Unregistered and off-label medicine use in highly specialised paediatrics at Tygerberg Hospital

Kooblal, Yajna (2016-03)

Thesis (MMed)--Stellenbosch University, 2016.

Thesis

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.

Inleiding: Die gebruik van niegoedgekeurde (NG) medisyne by kinders is ʼn algemene praktyk wat nog nie uitvoerig in Afrika ondersoek is nie. Oogmerk: Die oogmerk van die studie was om die omvang te ondersoek van die gebruik van ongeregistreerde (OR) en NG medisyne by hospitaalpasiënte wat in hoogs gespesialiseerde pediatriese sale by ʼn tersiêre hospitaal in Suid-Afrika opgeneem is. Doelstellings: Die primêre doelstelling van die studie was om die frekwensie van gebeure rakende OR en NG medisyne in hoogs gespesialiseerde pediatrie te bepaal. Die sekondêre doelstelling was om te bepaal watter OR en NG medisyne die gereeldste per pediatriese subspesialiteit voorgeskryf word. Respondente en metodes: Hierdie studie was ʼn prospektiewe beskrywende studie oor ʼn tydperk van drie maande (Oktober tot Desember 2011), waarin alle medisyne wat voorgeskryf is aan kinders (jonger as 18 jaar) wat vir hoogs gespesialiseerde hospitaalsorg by Tygerberg Hospitaal in Parow, Kaapstad, opgeneem is, opgeteken is. Pasiënte is in vier ouderdomsgroepe geklassifiseer: pasgeborenes (0–27 dae), babas (28 dae tot 23 maande), kinders (2–11 jaar) en adolessente (12–18 jaar). Data wat ingesamel is, het ingesluit demografiese data, diagnostiese data en data oor alle medikasiegebeure. Data-ontleding van medikasiegebeure het ingesluit registrasiestatus (waarin geïmproviseerde gebruik as OR gebruik gedefinieer is) en NG gebruik volgens dosis, frekwensie, toedieningsmetode, ouderdom en indikasie. Resultate: Daar was 1 514 medikasiegebeure vir 199 kinders (gemiddelde ouderdom?; bestek), met ʼn gemiddelde van 7 medisynes per kind (bestek 1–28). Die meerderheid medikasiegebeure was in die ouderdomskategorie van babas (44%), gevolg deur kinders (42%), adolessente (8%) en pasgeborenes (6%). Bykans die helfte (49%) van al die medikasiegebeure was óf OR (20%) óf NG (29%). Byna ʼn kwart (22%) van die pasiënte het OR medisyne ontvang, 68% NG medisyne en 24% sowel OR as NG medisyne. Die algemeenste rede vir die gebruik van NG medisyne was dosis vir gewig (22.2%), terwyl geïmproviseerde gebruik as OR gebruik by 5% van alle medikasiegebeure betrokke was. Geïmproviseerde gebruik (23%) en NG gebruik (42%) was veral algemeen by pediatriese aansteeklike siektes, veral vir antituberkulose-medisyne, wat die las van pediatriese siektes weens tuberkulose weerspieël en ook bevestig dat min van hierdie medisyne by kinders getoets is. Gevolgtrekkings: Die gebruik van NG en OR medisyne is algemeen in hoogs gespesialiseerde pediatrie in Suid-Afrika, veral by kinders met aansteeklike siektes. Die bevindinge dui op die behoefte aan toegewyde pediatriese kliniese toetse in Suid-Afrika om veiligheids- en doeltreffendheidsdata te verkry, veral om pediatriese medisyneformulering te verbeter.

Please refer to this item in SUNScholar by using the following persistent URL: http://hdl.handle.net/10019.1/98324
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