Buprenorphine / naloxone (Suboxone

1
Buprenorphine / naloxone (Suboxone) prescribing
in South Australia

• Adapted from National Opioid Pharmacotherapy
  Training Workshop for the Management of Opioid
  Dependence
• Module 2 Fundamentals Buprenorphine Program for
  Medical Practitioners
• Chapter of Addiction Medicine, Royal Australasian
  College of Physicians
• Last modified November 2nd, 2011

2
Want fast advice?

• Drug and Alcohol Clinical Advisory Serviceph
  8363 8633 24/7 advice from senior medical
  staff.
• Alcohol and Drug Information Serviceph 1300 13
  1340 24-hour information and counselling, links
  to a local DASSA counsellor. (SA callers - local
  call fee).
• Eastern DASSA Servicesph 8130 7500 (office
  hours) Ask for Senior Medical Staff.
• Drugs of Dependence Unitph 1300 652 584 (office
  hours)Advice on patient prescribing from a
  regulatory view point.

3
Learning objectives

• To assess a patient and negotiate a treatment
  plan
• range of treatment approaches for opioid
  dependence
• the role of buprenorphine/naloxone (Suboxone)
  film in detoxification and maintenance treatment
• To safely and effectively prescribe
  buprenorphine/naloxone (Suboxone) film
• clinical pharmacology
• how to structure OST
• Understand legal issues regarding the use of
  buprenorphine/naloxone (Suboxone)film
• Identify when and how to get support

4
Rationale and objectives in treating opioid
dependence
5
Opioids

• The illicit opioid scene in South Australia is
  changing. There is less heroin and more use of
  diverted prescribed opioids.
• Pharmaceutical opioids such as Slow Release
  morphine, oxycodone or hydromorphone
• may not be taken as prescribed
• higher or lower doses than prescribed
• different routes ie they may be injected
• altered to get immediate effects, not sustained
  release ie the formulation may be crushed which
  results in rapid effect of full dose
• Heroin
• Short acting opiate
• Metabolised to morphine within minutes, with
  comparable effects thereafter

6
Opioid substitution treatment

• Indicated for OPIOID DEPENDENCE under S100 of the
  PBS.
• 2 main drugs which are agonist/partial agonists
• Methadone prescriber needs to be accredited
• Buprenorphine as Mono-stand alone Subutex
  prescriber needs to be accredited
• Buprenorphine in combination with naloxone
  Suboxone film for 5 or less patients,
  prescriber does not need to be accredited.

7
If you are not a specially accredited opioid
substitution treatment prescriber

• you can prescribe only buprenorphine/naloxone
  (Suboxone) film for opioid dependent patients.
• you can only do so for 5 or less patients.
• you need an authority right from the start from
  the Drugs of Dependence Unit.

8
What is opioid dependence (DSM IV-TR)

• 3 occurring at any time in the same 12-month
  period

1. Tolerance
2. Withdrawal
3. Opioids taken in larger amounts or longer than
   intended.
4. Persistent desire or unsuccessful attempts to cut
   down or control opioid use.
5. A great deal of time is spent in activities
   necessary to obtain, use or recover from their
   effects.
6. Important social, occupational, or recreational
   activities are given up or reduced because of
   opioid use.
7. Opioid use is continued despite recurrent
   physical or psychological problem caused or
   exacerbated by opioids.

9
Natural history of heroin and other opioid
dependence especially those presenting to primary
care or specialist treatment agencies.

• Chronic, relapsing remitting condition
• Usually starts early twenties
• 25 remission rate per annum
• Most stop heroin use by late 30s to 40s
• 12 mortality rate per annum
• gt10 x greater than age, gender matched non-users
  
• Death from overdose, liver disease, suicide,
  trauma

10
Harms of illicit opioid use to the drug user and
community

• Physical complications
• Overdose, cardiovascular, thromboemboli,
  endocrine, immune function
• Blood borne viruses HIV, HCV, HBV.
• Mental health anxiety, depression, impaired
  cognition
• Social problems
• Social exclusion, poverty, disrupted employment
• Family and community disruption
• Productivity lost
• Criminal justice issues crime, policing, drug
  markets
• General ill-health and poor quality of life

11
Treatment pathways for dependent opioid users
?

• Generally 2 pathways of treatmentgt detoxificati
  on or withdrawal followed by abstinence based
  programs ORgt substitution sometimes called
  agonist substitution or opioid substitution
  or maintenance

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13
NB howeverrelapse rates are much higher in
abstinence based programs, so substitution is the
preferred option and is an evidence based
alternative.
14
Abstinence based approaches

• Patient needs to be withdrawn or detoxified
• Patient can then embark on abstinence based
  programs.

