Guidelines for Titration onto Buprenorphine in Opioid Dependence

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1 NHS Fife Community Health Partnership Addiction Services Guidelines for Titration onto Buprenorphine in Opioid Dependence Intranet Procedure No. A7 Author Dr L. Cockayne Copy No 1 Reviewer Lead Clinician Implementation April 2011 Status Authorised 2011 Last Review Approved By Medical Director Primary Care Next Review April 2013 Head of Nursing NHS Fife 1. Introduction 1.1. Buprenorphine hydrochloride (Subutex or Suboxone ) is licensed for the substitute treatment for opioid drug dependence, within a frame work of medical, social and psychological treatment. 1.2 Buprenorphine for opioid drug dependence is formulated as a sub-lingual tablet: buprenorphine (Subutex ) 0.4 mg, 2 mg or 8 mg tablets and buprenorphine/naloxone (Suboxone ) 2mg/0.5mg and 8mg/2mg tablets. 1.3 Buprenorphine is a partial agonist at the receptor and as such exhibits a different pharmacological profile to full agonists. Naloxone is an opioid antagonist with low bioavailability when taken sublingually and high bioavailability when injected. The addition of naloxone deters intravenous use and reduces diversion to illicit use. For this reason buprenorphine/naloxone (Suboxone ) is the formulation of choice for doses of 2mg or more. 2. Function 2.1 To ensure safe and effective prescribing during transfer onto buprenorphine in opioid dependence 3. Location 3.1 In patient s homes, GP practices and NHS premises as outpatient or inpatient. Page 1 of 8

2 4. Responsibility 4.1 NHS Clinical staff trained in the treatment of opioid dependence. 5. Operational System 5.1 Buprenorphine is a treatment option for Opiate-dependent patients using heroin and/or opioids (equivalent of no more than 30mg methadone) Patients with analgesia induced opioid dependence Methadone-dependent patients reduced/stabilised at doses of 30mg or less. 5.2 Exclusion criteria to consider when using buprenorphine treatment include: Hypersensitivity to buprenorphine Severe respiratory insufficiency Severe hepatic insufficiency Acute alcoholism or delirium tremens Acute mental health problems Recent head injury / loss of consciousness Breast feeding Children less than 16 years of age (buprenorphine) Children less than 15 years of age (buprenorphine/naloxone) 5.3 Pregnancy Buprenorphine/naloxone (Suboxone ) should not be used during pregnancy. If it is the prescriber s opinion that therapy in pregnancy is required the use of buprenorphine alone may be considered but would be off label. If pregnancy occurs while on Suboxone the mother and unborn child should be monitored closely and switched to buprenorphine alone if further treatment is required. 5.4 Buprenorphine/naloxone is licensed for use in adults and adolescents over 15 years of age. However, due to lack of data in adolescents (age 15 18), buprenorphine/naloxone should be used with caution in this age group. 5.5 As with methadone, caution should be taken if prescribing buprenorphine in combination with benzodiazepines or alcohol as this may cause respiratory depression. 5.6 Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing treatment. Hepatic function should be monitored in patients: with pre-existing liver enzyme abnormalities who are positive for viral hepatitis who use other potentially hepatotoxic medicines/substances 5.7 Criteria for titration using buprenorphine Page 2 of 8

