AACN News—November 2007—Certification

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Vol. 24, No. 11, NOVEMBER 2007


Pharmacotherapy Advances for Evidence-based Tobacco Cessation Strategies


Janie Heath, PhD, APRN, BC-ANP, ACNP
Claudia P. Barone, EdD, RN, LNC, CPC
Jeannette O. Andrews, PhD, BC-FNP, ACNP

Learning Objectives
At the end of this learning activity, the participant will be able to:
1. Discuss the FDA-approved first-line pharmacotherapy agents used in smoking cessation.
2. Describe the intervention that results in the best long-term success in smoking cessation.
3. Summarize Joint Commission measures for tobacco cessation in the acute and critical care setting.


Whether managing compromised airways or hypercoagulable states, acute and critical care nurses know all too well the devastating health effects of tobacco use. The physiological effects of tobacco use on endothelial and cell function of smokers and nonsmokers (those exposed to secondhand smoke) cannot be overemphasized. The harmful health effects stem from more than 4800 compounds, including known carcinogens that are released during direct inhalation or as second-hand smoke, from just 1 cigarette.1 Although nicotine is the addictive component of tobacco, it does not cause the tobacco-related diseases responsible for more than 450 000 deaths per year.2 It is certainly welcome news that smoking rates have declined, but 45.8 million persons continue to smoke in the United States.3 In addition, each adult smoker accounts for $3400 per year in smoking-related healthcare costs and lost productivity (approximately $156 billion per year). 2
. In 2002, the Joint Commission on Accreditation of Healthcare Organizations intervened to help combat the adverse health effects and healthcare costs from tobacco use. One of the core evaluation measures and quality indicators for hospital accreditation of the Joint Commission is that counseling about smoking cessation be provided to all patients admitted to the hospital with myocardial infarction, heart failure, or pneumonia.4 Because a healthcare provider’s advice to stop smoking is a strong motivator for patients to try to quit smoking,5 acute and critical care nurses using evidence-based strategies could have a major effect in motivating patients to quit smoking.
A meta-analysis of 29 studies revealed that, compared with smokers who do not receive an intervention from a clinician, smokers who receive a tobacco cessation intervention from a physician clinician or a nonphysician clinician are 2.2 and 1.7 times, respectively, as likely to quit (at 5 or more months after the intervention).5 Because the use of pharmacotherapy approximately doubles patients’ chances of quitting, cessation interventions should combine pharmacotherapy (when feasible and not contraindicated) with behavioral counseling.5
Some may argue that pharmacotherapy is costly and might not be a necessary component of a treatment plan for all patients, but it is the most effective known method of maximizing the odds of success for any given attempt to quit smoking (it usually takes 10 attempts to quit), particularly when combined with behavioral counseling.5 Others may also argue that pharmacotherapy is substituting “one drug for another,” when in fact patients may receive nicotine, but they are not exposed to the toxic components found in tobacco and tobacco smoke.5
The value of pharmacotherapy can be better understood if one considers that, under physiological conditions (pH = 7.3-7.5), nearly one third of nicotine is nonionized and readily crosses cell membranes.6 Once absorbed, nicotine stimulates the release of multiple neurotransmitters, inducing pharmacological effects such as pleasure and reward (dopamine), cognitive enhancement (acetylcholine), arousal (acetylcholine, norepinephrine), appetite suppression (norepinephrine), learning and memory enhancement (glutamate), reduction of anxiety and tension (b-endorphins and g-aminobutyric acid), mood modulation (serotonin), and appetite suppression (serotonin).6 Within seconds of smoking, nicotine enters the brain and activates the dopamine reward pathway. Activation of this pathway is what causes the “feel good” response as well as the relief of symptoms of nicotine withdrawal. This rapid dose-response, along with the short half-life of nicotine (2 hours), underlies why smokers trying to quit need frequent and repeated administration of nicotine.6 It also helps to explain the perpetuating use of tobacco and stresses the value of pharmacotherapy in helping break the cycle of tobacco dependence.
Since the evidence well supports the positive effect that nurses have with tobacco cessation interventions,7 acute and critical care nurses are well positioned to advocate for pharmacotherapy for tobacco-dependent patients, either through individual counseling or through hospital-wide tobacco cessation protocols/standing orders. We provide an overview of first-line agents that have proven efficacy and have been approved by the Food and Drug Administration for smoking cessation. Dosing considerations and daily costs for the use of the first-line agents are listed in Tables 1 and 2.

