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Prescribing for Dependence Policy Document Control Summary Ratified by: Date ratified: Authors: Integrated Governance Committee Feb 2017 Pharmacy Services, DTC Accountable Director: Medical Director Date issued: March 2017 Review date: Feb 2020 Target audience: All trust staff involved in addiction services and prescribing for addictions in SWLStGs Name of responsible committee: Drugs & Therapeutics Committee Policy Number: TWC21f 1 Version Control Summary Version Date Status Comments/changes 2.6 Dec 2011 Review 2.7 2.8 Sept 2012 Dec 2013 Aug 2014 Sept 2014 October 2014 Final 2.9 2.10 Dec 2014 April 2015 Final Final 2.11 Aug 2015 Final 3.0 Jan 2016 Draft Suboxone® & HTT alcohol detox amendments Addition of SROM and QTc advice Equivalencies to diazepam 5mg and their half-lives updated and equivalent doses of phenobarbital for common sedative hypnotic drugs added Procedure for the dispensing of methadone/buprenorphine to a third party and risk management. For the purposes of overseas travel by service users only, methadone 5mg tablets given formulary status. 7.1.4 Additional physical health monitoring at alcohol detox baseline. Alcohol detox: chlordiazepoxide switched to diazepam, which is now recommended first line. Summary One p7, 13.8, 16.10. Diazepam for alcohol detox simplified and SADQ reviewed by Dr K Chawla. Summary one p7, 13.8, 16.10. 13.1 DH Guidance on keeping health risks from drinking to a low level added. Feb 2016 8.1 Hepatitis B Vaccination added Apr 2016 Updated Summary 2, Prescribing benzodiazepines & management of benzodiazepine withdrawal and para 15. Equivalent doses of oral benzodiazepines.8.11.3: Statement added about missed methadone doses 8.12.4: Duration of missed buprenorphine doses amended from 5 days to 3 days. Added Appendix 8 (Prescribing Guidelines for Medicines used for abstinence or harmful drinking reduction) Oct 2016 Jan 2017 Feb 2017 2 Added para 8.9 & Appendix 9 (Management of Opioid Overdose in an Emergency) Section 9.5 & Summary 3: Updated choice of treatment for symptomatic treatment of opiate detoxification regime Added para 8.8 & Appendix 10 –take home naloxone protocol Added Appendix 12 Glossary of Acronyms Para 13.12 Alcohol withdrawal seizures states 5mg rectal diazepam for elderly patients –agreed to change this to 10mg, to bring in line with BNF and contents of ILS bags Para 15.8 BDZs for hypnotic use – 2nd line choice changed to zolpidem as temazepam non-formulary. Deleted triclofos, chloral hydrate and flurazepam as non-formulary. Contents Section 1 2 3 4 5 6 7 8 9 3 Title Executive Summary & Introduction Contents Summary 1 Alcohol withdrawal treatment for inpatient psychiatric wards Page 6 Summary 2 Prescribing benzodiazepines & management of benzodiazepine withdrawal 7 Summary 3 Prescribing opiates for addiction on admission to inpatient Psychiatric wards 9 Purpose Duties Ratification Process Consultation Process Training Needs Monitoring compliance with the policy Prescribing for 8.1 Assessment opiate 8.2 Decision for inpatient or outpatient detox dependence 8.3 Driving motor vehicles 8.4 Opiate initiation 8.5 Dispensing 8.5.1 Interval dispensing 8.5.2 Dispensing to a third party 8.5.3 Holiday prescriptions & travelling abroad 8.6 Management of additional illicit opiate use with treatment 8.7 Criteria for the Discontinuation of Prescriptions 8.8 Take-home Naloxone 8.9 Management of Opioid Overdose in an emergency (see Appendix 9) 8.10 Initiation of Opiate Prescribing in the Community 8.11 Methadone 8.11.1 Methadone: adverse effects and toxicity 8.11.2 Methadone in pregnancy and lactation. 8.11.3 Methadone titration 8.12 Buprenorphine 8.12.1 Contraindications, interactions & cautions 8.12.2 Adverse effects & toxicity 8.12.3 Pregnancy & Lactation 8.12.4 Titration 8.12.5 Transfer from Methadone to Buprenorphine 8.12.6 Transfer from Buprenorphine to Methadone 8.13 Suboxone® 8.14 Other Oral Opioids Sometimes Used for Maintenance 8.14.1 Dihydrocodeine 8.14.2 Slow Release Oral Morphine (SROM) Opiate 9.1 Pregnancy Detoxification 9.2 Methadone Regimes 9.2.1 QTc prolongation 9.3 Buprenorphine 9.4 Lofexidine 9.4.1 Side Effects/Precautions 9.4.2 Pregnancy and Lactation 9.4.3 Treatment Guidelines 9.5 Other symptomatic treatment 9.6 Inpatient Opiate Induction and Detoxification 10 10 10 10 10 11 11 21 10 11 Injectable Opiates Preventing 11.1 relapse with 11.2 Naltrexone 11.3 11.4 11.5 12 13 Management of pain when on opiates and/or naltrexone for addiction Prescribing for 13.1 Guidance on keeping health risks from drinking to a low Alcohol level; assessment & deciding on treatment dependence 13.1.1 Community & HTT detoxification 13.1.2 Inpatient detoxification 13.1.3 HTT detoxification 14 GBL Detoxification Protocol 15 Benzodiazepine & Z-drug prescribing 4 Contra-indications, interactions and precautions Pregnancy and lactation Adverse effects and toxicity Management of naltrexone precipitated withdrawal Naltrexone Challenge & Maintenance treatment 13.2 Alcohol Withdrawal Syndrome 13.3 Early withdrawal symptoms 13.4 Withdrawal fits (seizures) 13.5 Severe withdrawal/delirium tremens 13.6 Protracted withdrawal syndrome 13.7 Measurement of Withdrawal 13.8 Management of alcohol withdrawal 13.8.1 Community & HTT detox 13.8.2 Severe withdrawal or Delirium Tremens 13.8.3 Withdrawal fits or status epilepticus 13.8.4 Severe behavioural disturbance 13.8.5 Vitamin supplements 13.8.6 Chlormethiazole (Heminevrin) 13.8.7 Wernicke’s encephalopathy (WE) 13.9 Observation and monitoring 13.10 Alcohol or drug use in inpatients 13.11 Planning aftercare 13.12 Alcohol withdrawal seizures 13.13 Medication for alcohol relapse prevention 13.13.1 Acamprosate 13.13.2 Disulfiram 13.13.3 Naltrexone 14.1 Detoxification 14.2 Prescribing baclofen 14.3 GBL detoxification regimen 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9 Indications Adverse Effects of benzodiazepines and Z-drugs Dependence risk Prescribing guidance Long term prescribing Anxiolytic uses MHRA & NICE Advice Hypnotic Uses Benzodiazepine Withdrawal 15.9.1 Features of Withdrawal 15.9.2 Management of Benzodiazepine or Z-drug Withdrawal 15.9.3 Withdrawal Regimes 15.9.4 Follow up advice 15.10 Benzodiazepine Abuse and Dependence 15.10.1 Assessment of Dependence 15.10.2 Prescribing in Dependence 15.10.3 Maintenance prescribing 25 26 28 29 37 38 15.10.4 Inpatient treatment 15.10.5 Benzodiazepines in the elderly 16 CAMHS prescribing for substance misuse protocol 16.1 Introduction & Consultation Process 16.2 Purpose 16.2.1 Duties 16.3 Prescribing for 16/17 year olds 16.4 Prescribing to Young People under 16 years 16.5 Inclusion criteria for community prescribing 16.6 Practice/Procedure 16.6.1 Authorisation from Commissioners 16.6.2 Pre-treatment Assessment for prescribing purposes 16.6.3 Process to be followed if young person is in Tier 3 CAMHS 16.6.3.1 Initial assessment 16.6.3.2 Second stage assessment 16.6.3.3 Third stage assessment 16.6.3.4 Meeting with Initiating Consultant 16.6.3.5 Joint meetings 16.7 Process to be followed if young person is referred by Barnardo’s 16.8 Recording of information 16.9 Prescribing for Young people 16.9.1 Considerations for young people when prescribing. 16.9.2 Treatment of Opioid Dependence 16.10 Alcohol Detoxification 16.11 Benzodiazepines 16.12 Role of the care co-ordinator 44 Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 Appendix 7 Appendix 8 CIWA-AR (Modified)* SADQ (Severity of alcohol dependence questionnaire) AUDIT (Alcohol Use Disorders Identification Test) Objective Opiate Withdrawal scale (OOWS) Titration for opiate users CAMHs consent form for drug treatment Child needs risk assessment tool for clients in primary care Prescribing Guidelines for Medicines used for abstinence (Naltrexone, Disulfiram, Acamprosate) or harmful drinking reduction (Nalmefene) Management of opioid overdose in an emergency in adults and children over 12 years old Take home naloxone protocol Equality Impact Assessment Glossary of Acronyms References 52 54 55 56 57 58 59 61 Appendix 9 Appendix 10 Appendix 11 Appendix 12 Appendix 13 5 66 70 74 75 76 1. Executive Summary This document outlines the Trust’s prescribing policy for the treatment of dependence. This policy provides guidance for trust staff to prescribe, dispense and administer such medicines, thus enabling the Trust to minimise and manage the associated risks, as well as treating dependent patients using the available evidence base to inform practice. 6 Summary 1, Alcohol withdrawal treatment for inpatient psychiatric wards (see full guideline and SmPC for advice) v3.0 MODERATE SEVERE VERY SEVERE Alcohol units/day 20- 30 31 - 44 45 + SADQ 20-30 31 - 44 45 - 60 CIWA-AR 10-20 Severity Day 1 (Diazepam should be used first-line for the acute management of alcohol withdrawal) 10mg TDS Day 2 10mg AM 5mg MD 10mg PM Day 3 Day 4 >20 15mg TDS 20mg 20mg TDS 3-4 times a day 5mg AM 5mg MD 10mg PM 5mg TDS 15mg AM 20mg AM 10mg MD 15mg MD 15mg PM 20mg PM 10mg AM 15mg AM 20mg TDS 20mg AM 10mg MD 15mg MD 15mg MD 15mg PM 20mg PM 20mg PM 10mg TDS 15mg TDS Day 6 Day 7 5mg BD 5mg ON 10mg AM 15mg AM 5mg MD 10mg MD 10mg PM 15mg PM 15mg TDS 5mg AM 10mg AM 15mg AM 5mg MD 10mg MD 10mg MD 10mg ON 15mg PM 15mg PM 5mg TDS 10mg TDS 10mg AM, MD 15mg PM 10mg AM Day 8 5mg BD 5mg MD 10mg TDS 10mg PM 5mg AM Day 9 5mg ON 10mg AM 5mg MD 5mg MD 10mg PM 10mg PM 5mg AM, MD Day 10 5mg TDS 10mg PM 7 Day 11 5mg BD 5mg TDS Day 12 5mg ON 5mg BD Day 13 Vitamins -Offer ONE pair IM pabrinex OD for at least 3-5 days to all harmful or dependent drinkers who may possibly be malnourished or have decompensated liver disease. -After parental treatment offer oral thiamine 100mg TDS and vitamin B Co strong 2/day. -Patients showing sign of Wernicke’s Encephalopathy require IV pabrinex TWO pairs TDS IV at an Acute Hospital for supported treatment. 15mg AM,MD 20mg PM Day 5 Assessment -All patients asked alcohol normally consumed/week using AUDIT C. Full history for male patients drinking > 4 units and female patients > 3 units a day. Full AUDIT -Full history: drinking pattern, time of last drink, previous withdrawal symptoms or Delirium Tremens, tolerance, morning drinking, prioritization of drinking causing other problems (physical health, mental health, social or family life, work, financial or legal matters). Other possible organic causes. -INVESTIGATIONS: Physical appearance, INR, blood glucose, MCV, LFTs, Gamma GT, other drugs, and alcohol breath test (where possible). Respiratory rate, blood pressure, pulse and temperature 2 hourly in the first 24hrs then at least twice daily during detox. -Measure severity of withdrawal and dependence using SADQ and CIWA-AR -Ensure ‘when required’ long acting benzodiazepines are prescribed for the first 48hrs only when prescribing a fixed benzodiazepine regimen. 5mg ON Signs of withdrawal anxiety/agitation/irritability, nausea/vomiting/diarrhoea, convulsions, tremor of hands, tongue or eyelids, insomnia, hallucinations, sweating, fever with or without infection delirium, tachycardia &hypertension. See rating scale in full policy. Sign of Delirium Tremens (seen in 5% of severe withdrawals) Severe tremor, clouding of consciousness, delusions, confusion and disorientation, tachycardia >100/min, agitation, violent behaviour, delirium, fever with or without infection: temperature > 101°F/38.3°C and severe hallucinations (mainly visual, may be tactile or auditory) often causing extreme fear. Signs of Wernicke’s Encephalopathy (Send patient to an acute hospital for treatment) Ataxia (23%), hypothermia and hypotension, confusion (82%), ophthalmoplegia (29%) or nystagmus, memory disturbances, coma or unconsciousness. The ‘classic triad’ of symptoms occurs in only 10% of patients. Other Notes - Diazepam should be used first-line for the acute management of alcohol withdrawal. - Lorazepam may be required in the elderly or liver impairment. -25mg Chlordiazepoxide=10mg diazepam=1mg lorazepam -Delirium Tremens treatment. 1st line: reorientation, calm environment & pharmacological: long acting benzodiazepines. -Antipsychotics may be used for behavioural disturbance and paradoxical effects of benzodiazepines: haloperidol 2.5/5mg po/IM or olanzapine. Seizure threshold may be lowered and less effective than benzodiazepines for DTs. -Seizure treatment diazepam 5-10mg PR repeated 5 mins later if needed. -Diazepam should NOT be prescribed on discharge from inpatients. -Contact senior doctor for advice in difficult cases. Summary 2, Prescribing benzodiazepines & management of benzodiazepine withdrawal (see full guideline and SmPC for advice) v3.0 Benzodiazepine & Z-drug prescribing advice Use lowest benzodiazepine dose for briefest time: o no more than 2-4 weeks for hypnotics o Up to 4 weeks for anxiolytics Use only one benzodiazepine (give a long-acting type at night if need both a hypnotic & an anxiolytic effect) at any one time Do NOT exceed BNF dosing limits Reduce gradually after both short term & long term use (> 2 weeks) Only use in acute self-limiting situations/conditions Only use for severe symptoms (never mild symptoms) Do not routinely use in those with a history of addiction Patients who have not responded to one z-drug/benzodiazepine hypnotic should not be prescribed another. Another class of sedative may be tried e.g. promethazine. Prescribe a maximum of up to 30 days at a time Only give benzodiazepines longer term if treatment remains effective, reduces core symptoms of disorder, tolerance is incomplete Benzodiazepines are for short term relief (2-4 weeks only) of severe anxiety that is disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short term psychosomatic, organic or psychotic illness. 1st line treatment for insomnia is zopiclone. Avoid in children & adolescents, sedative antihistamines may be preferable Prescribing Benzodiazepines & Z-drugs in the elderly Increased sensitivity to the side-effects and drugs may accumulate. Half the normal dose should be used in frail elderly or those with renal impairment. Shorter acting benzodiazepines are preferable e.g. lorazepam. Equivalencies to Diazepam 5mg and their half-lives (hours) Chlordiazepoxide 12.5–15mg 6-12 nitrazepam 5mg 18-36 Oxazepam* 10mg 3-6 Clobazam 10mg 9-77 15mg clonazepam 250micrograms – 5-11 20-60 Temazepam* 10 mg 1mg Loprazolam* 500microgramszopiclone 3.75mg 3.5-6 6-20 1mg Lormetazepam* lorazepam 500 8-25 10 500micrograms-1mg micrograms Half-lives may double in the elderly or those with renal impairmentSee SmPC or contact Medicines Information for further advice 8 Benzodiazepine & Z-drug dependence Features of Benzodiazepine withdrawal Mostly occur on abrupt withdrawal (or after several days with long acting medicines): Anxiety, panic attacks, agoraphobia, insomnia, nightmares, depression, poor memory, loss of concentration & confusion, tremor, sweating, palpitations, perceptual distortions, depersonalization, hallucinations, psychotic symptoms, tingling and loss of sensation, formication, sensory hypersensitivity, muscle twitches and convulsions (rare). Assessment of Dependence Establish if there is physical dependence or not and should include: Daily use or not. Amount used and pattern (minimum and maximum dose) Duration of daily use (not all daily users are physically dependent) and duration of misuse overall. Presence of withdrawal symptoms, physical dependence and history of epileptic fits Previous prescribing and outcome of treatment Management of withdrawal Ideally switch to diazepam before commencing detox Withdraw in steps of 5-10% of daily dose every 1-2 weeks (can take over a year to complete schedule). Withdrawal schedules need to be flexible, tailored and agreed with the individual. Whenever possible, give the patient control of their withdrawal schedule. Provide agreed short-term goals of the withdrawal schedule in writing, review frequently and adjust as necessary. Design the schedule around the individual’s symptoms Avoid increases in dose whenever possible Advise against the use of recreational drugs or alcohol, to manage anxiety or insomnia during withdrawal Review 3-monthly Refer to addictions for: very high doses, intensive behavioural therapies, repeated withdrawal failures, severe complications post-withdrawal or simultaneous dependence on other substances. Summary 3, Prescribing opiates for addiction on admission to inpatient psychiatric (see guideline and SmPC for full advice) v3.0 Consider: -Use of heroin, diamorphine, methadone, other opiates (dihyrocodeine & buprenorphine), benzodiazepines & alcohol. -UDS must be completed. -Give written information on methadone treatment (e.g. methadone handbook). -Physical examination: examine injection sites, BP, pulse, BM and ECG, full blood count, urea and electrolytes, liver function tests with gamma glutamyl transferase (GGT), offer Hepatitis C testing and Hepatitis B vaccination, advise on blood borne viruses. Consider referral for HIV screening. -Do not prescribe to those clearly intoxicated. Obtain accurate drug history Confirm the dose of any opiate dependence treatment from a reputable source. Confirm: dose, prescriber and clinic details, dispensing pharmacy including last date picked up. Does the person have opiate treatment from an NHS or publicly funded institution? Yes No Continue on same maintenance dose. Let the relevant agency know the patient has been admitted. Methadone –use PRN regimen below -Refer to Community Drug and Alcohol Teams if the patient is interested, as soon as practicable Use the PRN regimen for private patients. PRN Methadone Regimen DAY 1 -Prescribe: “10mg (10mL) methadone liquid, 1mg/mL PRN max 40mg/24hurs When OOWS score 4 double ticks or more give a dose (see appendix 4). Dr Review after 40mg given” -Monitor the patient hourly using the opiate objective withdrawal scale (OOWS) for the first 4 hours, or until there are no further symptoms. Once signs of withdrawal have stopped monitor 4 hourly. -If signs of withdrawal persist after 40mg has been given and 4 hours has passed since the last dose, 10mg doses may be given four hours apart. Max total dose: 60mg in 24hours. Reasons for further doses must be documented in the notes. -Most cases will be managed with 40mg in the first 24 hours, severe cases may need 60mg. Contact a specialist should more then 60mg be needed. DAY 2 onward -STOP PRN dosing and give the total dose given on day 1. Further dose increases should be no more than 5-10mg on one day and no more than 30mg in the first week. Contact drug and alcohol services for advice. Other supportive treatment: -Diarrhoea: Loperamide 4mg immediately followed by 2mg after each loose stool for up to 5 days. Usual dose 6-8mg Maximum dose 16mg/24hours. -Nausea/vomiting: metoclopramide 10mg tds Stomach cramps: hyoscine butylbromide 20mg qds -Agitation /insomnia: promethazine 2550mg, max 100mg/24hrs, at night for hypnotic effect. Z-drugs and benzodiazepines should be avoided for insomnia, however if short courses of 3 days are used, they should be prescribed along with good sleep hygiene advice. -Muscular pain/headaches: paracetamol or NSAIDs. On discharge: Inform the relevant agency. Opiates are not routinely dispensed. 9 2. Purpose The purpose of this policy is to detail the procedures to be followed within South West London & St. George’s Mental Health Trust to ensure safe treatment of substance dependence. 3. Duties This policy will be reviewed on receipt of further national guidance, or in the event of any related critical incident. In the absence of either of these events, it will be reviewed on or before the date shown on the front cover page. 4. Ratification Process Key Area Clinical Lead Director Medical Director Working Group Drug & Therapeutics Committee Ratification Body Quality Governance Committee 5. Consultation Process This policy has been informed by national guidance and discussed in the Drugs & Therapeutics Committee (DTC) and with specific input from Trust Addictions Services. Comments from previous policies for the prescribing Z-drugs, benzodiazepines and opiates have been merged into this policy. An Equality Impact Assessment has been performed which identifies that the policy does not affect one group less or more favourably than another on the basis of race, ethnic origin, etc. 6. Training In order to ensure the health, safety and well-being of our service users and staff, the Trust aims to address the needs and impact of its corporate, mandatory and statutory training with a comprehensive and robust training needs analysis procedure. To this end, all Trust policies which have risk management training needs for permanent staff are included in the “Corporate, Mandatory and Statutory Training Policy & Training Needs Analysis Document” as managed by the Training and Development Department. This document is available on the Trust intranet. The following responsibilities should be noted:The policy author Service Directors (directly or by delegation) Staff Training & Development Department 10 Inform the Training & Development Department of any amendments to policy training needs Ensure all permanent staff are adequately trained as appropriate to the employee’s duties and work location, and to follow up on refresher training needs. This includes medical, nursing and any other Borough based Addictions staff involved with medication. Training is provided to new staff as part of the Team’s induction programme. Ensure that they attend all relevant training as detailed in their induction and annual development review. Provide access to training for all permanent staff. To maintain monitoring, reporting and review systems as per the “Corporate, Mandatory and Statutory Training Policy” 7. Monitoring compliance and effectiveness of this policy Compliance and effectiveness of this policy will be monitored, where possible, by the DTC. Element to be monitored Lead Tool Frequency Reporting arrangements Inpatient Psychiatric ward alcohol detox prescribing (POMH UK). Drugs and alcohol Clinical lead on DTC. FP10 CD prescribing to be audited in line with Medicines Code audit tool. CDs 3 monthly as part of medicines code. CD audit reports will go to Clinical governance groups. Prescribing of CDs as part of the routine monitoring recommended by the Medicines Code. 8.0 Chief Pharmacist Ward CDs are audited as per the Trust medicines code. CD reports to be sent to Trust Clinical Governance. Clinical audit to be sent to DTC. Clinical audits of prescribing for dependence will go to DTC. Actions and main outcomes will be documented in the minutes. DTC will interrogate the report and highlight deficiencies. Acting on recommendations and Lead(s) Actions for CD audits will be undertaken as per the Medicines Code. Actions from Clinical audits of prescribing for dependence will be held by the DTC and monitored by the DTC. Change in practice and lessons to be shared Required changes to practice will be identified and actioned within a specific time frame. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders. Prescribing for Opiate Dependence Opiates are psychoactive substances which can cause a multitude of effects including analgesia, euphoria, constipation, drowsiness and respiratory depression. Their euphoric effects and action on the reward system within the brain means they have a high potential for abuse. In the UK there are over 250,000 people using heroin problematically either by smoking, IM or IV routes. There are significant harms associated with heroin misuse. These range from crime and child neglect to the transmission of blood borne viruses such as hepatitis B, C and HIV through the sharing of injecting equipment. Treatment is effective in reducing the medical, psychological and social problems associated with opiate dependence. The overall aims of treatment are to: Remain healthy, until ready to achieve a Reduce the need for criminal activity to finance drug-free life drugs Stabilise on substitute medication to alleviate Minimise the risk of prescribed drugs being diverted withdrawal on to the illegal drug market; Reduce the use of illicit or non-prescribed Improve overall personal, social and family drugs functioning Deal with problems related to drug misuse Achieve a safe detoxification programme, minimising risks of adverse events. Reduce the dangers associated with drug misuse, particularly the risks of HIV, hepatitis Engage in treatment programmes and ongoing B and C, and other blood-borne infections psychosocial therapies. Reduce the duration of episodes of drug misuse Prescribing for opiate dependence may include: Stabilisation (e.g. methadone or buprenorphine ) Maintenance (e.g. methadone or buprenorphine ) Detoxification (e.g. using opioid or non-opioid medications) Relapse prevention (e.g. naltrexone) Whilst stabilisation followed by detox is the goal of some service users, longer term prescribing is a more realistic option for others. Longer term prescribing (two years or longer) has been demonstrated to reduce injecting, other drug use and criminal activity. Patients on treatment for two or more years are 10 times less likely to be successfully detoxed. Discussions and a goal for detox should be stated with every patient. 