Ask-Advise-Refer Brief Interventions for Assisting Patients with Quitting Note to instructor(s): Please update this slide by inserting instructor name(s). TRAINING OVERVIEW Epidemiology of Tobacco Use Addiction to Nicotine
Medications for Quitting Changing Behavior Note to instructor(s): This program is divided into three major sections: Epidemiology of Tobacco Use Addiction to Nicotine Medications for Quitting Changing Behavior EPIDEMIOLOGY of TOBACCO USE
This module focuses on the epidemiology of tobacco use and provides an overview of adverse health consequences associated with tobacco use. All forms of tobacco are harmful.
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 in 1982, 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). The first Surgeon Generals report on smoking was published in 1964since this time, dozens of Surgeon Generals reports have summarized the conclusive evidence from biologic, epidemiologic, behavioral, and pharmacologic studies that tobacco use is detrimental to health (USDHHS, 2010). It is well established that smoking harms nearly every organ in the body, causing a wide range of diseases and reducing quality of life and life expectancy (USDHHS, 2004; USDHHS 2010). Approximately 100 million persons died due to tobacco use in the 20th centurywhich is just a fraction of the number that we anticipate losing during the 21st century. Currently, 5.4 million deaths occur annually worldwide due to tobacco (WHO, 2008). If urgent action is not taken, by 2030 we will witness more than 8 million deaths annually and more than 80% of those deaths will be in developing countries (WHO, 2008). If current trends continue, one billion persons worldwide will die during the 21st century (WHO, 2008). While users of non-cigarette forms of tobacco (e.g., cigars, smokeless tobacco, pipes) often believe these products are safe (or safer), its important for clinicians to convey to their patients that all forms of tobacco are harmful.As the death toll continues to rise, public health advocates continue to work toward identifying effective ways to (1) prevent the onset of tobacco use and (2) help patients to cease use of all tobacco products. 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 providing comprehensive tobacco cessation counseling. U.S. Department of Health and Human Services (USDHHS). (1982). The Health Consequences of Smoking: Cancer. A Report of the Surgeon General (DHHS Publication No. PHS ). Rockville, MD: Public Health Service, Office on Smoking and Health. U.S. Department of Health and Human Services (USDHHS). (2004). The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta, GA: 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. U.S. Department of Health and Human Services (USDHHS). (2010). How Tobacco Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta, GA: 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. WHO Report on the Global Tobacco Epidemic, (2008). The MPOWER package. Geneva, World Health Organization. C. Everett Koop, M.D., former U.S. Surgeon General All forms of tobacco are harmful. TRENDS in ADULT SMOKING, by SEXU.S., 19552013
Trends in cigarette current smoking among persons aged 18 or older 17.8% of adults are current smokers Males Percent This graph demonstrates trends in smoking among adults in the U.S. between 1955 and 2013 (CDC, 1999; CDC, 2014a). 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. In 2013, results of the National Health Interview Survey (NHIS) indicated that approximately 42.1 million adults (17.8% of the U.S. adult population) were current smokers1 (CDC, 2014a); of these, 76.9% smoked every day and 23.1% smoked some days (CDC, 2014a). More men (20.5%) than women (15.3%) were current smokers (CDC, 2014a). An estimated 69% of all smokers want to quit completely (CDC, 2011), and in 2012, 53% of current cigarette smokers reported having tried to quit smoking in the past year (CDC, 2014b). 1Current 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 assessment. 2Former smokers: persons who reported having smoked 100 or more cigarettes during their lifetime but currently did not smoke. Centers for Disease Control and Prevention (CDC). (1999). Achievements in public health, 19001999: Tobacco useUnited States, 19001999. MMWR 48:986993. Centers for Disease Control and Prevention (CDC). (2011). Quitting smoking among adultsUnited States, 20012010. MMWR 60:15131519. Centers for Disease Control and Prevention (CDC). (2014a). Current cigarette smoking among adultsUnited States, 20052013. MMWR 63;11081112. Centers for Disease Control and Prevention (CDC). (2014b). Current cigarette smoking among adultsUnited States, 20052012. MMWR 63;2934. Females 20.5% 15.3% Year 69% want to quit 53% tried to quit in the past year Graph provided by the Centers for Disease Control and Prevention Current Population Survey; 19652013 NHIS. Estimates since 1992 include some-day smoking. STATE-SPECIFIC PREVALENCE of SMOKING among ADULTS, 2013
The prevalence of current smoking among adults varies by state, ranging from 10.6% in Utah and California (12.6%) to 28.2% in West Virginia and 28.3% in Kentucky (CDC, 2013). Cigarette excise taxes, which vary by state, impact the overall price of cigarettes for consumers and thereby impact per capita consumption and associated rates of tobacco-related morbidity and mortality (CDC, 2010). Most of the states with the highest smoking prevalence have the lowest state taxes on cigarettes. The state cigarette excise tax varies widely by state and city and ranges from a high of $6.16 per pack in Chicago, IL and $5.85 in New York City to 17 cents per pack in Missouri. The major tobacco states (KY, VA, NC, SC, GA, TN) average 48.5 cents per pack; other states average $1.68 per pack. Overall, the average is $1.54 per pack. On March 31, 2009, President Obama raised the federal cigarette tax from 39 cents per pack to $1.01 per 20-cigarette pack. State cigarette excise tax rates and rankings as of December 22, 2014, for several states (rank shown on left, out of 50 states and Washington, DC) (Campaign for Tobacco-Free Kids, 2014): 1New York $4.35 2Massachusetts $3.51 3Rhode Island $3.50 4Connecticut $3.40 5Hawaii $3.20 6Washington $3.025 47Alabama $0.425 48Georgia $0.37 49Louisiana $0.36 50Virginia $0.30 51Missouri $0.17 Note to instructor(s): Excise taxes for each state are available on the Campaign for Tobacco-Free Kids fact sheet, which is updated regularly to reflect changes in legislation. Nationally, the average price for a pack of cigarettes is approximately $6.18 (including statewide sales taxes but not local cigarette or sales taxes, other than New York Citys $1.50 per pack cigarette tax). Campaign for Tobacco-Free Kids. (2014). State Cigarette Excise Tax Rates & Rankings. Retrieved December 30, 2014, from Centers for Disease Control and Prevention (CDC). (2010). State cigarette excise taxesUnited States, MMWR 59:385388. Centers for Disease Control and Prevention (CDC). (2013). Behavioral Risk Factor Surveillance System Prevalence and Trends Data, Atlanta, GA: 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. Prevalence of current* smoking (2013) < 13.0% 13.0 15.9% 16.0 18.9% 19.0 21.9% 22.0% * Has smoked 100 cigarettes during lifetime and currently smokes either every day or some days. PREVALENCE of ADULT SMOKING, by RACE/ETHNICITYU.S., 2013
Multiple race 26.8% American Indian/Alaska Native 26.1% White 19.4% In 2013, the prevalence of smoking in the U.S. was highest among persons of multiple race (26.8%) and next highest among persons of American Indian/Alaska Native background (26.1%), non-Hispanic Whites (19.4%) followed by non-Hispanic Blacks (18.3%), Hispanics (12.1%), and non-Hispanic Asians (9.6%) (CDC, 2014). Centers for Disease Control and Prevention (CDC). (2014). Current cigarette smoking among adultsUnited States, 20052013. MMWR 63;11081112. Black 18.3% Hispanic 12.1% Asian 9.6% Percent Centers for Disease Control and Prevention (CDC). (2014). MMWR 63:11081112. PREVALENCE of ADULT SMOKING, by EDUCATIONU.S., 2013
No high school diploma 24.2% GED diploma 41.4% High school graduate 22.0% In 2013, the prevalence of current smoking1 in the U.S. was highest among adults (aged 25 years or older) who had received a General Educational Development (GED) diploma (41.4%). Persons with a graduate degree (masters, professional, or doctorate) had the lowest prevalence (5.6%) (CDC, 2014). Also notable is the fact that the prevalence of adult smoking is associated with poverty level. The prevalence is 16.2% for persons who are at or above the poverty level and 29.2% for persons who are below the poverty level (CDC, 2014). The smoking prevalence is 18.7% for persons aged 1824; 20.1% for persons aged 2544; 19.9% for persons aged 4564; and 8.8% for persons at least 65 years of age (CDC, 2014). Persons with a self-reported sexual orientation of lesbian/gay/bisexual exhibit a smoking prevalence of 26.6%, compared to 17.6% among straight persons. 1Current 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. Centers for Disease Control and Prevention (CDC). (2014). Current cigarette smoking among adultsUnited States, 20052013. MMWR 63;11081112. 20.9% Some college 9.1% Undergraduate degree 5.6% Graduate degree Percent Centers for Disease Control and Prevention (CDC). (2014). MMWR 63:11081112. TRENDS in TEEN SMOKING, by ETHNICITYU.S., 19772014
