Unlicensed and off-label prescription of systemic anti-infective agents to children

Abstract

Background: Systemic anti-infective agents are frequently used for common paediatric diseases such as otitis media, upper and lower respiratory tract infections, rhinitis and sinusitis. We studied the use of systemic anti-infective agents by children to assess the extent of off-label and unlicensed use of anti-infective agents. Methods: A population-based cohort study was conducted using the automated medical records in the Integrated Primary Care Information (IPCI) project in the Netherlands. The study population comprised a random sample (25%) of all children aged 0-16 years who were registered with a general practitioner during 1998. All prescriptions for systemic anti-infective agents during the study period were classified according to their licensing and off-label status. Results: Within the study population of 13,426 children (51.7% male, median age 8.67 years), 2094 children received 2855 prescriptions for systemic anti-infective agents in 1998. 2425 (85.9%) prescriptions were licensed drugs. Of the remaining 430 prescriptions (15.1%), 20 (0.7%) were prescriptions for anti-infective agents unlicensed for use in children, and 410 (14.4%) were off-label prescriptions for anti-infective agents licensed to children. The one-year risk to receive an unlicensed or off-label anti-infective agent was 17% among children with at least one prescription for a systemic anti-infective agent. Conclusion: This population-based study showed that a substantial proportion of systemic anti-infective agents prescribed by the general practitioner is licensed but prescribed in an off-label manner.