{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T02:04:40Z","timestamp":1777860280414,"version":"3.51.4"},"reference-count":31,"publisher":"SAGE Publications","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JRS"],"published-print":{"date-parts":[[2021,11,5]]},"abstract":"<jats:p>BACKGROUND: Off-label drug (OLD) use is common in neonates. OBJECTIVE: There is a dearth of information associating the OLD use and the risk of medication errors in critically ill neonates. Hence, the present study was carried out. METHODS: Drug prescriptions in neonates admitted to the intensive care unit of a tertiary care hospital between September 2018 and June 2019 were evaluated. Details on their demographics, reason for admission in intensive care unit, drug-related information and serum creatinine were extracted. United States Food and Drug Administration approved drug labels were compared. World Health Organization (WHO) anatomy, therapeutic and chemical (ATC) classification was used for drug categorization. We assessed the risk of medication errors in the adult population using a validated tool: medication risk score (MERIS). RESULTS: One hundred and seventy-one neonates with 2394 prescriptions were included in this study. Seventy one percent of the neonates in the present study received at least one OLD\/unlicensed prescription item. A trend in increased numbers of OLD\/unlicensed drug use in more premature and lower birth weight neonates were observed. Medication risk score was significantly higher in neonates receiving OLD\/unlicensed drugs compared to those with only labelled drugs. Very and extreme pre-term (along with very low and extremely low birth weight) neonates were at higher risk of medication errors compared to others. Presence of OLD\/unlicensed prescribed items is associated with a potentially increased risk of medication errors by an odds ratio of 20.4 compared to labelled drugs. CONCLUSION: Significant proportions of critically ill neonates received at least one OLD\/unlicensed drug and such use was associated with potentially increased risk of medication errors.<\/jats:p>","DOI":"10.3233\/jrs-200058","type":"journal-article","created":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T12:34:32Z","timestamp":1614342872000},"page":"279-293","source":"Crossref","is-referenced-by-count":4,"title":["Off-label drug use and the risk of medication errors in critically ill neonates: A conceptual pilot study"],"prefix":"10.1177","volume":"32","author":[{"given":"Kannan","family":"Sridharan","sequence":"first","affiliation":[{"name":", , Arabian Gulf University, , Kingdom of Bahrain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Muna","family":"Al Jufairi","sequence":"additional","affiliation":[{"name":", , Arabian Gulf University, , Kingdom of Bahrain"},{"name":"Neonatal Intensive Care Unit, Salmaniya Medical Complex, , , Kingdom of Bahrain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eman","family":"Al Ansari","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit, Salmaniya Medical Complex, , , Kingdom of Bahrain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","reference":[{"key":"10.3233\/JRS-200058_ref1","doi-asserted-by":"crossref","first-page":"982","DOI":"10.1016\/j.mayocp.2012.04.017","article-title":"Ten common questions (and their answers) about off-label drug use","volume":"87","author":"Wittich","year":"2012","journal-title":"Mayo Clin Proc"},{"key":"10.3233\/JRS-200058_ref2","doi-asserted-by":"crossref","first-page":"316","DOI":"10.1016\/j.phrs.2008.09.007","article-title":"Defining off-label and unlicensed use of medicines for children: Results of a Delphi survey","volume":"58","author":"Neubert","year":"2008","journal-title":"Pharmacol Res"},{"key":"10.3233\/JRS-200058_ref3","doi-asserted-by":"crossref","first-page":"35","DOI":"10.2298\/MPNS1502035G","article-title":"Reasons for and frequency of off-label drug use","volume":"68","author":"Golo\u010dorbin-Kon","year":"2015","journal-title":"Med Pregl"},{"key":"10.3233\/JRS-200058_ref4","doi-asserted-by":"crossref","first-page":"124","DOI":"10.1016\/j.ajp.2016.09.007","article-title":"Off-label drug use in psychiatry: A retrospective audit in a tertiary care hospital","volume":"24","author":"Sridharan","year":"2016","journal-title":"Asian