{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T05:37:57Z","timestamp":1781329077191,"version":"3.54.1"},"reference-count":26,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,5,19]],"date-time":"2023-05-19T00:00:00Z","timestamp":1684454400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Microbiol."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Off-label drug use is a global problem for which many countries and regions have issued legal provisions or reached an expert consensus. Off-label use is sometimes a necessity, especially since antibacterial drugs have become one of the most widely used drugs in pediatric settings and the issue of causing antimicrobial resistance has increasingly become unavoidable. It also poses additional risks, such as adverse drug reactions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Our study analyzed the antimicrobial prescriptions of pediatric inpatients in a large Chinese hospital in the first half of 2021. This retrospective investigation included 6,829 prescriptions, including 2,294 off-label prescriptions. We performed descriptive analyses of prescription antimicrobial agents among pediatric populations and reported the percentages and frequencies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> It was found that off-label use of antibiotics was present in many children (<jats:italic>n\u2009<\/jats:italic>=\u20091,665, 48.9%) and was most common in newborns (<jats:italic>n\u2009<\/jats:italic>\u2009=\u2009328, 82.8%). Among the commonly used antibiotics in pediatric patients, cephalosporins (<jats:italic>n\u2009<\/jats:italic>\u2009=\u20092,778, 40.7%) accounted for a relatively low proportion of offlabel use (<jats:italic>n\u2009<\/jats:italic>\u2009=\u2009360, 15.7%), while macrolides (<jats:italic>n\u2009<\/jats:italic>\u2009=\u2009628, 27.4%) and penicillins (<jats:italic>n\u2009<\/jats:italic>\u2009=\u2009610, 26.6%) accounted for a higher proportion. The off-label type mainly referred to the appropriate population (46.5%) and dosage (dose, 10.0%; frequency of administration, 48.3%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Off-label use was due to imperfect labels, improper medications, or medication errors. Only a few consensuses could apply to pediatric patients. More clinical trials are required to update the consensus, and drug labels must be continuously improved. The prescription behavior of doctors is also needed to be regulated. Rational use of drugs, especially antimicrobials, is the responsibility of all people, including the states, medical institutions, and individuals.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmicb.2023.1173042","type":"journal-article","created":{"date-parts":[[2023,5,19]],"date-time":"2023-05-19T06:00:29Z","timestamp":1684476029000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":9,"title":["Off-label use of antimicrobials among hospitalized children: a retrospective study of 3,406 patients"],"prefix":"10.3389","volume":"14","author":[{"given":"Lin","family":"Tang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ning","family":"Hou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,5,19]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"474","DOI":"10.1002\/pds.4978","article-title":"Off-label use of prescription analgesics among hospitalized children in the United States","volume":"29","author":"Carmack","year":"2020","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref2","doi-asserted-by":"publisher","first-page":"266","DOI":"10.3390\/antibiotics10030266","article-title":"Antibiotic resistant bloodstream infections in Pediatric patients receiving chemotherapy or hematopoietic stem cell transplant: factors associated with development of resistance, intensive care admission and mortality","volume":"10","author":"Castagnola","year":"2021","journal-title":"Antibiotics"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"410","DOI":"10.3760\/cma.j.issn.1001-0939.2015.06.005","article-title":"Expert consensus on the over-instruction usage of antibacterial drugs","volume":"38","author":"Chen","year":"2015","journal-title":"Chin. J. Tuberc. Respir. 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Pain Symptom Manag."},{"key":"ref7","doi-asserted-by":"publisher","first-page":"18","DOI":"10.2174\/1574884712666170317161935","article-title":"Pediatric off-label and unlicensed drug use and its implications","volume":"12","author":"Gore","year":"2017","journal-title":"Curr. Clin. Pharmacol."