The use of unlicensed and off label drugs in Tygerberg Hospital neonatal intensive care unit

Thomas, Angeline (2014-04)

Thesis (MMed)--Stellenbosch University, 2014.

Thesis

ENGLISH ABSTRACT: OBJECTIVE The aim of this study is to establish the frequency of unlicensed and off label drug use in infants admitted to the neonatal intensive care unit (NICU) in Tygerberg Hospital. METHOD This was a prospective descriptive survey conducted over 3 consecutive months (September 2011-November 2011) of all medicine charts of neonates admitted during this time period to the NICU. Data collected included demography, diagnoses, medicines prescribed according to dose, frequency, route of administration and indication. Medicine use was defined as unlicensed, licensed or off label use according to the latest South African Medicines Formulary (2012) and the manufacturer’s package insert. Unlicensed drug use is per definition a drug not registered with South African Medicine Control Council (SA MCC) for children and off label drug use is where the use is outside of its authorized license with SA MCC. RESULTS There were 112 neonates enrolled in the study, of whom 51% were preterm and 49% term infants. The most common diagnoses on admission for the preterm babies were hyaline membrane disease (33%) and sepsis (21%), while it was hypoxic ischemic encephalopathy (42%) and post-operative care (22%) for term infants. There were 759 drug events of which 37% were licensed and followed all the licensing terms, 51% were prescribed in an off label manner and the remaining 12% were of unlicensed drugs. The most common reasons off label drug use were for weight (74%), followed by age (44%), frequency (44%), indication (21%), or a route not described in the licensing terms (13%). There was a lack of pediatric data for 9% of the drugs prescribed. In 203 drug events (27%) a drug was used in an off label manner for more than one reason. Sixty one percent of the drugs used had no information on the use of the drug in neonates. CONCLUSION This is the first study conducted in an African NICU, according to our knowledge and the results are similar to studies conducted in Europe and America. Neonates are exposed to a significant proportion of unlicensed and off label drugs. Neonatal clinical trials should be conducted to address the need for proven safe and efficacious treatment for neonates.

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