Ask every patient about tobacco use at every visit using one of two models: the Five As or Ask, Advise, Refer.4 Patients who use smokeless tobacco often are forgotten during screening of nicotine use; be prepared to screen, advise, and initiate pharmacotherapy in these patients as well. Ensure that officewide interventions to facilitate smoking cessation are in place and can be delivered by any member of the healthcare team. Once patients who use tobacco are identified, promptly implement interventions.
The Five As Model
Ask. Asking about tobacco use at every visit improves screening and cessation rates. Approach patients in a nonaccusatory and nonjudgmental manner.4 This step can be completed by another member of the team when the patient's vital signs are recorded.4 Questions should be designed to identify current, former, and never-smokers. Patients who quit in the past 6 to 12 months should be assessed for challenges and offered support.4 Simply asking “Are you a smoker?” may not identify occasional or light smokers.10 Instead, ask a patient, “How much do you smoke?” or “Do you ever use any type of tobacco?”
Advise. Tobacco users should be urged to quit in a clear, strong, and personalized message that highlights the benefits of cessation. Clinicians may use influential social factors (such as children, grandchildren, or financial benefits) to help patients determine the personal benefits of quitting. For example, “I heard you mention that your shortness of breath makes it difficult for you to spend time with your grandchildren. If you are able to quit smoking, your shortness of breath may improve and you can spend quality time with your family.”
Assess. At every visit, assess the patient's motivation and readiness to quit smoking and identify barriers to quitting. Discuss previous quit attempts and patient timeline. If the patient is not yet ready to quit, incorporate behavioral change techniques into the visit (such as the Transtheoretical Model for Readiness to Change and the 5R's).4,6 Consider asking, “What do you dislike about being a smoker?”10
Assist. If the patient is ready to quit, help him or her develop a quit plan using the STAR method: Set a quit date (ideally, within 2 weeks); Tell family, friends, and coworkers and ask for support; Anticipate challenges; Remove tobacco products. Help patients identify their triggers and strategies for coping.11 Provide information about quitlines (such as 1-800-QUIT-NOW) and develop a pharmacologic treatment plan. Encourage all patients to use quitlines, which have a two to three times greater effect on smoking cessation than counseling alone in the primary care setting.12
Arrange. Contact patients during the first week of a cessation attempt, ideally on the planned quit date. A second follow-up is recommended within the first month. Congratulate patients who have remained abstinent; encourage patients who have used tobacco again to quit and make recommendations to address challenges. If patients are using pharmacologic treatments, PAs should assess for adherence, adverse reactions, and the patient's perception of the drug's usefulness.12
Ask, Advise, Refer (AAR) approach
The AAR model is a condensed, simpler approach to the 5As model that may be helpful for busy practitioners who are unable to complete all five steps of the 5As model. The steps are as follows:
- Ask patients about tobacco use.
- Advise patients to quit.
- Refer patients to resources, including quitlines and support groups.
Remember that with either approach, other members of the healthcare team can assist. For example, a clinical assistant can ask the patient about tobacco use while checking vital signs and can document the patient's answers in the medical record for follow-up during the clinician's visit.
The 5R's Model
This tool highlights areas of motivational interventions for patients not ready to quit.4
Relevance. Encourage the patient to indicate how quitting is personally relevant. Motivational information has the greatest effect if relevant to a patient's disease status (for example, chronic obstructive pulmonary disease [COPD]), family or social situation (such as children at home), health concerns, age, sex, and other patient characteristics such as personal barriers to cessation or previous quitting experience.
Risks. Encourage the patient to identify potential negative consequences of tobacco. Risks may include cardiovascular disease, lung cancer, and COPD.
Rewards. Ask the patient to identify potential relevant benefits of stopping tobacco use. Examples include improved sense of smell, saving money, lack of tobacco smell, healthier mouth, and improved personal and family health.
Roadblocks. Ask the patient to identify barriers to quitting and provide options to address barriers. Barriers may include withdrawal symptoms, fear of failure, weight gain, lack of support, and being around other tobacco users. Teach patients coping skills to address barriers to smoking cessation, recognize situations that increase their risk for smoking, and develop a plan to quit.13-15
Repetition. Repeat the assessment of readiness to quit. If the patient still is not ready to quit, repeat the intervention at a later date. Ongoing counseling and motivation strategies play a key role in helping patients quit tobacco use.