11 8.1 Assessment of prescribing opiates for dependence Opiate substitution therapy must only be prescribed after a full assessment of the patient and is indicated only if the diagnosis of opiate dependence is established by toxicological testing (e.g. urine or saliva). i However a negative toxicology screen does not exclude dependence and toxicology testing must also be interpreted in the context of history and examination. Baseline examination: physical examination (examine injection sites, BP, pulse, BM and ECG if available), full blood count, urea and electrolytes, liver function tests with gamma glutamyl transferase (GGT), consider referral for HIV screening. Appropriate interventions should be offered for those with a history of harmful or dependent levels of drinking. Advise on blood borne viruses, offer Hepatitis C testing Offer Hepatitis B vaccination. To aid with harm reduction programmes and in situations where an advantage for patient care is established without comprising patient safety the vaccine may be administered under a Patient Group Direction (PGD) by approved, trained and fully registered nurses. Refer to the PGD for details. Information should be provided with the initial written care plan (e.g. The Methadone Handbook (Preston, 1992) or Subutex… your guide (Schering-Plough, 2002) including information on: blood borne viruses, safer injecting, sexual practices, storage of opiates in the home, methadone effects and side effects and the effect of opiate overdose and how to manage others who overdose. 8.2 Decision for inpatient or outpatient stabilisation & detoxification A decision between either in-patient or out-patient settings for stabilisation and detoxification will depend upon an assessment of risks, which may include the following: History of seizures or delirium Diabetes Exceptionally high dosage (particularly Mental illness including organic brain damage short acting depressant drugs) Pregnancy Poly drug use/ chaotic drug use History of DVT/PE Poly pharmacy Poor social support network e.g. homelessness. Elderly and debilitated Childcare responsibilities Hypertension or ischaemic heart disease Poor mobility Significant renal or liver impairment 8.3 Driving motor vehicles The driving and vehicle licence agency (DVLA), through their drivers’ medical unit issues comprehensive guidance in “At a glance Guide to the current Medical Standards of Fitness to Drive” http://www.dvla.gov.uk This guidance refers to substance misuse including alcohol misuse amongst other conditions. It is the duty of the licence holder to notify the DVLA of any condition which may affect safe driving; the DVLA is then legally responsible for deciding if a person is medically unfit to drive. A patient on a consultant supervised oral methadone/ buprenorphine programme may be allowed to hold an ordinary car driving licence, see DVLA Guidance as above. The General Medical Council has issued guidance to doctors in relation to their responsibilities (GMC, 2013, accessed 13/2/2017 Further information at www.gmc-uk.org. ). The Driver and Vehicle Licensing Agency (DVLA)1 and Driver and Vehicle Agency (DVA)2 are legally responsible for deciding if a person is medically unfit to drive. This means they need to know if a driving licence holder has a condition or is undergoing treatment that may now, or in the future, affect their safety as a driver. You should seek the advice of an experienced colleague or the DVLA or DVA’s medical adviser if you are not sure whether a patient may be unfit to drive. You should keep under review any decision that they are fit, particularly if the patient’s condition or treatments change. The DVLA’s publication Assessing fitness to drive – a guide for medical professionals3 includes information about a variety of disorders and conditions that can impair a patient’s fitness to drive. The driver is legally responsible for informing the DVLA or DVA about such a condition or treatment. However, if a patient has such a condition, you should explain to the patient: 13 a. that the condition may affect their ability to drive (if the patient is incapable of understanding this advice, for example, because of dementia, you should inform the DVLA or DVA immediately), and b. that they have a legal duty to inform the DVLA or DVA about the condition. If a patient refuses to accept the diagnosis, or the effect of the condition on their ability to drive, you can suggest that they seek a second opinion, and help arrange for them to do so. You should advise the patient not to drive in the meantime. If a patient continues to drive when they may not be fit to do so, you should make every reasonable effort to persuade them to stop. As long as the patient agrees, you may discuss your concerns with their relatives, friends or carers. If you do not manage to persuade the patient to stop driving, or you discover that they are continuing to drive against your advice, you should contact the DVLA or DVA immediately and disclose any relevant medical information, in confidence, to the medical adviser. Before contacting the DVLA or DVA you should try to inform the patient of your decision to disclose personal information. You should then also inform the patient in writing once you have done so. 8.4 Opiate initiation On initiation review patients regularly (at least every few days if the dose is increased), check BP, pulse and ensure that the short opiate withdrawal signs and symptoms chart is completed at each attendance (Appendix 1). After initial stabilisation is complete, patients should be reviewed weekly until there is stable compliance and absence of other risks. Maintenance prescribing should be reviewed every 6 months with clinician and patient. Urine toxicology should be regularly obtained if possible and appropriate. Usually the treating team have the sole responsibility of supplying the prescription to the service user. Some SWLSTG addiction services run schemes in partnership with other providers. It is good practice for these arrangements to be supported by clear protocols, supervision and clinical governance structures. If a service user attends clearly intoxicated from either alcohol or drugs of dependence, medication should not be dispensed nor a prescription given, due to the risks of overdose and the service user should be invited to attend later that day or the following day. 8.5 Dispensing 8.5.1 Interval dispensing Daily-supervised consumption is usually recommended for the first 3 months, though this is dependent on individual circumstances e.g. employment, education, those with infants or pregnancy. Supervised consumption can be reviewed at any time if circumstances dictate and can be seen as a sign of progress if: the patient is not presenting other risk behaviour (i.e. additional illicit drug use, high levels of alcohol consumption, unstable mental health), or likely to divert the medication and not at risk of exploitation for their prescription. A stepped approach can be used to relax supervision for example: initially daily dispensing then twice weekly and weekly dispensing. Evidence of instability should result in review and possible return to daily supervised consumption. 8.5.2 Dispensing of methadone/buprenorphine to a third party It is recognised that there will be times when someone other than the client needs to collect methadone/buprenorphine on their behalf. This may be through reasons of ill health, disability, carer’s responsibility or work. Arrangements for collection by a third party will normally be on a short term basis and reviewed when the client is seen or through discussion with the client’s carer in the case of longer term illness. Although in law there is nothing to prevent the service user making this request to the chemist themselves, anyone prescribed methadone/buprenorphine by a Trust Team will be required to make this request to the Team via their Care Co-ordinator. 14 Where possible all requests for collection by 3rd parties will be discussed in the MDT meeting and a decision made on the basis of current/past illicit use, present/past psychiatric and physical health history, past and present engagement with services and individual client circumstances. Where it is not possible to wait until the MDT meeting the Care Co-ordinator will discuss the request with the senior nurse on duty and the Doctor on duty. A risk assessment should be carried out on each individual client and be ongoing. Where the risk assessment indicates current risk to the client and there is uncertainty as to whether the risk may be mitigated or relieved by allowing third party collection advice will be sought from the Team Consultant. The assessment should include in general the risks in relation to the client withdrawing from opiates, and/or misusing pain medication, or needing to order illicit drugs; balanced against the risk of the identified 3 rd party collecting methadone/buprenorphine on behalf of the client either using/misusing the prescribed medication. The individual risk assessment must be documented in the client record on RIO: stating that the medicine could only be collected by the named 3rd party, and a time period for collection must be specified and recorded on RIO. It is acknowledged that for some clients longer term arrangements will need to be agreed. For clients who are unable to attend appointments due to physical ill health problems a home visit will be arranged for review with the Care Co-ordinator and the Team Doctor or Team Consultant. The frequency of visits will be discussed and agreed in the MDT meeting and be dependent on hospital, hospice admissions and clients physical health. All clients who are receiving longer term 3rd party collection will be place in the Risk RED Zone, which will ensure weekly discussion of current risk. Teams should audit the 3rd party collectors identities with supplying community pharmacists. 8.5.3 Holiday Prescriptions and Travelling Abroad Service users are requested to provide adequate notice of travel (except in cases of clear urgency). Depending on the patient’s stability, length of holiday, and dose levels, the decision to allow TTO medication, or dispensing at a pharmacy at their destination will be made on a case by case basis by the Team. FP10s are valid in all UK countries, but not elsewhere in the EU or other countries. Trust guidance on quantities to supply should be observed. Methadone hydrochloride 5mg tablets are non-formulary; however on occasions, they are prescribed for service users to take on overseas travel due to the airport security restrictions on liquids and the impracticalities of travelling overseas with large volumes of methadone liquid. For the purposes of overseas travel by service users only, methadone 5mg tablets have formulary status. Travelling up to and including 3 months, or carrying no more than 3 months’ supply of medication, will not require a Home Office licence to export the drug from the UK, or import any remaining prescribed supply to the UK regardless of the drug(s) being carried. The prescriber will need to provide a letter containing the following information: Name Address Date of birth The outward and return dates of travel The country visited List the drugs carried, including dosages and total amounts 15 Those travelling abroad are advised to contact the Embassy/Consulate/High Commission of the country to be visited regarding their policy on the importation of controlled drugs, as the prescriber’s letter does not have legal validity for other countries. See http://drugs.homeoffice.gov.uk/drugs-laws/licensing/personal 8.6 Management of additional Illicit Opiate Use with treatment Consider changing to supervised consumption if not already the case. Those who are clearly motivated to cease or use on top to manage withdrawal symptoms may benefit from higher dose regimes; unless reporting hedonistic use and considering risk/benefit of high doses (>70mg/day).2 Continued prescribing in the face of alcohol or benzodiazepine misuse or continued use on top should follow a careful appraisal of risks versus benefits of continued treatment given with other interventions. 8.7 Criteria for the Discontinuation of Prescriptions Prescribing may come to an end for a number of reasons other than completion of treatment: Threatening and/or aggressive behaviour (including verbal abuse) to staff or others on the Trust premises. The Trust has a Zero Tolerance Policy. Where fundamental treatment goals cannot be agreed by negotiation and no progress is made to meet those goals. Use of alcohol or additional illicit drugs presenting high risk of overdose or other dangers. When physical tolerance to the drug has reduced. Prescriptions will normally be cancelled if not collected for three consecutive days. Retitration starting from lower dose may be necessary if three days of methadone are missed, or five days for buprenorphine. Non-attendance for follow up appointments or screening. Serious non-compliant behaviour e.g. falsifying of urine samples. If treatment is discontinued the patient’s GP needs to be informed. If the decision is made to discontinue prescribing of opiate substitution, a rapid reduction prescription can be offered. 8.8 Take-home Naloxone Naloxone is the emergency antidote for overdoses cause by heroin and other opiates/opioids (such as methadone and morphine). The main life-threatening effect of heroin and other opiates is to slow down and stop breathing. Naloxone blocks this effect and reverses the breathing difficulties. Drug treatment services are able to supply naloxone directly to individuals without the need for a prescription. See Appendix 10 for protocol, including inclusion/exclusion criteria, training requirements (staff, service users and carers) and naloxone take home checklist for service users and carers. Excluded service users & their carers can be prescribed or supplied naloxone to take home, if deemed appropriate, based on risk/benefit assessment by a prescriber. 8.9 Management of Opioid Overdose in an emergency If overdose of opioids or any other substances is suspected by healthcare professionals, local medical emergency procedures should be followed; refer to Appendix 9. 8.10 Initiation of Opiate Prescribing in the Community Buprenorphine and methadone are both first line treatments for either maintenance therapy or detoxification for patients dependent on opiates. If both drugs are equally suitable, methadone should be prescribed as the first choice. 8.11 Methadone (See SmPC for full guidance). To minimise the risk of confusion/overdose, SWLSTG will only prescribe 1mg/ml strength given as a single daily dose. Methadone Oral Solution and Oral Concentrate contain colorants to which some people may experience an allergic reaction. Methadone has a long plasma half-life of 10-25 hours (13-55 hours when given repeatedly). It takes 5 half lives or 3-10 days for methadone to reach steady state so a dose of methadone initiated on day one can become toxic by day 3. 8.11.1 Methadone: Adverse Effects and Toxicity Adverse Effects: 16 Respiratory depression, nausea, vomiting, dizziness, dysphoria, pruritis, impaired sexual function, constipation, urinary retention and hypotension. Serious respiratory depression or death is more likely with high starting doses and when given in the presence of other drugs e.g. alcohol, benzodiazepines and poor general health. Even in tolerant service users (which may never occur in some) after longer-term treatment a too rapid dose increase or inhibition of methadone’s metabolism by other medicines (e.g. fluoxetine plus ciprofloxacin) can cause problems. Methadone-induced QTc interval prolongation and torsade de pointes are more likely when: given concomitant medicines known to cause QTc prolongation (e.g. ciprofloxacin and antipsychotics) or on high doses (>100mg/day). ECG monitoring is recommended. 8.11.2 Methadone in Pregnancy and Lactation. Methadone does not appear to be teratogenic and can reduce the risk of using poor quality street drugs. There is some evidence of reduced plasma methadone levels in the last trimester due to a haemodilution effect and increased hepatic metabolism. This may require an increased or split dose. A foetal withdrawal syndrome may occur within the first 72 hours of delivery. Refer to prenatal mental health services and contact Medicines Information for advice. Methadone is excreted in breast milk in measurable but low concentrations in a dose related manner. The BNF suggests that breast-feeding during maintenance is possible but the dose should be as low as possible and the infant monitored for sedation, respiratory depression and neonatal abstinence syndrome. 8.11.3 Methadone Titration Day 1 Prescribe Methadone Oral Solution 1mg/1ml strength 10-30mgs/day or 10-20mgs if tolerance is uncertain or low. Doses up to 40mg may be given by experienced clinicians in heavily dependant individuals. A second dose may be given by an experienced clinician if there is evidence of persistent opioid withdrawal. Patients should be provided with written information on methadone Assess opiate withdrawal using signs and symptoms checklist (Appendix 4) Patients need to be informed that the drug will take some time to build up in their bodies Doses tolerated on day 1 may become a toxic dose on day 3 due to slower clearance rates and accumulation. Days 2-7 Increase doses by no more than 5-10mg each day, max dose increase 30mg above day 1 dose. Day 8+ Increase doses incrementally to a max of 60-120mg a day, to reach a level at which the patient reports feeling comfortable and is no longer using illicit heroin.3 Methadone is licensed for opiate dependence up to 100mg/day, however, evidence suggests that most patients are maintained when receiving doses of 60120mg/day. Missed doses Patients should be reassessed for intoxication and withdrawal if 3 or more days of methadone doses are missed. It may be appropriate to reduce the dose and re-titrate before recommencing treatment, because tolerance may be lost. If 5 or more days are missed, an assessment of tolerance will be necessary3. 8.12 Buprenorphine (Subutex®) (See SmPC for full advice) Buprenorphine is a semi-synthetic opiate that possesses partial agonist and antagonist activity. The maximum opioid activity is less than for a full agonist such as methadone. Full receptor blockade is achieved at doses of around 16 mg. Buprenorphine is easily crushed and inhaled or injected intravenously providing a euphoric effect, Suboxone® may be considered for such patients. Buprenorphine may be considered when treatment is preferable or more clinically appropriate than methadone in instances below: 17 Those wishing to stop completely as partial antagonist effects reduce the euphoric effect of additional opiates Buprenorphine causes less respiratory depression (unless combined with CNS depressants), is less toxic in overdose and causes less dysphoria than methadone. Hence it may be more useful than methadone in those with respiratory diseases, depression or benzodiazepine or alcohol abusers. In those whom methadone treatment was unsuccessful or less preferable. In those sedated on methadone. In those taking enzyme inhibitors or inducers. 8.12.1 Contra-indications, interactions & cautions Those requiring pain treatment with opiates may experience difficulties when prescribed buprenorphine. Buprenorphine binds tighter to opiate receptors pushing off other full opioid agonists which may result in precipitated withdrawal. Precipitated withdrawal may commence in the first 30 to 90 minutes, usually peaking within 3 hours and then subsiding. Less severe symptoms may continue after the second or third dose. Precipitated withdrawal may be treated with symptomatic medications and lofexidine. Buprenorphine (or Suboxone®, {buprenorphine/naloxone}) should not be used in those with hypersensitivity to the medicine, recent head injury, acute alcoholism or delirium tremens, severe alcohol dependence, adolescents under 15 years of age, severe respiratory problems, renal disease or hereditary galactose intolerance or glucose-galactose malabsorption. Liver dysfunction: Initiate with caution in those with mild or moderate dysfunction. Pre-existing liver infection or liver abnormalities increases the risk of liver dysfunction caused by buprenorphine. Monitor LFT’s periodically (e.g. 6 monthly) due to risk of deterioration in liver function. Respiratory disease: Inform the primary physician or prescriber before initiation and ensure a care plan is written to include close monitoring. Interactions include: o Benzodiazepines: increased risk of toxicity, CNS & respiratory depression and death. Avoid. o CNS depressants (e.g antidepressants, antipsychotics and anxiolytics). Increased risk of toxicity. Monitor closely. o Enzyme inhibitors (CYP3A4) (e.g. azole antifungals, indinavir, nelfinavir & ritonavir). Reduced dose of buprenorphine may be required. o Enzyme inducers (CYP3A4) (e.g. carbamazepine, phenytoin and rifampicin). Increased dose of buprenorphine may be required. o Monoamine oxidase inhibitors (MAOI) (e.g. moclobemide, phenelezine), exaggerated opioid effects. Monitor closely. 8.12.2 Adverse effects & toxicity Adverse effects due to buprenorphine are similar to those associated with other opioids, including: headaches, nausea and vomiting, sleep disturbances, drowsiness, sweating, constipation. High doses are usually well tolerated. Clinically significant respiratory depression occurs rarely, even in those with a low tolerance to opioids.4 • Longer-term use may result in prolonged mild withdrawal symptoms on discontinuation. This is possibly due to the drug being slowly released from fat storage. 8.12.3 Pregnancy & Lactation There is a paucity of evidence for buprenorphine in pregnancy, but studies have shown that the benefits for mother and foetus are similar to methadone.5 Low rates of prematurity and neonatal abstinence syndrome have been observed. However buprenorphine may interfere with analgesia during labour. Small amounts are distributed into breast milk. 8.12.4 Buprenorphine titration No methadone for at least 24hrs and heroin for 12hrs prior to initiation. Also abstain from other opiates. Transfer to Buprenorphine might involve some mild withdrawal for the first 2 to 3 days. Day 1 4-8 mg Day 2 Increase by 2-4mg if withdrawal present. Decrease by 2 mg if signs of intoxication. Day 3 Increase day 2 dose by 2-4 mg if withdrawal present. 18 Decrease day 2 dose by 2-4 mg if signs of intoxication. Stable dose range is 4–16 mg per day. Maximum daily dose is 32 mg. Dosing can be arranged on a three times a week regime (double or triple daily dose for 2 or 3 days’ treatment respectively). However this would only be appropriate for patients on doses where combining daily doses would not exceed 32mgs on any one day. Sudden cessation of buprenorphine will not cause significant withdrawal effects. Dose reduction and re-titration may be necessary if 3 or more days of buprenorphine are missed. If 5 days are missed, patients may require an assessment of opiate misuse before being restarted, to minimise the risk of withdrawal3. 8.12.5 Transfer from Methadone to Buprenorphine Transferring from methadone to buprenorphine puts patients at risk of precipitated withdrawal. It is advisable to prepare the patients for precipitated withdrawal and treat symptomatically as needed. Transfer from doses of methadone 40mg or less ONLY and not from over 60mg methadone. Stop methadone for at least 24hrs, withdrawal symptoms should appear before starting buprenorphine. 8.12.6 Transfer from Buprenorphine to Methadone 24 hours after the last dose of buprenorphine start methadone at an equivalent dose up to a maximum of 40 mg of methadone. Residual buprenorphine may take up to a week to wash out. In this time it may block the full agonist effects of methadone. Wait 2-3 days then titrate the methadone gradually, over at least a week. Buprenorphine dose Buprenorphine more than 8 mg 4 –6 mg 2 - 4 mg 8.13 First methadone dose 40 mg 30 mg 10 - 20 mg Suboxone® (see SmPC for full advice) Suboxone® is a combination of buprenorphine and naloxone which comes in 2mg/500mcg, and 8mg/2mg tablets, max maintenance dose 24/6mg each day. Suboxone® has no superior efficacy over buprenorphine alone. Switching buprenorphine to Suboxone® may be done directly without concerns.6 The intention of the naloxone component is to deter intravenous misuse. Suboxone® is indicated in the following instances: the substitution treatment for opioid dependence as part of medical, psychological and social treatment for patients over 15yrs For those patients at risk of crushing tablets to be used by intravenous injection or intranasally Those known to divert prescribed medication Those unable to comply with supervised consumption of buprenorphine in first 3 months of treatment due to work or child care commitments or physical disability Those transferred from another service already initiated on Suboxone®. For Adverse Effects, interactions & cautions, See 8.12.1 Naloxone has a much shorter half than buprenorphine; 1.2hours vs 32hours respectively. When Suboxone® is administered IV the presence of naloxone is likely to induce opiate withdrawal. Patients should be switched to buprenorphine if pregnant or breast feeding (See 8.12.2). Buprenorphine and Suboxone® should NOT be prescribed together. Prescribing Suboxone® - follow titrations as described for buprenorphine (8.12.4). 19 8.14 Other Oral Opioids Sometimes Used for Maintenance Methadone and buprenorphine are the mainstays of treatment. Oral opioids other than methadone or buprenorphine such as dihydrocodeine (DHC) and slow release oral morphine (SROM) are not licensed in the UK for the treatment of opiate dependence, and should not normally be used. 8.14.1 Dihydrocodeine (DHC) There is a small evidence base, though none that it is superior to other opioids, that it can be used effectively for maintenance. DHC tablets are difficult to supervise: they are short acting (frequent dosing required) and are easily diverted. DHC may occasionally be prescribed for some patients unable or unwilling to consider or tolerate methadone or buprenorphine. DHC should only be prescribed by a physician with appropriate specialist competencies. The clinician will need to ensure an adequate dose and frequency of consumption because of DHC’s short half life, and the patient will need to be carefully monitored. 