RPS Conference 2010, Abstracts 2010 - Royal Pharmaceutical Society

89
Unlicensed and off-label use of medicines in hospitalised children in Northern Ireland
and Singapore
Noraida Mohamed Shah 1 , Jeff Millership 1 , Paul Collier 1 , Ahmed Hawwa 1 , James McElnay 1 ,
Heather Steen 2 , Mike Shields 3 , Paul Ho 4 , Mui Ling Tan 4 , Xue Na Goh 4
1 School of Pharmacy, Queen’s University Belfast, Belfast, United Kingdom, 2 Royal Belfast
Hospital for Sick Children, Belfast, United Kingdom, 3 School of Medicine, Queen’s University
Belfast, Belfast, United Kingdom, 4 Department of Pharmacy, National University of Singapore,
Singapore, Singapore
Focal points
• The aim of the study was to determine and compare the extent of unlicensed and
off-label medicine use in hospitalised children in N. Ireland and Singapore.
• More medicines were prescribed in an unlicensed or off-label manner in N. Ireland
(10.4% and 32.6% respectively) as compared to Singapore (1.3% and 20.6%
respectively).
• This study highlights the need for further co-ordinated research to increase the
number of licensed medicines available for children internationally.
Introduction
Children (like adults) have a right to have access to medicines which have been designed,
tested and licensed for use within their age group. All medicines marketed in the UK must have
received a Marketing Authorisation (MA) or Product License (PL) from the Medicines and
Healthcare products Regulatory Agency (MHRA) as an assurance of safety, efficacy and
quality. Without an MA or a PL, a medicine is ‘unlicensed’, while the use of licensed medicines
outside the terms of their MA or PL is termed ‘off-label’. In Singapore, the licensed status of a
medicine is determined by the Health Sciences Authority (HSA). The aim of this study was to
determine and compare the extent of unlicensed and off-label medicine use in hospitalised
children in N. Ireland and Singapore. This study is part of a larger study funded by the British
Council Prime Minister’s II Initiative.
Method
A prospective cross-sectional study of medicines prescribed to children was conducted over 4
weeks at a children’s hospital in N. Ireland and a similar facility in Singapore. Both sites are
tertiary hospitals and the survey was conducted in paediatric medical and surgical wards in both
hospitals using a similar data collection form. The Summary of Product Characteristics and the
British National Formulary for Children (BNFc) were the primary and secondary reference
sources respectively used in classifying the use of the medicines in N. Ireland. In Singapore, the
primary reference used was the Paediatric Dosage Handbook (Lexi-Comp®), with secondary
reference sources being the website of the HSA, Medical Information Management System
(MIMS) Singapore and the medicine’s product insert.
Results
A total of 2,073 medicines were prescribed to 389 hospitalised children in N. Ireland (median of
4 medicines per child). Equivalent data in Singapore involved 252 children who were prescribed
a total of 674 medicines (median of 3 medicines per child). The percentage of unlicensed and
off-label medicine use in N. Ireland was higher when compared to Singapore as shown in Table
1, which also summarises other characteristics of such prescribing between the two sites. Most
medicines prescribed in Singapore are licensed by HSA. There were only 9 episodes of
extemporaneously prepared medicines (mainly crushing tablets to make a suspension), which
was the only example of unlicensed use, encountered throughout the study period in Singapore.