THE IMPLEMENTATION CONTEXT: BARRIERS AND FACILITATORS TO MEDICATIONS FOR OPIOID USE DISORDERS Mark P. McGovern, Elizabeth Saunders, Tiffany Hunt, Emily Barber-Dubois & Paul McLaughlin

Clinical Trials Network Mid-Atlantic Node Baltimore, Maryland 11 March 2016

APPROACH • Anecdotal experience in Connecticut • An implementation framework for categorizing barriers and facilitators to installing and sustaining • Narrative review: Methadone, buprenorphine and naltrexone IM

HOW TO SUCCESSFULLY OPEN TEN METHADONE CLINICS? • Fear, stigma, ignorance & lack of understanding:

Information about impact on public health (overdose death) & public safety (crime) • Community leaders against:

Community leaders in favor (law enforcement) • Zoning restrictions:

Buy a medical/professional office building

CONSOLIDATED FRAMEWORK FOR IMPLEMENTATION RESEARCH (Damschroder et al, 2009)

1. Intervention characteristics 2. Outer setting (community and systems) 3. Inner setting (organizational factors) 4. Characteristics of the providers

MEDICATIONS FOR OPIOID USE DISORDER TREATMENT • Methadone • Buprenorphine • Naltrexone IM

INTERVENTION CHARACTERISTICS: METHADONE • Methadone maintenance treatment has strict federal requirements, not flexible or adaptable (Hettema et al., 2009, King et al., 2007).

• Beliefs about efficacy differ widely between patients and clinicians: Clinicians unaware of meta-analyses and consistent evidence, patients believe it works and is lifechanging (Trujols et al. 2011, Nurco et al.,1988, Hettema et al., 2009)

• Clinicians beliefs about substituting one addictive drug for another • Lifelong treatment, perpetual dependency

INTERVENTION CHARACTERISTICS: BUPRENORPHINE • Many physicians are skeptical of buprenorphine’s efficacy, though others view it as a positive alternative to methadone (Barry et al, 2009; DeFlavio et al, 2015)

• Multiple formulations (tablet, film), and a sustained release formulation, offers dosing options and some flexibility (Larance et al, 2015; Nasser et al, 2016) • May not be as “addictive” as methadone, but unclear exit strategy (DeFlavio et al, 2015)

INTERVENTION CHARACTERISTICS: NALTREXONE IM • Packaged as kit containing dry compound, liquid diluent, and syringe (Must be refrigerated, warmed, then immediately injected) (Alanis-Hirsch et al, 2016) • Lower retention rates (Timko et al, 2016) • High cost ($1200/dose) (Alanis-Hirsch et al, 2016)

• Is not addictive, may not require lifelong maintenance

OUTER SETTING: METHADONE • Community discrimination: A bad, addictive drug used to control bad people (Goldstein 1992) • Patients feel looked down upon, as if they are receiving “free” drugs from the methadone clinic and are not seen as being “clean.” (Earnshaw et al., 2012). But also believe that treatment eliminates the need for crime to support addictive behaviors and reduces the use of illegal drugs (Mavis et al., 1991) • Many Medicaid programs do not cover the long term cost, although is cost-effective (Barnett et al., 2000, McCarty et al., 1999, French et al., 2008)

• Controversy in peer recovery community (NA World Services, 2007; 2016; White, 2011)

OUTER SETTING: BUPRENORPHINE • Belief that buprenorphine is an effective treatment among community members and opioid users (Daniulaityte et al, 2015; Fox et al, 2014; Shah et al, 2013)

• Belief that buprenorphine is associated with less withdrawal upon cessation, and less stigma due to setting (Bentzley et al, 2015; Grycynski et al, 2013; Schwartz et al, 2008; Yarborough et al, 2016)

• Less regulated than methadone but still restrictions (Arfken et al, 2010; Hutchinson et al, 2014)

• Variation in insurance coverage (Barry et al, 2009; DeFlaviro et al, 2015; Knudsen & Abraham, 2012)

