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NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY

NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY. “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. ADULT PER CAPITA CONSUMPTION OF TOBACCO, 1880-2000.

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NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY

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  1. NONPRESCRIPTION NICOTINEREPLACEMENT THERAPY

  2. “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

  3. ADULT PER CAPITA CONSUMPTION OF TOBACCO, 1880-2000 All forms of tobacco are harmful Adapted from NCI Smoking and Tobacco Control Monograph 8, 1997, p. 13. Data from U.S. Department of Agriculture. Reprinted with permission. Thun et al. Oncogene 2002;21:7307–7325.

  4. TRENDS in ADULT SMOKING, by SEX—U.S., 1955–2002 Trends in cigarette current smoking among persons aged 18 or older, by sex 22.5% of adults are current smokers Male 25.2% Percent Female 20.0% 70% want to quit Graph provided by the Centers for Disease Control and Prevention. 1955 Current Population Survey; 1965–2001 NHIS. Estimates since 1992 include some-day smoking.

  5. ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, 1995–1999 34% 28% 22% 9% 7% <1% TOTAL: more than 440,000 deaths annually Centers for Disease Control and Prevention. MMWR 2002;51:300–303.

  6. Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general. Quitting smoking has immediate as well as long-term benefits, reducing risks for diseases caused by smoking and improving health in general. Smoking cigarettes with lower machine-measured yields of tar and nicotine provides no clear benefit to health. Numerous diseases are caused by smoking. 2004 REPORT of the SURGEON GENERAL FOUR MAJOR CONCLUSIONS U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General, 2004.

  7. Cancers Lung Laryngeal, pharyngeal, oral cavity, esophagus Pancreatic Bladder and kidney Cervical and endometrial Gastric Acute myeloid leukemia Reduce fertility in women, poor pregnancy outcomes, low birth weight babies, sudden infant death syndrome Cardiovascular diseases Subclinical atherosclerosis Coronary heart disease Stroke Abdominal aortic aneurysm Respiratory diseases Acute respiratory illnesses, e.g., pneumonia Chronic respiratory diseases, e.g., COPD Cataract Periodontitis HEALTH CONSEQUENCES of SMOKING U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General, 2004.

  8. CAUSALLY ASSOCIATED HEALTH RISKS of SECOND-HAND SMOKE EVEN A LITTLE SECOND-HAND SMOKE IS DANGEROUS • Developmental effects • Fetal growth retardation, SIDS • Carcinogenic effects • Lung cancer, nasal sinus cancer • Cardiovascular effects • Heart disease mortality, acute and chronic CHD morbidity • Respiratory effects • Children: acute lower respiratory tract infections, asthma induction and exacerbation, chronic respiratory symptoms, middle ear infections • Adults: eye and nasal irritation National Cancer Institute. Health Effects of Exposure to Environmental Tobacco Smoke: The Report of the California Environmental Protection Agency, 1999.

  9. SMOKE-FREE WORKPLACE LAWS Exposure to second-hand smoke increases the risk of myocardial infarction. Smoke-free offices, restaurants, and bars: Delaware, California, Connecticut, Maine, Massachusetts, New York, Rhode Island Smoke-free offices and restaurants: Florida, Idaho, Vermont, Utah Smoke-free offices: Maryland

  10. ANNUAL SMOKING-ATTRIBUTABLE ECONOMIC COSTS—U.S., 1995–1999 Prescription drugs, $6.4 billion Other care, $5.4 billion Medical expenditures (1998) Ambulatory care, $27.2 billion Hospital care, $17.1 billion Nursing home, $19.4 billion Societal costs: $7.18 per pack Annual lost productivity costs (1995–1999) Men, $55.4 billion Women, $26.5 billion Billions of dollars Centers for Disease Control and Prevention.MMWR 2002;51:300–303.

  11. QUITTING: HEALTH BENEFITS Time Since Quit Date Circulation improves, walking becomes easier Lung function increases up to 30% Lung cilia regain normal function Ability to clear lungs of mucus increases Coughing, fatigue, shortness of breath decrease 2 weeks to 3 months 1 to 9 months Excess risk of CHD decreases to half that of a continuing smoker 1 year Risk of stroke is reduced to that of people who have never smoked 5 years Lung cancer death rate drops to half that of a continuing smoker Risk of cancer of mouth, throat, esophagus, bladder, kidney, pancreas decrease 10 years Risk of CHD is similar to that of people who have never smoked after 15 years

  12. CLINICAL PRACTICE GUIDELINE for TREATING TOBACCO USE and DEPENDENCE • Released June 2000 • Sponsored by the AHRQ (Agency for Healthcare Research and Quality) of the USPHS (US Public Heath Service) with: • CDC (Centers for Disease Control) • NCI (National Cancer Institute) • NIDA (National Institute for Drug Addiction) • NHLBI (National Heart Lung & Blood Institute) • RWJF (Robert Wood Johnson Foundation) http://www.surgeongeneral.gov/tobacco/

