Earlier this summer, the United States Food and Drug Administration (FDA) released a long-awaited proposed rule regarding the Patient Medication Information guide for prescription drugs and certain biological product. In the proposed rule, FDA is trying to amend its prescription drug labeling regulations to require a new type of medication guide – the Patient Medication Information – for all prescription drug products that are used, dispensed, or administered on an outpatient basis, including blood and blood components transfused in an outpatient setting.
In a statement released by FDA Commissioner Robert Califf, he noted that when prescription 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.” Califf went on to cite research that “suggests that medication nonadherence can contribute to nearly 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths in our country 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, and we are eager to fix it.”
The Patient Medication Information would highlight important information that patients need to know about the prescription drug product, including basic instructions on how to use the product. It would be a one-page, FDA approved document that followed a standardized format and content requirements and would be provided to patients with their prescription drug products. FDA believes that the consistent formatting of Patient Medication Information may help to not only facilitate translations to other languages but also make it easier for artificial intelligence and other technologies to convert the information to formats that assist the visually impaired.
The document would include the following information: the drug/biological name, a concise summary of the indications and uses, important safety information, common side effects, and directions for use. In addition to helping patients use their medications safely and effectively, the Patient Medication Information form would also replace two types of FDA-approved written prescription drug information and certain biological product information that are currently required.
The Patient Medication Information would also be stored electronically by the FDA and posted online for patients to access. While FDA would require paper versions of Patient Medication Information to be given out, patients have the ability to request a digital only version of the document. Additionally, companies that provide blood transfusions and blood components may be able to get a waiver from the requirement under the proposed rule.
If the proposed rule is finalized as is, all new drug application and biologics license application sponsors would need to submit a proposed Patient Medication Information for outpatient settings as part of their premarket application. Sponsors of approved abbreviated new drug applications will also need to use approved Patient Medication Information by referring to the Patient Medication Information of their reference listed drug with an already-approved Patient Medication Information. The FDA also plans to create a Patient Medication Information template for approved abbreviated new drug applications if the application references a listed drug whose approval has been withdrawn or for which no Patient Medication Information was approved prior to the withdrawn approval.
To see an example Patient Medication Information, click here. The proposed rule would take effect five years after finalization.
Interested parties can submit a comment until November 27, 2023.