The Value of Reporting Therapeutic Ineffectiveness as an Adverse Drug Reaction
- 85 Downloads
Therapeutic ineffectiveness is a frequent drug-related problem that can occur in a variety of different situations and be caused by different mechanisms. Examples are inappropriate use, interactions or metabolic abnormalities. Observations in patients of unexpected ineffectiveness can provide important information with regard to such situations. Therefore, ineffectiveness — especially when unexpected or unexplained — is a potentially important reportable event in pharmacovigilance. The terms regarding ineffectiveness in the WHO Adverse Reaction Terminology (WHOART) have been recently revised in order to enable optimal coding of such case reports.
KeywordsEnzyme Induction Spontaneous Reporting Therapeutic Failure Medical Drug Pharmacovigilance Centre
We thank Caroline Brock of EQUUS, London, for excellent administrative support, particularly in allowing us to capture the results of the workshop at the WHO Programme for International Drug Monitoring Annual Meeting, Ankara, Turkey, 1999.
- 3.The Uppsala Monitoring Centre. Safety monitoring of medicinal products - guidelines for the setting up and running of a pharmacovigilance centre. Uppsala: The UppsalaMonitoring Centre, 2000Google Scholar
- 5.Kimura K. The WHO data base on counterfeit pharmaceuticals. Geneva: World Health Organization, 1998Google Scholar
- 6.O’Brien CP. Drug addiction and drug abuse. In: Hardman JG, Limbird LE, editors. Goodman & Gilman’s the pharmacological basis of therapeutics. 9th ed. NewYork (NY): McGraw-Hill, 1996: 557–77Google Scholar
- 7.The Uppsala Monitoring Centre. Adverse reaction terminology. Uppsala: The Uppsala Monitoring Centre, 1998Google Scholar
- 8.The Uppsala Monitoring Centre. Guide to participating countries. Uppsala: The Uppsala Monitoring Centre, 1998: 9Google Scholar