NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY

NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY
This program focuses on nonprescription nicotine replacement therapy options for promoting tobacco cessation. Tobacco use is a complex, addictive behavior. Research shows that pharmacotherapy in combination with a behavioral intervention substantially increases patients’ likelihood of quitting (Fiore et al., 2000). Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000.

is the chief, single, avoidable cause of death
“CIGARETTE SMOKING… is the chief, single, avoidable cause of death in our society and the most important public health issue of our time.” As the former U.S. Surgeon General C. Everett Koop noted, “Cigarette smoking is the chief, single, avoidable cause of death in our society and the most important public health issue of our time” (USDHHS, 1982). This statement was published in a Surgeon General’s report in 1982 and remains true today, more than two decades later. Approximately 100 million persons died due to tobacco in the 1900s—which is just a fraction of the number that we anticipate losing during the first century of the 2000s. In 2002 alone, an estimated 4.83 million premature deaths occurred world-wide due to tobacco—2.41 million in developing countries and 2.43 million in industrialized nations (Ezzati & Lopez, 2003). Epidemiologist Richard Peto (2000) predicted that an additional 900 million persons are likely to die due to tobacco use over the next 100 years, if the current trends continue, bringing the two-century death toll to 1 billion lives lost. As the death toll continues to increase, public health efforts continue to work toward finding effective ways to (1) prevent the onset of tobacco use and (2) help patients quit using tobacco. Health care professionals can have an important public health impact by helping to counter tobacco use. However, research studies consistently demonstrate that students in the health professions receive insufficient training for assisting patients with quitting. Ezzati M, Lopez AD. Estimates of global mortality attributable to smoking in Lancet 2003;362: Peto R. Presented at Society for Research on Nicotine and Tobacco International Meeting, November 2000, London, England. U.S. Department of Health and Human Services. The Health Consequences of Smoking: Cancer. A Report of the Surgeon General. Rockville, MD: Public Health Service, Office on Smoking and Health, DHHS Publication No. (PHS) , 1982. C. Everett Koop, M.D., former U.S. Surgeon General

ADULT PER CAPITA CONSUMPTION OF TOBACCO, 1880-2000
All forms of tobacco are harmful This figure depicts the shifts in per capita consumption for the various tobacco products in the United States between 1880 and 2000 (Thun et al., 2002). During the late 19th and early 20th centuries, tobacco use was predominantly in the form of chewing tobacco, cigars, pipes and snuff. Now, the cigarette is the leading form of tobacco use in the United States. All forms of tobacco are harmful. Thun MJ, Henley SJ, Calle EE. Tobacco use and cancer: an epidemiologic perspective for geneticists. Oncogene 2002;21:7307–7325. 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.

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 This graph demonstrates trends in smoking among adults in the U.S. between 1955 and 2002 (CDC, 1999; CDC, 2004). Since 1990, the smoking prevalence among men and women has experienced only a slight decline, compared to previous decades, highlighting a need for enhanced tobacco control efforts (CDC, 1999; US DHHS, 2000). In 2002, results of the National Health Interview Survey indicated that approximately 45.8 million adults (22.5% of the U.S. adult population) are current smokers;* of these, 81.8% smoke every day and 18.2% smoke some days (CDC, 2004). Also in 2002, an estimated 46.0 million adults were former smokers,** representing 50.1% of persons who had ever smoked (CDC, 2004). This is the first time that more than half of ever smokers (persons who smoked at least 100 cigarettes in their lifetime) were former smokers. An estimated 70% of all smokers want to quit completely (CDC, 2002). In 2002, approximately 15.4 million (41.2%) every-day, current smokers stopped smoking at least 1 day during the past 12 months because they were trying to quit (CDC, 2004). ♪ Note to instructor(s): Cessation statistics vary depending on factors such as the duration of follow-up, definitions of abstinence, and whether reports of cessation were biologically confirmed. The Centers for Disease Control and Prevention (2002) report that 4.7% of smokers who had smoked every day or some days during the past year had quit and were able to maintain abstinence for 3 to 12 months in 2000. * Current smokers: persons who reported having smoked 100 or more cigarettes during their lifetime and who smoked every day or some days at the time of the interview. ** Former smokers: persons who reported having smoked 100 or more cigarettes during their lifetime but currently did not smoke. Centers for Disease Control and Prevention. Achievements in public health, 1900–1999: Tobacco use—United States, 1900–1999. MMWR 1999;48:986–993. Centers for Disease Control and Prevention. Cigarette smoking among adults—United States, MMWR 2002;51:642–645. Centers for Disease Control and Prevention. Cigarette smoking among adults—United States, MMWR 2004;53: 25.2% Percent Female 20.0% 70% want to quit Graph provided by the Centers for Disease Control and Prevention Current Population Survey; 1965–2001 NHIS. Estimates since 1992 include some-day smoking.

TOTAL: more than 440,000 deaths annually
ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, 1995–1999 Cardiovascular diseases 149,000 34% Lung cancer 125,000 28% Respiratory diseases 98,000 22% We now know that cigarette smoking is the #1 known preventable cause of premature death in the U.S. Each year, nearly half a million Americans die from cigarette smoking; one of every five deaths in the U.S. is smoking related (CDC, 1999). This number surpasses the combined death toll due to alcohol, car accidents, suicides, homicides, HIV disease, and illicit drug use. Average number of years of life lost because of smoking, for male and female smokers (CDC, 2002): Males 13.2 years Females 14.5 years A total of 442,398 annual deaths due to cigarette smoking are reported by the CDC as follows (CDC, 2002): Cardiovascular disease………… 148,605 Hypertension, ischemic heart disease, other heart diseases, cerebrovascular diseases, atherosclerosis, aortic aneurysm, other arterial disease Lung cancer………………………124,813 Trachea, lung, bronchus Respiratory diseases…………….. 98,007 Pneumonia, influenza, bronchitis, emphysema, chronic airway obstruction Second-hand smoke……………....38,053 Cancers other than lung…………..30,948 Lip, oral cavity, pharynx, esophagus, pancreas, larynx, cervix, uterus, urinary bladder, kidney, other urinary Other………………………………….1,972 Note that the second-hand smoke estimate of 53,000 lives lost (shown in the slide) derives from the NCI monograph Health Effects of Exposure to Environmental Tobacco Smoke (National Cancer Institute, 1999). Data presented in the slide are rounded for simplicity. Centers for Disease Control and Prevention. Achievements in public health, 1900–1999: Tobacco use—United States, 1900–1999. MMWR 1999;48:986–993. Centers for Disease Control and Prevention. Annual smoking-attributable mortality, years of potential life lost, and economic costs—United States, 1995–1999. MMWR 2002;51:300–303. National Cancer Institute. Health Effects of Exposure to Environmental Tobacco Smoke: The Report of the California Environmental Protection Agency. Smoking and Tobacco Control Monograph No. 10. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, NIH Publication No , 1999, pp. 185–264. Second-hand smoke 53,000 9% Cancers other than lung 31,000 7% Other 2,000 <1% TOTAL: more than 440,000 deaths annually Centers for Disease Control and Prevention. MMWR 2002;51:300–303.

2004 REPORT of the SURGEON GENERAL
FOUR MAJOR CONCLUSIONS 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. The four major conclusions of the 2004 Surgeon General’s Report on the health consequences of smoking are: (1) Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general. (2) Quitting smoking has immediate as well as long-term benefits, reducing risks for diseases caused by smoking and improving health in general. (3) Smoking cigarettes with lower machine-measured yields of tar and nicotine provides no clear benefit to health. (4) The list of diseases (shown on next slide) caused by smoking has been expanded to include abdominal aortic aneurysm, acute myeloid leukemia, cataract, cervical cancer, kidney cancer, pancreatic cancer, pneumonia, periodontitis, and stomach cancer. These are in addition to diseases previously known to be caused by smoking, including bladder, esophageal, laryngeal, lung, oral, and throat cancers, chronic lung diseases, coronary heart and cardiovascular diseases, as well as reproductive effects and sudden infant death syndrome. Smoking remains the leading cause of preventable death and has negative impacts on people at all stages of life. It harms unborn babies, infants, children, adolescents, adults, and seniors. U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2004. U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General, 2004.

HEALTH CONSEQUENCES of SMOKING
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 The 2004 Surgeon General’s Report on the health consequences of smoking describes a long list of diseases with sufficient evidence to infer a causal relationship with smoking. ♪ Note to instructor(s): For more detailed information and literature citations regarding risks for these tobacco-related illnesses, refer to the Pathophysiology of Tobacco-Related Disease module or the Surgeon General’s Report at U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Available at Accessed May 29, 2004. U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General, 2004.

