Alcohol Interventions: NICE guidelines. Professor Colin Drummond

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1 Alcohol Interventions: NICE guidelines Professor Colin Drummond

2 What this presentation covers Epidemiology Background Scope Methodology What is new? Implications for practice What s next? Conclusions

3 Epidemiology 3 rd leading cause of disability in Europe; 20,000 UK deaths 24% of adults hazardous/harmful drinkers; 4% alcohol dependence SIPS: 30% in PHC; 40% in ED; 65% in CJS; 50% in MH Consumption doubled in adolescents in past 10 yrs Alcohol related hospital admissions doubled in last 8 years Increasing prevalence of AD: M, M UK societal cost 25 billions Alcohol dependence years of potential life lost: 25 years

4 120 UK Health Performance Murray et al., 2013, Lancet % change DALYs % change 20 0 All causes Neoplasm Liver cancer Oral cancer Alcoholic liver dis Pancreatitis Alcohol use disorders

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6 Background Current practice and service provision across the country is varied and often poorly coordinated Lack of guidance on best practice Negative attitudes, lack of training and competence Only 6% per year of adults who are alcohol dependent receive treatment per annum (range 1%-8% across regions) compared to ~50% in class A drug misuse Low identification in primary care (1 in 60 harmful; 1 in 20 dependent drinkers) and mental health care Comorbid mental and physical disorders are common

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8 Prevalence Service Utilisation Ratio Gap between need and access (PSUR) by region North East Yorks and Humber Eastern South East East Midlands West Midlands South West London North West ENGLAND

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10 NICE Guidance Alcohol use disorders Preventing harmful drinking (PH24) Diagnosis and clinical management of alcohol related physical complications (CG100) Diagnosis, assessment and management of harmful drinking and alcohol dependence (CG) Related guidance Psychiatric comorbidity (CG) Complex pregnancies (CG)

11 NICE Guidance Alcohol use disorders Preventing harmful drinking (PH24) Diagnosis and clinical management of alcohol related physical complications (CG100) Diagnosis, assessment and management of harmful drinking and alcohol dependence (CG) Related guidance Psychiatric comorbidity (CG) Complex pregnancies (CG)

12 Clinical management CG100 Unplanned withdrawal: Admit high risk, vulnerable and under 16s Symptom triggered regime more cost effective Benzodiazepine or carbamazepine CIWA monitoring Wernicke s encephalopathy Oral thiamine for most Parenteral for malnourished, liver disease and in AED or admitted for acute illness or injury

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14 CG115 Scope Diagnosis, assessment and management of harmful drinking and alcohol dependence in young people and adults NHS funded services; full pathway Does not cover: children younger than 10 years pregnant women severe comorbidity Mutual aid organisations Overlap with other NICE guidelines! Prevention (PH24) Physical complications (CG100)

15 Definitions (Hazardous drinking consumption of alcohol likely to cause harm) Harmful drinking consumption already causing mental or physical health problems Alcohol dependence ICD10 definition Mild dependence = Severity of Alcohol Dependence Questionnaire (SADQ) score 15 or less Moderate dependence = SADQ score of Severe dependence = SADQ score of 31 or more.

16 Methodology Most comprehensive systematic review of the evidence base on alcohol treatment to date Core expert group supported by technical group Stricter inclusion/exclusion criteria for studies Meta-analyses based on new classification of studies Implications for different settings considered Consideration of different levels of severity/complexity Organisation and delivery of care Sequencing and combination of interventions Integrated care pathways

17 What we are saying that is new Importance of identification and assessment in both specialist and non-specialist settings including use of validated assessment tools Different treatment needed for different severity/complexity Importance of care coordination/case management, motivational interviewing, referral to mutual aid Need for combination treatments organised in a care pathway Wider indications for inpatient assisted withdrawal and structured day programmes Limited indications for residential rehabilitation Greater emphasis on individual needs

18 Management of harmful drinking and alcohol dependence Identification and assessment Care coordination Settings Assisted withdrawal Psychosocial interventions Pharmacological interventions Comorbidity Children and young people

19 Interventions: delivery and setting Competence, manuals, supervision Care coordination Intensive case management alcohol dependence Stepped care and Assertive Community Treatment Inpatient withdrawal management Structured intensive community programme Moderate severe dependence, social support, complex needs Residential rehabilitation Moderate severe dependence AND homeless 3 months

20 Assisted withdrawal Threshold for assessment: >20 AUDIT >15 units/day Community based withdrawal programme - most Inpatient assisted withdrawal >30 SADQ, fits or DTs OR plus benzodiazepine, mental or physical comorbidity, learning disability, cognitive impairment Lower threshold for homeless, older, younger, pregnancy, homeless Regimes Community: fixed dose Inpatient: fixed dose or symptom triggered

