US Representatives Push Congress to Pass Legislation to Digitalize Prescribing Information for Patients, Pharmacists

US Representatives Mikie Sherrill (NJ-11) and John Curtis (UT-03) proposed new FDA rule, The Prescription Information Modernization Act (HR 7559), would digitalize prescribing information (PI) for patients and pharmacists.¹

“Health care 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,” Rep. Sherrill said in a press release.¹

Printed labels—booklets containing the safety, science, and efficacy of prescription drugs or biological products—are sent to pharmacists from drugmakers, allowing them to determine whether the drug is a good treatment option for patients.² Health care practitioners could continue to receive these print labels if they chose, however, they would also have the option to receive it digitally.²

“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,” Sherrill said. “It’s time for Congress to think long-term and allow drug manufacturers to deliver prescribing information to pharmacists digitally rather than on paper.”¹

Current printed label requirements were established in 1962 and still mandated by law.¹ Print labels may take a year to reach patients through the supply chain, which may contain outdated and potentially harmful information.² Digitalized labeling provides more convenience, improves patient safety with current information, and is less wasteful to the environment, according to the legislators.¹

“It is vital that our health care system keep pace with technological advancements and that Congress works to update outdated standards,” Rep. Curtis said in a press release. “With this commonsense, bipartisan legislation, pharmacists and physicians will have the most up-to-date prescription information right at their fingertips, ensuring they can provide the best care to their patients. I look forward to moving this bill through Congress.”¹

The FDA mandates PI for health care practitioners.² According to its guidelines, PI must contain essential scientific information for safe and effective use of a drug or biological product, be informative, accurate, updated with new information, and neither false nor promotional.²

The Alliance to Modernize Prescribing Information states that modernization will allow health practitioners to have real-time drug information and be informed on the most critical safety updates, which they discussed in a report on the rule.² It is lower cost, as it avoids the development, print, package, and delivery of information, thereby providing faster delivery of these materials.²

Modernizing PI distribution aligns with current prescription distribution practices.² According to The Alliance information sheet, in 2019, 98.7% of prescriptions were electronically sent to the pharmacy.²

“This legislation will give pharmacists access to real time updates to reliable and trusted prescription drug information,” the American Pharmacists Association said in a statement. “This is important for managing patients’ medications and contributing to safe medication use.”¹

References

1. Reps. Sherrill and Curtis Introduce Legislation to Modernize Access to Prescribing Information. U.S. House of Representatives website. https://sherrill.house.gov/media/press-releases/reps-sherrill-and-curtis-introduce-legislation-modernize-access-prescribing. April 28, 2022. Accessed July 29, 2022.
2. Alliance to Modernize Prescribing Information. May 10, 2022. Accessed July 29, 2022.