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Current Drug Safety


ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Case Studies

Off-Label Use of Drugs and Adverse Drug Reactions in Pediatric Units: A Prospective, Multicenter Study

Author(s): Andrea D. Pratico*, Laura Longo, Silvana Mansueto, Lucia Gozzo, Ignazio Barberi, Venera Tiralongo, Vincenzo Salvo, Raffaele Falsaperla, Giovanna Vitaliti, Mario La Rosa, Salvatore Leonardi, Antonio Rotondo, Nicoletta Avola, Debora Sgarlata, Annalisa Damiano, Massimo Tirantello, Gaspare Anzelmo, Domenico Cipolla, Angelo Rizzo, Antonio Russo, Martino Ruggieri, Salvatore Salomone and Filippo Drago

Volume 13, Issue 3, 2018

Page: [200 - 207] Pages: 8

DOI: 10.2174/1574886313666180619120406

Price: $65


Background: Given the growing use of off-label in pediatric practice, there is a growing interest on pharmacovigilance programs monitoring the occurrence of adverse drug reactions related to off-label drug prescription in childhood.

Patients and Methods: The results of a one-year program of pharmacovigilance issued in the Sicilian Region, Italy, are herein presented. The study involved 6 pediatric and neonatal centres and prospectively reviewed the prescriptions of 5,060 patients, who were stratified for age (newborn, infant, children, adolescents).

Results: A total of 14,916 prescriptions were issued for 5,060 patients. Among them, 454 patients [8.97%] received at least one off-label drug. Among the off-label treated patients, 255 [56.2%] were newborns. Anti-infective drugs were the most frequent off-label used drugs, followed by drugs for alimentary tract and metabolism and drugs for blood or blood forming organs. Ninety adverse drug reactions were recorded [1.78% of the total patients]. They occurred after an off-label prescription in 33 out of 90 [36.7%], while those occurring after an on-label prescription were 57 [63.3%]. Patients treated with an off-label drug had a significantly higher risk of adverse drug reactions [7.3% vs. 1.2%; p <0.01].

Conclusion: The present study indicates that children admitted to neonatal intensive care units are likely to receive an off-label medication; children who receive an off-label medication are usually more likely to be treated with more medication than the others; adverse drug reactions occur in patients admitted in neonatal intensive care and pediatrics are units are more frequently with off-label than with on-label drugs.

Keywords: Drug safety, drug regulation, pharmacovigilance, adverse drug reactions, clinical trials, off-label prescription.

Graphical Abstract

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