15
Opiate withdrawal syndrome
?

• Increased pain
• Agitation, poor sleep
• Dysphoria
• Diarrhoea, abdo cramps
• Nausea, vomiting
• Increased BP, PR, RR
• Sweaty, ?urine
• Piloerection, runny nose, runny eyes
• Dilated pupils

Withdrawal from short acting opioids eg morphine,
heroin, codeine
Withdrawal from long acting opioids eg
methadone, buprenorphine
16
Withdrawal programs (detoxification)

• Detox does not cure dependence relapse common
• short-term intervention aims to interrupt pattern
  of heavy and regular drug use link to ongoing
  treatment
• Supportive care
• safe environment (inpatient / outpatient)
• patient information supportive counselling
• regular monitoring
• Medication
• buprenorphine is the preferred medication to
  assist with detox
• avoid benzodiazepines in outpatient settings
• limit access to medication (supervised, daily
  dispensing)

17
Post-withdrawal interventions

• Counselling
• various models (supportive, behavioural, dynamic)
• Cochrane limited efficacy outpatient counselling
  alone
• Residential rehabilitation (long term gt 3/12)
• Selfhelp (NA, Smart Recovery)
• Oral Naltrexone
• opioid antagonist that blocks effects of opioid
  use
• effective for those who take it, but high drop
  out rate (lt10 retention at 6 months)
• need 5-7 days opioid abstinence prior 1st
  naltrexone dose
• not available on PBS for opioids dependence (only
  for alcohol dependence)

18
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19
Opioid substitution treatment

• A long-acting prescribed opioid enables patient
  to cease other opioids and related behaviours
• Long term treatment opportunity for distance
  from drug-using lifestyle
• Combines medication ancillary services
• Medication options
• methadone (oral)
• buprenorphine (sublingual)
• buprenorphine-naloxone (sublingual)

Codeine, heroin
20
Outcomes of OST

• In treating heroin dependence
• reduces heroin use
• reduces mortality rates (3-4 fold reduction)
• reduces HIV transmission
• reduces criminality
• engages patient and allows other health and
  social conditions to be addressed
• In treating pharmaceutical opioid dependence
• methadone and buprenorphine both effective
  analgesics
• allows more structured treatment and reduces
  misuse
• easier monitoring other drug use (urine drug
  screens)

21
Many people eventually come off maintenance but
relapse can occur. Maintenance needs to be in
place for at least 6 to 12 months, often several
years to give the best chance of success.
22
Assessment and treatment selection
23
Case 1 Caroline

• 22 yr old presents with mother. Recently ended
  relationship with heroin user, and returned to
  living with parents.
• Was using heroin daily for past 3 months.
• Presents in withdrawal. She feels terrible and
  wants to stop drugs altogether.
• Her parents want the best for her.

24
Case 1 Caroline

• Q1. What further assessment do you undertake?
• Q2. What features of opiate withdrawal may you
  expect to encounter?
• Q3. What treatment approach do you recommend?

25
Key features of assessment

• Presenting problem
• Drug use (include all drug classes)
• quantity frequency route of administration
• duration of use when and amount last used
• severity of dependence and tolerance
• Risk practices / co-morbidities
• drug related / medical / psychiatric / social
• Patient treatment goals / expectancy

26
Conducting assessments

• History
• Examination
• Features of intoxication / withdrawal
• Evidence of drug use (eg injecting sites)
• Evidence of drug related harm
• Investigations
• Urine drug screens detect recent drug use
• 4-7 days short acting drugs (eg morphine,
  amphetamines)
• 7-10 days long-acting drugs (eg methadone,
  diazepam)

27
Complicated presentations

• Greater caution in managing patients with
• severe polydrug use (especially sedative drugs of
  alcohol, BZD dependence)
• severe mental health problems
• severe behavioural presentations
• pregnancy
• complex chronic pain or other medical conditions
• Seek specialist support

28
Want fast advice?

• Drug and Alcohol Clinical Advisory Serviceph
  8363 8633 24/7 advice from senior medical
  staff.
• Alcohol and Drug Information Serviceph 1300 13
  1340 24-hour information and counselling, links
  to a local DASSA counsellor. (SA callers - local
  call fee).
• Eastern DASSA Servicesph 8130 7500 (office
  hours) Ask for Senior Medical Staff.
• Drugs of Dependence Unitph 1300 652 584 (office
  hours)Advice on patient prescribing from a
  regulatory view point.

