The Value of Reporting Therapeutic Ineffectiveness as an Adverse Drug Reaction
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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.
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