1. Substance Abuse and Public Health Tobacco Control: Still the Number One Public Health Crisis Edward Anselm, M.D. Chief Medical Officer, Health Republic Insurance of New Jersey Assistant Professor of Medicine, Icahn School of Medicine at Mount Sinai eanselm@msn.com

2. Suggested reading  1. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. 2014 http://www.surgeongeneral.gov/library/reports/50-years-of-progress/exec-summary.pdf  2. USPSTF Tobacco Smoking Cessation in Adults and Pregnant Women: Behavioral and Pharmacotherapy Interventions: Evidence Summary http://www.uspreventiveservicestaskforce.org/Page/Document/behavioral-counseling-and- pharmacotherapy-interventions-for-/tobacco-use-in-adults-and-pregnant-women-counseling-and- interventions1 http://actiontoquit.org/wp-content/uploads/2015/09/PSTF-tobacco-fact-sheet-9-23-15.pdf  3. E-Cigs' Inconvenient Truth: It's Much Safer to Vape. Rolling Stone December 21 2015 http://www.rollingstone.com/politics/news/e-cigs-inconvenient-truth-its-much-safer-to-vape- 20151221?page=2

4. Trends in tobacco use  Adult smoking  Adolescent smoking  E-cigarette use  Demographic changes in tobacco use

5. CDC: Cigarette Smoking in the United States  http://www.cdc.gov/tobacco/campaig n/tips/resources/data/cigarette- smoking-in-united-states.html http://www.cdc.gov/tobacco/campaig n/tips/resources/data/cigarette- smoking-in-united-states.html  The percentage of U.S. adults who smoke cigarettes declined from 20.9% in 2005 to 16.8% in 2014. Among daily cigarette smokers, declines were observed in the percentage who smoked 20–29 cigarettes per day (from 34.9% to 27.4%) or ≥30 cigarettes per day (from 12.7% to 6.9%).

6. The decline in adult cigarette smoking has stalled Civilian, non-institutionalized adults, aged 18 years of age and over, who currently smoked cigarettes. Source: National Health Interview Surveys, 1965-2009.

7. Smoking Prevalence and Income 1997 to 2012: Overall smoking declined from 24.7% to 20.0%

8. Smoking Proves Hard to Shake Among the Poor New York Times March 25, 2014

9. LGBT  Studies consistently show LGBT smoking prevalence is 35 ‐ 200% higher than the general population.  New general population data show LGBT people smoke cigarettes at rates 68% higher than other groups  60% of poor lesbians of color in the Bronx were current smokers.

10. Smoking and Mental Illness National Survey of Drug Use and Mental Health 2009 to 2011; Adults over 18 Overall prevalence of smoking21.4% Prevalence of Any Mental Illness19.9% Prevalence of smoking among people w AMI 36.1%  AMI was highest among men, adults aged <45 years, and those living below the poverty level;  Smoking prevalence was lowest among college graduates.  During 2009–2011, adults with AMI smoked 30.9% of all cigarettes smoked by Adults. MMWR / February 8, 2013 / Vol. 62 / No. 5

11. JAMA 2000 Nov 22-29; 284 (20): 2606-10 Smoking and Mental Illness

22. A Brief History of Tobacco Control I  Early warnings 1948  First Surgeon General’s Report 1964  Fairness Doctrine 1967-1970  Removal of Tobacco advertisement from television and radio 1970  Tobacco Warning labels  Role of the Tobacco Institute  Marketing of light cigarettes

23. A Brief History of Tobacco Control II  Indoor pollution control 1987  First Clinical Practice Guideline on smoking cessation 1996  Master Settlement Agreement, 1998  Media-based interventions  Medications for smoking cessation  Telephonic quit lines

24. A Brief History of Tobacco Control III  Local and state interventions CDC documents best practices, 1999 sets funding targets @$15-20 per capita, 2007  FDA Regulation of nicotine, 2009  PPACA, 2009 Coverage for smoking cessation  Electronic Cigarettes  Harm reduction

25. Cost of a pack of cigarettes: NYS $10.25 PacksNumber ofCost per dayper monthper year percigarettes dayper day 0.510 $ 5.13 $153.75 $ 1,870.63 120 $10.25 $307.50 $ 3,741.25 1.530 $15.38 $461.25 $ 5,611.88 240 $20.50 $615.00 $ 7,482.50 360 $30.75 $922.50 $11,223.75

26. Evidence-based tobacco control  Taxes  Smoke-free environments  Counter-advertising  Smoking cessation  Systems Changes to Support Provider Interventions

