1

Policy Priority Roundtable 

Summary Report 

In 2020,

people had an opioid 

use disorder.18

Policy Priority Roundtable Summary Report

Improving Buprenorphine Access in Pharmacy Settings

Note: The roundtable report represents the opinions and recommendations of the pharmacy 

stakeholder participants in the roundtable and does not reflect an official position, policy, or 

set of recommendations from any federal or state agency

The overdose crisis has worsened over the past several years and is on track to claim over 

100,000 lives this year. This crisis affects all communities and has been fueled by heroin, illicit 

fentanyl, and prescription opioids. Buprenorphine treatment is associated with reduced 

risk of overdose death. The federal government has eliminated outdated rules that can limit 

access to this life-saving treatment, while increasing awareness and understanding of the 

medication.1 Despite these efforts, barriers to buprenorphine continue to persist in many 

settings. This roundtable was convened by the U.S. Department of Health and Human 

Services (HHS) consisting of pharmacy stakeholders from both retail and independent 

pharmacies, pharmacy associations, academics, and state and local public health partners 

to address barriers associated with buprenorphine access and availability in pharmacies.

Buprenorphine is a U.S. Food and Drug Administration (FDA)-approved medicine used to 

treat opioid use disorder (OUD) that can diminish the effects of opioid dependency, such 

as withdrawal symptoms and cravings; increase safety in cases of overdose; and lower the 

potential for opioid misuse, when taken as prescribed. Buprenorphine is the first medication 

to treat OUD that can be prescribed or dispensed in physician offices, which significantly 

increases access to treatment.2

 Studies have shown that buprenorphine cuts the risk of 

overdose in half3 and doubles the likelihood of patients engaging in long-term treatment.4

According to the Controlled Substances Act, buprenorphine is classified as a Schedule III 

substance based on its lower abuse potential than Schedule I or II substances such as full 

opioid agonists. 

The Toll of the Opioid Epidemic

5,600,000

In 2020, 80,411 out of

106,699, or of 

total overdose deaths 

involved opioids.19

5.6M

Despite the value and evidence supporting 

the safety and effectiveness of buprenorphine, 

recent reports reflect limited access to 

buprenorphine in many pharmacies, with 

buprenorphine availability in some areas 

ranging from 42 to 73 percent, depending 

on a number of factors.5–11 Characteristics 

include independent pharmacies that are 

less likely to stock buprenorphine (compared 

to chain pharmacies);5–7, 10 locations within 

non-Medicaid expansion states; locations 

within non-metropolitan counties;5 locations 

within Southern states;6 and locations within7

neighborhoods with lower health insurance 

rates.8 While these findings9 suggest that there 

are barriers to accessing10 buprenorphine, there 

is a need to understand what the barriers are 

and which measures11 might improve access.

75.4%,
Improving Buprenorphine 

2 Access in Pharmacy Settings

Barriers and Challenges to Buprenorphine Access 

in Pharmacies

It is not fully understood why there are such widespread limitations on access to 

buprenorphine in pharmacies. Pharmacy mandates, bureaucratic procedures, biases, 

gaps in care coordination for patients with OUD, mistrust, and fears of DEA enforcement 

may all contribute to limited availability.12

Some studies highlight pharmacists’ reluctance to provide buprenorphine to certain 

individuals, especially those that they suspect are seeking buprenorphine from far away 

or out of state.10-12 Furthermore, the increase of telehealth in response to the COVID-19 

pandemic, which was intended to increase access, may have inadvertently added new 

barriers with pharmacists seeing prescriptions from unfamiliar geographic areas. This in turn 

has influenced pharmacies to create gatekeeping measures such as geographic restrictions, 

telephone prescription “confirmations,” prescription cancellations, and refusals.

