Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia
To evaluate the prevalence of off-label and unlicensed prescribing in inpatients at a major paediatric teaching hospital in Western Australia and to identify which drugs are commonly prescribed off-label or unlicensed, including factors influencing such prescribing. A retrospective cross-sectional s...
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| Veröffentlicht in: | PloS one 2019-01, Vol.14 (1), p.e0210237 |
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| creator | Landwehr, Caitlin Richardson, Jennifer Bint, Lewis Parsons, Richard Sunderland, Bruce Czarniak, Petra |
| description | To evaluate the prevalence of off-label and unlicensed prescribing in inpatients at a major paediatric teaching hospital in Western Australia and to identify which drugs are commonly prescribed off-label or unlicensed, including factors influencing such prescribing.
A retrospective cross-sectional study was conducted in June, 2013. Patient and prescribing data were collected from 190 inpatient medication chart records which had been randomly selected from all admissions during the second week of February 2013. Drugs were categorised as licensed, off-label or unlicensed, according to their approved Australian registration product information (PI). All drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code.
There were 120 male and 70 female inpatients. The average age was 6.0 years (± 4.7). The study included 1160 prescribed drugs suitable for analysis. The number of drugs prescribed per patient ranged from 1 to 25 with an average of 6.1 (± 4.3). More than half (54%) were prescribed off-label. Oxycodone, clonidine, parecoxib and midazolam were always prescribed off-label. The most common off-label drugs were ondansetron (18.5%), fentanyl (12.9%), oxycodone (8.8%) and paracetamol (6.1%). Many ATC classifications included high off-label proportions especially the genitourinary system and sex hormones, respiratory system drugs, systemic hormonal preparations and alimentary tract and metabolism drugs.
This study highlights that prescribing of paediatric drugs needs to be better supported by existing and new evidence. Incentives should be established to foster the conduct of evidence-based studies in the paediatric population. The current level of off-label prescribing raises issues of unexpected toxicity and adverse drug effects in children that are in some cases severely ill. |
| doi_str_mv | 10.1371/journal.pone.0210237 |
| format | Article |
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A retrospective cross-sectional study was conducted in June, 2013. Patient and prescribing data were collected from 190 inpatient medication chart records which had been randomly selected from all admissions during the second week of February 2013. Drugs were categorised as licensed, off-label or unlicensed, according to their approved Australian registration product information (PI). All drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code.
There were 120 male and 70 female inpatients. The average age was 6.0 years (± 4.7). The study included 1160 prescribed drugs suitable for analysis. The number of drugs prescribed per patient ranged from 1 to 25 with an average of 6.1 (± 4.3). More than half (54%) were prescribed off-label. Oxycodone, clonidine, parecoxib and midazolam were always prescribed off-label. The most common off-label drugs were ondansetron (18.5%), fentanyl (12.9%), oxycodone (8.8%) and paracetamol (6.1%). Many ATC classifications included high off-label proportions especially the genitourinary system and sex hormones, respiratory system drugs, systemic hormonal preparations and alimentary tract and metabolism drugs.
