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Buprenorphine Guide for Nurses

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					                                                            8/24/2011




        Buprenorphine:
       A Guide for Nurses
           Colleen LaBelle, RN, ACRN, CARN
               LTJG Sara Azimi-Bolourian,
                    MSN,MHA,MBA
             ASPMN September 9th, 2011




                   Background
   The Food and Drug Administration (FDA) approved
    buprenorphine monotherapy product, Subutex®, and
    a buprenorphine/naloxone combination product,
    Suboxone®, for use in office-based settings (October
    2002)
   Recent studies attribute inadequate staff education
    and training to the inconsistency between science and
    practice. Nurses in these settings have reported
    attending the fewest ongoing clinical trainings in
    substance abuse (Wechsberg & Kasten, 2007).




              Background cont’
   Under the Drug Addiction Treatment Act of
    2000 (DATA 2000), Advanced Practice
    Nurses and Nurse Practitioners may not
    prescribe or dispense buprenorphine products
    for the treatment of addiction even in States
    that allow them to prescribe scheduled
    medications under certain controls,
    supervisions and other restrictions.




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                Background Cont’
   Nurses working in Opioid Treatment programs
    (OTPs) have essential roles in the
    assessment/screening, treatment monitoring and
    counseling of patients receiving buprenorphine for
    the treatment of addiction.
   Challenges to implementing treatment with a new
    population of patients addicted to opioids and other
    drugs, as well as medication diversion and patient
    confidentiality issues, require nurses to improve their
    professional skills and prepare them for the
    implementation of best practices in addiction settings.




                      Introduction
   The project initiated in 2006 to develop a guideline for
    nurse on use of buprenorphine in addiction treatment
    settings.
   An extensive research was done in the field of nursing
    and addiction treatment and recent evidence based
    practice information was incorporated into the
    publication. The final draft of the guideline was
    reviewed by two addiction expert nurses, as well as
    experts from SAMHSA, FDA and NIDA. The
    Guideline was published on March 25, 2009 and also
    available online at http://buprenorphine.samhsa.gov




            Purpose of This Guide
   This guide is intended to provide nurse (Including Registered
    Nurses (RNs), Licensed Practical Nurses (LPNs), Nurse
    Practitioners (NPs), and Advanced Practice Nurses (APNs)) with
    general infromation about buprenorphine products– Suboxone®
    (buprenorphine and naloxone) and Subutex (buprenorphine)–
    for the pharmacological treatment of opioid addiction. The guide
    can also serve as a resource to help working with community
    physicians to improve treatment outcomes for individuals
    receiving office-based treatment and primary care settings for
    opioid addiction.




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                   Learning Objective
The guide is intended to fulfill the following objectives:

   To provide nurses with general information on the pharmacology, safety
    profile, adverse effects, interactions, cautions, contraindications, and abuse
    potential of buprenorphine products (Suboxone® and Subutex®)

    To increase nurses’ factual knowledge on protocols for the use of
    buprenorphine products in medically-supervised withdrawal (detoxification)
    and maintenance treatment services

   To help nurses, in conjunction with authorized physicians, design strategies
    for providing comprehensive physical and psycho-social assessments,
    treatment monitoring and appropriate referral for individuals with opioid
    addiction and co-occurring medical and psychiatric conditions.




              Impact of the guideline
The potential impact of this Guide will be initially on:

        Nursing practice of nurses working with individuals who are addicted to
         opioids in office-based settings (e.g., dispencing responsibility, monitor
         adverse reactions)
        1200 SAMHSA’s certified Opioid Treatment Programs,
        Primary care settings,
        HIV clinics,
        Community health centers.
        Help nurses apply evidence-based practice during patient’s induction,
         stabilization, and maintenance.
         Enhance patient’s safety by reducing medication errors and overdoses. The
         Guide
        Further promoted to be used as an education supplemental resource in the
         Physician Clinical Support System, which provides mentoring to physicians,
         nurses, and physician assistants working with opioid dependence patients.
         Will promote a mutually respectful team environment in which nurses and
         physicians collaboratively work to improve the care provided to individuals
         who are addicted to opioids.




