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. 2023 Sep 14;13(9):e071079. doi: 10.1136/bmjopen-2022-071079

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

Olga Menang 1,2,✉, Andrea Kuemmerle 1,2, Karen Maigetter 1,2, Christian Burri 1,2
PMCID: PMC10503375  PMID: 37709326

Abstract

Objectives

The slow progress of pharmacovigilance (PV) in low-income 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, 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 other relevant websites from January 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: (1) 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 and (2) 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 also building capacity for advanced activities such as signal detection.

Keywords: adverse events, public health, therapeutics, health policy

STRENGTHS AND LIMITATIONS OF THIS STUDY.

  • To the best of our knowledge, this scoping review is the first to describe the strategies and interventions to improve pharmacovigilance capacity in low-income and-middle-income countries.

  • We conducted a comprehensive literature search of multiple electronic databases and merged the evidence with that identified in grey literature.

  • Our scoping review conformed to the methodologically rigorous methods manual by the Joanna Briggs Institute.

  • A limited search of selected national regulatory websites was conducted, because an extended search of national regulatory authorities websites would have required significant resources, beyond the scope of this research.

Introduction

Several low-income and middle-income countries (LMIC) are projected to receive novel vaccines and medicines in the coming years, some of which target diseases endemic in LMIC, for example, malaria, dengue and Ebola. Therefore, pharmacovigilance (PV) systems in these countries must be efficient and functional, in order to effectively monitor the safety and effectiveness of these novel products. In the past three decades, several global and local initiatives have aimed at building PV capacity in LMIC. Earlier assessments of PV systems in LMIC showed that only few countries had performing PV systems that could detect, evaluate and prevent medicine safety issues.1 2 Though more recent evaluations show important improvements,3 4 a majority of national regulatory authorities (NRA) in LMIC have not yet attained World Health Organisation (WHO) Global Benchmarking Tool (GBT) performance maturity level 3 (stable, well-functioning and integrated regulatory system) and level 4 (regulatory systems operating at advanced level of performance and continuous improvement).5

There have been several initiatives aimed at strengthening PV in LMIC in the past decades. In 2011, the WHO Global Vaccine Safety Blueprint (GVSB 1.0) proposed a three-part strategy for building vaccine PV: (1) build minimum capacity for passive vaccine safety surveillance in all countries, (2) build enhanced capacity for active surveillance in countries where newly developed vaccines will be introduced and (3) establish a global vaccine safety support structure.6 In 2013, a five-part PV enhancement strategy was proposed in a report submitted to the Safety and Surveillance Working Group of the Bill & Melinda Gates Foundation: (1) focus on a global health product pipeline, (2) implement a risk-based prioritisation of candidate drugs and vaccines, (3) invert the current capacity building paradigm, (4) incorporate sustainability from outset and (5) plan scalability.2 In 2021, the WHO GVSB 2.0 proposed to move from minimal and enhanced capacity concept proposed in GVSB 1.0 to maturity levels, using a scale of 1 (least developed) to 4 (regulatory system operating at advanced level), to assess the level of development of monitoring and regulatory systems.7

The slow progress of PV in LMIC not only raises questions about core challenges on the growth of PV, but also about the appropriateness of strategies and interventions used so far to develop PV. Describing these strategies and if possible, their outcomes, would be useful to guide decision making for future national PV strengthening initiatives. There have been only few scoping and systematic reviews on topics related to PV globally. These include reviews on interventions to improve adverse drug reactions (ADR) reporting among healthcare professionals (HCP)8 9 and the use of social media for PV.10 11 However, these reviews were not solely focused on LMIC and did not describe a holistic approach to developing PV in LMIC. Therefore, the objectives of the current scoping review are to describe strategies and interventions that have been implemented to strengthen national PV systems in LMIC and to recommend areas for future investments in capacity building. As PV systems in LMIC continue to mature, supported by multilateral agencies and donors, synthesised information on different enhancement approaches will be useful to national and global PV stakeholders, to support the development of functional and sustainable PV systems.

Methods

Research questions

  1. What interventions and strategies have been used to build national PV systems in LMIC in the last three decades and what are the outcomes?