This study highlights that prescribing of paediatric drugs needs to be better supported by existing and new evidence. Incentives should be established to foster the conduct of evidence-based studies in the paediatric population. The current level of off-label prescribing raises issues of unexpected toxicity and adverse drug effects in children that are in some cases severely ill.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0210237</identifier><identifier>PMID: 30620749</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Age ; Analgesics ; Analysis ; Archives & records ; Australia - epidemiology ; Child ; Child health ; Child, Preschool ; Children ; Children's hospitals ; Clonidine ; Clonidine - therapeutic use ; Computer and Information Sciences ; Cross-sectional studies ; Digestive tract ; Drug Administration Routes ; Drug dosages ; Drug labeling ; Drug metabolism ; Drug Prescriptions ; Drug use ; Drugs ; Female ; Fentanyl ; Gastrointestinal tract ; Handbooks ; Hormones ; Humans ; Incentives ; Inpatients ; Isoxazoles - therapeutic use ; Laws, regulations and rules ; Legislation, Drug ; Licensing, certification and accreditation ; Male ; Medicine and Health Sciences ; Metabolism ; Metabolites ; Midazolam ; Midazolam - therapeutic use ; Off-Label Use - legislation & jurisprudence ; Off-Label Use - statistics & numerical data ; Organic chemistry ; Oxycodone ; Oxycodone - therapeutic use ; Paracetamol ; Pediatrics ; Pediatrics - education ; Pediatrics - legislation & jurisprudence ; Pharmaceuticals ; Pharmacy ; Prescription drugs ; Product information ; Registration ; Respiratory system ; Sex hormones ; Side effects ; Studies ; Toxicity ; Urogenital system</subject><ispartof>PloS one, 2019-01, Vol.14 (1), p.e0210237</ispartof><rights>COPYRIGHT 2019 Public Library of Science</rights><rights>2019 Landwehr et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2019 Landwehr et al 2019 Landwehr et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-ea4ae72c97e940e979d126e1b57ec800d9bb12d0fbffe447e6a74ff5779027eb3</citedby><cites>FETCH-LOGICAL-c692t-ea4ae72c97e940e979d126e1b57ec800d9bb12d0fbffe447e6a74ff5779027eb3</cites><orcidid>0000-0001-7212-0667</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324807/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324807/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79343,79344</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30620749$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Figueras, Albert</contributor><creatorcontrib>Landwehr, Caitlin</creatorcontrib><creatorcontrib>Richardson, Jennifer</creatorcontrib><creatorcontrib>Bint, Lewis</creatorcontrib><creatorcontrib>Parsons, Richard</creatorcontrib><creatorcontrib>Sunderland, Bruce</creatorcontrib><creatorcontrib>Czarniak, Petra</creatorcontrib><title>Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>To evaluate the prevalence of off-label and unlicensed prescribing in inpatients at a major paediatric teaching hospital in Western Australia and to identify which drugs are commonly prescribed off-label or unlicensed, including factors influencing such prescribing.
A retrospective cross-sectional study was conducted in June, 2013. Patient and prescribing data were collected from 190 inpatient medication chart records which had been randomly selected from all admissions during the second week of February 2013. Drugs were categorised as licensed, off-label or unlicensed, according to their approved Australian registration product information (PI). All drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code.
There were 120 male and 70 female inpatients. The average age was 6.0 years (± 4.7). The study included 1160 prescribed drugs suitable for analysis. The number of drugs prescribed per patient ranged from 1 to 25 with an average of 6.1 (± 4.3). More than half (54%) were prescribed off-label. Oxycodone, clonidine, parecoxib and midazolam were always prescribed off-label. The most common off-label drugs were ondansetron (18.5%), fentanyl (12.9%), oxycodone (8.8%) and paracetamol (6.1%). Many ATC classifications included high off-label proportions especially the genitourinary system and sex hormones, respiratory system drugs, systemic hormonal preparations and alimentary tract and metabolism drugs.
