GUIDELINES FOR ALCOHOL DETOXIFICATION AT HMP BEDFORD

Transcription

1 GUIDELINES FOR ALCOHOL DETOXIFICATION AT HMP BEDFORD Policy Details NHFT document reference MMG027/HMP Version 1 Date Ratified May 2017 Ratified by HMP Bedford Drugs and Therapeutics Committee Implementation date May 2017 Responsible Director Medical Director Review Date May 2019 Related Policies & other documents MMP001 Control of Medicines Policy Freedom of Information category Guidance The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 1 of 26 Implementation Date: May 2017

2 TABLE OF CONTENTS 1. INTRODUCTION PURPOSE DEFINITIONS DUTIES HMP Bedford Drugs and Therapeutics Committee Head of Healthcare Doctors IDTS Staff GUIDELINES FOR ALCOHOL DETOXIFICATION Prisoners admitted from the community Prisoners transferred from other establishments Detoxification Process Detoxification medication Assessing the severity of alcohol dependence Initiating medication for alcohol dependence Withdrawal from co-existing benzodiazepine and alcohol dependence (see also Guidance for Prescribing and Management of Benzodiazepine Withdrawal) Management during detoxification Prophylactic vitamin supplementation Preventing relapse Discharge from prison TRAINING Mandatory Training Specific Training not covered by Mandatory Training MONITORING COMPLIANCE WITH THIS DOCUMENT REFERENCES AND BIBLIOGRAPHY RELATED TRUST POLICIES... 13

3 DOCUMENT CONTROL SUMMARY Document Title Document Purpose (executive brief) Guidelines for alcohol detoxification at HMP Bedford To provide guidance on the management of alcohol detoxification for prisoners admitted to HMP Bedford Status: - New / Update/ Review Areas affected by the policy Policy originators/authors Consultation and Communication with Stakeholders including public and patient group involvement New Prisoners admitted to HMP Bedford under the care of NHFT HMP Bedford Drugs and Therapeutics Committee Dr Konstantinos Stagias Consultant Psychiatrist Substance Misuse Janice Jones Pharmacist HMP Bedford Drugs and Therapeutics Committee Archiving Arrangements and register of documents Equality Impact Assessment (including Mental Capacity Act 2007) Training Needs Analysis See section 7 The Risk Department is responsible for this policy and will hold archived copies of this policy on a central register Control of Medicines Policy Monitoring Compliance and Effectiveness Meets national criteria with regard to NHSLA NICE NSF Mental Health Act CQC Other Further comments to be considered at the time of ratification for this policy (i.e. national policy, commissioning requirements, legislation) If this policy requires Trust Board ratification please provide specific details of requirements See section 8 N/A CG100/115 N/A N/A N/A N/A The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 3 of 26 Implementation Date: May 2017

4 1. INTRODUCTION These guidelines may be used for any prisoners requiring alcohol detoxification on admission to HMP Bedford. Alcohol detoxification is essential for prisoners admitted to HMP Bedford with a history of regular alcohol consumption. Medically assisted alcohol detoxification may be required for prisoners meeting criteria for alcohol dependence and consuming on average more than 15 units of alcohol daily. 2. PURPOSE To provide guidance on the management of alcohol detoxification in HMP Bedford. 3. DEFINITIONS NHFT - Northamptonshire Healthcare NHS Foundation Trust CIWA-Ar - Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised BAC - Blood Alcohol Concentration CSM - Committee for the Safety of Medicines 4. DUTIES 4.1. HMP Bedford Drugs and Therapeutics Committee Will approve and review these guidelines 4.2. Head of Healthcare Is responsible for the dissemination of this guideline to all relevant staff Clinical Directors and Clinical Tutors 4.3. Doctors Are responsible for reviewing the patient prescribing detoxification treatment and vitamin supplementation 4.4. IDTS Staff Are responsible for monitoring CIWA-Ar scores and for signs of alcohol withdrawal. 5. GUIDELINES FOR ALCOHOL DETOXIFICATION Some drinkers that consume alcohol in quantities outside healthy limits will develop an acute alcohol withdrawal syndrome when they abruptly stop or substantially reduce their alcohol consumption. Most patients manifest a minor symptom complex or syndrome, which may start as early as six to eight hours after an abrupt reduction in alcohol intake. It may include any combination of generalized hyperactivity, anxiety, tremor, sweating, nausea, retching, tachycardia, hypertension and mild pyrexia. These symptoms usually peak between 10 to 30 hours and subside by 40 to 50 hours. Seizures may occur in the first 12 to 48 hours and only rarely after this. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 4 of 26 Implementation Date: May 2017

