Julia Leung, PCP PharmD Candidate

Buprenorphine dispensing in an epicenter of the U.S. opioid epidemic: A

case study of the rural risk environment in Appalachian Kentucky

(Cooper, Hannah LF, et al. “Buprenorphine Dispensing in an Epicenter of the U.S. Opioid Epidemic: A Case Study of the Rural Risk Environment in
Appalachian Kentucky.” International Journal of Drug Policy, 2020, p. 102701., doi:10.1016/j.drugpo.2020.102701.)
 BACKGROUND – THE STUDY QUESTION?
Background  Opioid use disorder (OUD) has been expanding into rural Australia and North America
 In the rural US, rates of opioid overdose deaths have been equal to or higher than rates in the city over the past 10 years
 Rates of neonatal opioid withdrawal syndrome are higher in rural areas than in cities
 Rural areas face a wide implementation chasm—the gap between scientific advances and their application—for harm reduction services,
such as buprenorphine and other medications to treat OUD (MOUD)
 The Risk Environment Model (REM) suggests that political, social, economic, and physical environments intersect to shape susceptibility
to drug-related harms
 This model is important for helping us understand the relationships b/w environmental features and drug related harms
 Traditionally, this model has viewed macrolevel features as “forever outside” of context, unfamiliar, universal, and deterministic
 This study posits that all 3 levels—microlevel, mesolevel, and macrolevel—interplay locally, interacting within and across levels
 Specifically, the study seeks to describe pharmacists’ buprenorphine dispensing practices in 12 Kentucky counties and analyze how agents
from all 3 factors interact locally to form these attitudes and perceptions
 Qualitative interview data was integrated with policy, healthcare, and criminal justice research to provide a comprehensive and well-
rounded link between pharmacist attitudes and macrolevel influences. This provides insight on how policy and institutional changes can
be applied to reduce stigma and barriers against adequate MOUD dispensing.
Why this  Rural areas face unique barriers to adequate MOUD dispensing. It is unclear how macrolevel factors influence pharmacists’ attitudes and
study? behaviors towards dispensing buprenorphine in rural areas. Understanding pharmacists’ perceptions of buprenorphine dispensing and
analyzing how they are shaped by the rural risk environment is a crucial step to fighting the rising opioid epidemic in rural counties.
Null  N/A
Hypothesis

Summary Critique
Trial design  Case study  Qualitative research strengths
 Qualitatively interviewed local pharmacists to understand attitudes and practices towards harm include discovery and
reduction flexibility
 Sampled pharmacists from all 12 Appalachian Kentucky counties  Open-ended interview design
 In-person, semi-structured interviews were audiotaped and transcribed verbatim allowed researchers to identify
 Upon discovering barriers to buprenorphine dispensing during early interviews, the project was and subsequently focus on
altered to focus on the 3 most salient topics: salient issues that pharmacists
 A perceived DEA cap on dispensing considered when dispensing
 Conceptualized as a feature of macrolevel healthcare service/criminal justice environment  Cons of the case study design
 Conducted a policy review using Westlaw and internet searches include an inherent loss of
 Reviewed grey literature and media to explore how federal regulations against generalizability due to the
wholesalers/pharmaceutical companies may influence buprenorphine prescribing small sample size
 Opioid analgesics (OA) Marketing strategies and physician overprescribing  Case studies also at greater
risk for researcher bias
 Pharmaceutical OA marketing strategies conceptualized as macrolevel healthcare
service/criminal justice environment
 Physician overprescribing conceptualized as Mesolevel healthcare service/criminal justice
 environment
 Criminal justice vs. public health responses to the opioid epidemic
Pharmacists were asked about their opinions on these topics, and analysis of policy and existing data on
these topics was done to augment the qualitative data from the interviews.
Objectives  To describe pharmacists’ buprenorphine dispensing practices, conceptualized as a feature of the
mesolevel healthcare service/criminal justice environment
 To describe the formation of these practices within the local rural risk environment

