Federal pharmacist Paxlovid prescribing authority: A model policy or impediment to optimal care?

The U.S federal government leveraged emergency authority to allow pharmacists to prescribe Paxlovid (nirmatrelvir and ritonavir) during the COVID-19 pandemic. While heralded by pharmacy associations, the FDA framework included restrictions that arguably ran counter to clinical guidelines and evidence-based research and recommendations. These restrictions will limit the utility of pharmacist prescriptive authority for Paxlovid in practice. The experience of Paxlovid prescribing and a similar recent federal action illustrate the challenges inherent in federal oversight of pharmacist prescriptive authority. While initially more difficult to navigate for stakeholders, working with state legislatures and state boards of pharmacy has much stronger long-term potential to enable broad pharmacist prescriptive authority and benefit patient care. This commentary uses Idaho's pharmacist prescribing regulations as a comparison to the federal actions.


Background
For decades, pharmacy associations have advocated for an increased role for pharmacists as part of the broader healthcare team, with a major focus on pharmacists having the ability to initiate medications for patients. 1 There have been two primary targets for facilitating pharmacist medication initiation: 1) state law; and 2) federal law.
State governments have the primary responsibility of licensing health professionals and delineating their lawful scope of practice. 2,3 States have allowed pharmacists to initiate medications, most commonly through collaborative practice agreements with other providers, but more recently states have enabled independent prescriptive authority for specific medications or medication categories. 4,5 Most commonly, pharmacists can prescribe immunizations, opioid antagonists, hormonal contraceptives, and tobacco cessation products. [6][7][8] At the federal level, pharmacy associations have periodically explored the creation of a behind-the-counter (BTC) category of medications with the Food and Drug Administration (FDA). 9,10 A BTC class of medications would be somewhere between over-the-counter and prescription-only medications, where pharmacists would serve as the gatekeepers and have the ability to initiate BTC medications to consumers who meet certain criteria. 11 Recent action at the state and federal levels illustrate how these two diverging approaches to medication initiation compare in practice. Namely, Idaho has created a state framework for pharmacist prescriptive authority that has been adopted by subsequent states and is held out as model policy by think tanks. [12][13][14] Meanwhile, two federal agencies leveraged emergency authority to seemingly override state law and allow pharmacists to prescribe Paxlovid (nirmatrelvir and ritonavir) and pharmacy technicians to administer certain vaccines after they are initiated by pharmacists. [15][16][17][18] Both of these federal examples were limited to the COVID-19 pandemic, but they are illustrative of the approach that may accompany a BTC category of medications. This commentary will leverage these natural experiments in Idaho and federal emergency actions to compare and contrast the state versus federal approaches to medication initiation in practice. This comparison may prove useful to pharmacy stakeholders in determining the pros and cons of both pathways as a means of advancing patient care.

A. Federal Pharmacist Paxlovid Prescribing
The FDA revised its emergency use authorization for Paxlovid in July 2022, allowing pharmacists in all states to prescribe Paxlovid for patients who test positive for COVID-19. 17 Previously, FDA limited Paxlovid prescribing to physicians, physician assistants and advanced practice nurses. The FDA indicated that allowing pharmacists to prescribe Paxlovid was to "expand access to timely treatment" given that the medication must be Exploratory Research in Clinical and Social Pharmacy 9 (2023) 100244 taken within five days of symptom onset. 17 This approach leverages the accessibility of pharmacies, with convenient locations and extended hours of operations. 19 Unfortunately, the limitations on use were more extensive for pharmacists than other health professionals. 20 Specifically, prior to prescribing, pharmacists have to assess the patient's hepatic and renal function through health records from the past 12 months, or through consultation with the patient's traditional provider. Pharmacists were not seemingly afforded the benefit of patient self-reporting that the other Paxlovid prescribers were allowed.
This poses practical challenges as many patients seeking care at a pharmacy do not have a routine source of medical care, and thus the consultation route may not be viable. 21 Further, requiring health records within the past 12 months is also problematic as routine medical care was deferred by many during the global pandemic. 22

