Despite its effectiveness, only 11 percent of individuals with opioid use disorder (OUD) receive medication for opioid use disorder (MOUD).¹ Stigma and discrimination against individuals with OUD, misunderstandings about how MOUD works, a lack of opioid treatment programs,² a shortage of practitioners who prescribe medication for opioid use disorder,³ and the overall shortage of primary care and addiction treatment practitioners, particularly in rural areas,⁴ are key barriers to care; Community pharmacies can greatly expand access to medication for opioid use disorder by transforming them into low-barrier points for access for treatment. The U.S. has over 60,000 community pharmacies, and 90 percent of Americans live within five miles of a pharmacy.⁵

The overall purpose of the project funding this report is to demonstrate the real-world application and outcomes to inform two innovative models of pharmacy-based low-barrier buprenorphine induction and maintenance services. One innovative model is collaborative care through a collaborative practice agreement (CPA). A CPA is a voluntary, but formalized, agreement that establishes a relationship between one or more pharmacists and one or more physicians or other healthcare providers allowing the pharmacist to perform certain patient care functions.⁶ These functions may include modification or initiation of drug therapy, ordering, performing, or interpreting laboratory tests, and conducting physical assessments.⁷ The second innovative model is independent pharmacist prescribing of buprenorphine.

The project has two interconnected aims. The first aim is to implement the two innovative pharmacy-based models, with the CPA model implemented in Connecticut and the independent pharmacist prescribing model implemented in Ohio. The second aim is to understand the facilitators and barriers to implementing the two models across the United States and develop best practices and policy solutions to overcome the barriers. This report is a key aspect of the second aim. To expand one or both models into other states, an understanding of the differences in state practice of pharmacy and CPA laws and regulations, as related to OUD care, is needed.

References:

1. Nora Volkow, Making Addiction Treatment More Realistic and Pragmatic: The Perfect Should Not be the Enemy of the Good, NAT’L INST. ON DRUG ABUSE (Jan. 4, 2022), https://nida.nih.gov/about-nida/norasblog/2022/01/making-addiction-treatment-more-realistic-pragmatic-perfect-should-not-be-enemy-good.

2. Amanda Latimore et al., Exploring Urban-rural Disparities in Accessing Treatment for Opioid Use Disorder, AM.INST. FOR RESEARCH (Nov. 2021), https://www.air.org/resource/field/exploring-urban-rural-disparities-accessingtreatment-opioid-use-disorder.

3. Ryan K. McBain et al., Growth and Distribution of Buprenorphine-waivered Providers in the United States, 2007-2017, 172 ANNALS INTERNAL MED. 504, 506 (2020).

4. C. Holly A. Andrilla et al., Barriers Rural Physicians Face Prescribing Buprenorphine for Opioid Use Disorder, 15 ANNALS FAMILY MED. 359, 359 (2017); Kevin P. Conway et al., Rural and Urban Differences in Undersupply of Buprenorphine Provider Availability in the United States, 2018, 17 ADDICTION SCI. & PRAC. no. 5, at 2 (2022).

5. Lucas A. Berenbrok et al., Access to Community Pharmacies: A Nationwide Geographic Information Systems Cross-section Analysis, 62 J. AM. PHARMACISTS ASS’N 1816, 1818 (2022).

6. Prescriber Collaboration, NAT’L COMMUNITY PHARMACISTS ASSOC. (last accessed Nov. 1, 2024), https://ncpa.org/prescriber-collaboration.

7. Id.

The project proposal documents provide that the Legislation Analysis and Public Policy Association (LAPPA) will conduct research, review, and analysis of state laws and regulations in all 50 states plus the District of Columbia that may facilitate or serve as potential barriers to providing buprenorphine treatment in a pharmacy setting. As part of this research, review, and analysis, LAPPA will compile this information into a report containing a state-by-state summary of relevant statutes and regulations. As the project progressed, LAPPA and the project’s principal investigators decided to include Puerto Rico along with all states and the District of Columbia.

Note: The District of Columbia and Puerto Rico are not states. However, for simplicity’s sake in this report, from this point forward, the word “state” includes them, unless otherwise specified in the tex

The process LAPPA undertook to create this report involved three general steps:

1. Developing a set of data points to collect from each state (i.e., a state chart template);

2. Using the Westlaw research database to obtain state-specific information to complete each state’s chart; and

3. Collating the information from the individual charts to provide overall findings.

To develop the state chart template, LAPPA first worked with the project’s principal investigators to identify key elements for implementing pharmacy-based buprenorphine treatment for OUD, under either the CPA model or the independent pharmacist prescribing model. Next, LAPPA reviewed Connecticut’s and Ohio’s laws and regulations to get a sense of the types of statutory and regulatory provisions addressing those elements. Although LAPPA focused on the laws governing pharmacy practice and regulations promulgated by the state board of pharmacy, other areas of laws/regulations proved informative such as those governing healthcare providers in general, Medicaid, health insurance, and OUD treatment by physicians or other healthcare providers who are not part of opioid treatment programs (OTPs). Then, with this information in hand, LAPPA again consulted with the investigators to create the specific set of data points. The parties decided that the data points should be in the form of a set of questions to be answered in each state. This set of questions forms the state chart template, which, when filled out with state-specific information and answers, becomes a complete state chart.

