1. Practical Smoking Cessation Allan Prochazka, M.D., M.Sc. Denver VAMC

2. Outline 5 A’s Approach 5 A’s Approach –Ask –Advise –Assess –Assist –Arrange

3. AHQR Guidelines Released 6/00 Released 6/00 Based on review of > 3,000 studies Based on review of > 3,000 studies Nearly all are RCT’s Nearly all are RCT’s Probably the most evidence-based guideline in medicine Probably the most evidence-based guideline in medicine Resulted in the 5A’s approach Resulted in the 5A’s approach

4. Ask Ask all patients at each visit whether they smoke Ask all patients at each visit whether they smoke Why every visit? Why every visit? –Relapse among ex-smokers occurs even years after quitting Makes smoking salient for patients and providers Makes smoking salient for patients and providers Triggers quit attempts by patients and advice/interventions by providers Triggers quit attempts by patients and advice/interventions by providers

5. Implementation Electronic records Electronic records –VA is all electronic, reminders are automatically triggered, documentation of smoking status and advice is a performance measure for the hospital director Paper System Paper System »Decide who will be responsible and how one will track compliance

6. Advise Strongest data are for physician advice Strongest data are for physician advice –Other clinicians also likely to be effective Ideal to have a consistent approach across providers to reinforce the message Ideal to have a consistent approach across providers to reinforce the message –Patients will receive advice from multiple sources

7. Simple, direct message Simple, direct message –‘I’m your (doctor, nurse, therapist, health educator…) and the best thing you can do for your health is to quit smoking’ Avoid equivocation Avoid equivocation –‘You might want to think about someday perhaps considering quitting smoking’

8. Increasing Advice Effectiveness Link to patient’s health Link to patient’s health –Make the connection to other health problems »Asthma/Bronchitis/Emphysema »Heart disease »Reflux, ulcers »Skin changes »Vision—macular degeneration »Diabetes—accelerating effect of smoking on renal dysfunction, cardiovascular effects »Peripheral Vascular Disease

9. Use Ancillary Testing to Enhance Motivation to Quit –Pulmonary function testing and lung age »Portable units have greatly increased test quality »$500 - $1500, can be billed –Expired carbon monoxide testing »Instant feedback »No teaching required on meaning of CO »Low initial costs ($500-800)

10. Assess Identify willingness to quit Identify willingness to quit –Do you want to quit smoking? –If yes, when do you want to quit? »If ready now, then provide assistance on quitting at this visit and deal with other problems at the next visit »If not ready, then work on motivation and on barriers

11. Assess Identify Tobacco Dependence Identify Tobacco Dependence –DSM IV R criteria »Withdrawal with cessation »Smoking in the face of medical illness –Fagerstrom »How soon after awakening do you smoke your first cigarette? »If < 5 minutes, then highly dependent

12. Why bother with dependence? Why bother with dependence? –Reminder to providers –Identifies those who surely need more than advice –Reminder to patients when the diagnosis is shared with them

13. Increasing Motivation Relevance Relevance Risks Risks Rewards Rewards Roadblocks Roadblocks Repetition Repetition

14. Relevance Relevance –Personalize the effects of smoking –Consider influence on family members (e.g. parents smoking aggravating child’s asthma) Risks Risks –Generic risks are not as influential as personal risk –Short term risks are more salient than long term risks, especially for young people –Risks without benefits, sometimes lead to paralysis, so emphasize the improvements that are possible

15. Rewards Personal Personal –Taste/smell improve –Clothes, home, breath smell better Health Health –Improvement in current medical conditions –Avoidance of complications Economic Economic –Out of pocket costs of smoking can be significant expense for those on fixed income Social Social –Example for children –Self-control, mastery

16. Roadblocks Weight gain Weight gain Fear of failure Fear of failure Withdrawal symptoms Withdrawal symptoms Lack of support from family/friends Lack of support from family/friends ‘The only thing I have left is smoking’ ‘The only thing I have left is smoking’

17. Repetition Key point is that messages need to be repeated over time Key point is that messages need to be repeated over time A person may not be ready to take action today, that doesn’t mean he/she won’t be ready next week, next month or next year A person may not be ready to take action today, that doesn’t mean he/she won’t be ready next week, next month or next year Smokers also need to know that relapse after a quit attempt is normal, most will need several solid efforts to be successful Smokers also need to know that relapse after a quit attempt is normal, most will need several solid efforts to be successful

