FDA Proposes New, Easy-to-Read Medication Guide For Patients

To provide patients with accurate and timely information to help them take their prescription medications safely and effectively, the U.S. Food and Drug Administration has proposed a new, easy-to-read Medication Guide called Patient Medication Information.

The Patient Medication Information is for prescription drugs and certain biological products used on an outpatient basis, as well as for blood and blood components transfused in an outpatient setting.

FDA also proposes to translate the Patient Medication Information to other languages and make it easier for artificial intelligence or other technologies to convert the information, where feasible, to formats that assist the visually impaired.

These FDA-approved, one-page documents would highlight the essential information patients need to know in a standardized format, including Drug/Biological product name, Concise summary of the indications and uses, Important safety information, Common side effects, and Directions for use.

Patient Medication Information would be given to patients with their prescription drugs, which will also be available online.

FDA said that if approved, Patient Medication Information would replace two types of written prescription drug patient information and certain biological product information that are currently required.

FDA has sought public comments for the Medication Guide: Patient Medication Information proposed rule.

Evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes.

Research shows that medication nonadherence can contribute to nearly 25 percent of hospital admissions, 50 percent of treatment failures, and approximately 125,000 deaths in the United States each year.

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