Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Acknowledgements
The Drug and Alcohol Office and Department of Health are grateful for the contribution to the
development of this manual from the following sources.
The Australian Government Department of Health and Ageing National Clinical Guidelines and
Procedures for the Use of Buprenorphine/Methadone in the Treatment of Opioid Dependence,
from which much of the material is directly drawn.
The NSW Department of Health NSW Clinical guidelines for methadone and buprenorphine treatment of opioid dependence, from which the chapter summaries are adapted.
The Opioid Pharmacotherapy Advisory Committee (OPAC) and the clinicians at Next Step Drug and
Alcohol Services who have provided invaluable comments during the consultation process which
has preceded the development of many of the WA specific policies.
Prepared by
The Drug and Alcohol Office, Community Clinical Programs, in consultation with the
Community Program for Opioid Pharmacotherapy Management Committee
For further information, or to obtain copies of the documents, please contact:
Next Step Drug and Alcohol Services - Community Clinical Programs
Drug and Alcohol Office
PO Box 126, Mt Lawley WA 6929
Telephone (08) 9219 1919
ISBN: 978-1-876684-20-4
Drug and Alcohol Office (WAADA) 2006
Foreword
The Western Australia clinical policies and procedures for the use of methadone and
buprenorphine in the treatment of opioid dependence have been adapted from the national
guidelines to include the legislative and administrative requirements for W.A.
Compliance with the policies, procedures and clinical practices set out in this document is a
condition of authorisation for prescribers and dispensers of methadone and buprenorphine to
opioid dependent patients.
On occasions, clinicians may need to vary their clinical practice from that recommended in this
document according to patient requirements. In these circumstances clinicians should clearly
document the reasons for any variations and any advice received from the Clinical Advisory
Service. There should be no variation from the legislative or administrative requirements set out
in section 1 of this document.
The provision of methadone and buprenorphine treatment for opioid dependence in Western
Australia is managed jointly by the Department of Health (DOH) and the Drug and Alcohol Office
(DAO).
ii
TABLE OF CONTENTS
INTRODUCTION
1.0
LEGISLATIVE AND ADMINISTRATIVE REQUIREMENTS
1.1 LEGISLATIVE REQUIREMENTS
Authorisation as a methadone/buprenorphine prescriber in Western Australia
Authorisation as a methadone/buprenorphine dispenser in Western Australia
Authority to Prescribe
Conditions Associated with the Authority to Prescribe Opioid Pharmacotherapy
1.2
INFORMED CONSENT AND PATIENT INFORMATION.
Appeals/Complaints Process
5
5
5
5
6
6
9
10
2.0
CLINICAL PHARMACOLOGY
2.1
GENERAL INFORMATION
What is Methadone?
Pharmacokinetics
Drug Interactions
Safety
Withdrawal from methadone
What is buprenorphine?
Pharmacokinetics
Drug Interactions
Safety
Withdrawal from buprenorphine
Buprenorphine-naloxone combination product (Suboxone)
12
12
12
13
14
14
14
15
16
16
17
18
18
3.0
CLINICAL MANAGEMENT FOR MAINTENANCE TREATMENT
3.1
ENTRY INTO METHADONE/BUPRENORPHINE MAINTENANCE TREATMENT
Indications
1. Opioid dependence
2. Patient must be at least 16 years of age (see section 5.10)
3. Patient must have 100 points of ID (see Appendix 3 and section 3.10)
4. Patients must be able to give informed consent (see section 1.2)
Contraindications
Precautions
3.2
SELECTING MAINTENANCE PHARMACOTHERAPIES
3.3
ASSESSMENT FOR MAINTENANCE TREATMENT
3.4 COMMENCING MAINTENANCE TREATMENT
3.5
INDUCTION TO METHADONE TREATMENT
Commencing methadone from heroin use
Size of the first dose
Stabilisation
Monitoring during the first two weeks.
Dose titration
Methadone dose levels
Changing dose level
Split dosing of methadone
Transfer from other pharmacotherapies
From buprenorphine
From oral naltrexone
20
20
20
21
21
21
21
22
22
24
27
28
28
28
29
30
30
30
31
31
32
32
32
32
iii
3.6
3.7
3.8
3.9
3.10
3.11
3.12
4.0
TAKEAWAY AND MISSED DOSES
4.1
TAKEAWAY DOSES
Indications of stability
Contraindications
Authorisation of takeaway doses of methadone/
buprenorphine outside this schedule
Frequency of takeaway doses
Schedule for takeaway doses
Size of the takeaway doses
Dispensing of takeaway doses
Labelling and containers
iv
33
33
35
36
36
37
38
38
40
42
42
43
43
43
44
44
45
45
46
47
47
47
47
48
48
48
48
48
48
49
49
49
49
50
51
52
52
53
54
54
55
55
55
56
56
57
57
57
4.2
59
5.0
COMMON MANAGEMENT ISSUES
5.1
SIDE EFFECTS/ADVERSE DRUG REACTIONS
5.2
OVERDOSE
Methadone
Buprenorphine
5.3
DOSING INTOXICATED PATIENTS
5.4
VOMITED DOSES
5.5
INCORRECT DOSE ADMINISTERED
Methadone
Buprenorphine
5.6 CONTINUED HIGH RISK DRUG USE & POLYDRUG USE
Benzodiazepines
5.7
TREATING HOSPITALISED PATIENTS
5.8
ANALGESIA AND ANAESTHESIA
Analgesic requirements for inpatients on methadone
Analgesic requirements for patients on buprenorphine
5.9
DIVERSION OF METHADONE/BUPRENORPHINE
5.10 PATIENTS LESS THAN 18 YEARS OLD
5.11 PREGNANCY AND LACTATION
The patient who becomes pregnant while in buprenorphine treatment
Principles in managing pregnancy in opioid dependent women
Dose reductions or detoxification during pregnancy
Breastfeeding
Neonatal Withdrawal Syndrome
5.12 HIV
5.13 HEPATITIS B & C
5.14 PSYCHIATRIC COMORBIDITY
61
61
62
62
62
64
64
65
65
67
67
68
68
69
69
70
70
73
74
75
75
76
76
76
78
78
79
6.0
CLINICAL MANAGEMENT OF HEROIN WITHDRAWAL
6.1
HEROIN WITHDRAWAL IN CONTEXT
6.2
NON-PHARMACOLOGICAL ASPECTS IN MANAGING HEROIN WITHDRAWAL
The optimal setting for withdrawal
Getting organised for withdrawal
Supportive care
Monitoring
Scales for assessing opiate withdrawal
6.3
OVERVIEW OF BUPRENORPHINE IN THE MANAGEMENT OF HEROIN WITHDRAWAL
Efficacy of buprenorphine compared to other withdrawal medication regimes
Use of ancillary medications in conjunction with buprenorphine
Continued use of heroin and other drugs
Gateway model of treatment with buprenorphine
6.4
BUPRENORPHINE REGIMENS IN OUTPATIENT WITHDRAWAL SETTINGS
Flexible dosages
6.5
BUPRENORPHINE FOR HEROIN WITHDRAWAL IN RESIDENTIAL SETTINGS
6.6
TRANSITION TO POST-WITHDRAWAL TREATMENT
Transition to buprenorphine maintenance treatment.
Transition to methadone maintenance treatment
Commencing naltrexone treatment after short
duration buprenorphine withdrawal
80
80
81
82
83
83
84
84
85
85
86
86
87
88
88
89
90
90
90
90
v
vi
APPENDIX 1
92
APPENDIX 2
96
97
APPENDIX 4 URINALYSIS
98
99
100
102
APPENDIX 8 DIVERSION
104
105
106
108
109
111
121
LIST OF TABLES
Table 1 Effects of Methadone
Table 2 Effects of mono (Subutex) and combination (Suboxone) preparations
Table 3 Diagnostic Definition of Opioid Dependence (DSM IV)
Table 4 Key features of the assessment
Table 5 Key factors affecting precipitated withdrawal
Table 6 Common Side Effects with Methadone/Buprenorphine
Table 7 Signs and Symptoms of Methadone Overdose
Table 8 Clinical features of the Heroin Withdrawal Syndrome
Table 9 Criteria for residential withdrawal services
12
19
21
27
35
61
62
80
93
LIST OF FIGURES
Figure 1 Program Structure
Figure 2 Treatment Pathways for dependent heroin users
Figure 3 Plasma levels of Methadone during First 3 days of Dosing
Figure 4 Gateway Model of treatment with Buprenorphine
1
3
13
25
Section Summaries
The following pages contain the quick read summaries of each section. The reference to source
the full information is also provided.
Introduction
Summary
See page
vii
Chapter 1
viii
See page
Patients under the age of 18 years must be referred to Next Step Youth Service for
assessment. A copy of the assessment report must be attached to the Application for
Authority to Prescribe Pharmacotherapies to an Opioid Dependent Person.
Patients under the age of 16 will require special approval from the Department of
Health, Chief Executive Officer.
See page
Chapter 1
Summary
The patient must be able to give informed consent before the treatment begins.
This includes:
Explanation of treatment options, aims, policies and expectations
Warning not to drive or operate machinery during the first 10 days of treatment,
34 days after a dose increase or when taking other drugs (e.g. other CNS
depressants)
Written information about treatment
Signing of the consent to treatment form on the Authority to Prescribe
Pharmacotherapies form.
Documentation of a treatment plan.
Asking a patient to sign a release of information form for HIC data can help prevent
doctor shopping.
Confidentiality/Privacy legislation
Due to legislative requirements patients do need to sign appropriate consent forms to
allow the sharing of information between service providers and ensure appropriate
management. This is done when the patient signs the patient declaration form on the
application form.
ix
Chapter 2
Summary
Methadone pharmacology:
Onset of effects: 30 minutes
Peak effects: about 3-4 hours
Half-life: 1347 hours (mean 24 hours)
Blood levels continue to rise during the first week of daily dosing
Time to stabilise methadone in the body: 510 days
Side effects as for heroin
Methadone withdrawal onset: 3648 hours, peak intensity within 57 days.
13
14
Methadone does not cause damage to any of the major organs or systems of the body.
The major hazard is the risk of overdose, particularly at the time of induction to
treatment and when methadone is used in combination with sedative drugs. Slow onset
of action and long half life of methadone mean that toxic effects may become life
threatening many hours after ingestion. Clinical vigilance is most important in the first
14 days of treatment.
Buprenorphine pharmacology:
Onset of effects: 3060 minutes
Peak effects: 14 hours
Half life: 2072 hours (mean 34 hours)
Time to stabilise buprenorphine levels in the body: 710 days
Side effects as for heroin
Buprenorphine withdrawal onset 25 days, symptoms
generally milder than withdrawal from other opioids.
See Page
14
14
16
18
Summary
See Page
16
17
Chapter 2
19
xi
See page
Chapter 3
Opioid
xii
20
21
Contraindications:
Severe hepatic or respiratory insufficiency
Known hypersensitivity to the proposed drug formulation
Inability to give informed consent
Buprenorphine is not recommended in pregnancy and breastfeeding
22
Precautions:
High risk polydrug use or co-ocurring alcohol dependence
Acute or unstable psychiatric illness
Chronic pain
Concomittant medical problems
Cardiac vigilance required with methadone doses greater than 150mg
22
25
27
Summary
See page
27
All eligible patients merit prompt admission to treatment, but this is especially
important for:
Pregnant women
People with HIV and their opioid using partners
Hepatitis B carriers and their opioid using partners
People being released from correctional institutions
27
Chapter 3
Commencing treatment:
28
Patients need to begin methadone or buprenorphine treatment in a well supervised
setting to ensure frequent monitoring. Special attention needs to be given to patients
with the precautions listed above.
Safety is achieved by:
Establishing a therapeutic relationship that fosters good communication between
patient and doctor
Cautious initial dosing
Caution with concurrent prescribing of sedative medication
Caution when concomittant medical conditions are present
Repeated observation of the patient during the first week
Careful explanation of intoxicating effects and withdrawal during the induction and
maintenance phases of treatment
The treatment plan outlined at the initial assessment is developed during the first week of
treatment in collaboration between the patient, the prescriber and other members of the
treatment team. The plan should be reviewed at least every six months.
28
xiii
Chapter 3
Summary
xiv
See page
29
Starting dose methadone. Starting dose of 20-25mg and increase by 5mg every 2-3 days
subject to assessment. Caution: deaths in the first two weeks have been associated with
methadone doses in the range 25 100 mg/day. A dose of 20 mg for a 70kg patient with
low tolerance can be presumed safe.
29
Starting dose buprenorphine. The first dose of buprenorphine should not be given
until at least 6 12 hours after the patients last dose of heroin and at least 24 36
hours after the last dose of methadone to avoid precipitated withdrawal.
A starting dose of 4 8 mg of buprenorphine will be tolerated by most patients and will
lead to rapid stabilisation. Aim for dose of 12 - 16 mg by day 3 or 4.
Some patients may select slow increases in dose (perhaps fearing increased dependence
or side effects) but this may result in continuing withdrawal symptoms and low retention
rates.
33
35
Stabilisation is about titrating the dose against the needs of the (methadone)
individual patient. Dose changes should only be made after the (buprenorphine)
patient is assessed by the prescriber.
Assessment should include:
Features of intoxication or withdrawal over the preceding 24 hours (patients
self-report, examination)
Patients perception of dose adequacy and satisfaction with treatment
Patients adherence to dosing regimen
Other drug use (patients self-report, urine testing)
Side effects and adverse events (including intoxication and overdoses).
30
35
Summary
See page
30
33
Chapter 3
30
37
31
32
xv
Chapter 3
Summary
See page
36
38
xvi
40
32
32
Review all patients regularly, including those who appear to be progressing well
(at least 4 times per year). A review is a comprehensive reassessment of the patient and
progress in treatment. Patients should remain in treatment until they achieve their
agreed treatment goals. There is no optimal duration of treatment.
42
Coordinated care
People with opioid dependence usually have complex psychosocial and health problems.
Opioid treatment programs can provide a framework for enhanced care, involving
comprehensive assessment and treatment planning. Psychosocial interventions can add
to the effectiveness of pharmacotherapy programs and should be freely available to
all patients (not compulsory).
42
Community dispensing
Pharmacies must be approved to dispense pharmacotherapies to opioid dependent
people. Contact the Community Clinical program on 9219 1907 or 9219 1913 to locate
pharmacies. The prescriber must notify the CAS of any changes in dosing location prior
to the change occurring.
Pharmacies do charge dispensing fees for administering each dose. These fees are
set by individual pharmacies.
Administration
Methadone and buprenorphine can only be dispenpensed in accordance with a valid
prescription. Before administration the pharmacist should check that the prescription
is valid, confirm the identity of the patient and assess that the patient is not
intoxicated. Methadone and buprenorphine doses must be stored, dispensed and
recorded in accordance with the legislative requirements.
See page
43
46
International travel
Taking methadone or buprenorphine overseas requires careful consideration of the
stability of the patient and the rules and customs of the country being visited.
Advice should be sought from Community Clinical Programs 9219 1907/9219 1913.
49
48
48
Cessation of treatment
Outcomes of methadone and buprenorphine maintenance improve with increasing
time in treatment. It is recommended that patients be encouraged to remain in
treatment for at least 12 months to achieve enduring lifestyle changes.
Elements of successful withdrawal from therapy are:
Planning and collaboration between patient, prescriber and other staff
Flexible and slow dose reduction. Planned withdrawal can take months.
Psychosocial support such as supportive counselling, information and skills
training, close monitoring, residential rehabilitation, family involvement.
Aftercare: continuing counselling and involvement of the case manager,
careful handover to the patients general practitioner.
49
Chapter 3
Summary
xvii
Summary
See page
84
52
Chapter 3
The clinician should remain vigilant to the possibility that alcohol or other drug use may
increase to hazardous or harmful levels during and after cessation of treatment.
50
51
Buprenorphine
Dose > 16 mg 4 mg per week or fortnight
Dose 8 16 mg 2 4 mg per week or fortnight
Dose < 8 mg 2 mg per week or fortnight
xviii
Involuntary withdrawal
Patients may be removed from treatment for:
Violence or threat of violence against staff or other patients
Drug dealing on or near the clinic or dosing location
Diversion of dose
Unacceptable disruption to the local amenity
Dose reduction should be gradual. Rapid dose reduction or abrupt cessation of
treatment is warranted only in cases of violence, assault or threatened assault,
or repeated dose diversion.
51
Relapse
When relapse occurs after leaving treatment and the patient seeks readmission to
treatment this should be offered expeditiously and without recrimination.