8.14.2 Slow Release Oral Morphine (SROM) Slow-release oral morphine (SROM) has been proposed as an alternative maintenance pharmacotherapy to methadone for treatment of opioid dependence and may be useful in patients who fail to tolerate methadone. SROM should only be prescribed by clinicians with appropriate competencies. Slow-release oral morphine (SROM) formulations extend the dosing interval for morphine, thereby enhancing its potential as an alternative maintenance pharmacotherapy to methadone. Prescribing SROM Transfer from methadone to SROM 24 hours after the last methadone dose using an initial morphine:methadone dose ratio of approximately 3.5:1.7 Due to the paucity of evidence supporting the safety of this conversion, an initial 15% reduction from the converted dose is recommended. Safety concerns relating to the accumulation of methadone and individual variability in metabolism and response to each drug predicate the use of initial SROM doses that are lower than expected steadystate requirements. Round the SROM dose up or down to the nearest 10mg where appropriate. SROM doses may initially have to be increased by 10 – 30mg daily as required to minimise withdrawal As a strategy for achieving sustained suppression of opioid withdrawal, the suitability of once-daily or twice-daily SROM dosing varies considerably between individuals; notably due to patient choice. Increases in dose outside these guidelines maybe necessary following consultation with medicines information. 20 9.0 Opiate Detoxification Regimes Detoxification without the full agreement of the patient is unlikely to result in maintained abstinence. Overdose prevention must be discussed with patient (and carers if appropriate/possible) Very rapid detoxification regimes are generally used only in an inpatient setting. Detoxification can be carried out in the context of the patient’s wider recovery plan. 9.1 Pregnancy Detoxification from opiates in the first trimester is not advisable due to the risk of spontaneous miscarriage. It is safest in the second trimester. A rate of 1mg methadone per day has been suggested, though other studies have shown no increased risk of pre-term delivery in women who underwent a 21 day detoxification in the 2nd or 3rd trimester (Luty et al 2003). However detoxification in the 3rd trimester may lead to foetal distress and premature labour. Stress to the foetus due to exposure to repeated opiate withdrawal represents a higher risk than remaining on a stable maintenance dose of opiate substitute therapy. As a consequence, for women who are at high risk of relapse onto illicit opiates, it is preferable for them to remain on opiate maintenance therapy than to undergo detoxification. 9.2 Methadone The following are suggested detoxification regimes for methadone, but the rate of detoxification is usually decided in conjunction with the patient and clinician. Very Rapid from 30mg Day of detox. 1 Methadone dose 30 1mg per ml 2 20 3 20 4 20 5 15 6 15 7 15 8 10 9 10 10 10 11 5 12 5 13 5 2122 4 2324 2 4 month regime reduce by either 5 or 10 mg every week or fortnight until 30 mg is reached reduce by 5 mg every week or fortnight until 15 mg is reached reduce by 2-2.5 mg every week or fortnight Week of detox. 1-2 3-4 5-6 7-8 9-10 Methadone dose 1mg per ml 60 50 40 30 25 1112 20 1314 15 1516 10 1718 8 1920 6 9.2.1 QTc prolongation Many studies have reported on QTc interval prolongation caused by methadone and that there is a possibility of a dose dependent effect on increasing QTc interval36. As QTc interval increases, so does the risk for life-threatening arrhythmias such as polymorphic ventricular tachycardia or Torsades de Pointes. The risk of sudden cardiac death increases 4-fold when QTc is ≥ 500 msec.35 Sudden cardiac death has been reported in patients taking as little as 29mg/day of methadone.35 Buprenorphine appears to be associated with less QTc prolongation and therefore may be a safer alternative in this respect.8 9.2.2 Risk Factors for QTc Prolongation Medicines with potential to prolong QT interval (e.g. most antipsychotics; citalopram; erythromycin, hydroxyzine, antiarrhythmics, antimalarials) Hypokalaemia Hypomagnesaemia Hypocalcaemia Age Female sex 21 Advanced heart disease Congenital and acquired long-QT syndromes Family history of sudden death Anorexia Bradycardia 9.2.3. Patient education at time of prescribing Clinicians should ask patients about any history of structural heart disease, arrhythmia or syncope, and warn patients of the risk of arrhythmia before prescribing methadone. Educate patients/caregiver to seek medical attention immediately if any non-specific signs and symptoms of QTc prolongation occur such as syncope, seizures, or palpitations. 9.2.4 Monitoring Inpatients started on methadone should get a baseline ECG, which should be repeated after dose escalation to an oral methadone dose of 60mg/day. Consider repeating the ECG when steady state is achieved after dose escalation. For patients on an oral methadone dose of 60mg/day consider obtaining a follow-up ECG in 1-2 weeks, for doses ≥100mg/day a follow up ECG must be carried out. For patients with a previous ECG indicating borderline QTc prolongation, consider obtaining a follow-up ECG in 4-7 days. Stable outpatients should receive a baseline ECG before treatment, 30 days after treatment initiation, and annually9. More frequent ECG should be considered for patients using ≥60 mg/day of oral methadone and must be carried out for doses ≥100mg/day. An ECG should be obtained immediately in patients with unexplained syncope, palpitations, or seizures. Consider tapering methadone when QTc is prolonged ≥40 msec from baseline.10 Tapering methadone or eliminating other risk factors is recommended when QTc is >500 msec. 8 For action on finding abnormal QTc readings consult the Maudsley Prescribing Guidelines. Morphine is an alternative to methadone or buprenorphine where the QTc is prolonged. 9.3 Buprenorphine The following are suggested detoxification regimes for buprenorphine, but the rate of detoxification is usually decided in conjunction with the patient and clinician. Very rapid buprenorphine detoxification regime (Lintzeris 2001) The aim here is to achieve a peak buprenorphine dose about 50% greater than is required to cover withdrawal symptoms. This acts as a loading dose with a subsequent very rapid reduction reviewed daily with adjustments as necessary. Day of detox. Buprenorphine dose (mg) Lower-upper limits of buprenorphine Rapid dose Reduction Day of detox. 1 Buprenorphine dose 8 (mg) 1 6 2 8 3 10 4 8 5 4 6 - 7 - 8 - 9 0 4-8 4-12 4-16 2-12 0-8 0-4 0-2 0-1 0 2 6 Moderate rate dose Reduction Day of detox. 1-4 Buprenorphine dose (mg) 8 3 6 4 4 5 4 6 4 7 2 8 2 5-8 912 4 1316 2.8 1720 2 2124 1.6 2528 1.2 6 22 9 0.8 2932 0.8 10 0.8 3336 0.4 11 0.4 12 0.4 Gradual dose reduction Daily buprenorphine dose (mg) 16 8-16 2-8 2 Reduction rate 4 mg every 1-2 weeks 2-4mg every 1-2 weeks 2mg every 1-2 weeks 0.4-0.8 mg every 1-2 weeks 9.4 Lofexidine (See SmPC for full advice) Lofexidine is an alpha-2 adrenergic agonist which is licensed for the treatment of opiate withdrawal symptoms. It acts by suppressing opiate symptoms including sweating, chills, diarrhoea, myalgia and cramps Lofexidine is not a first line treatment for opiate withdrawal symptoms and is only used if detoxification using methadone or buprenorphine is not suitable. Lofexidine may be used in the community for the following patient groups: Patients with mild or uncertain dependence. Patients using no more than 0.5 g heroin or 30mg methadone daily Short drug and treatment histories Non polydrug users. Patients living in a safe stable environment with support Patients confirmed as medically and psychologically fit for treatment with no contraindications. Patients judged capable of being responsible for their medication. 9.4.1 Side Effects/Precautions Side effects include drowsiness, dry mouth, hypotension, bradycardia and rebound hypertension. Falls in blood pressure and/or pulse rate are the most usual reasons for intolerance. These reactions do not appear to be related to starting dose. May have a sedative effect thus advise not to drive or operate machinery Caution in those with severe coronary insufficiency, recent myocardial infarction, renal impairment and in people with marked bradycardia (55 beats per minute). Pulse should be assessed frequently. There have been reports of asymptomatic QT prolongation during treatment with lofexidine hence avoid use in those with known QT prolongation or if taking other drugs known to cause QT prolongation. Enhances sedative effects of alcohol, anxiolytics and hypnotics. May enhance the effects of anti-hypertensive therapy. Concomitant use of tricyclic antidepressants may reduce the efficacy of Lofexidine 9.4.2 Pregnancy and Lactation Safety in pregnancy is not established. Lofexidine may increase miscarriage risk. Use in pregnancy only after discussing the relative benefits and risks to mother and foetus. It is not known whether lofexidine is excreted in breast milk and caution should be exercised when it is administered to nursing women. 9.4.3 Treatment Guidelines Screen for suitability. Include a test for pregnancy. Pay special attention to pulse rate and consider the possibility of QT prolongation. An ECG may be indicated. Discuss alternative methods of detoxification. The prescribing doctor agrees lofexidine together with any adjunctive medication that may be required. Monitor BP & pulse for several days prior to commencing lofexidine. Before the first dose take baseline blood pressure and pulse rate and repeat 2 hours post dose. BP and PR are then taken daily whilst the dose is increasing or if symptoms of hypotension occur. Lofexidine is omitted if the systolic BP falls by 30mm or if the diastolic BP is less than 50mm or if the pulse rate falls below 55 bpm. The patient is monitored daily for the first 3 days of treatment. If detoxification is going well the patient can be reviewed on alternate days Two hours after the first dose symptoms may be significantly reduced although in practice it may take 2-5 days to build the lofexidine dosage up to an effective level. Not all withdrawal symptoms 23 are attenuated, particularly insomnia, lethargy and craving hence lofexidine withdrawal frequently requires augmentation with additional symptom focussed treatments. The total daily dose should be given in 2-4 doses. Lofexidine should be increased over 7-10 days to a maximum of 2.4mg then reduced over 2-4 days. Lofexidine withdrawal schedule I tablet = 0.2 mg. Day number Morning Max extra tabs 1 0.2 mg 2 0.2 mg 3 0.4 mg 4 0.4 mg 5 0.4 mg 2 6 0.4 mg 4 7* 0.4 mg 4 8* 0.4 mg 2 9* 0.4 mg 10 0.4 mg 11 0.4 mg 12 0.2 mg 13 14 Noon 0.2 mg 0.2 mg 0.4 mg 0.4 mg 0.4 mg 0.4 mg 0.4 mg 0'4 mg 0.4 mg 0.2 mg Evening 0.2 mg 0.2 mg 0.4 mg 0.4 mg 0.4 mg 0.4 mg 0.4 mg 0.4 mg 0.4 mg 0.2 mg Night 0.2 mg 0.2 mg 0.4 mg 0.4 mg 0.4 mg 0,4 mg 0.4 mg 0.4 mg 0.4 mg 0.4 mg 0,4 mg 0.2 mg 0.2 mg 0.2 mg Days 7, 8 and 9 may need to be repeated for patients withdrawing from methadone and may need to increase to 0.6 mg QDS. Omit days 6 – 8 if withdrawal is not severe. Consider adjuvant symptomatic treatment for restless legs, gut cramps, muscular aches and insomnia. Due to the risks around hypotension and bradycardia it may be safer to undertake lofexidine detoxification in an inpatient environment. 9.5 Other Symptomatic Treatment Diarrhoea: Loperamide 4mg immediately followed by 2mg after each loose stool for up to 5 days. Usual dose 6-8mg maximum dose 16mg. Nausea/vomiting: metoclopramide 10mg tds Stomach cramps: hyoscine butylbromide 20mg qds Agitation/insomnia: promethazine 25-50mg, max 24mg in 24hours. In patients who have not been dependent on benzodiazepines, alternatively zopiclone 7.5mg for short periods (i.e. 3 days). Muscular pain/headaches: paracetamol or NSAIDs. 9.6. Inpatient Induction and Detoxification Inpatient facilities may be used for stabilisation and detoxification from opiates and benzodiazepines, therapy can occur at a faster rate than in an outpatient setting and on nonspecialist wards. For patients not already receiving substitution therapy methadone is given in increments of between 5-20mg or buprenorphine is given in increments of 2-4mg in response to severity of opiate withdrawal symptoms over a 24-48hour period. The patient is then commenced on the total dose for the previous 24hours. The patient is closely monitored for signs of further opiate withdrawal or intoxication. Detoxification from methadone occurs at a rate of 5mg per day until the dose reaches 35mg then it is reduced at a rate of 5mg on alternate days. Methadone is usually given as a split dose morning and evening. Buprenorphine is reduced at a rate of 2mg on alternate days until 2mg then the rate is 0.8mg for two days and 0.4mg for two days. 24 10.0 Injectable Opiates Injectable opiate treatment should be prescribed in line with the principles of Injectable heroin (and injectable methadone): potential roles in drug treatment (NTA 2003) and once approval to prescribe has been obtained from The Department of Health, Trust’s Medical and nursing Director and the Trust’s accountable officer for controlled drugs. There are a small number of patients who are currently prescribed injectable methadone usually due to longstanding historical reasons: In this case the patient must be fully aware of the risks of continued IV use. Injection sites must be regularly checked and the treating team must ensure the patient has access to sterile injecting equipment. Service users should be given advice on safe injecting technique. It is advisable that any injectable prescribing is done with specific goals to reduce and stop illicit drug use. Also it is suggested that this could be a time limited treatment with a clear treatment contract between team and patient. Injectable methadone treatment may be considered in patients who fail to make progress and continue to exhibit high risk injecting behaviour as well as failing with oral substitute therapy. The risks of this treatment must be carefully considered before initiation and only as part of a wider care plan incorporating structured psychosocial treatment intervention. Injectable diamorphine treatment for opiate dependent patients can only be prescribed by doctors with a home office license and no patients are currently prescribed by SWLSTG services. 25 11.0 Preventing Relapse with Naltrexone Naltrexone is a non-addictive, non-euphorigenic, long acting opioid antagonist and can be prescribed as a prophylactic treatment to prevent opioid use and help maintain abstinence in highly motivated service users following detoxification. It can also be used in treatment for alcohol dependence to reduce risk or relapse after alcohol detoxification. Naltrexone is high affinity for μ, κ and to a lesser extent δ opiate receptor antagonist which competes with opiate agonists. By maintaining effective opioid-receptor blockade, stopping drug induced euphoria and other reinforcing effects of opioids, naltrexone also prevents opioids forming their dependence potential. It must be prescribed within a framework of medical, social and psychological treatment.11,12,13 The goal of treatment is to provide a sustained period of opioid abstinence whilst active attempts are made to reduce the potential for subsequent relapse.14,15,16 Effectiveness of long term maintenance treatment has not yet been confirmed, however it may be beneficial in highly motivated patients. The patient and their carers should be fully informed of the potential adverse effects as well as the benefits of naltrexone treatment. Written information and education should be made available. Consent and agreement to treatment should be obtained and documented Service users must understand that participation in psychosocial therapy is an integral part of their naltrexone treatment and this should be incorporated into the agreed care plan Service users should meet the following criteria in order to be eligible for naltrexone treatment: Have remained opioid-free for a minimum of 7-10 days ( 7 days for short acting opioids such as buprenorphine or 3-4 days after detoxification in an inpatient setting and 10 days for longer acting opioids such as methadone) Have a urine screen negative for opioid use Have completed a ‘naloxone challenge’ successfully if opiate dependent Have had recent liver function tests Aged 18 or over Be able to provide informed consent 11.1 Contra-indications, interactions & precautions Naltrexone is contraindicated in: Acute hepatitis or liver failure. Service users currently dependent on opioids. Concurrent use of opioid-containing medication. Hypersensitivity to naltrexone or any other component of the tablet patients receiving opioids. In emergency situation where opioids are required respiration rate should be monitored and medical assistance should be available. As naltrexone is extensively metabolised by the liver and excreted in the urine, caution should be observed when prescribing it to service users with impaired hepatic or renal function. LFTs should be carried out both before and during treatment at three monthly intervals during treatment. 11.2 Pregnancy and Lactation The safety of naltrexone in pregnancy has not been established. Animal studies do not suggest a teratogenic effect. Naltrexone should only be prescribed to pregnant or breast-feeding women when, in the judgement of the responsible clinician, the potential benefits outweigh the possible risks. 11.3 Adverse Effects and toxicity (See SmPC for full advice) The following side-effects have been reported before and during naltrexone therapy: difficulty sleeping, anxiety, nervousness, abdominal pain/cramps, nausea and/or vomiting, low energy, joint and muscle pain, headaches and less commonly chest pain, irritability, difficulty in concentrating affecting ability to drive. There is a risk of toxicity and opiate overdose in the event of a patient taking opiates to try to reverse the effect of naltrexone. Patients prescribed naltrexone must be warned of this risk. 26 11.4 Management of naltrexone precipitated withdrawal Naltrexone may precipitate a severe opioid withdrawal reaction if opioids are present. Symptoms of opioid withdrawal can appear after five minutes following ingestion and may last up to 48 hours. Symptoms include confusion, agitation, hallucinations, sweating, tachycardia, abdominal pain, and episodes of profuse vomiting and/or diarrhoea, which may result in significant fluid losses. Administration of an opioid in precipitated withdrawal has no effect and is potentially dangerous. Higher doses of opioids would be required to reverse the receptor block of naltrexone. The resulting respiratory depression may be deeper and more prolonged than that induced by opioid use on its own. In the event of suspected naltrexone precipitated withdrawal in the outpatient setting emergency services must be contacted as soon as possible. 11.5 Naloxone Challenge Naloxone challenge is recommended at times to screen for the presence of opioids, prior to commencement of naltrexone treatment and may be conducted by a doctor only. Naloxone has a shorter half-life than naltrexone. Naloxone is used because the opioid withdrawal syndrome it precipitates has a shorter duration and is less severe than the withdrawal precipitated by naltrexone. Therefore if the patient has used opioids or there are residual levels present in the service user’s body, the withdrawal symptoms will be substantially less severe and shorter in duration. The service user should be monitored throughout the naloxone challenge and all observations must be documented and the following process followed: Intravenous injection of 200micrograms naloxone hydrochloride injection is administered After 30 seconds, if no adverse reactions occur, a further i.v. injection of 600micrograms naloxone may be administered. Continue to observe the service user for opioid withdrawal effects for a further 30 minutes If a service user is suspected not to be opioid-free, the challenge may be repeated using a naloxone dose of 1.6 milligrams. If there is no evidence of any opioid withdrawal, naltrexone administration may be initiated with 25mg (half a tablet) orally for the first day. After 24 hours, if there are no symptoms of withdrawal, a regime of 50mg (one tablet) daily can be initiated. The maintenance dosing regime can be modified to three times a week e.g. 100mg (2 tablets) on Monday, 100mg (2 tablets) on Wednesday, and 150mg (3 tablets) on Friday. This regime should only be considered if it is likely to result in improved compliance. The three-times-a-week regime can be useful for ease of supervision of administration to improve adherence. Naltrexone is not currently supervised in the pharmacy setting and so a carer or family member should undertake this supervision. It is recommended that naltrexone treatment be continued for an initial period of 3 months, longer may be necessary as time to full recovery in opioid dependence is variable. Drug screening is recommended during the first 4-6 weeks and treatment should be reviewed on finding a positive result for existence of opiates. Missing doses by one day may not be clinically significant, and taking ‘make up’ doses are not recommended. 27 12.0 Management of pain when on opiates and/or naltrexone for addiction The treatment aim is to manage pain without inducing withdrawal or putting the patient at an increased risk of opiate toxicity. Patients must be informed of adverse effects and toxicity effects of analgesics. Where pain is mild or moderate, opiate substitution therapy should be unchanged and appropriate nonopiate analgesic prescribed e.g. Paracetamol or ibuprofen or a non-pharmacological treatment. Where non-opiate analgesics are ineffective or inappropriate or pain is severe addition opiates may be prescribed. Clinicians may only prescribe opiates for pain that they are familiar with. Confirm any missed doses of opiate substitution treatment. Patients with a history of substance misuse usually require higher opiate doses than normally required to treat pain. Assessment of chronic pain must exclude, physical co-morbidity, mood disorder, opioid hyperalgesia, psychological impact of the pain. The pain care plan must be documented and include consideration of increased opiate requirements and physical dependence. Good communication between those involved in the care is paramount: One team/clinic/practice must lead on the management of the pain. Assessment must involve collating information from all care groups. A single prescriber must receive all treatment plans and review documentation. A GP or specialist clinic may in general be the lead to supply medication to treat pain. Dispensing that limits diversion e.g. weekly. Care plan must be reviewed regularly with follow up arrangements stated. Specialist services i.e. pain clinic or palliative care must be used where appropriate.17 When increasing opiates for analgesics do not increase the dose by more than 50% of the current dose. Tolerance to an opioid analgesic may occur rapidly switching to another opiate may be of benefit.18 Regular short ‘courses’ of opioids are preferable to PRN analgesia in those with a history of substance misuse. Buprenorphine poses a particular problem as the analgesic effects of full opioids are blocked and withdrawal may be precipitated. A number of options may be considered when opiate analgesia is being considered for such patients: Management of pain in patients taking naltrexone should be as per management of pain in those taking buprenorphine above. Split the dose and consider increasing the dose after 24hrs to manage the pain and any withdrawal symptoms. Continue the buprenorphine at the current dose for addiction and administer short acting doses of full opiates. Titrate to manage the withdrawal. Suboxone® must not be stopped abruptly when prescribed with other opiates. People taking naltrexone should be provided with and carry a medical warning card and advised not to take any form of opioid related medication in conjunction with naltrexone and that they will not respond to opioid analgesics, Naltrexone treatment should be discontinued at least 72 hours prior to elective surgery. 