CLINICAL PRACTICE GUIDELINES FEBRUARY 2000

THE USE OF METHADONE

IN THE TREATMENT
OF OPIATE ADDICTION
PRESENT SITUATION
MODE OF ACTION OF METHADONE
DETOXIFICATION OR BRIEF SUBSTITUTION TREATMENT
METHADONE MAINTENANCE OR LONG-TERM TREATMENT
ADMINISTRATIVE ASPECTS OF METHADONE PRESCRIPTION
RECOMMENDATIONS ON THE ORGANIZATION
OF CARE AND SERVICES
APPENDICES
BIBLIOGRAPHY

INTRODUCTION
Since the program changes made in 1996 by
Health Canada’s former Bureau of Danger-
ous Drugs pertaining to narcotic and control-
led drugs, the Collège des médecins du
Québec and the Ordre des pharmaciens du
Québec, in collaboration with the ministère
de la Santé et des Services sociaux, have been
charged with overseeing the prescription and
distribution of methadone. Thus, the Collège
des médecins and the Ordre des pharmaciens
assembled a group of experts who, after re-
viewing the literature on methadone, consult-
ing the various groups involved and meeting
with patients, produced guidelines updating,
in Québec, the directives published in 1992
by Health Canada.
This document presents guidelines to as-
sist physicians and pharmacists and provide
them with a reference framework for the
treatment of the complex and multiple prob-
lems associated with opiate addiction.

Ordre
des pharmaciens
du Québec
COLLÈGE DES MÉDECINS
DU QUÉBEC

1
 1. PRESENT SITUATION
Dependence on opiates is a complex phenom-
enon involving the interaction of biological,
psychological and social factors. Heroin is
Waiting times one of the substances that cause strong de-
for methadone pendence very difficult to overcome for some
substitution treatment users. The majority of heroin addicts use the
could be reduced product intravenously. Methadone is now the
through greater only narcotic authorized in Canada for the
involvement on the treatment of opiate dependence. This drug
part of physicians has been the subject of a great many studies
and pharmacists. and publications in the last 40 years. Unfor-
tunately, access to methadone treatment re-
mains very limited despite the treatment’s
well recognized advantages. In Québec, a
mere 10% to 15% of heroin users benefit
from treatment, whereas certain European
countries, notably Switzerland, manage to
reach 50% to 60% of this vulnerable popula-
Traditionally, tion. This group has a higher morbidity/mor-
the prime goal tality rate than the same age group not using
of withdrawal and drugs, and it requires quality primary care.
maintenance treat- Waiting times for methadone substitution
ments was total absti- treatment could be reduced through greater
nence from the drug. involvement on the part of physicians and
Now there are other pharmacists.
goals directed toward Methadone treatment is indicated mainly
reducing the ill in the relief of the opiate withdrawal syn-
effects of the drug. drome during detoxification, and in long-
term opiate substitution therapy. This long-
term treatment is known to be effective in
decreasing the use of illicit drugs, reducing
the associated criminality and opening the
way to social reintegration. An important
point to remember is that treatments of this
kind put the opiate user in contact with a
health professional rather than a drug pusher.
The recent data in the literature confirm that
patients on maintenance therapy present less
risk of contracting infections whose transmis-
sion is linked to the use of intravenous drugs.
The morbidity and mortality associated with
the use of these substances are also reduced.
Furthermore, maintenance treatments have a
2
positive effect on public health by diminish-
ing the spread of the HIV and Hepatitis B
and C viruses. Everyone knows that these
health problems come at an enormous loss
and cost to society. In terms of the cost/ben-
efit ratio, it is estimated that a person on
methadone maintenance treatment costs less
than $4,000 per year, whereas a person who
is not treated costs between $40,000 and
$60,000 in expenditures of all kinds (legal,
incarceration, etc.). Another consideration is
that every case of HIV seropositivity entails
direct expenditures of roughly $100,000.
Traditionally, the prime goal of with-
drawal and maintenance treatments was to-
tal abstinence from the drug. Now there are
other goals directed toward reducing the ill
effects of the drug. The concept of reducing
the ill effects aims to reduce high-risk be-
haviour, improve the person’s state of health
and save lives, offering another possible ap-
proach to treatment to those for whom de-
toxification did not produce the expected re-
sults. The methadone and psychosocial
guidance make it possible for the patient to
look after his health, alter his lifestyle, change
his behaviour and circle of friends and ac-
quaintances, take care of his family, create a
new social network and reintegrate into so-
ciety.
The concept of methadone maintenance
over a long period is not new. As far back as
1963, Dale and Nyswander piloted a program
of this kind in New York. The majority of
European countries have now adopted this
approach. Closer to home, Ontario and Brit-
ish Columbia have already officially imple-
mented maintenance programs.
In this guide, we describe the principal
guidelines to be followed in the use of metha-
done both as an aid in withdrawal and as
substitution in long-term treatment.
 2. MODE OF ACTION OF METHADONE

Methadone is a synthetic opioid discovered Methadone is conjugated in the liver and

during the Second World War. It has an ago- excreted by the kidneys. Its metabolism de-
nist effect on nervous system µ receptors, pends on cytochrome P-450, so that other Methadone has a
giving it properties similar to those of mor- substances can have an inducing or inhibit- relatively long half-
phine. Its bioavailability when taken by ing effect that influences the dosage. The life, and the effect of
mouth is excellent, and its analgesic effect is plasma level necessary to keep the patient a single dose on a
favourably compared to that of morphine. It stable is usually in the order of 400 stabilized patient may
reaches its peak activity two to four hours nanograms per ml, 24 hours after adminis- last 24 to 36 hours,
after ingestion. tration of the last dose, although it can vary allowing him to func-
Methadone has a relatively long half-life, from one patient to another. But these assays tion normally without
and the effect of a single dose on a stabilized are still not very available. withdrawal symptoms
patient can last 24 to 36 hours, allowing him In appropriates doses, methadone is safe. or drowsiness.
to function normally without withdrawal The literature reports cases of prolonged and
symptoms or drowsiness. The morphine continuous use for more than 15 years with
receptor occupancy is such that the effect of no documented, significantly harmful effects.
heroin will be diminished or eliminated com- Like other opiates, its main adverse ef- In appropriate
pletely if the patient uses it. This is the phe- fects are constipation, weight gain, periph- doses, methadone
nomenon of crossed tolerance to other opi- eral edema, pruritus, drowsiness (overdose), is safe, with the
ates, by which the methadone blocks the sweating, gynecomastia, oligo-amenorrhea, literature reporting
euphoric effect produced by heroin. Stable reduced libido, sexual dysfunction, etc. The cases of prolonged
blood-serum levels are reached only after five physician should discuss these side effects and continuous use
consecutive days of administration of the with the patient and treat them if necessary. for more than
substance. A period of three to five days is 15 years with no
therefore necessary to confirm the effective- documented, signifi-
ness of the dose prescribed. cantly harmful
effects.

