Pharmacy-based CLIA-waived testing in the United States: Trends, impact, and the road ahead.

BACKGROUND: Federal authorization of the use of Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived point-of-care tests for SARS-CoV-2 by pharmacists during the pandemic resulted in a dramatic rise in the number of community pharmacies that became CLIA-waived test sites. Now as we exit the pandemic, the wide-ranging expansion of the scope of practice facilitated currently by the PREP Act is set to expire in fall 2024. As a result, American pharmacists' ability to offer CLIA-waived testing services will revert to a patchwork of state laws. OBJECTIVE: This study aims to examine both the number of pharmacies in the United States with CLIA Certificates of Waiver before and after the SARS-CoV-2 pandemic and the state-by-state differences in the percentage of pharmacies with CLIA Certificates of Waiver. METHODS: Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015, August 4th, 2019, November 26th, 2020, October 6th, 2021, November 23rd, 2022, and December 4th, 2023. The website allows for the exportation of demographic data on all CLIA-waived facilities by state. RESULTS: The total number of pharmacies with a CLIA-waiver grew from 10,626 (17.9%) locations in 2015 to 12,157 (21.4%) locations in 2019, to 15,671 (27.6%) locations in 2020, and to 29,011 (51.6%) locations in 2023. States demonstrated considerable variability in the percentage of pharmacies possessing a CLIA certificate of waiver in 2023, with a range of 10.7%-87.9%. CONCLUSIONS: Use of CLIA-waived tests in pharmacies has grown by 140% since 2019. The time period from 2019 to 2021 witnessed a 92.5% increase in pharmacies that possessed a certificate of waiver which was largely driven by the pandemic. Interestingly, from 2021 to 2023 the was continued growth in the market of 31.6%. This suggests that pharmacies continue to see opportunity in offering CLIA-waived testing services beyond those that had been extended as a result of the pandemic.

How to implement a "standard of care" regulatory model for pharmacists.

National pharmacy associations have increasingly explored regulation according to a "standard of care." In such a model, pharmacists can provide a wide range of clinical services aligned with their education and training. Based on Idaho's experience implementing this model, there are five critical steps states must take to enact a standard of care: 1) Adopt a broad definition of "practice of pharmacy;" 2) Allow elasticity for practice innovation over time; 3) Decide which limited instances still necessitate prescriptive regulation; 4) Eliminate all unnecessary regulations; and 5) Strengthen accountability for deviations from the standard of care. States wishing to adopt a standard of care approach can follow this five-step process to enhance patient care and mitigate the lag that is otherwise constant between laws and practice.

Pharmacist Prescribing Models for HIV Pre-exposure and Post-exposure Prophylaxis.

State strategies for pharmacist prescribing exist on a continuum from most restrictive to least restrictive. Using human immunodeficiency virus (HIV) pre-exposure prophylaxis and post-exposure prophylaxis as a case study, there are 3 viable pharmacist prescribing models: (1) population-based collaborative practice agreements; (2) government protocols; and (3) standard of care prescribing. The advantages and disadvantages of these 3 models are reviewed.

Implementation of the California advanced practice pharmacist and the continued disappointment of tiered licensure.

The Advanced Practice Pharmacist (APh) designation in California was created via legislation 10 years ago. California pharmacists who meet certain criteria can be designated as an APh and unlock additional practice authority. Just 1065 pharmacists, or 2% of licensed California pharmacists, have obtained the APh designation through 2022. APhs did not report benefiting from the designation as it relates to expanded scope of practice. This experience of low uptake and minimal benefit mirrors the tiered licenses created by three other states. More recent legislation broadened the independent prescriptive authority of APhs, but this increased value proposition aligns with the practice authority adopted by other states who have imposed fewer barriers to entry. Given the track record observed to date, we doubt that tiered licensure will ever prove successful in the pharmacy profession. Instead, state policymakers and pharmacy advocates should consider adopting a "standard of care" regulatory approach to improve patient access to safe and beneficial pharmacist services.

Expunging Board of Pharmacy Disciplinary Actions.

Boards of pharmacy have the authority to discipline licensees whose actions fall short of practice standards. Disciplinary action may include license suspension, revocation, practice restrictions, fines and reprimands. Once discipline is levied against a board of pharmacy licensee, it is usually part of the licensee's permanent record. At least four states have created a pathway for individuals to seek expungement of previous disciplinary actions levied by a board of pharmacy. These states have variations on what violations may be expunged and when. Given the evolving approach to the regulation of pharmacists, more states may want to consider expungement pathways in the years ahead.

The Basis for Elimination of the Jurisprudence Examination as a Condition of Pharmacist Licensure in Idaho.

