Drug product labeling is intended to provide full disclosure information, in a fair balance of beneficial and detrimental facts, for those who prescribe, administer and dispense drugs. A drug product that fails to comply with regulatory requirements for labeling is misbranded. The package insert is a frequently used form of product labeling. A compilation of some (but not all) package inserts is commercially produced as the Physician’s Desk Reference (PDR). A package insert contains a large amount of information under headings such as “indications,” “precautions,” “warnings,” and “contraindications.” The use of approved drugs “off-label” is generally not considered a violation of the federal Food, Drug & Cosmetic Act. Health care providers generally should consider the package insert within the context of an evolving body of medical science that includes newly discovered knowledge. The use of a drug “off-label” is usually not considered per se negligence. Health care providers should systematically consider information from the package insert, along with other information from the scientific literature and from institutional medication use evaluation, prior to deciding how to use drugs. The pharmacy and therapeutics committee is a valuable forum for considering information about the appropriate ways to use approved drugs.
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