12

Additionally, some pharmacists report rejecting new prescriptions due to historical 

utilization that does not account for new providers and patients. This limits the quantity 

that can be ordered or the number of prescriptions that can be filled.13 The confusion 

appears to stem from a misunderstanding of DEA regulations.14,15,16 Many pharmacies 

limit ordering of buprenorphine out of caution.17 Finally, self-reports indicate pharmacists’ 

stigmatization of people who need buprenorphine.10,14-16,18

To better understand barriers and associated challenges with access to 

buprenorphine, the Office of the Chief Medical Officer at the Substance Abuse and 

Mental Health Services Administration and the Office of the Assistant Secretary of 

Health, on behalf of HHS, convened a Policy Priority Roundtable on Buprenorphine 

Access and Availability in Pharmacy Settings. 

This meeting was supported and facilitated by representation from many operational 

divisions of HHS, including the Centers for Disease Control and Prevention, Centers for 

Medicare & Medicaid Services, FDA, the Health Resources and Services Administration, 

the Immediate Office of the Secretary, Indian Health Service, Office of the Assistant 

Secretary of Health, Office of the Assistant Secretary of Planning and Evaluation, 

National Institutes of Health, and National Institute on Drug Abuse. Other federal 

partners included the U.S. Drug Enforcement Administration (DEA) and the Office of 

National Drug Control Policy. 

This meeting occurred virtually on August 11, 2022, and August 12, 2022, with 

participants that included distributors, pharmacy executives from the major chains, 

individual pharmacists, practitioners, and individuals with lived experience with OUD. 

The purpose of this meeting was to identify barriers associated with buprenorphine 

access and availability in pharmacies and develop solutions to address the barriers. 

This report is based on stakeholder input from the August 11–12, 2022, Policy Priority 

Roundtable on Buprenorphine Access and Availability in Pharmacy Settings.
3

Policy Priority Roundtable 

Summary Report 

Framework for the Roundtable Discussions

During the Policy Priority Roundtable on Buprenorphine Access and Availability in 

Pharmacy Settings, meeting participants were asked to consider challenges and barriers 

(day 1) and solutions (day 2) across the buprenorphine supply chain. Participants were 

divided into three breakout groups based on their interest and expertise. The three 

groups—manufacturing & distribution; pharmacy; and prescriber & patient—were asked to 

describe the most relevant actions that HHS and other federal departments could consider 

to increase buprenorphine access.

Buprenorphine marketed as Schedule V narcotic analgesic20

DATA 2000 enabled X- waivered physicians to treat OUD with FDA-approved narcotic medications21

Buprenorphine approved by FDA for treatment of OUD20

Maximum number of patients to whom physicians could prescribe buprenorphine increased from 

30 to 10022

Maximum number of patients to whom physicians could prescribe buprenorphine increases to 27523

SUPPORT Act expanded privilege of prescribing buprenorphine to other qualifying practitioners, 

including nurses and physician assistants23

Federal legislation allowed for telehealth prescriptions of buprenorphine in wake of COVID–19 Public 

Health Emergency12

Updated HHS guideline exempted certain providers from waiver required to prescribe buprenorphine24

Removal of the DATA 2000 (X) Waiver

1985

2002

2006

2016

2018

2020

2021

2023

2000

Lack of Access Factors as Identified by Research

Independent 

pharmacies 

(non-chain)

Rural areas5 Southern 

states6 Varying insurance reimbursements8 Non-Medicaid expansion

status5

5–7,10 $

Buprenorphine Supply Chain

Manufacturing Pharmacy Prescribers of 

Buprenorphine 

and Patients
Improving Buprenorphine 

4 Access in Pharmacy Settings

Summary of Barriers Associated With Buprenorphine Access 

and Availability in Pharmacies 

Meeting participants identified barriers across the manufacturing, pharmacy, provider, 

and patient levels. Throughout the buprenorphine supply chain, five underlying themes 

emerged: (1) stigmatization; (2) patient burden; (3) classification of buprenorphine in 

the same category as other opioids; (4) fear of violating understood threshold rules; and 

(5) pharmacies losing money on dispensing buprenorphine prescriptions due to low 

reimbursement rates

Stigmatization

Stigmatization around OUD creates barriers for people to seek treatment 

and access care. Stigmatization can be defined as projecting negative 

attitudes against an identifiable group of people. It perpetuates fear 

or anger toward individuals with OUD, directing attention away from 

understanding the disease and treating the problem. Stakeholders noted 

the following common misconceptions:

 Buprenorphine has high value as a street drug.

