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Transcript
Appendix A OPIATE PRESCRIBING PROTOCOLS The following protocols contained in Appendices A and B are included as guidelines in good clinical practice. It is anticipated that the initiation of prescribing will be undertaken at the Substance Misuse Service prior to the patient becoming the responsibility of a practitioner within the scheme. Ongoing treatment will then be reviewed regularly in conjunction with the GP liaison nurses. There may be exceptional circumstances when it is considered necessary to undertake prescribing prior to referral to the Substance Misuse Service. In such circumstances the available guidance should be adhered to and a referral to the SMS should continue to be processed as normal Responsibilities of the prescribing doctor: 1. Substitute prescribing should not be undertaken in isolation. A multidisciplinary approach is essential. 2. Prescribing is the ultimate responsibility of the doctor. The responsibility cannot be delegated. Further advice will be available from GPwS1 and the Consultant in Substance Misuse. 3. The doctor prescribing controlled drugs for the management of drug dependence should have an understanding of the basic pharmacology, toxicology and clinical indications for the use of drug, dose regime and therapeutic monitoring strategy to prescribe responsibly. 4. In general no more than one week’s prescription should be dispensed at one time, except in exceptional circumstances e.g. proven stability/ disabled/ holiday. Instalment prescription forms (FP10 MDA) should be used for opiate prescribing. 5. The client should be advised of safety in storage of medication and advised regarding driving and other risks. A patient information leaflet will be provided by the SMS for participating practices. 6. Thorough, clearly written computer records of prescribing should be kept. Drugs to Prescribe for Opiate Dependence: Substitution of heroin for a longer acting oral preparation has proven health and social benefits and is an accepted treatment of opiate dependence. Methadone or Buprenorphine are the drug of choice as they are both long acting, straightforward to titrate, less likely to be diverted or injected and is backed by evidence of efficacy. 1 More detailed information on the evidence that underpins these protocols are obtainable from: http://www.nta.nhs.uk/clinical guidelines: http://www.smmgp.co.uk Protocol for Prescribing Methadone- this is for information only. Patients will only be eligible to join the NES when stabilised and assessed as suitable for management in primary care. 1. Titration from heroin to methadone. At this point a full assessment of the client’s illicit drug use has been obtained and a recommended range of prescribed methadone has been established. It has been explained to the client that:- It is a once daily liquid dose. It will not cause euphoria That the initial dose may not be high enough and may need some adjustment. It has been explained to the client to abstain from using heroin 6-8 hours prior to commencing methadone. Day 1 Methadone should be prescribed in a mixture of 1mg in 1ml. The starting dose should be no more 30 mg to reduce the risk of overdose. Ideally start at the beginning of the week to ensure that the client will get specialist support in the initial phase of their treatment allow easier titration and stabilisation and prevent overdose. Advise the client against using on top of methadone due to the high risk of overdose and delayed stabilisation. Explain the methadone effects last for approximately 24 hours, and that the drug builds up over several days. Day 2 Discuss any withdrawal symptoms or over medication. If continued withdrawal symptoms the methadone may be increased 5-10 mls every 2-4 days but not more than 30 mg weekly above the starting dose. Discuss any illicit drug use, and the potential risks. Day 3 2 Continue to titrate upwards until stabilisation has been achieved. Research has shown that: Higher dosing of methadone (i.e., 60-80mls) has higher retention rates in treatment. Greatly reduces illicit drug use and offending behaviour. Higher doses may be required depending on tolerance and specialist advice is recommended. Fortnightly prescriptions can be issued using FP10 instalment prescriptions, stating supervised from 13 months consumption if required. Protocol for Prescribing Buprenorphine/Suboxone (Suboxone is the preferred preparation) A new form of buprenorphine has been developed which includes a dose of the opioid antagonist naloxone (buprenorphine: naloxone 4:1) in a combined sublingual tablet. This new form is for use at the same buprenorphine dose (i.e. the current 8 mg sublingual buprenorphine being considered as the same therapeutic dose as the new combination of 8mg buprenorphine plus 2 mg naloxone). It has been presented as a new product, under the trade name Suboxone, and received product approval for addition treatment in many European countries in 2007. The rationale is that, when taken sublingually as intended, the naloxone is inactivated or is only absorbed at a dose which is insufficient to provoke withdrawal symptoms, but that if it is abused – by intravenous injection for example – opioid withdrawal effects results. The combination tablet is therefore expected to provide the same therapeutic benefit while preventing or reducing the liability for abuse. Clinical experience with this new combination product, is, so far, extremely limited in the UK, and it is too early to indicate the relative positions of these two versions of buprenorphine. Please refer to inpatient guidelines on buprenorphine and guidelines on naltrexone. Stabilization on Suboxone: Suboxone differs from buprenorphine (Buprenorphine) in that it allows for an initial dose on day one of 2-4 mgs, which may be followed by a further dose on the same day of 2-4 mg depending on the patient’s requirements. The dose thereafter can be titrated upwards by 2-8 mg per day to a maximum daily dose of 24 mg. Buprenorphine can be considered for patients 1. Less than 30 mls methadone daily (or can be reduced to this level). Direct equivalence between buprenorphine and methadone is difficult to estimate and is not a linear relationship; 12 to 16 mg of buprenorphine is approximately as effective as 50 to 80 mg of methadone in reducing heroin use and retaining clients in treatment. 