Parental reporting of suspected adverse drug reactions in children in Lagos, Nigeria

Objectives:To determine the feasibility of parental reporting of suspected adverse drug reactions (ADRs) to community pharmacies in Nigeria.Methods:Fifteen registered pharmacies were randomly selected in Lagos, Nigeria. Caregivers who procured antibiotics, antimalarials, paracetamol or ibuprofen for a child up to 12 years of age in these pharmacies between July and September 2007, were asked to report suspected ADRs in their child by filling in a questionnaire given to them by the pharmacist. If the caregivers suspected an ADR within 5 days of administering the medicine, they were asked to return the questionnaire within the following 7 days.Results:9023 drugs were procured for 2868 children (1807 (63%) of whom were male) and 689 (8%) of these drugs were administered by injection. Antibiotics (1975, 24%) were the most frequently procured type of drug of the four groups surveyed (antibiotics, antimalarials, paracetamol and ibuprofen) and chloroquine (445, 46%) was the most frequently procured antimalarial. 509 (18%) caregivers reported 575 suspected, mostly mild, ADRs (509 to antibiotics, 42 to antimalarials and 24 to analgesics). The two most frequently reported suspected ADRs were diarrhoea in 292/575 (51%) children and skin rashes in 103/575 (18%). The overall prevalence of ADRs in these children was 509/2868 (18%).Conclusion:Parental reporting of suspected ADRs to antibiotics, antimalarial and analgesics in their children is feasible in Nigeria. This method of pharmacovigilance should be used more extensively.