  13. The 5 A’s ASK ADVISE ASSESS ASSIST ARRANGE

  14. ASK • Ask about tobacco use • “Do you ever smoke or use any type of tobacco?” • “I take time to ask all of my patients about tobacco use—because it’s important.” The 5 A’s (cont’d)

  15. ADVISE • tobacco users to quit (clear, strong, personalized, sensitive) • “It’s important that you quit as soon as possible, and I can help you.” • “I realize that quitting is difficult. It is the most important thing you can do to protect your health now and in the future. I have training to help my patients quit, and when you are ready, I will work with you to design a specialized treatment plan.” The 5 A’s (cont’d)

  16. ASSESS • Assess readiness to make a quit attempt • Assist with the quit attempt ASSIST The 5 A’s (cont’d)

  17. The 5 A’s (cont’d) • Arrange follow-up care ARRANGE * 5 months (or more) postcessation PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPT Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, 2000.

  18. ASK about tobacco USE ADVISE tobacco users to QUIT ASSESS readiness to make a QUIT attempt ASSIST with the QUIT ATTEMPT ARRANGE FOLLOW-UP care THE 5 A’s: REVIEW

  19. Yes No Is the patient now ready to quit? Did the patient once use tobacco? No Yes Yes No Promote motivation Provide treatment The 5 A’s Prevent relapse* Encourage continued abstinence *Relapse prevention interventions not necessary if patient has not used tobacco for many years and is not at risk for re-initiation. IS a PATIENT READY to QUIT? Does the patient now use tobacco? Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, 2000.

  20. PHARMACOTHERAPY “All patients attempting to quit should be encouraged to use effective pharmacotherapies for cessation except in the presence of special circumstances.” Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, 2000.

  21. PHARMACOLOGIC METHODS: FIRST-LINE THERAPIES Two general classes of FDA-approved drugs for cessation: • Nicotine replacement therapy • Nicotine gum, patch, lozenge, nasal spray, inhaler • Psychotropics • Sustained-release bupropion

  22. FDA APPROVALS: SMOKING CESSATION 2002 Rx transdermal nicotine patch 1997 1996 OTC nicotine lozenge 1991 Rx nicotine inhaler; Rx bupropion SR Rx nicotine gum OTC nicotine gum & patch;Rx nicotine nasal spray 1984

  23. NRT: RATIONALE for USE • Reduces physical withdrawal from nicotine • Allows patient to focus on behavioral and psychological aspects of tobacco cessation IMPROVES SUCCESS RATES

  24. SYMPTOMS of NICOTINE WITHDRAWAL • Restlessness • Drowsiness • Fatigue • Impaired task performance • Nervousness • Sleep disturbances • Anger/irritability • Anxiety • Cravings • Difficulty concentrating • Hunger/weight gain • Impatience Hughes et al. Arch Gen Psychiatry 1991;48:52–59.

  25. Polacrilex Gum Nicorette (OTC) Generic nicotine gum (OTC) Lozenge Commit (OTC) Transdermal Patches Nicoderm CQ(OTC) Nicotrol (OTC) Generic nicotine patches (OTC, Rx) NRT: PRODUCTS Nasal Spray • Nicotrol NS (Rx) Inhaler • Nicotrol (Rx)

  26. PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS Cigarette Moist snuff 0 10 20 30 40 50 60 Time (minutes)

  27. NRT: PRECAUTIONS • Patients with underlying cardiovascular disease • Recent myocardial infarction • Life-threatening arrhythmias • Severe or worsening angina

  28. NRT: PRECAUTIONS (cont’d) • Patients with other underlying conditions • Active temporomandibular joint disease (gum only) • Pregnancy • Lactation Minimum age for FDA-approved NRT use: 18 years

  29. NICOTINE GUM: Nicorette; generic (GlaxoSmithKline; Watson Labs) • Approved for Rx use in 1984; OTC in 1996 • Resin complex • Nicotine • Polacrilin • Sugar-free chewing gum base • Buffering agents to enhance buccal absorption of nicotine • Available: 2 mg, 4 mg; regular, mint, orange

  30. NICOTINE GUM: DOSING Dosage based on current smoking patterns:

  31. NICOTINE GUM: DOSING (cont’d)

  32. NICOTINE GUM:DIRECTIONS for USE • Use gum according to recommended dosing schedule (to decrease cravings & withdrawal symptoms) • Chew each piece very slowly several times • Stop chewing at first sign of peppery, minty, or citrus taste or of slight tingling in mouth (~15 chews, but varies) • “Park” gum between cheek & gum (to allow absorption of nicotine across buccal mucosa)