29
Case 2 Pete

• 34 year old using heroin 8 years, now injecting
  2-3 times/day, or will use illicit oxycodone ,
  diazepam and alcohol when cannot get heroin.
• Few friends, estranged from family, not working.
• Days spent getting money and drugs, either
  intoxicated or in withdrawal.
• Inpatient detox 4 times in 2 years, relapsing
  soon after each attempt.
• Multiple overdoses most recent 2 weeks ago.

30
Case 2 Pete

• Presents anxious and agitated, runny nose,
  sweating, generalised aches, stomach cramps
• Requests diazepam for withdrawal and antibiotics
  for infected injecting sites on back of hand.

• Q1. Is Pete opioid dependent?
• Q2. What treatment plan would you negotiate?

31
Case 2 PeteIs Pete dependent?
Tolerance ?
Withdrawal ?
Opioids taken in larger amounts or longer than intended ?
Persistent desire or unsuccessful attempts to cut down ?
A great deal of time is spent in activities necessary to obtain, use or recover from their effects. ?
Important social, occupational, or recreational activities given up / reduced. ?
Opioid use is continued despite recurrent physical or psychological problem caused by opioids. ?
32
Case 2 PeteWhat treatment plan would you
negotiate?

• Treat infected hand with antibiotics
• Treat opioid dependence
• Suitable for buprenorphine/naloxone (Suboxone)
  film. Ambivalent about long-term treatment, so
  start on buprenorphine/naloxone (Suboxone) film
  to stabilise drug use and circumstances and
  decide on either withdrawal or maintenance at
  later review in a day or two.
• Avoid benzodiazepines.
• buprenorphine/naloxone (Suboxone) film better
  relief of withdrawal and less OD risk

33
Want fast advice?

• Drug and Alcohol Clinical Advisory Serviceph
  8363 8633 24/7 advice from senior medical
  staff.
• Alcohol and Drug Information Serviceph 1300 13
  1340 24-hour information and counselling, links
  to a local DASSA counsellor. (SA callers - local
  call fee).
• Eastern DASSA Servicesph 8130 7500 (office
  hours) Ask for Senior Medical Staff.
• Drugs of Dependence Unitph 1300 652 584 (office
  hours)Advice on patient prescribing from a
  regulatory view point.

34
Case 3 Tony

• 23 year old likes parties. Smokes ice (and
  takes ecstasy), often staying up for days.
• BZDs (eg 150mg oxazepam) to come down after ice
  binges. Also takes Panadeine forte sometimes for
  headaches last used 2 days ago.
• Urine Drug screen gtgt ve opiates, amphetamine,
  cannabis, BZD.
• In trouble from employer due to absences.
• Asks for buprenorphine/naloxone (Suboxone).

Q1. How do you respond to Tonys request?
35
Case 3 Tony

• Tony not opioid dependent and unsuitable for OST
  doesnt fit the S100 indications
• Brief intervention
• feedback how amphetamine use impacts upon recent
  problems and other drug use
• listen
• advise to reduce / stop ATS use
• goals get Tony to identify realistic goals
• strategies to achieve these referral for
  counselling

36
Want fast advice?

• Drug and Alcohol Clinical Advisory Serviceph
  8363 8633 24/7 advice from senior medical
  staff.
• Alcohol and Drug Information Serviceph 1300 13
  1340 24-hour information and counselling, links
  to a local DASSA counsellor. (SA callers - local
  call fee).
• Eastern DASSA Servicesph 8130 7500 (office
  hours) Ask for Senior Medical Staff.
• Drugs of Dependence Unitph 1300 652 584 (office
  hours)Advice on patient prescribing from a
  regulatory view point.

37
Clinical pharmacology buprenorphine BPN
Actions, pharmacokinetics, side-effects and
toxicity drug interactions
38
Buprenorphine preparations

• Low dose buprenorphine preparations for pain
  management in non-dependent patients
• Temgesic 0.2 mg sublingual tablets - for pain -
  not suitable for opioid dependence.
• Norspan topical 7 day patches release PBS
  schedule 8 for pain - not suitable for opioid
  dependence.
• High dose preparations for opioid dependent
  patients S100 for dependence
• Subutex 0.4, 2 and 8mg sublingual tablet.
• Suboxone (buprenorphine-naloxone in 41 ratio)
  2 and 8mg sublingual film reduces injecting and
  diversion (injected buprenorphine/naloxone
  (Suboxone) reduces desired effect of plain
  buprenorphine).

