Medication Therapy Management
Providing Medication Therapy Management for Smoking Cessation Patients
Journal of Pharmacy Practice 1-5 ª The Author(s) 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0897190014562381 jpp.sagepub.com
Tiffany D. Smalls, PharmD, CPh1, Amelia D. Broughton, PharmD2, Ericka V. Hylick, PharmD3, and Todd J. Woodard, PharmD, BCPP, BCPS, CGP4
Abstract Nearly 50 years ago, the Surgeon General of the US Public Health Service released the first report of the Surgeon General’s Advisory Committee on Smoking and Health. The report concluded that cigarette smoking caused lung and laryngeal cancer as well as bronchitis. Today, smoking is one of the leading preventable causes of deaths in the United States. Research has shown that it potentially causes more deaths than human immunodeficiency virus, illegal drug use, alcohol use, motor vehicle injuries, and firearm-related incidents. Health care providers play a critical role in guiding and directing patients to quit smoking by introducing them to smoking-cessation options. This is due to the fact that if these patients quit, they can reduce their cardiovascular risk. Pharmacists, being one of the easily accessible health care providers, have an advantage over other clinicians when it comes to influencing patients to quit smoking and to modify their lifestyles. Pharmacists through medication therapy management directly interact with these patients to manage medications as well as behavioral factors. Keywords smoking, cessation, nicotine replacement, bupropion, varenicline, medication therapy management, community, pharmacist
Introduction Cigarettes are among the most addicting products known, and the vast majority of people who quit smoking relapse within days.1 In the United States, less than 10% of the nearly 20 million people who quit smoking for a day remain abstinent 1 year later—equating to only 2% to 3% of smokers becoming nonsmokers annually.1 Smoking cessation research is dominated by the development and evaluation of interventions to improve the odds of quitting successfully.2 Currently, an estimated 42.1 million people—18% of adults aged 18 years or older—in the United States smoke cigarettes.3 The prevalence of use is greater among men than women by roughly 5%, rendering 20.5% versus 15.8%, respectively.3 These alarming statistics are worrisome for many, most concerning those within the health care industry. In 1999, Warner et al concluded that the peer-reviewed literature on the medical costs of smoking in the United States indicated that at least 6% to 8% of annual personal health expenditures in the United States, and possibly more, had been devoted to treating diseases caused by smoking.4 This percentage represents a solid estimation of expenditures related to 3 of smoking’s most frequent cited causes of death, which include lung cancer, heart disease, and chronic obstructive pulmonary disease.4 Sadly, although tobacco use is the main preventable cause of death and illness in the nation, cigarette smoking continues to cause 1 in every 5 deaths in the United States annually.5
Smoking is a difficult habit to break and even more deadly to sustain. Individuals who smoke are at risk for suffering damage to nearly every organ in their bodies, including but not limited to, the heart, blood vessels, lung, eyes, mouth, reproductive organs, bones, bladder, and digestive organs.5 Taking into account all factors that attribute to the economic burden the nation faces as a result of tobacco use among members of society, much of that attention must now be drawn toward the most important outcome—the devastation it wreaks on human health.5 Although health decline and financial demise are notable concerns for users and those who practice and bear the burden of health care in the United States, those who suffer the true effects of tobacco are the victims and loved ones who carry the physical and emotional toll that accompanies the results yielded from the actions and habits of those they endear most.4 Burden for all involved includes the medical costs plus loss of productivity attributable to smoking-related morbidity,
1
CVS Pharmacy, Quincy, FL, USA Walgreens, Co, Stockbridge, GA, USA 3 Children’s National Medical Center, Washington, DC, USA 4 The Family Health Centers of Georgia, Inc, Atlanta, GA, USA 2
Corresponding Author: Tiffany D. Smalls, CVS Pharmacy, Quincy, 1208W Jefferson St, Quincy, FL 32351, USA. Email: [email protected]
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Table 1. The ‘‘5As’’ Model for Treating Tobacco Use and Dependence. Ask about the tobacco use and identify and document tobacco use status of every patient at every visit. Advise patient to quit and provide information on the benefits of quitting. Assess is the tobacco user willing to quit at this time? Are there any challenges to remaining abstinent? Assist patient with finding resources and coming up with a quit plan. Offer medication and provide or refer for counseling or additional behavioral treatment to help the patient quit. For patients unwilling to quit at this time, provide motivational interventions designed to increase future quit attempts. For the recent quitter and any with remaining challenges, provide relapse prevention. Arrange follow-up to help the patient follow through with quitting.