3
 3. DETOXIFICATION OR
BRIEF SUBSTITUTION TREATMENT
Most first requests for help coming from pa-
tients dependent on illicit drugs are directed
In recent years, toward abstinence.
the use of opiates When the use of opioids is abruptly
(usually methadone) stopped, the patient’s life is not put in dan-
in decreasing doses, ger, even though he experiences the with-
administered in an drawal symptoms for a number of days. Some
inpatient or outpatient manage to overcome their dependence with-
setting, seems to be out help, but these cases are rare. The major-
the more accepted ity need support, often offered by commu-
method for clients nity groups or private organizations.. For
and caregivers alike. others, the suggested treatment is pharma-
cotherapy without opiates for a short period,
using an adrenergic ␣2 agonist, non-steroidal
anti-inflammatory agents, benzodiazepines,
neuroleptics, etc. But in recent years, the use
of opiates (usually methadone) in decreas-
ing doses, administered in an inpatient or
outpatient setting, seems to be the more ac-
As it does not cepted method for clients and caregivers
require a long-term alike. The treatment is usually spaced out
commitment, brief over a period of about 12 days in an inpa-
substitution therapy tient setting, or over several weeks or months
is one way to have in an outpatient setting (7 and 24 weeks).
the patient attempt
treatment. 3.1 GOAL
The goal may be abstinence, with all its at-
tendant physical and psychosocial benefits.
Brief substitution treatment, frequently given
in a crisis situation, relieves the patient’s dis-
tress, while offering investigation and treat-
ment of the diseases frequently associated
with heroin use, as well as preventive treat-
ment. Another advantage is that it puts the
patient in contact with the health care sys-
tem and provides help with the withdrawal
4
symptoms, while ensuring a certain respite
from the problems related to dependence.
Since it does not demand a long-term com-
mitment, brief substitution therapy is one way
to have the patient attempt treatment.
Unfortunately, relapse is very common.
The failure rate, with a return to the use of
illicit drugs being the criterion, can be higher
than 90%, even several months after the end
of withdrawal. The patient must be urged to
consult again in case of relapse. The brief
treatment may be repeated as often as the
patient’s condition requires it. Eventually, the
patient may accept long-term substitution
(maintenance) therapy, the most appropriate
treatment for this type of case.
3.2 DETOXIFICATION CRITERIA
(INPATIENT OR OUTPATIENT SETTING)
• Consent to treatment;
• Consent to communication between phy-
sician and pharmacist;
• Be 14 years of age or over. When a pa-
tient between the ages of 14 and 18 is hos-
pitalized, the person with parental author-
ity must be notified;
• Present a diagnosis of opiate dependence
according to DSM-IV diagnostic criteria
(See Diagnostic Criteria, Appendix 1);
• Have had an opiate-positive urine test and
present clinical evidence of opiate use.
Contraindication
Withdrawal during pregnancy (See Preg-
nancy and Methadone, page 14).
3.3 REQUIREMENTS
• A complete medical examination and an
appropriate health assessment based on
clinical indications (See Medical Record
and Health Assessment, Appendices 2
and 3);
• A detailed psychosocial assessment if the
professional expertise is available or, at
the very least, an identification of the main
psychosocial problems associated with the
drug use;
• A therapeutic contract signed by the pa-
tient and the physician, or a detailed an-
notation in the record that the contract was
explained to the patient. This contract
must lay out the rules to be observed, the
monitoring requirements and the possible
reasons for discontinuing the treatment;
note that the contract can serve as a thera-
peutic tool (See Standard Contract, Ap-
pendix 4);
• A presentation of the different therapeu-
tic options followed by an individualized
treatment plan outlining the goals, the
method to be used, the expected duration
of treatment, the frequency of medical
visits, the management of the medication
and the choice of pharmacy;
• An offer of psychosocial services.
3.4 SUBSTITUTION
PHARMACOTHERAPY
• It is administered orally only;
• The dosage is individualized for each pa-
tient;
• In the outpatient setting, the initial dose
is usually between 10 and 40 mg, but pru-
dence requires that it never exceed 40 mg
a day. The problem of severe intoxication
occurs most frequently at the start of treat-
ment in patients with no tolerance to
methadone. To achieve stable plasma lev-
els, the dose is maintained for four to six
days. Then the dose is adjusted according
to the signs of withdrawal or intoxication
5
(See Signs and Symptoms, Appendix 14)
for another period of four to six days be-
fore beginning the process of progres-
sively reducing the dose. The average
maximum dose is about 50 mg a day. With
this model, the duration of treatment is The concomitant use
seven to eight weeks. The maximum dose of benzodiazepines
could be increased, if the duration of treat- or alcohol could lead
ment is longer or if the goal is respite to overdose in the
rather than withdrawal; early stages of treat-
• Thereafter, the stable dose may be pro- ment. Therefore, it
gressively reduced by 10% every five is not advisable to
days; begin taking benzo-
• The concomitant use of benzodiazepines diazepines at the
or alcohol could lead to overdose in the same time as the
early stages of treatment; thus, it is not methadone.
advisable to begin taking benzodiazepines
at the same time as the methadone;
• Another medication may prove necessary,
depending on the patient’s symptoms
(e.g., constipation, insomnia).
Hospitalization (<14 days) is usually lim-
ited to patients presenting an unstable medi-
cal and/or psychosocial problem, and to those
for whom outpatient detoxification is an im-
possibility. With hospitalization, detoxifica-
tion is quickly achieved.
3.5 PHARMACEUTICAL SERVICES
LINKED TO METHADONE DISTRIBU-
TION
• The patient chooses a pharmacy from
among those offering the service;
• The physician makes personal contact
with the chosen pharmacist, informing
him of the patient’s name, type of pro-
gram, doses, and urine tests to be done;
• If the pharmacist agrees to take the pa-
tient on, the physician advises the patient
that he may obtain methadone from that
pharmacy only;
 • The prescription is always given to the
patient in a sealed envelope bearing the
name and address of the pharmacy from
which the patient will obtain his metha-
done. The prescription must include the
The prescription daily dose of methadone, the exact dura-
must include the daily tion of the prescription and the total dose.
dose of methadone, (See Standard Prescription, Appendix 6);
the exact duration of • The daily dose, diluted in a liquid excipi-
the prescription and ent that is not easily injectable, must be
the total dose. taken in the presence of the pharmacist.
No dose may be given to the patient to
take away with him. The patient must be
made to speak after the liquid is ingested.
3.8 MEDICAL RECORD
The medical record should contain the same
items of information, be it detoxification or
methadone maintenance treatment (See
Medical Record, Appendix 2).
3.9 PHARMACEUTICAL FILE
In addition to the elements required by regu-
lation, the pharmacist’s file should contain
the same items of information for detoxifi-
cation as for a methadone maintenance pro-
gram (See Pharmaceutical File, Appendix 8).

3.6 FREQUENCY OF MEDICAL VISITS

Visits should be weekly. Depending on the
patient’s needs, consultation for psychoso-
cial follow-up is advisable and post-detoxi-
fication follow-up should be offered.

3.7 URINE TESTING FOR DRUGS

The purpose of the testing is to make sure
the patient is taking opiates, and it must be
done before treatment is begun.
It is suggested that the test be repeated
every two weeks thereafter, in random fash-
ion.
The urine is tested for drugs and medica-
tions habitually used and abused by the pa-
tient and persons in his circle of friends and
acquaintances.
The urine specimens for testing at the
pharmacy must be obtained under supervi-
sion to authenticate the sample, or they must
be checked using the heat strip.*

* Heat strip: checks the temperature of the urine specimen

obtained.

