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Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. 2002

G W 't Jong, and P D van der Linden, and E M Bakker, and N van der Lely, and I A Eland, and B H C Stricker, and J N van den Anker
Pharmacoepidemiology Unit, Department of Internal Medicine, Epidemiology & Biostatistics, Erasmus Medical Centre Rotterdam, 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.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D008004 Licensure The legal authority or formal permission from authorities to carry on certain activities which by law or regulation require such permission. It may be applied to licensure of institutions as well as individuals. Institutional Personnel Licensure,Licenses,Licensure, Institutional, Personnel,Licensing,Permits,Institutional Personnel Licensures,License,Licensure, Institutional Personnel,Licensures,Licensures, Institutional Personnel,Permit,Personnel Licensure, Institutional,Personnel Licensures, Institutional
D008297 Male Males
D009426 Netherlands Country located in EUROPE. It is bordered by the NORTH SEA, BELGIUM, and GERMANY. Constituent areas are Aruba, Curacao, and Sint Maarten, formerly included in the NETHERLANDS ANTILLES. Holland,Kingdom of the Netherlands
D011307 Drug Prescriptions Directions written for the obtaining and use of DRUGS. Drug Prescribing,Drug Prescription,Drug Prescribings,Prescribing, Drug,Prescribings, Drug
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D004348 Drug Labeling Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information. Labeling, Drug,Package Inserts, Drug,Product Labeling, Drug,Black Box Warning,Boxed Warning,Drug Labelling,Black Box Warnings,Box Warning, Black,Box Warnings, Black,Boxed Warnings,Drug Package Insert,Drug Package Inserts,Drug Product Labeling,Insert, Drug Package,Inserts, Drug Package,Labeling, Drug Product,Labelling, Drug,Package Insert, Drug,Warning, Black Box,Warning, Boxed,Warnings, Black Box,Warnings, Boxed

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