Pedoman Klinis Program Terapi Rumatan Metadon (PTRM)

1. INTRODUCTION
ESSENTIALS OF METHADONE PRESCRINING
CHAPTER 1: ILLEGAL OPIOID USE AND RELATED HARM
Drug Dependence
Opioid Dependence
The harms related to Illegal Opioid use
Drug Misuse and HIV/AIDS in Vietnam
Treatment Approaches and Options
CHAPTER 2: A FRAMEWORK FOR TREATING OPIOID DEPENDENCE
Methadone Treatment – Philosophy, rational and aim
Treatment as a public health measure
Optimizing the benefits of methadone treatment
Guidelines for Hazard Prevention
CHAPTER 3: THE TREATMENT SETTING
Organisational Structure
The treatment Team
The roles, rights and responsibilities of health care provides
The monitoring Group
CHAPTER 4: CLINICAL PHARMACOLOGY
General Opioid Pharmacology
Methadone Pharmacology
CHAPTER 5: PRESCRIBING METHADONE
Legal requirements for prescribing methadone
Principles and process of methadone prescribing
Procedure checklist for a methadone clinic
CHAPTER 6: ENTRY INTO METHADONE TREATMENT PROGRAM
Inclusion and Exclusion criteria
Precautions
Priority for entry into treatment
The Clients/ Patient – Inclusion and Exclusion Criteria
Client rights and responsibilities
Client Flow
CHAPTER 7: ASSESSMENT FOR TREATMENT WITH METHADONE
CHAPTER 8: DOSING
CHAPTER 9: METHADONE OVERDOSE .......................
CHAPTER 10: DELIVERING EFFECTIVE METHADONE TREATMENT
CHAPTER 11: MANAGEMENT OF SPECIAL CLIENT GROUP
CHAPTER 12: PREVENTING RELAPSE
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2. CHAPTER 1: ILLEGAL OPIOID USE AND RELATED HARM
1.1. Introduction
This Chapter gives an overview of the issues related to drug use and HIV/AIDS. It also
specifically discussed drug dependence and opioid dependence and offers and
understanding of the various approaches to treatment that is available.
1.2. The harms related with Illegal Drug Use
Opioid dependence and injecting drug use is a serious problem in at least 138 countries in the
world. It is estimated that 13.5 million people are using opioids, including 9.2 million using heroin
(UNODC 2004 World drug report; WHO 2004). The global epidemic of heroin use continues to
spread and appears to be an increasing burden, mainly in developing countries with additional
health and social problems. There is a need to develop a broad range of community based
treatment responses to manage opioid dependence in developing world and transitional countries.
The rapid spread of HIV amongst injecting drug users in many parts of the developing world further
underscores the imperative to organise a comprehensive treatment approach.
Illegal opioid use is associated with a range of harms to the individual drug user and the community.
These include;
i. The risk of death - A long-term follow-up of heroin addicts showed they had a mortality
risk nearly twelve times greater than the general population (Oppenheimer et al, 1994).
ii. illnesses such as blood-borne diseases – HIV, Hepatitis B and C
iii. Other medical consequences of injecting drug use such as overdose (which can be
fatal), Endocarditis, Thrombophlebitis and transmission of other chronic viral infections
iv. family disruption; crime
v. lost productivity.
The health, social and economic costs to the individual and community associated with illegal drug
use, including opioids, are substantial.
Further harms and suffering, for which it is difficult to estimate the economic costs, include:
• the value of loss of life
• pain and suffering of the sick including reduced quality of life;
• suffering experienced by the rest of the community from drug-related mortality and morbidity;
and
• costs to the community from drug related crime including suffering of victims, families of drug
users and the drug users themselves.
1.3. Drug Misuse and HIV/AIDS in Vietnam
In Vietnam, since the late 1980s drug abuse has increased steadily particularly among youth.
Heroin has become the primary drug of concern. There are no reliable estimates of total number of
drug users in Vietnam but the Government maintains records on the number of registered drug
users, based primarily on reports of the police and drug treatment centres. In 1996 there were
69,195 users registered, but at the end of 2002 the number of drug addicts in whole country is
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3. 142,000. In reality, the actual number of drug users on a regular basis is believed to be much higher
(NCADP 2001, Bui 2003).
Despite the recent rapid increase in amphetamine-type stimulant use in the East Asia Pacific region,
heroin is still the major problem drug in the region and continues to dominate treatment demand and
present a major concern for transmission of HIV (UNODC RC 2004). Heroin use with high-risk
injecting practices and the spread of HIV/AIDS among IDUs and the subsequent HIV/AIDS
transmissions to the general community is becoming a serious problem.
In Vietnam there has been the steady increase in the incidence of injecting drug use. The Ministry of
Labor, Invalids and Social Affairs (MOLISA) reported that by November 2003, over 82% of drug
users had injected an illicit drug at least once. In addition, approximately 30% of the country’s drug
users were using intravenous (IV) methods and the sharing of needles/syringes and other drug
injecting equipment was becoming increasingly common. The behaviour of IDUs who have been
infected with HIV is of great concern of healthcare professionals. In some provinces, 64% to 88% of
people living with AIDS are IDUs, and among them 55% to 61% share needles (Tran, 2003). The
Ministry of Health (MOH) believes that this has led to a sharp increase in the incidence of HIV/AIDS
among IDUs, and identified injecting drug use as a major factor for the spread of HIV in Vietnam
(NCADP 2001, MOH 2004).
The cross over between IDUs and sex workers is well known all over the world. In Vietnam the
epidemic appears to be concentrated among those injecting drugs, those involved in sex work, and
those with other sexual infections (NASB 2001). Between 11% and 57% of IDUs had sex with sex
workers, and an increasing number of sex workers report injecting drugs. Such risk taking
behaviours have led to the rapid spread of HIV infection to the general population. In 1993,
HIV/AIDS was recorded in 93% of all districts and 49% of all communes in Vietnam, and many
provinces and cities has HIV/AIDS cases in every its district and ward (NSEB VN 2004). The HIV
infection cases has been increasing rapidly (1 - 2%) among pregnant women in Hai Phong, Quang
Ninh and An Giang (NSEB VN 2004)
1.4 DRUG DEPENDENCE AND OPIOID DEPENDENCE
1.4.1. Characteristics of drug dependence
• drug use becomes increasingly stereotyped in a persistent pattern, instead of drugs being
used in response to social or emotional cues
• drug-seeking acquires salience over other activities;
• tolerance (needing to use more heroin to get the same effect)
• withdrawal symptoms on cessation of drug use.
• subjective awareness of the compulsion to use the drug – ‘craving’;
• repeated relapse after attempts to cease drug use;
• continued drug use to prevent or relieve withdrawal symptoms
• continued desire to use drugs despite persistent and recurrent problems associated with
their use;
Neuro-adaptation is not an essential feature of drug dependence. Many dependent drug users do
not use enough drugs to be constantly neuro-adapted, and many others still may never become
neuro-adapted. However, drug users from both these groups may exhibit other features of drug
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4. dependence. Conversely, many people taking high doses of psychoactive drugs (eg cancer patients
taking morphine) are neuro-adapted to the drug but do not exhibit other features of dependence.
1.4.2. Opioid Dependence
What are Opioids?
Opioids are a class of drug that includes heroin , methadone, buprenorphine, opium, codeine,
morphine, pethidine, etc. Opioids relieve pain and bring on feelings of well-being. They are also
‘depressants’, which means they slow down the functions of the central nervous system, causing
respiratory depression, coma and possibly death in high doses.
What is Opioid dependence?
The way in which dependence on heroin and other opioids develops is much the same as for other
drugs. Opioid dependence is a neurobehavioral syndrome characterized by the repeated,
compulsive seeking or use of an opioid despite adverse social, psychological, and/or physical
consequences. Using daily or almost every day over a period of time leads to certain physical (the
body) and psychological (the mind and emotions) changes.
Physically, the body adapts or ‘gets used to’ having heroin on a regular basis. Eventually the drug
is needed to function ‘normally’, and more is needed to get the same effect. When this happens,
stopping or cutting down is very difficult because a person will start ‘hanging out’ or withdrawing.
Heroin may then be taken to ease or stop withdrawal occurring.
Psychologically, a person’s thoughts and emotions come to revolve around the drug. A person will
‘crave’ the drug (have strong urges to use), and feel compelled to use even though they know (or
believe) it is causing them difficulties - perhaps financial or legal worries, relationship problems,
work difficulties, physical health problems and psychological problems such as depression and
anxiety. This loss of control over heroin use is a key feature of dependence.
Opioid dependence have similar characteristics as of other drugs (see 4.1 above). Opioid
dependence is an ongoing and relapsing condition. Like many other chronic conditions, for
example, diabetes or arthritis, it will require long-term treatment. There is no quick fix or instant cure.
For most people it will take a number of attempts to reduce or stop heroin use completely.
Factors contributing to the development of opioid addiction include the reinforcing properties and
availability of opioids, family and peer influences, sociocultural environment, personality, and
existing psychiatric disorders. Genetic heritage appears to influence susceptibility to alcohol
addiction and, possibly, addiction to tobacco and other drugs as well (Goldstein A & Herrera
J,1995).
1.5.Treatment Approaches and Options
One of the aims in treating dependent patients is to return to them a greater degree of autonomy
and flexibility in their lives. There is no single effective treatment for the management of opioid
dependence, however current evidence indicates that a broad range of treatment options can
substantially impact on the course of opioid dependence.
For long-term reductions in heroin use, a treatment program needs to deal with the psychological
and social aspects of dependence, that is, the reasons for using heroin and the lifestyle that goes
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5. with it. This will involve combining methods, that include detoxification, outpatient programs,
therapeutic communities, self-help groups, and substitution treatment. The current options for opioid
dependence treatment, their benefits and considerations can be summarized in the following table:
Table 1: Benefits and considerations of selected treatment approach:
APPROACH BENEFITS CONSIDERATIONS
Detoxification program - helps manage withdrawal - does not produce long-term
- provides a break from heroin change
use and related harms - best as a starting point to
- links people to further treatment
treatment
- first step to abstinence
- helps people to reduce or - need to attend
Substitution treatment with
stop heroin use clinic/pharmacy regularly for
methadone
- gives people more time for dosing
other areas of their life - people still dependent on
- widely used, popular opioids; will be withdrawal
treatment period at the end of treatment
- a lot of evidence it works - may be side effects
- recommended treatment
- may need to reduce methadone
during
dose if people want to transfer to
regnancy/breastfeeding
buprenorphine
Naltrexone treatment - can help some people - must be completely detoxed
to remain heroin-free (i.e. abstinent) before starting treatment
after detox - not recommended for use in
- pregnancy/breastfeeding or
for people with certain
liverconditions (e.g. acute
hepatitis)
- opioid type pain-killers
(such as codeine or morphine) will
not work while taking naltrexone
- increased risk of overdose if
people use heroin after missing a
dose or stopping treatment, due to
loss of tolerance
Therapeutic community - provides high level of - there are different types of
support, structured program, and a programs, people should look
non-drug using environment around if possible to find one
- teaches skills to make that best suits them
long-term lifestyle changes - may be a waiting list
- usually cannot take children
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6. - provides high level of recommended people attend at least
Self-help groups (e.g. NA)
mutual support, social contact and 3 meetings to see how suitable self-
understanding between members help groups can be for them
- easy to access,
informal, free, regular, ongoing
- can be part of any
treatment plan where goal is to stop
using drugs
Counselling - can help with forming a - finding supportive and
treatment plan, reaching goals, and understanding counsellor is very
preventing relapse important
- links people to other - works best for people who
support service (e.g. want counselling
accommodation, employment
- range of services
available, easy to access
- can make other
treatments (e.g. methadone,
buprenorphine, naltrexone) more
effective
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7. CHAPTER 2: FRAMEWORK FOR TREATING OPIOID DEPENDENCE
2.1. Introduction:
Following chapter one, this section will discuss specifically about the philosophy, rational and
objectives of Methadone Treatment. Research findings on methadone treatments and guidelines for
hazard prevention are also provided in this chapter.
2.2. Philosophy of Methadone Treatment
The principles that underly Methadone Traetment are;
• Opioid-using persons have the right to assistance to achieve a quality of life in which there is
stability in personal and social relations, and physical and emotional well-being
• In order to achieve this quality of life, opioid-using persons should have access to treatment
to suit their needs, regardless of gender, age, geographic location, disability or ethnicity
• Unsanctioned opioid use is a public health problem, which requires the intervention and
collaboration of the public and private sectors.
• Treatment services for opioid-using persons should encourage as many drug users as
possible who are in need of treatment into treatment.
• Patients should be free to accept or decline any treatment offered to them.
2.3. The Rationale for the use of methadone
2.3.1. The costs of illicit drug use to the individual and community
The costs of illicit opioid use arise from:
• the loss of life through overdose and drug-related illness;
• treatment of overdose and other medical consequences of drug use;
• the transmission of disease, particularly HIV and hepatitis, mainly through use by injection;
• community loss due to criminal activity;
• law enforcement and judicial costs; and
• loss of quality of life for users and their families.
2.3.2.Opioid Dependence, Abstinence and Treatment
The combination of physical, psychological and social dimensions makes opioid dependence a
complex condition. For opioid dependence to be successfully overcome, it is usually necessary to
address all three dimensions. For many dependent drug users this may entail substantial physical,
psychological and lifestyle adjustments – a process that typically requires a long period of time. The
predominant view of opioid dependence is as a chronic, relapsing condition (McLellan et al 2000).
The community expectation of “treatment” of drug dependence is, in general, that it will result in
drug users achieving a drug-free lifestyle. Abstinence is an important long-term goal, but this
viewpoint of treatment does not adequately reflect the complexities of drug dependence, or the
extended treatment period required by some people. Furthermore, an emphasis solely on
abstinence to some extent devalues the other achievements that can be made through treatment.
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8. Evidence indicates that it is appropriate and necessary for treatment programmes, and for
individuals participating in treatment, to focus on initial goals of:
• reducing the use of illicit drugs;
• reducing the risk of infectious disease;
• improving physical and psychological health;
• reducing criminal behaviour;
• reintegration in the labour and educational process; and
• improving social functioning;
without necessarily ceasing drug use.
2.3.3. Effectiveness of methadone treatment
Heroin is a short-acting drug. When taken intravenously very high blood levels of the drug result.
These levels rapidly subside. This means that neuro-adapted heroin users fluctuate between
intoxication and withdrawal states.
Methadone maintenance is a medical treatment for opioid addiction. Methadone therapeutically
substitutes for other opioids and ameliorates problems because:
• The long half-life and a single daily dose slowly declining blood levels of methadone produce
a steady state which allows the patient to function normally.
• It is orally active, is slowly absorbed without producing intoxication and withdrawal
symptoms.
• It is cross-tolerant with heroin. The heroin user can reduce drug-seeking, develop normal
interests and pursue a more healthy and productive lifestyle.
• The process of social reintegration is facilitated by the therapeutic relationship established
between the doctor and patient and the provision of other services as required.
Programs vary in effectiveness, but overall, methadone treatment is very cost-effective and is
successful in reducing illegal drug use and needle sharing, reducing patients’ involvement in crime
and helping to improve their health and social functioning.
2.4. Methadone Treatment Approaches
Individual clients will differ in their needs and their needs are likely to change during the course of
methadone treatment. The level of supervision and intervention and the nature of treatment
appropriate for each client should be based on an assessment of their needs including reference to
the client’s current objectives in undertaking treatment, any relevant medical or psychiatric co-
