{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T11:01:45Z","timestamp":1789124505327,"version":"build-2803163510"},"reference-count":37,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2025,1,24]],"date-time":"2025-01-24T00:00:00Z","timestamp":1737676800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Children"],"abstract":"<jats:p>Background\/Objectives: Off-label drug use is prevalent in pediatric care, particularly in pediatric palliative care (PPC), due to the scarcity of pediatric-specific formulations and clinical trials. Differences in perception between healthcare professionals regarding off-label prescriptions underscore the complexity of this practice and highlight the need for improved collaboration to optimize therapeutic outcomes. Methods: A cross-sectional observational study was conducted from August to October 2021 at the PPC center of the University Hospital of Padova, Italy. Data were collected from medical records of 169 patients. Off-label prescriptions were independently assessed by two physicians and two clinical pharmacists using respective reference sources. Discrepancies were resolved through consensus. Statistical analyses included the \u03c72-test for categorical variables and t-tests for continuous data. Results: Among the 993 drug prescriptions analyzed, the pharmacists reported a higher proportion of off-label uses (32.9%) compared to the physicians (18.4%; p &lt; 0.05). After a consensus, 26.5% of the prescriptions were identified as off-label, with 67.9% due to indications, 49.6% due to dosage, and 44.4% due to age discrepancies. Conclusions: This study suggests a high prevalence of off-label prescribing in pediatric palliative care (PPC) and highlights differing professional perspectives, underscoring the potential benefits of exploring standardized protocols and enhanced interdisciplinary collaboration. Enhanced communication between healthcare providers, alongside the development of registries and clinical trials, is essential for improving the safety and efficacy of off-label drug use in pediatric populations. A flexible regulatory framework and customized galenic formulations could further support these goals.<\/jats:p>","DOI":"10.3390\/children12020124","type":"journal-article","created":{"date-parts":[[2025,1,24]],"date-time":"2025-01-24T03:26:31Z","timestamp":1737689191000},"page":"124","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1374-1505","authenticated-orcid":false,"given":"Daniele","family":"Mengato","sequence":"first","affiliation":[{"name":"Hospital Pharmacy Department, Azienda Ospedale-Universit\u00e0 Padova, Via Giustiniani, 35128 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4210-8509","authenticated-orcid":false,"given":"Anna","family":"Zanin","sequence":"additional","affiliation":[{"name":"Palliative Care and Pain Service, Department of Women\u2019s and Children\u2019s Health, University of Padua, Via Giustiniani, 3-35128 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Baratiri","sequence":"additional","affiliation":[{"name":"Palliative Care and Pain Service, Department of Women\u2019s and Children\u2019s Health, University of Padua, Via Giustiniani, 3-35128 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Pivato","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy Department, Azienda Ospedale-Universit\u00e0 Padova, Via Giustiniani, 35128 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Camuffo","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy Department, Azienda Ospedale-Universit\u00e0 Padova, Via Giustiniani, 35128 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8312-6976","authenticated-orcid":false,"given":"Franca","family":"Benini","sequence":"additional","affiliation":[{"name":"Palliative Care and Pain Service, Department of Women\u2019s and Children\u2019s Health, University of Padua, Via Giustiniani, 3-35128 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0396-4377","authenticated-orcid":false,"given":"Francesca","family":"Venturini","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy Department, Azienda Ospedale-Universit\u00e0 Padova, Via Giustiniani, 35128 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,1,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"643","DOI":"10.1586\/ecp.11.43","article-title":"Innovative clinical trial design for pediatric therapeutics","volume":"4","author":"Laughon","year":"2011","journal-title":"Expert. Rev. Clin. Pharmacol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"703","DOI":"10.1517\/14740338.5.5.703","article-title":"Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety","volume":"5","author":"Cuzzolin","year":"2006","journal-title":"Expert. Opin. Drug Saf."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.jpeds.2019.01.038","article-title":"Off-Label Drugs in Neonatology: Analyses Using Large Data Bases","volume":"208","author":"Jobe","year":"2019","journal-title":"J. Pediatr."