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

August 4, 2023

Couple reading medication guide together.

The US Food and Drug Administration (FDA) has proposed a new, easy-to-read medication guide for patients known as the Patient Medication Information (PMI)1. The new medical guide will be required for all prescription drugs and certain biological products, including both brand name and generic.

The FDA's proposal is based on extensive research indicating that many patients struggle to understand the written information that accompanies their prescription drugs. This lack of understanding can result in medication nonadherence, significantly impacting the product's safety and effectiveness. As cited in the proposed rule, "it is estimated that nonadherence contributes to as many as 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths in the US per year"23.

The PMI is designed to be a one-page, easy-to-read document that offers patient crucial information about their medication. It includes details like the drug/biologic product name, concise summary of the indications and uses, important safety information, common side effects, and directions for use. Additionally, the PMI will feature a designated section where patients can record their own questions and concerns.

Key Features of the Easy-Read Medication Guide

The PMI's key features include:

  • Clear and Concise Language: The new guide will utilize plain language to explain medication information, avoiding complex medical terminology. This will help patients to understand the purpose, dosage, side effects, and potential risks associated with their prescribed medications more easily by eliminating jargon and simplifying explanations.
  • Visual Aids: Acknowledging the effectiveness of visual communication, the easy-read PMI will include diagrams, illustrations, and icons to reinforce key points. Visual aids can be especially beneficial for individuals who have difficulty processing written content or those with visual impairments.
  • Logical Organization: The guide will be thoughtfully structured, presenting information in a logical sequence. This will allow patients to navigate the document more intuitively and find specific details they need, such as dosage instructions, storage guidelines, and precautions.
  • Translations and Accessibility: To cater to diverse patient populations, the PMI will be available in multiple languages. Additionally, the FDA aims to ensure that the guide is accessible to individuals with disabilities, including those with visual impairments who may require assistive technologies such as screen readers or braille formats.

Benefits of the PMI

The PMI's comprehensive approach holds significant potential for enhancing patient safety and healthcare outcomes by addressing various aspects of medication management and patient understanding. For example, the PMI could help to:

  • Reduce medication nonadherence
  • Improve patient understanding of their medication
  • Increase patient communication with their healthcare providers
  • Prevent medication errors
  • Improve patient health outcomes

What to Expect Next

The FDA is currently inviting public comment on the proposed PMI until November 27, 2023. After the public comment period, the FDA will review the comments and make a decision about whether to finalize the proposal. If the proposal is finalized, the PMI will be required to be included with all prescription drugs and certain biological products dispensed to patients in outpatient settings. The timing of implementation for the PMI is anywhere from one to five years after the final rule is published. The public comment period allows patients, healthcare professionals, and stakeholders to contribute valuable insights, leading to a more comprehensive and effective final PMI. The proposed implementation schedule for the PMI is summarized below:

NDAs, BLAs, and Efficacy Supplements

Time by which PMI must be submitted to the FDA

Applications submitted on or after the effective date of the final rule

Time of submission (part of application)

Applications pending at the time of the effective date of the final rule

No later than one year after the date of approval of the pending application

Applications approved on or before the effective date and that have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515

No later than one year after the effective date of the final rule

Applications approved from January 1, 2013, up to and including the effective date of the final rule that do not have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515

No later than two years after the effective date of the final rule

Applications approved from January 1, 2008, up to and including December 31, 2012, that do not have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515

No later than three years after the effective date of the final rule

Applications approved from January 1, 2003, up to and including December 31, 2007, that do not have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515

No later than four years after the effective date of the final rule

Applications approved on or before December 31, 2002, that do not have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515

No later than five years after the effective date of the final rule

Table 1: PMI Implementation Schedule

How Can We Help

The FDA's proposed easy-to-read PMI marks a significant milestone in patient-centered healthcare. By reimagining the way medication information is presented, this initiative addresses the longstanding challenges associated with complex medical language and supports individuals in making informed decisions about their treatment.

If a marketing application is in your near future, Sponsors are encouraged to understand the new PMI standard. At ProPharma, we continue to keep up on the current regulatory developments from the FDA and look forward to working with clients to ensure their development and marketing are in good regulatory compliance.

Contact us to learn how the new PMI implementation affects your company's marketing application and to explore ProPharma's regulatory expertise.

References

  1. Department of Health and Human Services, Food and Drug Administration. Medication Guides: Patient Medication Information. Federal Register. Vol. 88, No. 104, Wednesday, May 31, 2023. Proposed Rules. 2023-11354.pdf (govinfo.gov). 
  2. Kim, J., K. Combs, J. Downs, et al., "Medication Adherence: The Elephant in the Room," U.S. Pharmacist, Vol. 43, Issue 1, pp. 30–34, 2018 (available at: https://www.uspharmacist.com/article/medication-adherence-the-elephant-in-the-room#:~:text=Nonadherence%20can%20account%20for%20up,chronic%20medications%20is%20around%2050%25), accessed May 12, 2023. 
  3. Lam, W.Y. and P. Fresco, "Medication Adherence Measures: An Overview," BioMed Research International, pp. 217047, 2015, doi:10.1155/2015/217047. 

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