27. Systems Changes to Support Provider Interventions  Implement a tobacco-user identification system in every clinic  Provide education, resources, and feedback to promote provider intervention  Dedicate staff to provide tobacco dependence treatment and assess the delivery of this treatment in staff performance evaluations  Promote hospital/clinic policies that support tobacco dependence treatment (e.g., make “Ask/Assist” a standard of care, smokefree grounds, discharge referral protocol in hospitals) 2008 Clinical Practice Guideline: Treating Tobacco Use and Dependence

28. Reimbursement for Smoking Cessation Interventions  Medicare  Medicaid  Commercial  Affordable Care Act  Outline for Practice Transformation and other tools on the New York State Smokers Quitline/Provider Page http://www.nysmokefree.com/Subpage.aspx?P=0&P1=70

29. Barriers to implementation of tobacco control interventions  Money  Politics  Lack of self-efficacy  Bias  Minimal reimbursment

31. Effectiveness of Medications Odds ratioAbstinence Placebo1.013.8 Varenicline3.133.2 Nicotine nasal spray2.326.7 Nicotine patch2.326.6 Nicotine gum2.226.1 Nicotine inhaler2.124.8 Bupropion SR2.024.2 Nicotine lozenge 2 mg 4 mg 2.0 2.8 24.2/14.2* 23.6/10.2

32. Addictive elements of smoking  Nicotine Nicotine mediated dopamine release  Menthol and other anesthetics  Mono-amine oxidase inhibitors  Sensory cues Oro-pharygeal Tactile  Brand identification and loyalty  Flavorings (honey, licorice, cocoa)  Physiologic

33. Nicotine Dependency First cigarette within 30 minutes of awakening. Smoke more within the first few hours of awakening than the rest of the day Smoke when sick in bed Smoke in places where prohibited One or more pack per day Can be quantified through use of Fagerstrom Index 2013 ICD-9-CM Diagnosis Code 305.1 Tobacco use disorder tobacco used to the detriment of a person's health or social functioning; tobacco dependence is included. Excessive use of tobacco products. ICD-9-CM 305.1 is a billable medical code that can be used to specify a diagnosis on a reimbursement claim.

36. Nicotine Withdrawal Anxiety irritability anger restlessness difficulty concentrating craving

37. The Behavior of Smoking I Early Experimentation Brand Identification Regular Smokers Chippers Light Smokers Heavy Smokers Interest in quitting

38. The Behavior of Smoking II Nicotine delivery in eight seconds Most smokers maintain a steady level of nicotine 10-12 puffs per cigarette 20 cigarettes per day (200 puffs) 7300 cigarettes per year (73,000 puffs)

39. The Behavior of Smoking III Oft repeated habit Social situations Stress management Associated with food, alcohol Low awareness of risk Fear of failure

40. Tobacco Use and Mental Health  Nicotine and self medication  Episodic mood management  Depression  Depression in Patients with Co-morbid Illness  Substance abuse  Anxiety Disorders  OCD, ADD  Schizophrenia

41. Self Medication  Nicotine; MAO I Conditioned relaxation  Withdrawal Symptoms Craving Dysphoria  Situational mood modulation Triggers for relapse  Chronic mood modulation

42. What is being self-medicated?  The role of antidepressants in smoking cessation: Bupropion, Nortryptiline  Weight gain after discontinuation of nicotine or bupropion therapy  Improved cognition for people with schizophrenia, ADDHD, and OCD

44. The Natural History of Smoking Cessation in the United States 50 Million former smokers 5-8 efforts to quit smoking each effort resulted in longer periods of abstinence from smoking process over several years

45. Smoking Cessation and Weight Gain Smokers weigh less than non-smokers 5-10 pound gain, on average Less initial weight gain with use of medication (nicotine patch or buproprion, but not other medications)

46. Electronic Nicotine Delivery Systems: E-Cigarettes  Regulatory Perspectives Variation in products and their nicotine delivery Safety to vapers Safety to bystanders Use by children; flavored Efficacy in smoking cessation  Alternative to smoking  Aid in behavior change

47. Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach  Findings: Weighted averages of the scores provided a single, overall score for each product. Cigarettes (overall weighted score of 100) emerged as the most harmful product, with small cigars in second place (overall weighted score of 64). After a substantial gap to the third-place product, pipes (scoring 21), all remaining products scored 15 points or less.  Interpretation: Cigarettes are the nicotine product causing by far the most harm to users and others in the world today. Attempts to switch to non-combusted sources of nicotine should be encouraged as the harms from these products are much lower.  Nutt, D. J., Phillips, L. D., Balfour, D., Curran, H. V., Dockrell, M., Foulds, J.,... & Ramsey, J. (2014). Estimating the harms of nicotine-containing products using the MCDA approach. European addiction research, 20(5), 218-225.