Inclusion Qualitative interview with pharmacists in the 12-county area:  Purposive sampling, also
criteria o Pharmacists were selected using purposive sampling to create a sample that: known as “judgemental”
 Represented all 12 counties sampling, is prone to
 Represented enough independent and chain pharmacies to support comparisons of researcher bias
dispensing practices across the 2 types  Researcher selects the
sample based on their
Qualitative data on the following topics was combined with review of policy and existing datasets knowledge of the study
to get an overarching picture: and population
 Study did not provide
 Policy Review of perceived DEA cap and other dispensing regulations reasoning as to why or
 Opioid analgesics (OA) Marketing strategies how they knew their
 (1) lawsuits filed by Kentucky's Office of the Attorney General (OAG) against pharmaceutical sample was representative
companies for their Kentucky-based opioid marketing practices  All OAG documents
 (2) Hadland et al's analysis of Centers for Medicare and Medicaid Services (CMS) data on analyzed here describe
county-level opioid-analgesic marketing expenditures by pharmaceutical companies, aggregated allegations, and so have
across 2013-2015 not been proven
 Four OAG lawsuits were selected for analysis because they were current and thus likely
reflected recent practices; one (against Purdue) was initiated in 2007 and was selected because
of the magnitude of concern expressed in interviews about Oxycontin prescribing.
 Physician overprescribing
 Annual CDC county-level data on dispensed OA
 War on Drugs
 Vera Institute of Justice data to track rates of jail-based detention and jail/prison population size
over time
 Analyzed parallel data for 12 most populous counties in the US for context
 Gateway2Health Survey to obtain self-reported incarceration and drug-related stigma among
people who use drugs
 Used respondent-driven sampling methods to recruit adults living in 5 of the 12 counties
who in the past 30 days who used opioids or injected any drug to get high
Exclusion  N/A
criteria
Primary  Pharmacist attitudes and practices on dispensing buprenorphine, and opinions on:
Endpoints  DEA cap
 OA marketing and physician overprescribing
 War on drugs
Secondary  Policy review of DEA cap
Endpoints  OA marketing strategies and physician overprescribing
 Analysis of lawsuits against pharmaceutical companies
 CDC county-level OA prescribing data
 War on drugs
 County-level data on incarceration rates
 Gateway2Health survey
Monitoring  N/A  N/A
Statistical  N/A  N/A
analyses

