WANTED. Pharmacists to Help Patients Quit Smoking: Best practices and updates in cessation treatment. Robin Corelli, PharmD

Transcription

1 WANTED Pharmacists to Help Patients Quit Smoking: Best practices and updates in cessation treatment Robin Corelli, PharmD UCSF School of Pharmacy Karen Hudmon, DrPH, MS, RPh Purdue University College of Pharmacy

2 Target Audience: Pharmacists and Pharmacy Technicians ACPE#: L01-P/T Activity Type: Application-based

3 This activity is supported by an independent educational grant from Pfizer, Inc.

4 Disclosures Drs. Corelli and Hudmon declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria., The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

5 Learning Objectives At the completion of this application-based activity, participants will: 1. Summarize recent data regarding the safety and efficacy of available pharmacologic options for the treatment of tobacco use and dependence. 2. Discuss various approaches for use of cessation medications prior to the quit date. 3. Develop a treatment regimen that incorporates the most effective medications for smoking cessation, including medications doses, and routes and frequency of administration. 4. Explain the role of electronic nicotine delivery systems in quitting smoking.

6 Assessment Question #1 According to data from clinical trials, which of the following is most most effective for smoking cessation? A. Bupropion SR B. Electronic nicotine delivery systems (e.g., e-cigarettes) C. Nicotine replacement therapy D. Varenicline

7 Assessment Question #2 Which of the following smoking cessation medications has a boxed warning for serious neuropsychiatric side effects? A. Bupropion SR B. Varenicline C. A and B D. None of the above

8 Assessment Question #3 Which of the following nicotine replacement therapy formulations has the most compelling evidence for use prior to the quit date? A. Gum B. Inhaler C. Lozenge D. Patch

9 Assessment Question #4 Which of the following is the most appropriate combination therapy dosing for a patient who smokes one pack of cigarettes/day and smokes his first cigarette within 30 minutes of waking? A. 21 mg nicotine patch daily + 4 mg nicotine lozenge every 1-2h while awake B. 21 mg nicotine patch daily + 4 mg nicotine lozenge every 1-2h prn C. 21 mg nicotine patch + 14 mg nicotine patch daily D. 4 mg nicotine lozenge four times daily + nicotine nasal spray every 1-2h while awake

10 Assessment Question #5 Which of the following statement is TRUE regarding electronic nicotine delivery systems (ENDS; e.g., e- cigarettes)? A. ENDS are a safe alternative to cigarette smoking B. ENDS have lower exposure to carcinogens and toxins than tobacco smoke C. ENDS have a lower risk for nicotine dependence D. Electronic cigarettes are more effective than nicotine replacement therapy for quitting

11 The content for this session derives from the Rx for Change: Clinician-Assisted Tobacco Cessation program. Copyright The Regents of the University of California. All rights reserved.

12 CIGARETTE SMOKING 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

13 Tobacco Dependence: A 2-part problem Tobacco Dependence Physiological The addiction to nicotine Treatment Behavioral The habit of using tobacco Treatment Medications for cessation Behavior change program Treatment should address the physiological and the behavioral aspects of dependence.

14 Pharmacotherapy Clinicians should encourage all patients attempting to quit to use effective medications for tobacco dependence treatment, except where contraindicated or for specific populations* for which there is insufficient evidence of effectiveness. * Includes pregnant women, smokeless tobacco users, light smokers, and adolescents. Medications significantly improve success rates. Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

15 First-Line Pharmacotherapies Nicotine gum Nicorette (OTC) Generic nicotine gum (OTC) Nicotine lozenge Commit (OTC) Generic nicotine lozenge (OTC) Transdermal nicotine patch NicoDerm CQ (OTC) Generic nicotine patches (OTC, Rx) Nicotine nasal spray Nicotrol NS (Rx) Nicotine oral inhaler Nicotrol (Rx) Bupropion SR tablets Zyban (Rx) Generic (Rx) Varenicline tablets Chantix (Rx) These are the only medications approved by the FDA for smoking cessation.