21 AUDIT AUDIT > 20 AUDIT < 20 Consider need for alcohol withdrawal Outcome of assessment SADQ < 15 Typical drinks per day < 15 SADQ Typical drinks per day < 30 units Absence of comorbid features SADQ 30 Typical drinks per day 30 units Comorbid features present Consider Tier 2 or 3 interventions: Psychological and pharmacological interventions Comprehensive assessment where comorbid features present Outpatient (Tier 3 interventions): Assisted alcohol withdrawal Inpatient (Tier 4 interventions): Assisted alcohol withdrawal

22 Interventions Harmful/mild dependence CBT, BT, Social Network therapy BCT Non-responders: offer acamprosate or naltrexone plus psychosocial Moderate/severe dependence Assisted withdrawal followed by: Intensive rehabilitation programme Structured community programme Residential rehabilitation: homeless Acamprosate or naltrexone plus CBT, BT, SNT, BCT Disulfiram (second line, preference or not suitable for first line)

23 Psychological therapies Need for greater training, competency, supervision Use of evidence based therapy manuals Motivational interventions as routine approach from point of first contact Role of AA Some therapies have greater evidence of effectiveness: CBT, BT, SNT, BCT Should be time limited and provided against a background of care coordination/case management Delivery in structured day care for more severe/complex Limited indications for residential rehabilitation

24 Pharmacological therapies Naltrexone and acamprosate strongest evidence Better in dependent than harmful drinkers Disulfiram evidence base weaker, potential risks: therefore second line treatment Use with adjunctive psychosocial therapies and medical monitoring Duration 6-12 months Don t use GHB, antidepressants, benzodiazepines Some other promising medications, but currently lack sufficient evidence to recommend

25 Acamprosate NMDA antagonist, GABA agonist 19 RCTs; high quality Superior to placebo in abstinence and relapse to heavy drinking Start after withdrawal; dose mg Continue up to 12 months, monthly supervision Side effects: diarrhoea, abdominal pain, nausea vomiting, pruritis Contraindicated: pregnancy, breast feeding, renal and hepatic failure

26 Acamprosate meta-analysis Study or Subgroup Europe Barrias 1997 Besson 1998 Chick 2000 Geerlings 1997 Gual 2001 Kiefer 2003 Ladewig 1993 Paille 1995 Pelc 1992 Pelc 1997 Poldrugo 1997 Roussaux 1996 Sass 1996 Tempesta 2000 Whitworth 1996 Subtotal (95% CI) Total events Experimental Control Risk Ratio Risk Ratio Events Total Events Total Weight M-H, Random, 95% CI M-H, Random, 95% CI % 5.3% 9.8% 8.1% 6.7% 3.2% 3.6% 7.8% 6.0% 5.4% 5.5% 4.7% 6.1% 5.8% 8.4% 92.3% Heterogeneity: Tau² = 0.01; Chi² = 43.94, df = 14 (P < ); I² = 68% Test for overall effect: Z = 5.27 (P < ) 0.80 [0.67, 0.96] 0.71 [0.57, 0.87] 0.99 [0.93, 1.05] 0.83 [0.74, 0.93] 0.88 [0.76, 1.03] 0.80 [0.59, 1.09] 0.72 [0.54, 0.96] 0.84 [0.74, 0.95] 0.78 [0.65, 0.93] 0.70 [0.57, 0.86] 0.72 [0.59, 0.87] 1.06 [0.84, 1.34] 0.78 [0.65, 0.93] 0.80 [0.66, 0.96] 0.90 [0.81, 1.00] 0.83 [0.77, 0.89] Rest of the World Baltieri 2003 Namkoong 2003 Subtotal (95% CI) Total events Heterogeneity: Tau² = 0.01; Chi² = 1.39, df = 1 (P = 0.24); I² = 28% Test for overall effect: Z = 1.62 (P = 0.11) Total (95% CI) % Total events Heterogeneity: Tau² = 0.01; Chi² = 45.48, df = 16 (P = ); I² = 65% Test for overall effect: Z = 5.58 (P < ) Test for subgroup differences: Chi² = 0.00, df = 1 (P = 0.99), I² = 0% % 4.5% 7.7% 0.72 [0.53, 0.98] 0.91 [0.72, 1.16] 0.83 [0.66, 1.04] 0.83 [0.77, 0.88] Favours experimental Favours control

27 Naltrexone Opioid antagonist 27 RCTs; high quality Superior to placebo in relapse to heavy drinking and no. heavy drinking days Start after withdrawal; dose 25 -> 50mg Continue up to 12 months, monthly supervision Side effects: nausea, abdominal pain, reduced appetite, tiredness, hepatotoxicity in high doses, opioid blockade Contraindications: liver failure, renal failure, opioid medication

