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

[摘要] ENGLISH ABSTRACT: OBJECTIVEThe aim of this study is to establish the frequency of unlicensed and off label drug use ininfants admitted to the neonatal intensive care unit (NICU) in Tygerberg Hospital.METHODThis was a prospective descriptive survey conducted over 3 consecutive months (September2011-November 2011) of all medicine charts of neonates admitted during this time period tothe NICU. Data collected included demography, diagnoses, medicines prescribed accordingto dose, frequency, route of administration and indication. Medicine use was defined asunlicensed, licensed or off label use according to the latest South African MedicinesFormulary (2012) and the manufacturer's package insert. Unlicensed drug use is perdefinition a drug not registered with South African Medicine Control Council (SA MCC) forchildren and off label drug use is where the use is outside of its authorized license with SAMCC.RESULTSThere were 112 neonates enrolled in the study, of whom 51% were preterm and 49% terminfants. The most common diagnoses on admission for the preterm babies were hyalinemembrane 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 which37% were licensed and followed all the licensing terms, 51% were prescribed in an off labelmanner and the remaining 12% were of unlicensed drugs. The most common reasons offlabel 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 pediatricdata for 9% of the drugs prescribed. In 203 drug events (27%) a drug was used in an off labelmanner for more than one reason. Sixty one percent of the drugs used had no information onthe use of the drug in neonates.CONCLUSIONThis is the first study conducted in an African NICU, according to our knowledge and theresults 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 beconducted to address the need for proven safe and efficacious treatment for neonates.

[发布机构] Stellenbosch University