Office-based Treatment of Opioid Dependence with Buprenorphine: Follow-up Q & A Webinar with Case Discussions

Office-based Treatment of Opioid Dependence with Buprenorphine: Follow-up Q & A Webinar with Case Discussions David A. Fiellin, MD Professor of Medicine, Investigative Medicine and Public Health Yale University School of Medicine 1

Dr. Fiellin s Disclosures Dr. Fiellin has received honoraria from Pinney Associates for serving on external advisory boards monitoring the diversion and abuse of buprenorphine. The contents of this activity may include discussion of off label or investigative drug uses. The faculty is aware that is their responsibility to disclose this information. 2

Planning Committee, Disclosures AAAP aims to provide educational information that is balanced, independent, objective and free of bias and based on evidence. In order to resolve any identified Conflicts of Interest, disclosure information from all planners, faculty and anyone in the position to control content is provided during the planning process to ensure resolution of any identified conflicts. This disclosure information is listed below: The following developers and planning committee members have reported that they have no commercial relationships relevant to the content of this webinar to disclose: AAAP CME/CPD Committee Members Dean Krahn, MD, Kevin Sevarino, MD, PhD, Tim Fong, MD, Tom Kosten, MD, Joji Suzuki, MD and AAAP Staff Kathryn Cates-Wessel, Miriam Giles, Sharon Joubert Frezza, and Justina Andonian. All faculty have been advised that any recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported, or used in the presentation must conform to the generally accepted standards of experimental design, data collection, and analysis. Speakers must inform the learners if their presentation will include discussion of unlabeled/investigational use of commercial products. 3

Target Audience The overarching goal of PCSS-O is to offer evidence-based trainings on the safe and effective prescribing of opioid medications in the treatment of pain and/or opioid addiction. Our focus is to reach providers and/or providers-intraining from diverse healthcare professions including physicians, nurses, dentists, physician assistants, pharmacists, and program administrators. 4

Educational Objectives Describe the legislation relevant to officebased treatment with buprenorphine. Describe how to establish the diagnosis of opioid dependence. Describe the effectiveness of office-based treatment of opioid dependence. 5

Outline Drug Addiction Treatment Act of 2000 and Buprenorphine Establishing the Diagnosis Opioid Dependence Treatments for Opioid Dependence Components of Office-based Treatment of Opioid Dependence with Buprenorphine Effectiveness of Office-based Treatment of Opioid Dependence with Buprenorphine 6

Federal Efforts to Increase Access Fiellin and O Connor, NEJM 2002 Congress (2000) Drug Addiction Treatment Act o Allows qualifying physicians to use approved schedule III-V medications o Qualifying physician (defined later) FDA and DEA (2002) Approve buprenorphine and buprenorphine/naloxone for treatment of opioid dependence, schedule III 8

Drug Addiction Treatment Act of 2000 Practitioner requirements: Qualifying physician Has capacity to refer patients for appropriate counseling and ancillary services No more than 30 patients (in first year). Can notify Center for Substance Abuse Treatment after one year and increase to 100 patients 9

Buprenorphine Partial agonist at mu opioid receptor Lower abuse and diversion potential relative to full mu opioid agonists, especially when combined with naloxone Sublingual tablets (buprenorphine alone and buprenorphine/naloxone) or film (buprenorphine/naloxone) Prescribed by physicians and available at pharmacy 10

Opioid Dependence (DSM-IV, 3 or more within one year) Physical Dependence Tolerance Withdrawal Loss of control (addiction) Larger amounts/longer period than intended Inability to/persistent desire to cut down or control Increased amount of time spent in activities necessary to obtain opioids Social, occupational and recreational activities given up or reduced Opioid use is continued despite adverse consequences 12

Pathophysiology of Opioid Dependence Opioid dependence is a chronic, relapsing medical condition with biologic and behavioral components Neurobiological changes accompany the transition from use to dependence Neurobiological changes explain relapse even after detoxification Neurobiological changes form the rationale for the pharmacologic treatments 13

Treatment Options for Opioid High rates of relapse with: Dependence Pharmacologic withdrawal - detoxification o Followed by medication-free treatments Opioid antagonist treatment o Naltrexone Most effective treatments are opioid agonist treatments Methadone Buprenorphine 15

Components of Office-based Treatment of Opioid Dependence with Buprenorphine Physician with appropriate DEA registration Onsite or off-site counseling services Urine toxicology monitoring Pharmacy Method to screen for appropriate patients See http://pcssmat.org/resources/essentialmaterials/#1382013035-2-36 for examples of materials below: o Treatment agreements o Procedures for release of information o Patient log to avoid exceeding patient limit 17

Selecting Patients Who Are Appropriate for the Office Determine appropriateness of patient for office based buprenorphine treatment by considering the needs of the patient and the available resources For patients whose needs exceed that of the office, referral to alternative offices or specialty treatment programs is appropriate and prudent o http://findtreatment.samhsa.gov/treatmentlocator/faces/q uicksearch.jspx o http://buprenorphine.samhsa.gov/bwns_locator/ 18