  2. What are the major challenges encountered using these approaches?

  3. What are the lessons learnt and what recommendations can be made to policy-makers for developing PV in LMIC?

Study design

The scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews12 and conformed with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews).13 The protocol was developed according to the JBI scoping review template and was registered with Open Science Framework.

Eligibility criteria

The eligibility criteria were publications, peer-reviewed papers and policy papers within the last 30 years (1990–2021) that described strategies and intervention to establish or strengthen national PV systems in LMIC. Also included, were reports describing the capacity of national PV systems, if these included interventions to develop PV, and articles that described national PV systems and governance. Articles not specific to a LMIC, studies related to medicine-specific adverse events (AE) and data published before 1990 were excluded.

Information sources

This scoping review included primary research, both qualitative and quantitative, which described interventions or strategies to strengthen PV capacity, as well as policy and guideline papers from NRA. Literature searches were performed in MEDLINE, EMBASE, Web of Science, CINAHL and PDQ-Evidence. Sources of grey literature included Google Scholar, websites of technical agencies such as WHO and websites of selected NRA. A selection of NRA websites was necessary; because this scoping review was undertaken in the context of the PhD thesis of the first author. Therefore, NRA websites of countries initially identified to participate in the PhD research were prioritised for inclusion in the scoping review.

Search strategy

An initial limited search of MEDLINE, EMBASE, Epistemonikos, JBI Database of Systematic Reviews and Implementation Reports and Web of Science was undertaken to identify articles of interest. A librarian used text words contained in the titles and abstracts of relevant articles and the index terms used to describe these articles, to develop a full search strategy in MEDLINE (online supplemental appendix I: Search strategy in Ovid MEDLINE). This search strategy was adapted for each database cited above using the Polyglot Search Translator.14 A simpler search strategy was used to search Google Scholar. A grey literature search was conducted according to the Canadian Agency for Drugs and Technologies in Health Guide15 (online supplemental appendix II: Sources of grey literature search).

Supplementary data

bmjopen-2022-071079supp001.pdf (976.7KB, pdf)

Study selection

Identified citations from the searches were collated and uploaded into EndNote V.X9.3 (Clarivate Analytics, Pennsylvania, USA) and duplicates removed. To facilitate study selection, a decision tree was developed and tested by two reviewers (OM and AK), on a random sample of 100 titles and abstracts. Three batches of 100 titles and abstracts were tested until both reviewers agreed on the selection. OM reviewed 100% of titles and abstracts while AK reviewed 15%, as selected titles and abstracts were similar for both reviewers for the first 1500 titles and abstracts screened. Two batches of 10 full-text articles were tested until agreement on article selection; both reviewers reviewed all full texts selected at title and abstract screening. The results of the search and the study inclusion process were reported in full and presented in a PRISMA-ScR flow diagram.13

Data extraction

Data were extracted using a data extraction tool developed for the purpose by the reviewers (online supplemental appendix III: Data extraction instrument). Extraction parameters included the author, year of publication, nature and description of the intervention, the outcome, the challenges encountered and the lessons learnt. Extracted data were reviewed by AK and a third reviewer, KM, and was revised as needed.

Data analysis and presentation

The extracted data were presented in a descriptive summary aligned with the objectives of the review. Data were analysed by the nature of intervention, the outcome of the intervention, the challenges encountered and the lessons learnt and recommendations. Risk of bias or quality appraisal across studies was not conducted, which is consistent with the JBI Methods Manual, because the scoping review method is not intended to be used to critically appraise (or appraise the risk of bias of) a cumulative body of evidence.13

Patient and public involvement

Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research.

Results

Study selection

The study selection flow diagram is presented in figure 1. A total of 10 922 unique titles were screened, of which 152 articles were selected during title and abstract screening. Of these 152 articles, 57 articles and an additional 13 articles from Google Scholar and grey literature searches fulfilled eligibility criteria for inclusion in the review (figure 1). Online supplemental appendix IV: Articles excluded on full text provides citation details of papers excluded on full-text examination and reasons for their exclusion.