3 5.7.1 Completed assessment by clinicians must include: Mental health assessment Physical health assessment Drug-using history Life/social history which confirms high probability of opioid dependence. Assessed and confirmed opioid dependence Laboratory urine (or oral fluid) result within last 14 days positive to opioids Current drug diary conveying opioid use It is essential that all patients undergoing this procedure are provided with a copy of the buprenorphine information booklet and the contents discussed prior to Day 1 of the procedure Education to be completed prior to approval for buprenorphine titration comprises: Action, effects, side effects and administration of buprenorphine, including advantages and disadvantages over other treatment options. Overdose training. Issues related to pregnancy and contraception Potential impact on driving and employment Circumstances in which treatment may be withdrawn or ceased A discussion must take place with the prescriber to establish if buprenorphine prescribing is appropriate. The prescriber should confirm the maximum dose that the titration can reach without further discussion. This should be clearly documented in the patient s clinical records and appropriate prescribing initiated The patient must sign a consent form (Appendix 1) and contract (Appendix 2) which explains the procedure. A copy of this will be placed in the patient s clinical records The titration will be monitored by a clinician trained in buprenorphine titration Buprenorphine supply If onsite medication is not available an agreement must be made, in advance, with a community pharmacy to dispense buprenorphine in appropriate daily instalments. The instalments will be collected by the patient or designated representative. Buprenorphine will be prescribed as Suboxone for doses over 2mg unless the patient is pregnant or buprenorphine only (Subutex ) has been authorised by the responsible prescriber. 5.8 Induction to buprenorphine from methadone Prior to day 1 methadone dose must be reduced to 30mg or less. Thereafter dosing is as for transfer from heroin Caution: last methadone dose should be at least 24 hours (preferably 36 hours) before initial dose of buprenorphine Patients should be educated about the need to be in opioid withdrawal before the initial dose of buprenorphine; otherwise initial dose may precipitate symptoms of withdrawal Some patients may need to stop methadone 2 or 3 days prior to induction. 5.9 Induction to buprenorphine from heroin or other opioids for patients who are buprenorphine naïve or who need greater support or supervision. Day 1 Page 3 of 8

4 Ensure a current drug diary and results of a recent drug screen taken in last 4 weeks result are available. Establish that no opioids and other drugs (including alcohol) have been taken at least 12 hours before first dose of buprenorphine. Undertake drug testing using a near patient testing device and breathalyse for alcohol. If breath alcohol is greater than 20mmol/L or urine is positive for stimulants, delay induction and arrange review by medical staff. If induction is cancelled for a patient detoxifying from methadone, the patient may be prescribed methadone at a dose determined by medical staff. If induction is cancelled for a patient detoxifying from heroin or other opioids the patient will receive harm reduction advice. Complete the Clinical Opioid Withdrawal Scale (COWS) and record blood pressure and pupil size. (Appendix 3) Induction should only commence when moderate signs of withdrawal are evident. If unclear then the patient should be reassessed after one hour. The initial dose of buprenorphine will be 2-4mg regardless of current Heroin use. - 4mg should be administered if there are clear signs of moderate withdrawal. - 2mg should be administered if there are equivocal objective signs after discussion with the responsible prescriber. - If only minimal signs of withdrawal are evident the responsible prescriber should review the patient. The patient will take buprenorphine tablets sublingually under supervision. The patient will be reviewed minutes after the initial dose. Precipitated withdrawal should be excluded and then a further dose of 2-4 mg (depending on the COWS, blood pressure. and pupil size) may be allowed to a total maximum daily dose of 8 mg. This should be taken 90 minutes - three hours after initial dose. The total dose will be recorded in the patient s clinical records and surplus medication returned to the pharmacy by clinical staff. Day 2 Day 2 will normally be the next day, but if delayed the dose taken on day 1 may be prescribed for the intervening days. The practitioner will assess the patient and complete the COWS, blood pressure, Pulse and pupil size. If no signs of withdrawal are apparent then the total dose from Day 1 should be repeated. If obvious withdrawal features are present then the total dose from Day 1 together with an increment of 2-4 mg should be administered. The total dose will be recorded in the patient s clinical records and surplus medication returned to the pharmacy by the clinical staff. The patient will be monitored for a minimum of 30 minutes by clinical staff. Day 3 and onward The patient will be given Day 2 dosage and an extra 2-4 mg if COWS shows further opioid withdrawal symptoms. Repeat on subsequent days until there are no withdrawal symptoms. The key worker will review the patient at least weekly until the optimal dose is reached. Requests for further increases should be discussed with the prescriber Induction for patients who are not buprenorphine naïve Patients who have previously been established on prescribed buprenorphine may be titrated using supervised dispensing from the pharmacy. The regimen should be prescribed for the first 7 days based on current opioid use and past response to prescribing, then reviewed weekly with the prescriber until the optimal dose is reached. Page 4 of 8

