Tobacco Cessation Products Review

1. Tobacco Cessation Products Review Amy Bachyrycz, Pharm.D. Shared Faculty, UNM COP Walgreens Patient Care Center

2. Objectives • Tobacco cessation product review • Current clinical evidence regarding tobacco cessation • Case based application of tobacco cessation products (practice) • Pharmacist role and perspective in tobacco cessation efforts

3. What Can I do upon Graduation? • Prescribe and FDA approved products for TC • Prescribe TC to those pts under 18 yrs of age • Charge pts for the cognitive services included in TC • Counsel/Recommend for pregnant female pts on Medicaid & bill the state for the medication/counseling (via paper billing) • Follow-up with patients as your clinical judgment deems is necessary

5. Pathophysiology of Smoking • Repeated exposure develops neuroadaptation of the receptors • Develops tolerance to it’s own action with repeated use • Pharmacotherapies reduce withdrawal symptoms and block the reinforcing effects of nicotine • Without causing excessive adverse effects • All FDA approved tobacco cessation products are safe for short and long term use • Combination therapy may be indicated for patients that may have failed monotherapy or with heavy chemical addiction Jiloha R. Pharmacotherapy of Smoking Cessation. Indian J of Psych. 2014.

6. Why Do We Smoke? • Rewards • Boredom • Habit • Addiction

7. Neurobiology of Smoking • Tip of a lighted cigarette, burns at 800 degrees Celsius • With each puff, draws into one’s mouth gases and many sized particles • Of the 4000 chemicals identified in tobacco smoke, nicotine is responsible for a number of pathophysiological changes in the body • Nicotine remains dissolved in the moisture of the tobacco leaf as a water soluble salt, in a burning cigarette it volatilizes & remains suspended on minute droplets of tar as free nicotine • Droplets reach smallest alveoli of the lungs • About 90% of the nicotine present in inhaled smoke is absorbed (11-15 seconds) • Yields increase in dopaminergic activity and euphoria/pleasure

8. FDA Approved Products • NRT (also over-the-counter) • Patch, gum, lozenge • NRT (prescription only) • Inhaler, nasal spray • Varenicline • Zyban and generic

9. New Improved FDA Approved Products

10. Plasma Nicotine Concentrations Cigarette Moist snuff 0 10 20 30 40 50 60 Time (minutes)

11. Review of 5A’S • 5A’s are part of NM Board of Pharmacy protocol • 5A’s will gather all necessary info for workup/SOAP note • 5A’s will determine what behavioral modification you recommend for your patient • 5A’s will determine and justify what product you chose to prescribe • Ask every patient about tobacco use • Advise all smokers to quit • Assess smokers' willingness to quit • Assist smokers with treatment and referrals • Arrange follow-up

12. Fagerstrom • Smoking is a 2 part addiction • Determines level of addiction • How soon after waking do you smoke your first cigarette? • Time less than 5 minutes: 3 points • Time 5 to 30 minutes: 2 points • Time 31 to 60 minutes: 1 point • Interpretation • Heavy nicotine dependence: 5-6 points • Moderate nicotine dependence: 3-4 points • Light nicotine dependence: 0-2 points

13. Steps to Case Work-up • Identify patient is in Stage 2 model for change • Sign consent form • Complete 5A’s • Complete Fagerstrom (optional) • Agree on behavioral modifications to make • Agree on TC product, dose, side effects, contraindications • Write brief work-up/SOAP to store in pharmacy using 5A’s • Write script, fill and dispense (charge pt for med/counseling) • Notify PCP/healthcare team, w/ patient consent, within 15 dys

14. SOAP • Subjective • HPI (chief complaint, stage in quitting process) • SH (age, gender, occupation, etoh, cpd) • PMH Medications (prescription, OTC, discontinued meds) • Objective • Vitals • Lab Values • Assessment • Triggers and associations, readiness to quit, product justification • Plan • Quit date, 1800 Quit Now reference if appropriate • Specific pharmacotherapy and behavioral modifications • PCP/healthcare team notified and date documented

15. Case 1 • 65 y/o retired pt John Smith, DOB 10/22/48 • Appears depressed, no work-up or diagnosis • Smokes 1 ppd x 15 yrs • PMH: open heart surgery several years back • Meds: metoprolol and aspirin 81mg • References a positive experience with Commit lozenges • Ready to quit in the next 30 days

16. Case 1 Possible Regimens • CBT (lifestyle modifications) • Smokers do not plan to fail they fail to plan • Slip vs relapse plan of action • Smoke break plan of action • Crisis plan of action • Avoid triggers and associations • NRT (single or in combo) • Avoid in MI, arrhythmia, angina • Once on, smoking must cease • Gum or bupropion: evidence of appetite suppression • Nasal spray: avoid in asthma, COPD, URI

