Washington, D.C. — Last week, U.S. Representatives Mikie Sherrill (NJ-11) and John Curtis (UT-03) introduced The Prescription Information Modernization Act, legislation intended to update distribution methods for prescribing information (PI) for pharmacists and physicians. The bipartisan legislation garnered quick support from several key organizations, including the American Pharmacists Association. Joining Reps. Sherrill and Curtis in introducing the legislation are Reps. Tom O’Halleran and Markwayne Mullin.
Prescribing information refers to the bulky physical inserts included in the bulk shipment boxes of pharmaceutical products from a distributor, that manufacturers are required to provide to pharmacists and prescribers.
“It is vital that our health care system keep pace with private sector innovation and that Congress works to update outdated laws and regulations,” said Rep. Curtis. “With this bipartisan legislation, pharmacists and physicians will have the most up-to-date prescription information right at their fingertips; helping them provide the best care to their patients. The health and safety of Utahns and all Americans remains my priority, and I look forward to moving this bill through Congress.”
“Healthcare providers, pharmacists, and patients have greatly benefitted from modernizing and the transitioning to a digital interface, particularly when we were socially distant during the height of the pandemic,” said Rep. Sherrill. “Common sense modernization of the PI requirements will improve care by giving prescribers easy access to the most up-to-date product information available while reducing waste and unnecessary environmental damage. It’s time for Congress to think long-term and allow drug manufacturers to deliver prescribing information to pharmacists digitally rather than on paper.”
Currently, PI, information sent to providers that contains important information related to a specific drug, must be printed, running on average 45 pages per prescription, causing significant waste and environmental harm. PI is not the information patients receive with a prescription.
In 2014, the Food and Drug Administration (FDA) proposed a rule that would provide for electronic distribution of PI. Since that time, Congress has used the appropriations to prevent the FDA from finalizing that rule, requiring bulky paper labels to be printed and distributed, even though many are immediately discarded for being outdated.
The current requirement for printed labels was established in 1962. While digitizing the labeling is a more convenient method of distribution that also reduces waste, it also improves patient safety. Where electronic distribution of prescribing information ensures both patients and prescribers have the most up-to-date information, printed labeling can take, on average, 8-12 months to be printed and distributed, meaning information is often outdated by the time it reaches the prescribers.
The proposed FDA rule would give prescribers the option to choose which method of receiving PI they prefer for both their business and patients. In addition, the bulky paper distribution method has significantly contributed to waste in the industry, with some 90 billion sheets of paper that are printed each year to comply with the 1962 requirement.
“This legislation will give pharmacists access to real time updates to reliable and trusted prescription drug information. This is important for managing patients’ medications and contributing to safe medication use,” according to a statement from the American Pharmacists Association.