5 Auditory and visual hallucinations may develop; these are characteristically frightening and may last for five to six days. Delirium tremens (DTs) occurs uncommonly, perhaps in less than 5% of individuals withdrawing from alcohol. The syndrome usually starts some 48 to 72 hours after cessation of drinking and is characterized by coarse tremor, agitation, fever, tachycardia, profound confusion, delusions and hallucinations. Convulsions may herald the onset of the syndrome but are not part of the symptom complex. Hyperpyrexia, ketoacidosis, and profound circulatory collapse may develop. Evidence of physical dependence should always be sought because of the management implications; early morning retching, tremor, anxiety and irritability, ingestion of alcohol before midday, amnesia and "blackouts" are all suggestive. A history of previous withdrawal seizures and the development of delirium tremens clearly indicate a history of dependence. Individuals who are known or are suspected of being dependent on alcohol may require help to withdraw from alcohol Prisoners admitted from the community Before any prescribing of medication the patient must have an assessment of needs. A full medical history must be taken as is the case with all prisoners. This must include details of their alcohol consumption including details such as: What they drink? When they last drank? How much they drink daily? Drinking patterns such as binges or daily? Any health issues relating to alcohol dependence such as gastrointestinal or hepatic impairment. The patient must have had discussion with the prescriber to discuss the implications of chlordiazepoxide as a treatment, and the expectations for treatment. There needs to be documentary evidence of this in the notes. There needs to be a clear indication that the patient is dependent on alcohol before treatment is commenced. If the prisoner appears intoxicated or sedated, the first dose of Chlordiazepoxide must be withheld, whilst ongoing monitoring is offered Prisoners transferred from other establishments A patient transferred to HMP Bedford from another prison establishment on an established dose of chlordiazepoxide must be continued on their prescribing regime Detoxification Process An alcohol dependency scale, such as the Severity of Alcohol Dependence Questionnaire (SADQ) should be completed for all patients with suspected alcohol dependency problems. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 5 of 26 Implementation Date: May 2017

6 Cessation of drinking is unlikely to be complicated in milder dependence or where there is a history of binge drinking rather than daily consumption of alcohol. Following admission to HMP Bedford, the following investigations should be considered: Full blood count, B12, folate Liver function tests (including Gamma GT) Urea and Electrolytes, including calcium, phosphate and magnesium in severely dependent/malnourished patients at risk of re-feeding syndrome. Blood sugar levels Clotting screen Relevant investigations should be booked at secondary screening to occur within 10 days of admission or completion of alcohol detoxification as necessary On admission, the following should also be considered: Urine drug screen Full physical examination Baseline blood pressure (standing & lying) and pulse Medication history of prescribed and non-prescribed drugs All patients undergoing an alcohol detoxification should be on twice daily observations for at least the first three days of their treatment and until stable, due to risk of developing seizures, delirium tremens and Wernicke's Detoxification medication Assessing the severity of alcohol dependence Daily alcohol consumption (units per day): One unit of alcohol is 8 g of ethanol. The number of units included in an alcoholic drink can be calculated by the formula: Volume (litres) x % alcohol content (ABV) One unit of alcohol increases the Blood Alcohol Concentration by mg/dl. The time to reach peak alcohol levels is variable ( minutes). The rate of elimination follows zero order kinetics, on average one unit per hour. Medically assisted detoxification may be required when someone consumes at least 15 units of alcohol daily: Moderate dependence: units daily Severe dependence: units daily Very severe dependence: units daily AUDIT score Alcohol dependence is indicated from a score of 20 or more on the AUDIΤ (Alcohol Use Disorders Identification Test) questionnaire (Appendix 3). The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 6 of 26 Implementation Date: May 2017

7 SADQ score The Severity of Alcohol Dependence Questionnaire (SADQ) can calculate a score indicating severity of alcohol dependence (Appendix 4): Mild dependence: a score of 15 or less. Moderate dependence: a score of Severe dependence: a score of 31 or more Initiating medication for alcohol dependence Benzodiazepines have been shown to be efficacious in reducing signs and symptoms of withdrawal (Mayo-Smith 1997). Chlordiazepoxide is the drug of choice. As per PSO 3550, Chlordiazepoxide is a see to take medication. An initial dose of 40mg chlordiazepoxide is generally given at reception and an on going chlordiazepoxide detoxification regimen is initiated as per need. For prisoners identified as drinking more than 40 units daily an additional dose of 40mg chlordiazepoxide may be given on admission to the healthcare unit if the initial dose is given before 5 p.m. Due to the constraints relating to the prison environment, prisoners requiring more than two doses of chlordiazepoxide daily must be admitted to the health care unit. For further details of drug regimen see SystmOne Severity of Number of units SADQ score dependence per day Moderate Severe Very severe > 40 > 45 Very Severe Dependence (>40u): Point A Alcohol Detox Chart (Admit to Healthcare inpatient unit) Initial dose chlordiazepoxide 40mg with 1 pair Vit B and C amps IM (after admission to healthcare unit) day1: 160mg chlordiazepoxide; day 2 140mg chlordiazepoxide (continuing with IM Vit B and C + oral thiamine) day3: Point B. NB caution re-dose chlordiazepoxide in older people/liver impairment. Severe Dependence (30-39u): Point B Alcohol Detox Chart Initial dose chlordiazepoxide 40mg with thiamine 200mg (in reception) day1: 120mg chlordiazepoxide; day2: 100mg chlordiazepoxide (d1-2 continuing thiamine 200mg bd + VitB Co Strong 2 tab bd) day3: Point C Moderate Dependence (20-29u): Point C Alcohol Detox Chart Initial dose chlordiazepoxide 40mg with thiamine 200mg (in reception) day1-2: 80mg chlordiazepoxide: day3-4: 60mg chlordiazepoxide day5: 40mg chlordiazepoxide; day6: 20mg chlordiazepoxide day7: 10mg chlordiazepoxide The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 7 of 26 Implementation Date: May 2017

