the discovery and investigation into the adverse drug reactions caused by contaminated heparin in the USA in 2008 is discussed.

Keywords: Forensic pharmacovigillance, adverse drug reaction, contaminated heparin, oversulfated chondroitin sulfate

DOI: 10.3233/JRS-2012-0551

Journal: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 37-39, 2012