6
 4. METHADONE MAINTENANCE,
OR LONG-TERM TREATMENT
In maintenance treatment, methadone is ad-
ministered orally every day, usually for a
prolonged period the length of which is not
predetermined. Methadone is used as a sub-
stitute for heroin or other drugs similar to
morphine. Generally, the dose administered
is stable once the dosage is adjusted.
Psychological and social support services
likely to improve the effectiveness of the
pharmacotherapy should be offered in addi-
tion to the methadone substitution therapy.
4.1 SPECIFIC GOALS
• To reduce the morbidity and mortality
rate;
• To improve the state of health and quality
of life*;
• To decrease the use of drugs*;
• To decrease the number of intravenous
injections*;
• To decrease high-risk behaviour;
• To reduce the transmission of certain in-
fections (HIV, Hepatitis A, B and C, TB,
STD, etc.);
• To change lifestyle;
• To decrease illicit activities*;
• To promote social reintegration, notably
into the family unit*;
• To improve the cost/benefit ratio (treat-
ment cost versus cost of health services,
financial support, legal costs, etc.)* ;
• To protect public health.
* Scientific literature has already objectively demonstrated the
benefits of methadone maintenance programs.
7
4.2 CRITERIA FOR ADMISSION TO
TREATMENT
• Free and informed consent to treatment During maintenance
and consent to communication between treatment, methadone
physician and pharmacist; is administered orally
• Diagnosis of dependence as established every day, usually for
by the DSM-IV or life-threatening behav- a prolonged period
iour on the part of the patient; the length of which is
• Patient aged 14 or over. Obtaining, if pos- not predetermined.
sible, the support of the parents or respon-
sible authorities in the case of patients
between 14 and 18 years of age;
• Significant previous use of a substance
and/or several unsuccessful attempts at
withdrawal or abstinence;
• Opiate use confirmed by a urine test and
medical history;
• Commitment to comply with the pro-
gram’s conditions and willingness to sign
a contract;
• Priority access:
– pregnancy (See Pregnancy and
Methadone, page 14);
– particular medical situation such as
HIV, endocarditis,
– septicemia, septic arthritis, suicidal
behaviour or another life-threatening
behaviour on the part of the patient.
4.3 MEDICAL AND PSYCHOSOCIAL
ASSESSMENT
Medical assessment: this assessment should
be completed before treatment begins. Its
purpose is to document the dependence,
evaluate complications related to the drug
abuse (Hepatitis A, B, C, HIV-AIDS, TB),
as well as other medical problems, psychiat-
ric problems and high-risk behaviour, and to
recommend a comprehensive, realistic treat-
ment plan (See Medical Record, Appendix 2);
 • Health assessment: (See Appendix 3);
• Psychosocial assessment: This assess-
ment, conducted by qualified profession-
als, should be done at the same time as
the medical assessment and completed
The treatment before treatment is begun, except in emer-
plan must include, gency cases. It should be repeated as of-
among other things, ten as necessary during the course of treat-
the achievable medi- ment. Validated tools should be used in
cal, psychosocial and the social assessment. Unfortunately, a
pharmaceutical goals, psychosocial evaluation cannot always be
the patient’s expecta- completed owing to lack of resources,
tions, the method particularly when the physician is treat-
to be used, the fre- ing the patient in a private practice set-
quency of the follow- ting. At the very least, the physician
up and the point in should identify the main psychosocial
time at which goals problems associated with the drug abuse
will be reassessed. and obtain the expert assessments appro-
priate to his needs. Some patients may
refuse psychosocial services, but this is
not a contraindication to commencing or
continuing medical treatment.
• Programs offering psychological and so-
cial support services have a higher suc-
cess rate.
4.4 CONTRACT
The contract confirms the patient’s consent
and commitment to the methadone substitu-
tion treatment. This contract, which can also
be a therapeutic tool, must take into account
the patient’s goals. It should clearly describe
the responsibilities and obligations of all par-
ties and be signed by the patient and the phy-
sician. The patient should be given a copy,
and the original kept in the medical record
(See Standard Contract, Appendix 5).
8
4.5 TREATMENT PLAN
The treatment plan must include, among
other things, the achievable medical, psycho-
social and pharmaceutical goals, the patient’s
expectations, the method of treatment to be
used, the frequency of the follow-up, and the
point in time at which goals will be reas-
sessed.
4.6 PHARMACEUTICAL EVALUATION
• Patient’s consent to the exchange of in-
formation between the professionals in-
volved in the treatment program;
• Pharmacotherapeutic history;
• Lifestyle habits;
• Chronic disease(s);
• History of prior use of medications and
drugs;
• Presently prescribed medications;
• Over-the-counter medications;
• Information on the use of methadone;
• Communications with other pharmacists
(See Communication between Pharma-
cists, Appendix 10).
4.7 MEDICAL RECORD
See Appendix 2 for the essential record-
keeping elements.
4.8 PHARMACEUTICAL FILE
In addition to the elements required by regu-
lation, the pharmacist’s file should contain
the same items of information for detoxifi-
cation as for methadone maintenance treat-
ment (See Pharmaceutical File, Appendix 8).
4.9 FREQUENCY OF MEDICAL VISITS
Medical visits should occur at least once a
week during the dose titration period. There-
after, the visits may be spaced out gradually,
depending on the patient’s needs (from six
to eight weeks once the patient is stabilized).
4.10 PRINCIPLES GOVERNING THE
USE OF METHADONE IN MAINTE-
NANCE TREATMENT
Starting dose
Used only in its oral form, methadone must
replace heroin or other opiates and be admin-
istered in doses sufficient to prevent with-
drawal symptoms and compulsive heroin-
seeking behaviour, without inducing a state
of intoxication.
The starting dose, individualized accord-
ing to the patient’s prior use, is about 20 to
30 mg a day and should not exceed 40 mg a
day so that any possibility of serious intoxi-
cation is prevented, particularly at the start
of treatment. This starting dose must be ad-
justed in the subsequent four to six days, de-
pending on the symptoms of withdrawal or
intoxication. The concomitant use of alco-
hol or benzodiazepines, which potentiate
methadone, can lead to overdose.
Methadone titration is achieved in dose
levels of 5 mg to a maximum of 20 mg at a
time, depending on the patient’s symptoms
and prior use. Special attention must be paid
to the patient who takes other medications
likely to influence methadone metabolism,
such as cimetidine, carbamazepine, etc. (See
Signs and Symptoms, Appendix 14).
The medical assessment should be re-
peated when the dose exceeds 120 mg a day,
with justification for it clearly noted in the
patient’s record.
A few rare patients rapidly metabolize
methadone and, despite high doses, do not
obtain the expected therapeutic response.
Increasing the dose can produce signs of in-
toxication two to four hours after ingestion.
The dose may then be divided into two daily
doses to maintain adequate plasma levels.
Giving fractional doses is still an excep-
tional practice and must be clearly justified
in the patient’s record.
9
Criteria for increasing the dose are:
• signs and symptoms of withdrawal (See
Signs and Symptoms, Appendix 14);
• no decrease in the quantity or frequency
of opiate use;
• obsession with the need to use the sub- The starting
stance; dose must be indi-
• the use of a medication that increases vidualized according
methadone metabolism (See Appendix to the patient’s
15). prior use.
Maintenance dose
Once the patient is stabilized, free of symp-
toms of withdrawal or overdose, the dose
should be maintained at the same level for
several months. The physician should cau- Many experts
tion the asymptomatic patient who wants to recognize that
quickly decrease his doses, thinking that his adjustments in
problems have been resolved. individualized doses
The maintenance dose must be individu- lead to a better
alized according to the needs and tolerance retention rate and
of the patient. The average dose varies be- increased faithfulness
tween 80 mg and 90 mg a day. to treatment.
Many experts recognize that adjustments
in individualized doses lead to a better re-
tention rate and increased faithfulness to
treatment.
4.11 PHARMACEUTICAL SERVICES
LINKED TO METHADONE DISTRIBU-
TION
In Québec, methadone is obtained through
pharmacies. The patient is usually referred
to a pharmacy chosen by him and his physi-
cian. The prescribed methadone dose is usu-
ally diluted in juice (See Preparation of In-
dividual Doses, Appendix 12), which the
patient must drink in the pharmacist’s pres-
ence. In the early stages of treatment, the
patient may not take the methadone away
with him; he must come to the pharmacy
every day.
 Should the patient fail to come to the phar-
macy to receive his dose of methadone, the
dose may not be dispensed by the pharma-
cist at a later time. If the patient fails to come
to the pharmacy on three consecutive days
This therapeutic or more, the pharmacist will notify the phy-
tool is not a substitute sician of such, so that the latter may then re-
for dialogue and the assess the situation and adjust the dosage.
rapport that must be This is more of a safety measure than a dis-
established with the ciplinary one, as opiate tolerance decreases
patient; nor does it quickly.
replace good clinical At the start of treatment, the physician
judgment on the must contact the pharmacist who will offer
physician’s part. the supervised methadone-dispensing serv-
ices, giving him the patient’s name, the pre-
scribed dose and the urine tests to be done, if
appropriate. The prescription is given to the
patient in a sealed envelope bearing the phar-
macist’s name and address. If these condi-
tions are not respected, the pharmacist may
decide to refuse the prescription. The pre-
scription must include the daily dose, the
exact duration of the prescription’s validity,
the total quantity of methadone, as well as
the number of privileges and urine tests, if
appropriate (See Standard Prescription, Ap-
pendix 7). If the patient changes his phar-
macy, the physician must notify both phar-
macists concerned of such, so as to prevent
the patient from receiving methadone from
both of them.
4.12 URINE TESTS
Urine testing, like the patient questionnaire,
is a diagnostic and therapeutic tool provid-
ing information on drug use; it can also be
used to:
• detect pharmacological interactions;
• prevent the possibility of intoxication;