28 Study or Subgroup Europe Balldin, 2003 Chick 2000b Gastpar 2002 Guardia 2002 Heinla 2001 (C.Skill) Heinla 2001 (sup. beh) Kiefer 2003 Mann2012 Subtotal (95% CI) Total events Naltrexone meta-analysis Experimental Control Risk Ratio Risk Ratio Events Total Events Total Weight M-H, Random, 95% CI M-H, Random, 95% CI Heterogeneity: Tau² = 0.03; Chi² = 25.42, df = 7 (P = ); I² = 72% Test for overall effect: Z = 1.39 (P = 0.17) % 6.4% 3.7% 1.2% 6.0% 6.7% 2.7% 5.0% 39.8% 1.01 [0.92, 1.11] 0.99 [0.82, 1.20] 0.98 [0.68, 1.40] 0.45 [0.21, 0.97] 0.76 [0.61, 0.94] 1.06 [0.89, 1.26] 0.47 [0.29, 0.74] 1.05 [0.81, 1.38] 0.90 [0.77, 1.05] Rest of the World Anton 1999 Anton 2005 (C.Skills) Anton 2005 (MET) Anton 2006 (CBI) Anton 2006 (No CBI) Huang 2005 Killeen 2004 Kranzler 2000 Krystal 2001 Latt 2002 Lee 2001 Monti 2001 Morley 2006 Morris 2001 O'Malley 2008 Oslin 1997 Volpicelli 1992 Volpicelli 1997 Subtotal (95% CI) Total events % 2.6% 2.8% 7.2% 7.3% 0.4% 1.9% 3.6% 6.1% 2.8% 1.3% 2.2% 5.6% 3.6% 4.6% 0.5% 1.4% 2.6% 60.2% Heterogeneity: Tau² = 0.01; Chi² = 24.20, df = 17 (P = 0.11); I² = 30% Test for overall effect: Z = 3.94 (P < ) Total (95% CI) % Total events Heterogeneity: Tau² = 0.02; Chi² = 59.15, df = 25 (P = ); I² = 58% Test for overall effect: Z = 3.70 (P = ) Test for subgroup differences: Chi² = 0.83, df = 1 (P = 0.36), I² = 0% 0.63 [0.44, 0.91] 0.63 [0.40, 1.01] 0.78 [0.50, 1.21] 0.93 [0.80, 1.09] 0.90 [0.78, 1.04] 1.33 [0.34, 5.21] 1.24 [0.70, 2.18] 0.97 [0.67, 1.39] 0.85 [0.69, 1.05] 0.64 [0.41, 1.00] 0.63 [0.30, 1.31] 0.86 [0.51, 1.45] 1.04 [0.83, 1.31] 0.63 [0.44, 0.91] 0.79 [0.59, 1.05] 0.41 [0.13, 1.35] 0.42 [0.21, 0.83] 0.67 [0.42, 1.06] 0.82 [0.75, 0.91] 0.84 [0.77, 0.92] Favours [experimental] Favours [control]

29 Association between baseline severity and effect size in naltrexone versus placebo trials (logrr)

30 Cost effectiveness naltrexone and acamprosate

31 Disulfiram Aldehyde dehydrogenase blocker 3 RCTs (oral vs placebo); 4 vs active; quality moderate or poor Moderate or no effects Start 24 hrs after withdrawal; dose 200mg Side effects: interactions with alcohol, wide range of drugs, drowsiness, nausea, vomiting, halitosis, loss of libido psychotic reactions, peripheral neuritis, liver failure Contraindications: renal failure, hepatic or respiratory, diabetes, severe personality disorder, suicide risk, psychosis

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33 Special groups Children and young people under 18 Inpatient for withdrawal CBT, multi-component programmes Acamprosate or naltrexone (second line only) Families and carers Assessment and intervention in their own right

34 What next? NICE Quality Standards in alcohol treatment, 2011 NICE commissioning guidelines, 2011 DH Payment by Results, New DH alcohol strategy, 2012 NICE QOF and COF standards, 2013 New Public Health England, 2013 CG115 guideline revision, 2013

35 Alcohol PBR 4 clusters 1. Harmful/mild dependence 3 month care coordination, no detox, 4 sessions MET 2. Moderate dependence w/o complex 6 month care coordination, OP detox, naltrexone/acamprosate, structured community programme 3. Severe dependence w/o complex needs 12 months care coordination, IP detox, pharm, structured comm programme 4. Moderate/severe dependence w complex need 12 month care coordination, IP detox, structured comm programme, pharm, treatment of comorbidity, res rehab (0. Hazardous drinkers brief intervention)

36 Conclusions Treatment tailored to need Significant changes needed in organisation and delivery of care Some recommendations will be easier to implement than others Significant training implications for whole NHS workforce Some recommendations will reqiure additional investment Impact will be crucially dependent on funding and commissioning (which is currently in transition), and uptake by practitioners

37 Find out more Visit for: the full guideline the quick reference guide Understanding NICE guidance costing report and template audit support baseline assessment tool sample chlordiazepoxide dosing regimens

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