CAUSALLY ASSOCIATED HEALTH RISKS of SECOND-HAND SMOKE
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 EVEN A LITTLE SECOND-HAND SMOKE IS DANGEROUS As noted previously, an estimated 53,000 persons die annually in the United States due to second-hand smoke exposure. Despite the tobacco industry’s efforts to cast doubt on the link between second-hand smoke and health risks, few scientists and clinicians would deny that second-hand smoke is harmful. Even a little exposure is dangerous, because it alters endothelial function, immediately compromising the cardiovascular system (Otsuka et al., 2001). A report of the California Environmental Protection Agency (National Cancer Institute, 1999) summarizes the effects that are causally associated with second-hand smoke exposure. These include: Developmental effects: fetal growth (low birthweight or small for gestational age) and sudden infant death syndrome (SIDS) Respiratory effects in children: acute lower respiratory tract infections (e.g., bronchitis and pneumonia), asthma induction and exacerbation, chronic respiratory symptoms, and middle ear infections in children Respiratory effects in adults: eye and nasal irritation Carcinogenic effects: lung cancer and nasal sinus cancer Cardiovascular effects: heart disease mortality and acute and chronic coronary heart disease morbidity Effects with suggestive evidence of a causal association with second-hand smoke exposure include (not shown in slide): Developmental effects: spontaneous abortion and adverse impact on cognition and behavior Respiratory effects: exacerbation of cystic fibrosis, decreased pulmonary function Carcinogenic effects: cervical cancer Additionally, recent evidence suggests that second-hand smoke exposure is associated with pediatric dental caries (Aligne et al., 2003). Aligne CA, Moss ME, Auinger P, Weitzman M Association of pediatric dental caries with passive smoking. JAMA 2003;289: National Cancer Institute. Health Effects of Exposure to Environmental Tobacco Smoke: The Report of the California Environmental Protection Agency. Smoking and Tobacco Control Monograph No. 10. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, NIH Publication No , 1999, pp. 185–264. Otsuka R, Watanabe H, Hirata K, Tokai K, Muro T, Yoshiyama M, Takeuchi K, Yoshikawa J. Acute effects of passive smoking on the coronary circulation in healthy young adults. JAMA 2001;286: National Cancer Institute. Health Effects of Exposure to Environmental Tobacco Smoke: The Report of the California Environmental Protection Agency, 1999.

SMOKE-FREE WORKPLACE LAWS
Exposure to second-hand smoke increases the risk of myocardial infarction. In recent months, there has been a substantial increase in the number of states, and countries outside of the United States, that have implemented new smoke-free workplace laws. Indeed, the Centers for Disease Control and Prevention (CDC) has advised that people with cardiac conditions should avoid exposure to secondhand smoke as it can significantly increase the risk of a myocardial infarction. This warning follows on the heels of a study (Sargent et al., 2004) reporting that the number of hospital admissions for MI in Helena, Montana decreased by 40% after indoor smoking was banned in the city, and then rapidly returned to baseline levels when the smoking ban was overturned. During the same six months in the years before and after the law, the average number of admissions was 40 compared with a total of 24 admissions during the six months of the law. This is the first study to report such an association, and like any initial report, further research is needed to confirm these findings. However, the observation that admission rates for MI fell in the area where the law was implemented, but not outside the area, suggests that smoke-free laws not only protect people from the long term dangers of secondhand smoke but that they may also be associated with a rapid reduction in heart attacks. ♪ Note to instructor(s): Regular updates about smoke-free workplace laws can received by joining Joe Cherner’s listserv at The data presented in the slide are current as of July 13, 2004. Sargent R, Shepard R, Glantz S, Reduced incidence of admissions for myocardial infarction associated with public smoking ban: before and after study. BMJ 2004:328: 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

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 The economic costs of smoking to society are enormous (CDC, 2002). In 1998, personal health-care medical expenditures attributable to smoking in the U.S. were $75.5 billion: Ambulatory care $ million Hospital care $ billion Prescription drugs $6.364 billion Nursing home care $ billion Other care $5.419 billion Total $ billion The annual smoking-attributable productivity costs (in 1995–1999) are estimated at Men $ billion Women $ billion Total $ billion Infant (neonatal) costs (not shown in the slide) are estimated at $366 million, although this likely is understated because the value does not include future medical care costs for infants affected by maternal smoking or the current costs of treating infants for conditions related to passive exposure to tobacco smoke. Grand total annual smoking-attributable economic costs for adults and infants in the United States, 1995–1999 = $ billion. This is approximately $3,391 annually for each smoker. For each pack of cigarettes sold in 1999 (approximately 22 billion sold), $3.45 was spent on medical care attributed to smoking and $3.73 in productivity losses were incurred, for a total cost of $7.18 per pack of cigarettes (CDC, 2002). Centers for Disease Control and Prevention. Annual smoking-attributable mortality, years of potential life lost, and economic costs—United States, 1995–1999. MMWR 2002;51:300–303. 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.

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 The 1990 Surgeon General’s Report on the health benefits of smoking cessation outlines the numerous and substantial health benefits incurred when patients quit smoking (USDHHS, 1990). Health benefits realized 2 weeks to 3 months after quitting include the following: circulation improves, walking becomes easier, and lung function increases up to 30%. One to nine months later, lung ciliary function is restored. This improved mucociliary clearance greatly decreases the chance of infection because the lung environment is no longer as conducive to bacterial growth. Consequently, coughing, sinus congestion, fatigue, and shortness of breath decrease. In some patients, coughing might actually increase shortly after quitting. This is because the cilia in pulmonary epithelial cells are functioning “normally” and are more effectively clearing the residual tars and other accumulated components of tobacco smoke. One year later, excess risk of coronary heart disease is decreased to half that of a smoker. After 5 to 15 years, stroke risk is reduced to a rate similar to that of people who have never smoked. Ten years after quitting, an individual’s chance of dying of lung cancer is approximately half that of continuing smokers. Additionally, the chance of getting mouth, throat, esophagus, bladder, kidney, or pancreatic cancer is decreased. Finally, 15 years after quitting, an individual’s risk of coronary heart disease is reduced to a rate that is similar to that of people who have never smoked. Thus, the benefits of quitting are significant. It is never too late to quit to incur many of the benefits of quitting. The next two slides depict some advantages of quitting earlier in life, as opposed to later. American Cancer Society. American Lung Association. U.S. Department of Health and Human Services. The Health Benefits of Smoking Cessation. A Report of the Surgeon General. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention and Health Promotion, Office on Smoking and Health. DSSH Publication No. (CDC) , 1990. 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

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) In June 2000, the U.S. Public Health Service published a Clinical Practice Guideline for treating tobacco use and dependence (Fiore et al., 2000). This guideline, which summarizes over 6,000 articles in the literature, reaches a consensus on strategies and recommendations designed to assist health care providers in delivering state-of-the-art interventions for smoking cessation. The slides that follow describe feasible, practical, and effective behavioral strategies that clinicians can apply when assisting patients with quitting. These strategies derive from recommendations set forth in the Clinical Practice Guideline. The complete Guideline, along with supportive materials, is available at: Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000.

The 5 A’s ASK ADVISE ASSESS ASSIST ARRANGE
The Clinical Practice Guideline (Fiore et al., 2000) delineates five key components for tobacco cessation interventions. These components, referred to as the 5 A’s, offer a practical method for implementing tobacco counseling in clinical practice. The 5 A’s are as follows: Ask Advise Assess Assist Arrange ♪ Note to instructor(s): The 5 A’s presented in the guideline are a modified form of the National Cancer Institute’s original 5 A’s (Anticipate [tobacco use], Ask, Advise, Assist, and Arrange; Frankowski & Secker-Walker, 1994; Glynn & Manley, 1990). Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Frankowski BL, Secker-Walker RH. Pediatricians’ Role in Smoking Prevention and Cessation. Smoking and Tobacco Control Monograph No. 5. Bethesda, MD: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Cancer Institute. NIH Publication No , 1994. Glynn TJ, Manley MW. How to Help Your Patients Stop Smoking: A National Cancer Institute Manual for Physicians. Bethesda, MD: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Cancer Institute. NIH Publication No , 1990. ASSESS ASSIST ARRANGE

The 5 A’s (cont’d) 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.” ASK Ask. Tobacco smoke has the potential to interact with many medications, altering both drug levels and efficacy. Tobacco use also can induce early onset of disease and exacerbate existing medical conditions. It is appropriate, if not essential, for clinicians to assess and document each patient’s tobacco use status, preferably at each visit. Clinicians should think of tobacco use as being as important as evaluating vital signs during a routine medical screening and should ask about tobacco in the same way that they would ask about any other drug when obtaining a medication history. Clinicians also should consider including a query about tobacco use on the patient profile form that new patients complete. At a minimum, the form should assess tobacco use status (i.e., current, former, never). Appropriate language for assessing tobacco use status would be: “Do you ever smoke or use any type of tobacco?” This question will capture not only cigarette smoking, but all forms of tobacco. The query can be linked to the clinician’s knowledge of a patient’s disease status or medication profile. When asking about tobacco use, it is important to take a genuine and sensitive approach, conveying concern for the patient’s well-being. A judgmental tone likely will not result in accurate disclosure of tobacco use. ♪ Note to instructor(s): Refer students to the Tobacco Cessation Counseling Guidesheet for language for asking about tobacco use.