Trends in cigarette smoking among 12th graders: 30-day prevalence of use White Cigarette smoking among adolescents is a public health concern of utmost importance. In the U.S., experimentation with cigarettes and the development of regular smoking typically occur during adolescence. It is estimated that 6,100 persons became new smokers each day in 2007, with 59.7% of these persons being under the age of 18 years (the legal age for smoking) (SAMSA, 2008). The average age at first cigarette use is 16.9 years (SAMSA, 2008).Because most youth who smoke at least monthly continue to smoke in adulthood, tobacco use trends among youth are a key indicator of the overall health trends for the U.S. During 19911997, the smoking prevalence (defined as one or more cigarettes in the 30 days before survey completion) among high school seniors increased to 36.5%. At that time, the prevalence was highest among whites (40.7%) and lowest among blacks (14.3%). This worrisome increasing trend highlighted a need for tobacco prevention and cessation programs focused on this age group. In 2014, an estimated 13.6% of 12th graders (15.2% of males and 11.6% of females) had smoked one or more cigarettes in the past 30 days (Johnston et al., 2014). Among 8th- and 10th-grade students in 2014, the overall 30-day point prevalence for cigarette smoking was 4.0% and 7.2%, respectively (Johnston et al., 2014). As can be seen in the graph, smoking among adolescents varies substantially by racial/ethnic groups and the observed downward trend has slowed in recent years. Note to instructor(s): Monitoring the Future data, publications, and press releases are available at Johnston LD, OMalley PM, Bachman JG, Schulenberg JE. (December 18, 2013). Use of alcohol, cigarettes, and a number of illicit drugs declines among U.S. teens. University of Michigan News Service: Ann Arbor, MI. Retrieved December 30, 2014 from Substance Abuse and Mental Health Services Administration (SAMSA). (2008). Results from the 2007 National Survey on Drug Use and Health: National findings (Office of Applied Studies, NSHUH Series H-34, DHHS Publication No. SMA ). Rockville, MD. Retrieved December 30, 2014, from Percent Hispanic Black Institute for Social Research, University of Michigan, Monitoring the Future Project PUBLIC HEALTH versus BIG TOBACCO
The biggest opponent to tobaccocontrol efforts is the tobaccoindustry itself. Historically, public health efforts to reduce tobacco-related morbidity and mortality have faced strong opposition. The biggest opponent to tobacco control efforts is the tobacco industry itself. Most states fail to spend even the minimum amount recommended by the CDC for expenditures on tobacco control, yet over the past decade the tobacco industry has dramatically increased its promotional spendingfrom 1998 to 2008, their spending increased by more than 52% (Campaign for Tobacco-Free Kids, 2011). For every $1 spent by the states on tobacco control initiatives, it is estimated that the tobacco industry spends nearly $23 to market its products (Campaign for Tobacco-Free Kids, 2011). Campaign for Tobacco-Free Kids. (2011). Spending vs. Tobacco Company Marketing. Retrieved December 30, 2014, from Nationally, the tobacco industry is outspending our state tobacco control funding. For every $1 spent by the states, the tobacco industry spends $23 to market its products. TOBACCO INDUSTRY MARKETING
$8.37 billion spent in the U.S. in 2011 $23.0 million a day A report from the National Cancer Institute (NCI, 2008) delineates a causal association between tobacco advertising and promotion and increased tobacco use. Each year, the tobacco industry spends billions of dollars in promoting its products in the U.S. and abroad. This graph shows the most current data on advertising expenditures in the U.S., along with data for 1970, the first year for which these data are available in the FTC annual reports, to give a basis for comparison (FTC, 2013). Highlights of the report for 2011 are as follows: Annual spending (in the U.S. only) for advertising and promotional expenditures was $8.37 billion. The total number of cigarettes sold by major manufacturers to wholesalers and retailers in the U.S. declined 2.9from billion in 2010 to billion in 2011. Significant increases in marketing were witnessed when the Master Settlement Agreement, which introduced new marketing restrictions, went into effect in 1998. Federal Trade Commission (FTC). (2013). Cigarette Report for Retrieved December 30, 2014, from National Cancer Institute (NCI). (2008). The Role of the Media in Promoting and Reducing Tobacco Use. Tobacco Control Monograph No. 19. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. NIH Pub. No New marketing restrictions Billions of dollars spent Year Federal Trade Commission (FTC). (2013). Cigarette Report for 2011. The TOBACCO INDUSTRY For decades, the tobacco industry publicly denied theaddictive nature of nicotine and the negative health effects oftobacco. April 14, 1994: Seven top executives of major tobacco companies state, under oath, that they believe nicotine is not addictive: Tobacco industry documents indicate otherwise Documents available at The cigarette is a heavily engineered product. Designed and marketed to maximize bioavailability of nicotine and addictive potential Profits over people For decades, the tobacco industry has publicly denied the addictive nature of nicotine and the negative health effects of tobacco. On April 14, 1994, the top executives of all the major tobacco companies stated, under oath, that they believe nicotine is not addictive. Yet tobacco industry documents, which are now available publicly on the Internet (http://legacy.library.ucsf.edu), suggest otherwise. The cigarette is a heavily-engineered product that was designed and marketed to maximize the bioavailability of nicotine and hence maximize its addictive potential. Note to instructor(s): Consider proceeding to the link, and play this brief (1 minute), historic video segment for your audience. The tobacco industry is financially vested in selling its product and has taken affirmative steps to maximize profits and minimize anti-tobacco public health efforts. At times the industry has actively sought to disrupt particular public health programs and legislation, and other times it is simply trying to promote its own interests above the interests of the public health. An example of this is the development and marketing of light cigarettes. COMPOUNDS in TOBACCO SMOKE
An estimated 4,800 compounds in tobacco smoke, including 11 proven human carcinogens Gases Particles Carbon monoxide Hydrogen cyanide Ammonia Benzene Formaldehyde Nicotine Nitrosamines Lead Cadmium Polonium-210 Tobacco smoke, which is inhaled either directly or as second-hand smoke, contains an estimated 4,800 compounds. The majority of the compounds are present in the particulate phase, suspended in tobacco smoke. Based on a classification system by the International Agency for Research on Cancer, cigarette smoke contains 72 proven or suspected carcinogens, including 11 proven human carcinogens (Group 1) (Hecht, 2012; NCI, 2001). Examples of detrimental compounds (some of which are carcinogens) in tobacco smoke include the following: Carbon monoxide: automobile exhaust; binds to hemoglobin, inhibits respiration Hydrogen cyanide: gas chamber poison; highly ciliotoxic, inhibits lung clearance Ammonia: floor/toilet cleaning agent; irritation of respiratory tract Nicotine : addictive substance; toxic alkaloid Benzene: solvent, banned substance in organic chemistry labs; Group I carcinogen Nitrosamines: carcinogenic in animals and probably in humans; Group 2A and 2B carcinogens Lead: heavy metal, toxic to central nervous system; Group 2B carcinogen Cadmium: heavy metal found in rechargeable batteries; Group I carcinogen Hexavalent chromium: highlighted in the movie Erin Brockovich; Group I carcinogen Arsenic: pesticide; Group I carcinogen Polonium-210: radioactive agent; Group I carcinogen Formaldehyde: embalming fluid; Group 2B carcinogen Other substances in tobacco smoke (not listed above) with sufficient evidence to be classified as Group I carcinogens in humans include 2-naphthylamine, 4-aminobiphenyl, vinyl chloride, ethylene oxide, beryllium, and nickel. Note to instructor(s): It is important to emphasize that although nicotine is the addictive component of tobacco products, it does not cause the ill health effects of tobacco use. Hecht SS. (2012). Research opportunities related to establishing standards for tobacco products under the Family Smoking Prevention and Tobacco Control Act.Nicotine Tobacco Research 14 (1):1828. National Cancer Institute (NCI). (2001). Risks Associated with Low Machine-Measured Yields of Tar and Nicotine (NIH Publication No ). Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Nicotine is the addictive component of tobacco products, but it does NOT cause the ill health effects of tobacco use. TOTAL: >480,000 deaths annually
ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, 20052009 Percent of all smoking-attributable deaths Cardiovascular & metabolic diseases 160,600 Lung cancer 130,659 Pulmonary diseases 113,100 Second-hand smoke 41,280 Cancers other than lung 36,000 Other 1,633 33% 27% Cigarette smoking is the primary known preventable cause of premature death in the U.S., with nearly one of every five deaths being smoking related (Danaei et al., 2009). This number surpasses the combined death toll due to alcohol, car accidents, suicides, homicides, HIV disease, and illicit drug use. Between 2005 and 200, more than 480,000 deaths annually were attributable to smoking. This slide delineates the percentage of smoking-attributable deaths, by disease (USDHHS, 2014). Danaei G, Ding EL, Mozarrarian D, Taylor B, Rehm J, Murray CJL, Ezzati M. (2009). The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med 6(4): e U.S. Department of Health and Human Services (USDHHS). (2014). The Health Consequences of Smoking 50 Years of Progress. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Coordinating Center for Health Promotion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. 23% 9% 7% 480,000 deaths annually U.S. Department of Health and Human Services (USDHHS). (2014). The Health Consequences of Smoking50 Years of Progress: A Report of the Surgeon General. ANNUAL SMOKING-ATTRIBUTABLE ECONOMIC COSTS