    Buprenorphine and the Role of the
                Nurse
The nurse’s roles with patients receiving buprenorphine for the
  treatment of addiction (1) may be subject to State practice
  regulations and (2) may include, but not be limited to:

   Conducting screening, assessment, treatment monitoring,
    counseling, and supportive services;

   Educating patients, their family members, or other supportive
    individuals about buprenorphine therapy as well as risks,
    benefits, potential side effects, interactions, program
    requirements, consents, and treatment contracts;




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    Buprenorphine and the Role of the
                Nurse
   Involving patients in the development of the
    treatment plan, and working with the patient and the
    interdisciplinary team to individualize the plan for
    meeting the patients’ needs;

   Enhancing treatment readiness, supporting treatment
    completion, ensuring safety, and promoting sustained
    recovery outcomes for individuals undergoing
    buprenorphine treatment for opioid addiction;




    Buprenorphine and the Role of the
                Nurse
   Improving access, identifying community resources,
    and providing information about them; and
    explaining reimbursement options for office-based
    buprenorphine treatment;
   Assisting patients in accessing care elsewhere when
    the present practice is not a suitable option for them;
    and assisting patients in accessing other treatment
    options as needed (e.g., day treatment, residential,
    outpatient, methadone detoxification or maintenance,
    etc.).




         Nursing Practice and the Use of
  Buprenorphine for the Treatment of Opioid
                     Addiction
Screening:
 Initial screening (Drug Abuse Screening Test
  “DSAT-10”)
 Ruling out comorbid acute or chronic pain
  disorders and opioid dependence
 Ruling out polysubstnace use-consider using the
  Readiness Ruler




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               Screening Cont’
   Ruling out co-occurring psychiatric disorders—
    consider using Mental Health Screening Form
    III (MHSF-III)
   Questioning about potential pregnancy and
    child-bearing status
   Screening for infectious diseases (hepatitis
    viruses, HIV, tuberculosis (TB), sexually
    transmitted diseases (STDs))
   Screening out domestic violence or abuse




         Nursing Practice Cont’
Assessment:

   Complete history
   Physical examination
   Assessing intoxification and overdose
    (Withdrawal Instrument Score-COWS)




              Assesment Cont’
   Diagnosis of Opioid related disorders using
    DSM-IV-TR
   Appropriateness for treatment and setting
   Medical co-morbidities
   Psych co-morbidities
   Substance Abuse History, psychiatric disorder
    history, family history, and medical history




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                  A New Law
Drug Addiction Treatment Act (DATA)
                2000
 Amendment        to the Controlled Substances Act
 Allows   physician to prescribe narcotic drugs
    scheduled III, IV or V, FDA approved for
    opioid maintenance or detoxification
    treatment
    Prior   10/2002 no drug existed
    Methadone    does not qualify Schedule II




     Drug Addiction Treatment Act of 2000
                (DATA 2000)
   Expands treatment options to include both the
    general health care system and opioid treatment
    programs.
     Expands number of available treatment slots
     Allows opioid treatment in office settings
     Sets physician qualifications for prescribing the
      medication




     Giving opioid agonist treatment
           medication in OTP
   Medication ordered by OTP, under OTP DEA
    number
   Stored in OTP (DEA approved) safe
   Dispensed at OTP (not prescribed)
   Observed dose required by regulation
   No restriction in law on number of patients




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                        DATA 2000:
                   Physician Qualifications
    Physicians must:
       Be licensed to practice by his/her state
       Have the capacity to refer patients for psychosocial
        treatment
       Limit number of patients receiving buprenorphine
        to 30 patients for a least the first year
       File for a new waiver after first year to increase their
        limit to 100 patients.
       Be qualified to provide buprenorphine and receive a
        license waiver




                Only physicians can
              prescribe the medication.

                However, the entire
            treatment system should be
                    engaged.




                  DATA 2000: waiver
   After notification, (online, fax,
    or letter)
           Letter arrives from CSAT
         Attorney general assigns a
          second DEA#
         Waiver in effect in 45 days




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    New DEA number, (green card)
   Usually the old number is retained for other scheduled
    substances
   The new number is used only for DATA2000
   Usually the new number is exactly the old one, except
    the first letter is replaced by an X:
      Example: AM1234567

                  XM1234567




         FDA Approval and DEA
           scheduling: 2002
 Two sublingual tablets: Suboxone® and
  Subutex®
 Labeled for use in treatment of opiate
  addiction
 All buprenorphine products now schedule
  III




                    Conclusion
   This guideline provides nurses working in OTPs with
    information regarding screening and assessment of
    opioid dependence and its associated problems. It
    contains detailed protocols for the use of
    buprenorphine under a variety of clinical scenarios,
    including the use of buprenorphine with patients who
    are experiencing co-occurring pain or psychiatric
    disorders or chemical dependence involving more than
    one substance.




