Department of Medicine, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.
National Pharmaceutical Regulatory Agency, Ministry of Health, Petaling Jaya, Malaysia.
BMC Health Serv Res. 2024 Sep 3;24(1):1019. doi: 10.1186/s12913-024-11476-0.
Effective risk communication about medicines is crucial to the success of all pharmacovigilance activities but remains a worldwide challenge. Risk communication has been conducted in Malaysia for decades, yet awareness on the communication methods remains low among healthcare professionals. While international guidelines are available, clear guidance on effectively communicating the risks of medicines in specific countries is scarce. This study aimed to establish a consensus on the priority strategies for enhancing risk communication about medicines by regulators.
We conducted a two-round modified Delphi survey among local and international communication experts, and also recipients of medicines risk communication in Malaysia. We developed a list of 37 strategies based on the findings of our previous studies. In Round 1, participants were asked to rate the priority for each strategy using a 5-point Likert scale and suggest additional strategies via free-text comments. Strategies scoring a mean of ≥ 3.75 were included in Round 2. We defined consensus for the final list of strategies a priori as > 75% agreement. Data were analysed using descriptive statistics and thematic analysis.
Our final Delphi panel (n = 39, 93% response rate) comprised medicines communication experts from nine countries and Malaysian healthcare professionals. Following Round 1, we dropped 14 strategies and added 11 strategies proposed by panellists. In the second round, 21 strategies achieved consensus. The priority areas identified were to improve the format and content of risk communication, increase the use of technology, and increase collaboration with various stakeholders. Priority ratings for the strategy "to offer incentives to pharmaceutical companies which maintain effective communication systems" were significantly higher among recipients compared to communicators [χ = 10.1; p = 0.039] and among local versus international panellists [χ = 14.3; p = 0.007].
Our study identified 21 priority strategies, which were used to develop a strategic plan for enhancing medicines risk communication. This plan is potentially adaptable to all countries with developing pharmacovigilance systems. The difference in views between communicators and recipients, as well as local and international panellists, highlights the importance of involving multiple stakeholders in research.
有效的药品风险沟通对于所有药物警戒活动的成功至关重要，但这仍然是一个全球性的挑战。马来西亚已经开展药品风险沟通工作数十年，但医疗保健专业人员对沟通方法的认识仍然很低。虽然有国际指南，但关于如何在特定国家有效沟通药品风险的明确指导却很少。本研究旨在就监管机构加强药品风险沟通的优先策略达成共识。
我们在当地和国际沟通专家以及马来西亚药品风险沟通的接收者中进行了两轮改良 Delphi 调查。我们根据之前的研究结果制定了一份 37 项策略清单。在第一轮中，参与者被要求使用 5 分制 Likert 量表对每项策略的优先级进行评分，并通过自由文本评论提出其他策略。得分均值≥3.75 的策略被纳入第二轮。我们预先将最终策略清单的共识定义为>75%的一致意见。数据使用描述性统计和主题分析进行分析。
我们的最终 Delphi 小组（n=39，响应率 93%）由来自九个国家的药品沟通专家和马来西亚医疗保健专业人员组成。第一轮后，我们删除了 14 项策略，并添加了小组提出的 11 项策略。在第二轮中，有 21 项策略达成共识。确定的优先领域包括改进风险沟通的格式和内容、增加技术的使用以及增加与各利益相关者的合作。与沟通者相比，接收者对“为保持有效沟通系统的制药公司提供激励”这一策略的优先评级明显更高[χ2=10.1；p=0.039]，与本地小组相比，国际小组的优先评级也更高[χ2=14.3；p=0.007]。
我们的研究确定了 21 项优先策略，这些策略被用于制定一项加强药品风险沟通的战略计划。该计划可能适用于所有发展药物警戒系统的国家。沟通者和接收者之间，以及本地和国际小组之间的观点差异突出了在研究中纳入多方利益相关者的重要性。