disability, and premature mortality.4 Most notably, a 1998 publication by Longo et al states that annually employers in the United States lose over US$50 billion dollars in productivity due to smoking.6 Employers pay an additional US$624.00 annually for a one-pack-a-day smoker as opposed to their nonsmoking employees or those who have ceased smoking.6 The chemicals in tobacco smoke, which sum to around 60 carcinogenic agents, cause harm to the blood cells leading to an increased risk of developing atherosclerosis.5,7 Prolonged exposure to plaque buildup in major arteries and vessels can become problematic and lead to more severe health conditions such as coronary heart disease, chest pains, heart attack, heart failure, and various arrhythmias.5 Major risk factors associated with smoking include heart disease, hypercholesterolemia, hypertension, obesity, and peripheral arterial disease—a condition that can lead to progressive heart disease, heart attack, and stroke.5 The misconception that light or occasional smoking is not as harmful as habitual smoking is not valid; in fact, even light smoking can cause some damage to the blood vessels and the heart. Women on oral contraceptives and diagnosed patients with diabetes should be frequently encouraged to refrain from tobacco use and limit exposure to these toxic substances even through the second-hand route because smoking causes an even greater risk of heart and blood vessel injury in these subsets of population.5 In response to the silent, but costly, outcry that tobacco use is placing upon society, several organizations, and establishments have transitioned to become a nonsmoking environment to promote health, wellness, and a clean atmosphere for their employees’ visitors and patrons. In November 2011, a total of 174 countries agreed to implement an international treaty constructed by the joining of forces between the World Health Organization and the Tobacco Free Initiative.7 This movement entitled Smoke-Free Cities was designed to display an international commitment to eliminating the populations’ exposure to tobacco smoke. Although this is a notable achievement to tackle on an international platform, stateside organizations had already been working relentlessly for nearly 13 years prior to this commitment. In 1998, Longo et al reviewed how well America hospitals were complying with the Joint Commission on Accreditation of Healthcare Organizations tobacco control standards—which required banning smoking in hospital buildings.6 The study concluded by demonstrating that smoking bans were successfully implemented in several hospitals across the nation and that other industries looking to follow hospitals lead would likely be successful in repeating the same in their
respective areas of operation, despite the pressures of conforming to the social norm. For many of the reasons listed here and others too numerous to list, it is imperative to recognize that there are far more benefits to refrain from tobacco use that can be discussed in this single setting. Indeed, quitting can be trying, but millions of people have successfully quit and remained nonsmokers.5 There are a plethora of strategies, programs, and pharmaceutical agents available for use when ready to begin a cessation implementation plan. The first nicotine medication, nicotine gum (polacrilex), was introduced in 1984 by the Food and Drug Administration (FDA).1 Nicotine for smoking cessation use has since been shown to provide effective treatment for tobacco dependence. Optimal use strategies may lead to variation in the therapeutic regimen drafted for patients and may even require higher dosing or combination therapy to provide adequate outcomes.1 Therefore, understanding the benefits, but not ignoring the hardship associated with smoking cessation, this article is constructed in such fashion to shed light on how to manage the difficulty of smoking cessation in the light of medication therapy and disease state management.
The Role of Health Care Professionals in Smoking Cessation Health care professionals play a vital role in smoking cessation. They can raise awareness and emphasize the importance of quitting. With having the trust of the population, health care professionals have the unique opportunity to provide education on the dangers of smoking and exposure to second-hand smoke.8 The primary preventable cause of morbidity and mortality in the United States is tobacco. It is critical that health care professionals including physicians, nurses, pharmacists, psychologists, psychiatrists, and dentist help decrease tobacco consumption.8 Briefly discussing the benefits of smoking cessation can have a huge impact on patients. This may be achieved using the 5As that include Asking about tobacco use, Advising the patient to quit, Assessing readiness to quit, Assisting the patient in quitting, and Arranging for follow-up,9 refer to Table 1. Various smoking cessation and tobacco prevention resources are available to assist patients and initiate dialogue about the adverse health effects of tobacco use. Such health effects include increased risk of cardiovascular disease, respiratory disease, stroke, and various cancers.8 Battling the tobacco epidemic is of the utmost importance. It is essential
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that identified smokers are well informed to significantly increase their chance of quitting successfully.10
Pharmacist Approach: Smoking Cessation Pharmacists are among the most highly accessible as well as respected members of the primary health care team. Pharmacists are visited both by people who are sick and by people in good health, this holds true especially in the community setting. As a result, this provides pharmacist with the opportunity to promote smoking cessation to a wide spectrum of the community. Most people who have the desire to give up smoking are not necessarily ill and will therefore feel more comfortable in the pharmacy setting. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 introduced medication therapy management (MTM) and defined it as ‘‘a program of drug therapy management that may be furnished by a pharmacist and that is designed to assure, with respect to targeted beneficiaries that covered medications are appropriately used to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events, including adverse drug interactions.’’11,12 The pharmacist role in medication therapy review is to collect patient-specific information such as medication therapy to identify problems that may be related to the medication therapy.12 The pharmacist develops a prioritized list of medication-related problems and creates a plan to resolve the problems that are identified. These reviews can be comprehensive or targeted to an actual or potential medication problem. Whether comprehensive or targeted, the individual patient’s medications are evaluated in the context of the patient as a whole, taking into consideration all of the patient’s conditions and medication therapies.13 MTM in those patients who have decided to quit smoking requires the pharmacist to take multiple factors into consideration prior to making recommendations. Most patients who smoke have other medical problems that have to be considered. Medical conditions such as depression, hypertension, or diabetes would be most common. As a result, these patients will have additional medications that need to be managed with the nicotine replacement therapy (NRT). Currently, there are 7 FDA-approved medications available for the treatment of tobacco use, that is, bupropion (Wellbutrin1) SR, nicotine gum, nicotine inhaler, nicotine lozenge, nicotine nasal spray, the nicotine patch, and varenicline (Chantix1). All of the therapies have specific side effects, contraindications, warnings, and precautions. Another role of clinicians in MTM is to also consider the out-of-pocket expense for the patient as this has the potential to be one of the primary excuses for nonadherence to therapy. Because tobacco dependence is a chronic health condition, it usually requires several different interventions by the clinician. The ‘‘5As’’ of treating tobacco dependence (Ask, Advise, Assess, Assist, and Arrange follow-up) is a useful way to understand tobacco dependence and treatment and organize the clinical team to deliver that treatment,15 refer to Table 1.