51
52
Chapter 3
Naltrexone
Administering naltrexone to a patient who is physically dependent on opioids will
precipitate severe withdrawals. Patients transferring to naltrexone should withdraw
completely from methadone and buprenorphine before commencing naltrexone in
accordance with the timelines below:
Last dose
Commence Naltrexone
Methadone
14 days after the last dose
Buprenorphine
< 2 mg
4 5 days
> 2 mg
7 days
xix
ixx
See page
Takeaway doses
Supervised dosing is an essential component of methadone/buprenorphine treatment.
54
Chapter 4
xx
56
Summary
See page
55
55
58
Chapter 4
58
xxi
Summary
See page
Summary
Buprenorphine
Days missed*
1 - 4
If no evidence of intoxication dose as usual.
5 6
Consult prescriber.
> 7
Patient must see prescriber for re-induction.
* refers to days equivalent, if clients not dosing on a daily basis. E.g. a patient dosing
second daily only misses 2 doses to achieve 4 missed days.
Chapter 4
8
4
6
2
xxii
59
59
See page
Side effects
Methadone and buprenorphine have similar side effects to other opioids. Manage
according to nature and severity.
61
Overdose
Naloxone (Narcan) given intravenously, intramuscularly or subcutaneously is the
treatment of choice for an opioid overdose, since it leads to immediate reversal of
the overdose. Admission to hospital should always be recommended as the effect of
naloxone does not last as long as the effect of heroin or methadone.
62
Buprenorphine overdose:
The risk of lethal overdose on buprenorphine in an opioid dependent person is
less than that associated with methadone.
However the effects of buprenorphine are not reversed by the usual doses of
naloxone. Doses of 10 35 mg/70kg (10 30 times the dose used to reverse
heroin overdose) may be required to reverse the effects of buprenorphine
toxicity.
Consider the long duration of action of buprenorphine when treating the
effects of an overdose.
63
Intoxicated presentations
Patients should be assessed for intoxication prior to being dosed. Intoxicated patients
should not be dosed or be given takeaway doses and patients need to be made aware
of this at the commencement of treatment.
Signs of intoxication are set out in Appendix 7. Prescribers may give a reduced dose
if after reviewing the patient intoxication is assessed as mild.
64
Chapter 5
Methadone overdose:
Naloxone should be given as a prolonged infusion when treating methadone
overdose. Patients who are thought to have taken a methadone overdose
require prolonged observation
Methadone overdose is usually associated with the use of other drugs and
usually occurs within the first few days of induction to treatment. Patients
should be warned of these risks.
Deaths often occur at home during sleep. Dosing in the morning reduces the
risk. Family members should be warned that deep snoring during induction to
treatment could be a sign of dangerous respiratory depression and should be
reported to the prescriber.
Concomittant medical problems.
xxiii
Summary
See page
Vomited doses
Methadone
Vomiting more than 20 minutes after a methadone dose: reassure the patient that the
dose will have been adequately absorbed.
Vomiting less than 20 minutes after a methadone dose:
If a patient who has been in treatment for more than 2 weeks has been observed
by dispensing staff to vomit immediately after dosing a half dose may be
administered.
If a patient has been in treatment less than 2 weeks or there is uncertainty about
the event, review the patient 4 6 hours after dosing. If at this time the patient
appears to be experiencing withdrawal a dose supplementation of up to half the
patients usual dose can be given.
Monitor pregnant patients who vomit their methadone dose closely and give a
supplementary dose if necessary to avoid withdrawal, which distresses the foetus.
64
Chapter 5
Buprenorphine
Buprenorphine doses are absorbed sub-lingually within 2 7 minutes. Vomiting after
this time makes no difference to the absorbed dose.
xxiv
65
Summary
Incorrect buprenorphine (over) dose administered
Warn the patient of possible overdose effects, risks associated with extra drug use
and against driving or operating machinery
See page
67
Monitor the patient for at least 6 hours if any of the following apply:
-
The patient develops symptoms of overdose
-
The patient has commenced treatment in the last 2 weeks
-
The dose is 16mg and has been given to a patient whose normal dose is 4mg
-
A dose 64 mg or more was administered
The prescriber should review the patient before the next dose
67
Chapter 5
xxv
Summary
See page
Weigh the risks of combining methadone or buprenorphine with other drug use against
the benefits in reducing harms, improving health and improving social functioning. If the
disadvantages predominate and the patient appears unwilling or unable to change it may
be necessary to arrange the patients gradual withdrawal from treatment.
Patients who are currently using other opioids, benzodiazepines or alcohol in large doses
should not have takeaway doses.
Benzodiazepines
Prescribing benzodiazepines to patients who are dependent on benzodiazepines as well
as opioids may be necessary but caution must be exercised. Benzodiazepine injection is
associated with vascular damage and death. Injection of the gel capsule formulation of
temazepam has been reported to lead to limb amputations. This formulation should not
be prescribed.
68
Where possible benzodiazepines should be dosed daily with the patients methadone or
buprenorphine. More stable patients can be considered for less frequent dispensing of
benzodiazepines.
Chapter 5
Diversion of dose
The risk of diversion can be reduced by ensuring appropriate procedures and supervision
of on site dosing, and careful selection of patients for takeaway doses
On the first occasion patients who have diverted or attempted to divert their dose:
Should not be given any further takeaway doses for at least 6 months and
If it was a supervised dose of buprenorphine, should be transferred to methadone
for at least 6 months (if they do not want methadone they should be detoxed off
maintenance treatment)
Diverted their supervised dose of methadone should have their doses made up to
200ml with water or cordial and be administered in 50 ml aliquots.
xxvi
70
See page
68
69
Chapter 5
Summary
xxvii
xvii
Chapter 5
Summary
xxviii
See page
74
75
74
Child protection
On initial assessment, at treatment review and when assessing eligibility for takeaway
doses it is important to consider the safety and well being of any children in the
patients care. A parents enrolment in an opioid treatment program alone is not a
reason to make a report to the Department of Child Protection.
76
77
See page
78
78
79
Chapter 5
Summary
ixxx
1
See page
80
Chapter 6
Physical symptoms generally commence 6 24 hours after last use and peak in severity
during days two to four, generally subsiding by day seven.
xxx
2
80
81
82
83
Summary
See page
Supportive care
Patients need information regarding
The nature and duration of withdrawal symptoms
Strategies for coping with symptoms and cravings
Strategies to deal with high-risk situations
The role of medication
83
Monitoring
An important part of withdrawal treatment is regular and frequent monitoring to check:
General progress
Drug use
Response to medication
Severity of withdrawal symptoms (see Appendix 10 for withdrawal scales)
Complications or difficulties
Ongoing motivation levels
84
85
Patients should not receive the first dose of buprenorphine whilst they are still
experiencing heroin effects. It is preferable to withhold the first dose until the patient
is beginning to experience the early features of withdrawal.
Induction
Induction onto buprenorphine for the purposes of detoxification should follow the
same principles as for buprenorphine maintenance.
86
Review
Review by a trained health professional is recommended on a daily basis during the
first few days of the withdrawal regime. This is important so that doses can be
adjusted, if necessary, and any difficulties being experienced on the medication can
be addressed.
88
Chapter 6
xxxi
3
Summary
Transition to post withdrawal treatment
To buprenorphine maintenance: continue with an upward titration to optimal dose
To methadone maintenance: induct as per section 3.4 waiting at least 24 hours after
the last dose of buprenorphine before administering the first dose of methadone.
Chapter 6
To naltrexone: a number of procedures can be used, all patients need supervision and
access to the prescriber
xxxii
4
See page
90
Chapter 1
INTRODUCTION
Opioid dependence can result in a range of problems for the user, their family and friends and
for the wider community. These problems include health and social costs, the risk of overdose,
spread of blood borne viruses, the family breakdown; economic costs associated with morbidity,
mortality and absenteeism related to illicit drug use; and the cost of law enforcement for
drug related crime. Opioid replacement pharmacotherapy treatment is an effective strategy
for reducing the demand for drugs and the associated harms, by stabilising the lives of drug
dependent persons and reducing drug use and crime.
In Western Australia, opioid replacement treatment is available through the Community Program
for Opioid Pharmacotherapies (CPOP) a partnership program between government and community
service providers. The program adopts a shared care approach, with opioid treatment for
most people being provided by general practitioners and pharmacists in primary health care
settings. Next Step Specialist Drug and Alcohol Services provides support through education and
training, clinical consultancy and client referral as required. Next Step also provides services
directly to patients with more complex needs. The regulatory functions are provided through the
Pharmaceutical Services Branch within the Department of Health. The Drug and Alcohol Office
coordinates program management and policy development. Additionally, the Department of
Justice provides pharmacotherapy services for clients in custodial care.
Two pharmacotherapy medications are available, methadone and buprenorphine. Methadone
maintenance is now widely accepted as an effective treatment for opioid dependence. It
has been shown to achieve improvements in a number of areas, such as personal health and
social integration, reduction of criminal activity and reduced blood borne virus transmission.
Clinical trials have indicated that buprenorphine also has tremendous potential benefit as a
pharmacotherapy for the treatment of opioid addiction. Buprenorphine offers advantages in
terms of safety, the relative ease of withdrawal, the need for less frequent administration, and
flexibility with transition to other treatments. Methadone and buprenorphine as treatments for
opioid dependence are endorsed as a key strategies under the National Drug Strategy within the
framework of harm reduction.
PROGRAM STRUCTURE
The CPOP management structure is as follows:
Figure 1
Poisons Act 1964
& Regulations
Delegate of the
Department of Health
CPOP Management
Committee
Opioid Pharmacotherapy
Advisory Committee
(OPAC)
Mortality Review
Committee
5
1
Chapter 1
6
2
Chapter 1
Figure 2
Substitution
maintenance
treatment
Withdrawal
Methadone
Buprenorphine
Withdrawal from
substitution treatment
Postwithdrawal Interventions
Psychosocial interventions +/- naltrexone
Withdrawal Treatment
In general, withdrawal treatment is appropriate for those who are considering abstinenceoriented, post-withdrawal treatment (such as naltrexone, residential rehabilitation programs,
counselling or 12-step programs) or for those who are not interested in longer-term treatment,
and merely want a break from dependent heroin use. Buprenorphine can also be used to assist
the withdrawal process (see Section 6).
7
3
Chapter 1
8
4
Chapter 1
9
5
Chapter 1
Authority to Prescribe
Authorised methadone/buprenorphine prescribers must obtain from the Department of Health
Chief Executive Officer an individual patient authority for each patient being commenced on
treatment under Regulation 51C of the Poisons Regulations 1965.
An application for Authority to Prescribe opioid Pharmacotherapy form is completed by
the prescriber. The patient must also sign the application to indicate that they
acknowledge that the information will be forwarded to the Department of Health and
used for the management of the program.
The completed application for Authority to Prescribe opioid Pharmacotherapy form is
forwarded to the Clinical Advisory Service and the authorisation is issued by the
Department of Health. Specialist prescribers at Next Step may make direct application
to the Department of Health although they may consult the Clinical Advisory Service if
the need arises.
An authorisation number must be obtained prior to the writing of a prescription for
methadone or buprenorphine.
Authorisation is for a maximum maintenance dose of 120 mg of methadone or 24 mg of
buprenorphine.
The number of takeaways authorised on a prescription must be in accordance with the
policy on takeaway doses as set out in chapter 4 of this manual.
On completion the application form and record of the authority number should be filed
with the patients records.
Please note: An Authority to Prescribe opioid Pharmacotherapy application is required when
initiating prescribing for a patient transferring from another prescriber or for a patient that has
previously been treated by the same prescriber where the previous authorisation has expired or
been terminated.
Chapter 1
Maximum Dose
Approval must be obtained from the Department of Health to prescribe above a dose of 120mg
of methadone or 24 mg of buprenorphine. A completed Exceeding the Maximum Dose form is to
be completed and sent to the Clinical Advisory Service (CAS) for endorsement prior to forwarding
to the Department of Health. If approved an authorisation is issued by the Department of Health.
Prescriptions
A patient participating in the CPOP should only be prescribed one dose (excluding split doses) of
methadone or buprenorphine per day. In order to reduce the potential for dosing at multiple sites
to occur, when multiple prescriptions are written for a patient, the authorised prescriber must
ensure that the additional prescriptions do not authorise additional doses to be obtained from
another pharmacy on the same day.
11
7
Chapter 1
Assessment criteria
Suitability for maintenance treatment for patients under the age of 18 and the type of
pharmacotherapy prescribed will be determined by:
the history of AOD use
the physical and psychological assessment
evidence of opioid dependency and current physical dependence
prior treatment history and current reasons for seeking treatment
parental or family support
a comprehensive risk assessment (self harm/suicide, accommodation arrangements,
ongoing chaotic drug use, etc)
capacity to give informed consent to treatment. On assessment the young person must
be deemed mature enough to understand the risks and consequences of the treatment.
Copies of the relevant forms can be downloaded from the Department of Healths website
at: www.health.wa.gov.au/cpop or can be obtained by contacting Pharmaceutical Services
Branch at Department of Health on 08 9388 4980.
12
8
Chapter 1
Confidentiality/Privacy Legislation
The Commonwealth Privacy Act 1988 applies rules known as Information Privacy Principles and
National Privacy Principles to acts and practices engaged in by agencies and organisations in
relation to access, collection, use and disclosure of personal information, including a persons
health information.
The National Privacy Principles apply to private health services and medical
practitioners and pharmacists in private practice, and do not apply to State government
agencies such as the Department of Health or the Drug and Alcohol Office/Next Step.
However, as a matter of best practice, the CPOP will endeavour to uphold the National
Privacy Principles in relation to personal health information.
The patient has the right to:
know why personal information is being collected and how it will be used
know which organisations are being given their details and how this information will be
used by those organisations
find out what information an organisation holds about them and how it is managed
ask for access to their own medical records and be able to correct any inaccurate
information that has been recorded
13
9
Chapter 1
know when information will be provided without their permission e.g. in the case of
notification for the Register of Drug Dependent People or mandatory reporting of
notifiable sexually transmitted diseases
to refuse permission for the release of information without prejudicing future treatment
- permission must then be sought from the patient before information is released to
another party
Freedom of information legislation also provides patients with the right to access their medical
records held by public health services and correct any inaccuracies.
In signing the application for authority at the commencement of treatment patients provide
consent to GPs, pharmacists, Department of Health and Next Step to share information regarding
their pharmacotherapy treatment.
Appeals/Complaints Process
Patients have a right to appeal the decisions made about their treatment. The following
principles apply to patient appeals:
Patients have the right of access to procedures intended to resolve conflict between
themselves and those responsible for their treatment. Formal mechanisms are necessary
to ensure that complaints by patients receive attention.
Patients should be informed of their rights to register a complaint and the procedures
for doing so at the time of admission into methadone/buprenorphine treatment.
Patients who cannot read should be read their rights and obligations.
Where possible, patients should be retained in current treatment pending the resolution
of the complaint.
Making a complaint
Initially patients should be encouraged to discuss their concerns with the treatment provider
involved or the Coordinator of Client Management, Community Clinical Programs at Next Step 08
9219 1907.
If this does not adequately resolve the issue patients should contact the Manager, Community
Clinical Programs at Next Step on 08 9219 1919 to discuss the matter and explore options for
resolving the problem.
Where the above fails to achieve a satisfactory resolution, complaints can also be made to the
following agencies:
For concerns about breaches of privacy:
Contact the Privacy Commissioner on 1300 363 992
For concerns about discrimination:
Equal Opportunities Commission 9216 3900 or 1800 198 149 (country callers only)
For concerns about professional conduct of the treatment provider or any other matter:
Office of Health Review (08) 9323 0600 or 1800 813 583
10
14
Chapter 1
15
11
Chapter 2
Methadone is a potent synthetic opioid agonist, which is well absorbed orally and has a long
plasma half-life. Two preparations are available for methadone maintenance treatment in
Australia:
Methadone Syrup from Glaxo Smith Kline. This formulation contains 5 mg/ml methadone
hydrochloride, sorbitol, glycerol, ethanol (4.75%), caramel, flavouring, and sodium benzoate.
Biodone Forte from McGaw Biomed. This formulation contains 5mg/ml methadone hydrochloride
and permicol-red colouring.
Table 1: Effects of Methadone
Actions
Analgesia
Sedation
Respiratory depression
Euphoria (oral methadone causes less euphoria
than intravenous heroin)
Other Actions
Decreased blood pressure
Constriction of the pupils
Antitussive
Gastrointestinal tract actions
Reduced gastric emptying
Reduced motility
Elevated pyloric sphincter tone
Elevated tone of Sphincter of Oddi can
result in biliary spasm
Skin actions
Histamine release
The effects of methadone are qualitatively similar to morphine and other opioids. Most people
who have used heroin will experience few side effects from methadone. Once on a stable
dose, tolerance develops until cognitive skills and attention are not impaired. Symptoms of
constipation, sexual dysfunction and occasionally increased sweating can continue to be troubling
for the duration of methadone maintenance treatment.
