Patient Initiation: Buprenorphine/Naloxone

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1 Patient Initiation: Buprenorphine/Naloxone Kristin Wason, MSN, APRN, CARN Office-Based Addiction Treatment Program Boston Medical Center *Images used for educational purposes only. All copyrights belong to image owners*

2 Outline Referral Screener Intake Provider Visit Patient Education Case Study

3 Outline Referral Screener Intake Provider Visit Patient Education Case Study

4 Buprenorphine/Naloxone: Treatment Referral Requirements DSM-5 diagnosis of opioid use disorder (OUD) Able to meet program requirements Patient must agree with program goals Improve withdrawal and craving of opioid Cessation/improvement in illicit use Restoration of physiological function PCSS-MAT: Treatment Options for Opioid Dependence

5 DSM-5: Opioid Use Disorder (1) Table 1 (1/2): Summarized DSM-5 diagnostic categories and criteria for opioid use disorder Category Impaired Control Criteria Opioids used in larger amounts or for longer than intended Unsuccessful efforts on desire to cut back or control use Excessive amount of time spent obtaining, using, or recovering from opioids Craving to use opioids Social Impairment Failure to fulfill major role obligations at work, school, or home as a result for recurrent opioid use Persistent or recurrent social or interpersonal problems that are exacerbated by opioids or continued use of opioids despite these problems Reduced or given up important social, occupational, or recreational activities because of opioid use Table adapted from: Brezing & Bisaga (2015). Psychiatric Times. DSM V OUD Checklist:

6 DSM-5: Opioid Use Disorder (2) Table 1 (2/2): Summarized DSM-5 diagnostic categories and criteria for opioid use disorder Category Risky Use Criteria Opioid use in physically hazardous situations Continued opioid use despite knowledge of persistent physical or psychological problem that is likely caused by opioid use Pharmacological Criteria Tolerance as demonstrated by increased amounts of opioids needed to achieve desired effect: diminished effect with continued use of the same amount Withdrawal as demonstrated by symptoms of opioid withdrawal syndrome; opioids taken to relieve or avoid withdrawal Table adapted from: Brezing & Bisaga (2015). Psychiatric Times. DSM V OUD Checklist:

7 Referral Appropriateness for Buprenorphine Chronic pain: pain must not require full agonist management Consider opioid tolerance - Will partial agonist be effective? Does not require a higher level of care than specified treatment setting Not actively polysubstance using If so, is willing to detox or address use other substances ASAM (2015). Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use

8 Referral Process Many self-refer PCP or other provider Probation/court system Family, friend Referral: review chart for appropriateness If not appropriate: refer to another level of care If appropriate: proceed to screener

9 Case Study (1) Patient is a 32-year-old male, new to primary care. At his initial PCP visit, he reports using heroin IV daily for the past six months. He also reports history of chronic back pain s/p MVA. PT works in construction. He is currently sleeping on friends couches, but plans to move back into a sober house once he is able to stop using.

10 Case Study (2) PT requests refills for gabapentin 600 mg TID, and clonazepam 1 mg BID. He also requests a referral to the buprenorphine treatment program in which you work. His new PCP refills the gabapentin, but defers the clonazepam at this time. Referrals are placed for buprenorphine/ naloxone treatment and psychiatry. PT is agreeable to plan. Is this patient a potential candidate for treatment with buprenorphine/naloxone in an office-based setting? Any concerns?

11 Case Study Appropriate Referral? Yes He is a potential candidate for bupe/nlx treatment Meets the DSM-5 criteria for OUD He is working full time, suggesting some level of stability Requesting treatment is a good indication of motivation for recovery There are also hints of prior successes in recovery, since he was previously living in a sober house

12 Case Study Any Concerns? Yes - There are still some concerns Request for benzodiazepine Unknown pain level Some stability concerns remain as patient has relatively unstable housing We do not know how much heroin he is using daily

13 Case Study Chart Review: One PCP visit resulted in referral for bupe/nlx treatment 4 ED visits in the past year mostly related to substance use (abscess requiring I&D and antibiotics, 2 overdoses, back pain requesting narcotics) No hospitalizations, no surgeries, no admissions for mental health treatment No safety threats