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1542\/hpeds.2018-0168","article-title":"Off-label Medication Prescribing Patterns in Pediatrics: An Update","volume":"9","author":"Yackey","year":"2019","journal-title":"Hosp. Pediatr."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"w30124","DOI":"10.4414\/SMW.2022.w30124","article-title":"Off-label use of psychotropic drugs in a Swiss paediatric service: Similar results from two different cohort studies","volume":"152","author":"Feka","year":"2022","journal-title":"Swiss Med. Wkly"},{"key":"ref_6","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":"ref_7","doi-asserted-by":"crossref","first-page":"1050","DOI":"10.1111\/bcp.15995","article-title":"PAttern of drug use in PEdiatrics: An observational study in Italian hOSpitals (the PAPEOS study)","volume":"90","author":"Laurini","year":"2024","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1186\/s13052-020-0809-5","article-title":"Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit","volume":"46","author":"Gidey","year":"2020","journal-title":"Ital. J. Pediatr."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1007\/s11096-021-01303-5","article-title":"Regulating pediatric off-label uses of medicines in the EU and USA: Challenges and potential solutions: Comparative regulation framework of off label prescriptions in pediatrics: A review","volume":"44","author":"Guidi","year":"2022","journal-title":"Int. J. Clin. Pharm."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"949","DOI":"10.24953\/turkjped.2020.06.006","article-title":"Off-label drug use in pediatric patients: A comparative analysis with nationwide routine prescription data","volume":"62","author":"Bayar","year":"2020","journal-title":"Turk. J. Pediatr."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"e13869","DOI":"10.1111\/cts.13869","article-title":"Age-related off-label drug prescribing in pediatric patients in South Korea and consistency of labeling compared to the United States, Europe, and Japan","volume":"17","author":"Park","year":"2024","journal-title":"Clin. Transl. Sci."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"e529","DOI":"10.1016\/j.jpainsymman.2021.12.031","article-title":"International Standards for Pediatric Palliative Care: From IMPaCCT to GO-PPaCS","volume":"63","author":"Benini","year":"2022","journal-title":"J. Pain Symptom Manag."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1186\/s13052-020-00952-y","article-title":"An estimation of the number of children requiring pediatric palliative care in Italy","volume":"47","author":"Benini","year":"2021","journal-title":"Ital. J. Pediatr."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1346","DOI":"10.1089\/jpm.2024.0113","article-title":"A Nationwide Study to Evaluate Accessibility to Specialized Pediatric Palliative Care in Italy-Patients, Needs, and Critical Issues: The PalliPed Study","volume":"27","author":"Benini","year":"2024","journal-title":"J. Palliat. Med."},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"Bakaki, P.M., Horace, A., Dawson, N., Winterstein, A., Waldron, J., Staley, J., Knight, E.M.P., Meropol, S.B., Liu, R., and Johnson, H. (2018). Defining pediatric polypharmacy: A scoping review. PLoS ONE, 13.","DOI":"10.1371\/journal.pone.0208047"},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Zanin, A., Baratiri, F., Roverato, B., Mengato, D., Pivato, L., Avagnina, I., Maghini, I., Divisic, A., Rusalen, F., and Agosto, C. (2024). Polypharmacy in Children with Medical Complexity: A Cross-Sectional Study in a Pediatric Palliative Care Center. Children, 11.","DOI":"10.3390\/children11070821"},{"key":"ref_17","first-page":"426","article-title":"Polypharmacy among pediatric cancer patients dying in the hospital","volume":"23","author":"Tamir","year":"2021","journal-title":"Isr. Med. Assoc. J."},{"key":"ref_18","first-page":"e23082","article-title":"Awareness and Views of Pharmacists and Physicians Toward Prescribing of Drugs for Off-Label Use in the Pediatric Population in Saudi Arabia","volume":"14","author":"Alyami","year":"2022","journal-title":"Cureus"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"86","DOI":"10.18773\/austprescr.2023.022","article-title":"Ongoing challenges of off-label prescribing","volume":"46","author":"Day","year":"2023","journal-title":"Aust. Prescr."},{"key":"ref_20","first-page":"979","article-title":"Physician-pharmacist agreement about off-label use of medications in private clinical settings in Baghdad, Iraq","volume":"15","author":"Hussain","year":"2017","journal-title":"Pharm. Pract."},{"key":"ref_21","unstructured":"Italian Medicines Agency (AIFA) (2024, December 30). Early Access and Off-Label Use, Available online: https:\/\/www.aifa.gov.it\/en\/accesso-precoce-uso-off-label."},{"key":"ref_22","unstructured":"Orphanet (2024, December 23). Knowledge on Rare Diseases and Orphan Drugs. Available online: https:\/\/www.orpha.net\/en\/disease."