First-Line Therapies Nicotine Replacement Therapy NRT consists of using products that provide a small amount of nicotine delivered in low doses to assist with relieving the cravings of nicotine as well as help with the withdrawal symptoms that are commonly associated. All forms of NRT can be effective in promoting smoking cessation. Although not approved by the FDA, the combination of using different NRTs have a greater potential of being effective than just using 1 delivery form alone. For example, a combination of the nicotine patch and nicotine gum, nasal spray, or lozenge helps smokers remain abstinent for a longer period of time before relapsing. Nicotine patches use the transdermal route for nicotine delivery and can work in 2 different ways. The first is called a single-step approach, which delivers the same dosage of nicotine and does not allow for titration. A single-step product would be Nicotrol1. The second approach which is called the step-down approach uses 3 different strengths (21, 14, and 7 mg) of medication starting with the strongest dosing patch being applied first and slowly declining in dose over a period of time. This product is marketed as NicoDerm CQ1. Other options of NRT include the nicotine gum or lozenges, which some patients prefer because these dosage forms allow for the treatment of breakthrough craving, as well as the chewing or sucking satisfies the oral urge associated with smoking. The nicotine inhaler requires a prescription in the United States. The inhaler comes with several nicotine cartridges, which are inserted into the inhaler and ‘‘puffed’’ for about 20 minutes, up to 16 times a day. The dose is gradually decreased. The inhaler has some advantages over other nicotine replacement products:
it provides varying doses of nicotine on demand (as opposed to continuous doses with the patch or gum) and is relatively fast acting. Blood nicotine levels peak about 20 minutes after using the inhaler, comparable to the gum and faster than the patch; it satisfies oral urges; and most of the nicotine vapor is delivered into the mouth, not into the lung airways (although some people experience mouth or throat irritation and a cough).
The nicotine nasal spray satisfies immediate cravings by providing fast doses of nicotine. (Nicotine levels peak within 5-10 minutes after administering the spray.) It may be useful together with slower acting nicotine replacement therapies. The spray can irritate the nose, eyes, and throat, so it may not be suitable for people with allergies or sinus infections. Most people, however, can tolerate the side effects, which usually go away within the first few days. The nasal spray should be avoided in people who have reactive airway disease. Side effects of any nicotine replacement product may include headaches, nausea, and other gastrointestinal problems. People often experience sleeplessness in the first few days, particularly with the patch, but the insomnia usually passes.
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Patients using very high doses of nicotine are more likely to have symptoms. Reducing the dose can prevent these symptoms. Caution should be used in patients with cardiovascular risk (ie, myocardial infarction, arrhymias, and unstable angina).
Bupropion (Zyban1 and Wellbutrin SR) Bupropion-sustained release is a type of antidepressant that is also FDA approved for smoking cessation. Bupropion differs from most other antidepressants in that it increases the levels of dopamine, the brain chemical that appears to play a strong role in nicotine addiction. Using bupropion along with NRT may help control cigarette cravings. People usually start taking bupropion a week or 2 before quitting and continue taking it for 7 to 12 weeks. The usual maintenance dose is a 150-mg tablet taken twice a day. No single dose should be higher than 150 mg. Common side effects of bupropion include gastrointestinal problems, headaches, insomnia, dry mouth, and irritation. In very rare cases, seizures have occurred, although usually in people who exceeded the recommended dose or who were already at risk of seizures. Buproprion is not recommended in patients with seizure disorders or eating disorders.
Varenicline (Chantix) Varenicline helps with the craving for nicotine and withdrawal symptoms. Varenicline is a partial agonist at the a4b2 neuronal nicotinic acetylcholine receptor and has an FDA indication as an aid to smoking cessation treatment. The a4b2 neuronal nicotinic acetylcholine receptor releases dopamine in the central nervous system, and activation is thought to mediate dependence, including reinforcement, tolerance, and sensitization of the receptor. As a partial agonist, varenicline binds to the receptor and produces low to moderate levels of dopamine release that reduces craving and withdrawal symptoms. At the same time, varenicline acts as an antagonist, blocking the binding and positive reinforcement effects of smoked nicotine. Side effects to varenicline may include headaches; problems sleeping, sleepiness, and strange dreams; constipation; intestinal gas; nausea; changes in taste; depressed mood; thoughts of suicide; and attempted suicide. Varenicline is not recommended in patients with serious psychiatric illness and suicidality, depressive thoughts, and cardiovascular risks (ie, angina pectoris and myocardial infarction).
Second-Line Agents Although not FDA-approved specifically for smoking cessation, the prescription medications clonidine hydrochloride and nortriptyline hydrochloride are recommended as second-line agents. Clonidine is a centrally acting a2-agonist antihypertensive agent that about doubles cessation rates.16 Nortriptyline (Pamelor1 and Aventyl1). The tricyclic antidepressant nortriptyline may reduce the actions of nicotine and help smokers
quit. Quit rates with this medication are as high as 30%. Longterm abstinence rates are more than twice those of placebo (sugar pill). Patients should be started on the medication 1 to 4 weeks before the intended quit date. Since nortriptyline is a tricyclic antidepressant, it will have anticholinergic side effects such as drowsiness, dry mouth, constipation, urinary retention, and cognitive impairment. Clonidine may cause sedation, bradycardia, and hypotension.
