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National adaptation and implementation of WHO Model List of Essential Medicines: A qualitative evidence synthesis

['Elizabeth F. Peacocke', 'Global Health', 'Division For Health Services', 'Norwegian Institute Of Public Health', 'Oslo', 'Sonja L. Myhre', 'Hakan Safaralilo Foss', 'Faculty Of Medicine', 'University Of Oslo', 'Unni Gopinathan']

Date: 2022-04

Abstract Background The World Health Organization Model List of Essential Medicines (WHO EML) has played a critical role in guiding the country-level selection and financing of medicines for more than 4 decades. It continues to be a relevant evidence-based policy that can support universal health coverage (UHC) and access to essential medicines. The objective of this review was to identify factors affecting adaptation and implementation of WHO EML at the national level. Methods and findings We conducted a qualitative evidence synthesis by searching 10 databases (including CINAHL, Embase, Ovid MEDLINE, Scopus, and Web of Science) through October 2021. Primary qualitative studies focused on country-level implementation of WHO EML were included. The qualitative findings were populated in the Supporting the Use of Research Evidence (SURE) framework, and key themes were identified through an iterative process. We appraised the papers using the Critical Appraisal Skills Programme (CASP) tool and assessed our confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation working group-Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual). We screened 1,567 unique citations, reviewed 183 full texts, and included 23 studies, from 30 settings. Non-English studies and experiences and perceptions of stakeholders published in gray literature were not collected. Our findings centered around 3 main ideas pertaining to national adaptation and implementation of WHO EML: (1) the importance of designing institutions, governance, and leadership for national medicines lists (NMLs), particularly the consideration of transparency, coordination capacity, legislative mechanisms, managing regional differences, and clinical guidance; (2) the capacity to manage evidence to inform NML updates, including processes for contextualizing global evidence, utilizing local data and expert knowledge, and assessing budget impact, to which locally relevant cost-effectiveness information plays an important role; and (3) the influence of NML on purchasing and prescribing by altering provider incentives, through linkages to systems for financing and procurement and donor influence. Conclusions This qualitative evidence synthesis underscores the complexity and interdependencies inherent to implementation of WHO EML. To maximize the value of NMLs, greater investments should be made in processes and institutions that are needed to support various stages of the implementation pathway from global norms to adjusting prescribed behavior. Moreover, further research on linkages between NMLs, procurement, and the availability of medicines will provide additional insight into optimal NML implementation. Protocol registry PROSPERO CRD42018104112

Author summary Why was this study done? The World Health Organization Model List of Essential Medicines (WHO EML) has played a critical role in guiding the country-level selection and financing of medicines for more than 4 decades.

National medicine lists (NMLs) are perceived to be an important part of a country’s medicines policy; however, few efforts have been made to systematically integrate insights of WHO EML implementation from the empirical literature.

The objective of this study was to identify the factors that influence implementation of global normative guidance on essential medicines and provide insight on areas where additional support may facilitate country-level implementation. What did the researchers do and find? A qualitative evidence synthesis was undertaken, using the GRADE-Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach to assess how much confidence to place in the findings. A systematic search of 10 databases identified 23 articles for inclusion after assessing 1,567 unique citations and reviewing 183 full texts.

We found that implementation can be facilitated by national medicine selection committees that operate with consultative mandates, clear leadership and oversight, and monitoring and evaluation.

Implementation of NMLs also requires harmonization with reimbursement processes and recommended clinical practice. National standard treatment guidelines (STGs) therefore play a crucial role in translating intentions of NML to clinical practice, while legislation, oversight, and monitoring are additional tools for ensuring compliance.

The types of information used in adaptations are extremely important. Crucial to country relevant updates of NMLs is the balancing of global evidence, expert knowledge, and local data, and there is an opportunity for further use of health economic methods to inform decision-making on essential medicines. What do these findings mean? Updating NMLs following biannual global revisions of WHO EML requires significant financial and human resource investment by countries. The number of actors and processes underscore the complexity and interdependencies inherent to implementation of the EML.

These findings suggest that to maximize the value of NMLs, greater investments should be made in different types of institutions that are needed to support various stages along the implementation pathway from global norms to adjusting prescriber behavior.

