Literature DB >> 11087285

Unlicensed and off label prescribing of drugs in general practice.

J McIntyre1, S Conroy, A Avery, H Corns, I Choonara.   

Abstract

AIM: To determine the incidence and nature of unlicensed and off label prescribing of drugs for children in general practice.
METHODS: A retrospective analysis of all prescriptions for one year involving children (aged 12 years or under) from a single suburban general practice in the English Midlands. Prescribed drugs were categorised as licensed, unlicensed (without a product licence), or used in an off label way (outside the terms of their product licence).
RESULTS: During 1997 there were 3347 prescription items involving 1175 children and 160 different drugs. A total of 2828 (84. 5%) prescriptions were for licensed medicines used in a licensed way; 10 (0.3%) were for unlicensed medicines; and 351 (10.5%) were licensed medicines used in an off label way. For 158 (4.7%) the information was insufficient to determine licence status.
CONCLUSION: This is the first study to show that a significant number of drugs prescribed for children by general practitioners are off label and highlights the anomalies and inadequacies of drug information for prescribers.

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Mesh:

Year:  2000        PMID: 11087285      PMCID: PMC1718565          DOI: 10.1136/adc.83.6.498

Source DB:  PubMed          Journal:  Arch Dis Child        ISSN: 0003-9888            Impact factor:   3.791


  9 in total

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3.  Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children.

Authors:  S Conroy; I Choonara; P Impicciatore; A Mohn; H Arnell; A Rane; C Knoeppel; H Seyberth; C Pandolfini; M P Raffaelli; F Rocchi; M Bonati; G Jong; M de Hoog; J van den Anker
Journal:  BMJ       Date:  2000-01-08

4.  Unlicensed and off label drug use in paediatric wards: prospective study.

Authors:  S Turner; A Longworth; A J Nunn; I Choonara
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5.  Use of "off-label" and unlicensed drugs in paediatric intensive care unit.

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Journal:  Lancet       Date:  1996-02-24       Impact factor: 79.321

6.  Quality of prescribing for children in general practice.

Authors:  J C Catford
Journal:  Br Med J       Date:  1980-06-14

7.  Drug prescribing for children in general practice. A report from the Møre & Romsdal Prescription Study.

Authors:  J Straand; K Rokstad; U Heggedal
Journal:  Acta Paediatr       Date:  1998-02       Impact factor: 2.299

8.  Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study.

Authors:  S Turner; A J Nunn; K Fielding; I Choonara
Journal:  Acta Paediatr       Date:  1999-09       Impact factor: 2.299

9.  Use of drugs by children.

Authors:  G W Rylance; C G Woods; R E Cullen; M E Rylance
Journal:  BMJ       Date:  1988-08-13
  9 in total
  76 in total

Review 1.  Unlicensed and off-label drug use in children: implications for safety.

Authors:  Imti Choonara; Sharon Conroy
Journal:  Drug Saf       Date:  2002       Impact factor: 5.606

Review 2.  Medicines for children--the last century and the next.

Authors:  T Stephenson
Journal:  Arch Dis Child       Date:  2001-09       Impact factor: 3.791

3.  Off label prescribing to children in primary care in Germany: retrospective cohort study.

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4.  Unlicensed and off label drug use by children in the community: cross sectional study.

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Journal:  BMJ       Date:  2002-06-01

5.  Making medicines that children can take.

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6.  Testing new pharmaceutical products in children.

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7.  Antibiotic prescribing for children. Too much and too little? Retrospective observational study in primary care.

Authors:  Suzie Ekins-Daukes; James S McLay; Michael W Taylor; Colin R Simpson; Peter J Helms
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8.  Off-label prescribing to children in primary care: retrospective observational study.

Authors:  Suzie Ekins-Daukes; Peter J Helms; Colin R Simpson; Michael W Taylor; James S McLay
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9.  Research in general paediatrics.

Authors:  H M Sammons; J McIntyre; I Choonara
Journal:  Arch Dis Child       Date:  2004-05       Impact factor: 3.791

10.  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
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