5 Prescribing regimen as below: Buprenorphine dose Day 1 Day 2 Day 3 Day 4-7 4mg 8mg 6mg -12mg 8mg -16mg 8mg -16mg (day 1plus (day 2plus (day 3 plus 2-4mg) 2-4mg) 2-4mg) 6 Role of the pharmacist 6.1 The community pharmacist has an important role during the induction phase. He/she is uniquely placed to review the patient on a daily basis and to assess: Any adverse effects of buprenorphine during titration Regularity of attendance of patient at the pharmacy Supervised self administration by the sublingual route Appearance and behaviour of the patient 6.2 The pharmacist should be asked to report any missed doses during the titration phase to the prescriber. It is important to routinely obtain feedback from the Pharmacist in the regular clinical review of the patient s progress during the titration 7 Related Documents Appendix 1 Consent form Appendix 2 Patient contract Appendix 3 COWS (Clinical Opioid withdrawal Scale) 8 References Johnson RE, Jaffe JH, Fudale PJ (1992). A controlled trial of Buprenorphine treatment for Opioid dependence. JAMA 267(20): Barnett PG, Rodgers JH and Bloch DA. A meta-analysis comparing Buprenorphine to Methadone for treatment of Opioid dependence. Addiction 2001; 96: Chadderton A. Clinical issues in using Buprenorphine in the treatment of Opioid dependence. Drug and Alcohol Review 2000; 19: Ghodse.H. (1995) Drugs and Addictive Behaviour: A Guide to Treatment (2 nd Edition) Blackwell Scientific Publication, Oxford. Drug Misuse and Dependence Guidelines on Clinical Management (2007) Department of Health, London. Guidance for the use of Buprenorphine for the treatment of Opioid dependence in primary care SMMGP Revised 2nd Edition 2004 NICE (2007) Methadone and Buprenorphine for the Management of Opioid Dependence. NICE technology appraisal guidance 114. London: National Institute for Health and Clinical Excellence. Summary of Product Characteristics, Subutex and Suboxone Page 5 of 8

6 Appendix 1 Patient/parent/guardian s agreement to investigation or treatment (Procedures where consciousness not impaired) Patient s Surname: Patient s First Names: sample of Birth: Hospital Number / CHI: Name of procedure (include brief explanation if medical term not clear) Statement of Health Professional (to be filled in by health professional with appropriate knowledge of proposed procedure, as specified in consent guidance) I have explained the procedure to the patient/parent/guardian. In particular, I have explained: The intended benefits Serious or frequently occurring risks To determine the dose of Methadone/ Buprenorphine you require to prevent Opioid withdrawal symptoms without sedating you. 1. Risk of overdose if you use drugs and/or alcohol on top of prescribed medication. 2. In exceptional circumstances you may have an allergic reaction that may require further medical treatment. I have also discussed what the procedure is likely to involve, the benefits and risks of any available alternative treatments (including no treatment) and any particular concerns of this patient. The following leaflet/tape has been provided To: Patient / parent / guardian / carer / relative NAME: Signed Name (PRINT) Job Title Statement of patient/parent/guardian I agree to the procedure or course of treatment described above. I understand that you cannot give me a guarantee that a particular person will perform the procedure. The person will, however, have appropriate experience. I understand that the procedure will/will not involve local anaesthesia. Patient/parent/guardian s signature Name (PRINT) CONFIRMATION of consent (to be completed by a health professional when the patient is admitted for the procedure, if the patient has signed the form in advance). On behalf of the team treating the patient, I have confirmed with the patient/parent/guardian that she/he has no further questions and wishes the procedure to go ahead. Signed Name (PRINT) You may request a copy of this form please ask Copy given Page 6 of 8

