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Methods to Facilitate Smoking Cessation: Guidelines and Treatment Modalities

  • Authors: Ralph E. Small, PharmD, FAPhA ; Daniel T. Kennedy, PharmD, BCPS
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Target Audience and Goal Statement

This activity is intended for pharmacists.

By presenting the most current developments in the practice of pharmacy and pharmacotherapy, these conference summaries aim to enhance understanding of treatment of various disease states and reassess and modify current practice methods in order to enhance pharmaceutical care.

On completion of this continuing medical education offering, participants will be able to:

  1. Discuss diagnosis and monitoring for asthma and the long-term consequences of poorly controlled asthma.

  2. Describe devices that are specifically designed for monitoring and medication delivery in children.

  3. Describe the correct use and importance of the latest guidelines for smoking cessation.

  4. Describe the appropriate use of behavioral therapies and medications shown to be effective for patients attempting to quit smoking.

  5. Understand opportunities and strategies for developing smoking-cessation programs or clinics.

  6. Understand the mechanism of action of currently available options for contraception.

  7. Review education strategies and counseling tips for individuals seeking emergency contraception.


  • Ralph E. Small, PharmD, FAPhA

    Director of Ambulatory Care Practice, School of Pharmacy, Richmond, Virginia; and Professor of Pharmacy and Medicine, Department of Pharmacy and Internal Medicine, Virginia Commonwealth University, Richmond, Virginia

  • Daniel T. Kennedy, PharmD, BCPS

    Clinical Director of Pulmonary Research, Department of Group Practice, Richmond, Virginia; Assistant Clinical Professor, Department of Pharmacy, Richmond, Virginia

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    For Pharmacists

  • The American Pharmaceutical Association is approved by the American Council on Pharmaceutical Education (ACPE) as a provider of continuing pharmaceutical education. This activity has also been planned and implemented in accordance with the Quality Criteria of the American Council on Pharmaceutical Education (ACPE) through the sponsorship of The American Pharmaceutical Association.

    The American Pharmaceutical Association has assigned 3.0 contact hours (0.30 CEUs) of continuing pharmaceutical education credit . ACPE provider number: 202-999-01-156-H01

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Methods to Facilitate Smoking Cessation: Guidelines and Treatment Modalities

Authors: Ralph E. Small, PharmD, FAPhA ; Daniel T. Kennedy, PharmD, BCPSFaculty and Disclosures



Tobacco is the number one cause of preventable death and disease in the United States. Currently, approximately 24.7% of adults in the United States smoke.[1] Smokers have an increased risk of cerebrovascular disease, chronic obstructive pulmonary disease, and heart disease.[2] Cigarette smoking contributes to 30% of all cancer deaths and to 87% of lung cancer deaths annually.[3] More than 400,000 Americans die each year as a result of smoking-related illness, and this number continues to increase.[4] It has been estimated that smokers of 1 to 2 packs of cigarettes a day lose anywhere from 4.4 to 6.8 years of life.[5] The estimated annual direct and indirect costs attributed to smokers in the United States is $100 billion.[1]

The prevalence of adult smokers has remained consistent since the mid-1990s.[6] A more disturbing trend is the prevalence of cigarette smoking among high school students, which increased during the 1990s.[7] The National Youth Tobacco Survey (NYTS) administered during the fall of 1999 indicated that 12.8% of middle school students (grades 6-8) and 34.8% of high school students (grades 9-12) had used some type of tobacco within 30 days of the survey.[8] This report also estimated that the percentages of high school students who currently use bidis (5.0%) and kreteks (5.8%) are nearly as high as those who use smokeless tobacco (6.6%). Bidis are small, hand-rolled, flavored cigarettes primarily made in India and Southeast Asian countries.[9] Kreteks are produced predominantly in Indonesia and consist of two thirds tightly packed tobacco with one third shredded cloves.[10] These new tobacco products are of particular concern because they are desirable to the young smoker. They also may deliver more tar and nicotine due to the strain of tobacco used and the fact that these products are unfiltered. The Massachusetts Tobacco Control Program conducted a pilot study to determine the use of bidis in adolescents during March and April 1999.[9] This report demonstrated that of the 642 youths surveyed (self-reported grades 7-12), 40% had smoked bidis at least once and 16% were current smokers of bidis.