• document abstinence or usage;
• adjust the methadone dosage;
• modify the treatment plan; and
• grant privileges.
10
Urine testing, wherever it is available, is
done randomly, in a climate of respect for
the patient, and not for punitive reasons.
The results of urine tests and the value
placed on them must be interpreted in the
light of treatment goals so as to maximize
effectiveness and reduce risk. The presence
in the urine of any substance interfering
pharmacologically with the methadone, ei-
ther by decreasing or increasing the risk of
toxicity, must be taken into consideration.
This therapeutic tool is not a substitute for
dialogue and the rapport that must be estab-
lished with the patient; nor does it replace
good clinical judgment on the physician’s
part:
• A urine specimen must be collected be-
fore treatment to confirm the diagnosis of
narcotic use;
• The urine specimen must be collected
under direct supervision or checked with
a heat strip, at least twice a month, in ran-
dom fashion, during the first three months
of treatment. The patient is notified the
day before the specimen is to be collected
and analysed;
• After the first three months of negative
results for the presence of unauthorized
substances, the urine specimen is collected
at least once a month, in random fashion,
under direct supervision or checked with
a heat strip, and analysed. The patient is
advised the day before the specimen is to
be collected.
• If the presence of unauthorized substances
is detected, urine specimens will continue
to be collected and analysed at least twice
a month;
• After twelve months of negative results,
urine specimens may be collected and
analysed as the physician in his clinical
judgment sees fit;
• Note that the physician reserves the right
to order a urinalysis as often as he deems
it clinically necessary.
• The results of urine tests should be com-
municated to the pharmacist to facilitate
follow-up.
4.13 FAITHFULNESS TO THERAPEU-
TIC COMMITMENT: PRIVILEGE GRAN-
TED ONCE STABILITY IS ACHIEVED
Definition
A “privilege” may be defined as the permis-
sion granted to a patient to take away with
him one daily dose of methadone within a
seven-day period. It should be noted that
doses lost or destroyed will not be replaced.
The patient takes full responsibility to use it
for the purposes agreed to, and for the safety
of persons in his environment.
Criteria
Given methadone’s low toxicity threshold,
its management and control measures must
be presented as safety measures. Patients who
live in areas where drugs are used may have
difficulty keeping the medication for them-
selves. As long as they are not stabilized, they
are susceptible to difficulties in managing
their own medication. The granting of a privi-
lege confirms the patient’s earned achieve-
ment and facilitates his efforts to rebuild a
responsible and constructive lifestyle.
The privilege of allowing the patient to
take the methadone away with him is based
on his ability to manage his own medication;
this ability is reflected in demonstrated sta-
bility in terms of his functioning, the achieve-
ment of a number of set goals, and the re-
sults of urine tests.
In the first phase, stability is defined by
the patient’s general behaviour and how he
organizes his living environment and as-
sumes responsibilities such as taking his
methadone daily in the presence of the phar-
macist, keeping his appointments and hon-
ouring the conditions of the contract.
11
In the second phase, advanced stability
means that the patient has reassumed his re-
sponsibilities with respect to his health, his
family and children, voluntary work, school,
his job or any other role attesting to greater
social reintegration. A “privilege”
Before granting a privilege, the physician may be defined as
must evaluate the patient’s ability to safely the permission
manage his taking the methadone and hav- granted to a patient
ing it in his possession, while concomitantly to take away with him
taking other substances that could present one daily dose of
risks of intoxication or seriously interfere methadone within a
with the treatment goals. seven-day period.
Procedures
Privileges are not granted in the first three
months of treatment.
If the patient shows stability in terms of
his functioning and living environment, and The privilege of
if the results of the urine tests and the inter- allowing the patient
pretation of them are satisfactory, a first privi- to take the methadone
lege is granted for a period of three months. away with him is
A second and/or third privilege may be based on his ability
granted in the three subsequent months, af- to manage his own
ter consideration of the patient’s demon- medication; this abil-
strated capacity and fitness. But, depending ity is reflected in
on its clinical significance, the presence of demonstrated stability
illicit and unauthorized substances in the in terms of his func-
urine can in some cases constitute a contrain- tioning, the achieve-
dication to the privilege. ment of a number
A fourth and/or fifth privilege could be of set goals, and the
granted three months after obtaining the third results of urine tests.
privilege, depending on the patient’s dem-
onstrated progress in terms of achieving the
objectives, not only of abstinence from sub-
stances, but also of reassumed responsibili-
ties and improved social integration.
The maximum is five privileges in seven
days; this means that the patient will only
have to come to the pharmacy two days a
week.
 A visit to the pharmacy implies that the total
dose for that day has been ingested. The pa-
tient who is permitted to take his doses home
with him must be informed that he may be
asked at any time to come to the pharmacy
The maximum or the physician’s office and bring the re-
is five privileges maining doses with him. Appendix 16
in seven days, which presents an algorithm on the granting of privi-
means that the patient leges.
will come to the phar- The physician may, based on his assess-
macy only two ment of the patient and clinical judgment,
days a week. modify the timetable, but dispensations
should still be an exceptional occurrence and
be justified in the medical record; the phar-
macist should also be notified of any change.
If the patient becomes unstable again, one or
more privileges may be withdrawn.
Privileges may be withdrawn at any time,
Privileges may be if the patient does not honour his contract or
withdrawn at any if the physician or the pharmacist believes
time, if the patient that the safety of the patient or his environ-
does not honour his ment is compromised. We have listed below
contract or if the phy- a few situations where privileges could be
sician or pharmacist taken away :
believes that the • Evidence that the patient is not honour-
safety of the patient ing his initial contract;
or his environment • Evidence of falsified urine tests or pre-
is compromised. scriptions;
• Evidence of attempts to sell or share
methadone, or any other diverted use of
the medication;
• Compromised safety of the patient or his
environment.
If after six months, the patient is still not suf-
ficiently stabilized to be granted one privi-
lege, the treatment plan must be reassessed.
Finally, it should be noted that the maxi-
mum total dose to be taken home should
never exceed 600 mg (or the total of five
privileges). This may be restrictive for pa-
tients requiring a high dose and who have
honoured the terms of the contract over a long
period (four or five privileges). Accommo-
dations to the methadone dispensing program
should then be made with the pharmacist.
12
Work or study requirements are not justi-
fiable reasons for permitting a patient to take
home his methadone dose, apart from the
privileges obtained.
4.14 SPECIAL CONSIDERATIONS
Detention
Detention centres must ensure continuity of
treatment. Should the detention centre be
unable to provide the medication, the metha-
done will be temporarily dispensed by a phar-
macist offering this service. The methadone
will be forwarded in a sealed envelope and
given directly to a member of the nursing
staff, who will sign the delivery slip.
Special events such as vacations, deaths,
weddings, hospitalization, etc.
For vacations in Québec, the patient may
obtain his daily dose from a pharmacy that
offers supervised methadone-dispensing
services and whose pharmacist agrees to re-
ceive the patient. The request should be made
to the attending physician or pharmacist at
least two weeks before the departure date,
so that arrangements can be made with the
pharmacist or pharmacists who will receive
the patient.
In unexpected situations (e.g., death in the
family) where travel is necessary, permission
to bring one or more doses could be granted
as an exception to the rule, if clinical condi-
tions allow it. The patient could also, after
having made a specific request, obtain his
dose from a pharmacy offering methadone-
dispensing services.
In case of hospitalization, agreements
must be reached between the attending phy-
sician and the hospital physician to ensure
continuity of treatment.
4.15 PHARMACEUTICAL COUNSEL- A comfort scale should be established in
LING order to evaluate the patient’s condition as
To improve the clinical and pharmacothera- objectively as possible (See Pharmaceutical
peutic effectiveness of methadone substitu- File, Appendix 8).
tion treatment, counselling services must be The pharmacist shall refuse to dispense
offered. The pharmacist receives the patient the methadone dose if the patient arrives in- The pharmacist
in an area ensuring confidentiality (every day toxicated by drugs, medication or alcohol. receives the patient
for patients without privileges). This regular in an area ensuring
contact allows him to evaluate how the treat- Contact and/or consultation with confidentiality (every
ment is progressing, thus ensuring continu- the physician and/or psychosocial day for patients with-
ity of care with the multidisciplinary team or caregivers out privileges).
attending physician. Progress notes summa- • As soon as the situation demands it, ac- This regular contact
rizing interventions should appear in the pa- cording to the pharmacist’s assessment. allows him to evalu-
tient’s record. ate how the treatment
Managing the urine testing is progressing, thus
4.16 ROLE OF PHARMACIST Establishing a specimen collection calendar ensuring continuity
The pharmacist should be part of the treat- for analysis purposes, supervising the speci- of care with the
ment team and work closely with it, even if men collection, sending it to the laboratory, multidisciplinary
the patient is not under the care of a discussing the results, if necessary, and re- team or attending
multidisciplinary team. cording the results of urine tests in the file. physician.

