Literature DB >> 10325794

Unlicensed and off label drug use in neonates.

S Conroy1, J McIntyre, I Choonara.   

Abstract

AIM: To determine the extent of use of drugs that are either not licensed (unlicensed), or are outside the terms of their product licence (off label) in a neonatal intensive care unit.
METHODS: A prospective study was conducted over 13 weeks.
RESULTS: 455 prescription episodes were administered to 70 babies. 63 (90%) patients were given a drug that was either unlicensed or used in an off label way. 54.7% prescription episodes were off label, many for more than one reason, and 9.9% (45) were unlicensed; 35.4% (161) prescription episodes were licensed.
CONCLUSION: The use of unlicensed and off label drugs in neonatal intensive care seems to be far greater than other paediatric settings. This highlights the difficulties faced by those trying to ensure safe and effective prescribing for neonates. Urgent action is required to resolve this situation.

Entities:  

Mesh:

Year:  1999        PMID: 10325794      PMCID: PMC1720896          DOI: 10.1136/fn.80.2.f142

Source DB:  PubMed          Journal:  Arch Dis Child Fetal Neonatal Ed        ISSN: 1359-2998            Impact factor:   5.747


  6 in total

1.  Effects of oral and intramuscular vitamin K prophylaxis on vitamin K1, PIVKA-II, and clotting factors in breast fed infants.

Authors:  E A Cornelissen; L A Kollée; R A De Abreu; J M van Baal; K Motohara; B Verbruggen; L A Monnens
Journal:  Arch Dis Child       Date:  1992-10       Impact factor: 3.791

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

Authors:  S Turner; A Longworth; A J Nunn; I Choonara
Journal:  BMJ       Date:  1998-01-31

3.  Use of "off-label" and unlicensed drugs in paediatric intensive care unit.

Authors:  S Turner; A Gill; T Nunn; B Hewitt; I Choonara
Journal:  Lancet       Date:  1996-02-24       Impact factor: 79.321

Review 4.  Group B streptococcal infections.

Authors:  C J Baker
Journal:  Clin Perinatol       Date:  1997-03       Impact factor: 3.430

Review 5.  Pharmacokinetics and renal function in preterm infants.

Authors:  J N van den Anker
Journal:  Acta Paediatr       Date:  1996-12       Impact factor: 2.299

6.  Prevention of vitamin K deficiency in infancy by weekly administration of vitamin K.

Authors:  E A Cornelissen; L A Kollée; R A De Abreu; K Motohara; L A Monnens
Journal:  Acta Paediatr       Date:  1993-08       Impact factor: 2.299

  6 in total
  83 in total

Review 1.  Paediatric prescribing: using unlicensed drugs and medicines outside their licensed indications.

Authors:  J Collier
Journal:  Br J Clin Pharmacol       Date:  1999-07       Impact factor: 4.335

Review 2.  Drug trials in children: problems and the way forward.

Authors:  S Conroy; J McIntyre; I Choonara; T Stephenson
Journal:  Br J Clin Pharmacol       Date:  2000-02       Impact factor: 4.335

3.  Support for studies in paediatric medicine is needed.

Authors:  R Lennon; M Quinn; K Collard
Journal:  BMJ       Date:  2000-11-11

4.  Unlicensed and off label prescribing of drugs in general practice.

Authors:  J McIntyre; S Conroy; A Avery; H Corns; I Choonara
Journal:  Arch Dis Child       Date:  2000-12       Impact factor: 3.791

5.  Clinical trials of medicines in children.

Authors:  I Choonara
Journal:  BMJ       Date:  2000-11-04

Review 6.  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 7.  Medicines for children--the last century and the next.

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

8.  Presumed consent in emergency neonatal research.

Authors:  D J Manning
Journal:  J Med Ethics       Date:  2000-08       Impact factor: 2.903

9.  Implications of the Crown Report and nurse prescribing.

Authors:  T Stephenson
Journal:  Arch Dis Child       Date:  2000-09       Impact factor: 3.791

10.  Making medicines that children can take.

Authors:  A J Nunn
Journal:  Arch Dis Child       Date:  2003-05       Impact factor: 3.791

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.