morbidity, and the nature of their drug use.
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9. Where a high intervention approach is considered appropriate, it might include, in addition to the
provision of methadone, a high level of medical and casework intervention (such as contingency
contracting, motivational interviewing, relapse prevention and harm reduction counseling) as well as
access to crisis care, welfare advice and support, social skills training, vocational advice and
training and aftercare (following completion of methadone treatment).
For all clients, total drug abstinence is only one of a range of treatment objectives although this
outcome may, nonetheless, be achieved during the course of treatment.
2.4.1.Evidence-based approach to care
In a substantial proportion of patients, drug misuse tends to improve with time and age, particularly
when specific treatment and rehabilitation techniques are used.
There is also increasing evidence that treatment (medical and social) is effective in maintaining the
health of the individual and promoting the process of recovery.
Studies of self-recovery by drug users have shown that access to formal welfare supports, together
with encouragement from friends, partners, children, parents and other significant individuals, is
commonly involved in the pathway out of addiction.
Treatment studies do not support the view that a drug user has to reach ‘rock-bottom’ before being
motivated to change.
Harm minimisation refers to the reduction of various forms of harm related to drug misuse, including
health, social, legal and financial problems, until the drug user is ready and able to come off drugs.
A harm minimisation approach improves the public health and social environment by:
• Reducing the risk of infectious diseases and other medical and social harm: reducing the
rate of HIV among injectors in the drug misusing population.
• Reducing drug-related deaths Drug-related deaths can be reduced by:
- engaging and retaining dependent drug misusers in treatment
- improving individuals’ knowledge of both the risks of overdose, and methods of
avoiding overdose
- It is likely that a reduction in diversion of prescribed medicine onto the illegal market
would also avoid some drug-related deaths.
• Reducing criminal activity: Many drug misusers support their drug taking with significant
criminal activity, which is both costly and damaging to the individual and wider society.
2.5. Aims and Objectives of Methadone Treatment
The goals of methadone treatment are to reduce the health, social and economic harms to
individuals and the community associated with unsanctioned opioid use.
The common objectives of methadone treatment are:
• to reduce harmful opioid and other drug use;
• to improve the health and well-being of patients;
• to reduce illegal opioid use
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10. • to enhance the autonomy of patients
• to help reduce the spread of blood-borne communicable diseases associated with injecting
opioid use;
• to reduce transmission of infectious diseases, especially HIV, HBV and HCV
• to reduce deaths associated with opioid use;
• to reduce crime associated with opioid use;
• to facilitate an improvement in social functioning of patients; and
• to improve the economic status of patients and their families
The objectives of methadone treatment need to be tailored to the particular strengths and
weaknesses of each individual. For some severely dependent and dysfunctional individuals, very
modest goals of treatment may be appropriate, such as trying to reduce their injecting drug use, or
merely ensuring that they have access to clean needles and syringes. For other people with skills
and supports, goals such as abstinence from heroin and a return to employment may be more
appropriate goals.
2.6. Research Findings regarding Methadone Treatment
Methadone maintenance is a maintenance intervention. It is not a time-limited treatment. Any notion
of methadone maintenance as an effective time-limited treatment with the expectation of ‘cure’ is
not supported by the research literature. Research suggests that not all methadone programs are
equally effective. The following factors have been found to be associated with better outcomes for
methadone maintenance treatment:
• Time spent in methadone maintenance
The evidence suggests that the longer a patient remains in treatment, the more likely they
are to do well and, in the longer term, the more likely they are to do well after ceasing
methadone treatment. It is important to note that people who drop out of treatment,
particularly in the first year, have a very high rate of relapse to heroin use.
• Methadone dose
Higher methadone doses (generally 60 mg and more) have consistently been found to be
associated with lower rates of heroin use and longer retention in treatment.
• Medical and counselling services
The provision of adequate medical care and the availability of counselling services for those
patients who want them have been found to be associated with better outcomes and
retention rates in some studies.
• Quality of the therapeutic relationship
More effective programs are characterised by patients having a good relationship with one
staff member. In addition, certain staff attitudes – notably, acceptance of the notion of
indefinite maintenance rather than an orientation to abstinence – are to be associated with
better treatment outcomes.
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11. 2.7. The Benefits of Treatment
The benefits of treatment include:
• reduced risk of death - especially from drug overdose
• reduced heroin use (including ‘abstinence’, that is, not using any heroin)
• improved physical health (e.g. less risk of HIV, hepatitis C and bacterial infections)
• improved emotional health (e.g. reduction in depression, anxiety)
• reduced crime
• increased employment
• improved relationships and parenting
In general the impact of treatment should be viewed in terms of its capacity to:
• improve the quality and quantity of life of the individuals who come into treatment;
• improve the quality of life of their family;
• reduce criminal justice expenditure through diversion away from prison;
• reduce health and welfare costs;
• reduce the costs incurred by victims of crime; and
• improve the social environment.
2.8. Optimising the Benefits of Methadone Treatment
Factors which influence participation in methadone programs include;
• number and/or locations of programs,
• cost of treatment to the client,
• opening hours,
• assessment procedures,
• dosage,
• clinicians’ attitudes
• access to allied medical, psychological and welfare services.
The following principles should guide the provision of methadone programs:
Availability: Where a need for methadone services exists these services should be made
available. Partnerships should be maintained to ensure an appropriate mix and spread of
services as well as equity of access for disadvantaged groups.
Access: To be accessible to clients who need services, services should be located at
appropriate sites, treatment should be affordable to clients, and opening hours should
optimise service utilisation.
Acceptability: The operation of methadone services should be acceptable to major
stakeholders including clients, service providers and the local community.
Quality of care: A quality of care approach embraces strategies such as:
• the provision of information to clients about methadone treatment (including side
effects and drug interactions), program rules, their rights and responsibilities as
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12. clients, and special issues such as driving and operating machinery during
treatment;
• ensuring client confidentiality;
• client appeals procedures;
• monitoring and reporting on program performance and effectiveness; and
• a commitment to staff training and development programs.
2.9. Guidelines for Hazard Prevention
There are hazards associated with methadone treatment including overdose, accidental poisoning
of someone for whom methadone is not prescribed, and the illegal diversion of and trafficking in
methadone. The following are general guidelines to minimise the hazards associated with
methadone treatment:
• Methadone treatment should be available as one option for the treatment of dysfunctional
opioid use.
• Clinicians should be adequately trained in providing methadone treatment.
• Diagnostic and assessment procedures for methadone should be standardised (see
Standards of Operational Procedures of Methadone Maintenance Treatment).
• Methadone treatment should be voluntary and only those individuals assessed as suitable
by an approved doctor should receive this treatment.
• Administration of methadone should be closely supervised.
• Methadone treatment should occur in an environment, which is safe for patients, staff and
the community.
The extent to which methadone patients are required to, or do in fact wish to, reduce or eliminate
consumption of illegal drugs is one of the most critical and divisive issues in methadone
maintenance treatment. The goal of eliminating all illegal drug use, especially in the first few months
of treatment, is unrealistic and very likely to impede treatment progress and patient–clinician
rapport.
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13. CHAPTER 3: THE TREATMENT SETTING
3.1. Introduction:
This chapter is provides information and guidelines for the clinic/agency/site that provides the
Methadone Treatment. The key individuals involved in the Treatment Team, their roles and
responsibilities are suggested. However, it is important that before the start of the program, such
issues are discussed by the team once again in their own setting and changes to the roles agreed and
accepted by all concerned. This chapter also provides a checklist for the Methadone Clinic for its
preparation to start treatment.
3.2. Organisational Structure
Insert chart here
3.3. The Treatment Team
The Treatment Team at the Hai Phong Methadone program will include the following individuals:
i. Doctor as Prescriber
ii. Nurses
iii. Methadone dispensers – 2
iv. Counsellors
3.4. The role of healthcare providers in methadone treatment program
Doctor
• Medical assessment to identify the drug related problems faced by patients
• Develop treatment plan which will include identifying the intial dosage and subsequent
dose increment for patients
• Management of intoxication and withdrawal among patients
• Pharmacotherapy treatments
• Treatment of medical co-morbidities
• Management of psychiatric co-morbidities
• Referral to clinicians with special skills for clients who may need it
• Care of pregnant women and their neonates
• Coordinate care, patient follow ups and monitoring
Nurses
• To assist the doctor in screening and assessment of patients
• Provide information about drugs, methadone and related issues to all patients
• Management of intoxication and withdrawal – nursing
• Nursing support and assist the doctor in all other aspect of treatment and care for patients
Counselors
• Assist in the assessment process including identifying drug and alcohol related issues
among patients
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14. • Counseling, including motivational interviewing and relapse prevention
• Provide continued information and support regarding treatment, side effects, strategies to
overcome challenges related to drug use
• Patient follow up monitoring and review
• Case management of patients
• Working with families of patients to ensure adherence to treatment
• Referrals to clinicians with special skills especially in the area of mental health
• Referrals to social welfare services
Dispensers
• To ensure that the right methadone mixture is prepared and dispensed to the right patient (
2 dispensers are required for this task)
• To ensure that patients have consumed methadone and chances of deviation are minimal
or none.
• To observe patients for toxicity and withdrawal after dispensing
• To provide feedback to doctors regarding toxicity and withdrawals experienced by
patients
3.5. Supervision and Monitoring group
Progress toward the ideal pattern and delivery of shared care in any area will inevitably be
incremental and will rely on developing good communication, understanding and trust between all
the individuals and services involved. The development and management of shared care practice is
a crucial part of service development for drug misuse and related public health issues at local level.
The Director of Hai Phong Health Department will provide Leadership and Guidence to
the methadone program in Hai Phong city.
A Technical Working Group will be set up to provide technical and monitoring support.
Members of this Working Group are;
A monitoring group should also be set up. The monitoring group should review training needs,
clarify performance indicators and monitor the delivery and effectiveness of shared care service
provision in the methadone service.
The monitoring group should comprise the Director of Public Health (or deputy), representatives
from specialist treatment agencies, the Local Medical Committee and other members as required.
The involvement of a drug user representative in the monitoring group is highly recommended.
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15. 3.6. Checklist for a Methadone Treatment Clinic
3.6.1. Support Services:
• Security Officers
• Cleaners
• Volunteers
• Peer Educators
3.6.2. The minimum required documentation that a methadone clinic needs to have:
• Clinic policies and procedures for methadone treatment
• Staff education and training manual
• Standard Operating Procedures
• Assurance of the privacy and confidentiality of addiction treatment information
• Individual patient records
• A referral network of medical specialists and treatment facilities including mental heath
• Community referral resources, counseling services
3.6.3. Other requirements:
• Waste management system
• Adequate space for available interventions – doctors
examination room, counseling rooms, dispensing room, client waiting room,
client recovery room, meeting room
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16. CHAPTER 4: CLINICAL PHARMACOLOGY
4.1. Introduction
Familiarity with the characteristics of methadone pharmacology is necessary for the safe and
effective use of this drug. Prescribers need to be aware of the slow onset of peak blood levels and
long half life of methadone to ensure that it is safely used by patients. This chapter will discuss in
detail methadone pharmacology. For background reading in regards to general opioid
pharmacology, please refer to the Training Handouts which should accompany this clinical
guideline.
4.2. CLINICAL PHARMACOLOGY OF METHADONE
4.2.1. Actions
• Analgesia: acts on mu receptors, similar to morphine, peak effect 30–60 minutes (oral), 10–20
minutes (intravenous)
• sedation
• euphoria: less than intravenous heroin
• small pupils
• skin: vasodilation and itching, secondary to histamine release
• respiratory: depression, anti cough
• gastrointestinal tract :
- reduced gastric emptying;
- elevated pyloric sphincter tone;
- nausea and vomiting;
- reduced gut motility, leading to constipation;
- elevated tone of sphincter of Oddi, can result in biliary spasm
• endocrine:
- reduced Follicle Stimulating Hormone,
- Luteinising Hormone and elevate prolactin: these return to normal between 2 - 10 months
on methadone, and always on ceasing opioid use;
- elevated Anti-Diuretic Hormone, can lead to fluid retention and weight gain (most weight
gain results from increased dietary intake);
- reduced testosterone: can result in reduced libido
- reduced Adreno -Cortico-Trophic-Hormone: gynaecomastia has been reported in males ;
menstrual irregularities: 90% of women using heroin regularly have menstrual
abnormalities; 80% of these will revert to normal when stabilised on methadone
- Endocrine function may return to normal after 2-10 months on methadone
• cardiovascular: decreased blood pressure, rarely clinically significant
• increased sweating
People commencing on methadone are usually tolerant to the above effects because of their
prolonged use of opioids. However, during the initiation of treatment, when the dose is being raised,
patients should be warned of possible impairment of driving skills. Once on a stable dose sufficient
tolerance is developed such that cognitive skills and attention are not impaired. They are able to
drive cars safely.
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17. 4.2.2. Side Effects
Side effects of methadone present in:
- Sleep disturbances
- Nausea and vomiting
- Constipation
- Dry mouth
- Increased sweating
- Vasodilation and itching
- Menstrual irregularities in women
- Gynaecomastia in males
- Sexual dysfunction including impotence in males
- Fluid retention and weight gain
Discontinuing methadone, especially abruptly, results in a prolonged and symptomatically troubling
withdrawal syndrome.
Table 2: Common Adverse Effects
Side Effect Common Causes Response
Drowsiness after dose Excessive dose Review and maybe reduce dose
Use of other CNS depressants Reduce patient's use of other
(alcohol, benzodiazepines) drugs.
Craving for heroin Insufficient dose Review and maybe increase
dose.
Constipation Methadone Advise a high-fibre diet,
Dysfunctional diet adequate fluid intake, stool
Other lifestyle behaviours softeners and exercise.
Bowel stimulants if necessary
Dental problems Drug-induced reduced saliva Advise enhanced dental hygiene
(decayed teeth, periodontal volume (frequent brushing, flossing,
disease) Poor dental hygiene avoiding
High sugar diet sugary foods/drinks, chewing
non-sugar gum).
Weight gain Fluid retention. Review dose and reduce
Improved appetite. patient's salt intake.
Decreased activity. Review and change patient's
Hypothalamic hormone diet.
suppression Advise patient to increase
exercise
carefully.
Insomnia Excessive or insufficient dose. Review dose.
Timing of dose. Review timing of dose.
Stimulation by other drugs Identify stimulant drugs and
(coffee, tobacco, drugs such advise
as amphetamines and patient to avoid them.
pseudoephedrine). Review patient's general sleep
hygiene.
Lowered libido Higher doses. Review dose.
Psychological or social/ Check patient's history and
situational problems consider counseling.
Sweating Methadone Antiperspirants
SSRIs Weight loss
Weight gain/decreased Gradual increase exercise
17

