Understanding Printed Medication Information

PPLA champions the continued use of printed pharmaceutical literature as a vital component of patient safety. While digital tools have value, paper remains the most reliable, accessible, and regulated method of delivering essential drug information.

Printed medication information comes in multiple formats:

• Patient Medication Information (PMI): Consumer-focused summaries that include uses, risks, and directions for use—currently unregulated and inconsistently delivered in the U.S.
• Package Inserts (PIs): FDA-regulated documents written for healthcare professionals, containing complete prescribing details—dosage, administration, side effects, interactions, and warnings.
• Medication Guides (MedGuides): FDA-approved patient documents required for specific high-risk drugs, standardized for clarity and safety.

Why it matters: Printed literature supports adherence, reduces adverse drug events, and ensures vital information is available regardless of electronic access.

Patient Medication Information

Congress recognized the importance of consumer-friendly drug info with the 1995 law (PL 104-180), aiming for 95% of new prescriptions to be dispensed with useful PMI by 2006. Yet:

• FDA studies in 2001 and 2008 showed widespread failure. PMI leaflets met only half of the FDA’s own criteria, often lacking clarity, accuracy, and readability.
• No national standard exists. Pharmacies often alter the content, resulting in inconsistent and incomplete information for patients.
• Other developed nations distribute approved PMI with all prescriptions, unlike the U.S., where patients can receive drastically different information depending on the pharmacy.

PPLA advocates for a standardized, FDA-approved PMI to ensure all patients receive clear, reliable guidance.

Package Inserts

Package Inserts (PIs) are legally required and highly regulated by the FDA. They must include 18 specific content elements—ranging from boxed warnings and dosage guidance to patient counseling information.

• PIs are critical to patient safety, even though they’re designed for clinicians. Many patients actively seek out this thorough, unbiased source of information.
• In 2006, the FDA modernized PI requirements to make them easier to read, saving hundreds of millions in healthcare costs by preventing adverse events.
• Printing PIs requires specialized equipment and adherence to FDA Good Manufacturing Practices (cGMP)—highlighting their reliability and integrity in the drug supply chain.

Efforts to Eliminate Paper

Since 2001, various proposals have aimed to replace printed PIs with electronic versions. PPLA has fought back to preserve patients’ access to print:

• The FDA has repeatedly listed a shift to electronic-only inserts in its regulatory agenda, without stakeholder transparency.
• Industry concerns include patient access gaps, reliability issues, and the burden of shifting printing costs to pharmacies.
• In 2013, the GAO warned that removing printed PIs could “adversely impact public health.”
• PPLA has secured bipartisan support in Congress to prevent FDA funding from advancing an electronic-only policy.

Our position is clear: digital options can supplement print, but must never replace it.