16 Timeline for Medications and Electronic Rx nicotine gum Nicotine Delivery Systems (ENDS) Rx transdermal nicotine patch 1991 Rx nicotine inhaler; Rx bupropion SR First e-cigarette made OTC nicotine lozenge Rx varenicline e-cigarettes sold in US 1984 OTC nicotine gum & patch; Rx nicotine nasal spray

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18 Patient Cases

19 Case Presentations Brief description of case provided Discuss in groups of 2 or 3 Audience poll for recommended therapy regimen Data and discussion of treatment options Audience re-poll for recommended therapy regimen

20 Pharmacist s Patient Care Process Collect Ask about tobacco use and prior quit attempts Query patients regarding key issues Assess Readiness to quit Plan Facilitate quitting process; set a quit date Develop behavioral and pharmacologic treatment plan Implement Check for understanding and commitment to quit Follow-up: Monitor and Evaluate Monitor patient s progress throughout quit attempt

21 Case A: Greg Greg, 54 yo male with HTN, hyperlipidemia, depression, chronic rhinitis Current medications: Valsartan 80mg QAM for HTN Atorvastatin 40mg QAM for hyperlipidemia Bupropion XL 300mg QAM for depression Flonase (50mcg/spray), 1 spray in each nostril QAM for rhinitis Wants to quit in the next month; has joined a smoking cessation group program at work What questions do you want to ask Greg?

22 Key Considerations for Greg Tobacco use history: Current use: 25 cigarettes/day x 25 years; smokes within 20 min of waking Prior quit attempts: many, longest duration tobacco-free = 2 weeks Reasons for relapse: withdrawal, stress, after meals, other smokers Key issues for upcoming quit attempt: Reasons, motivation for wanting to quit: worsening CVD Confidence in ability to quit: high Other concerns: withdrawal symptoms during past quit attempt

23 Medication Selection for Greg Key considerations for medication selection: Previous failed quit attempts with monotherapy (patch, gum) Challenges adhering with complex regimens Currently taking bupropion XL 300mg daily for depression Concerned about side effects of varenicline Chronic rhinitis

24 Audience Poll #1 Which of the following treatment options is most appropriate for Greg? A. NRT monotherapy (gum, lozenge, patch, inhaler nasal spray) B. Combination NRT C. Bupropion SR D. Varenicline E. I don t know

25 OPTION #1: NRT Monotherapy Feature G L P I NS Available OTC Oral substitute for tobacco Relatively inexpensive* Long-acting; once daily dosing Used prn for nicotine withdrawal sx Used in combination with other NRTs G=gum; L=lozenge; P=patch; I=inhaler; NS=nasal spray * When compared to the cost of 1 pack of cigarettes/day ($6.17)

26 Long-Term Quit Rates: NRT Active drug Placebo 23.9 Percent quit Nicotine gum Nicotine patch Nicotine lozenge Nicotine nasal spray Nicotine inhaler Studies # Subjects 22,581 19,586 3, Data adapted from Stead et al. (2012). Cochrane Database Syst Rev.

27 Identify Key Issues to Streamline Product Selection Do you prefer a prescription or nonprescription medication? Would it be a challenge for you to take a medication frequently throughout the day (e.g., a minimum of 9 times)? With the exception of the nicotine patch, all NRT formulations require frequent dosing throughout the day. If patient is unable to adhere to the recommended dosing, these products should be ruled out as monotherapy because they will be ineffective. Ask these questions to reduce the time required for product selection. * Product-specific screening for warnings, precautions, contraindications, and personal preferences is also essential.

28 OPTION #2: Combination NRT Regimens with sufficient evidence to be recommended as first-line Combination NRT Long-acting formulation (patch) Produces relatively constant levels of nicotine PLUS Short-acting formulation (gum, lozenge*, inhaler, nasal spray) Allows for acute dose titration as needed for nicotine withdrawal symptoms *No combination data with lozenge were available when the CPG published Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

29 Plasma Nicotine Concentrations 25 Cigarette Cigarette Plasma nicotine (mcg/l) Moist snuff Moist snuff Nasal spray Inhaler Lozenge (2mg) Gum (2mg) Patch 0 1/0/ /10/ /20/1900 1/30/1900 2/9/ /19/ /29/ Time (minutes)

30 Multiple Treatment Comparison Meta-Analysis Comparison Odds ratio (95% CI) Nicotine gum vs Placebo 1.7 ( ) Nicotine patch vs Placebo 1.9 ( ) Other NRT* vs Placebo 2.0 ( ) Combination NRT vs Placebo 2.7 ( ) *Includes nicotine nasal spray, lozenge, and inhaler Strong evidence that combination NRT is more effective than NRT monotherapy Cahill et al. (2013). Cochrane Database Syst Rev 5:CD