18. fitness
Infertility Methadone Check hormone levels
Cachexia Consider hormone replacement
Hypothalamic suppression Counsel patience
Hypreprolactinaemia
4.2.3. Pharmacokinetics
Methadone is well absorbed after oral administration. There is wide individual variability in the
pharmacokinetics of methadone but in general, blood levels rise for about 3-4 hours following
ingestion of oral methadone and then begin to fall. Onset of effects occurs approximately 30
minutes after ingestion. The apparent half life of a single first dose is 12 – 18 hours with a mean of
15 hours. With ongoing dosing, the half life of methadone is extended to between 13 and 47 hours
with a mean of 24 hours. This prolonged half life contributes to the fact that methadone blood levels
continue to rise during the first week of daily dosing and fall relatively slowly between doses.
Figure 7-2: Plasma levels of methadone during first 3 days of dosing
*Preston A (1999) The New Zealand Methadone Briefing.
Methadone is 90% protein bound in blood. Methadone reaches steady state in the body (where
drug elimination equals the rate of drug administration) after a period equivalent to 4-5 half lives or
approximately 3-10 days. Once stabilisation has been achieved, variations in blood concentration
levels are relatively small and good suppression of withdrawal is achieved. For some, however,
fluctuations in methadone concentrations may lead to withdrawal in the latter part of the inter-dosing
interval. If dose increases or multiple dosing within a twenty-four hour period do not prevent this,
other agonist replacement treatment approaches such as buprenorphine should be considered.
----------------------------------------------------------------------------------------------
Onset of effects 30 minutes
----------------------------------------------------------------------------------------------
18