Some national pharmacy associations have recently joined in advocacy for a more portable pharmacist license. One impediment to accomplishing this is the state-specific nature of the pharmacy jurisprudence examination, leading to calls for the exploration of alternatives to, or outright elimination of, such examinations. This manuscript reviews the rationale for the elimination of the pharmacy jurisprudence examination in Idaho. The Idaho Board of Pharmacy reviewed the absence of similar jurisprudence examinations in other health professions, the role schools of pharmacy and employers play in preparing pharmacists for lawful practice, and how the adoption of a "standard of care" regulatory model changed thinking about the need for a jurisprudence examination. Idaho eliminated the examination in 2018, and no evidence demonstrating a public safety impact has yet materialized, while the number of Idaho licensed pharmacists has grown at a higher rate than its border states. State boards of pharmacy are in a position to decide whether keeping the pharmacy jurisprudence examination is necessary, and this manuscript reviews key considerations for other states.

Regulating Pharmacist Clinical Services: Is Legal Silence Golden or Deafening?

In the United States, the scope of practice of pharmacists is determined primarily at the state level. Not all state laws expressly permit or prohibit pharmacists from providing certain services; in between is a grey area of legal silence. Does legal silence permit pharmacists to perform a service that is not specifically permitted, but not expressly prohibited? Point-of-care testing provides a useful case study in legal silence: there are 1536 pharmacies currently holding a CLIA-waiver to administer tests in states reporting that pharmacists are not expressly permitted to administer tests. Legal silence may even provide a better framework for pharmacy based testing as it is naturally inclusive of any point-of-care test and no laws need updated when a new test comes to the market. Other health professions navigate this legal silence by governing according to a "standard of care." Rather than specifying a list of services a health professional can or cannot provide in law, it provides a flexible framework for the health professional to provide any service that other similarly situated health professionals would provide in the same or similar situation. A standard of care regulatory framework should thus be the target of the pharmacy profession in order to advance patient care.

Revisiting the continuum of pharmacist prescriptive authority.

Pharmacists in all states have prescriptive authority in some form. We identify two broad categories of pharmacist prescribing: dependent and independent. There are gradients within these broad categories that allow us to chart pharmacist prescribing on a continuum from most restrictive to least restrictive. Independent prescribing has seen the most innovation in recent years at the state level, with at least three states adopting a "standard of care" prescribing framework that allows pharmacists to exercise broad prescriptive authority including for conditions that require a diagnosis. Each of the approaches to pharmacist prescriptive authority have perceived advantages and disadvantages as it relates to improving patient care.

Extending COVID-19 Pharmacy Technician Duties: Impact on Safety and Pharmacist Jobs.

Background: The 2019 coronavirus pandemic (COVID-19) led to an expanded scope of practice for pharmacy technicians. As the pandemic wanes, state governments are faced with the decision of whether or not to make permanent the authority of pharmacy technicians to perform extended duties. Objective: Determine the impacts on patient safety and job market demands preadoption and postadoption of Idaho's expanded technician duties in 2017 as a natural experiment for expanded technician duties. Methods: Data from the National Practitioner Data Bank (NPDB) is used to explore patient safety outcomes in Idaho preadoption and postadoption and as compared with its border states. Data from Pharmacy Demand Reports is used to compare job postings in Idaho and its border state, and National Association of Boards of Pharmacy census data are used to compare growth in the number of pharmacists and technicians in Idaho and its border states over time. Results: For Idaho pharmacists, the average number of disciplinary actions reported against both pharmacists and technicians dropped after implementation of expanded technician duties. Idaho also had a lower rate of discipline for pharmacists and technicians than its border states. Idaho had the third highest job postings for pharmacists and the second highest for technicians among its border states. Idaho also had the largest growth in the number of licensed pharmacists and technicians of the observed states in the study period. Conclusion: Available statewide data from Idaho as compared with its border states suggests that expanded technician duties did not adversely impact patient safety outcomes or the pharmacist job market. Additional states may wish to expand pharmacy technician duties in the years ahead.

Opportunities for pharmacist prescriptive authority of buprenorphine following passage of the Mainstreaming Addiction Treatment (MAT) Act.

In December 2022, Congress passed the Mainstreaming Addiction Treatment Act, which removed the federal legal barrier to pharmacist buprenorphine prescribing. As a result, each state can now decide whether or not to allow pharmacists to prescribe buprenorphine as an additional access point to reduce fatal opioid overdoses. At least 10 states allow pharmacists to prescribe controlled substances under collaborative practice agreements. Two states (California and Idaho) have also created pathways for independent prescribing of buprenorphine by pharmacists. Additional states should seek to enable pharmacists to prescribe buprenorphine to increase access to a proven beneficial treatment and help reduce fatal opioid overdoses.