14 Outline Referral Screener Intake Provider Visit Patient Education Case Study

15 OBAT Screening Occurs in-person or over phone Includes: Demographics Substance use history Medical and mental health history Social history Treatment goals Boston Medical Center s Office Based Addiction Treatment Program Policy and Procedure Manual: Screener Template *Place reference: paste link from EdX Resource

16 Screener: Demographics

17 Screener: Substance Use History

18 Screener: Safety Information

19 Screener: Treatment History

20 Screener: Prior Treatment for Substance Use Disorder Prior treatment utilizing methadone, buprenorphine, injectable naltrexone Location, length of treatment, dose, reason for discontinuing treatment

21 Screener: Criminal History

22 Screener: Mental Health History

23 Screener: Medical History and Pain

24 Screener: Surgical History and Family History

25 Screener: Social Support and Stability

26 Screener Information Summarized and reviewed by clinical team If appropriate: schedule intake and waivered provider appointments If not appropriate, refer to another level of care

27 Case Study Phone Screen Results (1) Patient is screened for buprenorphine treatment The patient is a 32-year-old male who reports the following substance abuse history: Heroin first use age 20, last use yesterday. Reports using 1 gram daily (IV) Oxycodone first use age 18, last use 6 years ago. Reports taking 5-6 x30 mg tabs daily (PO, IN) Cocaine first use age 19, last use 1.5 months ago. Reports using ½ 1 gram 1 2x/week. (IN, IV) Benzo first use age 24, last use 1 week ago. Reports using 1 2 mg clonazepam PO once weekly, when he can t find heroin. Has never been prescribed. States he is willing to go without.

28 Case Study Phone Screen Results (2) Illicit Suboxone first use age 26, last use 2 months ago. Reports using 8 mg tab/film 1 2x weekly Denies alcohol and amphetamine use Has shared needles in past, currently uses the needle exchange program Reports 3 overdoses in lifetime, hospitalized for 1 overdose, naloxone was administered in 2 ODs Longest recovery time is 1 year, occurred summer 2014 summer 2015 when Rx d bupe/nlx Reports 20 detoxes, 2 residentials, and 1 bupe maintenance program = 16 mg/day for 1 yr, did well, d/c due to incarceration

29 Case Study Phone Screen Results (3) Currently on probation x 1 year. Not facing any time. No other legal issues or outstanding cases Mental health history: self-report of anxiety, never engaged in behavioral health services Medical history: significant for + HCV test at detox, chronic pain of 8/10 daily, pain is 2/10 with heroin Currently living on a friend s couch. In past, lived at a sober house, loved it, hopes to return Goals for buprenorphine treatment are stop using, get a good job, and repair relationships I ve damaged

30 Case Study Move forward to Intake? Using the information obtained from the screener and the chart review, would you: Move this patient forward to intake process for buprenorphine/naloxone treatment in an OTP setting? Move this patient forward to intake for buprenorphine treatment in a primary care setting? Refer to methadone maintenance due to high opioid tolerance and pain?

31 Case Study Move forward to Intake? Yes and Yes. Patient would be appropriate to progress to intake for treatment with buprenorphine/naloxone in either an OTP or a primary care/office-based treatment setting No major red flags for safety issues or active severe medical or mental health disease Some minor concerns about Benzo use. However, Benzo use does not appear to be at a high level as he is primarily using clonazepam once weekly to self-treat heroin withdrawal, he has never been prescribed, and is willing to go without benzodiazepines

32 Case Study Refer to Methadone Instead? No, this patient would not need to be referred to methadone maintenance Buprenorphine/naloxone has worked well in the past Patient s tolerance is not so high that bupe/nlx would not cover his dependency Pain score 8/10 without opioids, 2/10 with opioids, this is manageable Minimal polysubstance use

33 Outline Referral Screener Intake Provider Visit Patient Education Case Study

34 Intake: Initial Visit with Treatment Team Substance use history reviewed Education on buprenorphine/naloxone Guidelines and consents reviewed and signed (copies given to patient) Counseling requirement Pharmacy selection Consent for release of information as needed to social services, corrections, outside providers. Boston Medical Center s Office Based Addiction Treatment Program Policy and Procedure Manual: Intake Note Template and Treatment Agreement:

