Literature DB >> 12622766

Use of unlicensed and off-label medications in paediatric gastroenterology with a review of the commonly used formularies in the UK.

A Dick1, S Keady, F Mohamed, S Brayley, M Thomson, B W Lloyd, R Heuschkel, N A Afzal.   

Abstract

BACKGROUND: Use of unlicensed and off-label medications is common in hospital based paediatric practice. Whilst inpatient prescription can be closely monitored within the hospital setting, it is subspecialties like paediatric gastroenterology, caring for chronically ill children on an outpatient basis that require administration of regular medications in the community. Local practitioners rely on available paediatric formularies or information provided by the tertiary unit for monitoring and dispensing further prescriptions. AIM: To assess the proportion of unlicensed and off-label medications prescribed in a paediatric gastroenterology unit to children discharged to the community and assess adequacy of information about these medications in commonly used British formularies.
METHODS: All prescriptions prescribed over a six-month period (Jan-Jul 2002) either in the paediatric gastroenterology outpatient department or for children discharged home after an inpatient stay, were retrieved from the pharmacy database. The main outcome measures were to assess the proportion of medications prescribed for unlicensed or off-label use.
RESULTS: 308 patients received 777 prescriptions of which 384 (49%) were for unlicensed or off-label use. Of these 291 (76%) were off-label; 208 in relation to indication and 83 to child's age. 93 of the prescribed medications were unlicensed; 37 were due to manipulation of formulation. Of the commonly used formularies in the UK, only 'Medication for Children(R)' contained dosage information on more than half (9/13) of the most often prescribed off-label/unlicensed medications in paediatric gastroenterology.
CONCLUSIONS: Use of unlicensed and off-label medications remains a problem in paediatric practice. Until licensing laws change and more drugs are licensed in children, paediatric gastroenterologists remain responsible for provision of information to families, local practitioners, nurses and pharmacists. Of the commonly used formularies, 'Medicines for Children' is the most detailed and comprehensive, and should be available to all general practitioners and pharmacists in the UK. Clear communication between specialist units and local practitioners is imperative to ensure safe and effective prescribing to children.

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Year:  2003        PMID: 12622766     DOI: 10.1046/j.1365-2036.2003.01441.x

Source DB:  PubMed          Journal:  Aliment Pharmacol Ther        ISSN: 0269-2813            Impact factor:   8.171


  10 in total

Review 1.  Gastroenterology services in the UK. The burden of disease, and the organisation and delivery of services for gastrointestinal and liver disorders: a review of the evidence.

Authors:  J G Williams; S E Roberts; M F Ali; W Y Cheung; D R Cohen; G Demery; A Edwards; M Greer; M D Hellier; H A Hutchings; B Ip; M F Longo; I T Russell; H A Snooks; J C Williams
Journal:  Gut       Date:  2007-02       Impact factor: 23.059

2.  European evidence based consensus on the diagnosis and management of Crohn's disease: special situations.

Authors:  R Caprilli; M A Gassull; J C Escher; G Moser; P Munkholm; A Forbes; D W Hommes; H Lochs; E Angelucci; A Cocco; B Vucelic; H Hildebrand; S Kolacek; L Riis; M Lukas; R de Franchis; M Hamilton; G Jantschek; P Michetti; C O'Morain; M M Anwar; J L Freitas; I A Mouzas; F Baert; R Mitchell; C J Hawkey
Journal:  Gut       Date:  2006-03       Impact factor: 23.059

3.  'Poppy seeds' in stomach aspirates: is oral omeprazole extemporaneous dispersion bioavailable?

Authors:  Catherine Tuleu; Sara Arenas-Lopez; Chris Robinson; David McCarthy; Richard I J Paget; Shane Tibby; Kevin M G Taylor
Journal:  Eur J Pediatr       Date:  2007-07-20       Impact factor: 3.183

4.  Infliximab for the treatment of paediatric Crohn's disease: Obstacles to accessing a necessary therapy.

Authors:  Anthony Otley; Jeff Critch; J Decker Butzner
Journal:  Paediatr Child Health       Date:  2004-02       Impact factor: 2.253

5.  Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine.

Authors:  Maher R Khdour; Hussein Othman Hallak; Kawther Shab'an Atallah Alayasa; Qusai Nabeel AlShahed; Ahmed F Hawwa; James C McElnay
Journal:  Int J Clin Pharm       Date:  2011-05-13

6.  Clinical trials research in pediatrics: strategies for effective collaboration between investigator sites and the pharmaceutical industry.

Authors:  Andrew Bush
Journal:  Paediatr Drugs       Date:  2006       Impact factor: 3.022

7.  Off-label and unlicensed drug use in neonatal intensive care units in Turkey: the old-inn study.

Authors:  S Suna Oguz; H Gozde Kanmaz; Ugur Dilmen
Journal:  Int J Clin Pharm       Date:  2012-01-11

Review 8.  A literature review on off-label drug use in children.

Authors:  Chiara Pandolfini; Maurizio Bonati
Journal:  Eur J Pediatr       Date:  2005-05-24       Impact factor: 3.183

9.  Unlicensed and Off-Label Drug Use in Children Before and After Pediatric Governmental Initiatives.

Authors:  Jennifer Corny; Denis Lebel; Benoit Bailey; Jean-François Bussières
Journal:  J Pediatr Pharmacol Ther       Date:  2015 Jul-Aug

10.  Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia.

Authors:  Caitlin Landwehr; Jennifer Richardson; Lewis Bint; Richard Parsons; Bruce Sunderland; Petra Czarniak
Journal:  PLoS One       Date:  2019-01-08       Impact factor: 3.240

  10 in total

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