See chapter 5 for more information on side effects.
Because of its good oral bioavailability and long half-life, methadone is taken in an oral daily
dose.
12
16
Methadone is fat soluble and binds to a range of body tissues including the lungs, kidneys, liver
and spleen such that the concentration of methadone in these organs is much higher than in
blood. There is then a fairly slow transfer of methadone between these stores and the blood.
Methadone is primarily broken down in the liver via the cytochrome P450 enzyme system.
Approximately 10% of methadone administered orally is eliminated unchanged. The rest is
metabolised and the (mainly inactive) metabolites are eliminated in the urine and faeces.
Methadone is also secreted in sweat and saliva.
Chapter 2
Pharmacokinetics
There is wide individual variability in the pharmacokinetics of methadone but in general, blood
levels rise for about 3-4 hours following ingestion of oral methadone and then begin to fall.
Onset of effects occurs approximately 30 minutes after ingestion. The half-life of a single first
dose is 12 18 hours with a mean of 15 hours. With ongoing dosing, the half-life of methadone
is extended to between 13 and 47 hours with a mean of 24 hours. This prolonged half-life
contributes to the fact that methadone blood levels continue to rise during the first week of daily
dosing and fall relatively slowly between doses.
FIGURE 3
17
13
Onset of effects
30 minutes
Peak effects
Approx 3 hours
3-10 days
Drug Interactions
Chapter 2
Toxicity and death have resulted from interactions between methadone and other drugs. Some
psychotropic drugs may increase the actions of methadone because they have overlapping,
additive effects (e.g. benzodiazepines and alcohol add to the respiratory depressant effects of
methadone). Other drugs interact with methadone by influencing (increasing or decreasing)
metabolism (See Appendix 1). Drugs which induce the metabolism of methadone, can cause a
withdrawal syndrome if administered to patients maintained on methadone. These drugs should
be avoided in methadone patients if possible. If a cytochrome P450 inducing drug is clinically
indicated for the treatment of another condition seek specialist advice. Cytochrome P450-3A
inhibitors can decrease the metabolism of methadone and cause overdose.
18
14
Untreated methadone withdrawal symptoms may be perceived as more unpleasant than heroin
withdrawal, reflecting the more prolonged nature of methadone withdrawal. Factors that have
been identified as having the potential to influence the severity of withdrawal include the
duration of opioid use, general physical health, and psychological factors, such as the reasons for
undertaking withdrawal and fear of withdrawal.
What is buprenorphine?
Chapter 2
Buprenorphine is a derivative of the morphine alkaloid, thebaine, and is a partial opioid agonist
at the mu opioid receptors in the nervous system. Although buprenorphine is a potent mu
receptor agonist at low doses, there is a ceiling on its maximal opioid activity (Walsh et al
1994; Walsh et al 1995). Buprenorphine diminishes cravings for heroin, and prevents or alleviates
opioid withdrawal in dependent heroin users. Buprenorphine has a higher affinity for mu opioid
receptors than full opioid agonists. Because of this, buprenorphine can block the effects of
other opioid agonists in a dose-dependent fashion. By its dual effects of reducing craving and
attenuating the response to administered heroin, buprenorphine reduces the self-administration
of heroin. Methadone, a full opioid agonist, also reduces the impact of additional heroin, but
the effect of methadone is primarily due to the induction of cross-tolerance which is dose
dependent. In contrast buprenorphine achieves its effect primarily by prolonged occupancy of a
high proportion of opioid receptors, blocking the action of heroin.
Unlike methadone, the effect of buprenorphine on respiratory depression reaches a ceiling,
with higher doses not increasing respiratory depression to a significant degree. However, if
buprenorphine is used in combination with other central nervous system depressants, such as
benzodiazepines, the combined effect on respiration can be life threatening.
Buprenorphine also exhibits antagonist effects at the kappa opioid receptor. The role of these
receptors in humans is still poorly understood.
Two buprenorphine products are currently registered in Australia for the treatment of opiate
dependence within a framework of medical, social and psychological treatment: the mono
product (Subutex) is a sublingual tablet containing buprenorphine hydrochloride in 0.4, 2,
and 8mg strengths; the combination product (*Suboxone) is a sublingual tablet containing
buprenorphine hydrochloride and naloxone hydrochloride in a ratio of 4:1. Suboxone is available
in two dosage strengths: 2mg buprenorphine and 0.5mg naloxone, and 8mg buprenorphine and
2mg naloxone. Buprenorphine is also registered in Australia as Temgesic sublingual tablets and
ampoules for intramuscular or subcutaneous injection, for short-term (not more than one week)
relief of moderate to severe pain, including post-operative and terminal and chronic pain. A low
dose buprenorphine patch for transdermal administration is now available in Australia for pain
relief.
Sublingual buprenorphine tablets have approximately 30-35% of the bioavailability of intravenous
buprenorphine preparations. The bioavailability of sublingual buprenorphine is largely dependent
on the time the drug is in contact with the oral mucosa and appears to improve as individuals
practice taking their medication.
19
15
Chapter 2
Pharmacokinetics
Peak plasma concentrations are achieved one to two hours after sublingual administration.
Buprenorphine undergoes extensive first pass metabolism when taken orally. The major
metabolite, norbuprenorphine, has some opioid activity but the extent of its contribution to the
effects of buprenorphine is unknown.
Buprenorphine is principally metabolised by two hepatic pathways: conjugation with glucuronic
acid and N-dealkylation, mediated by the cytochrome P450 3A4 isozyme. The metabolites are
excreted in the biliary system, with enterohepatic cycling of buprenorphine and its metabolites.
Most of the drug is excreted in the faeces and, to a lesser extent, in the urine.
Buprenorphine is a long-acting drug with a terminal elimination half-life of 24 to 37 hours. Peak
clinical effects occur one to four hours after sublingual administration. Typically effects will
continue to be experienced for up to 12 hours at low doses (2 mg), but as long as 48 to 72 hours
at higher doses (16 or 32 mg). The prolonged duration of effect at high doses enables alternateday, and even 3-days-a-week dispensing regimes.
Onset of effects
30 - 60 minutes
1 - 4 hours
Duration of effects
7 10 days
Drug Interactions
The principal drug interactions of buprenorphine relate to its opioid activity.
Sedatives. Buprenorphine exerts additive sedative effects when used in conjunction with
other sedating medications. These include other opioids, benzodiazepines, alcohol,
tricyclic antidepressants, sedating anti-histamines, and major tranquillisers. The
combination of buprenorphine with benzodiazepines, alcohol and other sedatives has
been associated with fatal overdoses.
20
16
Chapter 2
Opioid Antagonists (naloxone and naltrexone). Buprenorphine has affinity for mu opioid
receptors similar to the opioid antagonists. In the event of overdose of buprenorphine,
very high doses of naloxone are required to reverse its effects Cases have been reported
in which naloxone in doses of 10 to 35mg was required, while in other cases doses of
2mg or less were reported to be effective in reducing respiratory depression (Boyd et al
2003). Because of the uncertain response to naloxone, prolonged ventilatory support
may be required in overdoses involving buprenorphine. Naltrexone can precipitate a
withdrawal reaction in patients on buprenorphine, although the effect may be delayed
(2 to 4 hours, occasionally up to 8 hours).
Opioid Agonists. Buprenorphine exerts a degree of blockade to the effects of full
agonist opioids, which may complicate the use of additional opioids for analgesia. The
initial dose of buprenorphine can precipitate opioid withdrawal in patients who have
recently used an opioid drug.
Hepatic Enzyme Inducers and Inhibitors. Buprenorphine metabolism can be influenced
by the presence of drugs and other compounds that are also metabolised by or affect
the activity of the cytochrome system (see Appendix 2). Patients who are concurrently
prescribed or using inhibitors of cytochrome P450 3A4 may have increased buprenorphine
blood concentrations, and those taking inducers may have decreased blood
concentrations. Such interactions are probably seldom of clinical significance.
Safety
High doses: Dose response studies show that, because of its ceiling effects, high doses (16 mg
daily or more) do not result in substantially greater peak opioid effects than lower doses (8 or
12 mg). Doses many times greater than normal therapeutic doses appear to be well-tolerated,
and rarely result in clinically-significant respiratory depression, except in individuals who are not
opioid tolerant. However, even low doses of buprenorphine can be toxic when combined with
sedatives such as benzodiazepines and alcohol (Faroqui et al 1983; Forrest 1983; Papworth 1983;
Sekar & Mimpriss 1987).
21
17
Chapter 2
18
22
TABLE 2
Population
Agonist effects
Agonist effects
Agonist effects
(reduced if swallowed)
Agonist effect
Precipitated withdrawal
Chapter 2
Note: Research and clinical experience in different populations of opioid users of the effects
of buprenorphine, alone and in combination with naloxone, are limited. This table summarises
current expert opinion of the likely immediate effects of buprenorphine, in doses of 8 to 32mg,
in different situations.
Mono product
(Subutex)
Sublingual or i.v.
Severe withdrawal due
to naloxone and
buprenorphine
May be mild withdrawal
Attenuated agonist effect
Precipitated withdrawal
Agonist effect initially
attenuated
Agonist effect may
initially be attenuated
Severe withdrawal
due to naloxone and
buprenorphine
Agonist effects (reduced
effects if swallowed)
Agonist effects
Agonist effects
Agonist effects
Precipitated withdrawal
All opioids have abuse potential, but as indicated in the table above, people who are frequent
users of heroin, methadone, or other opioid agonists that bind less tightly to opioid receptors
than buprenorphine, are unlikely to abuse buprenorphine. The effect of buprenorphine (taken
sublingually or by intravenous injection) in people in naltrexone maintenance treatment remains
unclear. Administration of buprenorphine to this population may result in an attenuated agonist
effect, particularly with low doses of naltrexone, as is generally the case with implanted
preparations of naltrexone.
as with all opioid drugs, the prescription of the buprenorphine-naloxone combination as a
takeaway medication for unsupervised administration needs to be based on a careful assessment
of the risk of injection of the preparation by the person for whom it was intended as well as the
potential for diversion for unauthorised use.
From Table 2 it will be apparent that the group most likely to inject the combination product
will be people on buprenorphine maintenance programs. In particular there is a risk that people
prescribed unsupervised doses of the combination product may inject their own medication.
Injection of drugs designed for sublingual administration is a health risk, and doctors have an
obligation to monitor patients closely. Specifically, patients receiving doses for unsupervised
administration should be monitored for signs of fresh injecting sites, and takeaway doses should
not be supplied to people with evidence of continued, recent injecting. (See also Section 4.)
23
19
Chapter 3
The objectives of substitution maintenance treatment with methadone or buprenorphine are to:
reduce illicit use of opioid drugs
reduce the risk behaviours associated with contracting and transmitting infectious
diseases;
reduce the incidence of death in associated with illicit opioid use;
improve the health, well-being and social functioning of patients;
reduce drug related crime
reduce other social costs of illicit opioid use.
motivate and support patients to achieve their positive lifestyle goals.
While the achievement of an opioid-free state is a long-term goal of maintenance treatment, it
must be recognised that this may not be the initial objective of the patient, nor, in some cases,
may it be appropriate. It is reasonable to expect, however, that methadone and buprenorphine
treatment will encourage patients to develop the motivation to become opioid free.
Indications
1. Opioid dependence
Methadone/buprenorphine maintenance treatment is indicated for those who are dependent
on opioids and who have had an extended period of regular opioid use. The diagnosis of opioid
dependence should be made by eliciting the features of opioid dependence in a clinical interview
(See Section 3.3 Assessment for maintenance treatment with methadone/buprenorphine). The
definitional criteria of The diagnostic and statistical manual of mental disorders, 4th edition
(DSM-IV) are useful to diagnose dependence.
20
24
A need for markedly increased amounts of opioids to achieve intoxication or desired effect;
Markedly diminished effect with continued use of the same amount of opioids.
Withdrawal as manifested by either of the following:
Opioids or a closely related substance are taken to relieve or avoid withdrawal symptoms.
Impaired control over use: Opioids are often taken in larger amounts or over a longer period
than was intended.
Wish to quit: There is a persistent desire or unsuccessful attempts to cut down or control
opioid use.
Chapter 3
Time factor: A great deal of time is spent in activities necessary to obtain opioids, use
opioids, or recover from their effects.
Life style changes: Important social, occupational, or recreational activities are given up or
reduced because of opioid use.
Continued use despite awareness it causing harm: The opioid use is continued despite
knowledge of having a persistent or recurrent physical or psychological problem that is likely
to have been caused or exacerbated by opioids.
Note: Neuroadaptation is not a prerequisite for the diagnosis of drug-dependence. However, in
the absence of neuroadaptation, the prescribing medical practitioner must clearly demonstrate
potential benefits to the individuals health and well-being that outweigh the potential
disadvantages of methadone or buprenorphine treatment, and alternative treatment options
should be carefully considered.
2. Patient must be at least 16 years of age (see section 5.10)
3. Patient must have 100 points of ID (see Appendix 3 and section 3.10)
4. Patients must be able to give informed consent (see section 1.2)
25
21
Contraindications
Chapter 3
The following patients are not suitable for treatment with either methadone or buprenorphine
respectively:
Methadone
Buprenorphine
It is recommended that specialist advice be sought from the Clinical Advisory Service in these
cases.
Precautions
Particular caution should be exercised by prescribers when assessing individuals with the
following clinical conditions as to their suitability and safety for treatment with methadone/
buprenorphine. Concomitant medical and psychiatric problems and other drug use increase the
complexity of management of patients on methadone/buprenorphine and may also increase the
risk of overdose and death. The prescribing doctor should seek specialist advice or assistance in
such cases.
High risk poly drug use: methadone/buprenorphine treatments should be approached with
caution in individuals using other drugs, particularly those likely to cause sedation such as
alcohol, as well as benzodiazepines, antipsychotics and antidepressants in doses outside
the normal therapeutic range. Particular attention should be given to assessing the level of
neuroadaptation to opioids, the likehood of continued use of other drugs and overdose risk.
(See Sections 5.2 and 5.6).
Co-occurring alcohol dependence: due to the significant management problems presented by
this group, consideration should be given to concurrent acamprosate or disulfiram therapy. If
acamprosate or disulfiram are used, a methadone liquid formulation that does not contain
alcohol should be considered to reduce the risk of reactions.
22
26
Chapter 3
27
23
Chapter 3
24
28
Buprenorphine is particularly useful in managing heroin withdrawal, in that it is not only effective
during the withdrawal period, but also facilitates links to post-withdrawal treatment. The use
of buprenorphine for several days generally alleviates withdrawal symptoms without significant
sedation, thereby allowing patients and clinicians to examine post-withdrawal issues relatively
early on in the withdrawal episode. (Many other withdrawal medications, such as benzodiazepines
or clonidine, cause patients to be either psychologically distressed or heavily sedated such that
this would not be possible.) A formal review of treatment plans should be structured several days
into the withdrawal episode, at which time treatment can be tailored accordingly.
Patients who are not interested in ongoing pharmacotherapy treatment can cease after a short
course of buprenorphine with minimal rebound discomfort. Alternatively, those patients who
want to extend the duration of their withdrawal program, or have reconsidered the role of a
maintenance treatment program, can continue buprenorphine treatment over a longer period of
time. Another benefit of buprenorphine is that naltrexone can be initiated after buprenorphine
administration with less delay and less severe withdrawal than is the case following methadone
maintenance treatment. These treatment pathways are shown in Figure 4.
Chapter 3
Withdrawal episode
Buprenorphine regime
for 4 - 8 days with
exploration of post
withdrawal treatment
plans
Substitution
maintenance treatment
Buprenorphine or
methadone
No ongoing
pharmacotherapy
Psychosocial
interventions
It is increasingly common for clinicians to be confronted with people requesting repeated, shortterm episodes of buprenorphine treatment, perhaps three or four episodes of detoxification
within a year. In this situation, where people are continually failing and relapsing, it may be
more useful to recommend methadone rather than another short-term episode of buprenorphine
treatment.
Response to treatment
Ultimately, the continued use of a medication should depend on its ability to meet the aims and
objectives of treatment. This requires the identification of treatment goals by the patient and
decisions about how the treatment outcomes will be assessed.
Where these goals are not being met, a review of treatment strategies should
occur, including:
- the role of psychosocial interventions
- levels of supervision, monitoring and review
- dose of the pharmacotherapy
- the role of adjuvant interventions
- a review of alternative opioid pharmacotherapies. For example, patients who cannot
stabilise their continued use of heroin, even on high doses of buprenorphine, may be
better suited to high doses of a full agonist (methadone).
Chapter 3
Adverse events
Individuals experiencing significant side-effects from one opioid medication may benefit from
treatment with an alternative medication. In particular, buprenorphine may be preferred by
individuals complaining of continued sedation under methadone.