Nonrecommended Agents Electronic Cigarettes E-cigarettes (E-cigs) were first introduced in the United States in 2007 as not containing tobacco but instead an atomizer that heats liquid containing nicotine, turning it into a vapor that can be inhaled and exhaled, creating a vapor cloud that resembles cigarette smoke. Smoking an E-cig is odorless because it doesn’t burn or produce any ash. This is thought by many as being a safer way to smoke and possibly utilized as a smoking-cessation aide. However, the use of E-cigs has not been rigorously studied, and the health effects to the smoker and those around them are not known. Also E-cigs are not FDA approved as smoking cessation therapy. The FDA and Health Canada have a number of safety concerns especially with the unknown safety effects. There aren’t any well-controlled trials that demonstrate E-cigs are effective in helping people to quit smoking. The FDA has also expressed concern about quality control and that some manufacturers may not adequately disclose all of the chemical ingredients in the E-cigs and the side effects of inhaling pure nicotine through E-cigs have not been well studied. Although E-cigs do not emit second-hand smoke, the effects of second-hand exposure to the vapor are not known. Until more is known about the potential risks, E-cigs should not be recommended as a safer alternative to smoking tobacco cigarettes and should not be used as a method of smoking cessation. Instead appropriate behavioral and pharmacotherapy management as outlined previously should be recommended and initiated in appropriate patients.17
Hookah Pipes/Water Pipes Hookah pipes or water pipe smoking began in ancient Persia and India, where they were used traditionally to smoke opium or hashish. Today, hookah pipe smoking is done by indirectly heating specially made tobacco in a bowl, usually with burning embers or charcoal. The tobacco smoke is then filtered through water or other liquids and then drawn through a rubber hose to a mouthpiece where it is then inhaled. This causes many to believe that this is an innocent habit. Only limited research has shown that the health risks are similar to that of cigarette smoking. Hookah pipes have been linked to lung, oral, stomach, and bladder cancers and cardiovascular disease. Because hookah pipe users often smoke the water pipe for longer durations of time than cigarettes (40-45 minutes or longer vs 5-10 minutes with cigarettes), there is concern that exposure to nicotine and other carcinogens is greater. This can also affect those who are
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Table 2. Smoking Cessation/Information Resources. Organization
Website
Phone number
CDC Smoking and Tobacco use Resources American Cancer Society The American Lung Association National Cancer Institute National Network of Tobacco Cessation Quitlines QuitNet
www.cdc.gov/tobacco/ www.cancer.org www.lungusa.org www.smokefree.gov www.naquitline.org www.Quintet.com
1-800-CDC-INFO (800-232-4636) Toll-free hotline: 1-800-ACS-2345 (1-800-227-2345) Toll-free hotline: 1-800-LUNGUSA (1-800-586-4872) Toll-free hotline: 1-877-44U-QUIT (1-877-448-7848) Toll free hotline: 1-800-QUITNOW (1-800-784-8669)
passively inhaling the smoke. In addition to the direct negative health consequences to smoking hookah pipes, they also put you at risk for infectious diseases such as tuberculosis, herpes, and hepatitis because the pipes are often passed around and shared mouthpieces are used. As a result just like E-cigs, hookah pipes are not recommended as a safer alternative to smoking cigarettes.17
Conclusion Pharmacist can play an integral role in assisting patients in smoking cessation. As a part of MTM, adherence and patient education, in addition to choosing appropriate pharmacotherapy, is crucial in aiding patients to sustain smoking cessation. Pharmacist can assist prescribers and patients in choosing medications. Educating patients on the health risks and behavioral interventions/modifications can be included in any MTM conducted session. Also choosing and assessing the correct pharmacotherapy and addressing any adverse effects and adherence-related problems can be conducted in any pharmacy setting especially the community. Table 2 provides more information on various organizations that may provide resources for patients and smoking cessation. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Henningfield JE. Nicotine medications for smoking cessation. New Eng J Med. 1995;333(18):1196-1203. 2. Smith AL, Chapman S. Quitting smoking unassisted: the 50-year research neglect of a major public health phenomenon. JAMA. 2014;311(2):137-138.
3. Web site. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/ adult_data/cig_smoking/. Accessed April 18, 2014. 4. Warner KE, Hodgson TA, Carroll CE. Medical costs of smoking in the United States: estimates, their validity, and their implications. Tob Control. 1999;8(3):290-300. 5. Web site. https://www.nhlbi.nih.gov/health/health-topics/topics/ smo/risks.html. Accessed April 19, 2014. 6. Longo DR, Feldman MM, Kruse RL, et al. Implementing smoking bans in American hospitals: results of a national survey. Tob Control. 1998;7(1):47-55. 7. Web site. http://www.who.int/kobe_centre/publications/makingcities_smokefree.pdf. Accessed April 26, 2014. 8. Web site. http://www.who.int/tobacco/resources/publications/wntd/ 2005/bookletfinal_20april.pdf. 9. Web site. http://www.cdc.gov/tobacco/campaign/tips/groups/healthcare-providers.html. 10. Web site. http://makesmokinghistory.org/quitting/for-health-careproviders.html. 11. Masica AL, Touchette DR, Dolor RJ, et al. Evaluation of a medication therapy management program in Medicare beneficiaries at high risk of adverse drug events: Study methods. In: Advances in Patient Safety: New Directions and Alternative Approaches. Vol. 4: Technology and Medication Safety. Rockville, MD: Agency for Healthcare Research and Quality; 2008. 12. Center of Medicare and Medicaid. Web site. http://www.cms.gov. Accessed April 20, 2014. 13. American Pharmacist Association. Web site. http://www.pharmacist.com. Accessed April 20, 2014. 14. American Cancer Society. Guide to Quitting Smoking. Web site. http://www.cancer.org/acs/groups/cid/documents/webcontent/ 002971-pdf. Updated January 17, 2013. Accessed April 18, 2014. 15. US Department of Verteran Affairs. Web site. http://www.healthquality.va.gov/tuc/phs_2008_quickguide.pdf. Accessed April 22, 2014. 16. Western Journal of Medicine. Web site. http://www.ncbi.nlm.nih. gov/pmc/articles/PMC1071687/. Accessed April 22, 2014. 17. PL Detail-Document, Electronic Cigarettes and Hookah Pipes. Pharmacist’s Letter/Prescriber’s Letter; May 2013.
