Drugs for Alcohol Dependence: Clinical Guidance and Three Way Agreement

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1 Drugs for Alcohol Dependence: Clinical Guidance and Three Way Agreement for County Durham In partnership with the GP, the client, and the County Durham Drug and Alcohol Service December 2015 Version 1.0 Status: Approved Document type: Clinical Guidance Page 1 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

2 Contents 1 Introduction Relapse Prevention Pharmacological Interventions Acamprosate Oral Naltrexone Disulfiram Prescribing and Medical Intervention Agreement Drugs for Alcohol Dependence, 3 way Agreement Pathway Page 2 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

3 1 Introduction This guidance aims to support the three way delivery of care between the GP, the client and the County Durham Drug and Alcohol Service. It provides the professionals offering care to alcohol clients a shared understanding of the pathways of care provided by the Service where GP continuation of care is indicated in partnership with the Service for clients initiated on oral naltrexone, acamprosate or disulfiram. It makes explicit which clinician is responsible for which aspect of the client s treatment and care during that individual s recovery journey. 2 Relapse Prevention Pharmacological Interventions The following interventions are considered for moderate and severe alcohol dependence after successful withdrawal (either community or inpatient). The following treatments may be initiated by the Service in combination with psychological intervention, in order to prevent relapse: Acamprosate Naltrexone Disulfiram Relapse prevention medication should be initiated as soon as possible after assisted withdrawal with regular supervision of compliance to treatment and engagement with psychological intervention. Medication may be prescribed for up to 6-12 months, or longer for those benefiting from the drug who want to continue. It is recommended that treatment should be stopped if drinking persists 4-6 weeks after starting the medication. Page 3 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

4 3 Acamprosate Background and indications Acamprosate is indicated in patients with moderate or severe alcohol dependence (as an adjunct with psychological interventions) to maintain abstinence. It is believed to act by stimulating GABAergic inhibitory neurotransmission and antagonizing excitory amino acids which may underlie some aspects of CNS vulnerability to relapse. Initiation By the Service as soon as possible after assisted withdrawal. A health assessment will be carried out to ensure all supporting documentation for treatment is available. Baseline blood tests (kidney and liver function tests) will be requested by the Service from the GP. The Service will discuss the treatment options with the client and provide patient information from the Choice and Medication website at The Service will prescribe and monitor the client for the first month. The Service will begin the psychological intervention and recovery support. Dose 1998 mg (666 mg morning, midday and night) if greater than 60 kg 1332 mg (666 mg morning, 333 mg at midday and at night) if less than 60 kg Side effects Gastrointestinal symptoms( common and self-limiting) Pruritis and maculopapular rash (less common) Bulbous skin reaction(rare) Contra-indications Pregnancy Breastfeeding Renal insufficiency (egfr less than 45) Page 4 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

5 Severe hepatic failure Monitoring and follow up arrangements If the client is stable, the Service will transfer the prescribing and drug monitoring to the GP after 1 month. At the point of transfer the service will issue a further 2 week prescription to ensure continuity of supply. The Service will continue to provide ongoing psychological intervention. Monthly supervision by the GP. The Service will provide 3 monthly updates to the GP. The Service will inform the GP of engagement with mutual aid groups. The Service will contact the GP after 6 months of therapy to review the need for continued prescribing for the client. When the client s treatment goals are met, the client will be discharged from the Service. Stop If drinking persists 4-6 weeks after starting the drug. If the client discontinues engagement with the Service and is not engaging with recovery support/mutual aid groups. The Service will inform the GP. Page 5 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

