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Methadone Clinical Guidelines



Pedoman Klinis Program Terapi Rumatan Metadon (PTRM)

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    Methadone Clinical Guidelines Methadone Clinical Guidelines Document Transcript

    • INTRODUCTIONESSENTIALS OF METHADONE PRESCRININGCHAPTER 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 OptionsCHAPTER 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 PreventionCHAPTER 3: THE TREATMENT SETTING Organisational Structure The treatment Team The roles, rights and responsibilities of health care provides The monitoring GroupCHAPTER 4: CLINICAL PHARMACOLOGY General Opioid Pharmacology Methadone PharmacologyCHAPTER 5: PRESCRIBING METHADONE Legal requirements for prescribing methadone Principles and process of methadone prescribing Procedure checklist for a methadone clinicCHAPTER 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 FlowCHAPTER 7: ASSESSMENT FOR TREATMENT WITH METHADONECHAPTER 8: DOSINGCHAPTER 9: METHADONE OVERDOSE .......................CHAPTER 10: DELIVERING EFFECTIVE METHADONE TREATMENTCHAPTER 11: MANAGEMENT OF SPECIAL CLIENT GROUPCHAPTER 12: PREVENTING RELAPSE 1
    • CHAPTER 1: ILLEGAL OPIOID USE AND RELATED HARM1.1. IntroductionThis Chapter gives an overview of the issues related to drug use and HIV/AIDS. It alsospecifically discussed drug dependence and opioid dependence and offers andunderstanding of the various approaches to treatment that is available.1.2. The harms related with Illegal Drug UseOpioid dependence and injecting drug use is a serious problem in at least 138 countries in theworld. 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 tospread and appears to be an increasing burden, mainly in developing countries with additionalhealth and social problems. There is a need to develop a broad range of community basedtreatment 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 furtherunderscores 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 druguse, 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 VietnamIn 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 ofdrug users in Vietnam but the Government maintains records on the number of registered drugusers, based primarily on reports of the police and drug treatment centres. In 1996 there were69,195 users registered, but at the end of 2002 the number of drug addicts in whole country is 2
    • 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 andpresent a major concern for transmission of HIV (UNODC RC 2004). Heroin use with high-riskinjecting practices and the spread of HIV/AIDS among IDUs and the subsequent HIV/AIDStransmissions 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 ofLabor, Invalids and Social Affairs (MOLISA) reported that by November 2003, over 82% of drugusers had injected an illicit drug at least once. In addition, approximately 30% of the country’s drugusers were using intravenous (IV) methods and the sharing of needles/syringes and other druginjecting equipment was becoming increasingly common. The behaviour of IDUs who have beeninfected with HIV is of great concern of healthcare professionals. In some provinces, 64% to 88% ofpeople living with AIDS are IDUs, and among them 55% to 61% share needles (Tran, 2003). TheMinistry of Health (MOH) believes that this has led to a sharp increase in the incidence of HIV/AIDSamong 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 theepidemic appears to be concentrated among those injecting drugs, those involved in sex work, andthose with other sexual infections (NASB 2001). Between 11% and 57% of IDUs had sex with sexworkers, and an increasing number of sex workers report injecting drugs. Such risk takingbehaviours 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 manyprovinces and cities has HIV/AIDS cases in every its district and ward (NSEB VN 2004). The HIVinfection cases has been increasing rapidly (1 - 2%) among pregnant women in Hai Phong, QuangNinh and An Giang (NSEB VN 2004) 1.4 DRUG DEPENDENCE AND OPIOID DEPENDENCE1.4.1. 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 donot use enough drugs to be constantly neuro-adapted, and many others still may never becomeneuro-adapted. However, drug users from both these groups may exhibit other features of drug 3
    • dependence. Conversely, many people taking high doses of psychoactive drugs (eg cancer patientstaking morphine) are neuro-adapted to the drug but do not exhibit other features of dependence.1.4.2. Opioid DependenceWhat 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, causingrespiratory 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 otherdrugs. Opioid dependence is a neurobehavioral syndrome characterized by the repeated,compulsive seeking or use of an opioid despite adverse social, psychological, and/or physicalconsequences. Using daily or almost every day over a period of time leads to certain physical (thebody) and psychological (the mind and emotions) changes.Physically, the body adapts or ‘gets used to’ having heroin on a regular basis. Eventually the drugis 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 (orbelieve) it is causing them difficulties - perhaps financial or legal worries, relationship problems,work difficulties, physical health problems and psychological problems such as depression andanxiety. 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). Opioiddependence is an ongoing and relapsing condition. Like many other chronic conditions, forexample, 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 andavailability of opioids, family and peer influences, sociocultural environment, personality, andexisting psychiatric disorders. Genetic heritage appears to influence susceptibility to alcoholaddiction and, possibly, addiction to tobacco and other drugs as well (Goldstein A & HerreraJ,1995).1.5.Treatment Approaches and OptionsOne of the aims in treating dependent patients is to return to them a greater degree of autonomyand flexibility in their lives. There is no single effective treatment for the management of opioiddependence, however current evidence indicates that a broad range of treatment options cansubstantially impact on the course of opioid dependence.For long-term reductions in heroin use, a treatment program needs to deal with the psychologicaland social aspects of dependence, that is, the reasons for using heroin and the lifestyle that goes 4
    • with it. This will involve combining methods, that include detoxification, outpatient programs,therapeutic communities, self-help groups, and substitution treatment. The current options for opioiddependence treatment, their benefits and considerations can be summarized in the following table:Table 1: Benefits and considerations of selected treatment approach: APPROACH BENEFITS CONSIDERATIONSDetoxification 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 attendSubstitution treatment with stop heroin use clinic/pharmacy regularly formethadone - 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 buprenorphineNaltrexone 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 toleranceTherapeutic 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 5
    • - provides high level of recommended people attend at leastSelf-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 drugsCounselling - 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 6
    • CHAPTER 2: FRAMEWORK FOR TREATING OPIOID DEPENDENCE2.1. Introduction:Following chapter one, this section will discuss specifically about the philosophy, rational andobjectives of Methadone Treatment. Research findings on methadone treatments and guidelines forhazard prevention are also provided in this chapter.2.2. Philosophy of Methadone TreatmentThe 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 methadone2.3.1. The costs of illicit drug use to the individual and communityThe 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 TreatmentThe combination of physical, psychological and social dimensions makes opioid dependence acomplex condition. For opioid dependence to be successfully overcome, it is usually necessary toaddress 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. Thepredominant 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 indrug users achieving a drug-free lifestyle. Abstinence is an important long-term goal, but thisviewpoint of treatment does not adequately reflect the complexities of drug dependence, or theextended treatment period required by some people. Furthermore, an emphasis solely onabstinence to some extent devalues the other achievements that can be made through treatment. 7
    • Evidence indicates that it is appropriate and necessary for treatment programmes, and forindividuals 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 treatmentHeroin 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 betweenintoxication and withdrawal states.Methadone maintenance is a medical treatment for opioid addiction. Methadone therapeuticallysubstitutes 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 issuccessful in reducing illegal drug use and needle sharing, reducing patients’ involvement in crimeand helping to improve their health and social functioning.2.4. Methadone Treatment ApproachesIndividual clients will differ in their needs and their needs are likely to change during the course ofmethadone treatment. The level of supervision and intervention and the nature of treatmentappropriate for each client should be based on an assessment of their needs including reference tothe client’s current objectives in undertaking treatment, any relevant medical or psychiatric co-morbidity, and the nature of their drug use. 8
    • Where a high intervention approach is considered appropriate, it might include, in addition to theprovision of methadone, a high level of medical and casework intervention (such as contingencycontracting, motivational interviewing, relapse prevention and harm reduction counseling) as well asaccess to crisis care, welfare advice and support, social skills training, vocational advice andtraining and aftercare (following completion of methadone treatment).For all clients, total drug abstinence is only one of a range of treatment objectives although thisoutcome may, nonetheless, be achieved during the course of treatment.2.4.1.Evidence-based approach to careIn a substantial proportion of patients, drug misuse tends to improve with time and age, particularlywhen specific treatment and rehabilitation techniques are used.There is also increasing evidence that treatment (medical and social) is effective in maintaining thehealth of the individual and promoting the process of recovery.Studies of self-recovery by drug users have shown that access to formal welfare supports, togetherwith encouragement from friends, partners, children, parents and other significant individuals, iscommonly involved in the pathway out of addiction.Treatment studies do not support the view that a drug user has to reach ‘rock-bottom’ before beingmotivated to change.Harm minimisation refers to the reduction of various forms of harm related to drug misuse, includinghealth, 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 TreatmentThe goals of methadone treatment are to reduce the health, social and economic harms toindividuals 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 9
    • • 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 familiesThe objectives of methadone treatment need to be tailored to the particular strengths andweaknesses of each individual. For some severely dependent and dysfunctional individuals, verymodest goals of treatment may be appropriate, such as trying to reduce their injecting drug use, ormerely ensuring that they have access to clean needles and syringes. For other people with skillsand supports, goals such as abstinence from heroin and a return to employment may be moreappropriate goals.2.6. Research Findings regarding Methadone TreatmentMethadone maintenance is a maintenance intervention. It is not a time-limited treatment. Any notionof methadone maintenance as an effective time-limited treatment with the expectation of ‘cure’ isnot supported by the research literature. Research suggests that not all methadone programs areequally effective. The following factors have been found to be associated with better outcomes formethadone 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. 10
    • 2.7. The Benefits of TreatmentThe 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 parentingIn 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 TreatmentFactors 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 11
    • 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 PreventionThere are hazards associated with methadone treatment including overdose, accidental poisoningof someone for whom methadone is not prescribed, and the illegal diversion of and trafficking inmethadone. The following are general guidelines to minimise the hazards associated withmethadone 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 eliminateconsumption of illegal drugs is one of the most critical and divisive issues in methadonemaintenance treatment. The goal of eliminating all illegal drug use, especially in the first few monthsof treatment, is unrealistic and very likely to impede treatment progress and patient–clinicianrapport. 12
    • CHAPTER 3: THE TREATMENT SETTING3.1. Introduction:This chapter is provides information and guidelines for the clinic/agency/site that provides theMethadone Treatment. The key individuals involved in the Treatment Team, their roles andresponsibilities are suggested. However, it is important that before the start of the program, suchissues are discussed by the team once again in their own setting and changes to the roles agreed andaccepted by all concerned. This chapter also provides a checklist for the Methadone Clinic for itspreparation to start treatment.3.2. Organisational StructureInsert chart here3.3. The Treatment TeamThe Treatment Team at the Hai Phong Methadone program will include the following individuals: i. Doctor as Prescriber ii. Nurses iii. Methadone dispensers – 2 iv. Counsellors3.4. 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 13
    • • 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 patients3.5. Supervision and Monitoring groupProgress toward the ideal pattern and delivery of shared care in any area will inevitably beincremental and will rely on developing good communication, understanding and trust between allthe individuals and services involved. The development and management of shared care practice isa 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 tothe 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 serviceprovision in the methadone service.The monitoring group should comprise the Director of Public Health (or deputy), representativesfrom 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. 14
    • 3.6. Checklist for a Methadone Treatment Clinic3.6.1. Support Services: • Security Officers • Cleaners • Volunteers • Peer Educators3.6.2. 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 services3.6.3. 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 15
    • CHAPTER 4: CLINICAL PHARMACOLOGY4.1. IntroductionFamiliarity with the characteristics of methadone pharmacology is necessary for the safe andeffective use of this drug. Prescribers need to be aware of the slow onset of peak blood levels andlong half life of methadone to ensure that it is safely used by patients. This chapter will discuss indetail methadone pharmacology. For background reading in regards to general opioidpharmacology, please refer to the Training Handouts which should accompany this clinicalguideline.4.2. CLINICAL PHARMACOLOGY OF METHADONE4.2.1. 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 sweatingPeople commencing on methadone are usually tolerant to the above effects because of theirprolonged 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 sufficienttolerance is developed such that cognitive skills and attention are not impaired. They are able todrive cars safely. 16
    • 4.2.2. Side EffectsSide 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 gainDiscontinuing methadone, especially abruptly, results in a prolonged and symptomatically troublingwithdrawal syndrome.Table 2: Common Adverse Effects Side Effect Common Causes ResponseDrowsiness after dose Excessive dose Review and maybe reduce dose Use of other CNS depressants Reduce patients 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 necessaryDental 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. patients salt intake. Decreased activity. Review and change patients 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 patients general sleep hygiene.Lowered libido Higher doses. Review dose. Psychological or social/ Check patients history and situational problems consider counseling.Sweating Methadone Antiperspirants SSRIs Weight loss Weight gain/decreased Gradual increase exercise 17