Baseline  Pharmacists interviewed:  Only able to interview 1

characteristic  Analysis achieved saturation with a sample of 14 pharmacists pharmacist at a retail chain, as
s/  Operated 15 pharmacies in 9 of 12 counties other chain-based pharmacists
Enrollment  2/3 men were either forbidden from
 All non-Hispanic White participating in interviews or
 Pharmacists constituted 23% of all retail pharmacies in the 12-county area reported they had no time
 Decreased external
validity for chain
retail-based
pharmacists in rural
areas
Primary  Pharmacists had deep roots in their communities; 9 had grown up in/near the counties they practiced  Bulk of results seem to be
Outcome  Pharmacists described residents as “loyal”, “trustworthy”, “kind” qualitative summaries of
 Reported that they operated “hometown pharmacies” that were tightly woven into the social fabric, interview responses
with residents having close ties with pharmacists  Due to semi-structured nature
 Reported that OUD was “rampant”, community “humming” with opioids of the interview, not all
 9 pharmacists asked to estimate percent of adult county residents who used opioids or injected pharmacists were asked the
drugs; median response 40% (range: 14% to 70%) exact same questions
 Unprompted, 5 reported having family members who struggled with substance use disorders  Risk of bias when interpreting
(SUD) and summarizing qualitative
 Number of buprenorphine prescriptions perceived as “exploding” answers
 6 pharmacies dispensed over 100 buprenorphine prescriptions per month  However, qualitative and semi-
 5 dispensed 20-50 prescriptions/month structured interviews allowed
 Buprenorphine dispensing for discovery of unprompted
information, such as the 5
 4 pharmacists refused to dispense buprenorphine
pharmacists who reported
 12 of 15 pharmacies limited number of buprenorphine prescriptions they filled
having family members with
SUD
 Unanswered questions on why
so many pharmacists, despite
their concern about the opioid
epidemic and the toll it took on
their beloved families and
communities, failed to
adequately dispense
buprenorphine
Why do you think this might be?
Secondary  The perceived DEA cap and other features of the buprenorphine regulatory environment
Outcomes  10 of 14 pharmacists reported that the DEA or wholesalers directly monitored the percent of controlled
substances that were opioids dispensed at each pharmacy
 Reported that pharmacies that went above a threshold (the cap) would be investigated by the DEA
 Policy review confirmed monitoring and revealed particularly aggressive surveillance and enforcement in
Kentucky
 While federal law does not impose direct caps, DEA regulations and the SUPPORT Act require wholesalers
implement systems to detect suspicious order of controlled substances; must notify DEA officials of
questionable or abnormally large orders.
 Pharmacies flagged by wholesaler algorithms may face consequences including supply freezes, DEA
investigation, denial of a pharmacy’s registration, and criminal charges.
 5 pharmacies have established an internal cap on buprenorphine dispensing, subsequently rationing
prescriptions for loyal/longtime patients
 5 pharmacists explicitly chose not to ration buprenorphine; either confident that their pharmacy did not surpass
the “DEA cap”, or supporting harm reduction efforts while risking professional and personal consequences
For those of you with retail experience, what are your perceptions on this DEA cap, and how do you deal with it?
 OA marketing and prescribing
 Analysis of Kentucky OAG lawsuits against 5 pharmaceutical companies identified 3 main strategies to
increase OA sales
1. Promoting misleading messages about risks and purposes of OA
2. Aggressive sales tactics
3. Compensating physicians
Has anyone experienced or witnessed any of these tactics used by pharmaceutical companies to promote the use of OA?
For those of you who have had retail experiences, have you encountered physicians who frequently prescribe OA and
what are your thoughts and opinions of them?
 OA prescribing rates rose 30% in these 12 counties b/w 2006-2012
 From 2006-2017, OA prescriptions per capita in the 12 rural counties were 2-3x that of the 12 most populous
counties in America
 Qualitative Results
 Low trust group
 For 6 pharmacists, OA legacy had destroyed trust in physicians prescribing buprenorphine
and buprenorphine itself
 3 refused to stock buprenorphine
 2 refused to accept new buprenorphine patients
 High trust group
 8 pharmacists retained their trust in physicians despite the OA legacy
 Recognized physicians’ roles in contributing to the local OA epidemic but refused to blame
them
 Believed that buprenorphine was an acceptable OUD treatment
 Chose to dispense buprenorphine prescriptions
 To comply with DEA regulations, 4 pharmacists limited dispensing to known customers and
patients who lived in the community
 3 pharmacists further limited dispensing to local/known prescribers
 Remaining pharmacists discussed no limits based on patient/prescriber characteristics
  War on Drugs
 War on drugs remains active in 12 counties
 Since 2000/2002, incarceration and detention rates have been higher in these 12 rural counties than in
urban areas
 By 2015, compared to residents of the 12 most populous US counties, residents of the 12 rural
counties were
 138% more likely to be incarcerated in a local jail
 216% more likely to be detained in a jail
 247% more likely to be admitted to prison
 40% more likely to be incarcerated in a prison
 Gateway2Health Survey
 Sampled 321 adults in 5 of the 12 counties who recently (within 30 days) used opioids or
injected any drug to get high
 66% reported feeling it was somewhat/very true that people were uncomfortable around
them and avoided them because of their drug use
 45% reported fearing rejection from friends due do their drug use
 2/3 reported fearing rejection from family due to their drug use
 27.4% reported that they had spent at least 1 day in jail/prison within the past 6 months
 2015 CDC data from 9676 people who inject drugs in 20 large US metropolitan areas
 36.5% spent 1 or more days in jail/prison in the past year (twice the reporting period of
Gateway2Health survey)
 Qualitative results
 6 Low trust pharmacists
 Dispensing practices aligned with stigma and War on Drugs
 Rejected the medical model of OUD and viewed it as a choice
 Viewed people who use drugs (PWUD) as “thieves” who endangered their tightknit
communities
 Worried that dispensing buprenorphine would attract PWUD to their pharmacies
 Viewed buprenorphine as the next wave of the opioid epidemic
 Rejecting buprenorphine prescriptions was a way to protect their hometowns, stop fueling
the opioid epidemic, and reject criminal enterprises
 Either refused to dispense buprenorphine at all, or refused to treat new patients
 8 High trust pharmacists
 Positive views of buprenorphine patients (“brave”, “commendable”)
 Accepted the medical model of OUD
 Noted possibility of diversion and worried about the impact of PWUD on other patients
 Actively tried to maintain compassion
 Dispensing practices designed to serve as many patients as possible without sparking an
investigation
Other  N/A N/A
Clinical
events
AUTHORS’ CONCLUSIONS
 Multilevel pathways to support dispensing practices that meet the demand for buprenorphine in this rural area
1. Buprenorphine and other MOUDs should be excluded from DEA and wholesaler monitoring protocols designed to reduce diversion of
OA.
2. Professional organizations could hold local meetings of pharmacists and prescribing physicians to restore trust, promote collaboration, and
build non-stigmatizing MOUD norms. Organizations are encouraged to continue filing lawsuits against pharmaceutical companies at
fault.
3. Expand advocacy efforts to end the War on Drugs to rural areas. Advocate to de-escalate highly punitive drug-related enforcement,
prosecutorial, and correctional strategies.
4. Local governmental and non-governmental organizations could implement interventions to reduce stigma towards buprenorphine and
PWUD. For example, the Ohio Opioid project fights drug-related stigma by targeting media, law enforcement and judges, faith
organizations, and PWUD.
STUDY BENEFITS AND LIMITATIONS
 High descriptive validity, as qualitative interviews were transcribed verbatim
 Findings were scrutinized by a practicing pharmacist in Kentucky with knowledge of policies and pharmacy practice. This enhanced interpretive
validity and reduced inter-rater bias.
 Qualitative interview data was integrated with policy, healthcare, and criminal justice research to provide a comprehensive and well-rounded link
between pharmacist attitudes and macrolevel influences. This provides insight on how policy and institutional changes can be applied to reduce stigma
and barriers against adequate MOUD dispensing.
 Qualitative, semi-structured interviews promoted discovery and flexibility. Participants had the opportunity to volunteer information and bring up
concerns that may have otherwise gone unnoticed.
 Decreased generalizability and external validity regarding chain retail pharmacies, as only 1 chain pharmacist was interviewed.
 Small sample size of 14 pharmacists may decrease external validity and generalizability to entire rural population.

