{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T17:26:25Z","timestamp":1784741185215,"version":"3.55.0"},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,1,15]],"date-time":"2024-01-15T00:00:00Z","timestamp":1705276800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003197","name":"Agenzia Italiana del Farmaco, Ministero della Salute","doi-asserted-by":"publisher","award":["PAPEOS\u2010AIFA prot. AVPM\/21436\/A"],"award-info":[{"award-number":["PAPEOS\u2010AIFA prot. AVPM\/21436\/A"]}],"id":[{"id":"10.13039\/501100003197","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>To assess the extent of off\u2010label drug use and the occurrence of suspected adverse drug reactions (ADRs) among paediatric patients in Italian hospitals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a 2\u2010year prospective cohort study across 22 Italian hospital wards from September 2020 to September 2022. As part of the surveillance project, we performed a 6\u2010month retrieval of all reported ADRs and evaluated all drug prescriptions for their possible off\u2010label use. Following an educational project on pharmacovigilance addressed to healthcare professionals in participating wards, the same data collection was performed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among the 892 patients included in the study, 64% were admitted to paediatric wards and 36% to neonatal wards. Fifty per cent of all drugs prescribed were used off\u2010label and mainly concerned the administration of a different dose from the one authorized. In neonatal wards, off\u2010label prescriptions occurred slightly more often, with antibacterials being the most frequently used off\u2010label drugs. A total of 35 reports of suspected ADRs were collected, five before the educational project and 30 afterwards. Based on product licence, 10 of the total 35 reports concerned at least one off\u2010label drug use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The off\u2010label use of drugs in treating paediatric patients was extensive in Italian hospitals. Regulatory interventions are needed to promote the use of drugs based on the latest available literature and improve ADR reporting on children. Paediatric indications and dosages of the drugs most commonly used in children should be supported by appropriate ad hoc studies.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.15995","type":"journal-article","created":{"date-parts":[[2024,1,2]],"date-time":"2024-01-02T03:23:15Z","timestamp":1704165795000},"page":"1050-1057","source":"Crossref","is-referenced-by-count":6,"title":["PAttern of drug use in PEdiatrics: An observational study in Italian hOSpitals (the PAPEOS study)"],"prefix":"10.1111","volume":"90","author":[{"given":"Marta","family":"Di Salvo","sequence":"first","affiliation":[{"name":"Hospital Pharmacy Azienda Ospedaliero\u2010Universitaria di Ferrara Arcispedale S. Anna  Cona Ferrara Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7897-2956","authenticated-orcid":false,"given":"Greta","family":"Santi Laurini","sequence":"additional","affiliation":[{"name":"Unit of Pharmacology, Department of Medical and Surgical Sciences University of Bologna  Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6253-4014","authenticated-orcid":false,"given":"Domenico","family":"Motola","sequence":"additional","affiliation":[{"name":"Unit of Pharmacology, Department of Medical and Surgical Sciences University of Bologna  Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgia","family":"Valpiani","sequence":"additional","affiliation":[{"name":"Research Innovation Office S. Anna University Hospital of Ferrara  Cona Ferrara Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ester","family":"Sapigni","sequence":"additional","affiliation":[{"name":"Hospital Care Sector \u2010 Regional Center of Pharmacovigilance \u2010 Directorate General for Personal Care Emilia Romagna Region Health Authority  Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana","family":"Pompilio","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy Azienda Ospedaliero\u2010Universitaria delle Marche  Ancona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Arzenton","sequence":"additional","affiliation":[{"name":"Department of Diagnostic and Public Health, Section of Pharmacology University of Verona  Verona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Marra","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy Azienda Ospedaliero\u2010Universitaria di Ferrara Arcispedale S. Anna  Cona Ferrara Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,1,15]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"European Medicines Agency.Guideline on good pharmacovigilance practices (GVP) product\u2010 or population\u2010specific considerations IV: paediatric population. Accessed October 24 2022.https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-good-pharmacovigilance-practices-gvp-product-population-specific-considerations-iv_en-0.pdf"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010015\u20100281\u20100"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0024061"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.0306\u20105251.2001.01407.x"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s43054\u2010020\u201000038\u20108"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228\u2010011\u20101183\u20104"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/08035259950168469"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/1741\u20107015\u201011\u2010238"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2012.26"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.677"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228\u2010014\u20101768\u20109"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.320.7227.79"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228\u2010008\u20100543\u20101"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.5.5.703"},{"key":"e_1_2_11_16_1","unstructured":"European Medicines Agency.Adverse drug reaction. 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