31 Combination NRT: Recommended Regimens Nicotine patch Dose: 21 mg/day x 4 6 wks 14 mg/day x 2 wks 7 mg/day x 2 wks PLUS Nicotine gum or lozenge (2 mg/4 mg; based on TTFC) Dose: Use 1 piece every 1 2 hours prn (use at least 4-5/day) OR Nicotine inhaler Dose: Use 1 cartridge (10 mg) every 1 2 hours prn OR Nicotine nasal spray Dose: Use 1 spray (0.5 mg) in each nostril every 1 2 hours prn

32 Combination NRT: Recommended Regimens Nicotine patch Dose: 21 mg/day x 4 6 wks 14 mg/day x 2 wks 7 mg/day x 2 wks PLUS Nicotine gum X or lozenge (2 mg/4 mg; based on TTFC) Dose: Use 1 piece every 1 2 hours prn (use at least 4-5/day) OR Nicotine inhaler Dose: Use 1 cartridge (10 mg) every 1 2 hours prn OR Nicotine nasal Xspray Dose: Use 1 spray (0.5 mg) in each nostril every 1 2 hours prn

33 OPTION #3: Bupropion SR Available for cessation: 150 mg tablets Considerations for Greg: Ease of use, twice-daily oral tablet Can be used in combination with NRT No medical history precluding use Might be beneficial in patients with depression Still smoking while on 300mg XL daily Dosing approaches Usual dose: 150mg every morning x 3 days, then 150mg twice daily x 7-12 weeks

34 OPTION #4: Varenicline Available for cessation: 0.5 and 1.0 mg tablets Considerations for Greg: Ease of use, twice-daily oral tablet Neuropsychiatric side effects in patients with psychiatric disorders Recent safety data for varenicline versus other agents (Anthenelli et al., 2016) Dosing approaches: Usual dose, with: Fixed Quit Flexible Quit Gradual Quit Anthenelli RM et al. Lancet 2016;387:

35 Varenicline: Standard Dosing Patients should begin therapy 1 week PRIOR to their quit date. The dose is gradually increased to minimize treatment-related nausea and insomnia. Initial dose titration Treatment Day Day 1 to day 3 Day 4 to day 7 Day 8 to end of treatment* Dose 0.5 mg daily 0.5 mg twice daily 1 mg twice daily * Up to 12 weeks, with an option to continue treatment in select patients.

36 Varenicline Quit Approaches FIXED QUIT approach Set quit date for 1 week after starting varenicline Continue treatment for 12 weeks FLEXIBLE QUIT approach Start taking varenicline and pick a quit date between 8 to 35 days from treatment initiation Continue treatment for 12 weeks GRADUAL QUIT approach Start taking varenicline and reduce smoking by 50% within the first 4 weeks, an additional 50% in the next 4 weeks, and continue until complete abstinence by 12 weeks Images from:

37 Multiple Treatment Comparison Meta-Analysis Comparison Odds ratio (95% CI) Nicotine gum vs Placebo 1.7 ( ) Bupropion SR vs Placebo 1.9 ( ) Nicotine patch vs Placebo 1.9 ( ) Other NRT* vs Placebo 2.0 ( ) Combination NRT vs Placebo 2.7 ( ) Varenicline vs Placebo 2.9 ( ) *Includes nicotine nasal spray, lozenge, and inhaler Strong evidence that varenicline is more effective than other monotherapies Cahill et al. (2013). Cochrane Database Syst Rev 5:CD

38 Selecting a Regimen for Greg INSERT TRIGGER TAPE Video (~5 seconds long) Male patient stating Chantix? Isn t that the drug that has all those horrible side effects?

39 Anthenelli RM et al. Lancet 2016;387:

40 Varenicline and Bupropion SR: Safety Update FDA-mandated clinical trial 24-week, double-blind; active and placebo-controlled: Varenicline: standard dosing, 12 weeks Bupropion SR: standard dosing, 12 weeks Nicotine patch: 21 mg/day with standard taper, 12 weeks Placebo, 12 weeks All arms: 13 counseling visits, 11 telephone calls Follow-up through 24 weeks Outcome = continuous abstinence Anthenelli RM et al. Lancet 2016;387:

41 Varenicline and Bupropion SR: Safety Update (cont d) Incidence of Moderate or Severe Neuropsychiatric Adverse Events Patient cohort Varenicline Bupropion SR Nicotine patch Placebo Non-psychiatric 1.3% 2.2% 2.5% 2.4% Psychiatric 6.5% 6.7% 5.2% 4.9% Anthenelli RM et al. Lancet 2016;387: No significant differences in neuropsychiatric events by treatment arm