8 (d1-7: continuing thiamine 200mg bd + VitB Co Strong 2 tab bd) Mild Dependence (15-20u) Mild dependence will usually be managed without use of medication. Where clinically appropriate, a patient may remain on the same dose for additional days or be moved to a higher point on the chart following a MDT discussion, where observations indicate that the prisoner is showing withdrawal symptoms. The CIWA-Ar score is an indicator of the severity of withdrawal symptoms. CIWA-Ar up to 10 suggests mild withdrawal, up to 15 indicates moderate withdrawal that may require additional medication and over 15 indicates severe withdrawal symptoms that will require additional medication and review of the prescribed regime. Any of the following conditions is believed to be increasing the medical risk and the possibility of adverse outcomes and complications: Current infectious disease such as pneumonia or urinary tract infection Tachycardia, defined as a heart rate above 120 beats per minute at admission Withdrawal signs accompanied by a blood alcohol concentration of more than 100 mg/dl at reception Previous epileptic seizures Previous delirious episode Prescribing in older people and those with liver impairment: Benzodiazepine doses may need to be reduced (chlordiazepoxide potentially halved) due to impaired drug clearance leading to accumulation. Monitor any dose-related adverse effects eg drowsiness, sedation, unsteadiness, fatigue, confusion Withdrawal from co-existing benzodiazepine and alcohol dependence (see also Guidance for Prescribing and Management of Benzodiazepine Withdrawal) At HMP Bedford all prisoners prescribed a withdrawal regimen for alcohol dependence are initially prescribed chlordiazepoxide 40mg twice daily. This is equivalent to 15mg diazepam twice daily. Prisoners are closely observed during the first few days of treatment and on completion of their alcohol detoxification for signs and symptoms of withdrawal from either alcohol or benzodiazepines. Following MDT discussion a prescriber with experience in drug and alcohol issues may adjust the point of prescribing on the detox chart or prescribe additional diazepam on completion of alcohol detox. In cases where the patient has been taking a benzodiazepine as a long-term medication for medical or mental health reasons, the original benzodiazepine may be co-prescribed following a decision by the general medical/ mental health team, if clinically indicated. Doses of chlordiazepoxide >200mg per day for alcohol dependence (or equivalent) are not recommended for use within HMP Bedford unless recommended by a consultant with IDTS experience. The consultant should also provide guidance on the monitoring and parameters of The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 8 of 26 Implementation Date: May 2017

9 ECG, blood pressure and heart rate, pulse oximetry (not to be <90%), respiratory rate (not to be <10/min) and temperature when giving high dose benzodiazepines Do not use antidepressants (including selective serotonin reuptake inhibitors [SSRIs]) routinely for the treatment of alcohol misuse alone. Benzodiazepines should only be used for managing alcohol withdrawal and not as ongoing treatment for alcohol dependence. There is no strong evidence to support the use of 2 agonists or magnesium in reducing the symptoms of alcohol withdrawal therefore these are not prescribed at HMP Bedford. If a drug is used at a dose or for an application that does not have UK marketing authorisation, informed consent should be obtained and documented. All prescribers should consult the SPC for a full description of the contraindications and the special considerations of the use of any medication Management during detoxification The following are to be monitored : Blood pressure and pulse daily: Diastolic blood pressure and/or heart rate above 100 may indicate the need to administer higher doses of benzodiazepines. Withdrawal symptoms twice daily for the first 5 days, then daily, using the attached checklist (Appendix 2). If CIWAR-Ar scores remain high, it may be an indication that further chlordiazepoxide may be required. In case of over-sedation, the next dose of chlordiazepoxide may be missed and the regime needs to be reviewed. Alcohol Withdrawal Seizures In people with alcohol withdrawal seizures, consider admitting to the healthcare unit for monitoring and ongoing observations. If alcohol withdrawal seizures develop in a person during treatment for acute alcohol withdrawal, review their withdrawal drug regimen. Those who have a seizure for the first time should be investigated to rule out an organic disease or structural lesion. Do not offer phenytoin to treat alcohol withdrawal seizures. Diazepam is advocated as benzodiazepine of choice for medically assisted alcohol withdrawal in those with a previous history of seizures (Taylor et al. 2012). It may also be used instead of chlordiazepoxide when supplies of chlordiazepoxide are limited (see SystmOne) Patients suspected of having Delirium Tremens or Wernicke s should be transferred to an acute medical hospital. Prison Health Care Unit does not have the facilities for administering IV fluids and these conditions are often associated with inter-current illnesses such as electrolyte imbalances and infections. If this is not immediately available, admit to the healthcare unit for monitoring and ongoing observations and review their withdrawal drug regimen. If symptoms persist or oral medication is declined, consider parenteral haloperidol and exclude comorbid acute medical conditions. Consider an antipsychotic (caution required due to lowering seizure threshold) in a patient with delirium who is distressed or considered a risk to themselves or others and if verbal and non-verbal de-escalation techniques are ineffective. This should normally be for a short-term only (usually for 1 week or less). Use antipsychotic drugs with extreme caution or not at The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 9 of 26 Implementation Date: May 2017

