PMI Readability Calculator
How Readable Is Your Medication Information?
The new FDA Patient Medication Information (PMI) standard requires medication information to be written at an 8th-10th grade reading level. This tool helps you see how readable your current medication information is compared to the new standard.
Enter a sample of your medication information below to see its readability score. The FDA's new PMI format is designed to be clearer for people with low health literacy, helping reduce medication errors.
The U.S. Food and Drug Administration (FDA) is proposing a major shift in how patients receive information about their prescription drugs. Right now, only about 150 out of thousands of prescription medications come with a Medication Guide - a printed sheet that explains risks and usage. Starting in 2025, patient medication information (PMI) will be required for every outpatient prescription drug in the U.S. This isn’t just a small update. It’s a complete overhaul of how drug information is delivered to patients.
What Is the New PMI Format?
The new PMI is designed to be simple, clear, and consistent. Every drug will come with a single-page document that follows the same layout, no matter where you fill your prescription. The goal? Help patients understand what they’re taking, how to take it, and what to watch out for - without having to dig through confusing medical jargon.
The PMI starts with a bold statement: "Use exactly as prescribed." That’s not just a reminder. It’s the foundation. After that, the document breaks down key details in a fixed order:
- How to take the medicine - including dose, timing, and route (oral, injection, etc.)
- Special handling instructions - like refrigeration or avoiding sunlight
- Storage and disposal - how to keep it safe at home and how to throw it out properly
- Warnings - serious risks like allergic reactions or dangerous interactions
- Common side effects - things that happen to many people
Text is sized at 12-point font, uses plain language, and avoids marketing language. No hype. No vague claims. Just facts based on the drug’s official prescribing information. The FDA tested dozens of versions with real patients before settling on this design. People with low health literacy understood the new format 25-40% better than current Medication Guides.
Why This Change Is Happening Now
Medication errors are a quiet crisis in American healthcare. According to the Institute of Medicine, they cause about 1.3 million injuries and 7,000 deaths each year. Many of these errors happen because patients don’t understand how to use their drugs - or they miss critical safety info buried in fine print.
Right now, if you get a blood pressure pill from one pharmacy and a painkiller from another, you might get two totally different formats. One might list side effects in bullet points. Another might bury them in paragraphs. Some don’t even include disposal instructions. That inconsistency creates confusion - and risk.
The FDA has tried to fix this before. Decades of attempts failed because drug companies pushed back, regulators shifted focus, and the issue got lost in bureaucracy. But with rising public concern over opioid misuse, medication safety, and health equity, the pressure finally stuck. The PMI rule is the result of years of research, patient testing, and stakeholder feedback.
What’s Different From Current Medication Guides?
Current Medication Guides are only required for drugs with serious risks - like blood thinners, certain antidepressants, or drugs with black box warnings. That’s less than 10% of all prescriptions. Most patients get a standard pharmacy label with their name, the doctor’s name, and dosage instructions. That’s it.
The new PMI changes everything. It applies to every single outpatient prescription - antibiotics, cholesterol pills, diabetes meds, even birth control. That’s over 6.7 billion prescriptions a year. For the first time, every patient gets the same level of clarity, no matter what they’re taking or where they live.
And it’s not just paper. The FDA is requiring digital options too. Pharmacies must offer PMI electronically - via email, app, or patient portal - as long as it’s accessible to people with disabilities (Section 508 compliant). This helps younger patients who prefer digital, but also ensures older adults or those without smartphones still get a printed copy.
What’s Missing From the PMI?
While the PMI improves safety, it’s not perfect. Researchers at the University of Pittsburgh pointed out a big gap: it doesn’t tell you how well the drug works.
Right now, a PMI might say, “Headache is a common side effect.” But what does “common” mean? Is it 1 in 10 people? 1 in 2? The FDA’s version doesn’t say. The Pittsburgh team created a prototype called “Decision Critical PMI” that includes numbers: “48% of patients experience fever,” “43% get headaches.” Patients said that made a huge difference. “If I know it’s almost half of people, I’m not scared when it happens,” one said.
Similarly, the PMI doesn’t explain how the drug works in the body. It doesn’t compare benefits to risks. For drugs like antidepressants or statins, where patients need to weigh long-term benefits against side effects, that’s a real limitation. The FDA says providers should explain benefits during the visit - but what if the patient forgets? Or doesn’t ask?
That’s why some experts think this is just Phase One. The FDA has already signaled they’re open to future updates based on patient feedback and research results.
