BUPRENORPHINE 2.0: CASE STUDIES AND PRACTICAL

APPLICATIONSSUBHADEEP (SHUBH) BARMAN MD, FASAM, FAPA

MEDICAL DIRECTOR, ADDICTION MEDICINE, PROHEALTH CARE

SECRETARY, WISCON SOCIETY OF ADDICTION MEDICINE

DISCLOSURES

• No financial conflicts of interest

• There may be discussion of off label uses of medications

OBJECTIVES

• Learn some basic principles of office based treatment of opioid use disorder with buprenorphine

• Learn about examples of work flow for induction and follow up visits

• Learn some principles of Drug Testing

• Case discussion to illustrate practical applications

HOW LONG HAVE YOU HAD YOUR WAIVER?

• 0 – 5 YEARS? – RELATIVELY NEW TO THIS BUSINESS

• 5-10 YEARS ? – HAVE BEEN DOING IT FOR SOME TIME

• 10-15 YEARS?- HAVE BEEN DOING IT FOR A WHILE

HOW LONG HAVE I BEEN DOING THIS ?

• Since 2011 – got my waiver in 2010 while in my residency

• Initially in Maine – 5 years – office based collaborative practice with RNs/ also saw patients in Integrated Opioid Treatment Program (Methadone clinic)

• In Wisconsin for the past 2 years – office based practice – also see patients in Partial hospital program (PHP) – inpatient consults in medical and psychiatric units

BASIC PRINCIPLES OF OFFICE BASED OPIOID TREATMENT • Practice setting – Office based? Partial Hospital? Primary/Specialty Care?

• Who else do you have on staff? Nurses/Medical Assistants/ Substance use disorder therapists?

• Urine or Saliva drug testing – who will be doing them? Which lab are you going to use to confirm your tests – what kind of point of care cups will you use – how frequently will you be testing?

• Who will be helping out with Prior authorizations? Formulations for insurances e.g. UHC prefers Zubsolv – Medicaid can use Suboxone/Zubsolv

CURRENT OFFICE WORK FLOW : Induction

• Office /Partial Hospital – Induction Visits

• For Patient actively using opioids – explain the risk associated with precipitated opioid withdrawal (Most patients seem to know what that is!) – review Treatment agreement before you send prescription

• Plan for induction earlier in the week (Mon/Tue) so that you can see them again for follow up later in the week (Thu/Fri)

• Prescribe first day dose – usually 8 mg of Suboxone/5.7 mg of Zubsolv- ask patient to pick it up from pharmacy – be proactive with Prior authorization

CURRENT OFFICE WORK FLOW : Induction

• Try and see patient earlier in the morning- around 8 am/9 am – let them know that you will see them twice that morning – be free till about noon – ask to bring a book etc

• Get a sample for Urine drug screen – to rule out any unexpected results (Rare to postpone induction)

• Check COWS – Clinical Opiate Withdrawal Scale (most widely used)

• Patients need to be experiencing opioid withdrawal symptoms – score at least 5 on COWS

CURRENT OFFICE WORK FLOW : Induction

• Administer first dose of 4 mg film Suboxone/ 2.9 mg tab of Zubsolv

• Ask patient to come back in approximately 2 hrs

• Check COWS again – usually there is a significant decrease – patient feels better

• Make decision about 2nd dose either then or later in the day if patient experiencing withdrawal symptoms/significant craving

CURRENT OFFICE WORK FLOW : HOME INDUCTION • Office /Partial Hospital

• For Patient NOT actively using opioids –Consider HOME INDUCTION if you/patient have some experience – review Treatment agreement before you send prescription – make sure Urine was negative for Opioids

• Give patient detailed instructions how to start Buprenorphine (unobserved)

• Prescribe 1-7 days – be proactive with Prior authorization – Try and see patient same week

CURRENT OFFICE WORK FLOW : Follow Up

• First follow up visit – try and see patient later in the same week

• No need for patient to take supervised doses in 2nd visit – only prescribe from appointment to appointment – You will see dramatic improvement in attendance rate!

