Butt in to Butt Out- Pharmacist led clinical model for managing nicotine dependency Emma Dean Acting Population Health and Health Promotion Coordinator Alfred Health Wednesday 30 th May 2018
2 Disclosures In relation to this presentation, I declare the following, real or perceived conflicts of interest: None
3 Learning objectives At the end of the session, participants will be able to: Identify the role of hospital pharmacists in managing nicotine dependency and encouraging smoking cessation Describe the impact of providing a brief intervention for smoking cessation Understand the characteristics of nicotine Recognise the key factors contributing to why people smoke including nicotine dependence Describe best practice use of pharmacotherapy for managing nicotine dependency and assisting smoking cessation Identify and manage drug interactions associated with smoking cessation
2008
Our transition to Totally Smokefree May 2008 Rapid transition within three months Objectives: To reduce exposure to passive smoke To demonstrate public leadership Actions: Policy change Communication strategies Signage Impact: High awareness Mixed compliance Unchanged clinical practice
A problem - A legal challenge
A new approach- May 2012 Refresh and relaunch Objectives: To reduce exposure to passive smoke To demonstrate public leadership To facilitate smoking cessation (and manage temporary abstinence) To denomalise smoking (prevent uptake and reduce the risk of relapse) Actions: Refreshed communication strategies Clinical management of nicotine dependency clinical guideline Education Impact: High awareness Increased compliance (but less of a focus on compliance!) Achievement of best practice clinical management Reduced smoking around campus perimeter
Totally Smokefree at The Alfred Video Click below to view https://www.alfredhealth.org.au/about/healthy-communities/smokefree-environment
Clinical Leadership Clearly defined clinical leadership Everyone s responsibility can be no one s responsibility Integrated within existing practice Without major resource injection Systematic Every person Every time Especially in those areas with greatest challenges Measure performance Normalise practice Emotionally compel health professionals (starttheconversation.org.au)
Clinical management of nicotine dependency Clinical leadership by pharmacy Pharmacist initiation of NRT Supported by nurse initiated NRT Within agreed treatment algorithm All forms of NRT available DTC approval Following discharge Global supply through ward imprests
Support for inpatients
Support for Patients Video Click below to view https://www.alfredhealth.org.au/about/healthy-communities/smokefree-environment/smoking-supportfor-patients
Prior to planned admissions
Smokefree outpatient clinic
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Why is it so hard to quit? People who smoke aren t weak nor are they simply making a bad lifestyle choice. Smoking is a complex process made up of: Nicotine dependence Behavioural connections Psychological connections
Nicotine Dependence Chronic medical condition with multiple cycles of relapse and remission Relapsed smokers need to be re-engaged and assisted through repeated quit attempts Under recognised by health professionals Assessment is important Time to first cigarette a reliable indicator
Positive Reinforcement Increase in dopamine Relief of Withdrawal Symptoms Binds to nach receptors nicotine Negative Reinforcement
Nicotine- Elimination Short half-life (around 2 hours) Affects the rate at which a smoker must replenish or top up their nicotine Nicotine is rapidly and extensively metabolised (90%) by the liver Primarily CYP2A6 to cotinine Also glucoronidation UGT1A4 Rate of nicotine metabolism is faster in women than men Rate of nicotine metabolism is faster in women taking OCP and even faster in pregnancy Slow metabolisers have lower nicotine dependence, smoke fewer cigarettes, respond better to NRT and are able to quit more easily. Considerable genetic polymorphism in CYP and UGT activity CYP2A6 gene variations can vary by four fold Wide individual variability in rate of metabolism
Nicotine withdrawal syndrome Symptoms begin within hours of quitting Dizziness, insomnia, restlessness, difficulty concentrating, irritability, increase appetite, mood changes Duration and severity of symptoms are highly variable among individuals Generally worst in first 24-48 hours Nicotine withdrawal symptoms are usually alleviated in 2-4 weeks
Other mechanisms underlying smoking Behavioural connections Behaviours closely linked to smoking Connections tend to be strong and have built up over many years E.g. drinking caffeinated or alcoholic beverages, taking a break at home or work, watching television, finishing a meal, talking on the phone Psychological connections Smoking is related to how they feel, their moods and emotions Commonly draw a connection between smoking and stress relief
Okay so what can we do?