39
Classification of opioids

• Methadone, morphine
• full agonist mu receptor
• receptor affinity comparable to heroin
• Buprenorphine
• Partial agonist mu receptor
• Receptor affinitymuch greater than methadone /
  morphine/naloxone / naltrexone

40
Current opioid pharmacotherapies available in
Australia
Methadone Full agonist
Buprenorphine Partial agonist
?
Naltrexone antagonist
41
Morphine Oxycodone Methadone
Buprenorphine

• Buprenorphine
• has a partial agonist action at the mu receptor
• Once it occupies the mu- receptor, blocks other
  opioids

42
Morphine Oxycodone Methadone
Naltrexone

• Naltrexone
• have a NO agonist action at the mu receptor
• blocks other opioids

43
Pharmacological properties of buprenorphine

• Reverses opiate withdrawal (doses gt4-8mg)
• Minimal opiate effects (eg sedation)
• Reduces effects other opioid use (doses gt16mg)
• Higher safety profile due to ceiling effects
• Low risk respiratory depression, even in opiate
  naive individuals
• Overdose risk with other sedatives (BZDs, EtOH)

44
Buprenorphine overdose

• Unusual in opioid tolerant ie opioid dependent
  patients.
• Can occur in opioid dependent patients if
  combined with alcohol or benzodiazepines or other
  sedatives.
• Requires high dose naloxone to reverse up to
  20mg .
• Maintain airway, give O2, administer IV fluids,
  get help!

45
Pharmacology

• Sublingual film 30-40 bioavailability
• Onset effects within 1 hour, peak 1-4 hrs,
  duration up to 24-48 hrs
• Few drug interactions of clinical significance
• hepatic CYP P450 metabolism
• reduces effects other opioid analgesics
• Side effects similar to other opioids
• headaches, constipation, sweating, nausea
• usually subside with time

46
Principles of safe and effective prescribing
safe inductioneffective maintenance treatment
responding to continued drug usetake
awaysaddressing co-morbidities
47
Principles safe induction onto buprenorphine/nalox
one (Suboxone) film

• Minor risk opioid overdose risk is increased if
  the patient is NOT dependent on opioids
• Main risk precipitated withdrawal
• Buprenorphine has higher affinity but lower
  activity at opioid receptors than heroin /
  morphine / methadone
• In patient who has recently used other opioids,
  Buprenorphine may precipitate withdrawal as it
  displaces full agonists and produces less opiate
  effects
• Delay first dose buprenorphine/naloxone
  (Suboxone) film until patient in early opiate
  withdrawal
• Communicating with patients
• Importance of being in mild withdrawal at first
  dose
• Caution use of other sedative drugs
• Discuss side-effects avoid driving, operating
  machinery until stable
• If encounter problems (withdrawal or over
  sedation) to contact you or pharmacist

48
Starting buprenorphine/naloxone (Suboxone) film
dosing

• Day 1 dose
• Delay first buprenorphine/naloxone (Suboxone)
  film dose until patient in early opiate
  withdrawal
• 6-12 hrs after short acting opioid (eg heroin,
  morphine, codeine)
• 24 hrs after long-acting opioid (eg methadone)
• 4mg if patient in mild opiate withdrawal at 1st
  dose
• 8mg if patient in mod-severe opiate withdrawal at
  1st dose
• Titrate dose on following days
• Increase by 2, 4 or 8mg per day as required
• Reach target dose by day 3 usually aim for
  12-24mg per day

49
Buprenorphine/naloxone (Suboxone) film dosing
regimens

• Maintenance treatment
• Individually titrate dose to achieve treatment
  goals (stop use other opioids, manage pain,
  prevent withdrawal)
• Most patients need 12 to 24mg (up to 32mg)
  buprenorphine/naloxone (Suboxone) film daily
• Withdrawal Treatment
• Short programs (lt14 days)
• 2-3 day induction, then taper dose to 0mg over
  3-4 days
• Patients may describe mild rebound opioid
  withdrawal symptoms on stopping
  buprenorphine/naloxone (Suboxone) film (for 2-5
  days) Avoid other sedatives (eg BZDs)

50
Examples of dosing regimes for withdrawal
Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
Detox Detox Detox Detox Detox Detox Detox Detox
A 6mg 8mg 10mg 8mg 6mg 4mg 2mg
B 4mg 8mg 6mg 4mg 2mg 0mg 0mg
51
Case 1 Caroline continued

• 22 yr old with brief duration opioid dependence
• good family supports and changed social
  conditions
• attempt outpatient withdrawal with
  buprenorphine/naloxone (Suboxone) film and
  ongoing counselling
• Used heroin 1-2 times a day past 3 months.
• Last used heroin 4 days ago, but used 20 tabs
  Panadeine forte over past 2 days for withdrawal.
  
