The World Health Organization (WHO) declared snakebite envenoming (SBE) as a neglected tropical disease in 2017. Antivenom is the gold standard of treatment, but many healthcare barriers exist, and hence, affected populations are often unable to access it. The challenge is further perpetuated by the lack of attention from national health authorities, poor regulatory systems and policies, and mismanagement of antivenom. This study aims to map the evidence regarding snake antivenom regulations globally and identify gaps in the literature to inform future research and policy. This review was conducted using the original Arksey and O’Malley framework by three independent reviewers, and the results were reported using the Preferred Reporting Items for Systematic reviews and Meta-Analysis Extension for Scoping Reviews (PRISMA-ScR). A search strategy was developed with assistance from a librarian, and six databases were searched: PubMed, SCOPUS, ProQuest Central, Africa Wide Web, Academic Search Output, and Web of Science. Screening was conducted independently by the reviewers, using Rayyan, and conflicts were resolved with discussions. A total of 84 articles were included for data extraction. The major themes that emerged from the included studies were regarding antivenom availability, accessibility, manufacturing, and regulations. The study revealed massive gaps in terms of policies governing antivenom management, especially in Asia and Africa. The literature does not offer sufficient evidence on management guidelines for antivenom in the endemic regions, despite identifying the challenges in supply. However, significant information from Latin America revealed self-sufficient production, involvement of national health bodies in establishing efficient regulations, effective distribution nationally and regionally, and technology sharing to reduce SBE-related mortality.

Introduction Snakebite envenomation has been declared a neglected tropical disease by the WHO since 2017. The disease is endemic in affected areas due to the lack of availability and access to antivenom, despite it being the standard treatment for snakebites. This challenge is perpetuated by the shortcomings of the regulatory systems and policies governing the management of antivenoms. This study aims to map the evidence about regulations of snake antivenom globally and identify gaps in the literature. This protocol provides an overview of the methodology and analysis which will be used to conduct the scoping review. Method and analysis The scoping review follows the guidelines from the Arksey and O’Malley framework for scoping reviews and will be reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. A search strategy was developed with assistance from a health sciences librarian, and the search was done using six relevant databases. The databases used are PubMed, SCOPUS, ProQuest Central, Africa Wide Web, Academic Search Output and Web of Science. Articles in the English language and between 2009 and 2023 were included. The search results were collated, duplicates were removed and results were exported to Rayyan (https://www.rayyan.ai/) for screening. The initial screening for titles and abstracts is currently in progress, and thereafter the second round of screening will be done for full texts. Data extraction will be done using Google Forms. The results of the review will be synthesised using quantitative and qualitative tools. Ethics and dissemination This review will provide guidance for studies investigating regulatory gaps globally and inform future policies governing antivenom management. Ethics approval for the complete postgraduate project was obtained from the University of Pretoria Research Ethics Committee. The review will be published in a scientific journal, and findings will also be disseminated using conference presentations. Trial registration This review has been registered on Open Science Framework (OSF): https://osf.io/54zja.

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