48. Fig. 2. Overall weighted scores for each of the products. Cigarettes, with an overall harm score of 99.6, are judged to be most harmful, and followed by small cigars at 67. The heights of the colored portions indicate the part scores on each of the criteria. Product ‐ related mortality, the upper dark red sections, are substantial contributors to those two products, and they also contribute moderately to cigars, pipes, water pipes, and smokeless unrefined. The numbers in the legend show the normalized weights on the criteria. Higher weights mean larger differences that matter between most and least harmful products on each criterion. Nutt DJ, Phillips LD, Balfour D, Curran HV, Dockrell M, Foulds J, Fagerstrom K, Letlape K, Milton A, Polosa R, Ramsey J, SweanorD. Estimating the harms of nicotine ‐ containing products using the MCDA approach. European Addiction Research. 2014 April; 20:218 ‐ 225 link: http://www.karger.com/Article/FullText/36022

49. Open questions about E- cigarettes safety  Thousands of flavors FDA-”generally recognized as safe”-for ingestion Vapers use changes in flavor to help maintain nicotine levels Diacetyl and “popcorn lung”  Other components of vapor Ethylene glycol Formaldehyde other

50. E-Cigs and Cessation Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross- sectional population study Jamie Brown et, al Addiction Accepted May 2014 Background And Aims Electronic cigarettes (e-cigarettes) are rapidly increasing in popularity. Two randomised controlled trials have suggested that e-cigarettes can aid smoking cessation but there are many factors that could influence their real-world effectiveness. This study aimed to assess, using an established methodology, the effectiveness of e-cigarettes when used to aid smoking cessation compared with nicotine replacement therapy (NRT) bought over-the-counter and with unaided quitting in the general population. Design And Setting A large cross-sectional survey of a representative sample of the English population. Participants The study included 5863 adults who had smoked within the previous 12 months and made at least one quit attempt during that period with either an e-cigarette only (n=464), NRT bought over-the- counter only (n=1922) or no aid in their most recent quit attempt (n=3477). Measurements The primary outcome was self-reported abstinence up to the time of the survey, adjusted for key potential confounders including nicotine dependence. Findings E-cigarette users were more likely to report abstinence than either those who used NRT bought over- the-counter (odds ratio 2.23, 95% confidence interval 1.70 to 2.93, 20.0% vs. 10.1%) or no aid (odds ratio 1.38, 95% confidence interval 1.08 to 1.76, 20.0% vs. 15.4%). The adjusted odds of non-smoking in users of e-cigarettes were 1.63 (95% confidence interval 1.17 to 2.27) times higher compared with users of NRT bought over-the-counter and 1.61 (95% confidence interval 1.19 to 2.18) times higher compared with those using no aid. Conclusions Among smokers who have attempted to stop without professional support, those who use e- cigarettes are more likely to report continued abstinence than those who used a licensed NRT product bought over-the-counter or no aid to cessation. This difference persists after adjusting for a range of smoker characteristics such as nicotine dependence.

51. Smokers Who Try E-Cigarettes to Quit Smoking: Findings From a Multiethnic Study in Hawaii  Pallav Pokhrel, Pebbles Fagan, Melissa A. Little, Crissy T. Kawamoto, and Thaddeus A. Herzog. Smokers Who Try E-Cigarettes to Quit Smoking: Findings From a Multiethnic Study in Hawaii. American Journal of Public Health: September 2013, Vol. 103, No. 9, pp. e57-e62.  doi: 10.2105/AJPH.2013.301453  Objectives. We characterized smokers who are likely to use electronic or “e-”cigarettes to quit smoking.  Methods. We obtained cross-sectional data in 2010–2012 from 1567 adult daily smokers in Hawaii using a paper-and-pencil survey. Analyses were conducted using logistic regression.  Results. Of the participants, 13% reported having ever used e-cigarettes to quit smoking. Smokers who had used them reported higher motivation to quit, higher quitting self-efficacy, and longer recent quit duration than did other smokers. Age (odds ratio [OR] = 0.98; 95% confidence interval [CI] = 0.97, 0.99) and Native Hawaiian ethnicity (OR = 0.68; 95% CI = 0.45, 0.99) were inversely associated with increased likelihood of ever using e-cigarettes for cessation. Other significant correlates were higher motivation to quit (OR = 1.14; 95% CI = 1.08, 1.21), quitting self-efficacy (OR = 1.18; 95% CI = 1.06, 1.36), and ever using US Food and Drug Administration (FDA)–approved cessation aids such as nicotine gum (OR = 3.72; 95% CI = 2.67, 5.19).  Conclusions. Smokers who try e-cigarettes to quit smoking appear to be serious about wanting to quit. Despite lack of evidence regarding efficacy, smokers treat e-cigarettes as valid alternatives to FDA-approved cessation aids. Research is needed to test the safety and efficacy of e-cigarettes as cessation aids.  Read More: http://ajph.aphapublications.org/doi/full/10.2105/AJPH.2013.301453http://ajph.aphapublications.org/doi/full/10.2105/AJPH.2013.301453