7 Appendix 2 TREATMENT / PRESCRIBING CONTRACT Patient Name: CHI No: I understand that it is in my best interests to be truthful about my drug use. sample I understand that during the period of time I being titrated onto medication I will not take any illicit drugs, over the counter medication containing Opiates or Alcohol. I understand that while being titrated, any behaviour which is abusive or aggressive will result in the Testing being cancelled. I agree to attend all appointments as requested and realise that failure to attend any appointment will lead to delay in my titration. I am responsible for attending all of my appointments on time. If I am unable to do so, I am responsible for telephoning in advance and making an alternative arrangement. I understand that if I attend an appointment under the influence of illicit drugs or alcohol, I will NOT be seen. Prescriptions will NOT be issued to individuals under these circumstances and any existing prescription will be suspended. I agree to provide samples for drug testing and comply with breath alcohol measurements when requested by Addiction Services staff. Failure to do so may result in my prescription being stopped. I agree to behave in a responsible manner while in a pharmacy. I understand that Methadone/ Buprenorphine will be supervised by the pharmacist who may refuse to dispense it if I appear to be under the influence of drugs or alcohol. I agree to be responsible for my medication and prescription and understand that these will not be replaced. Any attempt to change a prescription will result in loss of prescribing. I agree not to take any painkillers (other than aspirin, paracetamol or ibuprofen) unless these are prescribed by my GP. I understand that if I use other drugs on top of my prescription, this will increase my risk of overdose and that this is my own responsibility. I have discussed this with my Nurse / Doctor and understand fully. I understand that Addiction Services staff will communicate with my GP and pharmacist regularly. I HAVE READ THESE RULES AND FULLY UNDERSTAND THEM. I AGREE TO ABIDE BY THEM. I UNDERSTAND IF I DO NOT, MY PRESCRIPTION MAY BE STOPPED. Patient Signature Keyworker Signature Page 7 of 8

8 Appendix 3 Clinical Opioid Withdrawal Scale (COWS) For each item, circle the number that best describes the patient s signs or symptom. Rate on just the apparent relationship to opioid withdrawal. For example, if heart rate is increased because the patient was jogging just prior to assessment, the increase pulse rate would not add to the score. Patient s Name: and Time / / : Reason for this assessment: Blood pressure: / Pupil size (mm) Resting Pulse Rate: beats/minute Measured after patient is sitting or lying for one minute 0 pulse rate 80 or below 1 pulse rate pulse rate GI Upset: over last ½ hour 0 no GI symptoms 1 stomach cramps 2 nausea or loose stool 3 vomiting or diarrhea 5 Multiple episodes of diarrhea or vomiting 4 pulse rate greater than 120 Sweating: over past ½ hour not accounted for by room temperature or patient activity. 0 no report of chills or flushing 1 subjective report of chills or flushing 2 flushed or observable moistness on face 3 beads of sweat on brow or face 4 sweat streaming off face Restlessness Observation during assessment 0 able to sit still 1 reports difficulty sitting still, but is able to do so 3 frequent shifting or extraneous movements of legs/arms 5 Unable to sit still for more than a few seconds Pupil size 0 pupils pinned or normal size for room light 1 pupils possibly larger than normal for room light 2 pupils moderately dilated 5 pupils so dilated that only the rim of the iris is visible Bone or Joint aches If patient was having pain previously, only the additional component attributed to Opioids withdrawal is scored 0 not present 1 mild diffuse discomfort 2 patient reports severe diffuse aching of joints/ muscles 4 patient is rubbing joints or muscles and is unable to sit still because of discomfort Runny nose or tearing Not accounted for by cold symptoms or allergies 0 not present 1 nasal stuffiness or unusually moist eyes 2 nose running or tearing 4 nose constantly running or tears streaming down cheeks Tremor observation of outstretched hands 0 No tremor 1 tremor can be felt, but not observed 2 slight tremor observable 4 gross tremor or muscle twitching Yawning Observation during assessment 0 no yawning 1 yawning once or twice during assessment 2 yawning three or more times during assessment 4 yawning several times/minute Anxiety or Irritability 0 none 1 patient reports increasing irritability or anxiousness 2 patient obviously irritable anxious 4 patient so irritable or anxious that participation in the assessment is difficult Gooseflesh skin 0 skin is smooth 3 piloerrection of skin can be felt or hairs standing up on arms 5 prominent piloerrection Total Score The total score is the sum of all 11 items Initials of person completing Assessment: Score: 5-12 = mild; = moderate; = moderately severe; more than 36 = severe withdrawal D:\bup curr update\cl Tools fr ECS\22 COWS.doc Page 8 of 8

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