The 5 A’s (cont’d) 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.” ADVISE Advise. It is the clinician’s responsibility to improve the health of patients. Patients who use tobacco should be strongly advised to quit. At the very least, these patients should be advised to consider quitting. The message should be clear and strong, yet personalized and sensitive. The message must be delivered without judgment—or the clinician will likely waste that “teachable moment” and potentially alienate his or her patient. Tone and manner should convey a concern for the patient’s well-being as well as a commitment to help him or her quit—when the patient is ready. Consider the following statements: “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 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 clinician can personalize the message by tying tobacco use to current health or illness; its social and economic costs; the patient’s motivation level and readiness to quit; or the impact of tobacco use on children, others in the household and in their environment, and pets. For example: “If you continue to smoke, your [disease] will worsen/fail to improve.” Using a genuine and sensitive approach that acknowledges the difficulty of what is being requested, the clinician might move the patient forward in the process of preparing to quit.

The 5 A’s (cont’d) ASSESS Assess readiness to make a quit attempt
Assist with the quit attempt ASSIST Assess. After advising the patient to quit, the next step is to assess his or her readiness, or willingness, to try to quit. Is the patient considering quitting in the next month? Or did he or she quit recently? Assist. The patient’s readiness to try to quit will define the next course of action, which is delivering an intervention tailored to his or her needs. By being a good listener and gathering appropriate information, the clinician can effectively tailor the interventions. A patient who is not ready to quit will receive a very different type of intervention than will one who is ready to quit in the upcoming weeks. For the patient who is not ready to quit, a motivational intervention should be provided. If the patient is ready to quit in the next 30 days, appropriate counseling and assistance should be provided. The clinician could suggest that the patient enroll in a structured, intensive tobacco cessation program, to increase the likelihood of quitting—this is particularly important for persons who are at high risk of relapse or for patients who are highly dependent, refractory smokers (i.e., having made multiple serious quit attempts). Other patient populations that might be particularly well suited for structured programs include adolescent smokers, pregnant smokers, and patients with coexisting psychiatric conditions. A patient who recently quit (i.e., in the past 6 months) will need continued support and encouragement, and reminders regarding the need to abstain from all tobacco use—even a puff. A patient who has been off of tobacco for more than 6 months typically is relatively stable but often needs to be reminded to remain vigilant for potential triggers for relapse.

PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPT
The 5 A’s (cont’d) Arrange follow-up care ARRANGE Number of sessions Estimated quit rate* 0 to 1 12.4% 2 to 3 16.3% 4 to 8 20.9% More than 8 24.7% Arrange. The clinician should make certain to arrange for follow-up care and patient monitoring. With each contact, it is important to document the counseling session. These records can provide a starting point for subsequent discussions. Follow-up visits can be arranged in several ways. For example, the clinician can do the following: “Check in” with the patient when he or she next returns. Schedule specific follow-up visits to discuss tobacco cessation. Invite the patient to enroll in a tobacco cessation group with which the clinician is affiliated. With prior approval, call the patient at home to see how he or she is progressing. [If a message is left, the clinician should not indicate that he or she is calling regarding a quit attempt—this might be private information that the patient does not want others to hear.] Document key dates (e.g., quit dates, tobacco-free anniversaries); acknowledge important milestones. A follow-up contact should be scheduled within the first week after the quit date. The next follow-up is recommended within the first month. Further follow-up contact should be scheduled as needed or indicated. During the follow-up contacts, the patient should be congratulated for success. If tobacco use has occurred, the circumstances should be reviewed and a commitment sought to return to total abstinence. The patient should be reminded that lapses (slips) occur as part of the normal learning process and should be viewed as such. Pharmacotherapy use should be assessed, including compliance and side effects experienced. When appropriate, referral to more intensive treatment should be considered. According to the Clinical Practice Guideline (Fiore et al., 2000), multiple patient contacts are associated with higher quit rates. The estimated quit rates, based on number of treatment sessions (i.e., counseling contact sessions) are presented in this slide. Even brief interventions (i.e., asking about tobacco use and advising to quit) can increase patients’ readiness to quit. In a meta-analysis of trials assessing the effects of cessation advice from medical practitioners (Silagy & Stead, 2003), brief advice was associated with an increased likelihood of quitting (odds ratio, 1.69) versus no advice (or usual care); in addition, more intensive advice led to higher likelihood of quitting when compared to more minimal advice (odds ratio, 1.44). ♪ Note to instructor(s): A dose-response relationship also exists for the counseling session length and the total amount of contact time (combining across treatment sessions). The greater the amount of time spent with the patient, the more likely the patient is to achieve abstinence (Fiore et al ). Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Silagy C, Stead LF. Physician advice for smoking cessation (Cochrane Review). In: The Cochrane Library, Issue 2, Oxford: Update Software. * 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.

readiness to make a QUIT attempt
THE 5 A’s: REVIEW ASK about tobacco USE ADVISE tobacco users to QUIT As a final review, the 5 A’s are Ask about tobacco use. Advise tobacco users to quit. Assess readiness make a quit attempt. Assist with the quit attempt. Arrange follow-up care. Each of these is a key component of comprehensive tobacco cessation counseling interventions. ASSESS readiness to make a QUIT attempt ASSIST with the QUIT ATTEMPT ARRANGE FOLLOW-UP care

IS a PATIENT READY to QUIT?
Does the patient now use tobacco? Is the patient now ready to quit? Provide treatment The 5 A’s Promote motivation Yes No Did the patient once use tobacco? Prevent relapse* Encourage continued abstinence Yes No *Relapse prevention interventions not necessary if patient has not used tobacco for many years and is not at risk for re-initiation. This flow chart, which is presented in the Clinical Practice Guideline for treating tobacco use and dependence (Fiore et al., 2000), describes how to determine a patient’s readiness to quit and the general types of interventions that should be applied. Treatment for patients who are ready to quit should include all five of the key counseling components (the 5 A’s). Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, 2000.

PHARMACOTHERAPY “All patients attempting to quit should be encouraged to use effective pharmacotherapies for cessation except in the presence of special circumstances.” The U.S. Public Health Service Clinical Practice Guideline for treating tobacco use and dependence states that “All patients attempting to quit should be encouraged to use effective pharmacotherapies for smoking cessation except in the presence of special circumstances.” Use of pharmacotherapy requires special consideration in the following patient populations (Fiore et al., 2000): Patients with medical contraindications Patients smoking fewer than 10 cigarettes per day (light smokers) Pregnant or breast-feeding women Adolescents Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, 2000.

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 There are two general classes of FDA-approved drugs for cessation: Nicotine replacement therapy (NRT), which includes the nicotine gum, patch, lozenge, nasal spray, and inhaler. A nicotine sublingual tablet currently is available in Europe. Psychotropics such as bupropion SR, although other agents currently are being tested in clinical trials. According to the U.S. Public Health Service Clinical Practice Guideline for treating tobacco use and dependence, these agents are considered first-line pharmacotherapies for cessation (Fiore et al., 2000). Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000.

FDA APPROVALS: SMOKING CESSATION
2002 Rx transdermal nicotine patch 1997 1996 OTC nicotine lozenge ♪ Note to instructor(s): Throughout this module, Rx and OTC are used in slides to indicate prescription and over-the-counter products, respectively. This slide shows when the different pharmaceutical agents for smoking cessation received FDA approval: In 1984, the nicotine gum (Nicorette) was the first nicotine replacement product to be approved by the FDA. In 1991, prescription transdermal nicotine patches became available. In 1996, Nicorette gum, Nicoderm CQ patches, and Nicotrol patches became available without a prescription; the prescription nicotine nasal spray (Nicotrol NS) was approved the same year. Bupropion SR (Zyban) was approved in It’s the only nonnicotine product to be approved as an aid to smoking cessation. The nicotine inhalation system (Nicotrol inhaler) received FDA approval for prescription use in 1997. The most recent nicotine replacement product to be approved by the FDA is the nicotine lozenge (Commit). This product was approved for nonprescription use in 2002. 1991 Rx nicotine gum Rx nicotine inhaler; Rx bupropion SR OTC nicotine gum & patch; Rx nicotine nasal spray 1984

IMPROVES SUCCESS RATES
NRT: RATIONALE for USE Reduces physical withdrawal from nicotine Allows patient to focus on behavioral and psychological aspects of tobacco cessation The rationale for using NRT in tobacco cessation include the following: NRT reduces physical withdrawal symptoms associated with nicotine cessation. NRT increases success by preventing physical nicotine withdrawal symptoms, which are usually experienced following tobacco cessation. NRT allows the patient to focus on behavioral and psychological aspects of tobacco cessation. NRT helps alleviate withdrawal symptoms, allowing the patient to focus on the behavioral and psychological changes necessary for successful tobacco cessation. However, NRT itself can be addicting, and some patients have difficulty terminating its use. NRT improves success rates. The success rates of smoking cessation significantly improve with the use of NRT. A meta-analysis of 94 controlled trials of NRT showed that all products (gum, patch, inhaler, and nasal spray) result in statistically significantly improved abstinence rates when compared to placebo. Patients using NRT are 1.5–2 times more likely to successfully quit smoking than are those receiving placebo (Silagy et al., 2002). Advantages of NRT include the following: Patients are not exposed to the carcinogens and other toxic components found in tobacco and tobacco smoke. Provides lower, slower, and less variable plasma nicotine concentrations than cigarettes, which reduces the reinforcing effect of smoking. Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2002;4:CD IMPROVES SUCCESS RATES

