This systematic review protocol is guided by the updated Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol (PRISMA-P), which contains 17 items considered to be essential and minimum components of a systematic review.18

A comprehensive search strategy was developed with an information specialist using medical subject headings (MeSH) and text word terms. The MEDLINE search terms were tested to improve specificity and then translated to Ovid EMBASE and Scopus databases. The MEDLINE search strategy is presented as an online supplemental file S1. The choice of the database for the systematic review was based on the findings from an exploratory preliminary review. Ovid MEDLINE indexes articles from low-and-middle income countries such as the WHO Global Index Medicus. Therefore, the final review includes Ovid MEDLINE, Ovid and Epub Ahead of Print, In-Process, In-Data-Review & Other Non-Indexed Citations, Ovid Embase and Scopus.

Considering some indicators or assessment tools are not academically published and will be domiciled at the national level, grey literature is the essential source of information for this review. The grey literature search will be conducted using the WHO Institutional Repository for Information Sharing portal and country government websites. A customised Google engine will be used to identify relevant country documents using the following search parameters: ““national medicine*/drug/pharmaceutical policy” OR “access/availability” AND “essential medicines” AND “country name””. Where no official policy documents are found, we will contact the officials, for example, via the National Ministries of Health or through the WHO where email contacts are identified to request relevant documents.

Following a preliminary exploration of data, we agreed on the following eligibility criteria:

Indicators or assessment tools for any medicines policies, strategies or programmes implemented to improve access to medicines at a national or subnational level will be eligible. While there are several definitions of ‘indicators’ in the literature, there is consensus that the purpose of indicators or assessment tools in practice is to give information to policymakers about the state of achievement of national goals and priorities towards improvement.19 Therefore, the literature must include a focus on essential medicine policies to improve access to medicines. Commentaries or publications that are solely conceptual or theoretical will be excluded.

Study designs: both quantitative and qualitative studies that include indicators, tools or methods to assess performance with regard to access to medicines are eligible. For academic literature, studies must reference essential medicines and NMPs. Systematic reviews will be excluded.

Publication time frame: restricted to articles published after 2004 (after publication methodology for measuring access to medicines.12

Country/region: no restriction—all countries that have adopted the WHO’s essential medicines concept.

Language: English, Spanish and French studies.

Retrieved studies from the different databases will be exported to Zotero for deduplication. Data will be extracted by two independent reviewers (TO and ES) using a data extraction tool developed by the reviewers. Articles will be screened and selected based on the inclusion and exclusion criteria and the research question.

We will assess the agreement level between the two reviewers using a set of 100 articles. Each reviewer will screen the article title and abstract independently using the eligibility criteria and the agreement between the two reviewers assessed. To ensure that reviewers agree on how to identify eligible studies, an agreement training exercise was conducted for the reviewers. Following a review of the study objectives and eligibility criteria, the two reviewers (TO and ES) independently screened the titles and abstracts of 150 articles from an initial MEDLINE search. The per cent agreement across the two raters was over 90%, suggesting high agreement among the reviewers on the identification of eligible studies.

The reviewers will perform a complete title and abstract screening of all studies. Citations that are selected following title and abstract screening will then have their full text reviewed, and those meeting inclusion and exclusion criteria will have their data extracted. Where there is a disagreement in the title, abstract and full-text screening, a third reviewer (NP) and expert in the field of essential medicines will be consulted to resolve the disagreement.

The methodological quality of the studies will be assessed independently by two researchers (TO, ES) using the critical appraisal checklists from the Joanna Briggs Institute, and studies that fail to meet the quality standards will be excluded.20 21

We will collect the data using a data abstraction tool developed based on the findings from the preliminary review and guided by the Control Knobs Framework. The Control Knobs Framework is a health systems performance framework that identifies five key functions and priorities of government action that influence policy outcomes—which are completely or partially under government control—financing, payment, organisation, regulation and behaviour.

Identified access indicators across all publications will be grouped by essential medicines policies categorised using definitions from the Control Knobs frameworks as follows: Financing, which we define as strategies that focus on mechanisms by which funds are mobilised, allocated in the pharmaceutical system and the methods by which funds are paid out to those who deliver or provide health and medicine products.22Regulation defined as strategies that focus on the use of the full range of legal instruments, including laws, decrees, orders, codes, administrative rules, guidelines, wielded to change the behaviour of individuals and institutions.22–24Organization defined as strategies that focus on the division of activities among relevant institutions, their responsibilities, interactions and arrangements to optimise provision of medicines to the public. Data collected on the data abstraction tool will include bibliographical data (title, authors, journal/publication, year of publication and country of study), access to medicine indicators (such as availability, affordability and price), categorisation of medicines policy (financing, organisation and regulation) and description of medicines policy. The final systematic review will detail any modifications made to the data abstraction compared with this protocol.

The data analysis will present an overview of abstracted assessment indicators and instruments for national medicines policies specific to access to medicines. Identified access to medicine indicators and instruments will be annotated based on the ability to assess financing, organisation and regulatory strategies of essential medicine policies. Qualitative data analysis software tool will be used to code the strengths and weaknesses of existing instruments based on the aspects of the control knob framework relevant to evaluating the performance of national medicines policies. Findings will be presented in a descriptive narrative format as outlined in the PRISMA25 standards.

Following the analysis described, we will discuss the necessity and relevance of developing new ways to measure access to medicines policy implementation. The gaps identified from the analysis above will then be shared with experts for consultation and review to inform future discussion and research on monitoring and assessing medicine policies on access to medicines.

There will be no involvement from patients or members of the public in the design, conduct, reporting or dissemination plans of this study.