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                       Who Uses Heroin?

                       Individuals of all ages use heroin:
                              More than 3.7 million US residents aged
                               12 and older have used heroin at least
                               once in their lifetime.
                              Heroin use among high school students
                               is a particular problem. Slightly more
                               than 1 percent of US high school seniors
                               used the drug at least once in their
                               lifetime, and nearly half of those injected
                               the drug.


SOURCE: National Survey on Drug Use and Health, 2008; Monitoring the Future Survey, 2008.




                     Addiction: the disease
       1956: American Medical Association
       The illness can be described
       The course of the illness is predictable and
        progressive
       The disease is primary – that is, it is not just a
        symptom of some other underlying disorder
       It is permanent
       It is terminal: If left untreated, can lead to morbidity
        and mortality

                    Solutions Outpatient Services; Texas Department of State Health Services




             Addiction and the limbic system:

       The part of the brain hijacked by addiction is in
        the limbic system, the part responsible for
        survival.
       During withdrawal and craving, the limbic
        system’s message is ‘urgent need’ for survival.




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                       Repeated Opioid Use
      Repeated administration of opioids and activation of the mu
       receptors results in:
           Physical Tolerance
                Diminishing effect from the same dose or
                Need for larger doses to produce the same effect


           Physical Dependence
                If dose is reduced or stopped withdrawal syndrome develops
                Note different concept then DSM-IV “Dependence Disorders”


      Tolerance and dependence, which are dose related, manifest as
       an Opioid Withdrawal Syndrome
           Which develops upon reduction or cessation of opioid use




   Criteria for Office-based Treatment
      Meet eligibility criteria: Including DSM IV
       Criteria
      Understand treatment; give informed consent
      No medical or psychiatric contraindications to
       treatment
      Uphold elements of treatment agreement
      Comply with treatment and monitoring plan
      Medication safety: dosing and storage




                 What’s What?
            Agonists, Partial Agonists,
                and Antagonists
Agonist                     Morphine-like effect (e.g., heroin)



Partial Agonist             Maximum effect is less than a full agonist
                            (e.g., buprenorphine)




Antagonist                  No effect in absence of an opiate or opiate
                            dependence (e.g., naloxone)




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                Function at Receptors
                   Full Agonists
        Mu                   Full agonist binding …
     receptor

     • activates the mu receptor

     • is highly reinforcing

     • is the most abused opioid type

     • includes heroin, methadone, & others




           Full Agonist Activity Levels
         100

          90
                         Full Agonist              overdose
          80
                         (e.g. heroin, methadone, etc.)
          70

          60
Effect    50

          40
                                      Increasing dose produces
          30                          increasing receptor activity
          20

          10

           0
               no drug    low dose                           high dose
                                   DRUG DOSE




         Methadone Maintenance
   Evidence-based treatment using the medical
    model
   Includes interdisciplinary care, mandated
    counseling
   Includes behavioral interventions, testing
   Includes diversion control plans




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                    Drawbacks to Methadone
       Daily attendance
       Transportation
       Strict rules and monitoring
       Risk of diversion
       Risk of overdose
       Risk by association and location…
       Difficulty moving on…
       Stigma




        Methadone and HIV Prevention
        Methadone patients report less needle and syringe
         sharing
         Methadone patients are 3-6 times less likely to
         become HIV positive when compared to out-of-
         treatment heroin users, including the population
         that continues to use drugs.
        Buprenorphine maintenance is hoped to have a similar
         impact

    Drucker, 1998




        Medication Maintenance Goals
       Alleviate physical withdrawal
       “Narcotic blockade”
       Alleviate drug craving
       Normalized deranged brain changes
       Normalized deranged physiology




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               Function at Receptors
                 Partial Agonists
      Mu                 Partial agonist binding …
   receptor

