Supporting the Development of Trustworthy Essential Medicine Lists and their Synergy with Health Guidelines

Abstract

Essential Medicine Lists (EMLs) are important for the prioritization and availability of medicines around the world. Since the first Model List of Essential Medicines (MLEM) from the World Health Organization in 1977, the list has expanded from 208 to 479 medicines. The availability of essential medicines is a key priority under the World Health Organization’s Universal Health Coverage agenda & the United Nation’s Sustainable Development Goals (in particular goal 3.8 Coverage of Essential Health Services). EMLs are an important tool to inform health decisions at a country-level and at least 137 countries now have their own national EML. Despite this, there is wide variability in the methods used to develop them, and the certainty of evidence of medicines included on WHO’s MLEM and national EMLs. Additionally, a lack of coordination may result in time delays in updating EMLs or unnecessary duplication of efforts between EMLs and other evidence synthesis and health decision-making paradigms, such as health guidelines. In this thesis, we seek to understand the decision-making process for EMLs with particular focus on WHO’s MLEM, and to identify and advance opportunities to coordinate their development with health guidelines. This is accomplished through three papers, which build upon each other in this sandwich thesis. Paper 1 is a qualitative interview study with EML and guideline stakeholders to better understand decision-criteria and processes in EMLs. Paper 2 evaluates, using user-experience testing, a framework for the connection of guidelines and EMLs using an Evidence-to-Decision (EtD) framework for EMLs. Paper 3 presents a stakeholder-driven Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group concept paper exploring the conceptual challenges and opportunities of linking guidelines and EMLs using case studies on real-world implementation of this connection.