A descriptive, retrospective analysis of the quality of spontaneous adverse event reporting to the Côte d’Ivoire Pharmaceutical and Regulatory Authority and its impact on the causality assessment

Background: In Côte d’Ivoire, pharmacovigilance is not a routine activity in most healthcare facilities and many healthcare professionals have limited knowledge of pharmacovigilance methods. Objectives: This study aimed to evaluate the quality of adverse event (AE) reports submitted to the central Pharmacovigilance Unit in Côte d’Ivoire and to perform causality assessments (CAs) on each report. Design: This was a descriptive, retrospective analysis of AE reports notified between January 2019 and February 2020 by healthcare providers in Côte d’Ivoire. Methods: We assessed 141 verified reports of suspected adverse reactions to medicines, of which 118 reports were eligible for inclusion in the analysis of report quality using a modified Beckmann method. CAs were performed using the World Health Organization-Uppsala Monitoring Center (WHO-UMC) method and French CA method. Results: Of 118 AE reports, 28 (23.7%) had very good/good quality, 74 (62.7%) were average, 12 (10.2%) had poor quality, and 4 (3.4%) contained insufficient information for assessment. CAs could be performed for all reports except the four with insufficient information (three had no information on patient or suspected drug; all four had no information on the AE), although the reliability of the CA for poor quality reports was questionable. There was no significant difference in distribution of causality ratings calculated by the WHO-UMC method ( p = 0.42) or the French method ( p = 0.91) by report quality. Conclusion: There is underreporting of AEs in Côte d’Ivoire and most AE reports had average quality. The reliability of the CA, irrespective of method used, was dependent on the quality of reporting. Further training and mentoring of healthcare providers are required to increase the number and completeness of AE reports submitted to the central Pharmacovigilance Unit, and thereby directly support more accurate CAs in Côte d’Ivoire.