Figure 1.

Figure 1

Open in a new tab

PRISMA flow diagram—selection of relevant records. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PV, pharmacovigilance.

Nature and outcome of identified interventions and strategies

The regions and countries of papers included in the analysis of this review are presented in online supplemental appendix V: Regions and countries. Papers from East Asia Pacific region, Europe and Central Asia, Latin America and the Caribbean, Middle East and North Africa, South Asia, Sub-Saharan Africa and papers providing global/LMIC recommendations were included. Strategies and interventions identified to strengthen PV systems in LMIC were divided into two categories: (1) Interventions aimed at increasing PV knowledge and reporting of AE (ADR or adverse events following immunisation (AEFI)) and (2) Interventions aimed at building or strengthening various components of the national PV system. Details of each intervention are provided in online supplemental appendix VI: Nature of interventions and outcomes.

Interventions aimed at increasing PV knowledge and AE reporting

Forty-five papers described interventions aimed at increasing HCP PV knowledge and reporting of ADR or AEFI. These included educational interventions (lectures or workshops), alone or in combination with other interventions such as mobile and electronic reporting, enhanced passive and active surveillance or providing financial incentives.

Educational interventions

Although all publications included in the analysis had an educational component, 21 out of 70 (30%) reported exclusively educational or training workshops, aimed at educating and sensitising HCP on AE reporting and PV. Primarily provided by health institutions, these interventions were not reported as part of a broader PV strengthening scheme. The format, content and duration varied, with duration ranging from 45 min16 to several days.17 For a majority of these interventions, the content was information on ADR reporting and raising awareness on PV. In some cases, educational material such as handouts and job aids were distributed. Some interventions included practical sessions on completing AE reporting forms,18 feedback or reminders to HCP,19 and follow-up contacts to assess changes in AE reporting20 or to address any challenges encountered.21

There was an increase in the knowledge, attitude and practice skills of PV and ADR reporting rates for most educational interventions. After interventions, some papers reported a 12-fold increase in the number of ADR reported and an increase in the quality of ADR,22 or a 14-fold increase in ADR reporting,19 or as high as a 70-fold increase in the number of ADR reports.18 Only very few papers reported a small impact of education training. One of these was the training of naïve HIV-positive patients with limited literacy to identify and report ADR using pictorial representation.23

Mixed interventions

Eleven papers reported education in combination with other interventions such as financial incentives and changes in institutional ADR reporting policies. Two papers described provision of financial compensation (in addition to other changes) as an incentive for reporting ADR in a hospital setting. For the first, ADR increased from 29 at preintervention, to 277 at first intervention and to 666 at second intervention period, with an increase in the quality of reports.24 For the second, ADR increased from 577 to 832 after intervention, with an increase in reporting of serious ADR and improvements in reporting compliance.25

Other interventions included follow-up visits,26 providing feedback to HCP on ADR reporting and reviewing the quality and completeness of ADR27 or distributing standard operating procedures on ADR reporting, improving reporting mechanisms and supervisory visits.28 In Mozambique, in addition to training workshops on PV, a ‘yellow card’ system for spontaneous reporting of ADR was implemented, a district focal person to facilitate communication between the health staff and the PV unit was designated and after 5 months, HCP were retrained to reinforce learnings from the first workshop.29 These papers also reported an increase in PV knowledge and number of ADR reported.

Mobile phone and electronic reporting

Seven papers in this review described the use of mobile phones, mobile applications and electronic reporting platforms as mechanisms to increase AE reporting. For example, in Rwanda, patients were educated to report ADR using mobile phones either by accepting a call from physicians or by calling physicians directly. Compared with the previous months where no ADR were reported, 34 patients reported an ADR after intervention.30 Likewise, in Cameroon, 20 AEFI were received from a group reporting with a mobile phone, compared with 1 AEFI from the group reporting physically at the health facility.31 Other papers reported the development of mobile applications for reporting ADR32 and supporting ADR evaluation and causality assessment.33