6 4 Oral Naltrexone Background and indications Naltrexone is licensed for use in alcohol dependence as an adjunct to prevent relapse. It is recommended by NICE for use in patients with moderate and severe dependence to help maintain abstinence. Naltrexone is used as an adjunct to psychological interventions to support those who are trying to remain abstinent. It helps to reduce the risk of relapse to heavy drinking by reducing the desire for alcohol. Naltrexone is a long acting competitive opiate antagonist. Its mode of action is thought to be by reducing the pleasurable and rewarding effects of alcohol. Naltrexone is metabolized by the liver and excreted by the kidney. Initiation By the Service as soon as possible after assisted withdrawal. A health assessment will be carried out to ensure all supporting documentation for treatment is available. Baseline blood tests (kidney and liver function tests) will be requested by the Service from the GP. Confirm no concomitant use of opioids. Draw the client s attention to the information card issued with naltrexone on opioid-based analgesics. The Service will discuss the treatment options with the client and provide patient information from the Choice and Medication website at The Service will prescribe and monitor the client for the first month. The Service will begin the psychological intervention and recovery support. Dose Initially 25 mg/day (aiming for 50 mg/day) Most common side effects Gastrointestinal symptoms Headache Sleep disturbance Page 6 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

7 Rare side effects Hepatotoxicity Mood disturbance, depression or euphoria Idiopathic thrombocytopenia Contra-indications Patients currently dependent on opiates Acute hepatitis Acute liver failure/severe hepatic impairment Severe renal failure Monitoring and follow up arrangements If the client is stable, the Service will transfer the prescribing and drug monitoring to the GP after 1 month. At the point of transfer the service will issue a further 2 week prescription to ensure continuity of supply. The Service will continue to provide ongoing psychological intervention. Monthly supervision by the GP. The Service will provide 3 monthly updates to the GP. The Service will inform the GP of engagement with recovery support/mutual aid groups. The Service will contact the GP after 6 months of therapy to review the need for continued prescribing for the client. When the client s treatment goals are met, the client will be discharged from the Service. Stop If drinking persists 4-6 weeks after starting the drug. If the client discontinues engagement with the Service and is not engaging with mutual aid groups. The Service will inform the GP. Page 7 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

8 5 Disulfiram Background and indications This is a deterrent (aversive) medication used as adjunctive therapy in selected patients aiming for abstinence. The evidence for disulfiram is weaker than for acamprosate and naltrexone. NICE recommends its use as a second line option for moderate to severe alcohol dependence for patients who are not suitable for acamprosate or naltrexone or have a specified preference for disulfiram and who aim to stay abstinent from alcohol. The usual duration of treatment is 6 months or longer for those benefiting from the drug and who want to continue. Disulfiram prevents the breakdown of alcohol by irreversibly blocking the enzyme acetaldehyde dehydrogenase. Within 10 minutes of consuming alcohol patients experience an unpleasant reaction mediated by facial flushing, headache, palpitations, tachycardia, dyspnea, nausea and vomiting. The severity of the reaction varies between individuals and may occasionally become life threatening with hypotension, arrhythmias and collapse. The reaction can last for several hours with peak levels occurring at 8-12 hours. The action of disulfiram lasts for 7 days after the last dose and patients must be warned of this. Patients must be advised to avoid alcohol including low alcohol or non-alcohol beers and wines. They also need to be aware that some food, toiletries, perfumes, aerosol sprays and alcohol hand gels may contain enough alcohol to elicit a reaction. Disulfiram works by changing the expectancy of the effects of alcohol from positive to negative and aversive. In a 1992 study by Chick et al which examined supervised consumption of disulfiram against placebo showed 100 v 69 days abstinent in 6 months and a reduced alcohol use 80% v 50%, as well as an improvement in GGT levels. Response to treatment is better in those with a supervisor. It is not a standalone treatment and it is essential that the patient is actively engaged with psychosocial interventions aimed at relapse prevention. Some patients find that they have no reaction at standard dose and may require a higher dose of up to 600mg. For these people and those who drink through the reaction they Page 8 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