    • fitnessInfertility Methadone Check hormone levels Cachexia Consider hormone replacement Hypothalamic suppression Counsel patience Hypreprolactinaemia4.2.3. PharmacokineticsMethadone is well absorbed after oral administration. There is wide individual variability in thepharmacokinetics of methadone but in general, blood levels rise for about 3-4 hours followingingestion of oral methadone and then begin to fall. Onset of effects occurs approximately 30minutes after ingestion. The apparent half life of a single first dose is 12 – 18 hours with a mean of15 hours. With ongoing dosing, the half life of methadone is extended to between 13 and 47 hourswith a mean of 24 hours. This prolonged half life contributes to the fact that methadone blood levelscontinue 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 (wheredrug elimination equals the rate of drug administration) after a period equivalent to 4-5 half lives orapproximately 3-10 days. Once stabilisation has been achieved, variations in blood concentrationlevels 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-dosinginterval. 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
    • Peak effects Approx 3 hours ---------------------------------------------------------------------------------------------- Half life (in MMT) Approx 24 hours ---------------------------------------------------------------------------------------------- Time to reach stabilisation 3-10 days ----------------------------------------------------------------------------------------------4.2.4. MetabolismMethadone is extensively metabolised in the liver to active metabolites. Certain drugs are known toenhance methadone metabolism by inducing liver enzyme. See below for drug–methadoneinteractions.4.2.5. ExcretionAlthough methadone and metabolites are excreted in the urine, it is primarily metabolised by theliver. Increases in urinary pH can increase methadone clearance slightly. Patients with chronic renalfailure on dialysis do not accumulate methadone, and achieve similar blood levels for a given doseto patients with normal renal function.4.2.6. Methadone withdrawalThe 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 insomniaThis first, or acute, phase of withdrawal may then be followed by a period of protracted withdrawalsyndrome. 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 isdifficult for most people. Untreated methadone withdrawal symptoms may be perceived as moreunpleasant than heroin withdrawal, reflecting the more prolonged nature of methadone withdrawal. 19
    • Factors that have been identified as having the potential to influence the severity of withdrawal include theduration of opioid use, general physical health, and psychological factors, such as the reasons for undertakingwithdrawal and fear of withdrawal.4.2.7. Methadone intoxicationThe signs and symptoms of the methadone intoxication include • Stupor, coma • Pinpoint pupils • Hypotermia • Bradycardia • Hypotention • Hypoventilation • Cool moist skin • Pulmonary oedema • Death from respiratory depression4.2.8. Effects of Chronic administrationThe effects of the chronic administration of methadone often show: - Sleep disturbance - Teeth problems (reduced saliva) - Reduced libido - Lethargy - Excessive sweating - Constipation4.2.9. Drug interactionsToxicity and death have resulted from interactions between methadone and other drugs. Somepsychotropic drugs may increase the actions of methadone because they have overlapping, additiveeffects (e.g. benzodiazepines and alcohol add to the respiratory depressant effects of methadone).Other drugs interact with methadone by influencing (increasing or decreasing) metabolism. Drugsthat induce the metabolism of methadone can cause a withdrawal syndrome if administered topatients maintained on methadone. These drugs should be avoided in methadone patients ifpossible. If a cytochrome P450 inducing drug is clinically indicated for the treatment of anothercondition seek specialist advice. Cytochrome P450-3A inhibitors can decrease the metabolism ofmethadone and cause overdose. ***A full list of drug interaction between Methadone and other drugs: see Appendix 24.2.10. SafetyThe long term side effects of methadone taken orally in controlled doses are few. Methadone doesnot cause damage to any of the major organs or systems of the body and those side effects whichdo occur are considerably less harmful than the risks of alcohol, tobacco and illicit opiate use. The 20
    • major hazard associated with methadone is the risk of overdose. This risk is particularly high at thetime 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 highlydeceptive 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. FormulationsOne 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
    • CHAPTER 5: PRESCRIBING OF METHADONEQUALIFICATIONSTo 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 programTHE PRINCIPLES AND PROCESS OF METHADONE PRESCRIBINGSee 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 prescribing1. It is the responsibility of all doctors to provide care for general health needs and drug related problems. 22
    • 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 processThe responsibility of prescribingPrescribing is the particular responsibility of the doctor signing the prescription. The responsibilitycannot 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 (unlessotherwise stated) the range of dosages that are generally regarded as being suitable for treatingadults who have become opioid dependent.Deciding whether to prescribeBefore deciding whether to prescribe, the doctor should be clear as to what the functions of aprescription 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
    • - 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 goalsBefore 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 realisticgoals 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 weexpand this to say, doctors should record this in the clients case notes and review throughout theperiod of treatment – it is good practice to review this every 2-3 month?) (YES)PrescriptionThe 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 keepingThere should be clear and concise notes, properly signed, named and dated. A separate structuredsheet for recording prescribing must be kept. A patient-held record, countersigned by those involvedin 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 shouldideally be seen on each occasion by the prescribing doctor or an informed colleague.DispensingThe basic arrangements for effective supervised dosing are as follows:- Wherever possible, liaise with the dispensers about the specific patient and the prescribing regimen. 24
    • - 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 diversionTo minimise further the risk of inappropriate diversion onto the illicit drugs market, doctors andhealth 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 ofitems such as these. (refer to safety and storage of methadone at site?) *** YESEnding a failing treatmentThe decision to end a failing treatment should not be taken lightly, and should ideally be part of atreatment plan agreed with the patient. However, if a patient receiving treatment for drug use fails tocomply with that treatment, and consistently fails to make progress towards agreed and reasonablegoals, 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 treatmentcontact will cease.Due notice should be given of a reduction regime. Suggestions for referral for further assessmentwith local specialist services, to consider other treatment options and arrangements, will mean thepatient still has access to general medical care.(also refer to another section on withdrawal from Methadone?) 25
    • CHAPTER 6: ENTRY INTO METHADONE MAINTENANCE TREATMENT6.1. IntroductionThis chapter will provide guidelines on inclusion and exclusion criteria for patients to be admittedinto the treatment program. A section has also been developed to caution service providers aboutproblematic patients. This Chapter is developed to assist service providers in selection ofparticipants 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 thetime of presentation: 26
    • • 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 consequences6.3. Contraindications for Methadone Treatment & Exclusion CriteriaThe 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 cases6.4. Priority for entry into TreatmentThe 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
    • 6.5. PrecautionsParticular caution should be exercised by prescribers when assessing individuals with the followingclinical conditions as to their suitability and safety for treatment with methadone. Concomitantmedical and psychiatric problems and other drug use increase the complexity of management ofpatients on MMT and may also increase the risk of overdose and death. The prescribing doctorshould 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 problemsA significant proportion of methadone related deaths involve individuals who were in poor healthand had other diseases (particularly hepatitis, HIV and other infections), which may havecontributed to their death. This emphasises the importance of giving consideration to concomitantmedical problems. - Head injury and increased intracranial pressure: This is generally seen only in the hospital emergency setting 28
    • - 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 problems6.6. RegistrationThe Ministry of Health of Vietnam should establish and maintain a register of all heroin addictedpeople who are registered for methadone maintenance treatment at any of the sites that provide thistreatment in Hai Phong. This is to prevent anyone registering for treatment at more than one siteand also to prevent people using aliases.The registration process for patients eligible to enrol in the pilot methadone treatment programscould be based upon the information requirements used in other countries plus the unique identifierthat is the identity card that all Vietnamese nationals carry. Necessary consents for treatment needsto be sought by the clinicians prior to commencement of the methadone treatment program. Changeto seeking authority6.6. Clients’ Rights and ResponsibilitiesLegally competent clients have a common law right to make their own decisions about medicaltreatment 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
    • - 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 InformationThe clinician is responsible for providing each client at his or her level of comprehension, withsufficient 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 cantake away. It is important that this information is repeated and that client’s questions are answeredthroughout the induction period and after they are established in treatment.Obtain informed consent to methadone treatment in writing from the patient before commencingtreatment. 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 informationabout: • 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 stagesof treatment, after an increase in dose, or when patients are also taking other drugs. Warn patientsabout this effect before entry into treatment, when the dose of methadone is increased, or when theuse of other drugs is suspected.Patient information resources are available which can be provided to patients or a program specificpatient information booklet can be prepared (see Methadone Handbook for clients). 30
    • CHAPTER 7: ASSESSMENT FOR TREATMENT WITH METHADONE7.1. IntroductionThe previous chapter discussed factors that may indicate the suitability or non-suitability of patientsfor Methadone treatment. This chapter follows on by discussing assessment of patients who presentfor the treatment.Good assessment is essential to the continuing care of the patient. Not only can it enable thepatient to become engaged in treatment but it can begin a process of change even before a fullassessment is complete. Assessment skills are vital for all members of the multidisciplinary team,including counselors, nurses and doctors.7.2. Goals of assessmentThe 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 treatment7.3. 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
    • Key features of the assessment• Drug use historyOpioid 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 overdoseOther drug useincluding 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 HistoryThe aim assessing drug use history is to elicit as accurately as possible something aboutpast 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 influencedthe patient’s life.It should cover the following areas: 32
    • 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 overdoseOther drug useSimilarly with other drugs, Including alcohol, illegal and prescribed drugs, currentmedicationsAssessing 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 PracticeGuidelines.Assessing Opioid Withdrawal- Assessment of withdrawal from commonly used drugs, may use the followinginstruments:Withdrawal States from Commonly Used Drugs (see Appendix 3)The Subjective Opiate Withdrawal Scale (SOWS) (see Appendix 4) 33
    • 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 StatusThe aim of assessing health status is to ensure that the patient is fit to receive the treatment. Itwill also provide clinicians with an indication of other treatment that patients may need toreceive or referred to before they are started on MethadoneAreas 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) 34
    • - 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 StatusThe aim of assessing psychosocial status is to determine if the patient has suitable socialsupport that will enable the him/her to adhere to the program. Strong family support maydecrease drop out. On the other hand should the patient live with a partner who is an alcoholdependant, then clinicians should be aware of the possibility of disruption to the patientwhilst 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 35
    • - Impact of drug misuse on other aspects of the patient’s life7.7. Past TreatmentThe aim of assessing past treatment is to determine the patients resolve to seek treatment andalso to assess clients adherence to treatment programs and regimes. If client has tried othertreatment methods, this may indicate that he/she are serious to be in treatment. By knowing ifthey have managed to complete other treatment regime, clinicians are able to assess clientsadherence 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 relapses7.8. Assessing Patients Motivation and reasonsIt is clear that motivated clients are more likely to adhere and complete the treatment that areoffered to them. Clients who are resolved to improving their quality of health are also oftenmore successful. This is in contrast to clients who have been forced into treatment by familyor 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 36
    • - Had enough or usual source of drugs no longer available - Referred from another medical practitioner7.9. Physical ExaminationA physical examination is an important component of assessment. For example thepresence of needle track marks, and signs of intoxication or withdrawal are helpful inestablishing opioid dependence and its complications. Physical examination can also informthe doctor about other treatment that patients may require and therefore may affectmethadone 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. InvestigationsAn appropriate test for illicit drug use should be administered as part of patient assessmentfor methadone treatment. Clinicians should explain the role of drug testing at the beginningof treatment for addiction. 37
    • 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 TreatmentA 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 optionsA 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 38
    • • Conditions that are outside the area of the treating clinician’s expertise7.12. 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 39
    • 7.12.2. Establishing and defining a therapeutic relationshipThe initial assessment has been described as the most important component ofmethadone treatment, as it is the time when patient and clinician establish atherapeutic 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 greatvulnerability and expectation. The decision to seek methadone treatment is frequentlytaken 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 whenthey will be allowed to receive methadone. Such focusing on access to the drug ischaracteristic of drug dependence.Unless this issue is dealt with fairly early in the interview, it is difficult to establish anyrapport. Once opioid dependence is confirmed, the patient can be reassured abouttheir eligibility for methadone and issues such as treatment alternatives, side effects ofmethadone and program rules and procedures can be discussed more meaningfully.At the initial interview, in order to ensure their access to methadone, some patients willsay whatever they think their doctor wants to hear. For this reason, it is not oftenappropriate to set specific treatment goals at the initial interview, as patients tend tonominate unrealistic expectations of what they will achieve from treatment.Assessment is an ongoing process, and gaining a psychosocial history from thepatient does not stop at the first interview. The assessment interview is also the timefor setting the ground rules.7.12.3. QuestionnairesMost patients are willing and able to provide reliable, factual information regarding theirdrug use.Questions should be asked in a direct and straightforward manner, using simplelanguage 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?
