THE COLLEGE OF PHYSICIANS AND SURGEONS OF ONTARIO
ADDICTION RESEARCH FOUNDATION
ONTARIO COLLEGE OF PHARMACISTS
AUGUST 1996
PREFACE
The guidelines that follow represent a new standard of Practice for Ontario
for the prescribing of methadone in the maintenance treatment of opioid
dependence. Methadone remains the only opioid approved for long-term
pharmacological treatment of opioid dependence.
Where the new guidelines differ, with respect o the methadone maintenance
treatment, from the direction provided in the 1992 document titled "The use
of opioids in the management of opioid dependence" (Bureau of Dangerous
Drugs, Health and Welfare, Canada),.they replace, for Ontario, the 1992
document.
INTRODUCTION.
Methadone is a synthetic opioid agonist (i.e. it has actions similar to
those of morphine) with good oral bioavailability, equipotency with morphine
and a long duration of action. Methadone prevents withdrawal symptoms and
helps reduce drug cravings in opioid-dependent individuals.
Methadone was developed in Germany at the end of the second world war as a
substitute analgesic for morphine. Early research in the late 1940's by
Isbell and colleagues at the addiction Research Center in Lexington,
Kentucky, showed that it could also be used to treat withdrawal symptoms in
heroin-dependent individuals. In the early 1960's Dole and Nyswander
demonstrated the feasibility of using methadone as a maintenance medication.
Methadone maintenance involves the daily administration of methadone over an
extended period as an oral substitute for heroin or other morphine-like
drugs to opioid-dependent individuals. A single dose administered to a
stabilised individual lasts between 24 to 36 hours without causing euphoria,
sedation, or analgesia. This enables individuals to function normally and to
perform mental and physical tasks without impairment. In sufficient doses,
cross-tolerance to other opioids develops, i.e. methadone "blocks" the
euphoric effects of self-administered illicit opioids.
Numerous studies have shown that maintaining opioid-dependent individuals on
methadone has many benefits including:
decreased illegal activity
increased employment
reduced illicit drug use
improved health status
increased cost-effectiveness
Conversely, illicit opioid use has been associated with:
illegal activity
unemployment
family disruption
illnesses such as HIV/AIDS, hepatitis B and C, tuberculosis and sexually
transmitted diseases
death
Traditionally, methadone maintenance programs have been abstinence-oriented,
with the expectation that patients refrain from all non-prescription drug
use. Urine screening has been used as a primary means of determining
compliance. Patients have also been required to participate actively in
psychosocial treatment. While abstinence-based approaches have been
effective in assisting opioid users who are seeking to withdraw gradually
from opioids via methadone and who are committed to a drug-free lifestyle,
recent developments in Ontario have necessitated a fundamental rethinking of
service delivery goals and practices for the opioid-dependent patient.
First, the risk of HIV infection from intravenous drug use has increased the
acceptability of long-term methadone maintenance treatment. Second, there
has been an increase in the number of patients presenting for treatment who
list heroin as their primary drug of abuse. Finally, many of these
individuals are turning to treatment providers requesting methadone
treatment.
While not all opioid-dependent individuals are interested in or appropriate
candidates for methadone treatment, a considerable gap exists between the
demand for methadone treatment and its availability. There is also strong
support for developing new models of methadone treatment that are not
abstinence-based in order to serve a wider range of opioid users, including
those who are not able to achieve abstinence.
CRITERIA FOR ADMISSION
a) Individuals must meet criteria set out in the DSM-IV (Diagnostic and
Statistical Manual of Mental Disorders) for opioid dependence.
b) Individuals should be 18 yrs. of age or older.
c) There should be evidence of extensive past opioid use and/or failed
treatment attempts. Previous unsuccessful methadone treatment should not
exclude a patient from methadone treatment.
d) There should be at least one urine drug screen positive for opioids prior
to initiating methadone treatment.
ASSESSMENT
a) Informed Consent
Informed consent must be obtained prior to initiating the assessment
process.
b) Medical assessment
A medical assessment must be done prior to admitting an individual to a
methadone maintenance program. The purpose of the assessment is to:
determine a patient's suitability for methadone treatment (i.e. establish a
diagnosis of opioid dependence)
screen for medical complications associated with drug use (Hep B, Hep C,
HIV/AIDS, TB) including informed consent and pre- and post-test counselling
procedures
identify other medical or psychiatric conditions/problems
identify factors what put the individual at risk for harm (e.g., unsafe
sexual practices, emotional or physical abuse, lack of birth control,
suicidal ideation, etc.)
recommend a treatment plan to the patient
c) Psychosocial Assessment
The psychosocial assessment should be done as proximal to the medical
assessment as possible. It should be repeated as often as necessary during
the course of treatment. The use of a well-validated instrument (e.g. the
Addiction Severity Index) is recommended. The purpose of the assessment is
to:
gain an overview of problems in life functioning and establish baseline data
across various areas (medical, legal, drugs, alcohol, employment,
family/social, psychiatric)
identify psychosocial issues that require referral
establish a treatment plan, outlining objectives and conditions/expectations
d) Treatment Agreement
In order to ensure that all patients receiving methadone substitution have a
clear understanding of their responsibilities and obligations as partners in
the treatment process, all patients should sign a program treatment
agreement prior to receiving their first dose of methadone.