26
30
Chapter 3
31
27
Investigations
Urinary drug screens can be helpful in clarifying or confirming an unclear drug use
history. While delays in getting the results of routine urine tests often limit their
usefulness at initial assessment, conducting a urine drug screen prior to the
commencement of opioid substitution therapy provides supportive evidence of opioid use
that can otherwise be difficult to obtain.
Tests of viral serology (HIV, Hepatitis B and C) should be considered at some stage with
appropriate pre- and post-test counselling. (This is advisable after stabilisation, when
the patient is better able to understand the significance and consequences of testing).
Liver function tests are recommended at the commencement of treatment to establish
a baseline. Periodic monitoring of liver function is also recommended.
The initial assessment will enable a case formulation and an initial management plan to be
developed, which can be implemented directly. However, extra information will also need to be
gathered at subsequent reviews so that more comprehensive treatment plans can be developed.
32
28
Deaths during the induction phase of methadone treatment have been related to:
concomitant use of other drugs (particularly sedatives such as alcohol, benzodiazepines,
other sedatives and psychiatric medications)
inadequate assessment of tolerance
commencement on doses that are too high for the level of tolerance
lack of understanding of the cumulative effect of methadone
inadequate observation and supervision of dosing
individual variation in metabolism of methadone
concomitant medical conditions.
Chapter 3
Induct morphine, codeine and oxycodone users with the same caution as if they were
heroin users.
33
29
Dose titration
Stabilisation is about titrating the dose against needs of the individual patient.
Chapter 3
Do not increase the methadone dose for at least the first 3 days of treatment unless there are
clear signs of withdrawal at the time of peak effect (i.e. 3-4 hours after dose) as the patient will
experience increasing effects from the methadone each day.
Consider dose increments of 5mg every 2-3 days subject to assessment.
Total weekly increase should not exceed 20mg.
The maximum dose at the end of the first week should typically be no more than 40mg.
Consultation with the Clinical Advisory Service is required where a more rapid induction to
methadone is considered necessary.
Patients should be warned not to drive or operate machinery during periods of dose adjustments.
30
34
Chapter 3
35
31
Chapter 3
From naltrexone
Patients who have relapsed to opioid use following cessation of naltrexone (oral, implant) can
be considered for treatment with an opioid pharmacotherapy. Because of its safety profile during
induction buprenorphine is the drug of choice in this situation.
Patients who have been taking naltrexone lose tolerance to opioids. Consequently, patients
transferring from naltrexone should be treated as if they were nave to opioids and non tolerant to
their effects unless the clinical circumstances clearly indicate a return to regular, heavy heroin use.
Extreme caution should be exercised if commencing methadone, and the starting dose should be
no greater than 20mg. The first dose of methadone should not be given until at least 72 hours
after the last dose of naltrexone.
32
36
Research evidence indicates that the mono buprenorphine product (Subutex) and the
buprenorphine/naloxone combination (Suboxone) formulation are largely interchangeable.
There are some circumstances, eg. pregnancy, naloxone allergy, or the induction period for
patients with high levels of neuroadaption, when the mono product will be preferred.
In W.A. all patients are required to be treated with Suboxone unless evidence supports the use of
Subutex in the following special circumstances:
pregnant & breastfeeding women (patients must sign a consent form see Appendix 13)
clients with known allergies to Suboxone (prescribers must complete an adverse reaction
form)
patients on a low dose (<6mg) withdrawal regimen. (to be completed within 6 months)
Chapter 3
The aim should be to stabilise patients on an effective dose of buprenorphine as soon as possible.
More rapid dose induction (ie. 12 to 16mg by day 3) may be associated with better retention in
treatment (Doran et al 2005). However, this needs to be weighed against individual reactions to
initial dosing and safety considerations.
Rapid dose induction is most easily achieved with an initial dose in the range of 4 to 8mg. Higher
initial doses will facilitate rapid dose induction but increase the risk of precipitated withdrawal
(if the patient has recently used opioids) or sedation (if the patient has a lower level of opioid
dependence or also consumes other sedatives such as benzodiazepines).
Patients should ideally be observed for a few hours after the first dose, and a further dose
administered on the same day if there are no signs of sedation. An appropriate dose to achieve on
the first day is 6 to 8mg. This may be given as a single dose or, if resources permit, in two doses
of 3 or 4mg, four hours apart to reduce the risk of precipitated withdrawal and adverse effects.
37
33
Chapter 3
Buprenorphine precipitated withdrawal typically begins one to four hours after the first
buprenorphine dose, is generally mild to moderate in severity, and lasts for up to 12 hours. If
this happens, patients may require symptomatic withdrawal medication, and should be directed
to see their doctor. Administration of the first dose of buprenorphine early in the day provides an
opportunity to manage precipitated withdrawal if it occurs.
If precipitated withdrawal occurs following the initial buprenorphine dose, subsequent doses of
buprenorphine (taken the following day) should result in minimal withdrawal discomfort if the
patient has not used heroin during the intervening period. Patients who continue to use heroin
between their first and second doses of buprenorphine may have difficulty stabilising on the
treatment, with ongoing features of opioid withdrawal. They should be advised to cease heroin
use at least six hours prior to the next dose of buprenorphine.
34
38
Recommended strategy
Dose of methadone
when transferring to
buprenorphine
Dose of
buprenorphine
Patient expectancy
Use of other
medications
Chapter 3
Factor
Stabilisation
The optimal maintenance dose needs to be individualised according to the patients response to
buprenorphine. However, typically a maintenance dose will be in the range of 12 to 16mg/day.
Peoples responses vary considerably, according to the following factors:
1. rates of absorption or metabolism of buprenorphine. The duration of contact with the oral
mucosa is a significant factor for the absorption of buprenorphine. Hence, instructing patients
in the technique of administering buprenorphine is important.
2. experience of side-effects;
3. continued use of other drugs.
39
35
These variations require the clinician to titrate the buprenorphine dose to optimise treatment
objectives.
Chapter 3
Dose levels
The optimal maintenance dose needs to be individualised according to the patients response to
buprenorphine. Peoples responses vary considerably, according to the following factors:
1.
2.
3.
4.
36
40
Chapter 3
People wishing to reduce their use of heroin, or other opioids, can do so with increases in the
dose of buprenorphine, as higher doses of buprenorphine produce more effective blockade of
the effects of additional heroin. However, this only succeeds up to a point. Continued heroin
use despite adequate daily doses of buprenorphine may indicate that the patient needs more
intensive psychosocial interventions, and/or an alternative opioid substitution (e.g. methadone).
41
37
Chapter 3
Split dosing
Buprenorphine does not need to be provided more frequently than once a day for those on a
maintenance regimen. Therefore split dosing is not necessary.
38
42
Alternate-day or four-times-a-week regime: This involves attending the pharmacy for dosing on
alternate days (i.e. a dose every 48 hours), or attending four times a week (with 3 x 48 hour
doses and 1 x 24 hour dose each week (e.g. Mon; Tues; Thurs; Sat)). The advantage of the latter
approach (4 times a week) is that the patient is on a regular attendance each week, with less
likelihood of attendance errors on the patients part and dosing errors by the pharmacist.
The dose dispensed for a 48-hour period is initially double the normal daily (24 hour)
buprenorphine dose (to a maximum of 32mg at a time). While doses higher than 32mg have been
used, the registration of buprenorphine in Australia specifies a maximum dose of 32mg. More
regular supervision is needed when patients are switched to less frequent dosing.
The patient should be reviewed following the first or second 48-hour dose. Dose adequacy can be
inferred if patients report:
being as comfortable on the second day as on the first;
sleeping as well on the second night as on the day of dosing; and
no more cravings on the second day than on the first.
Chapter 3
If the patient reports onset of withdrawal or cravings, or sleep difficulties in the second day
then the 48-hour buprenorphine dose should be increased. If the patient reports features of
intoxication from the dose of buprenorphine during its peak effects (normally at about four
hours), the 48-hour dose should be reduced.
Patients on low doses of buprenorphine may find that double the dose does not last for 48 hours.
Patients on reducing doses of buprenorphine may need to switch to daily dosing as the dose
becomes lower (i.e. below 4mg). Some patients are not comfortable with double dose when
switched to less than daily dosing.
Three-times-a-week regime: Some patients may tolerate three-times-a-week dosing with
buprenorphine, reducing the inconvenience and costs of treatment further. This should be
attempted once a two-week trial on four-days-a-week dosing has been shown to be successful.
The recommended regime for a three-day dose is:
3-day dose = three times the normal 24 hour dose if 24 hour buprenorphine dose < 12 mg
3-day dose = 32 mg when 24 hour buprenorphine dose 12 mg.
As with alternate day regimes the dose should be titrated against symptoms
with frequent review following transfer to the regime. If a patient cannot
be stabilised on a three-times-a-week dosing regime, the four-times-a-week
dosing regime should be considered.
Some patients attempting alternate-day dosing may benefit from doses greater than 32mg,
however, there is limited evidence regarding the safety of higher doses, and buprenorphine is
registered in Australia with a maximum recommended dose of 32mg. Practitioners should be
aware of the medico-legal implications of off-label prescribing before they prescribe doses of
greater than 32 mg.
43
39
Chapter 3
When methadone patients take a dose of buprenorphine, the methadone is displaced from the
mu opioid receptors by buprenorphine. Patients on low doses of methadone (e.g. less than 30 mg)
generally tolerate this transition with minimal discomfort. Patients on higher doses of methadone
may find the replacement of methadone with buprenorphine causes significant discomfort.
However, the occurrence of precipitated withdrawal can be greatly minimised by careful initial
dosing and rapid titration to an appropriate maintenance dose of buprenorphine.
40
44
Chapter 3
Features of a precipitated withdrawal following the first dose of buprenorphine are typically
mild to moderate in severity, and may distress the unprepared patient. Symptoms commence
one to four hours after the first buprenorphine dose and last for up to 12 hours before subsiding.
Patients experiencing discomfort may re-present to the prescribing doctor later in the day and
require symptomatic withdrawal medication (eg clonidine 0.1mg, 3 to 4 hourly). Subsequent
doses of buprenorphine (the following day) are less likely to precipitate withdrawal symptoms.
There is a lack of research evidence, but the mono preparation is the preferred
formulation to administer following methadone to avoid any risk of withdrawal
that might be precipitated by the small amounts of naloxone that might be
absorbed from the combination product. Once induction with the mono product
is completed, the patient can be switched directly to the combination product.
Transferring from higher doses of methadone (>40mg)
This is associated with a significant risk of precipitated withdrawal and hence is difficult in
an outpatient setting. Transfer from higher doses of methadone can be safely undertaken in
inpatient settings (eg. detoxification units) where supervised clonidine and diazepam can be used
to manage withdrawal symptoms (Clark et al 2005). The critical issue in making such transfers
is to wait until the patient has signs of opioid withdrawal before administering the first dose of
buprenorphine. This may involve a delay of 72 hours after the last dose of methadone.
Buprenorphine can be commenced at low doses given frequently, i.e. 2mg bd increasing to 4mg
bd and then 8mg bd, titrating as necessary.
Due to the concerns for patient safety, transfers from doses of methadone > 40mg require a
completed patient consent form (see Appendix 13) to be attached to the application for authority
to prescribe. The patient is considered to be a transfer if it is less than 7 days since methadone
dosing ceased. If it is 7 days or more since the last methadone dose the patient is treated as a
new induction and patient consent is not required.
45
41
Self report
Self report can be a reliable guide to drug use in settings where no negative consequences result
from disclosure. However, in the clinical situation there are always contingencies which patients
may perceive as punitive. Consequently, caution should be exercised when making clinical
decisions based solely on self-reported drug use. The best information is usually obtained from a
combination of self-report and urinalysis.
Urine testing
Chapter 3
42
46
At least six monthly, a comprehensive review of treatment progress should be undertaken. If the
patient has at least two health professionals involved in their care (eg. Pharmacist, counsellor
or other specialist) a Coordinated Care Plan can be developed. Contact your local Division of
General Practice for more information on Care Plans.
Chapter 3
Once opioid use is stabilised, prescribing doctors need to monitor for the presence of, or
emergence of, other concurrent problems, particularly mental health issues. Such monitoring and
documentation of response to treatment is a critical part of effective treatment.
47
43
The patient obtains a new prescription from their prescriber to reflect the the increase
in takeaways if appropriate (dependent on patient stability and in some cases CAS
approval)
Storage
Methadone and buprenorphine must be stored in accordance with Regulations 56, 56A, 56E
and Appendix M (and other relevant sections) of the Poisons Regulations 1965. Methadone and
buprenorphine must be stored in a locked safe. If a pharmacist is on the premises then they can
be stored in a locked cupboard or drawer and the key kept in the possession of the pharmacist.
It is important that methadone and buprenorphine are securely stored immediately after dosing a
patient.
Chapter 3
Checking that the prescription satisfies the legal requirements, i.e is endorsed with a
DoH authorisation number and is valid
Ensure positive identification of the patient before administration of the dose
Checking the prescribers instructions (use of a daybook or diary is recommended)
Explaining any side effects of medication when appropriate
Assessing the patient for intoxication and contacting the prescriber if necessary
Ensure the dose is correct
Supervising the consumption of each dose
Dispensing any take away doses according to requirements
Maintaining contact with the prescriber and providing any relevant information
concerning the patients progress, including with regard to any missed doses, intoxicated
presentations etc.
Supporting the patient and encouraging a healthy lifestyle
Ensuring that patient information is kept confidential
Ensuring all pharmacy staff (including locum pharmacists) are appropriately trained and
informed of the CPOP requirements
Ensure that methadone and buprenorphine are stored in compliance with the Poisons
Regulations and that records are maintained as required (See Appendix 14 for recording
requirements).
44
48
Chapter 3
Patient identification
a recent photo of the patient endorsed by the prescribing doctor; or
a Next Step identity form.
This information must arrive at the pharmacy prior to the patient receiving the first dose of
methadone/buprenorphine. A prescriber may authorise the patient to deliver the original
prescription/documentation to a pharmacy. In this case faxed copies must also be sent to the
pharmacy.
Supply of methadone or buprenorphine can only be in accordance with the instructions on the
prescription. Amounts in excess of the total quantity ordered on the prescription, for a longer
period than that specified or after the expiry date must not be made. Missed doses cannot be
administered at a later date.
Takeaway doses must only be supplied in accordance with a prescription or instructions in writing
from the authorised prescriber.
Lost or stolen takeaway doses (see section 4) or vomited doses (see section 5.4) should not be
replaced without a written authorisation from the prescriber.
Other prescriptions
There is an increasing incidence of benzodiazepine abuse and dependence often
associated with opioid abuse.
A combination of opioid (that is, methadone and buprenorphine) and sedative drugs may
be potentially hazardous and requires close cooperation between the prescriber and the
dispenser.
49
45
If the patient presents a prescription from another prescriber for a drug that may be
abused, the prescriber should be advised that the patient is receiving pharmacotherapy
treatment.
Pharmacists must use their professional discretion in deciding if they should dispense any
prescription.
Pharmacists retain the right to refuse to dispense a legal prescription if an opinion is formed that
such a supply could compromise the well-being and overall health of the patient.
Pharmacotherapy administration
The duty pharmacist is to be satisfied that the administration of each dose is to the correct
person. If photographic identity cannot be established then administration should not occur.
Check that the prescription is valid. Check that the patient has not missed any doses prior to this
presentation (refer to Chapter 4 for instructions on management of missed doses).
Chapter 3
Assess the patient for intoxication (see Appendix 7 for indicators of intoxication). If the patient
appears intoxicated the prescriber should be contacted before administration occurs.
Administer the dose in a discreet manner to protect the confidentiality of the patient. Do not
allow paperwork to be viewed by persons not entitled to have access. The use of drop folders is
recommended.
Do not permit patients to enter the dispensary, to be aware of the number of patients attending
the pharmacy, the delivery arrangements for stock or of security arrangements.
Methadone administration
Conical measures are not accurate for measuring methadone. The use of syringes or suitably sized
cylindrical measures is recommended.
Supervise the consumption of the dose and follow-up with a drink of water or cordial. Cordial
assists in masking the bitter taste of methadone. Engage in a short conversation with the patient
after the administration to ensure that the complete dose has been swallowed by the patient.
Patients are not permitted to provide their own drink container. This is to prevent the dose being
spat back into the container and then being diverted or abused.
Rinse empty methadone bottles with water and deface the label before discarding.
46
50
Buprenorphine administration
When buprenorphine is to be administered some water or liquid should be given before hand to
pre-moisten the mouth to aid dissolution of the dose. The patient must not be allowed to handle
the tablets.
The dose should be crumbled in a commercial crusher to the consistency of large coffee
granules (if it is crushed to a powder it is harder to get under the tongue and keep it there long
enough for proper absorption) and handed to the patient in a clean container to place under the
tongue.