10 all for people with conditions such as Parkinson s disease or dementia with Lewy bodies (DLB). The usual recommended starting dose for haloperidol in liver units, (i.e. in patients with underlying liver disease) is 1.5 2mg TDS, although treatment with benzodiazepines should be the priority Prophylactic vitamin supplementation On reception, all prisoners with alcohol dependence should commence vitamin supplementation as per alcohol detox chart (Appendix 1 and SystmOne template): Pabrinex intramuscular injections one pair daily for 3 days are indicated for prisoners who are very severely dependent (daily alcohol consumption over 40 units) or malnourished. Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex Intramuscular, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex Intramuscular in patients who need treatment by this route of administration. Initial warning signs of a reaction to Pabrinex Intramuscular are sneezing or mild asthma, and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intramuscular is administered (See Appendix 6). The patient s consent should be obtained before administration and they should be informed of the risk of anaphylaxis. The number of actual anaphylaxis incidents is low and has been quoted as 1 per 5 million with intramuscular injections.(mcintosh et al 2005). Treatment for a presumptive diagnosis of Wernicke's consists of 2-3 pairs of Pabrinex IV ampoules administered three times a day for at least two days. Treatment may continue with 1 pair of Pabrinex IV ampoules for 3-5 days or for as long as clinical improvement continues. This treatment should always be administered in a general hospital setting. If parenteral thiamine is not clinically indicated, oral prophylactic vitamin supplementation should be offered: o Thiamine tablets 200mg twice daily o Vitamin B Compound Strong 2 tablets twice daily. Oral vitamin supplementation may continue for 14 days after the completion of the alcohol detoxification regime. Where a prisoner refuses admission to Healthcare for administration of IM Pabrinex, this should be clearly documented and signed by the prisoner. Where IM Pabrinex is clinically indicated the prisoner must attend the Healthcare Unit for administration and remain there for 30 minutes after the injection. The prisoner must be closely observed for signs of anaphylaxis. The prisoner MUST be closely monitored for signs of Wernicke's encephalopathy. Where signs or symptoms develop the prisoner should be transferred to an acute unit for IV administration, taking into account the Mental Capacity Act in the event of a refusal or a confused state. Food supplements may be considered if dietary intake is inadequate and where the BMI is <18.5. The Wernicke-Korsakoff syndrome develops in problem drinkers who are thiamine deficient. However, other as yet unidentified factors must be important in its genesis as thiamine deficiency is not invariably associated with the development of this syndrome. Wernicke's encephalopathy The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 10 of 26 Implementation Date: May 2017

11 comprises a triad of global confusion, eye signs and ataxia; the confusional state is accompanied by apathy, disorientation and disturbed memory, but drowsiness and stupor are uncommon. The ocular abnormalities include nystagmus, gaze palsies and ophthalmoplegia, while the ataxia affects the trunk and lower extremities. The clinical abnormalities may develop acutely or evolve over several days. Korsakoff's psychosis is an amnesic state in which there is profound impairment of both retrograde and anterograde memory but relative preservation of other intellectual abilities; confabulation may be a feature. Korsakoff's psychosis generally develops after an acute episode of Wernicke's encephalopathy. However, some patients develop a combined syndrome, from the outset, with memory loss, eye signs and unsteadiness but without confusion; others do not develop either the eye signs or ataxia. Post-mortem analysis has demonstrated that Wernicke s encephalopathy may occur in as many as 12.5% of chronic alcohol misusers. The discrepancy between the pathological findings and the clinical recognition of the syndrome may be explained by the fact that the classical presentation is seen in only 10% of patients. A presumptive diagnosis of the Wernicke-Korsakoff syndrome should therefore be made in patients with a history of hazardous or harmful drinking and one or more of the following otherwise unexplained symptoms: ataxia, ophthalmoplegia, nystagmus, confusion, memory disturbance, comatosed/unconscious, hypotension, and or hypothermia. Any prisoner presenting with the above signs should be immediately transferred to a General Hospital Preventing relapse For prisoners who have successfully completed their alcohol detoxification treatment and are due to be released, consideration should be given to introduction of relapse prevention medication. Before starting treatment with acamprosate, or oral naltrexone conduct a comprehensive medical assessment (baseline urea and electrolytes and liver function tests including GGT). In particular, consider any contraindications or cautions (see the SPC), and discuss these with the prisoner Discharge from prison Ideally, alcohol detoxification regime should have been completed. Prisoners who have not completed their alcohol detoxification should be referred to community drug and alcohol services for further follow up. On balance, supplying medication from prison services for a continued alcohol detoxification regime in the community should not be undertaken due to the risks of lack of supervision, change in tolerance levels and potential additional alcohol consumption. A week's supply of acamprosate or oral naltrexone if prescribed, could be issued from pharmacy. Vitamin supplementation should be reviewed and continued as deemed appropriate. GPs may prescribe oral thiamine 50 mg per day (as a single dose) during the maintenance stage following withdrawal, and for as long as malnutrition may be present. If the person has chronic alcohol dependence, oral thiamine may need to be continued indefinitely. 6. TRAINING 6.1. Mandatory Training There is no mandatory training associated with this policy. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 11 of 26 Implementation Date: May 2017