J Psychiatr"},{"key":"10.3233\/JRS-200058_ref5","doi-asserted-by":"crossref","first-page":"61","DOI":"10.3233\/JRS-140613","article-title":"Awareness about and views of parents on the off-label drug use in children","volume":"26","author":"Bang","year":"2014","journal-title":"Int J Risk Saf Med"},{"key":"10.3233\/JRS-200058_ref6","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1177\/1062860615599838","article-title":"Off-label prescribing: justified or not?","volume":"31","author":"Ruan","year":"2016","journal-title":"Am J Med Qual"},{"issue":"5","key":"10.3233\/JRS-200058_ref8","doi-asserted-by":"crossref","first-page":"839","DOI":"10.1007\/s00431-019-03556-9","article-title":"Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology","volume":"179","author":"Schrier","year":"2020","journal-title":"Eur J Pediatr"},{"key":"10.3233\/JRS-200058_ref10","doi-asserted-by":"crossref","first-page":"pii: e20170195","DOI":"10.1542\/peds.2017-0195","article-title":"Methodological and ethical issues in pediatric medication safety research","volume":"140","author":"Carpenter","year":"2017","journal-title":"Pediatrics"},{"key":"10.3233\/JRS-200058_ref11","doi-asserted-by":"crossref","first-page":"80","DOI":"10.1016\/j.phrs.2016.04.025","article-title":"Clinical research in neonates and infants: Challenges and perspectives","volume":"108","author":"Coppini","year":"2016","journal-title":"Pharmacol Res"},{"key":"10.3233\/JRS-200058_ref12","doi-asserted-by":"crossref","first-page":"e00304","DOI":"10.1002\/prp2.304","article-title":"Off-label drug use in hospitalized children: A prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia","volume":"5","author":"Tefera","year":"2017","journal-title":"Pharmacol Res Perspect"},{"key":"10.3233\/JRS-200058_ref13","doi-asserted-by":"crossref","first-page":"563","DOI":"10.1542\/peds.2013-4060","article-title":"American academy of pediatrics committee on drugs. Off-label use of drugs in children","volume":"133","author":"Frattarelli","year":"2014","journal-title":"Pediatrics"},{"key":"10.3233\/JRS-200058_ref14","first-page":"186","article-title":"Patterns of off-label prescribing in the pediatric intensive care unit and prioritizing future research","volume":"20","author":"Czaja","year":"2015","journal-title":"J Pediatr Pharmacol Ther"},{"key":"10.3233\/JRS-200058_ref15","doi-asserted-by":"crossref","first-page":"e20163518","DOI":"10.1542\/peds.2016-3518","article-title":"Comparative effectiveness research through collaborative electronic reporting (CER2) consortium. Beyond the label: Steering the focus toward safe and effective prescribing","volume":"139","author":"Czaja","year":"2017","journal-title":"Pediatrics"},{"key":"10.3233\/JRS-200058_ref16","doi-asserted-by":"crossref","first-page":"961","DOI":"10.1038\/nbt1109-961","article-title":"Pfizer settles largest ever fraud suit for off-label promotion","volume":"27","author":"Ratner","year":"2009","journal-title":"Nat Biotechnol"},{"key":"10.3233\/JRS-200058_ref17","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1186\/s12887-016-0551-8","article-title":"Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study","volume":"16","author":"de Souza","year":"2016","journal-title":"BMC Pediatr"},{"key":"10.3233\/JRS-200058_ref18","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1111\/bcpt.12473","article-title":"Detection of patients at high risk of medication errors: Development andvalidation of an algorithm","volume":"118","author":"Saedder","year":"2016","journal-title":"Basic Clin Pharmacol Toxicol"},{"key":"10.3233\/JRS-200058_ref19","doi-asserted-by":"crossref","first-page":"1167","DOI":"10.1093\/clinchem\/24.7.1167","article-title":"A useful method for predicting creatinine clearance in children","volume":"24","author":"Shull","year":"1978","journal-title":"Clin Chem"},{"key":"10.3233\/JRS-200058_ref22","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1016\/S1470-0328(03)00021-1","article-title":"Classification and heterogeneity of preterm birth","volume":"110","author":"Moutquin","year":"2003","journal-title":"BJOG"},{"key":"10.3233\/JRS-200058_ref24","doi-asserted-by":"crossref","first-page":"665","DOI":"10.1046\/j.1365-2125.2002.t01-3-01689.x","article-title":"Adverse drug reactions and off-label drug use in paediatric