Strategies and interventions to strengthen pharmacovigilance systems in low- and middle-income countries: a scoping review

Introduction In the past decades, numerous strategies have been proposed to strengthen pharmacovigilance (PV) systems in low-and-middle-income countries (LMIC). Though there has been progress, many PV systems in LMIC are still not performing adequately. The objectives of this scoping review are to describe strategies to strengthen PV in LMIC and to propose recommendations for future investments in capacity building. Methods The review was conducted following the Joanna Briggs Institute (JBI) guidelines on conducting scoping reviews. Literature searches were performed in MEDLINE, EMBASE, Web of Science, PDQ-evidence, CINAHL and relevant websites from 1990 to January 2021. Publications included were primary studies, articles, and policy and guideline papers, describing interventions to strengthen PV in LMIC. Two reviewers independently screened titles, abstracts and full-texts, and one reviewer performed data extraction and carried out a descriptive data analysis. Results 10,903 unique titles were screened and 152 were eligible for full text review. Of these, 57 and an additional 13 reports from grey literature fulfilled eligibility criteria for inclusion in the review. Forty-five papers (64%) described interventions aimed at increasing PV knowledge and reporting of adverse drug reactions (ADR), primarily education of healthcare professionals (HCP), alone or in combination with other interventions such as mobile and electronic reporting, enhanced passive and active surveillance. Twenty-five papers (36%) discussed interventions or strategies implemented at the national targeting different components of the national PV system, such as legal basis and guidelines for PV, PV organisation and infrastructure and PV procedures. Conclusions Results of this review suggest that educating HCP on ADR reporting is the most common approach to build PV capacity in LMIC. Though important, education alone is insufficient and should ideally be organised within the holistic framework of strengthening national PV systems, with a focus on building capacity for advanced activities such as signal detection. Key message There are numerous strategies and recommendations to strengthen PV systems in LMIC. However, the effective implementation of these strategies has not been extensively described in literature. This scoping review describes different interventions and strategies that have been implemented to build and improve PV capacity in systems in LMIC. An overview of current PV strengthening strategies and interventions, and when available, their outcome and impact, is useful to guide decision making for future investments in PV development in developing countries. Trial registration Open Science Framework () ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present work are contained in the manuscript and in the additional file