SYMPTOMS of NICOTINE WITHDRAWAL
Anger/irritability Anxiety Cravings Difficulty concentrating Hunger/weight gain Impatience Restlessness Drowsiness Fatigue Impaired task performance Nervousness Sleep disturbances ♪ Note to instructor(s): Refer students to the Withdrawal Symptoms Information Sheet handout. This handout describes each symptom, when it occurs postcessation, and how to cope with it. In addition to being an educational aid for students, it can be copied and distributed to patients who are quitting. When nicotine is abruptly discontinued the following withdrawal symptoms develop: Anger/irritability Anxiety Cravings Difficulty concentrating Hunger/weight gain Impatience Restlessness Drowsiness Fatigue Impaired task performance Nervousness Sleep disturbances Tobacco users usually experience a strong desire or craving for tobacco. In general, withdrawal symptoms peak 24–48 hours after cessation and gradually dissipate over the next 2–4 weeks. Strong cravings for tobacco may persist for months to years after cessation (Benowitz, 1992). Benowitz NL. Cigarette smoking and nicotine addiction. Med Clin N Am 1992;76:415–437. Hughes JR, Gust SW, Skoog K, Keenan RM, Fenwick JW. Symptoms of tobacco withdrawal. Arch Gen Psychiatry 1991;48:52–59. Hughes et al. Arch Gen Psychiatry 1991;48:52–59.

NRT: PRODUCTS Polacrilex Gum Lozenge Transdermal Patches Nasal Spray
Nicorette (OTC) Generic nicotine gum (OTC) Lozenge Commit (OTC) Transdermal Patches Nicoderm CQ (OTC) Nicotrol (OTC) Generic nicotine patches (OTC, Rx) Nasal Spray Nicotrol NS (Rx) Inhaler Nicotrol (Rx) Currently available formulations of NRT include gum, lozenges, transdermal patches, nasal spray, and inhaler. The nicotine gum, lozenges, and patches can be purchased without a prescription. The nicotine nasal spray and inhaler require a prescription. To reduce the likelihood of nicotine-related adverse effects, patients should discontinue tobacco use when using these products. Symptoms of nicotine toxicity include headache, nausea and vomiting, abdominal pain, diarrhea, drooling, dizziness, blurred vision, tremor, cold sweat, hypotension, and, in severe cases, respiratory depression.

PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Cigarette Moist snuff This graph depicts the plasma venous nicotine concentrations achieved with the various nicotine delivery systems. Peak plasma concentrations are higher and are achieved more rapidly when nicotine is delivered via cigarette smoke compared to the available NRT formulations. Among the NRT formulations, absorption is fastest with the nasal spray, followed by the gum, lozenge and inhaler; absorption is slowest with the transdermal formulations. The concentration time curves in this slide depict levels achieved after administration of a single dose of nicotine following a period overnight abstinence. The administration of nicotine varies with the cigarette smoked over 5 minutes, the moist snuff (2 grams) placed between the check and gum for 30 minutes, inhaler used over 20 minutes (80 puffs), gum chewed over 30 minutes, the lozenge held in the mouth for approximately 30 minutes and the patch applied to the skin for 1 hour. The data presented in the graph are from multiple studies and are meant to illustrate the differences between nicotine absorption from tobacco and NRT (Fant et al., 1999; Schneider et al., 2001; Choi et al., 2003). Because NRT formulations deliver nicotine more slowly and at lower levels (e.g., 30–75% of those achieved by smoking), these agents are far less likely to be associated with dependence when compared to tobacco-based products. Choi JH, Dresler CM, Norton MR, Strahs KR. Pharmacokinetics of a nicotine polacrilex lozenge. Nicotine Tob Res. 2003;5(5): Fant RV, Henningfield JE, Nelson RA, Pickworth WB. Pharmacokinetics and pharmacodynamics of moist snuff in humans. Tob Control 1999;8(4): Schneider NG, Olmstead RE, Franzon MA, Lunell E. The nicotine inhaler. Clinical pharmacokinetics and comparison with other nicotine treatments. Clin Pharmacokinet 2001;40(9):661–684. Time (minutes)

NRT: PRECAUTIONS Patients with underlying cardiovascular disease
Recent myocardial infarction Life-threatening arrhythmias Severe or worsening angina Before reviewing the individual NRT formulations, it is important to review some general precautions to consider when recommending its use as an aid for cessation. Nicotine activates the sympathetic nervous system leading to an increase in heart rate, blood pressure and myocardial contractility. Nicotine may also cause coronary artery vasoconstriction (Benowitz, 1997). These known hemodynamic effects of nicotine have led to concerns about the safety of using NRT in patients with established cardiovascular disease, particularly those with serious arrhythmias, unstable angina or myocardial infarction. Soon after the nicotine patch was approved, there were anecdotal case reports in the lay press linking NRT use (patch and gum) with adverse cardiovascular events (i.e., arrhythmias, myocardial infarction, stroke). Since that time, several randomized, controlled trials have evaluated the safety of NRT in patients with cardiovascular disease including angiographically-documented coronary artery stenosis, myocardial infarction, stable angina and previous coronary artery bypass surgery or angioplasty (Joseph et al., 1996; Tzivoni et al., 1998; Working Group for the Study of Transdermal Nicotine in Patients with Coronary Artery Disease, 1994). The results of these trials suggest there is no significant increase in the incidence of cardiovascular events or mortality among patients receiving NRT when compared to placebo. However, because these trials specifically excluded patients with unstable angina, serious arrhythmias and recent myocardial infarction, the Clinical Practice Guideline recommends that NRT be used with caution among patients in the immediate (within two weeks) postmyocardial infarction period, those with serious arrhythmias, and those with serious or worsening angina due to a lack of safety data in these high-risk populations (Fiore et al., 2000). The use of NRT in patients with cardiovascular disease has been the subject of numerous reviews and it is widely believed by experts in the field that the risks of NRT in this patient population are small relative to the risks of continued tobacco use (Benowitz & Gourlay, 1997; McRobbie & Hajek, 2001; Silagy et al., 2002; Benowitz, 2003; Joseph & Fu, 2003). Benowitz NL. The role of nicotine in smoking-related cardiovascular disease. Prev Med 1997;26:412–417. Benowitz NL. Cigarette smoking and cardiovascular disease: pathophysiology and implications for treatment. Prog Cardiovasc Dis 2003;46(1): Benowitz NL, Gourlay SG. Cardiovascular toxicity of nicotine: Implications for nicotine replacement therapy. J Am Coll Cardiol 1997;29:1422–1431. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Joseph AM, Norman SM, Ferry LH, et al. The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. N Engl J Med 1996;335:1792–1798. Joseph AM, Fu SS. Safety issues in pharmacotherapy for smoking in patients with cardiovascular disease. Prog Cardiovasc Dis 2003;45(6): McRobbie H, Hajek P. Nicotine replacement therapy in patients with cardiovascular disease: guidelines for health professionals. Addiction 2001;96(11): Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2002;4:CD Tzivoni D, Keren A, Meyler S, et al. Cardiovascular safety of transdermal nicotine patches in patients with coronary artery disease who try to quit smoking. Cardiovasc Drugs Ther 1998;12(3): Working Group for the Study of Transdermal Nicotine in Patients with Coronary Artery Disease. Nicotine replacement therapy for patients with coronary artery disease. Arch Intern Med 1994;154(9):

NRT: PRECAUTIONS (cont’d)
Patients with other underlying conditions Active temporomandibular joint disease (gum only) Pregnancy Lactation Other conditions where NRT should be used with caution include active temporomandibular joint disease (gum only), pregnancy, and lactation. Patients with active temporomandibular joint disease should not use the nicotine gum because doing so might exacerbate their condition. The FDA has classified nicotine as a pregnancy category D drug, meaning there is evidence of risk to the human fetus. Accordingly, none of the NRT formulations have been FDA approved for use in pregnancy. Although NRT may pose a risk to the developing fetus, some researchers have argued this risk is considerably less than the risks of continued smoking (Dempsey & Benowitz, 2001). Furthermore, NRT was not associated with adverse fetal effects in a recent study (Ogburn et al., 1999). Because it is assumed that NRT can cause fetal harm when administered to a pregnant woman, NRT during pregnancy should be reserved for women unable to quit using nonpharmacologic methods alone. Pregnant women should utilize pharmacologic aids for cessation only under the supervision of a physician. Consult with the patient’s obstetrician if needed. According to the U.S. Public Health Service Clinical Practice Guideline for treating tobacco use and dependence, if NRT use is warranted, it is prudent to prescribe doses at the low end of the effective dose range and to consider use of formulations that yield intermittent exposure (e.g., gum, nasal spray, or inhaler) instead of the patch, which provides continuous drug exposure (Fiore et al., 2000). Nicotine and cotinine are secreted in breast milk. In a recent small study, use of the nicotine patch was associated with less exposure to nicotine (compared to smoking) and did not adversely affect milk consumption among breast-feed infants. The investigators concluded that the use of NRT during breast feeding is safer than continued smoking (Ilett et al., 2003). Although levels achieved with NRT are less than those achieved with smoking, clinicians should be aware that the nursing infant is at risk for nicotine toxicity, especially if the mother concomitantly smokes and uses NRT. Use of NRT is not approved by the FDA for individuals under the age of 18 years. Dempsey DA, Benowitz NL. Risks and benefits of nicotine to aid smoking cessation in pregnancy. Drug Saf 2001;24:277–322. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Ilett KF, Hale TW, Page-Sharp M, et al. Use of nicotine patches in breast-feeding mothers: transfer of nicotine and cotinine into human milk. Clin Pharmacol Ther 2003;74(6): Ogburn PL, Hurt RD, Croghan IT, et al. Nicotine patch use in pregnant smokers: Nicotine and cotinine levels and fetal effects. Am J Obstet Gynecol 1999;181(3):736–743. Minimum age for FDA-approved NRT use: 18 years