18. Assist Behavioral Behavioral Drug Therapy Drug Therapy Smokers wanting to quit need both Smokers wanting to quit need both Dose of each one can be tailored to the patient’s needs Dose of each one can be tailored to the patient’s needs

19. Behavioral Key element is time with patient and empathic counselor Key element is time with patient and empathic counselor More time, more benefit, but get results even with small investments More time, more benefit, but get results even with small investments Goals Goals –Set a quit date –Tell family, friends, coworkers –Make the home smoke free, start acting like a non- smoker –Identify barriers to cessation

20. Goal: total abstinence after quit day Goal: total abstinence after quit day Review prior quit attempts, learn from them Review prior quit attempts, learn from them Anticipate triggers and challenges Anticipate triggers and challenges Encourage others in the home to quit Encourage others in the home to quit Provide options Provide options –Referral –Quitline –Self-help materials

21. Drug Therapy Nicotine Replacement Therapy (NRT) Nicotine Replacement Therapy (NRT) –Nicotine Gum –Nicotine Patch –Nicotine Nasal Spray –Nicotine Inhaler –Nicotine Lozenge Non-Nicotine Therapy Non-Nicotine Therapy –Bupropion (Zyban)

22. NRT Overall success rate comparable among the products Overall success rate comparable among the products Doubles the quit rate over advice alone Doubles the quit rate over advice alone –(e.g. 5-8% to 10-15%) Selection based on side effects, patient preference, insurance coverage Selection based on side effects, patient preference, insurance coverage PDR duration of therapy 8-12 weeks PDR duration of therapy 8-12 weeks Selected patients need longer therapy or higher doses Selected patients need longer therapy or higher doses

23. Nicotine Gum 2 forms (2 mg and 4mg), 4 mg best for most smokers 2 forms (2 mg and 4mg), 4 mg best for most smokers Available OTC and in Generic forms Available OTC and in Generic forms Absorption is buccal, so park and chew Absorption is buccal, so park and chew Regular dosing better than ad lib Regular dosing better than ad lib Typical patient will use 5-8 pieces per day Typical patient will use 5-8 pieces per day Cost $35-50 for 108 pieces Cost $35-50 for 108 pieces

24. Side Effects Side Effects –Dental trauma, jaw pain, nausea, upset stomach Duration of Use Duration of Use –8-12 weeks –2-5% have trouble quitting gum –Long term use combined with behavioral therapy (up to 5 years) safe and effective, 25% validated quit rate in Lung Health Study

25. Transdermal Nicotine 3 strengths (21, 14, 7 mg/24hr) 3 strengths (21, 14, 7 mg/24hr) Some patients require higher doses (e.g. very heavy smokers), but for typical pack a day smoker 21mg is the starting dose Some patients require higher doses (e.g. very heavy smokers), but for typical pack a day smoker 21mg is the starting dose 4-6 weeks on 21 mg, 2-4 weeks on 14 mg, then 2-4 weeks on 7 mg 4-6 weeks on 21 mg, 2-4 weeks on 14 mg, then 2-4 weeks on 7 mg Costs $35-50 per 14 day supply Costs $35-50 per 14 day supply

26. Side Effects Side Effects –Skin irritation (30%) –Skin allergy (1-4%) –Poor sleep/nightmares (10%) –Arm pain (2-4%)

27. Nasal Nicotine Spray Very rapid absorption of nicotine Very rapid absorption of nicotine Dosing 0.5 mg per spray, one spray in each nostril is one dose (about the amount of nicotine in one cigarette) Dosing 0.5 mg per spray, one spray in each nostril is one dose (about the amount of nicotine in one cigarette) Typical patient uses 3-6 doses per day Typical patient uses 3-6 doses per day Side Effects: mostly irritation, face pain, perhaps more likely to result in difficulty stopping use due to fast absorption Side Effects: mostly irritation, face pain, perhaps more likely to result in difficulty stopping use due to fast absorption Costs $46.99 per 10 ml vial (100 doses) Costs $46.99 per 10 ml vial (100 doses)

