PMID- 32239447 OWN - NLM STAT- MEDLINE DCOM- 20210715 LR - 20210803 IS - 1179-1942 (Electronic) IS - 0114-5916 (Print) IS - 0114-5916 (Linking) VI - 43 IP - 6 DP - 2020 Jun TI - Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi. PG - 583-593 LID - 10.1007/s40264-020-00925-4 [doi] AB - INTRODUCTION: Pharmacovigilance (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. OBJECTIVE: The 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). METHODS: An 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. RESULTS: In 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. CONCLUSION: Regular 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. FAU - Jusot, Viviane AU - Jusot V AUID- ORCID: 0000-0002-7747-8788 AD - GSK, Wavre, Belgium. viviane.x.jusot@gsk.com. FAU - Chimimba, Frider AU - Chimimba F AD - College of Medicine, University of Malawi, Blantyre, Malawi. FAU - Dzabala, Nettie AU - Dzabala N AUID- ORCID: 0000-0003-3655-0736 AD - College of Medicine, University of Malawi, Blantyre, Malawi. FAU - Menang, Olga AU - Menang O AD - PATH, Geneva, Switzerland. FAU - Cole, Joy AU - Cole J AD - GSK, London, UK. FAU - Gardiner, Gregory AU - Gardiner G AUID- ORCID: 0000-0002-4379-2613 AD - GSK, London, UK. FAU - Ofori-Anyinam, Opokua AU - Ofori-Anyinam O AUID- ORCID: 0000-0001-8099-6837 AD - GSK, Wavre, Belgium. FAU - Oladehin, Olakunle AU - Oladehin O AD - GSK, Lagos, Nigeria. FAU - Sambakunsi, Cecilia AU - Sambakunsi C AD - Pharmacy Medicines and Poisons Board, Lilongwe, Malawi. FAU - Kawaye, Mphatso AU - Kawaye M AD - Pharmacy Medicines and Poisons Board, Lilongwe, Malawi. FAU - Stegmann, Jens-Ulrich AU - Stegmann JU AUID- ORCID: 0000-0002-3792-4368 AD - GSK, Wavre, Belgium. FAU - Guerra Mendoza, Yolanda AU - Guerra Mendoza Y AUID- ORCID: 0000-0002-4001-7662 AD - GSK, Wavre, Belgium. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Drug Saf JT - Drug safety JID - 9002928 SB - IM EIN - Drug Saf. 2021 Jun;44(6):723. PMID: 33788174 MH - *Adverse Drug Reaction Reporting Systems MH - Africa South of the Sahara MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology MH - Health Personnel/*education/organization & administration MH - Humans MH - Malawi MH - Mentoring MH - *Pharmacovigilance MH - Pilot Projects PMC - PMC7235056 OAB - When a medicine or vaccine is made available for use, healthcare organisations maintain regular surveillance to confirm that the medicinal product is safe and effective. The efficiency of this surveillance depends mainly on the healthcare system and medical practices in place in each country. An important element is an effective procedure for identifying and reporting any unwanted medical occurrences (adverse events) after taking a medicinal product. In countries where regular safety surveillance has not been maintained, it is important to train and mentor healthcare providers on the need to be aware of adverse events and the importance of adhering to safety reporting procedures. GSK and partners conducted a pilot project in Malawi with the aim of improving adverse event reporting by training and mentoring healthcare providers. Training sessions and continuous mentoring were conducted over 18 months, involving 443 healthcare providers at 61 healthcare facilities. There was a large increase in the number of adverse events reported: from 22 in the 16-year period before the project started to 228 during the 18-month project period. This project showed that the training and mentoring programme for healthcare providers was effective in increasing the number of adverse events reported. This enabled Malawi to join the World Health Organization's international safety reporting scheme. Other countries facing similar challenges in safety surveillance systems could benefit from a similar approach. OABL- eng COIS- VJ, JC, GG, OO-A, OO, J-US and YGM are employees of the GSK group of companies. OO-A, YGM and J-US hold shares in the GSK group of companies. YGM reports personal fees from GSK, outside the submitted work. CS reports a grant from the GSK group of companies to conduct this study. FC, ND, OM and MK report no conflict of interest. EDAT- 2020/04/03 06:00 MHDA- 2021/07/16 06:00 PMCR- 2020/04/01 CRDT- 2020/04/03 06:00 PHST- 2020/04/03 06:00 [pubmed] PHST- 2021/07/16 06:00 [medline] PHST- 2020/04/03 06:00 [entrez] PHST- 2020/04/01 00:00 [pmc-release] AID - 10.1007/s40264-020-00925-4 [pii] AID - 925 [pii] AID - 10.1007/s40264-020-00925-4 [doi] PST - ppublish SO - Drug Saf. 2020 Jun;43(6):583-593. doi: 10.1007/s40264-020-00925-4.