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 FDA approved: 1984 Switched to OTC status: 1996 Available strengths: 2 mg, 4 mg (for heavy smokers) Mint flavor available: 1998 Generic OTC gum available: 1999 (Watson Laboratories) Orange flavor available: 2000 Description of Product Nicotine polacrilex (polé-ah-kril-ex) is a resin complex of nicotine and polacrilin in a sugar-free chewing gum base. The gum has a distinct, tobacco-like, slightly peppery, minty, or citrus taste and contains sorbitol as a sweetener. The gum also contains buffering agents (sodium carbonate and sodium bicarbonate) to increase salivary pH, thereby enhancing buccal absorption of nicotine. Clinical Efficacy (Silagy et al., 2002) Nicotine gum significantly improves long-term abstinence rates compared to placebo. A meta-analysis of 51 studies revealed the following estimated abstinence rates (6-12 months follow-up): Placebo % Nicotine gum 19.7 % The pooled odds ratio of abstinence for nicotine gum relative to placebo was 1.66 (95% CI, ). The 4 mg gum is more efficacious than the 2 mg gum as a cessation aid in highly dependent smokers (Fiore et al., 2000). Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2002;4:CD

NICOTINE GUM: DOSING Dosage based on current smoking patterns:
If patient smokes Recommended strength 25 cigarettes/day 4 mg <25 cigarettes/day 2 mg The dosage of nicotine gum is based on the patient’s current level of smoking. Nicotine gum is available in two different strengths: Patients who smoke 25 cigarettes a day or more should use the 4 mg strength. Patients who smoke fewer than 25 cigarettes a day should use the 2 mg strength. When the 2 mg strength gum is used properly, 0.8–0.9 mg of nicotine is absorbed from each dose (Benowitz et al., 1987). Nicotine plasma levels are lower (~8 mg/L) and peak approximately 30 minutes after chewing a 2 mg piece of nicotine gum compared to smoking a single cigarette with peak nicotine levels of ~26 mg/L, which are achieved within 10 minutes (Schneider et al., 1996). Benowitz NL, Jacob P, Savanapridi C. Determinants of nicotine intake while chewing nicotine polacrilex gum. Clin Pharmacol Ther 1987;41:467–473. Schneider NG, Lunell E, Olmstead RE, Fagerström KO. Clinical pharmacokinetics of nasal nicotine delivery. A review and comparison to other nicotine systems. Clin Pharmacokinet 1996;31:65–80.

NICOTINE GUM: DOSING (cont’d)
Recommended Usage Schedule for Nicotine Gum Weeks 1–6 Weeks 7–9 Weeks 10–12 1 piece q 1–2 h 1 piece q 2–4 h 1 piece q 4–8 h DO NOT USE MORE THAN 24 PIECES PER DAY Patients using nicotine gum are more likely to succeed if they chew the gum on a fixed schedule rather than as needed. This slide shows the manufacturer’s recommended dosing schedule. During the initial 6 weeks of therapy, patients should chew one piece of gum every 1–2 hours (while awake). In general, this amounts to at least nine pieces of gum daily. Patients can use additional pieces (up to the daily maximum of 24 pieces per day) if cravings occur between the scheduled doses. In general, heavier smokers will need more pieces to reduce their cravings. Patients will gradually increase the interval between doses using the following schedule: Weeks 7–9 1 piece every 2–4 hours Weeks 10–12 1 piece every 4–8 hours

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) Nicotine gum is not like ordinary chewing gum. It is a specially formulated nicotine delivery system that must be chewed properly for optimal results. When chewed like ordinary gum, nicotine will be rapidly released from the polacrilin resin, possibly leading to adverse effects including hiccups, heartburn, or gastric upset. ♪ Note to instructor(s): Instruct students to open the nicotine gum sample and follow along with the directions for use. This is an optional exercise. Current and former tobacco users should not participate. Nicotine gum: Directions for use The gum should be used on a regular basis (as previously reviewed) to reduce nicotine cravings and other withdrawal symptoms. Chew each piece of gum very slowly several times. Stop chewing at first sign of peppery, minty, or citrus taste or of a slight tingling in the mouth. (This usually happens after about 15 chews, but varies). “Park” the gum between the cheek and gum to allow absorption of nicotine across the buccal mucosa (mouth lining). ♪ Note to instructor(s): The number of chews necessary for the peppery, minty, or citrus taste or tingling sensation generally ranges from 15 to 30 chews. ♪ Note to instructor(s): Students participating in the gum-chewing exercise should be instructed to discard the gum immediately after experiencing the taste or tingling sensation to avoid adverse effects (especially in nicotine-naive individuals).

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) Nicotine gum: Directions for use (cont’d) When the taste or tingling dissipates (generally about 1–2 minutes), slowly resume chewing. When the taste or tingle returns, stop chewing and park the gum in a different place in the mouth. Parking the gum in different areas of the mouth will decrease the incidence of mucosal irritation. The chew/park steps should be repeated until most of the nicotine is gone. At this point, the taste or tingle does not return. On average, each piece of gum lasts 30 minutes.

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 The following is a review of proper chewing technique for nicotine gum: Chew slowly. Stop chewing at first sign of a peppery, minty, or citrus taste or a tingle. Park gum between cheek and gum. Chew again when the taste or tingle fades. Repeat steps 1–4 until most of nicotine is gone (taste or tingle won’t return; generally about 30 minutes). The health care provider should stress the importance of proper gum chewing technique to increase the likelihood of success with this form of NRT. Park

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 The goal of using nicotine gum is to slowly reduce the dependence on nicotine. The recommended dosing schedule will help reduce nicotine cravings gradually. Recommended strategies for discontinuing use include the following: Chewing each nicotine gum piece for only 10–15 minutes, instead of 30 minutes. Then gradually begin to reduce the number of pieces used. Try chewing each piece for longer than 30 minutes but reduce the number of pieces used daily. Substitute ordinary chewing gum for some of the nicotine gum you would normally use. Increase the number of pieces of ordinary gum as you cut back on the nicotine pieces.

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 To improve the chances of quitting, patients should use at least nine pieces of nicotine gum daily (one piece every 1–2 hours). Heavier smokers may need more pieces to reduce their cravings. It is important to emphasize that patients often do not use enough of the gum to derive benefit. Patients commonly chew too few pieces per day or shorten the length of treatment. For this reason, it may be preferable to recommend a fixed schedule of administration, tapering over 1–3 months (Fiore et al., 2000). The effectiveness of nicotine gum may be reduced by some foods and drinks, such as coffee, juices, wine or soft drinks. Patients should be instructed not to eat or drink for 15 minutes before using nicotine gum or while chewing a piece. Nicotine polacrilex is buffered to pH 8.5 to enhance buccal absorption of the drug. Acidic beverages may transiently reduce the pH of the saliva below that necessary for optimal buccal absorption of nicotine. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Do NOT eat or drink for 15 minutes BEFORE or while using nicotine gum.

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 Chewing the gum will not provide the same rapid satisfaction that smoking provides. Recall that buccal absorption of nicotine is delayed (peak nicotine concentrations are achieved within 30 minutes) compared to cigarette smoking (peak concentrations <10 minutes). Patients should be warned that chewing the gum too rapidly may result in excessive release of nicotine and effects similar to those associated with smoking a cigarette too rapidly or those experienced by nonsmokers when they inhale from a cigarette for the first time: Lightheadedness Nausea and vomiting Irritation of the throat and mouth Hiccups Indigestion

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 Side effects include the following: Mouth soreness Hiccups Dyspepsia Jaw muscle ache These are more common during the first few days of therapy. The consistency of nicotine gum (increased viscosity compared to ordinary chewing gum) may lead to increased adherence to dental work and may not be suitable for patients with the following: Extensive restorations (fillings) Bridges Dentures Caps or crowns Braces If excessive sticking or damage to dental work occurs, patients should discontinue use and consult a dentist.

