A literature review on off-label drug use in children

Pandolfini, Chiara; Bonati, Maurizio

doi:10.1007/s00431-005-1698-8

Cited by 305 publications

(249 citation statements)

References 70 publications

Supporting

Mentioning

216

Contrasting

Unclassified

Order By: Relevance

“…Many drugs used to treat children are either not licensed for, unlicensed, or are prescribed outside the terms of the product license, or "off-label" [15,16]. It is likely that the use of unlicensed or "off label" drug prescriptions is associated with a greater risk of ADRs in the paediatric population [17,18].…”

Section: Introductionmentioning

confidence: 99%

Active surveillance of adverse drug reactions in children in five Italian paediatric wards

Gallo¹,

Clavenna²,

Bonati³

et al. 2012

OJPed

Self Cite

View full text Add to dashboard Cite

Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot be compared for methodological reasons. A 6-month prospective observational study was, therefore, conducted on the paediatric wards of five hospitals in the Campania Region, Italy. Data were collected on all patients admitted to the wards during the study period through a structured questionnaire administered to the mothers and through a hospital chart review. Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most prescribed was systemic antibacterial agents (47%). Six ADRs occurred during hospitalization (incidence 0.9%; 95% CI 0.2% -1.7%). In addition, one child was admitted to a hospital for an ADR. Five out of seven ADRs occurred in girls. The skin was the most affected organ. The medications implicated were amoxicillin, acyclovir, ibuprofen, ceftriaxone, paracetamol, and ranitidine. According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. Consequently, healthcare personnel should be alert to the possibility of ADRs. More accurate reporting of ADRs in children would result in safer use of drugs in such patients.

show abstract

Section: Introductionmentioning

confidence: 99%

Active surveillance of adverse drug reactions in children in five Italian paediatric wards

Gallo¹,

Clavenna²,

Bonati³

et al. 2012

OJPed

Self Cite

View full text Add to dashboard Cite

show abstract

“…A carência de evidências seguras e de formulações padronizadas afeta, principalmente, crianças hospitalizadas, particularmente aquelas em unidades de tratamento intensivo, colocando em risco a eficácia e a segurança dos tratamentos. (Conroy, Mcintire, Choonara, 1999;Avenel et al, 2000;Conroy et al, 2000, Carvalho et al, 2003Santos, Coelho, 2006;Pandolfini, Bonati, 2005).…”

Section: Introductionunclassified

Prescrição e preparo de medicamentos sem formulação adequada para crianças: um estudo de base hospitalar

Costa

Lima

Coêlho

2009

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

Este trabalho teve como objetivo identificar medicamentos cuja forma ou formulação farmacêutica representa um problema em pediatria (Medicamento Problema -MP), bem como analisar as estratégias empregadas pelos médicos, para sua utilização nas crianças e os riscos envolvidos. Trata-se de um estudo descritivo, que tem como base um inquérito com pediatras de um hospital de referência do SUS em Fortaleza-Ceará, conduzido para identificação dos MPs em julho-agosto de 2004; uma análise das prescrições contendo adaptação de formas sólidas e uma observação direta do preparo dos medicamentos, que foram conduzidas em dezembro de 2004 e janeiro de 2005, respectivamente. Os medicamentos foram agrupados pela classificação ATC e pelo cálculo de frequências das variáveis. Os pediatras (N=48, 98%) identificaram: 16 produtos sem forma injetável, 32 injetáveis necessários em concentrações menores e 30 MP sem formulação líquida para uso oral. Foram analisadas 89 prescrições contendo adaptação de formas sólidas, envolvendo 119 itens de medicamentos; todas continham inadequações, sendo a principal a partição de comprimidos. As doses prescritas corresponderam ao preconizado em 33,6% dos casos. Adaptações foram realizadas em local inadequado, por profissional não qualificado e sem as boas práticas. Concluindo, a carência de formulações apropriadas ao uso pediátrico repercute na prática médica e é agravada pela inexistência de condições adequadas para a manipulação de medicamentos por farmacêuticos, nos hospitais brasileiros.Unitermos: Prescrição pediátrica. Formulações farmacêuticas/adaptações para uso pediátrico. Medicamentos/uso pediátrico. Farmácia hospitalar.This work aimed to identify medicines whose form or pharmaceutical formula presents a problem to pediatrics (Problem Medication -PM), the strategies employed by doctors to use them in children, and the potential risks involved. Descriptive study: based on a survey with pediatricians from a SUS (Public Health System) reference hospital in Fortaleza-CE (Northeastern Brazil), in order to identify PMs, from July to August 2004; an analysis of prescriptions containing modification of medicines in the solid forms; and a follow-up of medicinal preparations, developed in December 2004 and January 2005, respectively. The medications were grouped by an anatomic, therapeutic and chemical classification and by means of a calculation of variables frequency. The pediatricians (N=48, 98% of the total) identified as PMs: 16 products without an injectable form; 32 in an injectable form that should be presented in lesser concentrations; and 30 without a liquid formula for oral use. Eighty two (82) prescriptions containing modifications of solid forms, involving 111 medicinal items were analyzed, all of which contained inadequacies; the main one being the partition of pills. In 33.6% of the cases, the prescribed doses were in accordance with that generally recommended. The modifications were carried out in inadequate places, by nonqualified professionals and without the use of best practices. Th...

show abstract

“…[1][2][3] While the common practice of using off-label drugs in pediatrics is widely recognized as medically necessary, the lack of pediatric research and knowledge in the area of pediatric evidencebased treatment is of real concern. 4,5 When drugs are studied rigorously in children, it is clear that dosage regimes based on age, weight, and body surface area do not reflect actual pharmacokinetics of the drugs across the various stages of pediatric development. 6 Additionally, while a given drug may be effective in adult models of disease, in children, the optimal dose is often unknown, the efficacy is uncertain, the side effects are not established, and adverse outcomes are not described.…”

mentioning

confidence: 99%

Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Doherty

Pascuet

et al. 2010

Can J Anesth/J Can Anesth

View full text Add to dashboard Cite

A literature review on off-label drug use in children

Cited by 305 publications

References 70 publications

Active surveillance of adverse drug reactions in children in five Italian paediatric wards

Active surveillance of adverse drug reactions in children in five Italian paediatric wards

Prescrição e preparo de medicamentos sem formulação adequada para crianças: um estudo de base hospitalar

Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Contact Info

Product

Resources

About