Off-Label Use of Medicines in Children Attending a Secondary Healthcare Facility in Federal Capital Territory

Abstract

Before a new drug is approved for marketing in any country, it must have undergone three phases of clinical trials designed to assess its efficacy and safety when used according to an approved recommendation. After a drug has been tested and approved by the regulatory authorities, the drug is usually given a ‘label’ or ‘license’ which is a report describing the drug intended use and dosage. This study aimed at evaluating the use of medicines outside the terms stated in the label. The study was conducted using a data collection form to obtain information from patients’ case file. Data were analysed using Statistical Package for Social Sciences. The case notes of 449 patients were included in the study. The ages of the patients ranged from 4 days to 16 years. Females constituted 51.7% (232) and males 48.3% (217). A total of 1866 drugs were administered to patients, of which 469 (25.13%) were off-label prescriptions. The highest category of off-label drug was indication (45%). This study has revealed a considerable prevalence of off-label use of medicines, there is however need for proper pharmaceutical care to be emplaced in healthcare facilities so as to minimize off-label drug use and prevent adverse effect of drugs as a result of inappropriate use of medicines.