Citation: Peacocke EF, Myhre SL, Foss HS, Gopinathan U (2022) National adaptation and implementation of WHO Model List of Essential Medicines: A qualitative evidence synthesis. PLoS Med 19(3): e1003944. https://doi.org/10.1371/journal.pmed.1003944 Academic Editor: Aaron S. Kesselheim, Harvard University, Brigham and Women’s Hospital, UNITED STATES Received: July 13, 2021; Accepted: February 11, 2022; Published: March 11, 2022 Copyright: © 2022 Peacocke et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability: All relevant data are within the manuscript and its Supporting Information files. Funding: This work was partly supported by the Research Council of Norway through the Global Health and Vaccination Programme (GLOBVAC Project 234608). The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: The authors have declared that no competing interests exist. Abbreviations: CASP, Critical Appraisal Skills Programme; GRADE-CERQual, Grading of Recommendations Assessment, Development and Evaluation working group-Confidence in Evidence from Reviews of Qualitative research; HIC, high-income country; HTA, Health Technology Assessment; LMIC, low- and middle-income country; NML, national medicine list; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; SDG, Sustainable Development Goal; STG, standard treatment guideline; SURE, Supporting the Use of Research Evidence; UHC, universal health coverage; WHO EML, World Health Organization Model List of Essential Medicines

Introduction The World Health Organization Model List of Essential Medicines (WHO EML) offers a global evidence–informed reference list for countries to use in the adaptation of their national formulary or national medicines list (NMLs). It was established on the premise that some medicines are more important than others and hence should be defined as “essential” and that access to these should be strengthened [1,2]. The original 1977 list included 186 medicines deemed essential for every healthcare system and provided guidance on medicine selection for NMLs. The scope of WHO EML Expert Committee on Selection and Use of Medicines is to consider medicines from the perspective of public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness to identify those medicines that best satisfy the priority healthcare needs of a country’s population [3]. Currently, there are 2 WHO EMLs: WHO Essential Medicines List and WHO Essential Medicines List for Children (first created in 2007, from here on referred to as WHO Children’s List), and both are revised every 2 years. The categorization of medicines is twofold: “core” medicines represent the minimum medicines needed, while “complementary” medicines require specialized medical care, diagnostic, or monitoring facilities. From 2002, WHO sought to institutionalize an evidence-based process for making decisions about the inclusion of new medicines to WHO EML [2]. WHO recommends that all countries formulate and implement a comprehensive national medicines policy to improve access to safe and effective medicines of good quality [4]. A country’s NML is a government-approved list of medicines, which can often be adapted and implemented as a local formulary, or as a secondary list to the NML “tertiary list” [5]. The NML is intended to guide public sector procurement and supply, reimbursement schemes, medicine donations, and local production [6]. Moreover, NMLs can aid countries to prioritize medicines and can be used as the foundation for reimbursement schemes and national treatment guidelines (standard treatment guidelines, STG). Medicine use is a key driver of healthcare expenditure; thus, implementing a NML can be a strategy for promoting efficient use of healthcare resources [7]. However, in many contexts, the inclusion of medicines on the NML does not necessarily guarantee that these are accessible to populations, for example, due to stockouts or high out-of-pocket costs. The implementation process of a NML, including the steps for making these medicines accessible [8,9], is therefore more complex than a binary decision to include or exclude a medicine on the list. WHO EML is primarily used by countries as a basis for guiding national decisions about their own NMLs [8,9]. For several reasons, it has been heavily debated whether WHO EML or WHO Children’s List serve as an optimal point of reference for national medicines policy. A key issue has been that WHO EML is meant to define minimum needs for a health system and therefore do not necessarily include all effective medicines that may be necessary for a country. For example, it was only in 2002 that antiretroviral drugs against HIV/AIDS were included on the list, in spite of the increasing severity and destabilizing effect of the HIV/AIDS epidemic [10]. The delayed inclusion of antiretroviral medicines reflected the fact that affordability until then was a precondition for selection into WHO EML [11]. Since then, affordability has been viewed as a consequence that must be managed after selection into the list [12]. The additions of high-cost medicines for cancers, hepatitis C, and multidrug-resistant tuberculosis reinforced this way of dealing with affordability of included medicines [12]. In some cases, medicines on WHO EML have remained despite most nations using better and more cost-effective options [1]. Another tension has been between WHO EML and lack of consistency with treatment guidelines issued by other WHO committees [1], as well as discrepancies between national treatment guidelines and the medicines on the EML. In the latter case, there was a relatively long and notable gap between modern clinical practice guidelines for preventing and treating cardiovascular diseases and the medicines included on the list [13]. However, with concerted efforts, WHO EML has been modernized over time [13,14]. Questions have also been raised about the standard of applications submitted to WHO Expert Committee for Essential Medicines and the transparency of their decision-making process [15], which, arguably, has improved since major reforms were implemented in 2001 [12]. Despite these contentious issues, individual studies from a wide range of settings underscore that WHO EML often is a starting point for national medicines selection processes, particularly in low- and middle-income countries (LMICs) [16–20]. In response to global normative guidance that WHO EML represents, countries seek to adapt it by considering factors such as the disease burden in the country, the cost of medicines, specific concerns of patients or providers, and health systems capacity to deliver medicines to patients. In addition, other country-level considerations may influence this process such as the demographic profile, climate, and transportation infrastructure. To assess these factors, countries might establish institutions such as standing committees, set up processes for producing evidence reviews to inform cost-effectiveness, and assess preferences of patients and providers [21,22]. The revision of WHO EML is not accompanied by detailed guidance for national medicines selection processes [16]. Many articles have been published on this topic, especially studies that compare the coverage and access of medicines as listed on WHO EML with a country’s NML. However, the authors are not aware of any systematic efforts to analyze country-level experiences with adapting and implementing essential medicines lists. The implementation of WHO EML involves many steps that need to be better understood, resourced, and executed [19]. Thus, there is a need to explore the theory practice gap, namely how the global norm on essential medicines is integrated in real-world policymaking and translated to value for prescribers and patients. Four decades since its launch, WHO EML continues to play an important role internationally. It is intertwined in the United Nations Sustainable Development Goal (SDG) on global health and well-being, specifically, SDG targets 3.8 (universal health coverage, UHC) and 3b (access to medicines for all) [23]. By systematically integrating insights from qualitative studies of WHO EML implementation, we hope to better understand what impedes or facilitates adapting global normative guidance on essential medicines at the country level and what processes need to be in place to optimize implementation. Accordingly, the primary objective of this review was to identify factors affecting adaptation and implementation of WHO EML at the national level.