    • 7.12.4. Choosing the appropriate time for assessment In general, at assessment or in the first weeks of treatment, a methadone prescriber should ensure that physical health and psychological functioning have been assessed, either by themselves or by referral. Specific screening for HIV, Hepatitis B and C and for psychiatric illness is recommended. Some of these issues may be dealt with at the assessment interview, while others may be more appropriately attended to once the patient has been stabilised on methadone.7.13. Documentation and recordsThroughout treatment, it is important to maintain clear, concise and useful medicalrecords, which may include an identification form for each patient. Documentation shouldinclude: • personal details (including verification of identity ) • social and family situation • drug use history (including alcohol, illegal and prescribed drugs, current medications) • history of prior drug and alcohol treatment • other evidence of dependence • medical history, including psychiatric illness • mental state examination, signs of intoxication or withdrawal, presence of needle tracks • general physical examination • evidence of organic or psychiatric disease • management plan, including investigations.This information should be recorded on the Methadone Assessment Procedure forms(see Appendix 9).7.14. Reporting to the Regional Drug Misuse DatabasesAll clinicians who treat drug users for their problem drug misuse should provideinformation on a standard form to their local Regional Drug Misuse Database at the HaiPhong Provincial Health Services. Copies of the forms are available from the Databasemanager.A report to the Drug Misuse Database should be made when a patient first presents witha drug problem or re-presents after a gap of six months or more. All types of problemdrug misuse should be reported e.g. opiate, benzodiazepine, stimulant. The Drug Misuse Databases is the local source of epidemiological data on people presenting to services for problem drug misuse, and as such provide valuable information to those working with, and those planning, services for drug misusers. Information on all drugs of misuse is obtained.
    • CHAPTER 8: DOSING8.1. IntroductionHaving established the suitability of a patient for methadone treatment and registeredhim/her as a patient, an initial dose should be decided after careful assessment has beendone. Following the initial dose the clinicians are tasked with ensuring the right doseincrease is also carried out. This Chapter will guide clinicians in determining the rightdose for clients at various stages of treatment. Guidelines are also provided for situationswhen clients miss their doses and when a wrong dose is administered to patients.8.2. Induction to Methadone TreatmentObjectives during induction to methadone are to retain individuals in treatment byreducing the signs and symptoms of withdrawal and to ensure their safety.To achieve this clinicians should: • Carefully explain the intoxicating effects and withdrawal during the induction • establish a therapeutic relationship with patients to enable open discussions • Dose safely and carefuly • repeatedly observe patients. • clearly explain that it takes time to complete induction onto methadone and that patients will experience increasing effects from methadone over the first few days of treatment even if the dose is not increased.While doses of methadone which are too high can result in toxicity and death,inadequate commencement doses may cause patients experiencing withdrawalsymptoms to “top up” the prescribed dose of methadone with heroin, benzodiazepines orillicit methadone. This can also have potentially lethal consequences.An initial dose should usually be 20-30mg per day. It is unusual for patients to requiredoses higher than 30 mg, though patient review may show evidence of opioid withdrawalduring the first few days. Factors Determining the Initial Dose • The degree of tolerance to opioids • Concurrent medical conditions including impaired hepatic function • The time since the patients last drug use • The patient’s state of withdrawal or intoxication • The perceived likelihood of the patrients misuse of other drugs • The patient’s weight For most patients withdrawal symptoms will be alleviated but not entirely eliminated by doses less than 30mg.
    • 8.2.1. Size of first Dose and Preventing Deaths during InductionThe first dose of methadone should be determined for each patient based on theseverity of dependence and level of tolerance to opioids. • The history of quantity, frequency and route of administration of opioids, findings on examination, corroborative history and urine testing together provide an indication of the level of tolerance a patient has to opioids, but do not predict it with certainty. • A defined period of observation for signs and symptoms of opioid toxicity and withdrawal is a more accurate method of assessing opioid tolerance than history alone. In circumstances where there is doubt about the degree of tolerance, a review of the patient at a time when withdrawal symptoms are being experienced may help to resolve uncertainty about a safe starting dose. • Prescribers should make every effort to communicate with other practitioners who may have seen the patient previously in order to corroborate significant elements of the patient’s history and to assist in decision making about commencing treatment. • Deaths in the first two weeks have been associated with doses in the range 25-100 mg/day, with most occurring at doses of 40-60 mg/day. • Deaths during the induction phase of methadone treatment have been related to:  Concomitant use of other drugs (particularly sedatives such as alcohol and benzodiazepines);  Inadequate assessment of tolerance;  Commencement on doses that are too high for the level of tolerance;  Lack of understanding of the cumulative effect of methadone;  Inadequate observation and supervision of dosing;  Individual variation in metabolism of methadone. • If possible, patients should be observed 3-4 hours after the first dose (ie. at the time of peak effect) for signs of toxicity or withdrawal. (See Appendices 1 & 3) • If the patient is experiencing persistent withdrawal symptoms at 4 hours, a supplementary dose of 5mg can be considered. • When deciding on the commencing dose, also consider:  Where dosisng is to occur: Are staff and facilities available for observation and assessment of the patient before and after dosing?  Who will assess withdrawal/intoxication prior to dosing?  Time since last opioid use  Concomintant use of benzodiazepines or alchohol. The risk of overdose increases most markedly when other central nervous system
    • depressants are also used. If the patient shows signs of intoxication with benzodiazepines or alcohol, the dose should be withheld or reduced. • A dose of less than or equal to 20 mg for a 70kg patient can be presumed to be safe, even in opioid-naive users as this is the lowest dose at which toxicity has been observed. • Caution should be exercised for starting doses of 30mg or more. • Exercise extreme caution if an initial dose of methadone exceeding 40mg is considered necessary. Specialist consultation may be advisable.8.2.2. Timing of the First DoseWhen methadone is commenced in the morning, clinicians are able to observe patientsfor toxicity when peak blood levels occur two to four hours after dosing.The first dose of the methadone should not be delayed because of the patientsuse ofheroin the same day. It is important to start treatment and begin the behaviour changewhen the opportunity presents itself. If the patient is intoxicated with heroin, their firstdose of methadone should be delayed some hours.Because of methadone’s slow onset of action, most patients will have recovered fromany recent heroin effect by the time of peak of methadone effect. Substantial risk ofoverdose only exists when heroin or other drugs are used at the peak of the methadoneeffect (4-6 hours) after dosing.Fig 1: Dosing stages
    • Stabilization Dose Subsequent stabilization Maintenance up to 40 mg up to 60 mg from 60 – 120 mg Day 1 W1 W2 W3 W4 W5 W6 W7 W8Initial dose 15-30mg 8.3. Stabilisation dose This is a very important time, the course of which often significantly influences patients’ longer-term outcome. Because of the long half-life of methadone, peak serum levels progressively rise during the first week of treatment on a stable dose. There is good reason to be cautious about increasing the dose during the first week, as signs and symptoms of intoxication (usually nausea and drowsiness) may first appear on the third or fourth day of treatment. For each client the aim is to arrive at an effective maintenance dose using safe dose increments. Clinicians need to be aware of the pharmokinetics of methadone which determine the time taken to achieve a steady state plasma level of the drug. Steady state is the situation where drug elimination equals the rate of drug administration. Methadone has an average half-life in the body of 22 hours (range 15–32 hours), which means that it takes an average of four days to achieve the steady state plasma level associated with a particular dose. The implications of this are that it may take two, three or four days before toxic and potentially fatal drug levels are achieved. It is therefore important to advise clients that although they may not feel totally settled (‘satisfied’) on a given initial methadone dose, they will feel progressively more settled after their second, third and fourth days of that particular dose. Clients should also be advised of the risk of overdose if they use other depressant drugs, including alcohol and benzodiazepines, to deal with their unsettled feelings whilst stabilising on a particular dose. During the first two weeks of MMT the aim is to stabilise the patient so that they are not oscillating between intoxication and withdrawal. This does not necessarily mean that the patient will reach an optimum maintenance dose in that time and further dose adjustments may be required after the patient has been initially stabilised. 8.3.1.Dose titration Stabilisation is about titrating the dose against needs of the individual patient. It is recommended that patients attend daily during the first week for an assessment:
    • 1. To ensure that the patient is not exhibiting signs or symptoms of toxicity from opioids or other drugs (see Appendix 1) 2. Do not increase the methadone dose for at least the first 3 days of treatment unless there are clear signs of withdrawal at the time of peak effect (i.e 3-4 hours after dose) as the patient will experience increasing effects from the methadone each day. 3. To determine whether the patient is experiencing symptoms of withdrawal: using the Subjective Opiate Withdrawal Scale (SOWS) - see Appendix 4 for details, and Objective Opiate Withdrawal Scale (OOWS) – see Appendix 5 for details, or COWS ; take only few minutes to complete; 4. To determine the quantity and frequency of any continued unsanctioned opioid use – direct questioning in this regard is important. Increases of methadone are commonly required during this time. The recommended daily dose increment is between 5 and 10 milligrams every 3 days subject to assessment; The maximum dose at the end of the first week should typically be no more than 40mg. Total weekly increase should not exceed 20mg. 5. If the prescriber believes that greater increases are clinically indicated it may be useful to consult with an experienced prescriber, documenting the discussions in the patient’s case record before proceeding. 6. Patients should be warned not to drive or operate machinery during periods of dose adjustments.8.4. Subsequent Stabilisation PeriodMany things are likely to have changed, ambivalence may still be quite high and thetemptation to use illicit drugs often continues to be strong. Positive input is critical and toprovide support, this time often being stressful for them.Because of the pharmacology of methadone, to ensure safety, it is desirable thatpatients are reviewed at least once, and preferably twice by an experiencedclinician in the first week with a view to assessing intoxication from methadone. ***Patients should be observed daily prior to dosing and an assessment made ofintoxication. If any concern they should be seen by a doctor before the dose isadministered. The stabilisation period is also a time for consolidating the therapeuticalliance.Further dose adjustments may be required during this time. It is recommended thatincreases do not exceed 20 mg per week. Dose increases should only be consideredsubject to assessment by the prescriber. Assessment should include withdrawalseverity (see Appendix 4 & 5), intoxication (see Appendix 1), other drug use side effectsand patient perception of dose adequacy, and adherence to dosing regime. However, iflarger increments appear to be indicated it may be advisable to discuss this with anexperienced prescriber.