35 istock Intake: Laboratory Testing Urine toxicology screen and/or oral swab toxicology screen CBC, CMP/hepatic panel, HCG, RPR, hepatitis A, B & C serologies, HIV, TB, sexually transmitted infections ** Labs will be ordered based upon current clinical information ASAM (2015), BMC (2016)

36 Outline Referral Screener Intake Provider Visit Patient Education Case Study

37 Provider Visit Physical examination/assessment Review laboratory and toxicology results Check prescription drug monitoring program Confirmation of DSM-5 diagnosis: opioid use disorder Determine appropriateness of treatment with buprenorphine/ naloxone in clinical setting ASAM (2015), BMC (2016)

38 Provider Visit: Clinical Team Coordination Clinical team management under the guidance of the provider Nurse care manager model: nurses follow patient weekly and decrease with stabilization Waivered provider visits at least every three months Communication with provider ongoing: EMR, phone, in-person communication Follow up with PCP based on medical needs, provider preference AHRQ (2016)

39 Case Study Continued (1) Patient progresses to a nurse intake for treatment with buprenorphine: 1. In addition to a urine toxicology screen, what labs would you consider ordering? 2. Would you encourage a consent for release of information? If so, for whom?

40 Case Study Continued (2) Labs to consider ordering: HCV RNA, HCV genotype, hepatic panel. Depending on info gathered at intake and/or provider visit, may consider HIV, HAV and HBV serologies, CBC other labs Yes, would want signed releases for: Probation Consent for release to counseling with licensed clinician or psychiatry once he is connected

41 Outline Referral Screener Intake Provider Visit Patient Education Case Study

42 Patient Education Description Medication Administration Safety and Storage Overdose Prevention

43 Patient Education: Description Buprenorphine/Naloxone - What is it? FDA-approved medication for opioid dependence Tablet, film, buccal formulations Also available as an implant, and soon injectable formulation Scheduled/controlled medication Most states require valid government ID at pharmacy Long half-life SAMHSA (2016)

44 Patient Education: Description Buprenorphine/Naloxone - Formulations All images are used for illustration and educational purposes only. Copyrights belong to the image owners. HMS, course instructors and partner organizations do not endorse any commercial products. Suboxone.com

45 Patient Education: Description Buprenorphine/Naloxone How it Works Binds to opioid receptors to help treat opioid cravings and withdrawal Ceiling effect Blocks effects of opioids when taken as prescribed because the buprenorphine hangs on very tightly to opioid receptors (high affinity) not letting other opioids bind. Long half-life - only needs to be taken once, or twice daily Will result in physical dependence since bupe/nlx is an opioid Free Patient Educational Pamphlet on Buprenorphine

46 Patient Education: Medication Administration Tablets - dissolve under the tongue Film - under tongue or inside of cheek (Suboxone), inside of cheek only (Bunavail) Saliva should pool in front of mouth Do not drink/eat/smoke until after the medication is completely dissolved For tablets: 3 5 minutes or longer to dissolve For film:1 3 minutes to dissolve SAMHSA (2016)

47 Patient Education: Medication Administration Precautions Side-Effects: nausea, headache, sweating, constipation Potential Adverse Reactions: precipitated withdrawal, dependency, intoxication, allergic reactions, orthostatic hypotension, irregular heartbeat, insomnia, blurred vision, dizziness, and sleepiness. Neonatal abstinence syndrome. Adverse Events Specific to Suboxone Film: tongue sores/ulcers SAMHSA (2014) Suboxone.com

48 Patient Education: Medication Administration Interactions CNS Depressants Buprenorphine/naloxone with benzodiazepines, alcohol, or other CNS depressants increases risk: sedation, respiratory depression, and overdose Careful assessment determining appropriateness for treatment Monitor use of CNS depressants prior to treatment and during treatment PCSS-MAT Interactions of Benzodiazepines and Buprenorphine

49 Patient Education: Medication Administration Opioid Dependency Buprenorphine: partial agonist patients will become dependent If patients suddenly stop buprenorphine, withdrawal will occur If not opioid dependent, may become dependent Females of childbearing age neonatal abstinence syndrome risk The longer people are engaged in treatment the better they do Addiction is a chronic disease (like HTN, DM, asthma.)

