Prescription pattern of unlicensed and off-label medicines for children 0-5 years old in a tertiary hospital and a primary health centre in Nigeria

Abstract

"Objectives: To determine the extent and pattern of use of unlicensed and off-label medicines in children 0-5 years old in a tertiary hospital and a primary healthcare center in Nigeria. Design: Retrospective comparative analyses of prescriptions received by children on admission or as out patients in the research centers within a 12-month period (April, 2003- March, 2004). Setting: The research was carried out in two separate hospitals: • A tertiary teaching hospital, (Nnamdi Azikiwe University Taeching Hospital, Nnewi) and • A primary healthcare center, (Center for Community Medicine and Primary Healthcare, Neni) both located in Anambra state, Nigeria. Subjects: The subjects were children aged 0 – 5 years who attended the hospital during the study period. Outcome Measures: The extent and pattern of prescription of unlicensed and off-label medicines in the study population. Results: The 531 children involved in the study received 2190 prescriptions within the study period. Out of all those prescriptions, 446, (20.37%) were unlicensed while 470, (21.46%) were off-label. Reformulating adult dosage forms for pediatric use, such as crushing of tablets or emptying capsules were the most frequent form of unlicensed medicine use. Off-label medicines use observed in this study was prescribing doses in excess of recommended pediatric doses as well as use of medicines for indications other than those specified in the product license. Conclusion: We conclude that there are prescriptions of unlicensed and off-label medicines for children in the research centers. Further research on this subject is recommended in other parts of Nigeria and Africa."