  • activates the receptor at lower levels

  • is relatively less reinforcing

  • is a less abused opioid type

  • includes buprenorphine




         Partial Agonist Activity Levels
         100

         90                                        Full Agonist (e.g. heroin)

         80

         70

         60
EFFECT                                       But due to its “ceiling”
         50                                  maximum opioid agonist effect
                                             is never achieved
         40

         30                                 Partial Agonist (e.g. buprenorphine)

         20
                                    At therapeutic levels, act similar to full
         10
                                    agonists
          0
              no drug   low dose                          high dose
                               DRUG DOSE




   Function at Receptors: Antagonists

      Mu
                                   Antagonist binding …
   receptor

  • occupies without activating

  • is not reinforcing

  • blocks abused agonist opioid types

  • includes naloxone and naltrexone




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                     Naltrexone

       Pure opioid antagonist with good oral
        absorption
       Duration of action 24-48 hours
       1984: FDA approved to treat opioid
        dependence
       Well tolerated and safe




                     Naltrexone


   Low interest among “street addicts”
   No better than placebo except in highly
    motivated patients
   Impaired physicians > 80% abstinence at 18
    months




    BUPRENORPHINE




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               Function at Receptors
                 Partial Agonists
        Mu               Partial agonist binding …
     receptor

     • activates the receptor at lower levels

     • is relatively less reinforcing

     • is a less abused opioid type

     • includes buprenorphine




         Partial Agonist Activity Levels
         100

         90                                       Full Agonist (e.g. heroin)

         80

         70

         60
EFFECT                                      But due to its “ceiling”
         50                                 maximum opioid agonist effect
                                            is never achieved
         40

         30                                Partial Agonist (e.g. buprenorphine)

         20
                                   At therapeutic levels, act similar to full
         10
                                   agonists
          0
              no drug   low dose                         high dose
                               DRUG DOSE




     Goals of Pharmacotherapy with
             Buprenorphine:
   Prevention or reduction of withdrawal
    symptoms
   Prevention or reduction of drug craving
   Prevention of relapse to use of addictive drug
   Restoration to or toward normalcy of any
    physiological function disrupted by drug abuse




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                             Receptor Affinity

   •   AFFINITY is the strength with which a drug physically binds to a
       receptor
            Buprenorphine’s affinity is very strong and it will displace full
             agonists like heroin and methadone



     Mu                              Bup affinity is higher
                                       Full Agonist
   Receptor                         Bound to Receptor
                                            Therefore
                                     Full Agonist is displaced




                    Receptor Dissociation
  Speed (slow or fast) of disengagement or
    uncoupling of a drug from the receptor
       •    Buprenorphine’s dissociation is slow
       •    Therefore buprenorphine blocks heroin from binding


     Mu                             Bup dissociation is slow
   Receptor
                                               Therefore
                                        Full Agonists can’t bind


Borrowed from Tom Pichot, MD




                    Precipitating Withdrawal
      Buprenorphine will precipitate withdrawal when it
       displaces full agonist off the mu receptors


            100                                            Full Agonist (e.g. heroin)
             90
             80
                                        A Net Decrease in Receptor Activity if
             70
                                        a Partial Agonist displaces Full Agonist
             60
     %
             50
 Mu Receptor
  Intrinsic 40                                             Partial Agonist (e.g. buprenorphine)
   Activity 30
             20
             10
              0
                  no drug   low dose           high dose
                                 DRUG DOSE




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                Rapid onset of effect
   Readily absorbed sublingually:
     5-20 min. for tablet to dissolve


   Rapid onset of action: 30-60 min

   Peak plasma levels at 1-2 h

   Peak subjective/physiologic effect at 1-4 h




     How Does
Buprenorphine Work?

   “Ceiling effect” on opioid effects
   High affinity for opioid receptor
   Slow dissociation from opioid receptor
   Formulated with naloxone
       Naloxone blocks opiate effect if injected
       Naloxone is degraded (inert) if taking orally




            “Combo Tablet”
         Buprenophine/Naloxone
   Decreases abuse potential by injection route
   Sublingual use = Buprenorphine effect
         Buprenorphine has very good bioavailability and
         naloxone has very low bioavailability

   Parenteral use = Naloxone effect
         Acute opioid withdrawal in physically dependent
         patients