9 should be informed of the risk of repeated acetaldehyde toxicity leading to brain damage, liver damage and cardiac problems. Individuals likely to benefit most from disulfiram therapy are those who: Accept they have a drinking problem and are committed to treatment. Have no serious underlying psychiatric or medical conditions. Are aware of the consequence of consuming alcohol while on disulfiram therapy. Are willing to undergo adjunctive psychosocial support as part of their overall treatment. Have a spouse, close friend or professional colleague who can help supervise or Initiation witness their treatment and offer support. By the Service as soon as possible after assisted withdrawal. A health assessment will be carried out to ensure all supporting documentation for treatment is available. Baseline liver and kidney function blood tests will be requested by the Service from the GP. Before starting treatment the Service will check the cardiac status and blood pressure, and women of childbearing age will be offered a pregnancy test and advised to avoid pregnancy during treatment. The Service will discuss the treatment options with the client and provide patient information from the Choice and Medication website at The Service will warn clients about the interaction between disulfiram and alcohol, and the rapid and unpredictable onset of the rare complication of hepatotoxicity (clients will be advised that if they feel unwell or develop a fever or jaundice that they should stop taking disulfiram and seek urgent medical attention). The Service will begin the psychological intervention and recovery support. Disulfiram treatment starts 24 hours after the last alcoholic drink, typically at a dose of 200mg daily. The client will be supervised by the Service every 2 weeks for the first 2 months. The Service will prescribe for the client for the first 2 months. Page 9 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

10 Dose 200 mg daily for at least 1 week. If not sufficiently unpleasant reaction with alcohol consider an increase in dose (maximum dose 500 mg daily). Most common side effects Drowsiness Gastrointestinal symptoms Halitosis (bad breath) Hypertension generally mild and transient Rare side effects Hepatotoxicity (1/30,000). Hepatotoxicity is very rare and risk peaks between 6-12 weeks but can occur anytime and may be fatal. Risk is higher with co- existent liver disease. Stop medication and refer to medical specialist. If acutely unwell advise patient to attend emergency services. Allergic dermatitis and other dermatological reactions. Optic neuritis, peripheral neuritis and polyneuritis. Contra-indications Consumed alcohol in the last 24hrs Recent MI, angina, cardiac failure and uncontrolled hypertension History of CVA Pregnancy Breastfeeding Severe liver failure Drug Interactions The following drugs may be prescribed with caution: Disulfiram inhibits hepatic microsomal enzymes leading to interference of the metabolism of a variety of prescribed drugs: Warfarin enhanced effect therefore careful monitoring of INR required. Tricyclic s Disulfiram increases the plasma concentration of tricyclic s by 50% therefore risk of toxicity:may need to reduce dose or use alternative antidepressant. Page 10 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

11 Amitriptyline increased Disulfiram reaction. Phenytoin metabolism inhibited increasing risk of toxicity. Benzodiazepines metabolism inhibited so increased sedative effects. Disulfiram - Alcohol reaction (can be fatal at high doses): Severe flushing (red face) Difficulty breathing Headache Palpitations Hypotension Nausea and vomiting Monitoring and follow up arrangements If the client is stable, the Service will transfer the prescribing and drug monitoring to the GP after 2 months. At the point of transfer the service will issue a further 2 week prescription to ensure continuity of supply. The Service will continue to provide ongoing psychological intervention. Monthly supervision by the GP. LFTs will be monitored every 6 weeks for the first 3 months of treatment and then at 3-6 monthly intervals by the GP. The GP will be informed by the Service if a close relative/friend is involved in the dose supervision. The Service will provide 3 monthly updates to the GP. The Service will inform the GP of engagement with recovery support/mutual aid groups. The Service will contact the GP after 6 months of therapy to review the need for continued prescribing for the client. When the client s treatment goals are met, the client will be discharged from the Service. Page 11 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

12 Stop If patient reports symptoms suggesting hepatotoxicity i.e. jaundice, fever and abdominal pain. If persistent alcohol use on top of medication. If the client discontinues engagement with the Service and is not engaging with recovery support and mutual aid groups. The Service will inform the GP. Page 12 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

13 6 Prescribing and Medical Intervention Agreement Drug prescribed:.. Agreement between Client/ Carer/Prescriber and Recovery Co-ordinator within County Durham Drug and Alcohol Service/GP Client Name Carer Name Service Prescriber Name.. Recovery Co-ordinator Name.. GP Name... The Client 1. I will attend appointments as arranged with the prescriber. 2. I will engage with my recovery co-ordinator and attend psychosocial courses / mutual aid recovery support as agreed. 3. I understand that I will be discharged from the psychosocial provision of the service if I fail to attend group work and recovery support. My GP will be informed and will be advised to discontinue my medication. 4. I understand that I can be accompanied to my appointments by my carer, however this must be agreed in advance. 5. I will not attend appointments or pharmacy visits in an intoxicated state. 6. I will not bring any prescribed medication to appointments unless requested to do so. 7. I will take my medication as prescribed. I understand that it is an offence to supply prescribed medication to others and am aware that selling any prescribed medication will result in the immediate stopping of the medication and the police being informed. Page 13 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