    • Avoid concurrent prescribing of benzodiazepines because of the risks arising from theirinteraction with methadone and the potential for problematic benzodiazepine use.After a period of stabilisation in which the patient should be encouraged to abstaincompletely from heroin. Stabilisation is usually complete by the end of the 6th week ofmethadone treatment, but may take longer in some individuals.8.5. Maintenance doseGenerally patients receiving a daily dose of 60 mg or more have better treatmentoutcomes than those receiving less than 60 mg, in terms of: - Retention in treatment; - Unsanctioned opioid use; - HIV risk-taking behaviour; - Criminal activity.Cross tolerance to heroin increases as a function of increasing methadone dose andresults in blockade of the euphoric effect of concurrent heroin use. A daily methadonedose of 60mg or greater should be sufficient to ensure a substantial level of tolerance toeffects of heroin in the majority of individuals.However, each patient should be prescribed the dose that is best suited to his/herneeds. It is important to note that some patients may require considerably higher doses.Generally it is accepted that dosing at levels in excess of 100mg/day does not result inany additional benefit for the majority of patients.8.5.1. Effects of maintenance dose - Daily administration of methadone is recommended to ensure that plasma methadone levels are maintained and to avoid withdrawal symptoms - If plasma levels are not maintained, cross tolerance to heroin will be lessened, reducing the capacity of MMT to moderate the euphoric effect of heroin. Reduced compliance is therefore associated with an increased risk of relapse to heroin use8.6. Changing doseSome patients seem only to be happy while receiving ever-increasing doses ofmethadone, fruitlessly seeking the dose that will ‘hold’ them. Where this appears to bean unrealistic expectation, the prescriber should point this out. Other patients feelambivalent about being on methadone, are worried about side effects, and remain oninadequate doses, feeling poorly and often continuing to use heroin. Many womenbelieve they will put on weight on high doses of methadone, and remain on sub-therapeutic doses, continuing to use heroin but afraid to increase their dose. Suchpatients need encouragement and reassurance to bring their dose to a more satisfactorylevel.
    • Treatment is most effective when patients know their methadone dose, and feel that theyhave some degree of control over it. It is therefore best if the dose is negotiated betweenprescriber and patient. It is a legal requirement (and also good clinical practice) that oneach occasion a prescription for methadone is provided or renewed, the prescriber is topersonally assess the patient. When making decisions about changes in dosage thefollowing should be taken into consideration: - Concurrent use of illicit opioids and continued injecting use may indicate the need for a higher dose; - Individual variation in methadone metabolism. - Use of other medications (See Appendix 2). - Pregnancy (See Section 13.1 page 81). - Polydrug use (See Section 13.5 page 86).8.7. MISSED DOSESWhen clients miss methadone doses they often use other drugs to alleviate theirdiscomfort such as alcohol or benzodiazepines. Clients should therefore be assessed forintoxication before dosing is recommenced. If doses have not been collected orconsumed on 3 consecutive days or more, tolerance to opioids may be reduced placingpatients at increased risk of overdose when methadone is reintroduced. The doseshould be withheld pending assessment by the prescriber.Patients should be assessed for signs of intoxication and withdrawal before dosing isrecommenced after missed doses (Appendices 1, 4 & 5).If the dose has not been collected for 3 or more consecutive days the dose should bewithheld or reduced until the patient has been assessed by the prescriber.In general the following schedule can be presumed to be safe and effective, if the patienthas missed: - One day: No change in dose. - Two days: If no evidence of intoxication administer normal dose. - Three days: Administer half dose in discussion with the prescriber. - Four days: Patient must see prescriber. Recommence at 40mg or half dose whichever is the lower. - Five days or more: regard as a new induction.8.8. DOSE REGIMENS FOR VOLUNTARY AND INVOLUNTARYWITHDRAWAL FROM METHADONE MAINTENANCE TREATMENTThe majority of terminations are initiated at the request of the client. Factors thatmotivate patients to consider detoxification include lifestyle issues, tangible andintangible personal rewards, and perceptions and attitudes directed towards methadone.However, the final decision to discontinue methadone treatment is the responsibility ofthe prescribing medical practitioner in consultation with the client. The Provincial Health
    • Authority responsible for controlling the supply of methadone must be notified when thetreatment of each client is terminated. Withdrawal from methadone treatment should begradual in consultation with the patient.8.8.1. Voluntary withdrawalPatients who leave methadone treatment voluntarily after a gradual withdrawal frommethadone are least likely to relapse into heroin use. In most circumstances withdrawalfrom methadone should only be attempted when it is strongly desired by the patient andthey have been in treatment for at least 12 months.During voluntary methadone withdrawal, a flexible approach to dose reduction is advisedand it should be made in consultation with the client. In general, the slower the rate ofreduction, the less severe is the effects of withdrawal. Continued reduction of dose, evenat slower rates in the presence of significant physical or psychological distress in theclient is usually counterproductive. It may be appropriate to maintain a client at areduced dose for a prolonged period until the client feels comfortable and confident torecommence the reduction regime.Length of time in treatmentStudies have found the length of time in treatment is predictive of an improved treatmentoutcome. This relationship was evident for durations between 3 months and 2 years andwas linear. - A significant reduction in heroin use after treatment was only observed for those who spent more than 1 year in MMT. - Significant reductions in criminality were only observed while patients remained in treatment. - The findings of multiple observational studies indicate that it is a combination of treatment duration and behaviour change (ceasing heroin use, stable relationship, employment) during treatment which predicts positive post treatment outcomes. It is recommended that patients be encouraged to remain in treatment for at least 12 months to achieve enduring lifestyle changesManagement of voluntary withdrawal from MMT - Dose reductions should be made in consultation with the patient. Continued reduction in the face of significant distress is usually counterproductive. It may be appropriate to maintain a patient at a reduced dose for a prolonged period until the patient feels comfortable recommencing the reduction regime.
    • - During this phase the aim of any intervention is to ensure that the withdrawal process is completed with safety and comfort. - When a regime of reducing doses of methadone is used to manage withdrawal from heroin or methadone, typically signs and symptoms of withdrawal will begin to rise as the methadone dose falls below 20mg/day, with peak symptoms occurring two to three days after cessation of methadone. Subsidence of the symptoms is slow with studies reporting withdrawal scores not falling below baseline until 10 to 20 days after the cessation of methadone, depending on the duration of the methadone taper. - Clonidine offers no benefit as an adjunct to a regime of reducing doses of methadone, primarily because of a high incidence of hypotensive side effects when clonidine is used in this way. Clonidine can be given after cessation of methadone.Voluntary withdrawal regime - Recommend reducing dose by 10mg/week (5mg every 2-3 days) to a level of 40mg/day (2.5mg every 2-3 days), then 5mg/week. Rates of reduction should be negotiated with patients, and dose changes should occur no more frequently than once a week. - For individuals whose daily methadone dose is less than or equal to 40mg - the rate of dose reduction should be no faster than 5mg per week. - Abrupt cessation of methadone could be considered from 40mg/day in conjunction with clonidine and symptomatic medications to manage withdrawal signs and symptoms. - Where relapse occurs or is likely, further reductions in methadone dosage may need to be suspended and an increase in dose may be necessary. Individuals vary greatly and it is best to allow patients some control over the frequency and amounts that their dose is reduced during voluntary termination8.8.2. Involuntary withdrawalClinicians need to communicate in writing to patients at the beginning of methadonemaintenance treatment the conditions under which involuntary discharge may beinitiated. A decision to discharge a patient from a program against their wishes should beconsidered carefully.It is sometimes necessary to discharge a patient from treatment for the safety or wellbeing of the patient, other patients or staff. This may be the result of: - Violence or threat of violence against staff or other patients - Property damage or theft from the methadone program. - Drug dealing on or near program premises - Repeated diversion of methadone.
    • Interruption to treatment may also occur as the result of a change in the patient’ssituation such that they are no longer able to access methadone.Failure to attend for treatmentA patient who has not presented to pick up their methadone dose for 3 or moreconsecutive days should not receive methadone without consultation with the clinician.A patient who fails to attend for 5 or more consecutive days will be withdrawn frommethadone treatment and may only be reinstated into the program on the advice of themanagement of the program.Management of involuntary discharge from MMT - In some instances problems may be resolved by transferring the patient to another program rather than discharging them from methadone. - Abrupt cessation of methadone or rapid dose reduction may occasionally be warranted in cases of violence, assault or threatened assault against staff or patients. - Where treatment is interrupted for less severe breaches of clinic rules or for other reasons, patients should, where possible, reduction in dosage should be gradual and implemented, with counselling support; be withdrawn to 40mg/day according to the above voluntary withdrawal schedule. - Patients being discharged must be warned about the risks of illicit drug use, of possible reduced tolerance to heroin, and informed of other treatment options - A management plan regarding subsequent readmission must be developed for each patient involuntarily withdrawn from the program and this management plan must be recorded in the patient’s case recordAftercare and follow-up after treatment cessationAt the end of methadone treatment there should be some continued follow-up assistance(ie, aftercare). The form of aftercare can be ‘booster sessions’ to maintain skills etc,learnt in treatment, or it can be simple support and monitoring of progress as the clientreintegrates into the community.The client should understand the importance of continued contact with the counselor ormedical practitioner and should be made to feel that contact is not only acceptable butexpected.8.9. Side Effects of Methadone and DosesSleep disturbance A number of resources are available for patients experiencing sleep problems which include guidance regarding sleep hygiene and simple relaxation techniques.
    • Patients on methadone appear to be at increased risk of sleep apnoea and the use of hypnotic drugs may therefore paradoxically worsen sleep, by exacerbating sleep apnoea.Teeth problems All opioids including methadone reduce the production of saliva while illicit use is associated with poor nutrition and poor dental hygiene. Consequently dental problems are common at entry to MMT. It is common for patients to blame methadone for their dental problems. Salivary flow can be increased by chewing. Encourage patients to improve dental hygiene.Reduced libido and Reduced dose may help but needs to be balanced against thesexual dysfunction risk of return to heroin use.Lethargy Elucidate the cause. The methadone dose may need to be reduced.Excessive sweating Try reducing the dose although this may not alleviate the symptoms. Sweating can also be a prominent symptom in withdrawal and so careful history taking and observation of the patient prior to dosing may be necessary to assist in making the distinction.Constipation People rarely develop tolerance to the constipating effects of opioids and so patients may experience chronic constipation. Encourage patients to consume plenty of fruits and vegetables and non alcoholic fluids each day.8.10. INCORRECT DOSE ADMINISTEREDA patient who receives a methadone dose in excess of that prescribed is at risk ofoverdose.To prevent accidental methadone overdose: • Establish procedures for easy and accurate identification of patients to minimise the risk of inappropriate dosing. • Ensure patients are informed of the risks and signs and symptoms of overdose.In the case of an accidental overdose, the critical issues, which determine how cliniciansshould respond, are the patient’s level of tolerance and the amount of methadone givenin error (also see Section 11) • Patients in the first 2 weeks who receive an excess of any magnitude require observation for 4 hours. If signs of intoxication continue, more prolonged observation is required. This may require sending the patient to a hospital.