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          Buprenorphine is generally
            well tolerated but…
   Common side effects may include:
     Headache
     Constipation
     Nausea
     Anxiety
     Sweating
     Insomnia
     Pain




        Less Common Side Effects:
   Elevated Liver enzymes
   Liver toxicity
   Vomiting
   Drug/drug interactions
   CNS Depression
   Allergic reaction: rash, hives, bronchospasm




Buprenorphine treatment and HCV

    Hepatitis
      Case reports (4)
        Transaminase increased, 30-50 times normal,
        with intravenous buprenorphine in patients
        infected with hepatitis C
      Case Report (1)
        HIV and Hepatitis C positive became
        jaundiced, liver necrosis with sublingual
        buprenorphine
      Intravenous users recovered after stopped
        injecting, two did not stop sublingual




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    Buprenorphine treatment and HCV

           Case Reports (7) patients
                1 patients was injecting buprenorphine
                Other 6 took as prescribed sublingual
           Average ALT 39 times normal
           All had serologic evidence of HCV
           Buprenorphine continued in all with 3 having
            dose reduction of 50%
           All 7 patients recovered




                    Interactions, Cautions, and
                        Contraindications:
   Package insert Suboxone/Subutex:
           http://www.suboxone.com/pdfs/suboxonePI.pdf


   Complete list of substrates, inhibitors & inducers
     www.drug-interactions.com




                            Bioavailability
       Poor oral bioavailability
               Sublingual administration is the primary route of
                administration

       High lipid solubility
               Expected to be active by the intranasal route




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        Breaking down buprenorphine
   Hepatic metabolism:
     CYP450 3A4
     N-dealkylation to norbuprenorphine
     Glucuronidation


   Excretion
       30% urine: can test for buprenorphine in urine
       70% feces




        Pharmacodynamic drug interactions
   CNS depressants and sedatives
    (eg, benzodiazepines):
       All opioids have additive sedative effects when used in
        combination with other sedatives
            Increased potential for respiratory depression, heavy sedation, coma,
             and death

   Despite favorable safety, use caution with
    concomitant psychotropics (eg., benzodiazepines)




               Alcohol and Suboxone
   Deaths in France associated with central
    nervous system depressants including alcohol
    (Reynaud et al. 1998a,    Gaulier et al. 2000)
   Assess alcohol history:
     Address prior to OBOT; Detox, abstinence
     Monitor during treatment; breathalyzer, serum




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                     Overdose Risk
   Overdose risk low
        High doses should not produce significant CNS or
         respiratory depression
   Risk higher with combined abuse of other sedatives
    e.g. benzodiazepine
   Deaths reported from France
        Mono tablets dissolved and injected with concurrent high
         potency benzodiazepine use
   Relative NOT absolute contraindication for concurrent
    use with other sedatives




               Getting Started…




                            History
   Substance
   Prior treatments
   Medical
   Psychiatric
   Family




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                Nursing Assessment:
    Intake
    Consents/Contracts
    Education
    Urine toxicology screen
    LFT’s, Hepatitis serologies, RPR, CBC,
     pregnancy test




       Goal of Medical Assessment:
    Establish the diagnosis
    Determine appropriateness for treatment
    Make initial treatment recommendations
    Formulate initial treatment plan
    Plan for engagement in psychological treatment
    Ensure no contraindications to treatment
    Assess other medical problems
    Assess other psychosocial problems

    CSAT 2004




                                 Patient
                                Agreement

Sets the stage for ongoing relationship
Clear message about rules
Patient involvement
Behavior is part of treatment




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 How to Deal with Patients Day to
              Day
    Clinic guidelines
    Be consistent
    Book appointments that coincide with refills
    Inform patients refill will only occur at that
     time/group/ etc…
    Consent and contract spell out agreement…..Be
     Consistent




Rules & Expectations for the Patient

Treatment philosophy: what is expected
Medication dispensing procedures: when,
 how, who
Medication issues: side effects, symptoms
Behavioral component to therapy
Proper adherence to induction and
 maintenance protocols




Rules & Expectations for the Patient

      Dosing guidelines
      Urine testing procedures
      Illicit drug or alcohol use
      Selling or trading medication
      Personal treatment protocol
      Aggressive statements/acts
      Theft/destruction of property




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Rules & Expectations for the Patient

  Do both in writing and verbally
  Give the patient a copy
  Have patient sign and date a copy, and
    keep in the patient’s chart
  Review periodically (as needed) with
    patients
  Review (and revise as needed)
  All staff should be aware of the
    requirements




                 Induction




            Planning for Induction:

       Build a Relationship, Trust, support….
           Early stages of withdrawal prior to
            induction
       Review with patient ahead of time usage
        history, withdrawal, last use.
           Short acting, long acting opioids: What did
            they last use?