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.

Facilitating multistate pharmacy practice: Streamlining continuing pharmacy education requirements.

A major regulatory impediment to achieving multistate pharmacist licensure is state-specific Continuing Pharmacy Education (CPE) mandates. States vary on CPE requirements in 6 key domains, presenting a potentially significant administrative burden for multistate pharmacists. In the short term, replicating the nursing compact model of CPE regulation is the most viable model for the pharmacy profession. In this model, a pharmacist would have to follow just the CPE requirements for the state where the pharmacist maintains primary residence, and maintenance of this home state license would be automatically recognized by other states in which the pharmacist practices.

Pathways to pharmacist prescriptive authority: Do decentralized models for expanded prescribing work?

Scope of practice decisions, such as granting pharmacists independent prescriptive authority, are governed at the state level and are often contentious debates. Five states - Florida (FL), New Mexico (NM), Colorado (CO), Idaho (ID), and Oregon (OR) -- have created structures that can theoretically expand independent prescriptive authority through decentralized approaches rather than needing the legislature to approve each drug that pharmacists may prescribe. These approaches have the potential advantage of allowing the states to expand independent pharmacist prescriptive authority to address public health needs more quickly. Four distinct models have been identified from most to least restrictive in practice: 1) medical veto; 2) interdisciplinary committee; 3) board of pharmacy; and 4) pharmacist-determined. These models have generally focused on postdiagnostic and preventive care by pharmacists. In terms of enabling broad pharmacist prescribing, only two of these models have demonstrated success: board of pharmacy and pharmacist-determined. Pharmacy and public health stakeholders considering similar legislation in their own states should consider the success of these decentralized models prior to enacting legislation.

Pharmacy technician-administered immunizations: A five-year review.

In October 2020, the U.S. Department of Health and Human Services (HHS) issued guidance authorizing trained pharmacy technicians in all states to administer immunizations. Given that this action is temporary, it will be necessary for states to adopt their own legislation or regulations to sustain these efforts beyond the coronavirus pandemic. At least 11 different immunization administration training programs have emerged for pharmacy technicians. An increasing number of publications have emerged on pharmacy technician immunization administration, demonstrating the ability to train technicians and have them safely administer immunizations in practice. Supervising pharmacists reported initial hesitancy but strong acceptance of delegating this task after experience in practice. States should look to expand and make permanent the authority of pharmacy technicians to ensure these benefits can continue to be realized after the HHS guidance expires.

Pharmacist Prescriptive Authority for Acne: An Evidence-Based Approach to Policy.

The diagnosis of acne is typically straightforward and based on physical signs and symptoms. Some jurisdictions in Canada, the United Kingdom, and United States have enabled a pharmacist treatment model to diagnose and manage patients with mild acne using prescription medications. Studies have found the model to be safe and effective, while simultaneously increasing more timely access to care for patients which may reduce the potential adverse impacts of acne. Further, use of a standardized protocol may alleviate some of the concerns expressed over the model. This paper summarize answers to frequent questions to help policymakers consider the objective evidence for their jurisdiction.

Pharmacy Regulatory Innovation Index: Benchmarking the regulatory environment in 10 western states.

BACKGROUND: Pharmacy is among the most regulated of health professions on the basis of both word count and restrictions. State-level restrictions limit the ability of pharmacists to be fully engaged as members of the health care team. OBJECTIVE: This paper aimed to create a simple benchmark-the Pharmacy Regulatory Innovation Index (PRII)-that takes into account the scope-of-practice allowances that a state provides to pharmacists and the overall regulatory burden for the pharmacy profession using 10 western states as a sample. METHODS: A scorecard was developed on the basis of the activities reported as necessary for pharmacists to fully engage in the Pharmacists' Patient Care Process (PPCP). The laws and regulations of 10 western states were analyzed using plain-text interpretation. RESULTS: The 10 western states fall into 3 of 4 distinct quadrants. Three states appear in the highly regulated, low-innovation quadrant (Oregon, California, and Nevada), and 2 states appear in the low-regulated, high-innovation quadrant (Idaho and Washington). The remaining 5 states fall in the low-regulated, low-innovation quadrant (Alaska, Hawaii, Montana, Utah, and Wyoming). CONCLUSION: The PRII has been created to assess a state's regulatory burden and its scope-of-practice allowances, using the PPCP as a guide for innovation. States can use the PRII tool to benchmark their regulations in comparison with those of peer states and identify opportunities for improvement.