12 6.2. Specific Training not covered by Mandatory Training Ad hoc training sessions based on an individual s training needs as defined within their annual appraisal or job description 7. MONITORING COMPLIANCE WITH THIS DOCUMENT The table below outlines the Trusts monitoring arrangements for this document. The Trust reserves the right to commission additional work or change the monitoring arrangements to meet organisational needs. Aspect of compliance or effectiveness being monitored Method of monitoring Individual responsible for the monitoring Monitoring frequency Group or committee who receive the findings or report Group or committee or individual responsible for completing any actions Prescribing standards for alcohol detoxification Audit of prescription charts of patients with planned detoxification Chief Pharmacist Every 2 years. Medicines Management Committee Medicines Management Committee 8. REFERENCES AND BIBLIOGRAPHY Mayo-Smith M (1997) Pharmacological management of alcohol withdrawal Journal of the American Medical Association 278: Lingford-Hughes A R, Welch S, Nutt DJ (2004) Evidence-based guidelines for the pharmacological management of substance misuse, addiction and comorbidity: recommendations from the British Association for Psychopharmacology Journal of Psychopharmacology; 18(3): Sullivan J T Sykora K Schneiderman J, Naranjo CA Sellers EM (1989) Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar)' British Journal of Addiction ;84(11): McIntosh C Kippen V Hutcheson F McIntosh A (2005) Parenteral thiamine use in the prevention and treatment of Wernicke-Korsakoff syndromethe Psychiatrist; 29: Taylor, D. Paton, C. and Kapur, S. (2012) Prescribing Guidelines, 11th Edition. Bodmin: MPG Books British National Formulary 66 (2013). London: BMJ Publishing and RPS Publishing Heather, N., Raistrick, D. and Godfrey C. (2006) A Summary of the Review of the Effectiveness of Treatment for Alcohol Problems. London: National Treatment Agency for Substance Misuse. National Institute for Clinical Excellence (2010) Alcohol use disorders. Diagnosis and clinical management of alcohol related physical complications Clinical Guideline 100 London: NICE Available from The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 12 of 26 Implementation Date: May 2017

13 National Institute for Clinical Excellence (2011) Alcohol use disorders. Diagnosis assessment and management of harmful drinking and alcohol dependence Clinical Guideline 115 London: NICE Available from 9. RELATED TRUST POLICIES MMP 001 Control of Medicines Policy The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 13 of 26 Implementation Date: May 2017

14 Appendix 1 ALCOHOL DETOXIFICATION PRESCRIBING GUIDANCE FOR PRISONERS IN RECEPTION Prisoner gives a history of >15u/d daily alcohol consumption <2/52 OR >15u/d alcohol consumption >2/52 but not daily use Prisoner gives a history of daily alcohol consumption of more than 20 units for more than 2 weeks Offer to place prisoner on alcohol withdrawal observations. alcohol withdrawals present alcohol withdrawals absent >40 units/day: Admit to Healthcare*. Start alcohol detox Point A. Prescribe Pabrinex to be administered within healthcare wing. Place on alcohol withdrawal observations units/day: Admit to D wing. Start alcohol detox Point B Place on alcohol withdrawal observations units/day: Admit to D wing. Start alcohol detox Point C Place on alcohol withdrawal observations Place on alcohol withdrawal observations. *If prisoner declines to go to healthcare, they must be asked to sign a disclaimer form and be admitted to D wing. They must be taken to healthcare for the administration of each Pabrinex dose (and remain there for 30 minutes after each dose is given). The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG027 HMP Guidance for alcohol detoxification - (May2017-May2019) 14 of 26 Implementation Date: May 2017