At the national level, in Brazil, the national electronic reporting system, Notivisa, was replaced by VigiFlow and implemented at all levels of the health systems including a module for the public and another for industry. HCP were trained on PV during the process and the new tool was promoted through different platforms, resulting in a 62% increase in ADR received by Anvisa compared with the same period for the previous year, including reports from the public.34 Likewise, Mexico implemented VigiFlow, and e-reporting throughout the country, enabling ADR reporting from health services and industry, as well as analysis of safety data.35

Passive and active surveillance

Six papers in the current review reported implementation of enhanced passive and/or active surveillance, primarily during new product introduction, as mechanisms to increase reporting and collect more reliable PV data. These papers reported an increase in the number, timeliness and quality of ADR collected,36–38 even though one paper reported that the numbers reduced in subsequent months.39

Interventions aimed at strengthening various components of the national PV system

Twenty-five papers discussed interventions or strategies implemented at the national level that aimed to strengthen different components of the PV system. For example, PV in India was implemented in a stepwise approach, targeting different components and stakeholders of the PV systems. These steps included: (1) development and revision of PV guidelines; (2) establishing and training national safety and AEFI committees; (3) setting up regional ADR monitoring centres; (4) developing communication tools and guidelines; (5) integrating PV in public health programmes (PHP); (6) Android mobile application and toll-free helpline to enable reporting of ADR and (7) safety communication to stakeholders and the public through different media.40–42 A similar comprehensive approach was reported in Vietnam, and within 7 years of the creation of the national PV centre, both the quality and the quantity of ADR improved.43

In Malawi, the national PV system was enhanced through a combination of strategies targeting the PV organisation and infrastructure, PV procedures and AE reporting, national coordination of PV activities and training of PV personnel and HCP. During 18 months of implementation, 443 HCP at 61 healthcare facilities were trained in PV and the ADR and AEFI increased from 22 at preintervention to 228.44 Other interventions identified at the national level included creation of the national PV centre, integrating PV in curriculum of medicine, pharmacy and dentistry schools, building collaborations between NRA and PHP,45 development of PV policies and tools, and establishment and training of national safety review committees.46

In 2019, the National Drug Authority of Uganda published a 5-year (2018–2022) strategic plan to develop PV. The plan defined four strategic areas of development: (1) build PV infrastructure and technical capacity; (2) PV policy enhancement; (3) collaboration and information exchange and (4) visibility and awareness of PV and safety related information.47 In 2020, the Nigerian National Pharmacovigilance Policy was revised, providing a framework for the implementation of the policy, covering the entire scope of PV, including stakeholders, institutionalisation of PV policy documents, PV structures, human resources, industry, funding and monitoring and evaluation.48 In Namibia, results of a qualitative survey recommended several strategies for the integration of PV systems in public health: (1) enhancing reporting by integrating PV into the daily practice of HCP; (2) establishing policies addressing PV activities; (3) capacity-building through continuing professional education and support, advocacy, stakeholder engagement; (4) incentivising and recognition for PV performance and (5) facility-based policies for universal and inclusive reporting.49

This review also identified global recommendations on strengthening national PV systems. These included WHO’s Project 3-S (Smart Safety Surveillance), aimed at optimising post marketing surveillance of priority medicines and vaccines in LMIC. Six core strategies were proposed: (1) adopt a stepwise approach with an initial pilot for three new products; (2) leverage available resources from WHO partners and national PV centres; (3) partnership with industry; (4) develop a holistic country plan for PV as part of medicines regulation; (5) collaboration with other global initiatives and (6) build PV infrastructure progressively, from minimum to mid-range and advanced capacity.50 In 2018, Elshafie et al proposed different strategies to encourage the introduction and sustain the advancement of robust PV systems in developing countries: (1) enhancing spontaneous reporting through a combination of interventions; (2) training HCP and incorporation PV into educational institutions and curricula of HCP; (3) actively engaging the public to participate in PV; (4) facilitating ADR reporting by simplifying the process and enabling mobile and electronic reporting and enabling adequate data management and communication of safety signals; (5) establish well-organised healthcare systems, with effective policies and strict drug regulations and (6) implement regulations and guidelines for industry.51 Lastly, in 2021, PhArmacoVigilance Africa released the ‘Guide for Effective Implementation of the Pharmacovigilance Policy in Resource Limited Settings’, describing critical steps and actions for effective implementation of a national PV policy: (1) stakeholders’ engagement; (2) statutory endorsement; (3) institutionalisation of the PV policy; (4) addressing the roles and responsibilities of stakeholders and (5) securing funding.52

Main challenges in strengthening PV in LMIC

Underreporting of ADR

Associated with numerous factors including lack of/or inadequate knowledge of reporting procedures, unavailability of reporting forms, lack of motivation, and lack of adequate methods of communication.