Based on the discussions and review of Connecticut and Ohio information, LAPPA and the principal investigators concluded that the set of questions should cover:

• Whether a pharmacist can prescribe and/or administer buprenorphine, either independently or under a CPA, and if allowed, what steps a pharmacist must take to begin doing so;

• Whether a pharmacist can order and/or evaluate the results of laboratory tests, either independently or under a CPA, and if allowed, what steps a pharmacist must take to begin doing so;

• The requirements for entering CPAs and required elements of CPAs;

• Whether a pharmacist can provide services via telehealth;

• What pharmacist-provided services are covered under state Medicaid programs;

• Other laws/regulations governing the way physicians and other individual healthcare providers must offer MOUD to patients (other than those at OTPs); and

• To the extent that state laws/regulations do not allow for one or more of the above, what general types of actions state policymakers must take to change it.

As shown below, the final template contains 26 questions, subdivided into 10 topical areas. Nine of the ten topics contain more than one question. LAPPA assigned each question a number/letter code to allow precise references to individual questions throughout the report and in this summary.

Topic 1 – Prescribing buprenorphine without a CPA

• (1A) – Can a pharmacist prescribe buprenorphine without entering a CPA?

• (1B) – If the answer to (1A) is yes, what does a pharmacist need to do to start doing this?

• (1C) – If the answer to (1A) is not yes, what must state policymakers change to allow this?

Topic 2 – Administering buprenorphine without a CPA

• (2A) – Can a pharmacist administer buprenorphine without entering a CPA?

• (2B) – If the answer to (2A) is yes, what does a pharmacist need to do to start doing this?

• (2C) – If the answer to (2A) is not yes, what must state policymakers change to allow this?

Topic 3 – Ordering and evaluating lab tests without a CPA

• (3A) – Can a pharmacist order and/or evaluate the results of lab tests without entering a CPA?

• (3B) – If the answer to (3A) is yes, what does a pharmacist need to do to start doing this?

• (3C) – If the answer to (3A) is not yes, what must state policymakers change to allow this?

Topic 4 – Prescribing buprenorphine under a CPA

• (4A) – Can a pharmacist prescribe buprenorphine under a CPA?

• (4B) – If the answer to (4A) is yes, what does a pharmacist need to do to start doing this?

• (4C) – If the answer to (4A) is not yes, what must state policymakers change to allow this?

Topic 5 – Administering buprenorphine under a CPA

• (5A) – Can a pharmacist administer buprenorphine under a CPA?

• (5B) – If the answer to (5A) is yes, what does a pharmacist need to do to start doing this?

• (5C) – If the answer to (5A) is not yes, what must state policymakers change to allow this?

Topic 6 – Ordering and evaluating lab tests under a CPA

• (6A) – Can a pharmacist order and/or evaluate the results of lab tests under a CPA?

• (6B) – If the answer to (6A) is yes, what does a pharmacist need to do to start doing this?

• (6C) – If the answer to (6A) is not yes, what must state policymakers change to allow this?

Topic 7 – CPA procedures and requirements

• (7) – What are the requirements for a pharmacist entering a CPA?

Topic 8 – Telehealth

• (8A) – Can a pharmacist provide services via telehealth?

• (8B) – If the answer to (8A) is not yes, what must state policymakers change to allow this?

• (8C) – Are there any telehealth provisions that do (or could) apply to a pharmacist prescribing or administering buprenorphine?

Topic 9 – Medicaid

• (9A) – What services provided by a pharmacist does state Medicaid cover?

• (9B) – If the answer to (9A) does not clearly include pharmacists providing MOUD (either under or outside of at CPA), what must state policymakers change to allow this?

Topic 10 – Other laws/regulations related to providing MOUD

• (10A) – Beyond the topics covered above (and excluding methadone) are there any other laws/ regulations governing the way MOUD is provided to patients that currently apply to pharmacists?

• (10B) – If the answer to (10A) is no, are there any such laws/regulations that currently apply to non-pharmacists?

LAPPA and the project investigators made an intentional choice to look for state-specific information about whether a pharmacist can “prescribe” or “administer” buprenorphine rather than asking a broader question such as if a pharmacist can “initiate” treatment with buprenorphine. The reason is that that pharmacy laws/regulations generally do not define “initiate” or “initiating” and it appears, at least to LAPPA, that initiating treatment includes elements of dispensing drugs and medications. The fact that a pharmacist’s scope of practice includes dispensing buprenorphine prescribed by a physician or other healthcare provider to a patient is not in question. As a result, if initiating includes dispensing, then the answer to a question about initiating buprenorphine might be yes in every state. The more interesting information for this report, given the innovative models being implemented in Connecticut and Ohio, is whether pharmacists can do less traditional activities, such as prescribing or administering buprenorphine.