 Patients are selling their buprenorphine on the street.

 Providers are prescribing buprenorphine as a substitution for other 

opioids.

 Dispensing buprenorphine will attract undesirable clientele to the 

pharmacy.

 The pharmacy will get a bad reputation for attracting undesirable 

individuals to the community and distributing opioids into the 

community.

 Prescribers of buprenorphine prescribe too much and may not know if it 

will be diverted for recreational use.

Patient 

Barriers

 There are not enough buprenorphine prescribers, and individuals need 

to travel long distances to get treatment.

 Telehealth has expanded the number of individuals who can receive a 

prescription, but pharmacies are suspicious of prescriptions from outside 

of the community.

 Sometimes dosages will have to be increased or decreased as a part of 

treatment, but pharmacies will not allow, and insurance may not pay for, 

changes in buprenorphine dosages within the same month.

 Patients taking buprenorphine cannot request to fill their prescription 

early for any reason, even if they are about to travel.

 When patients or prescribers call pharmacies to see where to fill 

prescriptions, pharmacies are trained to not disclose which controlled 

medications they have on premises.

 Some pharmacies carry only certain forms of buprenorphine, forcing 

patients to search around for a different pharmacy or request that their 

prescriber change their prescription.
5

Policy Priority Roundtable 

Summary Report 

Summary of Barriers (continued)

Classification 

in the Same 

Category as 

Other Opioids

A controlled substance is one that is tightly controlled by the government 

because it may be misused, diverted, or cause addiction. The control 

applies to the way the substance is made, used, handled, stored, and 

distributed. Controlled substances include opioids, stimulants, depressants, 

hallucinogens, and anabolic steroids.

Although buprenorphine is a Schedule III drug, it is treated similarly as 

Schedule II opioid medications by distributors.

 Because pharmacies and distributors cap the total amount of controlled 

substances distributed, this limits the amount of buprenorphine that can 

be distributed.

 This classification may be the reason why some pharmacists are reluctant 

to fill prescriptions. They may see it as a further misdistribution of opioids.

Source: National Cancer Institute; 

https://www.cancer.gov/publications/dictionaries/cancer-terms/def/

controlled-substance

Fear of 

Violating Rules

Many stakeholders feared that they would violate rules against thresholds. 

Others feared being named in multidistrict litigations as contributing to the 

opioid pandemic. Examples of perceived violations included:

 Filling prescriptions from people who live more than 20–25 miles from 

the pharmacy.

 Filling too many prescriptions for buprenorphine at the same pharmacy.

 Requesting a high quantity of buprenorphine from the distributor.

 Accepting telehealth prescriptions without knowing whether the patient 

had seen the prescriber face-to-face within the last 24 months.

 Impending end to COVID-19 emergency rules, such as the allowance of 

telehealth prescriptions.

 A large number of new buprenorphine prescriptions from the same 

prescriber.

Pharmacies 

Losing 

Money on 

Every Prescription

Dispensing buprenorphine can be expensive because there are significant 

regulations regarding storage, the need to ensure legitimacy, and 

paperwork, combined with low reimbursement. Stakeholders noted the 

following:

 Pharmacies often report losing $10 for each buprenorphine prescription 

they fill. This is due to pharmacy staff labor hours combined with low 

reimbursement rates.

 Prior authorization is often required by private insurance payers, and this 

is a hurdle that takes pharmacy staff significant time to assess.