19. Peak effects Approx 3 hours
----------------------------------------------------------------------------------------------
Half life (in MMT) Approx 24 hours
----------------------------------------------------------------------------------------------
Time to reach stabilisation 3-10 days
----------------------------------------------------------------------------------------------
4.2.4. Metabolism
Methadone is extensively metabolised in the liver to active metabolites. Certain drugs are known to
enhance methadone metabolism by inducing liver enzyme. See below for drug–methadone
interactions.
4.2.5. Excretion
Although methadone and metabolites are excreted in the urine, it is primarily metabolised by the
liver. Increases in urinary pH can increase methadone clearance slightly. Patients with chronic renal
failure on dialysis do not accumulate methadone, and achieve similar blood levels for a given dose
to patients with normal renal function.
4.2.6. Methadone withdrawal
The signs and symptoms of the opioid withdrawal syndrome include:
irritability, anxiety, restlessness
dilated pulpils
apprehension
muscular and abdominal pains Onset:
chills 36 to 48 hours after last dose
vomiting, nausea
diarrhoea Peak:
yawning intensity within 2 to 4 days after last
lacrimation dose
piloerection, sweating
sniffing Duration:
sneezing 5 to 21 days (up to 2 months)
rhinorrhoea
Hypertension (mild)
general weakness and insomnia
This first, or acute, phase of withdrawal may then be followed by a period of protracted withdrawal
syndrome. The protracted syndrome is characterised by a general feeling of reduced well-being.
During this period, strong cravings for opioids may be experienced periodically.
The opioid withdrawal syndrome is rarely life-threatening. However, completion of withdrawal is
difficult for most people. Untreated methadone withdrawal symptoms may be perceived as more
unpleasant than heroin withdrawal, reflecting the more prolonged nature of methadone withdrawal.
19