28 13.0 Prescribing for Alcohol dependence 13.1 Guidance on keeping health risks from drinking to a low level; assessment & deciding on treatment The Chief Medical Officers’ guideline19 ‘How to keep health risks from drinking alcohol to a low level’ for both men and women states that: It is safer not to drink more than 14 units per week regularly, to keep health risks from drinking alcohol to a low level. If as much as 14 units per week is consumed, it is best to spread this evenly over 3 days or more. Having one or two heavy drinking sessions increases the risk of death from long term illnesses and from accidents and injuries. The risk of developing a range of illnesses (including, for example, cancers of the mouth, throat and breast) increases with any amount of alcohol on a regular basis. If a patient wishes to cut down the amount they are drinking, then a good way to help achieve this is to have several drink-free days each week. The Chief Medical Officers advise men and women who wish to keep their short term health risks from a single drinking occasion to a low level, can reduce these risks by: Limiting the total amount of alcohol drunk on any occasion; Drinking more slowly, drinking with food, and alternating with water; Avoiding risky places and activities, making sure you have people you know around, and ensuring you can get home safely. The sorts of things that are more likely to happen if the risks from how to drink correctly are not judged can include: accidents resulting in injury (causing death in some cases), misjudging risky situations, and losing self-control. These risks can arise for people drinking within the weekly guidelines for regular drinking, if they drink too much or too quickly on a single occasion; and for people who drink at higher levels, whether regularly or infrequently. Some groups of people are likely to be affected more by alcohol and should be more careful of their level of drinking on any one occasion: Young adults Older people Those with low body weight Those with other health problems Those on medicines or other drugs As well as the risk of accident and injury, drinking alcohol regularly is linked to long term risks such as heart disease, cancer, liver disease, and epilepsy. The Chief Medical Officers’ guideline19 on pregnancy and drinking is that: If a patient is pregnant or planning a pregnancy, the safest approach is not to drink alcohol at all, to keep risks to the baby to a minimum. Drinking in pregnancy can lead to long-term harm to the baby, with the more that is consumed then the greater the risk. Most women either do not drink alcohol (19%) or stop drinking during pregnancy (40%). The risk of harm to the baby is likely to be low if a woman has drunk only small amounts of alcohol before she knew she was pregnant or during pregnancy. Women who find out they are pregnant after already having drunk during early pregnancy, should avoid further drinking, but should be aware that it is unlikely in most cases that their baby has been affected. 29 Units of alcohol in beverages ONE UNIT OF ALCOHOL: 8g pure alcohol 1/2 pint of beer (4%) 125mL of table wine (10-12%) 20mL Measure of spirits (40%) 1 small glass of sherry (17.5%) 1/4 of a can (112.5mL) of strong lager UNITS/container: 9/bottle of table wine (75cl) 30/bottle of spirits (70cl 15/bottle of sherry (70cl) 4/can of strong larger (450mL) Dependent drinkers are those who are drinking to excess most days, having developed a craving for alcohol including physical withdrawals. They are likely to experience shakes, sweats and anxiety or irritability if they do not drink alcohol (see section 3, withdrawals). Models of Care for Alcohol Misuse (MOCAM) defines “harmful drinkers” as anyone drinking at levels above those recommended for sensible drinking, typically at higher levels than most hazardous drinkers, which would include dependent drinkers. The World Health Organisation (WHO) defines dependence in someone having experienced three or more of the following: A strong desire or compulsion to drink. Difficulty in controlling onset or termination of drinking or levels of alcohol use. A physiological withdrawal state upon cessation of alcohol or the use of alcohol to avoid withdrawal symptoms. An increased tolerance to alcohol. Progressive neglect of other interests. Persistent use of alcohol despite clear evidence and an awareness of the nature and extent of the harm it is causing Alcohol detoxification may be considered for patients where alcohol dependence has been established by assessment and the patient is motivated for abstinence from alcohol. In other cases, inpatient alcohol detoxification is likely to be the treatment of choice, and is required if the patient: Is severely dependent on alcohol and therefore likely to have severe withdrawal symptoms. Suffers with a serious or life threatening medical or psychiatric condition. Is at risk of suicide or homicide Has a current or past history of severe withdrawal symptoms such as delirium tremens (DTs) or epileptiform seizures. Assessment comprises: Initial screening using AUDIT-C if positive then followed up with full AUDIT Detailed alcohol use history, including details of previous alcohol detoxification (community or in patient). Current consumption (pattern, type of alcohol, units/day/week). Breath alcohol measurement (if negative request alcohol screen in urine) Clinical signs of withdrawal symptoms/signs e.g. tremor. Withdrawal symptoms reported by patient. Administration and scoring of SADQ for level of dependence Physical exam – check for hepatomegaly, stigmata. MCV, LFTs, Gamma GT, INR, blood glucose, other drugs (where possible). Other investigations may be necessary depending on differential diagnoses or concurrent conditions. 13.1.1 Community detoxification can be initiated in those patients who: are motivated for abstinence from alcohol. 30 have a stable social situation and there is a non alcohol-dependent adult in the household who is willing to support the patient through detoxification. have a level of alcohol dependence of moderate-severe, but not very severe according to SADQ or CIWA-AR. drink less than 30 units per day do not have a history of alcohol (or sedative) withdrawal convulsions, alcohol hallucinosis or delirium tremens (DTs). do not have a history of Wernicke ’s encephalopathy. do not have serious mental or physical health issues. have stable drug use (can include being on opiate substitution therapy). are not pregnant. 13.1.2 Inpatient detoxification is advised in: Service users who lack social support and / or live alone. Where there is marked social deprivation, homelessness/no fixed abode would make community detoxification unsafe and unrealistic. Difficulties in management including verbal / physical aggression, violent behaviour as an out-patient or during previous treatment. severe dependence significant co-morbid physical (epilepsy, severe malnutrition or severe liver impairment) or mental health issues history of seizures delirium tremens cognitive deficit or Wernickes encephalopathy multiple failed community detoxifications service users who drink over 30 units a day 13.1.3 HTT detoxification can be undertaken in those who: have been initiated on a detoxification regimen in inpatient adult psychiatric or acute services. Have already been initiated on Pabrinex (where required). This should be the first two IM doses in inpatient psychiatric services or one day of IV Pabrinex from acute medical units. Meet the criteria for a community detoxification as set out in 13.1.1 and will not accept inpatient detoxification as set out in 13.1.2. Physical assessment as set out in 13.1 has already been completed by the referrer. Medical responsibility lies with the consultant who will delegate physical monitoring to nurse practitioners as part of the care plan. 13.2 Alcohol Withdrawal Syndrome Not all heavy drinkers will experience withdrawal phenomena. However, there is a wide range of severity of withdrawal symptoms and in some cases withdrawal may be life-threatening. You must recognise early clinical features and treat them appropriately. 13.3 Early withdrawal symptoms occur up to 12 hours after the last drink (sometimes within a few hours if the patient is severely alcohol dependent): tremor, sweating, anorexia, nausea, insomnia and anxiety. In moderate withdrawal the signs are more marked and transient, auditory hallucinations in clear consciousness may also occur. 13.4 Withdrawal fits can occur at 12 to 48 hours, especially if there is a previous history of withdrawal fits or epilepsy. Fits tend to be generalised (if focal, suspect head injury) and may occur in bouts. 30% of cases are followed by DTs. 13.5 Severe withdrawal/delirium tremens usually develops after 72 hours and patients consuming more than 16 units per day (½ to a bottle of spirits per day or equivalent) are particularly at risk and occur in 5% of patients in severe withdrawal. Clinical features include: marked tremor, confusion (82%), disorientation, agitation, restlessness, fearfulness, visual and auditory hallucinations, delusions, autonomic disturbances, ophthalmoplegia (29%) tachycardia, sweating, fever and dehydration.20 31 13.6 Protracted withdrawal syndrome has been noted in many alcoholics, characterised by irritability, emotional lability, insomnia and anxiety that persists for weeks to months after alcohol withdrawal. It is due to the residual effects of alcohol on neuroadaptation in the central nervous system. It generally clears spontaneously after prolonged abstinence and resorting to benzodiazepines should be avoided. 13.7 Measurement of Withdrawal To manage and make the withdrawal safe and effective, the use of benzodiazepines is recommended. Withdrawal symptoms should be monitored twice a day over the first few days. The severity of withdrawal symptoms can be measured by using Addiction Research Foundation Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR), which is a very sensitive instrument and helps in adjusting the dose of benzodiazepines. Supportive care Medical care Moderate to high level required Moderate to Moderate high level CIWA-Ar 10required 20 Little required Severity Mild CIWA-Ar <10 Severe CIWA-Ar >20 Complicate d CIWA-Ar >10 plus medical problems Little required Pharmacological therapy Little to none required – may be symptomatic treatment only e.g. paracetamol Symptomatic and substitution treatment (e.g. diazepam) may be required High level required Medical monitorin g Symptomatic and substitution treatment (e.g. diazepam) usually required High level required Specialist medical care required Substitution and symptomatic treatments required Setting for treatment of withdrawal Home Home or community day services Community day services or hospital (inpatient) Hospital (inpatient) SADQ (Severity of alcohol dependence questionnaire) (See appendix 2) This is a self-administered, reliable questionnaire to measure the severity of alcohol dependence which can be classified as: 0-3 no dependence, 4-19 mild dependence, moderate (20-30), severe (up to 30-40) and very severe (up to 40-60). This instrument can also be used to predict the degree of withdrawal symptoms and rationalise the medication for detoxification. 13.8 Management of alcohol withdrawal Alcohol dependent patients exhibiting withdrawal features or at high risk of developing withdrawal (based on their previous history) should be prescribed benzodiazepines (diazepam 1st line). Do not prescribe benzodiazepines for those heavily intoxicated with alcohol. Dosage should be individually titrated against severity of withdrawal symptoms and signs. Suggested regimens are in the table below with additional ‘when required’ given after assessing with the CIWA-AR (10-15 for 5mg and ≥16 for 10mg diazepam once a day for the first 48 hours). When using fixed regimens, review after 24hrs, if ‘when required’ diazepam is used, as the regular dose may need to be increased. 32 Diazepam Detoxification table Severity MODERATE SEVERE VERY SEVERE Alcohol units/day 20- 30 31 - 44 45 + SADQ 20-30 31 - 44 45 - 60 CIWA-AR 10-20 Day 1 >20 20mg TDS 20mg 3-4 times a day 15mg AM 10mg MD 15mg PM 20mg AM 15mg MD 20mg PM 20mg TDS 10mg AM 10mg MD 15mg PM 15mg AM 15mg MD 20mg PM 20mg AM 15mg MD 20mg PM 10mg TDS 15mg TDS 15mg AM 15mg MD 20mg PM 10mg AM 5mg MD 10mg PM 5mg AM 5mg MD 10mg ON 15mg AM 10mg MD 15mg PM 10mg AM 10mg MD 15mg PM Day 7 5mg TDS 10mg TDS Day 8 5mg BD Day 9 5mg ON 10mg TDS Day 2 10mg AM 5mg MD 10mg PM Day 3 5mg AM 5mg MD 10mg PM Day 4 5mg TDS Day 5 5mg BD Day 6 5mg ON 15mg TDS Day 10 10mg AM 5mg MD 10mg PM 5mg AM 5mg MD 10mg PM 5mg TDS 5mg BD Day 11 5mg ON Day 12 Day 13 Diazepam should be used first-line for the acute management of alcohol withdrawal 15mg TDS 15mg AM 10mg MD 15mg PM 10mg AM 10mg MD 15mg PM 10mg TDS 10mg AM 5mg MD 10mg PM 5mg AM 5mg MD 10mg PM 5mg TDS 5mg BD 5mg ON 13.8.1 Community & HTT management of withdrawal Diazepam tablets should be prescribed for each 24 hour period (i.e. prescribe 3 doses for Day 1 and a dose for morning of Day 2) and the lunchtime dose for Day 2 if the next home visit is due in the afternoon. Thiamine 100mg three times a day & vitamin B co strong two tablets daily should be prescribed during detoxification and for one month after. All practitioners should be familiar with the range of alcohol withdrawal symptoms, and be alert to signs of severe withdrawal such as Delirium Tremens and convulsions and also be aware of signs of Wernicke’s encephalopathy which can be life threatening, and such cases must be transferred by emergency ambulance (call 999) to nearest A&E Dept. 33 Avoid high doses in the elderly and in liver impairment. Consider lorazepam in service users with liver disease (1mg lorazepam =10mg diazepam) The service user must abstain from alcohol totally when treatment starts. The service user should have had their last alcoholic drink at least 8-12 hours before starting the treatment regimen. An agreement/ contract of care relevant to their needs to ensure co-operation and compliance for a community detoxification will be completed by the service user To enable the service user to avoid accident or incident, s/he will be advised not to participate in any activity which demands excessive concentration e.g. operating machinery or driving nor in demanding physical activity Breath alcohol test will be done at each visit. Community detox treatment will be discontinued if there is a positive breath alcohol result. Following this the team will assess the need for ongoing input (i.e. HTT, admission or signposting for further appropriate support e.g. CAT / Equinox / GP). Advise the service user to eat a balanced nutritional diet which includes fresh fruit and vegetables and ensure prescribed medicines are taken after meals. Encourage the service user to drink plenty of fluids but not to take excessive quantities of coffee or other stimulants. Women, the elderly, or smaller (weight) and less severely dependent service users may require smaller doses of medication. If and when the service user is experiencing physical complications, carer can contact Trust teams, as well as the GP or A&E. If the service user is experiencing severe physical complications e.g. seizures, advise the carer to dial the Emergency Services (999) for an ambulance. If the service user becomes very drowsy it is advisable to omit the next dose of medication and discuss the matter with a nurse practitioner or consultant asap. Nurse Practitioners will observe the patient for any signs or symptoms of withdrawal during the visits. Failure to comply with community & HTT detox Detoxification treatment will be discontinued in the evidence of alcohol consumption i.e. positive breathalyser test at any stage during the detox regimen. The service user will be assessed for ongoing input, admission or signposting for further appropriate support e.g. CAT/Equinox/GP. Treatment may only be reconsidered after discussion with Team as to what realistic purpose it can serve. Aggressive behaviour (actual or threatened) will lead to termination of treatment. On completion of a community or HTT detox Service user will be assessed for ongoing need for CAT or Equinox input required e.g. Day Programme and/or one to one support, in-house support i.e. with keyworker, consultation with the dietician, residential rehabilitation, attending AA meetings. Consider referral to the mental health team if additional mental health comorbidities exist Consider recommending ongoing regular review with the GP for physical health monitoring. 13.8.2 In severe withdrawal or the DTs additional doses of diazepam orally should be given. For rapid response parental use of benzodiazepines e.g. lorazepam intramuscularly or diazepam intravenously may be necessary initially. On the other hand if the patient is very drowsy or over-sedated, the dosage of diazepam may need to be omitted or reduced. 13.8.3 Withdrawal fits or status epilepticus: - See respective sections in the ‘Blue book’. 13.8.4 Severe behavioural disturbance: Haloperidol should be reserved for patients who do not respond to benzodiazepines (or experience a paradoxical effect with benzodiazepines) and should not be regarded as a treatment of choice in withdrawal. If rapid tranquillisation becomes necessary then follow the guidelines for rapid tranquillisation. 13.8.5 Vitamin supplements: Dependent drinkers and those at a risk of Wernicke’s Encephalopathy (nystagmus, confusion, ataxia, ophthalmoplegia) will require IM (2 pairs daily) or IV (2 pairs TDS IV) 34 multivitamins (e.g. Pabrinex® High Potency) for 3 to 5 days followed by oral preparations (thiamine 100mg TDS and vitamin B co strong 2 OM) if they are malnourished or have decompensated liver disease. Anaphylaxis kits must be a viable when giving parenteral vitamins. 13.8.6 Chlormethiazole (Heminevrin®): Chlormethiazole (non-formulary) can lead to respiratory depression especially when taken with other CNS depressants; it is therefore not recommended. 13.8.7 Wernicke’s encephalopathy (WE) Inappropriately managed WE is the primary contributory cause of death in 17% of affected patients and results in permanent brain damage in 85% of survivors. Post-mortem analysis has demonstrated that WE may occur in as many as 12.5% of chronic alcohol misusers, although WE or Korsakoff’s psychosis has historically been diagnosed during life in only 5-20% of patients. The classically described triad of signs of acute confusion (82%), ataxia (23%) and ophthalmoplegia (29%) actually occurs in only 10% of patients; the triad cannot be used as the basis of a diagnosis. Call 999 for any patient with signs of Wernicke’s and arrange transfer to an acute hospital for treatment with IV Pabrinex®. 13.9 Observation and monitoring: blood pressure, pulse, body temperature, correction of dehydration or electrolyte imbalance (encourage 2L fluid/day) and treatment of concurrent conditions e.g. infection, hypoglycaemia, hepatic failure, GIT bleeding etc. Patients should be orientated and reassured that any distressing symptoms will eventually settle. An explanation of the symptoms and their relationship to excessive consumption should be given. Directive counselling during the process of detoxification can enhance patient's motivation to continue the treatment. During withdrawal patients often have alcohol cravings and are vulnerable to relapse. Therefore any unaccompanied leave from the ward should be carefully considered and patients should be advised not to go into pubs or places where alcohol is available. 13.10 Alcohol or drug use in inpatients: Patients must abstain from alcohol and/or other illicit substances whilst receiving in-patient detoxification. Consumption of alcohol or other non-prescribed drugs during detoxification may result in the patient being discharged. The patient should be asked to sign a form stating that they have read and understood the unit policy on this issue. This then allows some flexibility in making clinical decisions about discharge whilst leaving patients in no doubt that they can be discharged if they break the rules. To ensure this, a breath alcohol test or screening of blood/urine for alcohol or other substances should be performed regularly. If a patient does not comply with this, then for the safety of the other patients, discharge should be considered. 13.11 Planning aftercare: Well in advance of discharge a plan for further support in the community should be prepared with the patient's full participation and with the involvement of relevant community agencies. Community Drug & Alcohol Teams aim to provide a follow up service for patients who have undergone inpatient detoxification, providing prior agreement on follow-up between the patient and the Community Alcohol Team has been obtained. If the patient is discharged prior to completion of detoxification, clear instructions should be given regarding medication on discharge and where necessary arrangements made for ongoing supervision of detoxification (e.g. by the GP). Advice with regard to diagnosis, management and referral to specialist agencies is provided by the Community Drug & Alcohol Teams. 13.12 Alcohol withdrawal seizures If a fit/seizure occurs during alcohol withdrawal, it should be treated with rectal diazepam as outlined below. Alcohol withdrawal seizures do not respond to phenytoin. 35 Protect the patient from damage during the seizure by making the environment safe (by using padded bed rails / pillows for example). Do not restrain the patient. Call the medical emergency team. Administer diazepam rectal solution directly from the rectal tube container according to the following dosage schedule: Adults– the contents of one 10mg tube Elderly patients – the contents of one 10mg tube If no response is seen after 5 minutes, one further tube containing the same dosage can be administered. If there is still no response, refer to the guidelines for the treatment of status epilepticus. Once the seizure has ceased, place the patient in a semi-prone position with the head down to prevent aspiration and to help maintain the airway. The patient should be kept in this position until full consciousness is restored. Consider obtaining specialist advice regarding the need to start an anticonvulsant drug. 13.13 Medication for alcohol relapse prevention. See Appendix 8. Medication for relapse prevention is supported by NICE and clinical evidence for motivated patients, and should be done with a specialist with the appropriate skills21,22,23 13.13.1 Acamprosate Acamprosate is licensed for abstinence maintenance therapy for up to one year in motivated alcoholdependent patients to prevent relapse by modulating the gamma-aminobutyric acid/glutamate (GABA) system. Acamprosate should be stopped if there has been no major reduction in drinking, small lapses are acceptable. Adult dose 18-65 years, 60kg and over, 666mg three times daily; less than 60kg, 666mg at breakfast, 333mg at midday and 333mg. Acamprosate should be started immediately after the withdrawal period as it takes 7 days for the therapeutic effect to build up and possibly as an adjunct to psychological interventions. 8 13.13.2 Disulfiram Disulfiram is used as an adjunct in the treatment of chronic alcohol dependence (under specialist supervision) and is a negative reinforcer of abstinence. If disulfiram is taken regularly and alcohol is consumed, an unpleasant reaction can occur within 10 minutes of alcohol consumption and last several hours after alcohol is consumed. This may require intensive supportive therapy and oxygen should be available. Reactions include flushing of face, throbbing headache, palpitations, tachycardia, nausea, vomiting and, with large doses of alcohol, arrhythmias, hypotension and collapse. Alcohol should not be consumed for at least 24 hours before initiating treatment. Supervision of oral disulfiram may prevent relapse. Treatment should not be continued for longer than six months without review. 800mg should be given initially on the first day, reducing over five days to 100-200mg daily. The treatment is contraindicated in those with cardiac problems and psychosis. 13.13.3 Naltrexone Naltrexone is an opioid receptor antagonist which also blocks the body’s own natural endorphins and can be effective at blocking the pleasurable endorphin effects of alcohol.24,25 A systematic review of naltrexone treatment concluded that short–term treatment with naltrexone was effective at reducing craving for alcohol; however there were a number of limitations. Some major limitations of the available evidence include short study duration in many trials, small sample sizes in most trials and lack of data on psychosocial benefits.5 Naltrexone should be commenced under the supervision and advice of Drug and Alcohol Services. 36 14.0 GBL Detoxification Gamma butyrolactone (GBL) is a precursor of Gamma hydroxybutyric acid (GHB) known as ‘G’ and is taken typically in liquid form using a pipette.26 These drugs are both hypnotics. GBL is metabolised to GHB in the body but is more rapidly absorbed than GHB so has faster onset of action. Low doses have a euphoric affect, high doses produce sleep, also somnolence and confusion can occur at any dose. 1ml of high purity GBL is equivalent to about 2.5mg GHB. Usage becomes more problematic when the frequency of dosage increases dramatically27,28 Those dependent on GHB/GBL typically use 1-2mls of GHB/GBL every 1-2 hours continuously and may wake during the night to take the drug. Cessation of use leads to a rapid onset (3-4 hours) of possibly severe withdrawal symptoms including: sweating, agitation, tremor and intense craving. As the symptoms develop, users can experience severe delirium, respiratory depression and convulsions29,30,31 Toxicity includes nystagmus, aggression, urinary incontinence, nausea and possibly coma. In some cases GBL withdrawal can require ICU admission for delirium, seizures and rhabdomyolysis. Severe GBL withdrawal is a medical emergency.32 Due to short ½ life of about 20min for GBL, patients can move from deep coma to wakefulness in about 30 minutes 14.1 Assessment Prior to detoxification the patient should be fully assessed and any substance misuse, mental health and physical health history must be fully assessed. 