Lack of financial and human resources dedicated to PV

Primarily because PV activities in numerous LMIC rely largely on external funds. When these funds run out, PV activities also stagnate.

Insufficient national coordination of PV activities

Inadequate collaboration and coordination and conflict of interest between major national PV stakeholders hinders PV development.

Sustainability of interventions

Interventions were not sustained, because often, there were no long-term plans and continuous funding. Only few publications mentioned retraining of HCP, mentorship and supervisory visits and these often come at a cost.

Discussion

This scoping review is the first, to the best of our knowledge, to describe the strategies and interventions to improve PV capacity in LMIC in the last three decades. The main strategies identified were as follows:

  1. Educating HCP (and increasingly patients/consumers) on PV and reporting of ADR.

  2. Facilitating reporting of ADR using different mechanisms such as mobile and electronic reporting, enhanced passive and active surveillance.

  3. Integrating PV in PHP and developing mechanisms for coordination and information exchange.

  4. Establishing and training national safety committees and developing capacity for data analysis.

  5. Developing PV policies, guidelines and tools.

  6. Integrating PV in curriculum of HCP.

Two-thirds of papers identified in this review described interventions aimed at improving ADR reporting. Educating HCP on PV and ADR reporting is an effective method to change their attitude towards reporting, and provides them with an understanding of the ADR reporting process and other issues associated with under-reporting of ADR, such as fear of litigation.53 54 It is not surprising, therefore, given the major role played by HCP in reporting of ADR, that a majority of interventions identified in this review had an educational component. Findings revealed that these PV educational or training workshops were very effective in improving PV knowledge with a corresponding increase in the number and quality of ADR reports. This is in line with numerous previous scoping or systematic reviews aimed at mapping interventions to improve ADR reporting among HCP.8 9

Several papers also described training of other PV stakeholders such as the national safety review committees46 55–58 and consumers.30 37 59 60 National safety review committees perform causality assessments of serious cases and support analysis of national PV data. Nevertheless, the timing of the causality assessment is important and their work is dependent on stable funding. ADR from patients and consumers are an important source of information on the safety and effectiveness of medicines and provide useful information for improving drug safety and healthcare from a different perspective.61 Consequently, there is a global trend towards educating and empowering patients and consumers to report ADR, and studies have established the significant contribution of consumer reporting to signal detection.60 62 63 Educating HCP and other PV actors on different aspects of PV and ADR reporting remains an essential aspect of building national PV capacity and numerous organisations and NRA provide diverse PV training programmes. These types of interventions are often simple to implement and can attain HCP at all levels of the health system. However, mechanisms for measuring their long-term impact are needed and there is a need for retraining and continuous education to sustain acquired knowledge. Several papers in this review showed that the increase in ADR observed after the intervention periods was not sustained in subsequent months,18 22 39 and only few publications mentioned retraining of HCP,29 mentorship44 and supervisory visits28 45 64 as part of the interventions.