52. NICE Public Health Guidance: Tobacco: harm-reduction approaches to smoking Stopping smoking, but using one or more licensed nicotine- containing products as long as needed to prevent relapse Cutting down prior to stopping smoking (cutting down to quit) -with the help of one or more licensed nicotine-containing products (the products may be used as long as needed to prevent relapse) -without using licensed nicotine-containing products. Smoking reduction -with the help of one or more licensed nicotine-containing products (the products may be used as long as needed to prevent relapse) -without using licensed nicotine-containing products. Temporary abstinence from smoking -with the help of one or more licensed nicotine-containing products -without using licensed nicotine-containing products.

53. Public Health England's position on electronic cigarettes  Use of electronic cigarettes is about 95 percent safer than smoking.  Smokers who have tried other methods of quitting without success could be encouraged to switch to e- cigarettes. In addition to encouraging their use as a cessation tool, encouraging switching could help reduce smoking-related disease, death and health inequalities.  The authors also conclude there is no evidence that young people’s experimentation with e-cigarettes has led to increased smoking in this group.

54. Choices in smoking harm reductions interventions  Cutting down on number of cigarettes-Not effective without a quit date and a structured smoking cessation plan  Trial of medication without quitting  Medication to reduce smoking  Which drug  Role of counselling  Use of E-cigarettes

55. Methods of Smoking Cessation Self Help Physician Advice Counseling Social Support Hypnosis/Acupuncture Smoking Cessation Classes Medication

56. Choices in smoking cessation interventions  Counseling only  Drug only  Counseling and drug  Which drug Effort dependent treatment Effort independent treatment  How to manage side effects  What to do after relapse

57. Role of the Physician Five As Ask about smoking Advise tobacco users to quit Assess readiness to quit Assist with a plan for quitting Arrange follow-up 2 As + R Physicians can also help patients who smoke to quit through an effective 30-second intervention, 2 As + R (Ask, Advise, Refer): Physicians Ask patients if they smoke, Advise them to quit, and Refer them to cessation services (1-800-QUIT NOW or to community/ internet quit resources).

58. Smoking Cessation Interventions by Physicians: How well are they working? Advising Smokers and Tobacco Users to Quit. a rolling average represents the percentage of adults 18 years of age and older who are current smokers or tobacco users and who received cessation advice during the measurement year. Discussing Cessation Medication. a rolling average represents the percentage of adults 18 years of age and older who are current smokers or tobacco users and who discussed or were recommended cessation medications during the measurement year. Discussing Cessation Strategies. a rolling average represents the percentage of adults 18 years of age and older who are current smokers or tobacco users and who discussed or were provided cessation methods or strategies during the measurement year. NCQA CAHPS Questions

59. Over 75% of smokers recall having been advised to quit smoking in 2012 Discussing Cessation Strategies Commercial Medicaid HMO PPO HMO  2012 47.9 37.3 41.1  2011 47.6 40.1 40.3  2010 45.0 39.0 38.5  2008 49.7 43.3 40.8  2007 48.0 44.2 39.2  2006 43.2 42.6 36.7  2005 38.9 35.1 33.9  2004 36.8 32.7  2003 36.0 32.3 Discussing Cessation Medications Commercial Medicaid HMO PPO HMO  2012 52.9 44.6 45.8  2011 53.1 47.9 44.3  2010 52.4 47.2 42.7  2008 54.4 50.9 40.6  2007 50.9 49.6 38.7  2006 43.9 43.8 35.1  2005 39.4 36.7 31.8  2004 37.8 31.3  2003 37.6 31.5 NCQA 2013 State of Health Care Quality Report

60. Advances in Treatment I  Natural History of smoking cessation The successful Quitter makes 5-8 efforts Each quit attempt is longer than the previous Process over several years  Reasons for relapse Nicotine withdrawal symptoms Minor life stress Major life stress

61. New paradigms  Ask about E-cigarettes  Screen for, and treat mental illness  Harm reduction discussion  Support cessation or harm reduction efforts if already in progress, even if using e-cigarettes  Structured quit attempt  Opt to Quit program

