13 Aug Pharmacy Times: US Representatives Push Congress to Pass Legislation to Digitalize Prescribing Information for Patients, Pharmacists
by Erin Hunter for Pharmacy Times
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and still mandated by law.1 Print labels may take a year to reach patients through the supply chain, which may contain outdated and potentially harmful information.2 Digitalized labeling provides more convenience, improves patient safety with current information, and is less wasteful to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“It is vital that our health care system keep pace with technological advancements and that Congress works to update outdated standards,” Rep.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
- 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.
- Alliance to Modernize Prescribing Information. May 10, 2022. Accessed July 29, 2022.