Health-care expenditures $132.5 billion Lost productivity costs due to premature mortality $156.4 billion The economic costs to society associated with smoking are enormous. Grand total annual smoking-attributable economic costs in the United States is approximately $288.9 billion, of which an estimated $132.5 billion are due to health care expenditures and $156.4 billion are associated with lost productivity costs due to premature mortality. This latter number includes premature deaths due to second-hand smoke exposure but does not include lost productivity costs due to smoking morbidity; as such, this estimate significantly understates the full impact of lost productivity. Smoking-related health care expenditures account for approximately 8% (USDHHS, 2014) of total annual spending on health care in the U.S. For each pack of cigarettes sold, the societal costs due to smoking-related health care costs and lost productivity are estimated at $19.16 per pack, nearly 3 times the cost of the cigarettes ($6.18/pack; Campaign for Tobacco-Free Kids, 2014). Strong tobacco control programs can reduce the prevalence of smoking, save lives, and also substantially impact health-care expenditures. In California, the tobacco control program was associated with an estimated $86 billion reduction in total health costs between 1989 and 2004a strong return on investment (Lightwood et al., 2008). Campaign for Tobacco-Free Kids. (2014). State Cigarette Excise Tax Rates & Rankings. Retrieved December 30, 2014, from Lightwood JM, Dinno A, Glantz SA. (2008). Effect of the California Tobacco Control Program on personal health care expenditures. PLoS Med 5(8)e178:12141222. U.S. Department of Health and Human Services (USDHHS). (2014). The Health Consequences of Smoking 50 Years of Progress. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Coordinating Center for Health Promotion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Total economic burden of smoking, per year $288.9 billion Billions of US dollars Societal costs: $19.16 per pack of cigarettes smoked U.S. Department of Health and Human Services (USDHHS). (2014). The Health Consequences of Smoking50 Years of Progress: A Report of the Surgeon General. 2014 REPORT of the SURGEON GENERAL: HEALTH CONSEQUENCES OF SMOKING
MAJOR DISEASE-RELATED CONCLUSIONS: Cigarette smoking is causally linked to diseases of nearly allorgans of the body, diminished health status, and harm to thefetus. Additionally, smoking has many adverse effects on the body, such ascausing inflammation and impairing immune function. Exposure to secondhand smoke is causally linked to cancer,respiratory, and cardiovascular diseases, and to adverse effectson the health of infants and children. Disease risks from smoking by women have risen over the last50 years and for many tobacco-related diseases are now equal tothose for men. In 2014, the Surgeon General published a comprehensive report detailing the health consequences of smoking and the progress since 1964, when the first Surgeon Generals report on smoking was published. Major disease-related conclusions are: Cigarette smoking is causally linked to diseases of nearly all organs of the body, diminished health status, and harmto the fetus.Additionally, smoking has many adverse effects on the body, such as causing inflammation andimpairing immune function. Exposure to secondhand smoke is causally linked to cancer, respiratory, and cardiovascular diseases, and toadverse effects on the health of infants and children. Disease risks from smoking by women have risen over the last 50 years and for many tobacco-related diseases(lung cancer, chronic obstructive pulmonary disease, and cardiovascular diseases) are now equal to those for men. 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 (USDHHS). (2014). The Health Consequences of Smoking50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: 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. U.S. Department of Health and Human Services (USDHHS). (2014). The Health Consequences of Smoking50 Years of Progress: A Report of the Surgeon General. HEALTH CONSEQUENCES of SMOKING
Cancers Bladder/kidney/ureter Blood (acute myeloid leukemia) Cervix Colon/rectum Esophagus/stomach Liver Lung Oropharynx/larynx Pancreatic Pulmonary diseases Asthma COPD Pneumonia/tuberculosis Chronic respiratory symptoms Cardiovascular diseases Aortic aneurysm Coronary heart disease Cerebrovascular disease Peripheral vascular disease Reproductive effects Reduced fertility in women Poor pregnancy outcomes(e.g., congenital defects, low birth weight, preterm delivery) Infant mortality Other: cataract, diabetes (type 2), erectile dysfunction, impaired immune function, osteoporosis, periodontitis, postoperative complications, rheumatoid arthritis The 2014 Surgeon Generals Report on the health consequences of smoking describes a long list of diseases with sufficient evidence to infer a causal relationship with smoking. These are summarized on this slide it is clear that tobacco use negatively impacts virtually every organ system of the body. U.S. Department of Health and Human Services (USDHHS). (2014). The Health Consequences of Smoking50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: 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. U.S. Department of Health and Human Services (USDHHS). (2014). The Health Consequences of Smoking50 Years of Progress: A Report of the Surgeon General. FORMS of TOBACCO Cigarettes
Smokeless tobacco (chewing tobacco, oral snuff) Pipes Cigars Clove cigarettes Bidis Hookah (waterpipe smoking) Electronic cigarettes (e-cigarettes)* Many forms of tobacco are available in the U.S.: Cigarettes Smokeless tobacco (also called spit tobacco; includes chewing tobacco and oral snuff) Pipes Cigars Clove cigarettes Bidis Hookah (waterpipe smoking), also called shisha, narghile, goza, hubble bubble Electronic cigarettes (e-cigarettes) these are devices that deliver nicotine and are not a form of tobacco. Also referred to as electronic nicotine delivery systems, or ENDS. Several of these forms, such as hookah and e-cigarettes, have attained increased popularity in recent years. *e-cigarettes are devices that deliver nicotine and are not a form of tobacco. Image courtesy of the Centers for Disease Control and Prevention / Rick Ward HEALTH CONSEQUENCES of SMOKELESS TOBACCO USE
Periodontal effects Gingival recession Bone attachment loss Dental caries Oral leukoplakia Cancer Oral cancer Pharyngeal cancer Note to instructor(s): Please delete this slide if you are also teaching the Forms of Tobacco module. In addition to cosmetic concerns (e.g., halitosis, staining of teeth), the use of smokeless tobacco is associated with numerous adverse health effects (Ebbert et al., 2004) including the following: Periodontal Effects Regular users of smokeless tobacco are at significant risk for the development of gingival recession (complete or partial loss of the tissue covering the root of the tooth), caries, and tooth abrasion. The loss of gingival tissue, observed in up to 27% of smokeless tobacco users, generally occurs at sites constantly exposed to tobacco (Taybos, 2003). The high sugar content found in many smokeless tobacco products in contact with exposed tooth root tissue might account for the increased incidence of dental caries in smokeless tobacco users (Hatsukami & Severson, 1999; Taybos, 2003; Ebbert et al., 2004). Soft Tissue Alterations/Leukoplakia Smokeless tobacco users commonly develop an oral soft tissue condition called leukoplakia or "snuff dipper's lesion." These white-colored patches or plaques, which are observed in approximately 15% of chewing tobacco users and 60% of snuff users, generally develop at mucosal sites in contact with the tobacco (Ebbert et al., 2004; Taybos, 2003).Of concern is the fact that a small percentage of these lesions may transform into squamous cell carcinomas (Hatsukami & Severson, 1999; Napier & Speight, 2008). Following cessation,the oral leukoplakiaappears to regressor completely disappear in the majority of cases (Napier & Speight, 2008; Martin et al., 1999). Cancer The most serious consequence of smokeless tobacco use is an increased risk for developing oral and pharyngeal cancers;the risk appears to be dose related with heavy, long-time users being more likely to develop oral cancer compared with nonusers (Ebbert et al., 2004).The risk of developing oral and lung cancer among smokeless tobacco users appears to be lower than that of smokers, but higher than that of non-tobacco users (Boffetta et al., 2008). Boffetta P, Hecht S, Gray N, Gupta P, Straif K. (2008). Smokeless tobacco and cancer. Lancet Oncol 9:667675. Ebbert JO, Carr AB, Dale LC. (2004). Smokeless tobacco: An emerging addiction. Med Clin N Am 88:15931605. Hatsukami DK, Severson HH. (1999). Oral spit tobacco: addiction, prevention and treatment.Nicotine Tob Res 1:2144. Martin GC, Brown JP, Eifler CW, Houston GD. (1999). Oral leukoplakia status six weeks after cessation of smokeless tobacco use. J Am Dent Assoc 130:945954. Napier SS, Speight PM. (2008). Natural history of potentially malignant oral lesions and conditions: an overview of the literature. J Oral Pathol Med 37:110. Taybos G. (2003). Oral changes associated with tobacco use. Am J Med Sci 326:179182. Oral Leukoplakia Image courtesy of Dr. Sol Silverman - University of California San Francisco There is no safe level of second-hand smoke.
