oa South African Journal of Bioethics and Law - Prescription pattern of unlicensed and off-label medicines for children aged 0 - 5 years in a tertiary hospital and a primary health care centre in Nigeria
Background. Many medicines prescribed for children are unlicensed for their age category or used outside the specifications in the medicine licences (off-label use), and few medicines have been properly tested for use in children in clinical trials prior to licensing. These problems raise ethical and safety concerns about use of medicines in children. The pattern and extent of unlicensed and off-label use of medicines in the Nigerian health care system has been poorly documented.
Objectives. This research was carried out to study the pattern and extent of unlicensed and off-label use of medicines in children aged 0 - 5 years in a tertiary hospital and a primary health care centre in Nigeria.
Method. A retrospective study of prescriptions received by children during admission or as outpatients during the 12-month period April 2003 - March 2004 was done.
Results. The 531 children included in the study received 2 190 prescriptions during the study period. Of these 446 (20.4%) were for unlicensed use and 470 (21.5%) for off-label use. The most common form of unlicensed medicine use was modification of licensed dosage forms (e.g. crushing of tablets to make suspensions), while the most frequent pattern of off-label use was using doses other than those recommended for the paediatric age categories.
Conclusion. Unlicensed and off-label medicines are widely used for children in the centres studied. Further research on this subject is recommended in other parts of Nigeria and Africa.
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