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"826","DOI":"10.1002\/phar.1452","article-title":"Validation of a patient-level medication regimen complexity index as a possible tool to identify patients for medication therapy management intervention","volume":"34","author":"Hirsch","year":"2014","journal-title":"Pharmacotherapy"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1269","DOI":"10.1111\/bcp.12750","article-title":"Awareness, knowledge and views of off-label prescribing in children: A systematic review","volume":"80","author":"Balan","year":"2015","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Almintakh, L.S., Al Dossary, M.F., Altesha, A.M., Alqahtani, R.F., Alsomali, S.M., Banu, N., Ali, M.D., and Ahmed, A. (2024). Awareness, Practice, and Views of Pediatricians, General Physicians, and Pharmacists about Prescribing Off-label Medication in Pediatric Patients in Eastern Province, Saudi Arabia. Curr. Pediatr. Rev.","DOI":"10.2174\/0115733963298903240614072717"},{"key":"ref_26","doi-asserted-by":"crossref","unstructured":"Meng, M., Hu, J., Liu, X., Tian, M., Lei, W., Liu, E., Han, Z., Li, Q., and Chen, Y. (2024). Barriers and facilitators to guideline for the management of pediatric off-label use of drugs in China: A qualitative descriptive study. BMC Health Serv. Res., 24.","DOI":"10.1186\/s12913-024-10860-0"},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Nelson, K.E., Feinstein, J.A., Gerhardt, C.A., Rosenberg, A.R., Widger, K., Faerber, J.A., and Feudtner, C. (2018). Emerging Methodologies in Pediatric Palliative Care Research: Six Case Studies. Children, 5.","DOI":"10.3390\/children5030032"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"923","DOI":"10.1016\/j.jpainsymman.2020.06.014","article-title":"Off-Label and Unlicensed Drugs in Pediatric Palliative Care: A Prospective Observational Study","volume":"60","year":"2020","journal-title":"J. Pain Symptom Manag."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1007\/s13312-017-1045-y","article-title":"Ethical Off-label Drug use: Need for a Rethink?","volume":"54","author":"Zheng","year":"2017","journal-title":"Indian Pediatr."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1163\/15718093-bja10123","article-title":"Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe","volume":"31","author":"Roslin","year":"2024","journal-title":"Eur. J. Health Law"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"144","DOI":"10.1186\/s13052-018-0584-8","article-title":"Off-label drugs use in pediatric palliative care","volume":"44","author":"Marchetti","year":"2018","journal-title":"Ital. J. Pediatr."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1186\/s13052-024-01809-4","article-title":"The role and perception of the caregiver in a specialized pediatric palliative care center in medicine preparation and administration: A survey study","volume":"50","author":"Baratiri","year":"2024","journal-title":"Ital. J. Pediatr."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"100079","DOI":"10.1016\/j.ijnsa.2022.100079","article-title":"Nurse-pharmacist collaborations for promoting medication safety among community-dwelling adults: A scoping review","volume":"4","author":"Ravi","year":"2022","journal-title":"Int. J. Nurs. Stud. Adv."},{"key":"ref_34","doi-asserted-by":"crossref","unstructured":"Mengato, D., Zanin, A., Russello, S., Baratiri, F., Roverato, B., Realdon, N., Benini, F., and Venturini, F. (2024). Taking care of caregivers: Enhancing proper medication management for palliative care children with polypharmacy. Eur. J. Hosp. Pharm.","DOI":"10.1136\/ejhpharm-2024-004282"},{"key":"ref_35","doi-asserted-by":"crossref","unstructured":"Pornrattanakavee, P., Srichan, T., Seetalarom, K., Saichaemchan, S., Oer-Areemitr, N., and Prasongsook, N. (2022). Impact of interprofessional col-laborative practice in palliative care on outcomes for advanced cancer inpatients in a resource-limited setting. BMC Palliat. Care, 21.","DOI":"10.1186\/s12904-022-01121-0"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"1755","DOI":"10.1089\/jpm.2023.0186","article-title":"A Specialist Palliative Pharmacist Enriches the Interdisciplinary Team: A Case Series Discussion Illustrating the Entrustable Professional Activities for Specialist Hospice and Palliative Care Pharmacists","volume":"26","author":"Atayee","year":"2023","journal-title":"J. Palliat. Med."},{"key":"ref_37","unstructured":"(2024, December 31). Italian Medicines Agency (AIFA), Available online: https:\/\/www.aifa.gov.it\/en\/legge-648-96."}],"container-title":["Children"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2227-9067\/12\/2\/124\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T10:35:11Z","timestamp":1759919711000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2227-9067\/12\/2\/124"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,24]]},"references-count":37,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2025,2]]}},"alternative-id":["children12020124"],"URL":"https:\/\/doi.org\/10.3390\/children12020124","relation":{},"ISSN":["2227-9067"],"issn-type":[{"value":"2227-9067","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,24]]}}}