},{"key":"ref8","doi-asserted-by":"publisher","first-page":"50","DOI":"10.3969\/j.issn.1672-3384.2014.02.012","article-title":"A survey of off-label drug use prescriptions in outpatient of Beijing Children's hospital","volume":"12","author":"Guo","year":"2014","journal-title":"Clin. Med. J."},{"key":"ref9","doi-asserted-by":"publisher","first-page":"1","DOI":"10.2147\/PTT.S268462","article-title":"Off-label treatments for Pediatric psoriasis: lessons for the clinic","volume":"11","author":"Haulrig","year":"2021","journal-title":"Psoriasis"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"9","DOI":"10.3969\/j.issn.1672-3384.2021.06.002","article-title":"Expert consensus on off-label drug use of Shandong Province","volume":"6","author":"Hou","year":"2021","journal-title":"Clin. Med. J."},{"key":"ref11","year":"2023"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"393","DOI":"10.3390\/antibiotics10040393","article-title":"Antibiotic resistance in Pediatric infections: global emerging threats, predicting the near future","volume":"10","author":"Romandini","year":"2021","journal-title":"Antibiotics"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"2103","DOI":"10.1210\/clinem\/dgab276","article-title":"Aversion to off-label prescribing in clinical Pediatric weight management: the quintessential double standard","volume":"106","author":"San Giovanni","year":"2021","journal-title":"J. Clin. Endocrinol. Metab."},{"key":"ref14","doi-asserted-by":"publisher","first-page":"33","DOI":"10.2147\/IPRP.S231134","article-title":"Exploratory findings of prescribing unlicensed and off-label medicines among children and neonates","volume":"9","author":"Shakeel","year":"2020","journal-title":"Integr. Pharm. Res. Pract."},{"key":"ref15","doi-asserted-by":"publisher","first-page":"1267","DOI":"10.31838\/srp.2021.1.177","article-title":"Off-label prescribing practice in Pediatric settings: pros and cons","volume":"12","author":"Shanshal","year":"2021","journal-title":"Syst. Rev. Pharm."},{"key":"ref16","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1186\/s40779-021-00362-z","article-title":"Towards a better understanding of antimicrobial resistance dissemination: what can be learnt from studying model conjugative plasmids?","volume":"9","author":"Shen","year":"2022","journal-title":"Mil. Med. Res."},{"key":"ref17","doi-asserted-by":"publisher","first-page":"33","DOI":"10.3969\/j.issn.2096-3327.2022.11.002","article-title":"Expert consensus on off-label drug use of Shandong Province (2022 edition): part of Pediatric drug use","volume":"11","author":"Tang","year":"2022","journal-title":"Chin. J. Rational Drug Use."},{"key":"ref18","year":"2020"},{"key":"ref19","year":"2014"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"104","DOI":"10.15887\/j.cnki.13-1389\/r.2020.19.049","article-title":"Investigation and analysis of the current situation of over-instruction antibacterial drugs used in pediatrics","volume":"13","author":"Wu","year":"2020","journal-title":"Chin. J. Clin. Rational Drug Use."},{"key":"ref21","doi-asserted-by":"publisher","first-page":"473","DOI":"10.13664\/j.cnki.pcr.2020.06.019","article-title":"Comparative study on the administration policies of drugs used in the instructions of the Chinese and English premier leagues","volume":"6","author":"Xie","year":"2020","journal-title":"Pharm. Clin. Res."},{"key":"ref22","year":"2023"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"135","DOI":"10.4274\/JCP.2021.0019","article-title":"Antibiotic usage in the Pediatric population: the need for effective role of parents and prescribers","volume":"19","author":"Yusuf","year":"2021","journal-title":"J. Curr. Pediatr."},{"key":"ref24","first-page":"426","article-title":"Evidence-based evaluation on off-label drug use policies in 15 countries","volume":"12","author":"Zhang","year":"2012","journal-title":"Chin. J. Evid. Based Med."},{"key":"ref25","doi-asserted-by":"publisher","first-page":"335","DOI":"10.1007\/s12519-018-0176-0","article-title":"Antibiotic usage in Chinese children: a point prevalence survey","volume":"14","author":"Zhang","year":"2018","journal-title":"World J. Pediatr."},{"key":"ref26","doi-asserted-by":"publisher","first-page":"e14010","DOI":"10.1111\/ijcp.14010","article-title":"Recommendations on off-label use of intravenous azithromycin in children","volume":"75","author":"Zhou","year":"2021","journal-title":"Int. J. Clin. 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