School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.
, Auckland, New Zealand.
Drug Saf. 2020 Nov;43(11):1157-1170. doi: 10.1007/s40264-020-00980-x.
Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacists submit few CMs ADR reports.
The aim of this study was to explore New Zealand community pharmacists' views and experiences with ADR reporting for CMs.
Qualitative, in-depth, semi-structured interviews were undertaken with 27 practising community pharmacists identified through purposive and convenience sampling. Data were analysed using a general inductive approach.
Participants were familiar with systems for reporting ADRs, believed ADR reporting for CMs important, and that pharmacists should contribute. However, few submitted reports of CMs ADRs and none encouraged patients/consumers to do so. Participants explained this was because they had never been informed by patients about ADRs associated with CMs. Participants said they would report serious ADRs; time pressures, lack of certainty around causality, lack of awareness of mechanisms for reporting CMs ADRs, and lack of remuneration were deterrents to reporting. Participants were aware of intensive-monitoring studies for prescription medicines, understood the rationale for considering this approach for CMs and recognised there would be potential practical difficulties.
Participants used their knowledge of CMs safety concerns to minimise risk of harms to consumers from CMs use, but most had a passive approach to identifying and reporting ADRs for CMs. There is substantial potential for pharmacists to adopt proactive strategies in pharmacovigilance for CMs, particularly in recognising and reporting ADRs, and empowering CMs users to do the same.
发现与补充药物(CMs)相关的安全问题信号依赖于健康专业人员和患者/消费者自发报告。社区药剂师能够识别和报告与 CMs 相关的疑似药物不良反应(ADRs),但药剂师提交的 CMs ADR 报告很少。
本研究旨在探讨新西兰社区药剂师对 CMs ADR 报告的看法和经验。
通过目的性和便利性抽样,对 27 名执业社区药剂师进行了定性、深入、半结构化访谈。使用一般归纳方法分析数据。
参与者熟悉报告 ADR 的系统,认为报告 CMs ADR 很重要,药剂师应该做出贡献。然而,很少有报告 CMs ADR 的情况,也没有鼓励患者/消费者这样做。参与者解释说,他们从未从患者那里听说过与 CMs 相关的 ADR。参与者表示,他们会报告严重的 ADR;时间压力、因果关系缺乏确定性、对报告 CMs ADR 机制的认识不足以及缺乏报酬是报告的障碍。参与者了解处方药物的强化监测研究,理解考虑这种方法用于 CMs 的基本原理,并认识到这可能会存在实际困难。
参与者利用他们对 CMs 安全问题的了解,尽量减少 CMs 使用对消费者造成伤害的风险,但大多数人对识别和报告 CMs ADR 采取被动态度。药剂师在 CMs 药物警戒方面有很大的潜力采取主动策略,特别是在识别和报告 ADR 方面,并授权 CMs 用户也这样做。