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国家对世界卫生组织基本药物标准清单的适应和实施:定性证据综合分析。

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

机构信息

Global Health, Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway.

Faculty of Medicine, University of Oslo, Oslo, Norway.

出版信息

PLoS Med. 2022 Mar 11;19(3):e1003944. doi: 10.1371/journal.pmed.1003944. eCollection 2022 Mar.

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.

摘要

背景

世界卫生组织基本药物标准清单(WHO EML)在指导国家层面的药物选择和融资方面发挥了至关重要的作用,已有四十多年的历史。它仍然是一项相关的循证政策,能够支持全民健康覆盖(UHC)和获得基本药物。本研究旨在确定影响国家层面实施 WHO EML 的因素。

方法和发现

我们通过 2021 年 10 月前对 10 个数据库(包括 CINAHL、Embase、Ovid MEDLINE、Scopus 和 Web of Science)进行搜索,开展了定性证据综合研究。纳入的主要定性研究侧重于 WHO EML 的国家层面实施情况。在支持使用研究证据(SURE)框架中填充定性研究结果,并通过迭代过程确定关键主题。我们使用批判性评估技能计划(CASP)工具评估论文,并使用推荐评估、制定和评估工作组对定性研究证据的置信度(GRADE-CERQual)评估我们对研究结果的信心。我们筛选了 1567 个独特的引用,审查了 183 篇全文,并纳入了来自 30 个环境的 23 项研究。未收集非英语研究以及利益相关者的经验和看法的灰色文献。我们的研究结果主要围绕国家层面适应和实施 WHO EML 的三个主要观点:(1)为国家药物清单(NML)设计机构、治理和领导的重要性,特别是考虑透明度、协调能力、立法机制、管理区域差异和临床指导;(2)管理证据以更新 NML 的能力,包括使全球证据本地化、利用本地数据和专家知识以及评估预算影响的过程,本地相关的成本效益信息在此过程中起着重要作用;(3)NML 通过与融资和采购系统的联系以及捐助者的影响改变提供者的激励措施,从而影响采购和处方。

结论

本定性证据综合研究强调了实施 WHO EML 所固有的复杂性和相互依存性。为了最大限度地发挥 NML 的价值,应该对支持从全球规范到调整规定行为的实施途径各个阶段所需的流程和机构进行更多投资。此外,对 NML、采购和药物供应之间的联系进行进一步研究将为最佳 NML 实施提供更多见解。

协议注册号

PROSPERO CRD42018104112。

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