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Nathan, MS, Pharm DAssociate Professor of Pharmacy Practice International Drug Information Center (IDIC)LIU Pharmacy Arnold & Marie Schwartz College of Pharmacy and Health Sciences Brooklyn, New York Etty Vider, Pharm D Candidate LIU Pharmacy Arnold & Marie Schwartz College of Pharmacy and Health Sciences Brooklyn, New York US Pharm. A vast amount of practice-related information is available to today’s healthcare practitioner.
Specifically, pharmacists have access to drug information from a variety of resources, including print publications, subscription-based electronic databases (e.g., Clinical Pharmacology, Facts & Comparisons e Answers, Lexicomp Online, Micromedex Solutions, Up To Date), and/or free Internet resources (e.g., Drugs.com, Medscape.com).
Pharmacists are encouraged to become familiar with the structure and contents of the PI.
As with other drug information resources, the key for effective and efficient use of the resources is user familiarity with it. The role of FDA-approved labeling in medical malpractice litigation.
Generic drug products are required to have the same labeling as the brand-name drug to which they were compared at the time of approval (reference listed drug [RLD]).
This requirement excludes unavoidable differences, such as formulation, bioavailability, or pharmacokinetics.
As of April 2015, Daily Med contained the most up-to-date PIs for over 73,000 products.
In addition to the PIs for prescription drug products, labels are also provided for OTC products and veterinary drugs.
The PI is different from the Patient Package Insert (PPI), which contains information intended for patients, notwithstanding that the PPI may be required as part of the FDA-approved labeling for the drug.
This feature not only allows the user to obtain the most recently approved label, but also provides access to the previous versions of the PI.
Perhaps the most useful tool for obtaining PIs is the National Library of Medicine’s Daily Med service (
Following the original approval, changes to the PI may be required by the FDA based on information it gathers from mandatory industry reports to its Adverse Events Reporting System (AERS), manufacturer-submitted postmarketing studies, and/or voluntary adverse-event reports from clinicians and patients.
Likewise, a manufacturer can initiate a label change to support a new marketing claim or to strengthen a warning.