The conundrum of off-label and unlicensed drug usage in neonatology
نویسندگان
چکیده
منابع مشابه
The conundrum of off-label and unlicensed drug usage in neonatology.
“O desafio do uso seguro e adequado de medicamentos no período neonatal é intimidante e torna-se mais complexo pela notória falta de dados baseados em evidências para orientar a tomada de decisões. Os clínicos lutam com as escassas opções de medicamentos que não foram rigorosamente testados em recém-nascidos muito pequenos; o problema muitas vezes torna-se ainda mais complexo devido à inaceitav...
متن کاملUnlicensed and off label drug use in neonates.
AIM To determine the extent of use of drugs that are either not licensed (unlicensed), or are outside the terms of their product licence (off label) in a neonatal intensive care unit. METHODS A prospective study was conducted over 13 weeks. RESULTS 455 prescription episodes were administered to 70 babies. 63 (90%) patients were given a drug that was either unlicensed or used in an off label...
متن کاملIncidence of unlicensed and off-label prescription in children
BACKGROUND Many common drugs have not been licensed for use in children. METHODS This study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Pediatrics during a period of six months. A total of 8,559 prescriptions for 4,282 children were processed. RESULTS Off-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respect...
متن کاملUnlicensed and off label drug use by children in the community: cross sectional study.
formulations for a specific age group—for example, quinolones in children and xylometazoline 1% formulations for babies. The proportion of off label prescriptions was highest for 1-2 year olds (68 791 (17.9%, 17.8% to 18.1%) prescriptions) and lowest for 7-11 year olds (40 539 (10.5%, 10.4% to 10.6%) prescriptions). Of the 181 914 (8.8%) prescriptions for topical treatments of the skin, eye, or...
متن کاملUnlicensed and off-label drug use in children: implications for safety.
Throughout the world, many drugs prescribed for children are used in an off-label or unlicensed manner. The incidence of unlicensed and off-label drug prescriptions appears to be greatest in critically ill neonates and children and lowest in the general population. The risk associated with unlicensed and off-label drug use appears to be greater than for prescribing in accordance with the produc...
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ژورنال
عنوان ژورنال: Jornal de Pediatria
سال: 2012
ISSN: 0021-7557
DOI: 10.2223/jped.2243