Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands.
OBJECTIVE
Many drugs used in paediatric care are not licensed for that use or are prescribed outside the terms of the product license (off-label). Studies in the UK and Europe showed a large number of unlicensed and off-label drug prescription in specialised paediatric health care centres. We determined the extent and nature of use of unlicensed drugs and off-label prescriptions in children in a general hospital in the Netherlands.


METHODS
We conducted a longitudinal prospective cohort study in a dynamic population consisting of patients admitted to the paediatric ward and the neonatology unit of a general hospital during a 19-week period. Drug-licensing status of all prescriptions given to these patients was determined.


RESULTS
A total of 1017 prescriptions was administered to 293 paediatric patients for 114 different drugs. The median number of prescriptions per patient was three (interquartile range 2-5). The most commonly administered drugs were acetaminophen (14%), cefotaxime (8%), amoxicillin (7%), caffeine (4%) and prednisolone (4%). Four hundred and forty-three (44%) prescriptions were off-label, and 285 (28%) were for unlicensed drugs. Ninety-two percent of patients received one or more unlicensed or off-label prescriptions, and this proportion was significantly higher in children below 6 months of age than in older children.


CONCLUSIONS
This study shows that the extent of unlicensed and off-label drug prescription in a paediatric ward and neonatology unit of a general hospital is large and not smaller than in an academic paediatric setting. Lack of paediatric drug labelling is therefore not solely a problem with drugs used in university hospitals, but also in general hospitals. Efforts must be taken to change the current situation.
Pharmacoepidemiology Unit, Department of Internal Medicine, Epidemiology & Biostatistics, Erasmus Medical Centre Rotterdam, The Netherlands.
G W
GW
't Jong
P D
PD
van der Linden
E M
EM
Bakker
N
N
van der Lely
I A
IA
Eland
B H C
BH
Stricker
J N
JN
van den Anker
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004348:Drug Labeling; D011307:Drug Prescriptions; D004363:Drug Utilization / Q000639:trends*; D005260:Female; D006748:Hospital Departments; D006757:Hospital Units; D006769:Hospitals, General; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008004:Licensure; D008297:Male; D009426:Netherlands; D004364:Pharmaceutical Preparations; D011446:Prospective Studies
D004364:Pharmaceutical Preparations