Act 406 Allows Community-Pharmacy Service Delivery; HHS Follows With Groundbreaking Ninth PREP Amendment
The Public Readiness and Emergency Preparedness (PREP) Act was enacted in 2005 with little fanfare but consequential language related to the expansive authorities given to the secretary of the US Department of Health and Human Services (HHS).
For more than a decade and a half, declarations of public health threats can and have been made by HHS across a variety of outbreaks, including anthrax, Ebola, smallpox, and Zika. For each of these declarations comes a covered “countermeasure” or means of response to eliminate or reduce the threat.
The underlying basis for effect of each declaration is to eliminate or reduce liabilities for agents, distributors, officials, pharmaceutical manufacturers, program implementers, and providers of care. Yet declarations often come with the necessary expansion of activities and roles to increase the scale and speed to implement countermeasures.
For pharmacists, pharmacy students, and pharmacy technicians, the COVID-19 declaration, now with many amendments, produced not only expansions in pharmacists’ scope of practice for testing and treatment initiations, but also uniform practice advancement across the country, rather than patchwork and piecemeal advancements in some states. Yet these declarations are not permanent, and it is unclear how long these authorities will stick without state actions.
Arkansas Passes Law Modeled After the PREP Act COVID-19 Declaration With Amendments Focused on Pharmacists
On March 22, 2021, Arkansas Governor Asa Hutchinson signed Act 406 to amend the definition of practice of pharmacy. Modeled after the third and fourth amendments in the COVID-19 declaration pursuant to the PREP Act, it allows pharmacists to prescribe, administer, deliver, dispense, or distribute immunizations, medications, and vaccines to treat adverse reactions of administered vaccines or immunizations to individuals aged 3 years and older. Importantly, the Arkansas Department of Health and State Board of Pharmacy interpreted this definition to include monoclonal antibodies that prevent and treat COVID-19 as passive immunizations.1
Monoclonal Antibodies Get a Slow Start, But Then a Shot in the Arm (or Abdomen or Upper Thigh)
A few months ago, medical guests on the evening or morning news shows frequently mentioned the need to get the word out on monoclonal antibodies, calling the product(s) effective and widely available as early treatment.
Getting the word out, it seemed, was a public health imperative that could keep the death rate lower than it was in spring 2020 when there were no established treatment options and frequent deaths, while fear gripped the New York area.
Although the cable news commentaries had some effect, Florida’s rush to open a whopping 17 COVID-19 treatment centers across a geographically expansive and populous state using monoclonal antibodies for infusion helped the nation and apparently HHS wake up to a surprising reality. Unlike vaccination sites, which are plentiful across the country, thanks to community pharmacies, treatment sites for COVID-19 were and remain shockingly sparse. It was not so much that medical professionals did not know about the treatment options; rather, there was a lack of hospitals and physician clinics willing to focus on early identification and treatment in a traditional setting of care. HHS responded to allow pharmacists and pharmacies to step in and fill the void in the ninth amendment to the COVID-19 PREP Act Declaration, following the lead of Arkansas officials.2
Hospitals Are Overwhelmed; Physicians Do Not Want Symptomatic Patients in Their Practices
Pharmacies play an important role as the most frequented first line of inquiry for many patients with an array of symptoms, including cough, fever, and shortness of breath. During the pandemic, hospitals and the larger health systems’ staff members have often been overwhelmed, attempting to shunt the sick and symptomatic to emergency departments or provide advice to stay at home after testing positive. To avoid disruptions in non–COVID- 19 care, nearly every outpatient clinic requires a battery of questions regarding symptoms and travel.
State Innovations Are Proliferating
The Arkansas law and its recent interpretation have inspired similar moves by public health authorities in Mississippi, and now many states are looking to expand the role of pharmacists and pharmacy. Common threads in these states include previous success with COVID-19 vaccinations for hard-to-reach populations and strong relationships among pharmacies, their associations, and public health authority leadership. Atul Kothari, MD, a senior physician specialist in the outbreak response and hospital-acquired infections branch at the Arkansas Department of Health, asked the Arkansas Pharmacist Association for help. She fears that emerging variants from COVID-19 will create waves of peaks from the infections. Kothari thinks community pharmacists and their teams are ideal partners during outbreaks because of local, trusted community relationships.
What was initially 19 pharmacist community sites treating 1465 patients has grown to 30 sites offering between 2 and 120 treatments per week, according to internal survey data from the Arkansas Department of Health and Arkansas Pharmacists Association. Treatments at these sites are expected to reduce hospitalization and death by 70% to 85%. Scale during outbreaks matter, and up to 700 additional accessible pharmacy locations in all 75 Arkansas counties could offer the service in a dedicated separated pharmacy space, in a patient’s car or home, or in a pharmacy-leased or -owned clinic space. Although there are many challenges, including the complexity of credentialing and medical billing for the administration, testing, and treating, models of care and practice are economically sustainable and professionally rewarding. Let’s hope these developments are a harbinger of what is to come.
Happy American Pharmacists Month!
The pandemic has been rough, but it has also helped administrators and nonpharmacists appreciate the professionalism, skills, willingness, and “get after it” mind-set that pharmacists bring to the table in a more universally realized manner than ever before.
Troy Trygstad, PharmD, PhD, MBA, is vice president of pharmacy provider partnerships for Community Care of North Carolina, which works collaboratively with more than 2000 medical practices to serve more than 1.6 million Medicaid, Medicare, commercially insured, and uninsured patients. He received his PharmD and MBA degrees from Drake University and a PhD in pharmaceutical outcomes and policy from the University of North Carolina. He also serves on the board of directors of the American Pharmacists Association Foundation and the Pharmacy Quality Alliance.
John Vinson, PharmD, is chief executive officer and executive vice president of the Arkansas Pharmacists Association. He is also the executive director of the Arkansas Pharmacy Foundation and chairman of the Arkansas Immunization Action Coalition Board of Directors.
1. Arkansas State Board of Pharmacy overview of pharmacist scope for immunizations and vaccines (COVID 19 monoclonal antibodies). Arkansas State Board of Pharmacy. Accessed September 23, 2021. https:// www.pharmacyboard.arkansas.gov/wp-content/uploads/2021/08/ Arkansas-Overview-of-Pharmacist-Scope-for-Immunizations-and-Vaccines-COVID-19-Monoclonal-Antibodies.pdf
2. Public Readiness and Emergency Preparedness Act. Public Health Emergency. Updated September 28, 2021. Accessed September 30, 2021. https:// www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx