Transcript Slide 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
Want fast advice?
> Drug and Alcohol Clinical Advisory Service
ph 8363 8633
24/7 advice from senior medical staff.
> Alcohol and Drug Information Service
ph 1300 13 1340
24-hour information and counselling, links to a local DASSA counsellor.
(SA callers - local call fee).
> Eastern DASSA Services
ph 8130 7500 (office hours)
Ask for Senior Medical Staff.
> Drugs of Dependence Unit
ph 1300 652 584 (office hours)
Advice on patient prescribing from a regulatory
view point.
2
Drug and Alcohol Services South Australia
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
3
Drug and Alcohol Services South Australia
Rationale and objectives in
treating opioid dependence
4
Drug and Alcohol Services South Australia
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
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Drug and Alcohol Services South Australia
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.
6
Drug and Alcohol Services South Australia
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.
7
Drug and Alcohol Services South Australia
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.
8
Drug and Alcohol Services South Australia
‘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
• 2–5% remission rate per annum
• Most stop heroin use by late 30’s to 40’s
> 1–2% mortality rate per annum
• >10 x greater than age, gender matched
non-users
• Death from overdose, liver disease, suicide, trauma
9
Drug and Alcohol Services South Australia
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
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Drug and Alcohol Services South Australia

Treatment pathways for dependent
opioid users
Generally 2 pathways of treatment:
> detoxification or withdrawal followed by
abstinence based programs
OR
> substitution [sometimes called ‘agonist
substitution’ or ‘opioid substitution’ or
‘maintenance’]
11
Drug and Alcohol Services South Australia
Dependent opioid user
Detox
Substitution
maintenance treatment
Detox from
maintenance treatment
Post detox treatment options
counselling, residential rehabilitation, naltrexone
12
Drug and Alcohol Services South Australia
Dependent opioid user
Detox
Substitution
maintenance treatment
Detox from
maintenance treatment
Post detox treatment options
counselling, residential rehabilitation, naltrexone
NB …however…relapse rates are much higher in
abstinence based programs, so substitution is the preferred
option and is an evidence based alternative.
13
Drug and Alcohol Services South Australia
Abstinence based approaches
> Patient needs to be withdrawn or ‘detoxified’
> Patient can then embark on abstinence based
programs.
14
Drug and Alcohol Services South Australia

Opiate withdrawal syndrome
Withdrawal from short acting opioids
eg morphine, heroin, codeine
Withdrawal from long acting opioids
eg methadone, buprenorphine
15
>
>
>
>
>
>
>
>
Increased pain
Agitation, poor sleep
Dysphoria
Diarrhoea, abdo cramps
Nausea, vomiting
Increased BP, PR, RR
Sweaty, urine
Piloerection, runny nose,
runny eyes
> Dilated pupils
Drug and Alcohol Services South Australia
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)
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Drug and Alcohol Services South Australia
Post-withdrawal interventions
> Counselling
• various models (supportive, behavioural, dynamic)
• Cochrane: limited efficacy outpatient counselling alone
> Residential rehabilitation (long term > 3/12)
> Self–help (NA, Smart Recovery)
> Oral Naltrexone
• opioid antagonist that blocks effects of opioid use
• effective for those who take it, but high drop out rate
(<10% 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)
17
Drug and Alcohol Services South Australia
Dependent opioid user
Detox
Substitution
maintenance treatment
Detox from
maintenance treatment
Post detox treatment options
counselling, residential rehabilitation, naltrexone
18
Drug and Alcohol Services South Australia
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
•
•
•
19
Codeine, heroin
methadone (oral)
buprenorphine
(sublingual)
buprenorphinenaloxone (sublingual)
Drug and Alcohol Services South Australia
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)
20
Drug and Alcohol Services South Australia
Dependent opioid user
Detox
Substitution
maintenance treatment
Detox from
maintenance treatment
Post detox treatment options
counselling, residential rehabilitation, naltrexone
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.
21
Drug and Alcohol Services South Australia
Assessment and treatment
selection
22
Drug and Alcohol Services South Australia
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’.
23
Drug and Alcohol Services South Australia
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?
24
Drug and Alcohol Services South Australia
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
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Drug and Alcohol Services South Australia
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)
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Drug and Alcohol Services South Australia
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
27
Drug and Alcohol Services South Australia
Want fast advice?
> Drug and Alcohol Clinical Advisory Service
ph 8363 8633
24/7 advice from senior medical staff.
> Alcohol and Drug Information Service
ph 1300 13 1340
24-hour information and counselling, links to a local DASSA counsellor.
(SA callers - local call fee).
> Eastern DASSA Services
ph 8130 7500 (office hours)
Ask for Senior Medical Staff.
> Drugs of Dependence Unit
ph 1300 652 584 (office hours)
Advice on patient prescribing from a regulatory
view point.
28
Drug and Alcohol Services South Australia
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.
29
Drug and Alcohol Services South Australia
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?
30
Drug and Alcohol Services South Australia
Case 2: Pete
Is Pete dependent?
1. Tolerance
2. Withdrawal
3. Opioids taken in larger amounts or longer
than intended
31



