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PATIENT SAFETY

The New Food and Drug Administration Drug Package Insert: Implications for Patient Safety and Clinical Care

From the Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut.

Address correspondence to Paul G. Barash, MD, Department of Anesthesiology, Yale University School of Medicine, 333 Cedar St., P.O. Box 208051, New Haven, CT 06520-8051. Address e-mail to paul.barash{at}yale.edu.

Abstract

The United States Food and Drug Administration (FDA) is the scientific, regulatory, and public health agency that regulates many products, including food products, drugs, medical devices, radiation emitting devices, and cosmetics for the federal government of the United States. The FDA’s mission is to assure that consumer products made and sold in the United States are safe, effective, and pure. The purpose of the package insert (also known as prescription drug product insert or professional labeling) is to provide detailed drug information compiled and distributed by the drug manufacturer, after FDA review and approval. In 2006, the standard format for the package insert was changed in an attempt to make it more user-friendly and a more efficient resource tool for practitioners. According to the Institute of Medicine, in-hospital adverse drug reactions occur at a rate of 400,000 per year and incur $3.5 billion of extra hospital expense. It is expected that the new package insert format will enhance rapid access to important pharmacologic information and improve patient safety by decreasing medication errors.