20. Factors that have been identified as having the potential to influence the severity of withdrawal include the
duration of opioid use, general physical health, and psychological factors, such as the reasons for undertaking
withdrawal and fear of withdrawal.
4.2.7. Methadone intoxication
The signs and symptoms of the methadone intoxication include
• Stupor, coma
• Pinpoint pupils
• Hypotermia
• Bradycardia
• Hypotention
• Hypoventilation
• Cool moist skin
• Pulmonary oedema
• Death from respiratory depression
4.2.8. Effects of Chronic administration
The effects of the chronic administration of methadone often show:
- Sleep disturbance
- Teeth problems (reduced saliva)
- Reduced libido
- Lethargy
- Excessive sweating
- Constipation
4.2.9. Drug interactions
Toxicity and death have resulted from interactions between methadone and other drugs. Some
psychotropic drugs may increase the actions of methadone because they have overlapping, additive
effects (e.g. benzodiazepines and alcohol add to the respiratory depressant effects of methadone).
Other drugs interact with methadone by influencing (increasing or decreasing) metabolism. Drugs
that induce the metabolism of methadone can cause a withdrawal syndrome if administered to
patients maintained on methadone. These drugs should be avoided in methadone patients if
possible. If a cytochrome P450 inducing drug is clinically indicated for the treatment of another
condition seek specialist advice. Cytochrome P450-3A inhibitors can decrease the metabolism of
methadone and cause overdose. ***
A full list of drug interaction between Methadone and other drugs: see Appendix 2
4.2.10. Safety
The long term side effects of methadone taken orally in controlled doses are few. Methadone does
not cause damage to any of the major organs or systems of the body and those side effects which
do occur are considerably less harmful than the risks of alcohol, tobacco and illicit opiate use. The
20

21. major hazard associated with methadone is the risk of overdose. This risk is particularly high at the
time of induction to MMT and when methadone is used in combination with other sedative drugs.
The relatively slow onset of action and long half life mean that methadone overdose can be highly
deceptive and toxic effects may become life threatening (overdose) many hours after ingestion.
Because methadone levels rise progressively with successive doses during induction into treatment,
most deaths in this period have occurred on the third or fourth day of treatment.
4.2.11. Formulations
One preparations are available for methadone maintenance treatment in Hai phong
(Vietnam):
• Biodone Forte® from McGaw Biomed. This formulation contains 5mg/ml methadone
hydrochloride and permicol-red colouring.
21

22. CHAPTER 5: PRESCRIBING OF METHADONE
QUALIFICATIONS
To qualify for prescribing of methadone, a licensed clinician must meet the following criteria:
• The clinician has completed training that is provided by the Hai Phong Provincial Health
Services (PHS), or any other organization that Hai Phong PHS determines is appropriate for
the treatment and management of patients who are opioid dependent.
• The clinician holds authorization from the Hai Phong PHS.
LEGAL REQUIREMENTS FOR PRESCRIBING OF METHADONE
• An approved prescriber must obtain authority for each methadone patient. (Appendix 25)
• A patient must not be commenced on methadone until authority has been granted by the
Provincial Health authority. This step is required to ensure that the patient is not concurrently
receiving methadone from another prescriber.
• An authority is valid for one year and then further application must be sought (Appendix 26).
• A Termination of Methadone Treatment form (Appendix 17) must be completed and
forwarded to the Health Authority within 7 days for each patient discharged from a program
THE PRINCIPLES AND PROCESS OF METHADONE PRESCRIBING
See Appendix 13 for an example of a methadone prescription.
Key recommendations
• It is important to note that prescribing of licensed medications outside the recommendations
of the product’s license alters (and generally increases) the doctor’s professional
responsibility.
• Where the parent is opiate-dependent, and in receipt of a substitute drug prescription, their
children should not be authorised to collect their medication from the pharmacy.
• It is good practice for all prescriptions to be taken under daily supervision
• Keep good, clear, written records of prescribing.
• As newer ‘addiction’ drug treatments are developed, clinicians are advised to request
specialist advice to support the benefits of the pharmacological intervention they are either
considering or being requested to prescribe.
• Prescribing should be seen as an enhancement to other psychological, social and medical
interventions.
The minimum responsibilities of methadone prescribing
1. It is the responsibility of all doctors to provide care for general health needs and drug
related problems.
22

23. 2. Doctors should not prescribe substitute medication, such as methadone, in isolation. A
multidisciplinary approach to drug treatment is essential.
3. Prescribing is the particular responsibility of the doctor signing the prescription. The
responsibility cannot be delegated.
4. A doctor prescribing controlled drugs for the management of drug dependence should
have an understanding of the basic pharmacology, toxicology and clinical indications for the use
of the drug, dose regime and therapeutic monitoring strategy.
5. A full assessment of the patient, in conjunction with other professionals involved, should
always be undertaken and treatment goals set.
6. The clinician has a responsibility to ensure that the patient receives the correct dose and
that appropriate efforts are taken to ensure that the drug is used appropriately and not diverted
onto the illegal market. Particular care must be taken with induction on to any substitute
medication, especially where self-reporting of dosage is being relied upon.
7. Supervised consumption is recommended for all prescriptions.
8. The prescribing doctor should liaise regularly with the dispensing nurse about the specific
patient and the prescribing regime.
9. Clinical reviews should be undertaken regularly, at least every three months, particularly in
patients whose drug use remains unstable.
10. Thorough, clearly written records of prescribing should be kept.
Prescribing process
The responsibility of prescribing
Prescribing is the particular responsibility of the doctor signing the prescription. The responsibility
cannot be delegated.
A decision to prescribe, what and how much to prescribe will depend upon:
1. the overall treatment plan for the individual patient;
2. these Clinical Guidelines;
3. locally agreed protocols;
4. the doctor’s experience and level of training;
5. discussion with other members of a multidisciplinary team;
6. advice, where necessary, from a specialist in drug misuse.
The dosages stated in these Clinical Guidelines is for general guidance and represent (unless
otherwise stated) the range of dosages that are generally regarded as being suitable for treating
adults who have become opioid dependent.
Deciding whether to prescribe
Before deciding whether to prescribe, the doctor should be clear as to what the functions of a
prescription are. A prescription can:
- reduce or prevent withdrawal symptoms;
- offer an opportunity to stabilise drug intake and lifestyle whilst breaking with previous illicit
drug use and associated unhealthy behaviours;
- promote a process of change in drug taking and risk behaviour;
23

24. - help to maintain contact and offer an opportunity to work with the patient.
A methadone prescription should only be considered if:
- methadone is being taken on a regular basis – particularly for daily use;
- there is convincing evidence of current dependence (including objective signs of withdrawal
symptoms wherever possible);
- the patient is motivated to change at least some aspects of their drug use;
- the assessment clearly substantiates the need for treatment;
- the doctor is satisfied that the patient will co-operate and demonstrate adequate compliance
with the prescribing regime.
Setting goals
Before prescribing methadone the doctor should establish:
• what changes the patient wishes to make in the way he or she uses drugs;
• what lifestyle changes the patient wants to make;
• how a prescription might help the patient to achieve these changes;
In the light of the changes that the drug user would like to make; set mutually agreed and realistic
goals to be achieved within 4 - 12 weeks of starting the prescription. For example:
• to begin to tackle other problem areas e.g. legal, financial, accommodation and relationship
problems;
• to reduce or stop using illicit drugs;
• to review alcohol consumption;
• to reduce frequency of injecting;
• to attend appointments on time.
Goals should be recorded and reviewed regularly throughout the period of treatment. (*should we
expand this to say, doctors should record this in the clients case notes and review throughout the
period of treatment – it is good practice to review this every 2-3 month?) (YES)
Prescription
The prescription must show clearly:
• The patient’s name and address;
• Daily dose of methadone;
• The period of time for which the dose is to be administered including an expiry date;
• The prescription must be signed and dated by the prescriber.
Record keeping
There should be clear and concise notes, properly signed, named and dated. A separate structured
sheet for recording prescribing must be kept. A patient-held record, countersigned by those involved
in care, can be a useful adjunct to treatment. (check with Thu and Thai on this) ***
Other doctors who may see the patient should be informed of current treatment. The patient should
ideally be seen on each occasion by the prescribing doctor or an informed colleague.
Dispensing
The basic arrangements for effective supervised dosing are as follows:
- Wherever possible, liaise with the dispensers about the specific patient and the prescribing
regimen.
24

25. - As a general principle, substitute drugs should be dispensed on a daily basis.
- Supervised consumption should be arranged with the most appropriate clinic staff, e.g. clinic
nurse,
- Should we include a step – engaging the clients in a short discussion after they have taken the
drugs? *** (Should be in SOP)
Issue of diversion
To minimise further the risk of inappropriate diversion onto the illicit drugs market, doctors and
health professionals in multidisciplinary teams must have regard for the security of drugs,
prescription pads and headed notepaper, and take sensible precautions to avoid the risk of theft of
items such as these. (refer to safety and storage of methadone at site?) *** YES
Ending a failing treatment
The decision to end a failing treatment should not be taken lightly, and should ideally be part of a
treatment plan agreed with the patient. However, if a patient receiving treatment for drug use fails to
comply with that treatment, and consistently fails to make progress towards agreed and reasonable
goals, the doctor may have to consider ending that particular treatment.
It may be possible to agree with the patient some modified goals, which require very little treatment,
input or it may be necessary to acknowledge that nothing currently is being achieved and treatment
contact will cease.
Due notice should be given of a reduction regime. Suggestions for referral for further assessment
with local specialist services, to consider other treatment options and arrangements, will mean the
patient still has access to general medical care.
(also refer to another section on withdrawal from Methadone?)
25