Best practice for smoking cessation Interventions that combine pharmacotherapy and behavioural support increase smoking cessation success in a wide range of settings and populations Need to encourage people who smoke to use both pharmacotherapy and behavioural support
Importance of brief intervention Brief advice from a healthcare professional prompts people to quit NNT 1 in 33 Increases long-term abstinence rates by 1-3 percentage points (above unassisted quit rates, which are around 2-3%) Stead et al. 2013
Health professional advice is the greatest trigger Health Prof advice Something said by family/friends Someone else stopping Smoking restrictions NRT ad Gov ad Health warning Just decided New treatment Source: www.rjwest.co.uk- Smoking Toolkit Study 0 5 10 15 20 25 Percent
% of smokers Stage of change does not matter 100 90 80 89 70 60 % of total 50 40 30 20 10 0 52 27 11 Ready to quit 37 24 Not ready to quit Accepted treatment Abstinent at end of treatment (17 weeks) Pisinger et al. 2005
And it s the offer of support that s important Source: www.rjwest.co.uk- Smoking Toolkit Study
Not advising may be worse than useless Source: www.rjwest.co.uk- Smoking Toolkit Study
Pharmacotherapy Nicotine replacement therapy (NRT) Bupropion (Zyban ) Varenicline (Champix )
Nicotine replacement therapy Reduces motivation to smoke and the severity of withdrawal symptoms Six forms of NRT available in Australia Transdermal- patches Intermittent- gum, lozenge, mini-lozenge, mouthspray, inhalator Efficacy profile Increases quit rates by 50-70% compared to unassisted quitting (Stead et al. 2012) Safety profile Minimal addictive potential (Zwar et al. 2006) No serious side effects, usually minor and formulation related Does not produce dramatic surges in blood levels Best result = NRT (minimum 8/52) + behavioural advice + follow up (Stead et al. 2012) There are few contraindications associated with NRT use No evidence for weaning/tapering dose
Plasma nicotine (ng/ml) Plasma nicotine levels- single dose 25 20 Cigarette 15 Spray 10 Gum/Inhalator/Lozenge 5 0 10 20 30 40 50 60 Time (minutes) Patch Royal College of Physicians 2000
Combination Therapy Patch + Intermittent Patch: Steady protection Intermittent: Quicker and more flexible relief If possible use in anticipation of smoking trigger Adverse effect profile similar to mono-therapy Stead, 2012
35 Combination Therapy Combining the nicotine transdermal patch with an intermittent form of NRT has been shown to increase quit rates by 34-54% compared to patch alone (Stead et al. 2012) Shah et al. 2008- systematic review- five clinical trials of various smoking cessation regimens Combination therapy was significantly more effective than monotherapy in all pooled comparisons- the aggregated relative risk of abstinence was 1.42 (95% CI 1.21 1.67), 1.54 (95% CI 1.19 2.00), and 1.58 (95% CI 1.25 1.99) at 3, 6, and 12 months, respectively Included people who smoke < one pack/day- able to tolerate combination therapy without significant adverse effects
36 Higher doses Adding a second patch produce modest increase in quit rate, 14% (Stead et al. 2012) Carpenter et al. 2013 showed mixed evidence of higher doses of patch (up to 44mg) being superior (however these studies included smokers with higher dependence, perhaps diminishing the cessation outcomes)
37 Longer durations Schnoll et al. 2010- nicotine patches for 30 weeks (extended) compared to standard 8 weeks Week 24- point prevalence abstinence was two times greater for extended vs. standard Week 52- prolonged abstinence 29.1% vs 21.3% p=0.027 Rate of relapse also longer in extended treatment arm Schnoll et al. 2015- nicotine patches for 52 weeks (extended), 24 weeks (maintenance), 8 weeks (standard) Significantly greater abstinence at 24 weeks compared to standard treatment (OR 1.70 p=0.04) Longer duration of abstinence to relapse (mean 72 days vs 89 p<0.001), Reported smoking fewer cigarettes per day if not abstinent (mean 5.8 vs 6.4 p=0.02) Reported more abstinent days (mean 80.5 vs 68.2 days p=0.02)
38 Using NRT to reduce cigarette consumption Bollinger et al. 2000 & 2002- randomised smokers to nicotine 10mg inhaler or placebo for up to 18months Effectively and safely achieved sustained reduction in smoking over 24 months (reduced CO) Reduction by 50% positive influence on cardiovascular risk markers and QOL Well tolerated, mild adverse effects (Batra et al. 2005) Opportunity to engage a broader population of people who smoke Positive influence on development of motivation to quit
39 NRT use prior to quit date Shown to increase quit rates over and above the traditional quit date application by 35% (Stead et al. 2012) Self-efficacy is increased as increases confidence that NRT can assist in minimising withdrawal symptoms