14.2 Prescribing baclofen (See SmPC for full details) Baclofen is unlicensed for GBL detoxification and it may be used for GBL detoxification on specialist drugs and alcohol team advice only. Side-effects may be avoided by not rapidly titrating the dose. Common adverse effects that are particularly seen at the start of treatment include daytime sedation, drowsiness, and nausea. Occasionally dryness of the mouth, respiratory depression, light-headedness, lassitude, exhaustion, mental confusion, dizziness, retching, vomiting, headache and insomnia are seen. Baclofen is well tolerated when combined with alcohol.33 Prior to admission request that the patient does not take GBL for the preceding 2 hours. Immediately on admission to ward assess for withdrawal symptoms and ascertain amount of GBL used. The patient must not be kept waiting as they can start withdrawing very rapidly and may need medication very soon after admission. 14.3 GBL detoxification Detoxification involves high dose benzodiazepines and baclofen (to reduce craving and agitation).34 Day 1: Assess for withdrawal symptoms: pulse >90/min, fine tremor and sweating. This may not develop for 2-3 hrs. If experiencing withdrawal symptoms administer diazepam 20mg. Review 1-2 hrs later, if further agitation or tremor administer another 10-20mg diazepam and 10mg baclofen. Review every 4-6 hours and give continuing doses diazepam 10-20mg, up to 375mg diazepam in 24 hours. Most patients will require between 40-110mg, with an average dose of 70mg in 24 hours. Also continue baclofen so total dose is 10mg tds for 4 days. Omit both baclofen and diazepam if sedated Days 2-6: Once stable over next 2 days start reducing diazepam (given in split doses) Days 1-2: Diazepam 70mg Day 3 Diazepam 40-50mg Day 4 Diazepam 20-30mg Days 5-6 Diazepam 10mg Day 7 Stop If the patient develops delirium/confusion and muscle spasticity or becomes acutely unwell, transfer to an acute hospital immediately. Days 7-14 Any agitation and anxiety seen from day 7-14 can be treated with further doses of benzodiazepines. Mirtazapine has also been used by some centres 2nd line. 37 15.0 Benzodiazepine & Z-drug prescribing Benzodiazepines are licensed as both hypnotics and anxiolytics, inducing sleep and sedation. They act on benzodiazepine receptors to potentiate the effects of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the central nervous system. Benzodiazepines are widely prescribed both in primary care and psychiatric services. They are valuable in the treatment of mental health disorders and insomnia, however due to the risk of dependence with long term prescribing and abuse there is often uncertainty from clinicians about their use. Benzodiazepines may be differentiated from each other by the speed at which they reach peak plasma levels and the duration over which they work (i.e. diazepam works the quickest and lorazepam is one of the shortest acting). Drug BNF (1) Diazepam 5mg Alprazolam* 250 micrograms Maudsley (3) 5mg Bazire (4)a DoH (7) 5mg Clobazam 10mg Clonazepam** 250 micrograms Flurazepam* 7.5-15mg 5mg 500 micrograms (0.25-0.5mg) 15mg (10-25mg) 10mg 500 micrograms (0.25-4mg) 7.5-15mg Loprazolam* 0.5-1mg 0.5-1mg Lorazepam 500 micrograms Lormetazepam* 0.5-1mg Nitrazepam 5mg Oxazepam* 10mg Chlordiazepoxide* 12.5mg 12.5mg 0.5-1mg 500 500 micrograms micrograms 500 0.5-1mg micrograms 5mg 5mg (2.5-20mg) 15mg 15mg (10-40mg) 10mg 10mg Ashton Manual (2)b 5mg 250 micrograms 15mg 12.5mg 10mg 250 micrograms 7.5-15mg 500 0.5-1mg micrograms 500 500 micrograms micrograms 0.5-1mg 5mg 5mg 15mg 10mg Temazepam** 10mg 10mg 10mg * Non-formulary at SWLSTG. For further information see SmPC or contact Medicines Information for further advice. ** Please note: While there is broad agreement in the literature about equivalent doses of benzodiazepines, clonazepam has a wide variety of reported equivalences and particular care is needed with this drug. Inter-patient variability and differing half-lives mean the figures can never be exact and should be interpreted using clinical and pharmaceutical knowledge. These equivalents do not agree with those used by some authors. They are firmly based on clinical experience but may vary between individuals. Ashton also provides equivalent doses of benzodiazepines not prescribed in the UK. 15.1 Indications Principal indications for the use of benzodiazepines are: Hypnotic and anxiolytic Rapid tranquillisation of acutely disturbed behaviour Alcohol & benzodiazepine withdrawal Epilepsy, muscle spasm, anaesthesia 38 15.2. Adverse Effects of benzodiazepines and Z-drugs Benzodiazepines are considered one of the safer psychotropic drugs and adverse effects at BNF limits over 2-4 weeks are limited unless the patient is elderly or where there is hepatic or renal compromise. A full list may be found in the BNF or SmPCs. Memory problems (on both short & long term use) routinely occur and there is incomplete tolerance to memory effects even after long term use. Sedation, hangover & daytime sleepiness, impairing ability to drive or manage heavy machinery. Cognitive & motor effects Tolerance and dependence (on longer term use) Rebound insomnia/anxiety on stopping (short & long term use) Misuse, dependence, diversion and overdose Physical withdrawal (including delirium tremens). Older people are also more likely to become confused and ataxic leading to an increased risk of falls and injuries. Paradoxical reactions to benzodiazepines characterised by: increased talkativeness, emotional release, excitement, and excessive movement or aggression. 15.3 Dependence risk The greatest concern of prescribers is the risk of dependence on benzodiazepines. Overall the risk is low, 15% of non-substance misusing patients become dependant after 1-5 months of regular use. Development of dependence is considerably higher in addiction populations and there are strong links to those with alcohol or opiate use. Benzodiazepines should be prescribed for short term use with a clear indication. They are useful for self-limiting problems, providing symptomatic treatment rather than reversing underlying neurotransmitter abnormalities. Once the self-limiting problem has resolved, the benzodiazepine should be stopped. However for underlying problems that are not self-limiting the underlying problems must also be tackled, as the benzodiazepines will not resolve them (e.g. psychological issues) and there is danger of longer term benzodiazepine use. 15.4 Prescribing Guidance Use lowest benzodiazepine dose for briefest time: o Up to 2-4 weeks for hypnotics o Up to 4 weeks for anxiolytics Use only one benzodiazepine (give long-acting one at night if need both a hypnotic & an anxiolytic effect) at any one time Do NOT exceed BNF dosing limits Reduce gradually after both short term & long term use (> 2 weeks) Only use in acute self-limiting situations/conditions Only use for severe symptoms (never mild symptoms) Do not routinely use in those with a history of addiction Patients who have not responded to one hypnotic should not be prescribed another. 15.5 Long term prescribing Only give benzodiazepines longer term if treatment remains effective, reduces core symptoms of disorder, tolerance is incomplete (helped by using PRN and magnitude of effect remains worthwhile). Long term prescribing of benzodiazepines in people with learning disabilities and complex mental health needs, such as co-morbid autism and epilepsy may sometimes be necessary to treat over-arousal or challenging behaviours. Prescribing benzodiazepines for individuals in such cases may avoid high doses of other medication such as antipsychotics. However, regular review of such prescribing should be undertaken and documented in the patients notes. Tolerance develops rapidly to most unwanted effects such as a high, sedation, cognitive effects, ataxia and muscle relaxation, but may never be complete. Partial tolerance to antiepileptic effects may develop and break through seizures may occur. There is little tolerance to the anxiolytic and anti-panic effects especially at lower doses. 39 Benzodiazepines are classed as Schedule 4 controlled drugs. The Department of Health (and Scottish Executive) has issued a strong recommendation that as good practice, the quantity of schedule 2, 3, and 4 controlled drugs should not exceed 30 days. Prescribers will need to be able to justify on the basis of clinical need a supply of more than 30 days. 15.6 Anxiolytic Uses Benzodiazepines that are licensed for use in anxiety are diazepam, alprazolam (non-formulary in NHS), lorazepam and oxazepam (non-formulary). 15.7 MHRA & NICE Advice Benzodiazepines are indicated for short term relief (2-4 weeks only) of anxiety that is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short term psychosomatic, organic or psychotic illness. The use of benzodiazepines to treat short term mild anxiety is inappropriate and unsuitable. Treatment with a benzodiazepine should be limited to the lowest possible dose for the shortest possible time. NICE does not recommend benzodiazepines for panic disorder and usually for 2-4 weeks only in generalised anxiety disorder. Benzodiazepines are associated with a less good outcome in the long term. Alternatively the British Association of Psychopharmacology suggests alprazolam & diazepam are efficacious in acute treatment of anxiety but their use should be short term and only considered beyond this in treatment-resistant cases. Consider the use of benzodiazepines after non-response to SSRI & SNRI treatment. 15.8 Hypnotic Uses Hypnotics should only be prescribed after the cause of the insomnia has been investigated and nonpharmacological measures (such as ‘good sleep hygiene’, or cognitive and behavioural interventions) have been attempted where possible. Hypnotics should be prescribed in strict accordance with their licensed indications, at the lowest effective dose, for the shortest period possible. Treatment should ideally not continue for longer than 2 weeks. Occasionally, up to 4 weeks treatment may be required, but continued use should always be re-assessed after 2 weeks. The MHRA advised that benzodiazepines should only be used to treat insomnia when it is severe, disabling or subjecting the individual to severe distress. 4 Treatments available for insomnia include short acting medicines: o 1st line hypnotic treatment: zopiclone. o 2nd line hypnotic treatment: zolpidem. Diazepam and lorazepam are licensed for insomnia associated with anxiety. Diazepam, nitrazepam, and other benzodiazepines licensed for insomnia are not recommended because their long half-lives can lead to ‘hangover-effects’ the following day, and the drugs accumulate on repeated dosing. The use of benzodiazepines and Z-drugs for insomnia in children and adolescents are usually not recommended, a sedative antihistamine is preferable. If hypnotics are used in children, it should be under the supervision of a specialist. Patients who have not responded to a particular hypnotic should not be prescribed another. 15.9 Benzodiazepine Withdrawal 15.9.1 Features of Withdrawal Symptoms tend to occur shortly after abruptly stopping a benzodiazepine with a short half-life, or up to several days after stopping one with a long half-life. Short-acting benzodiazepines are more likely to lead to a withdrawal syndrome than long-acting drugs. anxiety, panic attacks, tremor, sweating, palpitations formication, sensory agoraphobia hypersensitivity perceptual distortions, insomnia, nightmares muscle twitches depersonalisation depression hallucinations, psychotic convulsions (rare). symptoms poor memory, loss of concentration & confusion tingling and loss of sensation 40 15.9.2 Management of Benzodiazepine or Z-drug Withdrawal Relatively easy withdrawal is possible in many people if the problems of continuing drug usage are explained to them. Motivate and encourage people to take some responsibility for their situation and its solution. Give non-drug advice simultaneously. This alone may be adequate for some people. 20-40% of long-term users stopped or at least halved their intake when sent a purpose-designed letter. The number of GABA receptors is slowly restored in response to benzodiazepine dose reduction and the rate of withdrawal of treatment must allow time for this to occur, to minimise withdrawal symptoms. Assess the degree of dependence: consider past and current (last 4 weeks) drug history Dependency is more likely with longer duration of treatment, higher doses, more potent benzodiazepines, shorter-acting drugs, and a history of anxiety problems. Assess the motivation to stop or change the pattern of drug use. Is this a suitable time to stop the drug? Consider symptoms of depression, anxiety, insomnia, whether any medical problems are well-controlled. Assess mental health, including general behaviour, mood, and cognitive state. Assess psychiatric history, including overdoses, previous depression, or psychosis. Where relevant, assess forensic (prison, probation) and/or social (employment, family, finances) history 15.9.3 Withdrawal Regimes The only acceptable strategy for stopping benzodiazepine use seems to be gradual withdrawal and replacement with non-drug therapy. Diazepam is a long-acting anxiolytic that causes less marked symptoms of withdrawal than other benzodiazepines, as its metabolites have long half-lives which ensures a gradual fall in blood concentrations. Converting to diazepam is recommended for reduction protocols, particularly for users of short acting benzodiazepines and z-drugs. Diazepam has the quickest onset of action, and is available in several different formulations and strengths. Once switched to diazepam the rate of withdrawal is in steps of 5-10% of their current daily dose every 1-2 weeks. Withdrawal schedules need to be flexible, tailored and agreed with the individual. Whenever possible, give the patient control of their withdrawal schedule. Provide agreed short-term goals of the withdrawal schedule in writing, review frequently and adjust as necessary. Design the schedule around the individual’s symptoms. Avoid increases in dose whenever possible. Advise against the use of recreational drugs or alcohol, to manage anxiety or insomnia during withdrawal. A beta-blocker such as propranolol should only be prescribed when prominent sympathetic over-activity, causing palpitations, tremor and sweating, develops during withdrawal. Prescribing antidepressants to manage anxiety during withdrawal is not recommended, except to treat panic disorder or clinical depression. Avoid antipsychotics, as these can exacerbate symptoms. Up to 15% of people develop protracted withdrawal symptoms that can persist for months or years. Carbamazepine may be used instead of benzodiazepines to control withdrawal symptoms from high doses of benzodiazepines. 15.9.4 Follow-up advice It is important to review regularly (at least every 3 months, or more frequently, according to clinical judgement) in order to monitor withdrawal symptoms, ensure compliance with the withdrawal regimen, offer support and encouragement, reinforce non-drug techniques, and clarify goals and targets met. If withdrawal symptoms occur, maintain the dosage until symptoms improve. Further reductions may need to be taken in smaller fortnightly steps. Aim to stop the drug completely. This can take from 4 weeks to over a year. Inform other doctors involved of the current treatment, in order to ensure continuity of care. Not all people are suitable for withdrawal of their treatment in a primary care setting. 41 Referral to secondary care, a local drugs and alcohol team, clinical psychologist, or trained counsellor may be appropriate: For patients on very high doses For more specialized and intensive behavioural therapies. For those people who fail to achieve withdrawal after repeated treatment and advice. If severe complications develop after withdrawal. If the person is simultaneously dependent on other drugs or alcohol. If there is coexisting physical or psychiatric morbidity. 15.10 Benzodiazepine Abuse and Dependence 15.10.1 Assessment of Dependence. Establish if there is physical dependence or not which should include: Daily use or not. Amount used and pattern (minimum and maximum dose) Duration of daily use (not all daily users are physically dependent) and duration of misuse overall. Presence of withdrawal symptoms, physical dependence and history of epileptic fits Previous prescribing and outcome of treatment 15.10.2 Prescribing in Dependence It is important to consider the pros and cons of prescribing to those who are using benzodiazepines illicitly and it is important that the benefits outweigh the risks. In addition the prescriber must be happy to take clinical responsibility. One or more of the following should be evident Physical dependence Risk of accidental overdose or overall harm Engagement can be improved if prescribed Only supply to these patients from specialist services If a benzodiazepine is prescribed for dependence ensures the following are considered: A specific plan for fast or slower withdrawal, which will include pace and dose reduction steps and enable service user to take responsibility of his/her treatment. Review dates are set. A default withdrawal plan if service user is non-compliant or treatment is interrupted. Use long acting benzodiazepine i.e. diazepam. There is no advice for the maximum amount to be prescribed and the pace of withdrawal but any dose above 40mg daily should be prescribed with caution after wide consultation. Consider the need for daily and supervised administration. Note that the diazepam metabolite half-life is 32 hours (range 21-50). 15.10.3 Maintenance prescribing Maintenance prescribing of benzodiazepines is not recommended as there is no robust evidence to support this though in very rare individual cases it might be appropriate for harm minimization. 15.10.4 Inpatient treatment Some severely benzodiazepine dependent patients including those with co-dependence, co-morbid physical or mental illness, or severe seizures may need admission to hospital for withdrawal. All patients on a benzodiazepine withdrawal schedule are to be assessed on admission, then at 2hrly intervals; as well as in-between for objective signs of withdrawal and/or at patient request. All assessments must be clearly documented. On objective signs of withdrawal the patient should be administered 10mgs to 20mgs of Diazepam based on their previous history and severity of withdrawal. The patient needs frequent observation, assessment, and close monitoring for signs of protracted withdrawal. In the event of withdrawal during this period the qualified nurse can increase the dose as per medication card. If the patient shows signs of continued/protracted withdrawal; the medical team should be informed and an immediate review of the medication treatment plan by the MDT on duty. In the event of over 42 medication intoxication/drowsiness the nurse may omit the next due dose on medication card. The medical team should be informed and the patient’s medication treatment plan reviewed. The patient can remain on the stabilisation dose for several days then commence reduction usually at 5mg per day. 15.10.5 Benzodiazepines in the elderly Benzodiazepines should be avoided where possible in older people or used with caution. Older people are more sensitive than younger people to the central nervous system depressant effects of benzodiazepines: confusion, night wandering, amnesia, ataxia, falls, hangover effects, delirium and pseudodementia. Factors that increase the risk of side-effects include: any degree of chronic renal failure. multiple physical problems and poly-pharmacy (particularly sedative and cardiovascular medicines) drug metabolism is less efficient than in younger people, so that drug effects last longer, and drug accumulation occurs with regular use. elderly people possibly have fewer neurones, alterations in the sensitivity of receptors and less cortical reserve than younger people. For benzodiazepines used in the elderly, dosage should be half that recommended for adults and used short-term (2 weeks) only. In addition, benzodiazepines without active metabolites (e.g. lorazepam and temazepam) are tolerated better than those with long half-lives (e.g. chlordiazepoxide, nitrazepam). There is a cohort of older people who have been on the benzodiazepines for a long time and because of tolerance, doses may seem untypically high. Older people can withdraw from benzodiazepines as successfully even if they have taken the drugs for years. Evidence suggests that dosage reduction and total withdrawal of benzodiazepines is accompanied by better sleep, improvement in psychological and physical health and fewer visits to doctors. Methods of benzodiazepine withdrawal in older people are similar to those recommended for younger adults. 43 16.0 Child & Adolescent Prescribing for Substance Misuse Protocol This protocol provides guidelines for services considering prescribing options for young people with substance misuse problems, including alcohol. 16.1 Introduction & Consultation Process A minority of young people under 18 across the Trust may require prescribing for the treatment of addiction in order to minimise the physical, social and emotional harm associated with dependence on alcohol or illicit substances. Treatment for substance misuse in under 18s needs to be part of a wider package of treatment delivered by mainstream children and family health, social and education services. Funding has been provided via City Bridges to commission a service for young people are at risk of sexual exploitation from Barnado’s. It is envisaged that some young people accessing this service may need specialist prescribing for addiction. Boroughs may also occasionally need to spot purchase this service from the Trust for other young people. This protocol was developed to ensure that substance misuse prescribing for under 18 year olds is undertaken following best practice guidance, and was subject to consultation with Tier 3 CAMHS teams, in particular Consultants, substance misuse specialist workers, Adult Community Drug and Alcohol Teams in the Trust, PCT community Pharmacy commissioners and the Drug & therapeutics committee. 16.2 Purpose Drug treatment goals for young people who regularly misuse substances should be to reduce immediate harms from substance misuse, stabilise the young person and enable them to move to abstinence from illegal drug misuse (though some drug use may still occur). Given the shorter history of substance misuse in the under-18s, and their continuing development and maturation, there is often the potential for rapid improvements to be made. Evidence and clinical experience suggest that young people’s specialist drug treatment is different from adult treatment and should be provided separately from adults. (DoH 2007) In addition any prescribing treatment should be done in conjunction with psychosocial interventions referring to The NICE guidance, Community-Based Interventions to Reduce Substance Misuse among Vulnerable and Disadvantaged Children and Young People (NICE, 2007d) 16.2.1 Duties The prescribing service will offer young people a prescribed substance as a substitute or treatment for an illicit more dependant substance in order to minimise physical social and emotional harm through controlled regular administration, regular reviews and monitoring. Referrals may come from the Tier 3 CAMHS service, the Young Peoples Substance Misuse team or they may come directly from the Barnardo’s project for victims of sexual exploitation. Relevant managers will need to be involved in order to liaise with commissioners about funding. A young person requiring prescribing will be referred to the Team Manager in Richmond CAMHS who will arrange a joint assessment with a CDAT Consultant and a CAMHS Consultant. This is a new development and at the moment prescribing will be initiated by a CDAT Consultant and one CAMHS Consultant who has some experience in substance misuse services. As the CAMHS Consultants become more experienced (and depending on the numbers of referrals this may take some time) they will in the future be able to initiate prescribing without the CDAT consultant, but with continuing supervision. If, following assessment, prescribing is indicated the CAMHS Consultant will liaise with the local CAMHS team to allocate a care co-ordinator if one is not already identified within the Tier 3 team. This will usually be the substance misuse specialist worker in the team if there is one. They will also liaise with the local CAMHS consultant who will take on the role of prescribing consultant for the weekly review and issue of prescriptions with the support of the initiating consultant. 44 Definitions for the purpose of the document: The Initiating Consultant is the consultant (will be the two consultants mentioned above in first year) who assesses and writes the initial prescription and draws up the plan to be followed. The Prescribing Consultant is the Tier 3 CAMHS consultant in liaison with the local CDAT and with the support of the Initiating Consultant. The Care Coordinator will usually be the substance misuse specialist worker who is usually part of or attached to the Tier 3 CAMHS team. Once the prescribing service begins it is very important that the local network continues to support them and remains involved. 