Evaluation of Pharmacovigilance Systems for Reporting Medication Errors in Africa and the Role of Patients Using a Mixed-methods Approach

Background: Reviewing the epidemiological profile of medication errors (MEs) reported by African countries and the systems put in place to report such errors is crucial because reporting plays an important role in improving patient safety. The objectives of this study were to characterize the profile of spontaneously reported MEs submitted by African countries to VigiBase; the World Health Organization (WHO) global database of individual case safety reports, describe systems in place for reporting these errors, and explore the challenges and facilitators for spontaneous reporting and understand the potential role of patients.

Methods: In the present study, we used, a mixed-methods sequential explanatory design involving a quantitative review of ME reports over a 21-year period (1997-2018) and qualitative interviews with employees from African countries that are members of the WHO Program for International Drug Monitoring (WHO PIDM). Descriptive statistics were used to summarize key variables of interest.

Results: A total of 4,205 ME reports were submitted by African countries to VigiBase representing 0.4% of all reports in the database. Only 15 countries out of the 37 WHO PIDM members from Africa contributed ME to reports, with 99% (3,874) of them reports originating from Egypt, Morocco, and South Africa. The reasons given for low reporting of MEs were weak healthcare and pharmacovigilance systems, lack of staff capacity at the national centers, illiteracy, language difficulties, and socio-cultural and religious beliefs. Some facilitators suggested by the participants to promote reporting included proactive engagement of patients regarding issues relating to MEs, leveraging on increased technology, benchmarking and mentoring by more experienced national centers. Sixteen of the twenty countries interviewed had systems for reporting MEs integrated into adverse drug reaction reporting with minimal patient involvement in seven of these countries. Patients were not involved in directly reporting MEs in the remaining 13 countries.

Conclusions: MEs are rarely reported through pharmacovigilance systems in African countries with limited patient involvement. The systems are influenced by multifactorial issues some of which are not directly related to healthcare.