• Adjust doses according to patient presentation – if ongoing opioid withdrawal symptoms then more likely to continue increasing dose.

• May need dose increase to 12-16 mg in the first week (Max. 24 mg/day)

Typical Buprenorphine Visit Follow Up

• Patient checked in – Check ePDMP – make sure nothing unexpected• MA obtains Urine drug test – sends me results through instant messaging

system while I am with patient • Get Interval History from last visit – review of any substance use since last

visit, changes in psychosocial situation including work, relationship, legal, attendance at community support meetings, medication response/side effects

• Check Empty Buprenorphine packaging • Review of systems – behavioral and physical health • Mental Status Exam/Physical exam • Any Changes in Treatment Plan- change in doses/change in psychosocial

treatment?

Progress Note- sample format

• Last seen

• Interval history

• Document empty buprenorphine packaging

• Review of systems

• Current medication list

• Medical history

• Examination – mental status/physical

• Assessment (Diagnosis) including Drug and Lab test information

• Plan

How Often Should I Follow Up Patient

• 1st 4-6 weeks – try and see patient on a weekly basis

• After that I usually extend visits to every 2 weeks for 3-4 visits

• Then I start seeing patients every 4 weeks (goal for each patient)

• Rarely I have seen patients every 8 weeks after a patient has been stable for at least 2 years – WOULD NOT RECOMMEND EXTENDING TO LESS THAN THAT

• Important of seeing patients every 4 weeks (not 30 days) – in that way I do not have buprenorphine due on weekends

• I usually prescribe 7-14-21 or 28 day supply – appointment to appointment – my show rate is around 92-95%

Principles of Drug Testing

Key principle: Providers should understand that drug tests are designed to measure whether a particular substance has been used within a particular window of time.

Drug test results cannot…

• Prove that substance use has not occurred• Identify every possible substance that may have been used• Rule out an SUD• Diagnose an SUD

Other principles of drug testing:

• Combined with a patient's self-report• Used as a therapeutic tool• Performed at intake to assist in a patient's initial assessment and treatment

planning• Used to monitor recent substance use in all addiction treatment settings• Used to monitor the effectiveness of a patient’s treatment plan

PROCESS OF DRUG TESTING

Presumptive and Definitive Tests

Technology• Immunoassay• Various chromatography and mass spectrometry techniques

Capability• Sensitivity• Specificity

Common model• Screen with immunoassays• Confirm with a more specific test to rule out false-positives

Presumptive Tests

• Should be routine• Used when it is a priority to have more immediate

(although less accurate results)• Not always necessary to use a confirmatory test if

patient confirms that he or she used a substance detected by a presumptive test

Definitive Tests

• Whenever a provider wants to: • Detect specific substances not targeted by presumptive tests • Quantify levels of the substance present• Refine the accuracy of the results

• When the results inform clinical decisions with major clinical or non-clinical implications for the patient

• If a patient disputes the findings of a presumptive test• Consider if presumptive test results are negative, but the patient

exhibits signs of relapse

Attach a meaningful therapeutic response to test results, both positive and negative, and deliver it to patients as quickly as possible.

Positive presumptive test results• Speak with the patient• Review all medications, herbal products, foods, and other

potential causes of positive results • Seek definitive testing if the patient denies substance use

Positive definitive test result• Consider intensifying treatment or adding adjunctive treatments

Suspected inaccurate results• Consider repeating the test, changing the test method,

changing/adding to the test panel, adding specimen validity testing, or using a different matrix

Frequency of testing should be dictated by patient acuity and level of care.

