Pharmacovigilance Reporting During Seasonal Malaria Chemoprevention in Nigeria: Findings From the 2020 Campaign

Abstract

Background Seasonal malaria chemoprevention (SMC) campaign is known to reduce malaria-related morbidity and mortality among children aged 3 -59 months in the Sahel regions of Africa. However, the success of the intervention may be adversely affected by the absence of a robust pharmacovigilance system to monitor safety. This paper aims to describe our pharmacovigilance reporting experience during the campaigns conducted across seven states in Nigeria in 2020. Methods The SMC campaigns were held from July to November 2020 over 4 cycles with about 12 million eligible children reached by trained community drug distributors. Suspected adverse drugs reactions were reported routinely through the national pharmacovigilance system. Completed PV forms submitted to the National Agency for Food, Drugs Administration And Control were retrieved and analyzed. Results The ADR reporting across the seven states was low, with 5 states failing to report any incidence. Abdominal pain, weakness, diarrhea, fever, rash and vomiting were reported, with vomiting being the commonest. Children aged 12-59 months accounted for most (~86%, 49/57) of the reports, with over 70% (40/57) of these reports completed by Community Health Extension Workers. The System Organ Class showed the gastrointestinal system as the most affected (65%, 37/57). Conclusion Our experience suggests potential ADR underreporting from the campaign. The quality and quantity of reports have been identified as a major concern, highlighting the need for active surveillance, strengthen health workers' capacity and the national pharmacovigilance system for optimum ADR reporting.