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Archives of Public Health
Published in: Archives of Public Health 1/2024

Open Access 01-12-2024 | Buprenorphine | Study Protocol

Protocol for the development of a consensus practice guideline To address clinical and regulatory barriers to buprenorphine dispensing in community pharmacy

Authors: Tyler J. Varisco, Hannah Fish, Joshua Bolin, David Dadiomov, Lucas G. Hill, Ekere J. Essien, Matthew A. Wanat, Diane Ginsburg, Jeanne Waggener, Sahar Yazdanfard, Juhyeon Song, Whanhui Chi, Douglas Thornton

Published in: Archives of Public Health | Issue 1/2024

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Abstract

Background

Less than half of community pharmacies in the United States stock buprenorphine products indicated for the treatment of opioid use disorder. This lack of access to buprenorphine in community pharmacies is a significant barrier to care. To address this issue, this protocol outlines a comprehensive approach to develop a practice guideline aimed at improving access to safe and effective opioid use disorder treatment in community pharmacies.

Methods

The guideline development process will proceed in three phases, following a technique closely aligned with the Institute of Medicine’s guidance on guideline development. The first phase will involve conducting qualitative interviews with pharmacists in three states to identify their beliefs toward buprenorphine dispensing. As limitations on buprenorphine supply are related to constraints at all levels of the drug supply and regulatory system, the second phase, we will recruit representatives from regulatory agencies, pharmacy organizations, the Drug Enforcement Administration, pharmaceutical wholesalers as well as addiction medicine physicians and psychiatric pharmacists to develop consensus recommendations through a modified Delphi design. This will be followed by a public comment period and external expert review of the recommendations led by the National Association of Boards of Pharmacy. Finally, in the third phase, a national, mixed media dissemination campaign will be led by the National Community Pharmacists Association (NCPA) to convey recommendations to practicing pharmacists.

Discussion

The guideline development process aims to incorporate the perspectives of multiple stakeholders and emphasize the importance of addressing the regulatory and pharmacy-specific aspects of care in addition to clinical evidence and guidance. The development of this guideline will provide targeted, multidisciplinary guidance for pharmacists, improving access to safe and effective opioid use disorder treatment in the community setting.