Electronic reporting of ADR is one of the main strategies used globally to improve spontaneous reporting of ADR by HCP.65 In many developed countries, patients and consumers can directly report ADR through web-based platforms. As seen in this review, NRA in LMIC are also moving towards implementing web-based electronic reporting and data management platforms such as VigiFlow34 35 to handle data at the national level. Likewise, mobile phones and mobile phone applications are increasingly used to expand and facilitate ADR reporting by HCP as demonstrated by several papers in this review.32 33 36 39 64 Enhanced passive and active surveillance are PV methods usually implemented during new medicines introduction, to increase and improve the collection and quality of PV data. The introduction of novel vaccines and drugs in LMIC represents an opportunity to strengthen national safety surveillance systems. Significant technical and financial efforts from national and global PV stakeholders are directed towards enhancing national PV systems prior to medicine introduction. In addition to other interventions, training of HCP and sometimes, patients, on PV and ADR is one of the key preparatory activities of vaccine introduction preparations, often implemented through passive, enhanced passive and active surveillance as identified in this review.36 37 39

One of the major challenges reported in this review is the sustainability of PV system activities, primarily related to another challenge, the lack of financial resources, which is in turn related to another challenge, the weak legal framework for PV. In fact, a strong legal basis is essential to allocate and ensure a dedicated budget for PV,66 and often, where there is a dedicated budget, the allocated amount is insufficient, making, a majority of PV activities heavily depend on external funding, especially through PHP.67 This means that PV activities are primarily opportunistic, based on availability of funds and human resources. In addition, due to lack of sustained funding and planning, there is inadequate coordination of PV activities and a high turnover of personnel assigned to PV activities.68 Consequently, PV activities are not sustained and often conducted without long-term strategic plans, as shown during this review, making it difficult to develop and implement a holistic approach to develop the PV system. It is imperative that these challenges are addressed, in order to ensure the steady growth of PV, with a logical progression from basic to fully functional systems.

About one-third of papers identified in this review presented a more comprehensive structured approach to develop national PV systems. When interventions are implemented in a structured manner and are supported by validated tools such as the WHO GBT, different components of the PV system can be systematically strengthened, by formulating institutional development plans that address identified gaps, prioritising interventions and facilitating monitoring of progress and achievements.5 69 As shown in the Results section, the stepwise implementation of PV in India, targeting the key indicators of the PV system,40–42 resulted in the creation of a performant PV system assessed at maturity level 4 for several functions such as clinical trial oversight, marketing authorisation and vigilance. India contributes 3% of ADR to the global safety database, with a completeness score of 0.93 out of 1. Likewise, in Malawi, a stepwise approach targeting different PV components, with the collaboration of different technical agencies, enabled the creation of a national PV system, with guidelines, organisational structure, PV infrastructure and mechanisms for ADR reporting and other PV processes such as active surveillance.44 56 70

Although several papers described different strengthening interventions at the national level with positive results, it was more difficult to identify national strategies with holistic operational plans in line with recent WHO recommendations, such as identified in Uganda,47 Tanzania71 and Nigeria.48 72 A recent publication has described the key strategies, outcomes, challenges and lessons learnt on building Eritrean national PV system. A system’s approach targeting all important aspects of PV was implemented, with adequate legal backing and dedicated human and financial resources. Within 9 years, a fully functional PV system was established, with Eritrea rated among the top reporting countries in Africa and achieving maturity level 3 on the WHO GBT.73 Such strategic documents on strengthening PV systems provide valuable information to national and global PV stakeholders on developing PV systems in LMIC and can be adapted to specific local contexts with feasible operational plans, providing a framework to build, track and continuously improve all components of the national PV system.

Overall, findings from this review revealed similar strategies and interventions aimed at building PV systems across several LMIC. There was a paucity of articles describing capacity building for more advanced PV activities such as establishing quality systems with procedures for aggregate data analysis and signal detection. Nevertheless, the interventions identified in this review, whether alone or in combination, resulted in an improvement in PV capacity, although not necessarily resulting in functional PV systems.

Lessons learnt and recommendations for strengthening PV in LMIC

Continuous HCP education and sensitisation

As revealed in this review, a majority of interventions to improve PV in LMIC were PV training workshops, often single-centre short-term activities. The importance of educating HCP and consumers on PV and reporting of ADR to improve safety surveillance cannot be overemphasised. However, these should ideally be needs-driven, continuous and combined with other activities such as mentoring, supervision and incentivisation (not necessarily financial).

Ensure sustainable financing for PV activities

PV in LMIC is still heavily dependent on external funding and activities are implemented as funding permits. A dedicated budget for PV is essential for long-term planning and sustainability.