Correct dosing technique is important to ensure the patient receives the full benefit of their
dose. Patients should be advised to keep the dose under their tongue until fully dissolved and not
to talk.
The patient should be supervised for at least two minutes or until the dose completely dissolves.
Patients are not permitted to provide their own drink container. This is to prevent the dose being
spat back into the container and then being diverted or abused.
Chapter 3
CANCELLINGOLDPRESCRIPTIONS
Where there is a possibility of a current prescription existing at a pharmacy, other than
the pharmacy nominated on the new script, it is essential that the prescriber contact
the pharmacy to cancel the earlier prescription.This avoids the possibility of the
patient dosing at two sites concurrently.
Changes to dose
When changing the dose of methadone/buprenorphine a prescription must reach the pharmacist
prior to the change in dose being affected.
Dispensing fees
Community pharmacies commonly charge patients a fee to cover the professional costs of
dispensing methadone and buprenorphine. Pharmacies are free to set fees at appropriate levels,
and the Pharmacy Guild of Australia (Western Australian Branch) provides advice on this matter.
51
47
Chapter 3
Provide a current endorsed photograph of the patient attached to the patient ID form
and a prescription to the patient to give to the new dispensing pharmacy
Fax the completed Pharmacy Transfer Notification form to the current pharmacy, new
pharmacy and CAS as a matter of priority.
The pharmacy must receive the information prior to the patient being transferred.
International Travel
Prescribing doctors should contact the Clinical Advisory Service for inquiries regarding
international travel, as arrangements vary depending on the country to be visited. Some prohibit
the import of methadone and/or buprenorphine and do not have methadone/buprenorphine
maintenance programs.
NB: Always express methadone doses in milligrams as concentrations per millilitre vary in other
countries.
Chapter 3
Longer treatment episodes. Evidence from methadone research suggests that long-term
outcomes are enhanced by treatment episodes of more than 12 months.
A more stable and supportive lifestyle. The longer treatment episode allows the opportunity
for the patient to establish a lifestyle away from heroin and other drug use prior to withdrawing
from methadone treatment. Premature withdrawal from pharmacotherapy (before the patient
has achieved a degree of stability in social circumstances and drug use) is more likely to be
associated with a relapse into dependent heroin use.
The likelihood of premature withdrawal from maintenance treatment is reduced if patients are
well-informed about how treatment works. A patient may wish to withdraw from maintenance
treatment for a range of reasons, (i.e. the need for interstate travel, concerns about side-effects
or about remaining in treatment too long). The clinician should discuss issues regarding the
duration of treatment and withdrawal early in the treatment program and provide information
regarding the process of withdrawal. Patient literature is now available regarding withdrawal
from methadone/buprenorphine treatment. Despite withdrawal from buprenorphine being
frequently described as milder than from other opioids, patients should be informed of the likely
duration of withdrawal symptoms.
53
49
Chapter 3
Dose reductions should be made in consultation with the patient. Patients should be aware of
their dose, except where an agreement has been reached between patient and service provider
to the administration of a blind dose. Continued reduction in the face of distress is usually
counterproductive. It may be appropriate to maintain a patient at a reduced dose for a prolonged
period until the patient feels comfortable recommencing the reduction regime.
During this phase the aim of treatment is to ensure that the withdrawal process is completed
with safety and comfort. Increased supportive counselling, as well as information and education,
should be available for patients withdrawing from methadone/buprenorphine. There may be a
role for other medication for symptomatic relief (clonidine). Caution should be applied regarding
the use of potential drugs of abuse (e.g. benzodiazepines).
50
54
Chapter 3
Graduated reduction over weeks results in better outcomes (less relapse to heroin use) than rapid
reductions. The following rates of dose-reduction are proposed, although reductions can occur
more rapidly or more slowly:
Reduction rate
Above 16 mg
8 - 16 mg
Below 8 mg
An increase in heroin or other drug use, or a worsening of the patients physical, psychological or
social well-being, may warrant a temporary cessation or slowing-down of the reduction rate.
Some patients will request dose reductions of less than 2mg. Reductions of 0.4mg or 0.8mg may
then be appropriate, especially for those coming off longer term treatment.
As 0.4mg tablets are not available in Suboxone, patients wanting to reduce in increments of
less than 2mg will be required to transfer to Subutex. Patients must be on a dose of 6mg or
less in order to qualify for Subutex for this purpose. Prescribers must complete an Application
for authority to prescribe and receive a new Department of Health authority number before
prescribing Subutex. A special 6 month limited authority will be granted in these situations,
prescribers should ensure that the patients withdrawal plan is managed within the 6 month time
frame.
Involuntary withdrawal
It is sometimes necessary to discharge a patient from treatment for the safety or well being of
the patient, other patients or staff. This may be the result of
violence or threat of violence against staff or other patients
diversion of methadone/buprenorphine
illegal activities such as, theft, property damage or drug dealing in or near the service
55
51
Chapter 3
Circumstances
Methadone
Buprenorphine
Abrupt cessation of
methadone or rapid dose
reduction
52
56
Chapter 3
Subsequent doses of naltrexone at 25mg for a further 2-3 days and then 50mg per day is
usually recommended. Clinical guidelines regarding the use of naltrexone should be
consulted (Bell et al. 2003).
Given the potential for patients to use heroin or other opioids following the cessation of
buprenorphine and prior to the commencement of naltrexone, some objective test should be
conducted prior to commencing naltrexone in order to exclude recent opioid use. The naloxone
challenge test or appropriate urine drug screening are recommended. However, a naloxone
challenge test is difficult to interpret if conducted within three days of buprenorphine use.
57
53
Chapter 4
Chapter 4
Patients who are found to have diverted their takeaway dose should not be given any further
takeaway doses and the Clinical Advisory Service should be notified of this event.
(see section 5.9)
59
55
The prescription must not be written until approval has been obtained from CAS.
Frequency of takeaway doses
It is important that takeaway doses do not place the patient or others at risk of harm.
Consequently the frequency of takeaway doses is restricted to the schedules set out below. It
is important the patients are seen by a dispenser (pharmacist or nurse) at least once per week.
To ensure this the frequency of takeaway doses is different for patients on less than daily dosing
with buprenorphine.
Patients transferring between prescribers (including interstate transfers to WA), where there is
no break in treatment, can continue to be prescribed takeaway doses if stability criteria with
the previous prescriber is confirmed and the new prescriber is satisfied that the patient remains
stable.
Time on methadone or buprenorphine treatment in prison does not count towards the length of
time in treatment for the purposes of calculating eligibility for takeaway doses.
The takeaway week should be defined (e.g. Monday to Sunday) to avoid any confusion.
Chapter 4
Where the prescriber decides that exceptional circumstances exist and supervised daily
dispensing arrangements cannot be made, an Application for Authorisation to Prescribe
Takeaway Doses form must be sent to the Clinical Advisory Service. The prescription must not be
written until approval has been obtained from CAS.
Methadone
Length of time in
treatment*
56
60
6 - 12 months
12 - 24 months
Buprenorphine (Suboxone)
Buprenorphine has a long half life (24 36H) and many patients can be dosed every second or
third day thus minimizing the need for takeaway doses. The long half life of buprenorphine can
also mean that takeaway doses are more easily diverted as missing part or all of a days dose
does not result in severe opiate withdrawal. For this reason no more than one takeaway dose per
week is permitted for patients prescribed buprenorphine until they have been on the program for
24 months
Length of time
In treatment*
Daily Dosing
Dosing every
second day
Dosing every
third day
Nil
Nil
Nil
6 - 24 months
1 per week
1 per week
1 per week
2 per week
2 per week
1 per week
*NB: Duration refers to continuous period of dosing with either methadone or buprenorphine.
It does not refer to continuity with the same service provider.
Chapter 4
61
57
(Date of dispensing)
(Date of dispensing)
Chapter 4
Alternatively, if the tablets are removed from the original blister packaging then they must be
packed in a container with a child resistant closure.
Attach an Appendix K label.
In the event that a patient reports that takeaway doses have been lost,
stolen or damaged, they should not be replaced*.
* Consideration should be given to the particular clinical situation of the patient in this situation
Prescribing regular takeaway doses
Where takeaway doses are prescribed on a regular or ongoing basis the prescriber should be
satisfied at each review that the patient continues to meet the stability criteria. Should the
patients situation become unstable or if contraindications are present the prescriber should
withdraw or reduce the number of takeaway doses prescribed.
58
62
Response
If no evidence of intoxication dose as usual
Three
Four
Five or more
Chapter 4
Two
Review the patient the following day and adjust the dose accordingly.
Response
If no evidence of intoxication dose as usual
5-6
7 or more
* refers to days equivalent if client is not dosing on a daily basis e.g. a client dosing second daily
only misses 2 doses to achieve 4 missed days
63
59
Chapter 4
The pharmacist should contact the prescriber. The buprenorphine dose prescribed should
be sufficient to last until the next scheduled dose (if this is 24 hours, then prescribe a
24-hour dose; if 48 hours - a 48-hr dose).
In circumstances where the pharmacist cannot contact the prescribing doctor, no
buprenorphine can be dispensed (as there is no valid prescription). However, this
increases the risk that the patient will drop out of treatment. To prevent this
happening, the prescriber can issue a prescription of buprenorphine to be administered
by the pharmacist as a one-off dose, for use if the patient on a three- or four-times-aweek regime misses the scheduled dosing day and presents on a non-scheduled day. This
prescription must not be greater than the usual 24-hour dose. The prescriber may
wish to limit the maximum level of such an emergency dose to a lower than usual dose
in order to discourage such occurrences.
Patients who repeatedly miss doses under these circumstances should be reviewed by
their prescribing doctor to find out why and whether these issues can be addressed.
Alternatively, consideration might be given to a more feasible dosing regime.
60
64
Withdrawal
symptoms
maximal before
next dose
Withdrawal
precipitated by
buprenorphine
dose
Headache
Nausea
Constipation
Weight gain,
particularly for
women
Lower dose
Poor sleep
Amenorrhoea or
oligomenorrhoea
Lowered sex
drive
Dental problems
Lowered bone
density
Chapter 5
Side effect
Feeling drowsy
after taking dose
65
61
Many patients report less sedation on buprenorphine than on methadone. Research evidence
suggests that buprenorphine has minimal effect on psychomotor performance (Lenne et al 2003;
Mintzer et al 2004), and less effect than methadone (Soyka et al 2005) or slow release oral
morphine (Giacomuzzi et al 2005). Any effect is likely to be greatest during the early stages
of treatment or following dose increases. At such times patients should be advised to exercise
caution in driving or operating machinery.
Buprenorphine appears to have minimal impact on hepatic function, although there have been
some reports of acute hepatitis following very high doses (>32mg iv).
5.2 Overdose
Table 7: Signs and Symptoms of Opioid Overdose
Pinpoint pupils
Nausea
Dizziness
Feeling intoxicated
Sedation/nodding off
Unsteady gait, slurred speech
Snoring
Hypotension
Chapter 5
Methadone
In Australia, more than 90% of deaths during stabilisation on methadone involved concurrent use
of other drugs, in particular, alcohol, benzodiazepines and antidepressants. Patients should be
warned of the risks associated with using other drugs when taking methadone. (See also Sections
5.3 and 5.6).
62
66
Death following methadone induction often occurs at home during sleep, many hours after peak
blood methadone concentrations have occurred. Typically overdose occurs around the third or
fourth day of methadone induction.
Given that many deaths occur during sleep, administration of methadone in the morning will
ensure peak methadone concentrations occur when patients are normally awake and other people
may be around if overdose should occur. Family members should be warned that deep snoring
during induction to treatment could be a sign of dangerous respiratory depression and should be
reported to the prescriber. Heavy snoring during maintenance treatment may be associated with
sleep apnoea and should also be reported.
Additional caution should be exercised with patients who:
Have concomitant medical conditions especially those that impact on respiratory drive
Have unstable mental health problems
Are on other sedative medications such as benzodiazepines and psychiatric medications.
Naloxone, which promptly reverses opioid induced coma, should be given as a prolonged infusion
when treating methadone overdose. A single dose of naloxone will wear off within one hour
leaving patients at risk of relapse into coma due to the long lasting effects of methadone.
Patients who are thought to have taken a methadone overdose require prolonged observation.
Buprenorphine
The risk of lethal overdose on buprenorphine in an opioid-tolerant individual is less than that
associated with the use of other opioid medications, such as methadone. This is due to the
ceiling dose response effects of buprenorphine. The poor bioavailability of buprenorphine when
taken orally reduces the risk of accidental overdose by children.
An opioid-nave individual may overdose with a high dose of buprenorphine. All patients should
be commenced on low doses (2 - 8mg), and even lower doses (2 or 4 mg) should be considered
where there is some doubt regarding the degree of neuroadaptation prior to commencing
treatment. Even low doses of buprenorphine can cause sedation in opioid naive individuals if
taken in combination with other sedative drugs.
While overdose on buprenorphine is relatively uncommon, there is a greater risk when it is
combined with other sedative drugs, such as alcohol, benzodiazepines, barbiturates, tricyclic
antidepressants and major tranquillisers. Several such deaths have been reported.
Chapter 5
Buprenorphine has a high affinity for mu opioid receptors, and is not easily displaced by
the antagonist, naloxone. Doses of 10 - 30 times the normal naloxone doses used to reverse
heroin overdose (up to 10 - 35 mg/70 kg) may be required to partially reverse the effects of
buprenorphine toxicity. However cases have also been reported where much smaller doses (2
4mg) of naloxone have been effective in reversing the effects of buprenorphine.
Methadone
Chapter 5
Vomiting after a dose of methadone creates uncertainty regarding the absorption of the dose.
The following procedures are recommended.
64
68
Situation
Response
Patient is pregnant
Chapter 5
Take extra care to elicit information from a new patient regarding the effect of the
dose so as to monitor the toxicity of the dose being administered.
If there is more than one patient with the same surname attach a cautionary note to the
patients record card alerting staff to this.
Check telephone contact details for patients are kept up-to-date.
Methadone
A patient who receives a methadone dose in excess of that prescribed, is at risk of overdose. To
prevent accidental methadone overdose procedures should be established for easy and accurate
identification of patients to minimise the risk of inappropriate dosing. Patients should be
informed of the risks and signs and symptoms of overdose.
Patients in the first 2 weeks who receive an overdose of any magnitude require observation for 4
hours. If signs of intoxication continue, more prolonged observation is required. This may require
sending the patient to an Emergency Department.
69
65
Patients who have been on a dose of methadone >40mg/day consistently for two months will
generally tolerate a dose double their usual dose, without significant symptoms. For an overdose
with greater than double the usual daily dose the patient will require observation for at least 4
hours. If signs of intoxication are observed, more prolonged observation must be maintained.
If patients are receiving regular takeaway doses, or if they do not attend daily, it cannot safely
be assumed that they have been taking their daily dose and have a known level of tolerance.
Therefore, such patients require observation in the event of overdose of >50% of their usual dose.
Patients in whom the level of tolerance is uncertain (dose <40mg/day, or in treatment for <2
months) require observation for at least 4 hours if they are given a dose >50% higher than their
usual dose.
Chapter 5
If the patient has left before the mistake is realised, every attempt must be made to contact the
patient.
Caution regarding inducing vomiting:
Inducing vomiting may be dangerous and is contraindicated if the patient has any signs of CNS
depression. Emesis more than ten minutes after dosing is an unsatisfactory means of dealing with
methadone overdose as it is impossible to determine if the entire dose has been eliminated. In
circumstances where medical help is not readily available or the patient refuses medical care,
induction of vomiting (by mechanical stimulation of the pharynx) within 5-10 minutes of ingesting
the dose may be appropriate as a first aid measure only. Ipecac syrup is contraindicated as its
action may be delayed.
66
70
Buprenorphine
The risks associated with an incorrect dose of buprenorphine are not as severe as with other
opioid medications.
In the event of an incorrect dose being administered:
the dispensing pharmacist (or nursing staff) should immediately notify the patient and
prescriber of the error
the patient should be warned of the likely consequences (increased sedation/drowsiness
may occur for several hours afterwards), and warned against any additional drug use,
and driving or operating machinery, for the rest of the day
if any of the following circumstances apply the patient should be monitored for at least
6 hours after an incorrect dose by trained health professionals or in the Accident &
Emergency Department of a hospital,
the patient is sedated following the dose (for any reason)
the patient is new to substitution treatment (within the first 2 weeks of treatment)
a buprenorphine dose of 64 mg was incorrectly administered (regardless of routine
daily dose).
It may be that a lower dose, or no dose, is required the following day (in effect, a two-day dose
has been administered).
