1. PHS Dartmouth Hitchcock Medical Center Elizabeth Maislen, APRN, CTTS CTOP Retreat May 22, 2014 Tobacco Treatment Update 2014

2. Disclosures None. I do not intend to discuss off label use of any products. I dont smoke and I dont vape or hookah. When patients ask, Did YOU ever smoke? I tell them Its not about me today, its all about YOU. Thank you to Susanne Tanski, MD

3. Key Points Review 7 first line medications and dosing Whats new from the FDA, changes in NRT package labeling Insurance coverage under ACA An array of tobacco/nicotine delivery products Electronic cigarettes Tobacco dependence, a chronic disease

4. Cessation Treatments are Underused! The treatments recommended in the PHS guideline are underused by smokers and health care providers. About 70% of smokers want to quit smoking, and about half try to quit each year. However, less than 10% succeed, in part because less than one-third of smokers who try to quit use proven cessation treatments. In 2010, less than half of smokers (48.3%) who saw a health professional in the past year reported receiving advice to quit

5. The Surgeon Generals Report Cigarettes and other tobacco products have evolved into highly engineered, addictive and deadly products, containing thousands of harmful chemicals causing a wide range of diseases, cancers and premature deaths. 9 of 10 smokers regret ever having started. 60% of current smokers perceive themselves at very addicted. Health Consequenses Smoking-50 years of Progress, UHDHHS, Report of Surgeon General 2014

6. Whats Different? Todays cigarette smokers, especially women, have much higher risk for lung cancer, COPD and CVD, despite smoking fewer cigarettes. The design of the cigarette is different. More nicotine is absorbed when smoked. Combinations of products in cigarettes. International Tobacco Control Study S. Glantz et al, 2-8-14; 2002-2011 longitudinal study

9. PHS is the chief, single, avoidable cause of death in our society and the most important public health issue of our time. C. Everett Koop, M.D., former U.S. Surgeon General CIGARETTE SMOKING… All forms of tobacco are harmful.

10. PHS Medications Seven first-line medications shown to be effective and recommended for use by the USPHS Guidelines Panel: –Nicotine Patch –Nicotine Gum –Nicotine Lozenge –Nicotine Inhaler –Nicotine Nasal Spray –Bupropion SR –Varenicline

11. Nicotine Patches 1mg /1cigarette 21 mg 14 mg 7 mg

13. PHS Nicotine Inhaler

14. PHS

16. FDA Labeling Update NO significant safety concerns associated with using more than one form of NRT NO significant safety concerns associated with using NRT at the same time as a cigarette Use longer than 12 weeks is safe! April 2013 www.fda.gov/ForConsumers/ConsumerUpdate/ucm345087.htmwww.fda.gov/ForConsumers/ConsumerUpdate/ucm345087.htm

17. FDA Changes to NRT Labels Previous labels Current labels

18. Bupropion Monocyclic antidepressant Unknown mechanism in tobacco cessation Dose Bupropion SR 150 mg a day x 3 days then 150 mg bid May cause dry mouth, insomnia

19. PHS Varenicline Effectiveness and abstinence rates for various medications and medication combinations compared to placebo at 6- months post-quit (n = 86 studies) Medication Number of arms Estimated odds ratio (95% C. I.) Estimated abstinence rate (95% C. I.) Placebo801.013.8 Varenicline (2 mg/day) 5 3.1 (2.5, 3.8) 33.2 (28.9, 37.8)

21. Varenicline=Chantix Starter dose pack Start with 0.5 mg a day x 3 days then increase to 0.5 mg bid x 4 days Then 1 mg bid 1 course of treatment is 3 months 2 courses of treatment is 6 months

22. PHS

29. Ask Ask about tobacco use. Identify and document tobacco use status for every patient at every visit. Advise Advise to quit. In a clear, strong and personalized manner urge every tobacco user to quit. Assess Assess willingness to make a quit attempt. Is the tobacco user willing to make a quit attempt at this time? Assist Assist in quit attempt. For the patient willing to make a quit attempt, use counseling or pharmacotherapy to help him or her quit. Arrange Arrange followup. Schedule followup contact, preferably within the first week after the quit date. The "5 A's" Model for Treating Tobacco Use and Dependence - 2000

30. Brief interventions have been shown to be effective In the absence of time or expertise: –Ask, advise, and refer to other resources, such as local group programs or the toll-free quitline 1-800-QUIT-NOW BRIEF COUNSELING: ASK, ADVISE, REFER (contd) This brief intervention can be achieved in less than 3 minutes.