50 Patient Education: Medication Administration Special Populations Liver Impairment: Monitor labs and physical symptoms Education about signs & symptoms of liver impairment Pregnancy Encourage patient to inform treatment team Reinforce that treatment will continue Most change to mono-tab (buprenorphine) Pain Buprenorphine/naloxone can only be prescribed for OUD, but it can help manage pain Providers can work together to help manage pain safely

51 Patient Education: Safety Storage Proper Storage and Handling Review any program policies on lost/stolen/destroyed medications Never share pills, even with the best of intentions Education regarding avoidance of pediatric exposure Provide the Poison Control Center phone number: This brochure available for free at:

52 Patient Education: Overdose Prevention Recommended for all patients entering treatment for substance use disorders Especially important for patients struggling with ongoing opioid use

53 Patient Education: Overdose Prevention Never use alone Do not lock the door Same dealer Test shot Sterile supplies Have naloxone on hand, know how to use Support system should have naloxone and know what to do Overdose looks like: blue lips and finger tips

54 Patient Education: Overdose Prevention Steps to Reverse an Overdose 1. Assess the scene 2. Assess the person 3. Call Rescue breathing 5. Administer naloxone

55 Patient Education: Overdose Prevention Overdose-lifeline.org Narcan.com Evzio.com All images are used for illustration and educational purposes only. Copyrights belong to the image owners. HMS, course instructors and partner organizations do not endorse any commercial products. Prescribe to Prevent - Prescribing information as well as patient education materials

56 Review of To Do s Prior to Starting Treatment Intake Complete Treatment agreement and consents reviewed and signed Recommended: Counseling in process with trained clinician Toxicology performed and reviewed Blood work complete and reviewed Cleared for treatment by waivered provider Once all of the above occurs, schedule buprenorphine/naloxone induction.

57 Outline Referral Screener Intake Provider Visit Patient Education Case Study

58 Case Study During this patient s intake for treatment with buprenorphine: What teaching points would you want to reinforce?

59 Case Study Teaching Points Review buprenorphine/naloxone pharmacology Emphasize that benzodiazepine and other sedative (gabapentin) use is dangerous when combined with Bupe/Nlx Signs of liver impairment since HCV status being worked up Proper storage of medication, especially since patient s living situation unstable Overdose prevention/naloxone training

60 Unit Resources: PCSS-MAT: Treatment Options for Opioid Dependence - A great website for providers that offers free webinars, modules, podcasts, calendar of live events making available the most effective medication-assisted treatments to serve patients in a variety of settings. This particular webinar discusses the pros and cons of the three primary treatment options for opioid use disorders: methadone, buprenorphine and naltrexone. Also considers issues of psychiatric co-morbidity or chronic pain, and how these conditions can be addressed in the context of treatment for OUD. Bup.Practice - DSM 5 Opioid Use Disorder Checklist - Buppractice is a website that provides 8 hours of qualified training for DATA2000 waivers as required by the DEA to prescribe buprenorphine. Currently MDs are required to complete 8 hours of qualified addiction training. NPs and PAs are required to complete an additional 16 hrs of training, for a total of 24 hrs. Additional 16 hrs can be done online through ASAM of PCSS-MAT.

61 ASAM (2015). Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use SAMHSA (2016) - Medication Assisted Treatment: Buprenorphine SAMHSA - Free Patient Educational Pamphlet on Buprenorphine PCSS-MAT - Current Understanding of the Interaction of Benzodiazepines and Buprenorphine : This module reviews some of the literature on combining these drugs, as well as alternative treatments for the anxious buprenorphine patient. Protecting Others and Protecting Treatment - Safe Storage (Free Brochure) Harm Reduction Coalition - a national advocacy and capacitybuilding organization that promotes the health and dignity of individuals and communities impacted by drug use. Prescribe to Prevent - Prescribing information and patient education materials

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