Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Viviane Jusot (), Frider Chimimba, Nettie Dzabala, Olga Menang, Joy Cole, Gregory Gardiner, Opokua Ofori-Anyinam, Olakunle Oladehin, Cecilia Sambakunsi, Mphatso Kawaye, Jens-Ulrich Stegmann and Yolanda Guerra Mendoza
Additional contact information
Viviane Jusot: GSK
Frider Chimimba: University of Malawi
Nettie Dzabala: University of Malawi
Olga Menang: PATH
Joy Cole: GSK
Gregory Gardiner: GSK
Opokua Ofori-Anyinam: GSK
Olakunle Oladehin: GSK
Cecilia Sambakunsi: Pharmacy Medicines and Poisons Board
Mphatso Kawaye: Pharmacy Medicines and Poisons Board
Jens-Ulrich Stegmann: GSK
Yolanda Guerra Mendoza: GSK

Drug Safety, 2020, vol. 43, issue 6, No 9, 583-593

Abstract: Abstract 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.

Date: 2020
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-020-00925-4 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:43:y:2020:i:6:d:10.1007_s40264-020-00925-4

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-020-00925-4

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().