2006 REPORT of theSURGEON GENERAL:INVOLUNTARY EXPOSURE to TOBACCO SMOKE Second-hand smoke causes premature death and diseasein nonsmokers (children and adults) Children: Increased risk for sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, and more severe asthma There is no safe level of second-hand smoke. As noted previously, approximately 50,000 persons die annually in the United States due to second-hand smoke exposure (USDHHS, 2006). Despite the tobacco industrys efforts to cast doubt on the link between second-hand smoke and health risks (USDHHS, 2006), few scientists and clinicians would deny that second-hand smoke is harmful. Major conclusions of the 2006 Surgeon Generals Report The Health Consequences of Involuntary Exposure to Tobacco Smoke (USDHHS, 2006) are: 1.Second-hand smoke causes premature death and disease in children and in adults who do not smoke. 2.Children exposed to second-hand smoke are at an increased risk for sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, and more severe asthma. Smoking by parents causes respiratory symptoms and slows lung growth in their children. 3.Exposure of adults to second-hand smoke has immediate adverse effects on the cardiovascular system and causes coronary heart disease and lung cancer. 4.The scientific evidence indicates that there is no risk-free level of exposure to second-hand smoke. 5.Many millions of Americans, both children and adults, are still exposed to second-hand smoke in their homes and workplaces despite substantial progress in tobacco control. 6.Eliminating smoking in indoor spaces fully protects nonsmokers from exposure to second-hand smoke. Separating smokers from nonsmokers, cleaning the air, and ventilating buildings cannot eliminate exposures of nonsmokers to second-hand smoke. In the 2014 Surgeon Generals Report on the health consequences of smoking, one of the major conclusions was stated as:Exposure to secondhand tobacco smoke has been causally linked to cancer, respiratory, and cardiovascular diseases, and to adverse effects on the health of infants and children (USDHHS, 2014). A comprehensive literature review concluded that the cardiovascular of second-hand smoke are substantial and rapid (Barnoya & Glantz, 2005).The effects of even brief exposure (minutes to hours) to second-hand smoke are often nearly as large (averaging 8090%) as chronic active smoking. Barnoya J, Glantz SA. (2005). Cardiovascular effects of secondhand smoke: nearly as large as smoking. Circulation 24;111:26842698. U.S. Department of Health and Human Services (USDHHS). (2006). The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Coordinating Center for Health Promotion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. U.S. Department of Health and Human Services (USDHHS). (2014). The Health Consequences of Smoking50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: 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. Respiratory symptoms and slowed lung growth if parents smoke Adults: Immediate adverse effects on cardiovascular system Increased risk for coronary heart disease and lung cancer Millions of Americans are exposed to smoke in their homes/workplaces Indoor spaces: eliminating smoking fully protects nonsmokers Separating smoking areas, cleaning the air, and ventilation are ineffective U.S. Department of Health and Human Services (USDHHS). (2006). The Health Consequences of Involuntary Exposure to Tobacco Smoke: Report of the Surgeon General. SMOKING CESSATION: REDUCED RISK of DEATH
Prospective study of 34,439 male British doctors Mortality was monitored for 50 years (19512001) On average, cigarette smokers die approximately 10 years younger than dononsmokers. Perhaps one of the greatest tobacco studies of all times is a prospective cohort of British male doctors (Doll et al., 2004). This study was conducted by Oxford University Professor Richard Doll, a leading cancer epidemiologist, who more than 50 years ago first reported that smoking causes lung cancer. Recent findings show a clear picture of the risks associated with smoking. Doll and colleagues compared the hazards of cigarette smoking in men who formed their smoking habits at different periods, and the extent of the reduction in risk when cigarette smoking was stopped at different ages. Quitting at ages 30, 40, 50, and 60 resulted in 10, 9, 6, and 3 years of life gained, respectively. On average, cigarette smokers die approximately 10 years younger than do nonsmokers, and of those who continue smoking, at least half will eventually die due to a tobacco-related disease. Persons who quit before age 35 add 10 years of life and have a life expectancy similar to men who had never smoked. In addition to losing years of life due to smoking, a 26-year prospective study of smoking in mid-life showed a dose-dependent reduction in the health-related quality of life in old age among men. Never smokers live longer than heavy smokers, and their extra years are of higher quality (Strandberg et al., 2008). Note to instructor(s): The number of years of life saved by quitting varies across studies. For example, in a CDC report (2002), it was shown that the average number of years of life lost because of smoking was 13.2 years for male smokers and 14.5 years for female smokers. Note to instructor(s):Sir Richard Doll passed away on Sunday July 24, He was the foremost epidemiologist of the twentieth century and is best known for his research establishing the correlation between smoking and lung cancer. It is a rare occasion when a researcher can, within the course of his or her own lifetime, both open and close the book on a research question of such profound public health importance as the link between smoking and cancer. Sir Richard Doll's pioneering research has, perhaps more so than any other epidemiologist of his time, altered the landscape of disease prevention and consequently saved millions of lives worldwide. Centers for Disease Control and Prevention (CDC). (2002).Annual smoking-attributable mortality, years of potential life lost, and economic costsUnited States, 19951999. MMWR 51:300303. Doll R, Peto R, Boreham J, Sutherland I. (2004). Mortality in relation to smoking: 50 years observations on male British doctors. BMJ 328(7455):15191527. Strandberg AY, Strandberg TE, Pitkala J, Salomaa VV, Tilvis RS, Miettinen TA. (2008). The effect of smoking in midlife on health-related quality of life in old age. Arch Intern Med 168:19681974. Years of life gained Among those who continue smoking, at least half will die due to a tobacco-related disease. Age at cessation (years) Doll et al. (2004). BMJ 328(7455):15191527. FINANCIAL IMPACT of SMOKING
Buying cigarettes every day for 50 years at $6.18 per pack* (does not include interest) $755,177 $338,335 In addition to the many health benefits of quitting, there are financial benefits associated with quitting. The financial costs of tobacco use can be substantial to a smoker, particularly when costs are accrued over a lifetime. What three levels of smokers who buy cigarettes every day for 50 years at $6.18 pack (average national cost; Campaign for Tobacco-Free Kids, 2014) will have if they instead bank their cigarette money each month:1 1 pack a day: $112,785 2 packs a day: $225,570 3 packs a day: $338,355 The cost of smoking is $2,256 per year for a pack-a-day smoker. 1 These values are not adjusted for interest rates, which vary over time. To compute values with associated interest, a savings calculator tool available is at Campaign for Tobacco-Free Kids. (2014). State Cigarette Excise Tax Rates & Rankings. Retrieved December 30, 2014, from $503,451 $225,570 Packs per day $112,785 $251,725 Dollars lost, in thousands * Average national cost, as of December Campaign for Tobacco-Free Kids, 2014. QUITTING: HEALTH BENEFITS
Time Since Quit Date Circulation improves, walking becomes easier Lung function increases 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 Generals 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. 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 (CHD) 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 individuals 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 individuals risk of CHD is reduced to a rate 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. U.S. Department of Health and Human Services (USDHHS). (1990). The Health Benefits of Smoking Cessation. A Report of the Surgeon General (DHHS Publication No. CDC ). 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. 1 year Risk of stroke is reduced to that of people who have never smoked Lung cancer death rate drops to half that of a continuing smoker Risk of cancer of mouth, throat, esophagus, bladder, kidney, pancreas decrease 5 years 10 years Risk of CHD is similar to that of people who have never smoked after 15 years TOBACCO DEPENDENCE: A 2-PART PROBLEM
Physiological Behavioral Treatment The addiction to nicotine Medications for cessation The habit of using tobacco Behavior change program Tobacco dependence is a chronic condition that requires a two-prong approach for maximal treatment effectiveness (Fiore et al., 2008). Prolonged tobacco use of tobacco results in tobacco dependence, which is characterized as a physiological dependence (addiction to nicotine) and behavioral habit of using tobacco. Addiction can be treated with FDA-approved medications for smoking cessation, and the behavioral habit can be treated through behavior change programs, such as individualized counseling and group or online cessation programs. The Clinical Practice Guideline for treating tobacco use and dependence (Fiore et al., 2008), which summarizes more than 8,700 published articles, advocates the combination of behavioral counseling with pharmacotherapy in treating patients who smoke. Note to instructor(s): Specific methods for treating tobacco use and dependence are covered in detail in the Assisting Patients with Quitting and Aids for Cessation modules. Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Treatment should address the physiologicaland the behavioral aspects of dependence. PROBLEM #1: ADDICTION TO NICOTINE
The next several slides describe the physiological properties of nicotine and its impact on the body. Nicotine addiction is a chronic condition with a biological basis.
