Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Family Medicine, Queens University, Kingston, Canada.
Department of Health Product Policy and Standards, World Health Organization, Geneva, Switzerland.
J Clin Epidemiol. 2024 Feb;166:111241. doi: 10.1016/j.jclinepi.2023.111241. Epub 2023 Dec 19.
Guidelines and essential medicine lists (EMLs) bear similarities and differences in the process that lead to decisions. Access to essential medicines is central to achieve universal health coverage. The World Health Organization (WHO) EML has guided prioritization of essential medicines globally for nearly 50 years, and national EMLs (NEMLs) exist in over 130 countries. Guideline and EML decisions, at WHO or national levels, are not always coordinated and aligned. We sought to explore challenges, and potential solutions, for decision-making to support trustworthy medicine selection for EMLs from a Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Working Group perspective. We primarily focus on the WHO EML; however, our findings may be applicable to NEML decisions as well.
We identified key challenges in connecting the EML to health guidelines by involving a broad group of stakeholders and assessing case studies including real applications to the WHO EML, South Africa NEML, and a multiple sclerosis guideline connected to a WHO EML application for multiple sclerosis treatments. To address challenges, we utilized the results of a survey and feedback from the stakeholders, and iteratively met as a project group. We drafted a conceptual framework of challenges and potential solutions. We presented a summary of the results for feedback to all attendees of the GRADE Working Group meetings in November 2022 (approximately 120 people) and in May 2023 (approximately 100 people) before finalizing the framework.
We prioritized issues and insights/solutions that addressed the connections between the EML and health guidelines. Our suggested solutions include early planning alignment of guideline groups and EMLs, considering shared participation to strengthen linkage, further clarity on price/cost considerations, and using explicit shared criteria to make guideline and EML decisions. We also provide recommendations to strengthen the connection between WHO EML and NEMLs including through contextualization methods.
This GRADE concept article, jointly developed by key stakeholders from the guidelines and EMLs field, identified key conceptual issues and potential solutions to support the continued advancement of trustworthy EMLs. Adopting structured decision criteria that can be linked to guideline recommendations bears the potential to advance health equity and gaps in availability of essential medicines within and between countries.
指南和基本药物清单（EML）在决策过程中既有相似之处，也有不同之处。获得基本药物是实现全民健康覆盖的核心。世界卫生组织（WHO）的 EML 近 50 年来一直指导着全球基本药物的优先排序，并且有超过 130 个国家制定了国家 EML（NEML）。在世界卫生组织或国家层面，指南和 EML 决策并不总是协调一致的。我们试图从推荐评估、制定和评估（GRADE）工作组的角度探索决策的挑战和潜在解决方案，以支持 EML 中值得信赖的药物选择。我们主要关注世界卫生组织的 EML；然而，我们的发现也可能适用于 NEML 决策。
我们通过让广泛的利益相关者参与，并评估案例研究，包括世界卫生组织 EML、南非 NEML 和与世界卫生组织 EML 应用于多发性硬化症治疗相关的多发性硬化症指南的实际应用，确定了将 EML 与卫生指南联系起来的关键挑战。为了解决这些挑战，我们利用了调查结果和利益相关者的反馈，并作为一个项目小组进行迭代会议。我们起草了一个挑战和潜在解决方案的概念框架。我们向 2022 年 11 月（约 120 人）和 2023 年 5 月（约 100 人）的 GRADE 工作组会议的所有与会者介绍了结果摘要，然后在最终确定框架之前征求了他们的反馈意见。
我们确定了优先考虑的问题和见解/解决方案，以解决 EML 和卫生指南之间的联系。我们提出的解决方案包括早期规划指南小组和 EML 的一致性，考虑共同参与以加强联系，进一步明确价格/成本考虑因素，并使用明确的共同标准来做出指南和 EML 决策。我们还提供了加强世界卫生组织 EML 和 NEML 之间联系的建议，包括通过情境化方法。
本 GRADE 概念文章由指南和 EML 领域的主要利益相关者共同制定，确定了支持继续推进值得信赖的 EML 的关键概念问题和潜在解决方案。采用可以与指南建议联系起来的结构化决策标准有可能在国家内部和之间促进卫生公平和基本药物供应的差距。
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