Rapid Evidence Review Summary Integration of Opioid Agonist Therapy (OAT) in Primary Care Settings
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July 23, 2018 Rapid Evidence Review Summary Integration of Opioid Agonist Therapy (OAT) in Primary Care Settings A. Background: OAT Guidelines in Primary Care Setting In July 2018, we undertook a rapid review of the literature on primary care-based service models for treatment of opioid use disorder, with a focus on increasing or integrating OAT in primary care settings in order to increase the number of providers prescribing suxboxone. Opioid agonist therapy (OAT) is part of the spectrum of care for people with opioid use disorder (OUD). OAT has been shown to be more effective to withdrawal management alone in terms of treatment retention, sustained abstinence from opioid use, and reduced risk of morbidity and mortality1. Buprenorphine/naloxone (Suboxone) is the recommended first-line treatment for OUD in adults, and youth ≥ 12 years with moderate/severe OUD. Methadone is the recommended second-line opioid agonist treatment if induction with buprenorphine/naloxone is contraindicated or not preferred2. OAT guidelines released by the BC Centre on Substance Use3 indicate that regardless of type of treatment administered, opioid agonist treatment should incorporate the following components: provider-led counselling, long-term substance use monitoring (e.g., regular assessment, follow-up and urine drug tests), provision of comprehensive preventive and primary care, and referrals to psychosocial treatment interventions, psychosocial supports, and specialist care, as required. Further, these guidelines emphasize that across the spectrum of care for OUD, evidence based harm reduction practices should be offered (e.g. Take-Home-Naloxone kits, access to supervised injection sites, education on safe injecting practice etc.). While treatment for OUD have historically been delivered outside of primary care, often in speciality facilities staffed by mental health addiction experts, there is growing recognition of the importance of increasing the capacity and access to OAT in primary care settings4. Primary care-based models for OAT have been found to be roughly equivalent in efficacy and outcomes to speciality treatment facilities in certain populations5, with the added advantage of helping to managing co-morbid health outcomes (e.g. chronic diseases)6. Primary care practitioners and care teams are encouraged to take on addiction care as part of their practice, as they are well suited to diagnosing and treating OUD and supporting long- term recovery. 1 British Columbia Centre on Substance Use and B.C. Ministry of Health. (2017). A Guideline for the Clinical Management of Opioid Use Disorder. Available from: http://www.bccsu.ca/care-guidance-publications/ 2 B.C. Ministry of Health & BC Centre on Substance Use. (2017). Opioid Use Disorder-Diagnosis and Management in Primary Care. Retrieved from: https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/bc-guidelines/opioid- use-disorder#induction 3 British Columbia Centre on Substance Use and B.C. Ministry of Health. (2017). A Guideline for the Clinical Management of Opioid Use Disorder. Available from: http://www.bccsu.ca/care-guidance-publications/ 4 Hostetter, M. & Klein, S. In Focus: Expanding Access to Addiction Treatment Through Primary Care. Retrieved from: https://www.commonwealthfund.org/publications/newsletter/2017/sep/focus-expanding-access-addiction-treatment- through-primary-care 5 Haddad, M. S., Zelenev, A., & Altice, F. L. (2015). Buprenorphine Maintenance Treatment Retention Improves Nationally Recommended Preventive Primary Care Screenings when Integrated into Urban Federally Qualified Health Centers. Journal of Urban Health: Bulletin of the New York Academy of Medicine, 92(1), 193–213. 6 Walley, A. Y., Palmisano, J., Sorensen-Alawad, A., Chaisson, C., Raj, A., Samet, J. H., & Drainoni, M. L. (2015). Engagement and substance dependence in a primary care-based addiction treatment program for people infected with HIV and people at high- risk for HIV infection. Journal of substance abuse treatment, 59, 59-66.
