Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the U.S. Food and Drug Administration (FDA). Evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes.
Currently, patients may receive one or more types of written information for prescription drugs and certain biological products, depending on the medication they are prescribed. Studies have found that the current system for written information for prescription drugs and certain biological products can be confusing, conflicting, incomplete, or repetitive.
When such critical information is difficult to understand, patients can become frustrated, stop taking their medications, or not take their medications as directed, which can be harmful to their health. Research suggests that medication nonadherence can contribute to nearly 25 percent of hospital admissions, 50 percent of treatment failures, and approximately 125,000 deaths in the U.S. each year. While medication nonadherence is complex, inconsistency with the existing types of written information for prescription drugs and certain biological products can negatively impact public health.
To address this problem, the FDA has proposed the requirement of a new medication guide called Patient Medication Information for prescription drugs and certain biological products (both brand name and generic) that are used, dispensed, or administered on an outpatient basis, as well as for blood and blood components transfused in an outpatient setting.
The Patient Medication Information guide 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 and easy-to-understand format to help patients use their prescription drug and certain biological products safely and effectively. Patient Medication Information’s consistent formatting may help facilitate translations 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
· Directions for use
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. In addition to the primary goal of more easily helping patients use medications safely and effectively, Patient Medication Information would also replace two types of FDA-approved written prescription drug patient information and certain biological product information that are currently required, which would reduce duplicate information and be more cost-efficient for drug and certain biological product manufacturers.
The FDA views this proposal as one way to fight the nation’s crisis with healthcare misinformation and disinformation, which is a top priority for the agency. 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 proposed rule is a practical step towards improving the nation’s health. The FDA’s public health mission is to ensure drugs and certain biological products are used safely and effectively, help people feel empowered and confident in their ability to manage their care, and prevent negative health outcomes.