Discussion WHO EML has played a critical role in guiding the country-level selection and financing of medicines for more than 4 decades. Accordingly, countries have accumulated a wealth of experience in utilizing WHO EML as a global normative tool and adapting it to the national context. Countries have also responded to its evolving normative value over time, with the inclusion of comparatively expensive and patented antiretroviral medicines in 2002 marking a pivotal moment in WHO EML’s history [1]. In recent years, the inclusion of high-priced medicines, such as for cancer and hepatitis C [16,53], have seen WHO’s Expert Committee on essential medicines using WHO EML proactively to promote greater affordability and access [54]. Attention has also focused on the functioning of WHO EML within the larger goal of health systems strengthening [7]. To our knowledge, this is the first systematic review of qualitative country-level evidence to identify key factors influencing the adaptation and implementation of WHO EML at the national level. The crucial role country-level institutional structures play in implementing essential medicines policies have been highlighted by high-level reviews, such as the 2017 Lancet Commission on essential medicines for UHC [55]. To translate global revisions to meaningful national medicines policy, our review identified a wide range of institutional features that countries need. Medicine selection committees that are transparently managed and with clear roles and responsibilities can encourage an effective adaptation process by securing the involvement of relevant expertise and stakeholders. Moreover, to improve implementation of NMLs, more attention to adherence and compliance strategies could be achieved through better coordination and oversight by these committees or other types of institutions that are delegated the necessary authority. National policymakers may—especially in decentralized health systems—need legislative and regulatory frameworks that can secure adherence to the NML and harmonize implementation across subnational levels and clinical entities (e.g., hospitals or regional health trusts) that are responsible for procuring medicines. Finally, once new medicines are prioritized for inclusion, formulation of STGs and equivalent guidance are critical to translating changes from the NML to clinical practice and value for patients. One barrier to the process of updating a NML in LMICs is the cost. This is especially true when it is necessary for selection committee members to be paid daily sitting allowances, as well as additional fees for consultation meetings and dissemination of the list [18,39]. Many countries—especially those where the health sector and academic institutions are underresourced—may lack resources and the specialized knowledge and skills to strengthen these institutions. There is potential for international collaborative initiatives as well as international assistance with country-level presence, such as WHO country offices, to better support these institutional aspects to successfully translate global revisions to locally relevant adaptions. Our review highlights how revisions and adaptations of a NML cannot occur in isolation from other areas of the pharmaceutical system. Greater clarity is needed about the relationship between a NML and the larger systems for regulating, financing, procuring, and delivering pharmaceuticals. Opaque systems and lack of formal links between the shaping of a NML and the financing and procurement of medicines can impede the translation of NMLs to available medicines in clinical practice. Provider incentives—if misaligned and left uncorrected—can impede the goals of an essential medicines policy [56,57]. Moreover, medicine programs led by international partners or donors may undermine government policy by, for example, offering medicines that are not listed on NMLs and not funded through national insurance schemes. This may, in turn, be detrimental to the value NMLs have as a tool for fair and progressive realization of UHC. A key difference between many HICs and LMICs with respect to linking essential medicines policy to the broader pharmaceutical system is the use of reimbursement lists with tight links to national health policy and financing of pharmaceuticals [30,46,58]. Finally, the review identified the relationship between revisions to NMLs and the use of HTAs to be underdeveloped. Since 2015, successive versions of WHO EML have seen additions of patented high-cost medicines [16,53]. These drugs have provoked the access to medicines debate in HICs and reinforced the idea that high-cost drugs are a challenge for all health systems, regardless of a country’s economic status [16,46]. Moreover, these additions have challenged the affordability of essential medicines which is defined as: “… those [medicines] that satisfy the priority health care needs of the population… at a price the individual and the community can afford” [59]. The recent expansions of WHO EML increase the necessity, especially in countries that face considerable resource scarcity and where medicines continue to account for a large proportion of health spending [60], to have sound prioritization processes. These should be guided by evidence on disease prevalence, efficacy and safety, and comparative cost-effectiveness. Increasingly, countries are using HTA to inform their priority-setting decisions. However, the full potential of health economics and HTA to manage government health spending is yet to be optimized during the decision-making processes of national medicine selection committees [20,22,39,49]. Our review identified that there are gaps in local data and domestic expertise in the context of implementation of NMLs, representing a barrier to locally relevant HTA and related prioritization processes [20,22,38]. Further guidance, capacity development, and collaboration on designing comprehensive prioritization processes that use HTA and incorporate local evidence to inform national medicines policy is needed. Such processes should also influence the decisions of international partners and donors that finance medicine programs. To gain greater insight into country-level implementation of WHO EML, there is a need for further primary country-level research on managing implementation processes of medicine policies. This includes the role of devolution as well as how the lists are disseminated to prescribers after inclusion of new medicines.