B. Context: OUD and OAT in Alberta From 2016 (month) to 2017 (month), 1, 288 people died from apparent accidental opioid poisoning7 in Alberta, notably rates of apparent accidental opioid drug toxicity deaths per 100,000 were three times higher among First Nations people compared to Non-First Nations people8. In Alberta, the rate of unique individuals dispensed methadone indicated for opioid dependence from community pharmacies per 100,000 increased 7% from 2016/2017 (n=4,006) to 2017/2018 (4,355).9 In addition, the rate of unique individuals dispensed buprenorphine/naloxone indicated for opioid dependence from community pharmacies per 100,000 continues to increase, as seen by the 66 per cent increase from 2016/2017 (n = 2,802) to 2017/2018 (n = 4,714)2. Overall, estimates suggest that more than 8,400 Albertans are on OAT for opioid use (2017/18), in addition there has recently been an expansion in public opioid clinics and treatment options which will serve up to 3,500 additional patients each year (triple the number of patients served in these clinics in 2017)10. C. Overarching Model Types Although evidence is lacking with regard to how one model of care performs compared with another, comparative research on these models may not be the most important determinant for informing further diffusion of OAT in primary care settings. Rather, the most effective model of care is likely to depend in part on the specific implementation setting, including unique characteristics of the target patient population (e.g., HIV infection, pregnant, or adolescent), what resources are available locally, expertise available, proximity to an addiction centers, geographic factors and others (Chou et al. 2016). In a systematic review article of primary care models for OAT11, authors reported that coordinated care models (with non-physician team members helping manage patient appointments and lab results) were the among the most common delivery structures studied. This article found that key factors associated with successful programs included integrated clinical teams with support staff who were often advanced practice clinicians (nurses and/or pharmacists) as clinical care managers. However, it should be noted that most studies in this review report patient retention as their primary outcome, further consideration should also be paid to other program outcomes including; opioid use, adherence, safety, treatment satisfaction and patient engagement in care. 7 Alberta Health. (2018). Opioids and Substance of Misuse: Alberta Report, 2018 Q1. Retrieved online: https://open.alberta.ca/dataset/1cfed7da-2690-42e7-97e9-da175d36f3d5/resource/dcb5da36-7511-4cb9-ba11- 1a0f065b4d8c/download/opioids-substances-misuse-report-2018-q1.pdf 8 Alberta Health. (2017). Opiods and Substance of Misuse among First National People in Alberta. Retrieved online: https://open.alberta.ca/dataset/cb00bdd1-5d55-485a-9953-724832f373c3/resource/31c4f309-26d4-46cf-b8b2- 3a990510077c/download/Opioids-Substances-Misuse-Report-FirstNations-2017.pdf 9 Alberta Health. (2018). Opioids and Substance of Misuse: Alberta Report, 2018 Q1. Retrieved online: https://open.alberta.ca/dataset/1cfed7da-2690-42e7-97e9-da175d36f3d5/resource/dcb5da36-7511-4cb9-ba11- 1a0f065b4d8c/download/opioids-substances-misuse-report-2018-q1.pdf 10 Alberta Health. (2018). Alberta’s Response to the Opioid Crisis: Quarterly Report Appendium May 2018. Retrieved online: https://www.alberta.ca/assets/documents/opioid-quarterly-report-addendium.pdf 11 Lagisetty, P., Klasa, K., Bush, C., Heisler, M., Chopra, V., & Bohnert, A. (2017). Primary care models for treating opioid use disorders: What actually works? A systematic review. PloS one, 12(10), e0186315. Page | 2
A variety of review articles and reports 12,13,14 characterize diverse OAT models based on broad overarching features, further details regarding primary care OAT models are presented in Table 1. While models reviewed were implemented in the United States, those models with most relevance to implementation in Alberta were prioritized. 12 Korthuis, P. T., McCarty, D., Weimer, M., Bougatsos, C., Blazina, I., Zakher, B., ... & Chou, R. (2017). Primary care–based models for the treatment of opioid use disorder: a scoping review. Annals of internal medicine, 166(4), 268-278. 13 Lagisetty et al. 2017 14 Chou, R., Korthuis, P. T., Weimer, M., Bougatsos, C., Blazina, I., Zakher, B. & McCarty, D. (2016). Medication-assisted treatment models of care for opioid use disorder in primary care settings. Page | 3