outpatients","volume":"54","author":"Horen","year":"2002","journal-title":"Br J Clin Pharmacol"},{"key":"10.3233\/JRS-200058_ref25","doi-asserted-by":"crossref","first-page":"1089","DOI":"10.1542\/peds.108.5.1089","article-title":"A survey of the use of off label and unlicensed drugs in a Dutch children\u2019s hospital","volume":"108","author":"Jong","year":"2001","journal-title":"Pediatrics"},{"key":"10.3233\/JRS-200058_ref26","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1136\/bmj.320.7227.79","article-title":"Survey of unlicensed and off label drug use in paediatric wards in European countries","volume":"320","author":"Conroy","year":"2000","journal-title":"BMJ"},{"key":"10.3233\/JRS-200058_ref27","doi-asserted-by":"crossref","first-page":"e52","DOI":"10.1542\/peds.110.5.e52","article-title":"Unlicensed and off-label use in an Australian neonatal intensive care unit","volume":"110","author":"O\u2019Donnell","year":"2002","journal-title":"Pediatrics"},{"key":"10.3233\/JRS-200058_ref28","doi-asserted-by":"crossref","first-page":"412","DOI":"10.1016\/j.jpeds.2007.07.050","article-title":"Medication use in the neonatal intensive care unit: Current patterns and off-label use of parenteral medications","volume":"152","author":"Kumar","year":"2008","journal-title":"J Pediatr"},{"key":"10.3233\/JRS-200058_ref29","doi-asserted-by":"crossref","first-page":"260","DOI":"10.1016\/j.ijpharm.2014.03.058","article-title":"More than 5 years of European Paediatric regulation: Statistics and industrial experience","volume":"469","author":"Winzenburg","year":"2014","journal-title":"Int J Pharm"},{"key":"10.3233\/JRS-200058_ref30","doi-asserted-by":"crossref","first-page":"144","DOI":"10.1111\/jcpt.12119","article-title":"Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the European Union Paediatric Regulation","volume":"39","author":"Lindell-Osuagwu","year":"2014","journal-title":"J Clin Pharm Ther"},{"key":"10.3233\/JRS-200058_ref31","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1007\/s11096-013-9755-2","article-title":"Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA","volume":"35","author":"Borges","year":"2013","journal-title":"Int J Clin Pharm"},{"key":"10.3233\/JRS-200058_ref32","doi-asserted-by":"crossref","first-page":"563","DOI":"10.1542\/peds.2013-4060","article-title":"American academy of pediatrics committee on drugs. Off-label use of drugs in children","volume":"133","author":"Frattarelli","year":"2014","journal-title":"Pediatrics"},{"key":"10.3233\/JRS-200058_ref33","doi-asserted-by":"crossref","first-page":"1609","DOI":"10.1542\/peds.113.6.1609","article-title":"Voluntary anonymous reporting of medical errors for neonatal intensive care","volume":"113","author":"Suresh","year":"2004","journal-title":"Pediatrics"},{"key":"10.3233\/JRS-200058_ref34","doi-asserted-by":"crossref","first-page":"2114","DOI":"10.1001\/jama.285.16.2114","article-title":"Medication errors and adverse drug events in pediatric inpatients","volume":"285","author":"Kaushal","year":"2001","journal-title":"JAMA"},{"key":"10.3233\/JRS-200058_ref35","doi-asserted-by":"crossref","first-page":"F472","DOI":"10.1136\/adc.2003.046060","article-title":"Medication errors in the neonatal intensive care unit: special patients, unique issues","volume":"89","author":"Gray","year":"2004","journal-title":"Arch Dis Child Fetal Neonatal Ed"},{"key":"10.3233\/JRS-200058_ref36","first-page":"598","article-title":"Your high-alert medication list is relatively useless without associated risk-reduction strategies","volume":"41","author":"Grissinger","year":"2016","journal-title":"P T"}],"container-title":["International Journal of Risk &amp; Safety in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/content.iospress.com\/download?id=10.3233\/JRS-200058","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T00:45:21Z","timestamp":1777509921000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/full\/10.3233\/JRS-200058"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,5]]},"references-count":31,"journal-issue":{"issue":"4"},"URL":"https:\/\/doi.org\/10.3233\/jrs-200058","relation":{},"ISSN":["0924-6479","1878-6847"],"issn-type":[{"value":"0924-6479","type":"print"},{"value":"1878-6847","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11,5]]}}}