Physical aspect Administrative duties

The pharmacist must observe on a daily ba- • Confirming the daily presence of patients
sis the patient’s condition as regards: in the pharmacy in order to obtain refunds
• signs of intoxication or withdrawal; for costs from the social services network;
• changes in appearance (cleanliness, dress, • Controlling the purchase and sale of
lifestyle habits); methadone;
• visible state of health. • Keeping a perpetual inventory of metha- A comfort
done powder and stock solutions; scale should be
Pharmaceutical aspect • Ensuring that the prescribing physician is established to evalu-
• Monitoring of effectiveness and toxicity; specifically authorized to prescribe metha- ate the patient’s con-
• Presence of an obsessive need for drugs; done. dition as objectively
• Psychological distress; as possible.
• Adverse side effects; Preparing a stock solution
• Medicinal interactions; (See Appendix 11)
• Direct supervision of the patient taking his
methadone dose (having the patient speak Preparing individual doses and labelling
after ingestion); the preparation
• Taking over-the-counter medications or (See Appendix 12)
obtaining prescriptions from other pre-
scribers, interfering with the treatment
plan;
• Reported purchase of syringes.

13
 4.17 PREGNANCY AND METHADONE
Given the greater risk of spontaneous abor-
tion or premature delivery, rapid withdrawal
from heroin or other opiates is not recom-
mended during pregnancy. In fact, metha-
Given the greater done substitution therapy is indicated during
risk of spontaneous pregnancy, even though the fetus is exposed
abortion or premature to methadone in utero. Methadone substitu-
delivery, rapid with- tion therapy produces better therapeutic re-
drawal from heroin sults than the continued use of heroin or other
or other opiates is not opiates and provides an opportunity for other
recommended during interventions within the health care system
pregnancy. (better prenatal care and the organization of
a way of life more compatible with the pa-
rental role). Therefore, pregnancy warrants
priority access to methadone maintenance
treatment.
In the last trimester of pregnancy, the
Because of the methadone doses may be increased to main-
complex problems tain plasma concentrations at a level that en-
and risks they face, sures the patient’s comfort and stability. The
these patients should doses are then decreased in the days follow-
be referred to centres ing the delivery. Newborns may present
offering specialized symptoms of withdrawal up to 14 days after
services for both birth, and they are very often underweight.
mother and child. Breast-feeding can be compatible with
mothers taking methadone under certain con-
ditions, but not with mothers who abuse other
drugs. However, this subject should be taken
up with the specialized medical team look-
ing after the mother and the child.
Because of the complex problems and
risks they face, these patients should be re-
ferred to centres offering specialized serv-
ices to both mother and child.
14
4.18 VOLUNTARY CESSATION OF
MAINTENANCE TREATMENT
It is possible, after a certain period of treat-
ment and clinical stability, that the patient
would consider withdrawal from methadone.
This withdrawal should only be done when
the patient feels ready and at a pace he can
tolerate.
It is preferable to spread the withdrawal
over a period of several months, even a year.
The symptoms of real discomfort frequently
do not appear until the starting dose has been
reduced by 30% to 50%. Note that, for a sig-
nificant number of patients in withdrawal,
their difficulties will be such that the with-
drawal period will have to be extended or
the doses stabilized over a period of several
months. Others simply cannot completely
stop taking methadone and will have to ac-
cept taking it for several years.
The dose is usually reduced by 10% at a
time, and the intervals between reductions
should be more than a week. When the daily
dose is not very high, it may have to be re-
duced one milligram at a time.
Follow-up should be ensured even after
complete withdrawal, given that certain with-
drawal symptoms persist for a long time.
When a patient deemed “unstable” wishes
to discontinue treatment, the situation should
be reassessed and the treatment plan revised,
if appropriate.
4.19 CESSATION OF TREATMENT
Certain situations involving violence or other
forms of intimidation, the inappropriate use
or trafficking of narcotics, etc., may necessi-
tate the immediate cessation of treatment.
When a relationship between the patient and
the treatment team is no longer possible, the
treatment must be discontinued and the pa-
tient clearly informed of such. For ethical
reasons and whenever possible, the patient
should be referred to another resource. A
prescription for rapid withdrawal at 10% a
day, without any privileges, could be given
when the patient leaves, depending on the
case.
4.20 OTHER SUBSTITUTION TREAT-
MENTS
There are now other medications that can
replace methadone in the treatment of opiate
dependence. Buprenorphine, a synthetic opi-
ate and agonist-antagonist, as well as
levoalpha acethylmethadol (Laam TM) are
among them. They are not yet officially rec-
ognized in Canada as heroin substitution
treatment, but they could be brought into use
sometime soon. This would broaden the
range of available products and offer more
choice to the physician, who must adapt the
treatment to suit the clinical situation.
4.21 THE TREATMENT OF PAIN AND
THE METHADONE PROGRAM
In dealing with the well known problem of
pain, it is important that the patient already
taking methadone be treated like any other
patient with a similar problem (injury, sur-
gery, etc.).
Because of tolerance phenomena, the an-
algesic effect of methadone may be lessened,
even eliminated completely, and the patient
may need an additional analgesic with a
higher total dose and closer intervals between
doses, compared to patients with the same
15
pathology who have never used opiates.
The physician must evaluate the pain and
prescribe the appropriate analgesic dose for
the length of time he deems sufficient, as for
any other patient. Should the patient require
analgesia for a relatively long period, giving When a relationship
fractional doses of the prescribed quantities between the patient
may have to be considered. and the treatment
Patients who having been taking metha- team is no longer
done for only a short time and have not yet possible, treatment
acquired a tolerance for the product require must be discontinued
special attention. and the patient
Agonist-antagonist medications such as clearly informed
pentazocine (TalwinTM), butorphanol tartrate of such.
(StadolTM) and nalbuphine hydrochloride
(NubainTM) should be avoided, as they can
induce acute withdrawal syndrome.
It is up to the patient to inform any physi-
cian other than his own methadone prescriber
that he is receiving methadone treatment.
Double doctoring for a narcotic prescription
is still a criminal act in Canada.
When the problem of pain is predictable,
for example, after elective surgery, the attend- Given the well
ing physician should contact the surgeon (See known problem of
Standard Letter, Appendix 9). pain, it is important
that the patient al-
4.22 PSYCHIATRIC COMORBIDITY: ready taking metha-
OPIATE DEPENDENCE AND MENTAL done be treated like
HEALTH PROBLEMS any other patient with
There is a high incidence of psychiatric prob- a similar problem
lems among patients with a dependence on (injury, surgery, etc.).
heroin. Problems of an affective nature, se-
vere anxiety or personality problems are fre-
quent. Identifying these problems is impor-
tant as patients may be using narcotics to
control the symptoms of these conditions. A
mental status examination is therefore essen-
tial, and a psychiatric assessment is some-
times called for.
 5. ADMINISTRATIVE ASPECTS
OF METHADONE PRESCRIPTION
5.1 SPECIFIC EXEMPTION
Under the terms of section 56 of the Con-
trolled Drugs and Substances Act, an exemp-
tion from the federal Minister of Health is
needed to prescribe methadone. The Collège
des médecins collaborates with the federal
government to facilitate access to detoxifi-
cation treatment, methadone maintenance
therapy and treatment for analgesic purposes.
Discussions are now under way between the
Collège des médecins and Health Canada to
have the Collège play a bigger role in the
process of obtaining exemptions. Physicians
will be informed in due time of any change
in the process.
5.2 LISTS OF PHYSICIANS AND
PHARMACISTS
The list of physicians authorized to prescribe
methadone, and the list of pharmacists of-
fering the service remain confidential. Phar-
macists are obligated to make sure that the
physician prescribing the methadone is in-
deed authorized to do so. They must there-
fore contact the syndic of the Collège des
médecins at (514) 933-4441, ext. 213 or at 1
888 MÉDECIN, ext. 213, to confirm the in-
formation.
5.3 RULES FOR THE PRESCRIPTION
OF METHADONE
All pharmacists may buy methadone under
the terms of the Narcotics Control Regula-
tions. It must be remembered that methadone
is a narcotic; therefore, a verbal prescription,
a prescription sent by fax, and prescription
renewal are forbidden. However, partial fill-
ing of a prescription is possible, as for all
medications in this class.
16
5.4 CHARACTERISTICS OF THE
CONDITIONS UNDER WHICH PHAR-
MACISTS PRACTISE
The Ordre des pharmaciens will specify the
required conditions for the practice of phar-
macists offering supervised methadone-dis-
pensing services.
Pharmacists offering this service must
have a balance that measures precisely. Such
a balance must at least have a sensitivity of
0,01 g (10mg).
The area ensuring confidentiality should
be a real space, not a virtual one. Toilets must
be available nearby for use when urine test-
ing services are requested.
The Ordre does not intend, for the time
being, to restrict the number of patients a
pharmacist may serve. However, certain cri-
teria will certainly limit the number of pa-
tients a pharmacist can manage. Among these
criteria, still to be defined by the Professional
Inspection Committee, are the following:
1. The complexity of cases;
2. Compliance with the guidelines formu-
lated by the Ordre des pharmaciens du
Québec and the Collège des médecins du
Québec;
3. File management, notably as regards
progress notes, refusals, and written phar-
maceutical opinions or advice;
4. Narcotics management;
5. Compliance with existing standards, no-
tably the standard on delegated acts in the
pharmacy.
Nothing in this document prevents free ad-
mission to a program from being conditional
upon particular requirements such as:
• charging a fee for urine specimen testing,
if necessary;
• choosing a specific pharmacist before ad-
vanced stability is reached;
• certain “good will” requirements, such as
those formulated in a therapeutic contract
(lack of violence, terms and conditions of
exclusion, etc.).
6. RECOMMENDATIONS ON THE
ORGANIZATION OF CARE AND SERVICES
The Collège des médecins recommends that
physicians working in private practice work
in partnership with a medical practitioners’
network or a structured multidisciplinary pro-
gram for the treatment of opiate addiction,
so as to facilitate communication, training,
and the organization of care, and to avoid
isolation.
With respect to the organization of serv-
ices and care, the Collège des médecins sug-
gests that new patients (or new requests for
methadone) be first evaluated and stabilized
by a multidisciplinary treatment team before
being referred to a family practitioner in the
community.
17
5.5. TRAINING
Because the problems involved in treating
opiate addiction are complex, the Collège des
médecins and the Ordre des pharmaciens pro-
mote and strongly encourage theoretical and
clinical training.
Before supporting physicians’ applications
by recommending that the federal Minister
of Health grant them an exemption under the
terms of the Controlled Drugs and Substances
Act, the Collège des médecins will in all like-
lihood require, among other things, special
training (or its equivalent), such as that now
offered by the Montreal-centre Regional
Board of Health and Social Services and cer-
tified by the Université de Montréal’s Depart-
ment of Continuing Medical Education.
Conversely, the system should make it
possible for a family physician faced with
an unstable patient to quickly consult a mul-
tidisciplinary team or refer the patient to it.
The Collège des médecins recommends
that physicians working in private practice
limit themselves to between 15 and 20 pa-
tients receiving methadone.
For its part, the Ordre des pharmaciens
encourages the creation of a support network
which, if it is created, would support phar-
macists newly involved in dispensing metha-
done and see to it that the competence of the
pharmacists involved is maintained.
 CONCLUSION
This entire discussion aside, one must keep
in mind that the prevalence of comorbidity
associated with opiate use in itself justifies
treatment.
The concept of reducing the ill effects
suggests that the notion of abstinence at all
costs should be relinquished. Thus, for rea-
sons of public health, a greater number of
physicians and pharmacists should become
MEMBERS OF THE WORKING GROUP
Dr. Michel Brabant, general practitioner,
Hôpital Saint-Luc du CHUM
Dr. Sidney Feldman, internist, Sir Morti-
mer B. Davis – Jewish General Hospital
Ms. Louise Petit, pharmacist, J. Matte
and L. Petit, pharmacists
ACKNOWLEDGMENTS
The Collège des médecins du Québec and the
Ordre des pharmaciens du Québec wish to
thank the following persons who participated
in the consultations or commented on the
work. They are Mr. Joseph Amiel, pharma-
cist, Dr. Lise Archibald, Ms. Hélène Beaulieu,
pharmacist at the ministère de la Santé et
18
involved in giving this vulnerable, high-risk
population the care and services they require.
Substitution therapy (brief or maintenance)
is a medically required service that should
be accessible within a reasonable period of
time to preserve the life and health of the
patient.
Dr. Marcel Provost, general practitioner,
Collège des médecins du Québec
Ms. Danielle Viens, pharmacist,
Ordre des pharmaciens du Québec
des Services sociaux, Dr. Alain Bérubé,
Dr. Suzanne Brissette, Dr. Julie Bruneau,
Dr. Daniel Cousineau, Ms. Helen Feldman,
psychologist, Mr. Jean-François Guévin,
pharmacist, Dr. Pierre Lauzon, Dr. Carole
Morissette, Mr. Livio Parolin, pharmacist,
and Mr. Jean Provost, pharmacist.
 APPENDIX 1

