Bill > HR5133

This bill aims to improve patient safety and understanding of prescription medications by requiring a standardized, printed patient medication information (PMI) sheet to be included with each prescription dispensed. The bill mandates that the U.S. Secretary of Health and Human Services develop regulations within one year that require pharmaceutical manufacturers to create a one-page, patient-friendly information document with specific content requirements. The PMI must be scientifically accurate, written in plain language, and include critical information such as the drug's established name, approved uses, proper usage directions, potential side effects, contraindications, interactions with other substances, and guidance on when to contact healthcare professionals. The document must also include a standardized format with consistent font, color, and graphics to enhance patient comprehension. The bill cites CDC data showing that nearly half of Americans use prescription drugs and argues that a mandatory paper PMI could potentially reduce adverse drug events and associated healthcare costs by $14.6 to $26.2 billion annually. Additionally, the bill recognizes that many patients cannot access electronic medication information, making a printed version essential. Pharmaceutical companies that fail to provide the required PMI would be in violation of misbranding regulations, thus subject to potential penalties.

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https://www.congress.gov/bill/119th-congress/house-bill/5133/all-info