Specific patient groups or settings Adolescents All formulations of NRT can be safely used by people aged over 12 years Limited efficacy data using alone- comprehensive counselling support essential (Fiore et al. 2008) Cardiovascular NRT can be recommended to people with stable cardiovascular disease There is also a growing body of evidence for the safety of NRT in smokers with acute coronary syndrome (can be considered under medical supervision) (Pipe et al. 2011, Fihh et al. 2012, Redi et al. 2011)
Specific patient groups or settings Pregnancy NRT may be considered in pregnant women who have failed to quit smoking using non-pharmacological strategies Use the lowest effective dose of NRT, and where possible intermittent formulations are preferred (Oncken et al. 2008) Breastfeeding NRT may be considered in breast feeding women who have failed to quit smoking using non-pharmacological strategies Use the lowest effective dose of NRT, and where possible intermittent formulations are preferred (Einarson et al. 2009)
Barriers to effective use of NRT in clinical practice Misguided concerns about safety and efficacy undermine the use of NRT Both health professionals and consumers Need to be addressed proactively with accurate information Evidence that NRT products are frequently used incorrectly, sub-optimally, or not al all (Shiffman et al. 2008) Consumer medication information leaflets Incorrect or no health professional advice Compliance is poor, especially in pregnancy (Coleman et al. 2011) Dose Duration of treatment If smokers are addressed with scientific information, approximately half of misinformed smokers say they would be more likely to use NRT as part of a quit attempt (Ferguson et al 2011).
How to boost patient compliance Concerns about safety NRT is always safer than smoking Safety profile- does not cause cancer, lung disease, cardiovascular disease Concerns about the addictiveness of NRT Minimal addictive potential Lack of confidence in efficacy Proven effective (significant increases chances of quitting); minimises nicotine withdrawal symptoms Not using enough More effective when dose titrated according to response Stopping NRT too early Needs to be taken for long enough to start to address other drivers of smoking Best not to cease until patient can resist cravings in situations
How to boost patient compliance. NRT is not working May require increased dose (combination therapy, more doses of intermittent, second patch) Are the products being used correctly/ Consider change to varenicline Side effects Decrease over time Are the products being used correctly? Cost NRT cost vs. cigarettes (and ongoing smoking- financial & health)
Varenicline (Champix)
Varenicline- Troubleshooting Nausea Always take with food Increase fluid intake, 10 glasses water /day if clinically appropriate Insomnia bring evening dose forward Renal impairment reduced dose 1mg per day If not tolerating for any reason consider reduced dose
EAGLES Study 8058 Treatment-seeking smokers History of psychiatric disorders (N=4074) Without a history of psychiatric disorders (N=3984) Primary affective disorders (70%), anxiety disorders (19%), psychotic disorders (9.5%), personality disorders (0.6% Randomly allocated to one of four treatment arms varenicline (1 mg twice daily) bupropion SR (150 mg twice daily), transdermal nicotine patch (21 mg with taper) placebo Anthenelli et al. 2016 Lancet 387 (10037): 2507-20
No significantly increased neuropsychiatric (NPS) safety risk attributable to varenicline or bupropion relative to nicotine patch or placebo. Anthenelli RM, et al. Lancet 2016.
Varenicline and cardiovascular safety Meta-analysis (Prochaska JJ & Hilton JF, 2012) found no significant increased risk of CV events. Varenicline also safe and effective in smokers with stable CVD (Rigotti et al. 2010). EAGLES extension trial (CV safety) (Benowitz et al. 2018) No evidence that pharmacotherapy increases the risk of serious CVD or CV adverse events in general smokers Excluded those with acute or unstable CVD
Drug Interactions Many interactions identified; varying clinical significance Chemicals in tobacco smoke can interact by two mechanisms Pharmacokinetic- usually poly-carbons not nicotine stimulation of hepatic enzymes antipsychotics (clozapine, olanzapine), warfarin & caffeine Pharmacodynamic- largely due to nicotine alter the expected response or actions of other drugs beta-blockers, insulin Dose adjustments may be required and based on clinical presentation and according to medical review
52 Conclusion People who smoke are expecting you to have a conversation with them about smoking Pharmacists have a pivotal role A brief intervention should be provided to all people who smoke regardless of their readiness to quit Best practice= pharmacotherapy PLUS behavioural support Combination therapy increases quit rates compared to patch only Cigarette smoking (and quitting) can affect medication levels via pharmacokinetic and pharmacodynamics interactions
Emma Dean Acting Population Health and Health Coordinator Lead Pharmacist- Smokefree e.dean@alfred.org.au www.starttheconversation.org.au
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