DIAGNOSTIC CRITERIA FROM DSM-IV

CRITERIA FOR SUBSTANCE DEPENDENCE
A maladaptive pattern of substance use, leading to clinically significant
impairment or distress, as manifested by three (or more) of the following,
occurring at any time in the same 12-month period:

1. Tolerance, as defined by either of the following:
a) a need for markedly increased amounts of the sub-
stance to achieve intoxication or desired effect;
b) markedly diminished effect with continued use of the
same amount of the substance.
2. Withdrawal, as manifested by either of the fol-
lowing:
a) the characteristic withdrawal syndrome for the sub-
stance (refer to Criteria A and B of the criteria sets
for withdrawal from a specific substance;
b) the same (or a closely related) substance is taken to
relieve or avoid withdrawal symptoms.
3. The substance is often taken in larger amounts or
over a longer period than was intended;
4. There is a persistent desire, or unsuccessful efforts
to cut down or control substance use;
5. A great deal of time is spent in activities neces-
sary to obtain the substance (e.g., visiting multiple
doctors or driving long distances), use the substance
(e.g., chain-smoking), or recover from its effects;
6. Important social, occupational or recreational ac-
tivities are given up or reduced because of sub-
stance use;
7. The substance use is continued despite knowing
that a persistent or recurrent physical or psycho-
logical problem is likely to have been caused or
exacerbated by the substance (e.g., current cocaine
use despite recognition of cocaine-induced depres-
sion, or continued drinking of alcoholic products
despite recognition that an ulcer was made worse by
alcohol consumption).
Specify if:
With physiological dependence: evidence of tolerance
or withdrawal (i.e., either Item 1 or 2 is present);
Without physiological dependence: no evidence of
tolerance or withdrawal (i.e., neither Item 1 nor 2 is
present).

Codification of Course Specifiers for Substance Dependence

0 Early full remission
0 Early partial remission
0 Sustained full remission
0 Sustained partial remission
2 On agonist therapy
1 In a protected environment
4 Mild/Moderate/Severe

19
 APPENDIX 2

MEDICAL RECORD
THE MEDICAL RECORD SHOULD CONTAIN THE FOLLOWING:

• Detailed history of the dependence on various

drugs, including alcohol and tobacco;
• Detailed ancillary examinations (see Health As-
sessment, Appendix 3);

• Detailed history of the recent use of all drugs,

prescribed or not (dose, administration route, fre-
• Lists of problems and diagnoses;

quency per day, number of days per month, time of • Treatment plan, with information annotated and
last use); rules explained to patient – a therapeutic “contract”;

• History of previous withdrawal or detoxification • Prescription: the prescription of methadone, with

program; the daily dose, the precise duration of the prescrip-
tion, the total dose, the number of authorized privi-
• History of intoxication (overdose); leges, the number of urine tests to be done, if ap-
propriate, and the name of the pharmacy to which
• Psychiatric history and suicide attempts;
the patient is referred;
• History of other medical problems including inju-
ries (resulting from aggressive activity or acci- • Date of next appointment.
dent), and a body systems review; The physician must also ensure that the clinical
• Identification of main social problems: family, criteria for the diagnosis and treatment of the heroin
addiction are clearly noted in the medical record.
children, work, financial situation, legal problems,
etc.;
Progress notes
• History of infections and immunization:
- Hepatitis A, B, C
Written at each visit, the progress notes should furnish
information on the signs and symptoms of withdrawal
- HIV or overdose of methadone, as well as its side effects.
- TB The notes should also contain the following informa-
- Others tion:
· Progress report on the dependence problem and
• High-risk behaviour:
other problems identified;
- sharing injection equipment (recent or past);
- sexual behaviour; · Onset of new problems, if applicable;
· The use of drugs and/or other substances since the
• Complete physical examination, with particular last visit;
attention to: · The results of ancillary examinations, if applicable,
- basic parameters, notably height, weight, body and the consequent medical management;
mass index; · Justification for any change in dosage or in the
- general appearance, including signs of intoxica- treatment plan, particularly in cases of high doses
tion and withdrawal; (>120 mg/day) and fractional doses;
- injection sites on limbs or neck (thrombophle- · Next appointment and new prescription.
bitis);
- auscultation of heart (murmur) and lungs; We might add that a summary of any pertinent
- signs of liver disease; communication with another health professional re-
- dental health; sulting from a telephone call from the pharmacist or a
- nasal septum; multidisciplinary meeting should be noted in the pa-
- skin lesions; tient’s record.
- examination of genitalia. At the end of treatment, the physician should inform
the patient of the availability of services and programs
• Structured mental status examination if indicated;
in case of relapse; and this should be charted.

20
 APPENDIX 3

HEALTH ASSESSMENT PRIOR TO METHADONE TREATMENT

• Tests to detect opiates and other substances in the • HbsAg

urine • Anti-HBs And vaccination if applicable
• Urinalysis • Anti-hepatitis A

• Pregnancy tests • HCV

• PPD • Anti-HIV, after counselling and obtaining consent

• CBC • Screening for other STDs, if indicated

• Creatinine • Recommendations according to age group and sex:

cholesterol, mammography, gynecological
• Total bilirubin cytology, etc.
• AST, ALT
Ancillary examinations must be justified on the
• VDRL
basis of medical observation.

APPENDIX 4

STANDARD CONTRACT: DETOXIFICATION

CONTRACT FROM CHUM’S HÔPITAL SAINT-LUC DETOXIFICATION

HEALTH AND DRUG ADDICTION PREVENTION UNIT
Participation in this program is free and voluntarily chosen. The clinic’s staff guarantees strict
confidentiality: no information of any kind will be disclosed to a third party without your consent.
During the withdrawal period, the urge to use substances will often be very difficult for you to control.
To increase your chances of success, we recommend that you abstain from all psychoactive substances
(including alcohol and marijuana) except the medication prescribed by the program’s physicians.
This includes substances that apparently have not been a problem in the past.