This study highlights that prescribing of paediatric drugs needs to be better supported by existing and new evidence. Incentives should be established to foster the conduct of evidence-based studies in the paediatric population. The current level of off-label prescribing raises issues of unexpected toxicity and adverse drug effects in children that are in some cases severely ill.</description><subject>Age</subject><subject>Analgesics</subject><subject>Analysis</subject><subject>Archives & records</subject><subject>Australia - epidemiology</subject><subject>Child</subject><subject>Child health</subject><subject>Child, Preschool</subject><subject>Children</subject><subject>Children's hospitals</subject><subject>Clonidine</subject><subject>Clonidine - therapeutic use</subject><subject>Computer and Information Sciences</subject><subject>Cross-sectional studies</subject><subject>Digestive tract</subject><subject>Drug Administration Routes</subject><subject>Drug dosages</subject><subject>Drug labeling</subject><subject>Drug metabolism</subject><subject>Drug Prescriptions</subject><subject>Drug use</subject><subject>Drugs</subject><subject>Female</subject><subject>Fentanyl</subject><subject>Gastrointestinal tract</subject><subject>Handbooks</subject><subject>Hormones</subject><subject>Humans</subject><subject>Incentives</subject><subject>Inpatients</subject><subject>Isoxazoles - therapeutic use</subject><subject>Laws, regulations and rules</subject><subject>Legislation, Drug</subject><subject>Licensing, certification and accreditation</subject><subject>Male</subject><subject>Medicine and Health Sciences</subject><subject>Metabolism</subject><subject>Metabolites</subject><subject>Midazolam</subject><subject>Midazolam - therapeutic use</subject><subject>Off-Label Use - legislation & jurisprudence</subject><subject>Off-Label Use - statistics & numerical data</subject><subject>Organic chemistry</subject><subject>Oxycodone</subject><subject>Oxycodone - therapeutic use</subject><subject>Paracetamol</subject><subject>Pediatrics</subject><subject>Pediatrics - education</subject><subject>Pediatrics - legislation & jurisprudence</subject><subject>Pharmaceuticals</subject><subject>Pharmacy</subject><subject>Prescription drugs</subject><subject>Product information</subject><subject>Registration</subject><subject>Respiratory system</subject><subject>Sex hormones</subject><subject>Side effects</subject><subject>Studies</subject><subject>Toxicity</subject><subject>Urogenital system</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNqNk12L1DAUhoso7rr6D0QDguBFxzT9SHMjDIMfAwsLfl6GNDmZydBJukm6uPf-cDNOd5mCgjTQcPKcNycv52TZ8wIvipIWb3du9Fb0i8FZWGBSYFLSB9l5wUqSNwSXD0_2Z9mTEHYY12XbNI-zsxKnKK3YefZr5V0IeQAZjUtyKIz-Bm6R02npvBcd9EhYhUbbGwk2gEKDhyC96YzdIO08MnYQ0YCNAYmIBBoEKCOiNxJFEHJ74LYuDCYmfWPRDwgRvEXLMUQveiOeZo-06AM8m_4X2bcP77-uPuWXVx_Xq-VlLhtGYg6iEkCJZBRYhYFRpgrSQNHVFGSLsWJdVxCFdac1VBWFRtBK65pShgmFrrzIXh51h94FPhkYOCmaGteUtCQR6yOhnNjxwZu98LfcCcP_BJzfcOGjkT3wGldKaMVkLUUla9rSrqyUToUwDKRUSevddNvY7UEl8w6vnYnOT6zZ8o274U1JqhbTJPBqEvDuekym_aPkidqIVJWx2iUxuTdB8mXdtJTVjBWJWvyFSp-CvZGphbRJ8VnCm1lCYiL8jBsxhsDXXz7_P3v1fc6-PmG3IPq4Da4fD-0X5mB1BOWhQz3oe-cKzA8TcOcGP0wAnyYgpb04df0-6a7ly9-_JAR5</recordid><startdate>20190108</startdate><enddate>20190108</enddate><creator>Landwehr, Caitlin</creator><creator>Richardson, Jennifer</creator><creator>Bint, Lewis</creator><creator>Parsons, Richard</creator><creator>Sunderland, Bruce</creator><creator>Czarniak, Petra</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0001-7212-0667</orcidid></search><sort><creationdate>20190108</creationdate><title>Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia</title><author>Landwehr, Caitlin ; Richardson, Jennifer ; Bint, Lewis ; Parsons, Richard ; Sunderland, Bruce ; Czarniak, Petra</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-ea4ae72c97e940e979d126e1b57ec800d9bb12d0fbffe447e6a74ff5779027eb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Age</topic><topic>Analgesics</topic><topic>Analysis</topic><topic>Archives & records</topic><topic>Australia - 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therapeutic use</topic><topic>Off-Label Use - legislation & jurisprudence</topic><topic>Off-Label Use - statistics & numerical data</topic><topic>Organic chemistry</topic><topic>Oxycodone</topic><topic>Oxycodone - therapeutic use</topic><topic>Paracetamol</topic><topic>Pediatrics</topic><topic>Pediatrics - education</topic><topic>Pediatrics - legislation & jurisprudence</topic><topic>Pharmaceuticals</topic><topic>Pharmacy</topic><topic>Prescription drugs</topic><topic>Product information</topic><topic>Registration</topic><topic>Respiratory system</topic><topic>Sex hormones</topic><topic>Side effects</topic><topic>Studies</topic><topic>Toxicity</topic><topic>Urogenital system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Landwehr, Caitlin</creatorcontrib><creatorcontrib>Richardson, Jennifer</creatorcontrib><creatorcontrib>Bint, Lewis</creatorcontrib><creatorcontrib>Parsons, Richard</creatorcontrib><creatorcontrib>Sunderland, Bruce</creatorcontrib><creatorcontrib>Czarniak, Petra</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - 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A retrospective cross-sectional study was conducted in June, 2013. Patient and prescribing data were collected from 190 inpatient medication chart records which had been randomly selected from all admissions during the second week of February 2013. Drugs were categorised as licensed, off-label or unlicensed, according to their approved Australian registration product information (PI). All drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code.