• OE signs of moderate severity opiate withdrawal

Q. What buprenorphine/naloxone (Suboxone) film
dosing regime would you prescribe?
52
Case 1 Caroline continued

• A. Example of proposed regime
• Day 1 4mg
• Day 2 8mg
• Day 3 6mg
• Day 4 4mg
• Day 5 2mg
• Day 6 stop

53
If considering prescribing buprenorphine/naloxone
(Suboxone) filmfor withdrawal you need

• An authority from the Drugs of Dependence Unit
  office hours only
• An OST pharmacy to dispense on daily basis
  observing doses
• A legal prescription

54
Prescription for buprenorphine/naloxone
(Suboxone) film assisted withdrawal over 5-7 days

• Needs
• The designated pharmacy
• The authority number
• The expiry date use this to make sure the
  patient comes back to see you at the appointed
  time.
• The number of unsupervised doses see below. Nil
  at the start
• Total dose over the duration of the script. Eg up
  to 8mg daily over 7 days 56mg in numerals and
  words
• Dose range to allow variation in response to
  patients needs

55
Want fast advice?

• Drug and Alcohol Clinical Advisory Serviceph
  8363 8633 24/7 advice from senior medical
  staff.
• Alcohol and Drug Information Serviceph 1300 13
  1340 24-hour information and counselling, links
  to a local DASSA counsellor. (SA callers - local
  call fee).
• Eastern DASSA Servicesph 8130 7500 (office
  hours) Ask for Senior Medical Staff.
• Drugs of Dependence Unitph 1300 652 584 (office
  hours)Advice on patient prescribing from a
  regulatory view point.

56
Case 1 Caroline continued

• She attends the following week. Reports the first
  few days of buprenorphine/naloxone (Suboxone)
  film were good, but admits to using heroin x 2
  after buprenorphine/naloxone (Suboxone) film
  dose stopped.
• She doesnt want long term treatment.

Q. How do you manage this scenario?
57
Case 1 Caroline continued

1. Resume buprenorphine/naloxone (Suboxone) film
   (eg at 4 to 8mg) to stabilise situation and stop
   further heroin use.
2. Engage with local D A counselling and support.
3. Review regularly.
4. Reassure that once stopped heroin use, can resume
   more gradual reductions off buprenorphine/naloxone
   (Suboxone) film in near future (eg reduce by
   2mg every 4-7 days).

58
If considering prescribing buprenorphine/naloxone
(Suboxone) film for maintenance you need

• An authority from the Drugs of Dependence Unit
  office hours only
• An OST pharmacy list from DDU to dispense on
  daily basis observing doses
• A legal prescription

59
Examples of induction regimes
  Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

B 4mg 8mg 12mg 12mg 12mg 12mg 12mg
C 8mg 16mg 16mg 16mg 16mg 16mg 16mg
60
Prescription for buprenorphine/naloxone
(Suboxone) film starting maintenance

• Needs
• The designated pharmacy
• The authority number
• The expiry date use this to make sure the
  patient comes back to see you at the appointed
  time
• The number of unsupervised doses see below, nil
  at the start
• Total dose over the duration of the script eg up
  to 16 mg of buprenorphine/naloxone (Suboxone)
  film for 7 days 112mg in numerals and words
• Dosage range to allow day by day variation during
  commencement.

61
Case 4 Lisa

• 29 yr old hairdresser released from hospital
  after bleeding gastric ulcer.
• 6 month history Nurofen plus dependence (24-48
  tabs / day), 5 year history cannabis and ecstacy
  use.
• Experiences opiate withdrawal when tries to stop.
  Presents seeking help.
• After discussion, she agrees to attempt
  outpatient withdrawal using buprenorphine.

Q. Describe how you would approach withdrawal
treatment.
62
Case 4 Lisa
Answer

• Permit for buprenorphine/naloxone (Suboxone)
  film and identify pharmacy
• Educate re how to take buprenorphine/naloxone
  (Suboxone) film, safety issues
• Buprenorphine/naloxone (Suboxone) film regime
  consecutive daily doses of 4mg, 8mg, 12mg, 8mg,
  6mg, 4mg, 2mg, stop
• Regular review ask about withdrawal symptoms,
  continued drug use, side effects, concerns,
  ongoing treatment plans)

63
Case 4 Lisa

• You review after 3 days and she states that the
  buprenorphine/naloxone (Suboxone) film is OK,
  and helping her pain.
• You again review her 2 days after last
  buprenorphine/naloxone (Suboxone) film dose
  (2mg). States that she resumed Nurofen plus
  towards end of withdrawal (albeit at lower doses
  8 tabs per day).
• States that buprenorphine/naloxone (Suboxone)
  film doesnt help control the pain.

