Protect Patient Safety: Demand Clearer Prescription Information!

The current FDA proposal for clearer, printed drug information lacks vital patient protections. Like countless Americans, families rely on prescription medications, and understanding the accompanying information is often a difficult task. We need clarity, accessibility, and convenience in prescription drug product information.

Join us in urging the FDA to reconsider the proposed rule in two essential ways:

1. Demand Scientifically Proven Clarity: Implement a standardized printed format thoroughly researched to enhance patient comprehension. This format should include color utilization, consistent headings, and minimum font sizes, tested rigorously with real patient populations to ensure effectiveness. When patients receive prescriptions, they need to fully understand crucial details such as dosage instructions, potential side effects, and interactions with other medications. Scientifically researched formats ensure that the information provided is not just comprehensive but also designed in a way that maximizes understanding.

2. Ensure Manufacturer Responsibility: Mandating drug manufacturers to supply printed information directly with the medication is essential for patients and their families. Firstly, it guarantees the consistency and accuracy of the information provided, eliminating the possibility of variations or errors that might occur if patients have to rely on different retail pharmacies for printed materials. Secondly, this approach ensures that patients, regardless of their age, income, or location, have equal access to essential drug details. Elderly individuals, those with limited internet access, or individuals residing in remote areas might face challenges in accessing digital information. By having printed information accompany the drug product, all patients can make informed decisions about their healthcare without barriers, promoting equitable access to vital health information.

Patient safety is at stake. Without clear and standardized printed information, lives are jeopardized.

Sign the Petition for Safer Medication Information!
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 don't believe the drafted rule achieves the FDA's 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.
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