31. 1.0 1.1 1.7 2.2 n = 29 studies Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008. With help from a clinician, the odds of quitting approximately doubles. Compared to patients who receive no assistance from a clinician, patients who receive assistance are 1.7–2.2 times as likely to quit successfully for 5 or more months. CLINICIANS CAN MAKE a DIFFERENCE

32. PHS

36. Type:PNG Website for this image First iPad App on Quit Smoking. Welcome visit Our WebSite: free-press-release.com Full-size image 660 × 396 ( Same size), 154KB Search by image Images may be subject to copyright.

37. Insurance Coverage of Cessation Treatments is Cost Effective Cessation treatments are both clinically effective and highly cost-effective relative to interventions for other clinical disorders. Cost-effectiveness analyses have shown that tobacco dependence treatment compares favorably with routinely reimbursed medical interventions such as the treatment of hypertension and high cholesterol, as well as preventive screening interventions such as periodic mammography and PAP tests.

38. Current Status of Cessation Coverage Nine states have laws or regulations in place requiring at least some private insurance plans to cover certain cessation treatments. (Colorado, Illinois, Maryland, New Jersey, New Mexico, North Dakota, Oregon, Rhode Island, and Vermont )

39. Medicaid Coverage and the ACA Section 4107 of the Affordable Care Act requires all state Medicaid programs to provide a comprehensive tobacco cessation benefit as defined by the USPHS guidelines to pregnant women who are enrolled in Medicaid, effective October 2010 As of January 2014, Section 2502 of the law bars state Medicaid programs from excluding cessation medications, including over-the-counter medications, from coverage.

40. Medicare Coverage Medicare recipients have access to individual cessation counseling and prescription cessation medications. The benefit covers two quit attempts a year and four counseling sessions per quit attempt. Medicare copayment, coinsurance, and deductibles for cessation treatments are waived under the Affordable Care Act, effective January 1, 2011.

41. Other forms of Tobacco Cigars Blunts Hookah or Water Pipe Vaping products Smokeless tobacco Chewing tobacco Snuff- moist and dry, sachel or Snus Dip Dissolvables

42. From Cigarette to Vapor Pen, an evolution in technology

43. Roll Your Own Cigarettes Roll in rolling machine or by hand rollies Use increases when branded cigarette prices go up Pipe tobacco Greater tar and nicotine yields/cigarette Likely inhale differently or more deeply, depositing smoke, nicotine and toxins in lungs Greater urinary concentrations of toxins Increases risks for lung and oral cancers Low cost=more affordable Addict Biol, 14, 2009, page 315 Tobacco Control, June 1998, Darrall & Figgins, page 168.

44. Dual Tobacco Use Combustible plus non combustible tobacco types Convenient packaging facilitates availability and ease of using both types of products. Snus package can fit just about anywhere, can be used in places where you cannot smoke.

45. PHS Electronic Cigarette A SMOKING CESSATION DEVICE?

46. PHS ELECTRONIC CIGARETTES Battery operated devices that deliver vaporized nicotine –Cartridges contain nicotine, flavoring agents, and other chemicals Battery warms cartridge; user inhales nicotine vapor or smoke Available on-line and in shopping malls –Not labeled with health warnings Preliminary FDA testing found some cartridges contain carcinogens and impurities (e.g., diethylene glycol) No data to support claims that these products are a safe alternative to smoking

47. PHS PHS-Sponsored Clinical Practice Guideline Treating Tobacco Use and Dependence: 2008 Update

48. PHS PHS-Sponsored Clinical Practice Guideline Treating Tobacco Use and Dependence: 2008 Update

49. PHS PHS-Sponsored Clinical Practice Guideline Treating Tobacco Use and Dependence: 2008 Update

50. Cloud Vape Pen

52. The Electronic Cigarette http://www.ispot.tv/ad/7fnS/njoy-e- cigarette-return-the-favor-song-by-avicii http://www.ispot.tv/ad/7fnS/njoy-e- cigarette-return-the-favor-song-by-avicii

53. What are the public health harms? Re-normalizing the image of smoking Allowed in places where smoking is not allowed Advertising is completely unrestricted, with TV ads for the first time since 1971 Largely indistinguishable from cigarettes Second-hand vapor is NOT just water vapor Emit variable levels of nicotine

54. So what to do? Research is imperative to assess second hand vapor effects (of all kinds), addiction potential and dual- use maintenance Must have a regulated product for an informed consumer, with fully disclosed labeling Until we know more about e-anything and cessation, we can still recommend medicinal NRT, quit lines and support while people are becoming non-tobacco users

55. Tobacco Dependence Tobacco dependence is a chronic disease, with most smokers making multiple quit attempts before succeeding. Many of these smokers require repeated intervention.

57. THANK YOU! (For not smoking)