15 APPENDIX 2 : Alcohol withdrawal Assessment Scoring Guidelines : (CIWA Ar) Nausea/Vomiting Rate on scale none 1 - mild nausea with no vomiting Intermittent nausea Constant nausea, frequent dry heaves and Vomiting Anxiety Rate on scale no anxiety, patient at ease moderately anxious or guarded, so anxiety is inferred equivalent to acute panic states seen in severe delirium or acute schizophrenic reactions Paroxysmal Sweats Rate on Scale no sweats 1 barely perceptible sweating palms moist beads of sweat obvious on forehead drenching sweats Tactile Disturbances Ask have you experienced any itching, pins & needles sensation, burning or numbness, or a feeling of bugs crawling on or under your skin? 0 - none 1 very mild itching, pins & needles, burning, or numbness 2 mild itching, pins & needles, burning or numbness 3 moderate itching, pins & needles, burning or numbness 4 moderate hallucinations 5 severe hallucinations 6 extremely severe hallucinations 7 continuous hallucinations Visual disturbances Ask Does the light appear to be too bright? Is its colour different than normal? Does it hurt your eyes? Are you seeing anything that disturbs you or that you know isn t there? Tremors have patient extend arms & spread fingers. Rate on scale no tremor 1 not visible, but can be felt fingertip to fingertip moderate, with patient s arms extended severe, even w/arms not extended Agitation Rate on scale normal activity 1 somewhat normal activity moderately fidgety and restless paces back and forth, or constantly thrashes about Orientation and clouding of sensorium Ask, What day is this? Where are you? Who am I? Rate scale Oriented 1 Cannot do serial additions or uncertain about date 2 Disoriented to date by no more than 2 calendar days 3 Disoriented to date by more than 2 calendar days 4 Disoriented to place and/or person Auditory Disturbances Ask, Are you more aware of sounds around you? Are they harsh? Do they startle you? Do you hear anything that disturbs you or that you know isn t there? 0 not present 1 very mild harshness or ability to startle 2 mild harshness or ability to startle 3 moderate harshness or ability to startle 4 moderate hallucinations 5 severe hallucinations 6 extremely severe hallucinations 7 continuous hallucinations Headache Ask, Does your head feel different than usual? Does it feel like there is a band around your head? Do not rate dizziness or light-headedness. 0 not present 1 very mild sensitivity 2 mild sensitivity 3 moderate sensitivity 4 moderate hallucinations 5 severe hallucinations 6 extremely severe hallucinations 0 not present 1 very mild 2 mild 3 moderate 4 moderately severe 5 severe 6 very severe 7 continuous hallucinations 7 extremely severe 1. Assess and rate each of the 10 criteria of the CIWA scale. Each criterion is rated on a scale from 0 to 7, except for Orientation and clouding of sensorium which is rated on scale 0 4. Add up the scores for all ten criteria. This is the total CIWA-Ar score for the patient at that time. Prophylactic medication should be started for any patient with a total CIWA-Ar score of 15 or greater (ie. Start on withdrawal medication). If started on scheduled medication, additional PRN medication should be given for a total CIWA-Ar score of 15 or greater. 2. Document vitals and CIWA-Ar assessment on the Withdrawal Assessment Sheet. Document administration of PRN medications on the assessment sheet as well. 3. The CIWA-Ar scale is the most sensitive tool for assessment of the patient experiencing alcohol withdrawal. Nursing assessment is vitally important. Early intervention for CIWA-Ar score of 8 or greater provides the best means to prevent the progression of withdrawal. 15

16 ALCOHOL WITHDRAWAL ASSESSMENT FLOWSHEET Date Time Pulse RR O² BP Assess and rate each of the following (CIWA-AR Scale): Nausea/vomiting (0-7) 0 none; 1 mild nausea, no vomiting; 4 intermittent nausea; 7 constant nausea, frequent dry heaves & vomiting Tremors (0 7) 0 no tremor; 1 not visible but can be felt; 4 moderate w/arms extended; 7 severe, even w/arms not extended Anxiety (0-7) 0 none, at ease; 1 mildly anxious; 4 moderately anxious or guarded; 7 equivalent to acute panic state Agitation (0 7) 0 normal activity; 1 somewhat normal activity; 4 moderately fidgety/restless; 7 paces or constantly thrashes about Paroxysmal Sweats (0 7) 0 no sweats; 1 barely perceptible sweating; palms moist; 4 beads of sweat obvious on forehead; 7 drenching sweat Orientation (0 4) 0 oriented; 1 uncertain about date; disoriented to date by no more than 2 days; 3 disoriented to dated by > 2 days; 4 disoriented to place and/or person Tactile Disturbances (0 7) 0 none; 1 very mild itch, P&N, numbness; 2 mild itch, P&N, burning, numbness; 3 moderate itch, P&N, burning, numbness 4 moderate hallucinations; 5 severe hallucinations; 6 extremely severe hallucinations; 7 continuous hallucinations Auditory Disturbances (0 7) 0 not present; 1 very mild harshness/ability to startle; 2 mild harshness, ability to startle; 3 moderate harshness, ability to startle; 4 moderate hallucinations; 5 severe hallucinations; 6 extremely severe hallucinations; 7 continuous hallucinations Visual Disturbances (0 7) 0 not present; 1 very mild sensitivity; 2 mild sensitivity; 3 moderate sensitivity; 4 moderate hallucinations; 5 severe hallucinations; 6 extremely severe hallucinations; 7 continuous hallucinations Headache (0 7) 0 not present; 1 very mild; 2 mild; 3 moderate; 4 moderately severe; 6 very severe; 7 extremely severe Total CIWA-Ar Score: PRN Med: (circle one) Dose given (mg): Diazepam Lorazepam Route: Time of PRN medication administration: Assessment of response (CIWA-Ar score minutes after medication administered) RN Initials Refer to reverse for detailed instructions in use of the CIWA-Ar scale Ppp Scale for Scoring: Tot Total Score = 0 9 absent or minimal withdrawal 10 19: mild to moderate withdrawal More than 20: severe withdrawal Indications for PRN medication: a. Total CIWA-AR score 8 or higher if not started on regime b. Total CIWA-AR score 15 or higher if on Scheduled medication. (Scheduled +prn method) Consider transfer to acute care for any of the following: Total score above 35 or respiratory distress SIGNATURE/ TITLE INITIALS SIGNATURE/TITLE INITIALS

