Community pharmacists are rallying behind a federal bill reintroduced last fall that would require drug manufacturers to provide printed medication information with every outpatient prescription.
Reps. Cliff Bentz, R-Ore., and Jared Golden, D-Maine, reintroduced the Patients’ Right to Know Their Medication Act in the House in September. The bipartisan bill would mandate drugmakers include one-page, printed, FDA-approved Patient Medication Information sheets with prescription drugs detailing the medication’s purpose, instructions for use and potential side effects. The legislation also directs the FDA to issue final regulations establishing a standardized format for the information sheets within one year of passage and requires timely updates as new drugs and safety information become available.
The legislation follows a 2023 FDA proposed rule that would have allowed drugmakers to provide the information electronically at a patient’s request. The FDA also proposed a rule in 2014 that would have eliminated the requirement to distribute printed prescribing information used by pharmacists to safely dispense medications in favor of electronic-only access. Neither rule was finalized.
While the FDA cited improved accessibility and consistency of drug information in its proposals, proponents of the new bill argue the shift to digital formats would disproportionately harm low-income, older and rural patients who lack reliable internet access.
The National Community Pharmacists Association is among the medical organizations that have endorsed the bill, citing the importance of clear, accessible information for patients without creating additional burdens for pharmacies.
“NCPA supports the legislation and believes that PMI should: 1) have demonstrated optimum understanding for patients; 2) be provided at no additional cost to pharmacies; and 3) minimize the administrative burden to community pharmacies,” a spokesperson told Becker’s March 10.
The National Rural Health Association, National Black Nurses Association and the Pharmaceutical Printed Literature Association have also endorsed the bill.
Drugmakers have pushed back on mandates to maintain printed information, arguing the requirements are burdensome and increase costs to consumers, Axios first reported March 10.
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