Table 1: OAT Primary Care Models Model Type: Characteristics Considerations Advantages Examples and References* Coordinated Care In a primary care clinic, two Level of training and Utilization of a skilled (Roll et al, 2015)15 Model different types of HCP actively specific-tasks by non- non-physician to offload (Alford et al., 2007)16 communicate to share care physician providers can physician burden. responsibilities (e.g. nurse case vary widely. manager, or pharmacist plus a Some indication that physician). Availability of additional this model allows for psychosocial services is improved team highly variable, which communication and could be more difficult for higher quality of care complex patients. delivery. Allows for other HCP (e.g. nurse) to help coordinate ongoing care. Coordinated Care The nurse care manager Requires additional Utilization of skilled Massachusetts nurse care Model-Nurse performs patient screening, training for nurse non-physician to offload manager model: Manager intake, education, observes and managers. prescribing physician supports induction, follow-up, burden, and an http://www.mass.gov/eohh maintenance, stabilization and emphasis on provider s/gov/departments/dph/sto ongoing medical management training. p-addiction/get- help-types- with the physician and team. of-treatment.html 15 Roll, D., Spottswood, M., & Huang, H. (2015). Using shared medical appointments to increase access to buprenorphine treatment. The Journal of the American Board of Family Medicine, 28(5), 676-677. 16 Alford, D. P., LaBelle, C. T., Richardson, J. M., O’Connell, J. J., Hohl, C. A., Cheng, D. M., & Samet, J. H. (2007). Treating homeless opioid dependent patients with buprenorphine in an office-based setting. Journal of General Internal Medicine, 22(2), 171-176. Page | 4
Model Type: Characteristics Considerations Advantages Examples and References* The prescribing physician (LaBelle et al., 2016)17 confirms the OUD diagnosis and (Alford et al., 2011)18 appropriateness of OAT and co- manages the patient with the nurse care manager. Coordinated Care Model of care for linking Requires strong Helpful in rural settings, ECHO Model: Model-Project primary care clinics in rural connections between allows for mentorship https://echo.unm.edu/nm- Extension for areas with a university health university health systems for OAT prescribing teleecho- Community system, emphasizing nurse and primary care clinics. providers including an clinics/opioid/benefits/ Healthcare practitioner screening and OAT internet based, Outcomes (ECHO) combined with counseling and Strong emphasis on audiovisual network for behavioral therapies educational and outreach provider education. components. Coordinated Care An informal network of rural Relies on provider training Well suited for rural (McConnell et al., 2016)19 Model- Southern primary care clinics that focus and collaboration as well health providers. Oregon Model on OAT delivery. This model as regional health network utilizes regular meeting of support. Grass roots, regional stakeholders and community-based effort 17LaBelle, C. T., Han, S. C., Bergeron, A., & Samet, J. H. (2016). Office-based opioid treatment with buprenorphine (OBOT-B): statewide implementation of the Massachusetts collaborative care model in community health centers. Journal of substance abuse treatment, 60, 6-13. 18 Alford, D. P., LaBelle, C. T., Kretsch, N., Bergeron, A., Winter, M., Botticelli, M., & Samet, J. H. (2011). Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Archives of internal medicine, 171(5), 425-431. 19 McConnell, K. J. (2016). Oregon’s Medicaid coordinated care organizations. Jama, 315(9), 869-870. Page | 5
Model Type: Characteristics Considerations Advantages Examples and References* primary care providers for Depending on setting, which may promote educations training and limited capacity for buy-in from clinicians development of practice psychosocial services and and community to standards around opioid care overcome stigma and prescribing for chronic pain and coordination/integration. resistance to OAT use. OUD treatment. Shared Care Model Speciality services (e.g. hospital, Requires connections with Helpful for patients Rapid Access Addiction rapid access addiction clinic, community primary care without a regular health Clinic at Saint Paul’s public or private OAT clinic) lead providers that offer OAT. care provider. Hospital, Vancouver, BC: the medication induction process and then later “hand http://www.providenceheal off” patients to primary care thcare.org/rapid-access- providers that offer OAT. addiction-clinic-raac (Kahan et al., 2009)20 https://www.pcpcc.org/initi Shared Care Model Experts at “hubs”, (specialized Requires strong -Designed to coordinate ative/vermont-hub-and- - Hub and Spoke drug treatment centers) serve connections between addition treatment with spokes-health- homes most clinically complex