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              Long Acting Opioids:

   24 hours for Oxycontin P.O.

   48+ hours for Methadone

   Much harder and longer process

       Patient and provider need to be

        Committed




Timing of induction: long-acting opioids


   Abstain for at least 48+ hours

   Assess for withdrawal

   Timing is often not a good indicator
       Need to assess symptoms
       Slow and Steady




        Buprenorphine induction: Long
         Acting Opioid….. Methadone
   Methadone in tissue stores are a factor.
     Decrease the daily dose until stable: ≤30 mg
      of methadone.
     Begin induction at least 48-96 hours after last
      dose of methadone. Give no further
      methadone once buprenorphine induction is
      started.
     Requires time, patience, and support.




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                Short Acting Opioids:
            8 to 12 hours

            Oxycodone (Percocet®, crushed
             Oxycontin®)

            Hydrocodone (Vicodin®)

            Heroin

            Morphine




        Timing of induction: short-acting
                    opioids

   Abstain 8-12 hours (mild withdrawal)
   If patient is not in documented withdrawal
       review history.
       Assess, support and wait
   What did they use in the last 24hours, ask
    the questions……
       Methadone, oxycontin, heroin…..




Patient instructions during first dose:

   Put tablet(s) under tongue: sublingual
   Don’t talk, don’t swallow: saliva pools
   May use mirror, watch the tablet(s)
    gradually shrink as they dissolve.
   May drink fluids before not during




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        Administration Techniques:
   Crush the tablet: pour under the tongue (not
    listed as route of administration)
     Shorter duration of absorption
     Decreased diversion
     Easier to observe for: providers, parents, program
      staff




             First dose of sublingual
                  buprenorphine
   Patient in clinical opiate withdrawal
   Objective signs are key to making dx (can be
    challenging)
   COWS > 8-12
   Start with 2-4mg sl
   Assess 40min-1 hour after dosing
       Better, worse, or the same




                      Induction:
   Continue to titrate until symptoms resolve
   Reassess patient 40minutes to 1 hour after first
    dose
   Dose with 2mg sl
   Reassess over the next few hours
   Stabilize day one around 8mg or per your
    protocol




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             Typical Target doses:

   First day: up to 8mg
   Second day: up to 16 mg
   Final dose usually 8-16 mg
       Receptor 95% occupied at 16mg
   Very few patients need up to 32mg (max)
   Target dose 8-16mg




Finding the correct dose:
          Assessment,   support, ongoing education
          Adjust  dose accordingly based on
           patient’s experiences on first day (i.e.,
           higher dose if there were withdrawal
           symptoms; lower dose if patient was
           over-medicated at end of first day)
          Goal:   Eliminate withdrawal, and craving




Buprenorphine Induction
    On second day, have patient return to the office
     for assessment, second day dosing
    Adjust dose accordingly based on patient’s
     experiences on first day (i.e., higher dose if there
     were withdrawal symptoms after leaving your
     office; lower dose if patient was over-medicated
     at end of first day)




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                                                                  8/24/2011




Buprenorphine Induction procedure
Patients not physically dependent on opioids
        For example, patient at high risk for relapse to opioid
          use, but just out of prison.
        First dose: 2 mg sublingual buprenorphine
        Monitor in office for 2+ hours after first dose
        Gradually increase dose over days




                 Comfort Measures:
   Ibuprofen: muscle aches
   Tylenol: pain, headache
   Maalox: GI distress
   Imodium: Diarrhea
   Compazine: Nausea, Vomiting
   Bentyl: abdominal cramps
   Benedryl, Trazadone, Tylenol PM: Sleep
   Clonidine: Severe anxiety




                 Comfort Measures:
       Taste perversion: strips, soda before, crush
       Headaches: Take before bed
       Nausea: Take at bedtime or with meals
       Sweating: Divide dose
       Insomnia: Take at night
       Dose splitting: patient preference, behavior,
        better tolerated




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                                                           8/24/2011




                     Follow up:
    Assess dose, frequency, cravings, withdrawal
    Ongoing education: dosing, side effects,
     interactions, support.
    Counseling, self help check in
    Psychiatric evaluation and follow up as needed
    Medical issues: vaccines, follow up, treatment HIV,
     HCV…Engage in care
    Pregnancy
    Social supports: housing, job, family, friends




              Monitoring




      Monitoring: Urine Screening
Why conduct urine drug testing?