DESIGNING A PHARMACOTHERAPY REGIMEN
Table 2 provides first-line pharmacologic options for smoking cessation. Clonidine and nortriptyline are considered second-line treatments because they are not FDA-approved for smoking cessation and have undesirable adverse reactions.4 Second-line treatments can be used if patients fail or cannot use first-line treatments, as both have been found to double the likelihood of sustained abstinence compared with placebo.4
The recommended dose of nortriptyline is 75 to 100 mg a day; clonidine does not have an established dosage range, although studies have used doses between 0.1 mg and 0.75 mg in both oral and transdermal forms. If clonidine is used, ensure that adherence is not an issue for the patient—if the drug is abruptly stopped, the patient's catecholamine level can cause BP to rise rapidly.4
Guidelines do not preferentially recommend a therapy, although varenicline has consistently shown the greatest sustained cessation. Bupropion and dual nicotine replacement therapy have the next highest cessation rates.4,16 No differences in cessation rates have been found among nicotine replacement therapies.16 Tell patients not to eat or drink for at least 15 minutes before taking nicotine replacement therapy products that are administered orally; eating or drinking elevates oral pH and reduces nicotine absorption.17,18
CHOOSING AN OPTIMAL TREATMENT
If an over-the-counter (OTC) nicotine replacement therapy is chosen, provide the patient with a prescription in case his or her insurance covers the medication, thus removing cost as a barrier to cessation. When recommending nicotine replacement agents, suggest two nicotine replacement agents (referred to as combination or dual nicotine replacement therapy) for the greatest likelihood of a successful cessation attempt. Nicotine patches provide prolonged nicotine release to minimize likelihood of withdrawal symptoms, and nicotine gum or lozenges can be used for breakthrough symptoms.19 Gum and lozenges can also be used for breakthrough cravings in patients who are using varenicline or bupropion. Table 2 describes advantages and disadvantages of each pharmacotherapy option. Most therapies are recommended for 3 to 6 months; however, for most patients, the risks of continued tobacco use are much greater than the risks of continuing nicotine replacement therapy to support smoking cessation.
In terms of successful cessation, evidence shows significant variation for efficacy of therapies. Without intervention, patients have a success rate of 5% to 11%; adding behavioral therapy alone increases the success rate to 19% to 21%.4
Despite variation in efficacy rates in the literature, all nicotine replacement therapy products are considered equally effective.20 Nicotine replacement therapy can improve cessation success by 50% to 70% compared with quitting without assistance. Combination nicotine replacement therapy is more effective than single-agent therapy.20 Single nicotine replacement therapy has shown cessation rates of 17% to 23%, with prolonged nicotine gum use (more than 14 weeks) increasing cessation rates to 26%.21,22
Combination pharmacotherapy and behavioral counseling is optimal, providing cessation rates of 21% to 27%.5,21 Varenicline provides the highest rates of cessation, 28% to 33%.5,21,23-25 Bupropion generally is considered the next most effective therapy, with cessation rates of 19% to 24%.5,21
Treating nicotine dependence remains challenging and sometimes highly debated since the arrival of electronic cigarettes (e-cigarettes) in 2007. Although potential therapies have remained consistent, some dosing strategies and safety warnings have changed.
Patients who use smokeless tobacco are candidates for pharmacotherapy and behavioral interventions. A Cochrane review specifically assessing cessation therapies in smokeless tobacco users found that bupropion, nicotine gum, and nicotine patches did not significantly improve abstinence rates; however, behavioral interventions, varenicline, and nicotine lozenges showed some level of improvement in abstinence.11
The concomitant use of varenicline with nicotine replacement therapy and a gradual reduction in number of cigarettes smoked has been evaluated as a potential option for patients. In a study of patients who were not ready to quit but were motivated and willing to slowly reduce the number of cigarettes smoked until they were cigarette-free, patients who use varenicline had significantly higher prolonged, continuous abstinence compared with those on placebo.26 Although this approach should not be used in all patients, it is a viable option for those not ready to quit immediately.
Clinicians often struggle to select an appropriate and effective cessation therapy in patients with mental health comorbidities. A pivotal trial, the EAGLES study, evaluated the safety and efficacy of varenicline and bupropion, both of which contained black box warnings for neuropsychiatric adverse events.19,27 The EAGLES study found that neither bupropion nor varenicline increased the incidence of neuropsychiatric adverse events.27 The study found that the patient's mental health history had a stronger influence on neuropsychiatric safety and efficacy; incidence of moderate-severe adverse neuropsychiatric adverse events ranged from 1.3% to 2.5% in patients without a history of mental health comorbidities and 5.2% to 6.7% in patients with a history of mental health comorbidities.27 As a result, the black box warnings were removed by the FDA in December 2016.28 Although clinicians should feel more comfortable with using these therapies in patients with mental health comorbidities, patients should still be advised of potential risk and should be monitored more closely.
Recommendations on the cardiovascular risk of varenicline are mixed. A review of three systematic reviews evaluated the cardiovascular risk of varenicline and found a slight increase in serious cardiovascular adverse events; however, only one review found a significantly increased rate of common cardiovascular events.29 For all three reviews, the number needed to harm (NNH) is about 454 patients.