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Providing Medication Therapy Management for Smoking Cessation Patients
Journal of Pharmacy Practice 1-5 ª The Author(s) 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0897190014562381 jpp.sagepub.com
Tiffany D. Smalls, PharmD, CPh1, Amelia D. Broughton, PharmD2, Ericka V. Hylick, PharmD3, and Todd J. Woodard, PharmD, BCPP, BCPS, CGP4
Abstract Nearly 50 years ago, the Surgeon General of the US Public Health Service released the first report of the Surgeon General’s Advisory Committee on Smoking and Health. The report concluded that cigarette smoking caused lung and laryngeal cancer as well as bronchitis. Today, smoking is one of the leading preventable causes of deaths in the United States. Research has shown that it potentially causes more deaths than human immunodeficiency virus, illegal drug use, alcohol use, motor vehicle injuries, and firearm-related incidents. Health care providers play a critical role in guiding and directing patients to quit smoking by introducing them to smoking-cessation options. This is due to the fact that if these patients quit, they can reduce their cardiovascular risk. Pharmacists, being one of the easily accessible health care providers, have an advantage over other clinicians when it comes to influencing patients to quit smoking and to modify their lifestyles. Pharmacists through medication therapy management directly interact with these patients to manage medications as well as behavioral factors. Keywords smoking, cessation, nicotine replacement, bupropion, varenicline, medication therapy management, community, pharmacist
Introduction Cigarettes are among the most addicting products known, and the vast majority of people who quit smoking relapse within days.1 In the United States, less than 10% of the nearly 20 million people who quit smoking for a day remain abstinent 1 year later—equating to only 2% to 3% of smokers becoming nonsmokers annually.1 Smoking cessation research is dominated by the development and evaluation of interventions to improve the odds of quitting successfully.2 Currently, an estimated 42.1 million people—18% of adults aged 18 years or older—in the United States smoke cigarettes.3 The prevalence of use is greater among men than women by roughly 5%, rendering 20.5% versus 15.8%, respectively.3 These alarming statistics are worrisome for many, most concerning those within the health care industry. In 1999, Warner et al concluded that the peer-reviewed literature on the medical costs of smoking in the United States indicated that at least 6% to 8% of annual personal health expenditures in the United States, and possibly more, had been devoted to treating diseases caused by smoking.4 This percentage represents a solid estimation of expenditures related to 3 of smoking’s most frequent cited causes of death, which include lung cancer, heart disease, and chronic obstructive pulmonary disease.4 Sadly, although tobacco use is the main preventable cause of death and illness in the nation, cigarette smoking continues to cause 1 in every 5 deaths in the United States annually.5
Smoking is a difficult habit to break and even more deadly to sustain. Individuals who smoke are at risk for suffering damage to nearly every organ in their bodies, including but not limited to, the heart, blood vessels, lung, eyes, mouth, reproductive organs, bones, bladder, and digestive organs.5 Taking into account all factors that attribute to the economic burden the nation faces as a result of tobacco use among members of society, much of that attention must now be drawn toward the most important outcome—the devastation it wreaks on human health.5 Although health decline and financial demise are notable concerns for users and those who practice and bear the burden of health care in the United States, those who suffer the true effects of tobacco are the victims and loved ones who carry the physical and emotional toll that accompanies the results yielded from the actions and habits of those they endear most.4 Burden for all involved includes the medical costs plus loss of productivity attributable to smoking-related morbidity,
1
CVS Pharmacy, Quincy, FL, USA Walgreens, Co, Stockbridge, GA, USA 3 Children’s National Medical Center, Washington, DC, USA 4 The Family Health Centers of Georgia, Inc, Atlanta, GA, USA 2
Corresponding Author: Tiffany D. Smalls, CVS Pharmacy, Quincy, 1208W Jefferson St, Quincy, FL 32351, USA. Email: [email protected]
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Table 1. The ‘‘5As’’ Model for Treating Tobacco Use and Dependence. Ask about the tobacco use and identify and document tobacco use status of every patient at every visit. Advise patient to quit and provide information on the benefits of quitting. Assess is the tobacco user willing to quit at this time? Are there any challenges to remaining abstinent? Assist patient with finding resources and coming up with a quit plan. Offer medication and provide or refer for counseling or additional behavioral treatment to help the patient quit. For patients unwilling to quit at this time, provide motivational interventions designed to increase future quit attempts. For the recent quitter and any with remaining challenges, provide relapse prevention. Arrange follow-up to help the patient follow through with quitting.
