Figueras Albert, Pedrós Consuelo, Valsecia Mabel, Laporte Joan-Ramon
Fundació Institut Català de Farmacologia. Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Barcelona, Spain.
Drug Saf. 2002;25(7):485-7. doi: 10.2165/00002018-200225070-00002.
Reporting of therapeutic ineffectiveness through adverse drug reaction spontaneous reporting systems has been proposed by some authors. In the WHO Adverse Reactions Terminology (WHO-ART) and Medical Dictionary for Regulatory Activities (MedDRA) terminology, the term therapeutic ineffectiveness includes drug interactions, resistance, tolerance and tachyphylaxis, as well as pharmaceutical defects such as substandard, adulterated, and counterfeit drugs. Under certain circumstances, reporting therapeutic ineffectiveness may contribute to identifying pharmaceutical defects. However, the best approach to avoid their occurrence would be implementing good manufacturing practices and strengthening quality control activities. This would prevent the misuse of spontaneous reporting of adverse drug reactions (e.g. when reporting of therapeutic ineffectiveness is 'suggested' by interested parties, especially when a generic product has been substituted for a branded original product).
一些作者提议通过药品不良反应自发报告系统报告治疗无效情况。在世界卫生组织不良反应术语（WHO-ART）和药品监管活动医学词典（MedDRA）术语中，治疗无效这一术语包括药物相互作用、耐药性、耐受性和快速减敏反应，以及诸如不合格、掺假和假药等药品缺陷。在某些情况下，报告治疗无效情况可能有助于识别药品缺陷。然而，避免其发生的最佳方法是实施良好生产规范并加强质量控制活动。这将防止药品不良反应自发报告的滥用（例如，当利益相关方“建议”报告治疗无效情况时，尤其是当通用产品替代品牌原研产品时）。