4. Persistent desire or unsuccessful attempts
to cut down

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 given up / reduced.

7. Opioid use is continued despite recurrent physical
or psychological problem caused by opioids.

Drug and Alcohol Services South Australia
Case 2: Pete
What treatment plan would you negotiate?
1. Treat infected hand with antibiotics
2. 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.
3. Avoid benzodiazepines.
> buprenorphine/naloxone (Suboxone®) film better
relief of withdrawal and less OD risk
32
Drug and Alcohol Services South Australia
Want fast advice?
> Drug and Alcohol Clinical Advisory Service
ph 8363 8633
24/7 advice from senior medical staff.
> Alcohol and Drug Information Service
ph 1300 13 1340
24-hour information and counselling, links to a local DASSA counsellor.
(SA callers - local call fee).
> Eastern DASSA Services
ph 8130 7500 (office hours)
Ask for Senior Medical Staff.
> Drugs of Dependence Unit
ph 1300 652 584 (office hours)
Advice on patient prescribing from a regulatory
view point.
33
Drug and Alcohol Services South Australia
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 >> +ve opiates, amphetamine,
cannabis, BZD.
> In trouble from employer due to absences.
> Asks for buprenorphine/naloxone (Suboxone®).
Q1. How do you respond to Tony’s request?
34
Drug and Alcohol Services South Australia
Case 3: Tony
> Tony not opioid dependent and unsuitable for
OST [doesn’t 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
35
Drug and Alcohol Services South Australia
Want fast advice?
> Drug and Alcohol Clinical Advisory Service
ph 8363 8633
24/7 advice from senior medical staff.
> Alcohol and Drug Information Service
ph 1300 13 1340
24-hour information and counselling, links to a local DASSA counsellor.
(SA callers - local call fee).
> Eastern DASSA Services
ph 8130 7500 (office hours)
Ask for Senior Medical Staff.
> Drugs of Dependence Unit
ph 1300 652 584 (office hours)
Advice on patient prescribing from a regulatory
view point.
36
Drug and Alcohol Services South Australia
Clinical pharmacology
buprenorphine [BPN]
Actions, pharmacokinetics, side-effects
and toxicity drug interactions
37
Drug and Alcohol Services South Australia
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 4:1 ratio)
2 and 8mg sublingual film: reduces injecting and diversion
(injected buprenorphine/naloxone (Suboxone®) reduces
desired effect of plain buprenorphine).
38
Drug and Alcohol Services South Australia
Classification of opioids
> Methadone, morphine
> Buprenorphine
• Partial agonist mu
receptor
• Receptor affinity
much greater than
methadone /
morphine/naloxone /
naltrexone
39
100
Full Agonists: Heroin, morphine,
methadone, codeine
Size of Opiate Agonist Effect.
.
• full agonist mu
receptor
• receptor affinity
comparable to
heroin
0
Threshold for respiratory
depression
Partial Agonists:
Buprenorphine
Antagonists: Naltrexone, naloxone
Drug Dose
Drug and Alcohol Services South Australia
Current opioid
pharmacotherapies
available in Australia
Methadone
Full agonist
Buprenorphine
Partial agonist
Naltrexone
[antagonist]
40

