Pharmacy-related buprenorphine access barriers: An audit of pharmacies in counties with a high opioid overdose burden
Introduction
Over 2 million individuals have a diagnosis of opioid use disorder (OUD) in the United States (US) (Substance Abuse and Mental Health Services Administration (SAMHSA, 2020a). Despite efforts at federal, state, and local levels to address the opioid epidemic, mortality from opioid overdoses remains high in many parts of the US (Hedegaard et al., 2018; Soelberg et al., 2017). Medications for opioid use disorder (MOUD), such as methadone and buprenorphine-naloxone (buprenorphine), are highly effective at reducing overdose mortality, non-medical opioid use, and other adverse outcomes (Sordo et al., 2017; National Academies of Sciences, Engineering, and Medicine, 2019). Unlike methadone, which must be distributed through federally-approved opioid treatment programs in the US, buprenorphine formulations can be prescribed by waivered clinicians (physicians, nurse practitioners, or physician assistants) in an office-based setting and then dispensed from a community pharmacy (Drug Addiction Treatment Act, 2000; Implementation of the Provision of the CARA, 2018).
Although the number of waivered clinicians has increased in recent years, barriers to buprenorphine access persist. Approximately 42 % of US counties in 2017 had no clinicians available to prescribe buprenorphine (Andrilla et al., 2019), with this lack of access disproportionately impacting rural communities where the overdose burden is often most pronounced (Andrilla et al., 2019; Rigg et al., 2018; Young et al., 2012). Even when waivered clinicians are available, patient access can remain a challenge. In a recent study among states with high rates of opioid-related mortality, only half of Medicaid patients seeking to initiate buprenorphine treatment with waivered clinicians were offered an appointment, and only one in four patients were offered same-day induction (Beetham et al., 2019). Variations across the country in insurance coverage for MOUD can also negatively impact timely access to buprenorphine due to prior authorization requirements (Hartung et al., 2019; Huskamp et al., 2018).
Accumulating evidence also suggests that pharmacies may limit patient access to buprenorphine (Cooper et al., 2020; Hill et al., 2020; Ventricelli et al., 2020). Although federal law does not explicitly place limits on the quantity of buprenorphine that can be ordered or dispensed by pharmacies, the Drug Enforcement Administration (DEA) regulations and The SUPPORT for Patients and Communities Act (SUPPORT Act) of 2018 require wholesalers to monitor controlled substance orders from pharmacies and promptly report suspicious activity to the DEA for subsequent investigation (Ostrach et al., 2020; Drug Enforcement Administration, 2019). A recent qualitative investigation found some independent pharmacies in Appalachia self-impose buprenorphine “caps” or patient limits to avoid triggering DEA investigation (Cooper et al., 2020). Additionally, pharmacies may restrict access to buprenorphine due to stigma towards patients with OUD and distrust of clinician prescribing practices or implement policies, such as identification requirements, that create access barriers (Cooper et al., 2020; Ventricelli et al., 2020). Although one study found that more than half of pharmacies in Texas were unable to dispense buprenorphine-naloxone (Hill et al., 2020), the scope of the problem has not been examined nationwide. The objective of this study was to quantify buprenorphine-naloxone availability in community pharmacies located in US counties with the highest opioid overdose burden.
Section snippets
Study design
We conducted a telephone-based audit study using a standardized script which included information commonly found on prescriptions (e.g., medication name, dose, duration) to assess the availability, formulation, and quantity of buprenorphine from community pharmacies. Additional information regarding the capacity of pharmacies to dispense the medication that day, provide a partial fill, and the necessity to order buprenorphine was also recorded. The audit script was developed and refined through
Results
Our sample included pharmacies in 473 counties across 40 US states and the District of Columbia. Of these 473 counties, there were 25 counties where only one pharmacy type was identified (19 chain pharmacies and 6 independent pharmacies) resulting in a final sample of 921 pharmacies (Fig. 1). The final sample included 467 (51 %) chain pharmacies and 454 (49 %) independent pharmacies.
Table 1 summarizes demographic characteristics of surveyed pharmacies. Pharmacies were concentrated in urban
Discussion
Among community pharmacies located in US counties with the highest opioid overdose mortality rates, we identified barriers to buprenorphine access in nearly 30 % of pharmacies. One in five pharmacies were unable or unwilling to fill a buprenorphine prescription entirely. Another 7% of pharmacies would not disclose controlled substance availability over the phone and thus required patients to visit the pharmacy in-person to obtain this information. Buprenorphine access barriers were more
Conclusions
Successful treatment of OUD requires patients to have timely and reliable access to MOUD. In addition to well-described barriers related to provider access and stigma, our study shows that one in five individuals who attempt to fill a buprenorphine prescription may experience some type of pharmacy-level barrier. These limitations were more pronounced among independent pharmacies and those in Southern states. At a minimum, addressing these barriers will require clarification of regulatory
Contributors
Daniel Hartung: Conceptualization, project administration, methodology, software, formal analysis, writing - original draft
Neda Kazerouni: Supervision, project administration, methodology, investigation, software, formal analysis, writing - original draft
Adriane Irwin: Writing - Review & editing
Ximena Levander: Writing - Review & editing
Jonah Geddes: Software, formal analysis, validation, review & editing
Kirbee Johnston: Data curation, formal analysis, review & editing
Carly Gostanian:
Role of funding
MedSavvy and Cambia Health Solutions supported this research by providing access to the NCPDP dataset and paid internships for pharmacy student research assistants during data collection. MedSavvy provided input in the study design and interpretation of data.
Declaration of Competing Interest
None.
References (36)
- 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) - et al.
Using the theory of planned behavior to investigate community pharmacists’ beliefs regarding engaging patients about prescription drug misuse
Res. Social Adm. Pharm.
(2019) - et al.
Report of the AACP special committee on substance abuse and pharmacy education
Am. J. Pharm. Educ.
(2010) - et al.
Opioid-related mortality in rural America: geographic heterogeneity and intervention strategies
Int. J. Drug Policy
(2018) - et al.
Pharmacist roles, training, and perceived barriers in naloxone dispensing: a systematic review
J. Am. Pharm. Assoc. (2003)
(2020) Class Action Lawsuits Filed AGAINST CVS, Walgreens, and Costco for Refusal to Fill Opioid Prescriptions for Chronic Pain Patients
(2020)Actions of the 2020 house of delegates – special session
J. Am. Pharm. Assoc.
(2020)- et al.
Geographic distribution of providers with a DEA waiver to prescribe buprenorphine for the treatment of opioid use disorder: a 5-year update
J. Rural Health
(2019) - et al.
Access to office-based buprenorphine treatment in areas with high rates of opioid-related mortality: an audit study
Ann. Intern. Med.
(2019) Pharmacy: addressing substance use in the 21st century
Subst. Abus.
(2019)
Multiple Cause of Death
Examining Concerns About Distribution and Diversion, 115th Congress
Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis
Drug Addiction Treatment Act H.R. 2634 C.F.R. § 106
DEA Announces Enhanced Tool for Registered Drug Manufacturers and Distributors to Combat Opioid Crisis
Buprenorphine coverage in the medicare part d program for 2007 to 2018
JAMA
Drug Overdose Deaths in the United States, 1999–2017
Availability of buprenorphine/naloxone films and naloxone nasal spray in community pharmacies in Texas, USA
Addiction
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