Preregistration

This protocol was registered with the Open Science Framework in March of 2023. Registration may be found at: https://​doi.​org/​10.​17605/​OSF.​IO/​6S9DY.
Appendix
Available only for authorised users
Literature
1.
Substance Abuse and Mental Health Services Administration. Treatment Improvement Protocol #63: Medications for opioid use disorder: for healthcare and addiction professionals, policymakers, patients, and families. 2021.
2.
Congress US. H.R.2634 - Drug Addiction Treatment Act of 2000. 2000.
3.
Beetham T, Saloner B, Wakeman SE, Gaye M, Barnett ML. Access to Office-based Buprenorphine Treatment in Areas with High Rates of opioid-related mortality: an audit study. Ann Intern Med. 2019;171(1):1–9.CrossRefPubMedPubMedCentral
4.
Suarez E Jr., Bartholomew TS, Plesons M, Ciraldo K, Ostrer L, Serota DP, et al. Adaptation of the Tele-Harm reduction intervention to promote initiation and retention in buprenorphine treatment among people who inject drugs: a retrospective cohort study. Ann Med. 2023;55(1):733–43.CrossRefPubMedPubMedCentral
5.
Molfenter T, Jacobson N, Kim JS, Horst J, Kim H, Madden L, et al. Building medication for opioid use disorder prescriber capacity during the opioid epidemic: prescriber recruitment trends and methods. J Subst Use Addict Treat. 2023;147:208975.CrossRefPubMedPubMedCentral
6.
Ward KM, Scheim A, Wang J, Cocchiaro B, Singley K, Roth AM. Impact of reduced restrictions on buprenorphine prescribing during COVID-19 among patients in a community-based treatment program. Drug Alcohol Depend Rep. 2022;3:100055.CrossRefPubMedPubMedCentral
7.
S.445. Mainstreaming Addiction Treatment Act of 2021, 117th Congress(2021).
8.
Varisco TJ, Wanat M, Hill LG, Thornton D. The impact of the mainstreaming addiction treatment act and associated legislative action on pharmacy practice. J Am Pharmacists Association. 2023;63(4):1039–43.CrossRef
9.
Hill LG, Loera LJ, Torrez SB, Puzantian T, Evoy KE, Ventricelli DJ, et al. Availability of buprenorphine/naloxone films and naloxone nasal spray in community pharmacies in 11 U.S. states. Drug Alcohol Depend. 2022;237:109518.CrossRefPubMed
10.
Diversion Control Division. Drug Enforcement Administration. DEA-Registered Manufacturer and Distributor Established Controlled Substance Quantitative Thresholds and the Requirement to Report Suspicious Orders. EO-DEA258, DEA-DC-065. 2023.
11.
Qato DM, Watanabe JH, Clark KJ. Federal and State Pharmacy regulations and dispensing barriers to Buprenorphine Access at Retail pharmacies in the US. JAMA Health Forum. 2022;3(8):e222839.CrossRefPubMed
12.
Cooper HL, Cloud DH, Freeman PR, Fadanelli M, Green T, Van Meter C et al. Buprenorphine dispensing in an epicenter of the U.S. opioid epidemic: a case study of the rural risk environment in Appalachian Kentucky. Int J Drug Policy. 2020:102701.
13.
Tanne JH. US pharmacy chains settle opioid lawsuits for $13bn. BMJ (Clinical Res ed). 2022;379:o2688.
14.
American Society of Addiction Medicine. The National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. Chevy Chase, MD; 2015.
15.
Cunningham C, Edlund MJ, Fishman M, Gordon AJ, Jones HE, Langleben D, et al. The ASAM national practice guideline for the treatment of opioid use disorder: 2020 focused update. J Addict Med. 2020;14(2S Suppl 1):1–91.
16.
Institute of Medicine. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical practice guidelines we can trust. 2011.
17.
Ajzen I. From intentions to actions: a theory of planned behavior. Action control: Springer; 1985. pp. 11–39.
18.
Merlin JS, Young SR, Azari S, Becker WC, Liebschutz JM, Pomeranz J, et al. Management of problematic behaviours among individuals on long-term opioid therapy: protocol for a Delphi study. BMJ open. 2016;6(5):e011619.CrossRefPubMedPubMedCentral
19.
Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process. 1991;50(2):179–211.CrossRef
20.
Fishbein M. A theory of reasoned action: Some applications and implications. 1979.
21.
Fleming ML, Barner JC, Brown CM, Shepherd MD, Strassels S, Novak S. Using the theory of planned behavior to examine pharmacists’ intention to utilize a prescription drug monitoring program database. Res Social Adm Pharm. 2014;10:285–96.CrossRefPubMed
22.
Fleming M, Bapat S, Varisco T. Using the theory of planned behavior to investigate community pharmacists’ beliefs regarding engaging patients about prescription drug misuse. Res Social Adm Pharm. 2019;15(8):992–9.CrossRefPubMed
23.
24.
Kind AJ, Jencks S, Brock J, Yu M, Bartels C, Ehlenbach W, et al. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: a retrospective cohort study. Ann Intern Med. 2014;161(11):765–74.CrossRefPubMedPubMedCentral
25.
26.
Sutton SFD, Hennings SJ, et al. Eliciting salient beliefs in Researchon the Theory of Planned Behaviour: the Effect of question wording. Curr Psychol. 2003;22s(3):214–51.
27.
Rogers JW, Fleming M, Tipton J, Ward A, Garey KW, Pitman EP. Investigating inpatient medication administration using the theory of planned behavior. Am J health-system Pharmacy: AJHP: Official J Am Soc Health-System Pharmacists. 2017;74(24):2065–70.CrossRef
28.
Thornton JD, Anyanwu P, Tata V, Al Rawwad T, Fleming ML. Differences between pharmacists’ perception of counseling and practice in the era of prescription drug misuse. Pharm Pract. 2020;18(1):1682.
29.
Clarke V, Braun V, Hayfield N. Thematic analysis. Qualitative Psychology: Practical Guide Res Methods. 2015;3:222–48.
30.
Liamputtong P. Handbook of research methods in health social sciences. 2019.
31.
Akins RB, Tolson H, Cole BR. Stability of response characteristics of a Delphi panel: application of bootstrap data expansion. BMC Med Res Methodol. 2005;5(1).
32.
Veugelers R, Gaakeer MI, Patka P, Huijsman R. Improving design choices in Delphi studies in medicine: the case of an exemplary physician multi-round panel study with 100% response. BMC Med Res Methodol. 2020;20(1).
33.
Centers for Disease Control and Prevention. Draft CDC clinical practice guideline for prescribing opioids—United States, 2022: overview of community engagement and public comment opportunities. Atlanta, GA: US Department of Health and Human Services.; 2022.
34.
Dowell D. CDC clinical practice guideline for prescribing opioids for pain—United States, 2022. MMWR Recommendations and reports. 2022;71.
35.
Mauro PM, Gutkind S, Annunziato EM, Samples H. Use of Medication for Opioid Use Disorder among US adolescents and adults with need for Opioid Treatment, 2019. JAMA Netw open. 2022;5(3):e223821.CrossRefPubMedPubMedCentral
36.
Varisco TJ, Abughosh S, Chen H, Cho SK, Fleming ML, Ziedonis D et al. Switching pharmacies leads to gaps in medication possession in individuals treated with buprenorphine. J Am Pharmacists Association. 2021.
37.
Thornton JD, Lyvers E, Scott VGG, Dwibedi N. Pharmacists’ readiness to provide naloxone in community pharmacies in West Virginia. J Am Pharm Assoc (2003). 2017;57(2s):S12-S8.e4.
Metadata
Title
Protocol for the development of a consensus practice guideline To address clinical and regulatory barriers to buprenorphine dispensing in community pharmacy
Authors
Tyler J. Varisco
Hannah Fish
Joshua Bolin
David Dadiomov
Lucas G. Hill
Ekere J. Essien
Matthew A. Wanat
Diane Ginsburg
Jeanne Waggener
Sahar Yazdanfard
Juhyeon Song
Whanhui Chi
Douglas Thornton
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Archives of Public Health / Issue 1/2024
Electronic ISSN: 2049-3258
DOI
https://doi.org/10.1186/s13690-024-01287-4

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