Parental Reporting Of Suspected Adverse Drug Reactions In Children

Abstract

Objective: This study aimed to assess the viability of parents reporting suspected adverse drug reactions (ADRs) to community pharmacies .

Methods: Fifteen registered pharmacies were randomly selected  Caregivers who purchased antibiotics, antimalarials, paracetamol, or ibuprofen for children up to 12 years old from these pharmacies between July and September 2007 were asked to report any suspected ADRs in their child by completing a questionnaire provided by the pharmacist. If caregivers suspected an ADR within 5 days of administering the medicine, they were requested to return the completed questionnaire within the following 7 days.

Results: A total of 9023 drugs were purchased for 2868 children, with 1807 (63%) being male, and 689 (8%) of the drugs were administered by injection. Antibiotics (1975, 24%) were the most frequently purchased drugs among the surveyed categories (antibiotics, antimalarials, paracetamol, and ibuprofen), with chloroquine (445, 46%) being the most commonl[1]y purchased antimalarial. Among the reported drugs, 509 (18%) caregivers reported 575 suspected ADRs, primarily mild ones (509 related to antibiotics, 42 to antimalarials, and 24 to analgesics). The most commonly reported suspected ADRs were diarrhea 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: The study concludes that parental reporting of suspected ADRs related to antibiotics, antimalarials, and analgesics in their children is feasible . This approach to pharmacovigilance should be expanded and utilized more extensively.