disability, and premature mortality.4 Most notably, a 1998 publication by Longo et al states that annually employers in the United States lose over US$50 billion dollars in productivity due to smoking.6 Employers pay an additional US$624.00 annually for a one-pack-a-day smoker as opposed to their nonsmoking employees or those who have ceased smoking.6 The chemicals in tobacco smoke, which sum to around 60 carcinogenic agents, cause harm to the blood cells leading to an increased risk of developing atherosclerosis.5,7 Prolonged exposure to plaque buildup in major arteries and vessels can become problematic and lead to more severe health conditions such as coronary heart disease, chest pains, heart attack, heart failure, and various arrhythmias.5 Major risk factors associated with smoking include heart disease, hypercholesterolemia, hypertension, obesity, and peripheral arterial disease—a condition that can lead to progressive heart disease, heart attack, and stroke.5 The misconception that light or occasional smoking is not as harmful as habitual smoking is not valid; in fact, even light smoking can cause some damage to the blood vessels and the heart. Women on oral contraceptives and diagnosed patients with diabetes should be frequently encouraged to refrain from tobacco use and limit exposure to these toxic substances even through the second-hand route because smoking causes an even greater risk of heart and blood vessel injury in these subsets of population.5 In response to the silent, but costly, outcry that tobacco use is placing upon society, several organizations, and establishments have transitioned to become a nonsmoking environment to promote health, wellness, and a clean atmosphere for their employees’ visitors and patrons. In November 2011, a total of 174 countries agreed to implement an international treaty constructed by the joining of forces between the World Health Organization and the Tobacco Free Initiative.7 This movement entitled Smoke-Free Cities was designed to display an international commitment to eliminating the populations’ exposure to tobacco smoke. Although this is a notable achievement to tackle on an international platform, stateside organizations had already been working relentlessly for nearly 13 years prior to this commitment. In 1998, Longo et al reviewed how well America hospitals were complying with the Joint Commission on Accreditation of Healthcare Organizations tobacco control standards—which required banning smoking in hospital buildings.6 The study concluded by demonstrating that smoking bans were successfully implemented in several hospitals across the nation and that other industries looking to follow hospitals lead would likely be successful in repeating the same in their
respective areas of operation, despite the pressures of conforming to the social norm. For many of the reasons listed here and others too numerous to list, it is imperative to recognize that there are far more benefits to refrain from tobacco use that can be discussed in this single setting. Indeed, quitting can be trying, but millions of people have successfully quit and remained nonsmokers.5 There are a plethora of strategies, programs, and pharmaceutical agents available for use when ready to begin a cessation implementation plan. The first nicotine medication, nicotine gum (polacrilex), was introduced in 1984 by the Food and Drug Administration (FDA).1 Nicotine for smoking cessation use has since been shown to provide effective treatment for tobacco dependence. Optimal use strategies may lead to variation in the therapeutic regimen drafted for patients and may even require higher dosing or combination therapy to provide adequate outcomes.1 Therefore, understanding the benefits, but not ignoring the hardship associated with smoking cessation, this article is constructed in such fashion to shed light on how to manage the difficulty of smoking cessation in the light of medication therapy and disease state management.
The Role of Health Care Professionals in Smoking Cessation Health care professionals play a vital role in smoking cessation. They can raise awareness and emphasize the importance of quitting. With having the trust of the population, health care professionals have the unique opportunity to provide education on the dangers of smoking and exposure to second-hand smoke.8 The primary preventable cause of morbidity and mortality in the United States is tobacco. It is critical that health care professionals including physicians, nurses, pharmacists, psychologists, psychiatrists, and dentist help decrease tobacco consumption.8 Briefly discussing the benefits of smoking cessation can have a huge impact on patients. This may be achieved using the 5As that include Asking about tobacco use, Advising the patient to quit, Assessing readiness to quit, Assisting the patient in quitting, and Arranging for follow-up,9 refer to Table 1. Various smoking cessation and tobacco prevention resources are available to assist patients and initiate dialogue about the adverse health effects of tobacco use. Such health effects include increased risk of cardiovascular disease, respiratory disease, stroke, and various cancers.8 Battling the tobacco epidemic is of the utmost importance. It is essential
Downloaded from jpp.sagepub.com at TEXAS SOUTHERN UNIVERSITY on December 12, 2014
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that identified smokers are well informed to significantly increase their chance of quitting successfully.10
Pharmacist Approach: Smoking Cessation Pharmacists are among the most highly accessible as well as respected members of the primary health care team. Pharmacists are visited both by people who are sick and by people in good health, this holds true especially in the community setting. As a result, this provides pharmacist with the opportunity to promote smoking cessation to a wide spectrum of the community. Most people who have the desire to give up smoking are not necessarily ill and will therefore feel more comfortable in the pharmacy setting. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 introduced medication therapy management (MTM) and defined it as ‘‘a program of drug therapy management that may be furnished by a pharmacist and that is designed to assure, with respect to targeted beneficiaries that covered medications are appropriately used to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events, including adverse drug interactions.’’11,12 The pharmacist role in medication therapy review is to collect patient-specific information such as medication therapy to identify problems that may be related to the medication therapy.12 The pharmacist develops a prioritized list of medication-related problems and creates a plan to resolve the problems that are identified. These reviews can be comprehensive or targeted to an actual or potential medication problem. Whether comprehensive or targeted, the individual patient’s medications are evaluated in the context of the patient as a whole, taking into consideration all of the patient’s conditions and medication therapies.13 MTM in those patients who have decided to quit smoking requires the pharmacist to take multiple factors into consideration prior to making recommendations. Most patients who smoke have other medical problems that have to be considered. Medical conditions such as depression, hypertension, or diabetes would be most common. As a result, these patients will have additional medications that need to be managed with the nicotine replacement therapy (NRT). Currently, there are 7 FDA-approved medications available for the treatment of tobacco use, that is, bupropion (Wellbutrin1) SR, nicotine gum, nicotine inhaler, nicotine lozenge, nicotine nasal spray, the nicotine patch, and varenicline (Chantix1). All of the therapies have specific side effects, contraindications, warnings, and precautions. Another role of clinicians in MTM is to also consider the out-of-pocket expense for the patient as this has the potential to be one of the primary excuses for nonadherence to therapy. Because tobacco dependence is a chronic health condition, it usually requires several different interventions by the clinician. The ‘‘5As’’ of treating tobacco dependence (Ask, Advise, Assess, Assist, and Arrange follow-up) is a useful way to understand tobacco dependence and treatment and organize the clinical team to deliver that treatment,15 refer to Table 1.