26. CHAPTER 6: ENTRY INTO METHADONE MAINTENANCE TREATMENT
6.1. Introduction
This chapter will provide guidelines on inclusion and exclusion criteria for patients to be admitted
into the treatment program. A section has also been developed to caution service providers about
problematic patients. This Chapter is developed to assist service providers in selection of
participants for the Methadone Treatment.
6.2. Indication & Inclusion Criteria
• Methadone maintenance treatment is indicated for those who are dependent on opioids and
who have had an extended period of regular opioid use.
• The diagnosis of opioid dependence should be made by eliciting the features of opioid
dependence in a clinical interview (see section 9. Assessment for treatment with
methadone).
• The FOLLOWING definitional criteria of the diagnostic and statistical manual of mental
disorders, DSM-IV (edition 4) are useful to diagnose dependence.
Diagnostic Definition of Opioid Dependence (DSM IV)
Dependence is defined as “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”:
• Tolerance as defined by either of the following:
- A need for markedly increased amounts of opioids to achieve intoxication or
desired effect;
- Markedly diminished effect with continued use of the same amount of opioids.
• Withdrawal as manifested by either of the following:
- The characteristic withdrawal syndrome for opioids. Opioids or a closely related
substance are taken to relieve or avoid withdrawal symptoms.
• Opioids are often taken in larger amounts or over a longer period than was
intended.
• There is a persistent desire or unsuccessful attempts to cut down or control
opioid use.
• A great deal of time is spent in activities necessary to obtain opioids, use
opioids, or recover from their effects.
• Important social, occupational, or recreational activities are given up or reduced
because of opioid use.
• The opioid use is continued despite knowledge of having a persistent or
recurrent physical or psychological problem that is likely to have been caused
or exacerbated by opioids.
NOTE:
A person diagnosed as opioid dependent may or may not be physically dependent on opioids at the
time of presentation:
26

27. • If there is no current physical dependence MMT will not usually be appropriate.
• For those not physically dependent at the time of presentation, the prescribing practitioner
must clearly document that the potential benefits to the individual’s health and social
functioning outweigh the disadvantages of MMT.
Inclusion criteria for Methadone Treatment:
• Opioid dependants
• Over 18 years of age
• Have been a resident of Hai Phong for 2 years
• Drug habit that have brought about negative bio-psycho-
psocial consequences
6.3. Contraindications for Methadone Treatment & Exclusion Criteria
The following categories of patients are not suitable for treatment with methadone:
• Patients with severe hepatic impairment (decompensated liver disease) as methadone
may precipitate hepatic encephalopathy
• Cases of poly drug use where the patient is not opioid-dependent
• Generally treatment other than methadone should be considered for a person under the
age of 18 years. The prescribing doctor should check jurisdictional requirements regarding
age limits for MMT.
• Where patients are unable to give informed consent due to the presence of a major
psychiatric illness or being underage, the prescribing doctor should consider relevant
secondary consultation and check jurisdictional requirements regarding obtaining legal
consent.
• Patients who are hypersensitive to methadone or other ingredients in the formulation.
• Patients with severe respiratory depression, acute asthma, acute alcoholism, head injury
and raised intracranial pressure, ulcerative colitis, biliary and renal tract spasm, and
patients receiving monoamine oxidase inhibitors or within 14 days of stopping such
treatment. It is recommended that specialist advice be sought in these cases
6.4. Priority for entry into Treatment
The groups in whom prompt access to methadone is often indicated are
• Pregnant women;
• HIV positive patients and their opioid-using partners;
• Those with strong family and/or community support (this factor needs to be discussed locally
and during the trainings) ??? *
27

28. 6.5. Precautions
Particular caution should be exercised by prescribers when assessing individuals with the following
clinical conditions as to their suitability and safety for treatment with methadone. Concomitant
medical and psychiatric problems and other drug use increase the complexity of management of
patients on MMT and may also increase the risk of overdose and death. The prescribing doctor
should seek specialist advice or assistance in such cases.
• High risk poly drug use:
Poly drug use is common, all opioid substitution treatments should be approached with caution
in individuals using other drugs, particularly those likely to cause sedation such as alcohol, as
well as benzodiazepines and antidepressants in doses outside the normal therapeutic range.
Particular attention should be given to assessing the level of physical dependence on opioids,
codependence on other drugs and overdose risk. (Appendix 2). The onset of withdrawal
depends on the half-life of the drug. Drugs with shorter half-lives induce earlier onset, shorter
duration and often more intense withdrawal reactions than long half-life drugs. These are
summarised in Appendix 1.
• Co-occurring alcohol dependence:
Due to the significant management problems presented by this group, consideration should be
given to concurrent disulfiram or acamprosate therapy.(Dr.Thai to change this) ***
• Recent history of reduced opioid tolerance:
Be cautious when providing treatment to patients who may have recently completed Naltrexone
treatment or have just been released from prison. These patients can have reduced tolerance to
opioids and are at significant risk of overdose if they use opioids.
• Psychiatric illness (see also section 13.6):
• People whose mental state impairs their capacity to provide informed consent (e.g. those
with an acute psychotic illness, cognitive impairment or a severe adjustment disorder)
should receive adequate treatment for the psychiatric condition so that informed consent
can be obtained before initiation of MMT. (Note: at entry to methadone most patients
exhibit some degree of depression which usually resolves quickly with MMT. Most of these
patients do not require antidepressant treatment before commencement of methadone)
• High risk of self-harm Individuals at moderate or high risk of suicide should not be
commenced on methadone in an unsupervised environment and specialist consultation
should be sought.
• Chronic pain:
Refer for specialist assessment first
• Concomitant medical problems
A significant proportion of methadone related deaths involve individuals who were in poor health
and had other diseases (particularly hepatitis, HIV and other infections), which may have
contributed to their death. This emphasises the importance of giving consideration to concomitant
medical problems.
- Head injury and increased intracranial pressure: This is generally seen only in the hospital
emergency setting
28

29. - Phaeochromocytoma: aggravated hypertension has been reported in association with heroin
use
- Asthma and other respiratory conditions: In such patients even usual therapeutic doses of
opioids may decrease the respiratory drive associated with increased airways resistance
- Special risk patients: Methadone should be used with caution in the presence of
hypothyroidism, adrenocortical insufficiency, hypopituitarism, prostatic hypertrophy, urethral
stricture, shock and diabetes mellitus
- Poor compliance: patients who exhibit poor compliance with treatment for major intercurrent
illness such as asthma or diabetes pose a particular challenge in MMT.
CAUTION with patients in any of the following categories:
• high risk polydrug use
• co-occurring alcohol dependence
• history of reduction in opioid tolerance
• psychiatric illness
• concomitant medical problems
6.6. Registration
The Ministry of Health of Vietnam should establish and maintain a register of all heroin addicted
people who are registered for methadone maintenance treatment at any of the sites that provide this
treatment in Hai Phong. This is to prevent anyone registering for treatment at more than one site
and also to prevent people using aliases.
The registration process for patients eligible to enrol in the pilot methadone treatment programs
could be based upon the information requirements used in other countries plus the unique identifier
that is the identity card that all Vietnamese nationals carry. Necessary consents for treatment needs
to be sought by the clinicians prior to commencement of the methadone treatment program. Change
to seeking authority
6.6. Clients’ Rights and Responsibilities
Legally competent clients have a common law right to make their own decisions about medical
treatment and their right to grant, withhold or withdraw consent before or during treatment.
The following principles should apply:
- The free and informed consent of each client to undertake treatment should be obtained in
writing before treatment begins.
- Clients should be given information on all aspects of treatment, including their obligations,
prior to giving consent.
- Written information should be provided to each client in a form that the client can take away.
Clients who cannot read should be read their rights and obligations at the time they enter the
program.
- In the case of clinics, the rules of the clinic should be on display for all clients to see.
29