42 Treatment arms: Efficacy (Weeks 9-24) Continuous Abstinence Patient cohort Varenicline Bupropion SR Nicotine patch Placebo Non-psychiatric 25% 19% 18% 11% Psychiatric 18% 14% 13% 8% Anthenelli RM et al. Lancet 2016;387: Highest efficacy with varenicline

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44 Audience Poll #2 Which of the following treatment options is most appropriate for Greg? A. Nicotine patch B. Short-acting NRT (gum, lozenge, inhaler, nasal spray) C. Combination NRT D. Varenicline E. I don t know

45 Summary of Therapy Options: Greg Preferred Options: Combination NRT (patch + short-acting formulation) Varenicline Less Preferred Option: NRT monotherapy with patch Inappropriate Options: NRT monotherapy (gum, lozenge, inhaler, nasal spray) Bupropion SR

46 14-day Follow-up with Greg INSERT TRIGGER TAPE Video (~15 seconds long) Male patient stating Thanks for following up, I really appreciate it. [pause] Yeah, I m doing better than I thought I would. Haven t had a cigarette in a week. [nod] Yep Yep Nope not really any issues other than I ve been having a hard time sleeping. Do you think that s the Chantix? What questions do you want to ask Greg?

47 Audience Poll #3 Which of the following might be contributing to Greg s insomnia? (check all that apply) A. Drug interaction between tobacco smoke and caffeine B. Wellbutrin XL C. Varenicline D. Nicotine withdrawal symptoms E. I don t know

48 Drug Interaction: Tobacco Smoke and Caffeine Constituents in tobacco smoke induce CYP1A2 enzymes, which metabolize caffeine Caffeine levels increase ~56% upon quitting Nicotine withdrawal effects might be enhanced by increased caffeine levels Decrease caffeine intake by 50% when quitting; no caffeine after 1PM for normal sleep/wake cycle Interaction is due to combustion products of tobacco, NOT nicotine.

49 Nicotine Withdrawal Effects Irritability/frustration/anger Anxiety Difficulty concentrating Restlessness/impatience Depressed mood/depression Insomnia Impaired performance Increased appetite/weight gain Cravings Most symptoms manifest within the first 1 2 days, peak within the first week, and subside within 2 4 weeks. Hughes. (2007). Nicotine Tob Res 9:

50 Case B: Natalie 37 yo, presenting with chronic respiratory symptoms x 6 mo; productive cough, SOB, decreased exercise tolerance Current meds: hormonal contraception (NuvaRing) PCP has strongly encouraged smoking cessation to manage respiratory symptoms No health insurance; concerned about costs of quitting What questions do you want to ask Natalie?

51 Pharmacist s Patient Care Process Collect Ask about tobacco use and prior quit attempts Query patients regarding key issues Assess Readiness to quit Plan Facilitate quitting process; set a quit date Develop behavioral and pharmacologic treatment plan Implement Check for understanding and commitment to quit Follow-up: Monitor and Evaluate Monitor patient s progress throughout quit attempt

52 Key Considerations for Natalie Key points to consider for medication selection: 20 cig/day, smokes within 10 min of waking Multiple failed quit attempts: hypnosis, acupuncture, cold turkey; no prior cessation medications or behavioral counseling History of bulimia in high school Female >35 yo on HC (increased risk) Interested in ENDS for cessation Has friend who used ENDS and decreased from 1 pack to ¼ pack per day

53 Audience Poll #4 Which of the following treatment options is most appropriate for Natalie? A. NRT initiated BEFORE the quit date B. Varenicline C. Bupropion SR D. Electronic nicotine delivery system E. I don t know

54 OPTION #1: Nicotine Patch Initiated Before the Quit Date Pre-Quit NRT ( nicotine preloading ) Use of NRT before the quit date (e.g., while smoking) Rationale Smoking while using NRT might reduce the reinforcing effects of inhaled nicotine from smoking Abrupt cessation and medication initiation problematic Early exposure to NRT can allow for (1) early dosage adjustment; (2) familiarity with the product; (3) enhanced confidence as the quit date approaches Concerns Potential for additive nicotine toxicity

55 Pre-Quit Initiation of NRT: Summary of Evidence Published RCTs (n=8*; >2,700 subjects) Baseline characteristics of study subjects Motivated to quit smoking Heavier smokers (mean, 25 CPD; range, 19-30) Pooled results show a modest but non-significant increase in quit rates with pre-quit NRT (RR 1.18, 95% CI ) Analysis of nicotine patch trials suggests a more pronounced response (RR 1.34, 95% CI ) Well tolerated no significant differences in SEs observed *NRT included patch (6 studies), lozenge (1 study), gum (1 study) Stead et al. (2012). Cochrane Database Syst Rev 11:CD