COMMITMENT TO PROGRAM
• I commit myself to keeping my appointments at
the clinic and at the pharmacy. I will not be intoxi-
cated when I come to these appointments, and I
will be on time. If I fail to keep my appointments
or if I arrive at the clinic or pharmacy in an intoxi-
cated state, my treatment could be interrupted. If I
fail to appear at the pharmacy two days in a row,
my methadone prescription will be cancelled auto-
matically. If on Tuesday at 3:00 p.m., I still have
not come to the outpatient clinic, the pharmacy
will be advised that my program has been termi-
nated.
• I agree to provide urine specimens when they are
requested to detect substances for treatment pur-
poses.
• I will be fully responsible for the prescription
which will be presented to me in a sealed envelope.
I will deliver it unopened to my designated phar-
macy. I commit myself to always delivering my
prescription to the same pharmacy for the entire
duration of my treatment program.
• Any violent behaviour, threats, intimidation, sale of
drugs or prescribed medication, theft, falsification
of prescriptions by me or anyone accompanying me,
will result in immediate exclusion from the pro-
gram. The Hôpital Saint-Luc and/or the pharmacist
will file complaints with the police, if need be.
I have read, or have had read to me, the commit-
ment I have made to the program. My questions have
been answered, and I freely and willingly commit
myself to this program.
Signature:
Witness:

21
 APPENDIX 5
STANDARD CONTRACT: METHADONE MAINTENANCE PROGRAM
HERZL FAMILY PRACTICE CENTRE METHADONE PROGRAM
THE SIR MORTIMER B. DAVIS – JEWISH GENERAL HOSPITAL
1. I declare that I have been a narcotic addict for the
past years.
2. I am asking to be accepted (or reaccepted) into the
methadone maintenance program of my own free
will.
3. I am committed to arriving on time for all my ap-
pointments at the clinic and at the pharmacy.
4. I agree to go daily to the pharmacy, to take my
methadone and to continue to go daily until I ob-
tain my first take-home privilege.
5. I am willing to produce urine specimens under
supervision whenever they are requested.
6. Since this program may also be part of a research
project, I will agree to answer any questionnaires
submitted to me. I understand that all answers to
these questionnaires, as well as all the information
in my file, will be treated in a strictly confidential
manner.
7. I understand that the following behaviour at the
clinic or pharmacy will automatically lead to im-
mediate exclusion from the program: violence,
intimidation, menacing attitude toward anyone in
the clinic or pharmacy, theft and sale of drugs. Any
complaint about me will be forwarded to the
police.
8. I understand that I will not be given take-home
privileges before a treatment period of three
months has elapsed. Thereafter, take-home privi-
leges will only be given on condition that my urine
specimens show no presence of narcotics or other
drugs except those prescribed by my own doctor or
other doctors in my treatment program. I under-
stand that take-home privileges may be withdrawn
if at any point I do not respect these conditions.
9. I understand that the dose of methadone dispensed
to take home with me is my full responsibility. It
will not be replaced if it is stolen, lost, spilled,
spoiled or vomited, etc.
10. I understand that this program includes different
types of treatment: individual counselling, marital
counselling, family therapy and group therapy.
Depending on my needs, which will be assessed by
the program’s care-givers, I may be offered one or
several types of supportive treatment. I understand
that I must attend these therapy sessions, in addi-
tion to the regularly scheduled meetings with my
doctor.
11. When I come to my appointment at the clinic,
I must go directly to the appropriate waiting room.
Wandering around in other areas of the hospital
will not be tolerated under any condition.
12. One of the program’s primary goals is to help me
enjoy life without resorting to drug use. My urine
specimens will be analysed for the presence or
absence of narcotics as well as other substances
such as tranquilizers, cocaine and sleeping pills.
I therefore understand that I must refrain from
taking any of these drugs, unless they are pre-
scribed by my own doctor or a doctor involved in
the program. I also understand that any other usage
will be considered to be the same as using street
drugs. (e.g., 222’s, etc.).
13. I understand that if I arrive at the pharmacy intoxi-
cated either by drugs, alcohol or any other medica-
tion, the pharmacist will be obliged to withhold my
methadone dose for that day, and I will have to
wait until the next day to receive my daily dose.
The same conditions apply to my appointments at
the clinic; if they are not respected, my appoint-
ment will be postponed.
14. If, after a three-month period, I have honoured this
contract (on time for my appointments, no use of
drugs other than those prescribed, etc.), I may
withdraw from the program if I feel that it does not
meet my needs. In this situation, the medical team
will discontinue the treatment by progressively
decreasing the daily dose of methadone.
22
 STANDARD CONTRACT: METHADONE MAINTENANCE PROGRAM (CONT.)
15. The treatment team is responsible for ensuring that 16. I agree to respect this contract and all its condi-
my needs are respected, even in difficult periods. If tions. I have read and understood all the clauses in
I believe that decisions made by your care-givers this contract, and I have been given a copy of it.
are not appropriate, I may submit a written request
to the program coordinator, asking him or her to
intervene.

Signature of patient Signature of witness

Welcome to our clinic. We sincerely hope you will attain

the goals you have set for yourself.

23
 APPENDIX 6

STANDARD PRESCRIPTION FORM – DETOXIFICATION TREATMENT

PRESCRIPTION FORM –
CHUM’S HÔPITAL SAINT-LUC DETOXIFICATION PROGRAM

Date:

Pharmacy:

Prescription of methadone

Date Day Dose

Day Month Year
1 mg
N
Day Month Year
2
E mg

Day Month Year

3
I M mg

Day Month Year

C 4 mg

Day Month Year E

P 5 mg

Day

S Month Year
6 mg

Total dose mg

The methadone must be diluted in at least 100 ml of orange juice and taken under the pharmacist’s visual supervi-
sion. The patient may not under any circumstances bring or supply the dose. The prescription must be brought to
you in a sealed envelope.
Do not dispense if the patient goes to a pharmacy other than the one cited in the prescription.
Do not dispense if the patient is under the influence of alcohol or intoxicated by medications or drugs.

Signature of physician:

24
 APPENDIX 7

STANDARD PRESCRIPTION – METHADONE MAINTENANCE TREATMENT PROGRAM

HERZL FAMILY PRACTICE CENTRE METHADONE MAINTENANCE PROGRAM
SIR MORTIMER B. DAVIS – JEWISH GENERAL HOSPITAL

Urine analysis for these dates: Supervised

Analyses d’urines aux dates suivantes : Supervisées
Day Month Year Day Month Year
Heat-Strip
Détection thermique
Day Month Year Day Month Year
Not supervised
Non supervisées

Name / Nom :

Address / Adresse:

N
Medication: Méthadone / Médicament : Méthadone
E
Total dose for the period starting:
Dose totale pour la période du :
Day Month Year

I Mto
au
Day Month Year

C
Daily dosage:
Posologie quotidienne :

The patient has to take his dose E For the following days:

P
in the presence of the pharmacist.
Le patient doit prendre sa dose Les jours suivants :

S
quotidienne devant le pharmacien.

The patient cannot take more than mg with him.

Le patient ne peut jamais apporter plus de mg chez lui.

All doses of the medication must always be diluted in 50 ml or 100 ml of soft drink or juice.
Toutes les doses du médicament doivent être diluées dans 50 ml ou 100 ml de boisson gazeuse ou de jus.

Signature: Lic. No: / N° de permis:

Date:

25
 APPENDIX 8

PHARMACEUTICAL FILE

Weekly Progress Report on Condition of Patient Receiving Methadone Treatment

Name: File:

Day Month Year Day Month Year

Week of to Dose mg

Present medication and dosage: (attach copy to patient’s file)

Comments:

Goals(s) for the week:

Weekly Comfort Scale

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

Very comfortable

Comfortable

Uncomfortable

Difficult

Severe

Unbearable

26
 PHARMACEUTICAL FILE (CONT.)

Daily Record from Day 1 to Day 7

Day: Time:

Appearance: Sobriety:

Urine specimens:

Comments:

Follow-up:

Signature of pharmacist:

Goals achieved:

Weekly Report

Significant change in: Personal hygiene; Dress; Behaviour.

Clinical Observations

Appetite:

Constipation:

Diaphoresis:

Urine Test
Day Month Year

Sent on: Heat-strip:

Results

Narcotics Benzodiazepines PCP

Comments :

Signature of pharmacist:

*Source: J. Matte and L. Petit, pharmacists

27
 APPENDIX 9

STANDARD LETTER CONCERNING ANALGESIA FOR A

PATIENT ON METHADONE TREATMENT
Standard Letter of the Centre de recherche et d’aide pour narcomane (CRAN)

Name of patient: Dateof birth:

Day Month Year

Dear Doctor,

This patient is being treated with methadone and takes mg a day. Methadone is a synthetic opioid
which acts on the same central nervous system receptors as morphine. Given its average half-life of 24 hours, this
substance may be administered by mouth just once a day, allowing the patient’s condition to remain stable. While
the dose administered to the patient is sufficient to maintain a stable condition, it has no analgesic effect whatso-
ever given the patient’s tolerance to the substance.