Chapter 5
71
67
Benzodiazepines
Benzodiazepine users exhibit overall patterns of increased risk and poorer psychological
functioning than other patients. Benzodiazepine injection is associated with vascular damage
as well as mortality. Injection of the gel capsule formulation of temazepam can lead to limb
amputations. This formulation should not be prescribed.
Patients should be advised about the interactions of benzodiazepines and methadone/
buprenorphine.
Chapter 5
68
72
The pharmacist at the dosing location should document that the patient has become an inpatient
and is being dosed elsewhere. To avoid double dosing the pharmacist should confirm that the
patient has been discharged and confirm the date on which the patient received a dose before
recommencing dosing. When a prescribing doctor is contacted regarding treatment he/she must
ensure that the dosing location has been notified.
Opioid dependent patients who are not on pharmacotherapy treatment
Opioid dependent people who are not on methadone or buprenorphine maintenance treatment
may experience withdrawal if admitted to hospital. Methadone or buprenorphine may be used to
treat withdrawal symptoms if withdrawal symptoms could be reasonably be expected to interfere
with the optimum medical management of the patient or if the patient is suffering from a serious
or life-threatening illness and the patients premature self-discharge before completion of
therapy would prejudice optimum management. In these circumstances consultation should occur
with the CAS.
Chapter 5
73
69
Chapter 5
Unfortunately the use of diverted medications can have serious and potentially fatal
consequences. In addition, such activities undermine the therapeutic benefits of the program for
the individual patient and damage the reputation of the program as a whole.
This needs to be balanced against the value of keeping patients in treatment when considering
the management options where diversion does occur.
70
74
Concerns about suspicion of diversion may arise from observations of patient behaviour or
information from other sources, such as other service providers, friends or family members of
the patient. The service provider will need to make a judgment as to the credibility of third
party reports. See Appendix 8 for a list of possible behavioural indicators of diversion and
recommended supervised dosing strategies to minimize the risk of diversion.
Chapter 5
75
71
Recommended action*
Suspected diversion
Where the pharmacist suspects the patient is diverting or attempting to divert their
medication, the pharmacist should discuss the concerns with the patient. This may clarify any
misunderstandings regarding the dosing requirements. If required a formal first warning should
then be given to the patient by the pharmacist outlining the concerns and consequences of
further diversion attempts. The prescriber and CAS should also be notified.
Further indications or evidence of subsequent diversion incidents should result in the pharmacist
referring the patient back to the prescriber where the above actions are recommended as per
confirmed diversion.
Chapter 5
Diversion of Suboxone
There are no Australian data to support the suggestion that the mono and combination products
differ significantly in abuse liability, and no information on how different drug-using populations
will respond to the introduction of the combination product. However, following the release of
the combination product in Australia, a post-marketing surveillance study will be undertaken by
the National Drug and Alcohol Research Centre. This study will assess relative rates of diversion
of the mono and combination products, as well as the relative efficacy of these tablets in the
usual practice setting.
72
76
Assessment criteria
Chapter 5
Suitability for maintenance treatment and the type of pharmacotherapy prescribed will be
determined by:
the history of AOD use
the physical and psychological assessment
evidence of opioid dependency and current physical dependence
prior treatment history and current reasons for seeking treatment
parental or family support
a comprehensive risk assessment (self harm/suicide, accommodation arrangements,
ongoing chaotic drug use, etc)
capacity to give informed consent to treatment. On assessment the young person must
be deemed mature enough to understand the risks and consequences of the treatment.
treatment history
77
73
Chapter 5
Buprenorphine is a Category C drug, which has implications for pregnancy. ADEC states that this
group of drugs has caused, or may be suspected of causing, harmful effects on the human fetus
or neonate without causing malformations. These effects may be reversible. Opioid analgesics
are capable of causing respiratory depression in the neonate, and withdrawal symptoms have
been reported in cases of prolonged use.
Methadone is also classed as a Category C drug because of the potential risk of respiratory
depression in the neonate and the likelihood of neonatal withdrawal syndrome.
Respiratory depression is not a significant problem in babies born to opioid dependent mothers
receiving methadone maintenance treatment. Babies born to mothers on methadone maintenance
treatment may experience a withdrawal syndrome. Available evidence gives little support to
the existence of a relationship between the severity of the neonatal withdrawal syndrome
and maternal methadone dose at delivery and its occurrence is unpredictable. The benefits of
methadone maintenance treatment for both the mother and the baby outweigh any risks from
the neonatal withdrawal syndrome.
Any woman patient seeking maintenance treatment who might become pregnant should be
counselled on the potential risks of buprenorphine during pregnancy, with this information being
reinforced and presented to them in writing.
74
78
The key issue for women who want to remain on buprenorphine during
pregnancy or breastfeeding is that they understand that the safety and
effectiveness of buprenorphine has not yet been fully evaluated
In addition women who have been stabilised on buprenorphine and who have been able to cease
heroin use may risk a return to regular heroin use as a result of being destabilised during the
transfer to methadone. For these reasons, it may be preferable for pregnant women who do
not wish to transfer to methadone to be maintained on buprenorphine. In this situation, advice
should be sought from an obstetrician and an addiction medicine specialist. Counselling must be
provided regarding treatment options to ensure that the woman is fully informed of the risks and
benefits of buprenorphine during pregnancy and breastfeeding. The mono preparation, Subutex
consent form signed by patient should be used in these situations (see Appendix 13 for template
form).
Termination of pregnancy
Women wishing to terminate the pregnancy should be referred to appropriate services.
Opioid using pregnant women not already in treatment should be given high priority for
assessment.
Naloxone challenge should not be used in pregnant women because this may precipitate
miscarriage or premature labour. Pregnant women should be maintained on an adequate dose of
methadone to achieve stability and prevent relapse or continued illicit opioid drug use.
Women already in methadone treatment who become pregnant can safely be maintained on
their current dose. Transfer to buphrenorphine is not advised because of the risk of precipitated
withdrawal.
The bioavailability of methadone is decreased in the later stages of pregnancy due to increased
plasma volume, an increase in plasma proteins that bind methadone and placental metabolism
of methadone. It may be necessary to divide the daily dose and possibly to increase the dose in
the third trimester of pregnancy to avoid withdrawal symptoms and minimise additional drug use.
The dose should be reviewed after birth and adjusted according to:
79
75
Signs of withdrawal
or
Risk of reverting to illicit drug use.
Breastfeeding
Breast milk contains only small amounts of methadone and mothers can be encouraged
to breastfeed regardless of methadone dose provided that they are not using other drugs.
Breastfeeding may reduce the severity of the neonatal withdrawal syndrome. Women receiving
high doses of methadone should be advised to wean their babies slowly to avoid withdrawal in
the infant.
Chapter 5
It is known that only small amounts of buprenorphine and buprenorphine-naloxone pass into
breast milk. Given that the infant swallows the milk, absorption of buprenorphine from breast
milk would be expected to be minimal. However, there is a lack of research evidence regarding
the safety and effects on development of breast fed babies exposed to buprenorphine. In the
absence of adequate information of the effects of buprenorphine and buprenorphine/naloxone
on breastfeeding infants, breastfeeding should be approached with some caution. However,
the potential risks of buprenorphine should be balanced with the overall positive effects of
breastfeeding. Consultation with a specialist paediatric unit with substance use expertise is
advised.
76
80
All babies born to opioid dependent mothers should be observed by experienced staff for the
development of withdrawal signs. It is recommended that a validated scale be used to assess the
presence and severity of the neonatal withdrawal syndrome (see Appendix 9).
Common signs include
Irritability and sleep disturbances
Sneezing
Fist sucking
A shrill cry
Watery stools
General hyperactivity
Ineffectual sucking
Poor weight gain
Dislike of bright lights
Tremors
Increased respiration rate
Withdrawal symptoms usually start within 48 hours of delivery but may be delayed for 7-14 days
in a small number of cases. Experience in the US suggests that in cases where withdrawal is
delayed it may be because methadone was being used in conjunction with illicit benzodiazepines
and the infant is withdrawing from the benzodiazepines.
Supportive treatment involves minimising environmental stimuli and enhancing the babys
comfort and may include:
soothing by holding close to the body or swaddling
keeping nostrils and mouth clear of secretions
use of a dummy to relieve increased sucking urge
frequent small feeds.
Chapter 5
Treatment should be based on the severity of the withdrawal signs. Use the Finnegan or modified
Finnegan (Appendix 9) to assess withdrawal severity. Treatment should be commenced when the
score averages 8 or more on three consecutive scores or 12 or more on two consecutive scores
when assessed by an experienced scorer. Improvement should be monitored using scores on the
screening tool.
Advice on current treatment options should be obtained from the Neonatal Intensive Care Unit at
King Edward Memorial Hospital.
Child protection
The Department of Health Guidelines for Responding to Child Abuse and Neglect and the
Impact of Family and Domestic Violence (2004) states that Department of Health and all
Health Workers are to take an active approach in their response to concerns about the care and
protection of children. A childs best interests must come first where there is a risk of child
abuse and neglect.
81
77
5.12 HIV
Treatment programs should ensure that HIV positive patients have access to specialist HIV
medical care so that the patients overall health may be monitored and appropriate treatment
provided as required. In general, patients who are HIV positive are able to comply with the
requirements and conditions of the methadone/buprenorphine maintenance program, however,
the medical, psychological and social implications of HIV infection may necessitate the provision
of additional services.
Methadone/buprenorphine doses must be monitored due to the potential for interactions with
HIV medications and the effects of related illnesses.
Higher doses may be necessary if HIV medications increase methadone /buprenorphine
metabolism (see also Appendix 1 & 2).
Flexibility in dosing arrangements may be needed if patients are unable to attend for daily dosing
due to illness. Discuss options with CAS.
Chapter 5
In the terminal stages of HIV-AIDS, service providers may need to work with hospice services in
managing methadone/buprenorphine treatment and AIDS conditions.
Hepatitis C
A high percentage of patients entering methadone/buprenorphine programs will be hepatitis C
antibody positive. Patients should be treated in accordance with national and state guidelines.
78
82
Patients who are hepatitis C antibody positive but who have 3 normal serum aminotransferases
(ALT and AST) over 6 months should have liver function tests repeated at 6 monthly intervals and
a Hepatitis C polymerase chain reaction test at 12 months.
If the patient has 3 abnormal serum aminotransferases over 6 months referral to a
gastroenterologist or liver clinic for specialist assessment and shared care is indicated.
The Hepatitis C Council is able to offer support and counselling (see Appendix 6)
Chapter 5
Depression has been found to predict poor psycho-social functioning and to increase the risk of
relapse to heroin use. Evidence of the effectiveness of antidepressants as adjuncts is equivocal
with only a few studies demonstrating favourable effects on mood. The SSRIs are the preferred
antidepressants.
83
79
Chapter 6
Hubbard, R.L., Marsden, M.E., Rachal, J.V., Harwood, H.J., Cavanaugh, E.R., & Ginzburg, H.M. (1989). Drug
abuse treatment a national study of effectiveness. University of North Carolina Press: North Carolina.
Vaillant , G.E. (1988). What does long term follow up teach us about relapse and prevention of relapse in
addiction. British Journal of Addiction, 83, 1143-57.
Simpson, D.D. & Sells, S.B. (1982). Effectiveness of treatment for drug abuse: An overview of the DARP research
program. Advances in Alcohol and Substance Abuse, 2, 7-29.
80
84
Chapter 6
Treatment Selection
Treatment selection is a synthesis of:
Assessment of the patient
Examination of the available treatment options and likely outcomes; and
Negotiation with the patient around a suitable pathway.
85
81
In considering possible modalities, it is important to remember that many people come for
treatment with misconceptions and/or inadequate information about the two major options
available.
In general, withdrawal treatment is appropriate for those who are considering abstinenceoriented post-withdrawal treatment (such as naltrexone, residential rehabilitation programs,
counseling or 12 step programs) or for those who are not interested in longer-term treatment and
merely want a break from dependent heroin use.
However, maintenance substitution treatment (with methadone or buprenorphine) may be
more appropriate for those with significant opioid dependence who will not accept residential
rehabilitation or naltrexone treatment, but nevertheless want to stop or permanently reduce
their heroin use and all the damage it is causing them.
Clinical decision making should have an evidentiary basis and patients should be presented with
the relative merits and the limitations of treatment outcomes associated with each approach.
Within such a framework there is widespread evidence suggesting that maintenance substitution
remains the gold standard treatment for most people with chronic heroin dependence by virtue
of its success in keeping patients in treatment and reducing drug-related harm.
Once it is established that withdrawal is to be attempted, consideration must be given to
the services needed to achieve the best outcome. An optimal setting and adequate supports
should be found for each patient and monitoring arranged for their personal requirements and
medication needs.
Chapter 6
Some patients may wish to persevere with an outpatient withdrawal, despite unsuitable home
environments or having repeatedly failed as outpatients before. Such attempts at outpatient
withdrawal may still be appropriate if its what the patient wants. However, clinicians should
first negotiate with their patient some mutually agreed criterion of failure (e.g. no significant
progress within a week) at which point a switch will be made to an alternative treatment
pathway.
82
86
Chapter 6
Patients often have limited concentration during withdrawal and information may have to be
repeated, perhaps even re-phrased, to be fully understood and absorbed. Written information is
valuable in these circumstances, and is also recommended for support people. Such information
can be provided by ADIS (see above).
87
83
Counselling during the withdrawal episode should be aimed specifically at supporting the patient
through problems associated with withdrawal and in facilitating post-withdrawal links. Many
patients will want to deal with a range of personal, emotional or relationship problems during
the withdrawal episode, but they should be persuaded to defer all this until later. Attempting
to work through such issues will almost certainly be emotionally painful and anxiety-provoking,
which can intensify cravings and place the whole withdrawal program in jeopardy.
Patients in withdrawal tend to be irritable, agitated, tired and run-down; they can suffer from
mood swings and poor sleep patterns, as well as difficulty in concentrating. This is definitely not
the optimal frame of mind in which to try to solve significant, long-standing life problems. Assure
your patients that you understand that they have many important issues to work through to get
their lives together again, but it is best to take one step at a time. There will be opportunities
for these wider problems to be addressed as part of their ongoing rehabilitation after they get
through withdrawal. On the other hand, crisis intervention may be required during a withdrawal
episode to ensure adequate accommodation, food or other urgent welfare issues.
In addition to supportive counselling from health professionals and the support of family, friends
and peer workers, heroin users may also benefit from 24-hour telephone counselling services for
help when others are unavailable. ADIS can provide this service and can also put patients in touch
with other such services available.
Monitoring
An important part of withdrawal service is regular and frequent monitoring, to check:
general progress
drug use
response to the medication(s)
severity of withdrawal symptoms (which can be facilitated by the use of withdrawal
scales)
complications or difficulties
ongoing motivation levels.
Doses of medication can then be adjusted according to the patients progress. It is recommended
that patients undergoing outpatient withdrawal be reviewed by a health professional (eg alcohol
and drug worker, general practitioner, or experienced pharmacist) at least daily during the first
few days of treatment.
Chapter 6
There are various opioid withdrawal scales available to refer to. Subjective scales are far more
sensitive to changes in withdrawal severity, and are better predictors of patient outcomes.
Objective scales are not only less sensitive, but usually need to be administered by a health
professional. They may nevertheless be useful in corroborating subjective ratings, particularly
in individuals who are thought to be over- or under- rating their withdrawal severity. Copies of
the Subjective Opioid Withdrawal Scale and Objective Opioid Withdrawal Scale are provided in
Appendix 10.
84
88
Chapter 6
1 Cheskin LJ, Fudala PJ, & Johnson RE (1994). A controlled comparison of buprenorphine and clonidine for acute
detoxification from opioids. Drug and Alcohol Dependence, 36(2), 115-21;
2 Nigam AK, Ray R, & Tripathi M. (1993). Buprenorphine in opiate withdrawal: A comparison with clonidine.
Journal of Substance Abuse Treatment, 10, 391-394;
3 OConnor PG, Carroll KM, Shi J, Schottenfeld RS, et al (1997). Three methods of opioid detoxification in a
primary care setting. Annals of Internal Medicine 127(7) 526-530;
4 Bickel WK, Stitzer ML, Bigelow GE, Liebson IA, et al (1988). A clinical trial of buprenorphine: Comparison with
methadone in the detoxification of heroin addicts. Clinical Pharmacology & Therapeutics, 247, 47-53;
5 Schneider U ;
6 Lintzeris N, Bell J, Bammer G, Rushworth L et al (2000) A radomised controlled trial of buprenorphine for the
management of outpatient heroin withdrawal. paper presented at the November 2000 National Methadone
Conference, Melbourne, Australia.
89
85
Chapter 6
86
90
All patients should be informed verbally and in writing of these risks and the advice documented
in the clinical records. Intoxicated patients should not be dosed with buprenorphine or sedative
medications.
