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Code · BILL · 117th Congress · H.R. 6519 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act regarding the patient medication information required to be include... · Sec. 2

Sec. 2. Findings

204 words·~1 min read·/bill/117/hr/6519/ih/section-2

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Congress finds the following: Prescription medications are important to the health and well-being of the American public. According to the Centers for Disease Control and Prevention (CDC), 48.9 percent of Americans used at least one prescription drug in the past 30 days. The utilization of prescription drugs can subject patients to adverse drug events; therefore, patient safety is of the utmost importance. Studies indicate that paper format patient medication information
(PMI)can help protect patients and prevent the majority of costly adverse drug events. In addition to bolstering patient safety, the mandatory use of a standardized PMI provided to all patients in nonhospital settings could reduce costs associated with emergency room visits and hospital admissions related to adverse drug events by $14.6 to $26.2 billion dollars annually. Many patients cannot access electronic versions of PMI, thereby necessitating a paper option. The Government Accountability Office found that relying on electronic labeling as a complete substitute for paper labeling could adversely impact public health. A congressionally mandated paper PMI is needed because no standardized PMI in a single page, paper copy, proven patient-friendly format is currently available to patients or required by the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ).
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Sec. 2
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