If, following a medical, surgical or dental procedure, this patient were to need an analgesic, you may prescribe
one in addition to his methadone, using the following parameters to guide you:

1. If, in your judgment, the pain will not be severe, the patient may take non-narcotic analgesics, such as
NSAIDS.

2. If, in your judgment, the pain will be severe enough to necessitate the prescription of narcotics, you must
avoid prescribing Talwin or Nubain, as these two substances have an antagonist effect which can precipitate
the withdrawal syndrome in persons on methadone maintenance. All the other narcotic analgesics are compati-
ble with methadone (codeine, oxycodone, hydrocodone, morphine, demerol, fentanyl, hydromorphone). If you
prescribe them, the doses should be the same as those prescribed for any patient, and they should be in addi-
tion to his methadone. Certain patients on methadone maintenance are extremely tolerant to the analgesic
effects of narcotics and may require considerably higher doses than are usually prescribed. Therefore, these
patients must be clinically evaluated and the dose adjusted to their therapeutic response.

If, after a general anesthetic or for any other reason, this patient could not take anything by mouth for several
days, doses of morphine equivalent to his daily dose of methadone should be administered parenterally, beginning
24 hours after his last dose of methadone. Morphine administered parenterally in fractional doses is equivalent,
milligram for milligram, to methadone administered orally. Thus, a patient receiving 60 mg of methadone per os
per day should feel stable with 10 mg of morphine administered parenterally every four hours, for a total daily
dose of 60 mg. If the patient were to need analgesics, his dose would have to be increased accordingly and his
therapeutic response monitored clinically.

Other pertinent information

Should you require additional information, please feel free to contact me.

Sincerely,

Patient’s pharmacy:

28
 APPENDIX 10

COMMUNICATION BETWEEN PHARMACISTS

Confidential Phamaceutical Summary Name/Given name:

Sender Recipient RAMQ number:

Community pharmacist
Hospital pharmacist Diagnoses :

Situation: Hospitalization
End of hospitalization
Outpatient consultation
Other Allergies:

Present Medication

Name/dosage/indication
1
2
3
4
5

Discontinued Medication

Problems Related to Pharmacotherapy (PRP)

PRP : Action taken / suggested: Follow-up suggested:

PRP : Action taken / suggested: Follow-up suggested:

PRP : Action taken / suggested: Follow-up suggested:

Comments

Name of pharmacist: Licence No.:

Signature: Date:

Tel: Fax:

The purpose of this form is to facilitate the transmission of essential information between hospital pharmacists and community pharmacists.

29
 APPENDIX 11

PREPARING A STOCK SOLUTION

To facilitate handling and to limit the possibility of The labels on these bottles of solution must contain
error, we suggest that a stock solution be prepared, so the following information:
that calculations are kept to a minimum.
For example, it is easy to make a 1 mg/ml stock Date of preparation
solution (in demineralized water), so that 40 ml is Lot number
equivalent to a 40-mg dose; the chosen excipient is Quantity
then added to complete the volume.
Expiry date
Stock solution stability is not a problem. However,
to prevent bacterial growth, we recommend that these Prepared by:
solutions be prepared for a maximum period of one to Checked by:
two weeks and be kept refrigerated. Like any other
compounded mixture, the shelf life should not exceed Preparation registers must be kept for the powder
one month (standard expiry date). as well as the stock solution.

APPENDIX 12

THE PREPARATION OF INDIVIDUAL DOSES

Methadone must be administered to the patient in a solution containing 100 ml of an excipient that is
not easily injectable. The table below specifies the stability of the methadone solution in a number of commonly
used excipients. These excipients are prepared according to the manufacturers’ instructions for each.

Excipients Stability (room Stability

temperature) 20-25 °C (refrigeration) 5 °C
Kool-Aid (grape) 17 days 55 days
Tang (orange) 11 days 49 days
Allen’s apple juice 9 days 47 days
Crystal light (grape) 8 days 34 days
Crystal light (grape but with 29 days Undetermined
0.1% sodium benzoate added)

Labelling the Preparation

When solutions are prepared beforehand, the pharma-
cist must prepare the labels in accordance with exist-
ing regulations and standards; thus, every label should
contain:
• Name and given name of patient, prescription
number, medication (name of medication, concen-
tration, posology and quantity), prescriber, date of
preparation and expiry date, identity of pharmacist-
proprietor (name, given name, address and
telephone number) and conservation method. It
should also contain a warning that the medication
contains active ingredients which could be very
toxic if taken by someone for whom it was not
intended.
It is recommended that doses be provided in indi-
vidual, daily amber-coloured bottles (as light can alter
the product), with a safety cap, of course.

30
 APPENDIX 13

METHADONE POWDER INVENTORY

Day Month Year
Date received: Invoice Number:

Date Quantity of Weight (mg) Quantity Prepared by: Initials of Stock solution
methadone (mg) remaining (mg) (Initials) pharmacist lot number

N.B.: We suggest that you make one inventory sheet per methadone format.

STOCK SOLUTION PERPETUAL INVENTORY

Day Month Year
Stock solution no.: Date:

Initial quantity Date Patient Prescription Prepared by: Pharmacist’s Quantity of stock
of stock solution dose (ml) number (Initials) initials solution remaining (ml)

N.B.: We suggest that you make one sheet per lot of stock solution.

31
 APPENDIX 14

SIGNS AND SYMPTOMS

Withdrawal Intoxication

• Insomnia • Lethargy
• Running nose • Psychomotor retardation
• Yawning • Drowsiness, coma
• Mydriasis • Respiratory depression
• Goose pimples, chills
• Anxiety
• Agitation
• Abdominal pain, diarrhoea
• Musculoskeletal pain

APPENDIX 15

MEDICATIONS THAT CAN ALTER PLASMA LEVELS

OF METHADONE OR ITS EFFECT

Diminish Augment

• Barbiturates • Amitriptyline
• Carbamazepine • Cimetidine
• Ethanol (chronic use) • Ethanol (acute intoxication)
• Phenytoin • Diazepam
• Rifampin • Fluvoxamine
• Ascorbic acid and urine acidifying agents • Ketoconazole
• Urine alkalinizing agents

32
 APPENDIX 16

PRIVILEGES ALGORITHM

0 PRIVILEGE
0 MONTHS

YES INITIAL STABILITY

SATISFACTORY URINE TEST NO

3 MONTHS
1ST
PRIVILEGE 0 PRIVILEGE

NO
INITIAL STABILITY
YES SATISFACTORY URINE TEST
NO

6 MONTHS Reassessment of
2 ND
AND/OR 3RD PRIVILEGE
treatment plan

ADVANCED STABILITY NO
YES SATISFACTORY URINE TEST

9 MONTHS
4 TH
AND/OR 5TH PRIVILEGE REMAIN AT 2-3 PRIVILEGES OR
WITHDRAW ONE PRIVILEGE OR MORE

ADVANCED STABILITY NO
YES SATISFACTORY URINE TEST

12 MONTHS
MAXIMUM 5 PRIVILEGES

Privileges 2 and 3 may be granted simultaneously or at different times, Initial stability: Keeps appointments
depending on the patient’s progress and the physician’s assessment of Honours contract
the situation. Similarly for privileges 4 and 5.
Advanced stability: Is socially reintegrated
Assumes responsibilities

33
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35
A publication of the
Collège des médecins du Québec
2170 René Lévesque Boulevard West
Montréal, Québec H3H 2T8
Telephone: (514) 933-4441
or 1 888 MÉDECIN
Fax: (514) 933-3112
Internet: http://www.cmq.org
E-mail: info@cmq.org
and the
Ordre des pharmaciens du Québec
266 Notre Dame Street West
Suite 301
Montréal, Québec H2Y 1T6
Telephone: (514) 284-9588
Fax: (514) 284-3420
Internet: http://www.opq.org

Coordination:
Collège des médecins du Québec
Public Affairs and Communications Department
Translation: Bernadette Griffin-Donovan
Revision of terminology: Sidney Feldman, M.D.
Graphic design: Denis L’Allier, Designer graphique inc.
Reproduction authorized with mention of source.

Legal Deposit: 1st Quarter, 2000

Bibliothèque nationale du Québec
National Library of Canada

Note: The masculine is used in this publication without

prejudice for the sake of concision.
The French version of this guide is available in full on the
Collège Internet site.

36