The American Pharmacists Association and NCPA partnered to submit comments to the FDA on increasing access to nonprescription drugs. The comments proposed utilizing the ACNU framework to successfully increase patient access while balancing safety concerns. The ACNU final rule was published in Dec. 2024 and allows certain products to be legally marketed without a prescription if additional considerations ensure appropriate self-selection or actual use. APhA and NCPA emphasized the importance of pharmacist involvement in this process and included recommendations on pharmacist access to electronic health records.
Action steps in the comments were for 1) FDA to clarify clear pathways for Rx-to-OTC switch with ACNU, 2) FDA to work with CMS to require Part D plan sponsors, state Medicaid agencies, Medicare Advantage plans, and others to cover any additional requirements and additions to pharmacists’ workflows under Scenario A or B and establish mechanisms to reimburse patients for products purchased outside pharmacies under the technology-enabled self-evaluation pathway, and 3) FDA to work with ONC to call upon HHS to leverage its influence of EHR systems to facilitate full integration of pharmacies and pharmacists wherever they exist in the health care system to ensure bi-directional (read/write) access to the patient’s health care record. Read the proposed blueprint here and the full comments here.