Nicotine Replacement Therapy
Starting in 1984, nicotine replacement therapies entered the US market, with the introduction of nicotine gum. Since then, 4 additional products have become available: an over-the-counter transdermal patch (1991), a prescription nasal spray (1996), a prescription oral inhaler (1997), and an over-the-counter lozenge (2002).8,9 The main mechanism of action of nicotine replacement therapies is thought to be through the dopamine reward pathway. Within seconds of inhaling a cigarette, nicotine receptors in the ventral tegmental area of the brain are stimulated, which results in release of dopamine into the nucleus accumbens. The rationale underlying use of nicotine replacement therapies for smoking cessation is to activate the dopamine reward pathway with a lower dose of nicotine for a slower steady state of plasma nicotine concentration.6 Thus, when used appropriately, nicotine replacement therapies help to reduce the physical withdrawal symptoms (usually subsiding within 2-4 weeks) associated with quitting nicotine.6 Regardless of which nicotine replacement product is used (Tables 1 and 2), the tobacco-dependent person will be able to focus more effectively on the behavioral and psychological aspects of quitting instead of focusing on the withdrawal.5

Nicotine Replacement Therapy Precautions
Although many experts believe that the risks of using nicotine replacement therapies are small compared with the risks of continued smoking,5 several circumstances exist in which the use of nicotine replacement therapies is not recommended or approved. Until evidence supports their safety and efficacy, nicotine replacement therapies should be used with caution and only under medical supervision in the following circumstances5:
• Myocardial infarction within past 2 weeks
• Serious arrhythmias
• Serious or worsening angina pectoris
• Less than 18 years of age
• Women who are pregnant or nursing (all nicotine replacement products are classified as pregnancy category D [evidence of risk to the human fetus]).

Nicotine Replacement Gum
Nicorette is the most common nicotine replacement gum. It is available over the counter as 2 mg or 4 mg in original, mint, orange, and fruit flavors. In addition to the precautions just listed, persons with a history of temporomandibular joint disease or denture use are advised to consider other nicotine replacement options. Proper dosing (Table 1) is essential for success in stopping smoking and decreasing possible adverse effects. Incorrect chewing (must chew slowly and upon tingling, park gum in cheek until tingling fades, and repeat cycle for at least 20 minutes) can result in lightheadedness, nausea and vomiting, throat and mouth irritation, mouth or jaw soreness, and dyspepsia or hiccups.8,9

Nicotine Replacement Lozenge
Commit is the only product that is a nicotine replacement lozenge. It is available over the counter as 2 mg or 4 mg in original and mint flavors. It is a nice alternative option for persons unable to use gum because they use dentures or have problems with the temporomandibular joint. The dosing (Table 1) is related to the timing of the first cigarette each day as opposed to the number of cigarettes smoked daily. Just as with nicotine gum, incorrect use (must not chew or swallow but allow lozenge to dissolve for at least 20 minutes) can result in lightheadedness, nausea and vomiting, and throat and mouth irritation.8,9

Nicotine Replacement Patch
Nicoderm is the most common nicotine replacement patch. It is available over the counter as a 24-hour release in strengths of 7 mg, 14 mg, and 21 mg. Smokers with a history of acute or chronic skin disorders are advised to consider other nicotine replacement options. The dosing (Table 1) is based on the number of cigarettes smoked per day, and correct application is essential for cessation success. Persons with sleep disturbances should remove the patch at bedtime. Although usually self-limiting, local skin irritation (can reverse with change in the product brand) and headache are possible adverse effects.8,9

Nicotine Replacement Nasal Spray
Nicotrol Spray is the only nicotine replacement nasal spray available. It requires a prescription and comes as 0.5 mg nicotine/50 ÌL (each bottle contains about 100 doses or 1 week’s supply). Smokers with acute or chronic nasal disorders or severe reactive airway disease are advised to consider other options for nicotine replacement therapy. As the fastest nicotine delivery agent available, the nasal spray is typically reserved for highly dependent individuals who have “tried everything.” Nasal and/or throat irritation, tearing, and headache are common possible adverse effects. For successful cessation outcomes, dosing (Table 2) usually requires at least 8 doses/day (1 dose = 2 sprays/nostril) for 3 to 6 months.8,9

Nicotine Replacement Nasal Inhaler
Nicotrol Inhaler is the only inhaler available for nicotine replacement therapy. It requires a prescription and resembles a cigarette. It comes as a 10-mg cartridge with a delivery capacity of 4 mg of inhaled nicotine vapor. Smokers with severe reactive airway disease are advised to consider other options for nicotine replacement therapy. For successful cessation outcomes, dosing (Table 2) usually requires at least 6 cartridges/day (1 cartridge is about 20 minutes of puffing) for 6 months.8,9

Bupropion Sustained-Release
Originally marketed as an atypical antidepressant, bupropion sustained-release (Zyban) by GlaxoSmithKline was approved by the Food and Drug Administration in 1997 as a nonnicotine medication for smoking cessation. Although the exact mechanism of action is unknown, bupropion sustained-release is thought to decrease craving for nicotine and symptoms of withdrawal by blocking neural dopamine or norepinephrine uptake in the central nervous system. Clinical trials involving more than 7000 patients confirm the effectiveness of bupropion sustained-release for tobacco cessation6; however it has several drawbacks: (1) it requires a prescription, (2) it must be used for 2 weeks before the quit date, (3) it is in pregnancy category B (no evidence of risk to animal fetus), and (4) it has numerous contraindications such as the following:8,9
• Seizure disorder
• Concomitant use of bupropion (eg, Wellbutrin) therapy
• Current or prior diagnosis of bulimia or anorexia nervosa
• Simultaneous abrupt discontinuation of alcohol or sedative (including benzodiazepines)
• Monoamine oxidase inhibitor therapy within past 14 days