17. Case 1 Possible Regimens • Bupropion (with or without NRT) • Taper (150mg daily x 3-7 dys, then bid thereafter) • Does not require taper to DC • Avoid in eating d/o, seizures, alcoholism, meds that lower seizure threshold, liver failure or elevated lipid panel, currently on Wellbutrin • Varenicline (USE ALONE) • Avoid in underlying anxiety/depression • Discuss side effects clearly • Nausea, dreams, neuropsych symptoms • Banned in commercial drivers, pilots, air traffic contr. • Careful in renal failure & underweight individuals

18. Varenicline and combination NRT, found most effective • Evidence Based Medicine Journal reported findings from 12 treatment specific reviews of high methodological quality: • Varenicline was superior to NRT monotherapy • Varenicline was superior to bupropion • Varenicline was not superior to combination NRT • NRT and bupropion were of equal efficacy • The reviews did not find an increase of neuropsychiatric events with either varenicline or bupropion compared to placebo • The reviews had compelling evidence that varenicline, after proper screening, does not cause an increase in serious adverse effects Ebbert J. Varenicline and combination nicotine replacement therapy are the most effective pharmacotherapies for treating tobacco use. Evid Based Med. 2013.

19. Varenicline Dosing Instructions • Starter Pack • Take 0.5mg daily on days 1 through 3 • Take 0.5mg bid on days 4 through 7 • Take 1mg bid thereafter • Continuing Pack • Take 1mg bid • Counseling Points • Take with food • Take at least 8 hrs apart, but not after 6pm • If side effects occur, immediately discontinue

20. Nicotine Gum Suggested Dosing

21. Nicotine Lozenge Dosing Dosage is based on the “time to first cigarette” (TTFC) as an indicator of nicotine addiction Use Commit Lozenge 2 mg: If you smoke your first cigarette more than 30 minutes after waking up Use Commit Lozenge 4 mg: If you smoke your first cigarette of the day within 30 minutes of waking up

22. Nicotine Lozenge Suggested Dosing

23. Nicotine Patch Suggested Dosing

24. Nicotine Nasal Spray • Aqueous solution in a 10-ml spray bottle • Start with 1–2 doses per hour • Increase prn to max. dosage of 5 doses per hour • For best results, use at least 8 doses daily for the first 6–8 weeks • Gradual tapering over an additional 4–6 weeks needed

25. Nicotine Inhaler • Start with 6 cartridges/day (4mg/cartridge delivered) • Increase prn to maximum of 16 cartridges/day • Use for minimum of 3 weeks, maximum of 12 weeks • Gradual dosage reduction over additional 6–12 weeks

26. Please write your script now! • Switch scripts • Please call out a piece of info. you are missing as the dispensing pharmacist or may be hard to interpret • Confirm you have all of the required information • Patient name, address, and DOB • Address must be on script per BOP law, so if you do not write it, the dispensing pharmacy must write it • Drug, strength, and instructions • Not generally acceptable includes: • Use as directed or as needed • See package directions • Quantity and number of refills • Difficult to interpret includes: • One box • Doctor signature and one other identifier (phone number)

27. Please re-write your script now! • Switch scripts • Re-confirm you have all of the required information • Patient name, address, DOB • Address must be on script per BOP law, so if you do not write it, the dispensing pharmacy must write it • Drug and instructions (must have a strength) • Not generally acceptable includes: • Use as directed or as needed • See package directions • Quantity and number of refills • Difficult to interpret includes: • One box (large or small, what package size?) • Doctor signature and one other identifier (phone number)

28. Product Success Rates • JAMA, January 2014 compiled results from 267 studies • NRT, 17.6% success rate • Bupropion, 19.1% success rate • Placebo, 10.6% success rate • Varenicline, 27.6% success rate • Combination, NRT 31.5% success rate (patch plus inhaler) Cahill K, et al. Pharmacological treatments for tobacco cessation. Jama. 2014.

29. Case 2 • Female Jonah Smith DOB 3/15/1980, owns a restaurant • No PMH and no medications • Smokes 15 cpd, mostly while at work • Interested in quitting to encourage her restaurant staff to quit • Failed NRT (patch alone) in past due to numbness in the arm

30. Case 2 Possible Regimens • CBT (lifestyle modifications) • NRT (single or in combo) • Wants to quit today • Bupropion (with or without NRT) • Varenicline (ALONE)

31. Varenicline with NRT • South Africa, JAMA 2014 (24 week trial, n=446)) • Identified that it is unclear if varenicline plus NRT is effective and safe • Nicotine patch plus varenicline vs. varenicline alone • Combination therapy was associated with higher abstinence rates at week 12 (55.4% vs. 40.9%) and week 24 (49.0% vs. 32.6%) • Combination therapy was associated with adverse events • Nausea, sleep disturbance, skin reactions, constipation, depression, • Only skin reaction reached statistical significance (P=0.03) Coenraad F, et al. Efficacy of varenicline combined with NRT vs. varenicline alone for smoking cessation. JAMA. 2014.