 Pharmacists are not allowed to modify the quantity or doses prescribed 

because the FDA label on the medications warns against it.
6

Policy Priority Roundtable 

Summary Report 

Recommendations To Increase Buprenorphine Access and 

Availability in Pharmacies

Meeting participants identified specific actions that may be taken by HHS and 

other federal agencies to increase access to buprenorphine at pharmacies. The list 

of recommendations appears below and is organized into three categories: (1) shortterm action items for messaging considerations; (2) long-term action items for funding 

consideration; and (3) regulatory and legislative actions. The left column denotes the 

barriers that are addressed by each category of recommendations. (This roundtable report 

represents the opinions of the participants only; no inference should be made concerning 

the position or policy of any federal or state agency).

Create opportunities where HHS and the U.S. Department of 

Justice come together to ensure consistent and clear messaging 

around the importance of increasing buprenorphine access in 

pharmacies. Messaging should clarify that buprenorphine is a 

life-saving medication as a component of treatment and harm 

reduction and that buprenorphine is different from other opioids. 

Denying buprenorphine access, in certain cases, may violate laws 

prohibiting disability rights discrimination.

Barriers Addressed

HHS and DEA should provide opportunities for stakeholders to talk directly to them about 

their concerns and to clarify what the regulations are. Ideas include convening a “road 

show” across the country where pharmacists can talk directly with DEA staff; and convening 

a “de-mystifying regulations day” that includes individuals from DEA and HHS providing 

clarification and opportunities for discussion with leadership at pharmacies, pharmaceutical 

companies, and big corporations that are part of the supply chain. [Note: A town hall with DEA 

occurred in March 2023.]

DEA could offer clear and written documentation to address fears and clarify points of 

misunderstanding regarding buprenorphine policy and investigations. Topics could include 

when COVID-19 public health emergency measures, such as telehealth prescriptions, will end. 

Ideas referenced in the meeting include developing a “Myth vs. Fact” document; and ensuring 

that regional DEA offices are all using the same regulations, which are clearly written and can be 

shared with pharmacies. [DEA has favorably responded to this action item.]

HHS should continue to consult with its Office for Civil Rights (OCR) and Office of the 

General Counsel regarding denials of prescribed medication, to a person with OUD, such as 

buprenorphine, as possible violations of federal civil disability rights and federal civil rights laws 

governing other protected classes (e.g., race, color and national origin), including the Americans 

with Disabilities Act, Section 504 of the Rehabilitation Act of 1993, Section 1557 of the Affordable 

Care Act, the Civil Rights Act of 1964, and other federal nondiscrimination laws to better inform 

providers of their obligations and duties under the law. Specifically, a request for written 

technical assistance guidance about the responsibilities of chain pharmacies by OCR should be 

considered.

HHS and DEA should enhance messaging that buprenorphine is a Schedule III medication 

and should be considered differently from other opioids which are Schedule II. Efforts 

should be considered to ungroup buprenorphine from the safeguards implemented as part 

of manufacturer-controlled safety procedures, algorithms used for opioid distribution to 

pharmacies, and pharmacies’ automated checks. 

Short-Term Action Items

Recommendations

Stigma

Reclass

Violation

Fears

Pharmacy

Burden*

* Gray = N/A

Patient

Burden

1.

1a.

1b.

1c.

1d.
7

Improving Buprenorphine 

Access in Pharmacy Settings

Long-Term Action Items

Recommendations for U.S. Government Actions To Increase 

Buprenorphine Access and Availability in Pharmacies

Barriers Addressed

HHS could consider enhancing partnerships with nongovernmental organizations to further disseminate clear and 

consistent messaging about buprenorphine. Many of the 

meeting participants noted they could help disseminate the 

message through communications channels such as boards of 

pharmacies; state pharmacy associations; pharmacy professional 

organizations; state regulatory and licensing boards; state 

attorney generals; HHS regional administrators; and pharmacy 

student organizations.

HHS should consider additional investments to fund educational 

opportunities for the health care and pharmacy workforce 

to reduce stigmatization and clarify misperceptions about 

buprenorphine. There should be emphasis that buprenorphine is 

a life-saving treatment for OUD, much like insulin is for diabetes. 