WHAT IS ADDICTION? Compulsive drug use, withoutmedical purpose, in the face ofnegative consequences Alan I. Leshner, Ph.D. Former Director, National Institute on Drug Abuse National Institutes of Health Many people believe that addiction is a result of weakness in character and an inability to change ones behavior. But is it really that simple? Research contradicts this position. Nicotine addiction is a form of chronic brain disease resulting from an alteration in brain chemistry (Leshner, 1997, 1999). Dr. Alan Leshner, the former director of the National Institute on Drug Abuse, simply defines drug addiction as compulsive use, without medical purpose, in the face of negative consequences (Leshner, 1997). Many smokers believe that smoking/dipping/chewing is simply a bad habit. Research has shown that nicotine addiction is a chronic condition, one with a biological basis. Nicotine stimulates the release of brain neurotransmitters, including dopamine, which activates the dopamine reward pathway. This induces feelings of pleasure, which reinforce repeat administration of the drug. With chronic administration, tolerance to the behavioral and cardiovascular effects of nicotine develops over the course of the day. Tobacco users regain sensitivity to the effects of nicotine after overnight abstinence from smoking. When tobacco users abruptly discontinue nicotine they experience symptoms of withdrawal. These withdrawal symptoms serve as a powerful stimulus to repeat nicotine administration (Benowitz, 1992; Benowitz, 2010). Benowitz NL. (1992). Cigarette smoking and nicotine addiction. Med Clin N Am 76:415437. Benowitz NL. (2010). Nicotine addiction. N Engl J Med 362:22952303. Leshner Al. (1997, April). Drug abuse and addiction are biomedical problems. Hosp Pract (special report):24. Leshner AI. (1999). Science-based views of drug addiction and its treatment. JAMA 282:13141316. Nicotine addiction is a chronic condition with a biological basis. NICOTINE DISTRIBUTION
Arterial Inhalation of tobacco smoke is an effective means of delivering nicotine to the central nervous system. After inhalation, nicotine is rapidly absorbed across pulmonary epithelium into the arterial circulation, traveling via the carotid arteries to the central nervous system. Nicotine readily penetrates the blood-brain barrier, resulting in transient exposure of the brain to high levels of nicotine. Nicotine has been estimated to reach the brain within 1020 seconds of inhalation. Following systemic distribution, brain nicotine levels decline rapidly (Benowitz et al., 2009). This graph depicts the arterial and venous concentrations of nicotine achieved during cigarette smoking. Within 1 minute after smoking a cigarette, arterial levels of nicotine are nearly seven times the corresponding venous levels (Henningfield et al., 1993). These rapid, high levels of nicotine in the central nervous system produce an almost immediate effect, thereby reinforcing the behavioral act of smoking, which further stimulates repeated administration. Benowitz N, Hukkanen J, Jacob P III. (2009). Nicotine chemistry, metabolism, kinetics and biomarkers. Handb Exp Pharmacol. 192:2960. Henningfield JE, Stapleton JM, Benowitz NL, Grayson RF, London ED. (1993). Higher levels of nicotine in arterial than in venous blood after cigarette smoking. Drug Alcohol Depend 33:2329. Venous Nicotine reaches the brain within 1020 seconds. Henningfield et al. (1993). Drug Alcohol Depend 33:2329. DOPAMINE REWARD PATHWAY Ventral tegmental area
Prefrontal cortex Dopamine release Drugs such as cocaine, heroin, amphetamine, and nicotine exert profound effects on the brain. These agents have in common the ability to stimulate the release of the neurotransmitter dopamine in the midbrain. Dopamine induces feelings of euphoria and pleasure and is responsible for activating the dopamine reward pathway (Leshner, 1997). The dopamine reward pathway, as depicted in this simplified diagram, is a network of nervous tissue in the middle of the brain that elicits feelings of pleasure in response to certain stimuli. The important interconnected structures of the reward pathway include the ventral tegmental area (VTA), the nucleus accumbens, and the prefrontal cortex (area of the brain responsible for thinking and judgment). The neurons of the VTA contain the neurotransmitter dopamine, which is released in the nucleus accumbens and in the prefrontal cortex. Behaviors that naturally stimulate the reward pathway include eating to relieve hunger, drinking to alleviate thirst, or engaging in sexual activity. On a primitive, neurochemical level, stimulation of the reward pathway reinforces the behavior so that it will be repeated. Obviously these behaviors are necessary for continued survival of the organism. The reward pathway can also be stimulated by drugs of abuse such as cocaine, opiates, amphetamine, and nicotine. When these unnatural stimuli trigger the reward pathway the same pleasurable feelings are elicited. Researchers believe that, with chronic drug use, the brain becomes chemically alteredtransforming a drug user into a drug addict (Leshner, 1997). Consider cigarette smoking as an example. Immediately following inhalation, a bolus of nicotine enters the brain, stimulating the release of dopamine, which induces nearly immediate feelings of pleasure and relief of symptoms of nicotine withdrawal. This rapid dose-response reinforces and perpetuates the smoking behavior. This slide was made available to the public through the National Institute on Drug Abuse and was adapted with permission by Dr. Rochelle D. Schwartz-Bloom, Duke University. Leshner Al. (1997, April). Drug abuse and addiction are biomedical problems. Hosp Pract (special report):24. Stimulation of nicotine receptors Nucleus accumbens Ventral tegmental area Nicotine entersbrain NICOTINE PHARMACODYNAMICS: WITHDRAWAL EFFECTS
Irritability/frustration/anger Anxiety Difficulty concentrating Restlessness/impatience Depressed mood/depression Insomnia Impaired performance Increased appetite/weight gain Cravings Most symptoms manifest within the first 12 days, peak within the first week, and subside within 24 weeks. Note to instructor(s): Refer students to the Withdrawal Symptoms Information Sheet handout. This handout describes several symptoms, when they occur postcessation, and how to cope with withdrawal. In addition to being an educational aid for students, it can be copied and distributed to patients who are quitting. When nicotine is discontinued abruptly, the following withdrawal symptoms develop (Hughes, 2007): Irritability/frustration/anger Anxiety Difficulty concentrating Restlessness/impatience Depressed mood/depression Insomnia Impaired performance Increased appetite/weight gain Cravings Note to instructor(s): Other symptoms of quitting have been described in the literature.Please refer to Hughes, 2007 for further details. Tobacco users usually experience a strong desire or craving for tobacco. In general, withdrawal symptoms manifest within the first 12 days, peak within the first week, and gradually dissipate over the next 24 weeks (Hughes, 2007). Strong cravings for tobacco may persist for months to years after cessation (Benowitz, 1992). Benowitz NL. (1992). Cigarette smoking and nicotine addiction. Med Clin N Am 76:415437. Hughes JR. (2007). Effects of abstinence from tobacco: valid symptoms and time course. Nicotine Tob Res 9:31527. Hughes. (2007). Nicotine Tob Res 9:315327. NICOTINE ADDICTION Tobacco users maintain a minimum serumnicotine concentration in order to Prevent withdrawal symptoms Maintain pleasure/arousal Modulate mood Users self-titrate nicotine intake by Smoking/dipping more frequently Smoking more intensely Obstructing vents on low-nicotine brand cigarettes As shown in the previous slide, tobacco users tend to carefully titrate, or regulate, their tobacco intake to maintain a relatively constant level of nicotine in the body, in order to (Benowtiz, 1999; Benowitz, 2008): Prevent withdrawal symptoms Maintain pleasure/arousal Modulate mood (e.g., to handle stress or anxiety) Although many tobacco users might not think about it consciously, they are able to alter nicotine delivery in a number of ways, including (Benowitz, 1999): By smoking or dipping more frequently By smoking more intensely (e.g., inhaling deeper or longer, smoking cigarette down to the filter) By obstructing the vents (with fingers or lips) on light cigarettes, thereby increasing the amount of nicotine delivered to the lung Excess nicotine concentrations will result in symptoms of nicotine toxicity. These include headache, nausea and vomiting, abdominal pain, diarrhea, salivation, dizziness, blurred vision, weakness, cold sweat, mental confusion, weakness and in severe overdose, hypotension, seizures and respiratory depression (Taylor, 2006). Benowitz NL. (1999). Nicotine addiction. Prim Care 26:611631. Benowitz NL. (2008). Clinical pharmacology of nicotine: implications for understanding, preventing, and treating tobacco addiction. Clin Pharmacol Ther 83:53141. Taylor P. (2006). Agents acting at the neuromuscular junction and autonomic ganglia. In Brunton LL, Lazo JS, Parker KL (eds.), Goodman and Gilman's The Pharmacological Basis of Therapeutics, 11th ed. New York: McGraw-Hill. Benowitz. (2008). Clin Pharmacol Ther 83:531541. FDA-APPROVED MEDICATIONS for CESSATION
Nicotine polacrilex gum Nicorette (OTC) Generic nicotine gum (OTC) Nicotine lozenge Nicorette Lozenge (OTC) Nicorette Mini Lozenge (OTC) Generic nicotine lozenge (OTC) Nicotine transdermal patch NicoDerm CQ (OTC) Generic nicotine patches (OTC, Rx) Nicotine nasal spray Nicotrol NS (Rx) Nicotine inhaler Nicotrol (Rx) Bupropion SR (Zyban) Varenicline (Chantix) Currently five formulations of nicotine replacement therapy and two non-nicotine agents have FDA approvals as aids for smoking cessation (Fiore et al., 2008). Medications that are available without a prescription include the nicotine gum, nicotine lozenge, and nicotine transdermal patch. Medications available only with a prescription are the nicotine nasal spray, nicotine inhaler, sustained-release bupropion, and varenicline. One formation of the generic transdermal patch also is available with a prescription. Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. These are the only medications that are approved for smoking cessation. Medications significantly improve success rates.
