Methadone Clinical Guidelines


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Methadone Clinical Guidelines

  1. 1. 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
  2. 2. 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
  3. 3. 142,000. In reality, the actual number of drug users on a regular basis is believed to be much higher(NCADP 2001, Bui 2003).Despite the recent rapid increase in amphetamine-type stimulant use in the East Asia Pacific region,heroin is still the major problem drug in the region and continues to dominate treatment demand 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
  4. 4. 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
  5. 5. with it. This will involve combining methods, that include detoxification, outpatient programs,therapeutic communities, self-help groups, and substitution treatment. The current options for 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
  6. 6. - 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
  7. 7. 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
  8. 8. 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
  9. 9. 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
  10. 10. • to enhance the autonomy of patients • to help reduce the spread of blood-borne communicable diseases associated with injecting opioid use; • to reduce transmission of infectious diseases, especially HIV, HBV and HCV • to reduce deaths associated with opioid use; • to reduce crime associated with opioid use; • to facilitate an improvement in social functioning of patients; and • to improve the economic status of patients and their 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
  11. 11. 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
  12. 12. clients, and special issues such as driving and operating machinery during treatment; • ensuring client confidentiality; • client appeals procedures; • monitoring and reporting on program performance and effectiveness; and • a commitment to staff training and development programs.2.9. Guidelines for Hazard 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
  13. 13. 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
  14. 14. • Counseling, including motivational interviewing and relapse prevention • Provide continued information and support regarding treatment, side effects, strategies to overcome challenges related to drug use • Patient follow up monitoring and review • Case management of patients • Working with families of patients to ensure adherence to treatment • Referrals to clinicians with special skills especially in the area of mental health • Referrals to social welfare services Dispensers • To ensure that the right methadone mixture is prepared and dispensed to the right patient ( 2 dispensers are required for this task) • To ensure that patients have consumed methadone and chances of deviation are minimal or none. • To observe patients for toxicity and withdrawal after dispensing • To provide feedback to doctors regarding toxicity and withdrawals experienced by 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
  15. 15. 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
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 19. 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
  20. 20. 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
  21. 21. 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
  22. 22. 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
  23. 23. 2. Doctors should not prescribe substitute medication, such as methadone, in isolation. A multidisciplinary approach to drug treatment is essential.3. Prescribing is the particular responsibility of the doctor signing the prescription. The responsibility cannot be delegated.4. A doctor prescribing controlled drugs for the management of drug dependence should have an understanding of the basic pharmacology, toxicology and clinical indications for the use of the drug, dose regime and therapeutic monitoring strategy.5. A full assessment of the patient, in conjunction with other professionals involved, should always be undertaken and treatment goals set.6. The clinician has a responsibility to ensure that the patient receives the correct dose and that appropriate efforts are taken to ensure that the drug is used appropriately and not diverted onto the illegal market. Particular care must be taken with induction on to any substitute medication, especially where self-reporting of dosage is being relied upon.7. Supervised consumption is recommended for all prescriptions.8. The prescribing doctor should liaise regularly with the dispensing nurse about the specific patient and the prescribing regime.9. Clinical reviews should be undertaken regularly, at least every three months, particularly in patients whose drug use remains unstable.10. Thorough, clearly written records of prescribing should be kept.Prescribing 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
  24. 24. - help to maintain contact and offer an opportunity to work with the patient.A methadone prescription should only be considered if: - methadone is being taken on a regular basis – particularly for daily use; - there is convincing evidence of current dependence (including objective signs of withdrawal symptoms wherever possible); - the patient is motivated to change at least some aspects of their drug use; - the assessment clearly substantiates the need for treatment; - the doctor is satisfied that the patient will co-operate and demonstrate adequate compliance with the prescribing regime.Setting 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
  25. 25. - As a general principle, substitute drugs should be dispensed on a daily basis.- Supervised consumption should be arranged with the most appropriate clinic staff, e.g. clinic nurse,- Should we include a step – engaging the clients in a short discussion after they have taken the drugs? *** (Should be in SOP)Issue of 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