28. Nicotine Inhaler Each cartridge 10 mg nicotine, 4 mg released, 2 mg absorbed Each cartridge 10 mg nicotine, 4 mg released, 2 mg absorbed Best with continuous puffing (80 deep inhalations over 20 minutes give 2 mg nicotine) Best with continuous puffing (80 deep inhalations over 20 minutes give 2 mg nicotine) Dosage 6-16 cartridges per day Dosage 6-16 cartridges per day Side Effects: mouth/nose irritation Side Effects: mouth/nose irritation Costs $51.69 per 42 cartridges Costs $51.69 per 42 cartridges

29. Nicotine Lozenge Approved 11/02 Approved 11/02 Available OTC, 2 mg and 4 mg Available OTC, 2 mg and 4 mg Allow lozenge to slowly dissolve, no chewing or swallowing of the lozenge—need to be careful not to develop too much saliva Allow lozenge to slowly dissolve, no chewing or swallowing of the lozenge—need to be careful not to develop too much saliva 20-30 minutes per lozenge 20-30 minutes per lozenge Dose 20 max per day Dose 20 max per day Side effects: hiccups, nausea, stomach upset, palpitations Side effects: hiccups, nausea, stomach upset, palpitations Cost $42.00 for box of 72 lozenges Cost $42.00 for box of 72 lozenges

30. Non-Nicotine Therapy Bupropion (Zyban) Bupropion (Zyban) Antidepressant, works in normal, non- depressed smokers Antidepressant, works in normal, non- depressed smokers Slower onset of action (7-10 days) Slower onset of action (7-10 days) Dosage: 150 mg a day for 3 days, then 150 mg bid, but not much difference in effectiveness between 150 and 300 mg /day Dosage: 150 mg a day for 3 days, then 150 mg bid, but not much difference in effectiveness between 150 and 300 mg /day Duration: 3 months, but longer term therapy is safe and effective Duration: 3 months, but longer term therapy is safe and effective

31. Costs VA $53 for one month Costs VA $53 for one month Side Effects Side Effects –Common »Shaky,tremor »Headache »Dry mouth –Rare but serious »Seizures »Avoid in those with epilepsy, active drug use, concomitant psychiatric medications, bulemia, MAOI use

32. Combined with NRT Combined with NRT –Borderline significance, but 9% better with patch combined with bupropion Very useful in healthy populations (e.g. worksite) and in those with active cardiac disease Very useful in healthy populations (e.g. worksite) and in those with active cardiac disease Hard to use in populations with lots of psychiatric comorbidity/substance abuse due to risk of seizures, precipitation of mania and need to add to already complex drug regimens Hard to use in populations with lots of psychiatric comorbidity/substance abuse due to risk of seizures, precipitation of mania and need to add to already complex drug regimens May be better in those with a depressive tendency May be better in those with a depressive tendency Less weight gain than with patch Less weight gain than with patch

33. Has been tested in several populations including patients with COPD, African Americans; effect appears to be robust Has been tested in several populations including patients with COPD, African Americans; effect appears to be robust Bottom Line: very useful agent for many populations Bottom Line: very useful agent for many populations

34. Arrange Followup greatly enhances cessation results Followup greatly enhances cessation results Can be in person or on the telephone Can be in person or on the telephone Linkage to Quitline in Colorado and other states may allow more intensive followup that would usually be available in primary care settings Linkage to Quitline in Colorado and other states may allow more intensive followup that would usually be available in primary care settings

35. Congratulate on success Congratulate on success Review lapses Review lapses Emphasize total abstinence Emphasize total abstinence Review drug therapy Review drug therapy Consider referral if needed Consider referral if needed

36. Cost Effectiveness $ per QALY No NRT NRT Brief31812120 Individual Intensive 18221455 Group Intensive 11081171

37. Conclusions Implement the 5A’s Implement the 5A’s Use combined drug and behavioral approaches Use combined drug and behavioral approaches Select drugs based on patient preference and associated medical conditions Select drugs based on patient preference and associated medical conditions Followup and allow patients to recycle Followup and allow patients to recycle Make a long term commitment Make a long term commitment