Best Practice for Smoking Cessation: Pharmacotherapy. Emma Dean Acting Population Health and Health Promotion Coordinator Lead Pharmacist- Smokefree

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Best Practice for Smoking Cessation: Pharmacotherapy Emma Dean Acting Population Health and Health Promotion Coordinator Lead Pharmacist- Smokefree

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 Short half-life (average 2 hours) In some individuals as short as 20-40minutes What it does: Dependence, short term relief of anxiety and low mood, increased arousal and concentration Minor haemodynamic effects: increased HR, transient increase in BP What it doesn t do: Not classed as carcinogen by IARC Does not cause cardiovascular disease Does not cause lung damage Plays a small role in human disease- people smoke for nicotine, but die from smoke

http://www.tobaccofreedom.org/issues/addiction/index.html

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

Nicotine withdrawal syndrome Symptoms begin within hours of quitting Duration and severity of symptoms are highly variable among individuals Generally worst in first 24-48 hours Symptoms are usually alleviated in 2-4 weeks Dizziness, insomnia, restlessness, difficulty concentrating, irritability, increase appetite, mood changes

Other mechanisms underlying smoking Psychological connection smoking is related to how clients feel, their moods and emotions commonly draw a connection between smoking and stress relief, feelings of comfort and relaxation Behavioural connections behaviours that are closely linked to their smoking connections tend to be strong and have built up over many years

Okay so what can we do?

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. Physician advice for smoking cessation. Cochrane Database of Systematic Reviews 2013, Issue 5. Art. No.: CD000165.

Best practice for smoking cessation 3%- 5% people who smoke, successfully quit cold turkey 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

Pharmacotherapy Nicotine replacement therapy (NRT) Transdermal- patches Intermittent- lozenges, mouthspray, gum and inhalator Bupropion (Zyban ) Varenicline (Champix )

Nicotine replacement therapy Increases quit rates by 50-70% compared to placebo Reduces cravings and minimises withdrawal symptoms Safety and efficacy profile Does not produce dramatic surges in blood levels Minimal addictive potential No serious side effects, usually minor and formulation related Best result = NRT (minimum 8/52) + behavioural advice + follow up No evidence for weaning the patch Stead 2012

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 (long acting and slow onset) to control baseline cravings Intermittent: Quicker and more flexible relief If possible use in anticipation of smoking trigger Adverse effect profile similar to mono-therapy

Nicotine patch Slow skin absorption takes several hours to reach steady state (depends on brand) If removed overnight, substantial nicotine levels are reached within 3 hours after a new patch is applied Fant 2000 Produces relatively constant withdrawal relief over 24 hours Can be started 2 weeks before setting quit date - increases quit rates by 35% (compared to traditional quit day application) Continue to use patch after a lapse- 4-5 times more likely to be abstinent at end of treatment period Mendelsohn 2013

Nicotine patch Apply to clean, hairless skin Hold firmly in place for 20 seconds after application to assist adhesion Swimming & showering ok after an hour Tape around edges if lifting Rotate patch around body Sleep disturbance (vivid dreaming) common if disrupting daily activities, put patch on in AM and remove PM, could try lower dose patch; does decrease over time; consider caffeine reduction < 10% have skin irritation (usually due to adhesive) cortisone cream may be helpful Different brands have different properties and deliver blood nicotine levels about half as those from smoking

Nicotine gum Nicotine is readily absorbed from oral mucosa membranes Two strengths- 2mg & 4mg gum Best to start immediately upon waking Use liberally (no greater than 1 piece/hour) Chew and park method chew every 2 seconds for approximately 30minutes Adverse effects- nausea, hiccups, bloating

Nicotine lozenge Nicotine is readily absorbed from oral mucosa membranes Strengths 2mg & 4mg lozenge (Nicorette Cooldrops ) 1.5mg & 4mg mini lozenge (Nicabate Mini lozenges ) Use liberally to suppress cravings/urges to smoke Lozenge should be placed in the mouth and moved from one side to the other until completely dissolved Should not be chewed, sucked or swallowed whole Adverse effects- hiccups, nausea, flatulence & sensitive mouth

Nicotine inhalator Nicotine is readily absorbed from oral mucosa membranes Strength- 15mg/cartridge When used as a cigarette, taking 8 times as many puffs as when smoking, delivers about 1 mg of nicotine A cartridge will deliver the same amount of nicotine (1 mg), at a uniform release rate, for the first seven consecutive uses Designed to combine pharmacological and behavioural substitution (hand to mouth ritual) Patients can self-titrate to the level of nicotine they require to relieve cravings Adverse effects- hiccups, sore throat, heartburn

Nicotine spray Nicotine is absorbed through oral mucosa membranes Oral spray form means that nicotine is administered instantaneously Strength- 1mg/dose (150 doses per device) Use liberally to suppress cravings/urges to smoke Priming is needed for first time use and if not used greater than 2 days Adverse effects- nausea, mouth irritation, taste disturbances, hiccups, indigestion

Troubleshooting Misconceptions can lead to inadequate dose Side effects of NRT can be nicotine withdrawal (or incorrect use) Common to underdose on NRT (overdosing is rare) Nicotine from all the intermittent products is absorbed through the buccal mucosa concurrent eating an drinking should be discouraged. Being nil oral is not a contraindication; avoid gum pre-op as can increase intra-gastric volumes.

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

The rate of neuro-psychiatric adverse events (AEs) was similar (not significantly different) across the four treatment groups (i.e. no indication that varenicline or bupropion are associated with these AEs anymore than nicotine patch or placebo) More AEs in the psychiatric cohort compared with the non-psychiatric cohort (i.e. people with mental illness were more likely to experience AEs, regardless of which medicine they were using)

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

Emma Dean Acting Population Health and Health Promotion Coordinator Lead Pharmacist- Smokefree e.dean@alfred.org.au