62. Advances in Treatment II  Correct use of medication Longer duration of treatment Increased use of behavioral interventions  Combination Therapy Nicotine plus bupropion Combination of Nicotine products  Treatment of Craving Clonidine Naltrexone Topiramate  Weight gain does not occur until medication is discontinued  Use telephonic counseling  Referral to psychiatry

63. Proactive Tobacco Treatment and Population-Level Cessation  Steven S. Fu, MD, et al  JAMA Intern Med. 2014;174(5):671-677.  Importance Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence- based treatments for tobacco use that include both behavioral counseling and pharmacotherapy.  Objective To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers.  Design, Setting, and Participants The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention.  Interventions Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services.  Main Outcomes and Measures The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization.  Results A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P =.02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1.03- 1.57]). In analyses accounting for nonresponse using likelihood-based not-missing-at-random models, the effect of proactive care on 6-month prolonged abstinence persisted (OR, 1.33 [95% CI, 1.17-1.51]).  Conclusions and Relevance Proactive, population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates.

64. Nicotine sampling Nicotine Therapy Sampling to Induce Quit Attempts Among Smokers Unmotivated to Quit: A Randomized Clinical Trial Matthew J. Carpenter, PhD; John R. Hughes, MD; Kevin M. Gray, MD; Amy E. Wahlquist, MS; Michael E. Saladin, PhD; Anthony J. Alberg, PhD, MPH Background: Rates of smoking cessation have not changed in a decade, accentuating the need for novel approaches to prompt quit attempts. methods: Within a nationwide randomized clinical trial (N=849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week intervention period, participants were followed up for 6 months to assess outcomes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combination of a PQA plus nicotine therapy sampling added samples of nicotine lozenges to enhance attitudes toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes included the incidence of any ever occurring selfdefined quit attempt and 24-hour quit attempt. Secondary measures included 7-day point prevalence abstinence at any time during the study (ie, floating abstinence) and at the final follow-up assessment. Results: Compared with PQA intervention, nicotine therapy sampling was associated with a significantly higher incidence of any quit attempt (49% vs 40%; relative risk [RR], 1.2; 95% CI, 1.1-1.4) and any 24-hour quit attempt (43% vs 34%; 1.3; 1.1- 1.5). Nicotine therapy sampling was marginally more likely to promote floating abstinence (19% vs 15%; RR, 1.3; 95% CI, 1.0-1.7); 6-month point prevalence abstinence rates were no different between groups (16% vs 14%; 1.2; 0.9-1.6). Conclusion: Nicotine therapy sampling during a PQA represents a novel strategy to motivate smokers to make a quit attempt.

65. Opportunistic interventions Brief opportunistic smoking cessation interventions: a systematic review and meta- analysis to compare advice to quit and offer of assistance Paul Aveyard, Rachna Begh, Amanda Parsons, and Robert West2 Article first published online: 28 FEB 2012DOI: 10.1111/j.1360-0443.2011.03770.x © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction Aims This study aimed to assess the effects of opportunistic brief physician advice to stop smoking and offer of assistance on incidence of attempts to stop and quit success in smokers not selected by motivation to quit. stop smoking Methods We included relevant trials from the Cochrane Reviews of physician advice for smoking cessation, nicotine replacement therapy (NRT), varenicline and bupropion. We extracted data on quit attempts and quit success. Estimates were combined using the Mantel–Haentszel method and heterogeneity assessed with the I2 statistic. Study quality was assessed by method of randomization, allocation concealment and follow- up blind to allocation.nicotine replacement Results Thirteen studies were included. Compared to no intervention, advice to quit on medical grounds increased the frequency of quit attempts [risk ratio (RR) 1.24, 95% confidence interval (CI): 1.16–1.33], but not as much as behavioural support for cessation (RR 2.17, 95% CI 1.52–3.11) or offering NRT (RR 1.68, 95% CI: 1.48– 1.89). In a direct comparison, offering assistance generated more quit attempts than giving advice to quit on medical grounds (RR 1.69, 95% CI: 1.24–2.31 for behavioural support and 1.39, 95% CI: 1.25–1.54 for offering medication). There was evidence that medical advice increased the success of quit attempts and inconclusive evidence that offering assistance increased their success. Conclusions Physicians may be more effective in promoting attempts to stop smoking by offering assistance to all smokers than by advising smokers to quit and offering assistance only to those who express an interest in doing so. View Full Article with Supporting Information (HTML)View Full Article with Supporting Information (HTML) Get PDF (98K)Get PDF (98K)