32. Case 3 • Female Debbie Juniper DOB 12/15/1985, is a nurse • You see her smoking in the designated smoke areas where you are on your rotation • No PMH and no medications • Smokes 5cpd while at work and 15 cpd while at home (1ppd) • Interested in quitting because she knows it is not healthy and you get to know her well that month and mention it to her • Also interested in quitting because her health insurance rate is higher as a smoker • Willing to try any available therapy as long as it is covered by her insurance or not to expensive

33. Case 3 Possible Regimens • CBT (lifestyle modifications) • NRT (single or in combo) • Gum and lozenge are not generally covered because of OTC status • Nasal and inhaler are expensive and not generally covered or need a prior authorization • Bupropion (with or without NRT) • Varenicline (ALONE)

34. Case 4 • You have an appt. with Mr. Bradshaw, a 46 y/o man who is 50lbs overweight • He is agitated because he had to wait while you finished up with a patient • He reports NKDA, however, he has HTN and hyperlipidemia • You notice a box of Marlboro lights in his left chest pocket, but he is NOT ready to quit

35. Case 4 Possible Suggestions • 5 R’s • Not ready to quit • Motivational counseling • Plan or Assist & Arrange • 1-800-QuitNow card • Free gum/patches if no current condition • Possible phone call in 30 days

36. Smokeless Tobacco • Clinical evidence is limited • All tobacco cessation products may be used

37. Varenicline in Smokeless Tobacco • Systematic review, meta-analysis • Evaluated 3 published randomized clinical trials involving 744 users comparing varenicline vs. placebo • Abstinence at 12 weeks (48.0% vs. 33.0%) • Abstinence at 26 weeks (49.0% vs. 39.0%) • Overall, no statistically significant differences in the incidence of adverse events Schwartz J, et al. Use of varenicline in smokeless tobacco cessation. Nicotine & Tobacco Research. 2015.

38. MM

39. Medical Marijuana • Protocol does not allow you to prescribe TC products for medical marijuana patients trying to quit • Extraction of marijuana is done with toxic chemicals like butane, propylene glycol which become inhaled by patients • As marijuana reaches legalization status in NM: • Patients may be interested in cessation • Patients may find long term studies prove respiratory diseases increase • Patients may be on concurrent medications that interact with the MM • Patients may be interested in safer options such as edibles • Patients may turn to their pharmacist for advice

40. Pharmacists Prescriptive Authority Protocol Highlights • Counseling x 90 minutes/patient • * You may charge for each visit • Must get some work-up of patient (PMH, SH) • Approved training (RX F C curriculum) • 2 Live CE’s Q 2 yrs • Prescribe FDA approved medications • Informed Consent w/ approval to notify PCP in 15 dys of Rx if identified • Pt F/u • * Group sessions are allowed

41. Patient Info. For Group Session • Benefits to quitting • Cough may resolve • Exercise tolerance improves rapidly • Bladder cancer: 50% reduction in 5 years • Lung cancer: 50% reduction in 10 years • Heart disease: 50% reduction in 1 year • Vascular disease: 50% reduction in 5 years • Mortality: improves lifespan by appx. 10-15 yrs

42. Pharmacists Must Refer… • For bupropion prescribing only • Seizure disorder/Eating disorder • Alcoholism • Liver cirrhosis • Contraindication to specific therapy • NRT • Arrhythmias • MI (h/o) • Angina, worsening • Varenicline • Depression/anxiety • Risks are greater than benefits

43. Barriers to Increased Pharmacist Intervention • Lack of federal provider status • Lack of third party payer coverage for products or visits • Lack of federal funds (excludes pregnant patients) • Lack of corporate support from employers • Workload difficult to manage with remote activity • F/u difficult (e.g. phone numbers disconnected, no-shows) • Pharmacists may not be comfortable prescribing to children <18 years of age • Pharmacists have limited info. to other PMH, lab values, etc.

44. Summary • Tobacco cessation product review includes products that may be more suitable for individual patients • Clinical evidence is limited (e.g. e-cigarettes, smokeless tobacco) and tobacco cessation efforts • All healthcare professionals have a role in tobacco cessation advocating • Pharmacist prescriptive authority exists, but barriers exist in NM