Off-label prescription: Practice and problems
نویسندگان
چکیده
منابع مشابه
[Off-label prescription: practice and problems].
Approval of a drug for clinical use requires production of data on efficacy and safety through submission of results from randomized controlled trials (RCTs), in which the new molecule is usually compared with placebo (or an active comparator) for a set of outcomes that will serve as the basis for the drug's indications. These indications are crucial, because drugs are approved on the basis of ...
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 prescription of respiratory drugs to children.
Many respiratory drugs are not available in formulations suitable for infants and toddlers. Efficacy and safety research is mostly restricted to older children. However, respiratory drugs are frequently used in children for common diseases like asthma, upper and lower respiratory tract infections, rhinitis and sinusitis. The unlicensed and off-label use of respiratory drugs in children were stu...
متن کاملOff-label prescribing: best practice or malpractice?
‘‘Labels’’ for medicines are also known as the ‘‘package inserts’’ that list the details of the approval granted by regulatory authorities such as the FDA (U.S. Food and Drug Administration) for the sale of medicines by the pharmaceutical industry. ‘‘Off-label’’ means utilizing an approved medicine in a manner not contained in the approved ‘‘label.’’ Although it is illegal for employees of the ...
متن کاملPharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012
BACKGROUND European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated ...
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ژورنال
عنوان ژورنال: Revista Portuguesa de Cardiologia (English Edition)
سال: 2013
ISSN: 2174-2049
DOI: 10.1016/j.repce.2013.01.016