German Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany; Institute for Medical Biometry, Informatics, and Epidemiology (IMBIE), University Hospital of Bonn, German; Center for Translational Medicine, Universität Bonn, Germany; Clinic for Dermatology and Allergology, University Hospital (RWTH), Aachen, Germany.
Dtsch Arztebl Int. 2018 Jun 8;115(23):393-400. doi: 10.3238/arztebl.2018.0393.
The adverse drug reaction database of the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) contains reports of suspected adverse drug reactions (ADRs) that are spon- taneously submitted by physicians, pharmacists, or patients. The aim of the present study was a descriptive analysis of all of these spontaneous reports.
345 662 spontaneously submitted reports were analyzed with respect to the number of reports per year, the sources of the reports, demographic variables, the most commonly reported ADRs, and the drug classes most commonly suspected.
The number of reports submitted spontaneously each year has grown steadily since 1978. At the least detailed level of analysis, "drugs for the treatment of nervous system disorders" were the most common class of drugs under suspicion of causing the reported adverse drug reactions (23.1%). In a more detailed analysis by therapeutic subgroup, the three subgroups most commonly reported as suspected of causing side effects were antithrombotic agents, systemic antibiotics, and psycholeptics-causing thrombocytopenia, diarrhea, and drug dependency as the most frequently reported ADRs, respectively. The order of drug classes most commonly causing ADRs differed markedly between the physicians' reports (diazepines, fluoroquinolones, heparins) and the patients' reports (interferons, anti- thrombotic drugs, selective immunosuppressant drugs). Patients more commonly reported subjectively perceived ADRs, while physicians more commonly reported findings or diagnoses that require medical expertise.
The increasing number of spontaneous reports is mainly due to reports forwarded from pharmaceutical companies to the BfArM. This, in turn, is probably a result of increasingly strict legal reporting requirements in Germany. The detected differences between physicians' and patients' ADR reports can be taken to indicate that patients should be more specifically informed and questioned about potential ADRs. By reporting adverse drug reactions, physicians may improve drug safety.
德国联邦药品和医疗器械研究所（Bundesinstitut für Arzneimittel und Medizinprodukte，BfArM）的药物不良反应数据库包含了医生、药剂师或患者自发提交的疑似药物不良反应（ADR）报告。本研究的目的是对所有这些自发报告进行描述性分析。
对 345662 份自发提交的报告进行了分析，分析内容包括每年报告数量、报告来源、人口统计学变量、最常报告的 ADR 以及最常怀疑的药物类别。
自 1978 年以来，每年自发提交的报告数量稳步增长。在最详细的分析水平上，“治疗神经系统疾病的药物”是最常见的可疑药物类别，引起报告的药物不良反应（23.1%）。在更详细的治疗亚组分析中，报告中最常怀疑引起副作用的三个亚组是抗血栓形成剂、全身抗生素和精神安定剂，分别引起血小板减少症、腹泻和药物依赖作为最常报告的 ADR。引起 ADR 的药物类别顺序在医生报告（地西泮、氟喹诺酮类、肝素）和患者报告（干扰素、抗血栓形成药物、选择性免疫抑制剂）之间有显著差异。患者更常报告主观感知的 ADR，而医生更常报告需要医学专业知识的发现或诊断。
自发报告数量的增加主要归因于制药公司向 BfArM 转发的报告。这反过来可能是德国越来越严格的法律报告要求的结果。医生和患者 ADR 报告之间发现的差异可以表明，应该更具体地告知和询问患者潜在的 ADR。通过报告药物不良反应，医生可以提高药物安全性。
