title: Forensic pharmacovigilance and substandard or counterfeit drugs.
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.
authors.affiliation: Vaccine Safety Specialist,Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. jerry.labadie@who-umc.org
authors.forename: Jerry
authors.initials: J
authors.lastname: Labadie
mesh_terms: D002487:Centers for Disease Control and Prevention, U.S. / Q000458:organization & administration; D003257:Consumer Product Safety; D058110:Counterfeit Drugs / Q000009:adverse effects*; D004340:Drug Contamination; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005104:Expert Testimony; D044707:Forensic Sciences / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D006493:Heparin / Q000009:adverse effects / Q000633:toxicity*; D006801:Humans; D060735:Pharmacovigilance; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration
chemical_list: D058110:Counterfeit Drugs; D006493:Heparin