Off-label Drug Use in Hospitalized Children
نویسندگان
چکیده
منابع مشابه
Off-label drug use in pediatric patients.
INTRODUCTION Until recently, it was considered unethical or impossible to perform clinical trials of new medicines in children. As a consequence, many medicines used for treating children are insufficiently documented with regard to dosing, efficacy, and safety. The off-label use of drugs has been extensive in treating the pediatric population. This article gives an overview of the extent and t...
متن کاملOff-label use of drugs in children.
The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, including more than 500 labeling changes. However, off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number of drugs still have no information in ...
متن کاملAnalysis of clinical trials and off-label drug use in hospitalized pediatric patients.
Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed children's hospital. The number and design of...
متن کاملOff-label drug use: author's reply.
The authors have stated that the accuracy of dose was checked from standard neonatal formularies, viz. British National Formulary 2005 and Neofax 2008, and stated that 75% of medications were not approved by FDA for neonatal use. They have not mentioned the document or the source that they relied upon to classify the drug as off-label or otherwise. It may not be advisable to decide if use of a ...
متن کاملOff‐label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia
Most of the medications which are currently used for the treatment of childhood diseases are either not licensed or being prescribed outside the terms of the product license (off-label prescribing). This study aimed at determining the extent of unlicensed and off-label drug uses and associated factors in children hospitalized in Gondar University Referral Hospital, Northwest Ethiopia. An instit...
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ژورنال
عنوان ژورنال: Archives of Pediatrics & Adolescent Medicine
سال: 2007
ISSN: 1072-4710
DOI: 10.1001/archpedi.161.3.282