B. Federal Pharmacy Technician Immunization Authority
In October 2020, the U.S. Department of Health and Human Services (HHS) issued guidance under the Public Readiness and Emergency Preparedness (PREP) Act authorizing trained pharmacy technicians in all states to administer certain immunizations initiated under the supervision of a qualified pharmacist. 16 HHS instituted two primary limitations on this authority.
First, HHS limited which technicians could qualify to administer vaccines. In states with a licensure or registration pathway, a technician had to satisfy all relevant state requirements. In the remaining states, a technician had to hold certification from either the Pharmacy Technician Certification Board or the National Healthcareer Association. HHS added a requirement that the technician must complete an ACPE-accredited training program, maintain certification in basic cardiopulmonary resuscitation, and complete at least two hours of continuing education on immunizations. 16 Second, HHS limited which individuals could be vaccinated by a pharmacy technician. For COVID-19 vaccines, patients had to be three years of age or older. For other Advisory Committee on Immunization Practices (ACIP) recommended vaccines, the same minimum age (3 years) applied, but HHS also established a maximum age of 18 as well. Under the plain text, a pharmacy technician could administer a COVID-19 vaccine to an adult of any age but could not necessarily immunize the same adult with a non-COVID vaccine (e.g., influenza) regardless of the similarity in injection technique. 16

State example: Idaho pharmacist prescriptive authority
Idaho has been a leader in enabling pharmacist prescriptive authority. 23 The state started with collaborative practice agreements, and eventually evolved into independent prescribing for specific medications and medication categories. 24 The state passed laws individually for immunizations, naloxone, epinephrine, smoking cessation, and tuberculin skin tests. 25,26 Each of these laws specified training criteria and other parameters ranging from medication-specific recordkeeping requirements or practice requirements (e.g., referring tobacco cessation patients to the state's quit line). 12 Medication-specific prescribing requirements were manageable for a small number of medications, but as pharmacist authority expanded, a new approach was needed. In 2017, Idaho switched to a flexible framework in which pharmacists could independently prescribe any medication that met the following criteria: • A new diagnosis is not required; • The condition to be treated is minor and generally self-limiting; • The condition has a CLIA-waived test to guide diagnosis; or • There is an emergency situation, whereby the patient's health or safety is threatened without immediate access to a prescription. 12 In promulgating rules to implement this prescribing framework, the Board of Pharmacy sought to replicate the practices of other independent prescribers. It did not require pharmacist to take medication-specific education, rather it limited pharmacist prescribing to those which the "pharmacist is educationally prepared and for which competence has been achieved and maintained." 12 Similarly, rather than establishing specific protocols for medications and medication categories, the Board deferred to clinical guidelines and the prevailing "standard of care." 27 In such a model, the standard of care is flexible and determined by the individual circumstances that present in practice rather than specific requirements codified in law. 28 If new evidence emerges or clinical guidelines change, pharmacists can quickly translate these changes into practice. The Board retains jurisdiction over pharmacist prescribing, and if a pharmacist deviates from the accepted standard of care, a disciplinary case may be brought forth.
Thus, rather than specifying individual drugs or drug categories that pharmacists can prescribe, Idaho allows pharmacists to exercise sound professional judgment within a standard of care. If a patient presents with a urinary tract infection, acne, a cold sore, or other conditions, a pharmacist may judge an uncomplicated case as minor and prescribe accordingly, if the pharmacist has access to sufficient information to make a prescribing decision and properly document it. [29][30][31][32] The primary difference between pharmacist prescribing and most other health professionals in Idaho is a requirement that pharmacist notify the patient's broader healthcare team of any medication prescribed within five days. This requirement was added to ensure that care was not further fragmented by patients seeking care at pharmacies.
Lastly, Idaho allows pharmacists to delegate any task to pharmacy technicians that aligns with the technician's education, training and experience. The pharmacist is responsible for appropriate delegation. Thus, a pharmacist can delegate vaccine administration for any patient, and Idaho was the first state to allow this pre-pandemic. [33][34][35][36]

