Aagaard Lise, Hansen Ebba Holme
Institute of Public Health, Clinical Pharmacology, Faculty of Health Sciences, University of Southern Denmark, J.B. Winslows Vej 19, 2., DK - 5000 Odense C, Denmark.
Curr Drug Saf. 2013 Jul;8(3):162-8.
Medical product information contains information about efficacy and safety for marketed pharmaceuticals. Three studies have compared safety labelling for different therapeutic categories in different countries and detected large variations in a number of reported adverse drug reactions (ADRs). The rapid increase in use of medications for treatment of ADHD symptoms has created concern due to lack of information about effects from long-term use. The aim of this study was to compare ADR information in product information (PI)/summary of product characteristics (SPC) for oral formulations of atomoxetine, methylphenidate and modafinil marketed by the same pharmaceutical companies in Australia, Denmark and the United States. Discrepancies in listed ADRs were defined as types of ADRs (system organ class) not listed in all countries. For ADRs where discrepancies were detected, we extracted information about study design (clinical trials, spontaneous report). Discrepancies in ADR labelling for the medications were found across the three countries. A total of 75 ADR categories were listed for atomoxetine and 80% of these were listed in all three countries. For methylphenidate, totally 101 ADR categories and for modafinil 115 ADR categories were listed. For both substances approximately 60% of listed ADRs were found in all three countries. Discrepancies were primarily detected for ADRs information based on clinical trials. For methylphenidate, many ADRs labelled in Australia and Denmark were not mentioned in PIs issued in the United States. In conclusion, information about possible ADRs associated with the use of a specific product should be made available worldwide, as the prescriber information about medicines' safety profile should not depend on the country in which the medication is licensed.
医疗产品信息包含已上市药品的疗效和安全性信息。三项研究比较了不同国家不同治疗类别的安全标签，并发现报告的药物不良反应（ADR）数量存在很大差异。用于治疗多动症症状的药物使用量迅速增加，由于缺乏长期使用效果的信息，引发了人们的担忧。本研究的目的是比较澳大利亚、丹麦和美国同一家制药公司销售的托莫西汀、哌甲酯和莫达非尼口服制剂的产品信息（PI）/产品特性摘要（SPC）中的ADR信息。列出的ADR差异定义为并非在所有国家都列出的ADR类型（系统器官类别）。对于检测到差异的ADR，我们提取了有关研究设计（临床试验、自发报告）的信息。在这三个国家中发现了这些药物ADR标签的差异。托莫西汀共列出75种ADR类别，其中80%在所有三个国家都有列出。哌甲酯共列出101种ADR类别，莫达非尼列出115种ADR类别。对于这两种药物，约60%列出的ADR在所有三个国家都有发现。差异主要在基于临床试验的ADR信息中检测到。对于哌甲酯，澳大利亚和丹麦标签中的许多ADR在美国发布的PI中未提及。总之，与使用特定产品相关的可能ADR信息应在全球范围内提供，因为关于药物安全概况的处方信息不应取决于药物获得许可所在的国家。
