Off-label Drug Prescribing: Deciphering the Ambiguity
نویسندگان
چکیده
منابع مشابه
Off-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 کاملOff-label prescribing in older patients.
The practice of off-label prescribing, i.e. prescribing drugs either for unregistered/unapproved therapeutic indications and age groups or using unregistered/unapproved doses or methods of administration, is common in older patients. This may be due to the poor representation of this group in pre-marketing clinical trials assessing therapeutic efficacy and safety of novel therapies or merely to...
متن کاملOff-Label Drug Information
drug into interstate commerce unless the FDA has approved the drug and its label.2 A second provision prohibits manufacturers from introducing misbrandeddrugs into interstate commerce.2 Misbranding is considered to occur if drug labeling contains information that describes unapproved uses or is misleading or insufficient to support safe use for approved indications.2 Materials are considered pa...
متن کاملOff-label prescribing in pediatric outpatients.
OBJECTIVE To study the characteristics of off-label prescribing and adverse drug reaction (ADR) occurrence in a sample of pediatric outpatients treated by general practitioners. METHODS A survey on pediatric drug prescribing was implemented in 46 general practices in southwestern France. All consecutive patients aged 0 to 16 years were included. Patient characteristics, reasons for consultati...
متن کاملAssessing the FDA via the Anomaly of Off - Label Drug Prescribing
I t is commonly thought that the U.S. Food and Drug Administration (FDA) regulates the use of all pharmaceutical drugs in the United States. In fact, most hospital patients are given drugs that are not FDA-approved for the prescribed use. The FDA does require that drugs undergo extensive testing before they are released onto the market and, if it concludes that a new drug is unsafe or not effec...
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ژورنال
عنوان ژورنال: International Journal of Contemporary Medical Research [IJCMR]
سال: 2020
ISSN: 2454-7379,2393-915X
DOI: 10.21276/ijcmr.2020.7.1.28