Who’s Affected - and How?
This change hits everyone in the healthcare chain:
- Drug manufacturers will have to create, test, and submit PMIs for every outpatient drug they make. That could mean 10,000+ documents per large company. They’ll get templates from the FDA, but it’s still a massive workload.
- Pharmacies will need to update systems to print or email PMIs automatically. Staff will need 2-4 hours of training, plus annual refreshers. Pharmacists estimate it’ll add 30-60 seconds per prescription - a small time cost, but a big one for busy stores.
- Doctors won’t have to do anything new directly, but they’ll need to be ready to answer questions about the PMI. Patients will come in with printed sheets and specific questions.
- Patients get a clearer, more consistent picture of their meds. For those with low health literacy, chronic conditions, or language barriers, this could be life-changing.
Costs are estimated at $1.2 billion over five years. Drugmakers pay about 65%, pharmacies 25%, and providers 10%. Small independent pharmacies are worried. About 15% say they might struggle to afford the upgrades without financial help.
What’s Next?
The proposed rule closed for public comments in November 2023. The FDA reviewed over 1,200 submissions from patients, pharmacists, doctors, and drug companies. The final rule is expected in early 2024.
Implementation will be phased:
- Larger drugmakers: 24 months after final rule
- Smaller companies: 36 months
By 2025, you should start seeing the new PMI at your pharmacy. The FDA is already preparing templates and a review team to handle the flood of submissions. International agencies like the European Medicines Agency are watching closely - they’re considering similar rules for 2025.
Why This Matters to You
If you or someone you care about takes prescription drugs, this change affects you. You’ll get the same clear, consistent information no matter where you go. No more guessing what “common side effects” means. No more missing storage instructions because they were printed in tiny font.
It won’t solve every problem. You still need to talk to your doctor. But now, you’ll have a reliable, easy-to-read reference to bring to those conversations. And that’s a big step toward safer, smarter care.
The real test won’t be whether the PMI is printed correctly. It’ll be whether patients actually use it - and whether it helps them avoid mistakes, stay on track, and feel more in control of their health.
Will all prescription drugs have the new PMI?
Yes. Starting in 2025, every outpatient prescription drug - including pills, injections, and blood products - will come with a standardized Patient Medication Information (PMI) document. This includes common drugs like antibiotics, blood pressure meds, and birth control. Inpatient hospital medications and over-the-counter drugs are not included.
Can I get the PMI electronically instead of on paper?
Yes. Pharmacies must offer the PMI in digital form - via email, text, or patient portal - as long as it meets accessibility standards (Section 508). You can choose paper or digital. If you don’t have a smartphone or email, the pharmacy must still give you a printed copy.
Does the PMI tell me how well the drug works?
Not yet. The current PMI format focuses on safety, usage, and side effects - but doesn’t include effectiveness rates or how the drug works in the body. For example, it might say "headache is common," but not that 43% of users experience it. Researchers are pushing for this info to be added in future updates.
Will this make my pharmacy visits longer?
Possibly at first. Pharmacists estimate it will add 30-60 seconds per prescription during the early rollout while systems adjust. After implementation, most pharmacies expect it to become part of their normal workflow. Training for staff is required, but the process is designed to be automated where possible.
Who paid for the development of the PMI?
The FDA designed the format using public input and patient testing at no cost to manufacturers. But drug companies will pay for creating and submitting the actual documents - estimated at 65% of the $1.2 billion total implementation cost over five years. Pharmacies cover 25% for system updates, and providers 10% for staff training.
Is this rule already in effect?
No. As of November 2025, the PMI rule is still proposed. The FDA is expected to finalize it in early 2024. Full implementation will begin in 2025, with larger manufacturers required to comply first. Smaller companies will have an extra year.
How does this affect patients with limited English proficiency?
The FDA requires PMIs to be available in languages spoken by significant patient populations in each state. Pharmacies must provide translations upon request. The plain language design also helps non-native speakers understand the content better than older, complex formats.
What You Can Do Now
Even before the PMI rolls out, you can prepare:
- Ask your pharmacist if they have a copy of the current Medication Guide for your drug - even if it’s not required.
- Write down questions about your meds before your doctor’s visit. Don’t wait until you get home.
- Keep a list of all your medications, including dosages and reasons for taking them.
- If you’re unsure about side effects or instructions, don’t guess. Call your pharmacy or provider.
The new PMI won’t replace conversations with your care team - but it will give you a stronger, clearer foundation to have them.