Varenicline
Approved by the Food and Drug Administration in May 2006, varenicline (Chantix) by Pfizer is the newest product on the market to help smokers quit. The first of its kind, varenicline binds with high affinity and selectivity at a4b2 neuronal nicotinic acetylcholine receptors. The efficacy of varenicline is thought to be the result of low-level or partial agonist activity at the receptor site combined with complete antagonist activity with nicotine binding.11 The partial agonist activity induces modest receptor stimulation that can be compared with receiving a “40-watt nicotine buzz” versus a “100-watt nicotine buzz” effect from smoking. Thus, this partial agonist activity attenuates the symptoms of nicotine withdrawal. As does bupropion sustained-release, varenicline requires a prescription and is in pregnancy category C. However, it needs to be used for only 1 week before the quit date, and except for requiring dosage adjustment for severe renal impairment, it has no contraindications (Table 2).8,9,11 Further evidence of the clinical efficacy of varenicline (randomized controlled trials involving more than 3000 patients) compared with bupropion sustained-release and placebo is summarized in Table 3. A possible adverse effect is nausea, which is usually self-limiting through dose adjustment, taking medication after eating, and taking medication with a full glass of water.

Conclusion
In summary, in the past decade, the number of effective pharmacological options for smoking cessation has tripled. Whether acute and critical care nurses have a direct effect (eg, individual/group counseling) or indirect effect (eg, implementation of inpatient protocols/orders) on tobacco cessation, it is critical to educate patients properly about pharmacotherapy to avoid nonadherence and continued tobacco use. Staying abreast of the latest evidence for tobacco cessation is not only good for high-quality outcomes for patients but for system outcomes as well.

About the Authors
Janie Heath is an associate dean of academic nursing practice and tobacco cessation program clinical operations director at Medical College of Georgia in Augusta, Ga. Claudia P. Barone is the dean of the College of Nursing and tobacco cessation provider education coordinator in the College of Public Health at the University of Arkansas for Medical Sciences in Little Rock, Ark. Jeannette O. Andrews is chair and assistant professor in the Department of Biobehavioral Nursing and tobacco cessation program clinical outcomes director at Medical College of Georgia in Augusta, Ga.

References
1. National Cancer Institute. Risks Associated With Low Machine-Measured Yields of Tar and Nicotine. Bethesda, Md: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; 2001. Smoking and Tobacco Control Monograph No. 13. NIH Publication No. 02-5074.
2. Centers for Disease Control and Prevention. Annual smoking-attributable mortality, years of potential life lost, and productivity losses: United States, 1997–2001. MMWR. 2005;54:625-628.
3. Centers for Disease Control and Prevention. Tobacco use among adults: United States, 2005. MMWR. 2006;55:1145-1148.
4. Joint Commission of American Hospital Organizations. Specification manual for national implementation of hospital core measures. Version 2.0—implementation to begin with July 2004 discharges. Available at: http://www.jcaho.org
/pms/core+measures/ information+on+final+specifications.htm. Accessed on February 1, 2007.
5. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence, Clinical Practice Guideline. Rockville, Md: US Department of Health and Human Services, Public Health Service; June 2000.
6. Benowitz NL. The biology of nicotine dependence: from the 1988 Surgeon General’s Report to the present and into the future. Nicotine Tob Res. 1999;1(Suppl 2):S159-S163.
7. Rice VH, Stead LF. Nursing interventions for smoking cessation. (Cochrane Review). In: The Cochrane Library, Issue 1. Chichester, UK: John Wiley and Sons; 2004.
8. Rx for Change: Clinician-Assisted Tobacco Cessation Curriculum. San Francisco, Calif: The Regents of the University of California, University of Southern California, and Western University of Health Sciences; 1999-2007. Available at: http://www.rxforchange.ucsf.edu. Accessed January 24, 2007.
9. Corelli R, Hudmon KS. Pharmacologic interventions for smoking cessation. Crit Care Nurs Clin. 2006;18:39-51.
10. 2006 Drug Topics Redbook. Montvale, NJ: Medical Economics Co; December 2006.
11. Foulds J. The neurobiological basis for partial agonist treatment of nicotine dependence: varenicline. Int J Clin Pract. 2006;60:571-576.
12. Gonzales D, Rennard SI, Billing CB, et al. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006;296:47-55.
13. Jorenby DE, Hays JT, Rigotti MD, et al. Effi cacy of varenicline, an a4b2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation. JAMA. 2006;296:56-63.
14. Tonstad S, Tonnesen P, Hajek P, et al. Effect of maintenance therapy with varenicline on smoking cessation. JAMA. 2006;296:64-71.;


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