    • • Patients who have been on a dose >40mg/day consistently for two months will generally tolerate a dose double their usual dose, without significant symptoms. For an overdose with greater than double the usual daily dose the patient will require observation for at least 4 hours. If signs of intoxication are observed, more prolonged observation must be maintained. • Patients in whom the level of tolerance is uncertain (dose <40mg/day, or in treatment for <2 months) require observation for at least 4 hours if they are given a dose >50% higher than their usual dose. - For Procedures to follow in all cases of dosing error, please refer to the next chapter on Overdose.(NEED SOMETHING ON UNDERDOSING)
    • CHAPTER 9: METHADONE OVERDOSE9.1. IntroductionThis chapter provides guidelines for clinicians in the events of methadone overdose.Overdose can happen both because the patient has used other drugs or because awrong dose has been administered to him/her. It is important that quick action is taken inall situations to save lives.9.2. General GuidelinesMost of deaths during stabilisation on methadone involved other drugs, in particular,alcohol, benzodiazepines and antidepressants. Patients should be warned of the risksassociated with using other drugs with methadone.(See Appendix 1 & 2, Section 13.5)Death during methadone induction often occurs at home during sleep, many hours afterpeak blood methadone concentrations have occurred. Typically overdose occurs aroundthe third or fourth day of methadone induction. • Given that many deaths occur during sleep, administration of methadone in the morning will ensure peak methadone concentrations occur when patients are normally awake and other people may be around if overdose should occur. • Naloxone, which promptly reverses opioid induced coma, should be given as a prolonged infusion when treating methadone overdose. A single dose of naloxone will wear off within one hour leaving patients at risk of relapse into coma due to the long lasting effects of methadone. • Patients who are thought to have taken a methadone overdose require prolonged observation. • Family members should be warned that deep snoring during induction to treatment could be a sign of dangerous respiratory depression and should be reported to the prescriber. Heavy snoring during maintenance treatment may be associated with sleep apnoea and should also be reported.9.3. Signs and Symptoms of Methadone Overdose • Pinpoint pupils • Nausea • Dizziness • Feeling intoxicated • Sedation/ nodding off • Unsteady gait, slurred speech • Snoring, loud snoring or gurgling noises – this is NOT a sign the person is OK, or ‘sleeping it off’. NEVER leave a person like this, try and wake them immediately • Hypotension • Cold, clammy skin • Slow pulse (bradycardia) • Shallow breathing (hypoventilation) or not breathing
    • • Frothing at the mouth (Pulmonary Oedema) • Being unresponsive, difficult or impossible to wake, comaNOTE: Symptoms may last for 24 hours or more. Death generally occurs fromrespiratory depression9.4. What to do in the event of Overdose?Errors have occurred in the administration of methadone to patients. The situationwhere a patient receives a dose in excess of that prescribed is of particular concern.The following guidelines are advisory only. In all cases, clinic and other staff involvedwith the patient should adopt measures considered reasonable and appropriate toeach individual.9.4.1. Preventive measuresTo minimise the possibility of dosing errors occurring it is recommended that:- At least one of the on duty staff be familiar with the clinics patients and procedures- All patients should have a photograph from which they can be easily and accurately identified attached to their record card.- Where there is more than one patient with the same name a cautionary note should be made on the patients record card alerting staff to this eg CAUTION - CLIENT WITH SAME/SIMILAR NAME.- For new patients who are unfamiliar to staff this should also be noted on patients record card eg CAUTION - NEW PATIENT. Extra care should be taken to elicit information from the patient regarding the effect of the dose to assist the monitoring of toxicity.- Where patients are on doses over 80 mg a cautionary note should also be made on the record card eg CAUTION - HIGHER DOSE.- Methadone Information Sheet, which lists symptoms of an overdose and indicates when medical assistance is necessary should be distributed to all patients.- This sheet should also advise patients against driving or operating machinery and taking other drugs. Contact telephone numbers and addresses of the nearest hospital should also be provided.- At the time of entry to the methadone program, the patient be encouraged to nominate a contact person to be notified in case of an emergency.
    • 9.5. Recommended course of action for accidental9.5.1. Excess less than 10 mg • The clinic or pharmacy manager and the patients prescriber should be notified. • The patient should be notified of the mistake and the possible consequences carefully explained. • The patient should be given a Methadone Information Sheet and advised to present to their nearest hospital should they develop any symptoms indicative of an overdose. • Where possible the patients nominated contact person should be informed and advised of the event. • The event should be recorded on a patient accident report form and in the patients case record.9.5.2. Excess greater than 10 mg • As above plus: • The possible seriousness of the excess carefully explained preferably by someone other than the person who administered the incorrect dose. • The prescriber should be contacted immediately for consultation • If medical help is not readily available or the patient is not prepared to receive medical care, and contingent of the patients consent the inducement of vomiting within 5 to 10 minutes of ingestion of the dose may be an appropriate First-Aid measure only.The administration of Ipecac Syrup is contraindicated due to its sometimes delayedaction. • If it is decided that the patient requires hospitalisation a staff member should explain this to the patient and escort the patient to the Accident and Emergency Department. The situation should be explained to the admitting nurse. • If the patient refuses to present to the Accident and Emergency Department, despite being advised of the potential lethality of the dose received the patient should be asked to sign a disclaimer absolving the clinic of further responsibility. This should be witnessed by another staff member where possible and recorded in writing. If the patient refuses to sign a disclaimer this preferably should be witnessed by another staff member and should also be recorded in writing in the presence of the patient
    • • The potential seriousness of the overdose should also be communicated to the patients nominated contact person. This person should be informed of the advice given to the patient.If the patient leaves the clinic before the mistake is realised the clinic and theprescriber need to be informed, and depending on the advice of the prescriber allefforts should be made to contact the patient or anybody who may know of theirwhereabouts. In attempting to locate a patient, their confidentiality should bemaintained at all times.Caution against inducing vomitting• Emesis is generally an unsatisfactory means of dealing with a methadone overdose as it is impossible to determine whether the stomach has been entirely emptied. Inducing emesis may be dangerous and is contraindicated in cases where the patient has signs of respiratory depression, obstructed airway, drowsiness or other CNS depression.• Where there is concern about the amount of methadone consumed it is best to err on the side of caution and have the patient present to the Accident and Emergency Department without delay.9.6. What to do If you find a person collapsed:If you find a person collapsed, and they are difficult to wake or cannot be woken, do thefollowing:• call Emergency (phone Nr, - to check with VN) for an ambulance• check that the person’s airway is clear. If not, remove anything from the person’s mouth and extend the neck to open the airway• check breathing. If the person is not breathing start mouth-to-mouth resuscitation immediately (gentle-breaths)• check circulation by feeling for a pulse in the person’s neck.If there is no pulse start heart massage immediately:• check Airway, Breathing and Circulation, put the person in the recovery position on their side• loosen any tight clothing that might restrict breathing• keep the person comfortably warm with blankets or a coat• do not give the person fluids• stay with the person until professional help arrives• explain to the ambulance crew what has happened and what you have done. If you have the information, tell them what the person has taken and how long ago Very important: • A person receives professional help as soon as possible. • Quick responses can save lives.
    • • Overdose is not a crime and the police are only called if they are needed.
    • CHAPTER 10: DELIVERING EFFECTIVE METHADONE TREATMENT(This chapter is the only outstanding chapter to be edited and checked for content andstructure)10.1. Introduction:To include10.2. Good medical practice in methadone programs involves:• Establishing to ensure the availability of comprehensive community-based treatment services• Highest quality experience for patients, providers, and staff. Providers and practice staff should have an appropriate level of training, experience, and comfort with this new form of treatment• Linkages with other medical and mental health professionals• Establishing and maintaining a non-judgmental relationship and a spirit of collaboration with each patient;• Respecting and protecting the patient’s privacy and confidentiality;• Maintaining good quality clinical notes which document assessment, key issues in patient management, and regular reviews of patients’ progress;• Maintaining the balance between structure (eg clear and fair program rules applying to all patients) and support (eg the flexibility to respond individually to patients).10.3. Review of Treatment ProgressThe purpose of monitoring the patient’s progress is not only for the clinician’s benefit. Itis also to highlight to the patient the progress or otherwise they are making.Once stabilisation is complete (may take some weeks but usually achieved within firstsix weeks), it is important that all patients, including those who appear to be doing well,be reviewed periodically. The actual time interval set is determined by the degree ofobserved stability of the patient. It is recommended that initially all patients be reviewedno less often than every 60 days and that this be extended to a maximum of 90 days asappropriate.Review of treatment progress should take into account:• adequacy of methadone dose• recent drug use – prescribed and other (including alcohol)• physical and psychological health• general social functioning• HIV, Hepatitis B and C risk-taking• progress of infectious diseases
    • • renewal of methadone prescription• any indicated investigations (See Appendix 11 - Prescription Review form)Most patients in methadone maintenance adapt to the routine of picking up theirmethadone daily, seldom requiring anything of treatment providers once stabilised.Others may be demanding and difficult, requiring considerable time and attention fromprescribers and other treatment providers. Remaining in treatment for an adequate period of time is critical for treatment effectiveness. The appropriate duration for an individual depends on their problems and needs, but research indicates that for most drug users, the threshold of significant improvement is reached after about three months in treatment, with further gains as treatment is continued. Most impact from treatment is gained when they stay in treatment for at least 12 months. Because people often leave treatment prematurely, and premature departure is associated with high rates of relapse to drug use, programmes need strategies to engage and keep patients in treatment.CONCURRENT DRUG USEA major goal of treatment is to reduce unsanctioned drug use and drug dependency.Monitoring concurrent drug use is an important component of methadone maintenanceprograms. Such monitoring is of value in evaluating the overall effectiveness of aparticular program and its individual treatment providers. For example if there is a highproportion of patients using heroin or other psychoactive drugs in hazardous ways thismay indicate an aspect of treatment needs to be changed.The prescriber’s chief concern should be safety – patients taking methadone with highdoses of other CNS depressants are vulnerable to overdoses, which can be lethal.Monitoring may also be useful in determining how well patients are progressing intreatment and whether changes in treatment should be made for patients with specificproblems.Hazardous alcohol consumptionThis is common among patients on methadone programs. It is therefore prudent todetect hazardous alcohol consumption patterns and intervene early, either by treatingthe patient yourself or referring them on.Alcohol consumption should be monitored by history, examination and whereappropriate liver function tests and breath alcohol readings. Methadone should not beadministered to a patient who presents smelling of alcohol.
