Neonatal Information On Approved Drug Labels: An Analysis Of Consistency In Drug Labeling
نویسندگان
چکیده
منابع مشابه
Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.
STUDY OBJECTIVES To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling. DESIGN Retrospective analysis. DATA SOURCES The Physicians' Desk Reference Web sit...
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Advances in pharmacogenetic research have improved our understanding of adverse drug responses and have led to the development of pharmacogenetic tests and targeted drugs. However, the extent of the communication process and provision of information to patients about pharmacogenetics is unclear. Pharmacogenetic information may be included in sections of a drug's package insert intended for pati...
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BACKGROUND In 2006, the US Food and Drug Administration reorganized the approved label format and content for prescription drugs -also known as the prescribing information (PI). This research examines primary care physicians' use of the new PI and how it may influence their perceptions about prescription drugs. METHODS A total of 500 physicians responded to an Internet survey that displayed a...
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We surveyed 10,303 United States physicians on where they obtain pharmacogenomic testing information. Thirty-nine percent indicated that they obtained this from drug labeling. Factors positively associated with this response included older age, postgraduate instruction, using other information sources, regulatory approval/ recommendation of testing, reliance on labeling for information, and per...
متن کاملPediatric information in drug product labeling.
To the Editor: The dearth of information on drugs for children led to children being called “therapeutic orphans.” In 1975, Wilson determined that 78% of drug labeling had inadequate pediatric information. In 1999, Wilson summarized 25 years of efforts to get pediatric information into labeling and extended his analysis. In the decade after Wilson’s review, regulations and legislation have led ...
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ژورنال
عنوان ژورنال: Value in Health
سال: 2014
ISSN: 1098-3015
DOI: 10.1016/j.jval.2014.03.976