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NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline title SCOPE Drug Misuse: opiate detoxification of drug misusers in the community, hospital and prison. 1.1 Short title Drug misuse detoxification 2 Background (a) (b) (c) The National Institute for Health and Clinical Excellence ( NICE or the Institute ) has commissioned the National Collaborating Centre for Mental Health to develop a clinical guideline on opiate detoxification of drug misusers in the community, hospital and prison settings for use in the NHS in England and Wales. This follows referral of the topic by the Department of Health and Welsh Assembly Government (see Appendix). The guideline will provide recommendations for good practice that are based on the best available evidence of clinical and cost effectiveness. The Institute s clinical guidelines will support the implementation of National Service Frameworks (NSFs) in those aspects of care where a Framework has been published. The statements in each NSF reflect the evidence that was used at the time the Framework was prepared. The clinical guidelines and technology appraisals published by the Institute after an NSF has been issued will have the effect of updating the Framework. NICE clinical guidelines support the role of healthcare professionals in providing care in partnership with patients, taking account of their individual needs and preferences, and ensuring that patients (and their carers and families, where appropriate) can make informed decisions about their care and treatment. 12 July 9 August 2005 Page 1 of 8

3 Clinical need for the guideline a) It is estimated that there are between 250,000 and 500,000 problem drug users in the United Kingdom, of whom about 145,000 are in treatment in any year. There is a government target of ensuring 200,000 are in effective treatment in 2008. The majority of those requiring treatment are opiate dependent (and currently or previously using illicit heroin), although the use of other drugs such as stimulants is known to be increasing. b) Severe opiate dependence is a disorder of multi-factorial aetiology, with multiple and varied perpetuating factors. It has a central feature of psychological reinforcement of repeated drug-taking behaviour and it is also has a marked withdrawal syndrome. Disturbances of the brain reward pathways may be important underlying pathological mechanisms. For this reason it is usually considered that a range of interventions may be required in addition to drug treatments. There may be associated compounding problems of family, social and criminal justice difficulties. c) For severely dependent opiate addicts and others with long-standing dependency, the disorder has characteristics of a long-term chronic relapsing disorder with periods of remission and relapse, so while abstinence may be a long-term goal for treatment this is not always achieved. Even when abstinence is achieved, it is not always clear what all the benefits are, and periods of relapse may still occur. d) The evidence for detoxification programmes including the use of a range of pharmacological interventions (including methadone, buprenorphien, lofexidine) and the appropriate settings in which to best provide these interventions is not as strong as the evidence for maintenance and harm reduction programmes. e) The societal costs of drug misuse have been estimated at many billions of pounds, with opiate dependence and other Class A drugs constituting the main cause of these costs. 12 July 9 August 2005 Page 2 of 8

f) Opiate substitution therapies (methadone and buprenorphine are most commonly used) allow the addict to replace street heroin with a longeracting, less euphoriant and safer drug while avoiding the withdrawal syndrome. Once stabilised, many patients remain on maintenance treatment, which brings improvements in illicit drug use, physical health, well-being, social stabilisation and reduced criminality and costs to society. g) Drug misusers in prison usually receive assistance with withdrawal symptoms and some receive a treatment programme in prison. Access to regular high levels of illicit drugs in prisons is limited, so most dependent drug users lose tolerance and are at risk of overdose if as commonly happens they relapse on release. h) Determining when to offer detoxification and where to provide it is often a difficult clinical decision. Clarity about the purpose of any treatment strategy is crucial because confusion between detoxification and maintenance programmes can lead to a lack of clear treatment aims and a poorer quality of care. 4 The guideline a) The guideline development process is described in detail in two publications which are available from the NICE website (see Further information ). The Guideline Development Process An overview for stakeholders, the public and the NHS describes how organisations can become involved in the development of a guideline. Guideline Development Methods Information for National Collaborating Centres and guideline developers provides advice on the technical aspects of guideline development. b) This document is the scope. It defines exactly what this guideline will (and will not) examine, and what the guideline developers will consider. The scope is based on the referral from the Department of Health (see Appendix). 12 July 9 August 2005 Page 3 of 8