patients, “hubs” and “spokes”. medical care and stabilize patients newly starting counselling supported http://www.healthvermont. OAT. After stabilization, some Might not be feasible in by community health gov/adap/documents/HUBS patients are transferred to the areas with significant teams and services. POKEBriefingDo “spokes”, which are primary geographic distance cV122112.pdf care providers who initiate and between “hubs” and -Facilitates knowledge continue prescribing for less “spokes”. sharing and education http://www.leg.state.vt.us/r complex patients. eports/2014ExternalReports 20Kahan, M., Wilson, L., Midmer, D., Ordean, A., & Lim, H. (2009). Short-term outcomes in patients attending a primary care–based addiction shared care program. Canadian Family Physician, 55(11), 1108-1109. Page | 6
Model Type: Characteristics Considerations Advantages Examples and References* opportunities for /299315.pdf primary care providers. http://www.achp.org/wp- content/uploads/Vermont- Health-Homes-for- Opiate- Addiction-September- 2013.pdf Other Models One Stop Shop Based in an existing mental health Requires rapid training of May be useful for (Conrad et al., 2015)21 Model clinic, this model provides willing local providers and rapid deployment integrated care for HIV and required state and in areas with hepatitis C infection, OAT, mental federal resources for specific OUD and health, primary care and needle outbreak response. HIV outbreaks. exchange. Reproducibility of this Developed in response to HIV model in other settings infection in rural Indiana due to has not been assessed. needle sharing. Multi-disciplinary Two physician disciplines working May be costly and not Can promote more (Fiellin et al., 2002)22 Model closely together within the same feasible in all settings. comprehensive clinic (e.g. addiction psychiatry and behavioural health internal medicine) counseling in addition to 21 Conrad C, Bradley HM, Broz D, Buddha S, Chapman EL, Galang RR, et al. Community Outbreak of HIV Infection Linked to Injection Drug Use of Oxymorhone – Indiana 2015. Morb Mortal Wkly Rep. 2015; 64(16):443–4. 22 Fiellin, D. A., Pantalon, M. V., Pakes, J. P., O'Connor, P. G., Chawarski, M., & Schottenfeld, R. S. (2002). Treatment of heroin dependence with buprenorphine in primary care. The American journal of drug and alcohol abuse, 28(2), 231-241. Page | 7
Model Type: Characteristics Considerations Advantages Examples and References* standard primary care counseling. Emergency This model focuses on emergency Requires strong Promising for areas (D’Onofrio et al. 2015)23 Department department (ED) physician connections with primary with high Initiation of OAT identification of OUD and initiation care clinics that offer prevalence of OUD, of OAT followed by instructions for OAT. and overdose. continuation of home induction, stabilization doses and connection Requires ED to be trained Helpful for patients to primary care for ongoing in OAT prescribing. who do not management. regularly access a primary care physician that offers OAT. *includes grey and published literature 23D’onofrio, G., O’connor, P. G., Pantalon, M. V., Chawarski, M. C., Busch, S. H., Owens, P. H. & Fiellin, D. A. (2015). Emergency department–initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial. Jama, 313(16), 1636-1644 Page | 8
D. Key Model Components: Within each model type there are differences in key components which are tailored in order to ensure relevance within local context. Key components for consideration are outlined below: Care coordination: A core component of successful OAT models were those that involved an integration/coordination of patient care in order to manage issues related to OUD, as well as any, psychological, medical and primary care needs.24 Models of care that used a designated non-physician staff member (e.g. nurse) in the integration/coordination role, were found to help reduce the burden on the physicians while increasing practice efficiency and permitting more patients to be effectively and safely treated. Psychosocial Treatment Interventions and Supports: Varying modalities for the delivery of these supports has been reported in primary care models. While deemed important by providers, and supported by best practice guidelines, relatively few studies have evaluated the comparative effectiveness of different psychosocial interventions given as a component of OAT in primary care based settings. In a review of different trials of psychosocial interventions there were no clear differences in outcomes between the different interventions25. This is consistent with outcomes of different types of psychotherapy in general. Various modalities of psychosocial treatment/support reported