30. - There should be procedures in place for protecting clients’ personal information.
- There should be a formal mechanism, established at the jurisdictional level, for resolving
grievances between clients and those responsible for their treatment. Clients should have the
right of access to these procedures and be informed of them at the commencement of
treatment and on request thereafter.
6.7. Informed Consent and Patient Information
The clinician is responsible for providing each client at his or her level of comprehension, with
sufficient information about the purpose, methods, demands, risks and inconveniences of treatment.
Written information in plain language should be provided to each client in a form that the client can
take away. It is important that this information is repeated and that client’s questions are answered
throughout the induction period and after they are established in treatment.
Obtain informed consent to methadone treatment in writing from the patient before commencing
treatment. Clients should be aware of their rights and obligations at the time they enter the program.
Clients must be free at any time to withdraw their consent.
For patients to make a fully informed decision, they should be provided with written information
about:
• The nature of methadone treatment (addictive qualities, side effects and drug interactions)
• Other treatment options
• Program policies and expectations
• Consequences of breaches of program rules
• Recommended duration of treatment
• Side effects and risks associated with taking methadone (see Section 7 page 33 & 10.9
page 65)
• Risks of other drug use
• The potential impact of methadone on their capacity to drive or operate machinery
• Confidentiality of client records
• The availability of further information about treatment
(please cross check with patient information in the Myanmar guidelines, page 24)
Methadone may affect the capacity of patients to drive or operate machinery during the early stages
of treatment, after an increase in dose, or when patients are also taking other drugs. Warn patients
about this effect before entry into treatment, when the dose of methadone is increased, or when the
use of other drugs is suspected.
Patient information resources are available which can be provided to patients or a program specific
patient information booklet can be prepared (see Methadone Handbook for clients).
30

31. CHAPTER 7: ASSESSMENT FOR TREATMENT WITH METHADONE
7.1. Introduction
The previous chapter discussed factors that may indicate the suitability or non-suitability of patients
for Methadone treatment. This chapter follows on by discussing assessment of patients who present
for the treatment.
Good assessment is essential to the continuing care of the patient. Not only can it enable the
patient to become engaged in treatment but it can begin a process of change even before a full
assessment is complete. Assessment skills are vital for all members of the multidisciplinary team,
including counselors, nurses and doctors.
7.2. Goals of assessment
The goals of the medical assessment of a patient who is addicted to opioids are to
• Examine the client’s needs, and establish the diagnosis or diagnoses
• Determine their suitability for treatment, and an appropriate treatment plan.
• Formulate an initial treatment plan
• Ensure that there are no contraindications to the recommended treatments
• Assess other medical problems or conditions that need to be addressed during
early treatment
• Assess other psychiatric or psychosocial problems that need to be addressed
during early treatment
7.3. Recommendations:
• The clinicians must ensure that an adequate assessment has been made before
prescribing methadone
• No clinicians should feel pressurized into issuing substitute medication until he or she is
satisfied that an appropriate assessment has been completed.
• Initial assessment may take more than one consultation.
• When an assessment has been conducted, consideration needs to be given to the
possibility of the treatment of choice.
• Irrespective of the drug of misuse with which the patient presents, the same fundamental
aims of assessment apply.
• Concerned relatives or professionals already involved should be encouraged to attend
with the patient.
• Clinicians should have a significant role in health education regarding drug misuse, and
will find value in giving accurate information to minimise the harm of more persistent drug
taking and the risks of developing significant dependence.
31

32. Key features of the assessment
• Drug use history
Opioid use
-Opioids used, quantity, frequency, route of administration, duration of current
episode of use, time of last use and use in the last 3 days
- Severity of dependence
- Age of commencement, age of regular use, age of dependence, timing and duration of
periods of abstinence
- Episodes of overdose
Other drug use
including alcohol, illegal and prescribed drugs, current medications
• Health status
- Diseases from drug use (blood borne viruses, others)
- Intercurrent health conditions (psychiatric, general)
• Psychosocial status
- Legal
- Social – employment, education/vocational skills, housing, financial, family
- Psychological – mood, affect, cognition.
• Past treatment
- Where
- When
- Periods of abstinence
- Degrees of success/acceptance of treatment
• Selection of treatment
- Motivation for treatment
- Trigger for seeking treatment
- Patient goals for treatment episode
- Stage of change
• Physical examination
- Observation of clinical signs related to drug use (needle track marks, intoxication,
withdrawal
- Evidence of medical problems (eg liver disease – jaundice, ascites, encephalopathy).
• Investigations
- Urine drug screening tests may be indicated if there are concerns about the
accuracy of the drug history and diagnosis.
- Investigations for HIV and hepatitis B and C if indicated.
7.4. Drug Use History
The aim assessing drug use history is to elicit as accurately as possible something about
past and current drug-taking behaviour. This is best determined by taking a careful history,
documenting the extent and duration of drug use, and the extent to which it has influenced
the patient’s life.
It should cover the following areas:
32

33. Opioid use
- The age of starting drug use (including alcohol and nicotine), age of regular use,
age of dependence
- Types and quantities of drugs taken (including concomitant alcohol misuse)
- Frequency of use and routes of administration
- Time of last use and dose
- Duration of current use
- Severity of dependence (see Section 8 page 41, Appendix 7) Need to change
- Periods of abstinence. If yes, triggers for relapse.
- Symptoms experienced when unable to obtain their drugs.
- Cost of drug /alcohol misuse
- Experience of overdose
Other drug use
Similarly with other drugs, Including alcohol, illegal and prescribed drugs, current
medications
Assessing opioid intoxication and toxicity
- Assessment of intoxication with methadone and other drugs (see Appendix 1)
Signs and symptoms to look for / enquire about:
Intoxication Toxicity
Slurred speech Drowsiness
Unsteady gait Shallow breathing
Drowsiness Poor circulation
Pupil constriction Slow pulse
Conjunctival Lowered
injection temperature
Alcoholic foetor Nausea and
vomiting
Disinhibition Headache
Drooling Confusion
Dizziness
Itching/scratchin
g
* From NSW Methadone Maintenance Treatment Clinical Practice
Guidelines.
Assessing Opioid Withdrawal
- Assessment of withdrawal from commonly used drugs, may use the following
instruments:
Withdrawal States from Commonly Used Drugs (see Appendix 3)
The Subjective Opiate Withdrawal Scale (SOWS) (see Appendix 4)
33