16.3 Prescribing for 16/17 year olds. Information for alternative treatment should be offered to the Young person prior to offering prescribing. The Children Act 1989 and 2004 states that Young people aged 16 + have the right to make their own decisions, although actively encouraged to involve carers/parents in the treatment plan, it is not necessary to obtain parental consent before prescribing to this age group unless it was felt that there was evidence of lack of capacity to consent or understand the treatment process under the Fraser Guidelines. Regular weekly review by prescribing consultant. Regular urine drug screening throughout treatment to establish dependency initially then monitor compliance and misuse in treatment. With constant referral to the Children’s Act 2004, Mental Capacity act 16 + and the NTA Guidelines, this policy will be updated as new developments occur. 16.4 Prescribing to Young People under 16 years Information on all treatment options focussing on psychosocial interventions should be offered and evidence of capacity to consent and understand the treatment process under the Fraser Guidelines should be established. These Guidelines are: The young person cannot be persuaded to inform parents/carers that they are seeking specialist treatment and that it is in the best interest of the young person to receive information and treatment without parental consent. They are likely to continue using/injecting with or without relevant information or treatment. The young person’s physical or mental health is likely to deteriorate if treatment is not received. Regular weekly review by prescribing consultant Regular urine drug screening initially to establish dependency and throughout treatment and to establish compliance or misuse of prescribed medication. Other relevant Children’s Services to be involved where appropriate. 16.5 Inclusion criteria for community prescribing There is scant research on specific pharmacological treatments for drug dependence and withdrawal for young people, although extrapolation from the adult literature may be cautiously considered. Buprenorphine and methadone are used in both detoxification and long-term stabilization (DoH 2007). The following applies to drugs only: Physical dependence established through assessment of substance misuse history, positive urine drug screen, a physical examination and corroboration of history and treatment history with other practitioners, in line with diagnostic guidelines. Young person has shown motivation towards treatment Young person agrees to work with their care co-ordinator to develop a care package 45 16.6 Young person agrees to regular urine drug screen and supervised consumption at the initiation of treatment and continuing supervision as necessary. Young person being released from custody where prescribing is necessary and is a priority. Has agreed to the relevant health checks/ blood tests. Risks such as mental health issues, violence and aggression, unstable accommodation and severe polysubstance misuse increase the risks associated with community prescribing and it may be that initiation or detoxification has to take place in an inpatient unit in these cases, however these are not automatic exclusion criteria for community prescribing and on balance it can be assessed as a harm reduction intervention. Practice/Procedure 16.6.1 Authorisation from Commissioners When a young person who may require prescribing has been identified, the local General Manager will approach Commissioners for authorisation. Once funding has been agreed the Rio number should be passed to the contracts manager, who will ensure that the invoice is raised. 16.6.2 Pre treatment Assessment for prescribing purposes: Parent/carer assessment to be carried out if appropriate. To include history of presenting problems with substance misuse and behaviour associated. Onset of any mental health, psycho-social or behavioural problems. Treatment history Development history Medical history, to include head injury. Education or work history. Peer relationship information Family history History of significant life events. 16.6.3 Process to be followed if young person is in Tier 3 CAMHS Assessment for young people with substance misuse problems should be comprehensive and multidisciplinary. As with adults, all domains of functioning should be assessed, but this should also include developmental needs, educational and language attainment, and emotional and physical health and safety. Young substance misusers require a risk assessment to assess areas such as self-harm, suicide intent, dangerousness, and child protection needs. Clinicians may need to follow local or national protocols and assessment procedures, such as the Common Assessment Framework (DfES) and The National Treatment Agency’ s guidelines for assessment of young people’s substance misuse. 16.6.3.1 Initial assessment To be carried out by care co-ordinator to establish dependence. To ascertain whether young person is appropriate for community prescribing or inpatient and if there is sufficient evidence to support this. Young person has had a recent health check/ blood tests (with consent) from GP to include access to advice and testing for Blood Borne Viruses Hep A, B, C and HIV where assessed as appropriate, arrange appointment with other relevant services such as sexual health where appropriate. Advice around smoking cessation and sexual health. Use of Opiate or Alcohol withdrawal or dependence scales to establish physical dependence (see appendix). Assessment of any mental health problems to include self harm – urgent response if needed. Assessment to establish if there is a multiple dependency. If this is the case more than one reduction regime will be required. Urine drug screen to be carried out. Examination of injecting sites with responsible adult present where appropriate, appropriate treatment or access to if needed. Hepatitis B vaccination Assessment of possible pregnancy 46 Investigate any other source of prescribed medication and inform relevant agency of intention to prescribe when assessment process is complete if relevant. Information to collect if already receiving substitute prescribing from another service: Who is prescribing, name of medication, dose, supervised consumption status, compliance to medication, dates of last script issued. Initial care plan to commence. Liaise with line manager and CAMHS consultant. 16.6.3.2 Second stage assessment Development of care plan. To be carried out by care co-ordinator A more in depth substance misuse assessment which looks at the wider context, to include social, cultural, language and cognitive development. Urine drug screen to be carried out. 16.6.3.3 Third stage assessment To be carried out by care co-ordinator. Inform local CAMHS Consultant at this stage if they are not already aware. Book an appointment via Richmond CAMHS Manager to see initiating consultant for a medical assessment at a young person suitable site in the borough. It is unlikely that this will be an emergency but in the event of an appointment being required while the identified CDAT consultant is on leave help would need to be sought from the local CDAT Consultant. Advise client that they will need to attend pharmacy daily for supervised consumption. Contact Pharmacist to provide the relevant prescribing information to provide the service. Contact GP to check no other prescribing is taking place; if this is the case gather information (see above). Advise client they may need to attend in withdrawals see prescribing regime for more detail. Urine drug screen to be carried out. 16.6.3.4 Meeting with Initiating Consultant Responsibilities The initiating consultant should not prescribe in isolation; they should work with other professionals involved and be an active part of the assessment and care plan. The initiating consultant should have an up to date knowledge and understanding of the pharmacology and clinical indications for use, dose regimes and therapeutic monitoring in young people. Full assessment in conjunction with other professionals involved and treatment goals set. Ensure that the correct dose is prescribed, both at induction and through treatment. Interventions should be in line with national and trust guidelines and any deviations should be recorded to include reasons why and appropriate supervision sought. Supervised consumption during treatment of opioid dependence is advised. The prescriber should liaise with the dispensing pharmacist about the client and prescribing regime. Clinical reviews to be undertaken regularly. Thorough clear written records to be kept on the appropriate database. Consent to treatment to be sought, confidentiality to be considered before treatment commences. Meeting Initiating consultant to assess recent use. Initiating consultant to check if any mental health/physical contraindications to prescribed medication. Relevant blood tests, health check results obtained prior to prescribing. Risk assessment. 47 Initiating consultant to advise of risk surrounding on top use and clear procedures given in the event of overdose. Leaflets to be given on medication to be prescribed and overdose prevention and management. Initiating consultant to advise on medication regime. Tier 3 CAMHS consultants who can review the young person with support from the initiating consultant. Care plan agreed between initiating doctors, care co-ordinator, young person and carer. Initiating consultant will then liaise with local 16.6.3.5 Joint meetings Meeting with Initiating Consultant and care co-ordinator to decide if prescribing is appropriate, decision made and young person informed (consent gained from young person/carer). Prescription issued. Prescriptions will be issued on FP10s from local teams with support from local CDAT as prescriptions must be logged on Scriptbase system. Arrangements may be able to be made for electronic prescribing if the local CDAT is nearby. Regular reviews between Prescribing Consultant, care co-ordinator, young person and carer. These should initially be weekly but if the young person is stable they can be fortnightly or monthly. Quarterly reviews (or more frequent if necessary) with initiating consultant, care co-ordinator and young person. Continuous consultation between Care Coordinator and Prescribing Consultant re changes to prescribing regime young person / carer informed. Support available from Initiating consultant. Urine drug screen to show positive result to indicate dependency. 16.7 Process to be followed if young person is referred by Barnardo’s Barnardo’s Project worker will contact Richmond CAMHS manager who will arrange medical assessment as outlined at 9.2.3. This will be the first assessment for these young people; in all other respects the procedure to be followed will remain the same. 16.8 Recording of information All information should be recorded on RiO in the usual way and all presentations recorded on NDTMS (data entry tool for the National Treatment Agency). 16.9 Prescribing for Young people 16.9.1 Considerations for young people when prescribing. Consider any regular alcohol or polydrug use that may have an impact on the administration of the prescribed medication. Informed consent and competency. Child protection issues. Professionals should actively encourage parent/carer involvement with consent from young person while considering the young person’s confidentiality, as this support improves outcomes If the young person is approaching their 18th birthday Borough and Trust Transition Policy will be followed. Ensuring that the young person receiving medication understands the risks and indications related to the medication prescribed and in what circumstances to seek advice from a pharmacist or doctor. The care co-ordinator will ensure that whenever they provide a paper prescription for the young person to take to the pharmacy, that they raise the following:o Have you taken this medication before? o Awareness about the effects of this medication and the associated risks that the young person needs to be aware of o What would they do if they experienced a different reaction to the medication or took the wrong dosage? o Remind the young person about safe handling and storage, such as that it is prescribed for them only and is not to be given to anyone else and it is to be kept in a cupboard away from the reach of other children Where a care co-ordinator is not a trained health professional, it is the responsibility of the team manager to ensure that all staff have the necessary skills and competencies to assess the safety of the young person when providing the paper prescription. Care co-ordinators who are not health trained professionals must receive an awareness training session about safe handling and usage of medication for the treatment of drug and alcohol dependence. 16.9.2 Treatment of Opioid Dependence 48 The use of methadone and buprenorphine is recommended in the treatment of young people who are opioid dependent. Methadone is not authorised for children, generally recognized to be those under 13 yrs and buprenorphine is authorised for those aged 16 yrs and above. Buprenorphine with naloxone (Suboxone ®) is authorised for those 15yrs and above. Lofexidine can also be used for detoxification particularly in those young people where dependence is unclear or uncertain though careful monitoring of blood pressure is indicated. In addition Lofexidine is only authorised for over 18yrs. Induction, stabilization and detoxification of methadone and buprenorphine as well as detoxification with lofexadine is similar to adults and must be done with references to SWLSTG Prescribing Policy for Opiate Dependence (Maintenance & Detoxification). However the following points must be noted with young people: Care should be taken on assessment of tolerance and dependence in young people which can be more uncertain in young people. Non-opioid medication, such as lofexidine, should be used as an alternative if tolerance is unclear and prescribing is deemed necessary. Dose induction is similar to that in adults, although greater care needs to be taken with dose in relation to body mass. Induction on to methadone is generally commenced at doses under 30 mg a day and much lower if tolerance is not clear. Buprenorphine should normally be commenced at 4 mg, increased to 8 to 12 mg rapidly and increased according to response. All doses must be carefully titrated and adjusted for height, weight and age. Procedure for supervised consumption at the community pharmacy: The Care Coordinator will attend the first visit to the pharmacist with the young person. Contract to be discussed and agreed with pharmacist. Pharmacist to contact Care Coordinator if young person is non compliant. Naltrexone should be considered in young people where there is community support from both substance misuse specialists and family. Young people should also be motivated and understand the full implications of the medication. Naltrexone is authorized for over 18yrs 16.10 Alcohol Detoxification Should be offered as part of a package to include psycho-social interventions. One of the recommended drugs for alcohol detoxification is usually Diazepam (Guidance for Pharmacological management of Substance Misuse among young people DoH 2009.) Full explanation of medication and regime to be given to young person and carer along with information sheets about treatment and do’s and don’ts for young person and carer. Severity of Alcohol Dependence Questionnaire (SADQ) to be filled out and breath alcohol minimum reading of below 0.35 mmols (equivalent to 5 units) required for commencement of medication, to be used where appropriate. The time of discontinuation of alcohol will depend on the units of alcohol consumed. The length of the detoxification period will depend on units consumed, compliance to treatment and/or any other complications in relation to treatment response. The dose should be titrated against withdrawal symptoms and score of SADQ. Starting dose for mild dependence is usually 10mg – 5mg -10mg of diazepam TDS initially and reducing over 7 days. 49 Example: Day Dose Frequency 1 10mg - 5mg - 10mg tds 2 5mg - 5mg -10mg tds 3 5mg - 5mg - 5mg tds 4 5mg bd 5 5mg nocte If withdrawal symptoms do not stabilise and there is evidence of seizures or delirium symptoms then the young person should be transferred to a general hospital immediately. The reduction should be monitored daily for the first seven days by the Care Coordinator for any signs of over sedation, seizures, interactions with co-existing illness such as anxiety disorder, this is to include ongoing assessment, vital signs monitoring and Alco meter readings. Care Coordinator to liaise with prescribing consultant. In the case of over-sedation there should be a reduction in dose. In the case of continuing signs of withdrawal additional doses of diazepam should be given. In the case of the young person not stabilising and are showing signs of delirium or seizures then a transfer to hospital should take place urgently. Alcohol detoxification needs to take place in an inpatient setting if there is a history of seizures, significant mental or physical health problems, pregnancy or lack of support. Acamprosate and disulfiram can be considered but will need specialist support and are not licensed in under 18yrs. 16.11 Benzodiazepines Benzodiazepine use among young people is more often characterised by bingeing rather than dependence. Benzodiazepine maintenance prescribing is not recommended for this age group. Detoxification, if required, should be gradual according to the length and severity of dependence. Diazepam at 30 mg per day is usually a sufficient initial stabilisation dose before reduction, even where previous use was higher. Benzodiazepine dependence and withdrawal can be associated with suicidal and self-harming behaviors in young people so monitoring of mental state is important (DoH 2007) any benzodiazepine prescribing will need to be done in conjunction with the SWLSTG Benzodiazepine Policy. 16.12 Role of the care co-ordinator The care co-coordinator can be any practitioner who has received the appropriate training to work with young people who also use drugs and or alcohol. This may not necessarily be a trained health professional. The care co-ordinator needs to have the relevant skills and competencies to carry out the roles and functions within the CMHT. Some of the competencies relating to treatment will include the following and all care co-ordinators will need to ensure they have an awareness of these and that they receive adequate supervision for their role in supporting treatment. · Support individuals who are substance users · Prescribe controlled drugs for substance users · Prepare to & administer medication to individuals, & monitor effects 50 · · · · · · · Supply and exchange injecting equipment for individuals Support individuals through detoxification programmes Supervise methadone consumption Employ techniques to help individuals to adopt sensible drinking behaviour Prepare prescriptions for controlled drugs Counsel individuals about their substance use Counsel groups of individuals about their substance use 51 Appendix1: CIWA-AR (Modified)* 35 NAME DATE OF BIRTH OTHER NAMES HOSPITAL NUMBER REPORTED DAILY ALCOHOL CONSUMPTION: REFER TO ALCOHOL GUIDELINES WHERE AVAILABLE Temperature (per axilla) Pulse (beats per minute) Respiration rate (inspirations per minute) Inform medical team if below 10/min Tremor (arms extended, fingers spread) Sweating (observation) Clouding of sensorium (“What day is this? What is this place?”) Quality of contact Agitation (your observation) Thought disturbances (flight of ideas, paranoid ideas) TIME /DATE 0) 37.0-37.5°C 1) 37.6-38.0°C 2) Greater than 38.0°C 0) 90-95 1) 96-100 2) 101-105 3) 106-110 4) 111-120 5) Greater than 120 1) 20-24 2) Greater than 24 0) No tremor 2) Not visible—can be felt fingertip to fingertip 4) Moderate with arms extended 6) Severe even with arms not extended 0) No sweat visible 2) Barely perceptible, palms moist 4) Beads of sweat visible 6) Drenching sweats 0) Orientated 2) Disorientated for date by no more than two days 3) Disorientated for date 4) Disorientated for place (reorientate if necessary) 0) In contact with examiner 2) Seems in contact, but is oblivious to environment 4) Periodically becomes detached 6) Makes no contact with examiner 0) Normal activity 2) Somewhat more than normal activity 4) Moderately fidgety and restless 6) Pacing, or thrashing about constantly 0) No disturbance 2) Does not have much 52 WARD: Visual disturbances (photophobia, seeing things) control over nature of own thoughts 4) Constantly troubled by unpleasant thoughts 6) Thoughts come too rapidly and in a disconnected fashion 0) Not present 2) Mild sensitivity (bothered by the lights) 4) Intermittent visual hallucinations (occasionally sees things you cannot) 6) Continuous visual hallucinations (seeing things constantly) TOTAL Alcohol withdrawal scale regime—NOTE CHANGE IN SCORE 1 Score four-hourly routinely 2 If greater than 6 score two-hourly 3 If greater than 9 score hourly *“With the modified scale, the reaction is significant at a score of 6, with benzodiazepines recommended after two scores of 9 or one of 12.” 53 Appendix 2: SADQ (Severity of alcohol dependence questionnaire)36 We would like to recall a recent month when you were drinking in a way, which for you was fairly typical of a heavy drinking period. Please fill in the month and the year: MONTH: ………………………………YEAR: ...................................................... We want to know more about your drinking during this time and how often you experienced certain feelings. Please put a tick to show how frequently each of the following statements applied to you during this typical period of drinking. Imagine the following situation: You have been completely off drink for a few weeks and you then drink very heavily for two days HOW WOULD YOU FEEL THE MORNING AFTER THOSE TWO DAYS OF DRINKING? Score 1) I wake up feeling sweaty 2) My hands shaking first thing in the morning 3) My whole body shakes violently first thing in the morning, if I don’t have a drink 4) I wake up absolutely drenched in sweat 5) I dread waking up in the morning 6) I am frightened of meeting people first 7) I feel on the edge of despair when I wake up 8) I feel very frightened when I wake up 9) I like to have a morning drink 10) I always gulp down my morning drink as quickly as possible 11) I drink in the morning to get rid of the shakes 12) I have a very strong craving for a drink when I wake up 13) I drink more than 1/4 bottle of spirits or 4 pints beer/1 bottle wine per day 14) I drink more than 1/2 bottle of spirits or 8 pints beer/2 bottles wine per day 15) I drink more than 1 bottle of spirits or 15 pints beer/4 bottles of wine per day 16) I drink more than 2 bottles of spirits or 30 pints beer/8 bottles wine per day 17) I would start to sweat 18) My hands would shake 19) My body would shake 20) I would be craving a drink Totals 54 0 Almost Never 1 Sometimes 2 Often 3 Nearly Always Appendix 3: AUDIT (Alcohol Use Disorders Identification Test)37 Circle the number that comes closest to the patient’s answer How often do you have a drink containing alcohol? (0) NEVER (1) MONTHLY OR LESS (2) TWO TO FOUR TIMES A MONTH (3) TWO TO THREE TIMES A WEEK (4) FOUR OR MORE TIMES A WEEK How many drinks containing alcohol do you have on a typical day when you are drinking? (Code number of standard drinks = units) (0) 1 OR 2 (1) 3 OR 4 (2) 5 OR 6 (3) 7 TO 9 (4) 10 OR MORE How often do you have six or more drinks on one occasion? (0) NEVER (1) LESS THAN MONTHLY (2) MONTHLY (3) WEEKLY (4) DAILY OR ALMOST DAILY How often during the last year have you found that you were not able to stop drinking once you had started? (0) NEVER (1) LESS THAN MONTHLY (2) MONTHLY (3) WEEKLY (4) DAILY OR ALMOST DAILY How often during the last year have you failed to do what was normally expected from you because of drinking? (0) NEVER (1) LESS THAN MONTHLY (2) MONTHLY (3) WEEKLY (4) DAILY OR ALMOST DAILY How often during the last year have you needed a first drink in the morning to get yourself going after a heavy drinking session? (0) NEVER MONTHLY (1) LESS THAN (2) MONTHLY (3) WEEKLY ALMOST DAILY (4) DAILY OR How often during the last year have you had a feeling of guilt or remorse after drinking? (0) NEVER (1) LESS THAN MONTHLY (2) MONTHLY (3) WEEKLY (4) DAILY OR ALMOST DAILY How often during the last year have you been unable to remember what happened the night before because you had been drinking. (0) NEVER (1) LESS THAN MONTHLY (2) MONTHLY (3) WEEKLY (4) DAILY OR ALMOST DAILY Have you or someone else been injured as a result of your drinking? (0) NO (2) YES, BUT NOT IN THE LAST YEAR (4) YES, DURING THE LAST YEAR Has a relative or friend or a doctor or other health worker been concerned about your drinking or suggested you cut down? (0) NO (2) YES, BUT NOT IN THE LAST YEAR (4) YES, DURING THE LAST YEAR Cumulative score……….. The minimum score (for non-drinkers) is zero and the maximum possible score is 40. A score of 8 or more indicates a strong likelihood of hazardous or harmful alcohol consumption. 