14 8. I will take responsibility for the safe keeping of my medication, away from children and others. I am aware that any loss of medication, for whatever reason, will not be replaced. 9. I will report any side effects or unwanted reaction immediately. 10. I understand that violence or theft to people or property, threats to staff and others, and using abusive language, may result in this contract being discontinued and treatment ceasing. In extreme cases, the police may be asked to intervene. 11. I will follow the complaints procedure if I am not satisfied with my treatment. The Carer (supporting compliance with prescribed medication) 1. I will witness medication being taken as prescribed. I understand that it is an offence to supply prescribed medication to others and I am aware that selling any prescribed medication will result in the immediate stopping of the medication and the police being informed. 2. I will support the client to take responsibility for the safe keeping of the medication, away from children and others. I am aware that any loss, for whatever reason, will not be replaced. 3. I will report any side effects or unwanted reaction that I have observed immediately. For disulfiram I understand that if the client feels unwell or develops a fever or jaundice that disulfiram should be stopped and urgent medical attention should be sought. 4. For disulfiram, I understand the alcohol-disulfiram reaction and the precautions to be taken. 5. I understand that I can accompany the client to their appointments. 6. I understand the actions to be taken if the client decides to discontinue treatment. County Durham Drug and Alcohol Service Clinical Service 1. I will order the relevant blood tests from the GP and client information concerning physical/mental health and current prescribing prior to initiation of treatment. Page 14 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

15 2. I will prescribe. The dosage will be determined by negotiation with those involved in this contract and according to the BNF and local policy/prescribing guidance. 3. I will prescribe and monitor for a period of 1 month for acamprosate and naltrexone or until stable. 4. I will prescribe and monitor for a period of 2 months for disulfiram, or until stable. 5. I will ensure that the client is fully informed about their treatment. Recovery Co-ordinator 1. I will pre-arrange appointments to review the client s recovery plan on a 3 monthly basis. 2. I will advise the GP of any changes to the recovery plan, or any changes in relation to risks. 3. I will discharge the client from psychosocial provision due to failure to attend group work, mutual aid or recovery support. 4. I will discharge the client from psychosocial provision when the client s treatment goals are met. The Service will inform the GP of engagement with recovery support activities/mutual aid groups to further support recovery. General Practitioner 1. I will order the relevant blood tests for the Service before initiation of acamprosate, oral naltrexone or disulfiram. 2. I will continue prescribing of. as agreed with the Service. 3. I will monitor the client s physical and mental health needs in accordance with local policy and prescribing guidance. 4. I will review the client s prescribing needs should I receive information that the client has been discharged from psychosocial provision due to failure to attend group work, mutual aid or recovery support. 5. At the end of a 6 month period I will discuss with the client/service the need for continued prescribing. Page 15 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

16 7 Drugs for Alcohol Dependence, 3 way Agreement Pathway CDDAS Clinical Service Health assessment, request blood test, LFT, U&E and GT s, Mental/physical health/prescribing update from GP NMP/medical appointment initiate treatment Letter to GP to advised of initiation of treatment and plan One two month monitoring of drug concordance, follow up blood tests via GP, prior to transfer of prescribing to GP when stable 2 week prescription issued/gp appointment CDDAS Recovery coordination/psychosocial support 3 monthly care plan/tops and update to GP Psychosocial group work Promote Recovery Groups/Mutual Aid Letter to transfer care to GP to include advice on monitoring required for ongoing prescribing Medical intervention contract and recovery plan Client discontinues engagement/discharged recovery goals met Discharge letter to GP GP review prescribing requirements following discharge from CDDAS Page 16 of 16 Approval date: 3 rd December 2015 (TEWV D&T)

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