Discussion
We have described two different models of pharmacist initiation of medications at the state and federal levels. The federal model is medication-specific and limited to those products that the federal agencies explicitly allow, in this case Paxlovid and vaccines. The appeal for pharmacy advocates is that a single FDA action (or HHS action) would enable prescribing of these medications in all 50 states and override perceived state inertia.
The primary drawback of the federal approach is that, because it is medication specific, the federal agencies add medication-specific red tape. Immunizations were loaded with training and continuing education requirements, for example. Worse yet, patient age limits were applied to immunizations that defied logic and ran counter to clinical guidelines and evidence-based research and recommendations. Similarly, the Paxlovid regulations included limitations that some experts feared would "undermine the Biden administration's goals of providing equitable and timely access to this potentially life-saving therapy." 20 Arguably, federal agencies are less responsive to individual pharmacists and other stakeholders, and therefore it is more difficult to rectify these shortcomings in medication-specific prescribing. For example, the federal government has historically placed restrictions on the prescribing of buprenorphine despite public health efforts to increase access to this medication. Healthcare providers had to obtain a special registration to prescribe buprenorphine and limited the number of patients that such providers could serve. 37 Because of these restrictions, fewer than 10% of medical providers held the proper registration to prescribe buprenorphine, and 42% of counties had no physicians eligible to prescribe it. 38,39 Still, it took nearly 20 years to remove these federal restrictions and necessitated a widespread public health campaign to do so. 40 Further, authority is granted on a medication-by-medication basis which can be slow and non-evolutionary. To the extent medication-specific requirements are added to each, the system could be overwhelming and difficult for pharmacists and pharmacies to comply.
State-level pharmacist prescriptive authority, by contrast, can provide a framework for prescribing that is much better aligned with other health professionals, including physicians, physician assistants, and advanced practice registered nurses. Rather than limiting prescribing to specific medications, states can adopt a framework for prescribing that is more broadly encompassing and avoids the red tape that has surrounded individual medication prescribing. Arguably, if the FDA had not intervened, Idaho pharmacists would have had broader prescriptive authority for Paxlovid without the FDA's limitations, and as such, would have been better positioned to improve access to patient care.
The drawback of the state approach is that pharmacy stakeholders have to win this authority in 50 different states. With differences in legislative timelines, processes, political climates, and stakeholders, this poses significant logistical challenges to accomplishing widespread authority. Further, 50 states may take different approaches, and therefore it may be difficult for national pharmacy companies to operationalize across state lines. Further, it may prove difficult to standardize laws across state laws. 41 The slow pace of progress of prescribing at the state-level is observed in other health professions. Nurse practitioners, for example, still do not have independent prescriptive authority in approximately half of the US despite their repeatedly-demonstrated safety and efficacy in treating patients. 42 Similarly, only 5 states allow psychologists to prescribe medications even though 20 years has passed since the first state did so. 43 While initially more difficult to navigate, the state approach has much stronger long-term potential to enable broad pharmacist medication initiation authority and benefit patient care. Pharmacy stakeholders could explore a short-term and long-term approach. Nudging FDA and HHS to enable pharmacist prescribing for certain products during the pandemic can loosen the lid on medication initiation. Stakeholders should then quickly seek to make this authority permanent at the state level so that it extends beyond the pandemic with an innovative, less-regulatory state framework. 44 With enough experience and a safe track record, this medication-specific authority at the state level can evolve and provide the momentum necessary to secure a broader prescribing framework over time for the betterment of patient care.

Disclaimer
The views expressed in this commentary are those of the authors alone, do not necessarily reflect those of their respective employers, and do not constitute legal advice.