Frequency• Initial phase of treatment: at least weekly• Stable in treatment: at least monthly (with consideration for less

frequent testing)

Randomness• When possible, testing should occur on a random schedule• A random-interval schedule is preferable to a fixed-interval

schedule

BIOLOGICAL MATRICES

Using Various Matrices

• Urine, blood, exhaled breath, oral fluid (saliva), sweat and hair• “Smarter” drug testing can mean using more than one matrix• Important to understand the advantages and disadvantages of each

matrix

Matrix Considerations

• Window of detection• Time to obtain results (availability of POCT)• Ease of collection (need for trained personnel, collection

facilities)• Invasiveness/unpleasantness of collection• Availability of the sample (e.g., renal health, shy bladder,

baldness, dry mouth)• Susceptibility of the sample to tampering

Information about matrices’ windows of detection and utility in addiction treatment

Additional considerations for each matrix

Urine• Most well-established and well-supported matrix• Most prone to tampering

Oral Fluid

• Appropriate for presumptive testing, but does not have nearly such an extensive body of research behind it as urine

• Shorter window of detection than urine (12-48 hours for most substances)

• Advantages include:• Unobtrusively collected • Does not require the same staff and bathroom facility

resources• So far, does not suffer from the same sample tampering

problems that urine has

CLINICAL CASES

CASE 1:

• Amanda – 37F woman with severe OUD – history of endocarditis –seen since a little more than a year ago – she had valve replacement surgery – attended PHP then IOP – did well on BUP 16 mg/day – also has social anxiety, MDD

• Earlier this year she started showing up with inconsistent results in urine drug tests – husband also in treatment (elsewhere- not very serious with recovery)

• Show example of drug test from Feb 2018

Tampering of Urine Specimen

• Presence of very HIGH Buprenorphine levels/Naloxone levels

• Absence of Norbuprenorphine levels – not physiologically possible

• Patient admitted to putting film in urine sample

• Did not discharge patient

• Referred to PHP and then IOP – doing well now – with recent dose increase to 20 mg/day

CASE 2:

• Mark – 29M man who started treatment since Feb 2018- severe OUD and cocaine use disorder- also co occurring mood instability – likely Bipolar disorder

• On Buprenorphine – 16 mg for a few months – continued cravings – then dose increased to 20 mg/day with some benefit for a few months –recurring use of cocaine

• Completed IOP – but then was resistant to ongoing psychosocial treatments – family member worked in the hospital which presented with some unique challenges

• Show example of drug test from May 2018 – Urine sample did not register in temperature scale – hence Oral fluid sample was done

Urine sample – Page 1

Urine sample – Page 2

Oral Fluid sample – same patient – page 1

Oral Fluid sample – Page 2

What do you think is going on with samples?

Use of Two Different Test Matrices when invalid specimen • Once we got the results of both tests

• Patient admitted to bringing his own sample of urine from earlier in the day after which he admitted to using heroin and cocaine

• Oral Fluid was able to confirm his use of substances

• Patient maintained stability for 2 more months – then relapsed but was resistant to higher levels of care

• Patient recommended to attend Opioid Treatment Program – has not followed through

CASE 3:

A patient and his significant other were recently started on buprenorphine but continue to struggle with cocaine and cannabis use. Neither is using opioids but cocaine and THC persistently positive. The 3rdweek after starting buprenorphine they call in panic stating, “our prescriptions were stolen…”It is a Friday afternoon.

What do you do?

A.) Call in clonidine and hydroxyzine –can’t refill the Rx early.

B.) Send in emergency Rx same dose, “you’ll have to pay out of pocket if the pharmacy lets you…”

C.) Send in a different dose or formulation so insurance may cover it.

D.) No Rx unless they file a police report.

E.) No Rx but head to the ED if withdrawal symptoms.

F.) None of the above –would do something else.