    • Benzodiazepine useIf this is evident from patient report the prescriber of the benzodiazepine should becontacted to confirm indications, dose and anticipated duration of treatment. It isexpected that such courses of medication be of short duration – less than two months.Where benzodiazepines appear to be indicated for the treatment of psychiatric illness areferral for psychiatric assessment is indicated.Heroin useContinuing heroin use can be a frustrating problem for clinicians. It is important thatother issues are not being overlooked such as inadequate methadone dose,undiagnosed or under treated psychiatric illnessSee Appendix 3 for intoxication and withdrawal states of commonly used substances.MONITORING DRUG USEMonitoring clients’ drug use can give useful information for making informed decisionson clinical management; patient safety from concurrent use of other drugs withmethadone and provide a basis for program evaluation. However, there is little evidenceto support the use of drug monitoring as a deterrent against unsanctioned drug use anddrug-positive results should not be used punitively.Current monitoring options used widely include urine testing, client self reporting andclinical observation. The validity and reliability of these techniques can be improvedwhen used in conjunction with one another.Self reporting although a subjective measure, is relatively unobtrusive and can be auseful indicator of episodes of clients’ drug use when used in certain settings. Self reportcan be a reliable guide to drug use in settings where no negative consequences resultfrom disclosure. Self-reporting is also conducive to facilitating an atmosphere of trustand good-will between staff and clients. However, caution should be exercised whenmaking clinical decisions based solely on self-reported drug use.Urine testing should only be undertaken with good reason, such as in the initial clinicalassessment of individual clients or as part of program evaluation. Urine testing can alsobe useful when clients are unstable (such as in the early stages of methadonetreatment) and when there is some uncertainty about their drug use.Urinalysis is an objective measure of drug use, however when undertaking urine testing,steps should be taken to ensure that urine substitution has not occurred: - Reliability of unobserved urines may be increased by checking the temperature of the urine sample. - Urinalysis will only detect recent drug use. The actual time frame varies depending on the drug being measured and will also depend on the threshold level set by the testing laboratory. Appendix 6 can be used as a guide. - False positives and false negatives do occur. - Research literature suggests that urine testing does not reliably reduce drug use. - Methadone programs should not be punitive.Urinalysis is most useful in the following circumstances:
    • - Patients in the early stages of treatment. - Where clarity of drug use is required for diagnostic purposesFrequency of urinalysis: - It is expected that the average number of tests will decrease the longer a patient has been in treatment.Clinical observation: refer to section 9.7 Physical examination, page 50sections havechangedSign of drug useFrequency of contactsMissed appointmentsMissed dosesPROTECTING PATIENTS AND STAFFThere are risks for patients and staff in methadone clinics, and it is important thatmethadone treatment occurs in an environment that is safe for all.Many patients, particularly early in treatment, feel alienated and angry. They are oftenantagonistic towards authority and may act this out toward treatment staff. Conflict is notuncommon among patients and between staff and patients. Clinicians, particularly thosemanaging large numbers of patients, need to develop policies and procedures to dealwith conflict. A friendly environment with firm and clearly communicated limits isimportant in order to contain conflict and patients’ acting-out behaviours.Program rules should be uncomplicated and made available in writing to patients at thebeginning of treatment. They may also be displayed in the clinic. Patients should beinformed regarding procedures for airing complaints. Patients who are not literate shouldbe read these rules and procedures.Treatment providers need to respect the privacy of patients strictly. This includes not‘passing on’ messages or notes to patients from others, and declining to answer evensimple requests such as “Has X been in yet?”, politely explaining the program policies reprivacy. In this way commitment to privacy can be demonstrated.TRAININGProper training on methadone treatment will be key to the successful introduction of thistreatment paradigm, regardless of the clinical setting of methadone treatment.All staff of service involved in contributing to methadone treatment should receiveadequate orientation, training, support and supervision. This includes nurses,pharmacists and counsellors. Basic and ongoing training in addiction treatment willgreatly enhance a clinician’s effectiveness in treating opioid addiction.Clinicians who are intending to become methadone prescribers should havedemonstrated knowledge and skills concerning methadone treatment before beingauthorised to prescribe methadone. The development of learning objectives, which
    • should be used as guidelines for the development of jurisdictional or professionaltraining programs and for evaluation of attainment of those skills.The number of clients that doctors are approved to treat should be determined by:• the expertise/experience of the doctor in treating drug dependence;• the accessibility of the doctor to the client whether the doctor is working fulltime or part-time in methadone treatment; and• the type of clients and/or type of setting in which the doctor is providing methadone treatment, including for example, the availability of other clinicians and ancillary services.CLIENT RECORDSCase records detailing clients’ clinical history and progress in treatment should beestablished and adequately maintained. Appropriate procedures should be implementedto ensure the security and confidentiality of records. It should be noted that records canbe accessed through legal means, such as the serving of subpoenas, and that while aservice may seek to restrict the public use of the records, this cannot be guaranteed.PRIVACY AND CONFIDENTIALITY ISSUESPractice policies and procedures should be established that will guarantee the privacyand confidentiality of addiction treatment patients. The privacy and confidentiality ofindividually identifiable information relating to patients receiving drug or alcoholtreatment is instructed in the National Strategy on HIV/AIDS Prevention And Control inViet Nam for the period 2004-2010 with a vision to 2020 . The MMT Service mustcomply with all applicable laws and regulations regarding the privacy and confidentialityof medical records in general, and of information pertaining to addiction treatmentservices in particular.Occasionally, clinicians will need to communicate with pharmacists and other healthcareproviders about the drug treatment of a particular patient (e.g., to verify a prescription),this requires clinicians providing opioid addiction treatment to obtain signed patientconsent before disclosing individually identifiable addiction treatment information to anythird party. It is particularly important to obtain patient consent. Clinicians should alsoconsult with their authorities concerning privacy and confidentiality rules in their locales.Some of the privacy and confidentiality issues that can arise in the course of methadonetreatment:- Information covered by the doctor/patient privilege- Circumstances in which confidential information is protected from disclosure- Exceptions to laws protecting medical information- Duty to report- Communications with third parties (e.g., families, employers, allied healthcare providers, third-party payers, law-enforcement officers, responses to subpoenas)
    • MONITORING SYSTEMThe Haiphong Health Departent has responsibility for collating and maintainingmethadone treatment data for consideration by the MOHROUTINE DATA COLLECTIONThe following items of data are considered important components of a minimum dataset,to be collected by service providers on an ongoing basis and assessed by the clinic.• Number of clients registered in treatment broken down by: - site of treatment - age; - gender (male, female); - employment status (including sickness allowance, disability , pension, sole parent pension, job etc, as separate categories); - proportion of clients entering treatment for the first time ever, readmissions, continuing treatment.• Retention in treatment: o Mean duration• Dose of methadone: - mean dose of methadone.• Death rates: - number of deaths from all causes, of clients in active treatment at the time of death, during the reporting year and the proportion that are opioid relatedPOINTS TO CONSIDER ABOUT TREATMENT - There is no ‘best method’. No one type of treatment will work for everyone. People may need to try a number of options before finding what best suits them. Also, a certain type of treatment may suit a person at one stage in their life, but may not be useful at another. - The importance of assessment. Treatment will be more effective if it fits in with a person’s individual circumstances. Everybody is different, and an assessment by a medical practitioner/health professional will help identify the types of treatment that best suit a person’s severity of dependence, goals and preferences. - Different treatments have different goals. Some treatments are aimed at getting people completely heroin-free (often called ‘abstinence-based’ treatment), such as therapeutic communities and many self-help groups (e.g. Narcotics Anonymous). Other treatments can be used to achieve abstinence, but are also able to stabilise people at a reduced, safer level of use (e.g. long-term methadone or buprenorphine program).
    • - Regardless of the treatment(s), any decrease in heroin use or the related harm is a positive outcome. For some people it may be that reduced or controlled use, stable relationships, employment or better health are more achievable than abstinence. These important changes may encourage abstinence in the future. - ‘Slip ups’ or lapses should not be viewed as failure. Lapses are a normal part of changing any human behaviour. Every time they occur, a person can learn from the experience and develop better ways of dealing with a similar situation in the future. It may be that only through a number of unsuccessful attempts at controlled use a person decides on a goal of abstinence.THE DOCTOR–PATIENT RELATIONSHIPThe nature of the relationshipIt is important for methadone prescribers to employ common sense, courtesy and anappropriate level of neutrality in establishing a relationship with patients. It is easy topresent the impression of being excessively distant, remote and authoritarian in order toprotect oneself from the demands and manipulations of the patient. At the other extremeit is also easy for the prescriber to become overly sympathetic to the patient and tooaccepting of the patient’s own account of their circumstances. In this situation doctorsmay come to see themselves as advocates and supporters of their patients to the extentof becoming enmeshed in what is happening to them.It is probably more beneficial for patients in the long term if the doctor preserves anappropriate neutrality: being concerned and caring but also recognising when patientsare making excessive demands and not rescuing them from their often self-inducedcrises.The therapeutic relationship should be based upon mutual understanding betweendoctor and patient of: • their respective views as to the cause and nature of the patient’s problems; • each party’s expectations of treatment – what doctor expects of patient, patient of doctor and patient of treatment; • how the patient’s goals might best be met.The more overt and collaborative the approach to treatment and the more responsibilityfor treatment is shared, the more effective the treatment is likely to be. Difficulties,disruptions and crises should be expected, however, but should not be a cause ofexcessive dismay or recrimination. It is helpful for the doctor to outline their approach tomethadone treatment.It is important that patients do not take on goals they are unlikely to reach as their failureto reach them may destabilise their progress in treatment. Treatment agreementsbetween patient and doctor are only useful when they have been arrived at throughnegotiation and when they are intended to encourage patient input rather than extractcompliance:
    • - Treatment agreements need to be flexible and realistic. - Goals in treatment need also to be short-term.This may be achieved by breaking down larger problems into smaller tasks for action orchange. This makes the management and resolution of large problems more feasibleand gives patients a sense of achievement and greater control.The smaller tasks/goals should be meet the following criteria: o Desirable o Evaluable o Positive o Specific in time frame o Achievable o MeasurableFurthermore, realistic treatment agreements can provide the treatment process with asense of structure and purpose beyond the daily dosing of methadone.It is essential to keep comprehensive records which are secure and confidential. Caserecords should be legible, reveal a comprehensive assessment and document eachinteraction between doctor and patient including the periodic reviews of the patient’sprogress.Problems in the doctor–patient relationshipSome opioid users have significant personality problems. Helping patients to minimizethese and overcome destructive tendencies is a challenge of the therapeuticrelationship.Realistic expectations, a non-judgmental attitude and patience on the part of the doctorare great assets. Assisting patients to identify and express their emotions appropriatelyand reduce impulsivity may improve patients’ social functioning and have a positiveimpact on the therapeutic outcome.Some patients will be difficult to like. They may be erratic and ungrateful, missappointments and demand favours, need and ask for help yet not accept advice.Treatment should be an attempt to break the familiar cycle of deviant behaviour,punishment and further deviant behaviour. It is therefore important to try to develop anattitude that does not exploit or punish. An important function of a methadone treatmentsetting is to contain acting-out behaviours of patients. It is helpful if aggressive outbursts,rule-breaking, manipulation and non-compliance can be managed constructively. Thiscan be a different experience for patients accustomed to being treated with punishmentand rejection.Changing established patterns of behaviour does not happen in a short time and thismay be one reason why longer durations of treatment are associated with betteroutcomes.The methadone prescriber has considerable power in the relationship with their patients.This can cause problems, particularly with a patient who is vulnerable or who hasdifficulty with authority figures. It is important to handle this power differential sensitively,
    • avoiding adversarial relationships with patients who resent their perceivedpowerlessness in regard to program rules.More importantly doctors must strive to avoid exploiting the doctor–patient relationship inprescribing methadone. Emotional exploitation can occur by prescribers taking anintrusive and voyeuristic interest in the often colourful details of the patient’s lifestyle andexperiences.COUNSELLING IN METHADONE MAINTENANCE PROGRAMSCounselling should not be seen as separate from other aspects of methadone treatment.Dedicated counselling sessions – which may be psychotherapy, drug counselling, grouptherapy or other counselling approaches – are offered in some methadone programs.However, counselling skills are also of value when not in focused, formal counselling,but in the day-to-day treatment of clients on methadone.These skills can be useful in the prevention and management of crises. Patients inmethadone treatment often appear at clinics with crises in their lives unrelated tomethadone treatment. The requisite skills to mange these crises are often indispensable.More commonly, problems arise relating to disputes over program rules, patientbehaviour and compliance. Resolving these often requires considerable skill andrestraint. In any treatment program there must be constant interaction between clinicstaff and patients. How these interactions are managed can have a major impact ontreatment outcome.When counselling may helpWhen a patient requests help with interpersonal or social or psychiatric issues, they maybe referred to an appropriate practitioner or managed by the prescriber who possessesthe required skills and is willing to engage the patient in counseling, it must be notified inwriting within seven days of discharge or termination from treatment.The decision to discontinue methadone treatment is the responsibility of the prescribingmedical practitioner and should be made in consultation with, and in usualcircumstances with the agreement of, the patient.
