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Why are the Package Inserts important?

Its availability, ease of use, contents, and legal weight make the PI the resource that should often be the starting point when initiating a search for drug information.

many, if not most, professional drug-information resources such as Micromedex Solutions and Clinical Pharmacology use the PI as the source of information for some of the content of their monographs.

the PI also has ramifications for state tort (liability) law...One tool used by the courts as evidence of standard of care has been the PI...the independent expert’s professional evaluation of the prescriber’s conduct may be based, in part, on whether he or she followed the information in the PI.

Although the learned intermediary is generally the physician, the PI may also be used as evidence of deviations from standard of care for pharmacists...when pharmacists receive a drug information inquiry or encounter a clinical dilemma, it may be wise to initiate the search for information with the PI.

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drug annotation

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