FDA proposes streamlined medication guides that it says could save lives

May 30 (UPI) -- The Food and Drug Administration on Tuesday proposed a new, easier-to-understand medication guide for patients that it said could reduce hospitalizations and even save lives.

Calling its new type of medication guide Patient Medication Information, the FDA said its proposal is designed for safety and efficacy.


"Patient Medication Information would provide patients with clear, concise, accessible, and useful written information for prescription drugs and certain biological products and would be delivered in a consistent an easy-to-understand format to help patients use their prescription drug and certain biological products safely and effectively," the FDA said in a press release Tuesday.

The proposed change would require certain medications to be accompanied by a one-page informational document showing the drug or biological product's name, a concise summary of its uses, safety information, side effects, and directions for use, in a standard format.

"Patient Medication Information would be given to patients with their prescription drugs and certain biological products when provided in an outpatient setting and also be available online for the public to access," the FDA said.

The proposal would replace the current written prescription drug patient information and biological product information requirements with the more streamlined successor.


"We also view this proposal as one way to fight our nation's crisis with health care misinformation and disinformation, which is a top priority for the agency," the FDA said.

According to the FDA, "research suggests that medication non-adherence can contribute to nearly 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths in our country each year."

"Having ready access to direct and easy to understand information in a consistent format for prescription drugs and certain biological products may reduce instances of both accidental and purposeful misinterpretations," the FDA continued.

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