NICOTINE GUM: SUMMARY ADVANTAGES DISADVANTAGES
Gum use may satisfy oral cravings. Gum use may delay weight gain. Patients can titrate therapy to manage withdrawal symptoms. 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 of nicotine gum include the following: Gum use may satisfy oral cravings. Gum use may delay weight gain (Fiore et al., 2000). Patients can titrate therapy to manage withdrawal symptoms. Disadvantages of the gum include the following: Gum chewing may not be socially acceptable. Gum may stick to dental work and dentures. Patients must use proper chewing technique to minimize adverse effects. The gum appears to be particularly helpful with patients who have weight gain concerns or who report boredom as a trigger for smoking. It may also be advantageous for persons who need to more tightly titrate nicotine levels to avoid distraction or irritability withdrawal symptoms in order to avoid injury, such as transportation workers or persons who work with heavy machinery. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000.

NICOTINE LOZENGE Commit (GlaxoSmithKline)
Approved for OTC use in 2002 Nicotine polacrilex formulation Delivers ~25% more nicotine than equivalent gum dose Available: 2 mg, 4 mg FDA approved for use without a prescription: 2002 Available strengths: 2 mg, 4 mg (for more dependent smokers) Description of Product Nicotine polacrilex (polé-ah-kril-ex) is a resin complex of nicotine and polacrilin in a sugar-free (contains Aspartame), light mint-flavored lozenge. The lozenges are meant to be consumed like hard candy or other medicinal lozenges (e.g., sucked and moved from side to side in the mouth until it dissolves). Because the nicotine lozenge dissolves completely, it delivers approximately 25% more nicotine than does an equivalent dose of nicotine gum. Like the nicotine gum, the lozenge also contains buffering agents (sodium carbonate and potassium bicarbonate) to increase salivary pH, thereby enhancing buccal absorption of the nicotine. Clinical Efficacy (Silagy et al., 2002) The nicotine lozenge approximately doubles the long-term abstinence rates compared to placebo (Shiffman et al., 2002). A meta-analysis of 4 studies using either the nicotine lozenge (nicotine polacrilin) or sublingual tablet (nicotine -cyclodextrin complex; not available in the U.S.) revealed the following estimated abstinence rates (6-12 months follow-up): Placebo % Nicotine lozenge 17.2 % The pooled odds ratio of abstinence for the nicotine tablet/lozenge relative to placebo was 2.08 (95% CI, 1.63–2.65). Shiffman S, Dresler CM, Hajek P, Gilburt SJ, Targett DA, Strahs KR. Efficacy of a nicotine lozenge for smoking cessation. Arch Intern Med 2002;162:1267–1276. Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2002;4:CD

NICOTINE LOZENGE: DOSING
Dosage based on the “time to first cigarette” (TTFC) as an indicator of nicotine addiction. Unlike other forms of NRT, which use the number of cigarettes smoked per day as the basis for dosing, the recommended dosage of the nicotine lozenge is based on the time to first cigarette (TTFC). Some experts believe that the best indicator of nicotine dependence is the need to smoke soon after waking (Heatherton et al., 1989). Based on this method, individuals who smoke their first cigarette of the day within 30 minutes of waking are considered to be more highly dependent on nicotine than are those who smoke their first cigarette more than 30 minutes after waking. Because the nicotine lozenge has been studied in clinical trials using the TTFC as a dosage selector, the product is licensed for use in the following manner: The nicotine lozenge is available in two different strengths: Patients who smoke their first cigarette of the day within 30 minutes of waking should use the 4 mg strength lozenge. Patients who smoke their first cigarette of the day more than 30 minutes after waking should use the 2 mg strength. Heatherton TF, Kozlowski LT, Frecker RC, et al. Measuring the heaviness of smoking: Using self-reported time to the first cigarette of the day and number of cigarettes smoked per day. Br J Addict 1989;84(7):791–799.

NICOTINE LOZENGE: DOSING (cont’d)
Recommended Usage Schedule for Commit Lozenge Weeks 1–6 Weeks 7–9 Weeks 10–12 1 lozenge q 1–2 h q 2–4 h q 4–8 h DO NOT USE MORE THAN 20 LOZENGES PER DAY Patients using the nicotine lozenge are more likely to succeed if they use the lozenge on a fixed schedule rather than as needed. This slide shows the manufacturer’s recommended dosing schedule. During the initial 6 weeks of therapy, patients should suck on one lozenge every 1–2 hours (while awake). In general, this amounts to at least nine lozenges daily. Patients can use additional lozenges (up to 5 lozenges in 6 hours or a maximum of 20 lozenges per day ) if cravings occur between the scheduled doses. Patients should gradually increase the interval between doses using the following schedule: Weeks 7–9 1 lozenge every 2–4 hours Weeks 10–12 1 lozenge every 4–8 hours

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 Nicotine lozenge: Directions for use (cont’d) To reduce the risk of gastrointestinal side effects, the lozenge should not be chewed or swallowed. The patient should occasionally rotate the lozenge to different areas of the mouth to minimize the potential for mucosal irritation. On average, the lozenge will completely dissolve in about 20–30 minutes.

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 To improve the chances of quitting, patients should use at least nine nicotine lozenges daily (one every 1–2 hours) during the first 6 weeks of treatment. The nicotine lozenge will not provide the same rapid satisfaction that smoking provides. Peak nicotine concentrations achieved for the lozenge range from 30 to 60 minutes (Choi et al., 2003) and are significantly prolonged compared to cigarette smoking (peak concentrations < 10 minutes). The effectiveness of the nicotine lozenge may be reduced by some foods and beverages, such as coffee, juices, wine, or soft drinks. Patients should be instructed not to eat or drink for 15 minutes before or while using the nicotine lozenge. Nicotine polacrilex is buffered to an alkaline pH to enhance buccal absorption of the drug. Acidic beverages may transiently reduce the pH of the saliva below that necessary for optimal buccal absorption of nicotine. Choi JH, Dresler CM, Norton MR, Strahs KR. Pharmacokinetics of a nicotine polacrilex lozenge. Nicotine Tob Res. 2003;5(5): Do NOT eat or drink for 15 minutes BEFORE or while using nicotine lozenge.

NICOTINE LOZENGE: ADD’L PATIENT EDUCATION (cont’d)
Side effects of nicotine lozenge include Nausea Hiccups Cough Heartburn Headache Flatulence Insomnia Side effects associated with the nicotine lozenge include the following: Nausea Hiccups Cough Heartburn Headache Flatulence Insomnia Patients who use more than one lozenge at a time, continuously use one lozenge after another, or chew or swallow the lozenge are more likely to experience heartburn or indigestion.

NICOTINE LOZENGE: SUMMARY
ADVANTAGES Lozenge use may satisfy oral cravings. The lozenge is easy to use and conceal. Patients can titrate therapy to manage withdrawal symptoms. DISADVANTAGES Gastrointestinal side effects (nausea, hiccups, and heartburn) may be bothersome. Advantages of nicotine lozenge include the following: Lozenge use may satisfy oral cravings. The lozenge is easy to use and conceal. Patients can titrate therapy to manage withdrawal symptoms. Disadvantages of the gum include the following: Gastrointestinal side effects (nausea, hiccups, and heartburn) may be bothersome.

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 FDA approved: 1991 Available OTC: 1996 Description of Product Transdermal nicotine delivery systems consist of an impermeable surface layer, a nicotine reservoir, an adhesive layer and a removable protective liner. The technology for delivery of nicotine across the skin varies by manufacturer. Nicoderm, manufactured by Alza, utilizes a rate-controlling membrane. Generic patches (previously marketed as ProStep), manufactured by Elan, employ nicotine-containing hydrogel-matrix concentration gradient technology. The Nicotrol and generic patches (previously marketed as Habitrol) utilize drug-dispersion-type systems whereby release of nicotine is controlled by diffusion of the drug across an adhesive layer (Gore & Chien, 1998). Clinical Efficacy (Silagy et al., 2002) The transdermal nicotine patch significantly improves long-term abstinence rates compared to placebo. A meta-analysis of 35 studies revealed the following estimated abstinence rates (6-12 months follow-up): Placebo % Nicotine patch 14.4 % The pooled odds ratio of abstinence for the transdermal nicotine patch relative to placebo was 1.74 (95% CI, ). Gore AV, Chien YW. The nicotine transdermal system. Clin Dermatol 1998;16:599–615. Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2002;4:CD

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) The nicotine in the patch is well absorbed across the skin. The delivery of nicotine to the systemic circulation avoids hepatic first-pass metabolism. Plasma nicotine concentrations from the patch are lower and fluctuate less than those achieved with tobacco products. Plasma nicotine levels obtained via transdermal delivery are approximately 50% lower than those achieved with cigarette smoking. Lower levels of nicotine still alleviate the symptoms of withdrawal but are far less likely to lead to dependence when compared to tobacco or other forms of NRT (Gore & Chien, 1998). Gore AV, Chien YW. The nicotine transdermal system. Clin Dermatol 1998;16:599–615.