Buprenorphine regime
for 4 - 8 days with
exploration of post
withdrawal treatment
plans
Substitution
maintenance treatment
Buprenorphine or
methadone
Chapter 6
Withdrawal episode
No ongoing
pharmacotherapy
Psychosocial interventions
91
87
Takeaway doses are not to be provided during the initial treatment period
(See section 4).
Patients unable to attend an authorised pharmacy daily for supervised dispensing should consider
alternative withdrawal medications.
There is no conclusive evidence of an optimal buprenorphine dosing regime for heroin
withdrawal. In general, daily buprenorphine doses of 4 to 16 mg appear to be most effective in
reducing withdrawal severity and heroin use (Gowing et al. 2006).
Induction onto buprenorphine for the purposes of detoxification should follow the same principles
as for buprenorphine maintenance. Once a stable dose is achieved, the rate of dose reductions
should be determined in consultation with the patient.
Some flexibility is allowable in doses to accommodate a range of factors, such as amount
of heroin use and psychological condition, impacting on each patients individual dosing
requirements and withdrawal severity.
Review by a trained health professional is recommended on a daily basis during the first few
days of the withdrawal regime. This is important so that doses can be adjusted, if necessary,
and any difficulties being experienced on the medication can be addressed. It is also needed to
ensure provision of appropriate support care and monitoring.
Chapter 6
Those patients who remain ambivalent about long-term post-withdrawal treatment and have not
been able to cease their heroin use, may need referral to an inpatient supervised withdrawal
program. Alternatively, an extension of the withdrawal regime over several weeks may be
warranted.
88
92
However, there are good reasons for not prolonging buprenorphine treatment:
Administration of buprenorphine for more than several days commonly produces rebound
withdrawal when ceased, typically starting 1 - 3 days after the last dose of buprenorphine,
peaking 2 - 5 days after the last dose, and with some symptoms persisting several weeks.
Prolonged, probably unsuccessful, attempts at withdrawal can be demoralising for the patient,
resulting in lowered capability, self-esteem, and/or confidence in the treatment provider. For
this reason, a limit on the time spent on a gradual reduction regime should be discussed with the
patient early in the program.
Longer-term maintenance substitution treatment (with buprenorphine or methadone) should be
recommended to patients who:
cannot stop, or markedly reduce, their heroin use during the withdrawal episode;
relapse into regular heroin use as the dose of buprenorphine is reduced or ceased;
do not feel confident about maintaining abstinence but do not want to relapse to
dependent heroin use and the associated harms.
It is recommended that such patients stabilise on a maintenance substitution medication for
a longer period of time before coming off their maintenance treatment, to give them the
opportunity to first distance themselves from heroin use and possibly to address any problematic
psychological and social issues which may be distressing them.
Chapter 6
93
89
The following regime is recommended for an admission time of approximately one week, and can
be tailored accordingly:
2
3
4
5
6
7
4 to 8 mg
4
4
0
0
to
to
to
to
8
6
4
2
mg
mg
mg
mg
This regime serves as a guide only, and considerable individual variation in withdrawal severity
and medication requirements should be expected.
Post-withdrawal options should be explored prior to discharge.
Naltrexone: Patients commencing naltrexone treatment should do so during their admission.
Buprenorphine: Patients wishing to commence buprenorphine maintenance treatment should
continue their buprenorphine as inpatients until transfer to a community-based provider can be
organised.
Chapter 6
The simplest approach is to wait seven days after last dose of buprenorphine before commencing
naltrexone. Precipitation of withdrawal by naltrexone is unlikely following a 7-day opioidfree period (Bell et al. 2003). However, the pharmacology of buprenorphine does enable the
commencement of naltrexone earlier than this (Umbricht et al 1999). Naltrexone commenced
early in the course of heroin withdrawal managed with buprenorphine (day 2 or 3 after
90
94
cessation of heroin while buprenorphine still being prescribed) will result in increased severity
of withdrawal on the day of the first dose of naltrexone, but may reduce the duration of
withdrawal. This approach is best undertaken in an inpatient or intensive day-care setting that is
able to respond to serious withdrawal symptoms if they occur.
A third option is to commence naltrexone 2 to 5 days after cessation of a brief course of
buprenorphine for management of heroin withdrawal. This is likely to be associated with mild to
moderate precipitated withdrawal. It is best undertaken in an inpatient or day care setting with
the ability to respond to severe withdrawal if it were to occur.
Administration of naltrexone within five days of stopping buprenorphine use is likely to result in
opioid withdrawal following the first dose of naltrexone. This typically commences 90 minutes to
4 hours after the first naltrexone dose, peaks around 3 to 6 hours after the naltrexone dose, and
generally subsides in severity within 12 to 24 hours. The withdrawal is frequently experienced as
moderate to severe at its peak. Subsequent doses of naltrexone produce considerably less severe
withdrawal discomfort.
Most patients undergoing this procedure request symptomatic medication, and clonidine (0.10.15 mg every 3 to 4 hours as required) and a benzodiazepine (eg diazepam 5mg, 3 to 4 hourly,
maximum of 30 mg in a day, as required) should be prescribed.
Chapter 6
95
91
Effect
Mechanism
Alcohol
Clinically important
Increased sedation,
increased respiratory
depression. Combination
may also have increased
hepatotoxic potential.
Barbiturates
Clinically important
Reduced Methadone
levels. Increased
sedation. Additive CNS
depression.
Barbiturates stimulate
hepatic enzymes
involved in methadone
maintenance.
Benzodiazepines
Clinically important
Enhanced sedative
effect.
Buprenorphine
Clinically important
Antagonist effect or
enhanced sedative and
respiratory depression.
Buprenorphine is a
partial agonist of opiate
receptors.
Carbamazepine
Clinically important
Reduced methadone
levels.
Carbamazepine
stimulates hepatic
enzymes involved in
methadone metabolism.
Chloral Hydrate
Clinically important
Chlormethiazole
Clinically important
Cimetidine
Possible increase in
Cimetidine inhibits
methadone plasma levels. hepatic enzymes involved
in methadone metabolism
Ciprofloxacin
Enhanced sedative
effect and respiratory
depression requiring
naloxone.
Probably by inhibiting
hepatic enzymes
involved in methadone
metabolism.
Cisapride
Domperidone
Metoclopramide
Theoretical
Theoretically might
increase the speed of
onset of methadone
absorption but not the
extent.
Cyclazine and
other sedating
anti-histamines.
Clinically important
Anecdotal reports of
injection of cyclazine
with opioids causing
hallucinations.
Reports of injections
of high doses of
dephenhydramine to
achieve buzz.
Additive psychoactive
effects. Anti muscarinic
effects at high doses.
(cyclazine is
not available in
Australia)
92
96
Status of Interaction
Drug
Status of Interaction
Effect
Mechanism
Desipramine
Clinically important
Other tricyclic
antidepressants
Theoretical
Disulfiram
Disulfiram inhibits
metabolism of alcohol
allowing metabolites to
build up.
Erythromycin
Increase in methadone
levels
Decreased methadone
metabolism.
Fluconazole
Fluoxetine
Sertraline
Clinically important
Decreased methadone
metabolism
Fluvoxamine
Clinically important
Decreased methadone
metabolism
Other SSRIs
Theoretical
Grapefruit juice
Decreased methadone
metabolism
Indinavir
Clinically important
Decreased methadone
metabolism
Ketoconazole
Clinically important
Decreased methadone
metabolism
MAOI (including
selegiline and
moclobemide)
CNS excitation,
delirium, hyperpyrexia,
convulsions, hypotension
or respiratory depression.
Meprobamate
Clinically important
Naltrexone
Clinically important
Blocks effect of
methadone (long acting)
Opioid antagonist
competes for opiate
receptors.
Naloxone
Clinically important
Blocks effects of
methadone (short acting)
but may be needed if
overdose suspected.
Opioid antagonist
competes for opiate
receptors.
Nevirapine
Clinically important
Decreased methadone
levels
Increased methadone
metabolism
97
93
Drug
Status of Interaction
Nifedipine
Increased nifedipine
levels. No effect on
methadone levels.
Methadone increases
metabolism of nifedipine.
Omeprazole
To date demonstrated
only in animals
Increased methadone
levels
Possibly an effect on
methadone absorption
from the gut.
Antagonist effect or
enhanced sedative and
respiratory depression
Pentazocine is a partial
agonist of opiate
receptors with weak
antagonist effect.
Phenytoin stimulates
hepatic enzymes involved
in methadone metabolism
Pentazocine
94
98
Effect
Mechanism
Phenobarbitone
Phenytoin
Clinically important
Reduced methadone
levels
Propanolol
To date demonstrated
only in animals.
Significance in humans
is not known. Exercise
caution when coadministering.
Enhanced lethality of
toxic doses of opioids
Rifampicin
Reduced methadone
levels
Rifampicin stimulates
hepatic enzymes involved
in methadone metabolism
Rifabutin
Occasionally clinically
important
Decreased methadone
levels
Increased methadone
metabolism.
Ritonavir
Clinically important
Increased methadone
metabolism.
Thioridazine
Clinically important
Enhanced CNS
depression.
Other protease
inhibitors
Theoretical
Urine acidifiers
e.g. ascorbic
acid vitamin C
Clinically important
Reduced plasma
methadone levels
Increased urinary
excretion of methadone
Urine alkalisers
e.g. sodium
bicarbonate
Clinically important
Increased plasma
methadone levels
Reduced urinary
excretion of methadone
Zidovudine
Clinically important
Unknown
Drug
Status of Interaction
Effect
Mechanism
Zopiclone
Clinically important
Other opioid
agonists
Clinically important
Other CNS
depressant
drugs (eg
neuroleptics,
hyoscine)
Clinically important
99
95
Substrates
Macrolide antibiotics:
Clarithromycin
Erythromycin
Anti-arrhythmics:
Quinidine
Benzodiazepines:
Alprazolam
Diazepam
Midazolam
Immune modulators:
Cyclosporine
Tacrolimus
HIV Antivirals:
Indinavir
Nelfinavir
Ritonavir
Saquinavir
Prokinetic
Cisapride
Antihistamines:
Astemizole
Calcium Channel
Blockers:
Amlodipine
Diltiazem
Felodipine
Nifedipine
Verapamil
100
96
Inducers (potentially
decreasing
blood levels of
buprenorphine)
HIV Antivirals:
Efavirenz
Nevirapine
Other
Barbiturates
Carbamazepine
Glucocorticoids
Modafinil
Phenobarbital
Phenytoin
Rifampin
St Johns wort
Item
No
Check
Points
with
Photo
Points
without
Photo
1
12
3
100
100
100
24
5
100
75
36
100
25
47
40
25
40
40
25
25
40
25
40
25
40
25
58
69
710
811
912
13
14
15
10
11
12
13
14
15
16
25
25
25
25
25
25
25
25
25
25
25
101
97
Appendix 4 Urinalysis
Drug
Alcohol
2 14 hours
Amphetamines
2 days
Barbiturates
Bezodiazepines
Cannabinoids
Cocaine
2 4 days
Methadone
3 days
Opiates
2 days
102
98
103
99
104
100
Hepatitis Council
Suite 3, 85 Stirling Street, Northbridge
Telephone: 1800 800 070
105
101
102
Intoxication
Overdose
Opioids
(eg methadone, heroin,
morphine)
Constriction of pupils
Itching/scratching
Sedation/somnolence
Lowered blood pressure
Slowed pulse
Hypoventilation
Loss of consciousness
Respiratory depression
Pinpoint pupils
Hypotension
Bradycardia
Pulmonary oedema
Alcohol
Relaxation
Disinhibition
Impaired coordination
Impaired judgement
Decreased concentration
Slurred speech
Ataxia
Vomiting
Disorientation/confusion
Respiratory depression
Loss of consciousness
Loss of bladder control
Benzodiazepines
(eg diazepam, oxazepam,
flunitrazepam)
Disinhibition
Sedation
Drooling
Incoordination
Slurred Speech
Lowered blood pressure
Dizziness
Stupor/coma
Ataxia
Confusion
Respiratory depression
Stimulants
(eg amphetamines, cocaine)
Hyperactivity
Restlessness
Agitation
Anxiety/nervousness
Great dilation of pupils
Elevated blood pressure
Increased pulse
Raised temperature
Sweating
Tremor
Panic attacks
Acute paranoid psychosis
Seizures
Cardiac arrhythmias
Myocardial ischaemia
Hypertensive crisis
Cerebrovascular accidents
Hyperpyrexia
Dehydration
Cannabis
Relaxation
Decreased concentration
Decreased psychomotor
performance
Impaired balance
Conjunctival infection
Paranoid psychosis
Confusion
Agitation
Anxiety/panic
Hallucinations
Toxicity
Slurred speech
Unsteady gait
Drowsiness
Pupil constriction
Conjunctival infection
Alcoholic foetor
Disinhibition
Drooling
Dizziness
Itching/scratching
Drowsiness
Shallow breathing
Poor circulation
Lowered temperature
Slow pulse
Nausea and vomiting
Headache
Confusion
From NSW Methadone Maintenance Treatment Clinical Practice Guidelines. Used with permission.
103
Appendix 8 Diversion
Minimising the Risk of Diversion
To minimise the risks of diversion, patients should be provided with clear guidance on how and
why medication is given, and how they should present during observed consumption to avoid
unnecessary suspicion of diversion.
Buprenorphine
1. Patients should have their mouth cavity inspected prior to receiving their dose (gum, lollies
should be removed).
2. The dose should be crumbled to large coffee granule size (to reduce potential for diversion)
and dispensed into a clear plastic cup. Powdering of the drug should be avoided since it
promotes both the rapid development of an easily swallowed particulate solution and the
pasting of the drug into the top of the gums where it might be removed from the clinic.
3. The contents of the cup should be tipped under the tongue and then the oral cavity inspected
to confirm placement under the tongue.
4. Patients should be told that three to five minutes is the time required to get the most from
the drug and advised not to swallow their saliva during this period as buprenorphine is not
effectively absorbed if swallowed.
5. Patients should have their mouth cavity inspected after they report having absorbed the
entire drug sublingually prior to leaving the dosing site.
Methadone
1. Patients should have their mouth cavity inspected prior to receiving their dose (gum, lollies
should be removed). Check sleeves (ask clients to remove coats and roll up sleeves) to ensure
receptacles are not hidden for spitting dose into.
2. Use an individual disposable cup for each patient, do not pour methadone into another drink
container.
3. Add water (or other drink) as per clients request to the dose. Monitor throat for swallowing
action.
4. Inspect mouth cavity to ensure dose swallowed and talk with client after dosing, ensuring
client opens mouth and talks normally.
Possible indicators of diversion or attempted diversion
It is difficult to provide absolute indicators therefore the following must be assessed in the
context in which they occur and with regard to knowledge of the client. Video surveillance is
recommended.
Receptacles in the mouth such as plastic caps, glad wrap
Not wanting to stay for supervision
Causing distractions
Reading books, magazines etc close to face
Touching mouth with hand or sleeve
Browsing shop
Spitting, coughing, sneezing
Out of character behaviour, nervousness, being over-nice, watching pharmacist closely
104
WARD
MRN
SURNAME
OTHER
NAMES
DOB/SEX
MR 520
DATE AND TIME IN HOURS
GASTROINTESTINAL
DISTURBANCES
METABOLIC/VASOMOTOR/
RESPIRATORY
DISTURBANCES
SYSTEM
S
C
O
R
E
High-Pitched Cry
Continuous High-Pitched Cry
Sleeps <1 hour after feeding
Sleeps <2 hours after feeding
Sleeps<3 hours after feeding
Mild Tremors Disturbed
Mod-Severe Tremors Disturbed
Mild Tremors Undisturbed
Mod-severe Tremors Undisturbed
Increased Muscle Tone
Excoriation (Specify area)
2
3
3
2
1
1
2
3
4
2
1
Myoclonic jerks
Generalised Convulsions
Fever (37.3o-38.3oC)
Fever (38.4oC and higher)
Frequent Yawning (>3-4 times)
Nasal Stuffiness
Sneezing (>3-4 times)
Nasal Flaring
Respiratory Rate >60/min
Respiratory Rate >60/min
with Retractions
Excessive Sucking
Poor Feeding
Regurgitation
Projectile Vomiting
Loose Stools
Watery Stools
TOTAL SCORE
SCORERS INITIALS
3
5
1
2
1
1
1
2
1
2
1
2
2
3
2
3
From NSW Methadone Maintenance Treatment Clinical Practice Guidelines. Used with permission.
