Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.

Background: Information regarding off-label and unlicensed medicine use among South African children is limited. This is a concern as the prescribing of off-label and unlicensed medicines can lead to issues of effectiveness and safety as well as raise liability issues in the event of adverse events. This potentially exposes physicians to legal penalties. Consequently, we sought to determine the prevalence of off-label and unlicensed medicine use among paediatric patients in South Africa to provide future direction.

Methods: This study retrospectively examined the use of medicine in a point-prevalence survey study (PPS) involving paediatric patients aged (0-2 years) admitted to selected public hospitals in Gauteng Province, South Africa. Data were collected per hospital over two days between February 2022 and July 2022. Demographics, duration of treatment, diagnosis, and medicines prescribed were collected from patient medical records using a mobile application. Prescribed medicines were reviewed against the medicine formularies and other databases to assess their appropriateness.

Results: From three academic hospitals, 184 patient records were reviewed. A total of 592 medicines were dispensed, of which 379 (64.0%) were licensed and 213 (36.0%) were used off-label/unlicensed for paediatric patients 0-2 years of age. The most prevalent off-label and unlicensed medicines were multivitamins (n = 32, 15.0%) and ampicillin injections (n = 15, 7.0%).

Conclusion: The frequency of unlicensed and off-label medicine prescribing shown in this study is consistent with the literature and can be considered high. This practice can pose a risk because it adversely affects patients if not properly regulated. Attention is needed to ensure future high-quality, safe, and effective use of medicines.