     • Drug abuse a chronic disorder – relapse can
       occur
     • Patients may deny or minimize use
     • Urine testing an integral part of on-going
       evaluation and treatment planning




                                                                 30
                                                                                       8/24/2011




         Characteristics of Abuse Potential
       Route of administration
           Faster route has a greater abuse potential
              Injecting IV  Injecting SQ  Oral



       Drug Half life
           Briefer half-life has a greater abuse potential
              Heroin  Methadone



       Lipophilicity (faster across blood brain barrier)
           Higher liophilicity has a greater abuse potential
              Heroin  Morphine  Methadone




Recognize Patient Requests or Behaviors
     That May Indicate Diversion
                                       Asking for
                                      higher dose
                                      than needed




                  Stealing                                Asking for early
                prescription        Diversion                  refills
                    pads




                                   Asking specifically
                                         for a
                                    buprenorphine-
                                     only product




                Proper Storage and Handling

   Avoid pediatric exposure
      Store the medication “out of the sight and reach of children”
      Keep the medication in the container it came in
          prescription vial with child resistant closure
      Never leave tablets out of the container – even for a few minutes
      Patients should obtain an extra prescription vial that is labeled properly if
       medication is to be stored in multiple locations
   Never share pills, even with the best of intentions
      Sharing pills is diversion
      The patient cannot guarantee the behavior of someone else with respect to
       the safe handling and storage of the medication
   Provide the Poison Control Center phone number
      1-800-222-1222




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                                                                                8/24/2011




                                     Referral and
                                    Discontinuation



      Higher level of care needed: MMTP,
       Residential, detox, IOP
      Immediate dismissal for behavior
      Taper for administrative non-compliance




             Special populations and
                 buprenorphine


     HIV (fewer clinically noted medication
      interactions with HAART)
     Cardiac (QT prolongation not an issue)
     Logistics (take homes easier in case of long
      distances from clinic)




      Addiction Alters Pain Experience
     Both stimulant and opioid abusers have less pain
      tolerance than peers in remission or matched controls
     Former opioid abusers have decreased pain tolerance
      to pain compared with non-addict siblings
     HIV-infected patients w/ hx of substance abuse
      required higher doses of opioid analgesics than
      patients without a hx of substance abuse



Martin J (1965), Ho and Dole V (1979), Compton P (1994, 2001), Swica Y (2002)




                                                                                      32
                                                                 8/24/2011




  Opioid Agonist Treatment and Pain

                     The “Opioid Debt”
  Patients who are physically dependent on opioids
  (ie. methadone, buprenorphine) must be
  maintained on daily equivalence before ANY
  analgesic effect is realized with opioids used for
  acute pain management


Doug Gourlay, MD College of Physicians and Surgeons of Ontario




     Buprenorphine as an Analgesic
        In U.S., sublingual formulation not developed for
         analgesic purposes
        Small studies in Europe and Asia demonstrate
         analgesic efficacy of sublingual formulation (0.2-0.8
         mg q 6-8 h) in post-operative pain
            Ceiling analgesic dose ~ 1.5-5 mg
            Onset of analgesia ~ 30 minutes
            Peak analgesia ~ 3 hours
            Duration of analgesia ~6-8 hours




             Acute Pain Management:
    Continue buprenorphine maintenance, titrate
     short acting opioid
    Likely to require higher doses due to
     competition at receptor
    Increased sensitivity to full agonist: CNS
     depression may occur




                                                                       33
                                                                       8/24/2011




                    Acute Pain Management
                          Approaches:
   Divide buprenorphine every 6-8 hours
   No ceiling analgesic effect
   Ceiling effect for respiratory depression
      May safely administer higher doses
      One case report 72mg acute pain
                 Book et al. 2007




