Off-label Use in Ambulatory Paediatric Clinics in a Central South African Hospital.

Aim: The aim of this article was to determine off-label (OL) use in paediatric ambulatory clinics in a South African central hospital.

Patients and methods: OL medicine events were documented in three paediatric clinics (general, highly specialized and dedicated HIV paediatric clinics) at Tygerberg Hospital, South Africa, and analysed according to South African medicine registration information.

Results: There were 2167 medicine events for 658 children. Mean age was 5.6 years (interquartile range 1.8-8.8). There were 123 OL medicine events (6%). Extemporaneous OL use was most common (n = 58, 47%), followed by weight (n = 45, 37%) and lack of paediatric data (n = 38, 31%). Of note was OL use for weight for general paediatrics (n = 32, 78%, p < 0.001), lack of appropriate paediatric data for highly specialized paediatrics (n = 26, 61%, p = 0.004) and extemporaneous use for HIV-infected children (n = 34, 87%, p < 0.001), with significant less OL use for HIV-infected children (p = 0.009).

Conclusions: Of note is significant extemporaneous OL use in HIV-infected children.