3 Ideally baseline liver function studies should be obtained for those clients deemed to be at high risk if liver damage i.e. heavy drinkers who have established liver damages, symptomatic hepatitis, and any other disease affecting the liver. About Buprenorphine: 1. It is a semi synthetic derivative of opium. 2. It has an effective duration of at least 24 hrs with a half-litre of 20-25 hrs. 3. It is available in 0.4mg, 2mg, and 8mg tablets. 4. Administration is via the sub-lingual route, and takes effect in 90-120mins Typical Opioid Withdrawal Schedule for Inpatients using Buprenorphine Day Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Buprenorphine 4mgs(+/-2mg) 8-12 mgs 8-12 mgs 10 mgs 8 mgs 6 mgs 4 mgs Day Day 8 Day 9 Day 10 Day 11 Day Day Day Buprenorphine 2.8 mg 2.0 mg 0.8 mgs 0.4 mgs 5. It binds to morphine receptors and acts as a partial agonist: because of this effect it may lead to a greater chance of stabilisation and less illicit use on top. 6. Less risk in overdose and lower risk of respiratory depression. 7. It is a useful alternative to methadone and can be considered for detox or maintenance. 8. It has lower euphoric effects at high doses. 9 Blockage of other opiates. 10. With doses between 8-16 mg daily it reduces illicit use on top. Consider Buprenorphine for the following client categories: 1. Clients new to treatment. 2. Clients requesting a detoxification programme 3. Clients wishing for an alternative to methadone 4 4. Clients on low doses of methadone and wish to become drug-free, but may struggle with a methadone detox. 5. Clients who are relatively stable on methadone but are using regularly on top. 6. Clients who have long term opiate problems and have failed to stabilise on methadone. 7. Clients who have previously been prescribed methadone but did not respond successfully to their treatment plan. 8. Clients over 18 years. Do not use Buprenorphine for clients who:1. Are pregnant or breastfeeding without specialist advice/experience. 2. Have severe liver damage Please Note: 1. There is a risk of injecting buprenorphine as it is only available as sub-lingual tablets and highly soluble. Therefore supervised consumption is recommended in the initial stages of treatment. 2. It is not picked up on a routine urine toxicology screen as an opiate and no buprenorphine specific test is Available locally via urine/mouth swab screening. Guidelines for prescribing Buprenorphine: 1. Clients using heroin should receive their first dose of Buprenorphine at least 6-8 hours after the last dose of heroin, and preferably experiencing as much withdrawal symptoms as tolerable. Taking Buprenorphine soon after using heroin will increase the withdrawal symptoms. 2. Clients on methadone should be reduced to 30 mls or less daily prior to transferring to buprenorphine. They should receive their first dose of buprenorphine at least 24 hours after the last dose of methadone and/or when experiencing withdrawal symptoms. 3. The other option available to the client, maybe to briefly come back to SMS titration clinic to be established on Buprenorphine. This would be arranged with keyworker, SMS and GP informed. 4. Full explanation of how Buprenorphine works explained to client. 5. Stabilisation on Buprenorphine usually achieved over three days. 6. Clients are unsettled for the first three days as the dose is titrated. 5 Administration procedure for Buprenorphine: Day 1 Start treatment early in the week to enable daily contact and monitoring for at least the first three days. Starting dose normally 4mgs Day 2 Assess for signs of withdrawal or sedation (it is unusual to experience sedation) and titrate accordingly. For withdrawal the dose should increase by 4 mg – 8mg. If presents sedated reduce by 2mg – 4mg Day 3 Repeat day two. The most commonly effective maintenance dose is between 816 mg daily, but lower or higher doses may be used (maximum 32mg) Tablets are taken in one single dose daily sublingual The GP Liaison nurse should see the client at least weekly for the first three weeks of treatment. Any serious side effects should be discussed with the GP Liaison Nurse/Prescribing Doctor. Any missed doses of buprenorphine should not be replaced, as buprenorphine is long acting and the clients should not experience withdrawal symptoms if one day is missed. Buprenorphine can be prescribed by instalments on an FP10 and in the initial stages of treatment daily supervised collection is advised. Liver function tests should be taken prior to treatment. Contra-indications: Buprenorphine (Buprenorphine) is contraindicated in cases of known hypersensitivity to buprenorphine, severe respiratory, severe respiratory or hepatic insufficiency, breastfeeding, acute alcoholism or DTs and in children less than 18 years of age. Caution: renal insufficiency. While buprenorphine should not be commenced in pregnancy patients already on buprenorphine can have the option of remaining on it. 6 Appendix B BENZODIAZEPINE PRESCRIBING PROTOCOLS The central aim of these guidelines is to reduce all benzodiazepine prescribing to an absolute minimum. Key Considerations: 1. Long term benzodiazepine use may cause harm, particularly at doses greater than the equivalent of 30 mg of diazepam daily. 