Spontaneous adverse drug reaction reporting during the seasonal malaria chemoprevention campaign in 2022

Abstract

Background Seasonal administration of antimalaria drug, sulphadoxine/pyrimethamine plus amodiaquine to children 3–59 months is a malaria preventive intervention used for the reduction of childhood malaria morbidity and mortality in area with highly seasonal malaria transmission like sub-Saharan Africa. This intervention has been deployed in Nigeria and other sub-Saharan African countries for years and may continue for more years to come either alone or combination with other novel interventions. Despite the importance of pharmacovigilance, there is currently a dearth of pharmacovigilance data in most African countries, especially in public health interventions like seasonal malaria chemoprevention campaigns. The availability of quality safety data is likely to improve the acceptability of this preventive intervention. Results The study identified vomiting as the most reported adverse drug reaction. Other reported reactions include weakness, fever, abdominal pain, convulsion, redness of the eyes, swollen hand/face, rash, itching, cough, headache, and excessive salivation. Using Naranjo scale, 69.2% of the reported reactions can be classified as possible; while 29.5% can be classified as probable, only 1.3% is classified as definite. 92.3% of reported adverse drug reactions were from children 12–59 months and 7.7% were from those 3–11 months. The proportion of ADRs classified according to the affected organ/system is as follows: central nervous system (10.26%), gastrointestinal (60.26%), ocular (10.26%), musculoskeletal (7.69%), and dermatological (11.53%). The study also suggests better tolerability to the seasonal malaria chemoprevention medicines with more implementation experience, as states with more implementation experiences reported fewer suspected adverse drug reactions. Conclusions The findings from this study provide additional information on possible adverse drug reactions during seasonal malaria chemoprevention campaigns. This additional information should be communicated to caregivers during the seasonal malaria chemoprevention campaigns as a way of building trust and improving acceptability of the intervention. Also, strengthening of the national pharmacovigilance system is vital to ensure improved timeliness, quality, and quantity of pharmacovigilance reporting on SMC intervention in Africa, as results from the study show low levels of pharmacovigilance reporting across the states.