Hohl Corinne M, Small Serena S, Peddie David, Badke Katherin, Bailey Chantelle, Balka Ellen
Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada.
Department of Emergency Medicine, University of British Columbia, Vancouver, BC, Canada.
JMIR Public Health Surveill. 2018 Feb 27;4(1):e21. doi: 10.2196/publichealth.9282.
Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported.
Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting.
This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice.
We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation.
Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care.
药物不良事件是与药物相关的意外且有害的事件。药物不良事件对患者护理、质量改进、药物安全研究和上市后监测都很重要，但却严重报告不足。
我们的目的是确定药物不良事件记录的障碍以及导致报告不足的因素。
这项定性研究于2014年3月至2016年12月在不列颠哥伦比亚省的1个门诊中心以及3家急症医院的急诊科和住院病房进行。我们完成了对全科医生、住院医师、急诊医师以及医院和社区药剂师的工作场所观察和焦点小组讨论。我们通过编码和迭代分析数据来分析现场记录，以识别新出现的概念、生成主题和事件总结，并创建工作流程图。临床医生通过将新出现的概念应用于他们临床实践中的病例来进行验证。
我们完成了238小时的观察，在此期间临床医生调查了65起可疑药物不良事件。观察到的事件通常很复杂，且需要一段时间才能确诊，需要多个医疗服务提供者的参与。医疗服务提供者在病历中记录药物不良事件以支持连续护理，但从未向外部机构报告。医疗服务提供者面临时间限制，而报告需要重复记录。
现有的报告系统不适合捕捉药物不良事件的复杂性质，也不适应工作流程，一线临床医生根本不会使用。集成到电子病历中的系统，利用现有数据避免重复记录，并生成警报以提高安全性，可能会解决现有系统的缺点，并作为更安全护理的副产品生成可靠的药物不良事件数据。
