School of Pharmacy, College of Medical and Dental Sciences, Sir Robert Aitken Institute for Medical Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
University Hospitals Birmingham NHS Foundations Trust, Birmingham, B15 2TH, UK.
Int J Clin Pharm. 2021 Dec;43(6):1693-1704. doi: 10.1007/s11096-021-01302-6. Epub 2021 Jul 2.
Background Direct oral anticoagulants (DOACs) have revolutionised anticoagulant pharmacotherapy. However, DOAC-related medication incidents are known to be common. Objective To assess medication incidents associated with DOACs using an error theory and to analyse pharmacists' contributions in minimising medication incidents in hospital in-patients. Setting A large University academic hospital in the West Midlands of England. Methods Medication incident data from the incident reporting system (48-months period) and pharmacists' interventions data from the prescribing system (26-month period) relating to hospital in-patients were extracted. Reason's Accident Causation Model was used to identify potential causality of the incidents. Pharmacists' intervention data were thematically analysed. Main outcome measure (a) Frequency, type and potential causality of DOAC-related incidents; (b) nature of pharmacists' interventions. Results A total of 812 reports were included in the study (124 medication incidents and 688 intervention reports). Missing drug/omission was the most common incident type (26.6%, n = 33) followed by wrong drug (16.1%, n = 20) and wrong dose/strength (11.3%, n = 14). A high majority (89.5%, n = 111) of medication incidents were caused by active failures. Patient discharge without anticoagulation supply and failure to restart DOACs post procedure/scan were commonly recurring themes. Pharmacists' interventions most frequently related to changes in pharmacological strategy, including drug or dose changes (38.1%, n = 262). Impaired renal function was the most common reason for dose adjustments. Conclusion Prescribers' active failure rather than system errors (i.e. latent failures) contributed to the majority of DOAC-related incidents. Reinforcement of guideline adherence, prescriber education, harnessing pharmacists' roles and mandating renal function information in prescriptions are likely to improve patient safety.
直接口服抗凝剂(DOACs)彻底改变了抗凝药物治疗。然而,已知 DOAC 相关的药物不良事件很常见。目的:使用错误理论评估与 DOAC 相关的药物不良事件,并分析药剂师在减少医院住院患者药物不良事件方面的作用。地点:英格兰西米德兰兹地区的一家大型大学附属医院。方法:从事件报告系统(48 个月期间)中提取与医院住院患者相关的药物不良事件数据,并从处方系统(26 个月期间)中提取药剂师干预数据。使用Reason 的事故因果模型识别事件的潜在因果关系。对药剂师干预数据进行主题分析。主要结果测量:(a)DOAC 相关事件的频率、类型和潜在因果关系;(b)药剂师干预的性质。结果:共纳入 812 项研究(124 项药物不良事件和 688 项干预报告)。漏用/漏服是最常见的药物不良事件类型(26.6%,n=33),其次是用药错误(16.1%,n=20)和用药剂量/强度错误(11.3%,n=14)。绝大多数(89.5%,n=111)药物不良事件是由主动失误引起的。患者出院时未提供抗凝药物供应以及未能在手术后/扫描后重新开始使用 DOAC 是常见的反复出现的主题。药剂师的干预措施最常涉及改变药物治疗策略,包括改变药物或剂量(38.1%,n=262)。肾功能不全是调整剂量的最常见原因。结论:与 DOAC 相关的药物不良事件主要是由于处方者的主动失误,而不是系统错误(即潜在失误)所致。强化指南遵循、对处方者进行教育、利用药剂师的作用并在处方中强制规定肾功能信息,可能会提高患者安全性。