Ideas included education modules at university and medical 

residency programs; during initial licensure and renewals for 

doctors, nurses, and pharmacists; during pharmacy residency 

programs; as part of eligibility process to be on state boards of 

pharmacy; and within student pharmacist groups.

HHS should consider providing technical assistance for studies or 

expert panels to explore expanded formularies for buprenorphine 

and whether the reimbursement rates are adequate. There are 

some state Medicaid agencies that still utilize prior authorizations. 

[Meetings with some of these state agencies have begun.]

Consider funding models for treatment expansion pilot studies.

Consider expanding the types of prescribers to include 

pharmacists. Consider conducting a pilot study to look at viable 

and effective models. [Note: Outside of research studies, this 

requires federal activity.]

HHS should explore demonstration projects for providing financial 

or other incentives for pharmacies to dispense buprenorphine. A 

pilot grant program could be used to test this model.

Consider a study to look at models of prescriber and pharmacist 

collaborations that are likely to increase access and safety.

2.

3.

4.

5.

5a.

5b.

5c.

Recommendations

Stigma

Reclass

Violation

Fears

Pharmacy

Burden*

* Gray= N/A

Patient

Burden*

Stigma

Reclass

Violation

Fears

Pharmacy

Burden*

* Gray = N/A

Patient

Burden*

Stigma

Reclass

Violation

Fears

Pharmacy

Burden

* Gray = N/A

Patient

Burden

Stigma*

Reclass*

Violation

Fears*

Pharmacy

Burden

* Gray = N/A

Patient

Burden
8

Policy Priority Roundtable 

Summary Report 

Recommendations for U.S. Government Actions To Increase 

Buprenorphine Access and Availability in Pharmacies 

(continued)

Regulatory and Legislative Actions

Remove the X-waiver for buprenorphine, recognizing that 

it is a treatment for OUD, as cases of diversion often involve 

seeking relief from withdrawal symptoms. [Note: This occurred 

following the convening with the passage of the 2023 

Appropriations Bill.]

Stigma

Reclass

Violation

Fears

Pharmacy

Burden*

* Gray = N/A

Patient

Burden

Stigma

Reclass

Violation

Fears

Pharmacy

Burden*

* Gray = N/A

Patient

Burden

Stigma*

Reclass*

Violation

Fears*

Pharmacy

Burden

* Gray = N/A

Patient

Burden

Barriers Addressed Recommendations

FDA should consider modifying the dosing guidance on 

buprenorphine medication packaging so that providers and 

pharmacists may have greater flexibility in terms of dosage, 

such as being able to halve films or tablets as needed.

Consider expanding the types of locations where a prescription 

can be filled. For example, allow community behavioral 

health centers, federally qualified health centers, and other 

community providers to dispense buprenorphine. This might 

be especially helpful in rural communities with few pharmacies. 

[This would require federal approval from DEA.]

6.

7.

8.
9

Improving Buprenorphine 

Access in Pharmacy Settings

Meeting Participants

This report is based on the thoughtful input of many stakeholders who were present for 

the Policy Priority Roundtable on Buprenorphine Access and Availability in Pharmacy 

Settings, held virtually on August 11 and August 12, 2022. The meeting participants are listed 

in alphabetical order by first name. Federal employees listed below participated as subject 

matter experts or as administrative support for the roundtable convening.