2. They are frequently used as a secondary drug of abuse, either to enhance the effect of the primary drug, or to reduce withdrawal effects. 3. They have a strong addictive potential and the withdrawal syndrome can be dangerous. 4. Illicit benzodiazepine use is widespread and causes a wide variety of harm related to: Ingestion (intoxication, bizarre behaviour). Injection (thrombosis, infection). Withdrawal (psychosis, fitting). Overdose. 5. Whilst there is no evidence to support the use for maintenance treatment. GPs should be able to accommodate and treat benzodiazepine users and prescribe where appropriate. When prescribed they should be withdrawn slowly and should only be used for detoxification from benzodiazepine addiction and not maintenance unless there are specific indications. People who tend to “binge”, or overuse are not suitable for long-term prescribing. 6. The illicit market is supplied mostly through prescribed benzodiazepines. 7. Prescribing benzodiazepines to young people for the treatment of sleeping problems, anxiety or other psychological difficulties is rarely justified. They are licensed for a maximum duration of 4 weeks. 8. There are no licensed indications for the prescription of benzodiazepines for more than 2-4 weeks. 9. Benzodiazepines are often taken in conjunction with opiates, and for those clients prescribed methadone, the methadone dose should be kept stable throughout the benzodiazepine reduction period, Concurrent detoxification of both drugs is not recommended in community setting. 7 10. The withdrawal syndrome is unpleasant and potentially dangerous. Sudden cessation of high-dose or long term regime (more than a few weeks) is not good practice. Withdrawal syndrome may start within hours, or be delayed a few weeks after withdrawing long-acting drugs. Symptoms may include: Confusion, psychotic-like states. Anxiety, insomnia, loss of appetite/weight. Tremor, perspiration, tinnitus, perceptual disturbance. Possibility of convulsions. Guidelines for prescribing: 1. Prescribing should only be initiated where there is clear evidence of dependency from the history and urine toxicology. (Caution clients may exaggerate the amount they are taking). This will be in conjunction with a full comprehensive assessment via the substance misuse service. 2. In general, it is recommended that a prescribing regime should be negotiated and agreed with the client. If considering a detox or reduction it should be determined by the individual capacity to tolerate symptoms or, more often, by their anticipation of unpleasant withdrawals. Clients may be reassured that they will suffer less withdrawal symptoms on a regime where the daily dose is reduced in small portions (range one-tenth to one-quarter) every fortnight. Normally clients are able to tolerate a reduction of 2.5 mg-5mg every two weeks. 3. For doses below 30 mg reduce by 2mg – 2.5mg every two weeks. 4. If withdrawal symptoms occur maintain the dose until symptoms improve. 5. If severe withdrawal symptoms occur, increase the dose to alleviate symptoms and reduce by smaller increments. 6. Convert all benzodiazepines to equivalent diazepam dose using the conversion chart below. 7. Prescribe for daily collection using instalment contract (reduces risks of diversion to black-market). 8. Overusing of daily dose of loss of medication. 9. Daily doses should be divided to reduce the risk of intoxication. 10. Regular review of the client’s progress by the GP and GP liaison nurse. 11. if carrying out a detox review the client six weeks after successful completion – consider whether there is a need of treatment for underlying mental health problems. 8 Conversion Table for Benzodiazepines to Diazepam Equivalent DRUG DIAZEPAM CHLORDIAZEPOXIDE LOPRAZOLAM LORAZEPAM OXAZEPAM TEMAZEPAM NITRAZEPAM DOSE EQUIVALENT TO 5 MG 15 MG 0.5MG 0.5MG 15 MG 10 MG 5MG 9 Appendix C Patients suitable for Treatment within Primary Care The SMS determines whether patients are suitable for management within primary care under this enhanced service. The following criteria apply: 1. If a patient is under 19 they need to be assessed by specialist under 19’s team and need to co-ordinate accordingly. 2. No severe and enduring mental heath issues that could affect ability to attend appointments and engage effectively with service 3. No severe alcohol use that could adversely affect prescribed medication ( e.g. methadone, benzodiazepine and heavy alcohol use could possibly potentiate unintentional over dose) 4. Those on benzodiazepines should be willing to convert to appropriate level of diazepam and be willing to engage in reduction programme 5. Show motivation to reduce or abstain from illicit drug use. 6. Only prescribed medications approved in the Department of Health Clinical Guidelines (2007) will be prescribed under the NES. 7. Patients must be willing to undertake a prescription on daily collection and the dose agreed with the individual GP via the GP Liaison Nurses. Frequency of collection may decrease on evidence of stability/compliance on an individual basis 10