NHS Fife Community Health Partnerships Subject Title Addiction Services Procedure for Community Detoxification using Prescribed Lofexidine with or without Naltrexone Intranet Procedure No. A2 Author Dr A Baldacchino Copy No 3 Reviewer Lead Clinician Implementation Date December 2003 Status Authorised 2011 Last Review Date April 2011 Approved by Medical Director Primary Care Next Review Date April 2013 Head of Nursing NHS Fife 1. Introduction 1.1 Lofexidine is an alpha adrenergic agonist drug that suppresses withdrawal overactivity of noradrenergic neurons. Thus it effectively suppresses autonomic signs of withdrawal, but is less effective at suppressing symptoms of subjective discomfort. It is a structural analogue of clonidine, but less sedating and less hypotensive. Lofexidine is formulated as 200 microgram tablets. 1. 2 Lofexidine is a treatment option for: Patients who are opioid dependent and seeking opioid detoxification e.g. heroindependent clients, opioid-dependent clients using combinations of heroin and illicit methadone (equivalent to less than 30ml methadone), methadone-dependent clients reduced/stabilised at doses 30ml or less or patients dependent on other prescribed opioids (usually for analgesia). Community detoxification from heroin/methadone as alternative to buprenorphine or continuing methadone reduction. Priority should be given to younger heroin users, heroin smokers and those not wanting or previously failed on methadone or buprenorphine substitution treatment. Stable immediate social environment is highly desirable with a nominated significant other present, such as immediate relatives. 1.3 Function To ensure safe and effective prescribing of lofexidine and minimise the negative effects of withdrawal from opioids. 2. Location Page 1 of 10
2.1 In client s homes, GP practices and NHS Fife premises. 3. Responsibility 3.1 Clinicians employed by NHS Fife who have received training in the use of lofexidine for opioid detoxification. 4. Operational System 4.1 Exclusions criteria to consider when using lofexidine treatment include: Under 18 years of age Hypersensitivity to lofexidine or to other imidazoline derivatives or any other excipient of tablet. Risk assessment using NHS Fife risk assessment tool indicates unacceptable risk of harm to self or others (If a home based detoxification is being carried out). 4.2 Caution if any of the following: Severe coronary insufficiency Recent myocardial infarction Cerebrovascular disease Chronic renal failure Bradycardia or hypotension Known history of QT interval prolongation or relevant family history Concomitant administration of drugs that prolong QT interval Pregnancy or breast-feeding (se BNF) Ongoing hazardous or harmful alcohol use or delirium tremens Acute mental health problems especially depressive illness 4.3 Lofexidine is not licensed for use in pregnancy and during breastfeeding or in children under 18 years old. 4.4 Criteria for community and home detoxification using Lofexidine: Completed Initial Assessment by Addiction Services clinicians including mental health assessment, physical health assessment, drug-using history, life/social history. The client must be opioid dependent and must not be taking stimulants, steroids or prescribed or illicit benzodiazepines as evidenced by recent drug testing. The results of a laboratory urine specimen or laboratory oral fluid test, taken within 14 days, must be available before prescribing Lofexidine to confirm current pattern of drug use. The client will provide a current drug and alcohol diary. Discussion with the responsible prescriber to establish if lofexidine prescribing is appropriate and the nature of the continuing treatment programme from either NHS Addiction Services or the General Practitioner. The Treatment plan will be recorded in the patient s clinical record. Page 2 of 10
The patient will have signed a contract which explains the procedure. A copy of this will be placed in the patients clinical records. The community detoxification programme will be monitored by a nurse trained in the use of lofexidine. Lofexidine will be prescribed by the client s General Practitioner or Addiction Services staff. The regime is agreed and the prescription is issued to be dispensed on a daily basis by the pharmacist. The Lofexidine Detoxification Chart (Appendix 1) will be completed by the Nurse undertaking community detoxification. 4.5 Lofexidine supply 4.5.1 The pharmacist will agree in advance to dispense the lofexidine in the appropriate instalments prior to the detoxification taking place. 4.5.2 A telephone call to the community pharmacist indicating the day s requirements will facilitate the process. 4.5.3 Lofexidine will be dispensed daily to the designated patient or named carer. 4.6 Induction of Lofexidine 4.6.1 Induction onto lofexidine from methadone: Prior to day 1 methadone dose should be reduced to 30mg or less. Ideally the last methadone dose should be 24 48 hours before the initial dose of lofexidine is issued. 