56 Rose et al. (2009). Nicotine Tob Res 11:

57 Nicotine Patch Initiated Before the Quit Date Percent quit Effect of pre-cessation nicotine patch use on long-term quit rates Nicotine patch (21 mg) x 2 weeks pre-quit Placebo patch x 2 weeks pre-quit p=0.03 at 6 months Weeks post-quit day Rose et al. (2009) Nicotine Tob Res 11:

58 Pre-Quit Initiation of NRT: Practical Considerations Limited evidence; not a routine first-line recommendation Most compelling evidence is with the patch formulation Treatment started 2 weeks before quit date (range, 2-4 weeks) Evidence for short-acting NRT is limited and unconvincing Gum and lozenge: not effective Nasal spray and inhaler: not studied Reserve for patients: With low confidence in medications (NRT) Working with smoking cessation specialists

59 OPTION #2: Varenicline Percent Considerations for Natalie: Ease of use, twice-daily oral tablet High efficacy No medical history precluding use Cost Varenicline vs placebo (n=27; 12,625 pts) Long-Term (>6 months) Quit Rates Varenicline vs bupropion SR (n=5; 5,877 pts) n=24,766 Varenicline vs NRT (n=5; 6,264 pts) Cahill et al. (2016). Cochrane Database Syst Rev 5:CD

60 Varenicline: Pros and Cons Pros Effective; 3-fold higher long-term quit rates vs. placebo Twice daily dosing; improved adherence Cons Screening and monitoring necessary for serious adverse effects Neuropsychiatric events Nausea / insomnia Cost

61 Comparative Daily Costs of Pharmacotherapy $16 $14 Average $/pack of cigarettes, $6.17 $12 $10 $/day $8 $6 $4 $2 $0 Bupropion Gum Lozenge Patch Nasal spray Inhaler SR Varenicline Trade $3.60 $3.60 $2.90 $7.99 $13.62 $8.25 $13.84 Generic $1.90 $3.33 $1.52 $ Wholesale acquisition cost from Red Book Online. Thomson Reuters, December Campaign for Tobacco-Free Kids. (2017). State Cigarette Excise Tax Rates & Rankings. Retrieved December 9, 2017, from

62 OPTION #3: Bupropion SR Pros Effective; 2-fold higher long-term quit rates vs. placebo Twice daily dosing; improved adherence Generic formulations available; less expensive Cons History of bulimia precludes use Screening and monitoring necessary for serious adverse effects Neuropsychiatric events Seizures

63 Bupropion SR: Contraindications, Warnings, and Precautions for Use Boxed Warning Increased risk of suicide in children, adolescents, and young adults Contraindications Seizure disorder Current or prior diagnosis of bulimia or anorexia nervosa Co-treatment with MAO inhibitors Known hypersensitivity to bupropion Warnings & Precautions Neuropsychiatric AEs and suicide risk in smoking cessation treatment Seizures (dose-related, other risk factors) Hypertension Psychosis and other neuropsychiatric reactions Angle closure glaucoma Hypersensitivity reactions GlaxoSmithKline Inc. (2017, May). Zyban Package Insert. Research Triangle Park, NC.

64 Bupropion SR: Seizure Prevalence in Clinical Trials Indication Dose (formulation) Seizures (n/n) % Bulimia mg TID (IR) 4/ Depression mg/day divided TID (IR) 13/3, Depression mg twice daily (SR) 3/3, Smoking cessation mg twice daily (SR) 6/5, IR= immediate-release; SR= sustained-release 1 Horne et al., J Clin Psychiatry (1988); 2 Johnston et al., J Clin Psychiatry (1991); 3 Dunner et al., J Clin Psychiatry (1998); 4 Hughes et al., Cochrane Database Syst Rev (2014)

65 OPTION #4: Electronic Nicotine Delivery System Devices similar in appearance to cigarettes, cigars, pipes, or pens Battery-operated devices that create a vapor for inhalation Simulates smoking but does not involve combustion of tobacco Also known as: E-cigarette, E-hookah, Hookah pen Vapes, Vape pen, Vape pipe Mods Images from Grana et al.,

66 ENDS for Cessation: Current Evidence Data from RCTs suggests ENDS are well-tolerated during short-term use Quality control for many products is lacking; consumers do not have reliable product information Adverse health effects associated with second-hand vapor exposure cannot be excluded Nicotine in ENDS solutions increases the risk of accidental poisoning Carcinogenic substances are present in some aerosols Battery safety concerns (e.g., overheating, fires, explosions), primarily with tank-models, pose additional health risks Health effects of long-term, regular use are unknown

