ASHP Advocacy Yields Major Win on Nationwide COVID-19 Prescribing Authority

Dear Colleagues,

This week we received great news for our patients and profession. The Food and Drug Administration (FDA) revised its Emergency Use Authorization (EUA) to authorize pharmacists as prescribers of Paxlovid for the treatment of COVID-19.

ASHP's advocacy on behalf of our profession, along with the engagement of our various partners and stakeholders, helped to achieve this tremendous advocacy win – one that recognizes the essential role of pharmacists as medication experts and patient care providers.

This latest news from the FDA is the capstone to a sustained advocacy effort that ASHP championed. Today, I want to reflect on the extensive work that got us to this point.

Laying the Groundwork
ASHP's advocacy began in March 2020 when we released recommendations for state and federal policymakers to respond to the emerging COVID-19 virus and asked the federal government to authorize pharmacists to order antiviral medications when they became available. We also released state scorecards highlighting where pharmacists would have the authority to test and treat for COVID-19.

At that time, we also sent a letter to Vice President Pence, who was leading the administration's response to the emerging pandemic, and we held numerous calls with the Project Warp Speed therapeutics team, FDA leadership, the transition team for then President-Elect Biden, and members of Biden's COVID-19 taskforce, among others, to advocate for pharmacists to have the authority to test and treat patients for COVID-19.

Advocating for PREP Act Authority
In May 2021, we continued our work, meeting with members of the White House COVID-19 response team to educate them about the role of pharmacists in vaccination and testing and advocate for utilizing pharmacists' expertise as a point of access for COVID-19 therapies. Last summer, our government relations staff team also held a number of meetings with the Department of Health and Human Services (HHS) COVID-19 response team and HHS Assistant Secretary for Health Adm. Rachel Levine, and worked extensively with the therapeutics leadership of HHS Assistant Secretary for Preparedness and Response to secure authorization of pharmacist ordering of treatments for COVID-19 under the Public Readiness and Emergency Preparedness (PREP) Act.

Our tremendous efforts paid off with HHS authorizing pharmacist prescribing of COVID-19 treatments under the PREP Act in September 2021. As I noted in my PREP Act blog, these efforts continue to bring us closer to achieving greater recognition as providers.

Removing the Final Barrier in FDA's EUA
The FDA's original EUA for Paxlovid did not include pharmacist prescribing of oral antivirals for the treatment of COVID-19, prompting ASHP to immediately issue a statement with four other pharmacy organizations asking the FDA to remove this federal barrier preventing patient's access to timely treatment.

In December 2021, ASHP met with the White House COVID-19 team and proposed a series of policy options for the administration to maximize patient access to oral antivirals.

For the past six months, we also continued our aggressive advocacy calling on the FDA directly to remove its limitation on pharmacists ordering oral antivirals. ASHP sent letters to Acting FDA Commissioner Janet Woodcock, President Biden, the White House COVID-19 Response Coordinator, the Centers for Medicare & Medicaid Services, and members of Congress, urging modification of the EUA to allow pharmacist prescribing of oral antivirals. ASHP also circulated a sign-on letter for hospitals and health systems to join in calling on FDA to remove barriers to pharmacist prescribing.

Throughout the COVID-19 pandemic, we have also engaged in numerous interviews with the media to educate the public and policymakers about the importance of utilizing pharmacists as patient care providers in the fight against COVID-19 and the challenges of FDA excluding pharmacists from prescribing antivirals.

Building on This Win
Our sustained engagement with government agencies on this critical work has helped secure a tremendous victory for the patients we serve this week. However, our advocacy on this effort is not yet over. We remain steadfast in our commitment to support our members and their patients as we continue to advance the recognition of pharmacy professionals. Now that the role of pharmacists as prescribers of oral antivirals against COVID-19 has been achieved, we must continue to call for reimbursement of pharmacist clinical services to ensure that all patients have access to the patient care services of pharmacists.

We want to thank all of the ASHP members, hospitals and health systems, and our partners in the other pharmacy organizations who have joined us to advocate for expanded access to pharmacist care with the goal of improving medication use for all patients.

As always, thank you for all that you do for your patients and our profession.



Posted on July 8, 2022