Service de Pharmacologie-Toxicologie et Pharmacovigilance, Centre Hospitalo-Universitaire d'Angers, 4 rue Larrey, F-49100, Angers, France.
Université d'Angers, 40 rue de Rennes, F-49035, Angers, France.
Fundam Clin Pharmacol. 2020 Oct;34(5):623-631. doi: 10.1111/fcp.12546. Epub 2020 Mar 13.
Self-medication (SM) is a common practice perceived by patients as harmless which can, however, entail health risks. The aim of the study was to identify drug-drug interactions (DDIs) involving SM drugs leading to adverse drug reactions (ADRs) in the National French Pharmacovigilance Database. All ADR reports from 1 January 1985 to 31 July 312018, coded as 'interaction' and 'self-medication', were selected and studied. Patient characteristics, the level and type of interaction, and the therapeutic classes of the drugs were examined. Adverse drug reactions were analysed and classified according to the system organ classes of the Medical Dictionary for Regulatory Activities. One hundred and three reports totalling 158 ADRs (71% severe cases) were included; 153 DDIs (59.5% pharmacodynamic) involving 234 drugs were identified. The latter included 119 SM drugs (51% available on prescription), mainly analgaesics, anti-inflammatory drugs, dietary supplements and antibiotics. Haemostasis disorders and renal failure were the most frequently reported ADRs. The analysis of reference documents raised concerns on the lack of information provided by package leaflets. In conclusion, the present study highlights the risks of medically unapproved re-use of prescription drugs or the consumption of dietary supplements without monitoring possible interactions and ADRs. Patient awareness could be improved by more regular updates of medication package inserts.
自我药疗（SM）是一种被患者视为无害的常见做法，但可能会带来健康风险。本研究旨在确定涉及自我药疗药物的药物-药物相互作用（DDI），这些相互作用导致法国国家药物警戒数据库中的药物不良反应（ADR）。选择并研究了所有 1985 年 1 月 1 日至 2018 年 7 月 31 日编码为“相互作用”和“自我药疗”的 ADR 报告。研究了患者特征、相互作用的程度和类型以及药物的治疗类别。根据监管活动医学词典的系统器官类别分析药物不良反应并进行分类。共纳入 103 份报告，总计 158 例 ADR（71%为严重病例）；共发现 153 例（59.5%为药效学）DDI，涉及 234 种药物。其中包括 119 种自我药疗药物（51%为处方药物），主要为镇痛药、抗炎药、膳食补充剂和抗生素。止血紊乱和肾衰竭是最常报告的 ADR。对参考文件的分析引起了对包装说明书提供信息不足的关注。总之，本研究强调了未经医学批准重新使用处方药物或在没有监测可能的相互作用和 ADR 的情况下消费膳食补充剂的风险。通过更定期地更新药物包装说明书，可以提高患者的意识。