4.7 Procedure: Day 1 4.7.1 Ensure a current drug diary and recent drug screen result is availab.00le. 4.7.2 The client should complete the Short Opioid Withdrawal Scale (SOWS) and the dedicated staff member should complete the Clinical Opioid Withdrawal Scale (COWS) where blood pressure, pulse rate and temperature are recorded. (Appendices 2 & 3). 4.7.3 The client will have collected the lofexidine and the first dose will be taken in front of the clinician. 4.7.4 The initial dose of lofexidine will be 200microgram. Following the initial dose the patient is observed for any signs of distress or reported light headedness and will have their blood pressure checked at half-hourly intervals. If there is no adverse effect further doses of 200microgram may be administered, according to withdrawal score, to a maximum of 800microgram in 24 hours. 4.7.5 If there is a significant drop in blood pressure (systolic less than 90mmHg or 30mmHg below reading recorded earlier), or pulse is below 55, lofexidine should be withheld. Treatment should be reviewed with the option to either continue at a reduced dose or discontinue. 4.8 Procedure: Day 2 4.8.1 Confirm patient s drug use since last seen. 4.8.2 The clinician will visit the client at home and the COWS is completed. 4.8.3 If no signs of withdrawal are apparent then a quarter of the total dose from Day 1 should be repeated. If obvious withdrawal features are present through the COWS then half of the total dose from Day 1 should be administered. Further doses can be introduced at six hourly intervals to a maximum of 1600microgram daily. Page 3 of 10
4.8.4 In all cases patients are monitored for a period of 30 minutes by the clinician. 4.9 Procedure: Day 3 4.9.1 Confirm patient s drug use since last seen. 4.9.2 Patients will be given a quarter of the Day 2 dosage and an extra 200 400 micrograms (1 2 tablets) if COWS shows further opioid withdrawal, To a maximum of 600microgram per dose or total daily dose of 2400microgram split over 4 doses. 4.9.3 The detoxification regimen is agreed and a prescription organised for the remaining days. Patients will be reviewed every 2-3 days as required. 4.9.4 The patient may also receive zopiclone 7.5mg per day for night sedation. This will be dispensed on a daily basis. 4.9.5 Sometimes a client may present with opioid withdrawal symptoms other than irregular sleep patterns. In exceptional circumstances the following maybe prescribed: Ibuprofen 400 mg four times daily prescribed for muscular aches and pain Hyoscine butylbromide 20 mg four times daily prescribed for stomach cramps Buccal prochlorperazine 3 6mg twice daily prescribed for nausea and vomiting 4.9.6 It is essential that all patients undergoing this procedure are provided with a copy of the lofexidine information booklet and the contents discussed on Day 1 of the procedure. Because of the time available it may also be an opportunity to reinforce harm reduction initiatives and undertake motivational work. Page 4 of 10
4.10 Detoxification/dose reduction schedule using Lofexidine: 4.10.1 Table for detoxification schedule using lofexidine (interpreted from Maudsley Prescribing Guidelines 9 th edition). Day 9.00 am 1.00 pm 6.00 pm 10.00 Notes pm 1 1 tablet 1 tablet 1 tablet 1 tablet Max 800mcg / 24 hours (Induction phase) 2 1-2 1-2 1-2 1-2 Max 1600mcg / 24 hours 3 1 3 Max 2400 mcg / 24 hours 4 Max 2400 mcg / 24 hours (Treatment phase) 5 Max 2400 mcg / 24 hours 6 Max 2400 mcg / 24 hours 7 Max 2400 mcg / 24 hours 8 Max 2400 mcg / 24 hours 9 (Reduction 2 tablets 1 tablet 1 tablet 2 tablets phase) 10 1 tablet 1 tablet 1 tablet 1 tablet 11 1 tablet 0 1 tablet 1 tablet 12 1 tablet 0 0 1 tablet 4.10.2 In the treatment phase the total dose required to prevent withdrawals should be given in four equal doses. 4.10.3 If withdrawals re-emerge on reduction of dose then the treatment phase may be extended for another 5 to 10 days prior to reduction. 4.10.4 Lofexidine should not be stopped abruptly as it may cause a rebound rise in blood pressure. The dosage should be reduced to a level at which the client has no side effects. If there is a need to stop lofexidine completely, this should be undertaken over 3 days. 4.11 In-patient use 4.11.1 Higher doses of lofexidine may be given initially for detoxification in the in-patient setting, up to a maximum of 2.4mg daily from day 1 provided that there is adequate monitoring of blood pressure, pulse and adverse effects. 4.11.2 If there is a significant drop in blood pressure (patients with a systolic blood pressure below 90 mm Hg, or 30mmHg below the baseline) or pulse less than 55bpm, then lofexidine should be with-held. The patient should be reassessed at least four hours later and if the blood pressure has recovered, they should recommence on a lower dose. If in doubt medical staff should be consulted. People with a pulse above 120 bpm or below 50 bpm should be discussed with the doctor. Page 5 of 10