When nicotine replacement therapy was approved 30 years ago, data were lacking on the duration of safe use, concomitant use of multiple nicotine replacement therapy, or use of the therapy in patients who were still smoking. New evidence has changed those warnings, which had limited use of nicotine replacement therapy in some patients.30 No significant safety concerns exist for use of dual OTC nicotine replacement products, or use of nicotine replacement therapy with another nicotine-containing product, such as a cigarette.30 Clinicians should feel comfortable providing nicotine replacement therapy in patients who are still smoking and not ready to quit but are motivated. However, evidence is mixed as to whether nicotine replacement therapy with a gradual decrease in the number of cigarettes smoked actually helps patients quit smoking and maintain cessation.31
Women who quit smoking before pregnancy or during pregnancy reduce the risk of adverse outcomes, including preterm birth (before 37 weeks), low birth weight, and infant mortality. However, data are limited assessing pharmacologic therapies in pregnant women with no data for bupropion or varenicline. The USPSTF recommends that behavioral interventions be the cornerstone of cessation efforts in pregnant patients who smoke.5
Smoking cessation therapy has been controversial in patients with cardiovascular disease. Nicotine replacement therapy may trigger cardiac events in the immediate post-myocardial infarction (MI) period. The American College of Cardiology and American Heart Association recommend against use of nicotine replacement therapy while patients are hospitalized for symptomatic MI; however, data regarding adverse reactions are limited and a small analysis found no difference in short- or long-term safety of nicotine replacement therapy compared with placebo post-MI.32 Advise patients with serious cardiovascular health concerns of the risks before starting nicotine replacement therapy.
THE ROLE OF E-CIGARETTES
Although a growing number of patients are interested in using e-cigarettes (also known as electronic nicotine delivery systems) as a method of quitting, the role of e-cigarettes is widely debated. At issue is whether these devices deliver a recreational drug or a medicine. An FDA final rule in 2016 drastically changed the landscape for e-cigarettes, imposing significant access restrictions and giving the FDA regulatory authority over all tobacco products, including e-cigarettes.33 Contents of e-cigarette liquid were previously unregulated, making much unknown about the chemicals contained in the liquid.32 The nicotine content or dosage is not tested, and e-cigarettes have been shown to release toxic chemicals (such as glycerin and formaldehyde) when heated.34 Further, a study has demonstrated development of severe respiratory disease (bronchiolitis obliterans, commonly referred to as “popcorn lung”) in users of e-cigarettes as a result of flavoring agents containing diacetyl, which has been well associated with bronchiolitis.35
Clinicians should expect more patients to ask about using e-cigarettes in cessation attempts. A recent study showed 15% of patients discussed e-cigarettes with their physician, and 61% of physicians recommended e-cigarettes as cessation tools despite limited evidence.36 Literature has shown significant variation in the efficacy of e-cigarettes as cessation tools; controversy exists as to whether e-cigarettes actually present a harm reduction strategy to combustible cigarettes or if they are simply a different risk.
E-cigarettes have shown benefit in managing withdrawal symptoms associated with quit attempts, such as anxiety and irritability.37 However, evidence also shows that patients who use e-cigarettes also use combustible cigarettes, posing challenges to permanently quitting, and some studies show that e-cigarette users are actually less likely to quit smoking.38 Trials also have shown the opposite, with moderate benefit in cessation, but these rates have been lower than success rates with traditional pharmacologic cessation tools.39,40
If patients ask about e-cigarettes and their role in cessation, be honest and say that much remains unknown about the potential health risks of these agents and evidence on their efficacy as cessation agents is limited. E-cigarettes should only be encouraged at this time as a cessation tool if patients cannot or will not use pharmacologic treatment options. The USPSTF concludes that the current evidence is insufficient to recommend e-cigarettes for tobacco cessation in adults.5
MONITORING AND FOLLOW-UP
The healthcare team should maintain contact (via telephone, Internet, or in-person follow-up) with a patient who smokes to ensure cessation is maintained and/or to facilitate a future smoking cessation attempt when a patient is most motivated to quit. Follow up within 1 week of the predetermined quit date, when the patient is at the highest risk of relapse.4 Congratulate patients on their successes and contact them at least four more times to improve abstinence rates.4 Clinical studies have shown a positive correlation between number of counseling sessions and abstinence rate. Remember that the more counseling interventions a clinician makes, the more likely a patient is to attempt and maintain cessation.4
Reassess patients who are unsuccessful at quitting. Evaluate pharmacologic and nonpharmacologic strategies, and set a new quit date if the patient is ready. Remind patients that a relapse is an opportunity for them to learn what tempted them to smoke and how to cope better with similar situations in the future.10
Tobacco dependence often requires multiple quit attempts, and patients may relapse after several years of cessation. Assess patients for tobacco use at every clinic visit and be prepared to make either behavioral interventions or initiate pharmacotherapy based on the patient's readiness to quit. Recent guideline updates do not preferentially recommend any one pharmacotherapy; however, e-cigarettes still have significant concerns and limited safety data, limiting their viability as a cessation tool until more long-term cessation and safety data are available.
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Keywords:Copyright © 2017 American Academy of Physician Assistants
smoking cessation; tobacco products; e-cigarettes; nicotine replacement therapy; varenicline; physician assistant