Q. What do you do?
64
Case 4 Lisa

• Explore her belief that buprenorphine/naloxone
  (Suboxone) film doesnt work
• marked reduction in Nurofen plus, and controlled
  pain whilst on higher buprenorphine/naloxone
  (Suboxone) film doses (8-12mg)
• differentiate gastric ulcer pain from opiate
  withdrawal (cluster of symptoms)
• Stabilise on higher dose buprenorphine/naloxone
  (Suboxone) film (eg 12 or 16mg) with view to
  stopping Nurofen plus altogether
• Review regularly (eg weekly) and UDS
• Assess for other mental health conditions
• Refer for counselling? addiction specialist

65
Supervised dosing everyone starts of daily
supervised treatment!

• Supervised dosing at pharmacy / clinic
• Advantages
• Minimises diversion to others
• Minimises misuse of medication (e.g. injecting)
• Greater medication adherence
• Disadvantages
• Inconvenience to patients and staff
• Cost to patients / health services
• Barrier to community integration

66
Take-away doses

• Medication dispensed for use at later time
• Prescriber has responsibility for authorising
• Balance between safety and convenience for
  patient
• Need to perform regular risk assessment
• Drug use opioids, BZDs, EtOH, (amphetamines,
  cannabis)
• Self-report and objective measures (urine drug
  screen)
• Adherence to appointments and dosing
• Safety of take-away doses (safe storage, history
  of abuse)
• Medical / psychiatric / social (and child safety)
  conditions

67
Take-away framework

• Basically with buprenorphine/naloxone (Suboxone)
  film
• gtgt none to start
• gtgt can increase over an 18 month period to 5
  unsupervised doses see next slide
• gtgt only with objective evidence of stability
• Clear urine drug screens
• No evidence of injecting
• No missed doses at chemist
• Regular attendance at doctor appointments

68
Take-away framework

• ...with buprenorphine/naloxone (Suboxone) film
  increase as follows
• If stable for 2 months - six per month
• Public holidays no more than 2 consecutively
• If stable for 9 mths - three/wk
• If stable for 18mths five/wk

69
Alternate-day buprenorphine/naloxone (Suboxone)
film dispensing

• Safety of buprenorphine/naloxone (Suboxone) film
  allows for alternate day and 3 day dosing for
  patients not suitable for take-aways
• Can be initiated once buprenorphine/naloxone
  (Suboxone) film dose stable (gt1 week)
• Alternate (2) day dosing 2 x daily dose (to max
  32mg)
• Three day dosing 3 x daily dose (to max 32mg)
• Not all patients stabilise on 2 or 3 day dosing
• Increased withdrawal, cravings and poor sleep on
  non-dosing days in about one third of patients

70
Examples of 2 and 3 day dosing regimes
M T W Th Fr Sa Su

14 day cycle 24mg No dose 24mg No dose 24mg No dose 24g
7 day cycle 24mg No dose 24mg No dose 32mg No dose No dose
71
Responding to continued drug use Review treatment

• Assess drug use, risk behaviours, medical,
  psychiatric, social circumstances
• Examine patient treatment goals
• Frequency of reviews and monitoring (urine
  tests)
• Medication regimes
• buprenorphine/naloxone (Suboxone) film dose
  consider increase
• Review take-aways
• Patient adherence (missed doses, appointments)
• Other prescribed drugs
• Psychosocial interventions and supports

72
Want fast advice?

• Drug and Alcohol Clinical Advisory Serviceph
  8363 8633 24/7 advice from senior medical
  staff.
• Alcohol and Drug Information Serviceph 1300 13
  1340 24-hour information and counselling, links
  to a local DASSA counsellor. (SA callers - local
  call fee).
• Eastern DASSA Servicesph 8130 7500 (office
  hours) Ask for Senior Medical Staff.
• Drugs of Dependence Unitph 1300 652 584 (office
  hours)Advice on patient prescribing from a
  regulatory view point.

73
Case 5 Jarred

• 21yrs 1st time in treatment. Uncertain of what
  to do.
• 2yr injecting heroin and oxycodone 2-3 times /
  day. Cannabis occasionally and alprazolam when
  hanging out.
• Never had HCV/HBV/HIV testing. No medical/mental
  health problems reported.
• Recent charges (possession stolen goods). Lives
  with friends in rented flat. Works shifts in
  factory.