Promote digitalisation of ADR reporting

Findings show that digitalising reporting of ADR increased reporting rates, and in some cases, the quality and timeliness of reports. Digitalisation, if successfully implemented, could potentially address under-reporting, especially related to unavailability of reporting tools and complex reporting mechanisms. These electronic platforms could also be used for signal detection and analysis of ADR.

Invest in advanced PV activities

Findings also revealed a gap in more advanced PV activities such as aggregate data analysis, signal detection, active safety surveillance and risk management and communication. With novel medicines increasingly introduced in low-resource settings, effective and adequate safety surveillance will depend on these countries’ capacity for signal detection, analysis and interpretation of safety data. Therefore, building capacity for advanced PV activities is an important area of investment for future PV strengthening initiatives.

Develop holistic PV strengthening plans

Lastly, improving PV systems should ideally be holistic, targeting all components of the PV system, with appropriate stakeholder engagement, plans for sustainability, and procedures to periodically assess improvements with validated tools. The WHO GBT assessments have enabled and motivated countries to develop such holistic system driven improvement plans.

Limitations of the research

This review aimed to identify strategies and interventions to build and strengthen PV systems in LMIC. The search strategy mainly identified interventions aimed at improving ADR knowledge and reporting among HCP, with fewer articles identified on strategic approaches to strengthen national PV systems in LMIC. This is probably because results of such strategies and activities are not often published in scientific literature and are uncommonly publicly available. In addition, there is also a possible publication bias with the effect that only reasonably successful interventions at the national level would likely be submitted for publication. A limited search of selected national regulatory websites was necessary, because an extended search of NRA websites would have required significant resources, beyond the scope of this research, as discussed in the Methods section.

Conclusions

Findings from this review show that a combination of interventions such as education, financial incentives, mobile and electronic reporting, and enhanced passive and active surveillance significantly improved ADR reporting. Educating HCP on PV was the most common approach to build PV capacity in LMIC. However, education alone is insufficient in that it must be continuous, and ideally organised within the framework of strengthening the national PV system. A structured holistic approach, targeting all PV components, with a particular focus on building capacity for more complex PV activities, is judicious and provides a framework to continuously build, track and improve national PV strengthening activities.

Supplementary data

bmjopen-2022-071079supp002.pdf (556.6KB, pdf)

Supplementary data

bmjopen-2022-071079supp003.pdf (753.5KB, pdf)

Supplementary Material

Reviewer comments
bmjopen-2022-071079.reviewer_comments.pdf (268.9KB, pdf)
Author's manuscript
bmjopen-2022-071079.draft_revisions.pdf (5.3MB, pdf)

Acknowledgments

The authors also wish to thank Andy Stergachis (Director, Global Medicines Program & Biomedical Regulatory Affairs Program, University of Washington School of Pharmacy) and Günther Fink (Head, Household Economics and Health System Research Unit, Swiss TPH) for reviewing this manuscript. Thanks to Hannah Ewald (University Medical Library, University of Basel, Switzerland) for advice on the research protocol, developing the search strategy and for conducting the literature searches. Thanks to Niranjan Bhat (PATH) and Emmanuel Mpinga Kabengele (Institute of Global Health at the University of Geneva) for reviewing the scoping review.

Footnotes

Contributors: OM: conceptualisation, data curation, formal analysis, methodology, project administration, resources, visualisation, writing—original draft, writing—review and editing; CB, AK and KM contributed to the study design and the analysis and interpretation of the data. All authors read and approved the final manuscript. CB is responsible for the overall content as guarantor.

Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests: None declared.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review: Not commissioned; externally peer reviewed.

Supplemental material: This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

Data availability statement

Data are available in a public, open access repository. Extra data can be accessed via the Dryad data repository at http://datadryad.org/ with the doi: 10.5061/dryad.5hqbzkh9h.

Ethics statements

Patient consent for publication

Not applicable.

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Data Availability Statement

Data are available in a public, open access repository. Extra data can be accessed via the Dryad data repository at http://datadryad.org/ with the doi: 10.5061/dryad.5hqbzkh9h.

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