Explore PPLA’s collection of issue briefs and one-pagers highlighting the critical role printed medication information plays in protecting patients, reducing healthcare costs, and supporting rural, sustainable, and secure care delivery. Each document below provides timely insights on the policy, safety, and system-wide implications of shifting away from printed drug labeling.
Featured Legislation: Patients’ Right to Know Their Medication Act (H.R. 5133)
September 2025 — Reps. Cliff Bentz (R-OR) and Jared Golden (D-MA) reintroduced bipartisan legislation to protect patient safety through access to standardized, printed medication information. The bill would require that all outpatient prescriptions be dispensed with a standardized, FDA-approved, printed Patient Medication Information (PMI) sheet. Please visit the Advocacy tab to learn more about what the bill does and why it matters.
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Featured Analysis: Burdens Without Benefits
July 2025 — This white paper critically examines the FDA’s proposed Patient Medication Information (PMI) rule, which would replace current labeling with a one-page handout. The analysis finds that the rule would impose heavy new costs on pharmacies, especially independents, while offering little evidence of improved patient safety or understanding. It also raises equity, privacy, and access concerns by shifting responsibility away from manufacturers and toward pharmacies.
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Featured Studies
An Economic Assessment of the FDA Proposal Rule: “Medication Guides: Patient Medication Information“
January 2023 — NDP Analytics assessed the costs of implementing the FDA’s proposed rule and how it will affect patient access to printed medication information.
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Pharmacy Practice: A Report on Pharmacists’ Use of Printed Package Inserts
January 2015 — NERA Economic Consulting designed and conducted research to address how and what extent pharmacists use the printed package inserts, how printed package inserts help to facilitate the appropriate dispensing of medication, and pharmacists’ perceptions of potential exclusive e-labeling schemes. Download Study
Patient Medication Information: Printed and/or Electronic?
January 2014 — Dr. Ruth Day of Duke University examined the cognitive benefits and public preferences of printed medication literature versus e-labeling. She concluded that 95% of older patients and young tech-savvy adults wanted to retain printed versions of their medication information over their electronic counterparts.
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PPLA Overview One-Pager
A snapshot of who we are, what we stand for, and why printed pharmaceutical literature is essential to patient safety.
Rural Health & Printed Information
Rural communities face unique risks from digital-only PMI. This brief explains how pharmacy closures and broadband gaps make print access critical.
Sustainability & Print
Printed medication information can be both patient-centered and environmentally responsible. This brief debunks myths about paper waste and highlights the industry’s sustainable practices.
Cybersecurity & Medication Access
Digital PMI is vulnerable to breaches, ransomware, and outages. This resource outlines how print protects patients against growing cybersecurity threats.
PMI: Side-by-Side Comparison
Compare current vs. proposed standards for Patient Medication Information (PMI) and see how the changes could affect readability, access, and patient outcomes.
Example of a Patient-Friendly Medication Format
This sample Patient Medication Information (PMI) sheet is based on research conducted by Dr. Ruth S. Day of Duke University. It’s designed to improve comprehension through clear layout, bold warnings, and easy-to-read sections—highlighting what a standardized, FDA-approved printed format could look like.
