Press Release PPLA
Washington, DC (April 26, 2024) – Healthcare experts are weighing in on the U.S. Food and Drug Administration’s (FDA) recently proposed rule that would limit access to printed Patient Medication Information (PMI). PMI is the pamphlet dispensed with prescriptions at the pharmacy with critical details about a drug’s side effects and instructions for use. The rule would put PMI on the path to a digital-only format, as well as impose 71.7 million workload hours and over $1.6 billion in costs annually onto pharmacies.
Dr. John Whyte, former U.S. Food & Drug Administration (FDA) Director of Professional Affairs and Stakeholder Engagement, Center for Drug Evaluation and Research, on printed PMI:
“For many people, a printed format simply works better at conveying information, which is why it makes little sense that the FDA would rip life-saving printed information from patients’ hands. At a time of rampant misinformation for which the FDA expressed an explicit priority to combat, the FDA should be making it easier for patients to learn about their medications, not harder.” – The Hill
National Transitions of Care Coalition (NTOCC) Executive Director Cheri Lattimer on Medication Non-Adherence:
“Few causes of death are so preventable yet so common as medication non-adherence, a silent killer that takes away more than 100,000 lives every year…This PMI is not standardized, [and is] overwhelming and hard to read and understand — leading to confusion, adverse health side effects, and — all too often — death.” – The South Florida Sun Sentinel
Indiana State Rep. Donna Schaibley (R-IN-24) on Community Pharmacies:
“…shifting the burden of printing this information from pharmaceutical companies to local pharmacies will put a significant strain on pharmacists who are already overworked and add new financial obligations that many pharmacies will struggle to meet.” – The Hamilton County Reporter
To avoid the FDA rule’s potential harm, a bipartisan group of lawmakers introduced the Patients’ Right to Know Their Medication Act (H.R. 1173), which would standardize PMI based on a scientifically tested design and guarantee drug manufacturers print PMI for every patient.
The Pharmaceutical Printed Literature Association
Chartered in 2001, the PPLA serves as the voice for our members, advocating for patient safety and risk communication by fighting to keep information on paper and readily accessible for patients and caregivers. This information helps drive the patient involvement model of health care, helping patients get the maximum benefits from the powerful drugs they take while minimizing risk.
For more information about PPLA, click here.