ArticleDrug safety2020
Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi.
Article in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 24 citations in OpenAlex.
- Article
- Developing a surveillance system for HIV pre-exposure prophylaxis (PrEP) use in pregnancy in Malawi.BMC pregnancy and childbirth · 2026Article
- Quality and Timeliness of Pharmacovigilance Reporting in Malawi: A Cross-Sectional Analysis of Individual Case Safety Reports.Drug, healthcare and patient safety · 2026Article
- Evaluating the effectiveness of AI-enhanced "One Body, Two Wings" pharmacovigilance models in China: a nationwide survey on medication safety and risk management.Frontiers in health services · 2025Article
- Building functional and sustainable pharmacovigilance systems: an analysis of pharmacovigilance development across high-, middle- and low-income countries.Therapeutic advances in drug safety · 2025Article
- Short-Term Training, a Useful Approach for Sustainable Pharmacovigilance Knowledge Development in Tanzania, Kenya, Ethiopia and Rwanda.Drug safety · 2024Article
- Training and education in pharmacovigilance: The experience from the Pharmacovigilance Programme of India.Indian journal of pharmacology · 2024Article
- Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK's Training and Mentoring Pilot Project in the Abidjan Region.Drug safety · 2024Article
- Adverse Drug Reactions Related with Antibiotic Medicines in Malawi: A Retrospective Analysis of Prevalence and Associated Factors.Drug, healthcare and patient safety · 2024Article
- Strategies and interventions to strengthen pharmacovigilance systems in low-income and middle-income countries: a scoping review.BMJ open · 2023Article
- Article
- Drug Safety Monitoring in Health Programs of Cameroon.Journal of pharmacovigilance · 2022Article
- Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa.BMC public health · 2022Article
- Burden of and factors associated with poor quality antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi.PloS one · 2022Article
- Considerations for Establishing Successful Coronavirus Disease Vaccination Programs in Africa.Emerging infectious diseases · 2021Review
Corrections and comments
- Erratum issued
Authors and funding
12 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
objectiveThe objective of this initiative was to improve reporting of adverse events (AEs) by strengthening passive safety surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare facilities (HCFs).
methodsAn 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders, and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representatives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of reports, serious AEs reported and timeliness of recording into VigiFlow.
resultsIn 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter, event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
conclusionRegular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi, but the transmission of reports to the national PV centre requires further improvement.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.