Q. What do you focus upon in the examination?
74
Case 5 Jarred
Answer

• Need to confirm history, identify co-morbidity
• Evidence of intoxication / withdrawal. In this
  case pupils constricted (1-2mm). Patient not
  overly sedated, but calm.
• Evidence of injecting drug use. Needle track
  marks on his left arm. Not infected.
• Evidence of drug related physical / mental state
  problems NAD.
• Urine test positive for opiates and
  benzodiazepines.

75
Case 5 Jarred

• Has older friends on methadone and
  buprenorphine/naloxone (Suboxone) and he is
  concerned about being stuck in treatment for
  years.
• He plans to go away for work when police charges
  have been dealt with. Also concerned about
  getting to the pharmacy every day as he works
  shifts.

Q. Describe how you would start
buprenorphine/naloxone (Suboxone) film
treatment?
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Case 5 Jarred
Answer

• Explain need to delay 1st buprenorphine/naloxone
  (Suboxone) film dose until in opiate withdrawal
  (probably next morning). Caution re other drug
  use.
• Initiate buprenorphine/naloxone (Suboxone) film
  (e.g. 4 to 8mg), and then increase dose (eg by 2
  to 4mg per day) on subsequent days until reports
  having stopped heroin use and comfortable (no
  withdrawal).

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Case 5 Jarred

• At review one week later. On 12mg
  buprenorphine/naloxone (Suboxone) film. Reports
• used heroin only once since starting
• not had any BZDs, but still smokes cannabis at
  night
• attending the pharmacy every day is difficult,
  and asks for take-away doses just like his
  friends get.

Q. How do you respond to his request?
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Case 5 Jarred
Answer

• Too early to authorise regular take-aways.
• Must demonstrate has ceased injecting and other
  high risk drug use such as BZDs for period of
  time. Work towards getting take-aways by
• getting regular urine drug tests
• being seen regularly for clinical review to check
  no injection marks
• Offer alternate (24mg) or three day (32mg) dosing
  until patient can qualify for regular take-aways.

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Case 5 Jarred... 3 years later

• Jarred has done well in treatment - stayed in
  work, no legal problems, stopped heroin and BZD
  use, still uses cannabis. Now on 6 take-away
  doses of buprenorphine/naloxone (Suboxone) film
  per week (dose 12mg / day). Recently resumed
  relationship with ex-girlfriend.
• Missed most recent appointment and presents 3
  days after the prescription expired. In a rush to
  get back to work and states that everything is
  fine. You issue a 1 month prescription and get a
  UDS. The result comes back positive for morphine,
  cannabis and BZDs.

Q. How do you respond?
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Case 5 Jarred... 3 years later

• It appears he has resumed heroin and BZD use. You
  should
• Assess drug use and any precipitants by both
  self-report, examination (evidence of injecting),
  and further UDS.
• Identify stressors.
• What assistance needed to stabilise drug use
  explore increased buprenorphine/naloxone
  (Suboxone) film dose, counselling, other
  changes.
• Review take-away conditions. Weekly take-away
  doses require that patients are not using other
  drugs such as heroin or high dose
  benzodiazepines, and undertake regular reviews
  and monitoring (including urine screening).

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Case 5 Jarred... 3 years later

• On review two weeks later, he admits to using
  heroin 2-3 times a week for the past 8 weeks. He
  reports taking diazepam on 2 occasions only.
• He has been giving buprenorphine/naloxone
  (Suboxone) film doses to his girlfriend to help
  her get over a heroin habit.
• He pleads with you not to lose his take-away
  doses otherwise she will get back into using
  heroin regularly again.

Q. How do you respond?
82
Want fast advice?

• Drug and Alcohol Clinical Advisory Serviceph
  8363 8633 24/7 advice from senior medical
  staff.
• Alcohol and Drug Information Serviceph 1300 13
  1340 24-hour information and counselling, links
  to a local DASSA counsellor. (SA callers - local
  call fee).
• Eastern DASSA Servicesph 8130 7500 (office
  hours) Ask for Senior Medical Staff.
• Drugs of Dependence Unitph 1300 652 584 (office
  hours)Advice on patient prescribing from a
  regulatory view point.

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Case 5 Jarred... 3 years later

• Options include
• Perform regular reviews over coming weeks,
  monitoring UDS and injecting sites.
• Engage his girlfriend into treatment.
• Adjust take-away schedule accordingly reduce
  take-aways (eg to 3 or 4 per week) until Jarred
  can provide some clean urine tests and stops
  injecting. Warn Jarred that continued injecting,
  BZD or heroin use will result in him losing his
  take-aways.