c) The areas that will be addressed by the guideline are described in the following sections. 4.1 Population 4.1.1 Groups that will be covered a) Adults who misuse opiates and have been identified as suitable for for a detoxification programme. 4.1.2 Groups that will not be covered a) Adults whose primary drug of misuse is a non-opiate. b) Adults who misuse alcohol, where the primary diagnosis and focus of intervention is alcohol misuse. c) Adults who misuse other prescription drugs for example, benzodiazepines. d) Adults who misuse solvents (for example, aerosols and glue) or other street drugs (for example, LSD [lysergic acid diethylamide]). e) Adults who have been prescribed opiates and related drugs for therapeutic purposes unrelated to substance misuse. 4.2 Healthcare setting a) The guideline will be of relevance to the NHS and related organisations, including: prison services specialist residential and community-based treatment settings. b) This is an NHS guideline. Although it will comment on the interface with other services such as those provided by social services, educational services and the voluntary sector, it will not provide specific recommendations directed solely to non-nhs services. 12 July 9 August 2005 Page 4 of 8

4.3 Clinical management The guideline will cover the following areas of clinical practice and will do so in a way that is sensitive to the cultural, ethnic and religious backgrounds of drug misusers and their carers. a) The guideline will cover detoxification programmes for opiate drug misusers in community, residential, prison and inpatient settings including the type and duration of the programme. b) The guideline will identify the most appropriate programmes for specific populations of opiate drug users. c) The guideline will make recommendations on the use of methadone, buprenorphine, lofexidine and other related products in opiate detoxification programmes, and the dose and duration of use. d) The guideline will include the treatment and management of non-opiate drug and alcohol misuse in the context of an opiate detoxification programme. e) When referring to pharmacological treatments, the guideline will wherever possible recommend use within their licensed indications. However, where the evidence clearly supports it, recommendations for use outside the licensed indications may be made in exceptional circumstances. f) The guideline will include the appropriate use of psychosocial interventions to support detoxification programmes. g) The guideline will consider the safety, side effects and other disbenefits of the interventions reviewed. h) The guideline will address the integration of the interventions reviewed with a broad approach to the care and treatment of drug misusers. 12 July 9 August 2005 Page 5 of 8

i) The guideline will cover the role of the family and carers in the treatment and support of drug misusers and the provision of relevant support and information to them. 4.4 Clinical management areas that will not be covered a) The guideline will not consider diagnosis or primary prevention. b) The guideline will not consider pharmacological maintenance programmes. 4.5 Status 4.5.1 Scope This is the consultation draft of the scope, which will go through a 4 week period of consultation with stakeholders (12 July to 9 August 2005) and be reviewed by the Guidelines Review Panel and the Institute s Guidance Executive. The guideline will incorporate the following NICE guidance, which is published or in development: Methadone and buprenorphine for the treatment of opiate drug misuse. NICE Technology Appraisal. (Publication expected March 2007.) Naltrexone to prevent relapse in drug misuse. NICE Technology Appraisal. (Publication expected March 2007.) Schizophrenia: core interventions in the treatment and management of schizophrenia in primary and secondary care. NICE Clinical Guideline No. 1 (2002). Anxiety: management of anxiety (panic disorder, with or without agoraphobia and generalised anxiety disorder) in adults in primary, secondary and community care. NICE Clinical Guideline No. 22 (2004). Depression: management of depression in primary and secondary care. NICE Clinical Guideline No. 23 (2004). 12 July 9 August 2005 Page 6 of 8

Drug Misuse: psychosocial management of drug misusers in the community and in prison. NICE Clinical Guideline (in progress). 4.5.2 Guideline The development of the guideline recommendations will begin in October 2005. 5 Further information Information on the guideline development process is provided in: The Guideline Development Process An overview for stakeholders, the public and the NHS Guideline Development Methods Information for National Collaborating Centres and guideline developers These booklets are available as PDF files from the NICE website (www.nice.org.uk/guidelinesprocess). Information on the progress of the guideline will also be available from the website. 12 July 9 August 2005 Page 7 of 8

Appendix Referral from the Department of Health and Welsh Assembly Government Detoxification in opiate drug misuse The Department of Health and Welsh Assembly Government asked the institute to prepare a guideline for the NHS in England and Wales on opiate detoxification of drug misusers in the community, hospital and prison settings. The guidance will: by using the evidence base examine the effectiveness and cost effectiveness of detoxification regimes for the management of opiate misusers identify those groups of drug misusers who are most likely to benefit from detoxification regimes, and identify the key components of the effectiveness of detoxification within a wider package of pharmacological interventions, and the overall care provided for drug misusers. 12 July 9 August 2005 Page 8 of 8