Medication Guides:  Patient Medication Information; Proposed Rule
2012-117 Proposed Rule Medication Guides Patient Medication Information CDER OPEN
2023-06-23 2023-06-08 2023-07-24 2023-07-03 2023-06-26 2023-07-06 2023-08-16 2023-07-31 2023-07-28 2023-09-12
FDA-2019-N-5959-0103 FDA-2019-N-5959-0092 FDA-2019-N-5959-0124 FDA-2019-N-5959-0110 FDA-2019-N-5959-0105 FDA-2019-N-5959-0114 FDA-2019-N-5959-0129 FDA-2019-N-5959-0127 FDA-2019-N-5959-0126 FDA-2019-N-5959-0146
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https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0103 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0092 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0124 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0110 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0105 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0114 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0129 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0127 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0126 https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0146
Amanda D Bruce Barbara Steven Anonymous Supriya Kevin Muaz Russell
Colandro Porter Brod Dunker Burdzy Anonymous Ziska Chevalier Chaudhry Haraf
I support the proposed rule, Medication Guides: Patient Medication Information, as a new type of medication guide to help patients use prescription drugs safely and effectively. The current medication guide does not provide a clear, concise, accessible, and sufficiently useful guide for patients. There is evidence that prescription drug product information may help patients use their prescription drugs safely and effectively, reducing preventable adverse drug events and improving health outcomes. As a nurse practitioner, I treat patients with diabetes, and medication errors can be life threatening, and could cause severe hypoglycemia or hyperglycemia. My patients have a wide range of literacy levels, and the clearer the labeling, the less room there is for error. An important element of the proposed rule is the requirement that patient mediation information be scientifically accurate and based on and consistent with the prescription drug to prevent misleading information. The changes to the new medication guide will provide patients with easy-to-read and concise information regarding their drugs, a clear understanding of the drug, and possible adverse reactions, and the ability to recognize when to call the doctor. For a majority of patients I talk to, the information they currently get is more than they are willing to read and is not laid out well. Information is not clearly labeled and is not always easy to find. I sometimes highlight certain areas that are of importance to the patient. Some patients ask that we do not give them the information at all since at our location we provide the information on separate sheets and sometimes they receive 5 pages of information.The drug package inserts should be done away with entirely as a part of this new patient information rule. The package insert is written in technical terms, and we usually pull the package insert off the bottle when they arrive and discard it. That is a lot of waste of paper when all that information is available online through multiple sources such as Facts and Comparisons, Clinical Pharmacology, DailyMed, etc. I believe patients would be more likely to read a shorter, more concise information sheet. The iPledge REMS program continue to widen health disparities. Much of this could have been prevented by involving dermatologists in the pre-testing. There are still technical issues including lack of privacy as designees in any practice can be seen by all users.The following are the top priorities to address:test proposed changes to REMS system prior to implementation with physicians, patients, and pharmacists; allow for ample time for stakeholders to transition to a new platform including beta-testing; improve support services for prescribers when there is REMS System failure; and facilitate greater transparency between drug sponsors, REMS administrators, and stakeholders, including a named point of contact for key stakeholders. nker The proposed rule to change the regulations for prescription drug products to simplify and highlight essential information can have a substantial positive effect on patient health literacy and education. Most people do not read the current patient package insert provided because it pertains too much information and is not direct, to-the-point information. The proposed Patient Medical Information (PMI) insert gives patients access to essential information on one page and lists need-to-know information in a standardized format. The PMI would include the product name, important safety information, common side effects, and a concise summary of indications and uses. As you can see, this provides critical information in a simplified and more effective manner. Multiple studies have shown that the current information provided with prescription drugs can be confusing, conflicting, and incomplete (Califf, 2023). When people are not provided with the proper prescription education, this can lead to the cessation of medication or improper use. Rightfully, one of the FDAs top priorities is to reduce misinformation and disinformation. When an individual has direct and easy-to-understand information in a consistent format, this can reduce both accidental and purposeful misinterpretations (Califf, 2023). I have been a registered nurse for over ten years and have worked most of that time in emergency rooms around the United States. I can attest that most patients do not know the side effects, precautions, or indications for their daily medications. The most often response I would hear when a patient is asked why they take a particular medicine is, My doctor told me to take it. This is not health literacy and does create informed patients. I firmly believe that simplifying and reducing the information provided with medication prescriptions will increase patient education and willingness to engage in health literacy and reduce misuse and misinformation. I appreciate your consideration.References:Califf, R. (2023, May 30). Fda proposes new, easy-to-read medication guide for patients, patient medication information. