Adverse Effects from Antibiotics for Acute Respiratory Tract Infections in Children: Comparison of Two Data Sources

BACKGROUND: Outpatient acute respiratory tract infections (ARTIs) account for the majority of antibiotic exposure in children. Thus, is is essential to understand the outcomes and adverse effect profiles of different therapeutic approaches to managing these common infections. In a study comparing the effectiveness of narrow- and broad-spectrum antibiotics for treatment of ARTIs, we compared rates of adverse effects reported by patients to rates obtained by the electronic health record. METHODS: We used a retrospective cohort and a prospective cohort, both of which included children treated with antibiotics for an ARTI (acute otitis media, Group A streptococcal pharyngitis, acute sinusitis) in a network of 31 pediatric primary care practices. In the retrospective cohort, adverse drug effects including diarrhea, candidiasis, non-candida rash, other allergic reaction, vomiting, and unspecified adverse effects were identified by ICD codes from the electronic health record (EHR). In the prospective cohort, a stratified sample of caregivers were contacted by telephone to complete two structured interviews, one at 5–10 days and one at 14–20 days post diagnosis. At the second interview, the caregiver was asked about the occurrence of diarrhea, rash, upset stomach and vomiting. Propensity-score based full matching was conducted to obtain estimates adjusted for patient and provider characteristics. RESULTS: Overall, 1038 (3.5%) of the 30086 children in the restrospective cohortexperienced an adverse effect that was captured in the EHR. and 599 (28%) of the 2085 children included in the prospective cohort reported an adverse effect. See the table for analysis results. CONCLUSION: Narrow-spectrum antibiotics were associated with a reduced risk of adverse effects compared with broad-spectrum antibiotics in both cohorts. The rate of adverse effects observed in EHR data was nearly 10-fold lower than the rate of patient-reported adverse effects. DISCLOSURES: T. Zaoutis, Astellas: Consultant, Consulting fee; Merck: Grant Investigator, Research grant; nabriva: Consultant, Consulting fee