Department of Clinical, Pharmaceutical and Biological Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK; Ministry of Health, Kuwait.
School of Health & Social Wellbeing, University of the West of England, Bristol, UK.
Res Social Adm Pharm. 2023 Jan;19(1):28-56. doi: 10.1016/j.sapharm.2022.07.003. Epub 2022 Jul 16.
Regulatory medicines risk communications aim to prevent patient harm through the dissemination of safety information to healthcare professionals (HCPs), patients, and the public. Evidence suggests that in addition to implementing the required changes, HCPs also respond to these communications through unintended and unwarranted actions and behaviours such as stopping medicine courses unnecessarily, and blanket actions spilling over to unintended patients' populations. Misunderstanding and mis-implementation of medicines risk communications could jeopardise patients' safety and clinical outcomes. Therefore, it is important to understand the determinants that affect HCPs responses to medicines risk communications. This systematic review aims to identify the factors that affect the implementation of risk communications by healthcare professionals.
Fifteen databases, including EMBASE, PubMed, Scopus, Web of science, CINAHL PLUS were searched in April-May 2018, and the search was updated again in June 2021 to identify studies reporting on factors influencing HCPs' uptake of medicine risk alerts. We used keywords such as risk communication, safety update, and safety regulation. Studies were excluded if they did not involve pharmacovigilance or patient safety alerts; or if they only focused on measuring HCPs' practice after alerts; or evaluating the effectiveness of risk minimisation measures without reporting on factors affecting HCPs' actions. Studies relating to occupational hazards, case reports, interventional studies, and studies not involving HCPs were also excluded. The Mixed Method Appraisal Tool (MMAT) was used to assess the quality of the included studies. A Narrative synthesis approach was undertaken using thematic analysis and concept mapping, followed by a critical reflection of the synthesis.
Twenty-eight studies met our criteria and were included in the synthesis. We identified four themes summarising the factors influencing HCPs' implementation of risk communications. These include HCPs: knowledge of medicine alerts; perceptions of alerts; attitudes, and concerns regarding medicine alerts; and the self-reported impact of these alerts. Our concept mapping exercise identified key interactions between different stakeholders, and these interactions determine HCPs' implementation of medicine risk communications. These stakeholders comprise of alert developers, including the sources and senders of safety information, and the receivers of safety information including health care institutions, HCPs, patients and their carers.
Healthcare professionals are crucial to translating risk communication messages into clinical practice. However, if they have inadequate information about the content of the alert, and have inaccurate perceptions about the alert, they may not implement the required clinical changes as intended. Communication of medicine risk alerts does not always translate into improved patient care, due to a complex interaction between stakeholders involved in the creation and implementation of these alerts. These complex interactions should be the subject of future research efforts to understand the alert-implementation trajectory and identify the mediators for change and interventions to improve implementation.
监管药品风险沟通旨在通过向医疗保健专业人员（HCPs）、患者和公众传播安全信息来预防患者伤害。有证据表明，除了实施必要的变更外，HCPs 还会通过意外和不必要的行为做出回应，例如不必要地停止用药疗程，以及将行动无差别地扩展到非预期的患者群体。对药品风险沟通的误解和执行不当可能会危及患者的安全和临床结果。因此，了解影响 HCPs 对药品风险沟通做出回应的因素非常重要。本系统评价旨在确定影响医疗保健专业人员实施风险沟通的因素。
2018 年 4 月至 5 月，我们检索了 15 个数据库，包括 EMBASE、PubMed、Scopus、Web of Science 和 CINAHL PLUS，并于 2021 年 6 月再次更新检索，以确定报告影响 HCPs 接受药品风险警报的因素的研究。我们使用了风险沟通、安全更新和安全监管等关键词。如果研究不涉及药物警戒或患者安全警报；或者仅关注警报发布后 HCPs 的实践；或者评估风险最小化措施的有效性而不报告影响 HCPs 行动的因素，则将其排除在外。还排除了与职业危害、病例报告、干预性研究和不涉及 HCPs 的研究。使用混合方法评估工具（MMAT）评估纳入研究的质量。采用主题分析和概念映射进行叙述性综合，并对综合结果进行批判性反思。
有 28 项研究符合我们的标准并纳入综合分析。我们确定了四个主题，总结了影响 HCPs 实施风险沟通的因素。这些因素包括 HCPs：对药品警报的了解；对警报的看法；对药品警报的态度和关注；以及这些警报对他们的自我报告影响。我们的概念映射练习确定了不同利益相关者之间的关键相互作用，这些相互作用决定了 HCPs 对药品风险沟通的实施。这些利益相关者包括警报开发人员，包括安全信息的来源和发送者，以及安全信息的接收者，包括医疗机构、HCPs、患者及其护理人员。
医疗保健专业人员是将风险沟通信息转化为临床实践的关键。然而，如果他们对警报的内容了解不足，并且对警报的看法不准确，他们可能不会按照预期实施所需的临床变更。由于涉及创建和实施这些警报的利益相关者之间存在复杂的相互作用，药品风险警报的沟通并不总是转化为改善患者护理。这些复杂的相互作用应该成为未来研究的主题，以了解警报实施轨迹，确定中介因素，以及改进实施的干预措施。
