Affiliations: Department of Pharmacology and Clinical Pharmacy, K.B Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India | Department of Pharmacology, Smt. N.H.L Municipal Medical College, Seth V.S General Hospital, Ellisbridge, Ahmedabad, Gujarat, India
Note: [] Address for correspondence: Mohd Masnoon Saiyed, Department of Pharmacology and Clinical Pharmacy, K.B Institute of Pharmaceutical Education and Research, Gh-6, Sector 23, Gandhinagar-382024, Gujarat, India. Tel.: +91 9662202921; E-mail: [email protected]
Abstract: BACKGROUND: The lack of specific medicines and labeling recommendations for the pediatric population is a long-standing problem. Using data from an observational study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that off-label status is a risk factor for ADRs. METHODS: A prospective intensive surveillance was conducted at a pediatric ward of a public teaching hospital. Adverse events to labeled and off-label use were assessed for incidence, severity and predictors. A multivariate Cox proportional hazards regression model used to assess off-label use is a risk factor for ADR occurring. RESULTS: Off-label and labeled use were responsible for 34 (67%) and 17 (33%) ADRs respectively. Medicines which lacked complete pediatric labeling had the greatest odds for ADRs (9.21% of medicines in this category were implicated, OR 2.84 (95% CI 1.37–7.09). Number of off-label medicines given to patient significantly increased the hazard of an ADR (hazard ratio (HR) 1.28, 95% CI 0.43–3.78, P = 0.002). Number of medicines given also significantly increased the hazard (HR 1.2, 95% CI 0.80–1.71, P < 0.001). CONCLUSIONS: Use of off-label medicines were more likely to be implicated in an ADR than labeled medicines. This off-label use would be acceptable if evidence of potential benefits outweighs ADRs risk.
Keywords: Adverse drug reactions, pediatrics, prescribing, off-label
