Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists

<b>Background/Objectives</b>: 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 pre...

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Main Authors: Daniele Mengato, Anna Zanin, Fernando Baratiri, Lisa Pivato, Laura Camuffo, Franca Benini, Francesca Venturini
Format: Article
Language:English
Published: MDPI AG 2025-01-01
Series:Children
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Online Access:https://www.mdpi.com/2227-9067/12/2/124
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author Daniele Mengato
Anna Zanin
Fernando Baratiri
Lisa Pivato
Laura Camuffo
Franca Benini
Francesca Venturini
author_facet Daniele Mengato
Anna Zanin
Fernando Baratiri
Lisa Pivato
Laura Camuffo
Franca Benini
Francesca Venturini
author_sort Daniele Mengato
collection DOAJ
description <b>Background/Objectives</b>: 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. <b>Methods</b>: 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 χ<sup>2</sup>-test for categorical variables and <i>t</i>-tests for continuous data. <b>Results</b>: Among the 993 drug prescriptions analyzed, the pharmacists reported a higher proportion of off-label uses (32.9%) compared to the physicians (18.4%; <i>p</i> < 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. <b>Conclusions</b>: 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.
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spelling doaj-art-4d14c1c99bfb4254a245d31b5ab4aca02025-08-20T03:12:08ZengMDPI AGChildren2227-90672025-01-0112212410.3390/children12020124Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and PharmacistsDaniele Mengato0Anna Zanin1Fernando Baratiri2Lisa Pivato3Laura Camuffo4Franca Benini5Francesca Venturini6Hospital Pharmacy Department, Azienda Ospedale-Università Padova, Via Giustiniani, 35128 Padua, ItalyPalliative Care and Pain Service, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3-35128 Padua, ItalyPalliative Care and Pain Service, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3-35128 Padua, ItalyHospital Pharmacy Department, Azienda Ospedale-Università Padova, Via Giustiniani, 35128 Padua, ItalyHospital Pharmacy Department, Azienda Ospedale-Università Padova, Via Giustiniani, 35128 Padua, ItalyPalliative Care and Pain Service, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3-35128 Padua, ItalyHospital Pharmacy Department, Azienda Ospedale-Università Padova, Via Giustiniani, 35128 Padua, Italy<b>Background/Objectives</b>: 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. <b>Methods</b>: 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 χ<sup>2</sup>-test for categorical variables and <i>t</i>-tests for continuous data. <b>Results</b>: Among the 993 drug prescriptions analyzed, the pharmacists reported a higher proportion of off-label uses (32.9%) compared to the physicians (18.4%; <i>p</i> < 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. <b>Conclusions</b>: 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.https://www.mdpi.com/2227-9067/12/2/124off-labelpalliative carepolypharmacypharmacovigilanceregulatory complianceclinical effectiveness
spellingShingle Daniele Mengato
Anna Zanin
Fernando Baratiri
Lisa Pivato
Laura Camuffo
Franca Benini
Francesca Venturini
Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists
Children
off-label
palliative care
polypharmacy
pharmacovigilance
regulatory compliance
clinical effectiveness
title Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists
title_full Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists
title_fullStr Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists
title_full_unstemmed Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists
title_short Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists
title_sort polypharmacy in pediatric palliative care exploring discrepancies between physicians and pharmacists
topic off-label
palliative care
polypharmacy
pharmacovigilance
regulatory compliance
clinical effectiveness
url https://www.mdpi.com/2227-9067/12/2/124
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