Effectiveness of Office-based Treatment of Opioid Dependence with Buprenorphine Treatment practices Mental health and substance use among those seeking treatment Outcomes o Retention and Drug use o HIV risk behaviors o Patient satisfaction o Provider satisfaction and challenges 20

Treatment Outcomes 21 Alford, Arch Int Med, 2011

Physician s Perception of Challenges Decrease with Experience 1 = doesn't affect at all 5 = strongly affects 22 Netherland, JSAT, 2008

Physician Clinical Support for Office-based Medication Assisted Treatment PCSS-MAT http://pcssmat.org o Offers waiver trainings at no charge Network: o National Experts o Mentoring physicians Services: o Telephone, email support, site visits Web-based content: o Treatment guidances o Didactics o Clinical Resources Egan, JGIM, 2010 23

Summary Opioid dependence due to prescription opioids and heroin is prevalent and increasing The neurobiological changes that occur in opioid dependence respond to medication and counseling Office-based treatment with buprenorphine is a viable option under DATA 2000 Matching patients to office-resources is important With office-based treatment: o o o o Drug use decreases for many Retention is modest Patient satisfaction is high Provider satisfaction is high and challenges decrease with time Support systems such as PCSS-MAT can help expand office-based treatment with buprenorphine 24

Follow-up Patient compliance Insurance or reimbursement costs Consensus/compliance from other departments or colleagues Administrative support not available Insufficient time for implementation 25

Unanswered Questions 1. What do you recommend for patients who referred to me from other docs and are on large amounts of buprenorphine say 4-8mgs films a day? 2. How do we decide the correct maintenance dose for a patient? Medicaid here mandates maintenance dose of <= 16 mg per day after 6 months. 3. Transfer from office based buprenorphine to an OTP 4. More information about non-supervised induction protocol 5. Please explain the method of counting the number of patients e.g. 100 patients monthly or biweekly? 26

Case- Candidate for Rx? Mrs. Ash is a 59 year old female with osteoporosis, depression, nicotine dependence and of low back pain secondary to vertebral compression fractures. She is referred to you by her primary care physician, at the request of her daughter, who says her mother is addicted to narcotics. Mrs. A reports that she wakes with LBP that gradually improves during the day if she takes her sustained release MSO4. Once or twice a day she takes a hydrocodone/acetaminophen if she is going to go out shopping or walking with her friend, daughter and granddaughter. Mrs. Ash comes to her primary care visits every 3 months, participates with physical and aquatherapy twice a week, and has been adherent to her CaCO3, pamidronate, fluoxetine, and MSO4 prescriptions. Two years ago she received 20 mg of MSO4 bid, now she receives 40 mg of MSO4 bid and prn hydrocodone/acetaminphen. Is this patient opioid dependent? Should she receive methadone or buprenorphine? 27

Case Duration of Rx? 39-year old graphic artist who has been in treatment and doing well on 16 mg per day of buprenorphine for the last 12 months. He married 6 months ago, and he and his wife are expecting a baby in 5 months. He tells you that he wants to be off maintenance treatment when his child is born. His wife supports his decision, but does not think it is necessary. She says she does not want to risk his using drugs again. They both say that getting treatment (buprenorphine and counseling) without disrupting his job made all the difference. He feels like he now has his life back. He made a successful entry into treatment and had been stable for 6 months when urine drug screens were positive for heroin and cocaine. He said that he used heroin when school buddies came into town for a conference, and then he continued to use for two weeks. His wife didn t know about his relapse. You changed his appointments for urine testing to weekly and increased his counseling appointments to twice weekly for 3 months. After that period (3 months), there were no positive urine drug screens. His wife, his counselor and you have seen treatment stability since then. 28

References Buprenorphine maintenance treatment in a primary care setting: outcomes at 1 year. Soeffing JM, Martin LD, Fingerhood MI, Jasinski DR, Rastegar DA. J Subst Abuse Treat. 2009 Dec;37(4):426-30. doi: 10.1016/j.jsat.2009.05.003. Epub 2009 Jun 23. PMID: 19553061 Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. J Subst Abuse Treat. 2008 Jul;35(1):87-92. Epub 2007 Oct 15. PMID: 17933486 Buprenorphine retention in primary care. Stein MD, Cioe P, Friedmann PD. J Gen Intern Med. 2005 Nov;20(11):1038-41. PMID: 16307630 Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction A Treatment Improvement Protocol (TIP) #40 http://buprenorphine.samhsa.gov/bup_guidelines.pdf Clinical practice. Office-based treatment of opioid-dependent patients. Fiellin DA, O'Connor PG. N Engl J Med. 2002 Sep 12;347(11):817-23. PMID: 12226153 Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi:10.1001/archinternmed.2010.541. PMID: 21403039 Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. Fiellin DA, Pantalon MV, Chawarski MC, Moore BA, Sullivan LE, O'Connor PG, Schottenfeld RS. N Engl J Med. 2006 Jul 27;355(4):365-74. PMID: 16870915 29

