title: The new Food and Drug Administration drug package insert: implications for patient safety and clinical care.
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.
authors.affiliation: Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut 06520-8051, USA.
authors.forename: Kelley Teed
authors.initials: KT
authors.lastname: Watson
authors.forename: Paul G
authors.initials: PG
authors.lastname: Barash
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D017277:Drug Approval; D004346:Drug Information Services / Q000266:history / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000266:history / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D033161:Government Regulation; D049672:History, 19th Century; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D020407:Internet; D008508:Medication Errors / Q000517:prevention & control*; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history / Q000331:legislation & jurisprudence