Pharmacovigilance reporting during seasonal malaria chemoprevention campaign: Findings from northern Nigeria

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, success intervention may be adversely affected by absence a robust pharmacovigilance system monitor safety. This paper aims describe our reporting experience during campaigns conducted across seven states Nigeria 2020. The SMC were held over four cycles from July November 2020, with nearly 12 million eligible reached trained community drug distributors. Suspected adverse reactions reported routinely through national (PV) system. Completed PV forms submitted National Agency for Food, Drugs Administration Control retrieved analyzed. reaction (ADR) was low, no ADR reports five states. ADRs included abdominal pain, weakness, diarrhea, fever, rash, vomiting. Vomiting most ADR, accounting almost half (28/57) all cases. Children 12–59 accounted (?86%, 49/57) reports, 70% (40/57) these completed health extension workers. organ classification showed that gastrointestinal mainly (65%, 37/57). Our suggests gaps surveillance system, highlighting need consider an active address behavioural factors, explore use digital