17 APPENDIX 3: AUDIT Questionnaire This is one unit of alcohol and each of these is more than one unit AUDIT C Questions How often do you have a drink containing alcohol? How many units of alcohol do you drink on a typical day when you are drinking? Scoring system Never Monthly or less 2-4 times per month 2-3 times per week 4+ times per week Your score How often have you had 6 or more units if female, or 8 or more if male, on a single occasion in the last year? Never Less than monthly Monthly Weekly Daily or almost daily Scoring: A total of 5+ indicates increasing or higher risk drinking. An overall total score of 5 or above is AUDIT-C positive. SCORE

18 Score from AUDIT- C (other side) SCORE Remaining AUDIT questions Questions How often during the last year have you found that you were not able to stop drinking once you had started? How often during the last year have you failed to do what was normally expected from you because of your drinking? How often during the last year have you needed an alcoholic drink in the morning to get yourself going after a heavy drinking session? How often during the last year have you had a feeling of guilt or remorse after drinking? How often during the last year have you been unable to remember what happened the night before because you had been drinking? Have you or somebody else been injured as a result of your drinking? Has a relative or friend, doctor or other health worker been concerned about your drinking or suggested that you cut down? Scoring system Never Never Never Never Never No No Less than monthly Less than monthly Less than monthly Less than monthly Less than monthly Monthly Monthly Monthly Monthly Monthly Yes, but not in the last year Yes, but not in the last year Weekly Weekly Weekly Weekly Weekly Daily or almost daily Daily or almost daily Daily or almost daily Daily or almost daily Daily or almost daily Yes, during the last year Yes, during the last year Your score Scoring: 0 7 Lower risk, 8 15 Increasing risk, Higher risk, 20+ Possible dependence TOTAL Score equals AUDIT C Score (above) + Score of remaining questions TOTAL

19 APPENDIX 4: SEVERITY OF ALCOHOL DEPENDENCE QUESTIONAIRE (SADQ-C) 1 NAME AGE No. DATE: Please recall a typical period of heavy drinking in the last 6 months. When was this? Month:. Year.. Please answer all the following questions about your drinking by circling your most appropriate response. During that period of heavy drinking 1. The day after drinking alcohol, I woke up feeling sweaty. 2. The day after drinking alcohol, my hands shook first thing in the morning. 3. The day after drinking alcohol, my whole body shook violently first thing in the morning if I didn't have a drink. 4. The day after drinking alcohol, I woke up absolutely drenched in sweat. 5. The day after drinking alcohol, I dread waking up in the morning. 6. The day after drinking alcohol, I was frightened of meeting people first thing in the morning. 7. The day after drinking alcohol, I felt at the edge of despair when I awoke. 8. The day after drinking alcohol, I felt very frightened when I awoke. 9. The day after drinking alcohol, I liked to have an alcoholic drink in the morning. 10. The day after drinking alcohol, I always gulped my first few alcoholic drinks down as quickly as possible. 11. The day after drinking alcohol, I drank more alcohol to get rid of the shakes.

20 12. The day after drinking alcohol, I had a very strong craving for a drink when I awoke. 13. I drank more than a quarter of a bottle of spirits in a day (OR 1 bottle of wine OR 8 units of beers ). 14. I drank more than half a bottle of spirits per day (OR 1.5 bottles of wine OR 15 units of beer). 15. I drank more than one bottle of spirits per day (OR 3 bottles of wine OR 30 units of beer). 16. I drank more than two bottles of spirits per day (OR 6 bottles of wine OR 60 units of beer) Imagine the following situation: 1. You have been completely off drink for a few weeks 2. You then drink very heavily for two days How would you feel the morning after those two days of drinking? 17. I would start to sweat. NOT AT ALL SLIGHTLY MODERATELY QUITE A LOT 18. My hands would shake. NOT AT ALL SLIGHTLY MODERATELY QUITE A LOT 19. My body would shake. NOT AT ALL SLIGHTLY MODERATELY QUITE A LOT 20. I would be craving for a drink NOT AT ALL SLIGHTLY MODERATELY QUITE A LOT SCORE CHECKED BY: ALCOHOL DETOX PRESCRIBED: YES/NO NOTES ON THE USE OF THE SADQ The Severity of Alcohol Dependence Questionnaire was developed by the Addiction Research Unit at the Maudsley Hospital. It is a measure of the severity of