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-proposes-new-easy-read-medication-guide-patients-patient-medication-information After reading this proposed rule, I agree that there should be a standardized way that medication information is presented to patients. Given the limited time patients have with their practitioners to discuss the complexity of medications, patients rely on information they receive from other sources. Being that not all sources are reliable, reputable or accurate, it is essential for medication information be available in a clear, concise, and easy to understand format. Providing this information can help reduce confusion, medication noncompliance, and give patients more control and autonomy over their medication treatments. It prioritizes patient-centered care and medication prescribing. Patients heavily rely on literature that is accurate and clear to make healthcare decisions especially between choosing to take a medication or not. Pharmacists in one study by Alefishat et al. (2021) reported that Internet-based data can be beneficial but could actually be detrimental due to the fear and misinformation that can be found through Internet sources for medication information. This highlights the need for standardized medication information that is readily available to patients when needed. Hello,I wanted to inquire on regulations of  medication guides and PMI. With regards to printed handouts, is there a way that we can have med guides/PMI default to QR code (electronic) instead of paper. Patients that decline the electronic delivery or QR code can have drug information printed off. Also, is there guidance on existing med guides provided via QR code. We are looking to incorporate software (MedsOnCue) into our facility but wanted to make sure it is in line with FDA guidelines. As a professional in pharmaceutical sciences and accounting who has worked with non-profits and university research programs on both financial and health literacy, I support the FDAs proposed rule for the development of PMIs which can benefit patients and healthcare providers.  Promoting stronger health literacy within the population can improve adherence to the drug regimen and the patients health outcomes.  Standardization of a PMI template and simplifying access through electronic means would further facilitate health communications between the patient and their healthcare providers during the patient care process.  The implementation of the PMI would also contribute to a more independent and informed decision-making process for patients navigating outpatient procedures such as the blood transfusion services discussed in the proposed rule.  While there will be increased costs because of the development of the PMI, the benefits that it will provide to patients and providers would include better care management and reducing risks pertaining to drugs and outpatient services.  This can also reduce healthcare associated costs in the long term due to better compliance. From my work with my mentors in cancer education, individuals who were provided with clear instructions for self-exams and benefits for early screenings per guidelines from the American Cancer Society such as for breast or colon cancers, found information relevant to their personal needs helpful. The proposed rule for the PMI would positively help improve patient health literacy and guide those involved with developing and disseminating PMIs to provide resources which can mitigate risks for drugs and services in an outpatient setting.  On the other hand, I do understand that costs may be a factor, especially the increased resources which would be needed to ensure that the PMI development process move accordingly per the proposed rules.  For dispensers and other individuals who may have limited resources or will accrue additional expenses as a result of PMI distribution, the FDA should work with ensuring that implementation of PMIs would be as smooth as possible so that benefits can be realized. I concur with the proposed rule Medication Guides: Patient Medication Information. My rationale for support is that the rule will help patients use their prescription medicine products safely and effectively, we must give patients written information about them that is clear, succinct, accessible, and helpful. This information must be presented in a way that is consistent and simple to understand. Further, the information paly a significant role because without this information, patients are unable to determine which medication is best for them as well as even if they do, how to take it. Finalizing the rulemaking help on the gathering, application, and management of knowledge regarding the use of drugs. The range of information about drugs includes identification, price, pharmacokinetics, dose, and side effects.in addition, it will help to monitor medication. It is crucial to routinely evaluate all prescription medications, over-the-counter medications, and supplements because all medications can have side effects that can result in new symptoms or exacerbate current symptoms. Its also critical to consider potential interactions. To Whom It May Concern, I am writing because I am concerned about your proposed rule regarding printed prescription drug information for patients. I appreciate that the FDA recognizes the importance of printed drug information for patients, but I believe the proposed rule lacks important patient protections. I dont believe the drafted rule achieves the FDAs stated goal of improving health because it does not require clear and useful printed prescription drug product information provided in the right manner. Like most Americans, my family and I take prescription medication, and we struggle to understand the printed medication information that accompanies our medications. We need to improve our understanding of the drugs we are taking and need improved printed copy to help us.I need clear, always accessible and useful written prescription drug product information.  Patients need a standardized layout researched to improve patient understanding and retention of information. Standardization principles should include use of color, consistent headings and MINIMUM FONT SIZES to increase understanding. Patient understanding and retention of information should be rigorously tested with REAL patient populations taking REAL prescription medication before adoption. Why would the FDA consider a change in prescription information for patients without first researching a format that improves patient understanding? I also believe the FDA should require standards for high quality printing and inspection so that ALL required information is present. The FDA rule, as it currently stands, could force the elderly and other patients to access life-saving information by only electronic means. This goes against common sense and can put Americans lives at risk. People deserve full access to their prescription drug information at all times, no matter their age, income, or geographic location. I urge you to revise your proposed rule for patient medication information in two ways:1.Require a standardized printed format that has been scientifically researched and proven to improve patient understanding.2.Require the drug manufacturer to supply the printed information and have it accompany the drug product and not printed in a retail pharmacy.Doing so will help save lives and improve medication outcomes. Thank you for your time and consideration.