ASHP's Office of Government Relations continues to work to ensure that the voices of hospital and health-system pharmacists are represented throughout all levels of government. Together with our members, we made significant progress on our advocacy priorities in 2021. Here is an update on some key victories:
HHS Authorizes Pharmacists to Prescribe and Administer COVID-19 Therapeutics
The Department of Health and Human Services (HHS) announced an amendment to the Public Readiness and Emergency Preparedness (PREP) Act declaration to allow licensed pharmacists to order and administer select COVID-19 therapeutics, including subcutaneous monoclonal antibodies. ASHP led a joint effort with other pharmacy organizations urging HHS to issue an additional PREP Act declaration permitting qualified pharmacists to order and administer therapeutics for prophylaxis or treatment of COVID-19.
ASHP Recommendations Included in White House Report on the Drug Supply Chain
A new report released by the White House this year assessed vulnerabilities in critical supply chains and outlines recommendations to strengthen their resilience. The report, Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth, identifies three pillars of the pharmaceutical supply chain that align with ASHP’s recommendations from 2018 and 2020 to strengthen supply chain security: the ability to manufacture high-quality medications, diversification of the pharmaceutical supply chain, and redundancy within the supply chain.
FDA Amends Hospital/Health System Sterile Compounding Guidance
The Food and Drug Administration (FDA) released its long-awaited revised draft guidance on hospital and health-system compounding. ASHP is pleased that FDA’s revised draft guidance addresses many of the concerns we raised in our comments on the 2016 draft guidance, including removal of the “one-mile radius” requirement. FDA’s revised draft guidance also includes new flexibility for hospitals and health systems that must regularly compound copies of commercially-available products to meet the clinical needs of pediatric and other patients. Specifically, as ASHP requested in its 2016 comments on the draft guidance, FDA introduced flexibility to allow formulary or EHR-level documentation of significant clinical difference for copies that must be routinely compounded for certain patient populations. ASHP’s Hospital and Health-System Compounding Issue Brief includes additional details regarding the proposed enforcement framework and the copies flexibility outlined in the revised draft guidance.
Pharmacists Recognized as Providers in Medicaid Programs in 40 States
With the hard work of ASHP State Affiliates, 40 states have recognized pharmacists as a provider in their Medicaid programs. ASHP state affiliates worked hard within their state capitols to push for recognition with their state Medicaid programs. This effort has expanded pharmacist reimbursement for services the most at risk patients.
Following ASHP and Affiliate’s Advocacy, Pharmacists Expanded Scope to Provide Care in all 50 States
Following ASHP’s advocacy, HHS has expanded pharmacist ability to provide care in all 50 states. Through continuous advocacy and education by ASHP and its state affiliates, state legislatures have seen the benefit of a pharmacist’s role on the healthcare team and expanded their scope of practice to reflect that benefit. Here is a chart of the 2021 state victories for pharmacy.