First-Line Therapies Nicotine Replacement Therapy NRT consists of using products that provide a small amount of nicotine delivered in low doses to assist with relieving the cravings of nicotine as well as help with the withdrawal symptoms that are commonly associated. All forms of NRT can be effective in promoting smoking cessation. Although not approved by the FDA, the combination of using different NRTs have a greater potential of being effective than just using 1 delivery form alone. For example, a combination of the nicotine patch and nicotine gum, nasal spray, or lozenge helps smokers remain abstinent for a longer period of time before relapsing. Nicotine patches use the transdermal route for nicotine delivery and can work in 2 different ways. The first is called a single-step approach, which delivers the same dosage of nicotine and does not allow for titration. A single-step product would be Nicotrol1. The second approach which is called the step-down approach uses 3 different strengths (21, 14, and 7 mg) of medication starting with the strongest dosing patch being applied first and slowly declining in dose over a period of time. This product is marketed as NicoDerm CQ1. Other options of NRT include the nicotine gum or lozenges, which some patients prefer because these dosage forms allow for the treatment of breakthrough craving, as well as the chewing or sucking satisfies the oral urge associated with smoking. The nicotine inhaler requires a prescription in the United States. The inhaler comes with several nicotine cartridges, which are inserted into the inhaler and ‘‘puffed’’ for about 20 minutes, up to 16 times a day. The dose is gradually decreased. The inhaler has some advantages over other nicotine replacement products:
it provides varying doses of nicotine on demand (as opposed to continuous doses with the patch or gum) and is relatively fast acting. Blood nicotine levels peak about 20 minutes after using the inhaler, comparable to the gum and faster than the patch; it satisfies oral urges; and most of the nicotine vapor is delivered into the mouth, not into the lung airways (although some people experience mouth or throat irritation and a cough).
The nicotine nasal spray satisfies immediate cravings by providing fast doses of nicotine. (Nicotine levels peak within 5-10 minutes after administering the spray.) It may be useful together with slower acting nicotine replacement therapies. The spray can irritate the nose, eyes, and throat, so it may not be suitable for people with allergies or sinus infections. Most people, however, can tolerate the side effects, which usually go away within the first few days. The nasal spray should be avoided in people who have reactive airway disease. Side effects of any nicotine replacement product may include headaches, nausea, and other gastrointestinal problems. People often experience sleeplessness in the first few days, particularly with the patch, but the insomnia usually passes.
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Patients using very high doses of nicotine are more likely to have symptoms. Reducing the dose can prevent these symptoms. Caution should be used in patients with cardiovascular risk (ie, myocardial infarction, arrhymias, and unstable angina).
Bupropion (Zyban1 and Wellbutrin SR) Bupropion-sustained release is a type of antidepressant that is also FDA approved for smoking cessation. Bupropion differs from most other antidepressants in that it increases the levels of dopamine, the brain chemical that appears to play a strong role in nicotine addiction. Using bupropion along with NRT may help control cigarette cravings. People usually start taking bupropion a week or 2 before quitting and continue taking it for 7 to 12 weeks. The usual maintenance dose is a 150-mg tablet taken twice a day. No single dose should be higher than 150 mg. Common side effects of bupropion include gastrointestinal problems, headaches, insomnia, dry mouth, and irritation. In very rare cases, seizures have occurred, although usually in people who exceeded the recommended dose or who were already at risk of seizures. Buproprion is not recommended in patients with seizure disorders or eating disorders.
Varenicline (Chantix) Varenicline helps with the craving for nicotine and withdrawal symptoms. Varenicline is a partial agonist at the a4b2 neuronal nicotinic acetylcholine receptor and has an FDA indication as an aid to smoking cessation treatment. The a4b2 neuronal nicotinic acetylcholine receptor releases dopamine in the central nervous system, and activation is thought to mediate dependence, including reinforcement, tolerance, and sensitization of the receptor. As a partial agonist, varenicline binds to the receptor and produces low to moderate levels of dopamine release that reduces craving and withdrawal symptoms. At the same time, varenicline acts as an antagonist, blocking the binding and positive reinforcement effects of smoked nicotine. Side effects to varenicline may include headaches; problems sleeping, sleepiness, and strange dreams; constipation; intestinal gas; nausea; changes in taste; depressed mood; thoughts of suicide; and attempted suicide. Varenicline is not recommended in patients with serious psychiatric illness and suicidality, depressive thoughts, and cardiovascular risks (ie, angina pectoris and myocardial infarction).
Second-Line Agents Although not FDA-approved specifically for smoking cessation, the prescription medications clonidine hydrochloride and nortriptyline hydrochloride are recommended as second-line agents. Clonidine is a centrally acting a2-agonist antihypertensive agent that about doubles cessation rates.16 Nortriptyline (Pamelor1 and Aventyl1). The tricyclic antidepressant nortriptyline may reduce the actions of nicotine and help smokers
quit. Quit rates with this medication are as high as 30%. Longterm abstinence rates are more than twice those of placebo (sugar pill). Patients should be started on the medication 1 to 4 weeks before the intended quit date. Since nortriptyline is a tricyclic antidepressant, it will have anticholinergic side effects such as drowsiness, dry mouth, constipation, urinary retention, and cognitive impairment. Clonidine may cause sedation, bradycardia, and hypotension.
