FDA proposes concise medication information guide for patients

Key takeaways:

• The FDA seeks to improve currently complex medication guides.
• The guide would apply to prescription drugs, biological products and blood or blood components administered in outpatient settings.

The FDA has proposed a rule that would require patients to receive an easy-to-read medication information guide when they are prescribed drugs and certain biological products, the agency announced in a press release.

The Patient Medication Information guide “will highlight the most important information that patients need to know about the prescription drug product, including basic directions on how to use the product,” Bryon M. Pearsall, JD, RPh, the director of the FDA’s Division of Medical Policy Programs, told Healio.

According to the FDA, the guide would cover information on prescription drugs and certain brand name and generic biological products that are used, dispensed or administered in an outpatient setting.

Additionally, “when blood or blood components are administered on an outpatient basis, transfusion services would be considered authorized dispensers and would be required to provide Patient Medication Information to each patient,” Pearsall said.

The information covered for each product would include:

• the drug or biological product’s name;
• a summary of indications and uses;
• important safety information;
• common adverse events; and
• directions for use.

Pearsall added that while the Patient Medication Information guide can be handled electronically, a paper copy must always be available.

“It would also be available online for the public to freely access,” he said.

The guide would improve currently available information on medications, which have a tendency of being “lengthy, complex and difficult for patients to understand, especially those with low literacy and comprehension skills,” Pearsall said.

“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 and easy-to-understand single-page format to help patients use their prescription drugs and certain biological products safely and effectively,” he said.

The FDA also noted that when medication information is difficult to understand, many patients misuse or discontinue their treatments. According to the agency, medication nonadherence poses a significant risk to patients by contributing to almost 25% of hospital admissions, 50% of treatment failures and around 125,000 deaths in the United States each year.

The public comment period on the proposal is open until Nov. 27, after which “we will review and address the comments received and develop a final rule for publication,” Pearsall said.

If finalized, Patient Medication Information would replace current medication guides and patient package inserts, according to Pearsall.

“Because of the large number of prescription drug products affected, this is currently identified as a 5-year implementation schedule,” he said. “New Drug Applications and Biologics License Applications submitted on or after the effective date of the final rule would include Patient Medication Information with the application.”

As for prescription products approved before the implementation date of the rule, “submission of Patient Medication Information would primarily be based on approval date, with newer products submitting Patient Medication Information first,” Pearsall said.

A Patient Medication Information guide for a hypothetical product can be seen here, while comments on the proposal can be submitted here.

References:

• FDA proposes new, easy-to-read medication guide for patients, Patient Medication Information. https://www.fda.gov/news-events/press-announcements/fda-proposes-new-easy-read-medication-guide-patients-patient-medication-information. Published May 30, 2023. Accessed June 1, 2023.
• Patient Medication Information. https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information. Accessed June 1, 2023.