PHARMACOTHERAPY Clinicians should encourage allpatients attempting to quit to useeffective medications for tobaccodependence treatment, except wherecontraindicated or for specificpopulations* for which there isinsufficient evidence of effectiveness. The U.S. Public Health Service Clinical Practice Guideline for treating tobacco use and dependence states that clinicians should encourage all patients attempting to quit to use effective medications for tobacco dependence treatment, except where contraindicated or for specific populations for which there is insufficient evidence of effectiveness (Fiore et al., 2008, p. 106). Use of pharmacotherapy requires special consideration in the following patient populations (Fiore et al., 2008): Pregnant or breast-feeding women Smokeless tobacco users Patients smoking fewer than 10 cigarettes per day (light smokers) Adolescents Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. * Includes pregnant women, smokeless tobacco users, light smokers, and adolescents. Medications significantly improve success rates. Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008. PHARMACOTHERAPY: USE in PREGNANCY
The Clinical Practice Guideline makes no recommendationregarding use of medications in pregnant smokers Insufficient evidence of effectiveness Category C: varenicline, bupropion SR Category D: prescription formulations of NRT The Clinical Practice Guideline states that pregnant smokers should be encouraged to quit without medication based on insufficient evidence of effectiveness and hypothetical concerns with safety. Pregnant smokers should be offered person-to-person psychosocial interventions that exceed minimal advice to quit (Fiore et al., 2008). The FDA has classified both bupropion and varenicline as a pregnancy category C agent based on a lack of controlled studies in pregnant women and animal studies that have demonstrated fetal harm (vareniclinedecreased fetal weights, decreased fertility in offspring; bupropionfetal malformations and skeletal variations) in dosages exceeding the maximum recommended human dose (on a mg/m2 basis).The manufacturers of bupropion and varenicline both recommend use during pregnancy only if the potential benefit justifies the potential risk to the fetus (GlaxoSmithKine, 2014; Pfizer, 2014). Note to instructor(s): The manufacturer of Zyban (GlaxoSmithKline) maintained a bupropion pregnancy registry from September 1, 1997 through March 31, 2008 and published and interim reports every 6 months.After more than a decade of surveillance, the registry was closed based on evidence that excluded a major teratogenic effect in pregnancies with exposure to any formulation of bupropion (GlaxoSmithKline, 2008). The FDA has classified prescription formulations of 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 (Benowitz & Dempsey, 2004). However, because it is assumed that NRT can cause fetal harm the Clinical Practice Guideline does not recommend its use during pregnancy (Fiore et al., 2008). The American College of Obstetrics and Gynecology endorses counseling, including referral to tobacco quitlines and recommends the use of NRT only for women who can be closely monitored and demonstrate a clear commitment to quitting smoking (ACOG, 2010). American College of Obstetrics and Gynecology (2010). Committee opinion no. 471: Smoking cessation during pregnancy. Obstet Gynecol. 116:124144. Benowitz NL, Dempsey DA. (2004). Pharmacotherapy for smoking cessation during pregnancy. Nicotine Tob Res 6(Suppl. 2):S189S202. Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. GlaxoSmithKline Inc. (2014, August). Zyban Package Insert. Research Triangle Park, NC. GlaxoSmithKline. (2008, August). The bupropion pregnancy registry. Final report 1 September 1997 through 31 March Wilmington, NC. For Information on obtaining the report, see Pfizer Inc. (2014, October).Chantix Package Insert. New York, NY. Because of the serious risks of smoking to the pregnant smoker and the fetus, whenever possible pregnant smokers should be offered person-to-person psychosocial interventions that exceed minimal advice to quit. Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008. PHARMACOTHERAPY: OTHER SPECIAL POPULATIONS
Pharmacotherapy is not recommended for: Smokeless tobacco users No FDA indication for smokeless tobacco cessation Individuals smoking fewer than 10 cigarettes per day Adolescents Nonprescription sales (patch, gum, lozenge) are restricted to adults 18 years of age NRT use in minors requires a prescription Pharmacotherapy is not recommended for use in smokeless tobacco users, individuals smoking fewer than 10 cigarettes per day (light smokers), or adolescents because of insufficient evidence of effectiveness (Fiore et al., 2008). These populations tend to be excluded in randomized controlled trials, and therefore limited data are available. Non-prescription NRT sales (nicotine patch, gum, lozenge) are restricted to adults 18 years of age, and use of NRT use in minors requires a prescription. For each of these special populations, the recommended treatment is behavioral counseling (Fiore et al., 2008). Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Recommended treatment is behavioral counseling. Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008. NRT products approximately doubles quit rates.
NRT: RATIONALE for USE Reduces physical withdrawal from nicotine Eliminates the immediate, reinforcing effects of nicotine that is rapidly absorbed via tobacco smoke 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 alleviating physical nicotine withdrawal symptoms, which are usually experienced following tobacco cessation. This makes patients more comfortable while they are quitting. NRT eliminates the immediate, reinforcing effects of nicotine that is rapidly absorbed via tobacco smoke. NRT allows the patient to focus on behavioral and psychological aspects of tobacco cessation. While NRT products are helping to alleviate withdrawal symptoms, the patient is able to focus on the behavioral and psychological changes necessary for successful tobacco cessation. NRT itself can be addicting, and although their addictive properties are negligible compared to tobacco products, some patients might have difficulty terminating NRT use. NRT use significantly improves the success rates of smoking cessation. Meta-analyses of controlled trials of NRT have found that all products (gum, patch, lozenge, inhaler, and nasal spray) significantly improve abstinence rates when compared to placebo. Use of NRT approximately doubles long-term quit rates relative to placebo (Fiore et al., 2008; Stead et al., 2012). Advantages of NRT include the following: Patients are not exposed to the carcinogens and other toxic components found in tobacco and tobacco smoke. NRT provides lower, slower, and less variable plasma nicotine concentrations than do cigarettes, which reduces the behaviorally reinforcing effect of smoking. Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Stead LF, Perera R, Bullen C, Mant D, Hartmann-Boyce J, Cahill K, Lancaster T. (2012). Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 1:CD NRT products approximately doubles quit rates. 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, the nasal spray has the most rapid absorption, 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 of overnight abstinence. The administration of nicotine varied across the studies as follows: the cigarette was smoked over 5 minutes, the moist snuff (2 grams Copenhagen) was placed between the check and gum for 30 minutes, the inhaler was used over 20 minutes (80 puffs), the gum was chewed over 30 minutes, the lozenge was held in the mouth for approximately 30 minutes, and the patch was applied to the skin for 1 hour. The data presented in the graph derive from multiple studies and are meant to illustrate the differences between nicotine absorption from tobacco and NRT (Choi et al., 2003; Fant et al., 1999; Schneider et al., 2001). Because NRT formulations deliver nicotine more slowly and at lower levels (e.g., 3075% of those achieved by smoking), these agents are far less likely to be associated with dependence when compared to tobacco products. Choi JH, Dresler CM, Norton MR, Strahs KR. (2003). Pharmacokinetics of a nicotine polacrilex lozenge. Nicotine Tob Res 5:635644. Fant RV, Henningfield JE, Nelson RA, Pickworth WB. (1999). Pharmacokinetics and pharmacodynamics of moist snuff in humans. Tob Control 8:387392. Schneider NG, Olmstead RE, Franzon MA, Lunell E. (2001). The nicotine inhaler. Clinical pharmacokinetics and comparison with other nicotine treatments. Clin Pharmacokinet 40:661684. Time (minutes) NICOTINE GUM Nicorette; generics
Resin complex Nicotine Polacrilin Sugar-free chewing gum base Contains buffering agents to enhance buccal absorption of nicotine Available: 2 mg, 4 mg; original, cinnamon, fruit and mint (various) flavors FDA approved: 1984 Switched to OTC status: 1996 Available strengths: 2 mg, 4 mg Available flavors:Nicorette (GlaxoSmithKline) gum: original; mint (released 1998); FreshMint (coated formulation, released 2005); Fruit Chill (coated formulation, released 2006); Cinnamon Surge (coated formulation, released 2007); White Ice Mint (coated formulation, released 2008); Nicorette Orange (no longer availablediscontinued by GlaxoSmithKline 12/2005) Generic gum: original; mint; coated-mint Description of Product Nicotine polacrilex (pol-ah-kril-ex) is a resin complex of nicotine and polacrilin in a sugar-free chewing gum base. The original flavor gum has a distinct, tobacco-like, slightly peppery taste.Newer, softer to chew formulations, in a variety of flavors, have been released over the years to increase palatability. All gum formulations contain buffering agents (sodium carbonate and sodium bicarbonate) to increase salivary pH, thereby enhancing buccal absorption of nicotine. Clinical Efficacy (Fiore et al., 2008) In a meta-analysis of 13 trials, nicotine gum was found to significantly improve quit rates compared to placebo. The effectiveness and abstinence rates at 6-months post-quit date are shown in the table below. The 4-mg gum is more efficacious than the 2-mg gum as a cessation aid in highly dependent smokers (Fiore et al., 2008). Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Treatment Estimated odds ratio (95% CI) Estimated abstinence rate (95% CI) Placebo 1.0 13.8% Nicotine gum (614 weeks) 1.5 (1.21.7) 19.0% (16.521.9) Nicotine gum, long-term (>14 weeks) 2.2 (1.53.2) 26.1% (19.733.6) Continuous 6-month abstinence rate (active / placebo)