Nonrecommended Agents Electronic Cigarettes E-cigarettes (E-cigs) were first introduced in the United States in 2007 as not containing tobacco but instead an atomizer that heats liquid containing nicotine, turning it into a vapor that can be inhaled and exhaled, creating a vapor cloud that resembles cigarette smoke. Smoking an E-cig is odorless because it doesn’t burn or produce any ash. This is thought by many as being a safer way to smoke and possibly utilized as a smoking-cessation aide. However, the use of E-cigs has not been rigorously studied, and the health effects to the smoker and those around them are not known. Also E-cigs are not FDA approved as smoking cessation therapy. The FDA and Health Canada have a number of safety concerns especially with the unknown safety effects. There aren’t any well-controlled trials that demonstrate E-cigs are effective in helping people to quit smoking. The FDA has also expressed concern about quality control and that some manufacturers may not adequately disclose all of the chemical ingredients in the E-cigs and the side effects of inhaling pure nicotine through E-cigs have not been well studied. Although E-cigs do not emit second-hand smoke, the effects of second-hand exposure to the vapor are not known. Until more is known about the potential risks, E-cigs should not be recommended as a safer alternative to smoking tobacco cigarettes and should not be used as a method of smoking cessation. Instead appropriate behavioral and pharmacotherapy management as outlined previously should be recommended and initiated in appropriate patients.17
Hookah Pipes/Water Pipes Hookah pipes or water pipe smoking began in ancient Persia and India, where they were used traditionally to smoke opium or hashish. Today, hookah pipe smoking is done by indirectly heating specially made tobacco in a bowl, usually with burning embers or charcoal. The tobacco smoke is then filtered through water or other liquids and then drawn through a rubber hose to a mouthpiece where it is then inhaled. This causes many to believe that this is an innocent habit. Only limited research has shown that the health risks are similar to that of cigarette smoking. Hookah pipes have been linked to lung, oral, stomach, and bladder cancers and cardiovascular disease. Because hookah pipe users often smoke the water pipe for longer durations of time than cigarettes (40-45 minutes or longer vs 5-10 minutes with cigarettes), there is concern that exposure to nicotine and other carcinogens is greater. This can also affect those who are
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Table 2. Smoking Cessation/Information Resources. Organization
Website
Phone number
CDC Smoking and Tobacco use Resources American Cancer Society The American Lung Association National Cancer Institute National Network of Tobacco Cessation Quitlines QuitNet
www.cdc.gov/tobacco/ www.cancer.org www.lungusa.org www.smokefree.gov www.naquitline.org www.Quintet.com
1-800-CDC-INFO (800-232-4636) Toll-free hotline: 1-800-ACS-2345 (1-800-227-2345) Toll-free hotline: 1-800-LUNGUSA (1-800-586-4872) Toll-free hotline: 1-877-44U-QUIT (1-877-448-7848) Toll free hotline: 1-800-QUITNOW (1-800-784-8669)
passively inhaling the smoke. In addition to the direct negative health consequences to smoking hookah pipes, they also put you at risk for infectious diseases such as tuberculosis, herpes, and hepatitis because the pipes are often passed around and shared mouthpieces are used. As a result just like E-cigs, hookah pipes are not recommended as a safer alternative to smoking cigarettes.17
Conclusion Pharmacist can play an integral role in assisting patients in smoking cessation. As a part of MTM, adherence and patient education, in addition to choosing appropriate pharmacotherapy, is crucial in aiding patients to sustain smoking cessation. Pharmacist can assist prescribers and patients in choosing medications. Educating patients on the health risks and behavioral interventions/modifications can be included in any MTM conducted session. Also choosing and assessing the correct pharmacotherapy and addressing any adverse effects and adherence-related problems can be conducted in any pharmacy setting especially the community. Table 2 provides more information on various organizations that may provide resources for patients and smoking cessation. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
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3. Web site. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/ adult_data/cig_smoking/. Accessed April 18, 2014. 4. Warner KE, Hodgson TA, Carroll CE. Medical costs of smoking in the United States: estimates, their validity, and their implications. Tob Control. 1999;8(3):290-300. 5. Web site. https://www.nhlbi.nih.gov/health/health-topics/topics/ smo/risks.html. Accessed April 19, 2014. 6. Longo DR, Feldman MM, Kruse RL, et al. Implementing smoking bans in American hospitals: results of a national survey. Tob Control. 1998;7(1):47-55. 7. Web site. http://www.who.int/kobe_centre/publications/makingcities_smokefree.pdf. Accessed April 26, 2014. 8. Web site. http://www.who.int/tobacco/resources/publications/wntd/ 2005/bookletfinal_20april.pdf. 9. Web site. http://www.cdc.gov/tobacco/campaign/tips/groups/healthcare-providers.html. 10. Web site. http://makesmokinghistory.org/quitting/for-health-careproviders.html. 11. Masica AL, Touchette DR, Dolor RJ, et al. Evaluation of a medication therapy management program in Medicare beneficiaries at high risk of adverse drug events: Study methods. In: Advances in Patient Safety: New Directions and Alternative Approaches. Vol. 4: Technology and Medication Safety. Rockville, MD: Agency for Healthcare Research and Quality; 2008. 12. Center of Medicare and Medicaid. Web site. http://www.cms.gov. Accessed April 20, 2014. 13. American Pharmacist Association. Web site. http://www.pharmacist.com. Accessed April 20, 2014. 14. American Cancer Society. Guide to Quitting Smoking. Web site. http://www.cancer.org/acs/groups/cid/documents/webcontent/ 002971-pdf. Updated January 17, 2013. Accessed April 18, 2014. 15. US Department of Verteran Affairs. Web site. http://www.healthquality.va.gov/tuc/phs_2008_quickguide.pdf. Accessed April 22, 2014. 16. Western Journal of Medicine. Web site. http://www.ncbi.nlm.nih. gov/pmc/articles/PMC1071687/. Accessed April 22, 2014. 17. PL Detail-Document, Electronic Cigarettes and Hookah Pipes. Pharmacist’s Letter/Prescriber’s Letter; May 2013.
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