Browsing by Author "Kooblal, Yajna"

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    Unregistered and off-label medicine use in highly specialised paediatrics at Tygerberg Hospital
    (Stellenbosch : Stellenbosch University, 2016-03) Kooblal, Yajna; Kruger, Mariana; Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Paediatrics and Child Health.
    ENGLISH SUMMARY: Introduction: Off-label (OL) medicine use in children is a common practice not yet extensively investigated in Africa. Aim: The aim of the study was to determine the extent of unregistered (UR) and OL medicine use in inpatients admitted to highly specialised paediatric wards at a tertiary hospital in South Africa. Objectives: The primary objective of the study was to determine the frequency of UR and OL medicine events in highly specialised paediatrics. The secondary objective was to determine the most frequently prescribed UR and OL medicines per paediatric subspecialty. Respondents and methods: This was a prospective descriptive study over a period of three months (October to December 2011), documenting all medicines prescribed to children (under 18 years) admitted for highly specialised inpatient care to Tygerberg Hospital in Parow, Cape Town. Patients were classified into four age groups: newborns (0–27 days), infants (28 days to 23 months), children (2–11 years) and adolescents (12–18 years). Data collected included demographic data, diagnostic data and data concerning all medicine events. Data analysis of medicine events included registration status (defining extemporaneous use as UR use) and OL use according to dose, frequency, route of administration, age and indication. Results: There were 1 514 medicine events for 199 children (mean age?; range), with an average of 7 medicines per child (range 1–28). The majority of the medicine events were in the age category infants (44%), followed by children (42%), adolescents (8%) and neonates (6%). Nearly half (49%) of all the medicine events were either UR (20%) or OL (29%). Almost a quarter (22%) of the patients received a UR medicine, 68% an OL medicine and 24% both a UR and an OL medicine. The most common reason for OL medicine use was dose for weight (22.2%), while extemporaneous use as UR use involved 5% of all medicine events. Extemporaneous use (23%) and OL use (42%) were particularly common in paediatric infectious diseases, especially for antituberculosis medicines, reflecting the burden of paediatric disease due to tuberculosis and also confirming that few of these medicines have been tested in children. Conclusions: OL and UR medicine use is common in highly specialised paediatrics in South Africa, especially for children with infectious diseases. The findings indicate the need for dedicated paediatric clinical trials in South Africa to establish safety and efficacy data, especially to improve paediatric medicine formulations.