  33. NICOTINE GUM:DIRECTIONS for USE (cont’d) • Resume slow chewing when taste or tingle fades • When taste or tingle returns, stop and park gum in different place in mouth • Repeat chew/park steps until most of the nicotine is gone (taste or tingle does not return; generally 30 minutes)

  34. NICOTINE GUM:CHEWING TECHNIQUE SUMMARY Chew slowly Chew again when the taste or tingle fades Stop chewing at first sign of peppery, minty, or citrus taste or tingle Park

  35. NICOTINE GUM:GRADUAL REDUCTION of DOSE Recommended strategies for discontinuing use of nicotine gum: • Chew gum for 10–15 minutes instead of 30 minutes • Chew each piece for more than 30 minutes but reduce the number of pieces used daily • Substitute ordinary chewing gum for nicotine gum

  36. NICOTINE GUM: ADDITIONAL PATIENT EDUCATION • To improve chances of quitting, use at least nine pieces of gum daily • The effectiveness of nicotine gum may be reduced by some foods and beverages:  Coffee Juices Wine Soft drinks Do NOT eat or drink for 15 minutes BEFORE or while using nicotine gum.

  37. NICOTINE GUM:ADD’L PATIENT EDUCATION(cont’d) • Chewing gum will not provide same rapid satisfaction that smoking provides • Chewing gum too rapidly can cause excessive release of nicotine, resulting in • Lightheadedness • Nausea/vomiting • Irritation of throat and mouth • Hiccups • Indigestion

  38. NICOTINE GUM:ADD’L PATIENT EDUCATION(cont’d) • Side effects of nicotine gum include • Mouth soreness • Hiccups • Dyspepsia • Jaw muscle ache • Nicotine gum may stick to dental work • Discontinue use if excessive sticking or damage to dental work occurs

  39. NICOTINE GUM: SUMMARY DISADVANTAGES • Gum chewing may not be socially acceptable. • Gum is difficult to use with dentures. • Patients must use proper chewing technique to minimize adverse effects. ADVANTAGES • Gum use may satisfy oral cravings. • Gum use may delay weight gain. • Patients can titrate therapy to manage withdrawal symptoms.

  40. NICOTINE LOZENGECommit (GlaxoSmithKline) • Approved for OTC use in 2002 • Nicotine polacrilex formulation • Delivers ~25% more nicotine than equivalent gum dose • Available: 2 mg, 4 mg

  41. NICOTINE LOZENGE: DOSING Dosage based on the “time to first cigarette” (TTFC) as an indicator of nicotine addiction.

  42. NICOTINE LOZENGE: DOSING (cont’d)

  43. NICOTINE LOZENGE:DIRECTIONS for USE (cont’d) • Do not chew or swallow the lozenge • Occasionally rotate the lozenge to different areas of the mouth • Lozenge will completely dissolve in about 2030 minutes

  44. NICOTINE LOZENGE: ADDITIONAL PATIENT EDUCATION • To improve chances of quitting, use at least nine lozenges daily during the first 6 weeks • The lozenge will not provide same rapid satisfaction that smoking provides • The effectiveness of nicotine lozenge may be reduced by some foods and beverages:  Coffee Juices Wine  Soft drinks Do NOT eat or drink for 15 minutes BEFORE or while using nicotine lozenge.

  45. NICOTINE LOZENGE:ADD’L PATIENT EDUCATION(cont’d) • Side effects of nicotine lozenge include • Nausea • Hiccups • Cough • Heartburn • Headache • Flatulence • Insomnia

  46. NICOTINE LOZENGE: SUMMARY DISADVANTAGES • Gastrointestinal side effects (nausea, hiccups, and heartburn) may be bothersome. ADVANTAGES • Lozenge use may satisfy oral cravings. • The lozenge is easy to use and conceal. • Patients can titrate therapy to manage withdrawal symptoms.

  47. TRANSDERMAL NICOTINE PATCH • Approved for Rx use in 1991; OTC in 1996 • Current products include • Nicoderm CQ PatchOTC (GlaxoSmithKline) • Nicotrol PatchOTC (Pharmacia) • Generic ProductsRx, OTC

  48. TRANSDERMAL NICOTINE PATCH • Nicotine is well absorbed across the skin • Delivery to systemic circulation avoids hepatic first-pass metabolism • Plasma nicotine levels are lower, fluctuate less than with smoking • Relieve nicotine withdrawal • Low potential for dependence (compared to rapid delivery systems)

  49. TRANSDERMAL NICOTINE PATCH:PREPARATION COMPARISON

  50. TRANSDERMAL NICOTINE PATCH: DOSING

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