21 dependence. The AUDIT questionnaire, by contrast, is used to assess whether or not there is a problem with dependence. The SADQ questions cover the following aspects of dependency syndrome: physical withdrawal symptoms affective withdrawal symptoms relief drinking frequency of alcohol consumption speed of onset of withdrawal symptoms. Scoring Answers to each question are rated on a four-point scale: Almost never - 0 Sometimes - 1 Often - 2 Nearly always - 3 A score of 31 or higher indicates "severe alcohol dependence". A score of indicates "moderate dependence" A score of below 16 usually indicates only a mild physical dependency. A chlordiazepoxide detoxification regime is usually indicated for someone who scores 16 or over. It is essential to take account of the amount of alcohol that the patient reports drinking prior to admission as well as the result of the SADQ. There is no correlation between the SADQ and such parameters as the MCV or GGT.

22 APPENDIX 5: DOSING REGIMENS - NICE CG115

23 Appendix 6 Diazepam detox chart

24

25 Appendix 7 - Administration of Pabrinex 1. Name of the medicinal product Pabrinex Intramuscular High Potency, Solution for injection 2. Qualitative and quantitative composition Each presentation (carton) contains either 5ml or 2ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2. Each No. 1 ampoule contains: 5ml ampoule Thiamine Hydrochloride Riboflavin (as Phosphate Sodium) Pyridoxine Hydrochloride Each No. 2 ampoule contains: Ascorbic acid 250mg 4mg 50mg 2ml ampoule 500mg Nicotinamide 160mg For a full list of excipients, see section Pharmaceutical form Solution for injection. 4. Clinical particulars 4.1 Therapeutic indications Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, after acute infections, post-operatively and in psychiatric states. 4.2 Posology and method of administration Pabrinex is also available as an Intravenous High Potency Injection. Therefore before administration ensure that both the Summary of Product Characteristics and ampoule labels refer to the INTRAMUSCULAR injection. The contents of one ampoule number 1 and one ampoule number 2 of Pabrinex Intramuscular High Potency (total 7ml) are drawn up into a syringe to mix them just before use, then injected slowly high into the gluteal muscle, 5cm below the iliac crest. Adults: The contents of one pair of ampoules (7ml) twice daily for up to 7 days. Elderly: As for adults. Children: Pabrinex Intramuscular High Potency is rarely indicated for administration to children, however suitable doses are as follows: Under 6 years quarter of the adult dose 6-10 years third of the adult dose years half to two thirds of the adult dose 14 years and as for the adult dose over 4.3 Contraindications Known hypersensitivity to any of the active constituents or to the excipients. 4.4 Special warnings and precautions for use Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex Intramuscular, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex Intramuscular in patients who need treatment by this route of administration. Initial warning signs of a reaction to Pabrinex Intramuscular are sneezing or mild asthma, and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intramuscular High Potency is administered. This medicine is for injection into a muscle only and should not be given by any other route Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions. 4.5 Interaction with other medicinal products and other forms of interaction The content of pyridoxine may interfere with the effects of concurrent levodopa therapy. 4.6 Fertility, pregnancy and lactation No adverse effects have been noted at recommended doses when used as clinically indicated. However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women. 4.7 Effects on ability to drive and use machines None stated. 4.8 Undesirable effects Adverse reactions reported as possibly associated to Pabrinex are presented in the following table by MedDRA System Organ Class (SOC), Preferred Term and frequency. The following frequency categories are used: Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1,000); Very rare (<1/10,000), including isolated reports.

26 Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure. Therefore it is not possible to estimate the true incidence of adverse reactions and the frequency is unknown. Tabulated summary of adverse reactions SYSTEM ORGAN CLASS (SOC) FREQUENCY ADVERSE REACTION Immune system disorders Unknown Hypersensitivity (including anaphylaxis, rash and urticaria) Nervous system disorders Unknown Paraesthesia Vascular disorders Unknown Hypotension General disorders and Unknown Injection site reactions (including pain and swelling) administration site conditions Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Overdose In the unlikely event of over dosage, treatment is symptomatic and supportive. 5. Pharmacological properties 5.1 Pharmacodynamic properties Pabrinex Intramuscular High Potency contains vitamins B1, B2, B6, nicotinamide and vitamin C. ATC code: A11EB 5.2 Pharmacokinetic properties None supplied. 5.3 Preclinical safety data There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics. 6. Pharmaceutical particulars 6.1 List of excipients Edetic acid Sodium hydroxide Benzyl alcohol Water for Injections 6.2 Incompatibilities None stated. 6.3 Shelf life 24 months. 6.4 Special precautions for storage Store in a refrigerator at 2 C to 8 C. Keep the container in the outer carton. Do not freeze. 6.5 Nature and contents of container Pabrinex Intramuscular High Potency is supplied in pairs of (5ml and 2ml) amber glass ampoules in packs of 10 pairs. 6.6 Special precautions for disposal and other handling In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present. 7. Marketing authorisation holder Archimedes Pharma UK Limited Galabank Business Park Galashiels TD1 1QH United Kingdom 8. Marketing authorisation number(s) PL 12406/0004