NICOTINE LOZENGE Nicorette Lozenge and Nicorette Mini Lozenge; generics Nicotine polacrilex formulation Delivers ~25% more nicotine than equivalent gum dose Sugar-free mint, cherry flavors Contains buffering agents toenhance buccal absorption ofnicotine Available: 2 mg, 4 mg FDA approved for use without a prescription: 2002 Available strengths: 2 mg, 4 mg Generic lozenge available: 2006; Nicorette Mini available: 2010 Available flavors: Nicorette (GlaxoSmithKline) lozenge: mint; cherry. The Commit name is no longer used by GlaxoSmithKline (it was replaced with the Nicorette Lozenge), and the cappuccino flavor is no longer available. Nicorette Mini lozenge: mint Generic lozenge: original; mint Description of Product Nicotine polacrilex (pol-ah-kril-ex) is a resin complex of nicotine and polacrilin in a sugar-free (contains aspartame) mint (various), or cherry flavored lozenge. The lozenge is 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 (Choi et al., 2003). 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 (Fiore et al., 2008) Data from a large randomized clinical trial suggest the nicotine lozenge improves quit rates significantly compared to placebo. The effectiveness at 6-months post-quit date are as follows: Choi JH, Dresler CM, Norton MR, Strahs KR. (2003). Pharmacokinetics of a nicotine polacrilex lozenge. Nicotine Tob Res 5:635644. Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Treatment Odds ratio (95% CI) Continuous 6-month abstinence rate (active / placebo) Nicotine lozenge (2 mg) 2.0 (1.42.8) 24.2% / 14.4% Nicotine lozenge (4 mg) 2.8 (1.94.0) 23.6% / 10.2% TRANSDERMAL NICOTINE PATCH NicoDerm CQ; generic
Nicotine is well absorbed across the skin Delivery to systemic circulation avoids hepatic first-pass metabolism Plasma nicotine levels are lower and fluctuate less than with smoking FDA approved: 1991 Available OTC: 1996 Description of Product Transdermal nicotine delivery systems consist of an impermeable surface layer, a nicotine reservoir, an adhesivelayer, and a removable protective liner. The technology for delivery of nicotine across the skin varies by manufacturer.NicoDerm CQ (GlaxoSmithKline) uses a rate-controlling membrane. The generic patches (previously marketed asHabitrol) use drug-dispersion-type systems whereby release of nicotine is controlled by diffusion of the drug across anadhesive layer (Gore & Chien, 1998). Nicotine is well absorbed across the skin; 6882% of the dose released fromthe patch reaches the systemiccirculation.Plasma nicotine concentrations from the patch rise slowly over 14 hours and peak within 312 hoursfollowing application [Benowitz et al., 2009].Blood levels of nicotine achieved with the transdermal patch are lowerand fluctuate less than do those achieved with tobacco products or other NRT formulations. Clinical Efficacy (Fiore et al., 2008) In a meta-analysis of 25 trials, the transdermal nicotine patch was found to significantly improve quit rates compared to placebo. The effectiveness and abstinence rates at 6-months post-quit date are as follows: Benowitz NL, Hukkanen J, Jacob P. (2009) Nicotine chemistry, metabolism, kinetics and biomarkers. Handb Exp Pharmacol: Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Gore AV, Chien YW. (1998). The nicotine transdermal system. Clin Dermatol 16:599615. Treatment Estimated odds ratio (95% CI) Estimated abstinence rate (95% CI) Placebo 1.0 13.8% Nicotine patch (614 weeks) 1.9 (1.72.2) 23.4% (21.325.8) Nicotine patch, (>14 weeks) 1.9 (1.72.3) 23.7% (21.026.6) NICOTINE NASAL SPRAY Nicotrol NS
Aqueous solution of nicotine in a 10-ml spray bottle Each metered dose actuation delivers 50 mcL spray 0.5 mg nicotine ~100 doses/bottle Rapid absorption across nasal mucosa FDA approved: March 1996 (prescription only) Description of Product Nicotrol NS (Pfizer) is an aqueous solution of nicotine available in a metered-spray pump for administration to the nasal mucosa. Each actuation delivers a metered 50-L spray containing 0.5 mg of nicotine. Each bottle contains approximately 100 doses (200 sprays) or about a 1-week supply (Pfizer, 2010). Nicotine is absorbed rapidly, and plasma nicotine concentrations attained via the nasal spray are comparable to (but lower than) those achieved by smoking. The nasal spray has a faster onset of action (tmax 1113 minutes) compared to the gum, patch, or inhaler (Schneider et al., 1996). Note to instructor(s): The nicotine nasal spray has a higher dependence potential relative to other NRT formulations but a lower dependence potential relative to tobacco products. About 1320% of patients continue to use the nicotine nasal spray for longer periods than recommended (612 months) (Fiore et al., 2008; Hajek et al., 2007), and 5% use the spray at higher doses than recommended (Fiore et al., 2008). Clinical Efficacy (Fiore, et al., 2008) In a meta-analysis of four trials, the nicotine nasal spray was found to significantly improve quit rates compared to placebo. The effectiveness and abstinence rates at 6-months post-quit date are as follows Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Hajek P, McRobbie H, Gillison F. (2007). Dependence potential of nicotine replacement treatments: effects of product type, patient characteristics, and cost to user. Prev Med 44:230234. Pfizer Inc. (2010, January). Nicotrol NS Package Insert. New York, NY. Schneider NG, Lunell E, Olmstead RE, Fagerstrm KO. (1996). Clinical pharmacokinetics of nasal nicotine delivery. A review and comparison to other nicotine systems. Clin Pharmacokinet 31:6580. Treatment Estimated odds ratio (95% CI) Estimated abstinence rate (95% CI) Placebo 1.0 13.8% Nicotine nasal spray 2.3 (1.73.0) 26.7% (21.532.7) NICOTINE INHALER Nicotrol Inhaler
Nicotine inhalation system consists of: Mouthpiece Cartridge with porous plug containing 10 mg nicotine and 1 mg menthol Delivers 4 mg nicotine vapor, absorbed across buccal mucosa FDA approved: May 1997 (prescription only) Description of Product The Nicotrol Inhaler (nicotine inhalation system; Pfizer) consists of a mouthpiece and a plastic cartridge delivering 4 mg of nicotine as an inhaled vapor from a porous plug containing 10 mg of nicotine and 1 mg of menthol (Pfizer, 2008). Menthol is added to decrease the irritant effects of nicotine (Schneider et al., 2001). Given that the usual pack-a-day smoker repeats the hand-to-mouth motion up to 200 times per day or 73,000 times each year, it is not surprising that many smokers find they miss the physical manipulation of the cigarette and associated behaviors that go with smoking. The nicotine inhaler was designed to provide nicotine replacement in a manner similar to smoking while addressing the sensory and ritualistic factors important to many smokers (Schneider et al., 2001). As a patient puffs on the inhaler mouthpiece, buccal nicotine vapor is released and delivers nicotine to the mouth and throat, where it is absorbed through the mucosa. Less than 5% of the nicotine in a dose reaches the lower respiratory tract. With an intensive inhalation regimen (80 puffs over 20 minutes), about 4 mg of nicotine is delivered and, of that, 2 mg is absorbed. Plasma nicotine levels are 5070% lower than those achieved with cigarette smoking, and peak nicotine concentrations occur after 30 minutes, compared to 5 minutes after cigarette smoking (Schneider et al., 2001). Clinical Efficacy (Fiore et al., 2008) In a meta-analysis of six trials, the nicotine nasal spray was found to significantly improve quit rates compared to placebo. The effectiveness and abstinence rates at 6-months post-quit date are as follows: Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Pfizer Inc. (2008, December). Nicotrol Inhaler Package Insert. New York, NY. Schneider NG, Olmstead RE, Franzon MA, Lunell E. (2001). The nicotine inhaler. Clinical pharmacokinetics and comparison with other nicotine treatments. Clin Pharmacokinet 40:661684. Treatment Estimated odds ratio (95% CI) Estimated abstinence rate (95% CI) Placebo 1.0 13.8% Nicotine inhaler 2.1 (1.52.9) 24.8% (19.131.6) BUPROPION SR Zyban; generics
Nonnicotine cessation aid Sustained-release antidepressant Oral formulation FDA approved for smoking cessation: May 1997 (prescription only), generic approved in 2004 Description of Product Bupropion sustained-release (SR) tablets are an oral antidepressant medication used as a nonnicotine aid to smoking cessation (GlaxoSmithKline, 2014). The same chemical agent is marketed as Wellbutrin for use in treating depression. Clinical Efficacy (Fiore et al., 2008) In a meta-analysis of 24 trials, bupropion was found to significantly improve quit rates compared to placebo. The effectiveness and abstinence rates at 6-months post-quit date are as follows: Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. GlaxoSmithKline Inc. (2014, August). Zyban Package Insert. Research Triangle Park, NC. Treatment Estimated odds ratio (95% CI) Estimated abstinence rate (95% CI) Placebo 1.0 13.8% Bupropion SR 2.0 (1.82.2) 24.2% (22.226.4) Estimated abstinence rate (95% CI)
VARENICLINEChantix Nonnicotinecessation aid Partial nicotinicreceptor agonist Oral formulation FDA approved for smoking cessation: May 11, 2006 (prescription only) Description of Product (Pfizer, 2014) Varenicline is a partial agonist selective for the 42 nicotinic acetylcholine receptor indicated for use as an aid to smoking cessation treatment. Clinical Efficacy (Fiore et al., 2008) In a meta-analysis of four trials, varenicline was found to significantly improve quit rates compared to placebo. The effectiveness and abstinence rates at 6-months post-quit date are as follows: Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Pfizer Inc. (2014, October). Chantix Package Insert. New York, NY. Treatment Estimated odds ratio (95% CI) Estimated abstinence rate (95% CI) Placebo 1.0 13.8% Varenicline (1 mg/day) 2.1 (1.53.0) 25.4% (19.632.2) Varenicline (2 mg/day) 3.1 (2.53.8) 33.2% (28.937.8) LONG-TERM (6 month) QUIT RATES for AVAILABLE CESSATION MEDICATIONS
