Pharmacovigilance: Adverse drug reactions (ADRs) in pediatric patients in Ethiopia. Retrospective study

Objective: To Characterize spontaneously reported pediatric adverse drug reactions (ADRs) in Ethiopia. Method: The detail of reported pediatric ADRs data to Ethiopian national Pharmacovigilance (PV) center during the 5year period (May/2014 to 2019) was collected. Data collection was done using the suspected ADRs reporting form and a retrospective analysis was done after excluding incomplete data's. The data were analyzed in respect of age, sex, rate of reporting, suspected ADRs, suspected drugs, seriousness, onset and outcome. Result: Pediatric ADRs reporting rate was 0.9 per million children per year. A total of 218 reports containing 294 suspected drugs, 460 ADRs and 354 affected body systems (SOCs) were reported from government and private health facilities. Out of which, 53.6% were females. A majority, 201 (92.2%) and 166 (76%) reports were submitted by government health facilities and pharmacists respectively. >75% of ADRs affecting the skin, general disorders and nervous system. >75% of drugs associated with ADRs were anti-infective drugs 206 (70%) followed by nervous system drugs 20 (6.8%). Among anti-infective drugs, antibiotics, antiretroviral and ant-tuberculosis drugs represented 97% of drugs responsible for ADRs and 25% of ADRs were serious. Conclusion: Pediatric ADRs reporting rate was very low and public health program medicine safety monitoring is inadequate in Ethiopia. This suggests that the ADRs monitoring system was generally weak. Anti-infective drugs and nervous system drugs were responsible for the majority of ADRs and for all reported fatalities. The most common adverse reactions in pediatrics were skin disorders.