GENERALIZABILITY/CRITIQUE/DISCUSSION
How did funding affect the outcome?
The study was supported by two grants from the National Institute on Drug Abuse. The authors did not report any conflicts of interest or affiliations with
pharmaceutical companies that could lead to bias.
Was the design of the study appropriate?
Yes, the qualitative case study employed semi-structured one-on-one interviews with pharmacists to explore their MOUD dispensing practices and beliefs. A
in-person interview method is appropriate, as it is the ideal method for participants to communicate their attitudes and perceptions in detail.
How do the results correlate with the study objective?
The main objective of this study was to explore buprenorphine dispensing practice in 12 Appalachian Kentucky counties and analyze how rural risk
environment shaped these practices. The results showed that the War on Drugs, aggressive and fraudulent OA marketing, DEA and wholesaler monitoring
may reinforce stigma again PWUD and delegitimize buprenorphine as a medical treatment. In contrast, high-trust pharmacist actively opposed buprenorphine
stigma, exhibited compassion for PWUD, and differentiated between buprenorphine and OAs.
How does the study relate to or change clinical practice?
This study provides valuable insight to the macrolevels that contribute to the attitudes and dispensing practices of pharmacists in these 12 rural counties. These
findings inform us of the most prominent issues that pharmacists face when deciding whether to dispense MOUDs. Efforts should focus on eliminating
buprenorphine from DEA and wholesaler monitoring protocols, building trust between pharmacists and physicians, and fighting stigma by educating not only
pharmacists but also the community at large.

How can we reduce stigma moving forward?

School curriculum, non-stigmatizing language in media

Other References: N/A