Drug and Alcohol Services South Australia
Morphine
Oxycodone
Methadone
Buprenorphine
> Buprenorphine:
• has a partial agonist action at the mu receptor
• Once it occupies the mu- receptor, blocks other opioids
41
Drug and Alcohol Services South Australia
Morphine
Oxycodone
Methadone
Naltrexone
> Naltrexone:
• have a NO agonist action at the mu receptor
• blocks other opioids
42
Drug and Alcohol Services South Australia
Pharmacological properties of
buprenorphine
> Reverses opiate withdrawal (doses >4-8mg)
> Minimal opiate effects (eg sedation)
> Reduces effects other opioid use (doses >16mg)
> Higher safety profile due to ‘ceiling effects’
• Low risk respiratory depression, even in opiate naive
individuals
• Overdose risk with other sedatives (BZDs, EtOH)
43
Drug and Alcohol Services South Australia
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!
44
Drug and Alcohol Services South Australia
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
45
Drug and Alcohol Services South Australia
Principles of safe and
effective prescribing
safe induction
effective maintenance treatment
responding to continued drug use
take aways
addressing co-morbidities
46
Drug and Alcohol Services South Australia
Principles safe induction onto
buprenorphine/naloxone (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
•
•
•
•
47
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
Drug and Alcohol Services South Australia
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
48
Drug and Alcohol Services South Australia
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 (<14 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)
49
Drug and Alcohol Services South Australia
Examples of dosing regimes – for
withdrawal
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
A
6mg
8mg
10mg
8mg
6mg
4mg
2mg
B
4mg
8mg
6mg
4mg
2mg
0mg
0mg
Detox
50
Drug and Alcohol Services South Australia
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.
51
What buprenorphine/naloxone (Suboxone®)
film dosing regime would you prescribe?
Drug and Alcohol Services South Australia
Case 1: Caroline
A.
continued
Example of proposed regime
Day 1: 4mg
Day 2: 8mg
Day 3: 6mg
Day 4: 4mg
Day 5: 2mg
Day 6: stop
52
Drug and Alcohol Services South Australia
If considering prescribing
buprenorphine/naloxone (Suboxone®) film
for 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
53
Drug and Alcohol Services South Australia
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
patient’s needs
54
Drug and Alcohol Services South Australia
Want fast advice?
> Drug and Alcohol Clinical Advisory Service
ph 8363 8633
24/7 advice from senior medical staff.
> Alcohol and Drug Information Service
ph 1300 13 1340
24-hour information and counselling, links to a local DASSA counsellor.
(SA callers - local call fee).
> Eastern DASSA Services
ph 8130 7500 (office hours)
Ask for Senior Medical Staff.
> Drugs of Dependence Unit
ph 1300 652 584 (office hours)
Advice on patient prescribing from a regulatory
view point.
55
Drug and Alcohol Services South Australia
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 doesn’t want long term treatment.
Q.
56
How do you manage this scenario?
Drug and Alcohol Services South Australia
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).
57
Drug and Alcohol Services South Australia
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
58
Drug and Alcohol Services South Australia
Examples of induction regimes
59
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
Drug and Alcohol Services South Australia
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.
60
Drug and Alcohol Services South Australia
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.
61
Describe how you would approach withdrawal
treatment.
Drug and Alcohol Services South Australia
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)
62
Drug and Alcohol Services South Australia
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
doesn’t help control the pain.
Q.
63
What do you do?
Drug and Alcohol Services South Australia
Case 4: Lisa
1. Explore her belief that “buprenorphine/naloxone
(Suboxone®) film doesn’t 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)
2. Stabilise on higher dose buprenorphine/naloxone
(Suboxone®) film (eg 12 or 16mg) with view to stopping
Nurofen plus altogether
3. Review regularly (eg weekly) and UDS
4. Assess for other mental health conditions
5. Refer for counselling? addiction specialist
64
Drug and Alcohol Services South Australia
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
65
Drug and Alcohol Services South Australia
‘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
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Drug and Alcohol Services South Australia
‘Take-away’ framework
Basically with buprenorphine/naloxone (Suboxone®) film:
>> none to start
>> can increase over an 18 month period to 5 unsupervised
doses [see next slide]
>> only with objective evidence of stability:
•
•
•
•
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Clear urine drug screens
No evidence of injecting
No missed doses at chemist
Regular attendance at doctor appointments
Drug and Alcohol Services South Australia
‘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
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Drug and Alcohol Services South Australia
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 (>1 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
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Drug and Alcohol Services South Australia
Examples of 2 and 3 day dosing regimes
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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
Drug and Alcohol Services South Australia
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