References Drug Addiction Treatment Act of 2000. http://buprenorphine.samhsa.gov/fulllaw.html Factors affecting willingness to provide buprenorphine treatment. Netherland J, Botsko M, Egan JE, Saxon AJ, Cunningham CO, Finkelstein R, Gourevitch MN, Renner JA, Sohler N, Sullivan LE, Weiss L, Fiellin DA; BHIVES Collaborative. J Subst Abuse Treat. 2009 Apr;36(3):244-51. doi: 10.1016/j.jsat.2008.06.006. Epub 2008 Aug 20. PMID: 18715741 Home buprenorphine/naloxone induction in primary care. Lee JD, Grossman E, DiRocco D, Gourevitch MN. J Gen Intern Med. 2009 Feb;24(2):226-32. doi: 10.1007/s11606-008-0866-8. Epub 2008 Dec 17. PMID: 19089508 Integrating buprenorphine treatment into office-based practice: a qualitative study. Barry DT, Irwin KS, Jones ES, Becker WC, Tetrault JM, Sullivan LE, Hansen H, O'Connor PG, Schottenfeld RS, Fiellin DA. J Gen Intern Med. 2009 Feb;24(2):218-25. doi: 10.1007/s11606-008-0881-9. Epub 2008 Dec 17. PMID: 19089500 Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. Fiellin DA, Moore BA, Sullivan LE, Becker WC, Pantalon MV, Chawarski MC, Barry DT, O'Connor PG, Schottenfeld RS. Am J Addict. 2008 Mar-Apr;17(2):116-20. doi: 10.1080/10550490701860971. PMID: 18393054 Narrative review: buprenorphine for opioid-dependent patients in office practice. Sullivan LE, Fiellin DA. Ann Intern Med. 2008 May 6;148(9):662-70. PMID: 18458279 Office-based management of opioid dependence with buprenorphine: clinical practices and barriers. Walley AY, Alperen JK, Cheng DM, Botticelli M, Castro-Donlan C, Samet JH, Alford DP. J Gen Intern Med. 2008 Sep;23(9):1393-8. doi: 10.1007/s11606-008-0686- x. PMID: 18592319 30

References Patient satisfaction with primary care office-based buprenorphine/naloxone treatment. Barry DT, Moore BA, Pantalon MV, Chawarski MC, Sullivan LE, O'Connor PG, Schottenfeld RS, Fiellin DA. J Gen Intern Med. 2007 Feb;22(2):242-5. PMID: 17356993 Prevalence of mood and substance use disorders among patients seeking primary care office-based buprenorphine/naloxone treatment. Savant JD, Barry DT, Cutter CJ, Joy MT, Dinh A, Schottenfeld RS, Fiellin DA. Drug Alcohol Depend. 2013 Jan 1;127(1-3):243-7. doi: 10.1016/j.drugalcdep.2012.06.020. Epub 2012 Jul 6. PMID: 22771144 The association between cocaine use and treatment outcomes in patients receiving office-based buprenorphine/naloxone for the treatment of opioid dependence. Sullivan LE, Moore BA, O'Connor PG, Barry DT, Chawarski MC, Schottenfeld RS, Fiellin DA. Am J Addict. 2010 Jan-Feb;19(1):53-8. doi: 10.1111/j.1521-0391.2009.00003.x. PMID: 20132122 The Physician Clinical Support System-Buprenorphine (PCSS-B): a novel project to expand/improve buprenorphine treatment. Egan JE, Casadonte P, Gartenmann T, Martin J, McCance-Katz EF, Netherland J, Renner JA, Weiss L, Saxon AJ, Fiellin DA. J Gen Intern Med. 2010 Sep;25(9):936-41. doi: 10.1007/s11606-010-1377-y. Epub 2010 May 11. PMID: 20458550 31

PCSS-O Colleague Support Program and Listserv PCSS-O Colleague Support Program is designed to offer general information to health professionals seeking guidance in their clinical practice in prescribing opioid medications. PCSS-O Mentors comprise a national network of trained providers with expertise in addiction medicine/psychiatry and pain management. Our mentoring approach allows every mentor/mentee relationship to be unique and catered to the specific needs of both parties. The mentoring program is available at no cost to providers. For more information on requesting or becoming a mentor visit: www.pcss-o.org/colleague-support Listserv: A resource that provides an Expert of the Month who will answer questions about educational content that has been presented through PCSS-O project. To join email: pcss-o@aaap.org. 32

PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: American Dental Association (ADA), American Medical Association (AMA), American Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American Society for Pain Management Nursing (ASPMN),and International Nurses Society on Addictions (IntNSA). For more information visit: www.pcss-o.org For questions email: pcss-o@aaap.org Twitter: @PCSSProjects Funding for this initiative was made possible (in part) by Providers Clinical Support System for Opioid Therapies (grant no. 5H79TI023439) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the 33 official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.