Search

Introduction: Pharmacovigilance (PV) in sub-Saharan Africa relies on passive surveillance but underreporting of adverse events (AEs) by health care professionals (HCPs) is a major challenge. A PV enhancement project was implemented to address this in Côte d'Ivoire. Objective: To improve safety surveillance of medicines through PV training and mentoring of HCPs in selected health care facilities (HCFs). Methods: This collaborative project between national PV stakeholders, GSK, and PATH was implemented from September 2018 to February 2020 in Abidjan region, Côte d'Ivoire. Trained PV focal points provided training and regular mentoring of HCPs. Key performance indicator (KPI) categories for AE reporting were the volume of AE reports, efficiency of report transmission and data entry, quality of reports, and quality of the central (Vigilance Unit) response to AE reports. Results: Overall, 1427 HCPs at 91 HCFs were trained. In the 8 months before implementation, 33 AE reports were received versus 85 after 3 months and 361 after 18 months of implementation (71 [83.5%] and 278 [77.0%], respectively, from Abidjan). The KPIs with the highest proportions were: AE reports received centrally (100%), complete AE reports (69.0%), AE reports entered into the local PV database within 48 h (99.6%), and AE reports entered into the global database, VigiBase (86.7%). Report notification within 72 h, causality assessment, and serious AE reporting had proportions below 20%; feedback to reporters was provided for only 0.4% of reports. Conclusion: Regular PV trainings and mentoring improved AE reporting in Côte d'Ivoire but further enhancement is required to improve passive safety surveillance. Plain Language Summary: Medicines and vaccines should be safe and effective for use in the general population. Health care professionals therefore have the responsibility to continuously monitor medicinal products and report any unwanted medical occurrence (adverse event). Training and mentoring of health care professionals can improve adverse event reporting. In Côte d'Ivoire, a training and mentoring project was implemented by GSK, PATH (a non-governmental organisation), and the Ministry of Health, with the objective of increasing adverse event reporting. Over the period of 18 months, 1427 health care professionals from 91 health care facilities in the Abidjan region received training and mentoring. Between January and August 2018, before the project began, 33 adverse event reports were submitted at the central level (to the country's Vigilance Unit), with 11 (33.3%) from the Abidjan region. From September to December 2018, the first three months of project implementation, 85 reports were received, with 71 (83.5%) coming from the Abidjan region. This number increased to 361 by the end of the 18-month project, with 278 (77.0%) coming from the Abidjan region. Training of health care professionals therefore improved adverse event reporting, mainly from the Abidjan region but also nationwide. Assessments of the efficiency of adverse event reporting and the quality of adverse events reports received by the Vigilance Unit showed promising results, although there was room for improvement. Lessons learned from this project can flexibly serve the needs of other countries with less functional systems for reporting adverse events associated with medicinal products. [ABSTRACT FROM AUTHOR]