DOI: 10.5061/dryad.5hqbzkh9h
title: Strategies and interventions to strengthen pharmacovigilance systems in low- and middle-income countries: A scoping review

description: Objectives The slow progress of pharmacovigilance (PV) in
 low-and-middle-income countries (LMIC) raises questions about core
 challenges on the growth of PV, and the appropriateness of strategies used
 so far to develop PV. Therefore, this scoping review aims to describe
 strategies and interventions to strengthen PV in LMIC and to propose
 recommendations for future investments in PV capacity building.  
 Inclusion criteria Publications included were primary studies, articles,
 and policy and guideline papers, describing interventions to strengthen PV
 in LMIC.    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. Two reviewers independently screened titles, abstracts and
 full-texts. One reviewer performed data extraction and descriptive
 analysis, which were reviewed by two other reviewers.   Results
 10,922 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. These were
 grouped into two categories: i) Interventions aimed at increasing PV
 knowledge and adverse drug reactions (ADR) reporting (45 papers),
 primarily education of healthcare professionals (HCP), alone or in
 combination with other interventions such as mobile and electronic
 reporting; ii) Interventions aimed at strengthening various components of
 the national PV system (25 papers), describing strategies or mixed
 interventions implemented at the national level, targeting different
 components of the national PV system.   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.
description: This scoping review included primary research, both qualitative
 and quantitative, that described interventions or strategies to strengthen
 pharmacovigilance (PV) capacity, as well as policy and guideline papers
 from national regulatory authorities (NRA). An initial limited search of
 MEDLINE, EMBASE, Epistemonikos, Joanna Briggs Institute (JBI) Database of
 Systematic Reviews and Implementation Reports and Web of Science was
 undertaken to identify articles of interest. This search strategy was
 defined in MEDLINE and was adapted for each database above using the
 Polyglot Search Translator. The search was performed on 25 Jan 2021 in the
 following databases: Ovid Medline, Ovid Embase, CINAHL via Ebsco, Web of
 Science core Collection, PDQ Evidence. Sources of grey literature included
 Google Scholar, websites of technical agencies such as WHO, and websites
 of selected NRA. A simpler search strategy was defined.
 Identified citations from the searches were collated and uploaded
 into EndNote X9.3 (Clarivate Analytics, PA, USA) and duplicates removed.
 Three batches of 100 titles and abstracts were tested until two reviewers
 agreed on the selection. Two batches of 10 full-text articles were tested
 until agreement on article selection. The results of the search and the
 study inclusion process were reported in full and presented in a Preferred
 Reporting Items for Systematic Reviews and Meta-analyses extension for
 scoping review (PRISMA-ScR) flow diagram (Figure 1: Prisma flow diagram –
 selection of relevant records). Abstracts of articles
 were selected if they met the following inclusion criteria:
 Peer-reviewed papers, and policy papers within the
 last 30 years (1990 to 2021) that described strategies and intervention to
 establish or strengthen national PV systems in LMIC
  Papers describing the capacity of national PV systems if these
 included interventions to develop PV  Articles that
 described national PV systems and governance 
 Data were extracted using a data extraction tool developed for
 the purpose by the reviewers. Extraction parameters included the author,
 country, year of publication, objective of the research, nature and
 description of the intervention, the outcome, the challenges encountered
 and the lessons learnt. The extracted data were presented in a descriptive
 summary aligned with the objectives of the review. 
 Articles were further divided into two categories:
 1) Articles describing interventions aimed at increasing
 pharmacovigilance knowledge and reporting of adverse events.
 2) Articles that described interventions aimed at building or
 strengthening various components of the national PV system.