Limitations Studies were excluded if they were not in English or if they did not include qualitative data that documented experiences and perceptions of relevant stakeholders through interview or document review. There is therefore a risk that important experiences and perspectives published in gray literature may have been missed in this review. An information specialist completed the search 3 times, in June 2018, July 2020, and October 2021.

Conclusions The findings of this study may be valuable for national policymakers and practitioners, who are developing and implementing global normative guidance on essential medicines. This qualitative evidence synthesis documented a complex web of actors involved in adapting and implementing an EML, including clinicians, pharmacists, hospital administrators, insurance providers, national policymakers, the pharmaceutical industry, and international donors. These actors engage in a wide range of processes influencing implementation: policymaking, production, procurement, purchasing, prescribing, adherence, compliance, and enforcement. Overall, these actors and processes underscore the complexity and interdependencies inherent to implementation. To maximize the value of NMLs, greater investments should be made in different types of institutions that are needed to support various stages along the implementation pathway from global norms to adjusting prescriber behavior. Further research on linkages between NMLs, procurement, and the availability of medicines will provide additional insight into optimal implementation.

Acknowledgments We would like to thank the following people for their contribution: Astrid Merete Nøstberg, information specialist at the Norwegian Institute of Public Health, and Simon Lewin and Lumbwe Chola who provided guidance on the methods and manuscript.

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