Guidance Recap Podcast | Podcast for Patients on Patient Medication Information (PMI) Proposed Rule
Thank you for joining us for another episode of the Guidance Recap Podcast. The Guidance Recap Podcasts provide highlights of FDA guidance documents straight from the authors. Today, we’re expanding our podcast beyond guidance documents to discuss an FDA proposed rule on Medication Guides called Patient Medication Information. Today’s discussion will focus on important points for patients about this proposed rule. My name is Kylie Haskins, and I am the host for today’s podcast. In this episode, I am excited to be talking with Chris Diamant. He is a Regulatory Counsel in the Office of Medical Policy for the Center for Drug Evaluation and Research or CDER. He will be sharing some thoughts with us on the Patient Medication Information Proposed Rule that FDA published in May 2023. Welcome, Chris. Thank you for speaking with us today.
For listeners less familiar with this topic, could you explain what is a proposed rule?
Yes. Rules are referred to as regulations and are made by federal agencies such as FDA. A regulation is a general statement issued by an agency, board, or commission that has the force and effect of law. A proposed rule announces the agency’s plan to add, remove, or change a regulation. Federal regulations are created through a process known as "rulemaking." The rulemaking process is governed by U.S. laws, and these laws grant FDA the authority to issue a rule. U.S. law requires the publication of a new regulation in the Federal Register so that anyone can comment on a proposed rule. After this public comment period ends, FDA reviews the comments received. FDA may continue with the rulemaking process and issue what is called a final rule. The final rule explains the regulatory requirements, which are the codified portions of the final rule. Codified portions of the final rule have the force and effect of the law, and they are published in the Code of Federal Regulations. If FDA decides not to issue a final rule, then it has the option of issuing a new or modified proposal or withdrawing the proposal.
Regulations.gov is a U.S. government website that offers more information on the rulemaking process.
Could you provide a brief overview of the proposed rule on Patient Medication Information and explain why it is important for patients?
The proposed rule, if finalized, would require the creation of a new type of Medication Guide called Patient Medication Information or PMI for short. PMI would be a one-page document with standardized format and content that would be submitted by drug sponsors to FDA for approval. Patients would receive PMI for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. The intent of the proposed rule is to ensure patients receive essential written information about their outpatient prescription drug products, including blood and blood components.
Outpatient settings are places like retail pharmacies, hospital ambulatory care pharmacies, and other places, such as infusion suites or dialysis centers, where prescription drugs are dispensed or administered by a health care provider to the patient.
The proposed rule is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively in an outpatient setting.
What type of information is in the proposed PMI and will PMI be printed for patients?
The PMI would include the following information:
- Drug Name
- Important Safety Information
- Common Side Effects, and
- Directions for Use
Importantly, PMI would be one page in length. It would be written in language that is easy to understand. A printed copy of the PMI must be made available, but it can be distributed electronically if that is how the patient prefers to receive the information. FDA will keep approved PMI in an electronic database that will be available for free to the public.
The proposed rule snapshot that accompanies this podcast includes an example of a PMI for a fictitious prescription drug.
Does the proposed rule alter any interactions between a patient and their clinician or pharmacist?
No. PMI would neither replace patient counseling nor the drug’s Prescribing Information or Instructions for Use documents.
What is the current status of the proposed rule?
The comment period for the rule closed on November 27, 2023. As of this taping, FDA is reviewing the comments submitted.
Why did FDA issue the PMI proposed rule?
FDA has long recognized the importance of providing patients with written information about their prescription drug products. Written information can help patients use prescription drug products safely and effectively.
Today, patients may receive one or more types of written medication information regarding prescription drug products. Sometimes, this information is duplicative, incomplete, conflicting, or difficult to read and understand.
The proposed PMI would provide patients with clear, concise, accessible, and useful written information about their prescription drug products used, dispensed, or administered in an outpatient setting. PMI would be a one-page document written and presented in an easy-to-understand format. The type of information included in PMI would be consistent across all PMI documents.
Moreover, the proposed rule would require blood establishments to make PMI available to transfusion services for distribution to patients.
What are the current written medication information documents available to patients for prescription drugs?
FDA currently requires two types of written information be distributed to patients. One is called the Patient Package Insert or PPI. PPIs are FDA-approved documents that are required to be distributed to patients who receive oral contraceptives or estrogen-containing products.
Another type of written information is called the Medication Guide. These medication guides are FDA approved. Currently, Medication Guides are required only for certain prescription drugs that FDA determines pose a significant and serious public health concern.
Additional types of patient information documents are developed and provided to patients. For example, consumer medication information and Instructions for Use documents. FDA approves the Instructions for Use documents but not the consumer medication information.
Would the proposed PMI replace all existing written prescription medication information for patients?
In time, the proposed PMI would replace two of the written medication documents approved by FDA. These are the Patient Package Inserts and the current Medication Guides distributed for certain prescription drugs. The Instructions for Use documents would not be affected by the proposed rule.
When would the requirement for PMI take effect?
FDA proposes that the new requirements would become effective 6 months after a final rule is published in the Federal Register. For instance, if the final rule is published in the Federal Register on August 1, 2024, then it would become effective on February 1, 2025.
Once the final rule goes into effect, FDA is proposing a 5-year implementation schedule for PMI for prescription drug products (except blood and blood components).
On the effective date of the final rule, there will be a number of approved, pending, and new drug applications. Some of these drug applications will already have FDA-approved Patient Package Inserts or Medication Guides. Some of these drugs will be approved but will not have any written patient medication information. FDA is proposing a staggered implementation schedule to address the requirement for PMI for each application category.
Can you discuss PMI for blood or blood components more specifically?
Yes. The proposed rule would require PMI for blood and blood components transfused at outpatient settings. The PMI would include information on the blood component transfused, including important safety information and common side effects.
FDA did not propose an implementation schedule for blood establishments to develop and distribute PMI and for licensed establishments to submit PMI to FDA for approval in the proposed rule. We are considering the public comments as we determine an appropriate schedule in the final rule.
For our final question, what are a couple of key items about the proposed rule that you especially want listeners to remember?
I think the most important thing to remember is that PMI is for patients. The written information would be for all prescription drugs dispensed and administered at outpatient settings, including blood or blood components transfused at outpatient settings.
PMI would be distributed to patients in outpatient settings, such as pharmacies, and it will be written in easy-to-understand language. When patients receive their prescriptions, PMI will be provided by default as a paper document. Some pharmacies may have the capability to provide the PMI electronically, and the proposed rule will expand patient choice by offering the option to receive PMI in an electronic format at the patient’s request.
The intent of PMI is to provide patients with the information needed to help them take their prescription drug products safely and effectively.
Chris Diamant, thank you for taking the time to share your thoughts on the proposed rule on Patient Medication Information. We all have learned so much from insights on this document. We would also like to thank the proposed rule working group for writing and publishing this document.
To the listeners, we hope you found this podcast useful. We encourage you to look at the accompanying proposed rule snapshot and to read the proposed rule.