in various models included; regular brief counselling by a physician, psychologist led behavioural counseling, nurse led behavioural counseling, referral to off-site psychological services, referral to community and social support services, onsite individual and group counselling, onsite licensed clinical social worker with experience in pain and addiction, onsite peer supported counselling, health promotion, individual and family support and others. Educational and outreach: Although the education and outreach component was not as well-defined in some models, this was viewed as critical for reducing stigma associated with OAT, increasing the pool of prescribing physicians, and increasing uptake, particularly in settings in which stigma is still high26. In a survey of physicians, providers felt that this stigma was rooted in a general lack of training and understanding, which emphasized the need for education for physicians, other health care providers and even the community regarding the effectiveness of OAT27,28. Education was also viewed as critical for improving standards and quality of care. A number of approaches to education and outreach were described, including a Web-based learning network and educational resources, internet-based mentoring by more experienced physicians, meetings of community stakeholders, in-person educational sessions with patient and clinician educational sessions, and others. 24 Lagisetty,P., Klasa, K., Bush, C., Heisler, M., Chopra, V., & Bohnert, A. (2017). Primary care models for treating opioid use disorders: What actually works? A systematic review. PloS one, 12(10), e0186315. 25 Chou, R., Korthuis, P. T., Weimer, M., Bougatsos, C., Blazina, I., Zakher, B. & McCarty, D. (2016). Medication-assisted treatment models of care for opioid use disorder in primary care settings. 26 Chou, R., Korthuis, P. T., Weimer, M., Bougatsos, C., Blazina, I., Zakher, B. & McCarty, D. (2016). Medication-assisted treatment models of care for opioid use disorder in primary care settings. 27 Molfenter, T., Sherbeck, C., Zehner, M., Quanbeck, A., McCarty, D., Kim, J. S., & Starr, S. (2015). Implementing buprenorphine in addiction treatment: payer and provider perspectives in Ohio. Substance abuse treatment, prevention, and policy, 10(1), 13. 28 Chou, R., Korthuis, P. T., Weimer, M., Bougatsos, C., Blazina, I., Zakher, B. & McCarty, D. (2016). Medication-assisted treatment models of care for opioid use disorder in primary care settings. Page | 9
A core component of the Hub and Spoke model [as outlined in Table 1] involved outreach to prescribers in the community to increase the number of trained prescriber physicians. Furthermore, the ECHO model of care, that links primary care clinics in rural areas with a university health system, provides mentorship for providers, including an Internet- based, audiovisual network for provider education and provides free prescription training several times per year. ECHO staff also provide patient education 1- to-1 or in group settings. Medication dispensing: This varies widely as dependent on OAT medication, primary care model type, as well as regulatory guidelines. Some models integrate daily-dispended OAT medications in primary care settings for the duration of patient care, however, multiple models have pharmacists supervise dispending of OAT (buprenorphine or methadone)29, 30. As indicated by British Columbia’s diagnosis and management of OUD in primary care guidelines, once a stable dose is achieved, patients can be transferred to receive daily dispensed doses at a community pharmacy or prescribed take-home doses (1-2 week supply), at clinician discretion. Treatment monitoring: Most interventions noted that they used urine drug screening as a tool to monitor adherence to medication and drug misuse. To encourage patient retention, low threshold models do not automatically suspend patients for failing screening for illicit substance31. Further, OUD treatment guidelines indicate that given the chronic nature of OUD, relapse is common, and patients should not be asked to leave treatment if they do relapse32. Induction type: Twenty-nine studies included in the systematic review by Lagisetty et al. 2017 supervised patient induction in primary care, with frequent appointments and supervised medication dosing. Some home inductions have proved successful for select patients and can make treatment more convenient for patients and providers, this model of induction can also increase patient autonomy. E. Barriers to Implementing OAT in Primary Care There exist a number of barriers which can hinder the diffusion of OAT in primary care settings in Alberta. A variety of studies have reported that complex regulatory