28.0 23.9 19.7 18.9 17.1 16.3 15.9 This bar chart summarizes the long-term (6-month) quit rates observed with the different NRT products, bupropion SR and varenicline (Cahill et al., 2012; Stead et al., 2012; Hughes et al., 2014). These data are derived from 161 different randomized-controlled trials; therefore, it is inappropriate to make direct comparisons between the active medications with respect to clinical efficacy. What this chart does illustrate, however, is that the quit rates from each of the methods is approximately twice that of its corresponding placebo control treatment arm. Each of the pharmacotherapy options depicted in the chart is considered effective and any medication can be recommended, if not contraindicated. However, when assisting patients in choosing a product, clinicians should consider additional factors including: the number of cigarettes smoked per day (or time to first cigarette), advantages and disadvantages of each product, methods used for prior quit attempts, reasons for relapse, and the patients own preferences. Behavioral counseling should be used in conjunction with all pharmacologic therapies. Cahill K, Stead LF, Lancaster T.Nicotine receptor partial agonists for smoking cessation. (2012). Cochrane Database Syst Rev 4:CD Hughes JR, Stead LF, Hartmann-Boyce J, Cahill K, Lancaster T. (2014). Antidepressants for smoking cessation. Cochrane Database Syst Rev 1:CD Stead LF, Perera R, Bullen C, Mant D, Hartmann-Boyce J, Cahill K, Lancaster T. (2012). Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 11:CD Percent quit 11.8 12.0 11.5 10.0 9.8 9.1 8.4 Data adapted from Cahill et al. (2012). Cochrane Database Syst Rev; Stead et al. (2012). Cochrane Database Syst Rev;Hughes et al. (2014). Cochrane Database Syst Rev COMBINATION PHARMACOTHERAPY
Regimens with enough evidence to be recommended first-line Combination NRT Long-acting formulation (patch) Produces relatively constant levels of nicotine PLUS Short-acting formulation (gum, inhaler, nasal spray) Allows for acute dose titration as needed for nicotine withdrawal symptoms Bupropion SR + Nicotine Patch While the use of first- and second-line medications approximately double the likelihood that a patient will successfully quit smoking, data from clinical trials suggest that only 1933% of patients remain abstinent six months after quitting (Fiore et al, 2008). Given these low success rates, clinicians and researchers have explored modified approaches to standard therapies, including the use of combination therapy. Data from randomized, controlled trials suggest that certain combinations of first-line cessation medications are efficacious in promoting long-term abstinence and the 2008 Clinical Practice Guideline recommends that clinicians consider the use of combination therapy as a first-line treatment approach for patients during a quit attempt (Fiore et al., 2008). Plasma levels of nicotine achieved with standard doses of NRT are generally much lower than those attained with regular smoking.As such, conventionally dosed NRT may deliver sub-therapeutic nicotine levels for some individuals, and in particular, for moderate-to-heavy smokers. Dual NRT regimens, which typically consist of a long-acting agent (e.g., nicotine patch) in combination with a short-acting formulation (i.e., gum, lozenge, inhaler, or nasal spray) are being increasingly used as initial therapy.The long-acting formulation, which delivers nicotine at relatively constant level, is used to prevent the onset of severe withdrawal symptoms while the short-acting formulation, which delivers nicotine at a more rapid rate, is used as needed to control withdrawal symptoms that may occur during potential relapse situations (e.g., after meals, during times of stress, when around other smokers). Evidence suggests that patients who use combination NRT are 1.3 times as likely to remain abstinent when compared with patients who use single-agent NRT (Stead et al., 2012). Similarly, quit rates with combination therapy that included NRT (gum, patch, lozenge) and bupropion SR were 1.2 times those attained with bupropion SR alone (Stead et al., 2012). Note to instructor(s):Experience with other combinations of first-line agents is limited. Randomized trials with varenicline in combination with the nicotine patch have yielded conflicting short-term results (Hajek et al., 2013; Koegelenberg et al., 2014), and a randomized trial of varenicline combined with bupropion SR showed no significant improvement at one-year follow up compared with varenicline alone (Ebbert et al., 2014). While varenicline in combination with bupropion or NRT appears to be reasonably well tolerated, further studies are necessary to establish the long-term safety and efficacy of these combinations. Fiore MC, Jan CR, Baker TB, et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. Stead LF, Perera R, Bullen C, Mant D, Hartmann-Boyce J, Cahill K, Lancaster T. (2012). Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 1:CD Hajek P, Smith KM, Dhanji AR, et al. (2013). Is a combination of varenicline and nicotine patch more effective in helping smokers quit than varenicline alone? A randomised controlled trial. BMC Med 11:140. Koegelenberg CF, Noor F, Bateman ED, et al. (2014). Efficacy of varenicline combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a randomized clinical trial. JAMA 312:15561. Ebbert JO, Hatsukami DK, Croghan IT, et al. (2014). Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA311:15563. IDENTIFY KEY ISSUES to STREAMLINE PRODUCT SELECTION*
Do you prefer a prescription or non-prescriptionmedication? Would it be a challenge for you to take amedication frequently throughout the day, e.g., aminimum of 9 times? With the exception of the nicotine patch, all NRT formulations require frequent dosing throughout the day. If patient is unable to adhere to the recommended dosing, these products should be ruled out as monotherapy because they will be ineffective. With seven similarly-effective FDA-approved medications for cessation, selecting the best product for a patient can be a challenge. On this slide, we list a brief approach to narrowing the options. Consider asking patients whether they prefer a prescription or non-prescription medication. This is particularly relevant for non-prescribing health care providers, such as pharmacists, for who contacting a physician would be necessary for the prescription options. A second, very useful question is, Would it be a challenge for you to take a medication frequently throughout the day, e.g., a minimum of 9 times initially?With the exception of the nicotine patch, all NRT formulations require frequent dosing throughout the day, and if a patient is unable to adhere to the recommended dosing schedule, these products should be ruled out as monotherapy because they will be ineffective. Once these two questions have been asked, clinicians should ensue by asking product-specific questions for the remaining options. Additionally, it is important to ask the patient whether they have any personal preferences. Asking these two questions will significantly reduce the time required for product selection. * Product-specific screening, for warnings/precautions/contraindications and personal preferences, is also essential. ADHERENCE IS KEY to QUITTING
Promote adherence with prescribed regimens. Use according to dosing schedule, NOT asneeded. Consider telling the patient: When you use a cessation product it is important to read all the directions thoroughly before using the product. The products work best in alleviating withdrawal symptoms when used correctly, and according to the recommended dosing schedule. Comprehensive counseling not only provides patients with information and social support for their quit attempts, but it also could improve the poor adherence rates commonly observed with treatment regimens for cessation (Hajek et al., 1999; Pierce & Gilpin, 2002; Schneider et al., 2003; Shiffman et al., 2008). When counseling quitters for pharmacotherapy, particularly with short-acting forms of NRT, it is important to emphasize the need to use the products correctly and to adhere to the recommended dosing schedule. Patients who use more lozenges, for example, have been shown to be more likely to achieve abstinence (Shiffman et al., 2002). Hajek P, West R, Foulds J, Nilsson F, Burrows S, Meadow A. (1999). Randomized comparative trial of nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler. Arch Intern Med 159:20332038. Pierce JP, Gilpin EA. (2002). Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA 288:12601264. Schneider MP, van Melle G, Uldry C, Huynh-Ba M, Fallab Stubi CL, Iorillo D, et al. (2003). Electronic monitoring of long-term use of the nicotine nasal spray and predictors of success in a smoking cessation program. Nicotine Tob Res 5:719727. Shiffman S, Dresler CM, Hajek P, Gilburt SJA, Targett DA, Strahs KR. (2002). Efficacy of a nicotine lozenge for smoking cessation. Arch Intern Med 162;12671276. Shiffman S, Ferguson SG, Rohay J, Gitchell JG. (2008).Perceived safety and efficacy of nicotine replacement therapies among US smokers and ex-smokers: relationship with use and compliance. Addiction 103:13711378. COMPARATIVE DAILY COSTS of PHARMACOTHERAPY
Average $/pack of cigarettes, $6.18 This slide presents the approximate daily costs of treatment for the various pharmacotherapies for cessation. These are estimates* based on the recommended initial dosing for each agent. Costs can vary considerably depending on the patients 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 cost for one pack of cigarettes (national average, approximately $6.18) is shown (Campaign for Tobacco-Free Kids, 2014). For most cessation medications, the daily cost of therapy is substantially less than the cost of one pack of cigarettes. *Cost calculated using the most expensive wholesale acquisition cost (WAC) for each trade name agent and the least expensive WAC for each generic product (Redbook, 2014). Campaign for Tobacco-Free Kids. (2014). State Cigarette Excise Tax Rates & Rankings. Retrieved December 30, 2014, from Red Book Online. (2014, December). New York, NY: Thomson Reuters. $/day CLOSE TO HOME 2000 John McPherson.
Medications are effective, but they are just one component of comprehensive treatment for tobacco cessation. Behavior change is equally important. Patients often describe tobacco cessation as the most difficult achievement of their life. Tobacco users can be very creative in the methods they choose for quitting, as is illustrated in this cartoon. Medications are effective, but they are just one component of comprehensive treatmen