Stolen Medications

• I typically do not refill lost/stolen medications

• If you chose to not do such – please document your rationale

• Recommend police report

• Can understand that NOT all situations are the same

CASE 4: Cannabis use in patients with OUD

• Casey 35M – severe OUD – inducted on Buprenorphine in October 2016- history of methadone which was not helpful – did very well in IOP- stabilized very quickly

• Also has co occurring chronic PTSD, MDD from childhood abuse – on Quetiapine, Clonidine, Gabapentin, Venlafaxine

• Engaged in individual psychotherapy – initially engaged well but in the next 6 months started to deteriorate – started using cannabis daily about a year ago – opioid use stable

CASE 4: continued

• Tried to engage patient – with motivational approach

• Did not think discharging from practice was warranted

• However was concerned due to clinical deterioration since daily use of cannabis –not functioning well

• Referred to IOP for managing cannabis use – attended but superficial adherence

• Significant psychosocial stressors – conflicts with wife – who attends OTP – also uses cannabis daily

WHAT WOULD YOU DO?

• Continue efforts to engage patient?

• Make changes in medication regimen?

• Discharge patient ?

• Something else?

What Happened to patient

• He continued to deteriorate clinically – wanted to be taken off every medication despite risks

• Made efforts for him to attend PHP to address co occurring substance use and mental health

• He did not wish to attend

• Then started to miss appointments very frequently – got OWI

• Discharged patient – after multiple attempts to engage – in July 2018

CASE 5: Cocaine/Stimulant use in patients with OUD • Karen 31F – with severe OUD/severe stimulant and cocaine use – also GAD,

Depression- which was treated with Zoloft, Clonidine and Abilify

• Admitted to PHP in June 2018 – inducted on Buprenorphine – stabilized on 20 mg/day – she had failed multiple treatments in the past – both inpatient and outpatient

• Opioid use – stabilized soon but stimulant use didn’t

• She attended IOP for 2 weeks with no change in cocaine/stimulant use

WHAT WOULD YOU DO?

• Continue efforts to engage patient in IOP?

• Make changes in medication regimen?

• Discharge patient ?

• Refer to PHP again?

• Something else?

What Happened to patient

• She was referred back to PHP

• Going back to PHP a second time helped- she was more serious about complete recovery

• Her stimulant and cocaine use stopped

• She would use with boyfriend and also another friend – she started to find new support systems

• Successfully completed PHP and then IOP

• Only one brief lapse in the past 2 months

• Doing well now – last seen 10 days ago

CASE 6:

• Chad 48M– with severe OUD/alcohol use – also GAD, chronic pain – was self referred – using prescription opioids

• Started on Buprenorphine- April 2018 – stabilized on 8 mg/day – discussion about alcohol use

• Attended IOP did well – attended 12 step meetings/ individual therapy

• After a few months Buprenorphine was increased to 12 mg/day with benefit

• Urine sample – July 2018

Urine sample – Page 1

Urine sample – Page 2

What Do you think is going on?

Alcohol Use in Patients with OUD

• Patient admitted to brief relapse on alcohol use in the context of work related stressors

• Reiterated risks associated with use of alcohol while on Buprenorphine

• Use of Ethyl Glucuronide and Ethyl sulfate – very helpful- can detect use up to 80 hrs

• Breathalyzer – only detects the past few hours

What was the outcome?

• Patient started on Gabapentin for management of alcohol use and GAD

• He has been abstinent for the past 2 months

• Doing well – remains engaged with individual therapy/12 step groups last seen earlier this week

• His son 21 M – was started on Buprenorphine about 10 days ago

Useful Resources:

• https://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf?sfvrsn=24

• https://www.asam.org/quality-practice/guidelines-and-consensus-documents/drug-testing

• http://pcssnow.org/

• http://eguideline.guidelinecentral.com/i/706017-asam-opioid-patient-piece/0

• https://store.samhsa.gov/shin/content/SMA16-4993/SMA16-4993.pdf

• https://store.samhsa.gov/product/TIP-63-Medications-for-Opioid-Use-Disorder-Full-Document-Including-Executive-Summary-and-Parts-1-5-/SMA18-5063FULLDOC

THANK YOU!

• Questions/ Comments

• subhadeepbarman@yahoo.com

• Subhadeep.Barman@phci.org