67 ENDS for Cessation: Recommendations for Clinicians Assess ENDS use along with tobacco use during clinical encounters Actively discourage ENDS use in current non-smokers Until more is known about the potential risks, ENDS should not be promoted as a safe alternative to smoking ENDS have not been proven to be effective for cessation Until long-term efficacy data are available, clinicians should recommend evidence-based, FDA-approved treatments for smoking cessation

68 ENDS for Cessation: Recommendations for Clinicians (cont d) Evidence suggests that ENDS use is less harmful than smoking Potentially increased risk with dual use (tobacco + ENDS) ENDS might have a role in patients who are unable to quit smoking using proven methods Weigh risks and benefits on a case-by-case basis Currently, ENDS are unregulated; most contain low toxic constituents (in lower concentrations compared to tobacco smoke) Advise patients to quit smoking entirely even low levels of smoking impose significant health risks

69 ENDS: Risks of Dual Use with Cigarettes Health Consequences of Light Smoking Smoking 1-4 cigarettes/day is associated with significantly higher risk of dying from ischemic heart disease (both sexes) and lung cancer (females) 1 Light and intermittent smoking carry nearly the same risk for cardiovascular disease as does daily smoking 2 Light smokers (1-10 cigarettes/day) have higher all-cause mortality risk than do never smokers 3 There is no risk-free level of exposure to tobacco smoke 1 Bjartveir & Tverdal, Tobacco Control (2005); 2 Schane et al., Circulation (2010); 3 Inoue-Choi et al, JAMA Int Med (2017)

70 U.S. Position The current evidence is insufficient to recommend electronic nicotine delivery systems (ENDS) for tobacco cessation. Clinicians should direct patients who smoke tobacco to other cessation interventions with established effectiveness and safety. Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions. U.S. Preventive Services Task Force, September 2015.

71 Summary of Therapy Options: Natalie Preferred Option: Varenicline Less Preferred Option: NRT patch (initiated before the quit date) Inappropriate Options: Bupropion SR Electronic nicotine delivery systems Short-acting NRT (initiated before the quit date)

72 Drugs don t work in patients who don t take them. C. Everett Koop, M.D., former U.S. Surgeon General Medication adherence should be assessed at each encounter.

73 Key Take-Home Points Many options currently exist for treatment of tobacco use and dependence. Treatment should consist of behavioral counseling in combination with one or more medications for cessation (when not contraindicated). The most effective monotherapy medication is varenicline. Combination nicotine replacement therapy has comparable efficacy as varenicline. ENDS are not currently recommended for cessation. Treatment selection should be patient-specific.

74 Contact Information Robin Corelli, PharmD UCSF School of Pharmacy Karen Hudmon, DrPH, MS, RPh Purdue University College of Pharmacy

75 Assessment Question #1 According to data from clinical trials, which of the following is most most effective for smoking cessation? A. Bupropion SR B. Electronic nicotine delivery systems (e.g., e-cigarettes) C. Nicotine replacement therapy D. Varenicline

76 Assessment Question #2 Which of the following smoking cessation medications has a boxed warning for serious neuropsychiatric side effects? A. Bupropion SR B. Varenicline C. A and B D. None of the above

77 Assessment Question #3 Which of the following nicotine replacement therapy formulations has the most compelling evidence for use prior to the quit date? A. Gum B. Inhaler C. Lozenge D. Patch

78 Assessment Question #4 Which of the following is the most appropriate combination therapy dosing for a patient who smokes one pack of cigarettes/day and smokes his first cigarette within 30 minutes of waking? A. 21 mg nicotine patch daily + 4 mg nicotine lozenge every 1-2h while awake B. 21 mg nicotine patch daily + 4 mg nicotine lozenge every 1-2h prn C. 21 mg nicotine patch + 14 mg nicotine patch daily D. 4 mg nicotine lozenge four times daily + nicotine nasal spray every 1-2h while awake

79 Assessment Question #5 Which of the following statement is TRUE regarding electronic nicotine delivery systems (ENDS; e.g., e- cigarettes)? A. ENDS are a safe alternative to cigarette smoking B. ENDS have lower exposure to carcinogens and toxins than tobacco smoke C. ENDS have a lower risk for nicotine dependence D. Electronic cigarettes are more effective than nicotine replacement therapy for quitting