If the patient is requesting treatment for their opioid dependence at an
addiction treatment centre that does not offer comprehensive medical care,
the treatment agreement should also specify that the physician who
prescribes methadone for them does not offer such care. Patients should be
informed that it is their responsibility to arrange to have a family
physician. If the patient requests assistance, a staff member should be
delegated to help. Certain clinical situations (e.g. pregnancy) require
special consideration. Refer to the Clinician's Manual for Methadone
Treatment for advice on such situations.
The patient should receive an orientation to the program including
information about methadone. The patient should be given an opportunity to
ask questions about methadone or any other currently prescribed drug.
The treatment agreement should be signed by the patient in duplicate - one
copy to be retained by the patient and the other copy to be placed in the
patient's health record.
METHADONE DOSING ISSUES
a) Methadone Dose Stabilisation
The initial dose of methadone is administered after the medical assessment
has been completed and a diagnosis of opioid dependence has been
established. The following protocol is suggested:
the initial dose should be 15 - 30 mg of methadone per day
dose adjustments should be made every 3 - 4 days until the patient is
comfortable or a total daily dose of 60 mg has been reached.
after 60 mg, dose changes (5 - 10 mg) should only be made every 7 days if
needed; if the patient is receiving 80 mg or more and continues to use
drugs, complains of withdrawal and/or urges to use, the physician should
reassess the patient
criteria for dose increases include:
a) signs and symptoms of withdrawal (objective and subjective)
b) amount and/or frequency of drug use not decreasing
c) persistent cravings for opioids
b) Maintenance
Once a patient has been stabilised on methadone, dose changes may be made
only after the physician has reassessed the patient.
Although maintenance doses of methadone should be individualised to suit
each patient research evidence suggests that (as a general rule) higher
doses of methadone (>60 mg) are associated with better retention rates in
treatment and greater decreases in heroin use.
c) Missed Doses
If a patient does not attend on three consecutive days to drink his/her
methadone dose, he/she should be reassessed by the physician before being
medicated. For additional information refer to the Clinician's Manual for
Methadone Treatment.
d) Deferral To Medicate
Patients should not be medicated if they appear to be intoxicated; patients
may be asked to wait to be reassessed at a later time.
COUNSELLING
There is strong evidence to support improved treatment outcomes when
methadone maintenance includes counselling services. The program reserves
the right to determine counselling requirements on an individual patient or
program-wide basis. Additional information on counselling may be found in
the Clinician's Manual for Methadone Treatment.
URINE TOXICOLOGY SCREENING
a) Urine toxicology screens are done to ensure that the patient is ingesting
the methadone that is prescribed for them and to detect whether they are
taking any other non-prescribed drugs. As a general rule, the validity of
the urine screen results increases if the collection is done under
supervision.
b) A minimum of one urine drug screen is advised prior to initiation of
methadone treatment.
c) Urine samples should be tested twice weekly during the methadone dose
stabilisation period (usually the first 8 weeks of treatment)
d) Once a patient is considered to be "functionally stable" (please refer to
"Carry or Take-home Medication" below for the definition of functional
stability), the physician may set a weekly or twice monthly urine testing
schedule depending on the patient's progress. In this instance, a random
schedule is recommended.
e) Patients who are functionally stable for a one year period (i.e. one year
of drug-free urine samples) may leave one urine sample monthly. A random
schedule is recommended.
f) If the presence of illicit drugs and/or unexpected absence of methadone
or its metabolites is detected following the schedule outlined in d) and e),
(vide supra), the twice weekly urine testing schedule may be reinstated for
a specified period of time.
g) The physician has the right to request additional urine samples at any
time. This should be clearly stated in the program treatment agreement.
CARRY OR TAKE-HOME MEDICATION
Carry or take-home medication may be used as a therapeutic tool to assist
patients in re-establishing their lives along more constructive lines.
a) Carry or take-home medication is not recommended during the first three
months of treatment (see Table 1).
b) Carry or take-home medication may be given to patients who are considered
to be functionally stable. Stability may be assessed by a measured
consideration of behavioural and other criteria, including the following:
1) program participation:
attends as required for methadone
attends scheduled appointments
complies with treatment agreement
2) cognitive stability including the ability to assume responsibility for
the care of the medication and to use it as prescribed.