There were 120 male and 70 female inpatients. The average age was 6.0 years (± 4.7). The study included 1160 prescribed drugs suitable for analysis. The number of drugs prescribed per patient ranged from 1 to 25 with an average of 6.1 (± 4.3). More than half (54%) were prescribed off-label. Oxycodone, clonidine, parecoxib and midazolam were always prescribed off-label. The most common off-label drugs were ondansetron (18.5%), fentanyl (12.9%), oxycodone (8.8%) and paracetamol (6.1%). Many ATC classifications included high off-label proportions especially the genitourinary system and sex hormones, respiratory system drugs, systemic hormonal preparations and alimentary tract and metabolism drugs.
This study highlights that prescribing of paediatric drugs needs to be better supported by existing and new evidence. Incentives should be established to foster the conduct of evidence-based studies in the paediatric population. The current level of off-label prescribing raises issues of unexpected toxicity and adverse drug effects in children that are in some cases severely ill.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>30620749</pmid><doi>10.1371/journal.pone.0210237</doi><tpages>e0210237</tpages><orcidid>https://orcid.org/0000-0001-7212-0667</orcidid><oa>free_for_read</oa></addata></record> |
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| recordid | cdi_plos_journals_2165057282 |
| source | Public Library of Science (PLoS) Journals Open Access; MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Age Analgesics Analysis Archives & records Australia - epidemiology Child Child health Child, Preschool Children Children's hospitals Clonidine Clonidine - therapeutic use Computer and Information Sciences Cross-sectional studies Digestive tract Drug Administration Routes Drug dosages Drug labeling Drug metabolism Drug Prescriptions Drug use Drugs Female Fentanyl Gastrointestinal tract Handbooks Hormones Humans Incentives Inpatients Isoxazoles - therapeutic use Laws, regulations and rules Legislation, Drug Licensing, certification and accreditation Male Medicine and Health Sciences Metabolism Metabolites Midazolam Midazolam - therapeutic use Off-Label Use - legislation & jurisprudence Off-Label Use - statistics & numerical data Organic chemistry Oxycodone Oxycodone - therapeutic use Paracetamol Pediatrics Pediatrics - education Pediatrics - legislation & jurisprudence Pharmaceuticals Pharmacy Prescription drugs Product information Registration Respiratory system Sex hormones Side effects Studies Toxicity Urogenital system |
| title | Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-28T23%3A31%3A22IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Cross-sectional%20survey%20of%20off-label%20and%20unlicensed%20prescribing%20for%20inpatients%20at%20a%20paediatric%20teaching%20hospital%20in%20Western%20Australia&rft.jtitle=PloS%20one&rft.au=Landwehr,%20Caitlin&rft.date=2019-01-08&rft.volume=14&rft.issue=1&rft.spage=e0210237&rft.pages=e0210237-&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0210237&rft_dat=%3Cgale_plos_%3EA568795991%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2165057282&rft_id=info:pmid/30620749&rft_galeid=A568795991&rft_doaj_id=oai_doaj_org_article_504dafd9c5ca4c5787b34dfc8090e23d&rfr_iscdi=true |