55 Appendix 4: Objective Opiate Withdrawal scale (OOWS)38 PATIENT NAME……………………………………………. RIO NO: …………………. The checklist should be filled in each time the patient attends during stabilisation/dose titration on opiate substitute medication. The patient should be asked if they have experienced or noted the sign/symptom in the preceding 24 hours. The checklist should be completed hourly on admission to acute inpatient wards for titration of methadone. A tick (√) should be recorded if the patient reports the experience of each sign/symptom in the preceding 24 hours. If a sign is objectively present, record two ticks (√√). If a sign/symptom is not experienced record a cross (X). N.B. Signs are underlined & marked with *. Observer Initials & date & time 1 Tremor (hands) 2 Anxiety 3 Yawning* 4 Sweating* 5 Runny nose* 6 Watering eyes* 7 Gooseflesh* 8 Muscle twitches 9 Hot/cold flushes 10 Restlessness 11 Vomiting* 12 13 Pupil size (mm) ≥ 4mm (abnormal) Stomach/abdominal cramps 14 Loss of appetite 15 Aching bones & muscles 16 Irritability 17 Nausea 18 Sleeplessness 19 /diarrhoea* 20 Blood pressure & Pulse rate >80Bpm (abnormal) Double ticks for 4 different observations in the grey boxes may mean that a further dose of methadone is required during titration. Items in the grey boxes form part of the OOWS. 56 Appendix 5: Titration for opiate users This leaflet is designed to explain the process of induction onto methadone or buprenorphine for people who are dependent on opiates such as heroin. What is titration? ● Titration occurs when a person is started on a low dose of either methadone or buprenorphine on the first day of prescribing. The dose is increased gradually over the next few days. During this process you will be monitored at the clinic. ● Methadone and buprenorphine can take 5 days to build up in the body so it is important not to give someone too much initially as they could overdose. Also it is difficult to know exactly how much medication someone may need to treat their withdrawal symptoms as drugs bought on the street are not pure. This means we gradually increase the prescribed medication to reach a dose at which a person is comfortable. What should I do before titration? ● You need to be signed up with a GP and identify a chemist with help from your key worker. You may need some blood tests particularly if you are starting buprenorphine. ● We will fully assess you and confirm you are dependent on opiates by doing 2 urine drug screens several days apart. ● Do not use any illicit drugs on the day you are due to start titration. We would advise not using any heroin for at least 8-12 hours and methadone for 24 hours before starting. With buprenorphine you will need to have started withdrawing before taking the medication otherwise you may feel unwell. Also we advise that you to not drink heavily during titration ● We commence titration in the morning, but it is also possible to be seen again later the same day if you are experiencing withdrawal symptoms. assess the best dose of medication you need. You could also overdose. What can I do? During the titration process these things may help. ● Spending time with family or friends who do not use drugs for support. ● Eating small regular meals and drinking fluids such as water ● Using over the counter remedies such as paracetamol for aching legs (but make sure there is no codeine in the medicine as this is an opiate). ● Doing other things you enjoy that do not involve drugs ● Talking to your key worker at the team. What are the risks? ● It is very important to be aware that there is a risk of overdose when starting methadone or buprenorphine. ● To prevent this we would advise you not to use additional illicit drugs or alcohol if possible. ● If you do however try to be as safe as possible by only using with someone else present who can call an ambulance. ● Also try to smoke not inject and use as little as possible. ● If you feel drowsy go to hospital or call the clinic What happens after titration? ● Initially the prescription will be dispensed daily under supervision. ● This is because the risk of overdose is highest in the first few months of methadone or buprenorphine treatment. ● However this will be reviewed during your treatment How will I feel? ● We will also continue to monitor you using urine ● You may feel uncomfortable over the first few drug screens. days of titration as the dose of methadone or buprenorphine is building up. But we advise you ● Your key worker will continue to work with you in all aspects of your treatment. not to use street drugs as we may not be able to continue and it makes it to more difficult to Contact your care coordinator, key worker, pharmacist or contact Medicines Information on 0203 513 6829 for further advice. 57 Appendix 6: CAMHS Consent form for drug treatment Team Address Medication to be commenced............................................................................................. The Doctor prescribing me/my child the medication specified above has explained the following information to me/my child: Rational for drug treatment Delay or onset of effect Time and course of treatment possible side effect the need to take medication as prescribed Advised that I may require blood tests i.e. Liver function tests to commence treatment. If I use other illicit drugs or misuse alcohol on top of treatment my prescription would be stopped. I will undergo supervised urine drug screening during treatment. I must attend all appointments with the doctor and key worker in order to collect my prescription. I understand all of the above and I agree to/agree to my child commencing the medication specified above. I also understand that my response to medication will be reviewed regularly and that I can discuss changing my mind about taking any medication at any time. I am currently not on any other medication/ I am on …...................................................... Child/Young Persons name Date of Birth Address GP Postcode Key worker (young person) Signature.................................................... Date........................................... Carer/family signature…………………………………………..Date……………………………… Clinician..............................................Signed.................................Date......................... The use of this medication does/does not comply with NICE guidance and pharmaceutical licensing. I discussed this with family and have given leaflets/information and demented this in the electronic care notes. Fraser Guidelines In 1985, Lord Fraser said in judgement of the Gillick case, that a doctor can give contraceptive advice or treatment to a person under 16 years of age without parental consent, providing the doctor is satisfied that: The young person will understand the advice. The young person cannot be persuaded to tell his or her parents or allow the doctor to tell them that they are seeking contraceptive advice. The young person is likely to begin or continue having unprotected sex with or without contraceptive treatment. The young person’s physical or mental health is likely to suffer unless he or she receives contraceptive advice or treatment. Although the above guidelines apply to health professionals it also might highlight the fact that young people themselves have the right to confidentiality and privacy. 58 Appendix 7: Child Needs Risk Assessment Tool for clients in primary care Clients Name: Date of Birth Assessment date Assessed by: The purpose of this section is to ensure that in all settings the needs of the dependent children are taken into account Does the patient have (or likely to have) dependent children or close contact with children? Yes No unsure Who has parental responsibility for the child? Child (ren) details: Please specify Name D.O.B Address Primary carer GP (if different) School/nursery/play group. Is the MH of the client likely to impact on his/her capacity to meet the needs of the child (ren)? Are there any alternative parenting or private fostering arrangements? Are there any concerns as to whether the child’s needs are being met? Concerns about child’s appearance Concerns about child’s development (walking or crawling) Concerns about child’s language development or behaviour Other (please specify) If the client is unable to fulfil duties, is there an identified parent/carer who is able to and does fulfil these tasks (grandparent/co parent)? Yes No Unsure Yes No Unsure Please specify yes no Who looks after the child (ren) whilst parent is at their appointment? If yes, Contact name Please specify Who lives at home with the client and child (ren) or normally visits? Please specify 59 Are there any safeguarding concerns?(Include any previous concerns) Has a CAF been completed in the past? Is the patient involved in the BUMPS specialist midwife clinic? Yes No Yes No Yes No Is there involvement including open cases with health visitors? FOR GP (if completing): Has the patient been referred to the Primary Care Liaison Nurse- and are they aware of any risk to child (ren) Yes No If yes, Contact name Yes No comments NOTES ON COMPLETING THE ASSESSMENT ON RISK TO CHILD Assessment of mental health should take into account: 1) the present mental state of the patient and any relevant history 2) the patients use of/attitude towards use of treatment and the impact of treatment Assessment of capacity to meet needs of the child (ren) should take into account ages of the child, support networks and capacity for parenting tasks such as: 1) The physical appearance of the child including weight, height, signs of tiredness. 2) How the parent converses with and responds to the child including type of language, managing tension and conflict. How does the child respond to the observer? Appropriately shy and wary or isolated or over familiar? 3) Is the child of school age and accessing school? Is play and the activities age appropriate for the child's development. 4) Does the parent enable and encourage appropriate peer contact and social relationships 5) Is the physical environment safe and age appropriate e.g. access to kitchen, stairs, implements for young children etc 60 Appendix 8: Prescribing Guidelines for Medicines used for abstinence (Naltrexone, Disulfiram, Acamprosate) or harmful drinking reduction (Nalmefene) Medicines used to help patients sustain abstinence from alcohol 1st line: Acamprosate is by far the most commonly prescribed medicine and is useful for those experiencing cravings for alcohol. Disulfram is most useful for stable patients who need a further deterrent as severe side effects are experienced should someone drink alcohol while being prescribed. Naltrexone can be used as per NICE along with psychosocial intervention to reduce the risk of relapse, as support treatment in abstinence and to reduce the craving for alcohol. It is also a full opiate blocker. Following detox, medicines for abstinence may be initiated by a Drug and Alcohol Team (DART) or after inpatient admission (Crawley Hospital or Kingston) in those that are willing and feel they would benefit. Service users are transferred to the community psychosocial team; there is no further medical input required from the treatment team at this point. If needed, medical advice and support can be obtained from DART and the supply is sourced from their GP. Nalmefene is as a possible treatment for people with alcohol dependence whoxxxix&xl: o are still drinking more than 7.5 units per day (for men) and more than 5 units per day (for women) 2 weeks after an initial assessment and o do not have physical withdrawal symptoms and o do not need to either stop drinking straight away or stop drinking completely. o These patients do not necessarily require a detox and do not meet the threshhold to be seen by most alcohol treatment teams. Those requiring medicines for detox (i.e. chlordiazepoxide) are not initially suitable for nalmefene. This product requires extra monitoring, report adverse effects to the MHRA: www.yellowcards.gov.uk Nalmefene should be taken at a dose of 18mg 1-2hrs before the anticipated time of drinking. Prescribe 18mg each day, when required, supply 14 doses in 28 days, with a maximum supply of 6 months to ensure it is reviewed. Should the harmful drinking have not improved at 6 months, nalmefene should be stopped and alternatives considered. Those requiring daily administration of nalmefene should be considered for a switch to naltrexone 50mg daily (unlicensed), which has evidence to support abstinence maintenance and is a more cost effective alternative. Psychosocial support All medicines list above have been shown to be effective and licensed when given in combination with psychosocial input. Psychosocial input can be from the Substance Misuse Recovery Teams (SMRTs) and/or Mutual Aids Groups such as Alcoholics Anonymous (AA). The level of psychosocial support given by SMRTs is to NICE standards which are more in depth then the brief interventions undertaken in clinical trials with nalmefene. Specialists initiating medicines for abstinence in initiating medicines for abstinence and harm reduction will refer for psychosocial support and communicate to GP the care plan (including investigations, recommended monitoring and review) for continued supply of medicines. GPs can refer patients for 12 weeks support (as per NICE) directly for those started on nalmefene by them: 61 Sutton (CDS), T:020 8773 9393 & E:[email protected] Merton (MACS Project), T: 0800 043 2296 (free) or 020 8417 1960/ 0208 417 1975/ 0786 604 5624. Richmond (CRI), T:020 8891 0161,M:07795 391 187, F:020 8892 3363 & E:[email protected] Kingston (Wellbeing Service) T: 020 8274 3051 or E:[email protected] The community psychosocial team acknowledges the referral and will continue communicating with the GPabout the progress of the service user under their care. They will inform the GP should the patient disengage from the programme as nalmefene should be discontinued. GP monitoring & review requirements Medicines for abstinence and harm reduction require very little medical review (alcohol consumption, overall functioning and side-effects). They should be continued for 6 months to 1 year, or indefinitely if the patient continues to derive benefits and remains abstinent from alcohol, or reduced harmful drinking with nalmefene. Disulfram cannot be combined with alcohol, acamprosate and naltrexone can be given up to one month if someone relapses back to alcohol use. Nalmefene should be discontinued if the patient does not experience a reduction in their harmful drinking at 4 weeks. Useful references Information on medicines for substance misuse (and mental health) may be found on the information website: http://www.choiceandmedication.org/swlstg-tr/ https://www.nice.org.uk/guidance/ta325 - Nalmefene www.nice.org.uk/guidance/CG115 - Alcohol use disorders http://www.medicines.org.uk/emc/ - Summary of Product Characteristics (for Medicines) 62 Transfer of Care Disulfram, acamprosate & naltrexone for abstinence of alcohol Section A: To be completed by the hospital consultant initiating the treatment GP Practice Details: Patient Details: Name: ……………………………………… Name: ……………………………………………… Address: …………………………………… Address: …………………………………………… Tel no: ……………………………………… DOB: ….…../……..…/………… NHS.net e-mail: …………………………… NHS number (10 digits): ………………………… Consultant name: ………………………. Form of psychosocial support: Clinic name & Address: …………………, (Name & contact details of service, where Tel no: ……………………………………… applicable) NHS.net e-mail: …………………………… …………………………………………………… Diagnosis & Severity: Drug name & dose to be prescribed by GP: …………………………………………………… ……………………………………………………………. Dear Dr. …………………….., Your patient was seen for alcohol detoxification and has agreed to psychosocial support in the form noted above. Where the person has opted for non-NHS funded psychosocial support, they have been advised that the medicines considered to be ineffective and should be stopped should they not engage with the support on offer and to advise you as such for you to stop them. I have stabilised the patient on the medicine above for alcohol abstinence. I request your agreement to transfer the care of this patient from the next supply in 2-4 weeks’ time accordance with the (attached) Prescribing guide. Patient information has been given outlining potential aims and side effects of this treatment. The patient has given me consent to treatment and transfer the care back to you, and has agreed to comply with instructions and follow up requirements by you: Please monitor the following: 1. 2. 3. 4. 5. 6. 7. 8. Encourage adherence. Monitor any side effects of medication. General health Report any adverse reactions to the MHRA via the ‘yellow card system’. Check for interactions with other medicines Annually assess if the patient derives benefit and remains abstinent from alcohol. Refer back to secondary care between regular reviews if concerned about patient’s condition The patients medicines should be stopped immediately if they start drinking with naltrexone or disulfiram. Acamprosate can be continued for a month if the patient stat to drink as if may help to induce abstinence once more. The following investigations have been performed and are acceptable: Test / Assessment Tool Result / Score Date Test / Assessment Tool Result / Score Date LFTs Other relevant information: ……………………………………………………………………………………….. ……………………………………………………………………………………………………………………….. Section B: To be completed by the GP and returned to the consultant as detailed in Section A above Please sign and return your agreement to shared care within 14 days of receiving this request Tick which applies: □ I accept the transfer of care as per the prescribing agreement and above instructions □ I would like further information. Please contact me on:………………………. □ I am not willing to undertake transfer of care for this patient for the following reason: ………………………………………………………………………………………………………………. GP name & signature: ………………………………………………Date: …/…/….. Section C: To be completed by the NHS funded psychosocial support team □The patient detailed above has completed the course of psychosocial support set for them, please continue to supply the medicines in line with the recommendations from the drug addictions prescribing specialist. □The patient has not completed the course of psychosocial support set for them. The patient should be reviewed and you should consider stopping their medicines with them. Prescribing 63 these medicines without adequate psychosocial support is unlikely to be effective. Date: …………./………../…………. Name and signature of practitioner………………………………… Other Clinical Particulars This table is not exhaustive; see individual SmPCs for full prescribing details. www.emc.medicines.org.uk *Refer back to a specialist or contact Specialist Medicines Information (020 3513 6829) for review/advice if the medicine(s) if needed. Management of side-effects Side-effect Acamprosate Diarrhoea, nausea stomach pain, flatulence Headaches Opioid receptor modulators (naltrexone /nalmefene) Anorgasmia, decreased libido Allergic reaction: ash, pruritus, wheeze Arrhythmias Nausea, vomiting, abdominal cramps, diarrhoea Headache Muscle pain polydipsia Rash, pruritis Depression, suicidal ideation hallucinations thrombocytopenia Liver damage Disulfram Sleepiness and fatigue Halitosis Nausea & vomiting Shortness of breath Allergic skin reactions Decreased libido Liver damage (hepatitis) Peripheral neuropathy High or low mood or psychotic symptoms 64 Management Usually self-limiting, supportive advice usually sufficient: drink plenty of fluids, oral rehydration salts or take with food for nausea. Slow titration, reducing the dose temporarily and paracetamol may all help. Try decreasing the dose or stop* Stop, refer to physician for treatment. Switch.* Advise take with largest meal of the day, responds to dose reduction. Self-limiting, occurs in the first 24hrs usually. Self-limiting, simple analgesia. Stop if it does not resolve. Wears off after 1 week Consider dose reduction Stop* Stop* Stop* Stop* Increase frequency of monitoring, consider reducing the dose for twice the upper limit and stopping the medicines for three times the upper limit Usually on initiation or dose increase. Usually self-limiting on initiation. Advise on taking with food or reduce the dose. Stop* Antihistamines help or stop* Stop or consider dose reduction* Increase frequency of monitoring, consider reducing the dose for twice the upper limit and stopping the medicines for three times the upper limit Decreasing the dose can help or stop* Stop* Interactions Clinical meaningful interactions to note with other medicines are rare with these medicines, review the SmPC should adverse effects occur. Caution when combining strong opioids with naltrexone or nalmefene due to the risk of respiratory depression. Disulfiram should not be combined with alcohol. Assessment of the risk of this should be done with the patients before it is initiated. References http://www.nice.org.uk/guidance/ta325/resources/guidance-nalmefene-for-reducing-alcoholconsumption-in-people-with-alcohol-dependence-pdf London New Drugs Group / London Medicines Evaluation Network Review. Nalmefene for alcohol dependence. October 2013. Available [Online] via: http://www.medicinesresources.nhs.uk/upload/Nalmefene_final.pdf (Accessed 7th April 2014) 65 Appendix 9: Management of Opioid Overdose in an Emergency in adults and children over 12 years old (V201612) If overdose of opioids or any other substances is suspected, local medical emergency procedures should be followed. In most outpatient clinics this requires that emergency medical assistance is summoned (by calling 9999) and the patient is supported until emergency assistance is available. Naloxone should only be administered by those suitably trained in recognising the symptoms of overdose and competent to administer naloxone. This guidance relates to emergency use of naloxone in treatment of opioid induced respiratory depression. Naloxone is not effective against respiratory depression caused by non-opioid drugs. Naloxone HCL 400 micrograms (mcg)/1ml ampoules are available in the emergency medicines pouch. Emergency management of opioid overdose should be started if opioid overdose is suspected following subjective and objective assessment; where contraindications and complicating factors are not present. Management should be carried out in conjunction with Emergency Life Support, where indicated, as naloxone is an adjunct to these protocols. The goal of naloxone administration is to achieve adequate spontaneous ventilation. In the absence of signs of opioid withdrawal, there is no maximum dose of naloxone that can be administered. However, if a clinical effect does not occur after 10 mg, other causes of decreased level of consciousness should be considered and (if not already arranged) transfer to an acute hospital should be initiated. Dosing of Naloxone is dependent on the conscious level of the patient and the respiratory rate. The recommended protocol for suspected opioid overdose in an adult or child 12yrs and over can be found in Figure 1 below. Naloxone must be given with great caution to patients who have received longer-term opioid/opiate treatment for pain control or who are physically dependent on opioids/opiates. Use of naloxone in patients where it is not indicated, or in larger than recommended doses, can cause a rapid reversal of the physiological effects for pain control, leading to intense pain and distress, and an increase in sympathetic nervous stimulation and cytokine release precipitating an acute withdrawal syndrome. Signs and symptoms of opioid withdrawal include: Anxiety and irritability Dilated pupils Sweating Nausea and vomiting Diarrhoea Naloxone has a much shorter half-life (1 -1.5 hours) than most opioids such as codeine (approx. 3hrs), methadone (approx.12-24hrs) and morphine (2-4hrs). There is a risk that opioid toxicity will recur as the naloxone wears off while the opioid remains in the blood stream. Respiratory rate and oxygen saturation should be monitored closely until stable. The length of this period of monitoring will be dependent on the half-life of the opioid causing toxicity. The half-life of morphine and some other opioids is prolonged in renal failure and other metabolic disturbance. 66 Appendix 9: contd Naloxone (400 micrograms/1ml amps) for opioid overdose in those over 12 years in mental health inpatient units ONLY Only administer naloxone if you are trained & can recognise the symptoms of opioid overdose. Respiratory rate (RR) more than1012/min Stage 1 Conscious level: Alert NO Continue to observe and monitor patient YES Contact emergency Services Respiratory rate less than 10-12/min Stage 2 Conscious level: Voice Administer oxygen at 12-15 L/min via face mask. Administer IM initial dose: 400 micrograms OR 100 micrograms if taking opiates for chronic pain. Repeat dose of 400 micrograms every 23 mins until RR more than 10-12/min, max 10mg. YES NO RR less than 10-12/min Stage 3 Conscious level: Pain or Unresponsive NO Attempt to awaken patient, if necessary open airway and attempt CPR. Administer oxygen 12-15 L/min via face mask. Administer IM initial dose: o 400 micrograms o OR 100 micrograms if taking opiates for chronic pain o OR 800 micrograms for apneic patients. Repeat dose of 400micrograms every 2-3 mins until RR more than 10-12/min, max 10mg. Monitor RR every 5 minutes for 15 minutes then every 10 min (if improves) Record conscious level & RR on the NEWS/PEWS chart Continually assess conscious level after administering doses and provide appropriate supportive treatment i.e. maintaining airway & CPR. Most overdoses will respond to 400-800micrograms Opioid induced cardiorespiratory arrest should be given a minimum of 1.6mg No response after administration of 10mg, review diagnosis. References 1, Naloxone 400micrgrams/ml solution for injection. Hameln Pharmaceuticals. www.medicines.org.uk. EMC last updated 11-Nov-2014. 2, TWC21f Prescribing for dependence Policy. SWLSTG. 