3) abstinence or non-harmful use of drugs (harm can be seen as a continuum
and can result from a single use or from long term use of drugs, measurable
in four basic ways: physiological, psychological, inter-personal/social, and
societal)
4) social integration, including: employment, school attendance, child care
responsibilities, volunteer work
c) A suggested schedule for granting carry medication is outlined in table 1.
d) Patients who are eligible for and receive carry medication must accept
responsibility for the take-home doses (which includes the safe-keeping of
the medication) and use them for their intended purposes.
e) Patients who have take-home medication should be informed that they may
be asked at any time to appear in the clinic and bring with them the
remainder of their carry medication. this procedure is used to deter
patients from diverting their methadone doses.
f) Carry medication may be cancelled at any time by the prescribing
physician if he/she believes that the safety of the patient or that of
others is at risk. Situations where the cancellation of carry medication
might be considered are as follows:
reasonable evidence that the patient has failed to meet the terms of the
treatment agreement sustained use of unauthorised drugs
the patient has produced an unacceptable urine sample or has tampered with
the collection of his/her required urine sample (for example, but not
limited to substituting another person's urine or some other material for
his/her own urine; adding some contaminant to the urine sample submitted;
providing a previously collected (i.e. "stale") sample of his/her own urine
instead of a fresh sample collected under supervision; diluted his/her own
urine sample) the patient has approached another methadone-treated patient suggesting or
proposing to sell, buy or share any urine sample, or to tamper with any
urine sample the patient has diverted, or allowed to be diverted, any part of his/her
methadone (i.e. has failed to consume part or all of the methadone dose
prescribed for him/her and allowed it to become available for use by anyone
else) the patient has approached another methadone-treated patient suggesting or
proposing to sell, buy, or share methadone.
Exceptions to the Carry Criteria
It is recognised that occasions will arise where an extension of the regular
carry arrangements may be appropriate, such as:
annual vacation to areas where methadone is not readily available compassionate leave
out-of-town employment opportunities It is the responsibility of the prescribing physician to decide whether to approve the request. Once this decision is made, the carry medication days
may be extended beyond 6 days to a limit of 14 days. Alternatively, the prescribing physician may suggest pick-up in a community pharmacy in lieu of the extension beyond 6 days.
INVOLUNTARY DISCHARGE
While a comprehensive treatment system would have options and levels of care
that are appropriate for the diverse range of individuals who are opioid
dependent, specific programs and practitioners have the right to determine
who they will treat and to discharge or to transfer a patient to another
program/physician if deemed necessary. If the decision is made to discharge
a patient from treatment, the general guidelines issued by the College of
Physicians and Surgeons of Ontario (CPSO) for ending doctor-patient
relationships should be followed.
It is important to balance the needs of the patient for care with other
issues including program standards and the safety of other individuals when
considering involuntary discharge.
Involuntary discharge from methadone treatment will be considered when
evidence indicates that the following has occurred:
a) Threats:
the patient has threatened the safety or well-being of a staff member or
another patient by oral or written action;
b) Disruptive Behaviour:
the patient has engaged in disruptive behaviour on the premises;
c) Violent Behaviour:
the patient has engaged in violent behaviour towards a staff member, a patient or another person;
d) Illegal Activity:
the patient has engaged in an illegal act on the premises;
e) Diversion of Methadone:
the patient has diverted, or allowed to be diverted, any part of his/her prescribed methadone;
f) Failure to Meet Program Criteria:
the patient has failed to meet criteria for continuation in methadone
substitution treatment, i.e., the patient has not adhered to the criteria
outlined in the treatment agreement;
g) Contraindication of Methadone:
methadone has become contraindicated for the patient, in the opinion of the
prescribing physician;
h) Missed Medication:
the patient headache Failed to pick up doses of methadone for 3 consecutive days, unless alternative arrangements for pickup have been previously made (e.g. vacation privileges, community pharmacy pick-up arrangements) or these is convincing evidence that the failure to pick up was beyond the patient's control.
Table 1
Level
Characteristics
Take Home
Medication Days
No. Of Doses
Level I
Patient has been in a treatment program for 3 months and the patient is
functionally stable for the last 4 weeks.
Sunday
Statutory Holidays
1 take home dose
Level II
Patient has been in a treatment program for 3 months; no unauthorised drug
use for the last month and is functionally stable for the last 4 weeks.
or
Patient has been in a treatment program for 6 months; urine screens show
occasional drug use - but the patient is otherwise stable.
Wednesday
Saturday, Sunday
Statutory Holidays
(same as above)
3 take home doses
Level III
Patient has been in a treatment program for 6 months; no unauthorised drug
use for the last month and is functionally stable.
or
Patient has been ins a treatment program for 12 months or longer; urine
screens show occasional drug use - but the patient is otherwise stable.
Monday/Tuesday
Wednesday
Thursday/Friday
Saturday, Sunday,
Statutory Holidays
(same as above)
5 take home doses
Level IV
Patient has been drug-free for 12 months and is functionally stable
attend once a week 6 take home doses.
