Off-label prescribing for children with chronic diseases in Nigeria; findings and implications

Abstract

ABSTRACTBackground: Prescribing medicines in an off-label manner for children with chronic conditions is sparsely documented, even more so among developing countries. This needs addressing. The objective of this research was to investigate the extent of off-label prescribing among children with epilepsy, asthma, and sickle cell anaemia in Nigeria.Methods: Prescriptions for children ≤16 years documented in their case files that attended paediatric clinics in Lagos, Nigeria, for these three conditions between January and October 2015, were reviewed retrospectively to extract data on the medicines prescribed. British National Formulary for children and American Hospital Formulary Service Drug information were used as references.Results: 477 patients received 1746 prescriptions. Off-label prescriptions were seen in 7.7% of prescriptions, related to dose (93; 68.9%), indication (22; 16.3%), and age (20; 14.8%). Nervous system (525; 30.1%) and anti-infective (441; 25.2%) medicines were the most prescribed but only 9.5% and 8.2% of the respective prescriptions were off-label. Children with epilepsy received the most number (94; 69.6%) of off-label prescriptions. The three chronic conditions did not associate significantly with the category of off-label medicine prescribed (p = 0.925).Conclusion: Off-label prescribing for children with epilepsy, asthma and sickle cell anaemia occurs. Encouragingly, the overall rate appears low in Nigeria.