105
Time
PLEASE SCORE EACH OF THE 16 ITEMS BELOW ACCORDING TO HOW YOU FEEL
NOW
(CIRCLE ONE NUMBER)
SYMPTOM
A LITTLE
NOT AT ALL
MODERATELY
QUITE A BIT
EXTREMELY
I feel anxious
I am perspiring
My nose is running
I have goosebumps
I am shaking
11 I feel restless
12 I feel nauseous
14 My muscles twitch
106
Time
SIGN
MEASURES
Yawning
0 = no yawns
1 = 1 yawn
Rhinorrhoea
0 = < 3 sniffs
1 = 3 sniffs
0 = absent
1 = present
Perspiration
0 = absent
1 = present
Lacrimation
0 = absent
1 = present
Tremor (hands)
0 = absent
1 = present
Mydriasis
0 = absent
1 = 3 mm
0 = absent
Restlessness
0 = absent
10
Vomiting
0 = absent
1 = present
11
Muscle twitches
0 = absent
1 = present
12
Abdominal cramps
0 = absent
1 = Holding stomach
13
Anxiety
0 = absent
1 = mild severe
TOTAL SCORE
SCORE
Range 0-13
Handelsman, L., Cochrane, K. J., Aronson, M. J. et al. (1987) Two New Rating Scales for Opiate
Withdrawal, American Journal of Alcohol Abuse, 13, 293-308
107
Onset
Duration
Symptoms
Opioids
Peaks 2-4
Ceases 7-10 days
(short acting).
Longer for long
acting opioids.
Alcohol
As blood alcohol
falls, depends on
rate of fall and
hours after last
drink.
5-7 days
Benzodiazepines
1-10 days
depending on halflife
3-6 days
Stimulants
8-36 hours
Several days,
occasionally 2-3
weeks
Cannabis
Usually days
Weeks
108
109
110
111
Surname
Given name(s)
Date of Birth
Telephone No.
2. Current Dose
mg.
Temporary
pw
6. Current Pharmacy (block letters)
7. Patient Review (see stability criteria over page)
The patient is stable and there are no contraindications to prescribing takeaway doses.
Yes
8. Number of takeaway doses is within the schedule allowed (see over for schedules)
Yes
No
(no further approval required, complete declarations and file on patient file)
(complete information overleaf and fax both pages and any supporting evidence to CAS
on 9471 0444)
NB: All takeaway doses of Subutex are considered to be outside of the schedule and approval from
CAS must be obtained before scripts are provided
DECLARATION BY PATIENT
I understand that there are safety requirements for takeaway doses and undertake responsibility for the
safe use of the takeaway doses that I will receive.
1. Takeaway doses must be stored in a place that is out of each of children. A locked cabinet is ideal.
2. In order to reduce the risk of theft, the whereabouts of the dose should not be made known to
others.
3. The dose must be consumed according to the directions given by the prescriber. When more than
one takeaway dose is provided, each dose must be taken on the day for which it is prescribed. Doses
should not be stockpiled and no more than the prescribed daily dose should be taken.
4. Doses are not to be sold or given away.
There will be no replacement of doses that are spilled, vomited, lost or stolen. If any of these occur,
my prescriber must be notified as soon as possible.
Signed (Patient)
Date
DECLARATION BY PRESCRIBER
I certify
(a) that I have clinically assessed the patient as suitable for takeaway doses
(b) provided advice regarding storage and access to the takeaway dose(s), especially
with regard to children, and
(c) I have witnessed the above signature
Signed (Prescriber)
Date
To prescribe takeaway doses outside of the schedule of frequency to stable clients or to provide takeaway
doses of Subutex, approval must be obtained from CAS. Complete the additional information below and the
declarations on the front page. Then fax both sides of this form to CAS on 9471 0444.
Please describe the special circumstances warranting takeaways outside of the schedule or takeaway doses
of Subutex (attach any supportive documentation e.g: evidence of employment)
CAS Consultant
Indications of stability
No recent injection sites
In a maintenance program for treatment more than 6
months
Regular and reliable contact with the prescriber and
pharmacy
SCHEDULES OF FREQUENCY (for more information see Section 4 of the Policy and Procedure manual)
Methadone
Time in treatment*
6 - 12 months
After six months of continuous treatment and where the patient is assessed as stable and is working towards achieving treatment goals, they may be eligible for one
takeaway dose of methadone per week.
12 - 24 months
After 12 months of continuous treatment and where the patient has demonstrated
stability with one takeaway dose per week they may be eligible for two non-consecutive takeaway doses per week.
After 2 years of continuous treatment and where the patient has demonstrated stability with two takeaway doses per week they may be eligible for 3 takeaway doses
of methadone per week. Only two of these may be consecutive.
Suboxone
Time in treatment*
Daily Dosing
6 - 24 months
1 per week
2 per week
1 per week
*NB: Duration refers to continuous period of dosing with either methadone or buprenorphine. It does not refer to
continuity with the same service provider. This allows for transfers between service providers for stable clients.
113
Surgery stamp
I
(patient name) voluntarily consent to starting
treatment with methadone. I understand that methadone is a long acting, addictive opioid drug that
is prescribed as treatment for opioid dependency. I understand that the duration of treatment will
be tailored to meet my particular needs in consultation with my doctor.
I have been given written information about the potential side effects of methadone and the
conditions associated with methadone treatment. I have read and understood the treatment
requirements. I am aware that other treatment options are available. These include detoxification,
counselling, residential rehabilitation and other medications such as buprenorphine and naltrexone. I
also understand it is my responsibility to be aware of the drug and alcohol policy of my employer.
I understand that the objectives of methadone treatment are to:
Reduce my opioid drug use and to help me become drug free
Reduce my risk of overdose and of contracting or transmitting blood borne diseases
Improve my physical, psychological and social well-being.
I understand that before I can receive methadone, authorisation must be obtained from the W.A.
Department of Health and my name will be included on the register of notified drug addicts. I
understand that methadone is taken orally in the form of a liquid that is swallowed and that I will
need to attend a community pharmacy for daily supervised methadone dispensing.
I understand that the disadvantages of methadone treatment include the following:
Methadone is a drug of dependency and can result in withdrawal symptoms if I stop or reduce
my dose.
The requirement for supervised dosing imposes restrictions on employment and travel.
There is a daily dispensing fee, set by the pharmacy that I must pay before each dose.
Methadone effects capacity to drive, operate machinery or work at heights during the early
stages of treatment or following dose increases. I understand that I have to refrain from
these activities during this time.
I have been informed that there are risks associated with methadone treatment during pregnancy
and understand that if I become pregnant I must advise my prescribing doctor as soon as possible to
discuss treatment options.
I am aware that methadone is dangerous to combine with other sedating drugs or medications such
as other opioids (e.g. heroin, morphine, codeine), benzodiazepines or alcohol. I understand that
there is a risk of overdose and death from this effect.
I understand that I have given permission for the sharing of information relevant to my treatment
to the Department of Health, Next Step and my pharmacy as stated on the application for authority
form.
Patient:
Date:
114
GP:
(signature)
(signature)
Next Step Community Clinical Programs template Methadone Treatment Consent July 2007
METHADONE TREATMENT
CONSENT FORM
Surgery stamp
I
(patient name) voluntarily consent to starting
treatment with Subutex. I understand that Subutex is a long acting, addictive opioid drug that is
prescribed as treatment for opioid dependency. Subutex must be administered sublingually (under
the tongue).
I have been given written information about the potential side effects of Subutex and the conditions
associated with Subutex treatment. I have read and understood the treatment requirements. I
am aware that other treatment options are available. These include detoxification, counselling,
residential rehabilitation and other medications such as buprenorphine and naltrexone. I also
understand it is my responsibility to be aware of the drug and alcohol policy of my employer.
I understand that the objectives of Subutex treatment are to:
Reduce my opioid drug use and to help me become drug free
Reduce my risk of overdose and of contracting or transmitting blood borne diseases
Improve my physical, psychological and social well-being.
I understand that before I can receive Subutex, authorisation must be obtained from the W.A.
Department of Health and my name will be included on the register of notified drug addicts. I
understand that Subutex is taken orally in the form of a liquid that is swallowed and that I will need
to attend a community pharmacy for daily supervised Subutex dispensing. Takeaway doses are not
usually allowed other than in very exceptional circumstances.
I understand that the disadvantages of Subutex treatment include the following:
Subutex is a drug of dependency and can result in withdrawal symptoms if I stop or reduce
my dose.
The requirement for supervised dosing imposes restrictions on employment and travel.
There is a daily dispensing fee, set by the pharmacy that I must pay before each dose.
Subutex effects capacity to drive, operate machinery or work at heights during the early
stages of treatment or following dose increases. I understand that I have to refrain from
these activities during this time.
I have been informed that there are risks associated with Subutex treatment during pregnancy and
understand that if I become pregnant I must advise my prescribing doctor as soon as possible to
discuss treatment options.
I am aware that Subutex is dangerous to combine with other sedating drugs or medications such as
other opioids (e.g. heroin, morphine, codeine), benzodiazepines or alcohol. I understand that there
is a risk of overdose and death from this effect.
I understand that I have given permission for the sharing of information relevant to my treatment
to the Department of Health, Next Step and my pharmacy as stated on the application for authority
form.
Patient:
Date:
GP:
(signature)
Next Step Community Clinical Programs template Subutex Treatment Consent July 2007
BUPRENORPHINE
(SUBUTEX) TREATMENT
CONSENT FORM
(signature)
115
Surgery stamp
I
(patient name) voluntarily consent to starting
treatment with Suboxone. I understand that Suboxone is a long acting, addictive opioid drug that is
prescribed as treatment for opioid dependency. I understand that the duration of treatment will be
tailored to meet my particular needs in consultation with my doctor.
I have been given written information about the potential side effects of Suboxone and the
conditions associated with Suboxone treatment. I have read and understood the treatment
requirements. I am aware that other treatment options are available. These include detoxification,
counselling, residential rehabilitation and other medications such as buprenorphine and naltrexone.
I also understand it is my responsibility to be aware of the drug and alcohol policy of my employer.
I understand that the objectives of Suboxone treatment are to:
Reduce my opioid drug use and to help me become drug free
Reduce my risk of overdose and of contracting or transmitting blood borne diseases
Improve my physical, psychological and social well-being.
I understand that before I can receive Suboxone, authorisation must be obtained from the W.A.
Department of Health and my name will be included on the register of notified drug addicts. I
understand that Suboxone is taken orally in the form of a liquid that is swallowed and that I will
need to attend a community pharmacy for daily supervised Suboxone dispensing.
I understand that the disadvantages of Suboxone treatment include the following:
Suboxone is a drug of dependency and can result in withdrawal symptoms if I stop or reduce
my dose.
The requirement for supervised dosing imposes restrictions on employment and travel.
There is a daily dispensing fee, set by the pharmacy that I must pay before each dose.
Suboxone effects capacity to drive, operate machinery or work at heights during the early
stages of treatment or following dose increases. I understand that I have to refrain from
these activities during this time.
I understand that Suboxone has not been cleared for use during pregnancy and if I become pregnant
I must advise my prescribing doctor as soon as possible to discuss treatment options.
I am aware that Suboxone is dangerous to combine with other sedating drugs or medications such as
other opioids (e.g. heroin, morphine, codeine), benzodiazepines or alcohol. I understand that there
is a risk of overdose and death from this effect.
I understand that I have given permission for the sharing of information relevant to my treatment
to the Department of Health, Next Step and my pharmacy as stated on the application for authority
form.
Patient:
Date:
116
GP:
(signature)
(signature)
Next Step Community Clinical Programs template Subutex Treatment Consent July 2007
BUPRENORPHINENALOXONE (SUBOXONE)
TREATMENT
CONSENT FORM
I,
am currently regularly taking buprenorphine for the management of my opiate dependence, and
wish to continue treatment with buprenorphine during my pregnancy / period of breastfeeding,
rather than:
transfer to methadone, or
withdraw from buprenorphine
In making this decision, I understand that:
the safety of buprenorphine during pregnancy or breastfeeding remains uncertain at this
stage,
pregnancy and breastfeeding are currently listed as contraindications for the use of
buprenorphine in Australia by the Therapeutic Goods Administration,
I will need to attend regularly (and as directed) for antenatal care at
Hospital,
I will need to attend regularly for appointments with my treatment team at
I give permission for my prescribing doctor to consult with my obstetric health care service
providers on my progress.
Yes
No
I have been provided with written information about buprenorphine and all my questions have
been answered
Client signature:
Date:
Date:
Witness name:
(PLEASE USE BLOCK LETTERS)
Date:
Witness signature:
Next Step Community Clinical Programs template Subutex in PREGNANCY CLIENT Consent July 2007
117
I,
(full name)
mg methadone since
mg on
(date) at
am/pm
at
(pharmacy).
mg on
(date) at
am/pm at
(pharmacy).
Client signature:
Date:
Date:
Witness name:
(PLEASE USE BLOCK LETTERS)
Date:
Witness signature:
118
Next Step Community Clinical Programs template HIGH DOSE METHADONE TRANSFER CLIENT Consent July 2007
Next Step Community Clinical Programs template PAIN MEDICATION CLIENT Consent July 2007
I,
the medication
In extreme emergencies, should I need to seek an alternative supply, I will inform my doctor
as soon as possible and arrange an appointment to discuss the management plan and future
prescribing options.
Patient signature:
GP signature:
Date:
Date:
119
Benzodiazepines are sedative drugs which have been used to treat anxiety and insomnia. However
there are a number of problems that can occur with the use of these drugs.
Benzodiazepines can cause sleepiness, confusion, short-term memory loss and unsteadiness
(therefore increasing the risk of accidents, injury and falls). Benzodiazepines can be dangerous
when combined with alcohol, illegal drugs or many prescription medicines. Use of benzodiazepines
can also make driving dangerous.
Benzodiazepines are addictive drugs and will only be prescribed in a controlled manner. In order to
make sure that these are prescribed safely, I agree that:
1. Dr
may obtain information about previous prescriptions for benzodiazepines and other medications
from the Health Insurance Commission, the Department of Health and
2. I will attend appointments on time as agreed and I will not seek benzodiazepine supplies earlier
than the agreed date.
3. I will not seek supplies from other practices except in extreme emergencies. Should such an
emergency occur, I will attend this practice at the first available chance to discuss the plan for
further prescribing.
4. Once a prescription has been written or a drug has been dispensed it is my responsibility to
make sure that the script or the drug is safe. No repeat scripts will be written for lost or stolen
medication or scripts.
5. I will not give away or sell any of these supplies and will only take this medication as directed by
my doctor.
6. If I am not able to stay within this agreement, I understand that my prescriptions may be ceased.
I,
(print patient name) have read the information on this page and agree to the above conditions.
Patient signature:
GP signature:
120
Date:
Date:
121
SIGNATURE
DATE
DUTY PHARMACISTS
NAME
SIGNATURE
DATE
122
123
Year
Patient Name
(First name and Surname)
HDWA
No.
1*
2*
Dose
#
in (mg)
Number Of Doses
Missed
Takeaways
Print Pharmacists Name
M ,B or X
HDWA No.
1*
2*
#
Pharmacists Signature
Date
This report is to reach the Department of Health no later than seven (7) days after the end of the month
during which the transactions occurred and may be sent with the Drugs of Dependence
monthly transaction report.
All correspondence to the Manager, Drugs of Dependence, Department of Health, PO Box 8172, Perth Business Centre, Perth WA 6849
For further information telephone 08 9388 4945 or fax 08 9388 4988
124
Pharmacy Name
June
May
April
March
February
January
NAME OF CLIENT:
10
10
10
10
10
10
11
11
11
11
11
11
12
12
12
12
12
12
13
13
13
13
13
13
14
14
14
14
14
14
15
15
15
15
15
15
16
16
16
16
16
16
17
17
17
17
17
17
18
18
18
18
18
18
19
19
19
19
19
19
20
20
20
20
20
20
21
21
21
21
21
21
22
22
22
22
22
22
23
23
23
23
23
23
24
24
24
24
24
24
25
25
25
25
25
25
DRUG: Methadone
26
26
26
26
26
26
27
27
27
27
27
27
28
28
28
28
28
28
Subutex
29
29
29
29
29
29
30
30
30
30
30
31
31
31
Suboxone
125
126
December
November
October
September
August
July
NAME OF CLIENT:
10
10
10
10
10
10
11
11
11
11
11
11
12
12
12
12
12
12
13
13
13
13
13
13
14
14
14
14
14
14
15
15
15
15
15
15
16
16
16
16
16
16
17
17
17
17
17
17
18
18
18
18
18
18
19
19
19
19
19
19
20
20
20
20
20
20
21
21
21
21
21
21
22
22
22
22
22
22
23
23
23
23
23
23
24
24
24
24
24
24
25
25
25
25
25
25
DRUG: Methadone
26
26
26
26
26
26
27
27
27
27
27
27
28
28
28
28
28
28
Subutex
29
29
29
29
29
29
30
30
30
30
30
30
31
31
31
31
Suboxone
127
128