    • CHAPTER 11: MANAGEMENT OF SPECIAL CLIENT GROUPS11.1. IntroductionThis section considers the special needs of certain client groups and how to deal withthese needs.Methadone treatment has been demonstrated to be useful in the management of manyopioid-dependant pregnant women and in the prevention and management of particularinfectious diseases, especially HIV/AIDS.11.2. Opioid Using Pregnant Women• Pregnant women who are dependent on opioids are at high risk of experiencing complications, generally as a result of: - inadequate antenatal care; - lifestyle factors including smoking, poor nutrition, high levels of stress and deprivation; - repeated cycles of intoxication and withdrawal which can harm the foetus or precipitate premature labour or miscarriage.• Pregnant opioid dependent women need to have priority for access to methadone maintenance programs in order to minimise the risk of complications.• Methadone maintenance treatment: - enables stabilisation of drug use and lifestyle, - reduces or eliminates illicit opioid drug use and can help stabilise the in utero environment, - facilitates access to comprehensive antenatal and postnatal care, - does not increase the risk of congenital abnormalities in the foetus.• Methadone has the potential risk of respiratory depression in the neonate and the likelihood of neonatal withdrawal syndrome. - Respiratory depression is not often a significant problem in babies born to opioid dependent mothers receiving methadone maintenance treatment. - Babies born to mothers on methadone maintenance treatment may experience a withdrawal syndrome. Available evidence gives little support to the existence of a relationship between the severity of the neonatal withdrawal syndrome and maternal methadone dose at delivery. Its occurrence is unpredictable. The benefits of methadone maintenance treatment for both the mother and the baby outweigh any risks from the neonatal withdrawal syndrome.11.3. Management in pregnancy• Antenatal and postnatal patients should be managed in collaboration with a specialist obstetric service experienced in the management of drug dependency
    • during pregnancy. The methadone clinicians should jointly manage these patients with the obstetric service available to or chosen by the patient. Regular examination of the patient during pregnancy is important in order to: - assess individual response to adequacy of methadone dose and alteration as required; - discuss the effect of methadone in pregnancy; - determine and counsel re any other drug use; - discuss likely withdrawal effects on the baby after delivery; - discuss any other issues that may arise, including implications of HIV seropositivity where appropriate.• Opioid using pregnant women not already in treatment should be given high priority for assessment. Naloxone challenge should not be used in pregnant women because this may precipitate miscarriage or premature labour.• Pregnant women should be maintained on an adequate dose of methadone, to achieve stability and prevent relapse or continued illicit opioid drug use. - Women already in methadone treatment who become pregnant can safely be maintained on their current dose. - The bioavailability of methadone is decreased in the later stages of pregnancy due to increased plasma volume, an increase in plasma proteins which bind methadone and placental metabolism of methadone.• It may be necessary to divide the daily dose and possibly increase the dose in the third trimester of pregnancy to avoid withdrawal symptoms and minimize additional drug use• Babies born of methadone-maintained mothers may go through a withdrawal abstinence syndrome, which sometimes requires treatment. Some women may be initially reluctant to advise other health practitioners of the fact that they are on a methadone program. Clients should be counselled about the need for a partnership approach between the MMT services and other relevant services.11.4. Dose reductions or detoxification during pregnancyBecause pregnancy affects the metabolism of methadone, clients may need an increasein their doses and/or to have divided doses. Many women want to decrease their doseduring pregnancy but withdrawal during pregnancy or a return to unsanctioned opioiduse are in themselves associated with risks.
    • Opioid withdrawal in the first trimester of pregnancy is thought to be associated with anincreased risk of miscarriage. Opioid withdrawal in the third trimester of pregnancy maybe associated with foetal distress and death. Therefore, it is important that pregnantwomen are not exposed to withdrawal during the first and third trimesters. Theseaspects need to be discussed with the client and clients should be closely monitored.If dose reductions or detoxification are to be undertaken during pregnancy these shouldbe implemented in the second trimester. - Dose reductions should only occur if the pregnancy is stable. - The magnitude and rate of reduction needs to be flexible and responsive to the symptoms experienced by the woman concerned. - Withdrawal symptoms should be avoided as much as possible as they cause considerable distress to the foetus. - Careful monitoring of the pregnancy and foetus should be undertaken during dose reduction. - In most instances, dose reductions of 2.5mg-5 mg per week are considered safe.11.5. Breastfeeding - Breast milk contains only small amounts of methadone and mothers can be encouraged to breastfeed regardless of methadone dose provided that they are not using other drugs. - Breastfeeding may reduce the severity of the neonatal withdrawal syndrome. - Women receiving high doses of methadone should be advised to wean their babies slowly to avoid withdrawal in the infant.11.6. Neonatal Withdrawal SyndromeThe occurrence and severity of neonatal withdrawal is very unpredictable. Severity ofwithdrawal is probably ameliorated if neonates can be kept with their mothers rather thanin the neonatal intensive care nursery, which may be stressful and overstimulating.However, this is not always possible.All babies born to opioid dependent mothers should be observed by experienced staff forthe development of withdrawal signs. It is recommended that a validated scale be usedto assess the presence and severity of the neonatal withdrawal syndrome (see Appendix3).Common signs include: - Irritability and sleep disturbances - Sneezing - Fist Sucking - A shrill cry - Watery stools - General hyperactivity - Respiration rate - Ineffectual sucking - Poor weight gain
    • - Dislike of bright lights - Tremors - IncreasedLess common signs: - Yawning - Vomiting - Increased mucus production - Increased response to sound - Convulsions (rare).Withdrawal symptoms usually start within 48 hours of delivery but may be delayed for 7-14 days in a small number of cases. Experience suggests that in cases wherewithdrawal is delayed it may be because methadone was being used in conjunction withillicit benzodiazepines and the infant is withdrawing from the benzodiazepines.Supportive treatment involves minimising environmental stimuli and enhancing thebaby’s comfort and may include: - Soothing by holding close to the body or swaddling. - Keeping nostrils and mouth clear of secretions. - Use of a dummy to relieve increased sucking urge. - Frequent small feeds.Treatment with opioids should be considered for infants who exhibit severe withdrawalsymptoms.Indications for treatment: - Seizure - Weight loss (poor feeding, diarrhoea and vomiting, dehydration) - Poor sleep - FeverTreatment should be based on the severity of the withdrawal signs. Options to beconsidered include: - Oral Morphine Preparation - 2 mg/ml morphine dilution (can be further diluted) - Tincture of opium - 0.4mg/ml dilution • Treatment with opioids should be used with extreme caution • It is recommended that neonatal care be managed in collaboration with a specialist obstetric or paediatric service which is experienced in the management of babies born to drug dependent mothers. 11.7. Management of Patients with HIV/AIDS (this section needs moreinformation and guidelines)
    • Where a patient is referred or presents for urgent assessment due to their HIV positivestatus, this should be confirmed with the referring doctor or agency or by a further HIVantibody test. When HIV antibody testing is conducted, patient consent must be obtainedprior to the test and confidentiality of results and other personal information must beensured. Pre- and post-test counselling should be an integral part of the procedure.Methadone programs should provide or refer HIV positive patients to specialist HIVmedical facilities, so that their health may be appropriately monitored.Generally, in the early stages patients who are HIV antibody positive are able to managethe routine and conditions of methadone programs. However, the medical, psychologicaland social implications of HIV/AIDS may require some flexibility in the arrangements forongoing treatment. This may need to be negotiated with the responsible jurisdictionalauthority, such as alternative dosing options include: - Collection of daily methadone dose by a responsible adult; - Home deliveries; - Takeaway doses.These clients may have a series of conditions, methadone doses must be monitored dueto the potential for interactions between methadone and HIV medications and the effectsof related illnesses, such as depression and tuberculosis, and may be treated withpharmacological agents that interact with methadone (see Appendix 2). If HIVmedications increase methadone metabolism, clients may require higher doses ofmethadone where tolerance to opioids has developed due to other pain reliefmedications (see Appendix 2). Clinicians need to be aware of these issues in themanagement of these clients.In the terminal stages of HIV-AIDS, methadone service providers may need to work withhospice services in managing methadone treatment and HIV/AIDS conditions. Wherepartners or carers of clients with HIV/AIDS have also had a history of injecting drug use,additional support may be required.11.8. Management of Patients with HepatitisHepatitis BAll patients on the methadone program who are found to have no immunity to theHepatitis B virus should be recommended to have, or be offered, Hepatitis B vaccination.Patients who are either acutely infected with Hepatitis B or who are chronic carriersshould be referred to a gastroenterologist for specialist assessment and follow-up.Hepatitis CPatients who are antibody positive for Hepatitis C but who have normal serumaminotransferases (ALT, AST) with no signs of chronic liver disease may have liverfunction tests repeated at 6-month intervals for two years. If the patient has signs ofchronic liver disease or has intermittent or persistently abnormal liver function (at anylevel) referral for specialist assessment is indicated.A high percentage of patients entering methadone programs will be hepatitis C antibodypositive.
    • - Patients who are hepatitis C antibody positive but who have 3 normal serum aminotransferases (ALT and AST) over 6 months should have liver function tests repeated at 6 monthly intervals and a Hepatitis C polymerase chain reaction test at 12 months. - If the patient has 3 abnormal serum aminotransferases over 6 months referral to a gastroenterologist or liver clinic for specialist assessment and shared care is indicated. - (DR. THAI WILL CHECK WITH RACHEL AND CARE AND TREATMENT TEAM TO FILL IN THE INFORMATION RELEVANT FOR VIETNAM)Impaired liver functionPatients with chronic liver disease on long term methadone maintenance generally donot need dose alterations but abrupt changes in liver function might necessitatesubstantial dose adjustments.11.9. Poly drug useHigh percentages of patients are likely to be using benzodiazepines or alcohol athazardous or harmful levels. Patients at high risk from polydrug use: - frequently present intoxicated or with signs of benzodiazepine or alcohol withdrawal; - regularly use other drugs at levels above normal therapeutic doses.At the time of their entry to methadone treatment, service providers also need to beaware that: - These patients may develop significant alcohol and drug use habits that are potentially harmful whilst receiving methadone treatment. - Some clients mistakenly believe that once on methadone, they won’t develop other drug dependencies. Therefore, they should be alert to the possible development of new dependencies, and the need for appropriate interventions.It is recommended that specialist advice be sought when treating patients at high riskfrom polydrug use especially where sedatives are involved. Patients who have multipledrug dependence should, where possible, be managed in services that providecomprehensive, quality care. Options for these clients include: - counselling on the dangers of intoxication, the harms of polydrug use and on ways to reduce or stop hazardous use of alcohol and other drugs. - Selective detoxification.11.10. Psychiatric Co morbidityPeople presenting for methadone treatment frequently have psychiatric co morbidity. Inmost instances no additional special care is needed but where significant conditions aresuspected, particularly where psychotic features are present, it is appropriate to seek apsychiatric opinion. In instances where there is significant psychiatric co morbidity, there
    • should be a process of shared care involving mental health and drug and alcoholservices.Dual DiagnosisThis refers to a situation in which a drug user has a psychiatric diagnosis additional to adiagnosis relating to substance abuse. It is sometimes referred to as psychiatric co-morbidity.Dual diagnosis is an important and difficult area of medicine. Most drug users who seekentry to methadone programs are leading dysfunctional lives, have disruptedrelationships and mood disturbances. Often such disturbances appear to be aconsequence of the drug dependence and drug-using lifestyle, and improve after aperiod of stabilisation on methadone. However, in some patients there are persistentdeviations in mood and temperament, which warrant a further diagnosis.These patients require further assessment and treatment if they are to derive the fullbenefit from methadone maintenance or other forms of treatment for their drug use.It is important for methadone clinic staff to be aware that there is a high incidence ofpsychiatric co-morbidity among dysfunctional drug-using patients and that it is importantto recognise the psychiatric diagnosis. For certain conditions it is important thattreatment also be offered. It is also important that their drug using problem be treated.Identification of treatment resources or referral lines able to assist in the management ofthese patients is necessary.Co-existing psychiatric syndromesThe drug dependent population has about seven times the incidence of a psychiatricdisorder as the general population over a range of diagnoses. Some of these conditionsrespond well to treatment while for others there is no effective treatment. Wheretreatment is effective for the psychiatric condition this often leads to a markedimprovement in patient functioning and less relapse into dysfunctional drug-using.Accurate psychiatric diagnosis may also serve to identify patients who are likely tobenefit from psychotherapy as an adjunct to methadone maintenance.Opioid-dependent individuals are approximately: - 24 times more likely than the general population to have antisocial personality disorder (ASPD); - 13 times more likely to have an alcohol use problem; - 9 times more likely to have schizophrenia; - 5 times more likely to have a depressive illness; - 3 times more likely to have an anxiety disorder.Diagnosis of all forms of personality disorder is difficult, much of the behaviourassociated with illicit drug use being antisocial. Once such drug use diminishes, a largeamount of this behaviour disappears. Most of the personality disorder diagnoses areunhelpful as there is no specific treatment available.