                    Acute Pain Management
                          Approaches:
   Discontinue the buprenorphine
        Treat with as full opioid agonist
        Titrate to effect: withdrawal/analgesia
   Resolution of pain
        Discontinue full agonist
        Restart buprenorphine after induction




Buprenorphine Maintenance: Acute Pain
    Mild - moderate pain (e.g., dental extraction)
         1)       Continue buprenorphine maintenance
         2)       Use short-acting opioid analgesics


    Moderate - severe pain (e.g., renal stone)
         1)       Discontinue buprenorphine
         2)       Treat with opioid analgesics until pain resolves
         3)       Re-induction with buprenorphine using established
                  protocols


    Alford DP, Compton P, Samet JH. Annals of Internal Medicine 2006




                                                                             34
                                                                     8/24/2011




             Buprenorphine Maintenance
                Acute Pain: Inpatient
Moderate - severe pain (e.g., elective surgery, trauma)
   1)    Discontinue buprenorphine
   2)    Methadone ~ 30-40 mg po qd for opioid maintenance
   3)    Opioid analgesics until pain resolves
   4)    Discontinue methadone and re-induction with
         buprenorphine using established protocols


  Alford DP, Compton P, Samet JH. Annals of Internal Medicine 2006




            Chronic Pain Management
            Buprenorphine Maintenance
       Try non-pharmacologic and nonopioid therapies

       If pain persists and opioid analgesics are required…
           Because buprenorphine may cause precipitated
            withdrawal with concurrent long-acting opioid
            analgesics…

           Buprenorphine-maintenance should be discontinued and
            patient’s opioid dependence treated in a methadone
            maintenance treatment program




                     Pregnancy




                                                                           35
                                                                8/24/2011




Patient Selection: Issues Involving Consultation with the
                         Physician
   Pregnancy
    Currently buprenorphine is a Category C
     medication. This means it is not approved for
     use during pregnancy.
    Studies conducted to date suggest that
     buprenorphine may be an excellent option for
     pregnant women.
    Randomized trials are underway to determine
     the safety and effectiveness of using
     buprenorphine during pregnancy.




      Buprenorphine and Pregnancy
     Neonatal abstinent syndrome (NAS)
      -Within 12 to 48 hours, peaks 72 to 96, lasts 120-168
        hours (some seen 6 to 10 weeks)
     Found to be less intense than methadone
      (Johnson et al. 2003)




      Buprenorphine and Pregnancy

     Buprenorphine (Category C) use in pregnancy.
     Should not use combo tablet, Suboxone®
      (buprenorphine/naloxone), during pregnancy.
     Switch to mono tablet Subutex®
     Pregnant women treated with buprenorphine have had good
      withdrawal suppression with once daily dosing
     Minimal information regarding need for dose adjustments
      during pregnancy e.g. third trimester




                                                                      36
                                                                                               8/24/2011




                                         Managing Pregnancy on
                                            Buprenorphine
   Mono tablet
   Smaller prescriptions (limit diversion)
   Frequent Visits
   Urine toxicology screens (buprenorphine)
   Counseling, support
   High Risk OB Setting




                                         Patients’ Main Concerns
   “DCF” / Department of Family and Children
   Neonatal Abstinence Syndrome
   Disclosure
   HCV
   Parenting/ Housing




                                         Buprenorphine Efficacy
      Remaining in treatment (nr)




                                    20


                                    15
                                             75% Retention
                                             75% UTS negative in treatment
                                    10
                                             20% mortality in the placebo group

                                    5                                 Control   N=20

                                                                      Buprenorphine     N=20


                                    0
                                         0    50   100   150   200    250   300        350
                                                    Treatment duration (days)

Kakko J et al. Lancet 2003




                                                                                                     37
                                                        8/24/2011




    Thank You for your attention..


   Colleen.labelle@bmc.org
   Sara.Azimi-Bolourian@SAMHSA.hhs.gov




                     Thank You
   “If we do nothing people will die”
       Dr Wesley Clark Director Center for Substance
        Abuse Treatment and Mental Health Services
        Administration, U.S. Department of Health and
        Human Services




        Websites on Buprenorphine
   www.buprenorphine.samhsa.org

   www.asam.org

   Email or phone support:
        Colleen.Labelle@bmc.org
       617-414-7453




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