3, See the current BNF www.medicinescomplete.com 67 If the patient is Alert, with respiratory rate of 10-12/minute or more, follow Stage 1: Assess patient, if: RR>10-12/min Assess Consciousness according to AVPU scale; if level A, continue to observe and monitor patient If the Respiratory rate falls below 10-12 respirations/minute, move to Stages 2 or 3 If the patient has decreased conscious level, responding to voice, follow Stage2: Assess patient, if: RR<10-12/min Assess Consciousness according to AVPU scale; if level V - Contact emergency services. - Administer oxygen at 12-15 liter/min according to Trust Medical Emergency & resuscitation Policy to reduce chances of acute lung injury. - Monitor and reassess at 15 minute intervals until RR> 10-12/min - Administer initial adult dose of naloxone hydrochloride 400 IM*, repeat administration at 2 to 3 minute intervals until RR>10-12/min and monitor the patient. - Repeat dose of 400mcg every 2-3mins up to maximum of 10mg until RR>10-12/min. It is estimated that most overdoses will respond to 400 - 800 micrograms of naloxone. - Monitor RR every 5 minutes for 15 minutes then every 10 minutes - Patients who have responded satisfactorily to the emergency treatment of opioid overdose with naloxone should be referred to hospital for medical follow assessment and follow up. This can usually for be for at least 48 hours. - If no response is observed proceed to Stage 3 ‘P or U’. If the patient has significantly reduced conscious level, responding only to pain, or unresponsive, follow Stage 3; Assess patient, if: RR<10-12/min Assess Consciousness according to AVPU scale; if level P or U - Contact emergency services. - Attempt to awaken patient. If necessary provide cardio respiratory support such as maintenance of a free airway and cardiopulmonary resuscitation (CPR), as per Trust Medical Emergency & resuscitation Policy. - Administer oxygen at 12-15liter/min (according to Trust Medical Emergency & resuscitation Policy) to reduce chances of acute lung injury. - Administer initial adult dose of naloxone hydrochloride 400 IM*, repeat administration at 2 to 3 minute intervals until RR>10-12/min and monitor the patient. - For apneic patients, an initial dose of at least 800mcg of naloxone should be given. - Repeat dose of 400mcg every 2-3mins up to maximum of 10mg until RR>10-12/min. It is estimated that most overdoses will respond to 400 - 800 mcg of naloxone. - Patients in cardio-respiratory arrest following suspected opioid overdose should be given a minimum of 1.6mg of naloxone. - If no response is observed after administration of 10mg naloxone i.e. no improvement in respiratory function, the diagnosis of opioid induced or partial opioid induced toxicity should be questioned and a re-evaluation made. *The recommended dose for adults in post-operative respiratory depression and for palliative care and chronic opioid/opiate use by intravenous injection is 100 to 200 micrograms (1.5 to 3 micrograms/kg). If the response is inadequate, give subsequent dose of 100 micrograms every two minutes. 68 Naloxone Route of Administration Naloxone injection is licensed for administration by subcutaneous (SC), intramuscular (IM) or intravenous (IV) injection. SWLSTG recommended route of administration is IM. The duration of action is dependent on the dose given and route of administration. The IM route provides a more prolonged effect and a dose administered via this route may take longer to take effect (approximately 2-5 minutes). Contraindications and Adverse Effects Patients with known hypersensitivity to naloxone. Abrupt reversal of opioid depression may result in a range of symptoms including: Nausea & vomiting Sweating Hypertension Tremulousness Ventricular tachycardia Hyperventilation Refer to the current British National Formulary (BNF) or Summary of Product characteristics (SPC) for more information. Special Warnings and Precautions for Use Naloxone should be administered with caution in patients with the following conditions: Renal impairment Liver disease Pre-existing cardiac disease or those who have received potentially cardio-toxic drugs Pregnancy Other co-morbid conditions where opioid withdrawal may require additional/inpatient monitoring Children 11 years old and under Naloxone dosing regimes for children 11 years old and under are provided in the BNF for children. Clinicians should follow BNF recommendations for children 11 years old and under, and seek specialist advice at the earliest opportunity. 69 Appendix 10: Naloxone to take home protocol This is a framework for the supply of naloxone injections by Trust staff and partner agency workers working within substance misuse services to patients/carers for the purpose of saving life in an emergency through reversal of the effects of opioid overdose. Naloxone is a prescription Only Medicine (POM) but is exempt from prescription only medicine requirements(2015/1503 regulations), when supplied by trained staff in a drug service commissioned in England by a NHS body, a local authority, Public Health England or Public Health Agency. In an emergency situation anyone can use any available naloxone to save a life. Naloxone is the emergency antidote for overdoses caused by heroin and other opiates/opioids (such as methadone and morphine). Most opioid overdoses occur away from healthcare settings, mainly in homes, among the homeless or in public places. The time delay before the arrival of emergency services contributes to the high mortality rates associated with accidental opioid overdose. As most opioid overdoses are witnessed, this provides opportunities for life saving interventions before the arrival of emergency services. This framework takes in to consideration The UK Department of Health (DH) and National Treatment Agency (NTA) published ‘Reducing Drug-Related Harm: An Action Plan’ in 2007. Department of Health Widening the availability of Naloxone, 24 June 2016. Training & supply Staff Only trained authorised workers and staff can supply naloxone to a patient/carer. Trust Staff will be identified as suitable trainers. These staff will then undergo training to enable them to cascade the training to other staff working within Substance Misuse Services. All staff implementing the protocol must complete the appropriate training in the prevention and management of opioid overdose, cardio-pulmonary resuscitation (CPR), and naloxone administration. All staff implementing the protocol will receive annual training updates. A competency assessment (attached) must be completed following initial training and at each update. Patients Take home naloxone must be provided as part of a comprehensive overdose management package, including training on the prevention and management of opioid overdose. Prior to supplying take-home naloxone, staff will ensure that the patient/carer/friend/outreach or hostel worker willing to administer the naloxone in the event of an opioid overdose has been instructed and trained in how to inject naloxone. The training may be delivered on an individual or group basis. The take home naloxone checklist (attached) must be completed by the patient/carer/friend/outreach or hostel worker and the staff member after training. The patient has the right to refuse to attend a training programme and/or decline the supply of take home naloxone. In this case, the patient will instead be supplied with written harm reduction information on overdose prevention. It will be explained to the patient and/or their carer that at this stage naloxone can only be supplied following successful completion of the training session. Advice will be given that this training session can be accessed any time in the future as initially declining does not exclude future opportunities. Strength and formulation of drug: Sealed tamper evident pack includes naloxone injection 1mg/1ml in prefilled syringe, 2 x 23G 1.25 needle, manufacturers’ information leaflet, National Naloxone Programmed simplified flowchart for administration 70 When naloxone is supplied the expiry date of the medicine should be highlighted to the recipient. The recipient should be encouraged to return the naloxone to the service before the expiry date to collect a further supply. Patient criteria for provision of naloxone is taken from World Health Organisation criteria Eligible: People who have given consent, either through willing attendance at the training or via an advance directive People injecting heroin/illicit opioids aged 18 or over. People who have reported one or more overdoses in previous five years. Those with loss of tolerance: recently released from prison, recently undergone detoxification or a period of being opioid free. Recently commenced opioid substitution treatment (risks of overdose increase during titration period). People with polydrug use (using substances in addition to opioids prescribed or illicit). People who have co-morbid conditions e.g. HIV, hepatitis C, that cause liver disease leading to impaired metabolism of opiates. A carer, family member, friend or outreach worker (16 years or over) liable to be on hand in case of overdose. A named individual in a hostel (or other facility where drug users gather and might be at risk of overdose), which could be a manager or other staff. Exclusion criteria: Lack of capacity. Refusal to attend the appropriate training. Non-engagement at appropriate training. Known hypersensitivity to naloxone or any component of the preparation. Declined supply of naloxone to take home Pregnancy (service user) Cardiovascular disease (service user) Patients excluded can be referred to a prescriber for naloxone to be authorised/prescribed if appropriate. 71 Appendix 10: contd Competency Assessment – Naloxone staff training Overdose Context Issues Causes of overdose. Identifying groups of people who are especially at risk of overdosing. Drug-related death Knows approximate numbers of opioid related deaths and how/when reports are published Is aware of trends in the UK and locally related to own area Is aware of the fact that most overdoses which include the use of opioids are witnessed and how this relates to harm reduction opportunities and saving of life. Opportunities for preventing drug-related deaths. Is aware of the risk factors in overdose – including popular myths Has a good understanding of which are high risk times for individuals who use opioids Complete Procedure Has read and understood the Take Home Naloxone Procedure Understands the requirements of audits and gaining consent according to policies Knows the procedure for ordering new supplies of naloxone if this is relevant to their role Can correctly record supplies of naloxone if this is relevant to their role. Complete Management of emergency situations Understands the signs and symptoms of an opioid overdose Correctly understands the immediate assessment of consciousness and breathing in someone suspected of an opioid overdose Shows good knowledge and skills in: - Resuscitation techniques - Placing an individual in the recovery position - How and when to call for assistance Understands the requirement around recording and completing incident reports if required Complete Naloxone The role of Naloxone in an emergency. The properties and action of naloxone The administration of naloxone Recorded Observations Is able to deliver sessions/advice to service users on the management of opioid overdose and administration of naloxone Is aware of all supporting literature available when advising service users and/or their carers/friends and can demonstrate how this supports verbal guidance Name & signature of staff……………………………..…….. Date……………… Name & Signature of trainer/manager…………………………………………… 72 Complete Appendix 10: contd Service user/Carer/friend/outreach or hostel worker take home naloxone checklist I have been given training in the dangers of opioid overdose, basic resuscitation and the appropriate administration of naloxone. I have/Service user has given consent to be treated I am aware that the needle supplied is strictly for naloxone use only. I understand that naloxone is a treatment specific drug that reverses the effect of overdose and needs to be used solely for the purpose of saving lives. I agree to be contacted in the future in relation to any training needs or data collection. Upon discovering a suspected overdose, I am aware an ambulance should be called immediately followed by a single cycle of community life support (BLS). I understand that a single dose of 0.4ml (0.4mg) should be administered intramuscularly (outer thigh muscle or muscles of the upper arm only) immediately if a patient is identified as likely to have taken, or be at risk of, an opioid overdose. Can be administered through clothing if deemed necessary. I will endeavour to ensure that once used the pack must be taken to a safe place to be destroyed. Either handed to the ambulance crew or taken to a needle exchange provider e.g. a community pharmacy. Name Case number(if applicable) Address DOB Telephone Service: Sutton Inspire Tick (relevant) Training has been received covering the following: Causes of overdose. Drug-related death Recognising overdose signs and symptoms. Basic first aid skills Identifying groups of people who are especially at Resuscitation techniques risk of overdosing. Take Home Naloxone Opportunities for preventing drug-related deaths. The role of Naloxone in an emergency. Attended 1-2-1 training session and deemed competent Attended training session with carer/family/friend, deemed competent & consent obtained from person using opioids Attended group training session and deemed competent Given printed guidance Info on safe storage of medication given/risks to children and young people discussed. Naloxone HCL 1mg/ml (2ml pre filled syringe) given: Batch No and Expiry Noted on electronic record (inc batch No & Expiry) Service user/carer/friend Signature Staff name & signature Date 73 Appendix 11: Equality Impact Assessment Equality Impact Assessment for Trust Prescribing for Dependence Policy To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval. Yes/No Comments 1. Does the policy/guidance affect one group less or more favourably than another on the basis of: Race No Ethnic origins (including gypsies and No travellers) Nationality No Gender No Culture No Religion or belief No Sexual orientation including lesbian, gay and No bisexual people Age No Disability - learning disabilities, physical No disability, sensory impairment and mental health problems 2. Is there any evidence that some groups are affected No differently? 3. If you have identified potential discrimination, are any N/A exceptions valid, legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be N/A negative? 5. If so can the impact be avoided? N/A 6. What alternatives are there to achieving the N/A policy/guidance without the impact? 7. Can we reduce the impact by taking different action? N/A 74 Appendix 12 Glossary of Acronyms Acronym/Abbreviation AUDIT C BMs BP CAMHS CAT CDAT CD CNS CYP DHC DTC DTs DVLA DVT ECG ETOH EU Gamma GT GBL GMC HTT INR IM IV LFTs MAOI MCV MD MDT Mg MOCAM NDTMS NSAIDS OD, BD, TDS OOWS PE PRN QT RIO SADQ SmPC SROM SWLStG TTO TWC UDS WHO 75 Definition Alcohol Use Disorders Identification Test Blood glucose Blood pressure Child and Adolescent Mental Health Service Community Alcohol Team Community Drug and Alcohol Team Controlled Drug Central Nervous System Cytochrome P Dihydrocodeine Drugs and Therapeutics Committee Delirium Tremens Driving and Vehicle Licence Agency Deep Vein Thrombus Electrocardiogram Alcohol European Union Gamma glutamyl transferase Gamma butyrolactone General Medical Council Home Treatment Team International normalised ratio Intramuscular Intravenous Liver Function Tests Monoamine oxidase inhibitors Mean Corpuscular volume Midday Multidisciplinary Team Milligram Models of Care for Alcohol Misuse Data entry tool for the National Treatment Agency Non-steroidal anti-inflammatory drugs Once daily, twice daily, three times daily Objective Opiate Withdrawal Scale Pulmonary Embolus ‘Pro re nata’ when required administration Measure of the time between the start of the Q wave and the end of the T wave in the hearts electrical cycle Patients electronic care record (patient’s notes) Severity of alcohol dependence questionnaire Summary of Medicines Product Characteristics Slow release oral morphine South West London and St Georges Mental Health NHS Trust To Take Out (discharge prescription) Trust wide Clinical (policy) Urine Drug Screen World Health Organisation Appendix 13: References Opiate specific references: Best, D., Harris, J., Glossop, M. et al. (2000) Use of non-prescribed methadone and other illicit drugs during methadone treatment. Drug and Alcohol Review, 19: 9-16 BNF. (2009). British National Formulary 57, March 2009. London: BMJ Group & RPS Publishing DVLA. (2009). At a glance Guide to the current Medical Standards of Fitness to Drive. Swansea: DVLA GMC (2004). Confidentiality: protecting and providing Information. London: GMC. Lintzeris N et al. (2001) National Clinical Guidelines for the use of Buprenorphine in the Treatment of Heroin Dependence. Commonwealth of Australia. Luty, J., Nikolaou, V. & Bearn, J. (2003). Is opiate detoxification unsafe in pregnancy? J Subst Abuse Treat, 24: 363-367 NICE (2007a) Drug misuse: Opiate Detoxification. NICE clinical guideline 52. London: National Institute for Health and Clinical Excellence NICE (2007b) Methadone and Buprenorphine for the Management of Opiate Dependence. NICE technology appraisal guidance 114. London: National Institute for Health and Clinical Excellence Schering-Plough. (2002). Subutex… your guide. Schering-plough. Preston, A. (2010) The methadone handbook 11th edn. Dorchester: Exhnage Supplies. S CAMHs specific references: Fraser Guidelines Mental Capacity Act Children’s Act 1989 & 2004 Department for Children, Schools and Families (DCSF), Department of Health (DH) and National Treatment Agency for Substance Misuse (NTA) (2009) Joint Guidance on Development of Local Protocols between Drug and Alcohol Treatment Services and Local Safeguarding and Family Services National Treatment Agency (2007) Assessing young people for substance misuse National Treatment Agency (2008)The role of CAMHS and addiction psychiatry in adolescent substance misuse services National Treatment Agency (2009) Young People’s specialist substance misuse treatment – Exploring the evidence National Treatment Agency (2008) Guidance on commissioning young people’s specialist substance misuse treatment services Gilvarry E, Briton J, (2009) Guidance for the pharmacological management of Substance Misuse among Young People London: Department of Health & National Treatment Agency Department of Health (2007) Drug Misuse and Dependence. UK Guidelines on clinical management. London: Department of Health (2009) Guidance for the pharmacological management of substance misuse among young people Dr Bruce Trathen MBBS MRCPsych (2006). Short Opiate Withdrawal Scale Edwards & Gross (1976) and Edwards (1978) Severity of Alcohol Dependence Questionnaire SADQ All other references: i WHO (1992) The ICD-10 classification of mental health and behavioural disorders-clinical descriptions and diagnostic guidelines. Geneva: WHO 2 Best, D., Harris, J., Glossop, M. et al. (2000) Use of non-prescribed methadone and other illicit drugs during methadone treatment. Drug and Alcohol Review, 19: 9-16 3 Department of Health (2007). Drug misuse and dependence: UK guidelines on clinical management. London: DoH 76 4 Walsh SL and Eissenberg T. The clinical pharmacology of buprenorphine: Extrapolating from the laboratory to the clinic. Drug and Alcohol Dependence 2003; 70: 513-527 5 Johnson, R. E., Jones, H. E. & Fischer G. (2003). Use of buprenorphine in pregnancy: patient management and effects on neonate. Drug Alcohol Dependence, 70: S87-101. 6 Harris DS, Jones RT, Welm S, et. al. Buprenorphine and naloxone coadministration in opiate dependent patients stabilized on sublingual buprenorphine. Drug and Alcohol Dependence 2000; 61: 85-94 7 Timothy B et al (2003) Comparative pharmacodynamics and pharmacokinetics of methadone and slow-release oral morphine for maintenance treatment of opiod dependence, Drug and Alcohol Dependence 72 (2003) 85-94. 8 Maudsley Prescribing Guidelines, 2012 Edition. 9 Krantz MJ, Martin J, Stimmel B, et al. QTc Interval Screening in Methadone Treatment. Ann Intern Med. 2009;150:387-395. 10 Cruciani RA. Methadone: To ECG or Not to ECG…That Is Still the Question. Journal of Pain and Symptom Management. 2008;1-8 11 National Institute for Health and Clinical Excellence. Naltrexone for the management of Opioid Dependence. Technology appraisal 115, January 2007. 12 Tucker T, Ritter A. Naltrexone in the treatment of heroin dependence: a comprehensive review. Drug Alcohol Rev 2000; 19:73-82. 13 Peterson T and Mc Bride A, editors. Working with substance misusers: A guide to theory and practice. Routledge 2002. 14 Lingford-Hughes, A.R., Welch, S and Nutt DJ. Evidence-based guidelines for the pharmacological management of substance misuse, addiction and comorbidity: recommendations from the British Association for Psychopharmacology. Journal of Psychopharmacology 2004; 18 (3): 293-335. 15 Department of Health (England) and the devolved administrations. Drug Misuse and Dependence: UK guidelines on Clinical Management. London: Department of Health (England), the Scottish Government, Welsh Assembly Government and Northern Ireland Executive, 2007. 16 Washton AM, Gold MS, and Pottash AC. Successful use of naltrexone in addicted physicians and business executives. Adv Alcohol Subst Abuse 1984; 4: 89-96. 17 The British Pain Society, The Royal College of Psychiatrists, The Royal College of General Practitioners and Advisory Council on the Misuse of Drugs. Pain and Substance Misuse: improving the patient experience. April 2007 18 Savage S, Kirsh K, Passik S. Challenges in using opioids to treat pain in persons with substance use disorders. Addiction Science & Clinical Practice 2008; June:4-25. 19 How to keep health risks from drinking alcohol to a low level: public consultation on proposed new guidelines. Department of health, January 2016; accessed 27/01/2016; URL https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/489796/CMO_alcoh ol_guidelines.pdf 20 Harper CG et al. Clinical signs in the Wernicke-Korsakoff complex: a retrospective analysis of 131 cases diagnosed at necropsy. Journal of Neurology, Neurosurgery and Psychiatry 1986; 49: 341-345. 21 Garbutt JC, West SL, Carey TS, Lohr KN, Crews FT. Pharmacological treatment of alcohol dependence: a review of the evidence. JAMA 1999; 281 (14): 1318-25. 22 Kranzler HR, Van Kirk J. Efficacy of naltrexone and acamprostate for alcoholism treatment: a meta-analysis. Alc Clin Exp Res 2001; 25(9): 1335-41. 23 NICE document on alcohol treatment 24 Sinclair JD. Evidence about the use of naltrexone and for different ways of using it in the treatment of alcoholism. Alcohol and Alcoholism 2001;36(1):2-10 25 Srisurapanont M , Jarusuraisin N. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev 2005 Jan 25;(1):CD001867. 26 Wood DM, Warren-Gash C, Ashraf T, Greene SL, Shather Z, Trivedy C, Clarke S, Ramsey J, Holt DW, Dargan PI. Medical and legal confusion surrounding gamma-hydroxybutyrate (GHB) and its precursors gamma-butyrolactone (GBL) and 1,4-butanediol (1,4BD). Q J Med 2008; 101: 23-29. 27 Carter L.P, Koek W., France C.,P. Behavioural analyses of GHB: Receptor mechanisms. 77 Pharmacology and therapeutics. 2009; 121: 100-114. 28 Gonzalez A., Nutt D., J. Gamma hydroxyl butyrate abuse and dependency. Journal of Psychopharmacology. 2005: 19(2): 195-204. 29 McDonough M, Kennedy N, Glasper A, Bearn J. Clinical features and management of gammahydroxybutyrate 30 LeTourneau JL, Hagg DS, Smith SM. Baclofen and gamma-hydroxybutyrate withdrawal. Neurocrit Care. 2008; 8: 430-433. (GHB) withdrawal: a review. Drug Alcohol Depend. 2004; 75: 39. 31 Wojtowicz JM, Yarema MC, Wax PM.Withdrawal from gamma-hydroxybutyrate, 1,4-butanediol and gammabutyrolactone: a case report and systematic review. CJEM. 2008; 10: 69-74. 32 Wood DM, Brailsford AD, Dargan PI. Acute toxicity and withdrawal syndromes related to gammahydroxybutyrate (GHB) and its analogues gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD). Drug Test Anal 2011; 6 May Epub ahead of print [DOI 10.1002/dta.292] 33 Evans & Bisagra (2009). You have free access to this content Acute Interaction of Baclofen in Combination With Alcohol in Heavy Social Drinkers Alc Clin Exp Res., 33:1;19-30 34 Bell J, Collins R. Gamma-butyrolactone (GBL) dependence and withdrawal. Addiction. 2011; 106: 442-447. 35 A. Foy, S. McKay, S. Ling, M. Bertram and C. Sadler Internal Medicine Journal 36 (2006) 150– 154 36 Stockwell, T., Hodgson, R . Edwards, G., Taylor, C. and Rankin. H. (1979) The development of a questionnaire to measure seventy of alcohol dependence. British Journal of Addiction 74, 79-87. 37 Saunders, J.B., Aasland, O.G., Babor, T.F., De La Fuente, J.R. and Grant, M., 1993. Development of the Alcohol Use disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption. II. Addiction88, pp. 791–804. 38 Handelsman, L., Cochrane, K. J., Aronson, M. J. et al. (1987) Two New Rating Scales for Opiate Withdrawal, American Journal of Alcohol Abuse, 13, 293-308 xxxix http://www.nice.org.uk/guidance/ta325/resources/guidance-nalmefene-for-reducing-alcoholconsumption-in-people-with-alcohol-dependence-pdf xl London New Drugs Group / London Medicines Evaluation Network Review. Nalmefene for alcohol dependence. October 2013. Available [Online] via: http://www.medicinesresources.nhs.uk/upload/Nalmefene_final.pdf (Accessed 7th April 2014) 78