OUTER SETTING: NALTREXONE IM • Because it lacks a synthetic opioid, is viewed as more consistent with abstinence goals (Uebelacker et al 2016) • May solve barriers associated with transportation and time commitment (Uebelacker et al 2016) • May be more acceptable to policymakers and law enforcement because of no diversion risk and belief in eventual exit strategy • Variable insurance coverage reduces adoption (Heinrich & Hill, 2008)

INNER SETTING: METHADONE • MMT providers believe that continued treatment will increase a patients physical and dental health, as patients begin to take better care of themselves and seek out treatment for other conditions. (Kreek et al., 1983) • MMT providers use take home dosing as incentives for negative urine drug screens (Kidorf et al., 1994)

• Non-profit programs are more likely to offer psychiatric services, infectious disease testing, and psychosocial services (Bachhuber et al, 2014)

INNER SETTING: BUPRENORPHINE • Primary care support staff often not trained in addiction treatment (DeFlavio et al, 2015) • Lack of expert support and workflow challenges (DeFlavio et al, 2015; Hutchinson et al, 2014; Molfenter et al, 2015)

• Physicians may face opposition to prescribing buprenorphine from other staff within the organization--administrative staff, nurses, other physicians (Hutchinson et al, 2014)

INNER SETTING: NALTREXONE IM • Physician administering treatment must be in patient’s insurance network; level of care transitions a challenge (Alanis-Hirsch et al, 2016) • Requires culture, staff and workflow shifts, particularly to complete naltrexone induction (Alanis-Hirsch et al, 2016; Ling et al, 2012)

• Abstinence philosophy still at some odds with naltrexone IM (Alanis-Hirsch et al, 2016; Oser & Roman, 2008; Reece et al, 2007)

CHARACTERISTICS OF PROVIDERS: METHADONE • Some treatment providers believe that methadone substitutes one addiction for another and is not a true tool for recovery (Kang et al., 1997; Nurco et al., 1988 ). • Health care providers blame opioid addiction as the primary source for all other medical concerns, and advise patients to taper off methadone before medical treatment (Nyamathi et al., 2007, Earnshaw et al., 2012). • Hospital nursing staff admit to finding it challenging to provide optimal care to methadone patients and avoid judging the patient( Shaw et al., 2016, Natan et al., 2009).

CHARACTERISTICS OF PROVIDERS: BUPRENORPHINE • High levels of mistrust of patients seeking buprenorphine treatment (DeFlavio et al, 2015; Schuman-Olivier et al, 2013)

• Physicians lack confidence in treating opioid use disorders (1/4 of PCP confident) (Barry et al, 2009; DeFlavio et al, 2015; Hutchinson et al, 2014)

• With experience prescribing, physicians are less concerned about induction logistics, access to consultation with addiction experts, and access to mental health services (Netherland et al, 2009)

CHARACTERISTICS OF PROVIDERS: NALTREXONE IM • Belief that patients receiving naltrexone will require more time, be disruptive in a practice setting • Induction viewed as time-consuming process and physicians unfamiliar and insecure with medication • Pharmacies less willing to carry naltrexone due to strict requirements of transport and storage (Alanis-Hirsch et al, 2016)

MAT BY CFIR DIMENSIONS: CONCLUSIONS 1. Intervention characteristics • Balancing access with quality monitoring • Diversion; Hassle with naltrexone IM • Short-term or lifelong 2. Outer setting • Information or litigation • Abstinence vs. medication-assisted • Cost and insurance

MAT BY CFIR DIMENSIONS: CONCLUSIONS 3. Inner setting • Leadership • Workflow 4. Characteristics of the providers • Ways to support self-efficacy • Medication-assisted treatment or treatment-assisted medication? • Definitions of recovery: Who decides?

Mark McGovern Professor Department of Psychiatry Department of Community & Family Medicine The Dartmouth Institute for Health Policy & Clinical Practice Dartmouth Geisel School of Medicine 46 Centerra Parkway, Suite 300 Lebanon, NH 03766 [email protected]