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Drug and Alcohol Services South Australia
Want fast advice?
> Drug and Alcohol Clinical Advisory Service
ph 8363 8633
24/7 advice from senior medical staff.
> Alcohol and Drug Information Service
ph 1300 13 1340
24-hour information and counselling, links to a local DASSA counsellor.
(SA callers - local call fee).
> Eastern DASSA Services
ph 8130 7500 (office hours)
Ask for Senior Medical Staff.
> Drugs of Dependence Unit
ph 1300 652 584 (office hours)
Advice on patient prescribing from a regulatory
view point.
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Drug and Alcohol Services South Australia
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.
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What do you focus upon in the examination?
Drug and Alcohol Services South Australia
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.
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Drug and Alcohol Services South Australia
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.
75
Describe how you would start
buprenorphine/naloxone (Suboxone®) film
treatment?
Drug and Alcohol Services South Australia
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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Drug and Alcohol Services South Australia
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.
77
How do you respond to his request?
Drug and Alcohol Services South Australia
Case 5: Jarred
Answer:
Too early to authorise regular take-aways.
1. 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
2. Offer alternate (24mg) or three day (32mg) dosing until
patient can qualify for regular take-aways.
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Drug and Alcohol Services South Australia
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.
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How do you respond?
Drug and Alcohol Services South Australia
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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Drug and Alcohol Services South Australia
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.
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How do you respond?
Drug and Alcohol Services South Australia
Want fast advice?
> Drug and Alcohol Clinical Advisory Service
ph 8363 8633
24/7 advice from senior medical staff.
> Alcohol and Drug Information Service
ph 1300 13 1340
24-hour information and counselling, links to a local DASSA counsellor.
(SA callers - local call fee).
> Eastern DASSA Services
ph 8130 7500 (office hours)
Ask for Senior Medical Staff.
> Drugs of Dependence Unit
ph 1300 652 584 (office hours)
Advice on patient prescribing from a regulatory
view point.
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Drug and Alcohol Services South Australia
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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Drug and Alcohol Services South Australia
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
family’s 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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Drug and Alcohol Services South Australia
Stopping OST
> Chronic condition needs long-term treatment. Better
outcomes after >12months 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 don’t have to
be hurried towards the end.
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Drug and Alcohol Services South Australia
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
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Drug and Alcohol Services South Australia
Want fast advice?
> Drug and Alcohol Clinical Advisory Service
ph 8363 8633
24/7 advice from senior medical staff.
> Alcohol and Drug Information Service
ph 1300 13 1340
24-hour information and counselling, links to a local DASSA counsellor.
(SA callers - local call fee).
> Eastern DASSA Services
ph 8130 7500 (office hours)
Ask for Senior Medical Staff.
> Drugs of Dependence Unit
ph 1300 652 584 (office hours)
Advice on patient prescribing from a regulatory
view point.
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Drug and Alcohol Services South Australia
Maintenance prescription for
buprenorphine/naloxone (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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Drug and Alcohol Services South Australia
Safe and effective buprenorphine/naloxone
(Suboxone®) film treatment:
Key points
1.
High dose buprenorphine may be used for detox or
maintenance treatment of opioid dependent patients.
2.
Induction:
•
•
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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.
3.
For detox: 8 to 16mg daily, then taper to zero over 1-2 weeks.
4.
For maintenance: most patients require 12 to 24mg daily.
5.
Warn patients about using other sedatives and never dose an
intoxicated /sedated patient.
6.
Take-away doses only for low-risk patients.
7.
Link patient to appropriate medical and psychosocial services.
8.
Seek help if uncertain.
Drug and Alcohol Services South Australia
Interested in becoming an accredited
OST prescriber?
Contact the DASSA GP Program – Project Officer
Telephone: (08) 8274 3306
Email: [email protected]
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Drug and Alcohol Services South Australia
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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Drug and Alcohol Services South Australia
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 the
GP Program Project Officer by fax:
(08) 8274 3320
or email:
[email protected]
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Drug and Alcohol Services South Australia