In most states, what scope of practice laws/regulations authorize a pharmacist to do as a matter of general practice is different from what those laws/regulations authorize a pharmacist to do under a CPA. As a result, the questions in Topics 4, 5, and 6 intentionally mirror the Topic 1, 2, and 3 questions with the only difference being the setting of pharmacist practice (“without a CPA” versus “under a CPA”). Separating out the data point questions for these two settings makes it easier to discern the differences.

Across all completed state charts, the format of the responses to the seven questions beginning with “can” (i.e., (1A), (2A), (3A), (4A), (5A), (6A), and (8A)) are similar. LAPPA first provides a brief upfront answer, such as “yes,” “no,” or “unclear.” LAPPA then describes, in bullet point fashion, the language in specific laws and regulations that led LAPPA to reach its conclusion. LAPPA also provides citations for and publicly available (i.e., non-subscription) website links to those laws and regulations. The responses to questions (7), (8C), (9A), (10A), and (10B) are similar, with description about, as well as citations and publicly available links to, relevant laws and regulations. The remaining 14 template questions ask what a pharmacist must do to begin an activity or what state policymakers must change to allow an activity. In general, responses to these 14 questions are shorter and do not contain statutory or regulatory citations.

While reviewing and analyzing both the overall findings and individual state-by-state charts in this report, readers should keep in mind several limitations to the analysis as well as other general considerations.

This report focuses on state information only. As a result, federal laws, regulations, or other guidance related to the telehealth and Medicaid questions are not considered.

With the lone exception of the Medicaid questions, the information contained within the report is based on a systematic review of statewide laws and regulations. As a result, question responses generally do not reflect any secondary materials that may exist in a state, such as state board of pharmacy or state attorney general opinions or memoranda about the scope of pharmacist practice. While LAPPA did not intentionally omit any information, LAPPA suspects that there may be additional information in some states that is relevant to answering the template questions.

LAPPA compiled the information in each state chart between July and October 2024. Changes made to state laws and regulations after the date of compilation are not included in this report.

Determining what a state’s Medicaid program covers is complex and challenging, and the answer is not always found in state laws or regulations. Accordingly, in answering question (9A) throughout, LAPPA relied on two reports that contain information about Medicaid coverage for pharmacist services., Where utilized, the individual state chart contains a citation to the respective source.

The upfront answer (e.g., “yes,” “no,” or “unclear”) contained in responses to many data point questions represents LAPPA’s conclusion based on the available information. While the verbatim text of cited statutory and regulatory provisions represents objective information, determining what a provision means when the language is not expressly clear involves an element of subjectivity. As the difference between “yes,” “no,” or “unclear,” is small in some cases, LAPPA fully expects that all readers may not completely agree with all conclusions herein. Also, note that the answer “unclear” does not mean no. It means that, in LAPPA’s opinion, the available information could support either a “yes” or a “no” answer, depending on interpretation.

As a help to readers, LAPPA chose to provide links to non-subscription webpages containing the cited statutes and regulations. However, including such links introduces some potential problems. First, due to how some non-subscription websites are structured or the materials presented, LAPPA cannot always link to the specific statute or regulation cited. Rather, the link may refer the reader to a much larger grouping of laws/regulations requiring further searching to uncover the cited provision. Second, some non-subscription sources for laws and regulations are not continuously updated and therefore do not yet contain the changes made in the most recent legislative session. Third, links may become inactive over time due to website restructuring, changes to laws, or another reason. Note that all links worked at the time LAPPA included them in a state chart.

State terminology for CPAs, as well as the state’s description of underlying purpose of the CPA, varies widely. For instance, a state may call a CPA a written protocol, a collaborative drug therapy management agreement, a practice agreement, or something else. Likewise, states may refer to the purpose of CPAs as providing drug therapy management, collaborative practice, medication therapy services, or something else. Within each state’s chart, the responses uses the terms found within that state’s laws and regulations. Where a state has a different term for a CPA, LAPPA includes a footnote next to the state name in the chart’s title providing this information.

This list identifies the abbreviations and acronyms used throughout this analysis.

• APRN – Advance practice registered nurse

• CLIA - Clinical Laboratory Improvement Amendments of 1988

• CPA – Collaborative practice agreement

• DEA – U.S. Drug Enforcement Administration

• FDA – U.S. Food and Drug Administration

• MAT – Medication assisted treatment (or medication for addiction treatment)

• MOUD – Medication(s) for opioid use disorder

• OTP – Opioid treatment program

• OUD – Opioid use disorder

• SAMHSA – Substance Abuse and Mental Health Services Administration

• SUD – Substance use disorder