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Survey of unlicensed and off label drug use in paediatric wards in European countries

BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7227.79 (Published 08 January 2000) Cite this as: BMJ 2000;320:79

Survey of unlicensed and off label drug use in paediatric wards in European countries.

EDITOR-Conroy et al show the widespread use of unlicensed or off
label drugs in children admitted to hospital [1]. Whilst it is not illegal
to use medicines in this way, the responsibility for any adverse events
becomes the clinicians or the pharmacists, rather than the manufacturers.
However, much unlicensed use may be recommended in local or national
guidelines.

As part of our trust's response to unlicensed drug use in children, I
reviewed all drugs recommended in our local Paediatric Medical Guidelines.
These contained 69 guidelines for acute management and elective
investigation of children. The guidelines recommended 86 drugs, but only
47(55%) were licensed for use in children. A further 14 drugs were
licensed only for children above a certain age or weight, 24 were
unlicensed or off label and the status of one drug (methylcellulose) is
unknown. Five drugs used for investigations were not licensed or the
license was restricted.
National guidelines also recommend drugs that are unlicensed for children.

The British Thoracic Society guidelines for treating tuberculosis
recommend Pyrazinamide should be given routinely, despite the fact this
drug is not licensed for children [2]. Primaquine is recommended by
national guidelines for use in Vivax malaria, but is unlicensed [3].

Paediatric guidelines (both local and national) need to acknowledge the
licensed status of the drugs recommended. Linking guidelines to the Royal
College of Paediatrics and Child Health's formulary (Medicines for
Children) might facilitate this.

F Andrew I Riordan
Consultant Paediatrician

Dept of Child Health,
Birmingham Heartlands Hospital,
BIRMINGHAM B9 5SS

References.

1.Conroy S et al. Survey of unlicensed and off label drug use in
paediatric wards in European countries. BMJ 2000;320:79-81

2. Joint Tuberculosis Committee of the British Thoracic Society.
Chemotherapy and management of tuberculosis in the United Kingdom:
recommendations 1998. Thorax 1988;53:536-548

3. Benign malarias (treatment). British National Formulary 1998;283-
284

Competing interests: No competing interests

17 January 2000
Andrew I Riordan