The use of unlicensed and off-label medications in children

Abstract

Introduction:

In the absence of standard paediatric prescribing information, clinicians often use medicines in an off-label manner. The aim of this study is to provide an insight on the experience and views of healthcare professionals on the use of unlicensed and off-label medicines in children.

Methods:

A survey instrument composed of 18 questions distributed among healthcare professionals (pharmacist, nurse and prescribers) in Paediatric Medical Ward (PMW), Paediatric Surgical Ward (PSW) and Neonatal Intensive Care unit in Miri General Hospital.

Results:

A total of 54 healthcare professionals responded to the questionnaire. Most of the respondents (75.9%) indicated familiarity with the terminology unlicensed medicines while 59.3% indicated they were familiar with the term off-label medicines prior to receiving the questionnaire. About 90% of respondents had come across a dosing error in a paediatric prescription in their professional practice despite the majority (94.4%) of respondents said they double checked doses of medicines used in children if a calculation required in deciding on the dose.

Conclusion:

It is accepted that off-label and off-licence prescribing in paediatric practice is acceptable and essential when no suitable alternative to the required treatment is available.