The U.S. Food and Drug Administration (FDA) said it makes it a priority to provide people with accurate and timely information to help them take their prescribed medications safely and effectively.
Based on the fact that “evidence suggests that easier-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes,” the agency proposed requiring a new type of Medication Guide called “ Patient Medication Information” , for prescription drugs and certain biological products (both brand name and generic) used, dispensed or administered on an outpatient basis, as well as blood and blood components transfused in an outpatient setting.
Currently, patients may have information about medications or certain biological products, depending on which product they are prescribed. However, studies have found that the current system of written information to describe them can be confusing, contradictory, incomplete or repetitive.
When that critical information is difficult to understand, patients may become frustrated, stop taking their medications, or not take them as directed, which can be detrimental to their health.
The FDA mentioned in a statement that there are studies that suggest that medication non-adherence can contribute to almost 25% of hospital admissions, 50% of treatment failures and approximately 125,000 deaths in the US each year. .
While noncompliance is a complex issue, “inconsistency with existing types of written information for prescription drugs and certain biological products may adversely affect public health.”
The standardized format of “Patient Medication Information” can help with translations into other languages and make it easier for artificial intelligence or other technologies to convert the information, when possible, into formats that help people with visual impairments.
These one-page documents would highlight essential information patients need to know in a standardized format, including:
• Name of drug/biological product
• Concise summary of indications and uses
• Important Safety Information
•Common side effects
• Instructions for use