    • Many opioid users (especially female) exhibit symptoms of anxiety and depression at thetime of presentation for treatment. Depression may contribute to, be caused by, beindependent of, or exacerbate problems of opioid dependence. Sometimes depressionresolves with methadone maintenance.There is also reasonable evidence that patients with a diagnosis of depression respondwell to psychotherapy and that those receiving such treatment show more improvementin overall functioning than those who do not receive it.After stabilisation on methadone, screen all patients again for psychiatric disorders. Acareful and detailed mental state examination will usually suffice.11.11. Methadone and analgesiaManagement of acute pain in hospital for patients on MMTMethadone clients admitted to hospital should have their methadone treatmentcontinued. Due to their tolerance of opioids these clients will require larger doses ofanalgesia for adequate pain relief. The dose and route of administration should bediscussed with practitioners with appropriate expertise in pain management.Methadone clients who have a painful condition may need an increased methadonedose for a time to deal with the pain but an increased methadone dose may not in itself,be sufficient for acute painful conditions.Drugs with mixed agonist/antagonist opioid properties such as pentazocine (Fortral) orpartial agonists such as buprenorphine should not be administered to methadone-maintained patients as they may precipitate an acute withdrawal syndrome.Methadone maintenance patients who are not allowed oral intake, as may occur afterabdominal surgery, should be given parenteral opioid analgesia, preferably bycontinuous infusion in doses adequate to provide pain relief. Once able they should berecommenced on oral methadone and continue with parenteral opioid for analgesia,progressively reducing the dose.Analgesic requirements for patients on methadoneConsider non-opioid analgesics (NSAIDs or paracetamol). Where parenteral analgesicsare required, consider ketorolac or tramadol.There is evidence of cross tolerance between methadone and anaesthetic agents andso patients on methadone may require higher doses of anaesthetic agents in the eventof dental or surgical procedures.
    • Management of patients with chronic painMany patients with chronic pain become dependent upon medication used to relievepain. Those who have come to regularly abuse prescribed analgesics, particularlyparenteral forms, often function far better when placed on oral methadone.It is not uncommon for patients in methadone maintenance programs to becomesomatically focused and to develop multiple chronic pain complaints. It is often difficult toevaluate these problems and careful, appropriate medical assessment for potentiallytreatable conditions is needed. However, it is also important to recognise that the goal ofachieving total abolition of pain cannot be achieved in most patients with chronic painand this has to be the cornerstone of management.Patients needing methadone for ongoing management of chronic pain need acomprehensive management plan. It is recommended that specialist advice be soughtregarding such patients.
    • CHAPTER 12: PREVENTING RELAPSE12.1. IntroductionRelapse is a common experience when changing drug use behaviour. Researchevidence indicates that major predictors of relapse risk are belief systems consistentwith disease models, and the absence of coping skills.12.2. StrategiesThe following strategies are useful in preventing and managing relapse: • Enhance commitment to change (e.g. use motivational interviewing) • Identify high-risk situations, for example: - When does the patient use heavily? - What situations have been associated with relapse in the past? • Teach coping skills, for example: problem solving; social skills; self-management skills; self monitoring of drug use and drug-related harm • Develop strategies that can be part of a relapse drill • What should the patient do in the event of a lapse occurring? • Where can they get support? • What role can friends/family provide? • How soon should the patient make an appointment to come back to your practice?Counsellors can use relapse prevention training to give drug users the skills andconfidence to avoid lapses to drug use, as well as the techniques to stop any lapses thatdo occur from becoming major relapses. A large part of this will be identifying high risksituations and learning to either avoid or to cope with them.12.3. Psychological Factors in TreatmentStages of changeWhen in contact with people seeking help with a drug problem, it is useful to considerthe concept of ‘stages of change’ to enable the targeted provision of appropriateservices.The stages of change model was developed by Prochaska and DiClemente (1986) to describe the processes involved in people trying to stop tobacco smoking, and is a useful model in understanding other forms of behaviour change. Individuals (may) pass through a number of stages during the process of behaviour change.Motivation to change is not a fixed state in a person, but rather is subject to manyforces-including the intervention of health workers. The health worker can assist clientsto move from one stage to the next-but can also contribute to the client movingbackwards. Not everyone is in an active stage-not all drug users want to stop using
    • drugs. Most people who achieve lasting changes in their behaviour do so after severalattempts. Much can be learnt from unsuccessful attempts.1. Pre-contemplation StageHappy users, who have not allowed any concerns they may have about their drug use to influence their actions. They will often not immediately recognise problems they are having as resulting from their drug use.During Pre-contemplation the pros of continuing use outweigh the cons of continueddrug use. Disadvantages of change outweigh advantages. You may be concerned aboutsome consequence of your patient’s drug use, but the patient may accept this ascollateral damage.Commonly, there is resistance to ‘action oriented interventions’ and explanations abouthow to ‘give up’, but relevant information about risks, and how to avoid or minimisethem, may be well received. For example, a person injecting amphetamines mightwelcome information about how to avoid blood borne viruses or how to manage sleepdisorders. A heroin user may be keen to get advice on how to avoid overdose.Use motivational interviewing to help the patient explore the advantages anddisadvantages of current patterns of drug use. Motivational interviewing is a method to work with ambivalence and help patients explore their reasons to change drug use. The basic Elements of motivational interviewing include: a. express empathy b. develop discrepancy c. avoid argumentation d. roll with resistance e. support self-efficacy2. Contemplation stageThey have realised that their drug use is doing harm and are weighing up the benefitsand the costs of continuing to use. The balance of costs and benefits begin to shift,although there is still ambivalence about change.Explore this ambivalence using motivational interviewing.3. Preparation StageThe balance has shifted. The patient is preparing to take action and has confidence intheir capacity to change. Change is seen as worthwhile. This is often a planning stage.Goal setting, identifying internal and external supports/ resources and identifyingstrategies to support change can help.
    • 4. Action stageThe patient is taking steps to change. Support and specific skill training can be provided.Review initial reasons that led to the decision to change. They are implementingstrategies to change their drug use pattern. They usually spend the least time in thisstage as they are either waiting to enter treatment, relapsing and returning to thinkingabout stopping or on the way to maintenance.5. Maintenance stage Patients have succeeded in stopping their harmful drug use and are concentrating on continuing that progress. An intervention technique known as relapse prevention teaches strategies for dealing with the pressures to relapse.Changes in behaviour maintained for six months or more are usually associated withsubstantial improvements in the quality of life (e.g. housing, employment, relationships,physical and mental wellbeing). Without such changes, the effort to change may notseem worth it and relapse is more likely. Encourage patients to articulate the positivereasons for maintaining change to reinforce their decisions.RelapseRelapse occurs when patients have not managed to maintain abstinence for one of anynumber of reasons. It could be a reasoned choice about the benefits of returning to druguse or it could be a slip related to a variety of emotional or social triggers. Relapse maytake the user into any of the other stages of behaviour. pre-contemplative contemplative preparation relapse active maintenanceThis diagram highlights the relapsing-remitting nature of addiction. Relapse should notbe seen as a treatment failure, but as a common characteristic of therapy. Most users willwork through this cycle several times in their drug-using careers; some will never escapeit.
    • 12.4. Quality of LifeSuccessful maintenance of change is associated with factors such as employment, thequality of relationships, financial security, housing and spiritual support (variouslydefined). You cannot be expected to address all these factors, but you may be able tofacilitate access to a range of advice and support services. These might include, but arenot limited to: • housing services • financial support services • legal advice • employment, education and training12.5. Complying to the TreatmentThe management of drug misuse and dependence presents a considerable clinicalchallenge to all practitioners. However, well-delivered treatment with good outcomesenhances the clinician’s competence and confidence in tackling these complex problemsto the benefit of the individual patient and to society.Withdrawal and detoxification regimens have a high failure rate unless linked to long-term rehabilitation. Nevertheless, complying with the overall treatment package is thekey to treatment success and monitoring progress along these lines is critical. Failure toidentify and address non-compliance at an early stage can result in loss of therapeuticendeavour and the will to change on behalf of the patient. Non-compliance withprescribed medication can actually aggravate a person’s drug problem.12.5.1. Consequences of non-compliance • The patient may take an excess of the drug and risk overdose. • The drug may get into the wrong hands, risking the safety and well-being of others. • The patient may sell the drug to purchase other illicit drugs, thereby perpetuating controlled drug misuse and contributing to the illicit market. • Diversion of methadone into the illicit market may contribute significantly to risks of death from overdose.12.5.2. Improving complianceReviewing during treatmentArrange to see the patient weekly in the first few weeks. Though change will occurslowly, a weekly consultation gives a valuable opportunity to build up a relationship oftrust and understanding. Once a patient is stable, fortnightly or monthly appointmentsmay be sufficient. A full review should be undertaken every three months. • If is the dose sufficient? - Look for signs of withdrawal or toxicity.
    • - Encourage feedback from the community pharmacist and other professionals who may be seeing the patient more frequently. • Is the patient continuing to use illegal drugs?If the patient is continuing to inject drugs, despite the obvious health risks, ensure thathe/she is obtaining safe practice of use. It may be that the doses of the substitute drugare insufficient. Continued injecting use can be confirmed by physical examination ofinjecting sites. • Is the substitute drug dose inadequate? - Consider increasing the dose by small increments on a daily or weekly basis until the signs of withdrawal have disappeared and misuse of illegal drugs reduces or ceases. - Do not continue to increase the dose if there are signs of intoxication. - Randomised collection of urine specimens every few months may be helpful. - Keep a careful note of the use of any unauthorised drugs (type, quantity and route) and ask about any legal, medical or social changes. - Review treatment goals regularly, on at least a three-monthly basis.Supervised consumptionSupervised consumption provides the best guarantee that the drug is being taken asdirected.All new patients being prescribed methadone should be required to take their daily doseunder the direct supervision of a professional.Arrangements for daily dispensing through instalment prescribing.Improving patient attendanceDrug misusers respond best when they are treated like any other patients and are ableto keep appointments on time, if it is part of a clear treatment contract. It may be easierfor them to comply where late appointments or a drop-in system are available.