4.12 Naltrexone for relapse prevention 4.12.1 Naltrexone is a long acting opioid antagonist without agonist action and is given in tablet form. If taken by a dependent individual it will precipitate opioid withdrawal symptoms, but has no subjective effect if taken 7 10 days after completion of opioid detoxification. If taken on a regular basis after detoxification it can assist in relapse prevention by producing blockade or marked attenuation of the subjective effects of exogenously administered opioids. The blockade effect is competitive and the patient is warned that it is possible, but hazardous, to override the block with very large doses of opioids. 4.12.2 Initiate naltrexone treatment between day 8 day 12 of the lofexidine detoxification programme. 4.12.3 A negative urine test to confirm no opioids within 12 hours of initiation of naltrexone is essential. 4.12.4 The patient is given a caution card issued by the drug manufacturer. 4.12.5 Liver function tests should be monitored before commencing treatment, after 4 weeks and then every 6 months. Naltrexone should not be given if there is evidence of hepatic impairment. 4.12.6 Give naltrexone 25mg initially on day 1 then 50mg a day from day 2 for the subsequent two weeks. Then total weekly dose may be divided and given on 3 days of the week. For example, 100mg on Mondays and Wednesdays and 150mg on Fridays. 4.12.7 Ideally naltrexone should be supervised by health care worker or responsible relative. 4.12.8 Naltrexone needs to be continued for at least 6 12 months. Prescribing will normally revert to the G.P. after 4 weeks. 4.12.9 Naltrexone does not prevent the use of other classes of drugs. There is some evidence that it reduces alcohol consumption. 4.12.10 Naltrexone should be used with caution in pregnant opioid users. 4.12.11 Naltrexone should be used only as an adjunct to other forms of support and treatment for patients who have recently come off opioids, in this case lofexidine. 4.13 Role of the key worker 4.13.1 To provide a safe and effective home detoxification programme tailored to meet the needs of the client who wishes to become free from opioids. 4.13.2 Throughout the detoxification programme the key worker will undertake motivational work exploring issues relating to lifestyle changes which will assist the client in his / her goal of abstinence. 4.13.3 The home detoxification nurse practitioner will see the client every day for the first three days, then every 2-4 days as required. 5 Risk Management Page 6 of 10
5.1 The importance of regular supervision and observation of clients undergoing lofexidine detoxification cannot be overstated. Any unexplained absences of clients should be a cause for concern and signs of intoxication should prompt an urgent clinical evaluation. This is then dealt with in consultation with the Consultant in Addictions. 6 Related Documents 6.1 The Lofexidine Detoxification Chart (Appendix 1) 6.2 Short Opioid Withdrawal Scale (Appendix 2) 6.3 Clinical Opioid Withdrawal Scale (Appendix 3) 7 References 7.1 Drug Misuse and Dependence Guidelines on Clinical Management (2007) Department of Health, London. 7.2 Prescribing Guidelines 9 th Edition D.Taylor et al Maudsley 2007 7.3 Ghodse.H. (1995) Drugs and Addictive Behaviour: A Guide to Treatment (2 nd Edition) Blackwell Scientific Publication, Oxford. 7.4 Johnson RE, Jaffe JH, Fudale PJ (1992). A controlled trial of Buprenorphine treatment for opioid dependence. JAMA 267(20): 2750-2755 7.5 White R, Alcorn R, Feinmann C (2001). Two methods of community detoxification from Opioids: an open-label comparison of Lofexidine and Buprenorphine. Drug and Alcohol Dependence 65; 77-83 7.6 Southend Community Care Services NHS Trust. Britlofex (Lofexidine) Home Detoxification Programme: A Users Guide. 7.7 Forth Valley Primary Care NHS Trust Community Alcohol & Drug Services (1998) Lofexidine Detoxification Protocol and Guidelines 7.8 Ayrshire & Arran Primary Care NHS Trust (2000) Working Through It A Workbook to assist in the detoxification process Page 7 of 10
Appendix 1 The Lofexidine Detoxification Chart Start Date of Detoxification:-... Please enter Lofexidine dose taken in appropriate times. 9.00 am 1.00 pm 6.00 pm 10.00 pm Extra Dose 1 Monday 2 Tuesday 3 Wednesday 4 Thursday 5 Friday 6 Saturday 7 Sunday 8 Monday 9 Tuesday 10 Wednesday 11 Thursday 12 Friday OBSERVATIONS Week 1 Day Monday Tuesday Wednesday Thursday Friday BP Pulse Pupil size Week 2 Day Monday Wednesday Friday BP Pulse Pupil size Designated home detoxification practitioner Appendix 2 Page 8 of 10
SHORT OPIOID WITHDRAWAL SCALE None (0) Mild (1) Moderate (2) Severe (3) TOTAL Feeling sick Stomach Cramps Muscle Spasms/Twitching Feelings of Coldness Heart Pounding Muscular Tension Aches and Pains Yawning Runny Eyes Insomnia/Problems Sleeping TOTAL /30 Page 9 of 10
Appendix 3 Clinical Opioid Withdrawal Scale 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: Date and Time / / : Reason for this assessment: Resting Pulse Rate: beats/minute Measured after patient is sitting or lying for one minute 0 pulse rate 80 or below 1 pulse rate 81-100 2 pulse rate 101-120 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 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 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; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal D:\bup curr update\cl Tools fr ECS\22 COWS.doc Page 10 of 10