TRANSDERMAL NICOTINE PATCH: PREPARATION COMPARISON
Product Nicotrol Nicoderm CQ Generics Nicotine delivery 16 hours 24 hours Availability 5 mg patch 10 mg patch 15 mg patch 7 mg patch 14 mg patch 21 mg patch 11 mg patch 22 mg patch Products Available Nicotrol PatchOTC (Pharmacia; formerly distributed by McNeil) Switched to OTC status: July 1996 Availability: 15 mg, 10mg, 5mg (16-hour nicotine delivery system) Note: Prior to 2002, this product was available only as a 15 mg patch for use over six weeks, without taper. Current product labeling recommends a gradual dosage reduction over 10 weeks. Nicoderm CQ PatchOTC (GlaxoSmithKline; manufactured by Alza) Switched to OTC status: August 1996 Availability: 7 mg, 14 mg, 21 mg (24-hour nicotine delivery system); also available in a clear formulation Generic nicotine patchRx,OTC (formerly Habitrol Transdermal System) Manufacturers: OTC product (Novartis Consumer Health) Rx product (Schein Pharmaceuticals) Available OTC: November 1999 Availability: 7 mg, 14 mg, 21 mg (24-hour nicotine delivery system) Note: Novartis manufactures the OTC product but has sold the rights to a private label company that is responsible for marketing and distributing the product for various retail pharmacies (e.g. CVS, Duane Reade, Kroger, Longs, Rite-Aid, Sav-on Osco, Target, Walgreens, Walmart “Equate” label). The product is labeled as Nicotine Transdermal System Step 1, Step 2, and Step 3. Generic nicotine patchOTC (previously ProStep [Lederle]) Switched to OTC status: December 1998 Availability: 11 mg, 22 mg (24-hour nicotine delivery system) Note: This product is manufactured by Elan Pharmaceuticals and distributed by Perrigo Company to drug stores, grocery stores, and discount stores under private label.

TRANSDERMAL NICOTINE PATCH: DOSING
Product Light Smoker Heavy Smoker Nicotrol 10 cigarettes/day Not indicated >10 cigarettes/day Step 1 (15 mg x 6 weeks) Step 2 (10 mg x 2 weeks) Step 3 (5 mg x 2 weeks) Nicoderm CQ Step 2 (14 mg x 6 weeks) Step 3 (7 mg x 2 weeks) Step 1 (21 mg x 6 weeks) Step 2 (14 mg x 2 weeks) Generic (formerly Habitrol) Step 1 (21 mg x 4 weeks) (formerly ProStep) 15 cigarettes/day 11 mg x 6 weeks >15 cigarettes/day 22 mg x 6 weeks The dosing schedules for the nicotine patches vary. When recommending a product and a dosing schedule for a patient, it is important to ask a few questions. Determine how many cigarettes the patient smokes per day and if he or she has strong morning cigarette cravings. In general, heavy smokers will require higher doses for a longer duration of therapy. Patients with sleep disturbances (insomnia) may tolerate the 16-hour patch better. Some data suggest that patients with strong morning cigarette cravings may have more success with a 24-hour patch (Shiffman et al., 2000). Patients may need to switch patch strengths during the first 2 weeks of therapy to determine correct strength. For patients experiencing withdrawal symptoms or cigarette cravings, increase to a higher dose. Patients experiencing side effects (e.g., dizziness, perspiration, nausea, vomiting, diarrhea, headache, abdominal pain) should use the next lower dose. ♪ Note to instructor(s): Some students may ask about use of higher than recommended doses of transdermal nicotine for heavy smokers. High-dose transdermal nicotine (44 mg/day) appears to be safe (Dale et al., 1995; Fredrickson et al., 1995). However, trials evaluating higher doses of NRT have yielded conflicting results. Some studies suggest higher doses of NRT may be more effective in heavy smokers (Dale et al., 1995; Tonnesen et al., 1999), whereas others have demonstrated slight but not statistically significant improvements in cessation rates (Jorenby et al., 1995; Hughes et al., 1999). Thus, despite the small number of trials that have examined high-dose NRT therapy, the results appear promising and this approach may be appropriate for patients who have been unable to quit using conventional doses of transdermal NRT. Dale LC, Hurt RD, Offord KP, Lawson GM. High-dose nicotine patch therapy; percentage of replacement and smoking cessation. JAMA 1995;274:1353–1358. Fredrickson PA, Hurt RD, Lee GM, et al. Safety and tolerability of high dose transdermal nicotine therapy for heavy smokers. Psychopharmacology 1995;122:215–222. Hughes JR, Lesmes GR, Hatsukami DK, et al. Are higher doses of nicotine replacement more effective for smoking cessation? Nicotine & Tobacco Research 1999;1:169–174. Jorenby D, Smith SS, Fiore MC, et al. Varying nicotine patch dose and type of smoking cessation counseling. JAMA 1995;274:1347–1352. Shiffman S, Elash CA, Paton SM, et al. Comparative efficacy of 24-hour and 16-hour transdermal nicotine patches for relief of morning craving. Addiction 2000;95(8): Tonnesen P, Paoletti P, Gustavsson G, et al. Higher dosage nicotine patches increase one-year smoking cessation rates: Results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society. Eur Respir J 1999;13:238–246.

TRANSDERMAL NICOTINE PATCH: DIRECTIONS for USE
Choose an area of skin on the upper body or the upper outer part of the arm Make sure the skin is clean, dry, and hairless Hair will interfere with application of the patch Do not shave; this may irritate the skin ♪ Note to instructor(s): Instruct students to remove the sample nicotine patch from the foil pouch and follow along with the directions for use. This is an optional exercise. Current tobacco users should not participate. Alternatively, distribute samples of the nicotine patch for students to handle but not apply. ♪ Note to instructor(s): Before distributing the patches during class, it is helpful to make a horizontal cut across the upper corner of the patch with scissors or clippers. This will allow the students to quickly open the foil pouch during class. If this step is not performed before class, participants may be unable to or have a extremely difficult time opening the child-resistant foil pouch. Transdermal nicotine patch: Directions for use Choose an area of skin on the upper body or the upper outer part of the arm. To ensure that the patch will adhere well, make sure the skin is nonhairy, clean (not oily), dry, and free of creams, lotions, oils or powder. Hair will interfere with the application of the patch. Do not shave the area because this may cause skin irritation.

TRANSDERMAL NICOTINE PATCH: DIRECTIONS for USE (cont’d)
Do not apply patch to skin that is inflamed, burned, or irritated in any way (these conditions may alter nicotine absorption) Apply patch to a different area each day The same area should not be used again for at least 1 week Transdermal nicotine patch: Directions for use (cont’d) Do not apply the patch to skin that is inflamed, burned, broken out, or irritated in any way, because these conditions may alter the amount of drug absorbed. The patch should be applied to a different area each day. To minimize the potential for local skin reactions, the same area should not be used again for at least 1 week.

Remove patch from protective pouch Transdermal nicotine patch: Directions for use (cont’d) Remove patch from protective pouch (save pouch for later disposal of used patch). ♪ Note to instructor(s): The appearance of the transdermal patch will be slightly different for each manufacturer. ♪ Note to instructor(s): Scissors or clippers will be necessary for this step. It is recommended that the instructor perform this step before class to save time. If this is not done before class, instruct the student to use care while cutting the foil pouch so as not to damage the transdermal patch.

Peel off half of the backing from the patch Transdermal nicotine patch: Directions for use (cont’d) Remove half of the protective liner from the patch. Try not to touch the exposed adhesive (i.e., the sticky side) because nicotine on hands can get into the eyes or nose and cause stinging or redness.

Apply adhesive side of patch to the skin Peel off remaining protective covering Press firmly with palm of hand for 10 seconds Make sure the patch sticks well to skin, especially around the edges Transdermal nicotine patch: Directions for use (cont’d) Immediately apply the sticky side of the patch to the skin. Peel off remaining half of protective covering. Press the patch firmly on the skin with the palm of the hand for 10 seconds. Make sure the patch sticks well to the skin, especially around the edges. This is necessary to ensure a good seal.

Wash hands (nicotine on hands can get into eyes or nose and cause stinging or redness) Do not leave the patch on skin for more than 16 hours (Nicotrol) or 24 hours (Nicoderm, generic patches—doing so may lead to skin irritation Adhesive remaining on skin may be removed with rubbing alcohol or acetone Dispose of a used patch by folding onto itself, completely covering the adhesive area Transdermal nicotine patch: Directions for use (cont’d) Wash hands after patch application as nicotine on hands could get into the eyes or nose and cause stinging or redness. After 16 or 24 hours (depending on formulation and dosing regimen), remove old patch. The patch should not be left on the skin for more than 16 hours (Nicotrol) or 24 hours (Nicoderm, generic patches) because this may lead to skin irritation. Any adhesive remaining on the skin may be removed with rubbing alcohol or acetone Dispose of a used patch by folding onto itself, completely covering the adhesive area.