34. The Objective Opiate Withdrawal Scale (OOWS) (see Appendix 5)
Or Clinical Opiate Withdrawal Scale (COWS) - see Appendix 6 (Need to
choose COWS)
7.5. Health Status
The aim of assessing health status is to ensure that the patient is fit to receive the treatment. It
will also provide clinicians with an indication of other treatment that patients may need to
receive or referred to before they are started on Methadone
Areas to assess are:
7.5.1. Medical history
- General medical presentstion
- Cardio, Respiratory
- Genital/urinary
- Gynacological
- Musculo-skeletal
- Neurological
- Gastro-intestinal
- Last cervical smear
- Operations, accidents, head injury
7.5.2. Injecting practice and risk of HIV and hepatitis transmission
- Past history
- Hepatitis B, C status if known
- HIV status if known
- Complications of drug use – abscesses, thrombosis, viral illnesses, chest
problems
- Current usage and why patient changed to injecting
- Supply of needles and syringes
- Injecting practice: sharing injection equipment/paraphernalia, how to inject
safely, clean equipment and dispose of used equipment.
- Knowledge of HIV/Hep B and C issues and transmission
- Has patient ever thought of/tried other methods of use?
7.5.3. Sexual behaviour
- Sexual partner(s)
- Knowledge of STD
- Safe sex practice, use of condom
7.5.4. Assessment of mental health
- Psychiatric admissions/outpatient attendance
- Any overdoses (accidental or deliberate)
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35. - Any previous episodes of depression or psychosis
- Treatment with any psychotropic or analgesics at any time
- Risk of suicide and self-harm.
- Drug of misuse often has a psychoactive component, e.g. can cause
hallucinations (cocaine), depression or anxiety, either during use or as part of
withdrawal.
- General behaviour: e.g. restlessness, anxiety, irritability can be caused by
either
- intoxication with stimulants or hallucinogens, or by withdrawal from opiates.
- Mood: depression can be caused by withdrawal from stimulants (eg.
amphetamine withdrawal) or by alcohol or sedative drugs. Assess the risk of
self-harm.
- Delusions and hallucinations: common with stimulant and hallucinogens use.
- Confusional states
- Referral to an addiction mental health specialist for a full mental health
assessment may be required before starting treatment for addiction.
7.6. Psychosocial Status
The aim of assessing psychosocial status is to determine if the patient has suitable social
support that will enable the him/her to adhere to the program. Strong family support may
decrease drop out. On the other hand should the patient live with a partner who is an alcohol
dependant, then clinicians should be aware of the possibility of disruption to the patient
whilst on methadone.
Areas to assess are;
7.6.1. Social history
- Family situation – especially children
- Employment situation
- Education/vocational skills
- Accommodation situation
- Financial situation, including debt
- Overall social and general welfare
- Local support networks.
7.6.2. Psychological
- Mood, affect, cognition
7.6.3. Legal implication
- Past and present contact with the criminal justice system
- Past custodial sentences
- Currently offending
- Outstanding charges
7.6.4. Other
- Drug and alcohol misuse in partner, spouse and other family members
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36. - Impact of drug misuse on other aspects of the patient’s life
7.7. Past Treatment
The aim of assessing past treatment is to determine the patients resolve to seek treatment and
also to assess clients adherence to treatment programs and regimes. If client has tried other
treatment methods, this may indicate that he/she are serious to be in treatment. By knowing if
they have managed to complete other treatment regime, clinicians are able to assess clients
adherence to the methadone program.
It should cover the following areas;
• History of prior episodes of treatment for dependence, where, when
• Previous efforts to reduce or stop taking drugs: when, how, where, duration
• Degrees of success/acceptance of treatment
• Contact with other doctors, social services, community services
• Previous rehabilitation admissions, how long they lasted and the cause of any
relapses
7.8. Assessing Patients Motivation and reasons
It is clear that motivated clients are more likely to adhere and complete the treatment that are
offered to them. Clients who are resolved to improving their quality of health are also often
more successful. This is in contrast to clients who have been forced into treatment by family
or community.
Areas to assess are;
7.8.1. Assessing motivation
Is the drug user motivated to stop or change their pattern of drug use or to
make other changes in their life? Here you may need to encourage realism
and what short, intermediate and long-term goals the patient seeks. There is
motivation to make changes in other parts of life e.g. personal relationships,
accommodation and employment.
7.8.2. Reasons for seeking treatment
- In crisis
- Impending court case/in prison
- Referred from court
- On the recommendation of the court or a social worker
- Want information and advice about the effects of the drug they are
taking
- Have had a recent health risk or have anxieties over their drug taking
- Their behaviour is causing concern to others e.g. may have been
brought along by a concerned parent, or friends
- Suffering from mental illness
- Pregnant
- Want help with their drug misuse and motivated to change behaviour
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37. - Had enough or usual source of drugs no longer available
- Referred from another medical practitioner
7.9. Physical Examination
A physical examination is an important component of assessment. For example the
presence of needle track marks, and signs of intoxication or withdrawal are helpful in
establishing opioid dependence and its complications. Physical examination can also inform
the doctor about other treatment that patients may require and therefore may affect
methadone treatment.
Areas to assess are:
7.9.1. Assessing general health
• Evidence of medical problems (eg liver disease – jaundice, ascites,
encephalopathy).
(See Appendix 9)
7.9.2. Common co-morbid medical conditions
• Evidence of chronic diseases that require treatment such as diabetes and
hypertension.
• During the course of a medical history and physical examination, the possible
existence of these conditions should be evaluated. Refer to Appendix 9 for a
detailed list of selected medical disorders delated to drug and alcohol use.
7.9.3. Infectious diseases
• Evidence of HIV, Hep C or Hep B
• Offer hepatitis B vaccination if the patient is not immune and advise Hep C
carriers about the risks of blood to bllod transmission and its
prevention
• Evidence of Tuberculosis
7.9.4. Other conditions include:
• nutritional deficiencies and anemia caused by poor eating habits;
• chronic obstructive pulmonary disease secondary to cigarette smoking;
• impaired hepatic function or moderately elevated liver enzymes from various
forms of chronic hepatitis (particularly hepatitis B and C) and alcohol
consumption;
• cirrhosis,
• neuropathies
• cardiomyopathy secondary to alcohol dependence.
7.10. Investigations
An appropriate test for illicit drug use should be administered as part of patient assessment
for methadone treatment. Clinicians should explain the role of drug testing at the beginning
of treatment for addiction.
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38. Before any test, full informed consent should be obtained from the patient, and appropriate
counseling should be provided for certain infectious diseases (e.g., HIV, hepatitis C).
Abnormalities or medical problems detected by laboratory evaluation should be addressed
as they would be for patients who are not addicted.
7.10.1. Urine assessment
Urine analysis should be regarded as an adjunct to the history and examination in
confirming drug use, and should be obtained at the outset of prescribing and
randomly throughout treatment. Results should always be interpreted in the light of
clinical findings, as false negatives and positives can occur.
If the drug user is dependent, opiates persist in the urine for up to 24 hours
(methadone up to 48 hours). Approximate drug detection times in urine are shown
below in Appendix 6.
A negative test does not necessarily mean that the patient is not using an opioid. It
may mean that the patient has not used an opioid within a period of time sufficient to
produce measurable metabolic products or that the patient was not using the drug for
which he or she was tested.
As with any patient, the clinician is alerted to a spectrum of possibilities and works
with the patient using the information collected from the toxicology screen.
Toxicology testing for drugs of abuse that takes place at scheduled visits cannot be
truly random; nevertheless, it is clinically worthwhile.
7.11. Suitability for Methadone Treatment
A patient to be a suitable candidate for methadone treatment:
• The person has an objectively diagnosis of opioid dependence
• Express of interest in the methadone treatment
• No contraindication (i.e. known hypersensitivity) to methadone
• Willingness of participating with the treatment and to follow safety precautions of the
treatment
• Understanding of the process, the risks and benefits of methadone treatment
• Agree to treatment after a review of treatment options
A patient is less likely suitable candidate for methadone treatment:
• Dependence on benzodiazepines and/or other depressant substances (including
alcohol)
• Severe mental health issues: eg. significant psychiatric disorders; active or chronic
suicidal or homicidal
• Significant medical complications
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39. • Conditions that are outside the area of the treating clinician’s expertise
7.12. Effective Assessment
7.12.1. Attitute of the clinicians
7.12.2. Effective Questionaire
7.12.3. Appropriate time of assessment
7.12.1. Attitude of the clinician
The attitude of the clinician is very important for an effective assessment of patients who
have an addiction. Patients are often hesitant or reluctant to disclose their drug use or
problems. Patients who are addicted report discomfort, shame, fear, distrust, hopelessness,
and the desire to continue using drugs as reasons they do not discuss addiction openly with
their clinicians.
Clinicians need to approach patients who have an addiction in an honest, respectful, just as
they would approach patients with any other medical illness or problem.
A clinician has responsibility to deal appropriately with his or her own attitudes and emotional
reactions to a patient. For evaluation to be effective, personal biases and opinions about
drug use, and other emotionally laden issues must be set aside or dealt with openly and
therapeutically.
Suggested elements which improve an effective assessment:
• Ability to establish a helping
alliance
• Good interpersonal skills
• Non-possessive warmth
• Friendliness
• Genuineness
• Respect
• Affirmation
• Empathy
• Supportive style
• Patient-centered approach
• Reflective listening
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40. 7.12.2. Establishing and defining a therapeutic relationship
The initial assessment has been described as the most important component of
methadone treatment, as it is the time when patient and clinician establish a
therapeutic relationship.
It is important to demonstrate an accepting, non-judgmental approach to patients,
being neither authoritarian nor overly intrusive.
For the prospective patient, the assessment interview is often a time of great
vulnerability and expectation. The decision to seek methadone treatment is frequently
taken at a time of crisis. Many patients feel ambivalent about methadone maintenance,
and entering treatment may be marked by a sense of failure and guilt.
Despite this ambivalence, patients usually appear preoccupied with whether and when
they will be allowed to receive methadone. Such focusing on access to the drug is
characteristic of drug dependence.
Unless this issue is dealt with fairly early in the interview, it is difficult to establish any
rapport. Once opioid dependence is confirmed, the patient can be reassured about
their eligibility for methadone and issues such as treatment alternatives, side effects of
methadone and program rules and procedures can be discussed more meaningfully.
At the initial interview, in order to ensure their access to methadone, some patients will
say whatever they think their doctor wants to hear. For this reason, it is not often
appropriate to set specific treatment goals at the initial interview, as patients tend to
nominate unrealistic expectations of what they will achieve from treatment.
Assessment is an ongoing process, and gaining a psychosocial history from the
patient does not stop at the first interview. The assessment interview is also the time
for setting the ground rules.
7.12.3. Questionnaires
Most patients are willing and able to provide reliable, factual information regarding their
drug use.
Questions should be asked in a direct and straightforward manner, using simple
language and avoiding street terms.
Utilising open-ended questions will elicit more information than simple, closed-ended,
“yes” or “no” or single-answer questions, examples:
• How has heroin use affected your life?
• How has heroin affected your life?
• In the past, what factors have helped you stop using?
• What specific concerns do you have today?
• How often do you use heroin?
• When was the last time you were using heroin?
• How many times did you use last month?