  26. 26. 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
  27. 27. • If there is no current physical dependence MMT will not usually be appropriate. • For those not physically dependent at the time of presentation, the prescribing practitioner must clearly document that the potential benefits to the individual’s health and social functioning outweigh the disadvantages of MMT. Inclusion criteria for Methadone Treatment: • Opioid dependants • Over 18 years of age • Have been a resident of Hai Phong for 2 years • Drug habit that have brought about negative bio-psycho- psocial 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
  28. 28. 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
  29. 29. - Phaeochromocytoma: aggravated hypertension has been reported in association with heroin use - Asthma and other respiratory conditions: In such patients even usual therapeutic doses of opioids may decrease the respiratory drive associated with increased airways resistance - Special risk patients: Methadone should be used with caution in the presence of hypothyroidism, adrenocortical insufficiency, hypopituitarism, prostatic hypertrophy, urethral stricture, shock and diabetes mellitus - Poor compliance: patients who exhibit poor compliance with treatment for major intercurrent illness such as asthma or diabetes pose a particular challenge in MMT. CAUTION with patients in any of the following categories: • high risk polydrug use • co-occurring alcohol dependence • history of reduction in opioid tolerance • psychiatric illness • concomitant medical 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
  30. 30. - There should be procedures in place for protecting clients’ personal information. - There should be a formal mechanism, established at the jurisdictional level, for resolving grievances between clients and those responsible for their treatment. Clients should have the right of access to these procedures and be informed of them at the commencement of treatment and on request thereafter.6.7. Informed Consent and Patient 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
  31. 31. 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
  32. 32. 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
  33. 33. Opioid use- The age of starting drug use (including alcohol and nicotine), age of regular use, age of dependence- Types and quantities of drugs taken (including concomitant alcohol misuse)- Frequency of use and routes of administration- Time of last use and dose- Duration of current use- Severity of dependence (see Section 8 page 41, Appendix 7) Need to change- Periods of abstinence. If yes, triggers for relapse.- Symptoms experienced when unable to obtain their drugs.- Cost of drug /alcohol misuse- Experience of 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
  34. 34. The Objective Opiate Withdrawal Scale (OOWS) (see Appendix 5) Or Clinical Opiate Withdrawal Scale (COWS) - see Appendix 6 (Need to choose COWS)7.5. Health 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
  35. 35. - Any previous episodes of depression or psychosis - Treatment with any psychotropic or analgesics at any time - Risk of suicide and self-harm. - Drug of misuse often has a psychoactive component, e.g. can cause hallucinations (cocaine), depression or anxiety, either during use or as part of withdrawal. - General behaviour: e.g. restlessness, anxiety, irritability can be caused by either - intoxication with stimulants or hallucinogens, or by withdrawal from opiates. - Mood: depression can be caused by withdrawal from stimulants (eg. amphetamine withdrawal) or by alcohol or sedative drugs. Assess the risk of self-harm. - Delusions and hallucinations: common with stimulant and hallucinogens use. - Confusional states - Referral to an addiction mental health specialist for a full mental health assessment may be required before starting treatment for addiction.7.6. Psychosocial 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
  36. 36. - 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
  37. 37. - 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
  38. 38. Before any test, full informed consent should be obtained from the patient, and appropriate counseling should be provided for certain infectious diseases (e.g., HIV, hepatitis C). Abnormalities or medical problems detected by laboratory evaluation should be addressed as they would be for patients who are not addicted. 7.10.1. Urine assessment Urine analysis should be regarded as an adjunct to the history and examination in confirming drug use, and should be obtained at the outset of prescribing and randomly throughout treatment. Results should always be interpreted in the light of clinical findings, as false negatives and positives can occur. If the drug user is dependent, opiates persist in the urine for up to 24 hours (methadone up to 48 hours). Approximate drug detection times in urine are shown below in Appendix 6. A negative test does not necessarily mean that the patient is not using an opioid. It may mean that the patient has not used an opioid within a period of time sufficient to produce measurable metabolic products or that the patient was not using the drug for which he or she was tested. As with any patient, the clinician is alerted to a spectrum of possibilities and works with the patient using the information collected from the toxicology screen. Toxicology testing for drugs of abuse that takes place at scheduled visits cannot be truly random; nevertheless, it is clinically worthwhile. 7.11. Suitability for Methadone 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
  39. 39. • 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