TRANSDERMAL NICOTINE PATCH: ADDITIONAL PATIENT EDUCATION
Water will not harm the nicotine patch if it is applied correctly; patients may bathe, swim, shower, or exercise while wearing the patch Do not cut patches to adjust dose Nicotine will evaporate rapidly Patch will be rendered useless Keep new and used patches out of the reach of children and pets Water will not harm the nicotine patch if it is applied correctly. Patients may bathe, swim, shower, or exercise while wearing the patch. Due to the high cost of nicotine patches, patients will often try to economize by cutting patches in half to save money. It is important to tell patients that they should not cut patches to adjust the dose. The nicotine will evaporate rapidly from the edges of a cut patch, rendering the product useless. Keep new and used patches out of the reach of children and pets.

TRANSDERMAL NICOTINE PATCH: ADD’L PATIENT EDUCATION (cont’d)
Side effects to expect in first hour: Mild itching Burning Tingling After patch removal, the skin may appear red for the next 24 hours If skin stays red more than 4 days or swells, or if a rash appears, contact health care provider; do not put on a new patch Shortly after applying the nicotine patch, patients may experience the following: Mild itching Burning Tingling This is normal and should resolve within an hour. After removal, the skin under the patch may appear red for the next 24 hours. If a skin rash develops after using a nicotine patch, or if the skin under the patch becomes swollen or very red, the patient should contact a health care provider. The patient should not apply a new patch.

TRANSDERMAL NICOTINE PATCH: ADD’L PATIENT EDUCATION (cont’d)
Additional possible side effects: Vivid dreams or sleep disturbances Headache Local skin reactions (erythema, burning, pruritus) Usually caused by adhesive Up to 50% of patients experience this reaction Incidence may be higher with 24-hour products Less than 5% of patients discontinue therapy Avoid use in patients with dermatologic conditions (e.g., psoriasis, eczema, atopic dermatitis) Additional possible side effects: Vivid dreams or sleep disturbances More common with 24 hour formulations. Remove patch at bedtime if side effect becomes troublesome. Headache Local skin reactions (erythema, burning, pruritus) Usually caused by irritation resulting from skin occlusion or a reaction to the adhesives. Up to 50% of patients experience this reaction. Incidence may be higher with 24 hour products. Less than 5% discontinue therapy: Make certain patient is rotating patch application sites. Consider different brand of patch. Each manufacturer uses different adhesives. Consider treating skin reactions with OTC hydrocortisone cream (1%) or oral antihistamines. Patients with dermatologic conditions (e.g., psoriasis, eczema, atopic dermatitis) are more likely to experience skin irritation and should not use the nicotine patch.

TRANSDERMAL NICOTINE PATCH: SUMMARY
ADVANTAGES The patch provides consistent nicotine levels. The patch is easy to use and conceal. Fewer compliance issues are associated with the patch. DISADVANTAGES Patients cannot titrate the dose. Allergic reactions to adhesive may occur. 16-hr patch may lead to morning nicotine cravings. Patients with dermatologic conditions should not use the patch. Advantages of the nicotine patch include the following: Steady-state nicotine levels are achieved throughout the day. The patch is easy to use and conceal. Fewer compliance issues are associated with the patch. Disadvantages of the patch include the following: Patients cannot titrate the dose. Allergic reactions to the adhesive may occur. The 16-hour patch may result in morning cravings for nicotine. Patients with underlying dermatologic conditions (e.g., psoriasis, eczema, atopic dermatitis) should not use the patch because they are more likely to experience skin irritation.

LONG-TERM (6 month) QUIT RATES for AVAILABLE CESSATION MEDICATIONS
23.9 19.7 19.3 17.2 17.1 There are limited head-to-head trials comparing the various tobacco cessation therapies. In a randomized controlled trial comparing the four NRT formulations, all products were equally efficacious, but patient compliance was higher with the patch, followed by the gum, which was higher than the inhaler and nasal spray (Hajek et al., 1999). This graph summarizes the long term (6 month) quit rates observed with the different nicotine replacement products and bupropion SR (Hughes et al., 2003; Silagy et al., 2002). Keep in mind that these data are taken from 114 different placebo-controlled trials and it is therefore not appropriate to directly compare the active medications with respect to clinical efficacy. What this graph does illustrate, is that the quit rates from each of the methods is approximately double that of placebo. All of the above methods are considered effective. When patients ask for assistance in their quitting attempt, any product can be recommended if not contraindicated. However, when assisting patients in choosing a product, additional factors need to be considered. Quantity of cigarettes smoked per day, degree of nicotine dependence, advantages and disadvantages of each product, previous quit attempts and cause for failure, and the patient’s own product preference need to be considered. Behavioral therapy should accompany all pharmacologic therapies. Hajek P, West R, Foulds J, Nilsson F, Burrows S, Meadow A. Randomized comparative trial of nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler. Arch Intern Med 1999;159:2033–2038. Hughes JR, Stead LF, Lancaster. Antidepressants for smoking cessation. Cochrane Database Syst Rev 2003;(2):CD Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2002;4:CD 14.4 Percent quit 11.5 11.8 10.2 8.9 9.1 8.4 Data adapted from Silagy et al. Cochrane Database Syst Rev, 2002 and Hughes et al., Cochrane Database Syst Rev, 2000

Reserve for patients unable to quit using monotherapy.
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 withdrawal symptoms Combination NRT involves the use of a long-acting formulation (patch), which produces relatively constant levels of nicotine in the body, in combination with a short-acting formulation (gum, lozenge, inhaler, or nasal spray) to allow for acute dose titration as needed for withdrawal symptoms. The U.S. Public Health Service Clinical Practice Guideline for treating tobacco use and dependence recommends that combination therapy be used in patients unable to quit using monotherapy, based on the results of several small studies that found combination NRT to be more efficacious than monotherapy (Fiore et al., 2000). Combination therapy is not routinely recommended for all patients due to the increased risk of nicotine toxicity and lack of long-term safety data. However, this strategy makes pharmacologic sense and is one that will undoubtedly be the subject of future research studies. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, 2000. Reserve for patients unable to quit using monotherapy.

COMPARATIVE DAILY COSTS of PHARMACOTHERAPY
$6.07 $5.81 $4.98 The approximate daily costs of treatment for the various pharmacotherapies for cessation are presented in this slide. These are estimates based on the recommended initial dosing for each agent. These costs can vary considerably depending on the patient’s level of smoking, degree of nicotine dependence, product selection (trade versus generic), and need for additional doses of short-acting NRT (gum, lozenge, nasal spray, or oral inhaler). As a comparison, the daily cost for one pack of cigarettes (range, $2.79 per pack in Kentucky to $4.81 per pack in New Jersey; values include cost of premium cigarettes at $2.37 per pack + $0.39 federal tax + June 2004 state tax) is shown (U.S. Department of Agriculture, 2003; Campaign for Tobacco-Free Kids, 2004). In general, the daily cost of pharmacotherapy approximates the cost of one pack of cigarettes. For more exact estimates, refer to the Pharmacologic Product Guide. Campaign for Tobacco-Free Kids. State Cigarette Excise Tax Rates. Available at Accessed June 7, 2004. U.S. Department of Agriculture, Market and Trade Economics Division, Economic Research Service. Tobacco Situation and Outlook Yearbook. Report TBS December Available online at: Accessed February 27, 2004. $2.79 in KY $4.81 in NJ $4.30 $3.91 $3.40 Cost per day, in U.S. dollars

The RESPONSIBILITY of HEALTH PROFESSIONALS
It is inconsistent to provide health care and —at the same time— remain silent (or inactive) about a major health risk. As a final note, it is important to emphasize that it is inconsistent, and perhaps unethical, to provide health care and—at the same time—remain silent (or inactive) about a major health risk. Addressing tobacco use is an essential component of clinical care. Promoting tobacco cessation is, in itself, an important component of therapy—it has immediate payoff in terms of both health improvements and cost savings (Lightwood et al., 1997). The primary goal of the Rx for Change tobacco cessation training program is to provide future health professionals with the knowledge and skills necessary to make an impact in reducing the incidence of tobacco-related disease in the U.S. and abroad. Clinicians can make a difference. Lightwood JM, Glantz SA. Short-term economic and health benefits of smoking cessation: myocardial infarction and stroke. Circulation 1997;96: TOBACCO CESSATION is an important component of THERAPY.

DR. GRO HARLEM BRUNTLAND, DIRECTOR-GENERAL of the WHO:
“If we do not act decisively, a hundred years from now our grandchildren and their children will look back and seriously question how people claiming to be committed to public health and social justice allowed the tobacco epidemic to unfold unchecked.” This quote, from Dr. Gro Harlem Bruntland, Director-General of the World Health Organization, is the closing remark in the 2001 Surgeon General’s Report on Women and Smoking (US DHHS, 2001). It appropriately emphasizes the urgency of the need for clinicians and other health professionals to take a more active role in countering tobacco use. U.S. Department of Health and Human Services. Women and Smoking: A Report of the Surgeon General. Washington, DC: Public Health Service; 2001. US Department of Health and Human Services. Women and Smoking: A Report of the Surgeon General. Washington, DC: Public Health Service, 2001.

NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY

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NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY

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