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Case 5 Jarred... another 2 years later

• It is now 2 years later. Jarred broke up with his
  ex-girlfriend, and has been doing well no drug
  use in the past year, and is still on 12mg
  buprenorphine/naloxone (Suboxone) film.
• He is now engaged to Kate, a non-drug user from
  interstate. She is 3 months pregnant and they
  plan to move back to her familys home in the
  next few months to have the baby there. He is
  confident of getting work there through friends.
  
• Jarred asks you about getting off
  buprenorphine/naloxone (Suboxone) film.

Q1. What factors are associated with a better
prognosis for coming off OST without
relapse? Q2. How should he attempt withdrawal
off buprenorphine/naloxone (Suboxone) film?
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Stopping OST

• Chronic condition needs long-term treatment.
  Better outcomes after gt12months OST. Consider
  when
• no unsanctioned drug use for months / years
• stable social environment patient has a life
  that does not revolve around drugs
• stable medical / psychiatric conditions
• patient informed consent
• Gradual dose reductions (eg 2mg every 2 weeks)
• slow down or stop reductions if patient not
  coping (resumes drug use, severe cravings,
  psychosocial instability)
• Explore interstate transfer so that reductions
  dont have to be hurried towards the end.

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Complicated patients

• Severe poly-drug use
• Alcohol, BZD dependence
• Psychiatric co-morbidity
• Common in drug users but often defer diagnosis
  until maintenance treatment stabilised
• Severe side effects to OST
• Complicated behavioural issues
• Pregnancy
• Complex chronic pain presentations

87
Want fast advice?

• Drug and Alcohol Clinical Advisory Serviceph
  8363 8633 24/7 advice from senior medical
  staff.
• Alcohol and Drug Information Serviceph 1300 13
  1340 24-hour information and counselling, links
  to a local DASSA counsellor. (SA callers - local
  call fee).
• Eastern DASSA Servicesph 8130 7500 (office
  hours) Ask for Senior Medical Staff.
• Drugs of Dependence Unitph 1300 652 584 (office
  hours)Advice on patient prescribing from a
  regulatory view point.

88
Maintenance prescription for buprenorphine/naloxon
e (Suboxone) film

• Needs
• The designated pharmacy.
• The authority number.
• The expiry date use this to make sure the
  patient comes back to see you at the appointed
  time.
• The number of unsupervised doses see below, nil
  at the start.
• Total dose over the duration of the script eg
  16mg of buprenorphine/naloxone (Suboxone) film
  for 14 days 224mg in numerals and words.

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Safe and effective buprenorphine/naloxone
(Suboxone) film treatment Key points

• High dose buprenorphine may be used for detox or
  maintenance treatment of opioid dependent
  patients.
• Induction
• Delay first dose buprenorphine/naloxone
  (Suboxone) film until patient in mild opiate
  withdrawal.
• Start 4-8mg day 1, then increase dose (2, 4 or
  8mg) every day until not using other opioids, no
  withdrawal / cravings.
• For detox 8 to 16mg daily, then taper to zero
  over 1-2 weeks.
• For maintenance most patients require 12 to 24mg
  daily.
• Warn patients about using other sedatives and
  never dose an intoxicated /sedated patient.
• Take-away doses only for low-risk patients.
• Link patient to appropriate medical and
  psychosocial services.
• Seek help if uncertain.

90
Interested in becoming an accredited OST
prescriber?

• Contact the DASSA GP Program Project Officer
• Telephone [phone]
• Email dassa.gpprogram_at_health.sa.gov.au

91
Pharmacotherapy Accreditation Training necessary
for prescribing of methadone and buprenorphine
mono Subutex for dependence

• ½ day workshop
• Take-home exam
• 2 clinical sessions
• One with standardised patients 2 new
  assessments
• One with real patients at Eastern DASSA Services
  coming in for reviews.
• ?
• Recommendation to DDU
• ?
• Accreditation

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Post on line course Examination

• If you are interested in obtaining RACGP or ACRRM
  CME credits for this course you need to complete
  the quiz that can be downloaded from the DASSA
  website where you have accessed this file at
  http//www.dassa.sa.gov.
• /Methadone and /or Buprenorphine prescribing
• /Buprenorhine/Naloxone (Suboxone)
  prescribing
• Please print off, complete and submit to theGP
  Program Project Officer by fax
• [phone]
• or email
• dassa.gpprogram_at_health.sa.gov.au

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