Daniel Schwartz

U.S. Department of Health and Human 

Services

Doug Thornton

Prescription Drug Misuse Education and 

Research Center at the University of Houston 

College of Pharmacy

Elizabeth Barfield

National Institute on Drug Abuse, National 

Institutes of Health

Ellen Blackwell

Centers for Medicare & Medicaid Services

Ford Baker

Louisiana Department of Health, Office of 

Behavioral Health

Frances Levin

Columbia University

Frank Bajowski

Capital Consulting Corporation

Hannah Fish

National Community Pharmacists Association

Heather Boyd

American Pharmacists Association

James Hussey

Louisiana Department of Health, Office of 

Behavioral Health

Jenna Bluestein

Office of National Drug Control Policy, 

Executive Office of the President

Jillanne Schulte Wall

American Society of Health-System 

Pharmacists

John Beckner

National Community Pharmacists Association

Participants

Aakash Shah

U.S. Department of Health and Human 

Services

Allie Jo Shipman

National Alliance of State Pharmacy 

Associations

Anne Burns

American Pharmacists Association

Ben Maclean

Boulder Care

Ben Miskle

University of Iowa

Bill Cover

National Association of Boards of Pharmacy

Brian Clear

Bicycle Health Medical Group

Charles Tarasidis

Carilion Clinic

Christina Mikosz

Centers for Disease Control and Prevention

Christina Mullins

West Virginia Department of Health and 

Human Resources

Christine Cichetti

Substance Abuse and Mental Health Services 

Administration

Christopher Jones

Centers for Disease Control and Prevention

Corey Barton

American Society of Addiction Medicine

Daniel Blaney-Koen

American Medical Association
Improving Buprenorphine 

10 Access in Pharmacy Settings

John McIlveen

Oregon Health Authority

Jon Oliver

U.S. Department of Health and Human 

Services, Office of the Assistant Secretary for 

Planning and Evaluation

Josh Shapiro

Capital Consulting Corporation

Justine Pope

Boulder Care

Karen Stubbs

Los Angeles Department of Health

Kathryn Cates Wessel

American Academy of Addiction Psychiatry

Kathy Pham

American College of Clinical Pharmacy

Kelly Clark

Addiction Crisis Solutions

Lindsey Loera

University of Texas at Austin College of 

Pharmacy

Lucas Hill

The University of Texas at Austin

Marla Kushner

American Osteopathic Academy of Addiction 

Medicine

Matthew Strait

Drug Enforcement Administration

Mellie Randall

National Association of State Alcohol and 

Drug Abuse Directors

Meriam Mikre

U.S. Department of Health and Human 

Services

Michael Forman

Centers for Medicare & Medicaid Services

Michelle Dirst

American Academy of Addiction Psychiatry

Morgan Godvin

Oregon Alcohol and Drug Policy Commission

Nadine Benton

Substance Abuse and Mental Health Services 

Administration

Neeraj Gandotra

Substance Abuse and Mental Health Services 

Administration

Nick Reuter

Indivior

Patrick Kelly

Healthcare Distribution Alliance

Phil Masiakowski

Westat

Preethy George

Westat

Quinetta Womack

Louisiana Department of Health, Office of 

Behavioral Health

Rebecca Baker

National Institutes of Health

Meena Vythilingam

U.S. Department of Health and Human 

Services

Rebekah Rollston

Bicycle Health Medical Group

Shari Ling

Centers for Medicare & Medicaid Services

Shoma Ghose

Westat

Stephen Hayes

Health Resources and Services Administration

Susan Kerin

Capital Consulting Corporation

Ted Hall

U.S. Public Health Service/Indian Health 

Service; Ho-Chunk Nation Health Department

Terry Horton

Indivior

Thomas Prevoznik

Drug Enforcement Administration

Meeting Participants (continued)
11

Policy Priority Roundtable 

Summary Report 

Traci Perry

Louisiana Department of Health, Office of 

Behavioral Health

Udi Ghitza

National Institute on Drug Abuse, National 

Institutes of Health

Wilson Compton

National Institute on Drug Abuse, National 

Institutes of Health

Yngvild Olsen

Center for Substance Abuse Treatment, 

Substance Abuse and Mental Health Services 

Administration

Zachary Krauss

Cedarville University

Meeting Participants (continued)

Administrative Support provided by:

Tracie Pogue

Substance Abuse and Mental Health 

Services Administration

Brian Gac

U.S. Food and Drug Administration, 

Controlled Substances Program

Andriel Ugbomeh

U.S. Food and Drug Administration
Improving Buprenorphine 

12 Access in Pharmacy Settings

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