Washington, DC (April 02, 2024) – A recent study from MLPS (Medical Leaflet = Patient Safety) highlights the massive costs that would result from proposed changes in how patient medication information (PMI) is delivered. The study analyzed a proposal by the European Commission to allow member countries to switch PMI delivery to a digital and print-on-demand system. They found that changing PMI delivery away from a printed format would cost the European Union up to €3.5 billion, or $3.78 billion, annually. A similar proposal from the U.S. Food and Drug Administration (FDA) would cost pharmacies more than $1.6 billion annually.
PMI refers to the life-saving information dispensed at the pharmacy detailing a drug’s purpose, instructions for use, and potential side effects. The FDA recently proposed a rule that would force pharmacies, not drug manufacturers, to be responsible for the cost and labor of printing PMI. Because printed PMI would still need to be provided if asked for, the rule would force pharmacies, not drug manufacturers, to be responsible for the cost and labor of printing PMI. This would increase pharmacist workloads by 71.7 million hours, the equivalent of 35,858 full-time pharmacy technicians, and cost over $1.6 billion a year.
Key Highlights from the MLPS Study:
- “The estimated total cost of Print on Demand (PoD) leaflets across Europe-27 ranges from €1.680 billion to €3.495 billion annually, depending on whether leaflets are printed in black or four-color ink.”
- “A substantial portion of citizens (46%) lack the digital skills needed to access electronic product information, requiring physical leaflets for detailed medication information.”
- “All things considered, even though the total number of leaflets printed will down from 8,575 to 1,292 million, the cost will skyrocket to a scenario where the leaflets will be PoD in the pharmacies in colour (€2,497 million) or in black ink (€1,200 million).”
The bipartisan Patients’ Right to Know Their Medication Act (H.R. 1173) would protect patients’ access to printed PMI and avoid the massive costs associated with a change in PMI delivery. Introduced by Representatives Jared Golden (D-ME), Buddy Carter (R-GA), Dutch Ruppersberger (D-MD), and Bruce Westerman (R-AR), the bill has 14 bipartisan cosponsors.
H.R. 1173 requires drug manufacturers to provide printed PMI, approved by the FDA, for every American taking prescription medications. Americans reference PMI to take their medications correctly, proving particularly important given that medication non-adherence kills over 100,000 people every year.
The Patients’ Right to Know Their Medication Act is cosponsored by Reps. Zoe Lofgren (D-CA), Jeff Van Drew (R-NJ), Chellie Pingree (D-ME), Yvette Clarke (D-NY), David Trone (D-MD), Terri Sewell (D-AL), Chris Pappas (D-NH), Jill Tokuda (D-HI), Brad Schneider (D-IL), Mary Sattler Peltola (D-AK), and Marie Gluesenkamp Pérez (D-TX).
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.