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Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital
PURPOSE: To estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia. METHODS: A 12-month retrospective study was conducted at Princess Margaret Hospital using medication chart records randomly selected from 145,550 pati...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355417/ https://www.ncbi.nlm.nih.gov/pubmed/25756896 http://dx.doi.org/10.1371/journal.pone.0120630 |
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author | Czarniak, Petra Bint, Lewis Favié, Laurent Parsons, Richard Hughes, Jeff Sunderland, Bruce |
author_facet | Czarniak, Petra Bint, Lewis Favié, Laurent Parsons, Richard Hughes, Jeff Sunderland, Bruce |
author_sort | Czarniak, Petra |
collection | PubMed |
description | PURPOSE: To estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia. METHODS: A 12-month retrospective study was conducted at Princess Margaret Hospital using medication chart records randomly selected from 145,550 patient encounters from the Emergency Department, Inpatient Wards and Outpatient Clinics. Patient and prescribing data were collected. Drugs were classified as off-label or unlicensed based on Australian registration data. A hierarchical system of age, indication, route of administration and dosage was used. Drugs were classified according to the Anatomical Therapeutic Chemical Code. RESULTS: A total of 1,037 paediatric patients were selected where 2,654 prescriptions for 330 different drugs were prescribed to 699 patients (67.4%). Most off-label drugs (n = 295; 43.3%) were from the nervous system; a majority of unlicensed drugs were systemic hormonal preparations excluding sex hormones (n = 22, 32.4%). Inpatients were prescribed more off-label drugs than outpatients or Emergency Department patients (p < 0.0001). Most off-label prescribing occurred in infants and children (31.7% and 35.9% respectively) and the highest percentage of unlicensed prescribing (7.2%) occurred in infants (p < 0.0001). There were 25.7% of off-label and 2.6% of unlicensed medications prescribed across all three settings. Common reasons for off-label prescribing were dosage (47.4%) and age (43.2%). CONCLUSION: This study confirmed off-label and unlicensed use of drugs remains common. Further, that prevalence of both is influenced by the clinical setting, which has implications in regards to medication misadventure, and the need to have systems in place to minimise medication errors. Further, there remains a need for changes in the regulatory system in Australia to ensure that manufacturers incorporate, as it becomes available, evidence regarding efficacy and safety of their drugs in children in the official product information. |
format | Online Article Text |
id | pubmed-4355417 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-43554172015-03-17 Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital Czarniak, Petra Bint, Lewis Favié, Laurent Parsons, Richard Hughes, Jeff Sunderland, Bruce PLoS One Research Article PURPOSE: To estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia. METHODS: A 12-month retrospective study was conducted at Princess Margaret Hospital using medication chart records randomly selected from 145,550 patient encounters from the Emergency Department, Inpatient Wards and Outpatient Clinics. Patient and prescribing data were collected. Drugs were classified as off-label or unlicensed based on Australian registration data. A hierarchical system of age, indication, route of administration and dosage was used. Drugs were classified according to the Anatomical Therapeutic Chemical Code. RESULTS: A total of 1,037 paediatric patients were selected where 2,654 prescriptions for 330 different drugs were prescribed to 699 patients (67.4%). Most off-label drugs (n = 295; 43.3%) were from the nervous system; a majority of unlicensed drugs were systemic hormonal preparations excluding sex hormones (n = 22, 32.4%). Inpatients were prescribed more off-label drugs than outpatients or Emergency Department patients (p < 0.0001). Most off-label prescribing occurred in infants and children (31.7% and 35.9% respectively) and the highest percentage of unlicensed prescribing (7.2%) occurred in infants (p < 0.0001). There were 25.7% of off-label and 2.6% of unlicensed medications prescribed across all three settings. Common reasons for off-label prescribing were dosage (47.4%) and age (43.2%). CONCLUSION: This study confirmed off-label and unlicensed use of drugs remains common. Further, that prevalence of both is influenced by the clinical setting, which has implications in regards to medication misadventure, and the need to have systems in place to minimise medication errors. Further, there remains a need for changes in the regulatory system in Australia to ensure that manufacturers incorporate, as it becomes available, evidence regarding efficacy and safety of their drugs in children in the official product information. Public Library of Science 2015-03-10 /pmc/articles/PMC4355417/ /pubmed/25756896 http://dx.doi.org/10.1371/journal.pone.0120630 Text en © 2015 Czarniak et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Czarniak, Petra Bint, Lewis Favié, Laurent Parsons, Richard Hughes, Jeff Sunderland, Bruce Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital |
title | Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital |
title_full | Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital |
title_fullStr | Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital |
title_full_unstemmed | Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital |
title_short | Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital |
title_sort | clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355417/ https://www.ncbi.nlm.nih.gov/pubmed/25756896 http://dx.doi.org/10.1371/journal.pone.0120630 |
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