WHO Essential Medicines List and WHO Guidelines: Recommendation Mapping and Discordance Analysis

Article type
Authors
Chi Y1, Moja L2, Reveiz L3, Thomas R4, Ford N5, Nowak A6, Piggott T7, Schünemann H8
1Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Beijing Yealth Technology Co., Ltd, Beijing, China
2Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland
3Evidence and Intelligence for Action in Health Department, Pan American Health Organization, Washington DC, USA
4Department of Guidelines Review Committee, World Health Organization, Geneva, Switzerland
5Department of HIV, Hepatitis and Sexually Transmitted Infections, World Health Organization, Geneva, Switzerland
6Evidence Prime, Krakow, Poland
7Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Peterborough Public Health , Peterborough, Canada
8Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Clinical Epidemiology and Research Centre, Department of Biomedical Sciences, Humanitas University, Milan, Italy
Abstract
"Background
The World Health Organization (WHO) Essential Medicines List (EML) and WHO guidelines serve as a critical resource for countries to inform decisions on healthcare policies. These instruments should act synergistically through consistent recommendations. However, there is a lack of clarity on the extent and nature of discordance and misalignment between the WHO EML and guidelines which could affect the efficient use and adoption of medicines.
Objectives
To map and analyse the recommendations and indications of medicines between the WHO EML and WHO guidelines to identify discordances, understanding potential causes and implications.
Methods
We will map and analyse recommendations about medicines from the WHO EML and WHO guidelines according to scenarios outlined in Box 1, specifically focusing on recommendation direction discordance, recommendation partial misalignment, and recommendation gaps. We will extract the certainty of evidence and strength of recommendations, and evidence-to-decision (EtD) framework to explain the underlying factors preventing or inducing recommendation direction discordance, partial misalignment, and recommendation gaps.
Results
We will present analyses on:
1) identified areas where EML and guideline complement each other and areas where there is limited overlap;
2) identified discordances between EML and guideline recommendations on medicines for corresponding indications;
3) data derived from scenarios when essential medicines are supported by strong and conditional, positive and negative guideline recommendations.
We will also report on factors that might cause recommendation discordance, misalignment, and gaps between WHO EML and guidelines decisions. This might include lack of sufficient and conclusive evidence, considerations on cost-effectiveness and affordability, implementation and accessibility, panel composition and evaluation approach, and time lag and update frequency.
Conclusions
It is essential to ensure consistent recommendations on medicine use between different actors in the decision-making ecosystem for coordinated evidence-based policies. This consistency can enhance WHO's role in improving global affordability and access to medicines, addressing the time lag between guidelines and EMLs, as well as strengthening the link between the WHO EML and national EMLs. This in turn may improve the responsiveness of both EML and guidelines, and the accessibility and affordability of essential medicines to tackle evolving healthcare needs effectively and efficiently.
Public involvement: Not applicable."