frameworks can hinder the ability of health care provider to prescribe treatment. Currently in Alberta, physicians are able to prescribe buprenorphine-naloxone (Suboxone) to patients following registration with the Triplicate Prescription Program (TPP). Completion of an online prescribing course is recommended by the CPSA. In order to prescribe methadone, physicians require methadone approval from the College of Physicians and Surgeons, as well as specific education and training33. In addition, Alberta nurse practitioners (NPs) can also now prescribe buprenorphine-naloxone (Suboxone) to patients to treat an addiction to opioids. NPs 29 Lintzeris, N., Ritter, A., Panjari, M., Clark, N., Kutin, J., & Bammer, G. (2004). Implementing buprenorphine treatment in community settings in Australia: experiences from the Buprenorphine Implementation Trial. The American journal on addictions, 13(S1), S29-S41. 30 Gossop, M., Stewart, D., Browne, N., & Marsden, J. (2003). Methadone treatment for opiate dependent patients in general practice and specialist clinic settings: outcomes at 2-year follow-up. Journal of Substance Abuse Treatment, 24(4), 313-321. 31 Bhatraju, E. P., Grossman, E., Tofighi, B., McNeely, J., DiRocco, D., Flannery, M., ... & Lee, J. D. (2017). Public sector low threshold office-based buprenorphine treatment: outcomes at year 7. Addiction science & clinical practice, 12(1), 7. 32 B.C. Ministry of Health & BC Centre on Substance Use. (2017). Opioid Use Disorder-Diagnosis and Management in Primary Care. Retrieved from: https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/bc-guidelines/opioid- use-disorder#induction 33 College of Physicians and Surgeons. (2018). Opioid Agonist Treatment Program. Retrieved online: http://www.cpsa.ca/physician-prescribing-practices/methadone-program/ Page | 10
must be registered to prescribe TPP listed drugs and also complete necessary training. In studies, the better utilization of NPs and pharmacists in patient management has been seen as an enabler in OAT diffusion, however training and regulatory requirements are barriers34. Beyond the need for reductions in regulatory barriers in prescribing practices, persistent stigmatization of people with OUD, including engrained perceptions of addiction as moral failing, and not as chronic health condition, can impede the willingness of primary care providers to integrate OAT into practice35,36. Further, stigmatization of OAT and OUD amongst other patients, law enforcement, policymakers, and community members can also significantly impede the implementation of this treatment option. There also exist barriers to implementation in terms of institutional support, and the provision of adequate staffing support. In a study conducted by Walley et al. (2008), physicians in Massachusetts who were waivered to prescribe buprenorphine were surveyed37. This study found that of the 235 that answered the survey, 66% had prescribed at least once, and 34% had never prescribed buprenorphine. Of the non-prescribers, the following barriers were reported (in descending order or importance); insufficient office support. insufficient nursing support, lack of institutional support, insufficient staff knowledge, low demand for services, and payment issues. Of the physicians who were already prescribing buprenorphine in their office-based practices, the biggest barriers (in descending order of importance), included: were payment issues, insufficient nursing support, insufficient office support, insufficient institutional support, and pharmacy issues. This study emphasizes the importance of sponsored training for physicians, resources and staffing for coordination and integration of care, provision of non-physician staff with expertise in OUD, as well as offloading burden from prescribing physician. 34 Chou, R., Korthuis, P. T., Weimer, M., Bougatsos, C., Blazina, I., Zakher, B. & McCarty, D. (2016). Medication-assisted treatment models of care for opioid use disorder in primary care settings. 35 Van Hout, M. C., Crowley, D., McBride, A., & Delargy, I. (2018). Optimising treatment in opioid dependency in primary care: results from a national key stakeholder and expert focus group in Ireland. BMC family practice, 19(1), 103. 36 Huhn, A. S., & Dunn, K. E. (2017). Why aren't physicians prescribing more buprenorphine?. Journal of substance abuse treatment, 78, 1-7. 37 Walley, A. Y., Alperen, J. K., Cheng, D. M., Botticelli, M., Castro-Donlan, C., Samet, J. H., & Alford, D. P. (2008). Office-based management of opioid dependence with buprenorphine: clinical practices and barriers. Journal of general internal medicine, 23(9), 1393-1398. Page | 11
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