A healthcare professional can greatly influence a quit attempt by an adolescent smoker through patient education and counseling.[11] Educating children about the dangers of starting smoking cannot be emphasized strongly enough, as more than 80% of current adult tobacco users started before the age of 18.[12] If current trends continue, as many as 5 million children living today will die prematurely from the initiation of cigarette smoking as adolescents.[13]

All healthcare professionals must be aware of these trends and promote smoking cessation to decrease the health burden and economic impact ($50 billion in medical expenditures and $50 billion in indirect costs annually) caused by smokers.[1] Despite these facts, the response of both clinicians and the US healthcare system has been lacking.[14] A recent evaluation of smoking cessation practices by pharmacists disclosed that pharmacists do not routinely identify smokers, engage smokers in smoking cessation-related activities, or document smoking cessation patient information and outcomes.[15]

Due to the staggering morbidity, mortality, and economic impact of cigarette smoking in the United States, it is believed that pharmacists could assume a leadership role in smoking cessation and prevention. The pharmacist is in an ideal position to promote smoking cessation because of the number of patients seen in pharmacy practice as well as the availability of nonprescription nicotine replacement therapies (NRTs). A pharmacist's role in a smoking cessation program at a managed health care organization, as well as at a health maintenance organization, has been described in the literature.[16,17] Favorable outcomes of a smoking cessation program offered to community, managed care, and hospital pharmacists have also been reported.[18] However, an intensive, patient-specific model of smoking cessation designed exclusively for implementation in community pharmacy practice is not currently available.

With a summary of the literature justifying the need for smoking cessation clinics to be established, individuals from the Virginia Commonwealth University (VCU) School of Pharmacy sought a partner in community pharmacy practice who had similar concerns and vision for preventing tobacco-related illnesses. With the patient care and service focus of Target Pharmacy, and the goal of the VCU School of Pharmacy to establish a program to help people quit smoking, a collaboration was initiated. The goal was to provide an ongoing smoking cessation program that would assist people who smoke to quit and therefore, enhance the quality and length of their lives. Realizing that this would be a long-term program, a mutually agreeable strategic plan was developed. This allowed the partners to discuss and include in their plans such topics as use of clinical practice guidelines, integration of practice tools with everyday responsibilities, potential use of educational resources, training of health professionals in smoking cessation, appropriate opportunities for referral to a physician, and overlap of disease state management programs with the screening and prevention efforts of the pharmacy staff.

New Smoking Cessation Guidelines

Pharmacotherapies have been recommended by the U.S. Department of Health and Human Services' Public Health Service in its clinical practice guidelines for 2000, "Treating Tobacco Use and Dependence."[14]

A comparison of the 2000 guidelines with the previous (1996) guidelines reveals the progress made in tobacco research. Among the important differences between the documents are the following:

  • There are now 7 efficacious smoking cessation medications, allowing the clinician and patient many more treatment options than previously. Further information is also available on the efficacy of combinations of NRTs and pharmacotherapies that are obtained over the counter.
  • The updated guidelines point to additional efficacious counseling strategies. These include telephone counseling as well as counseling that helps smokers enlist support outside the treatment context.
  • The updated guidelines contain strong evidence that smoking cessation treatments shown to be efficacious are cost-effective relative to other routinely reimbursed medical interventions, such as treatment of hyperlipidemia and mammography screening.

The updated guidelines contain the following statements that may give hope to the 7 out of 10 smokers who try to quit each year:

  • Tobacco dependence is a chronic condition that often requires repeated intervention. However, effective treatments exist that can produce long-term or even permanent abstinence.
  • Patients willing to quit tobacco use should be provided with treatments identified as effective in these guidelines; patients unwilling to try quitting should be provided with a brief intervention designed to increase their motivation to quit.
  • Clinicians must actively assess and treat tobacco use. In addition, it is essential that healthcare administrators, insurers, and purchasers adopt and support policies and practices aimed at reducing tobacco-use prevalence.
  • The guidelines recommend that brief tobacco dependence treatment -- even a few minutes spent by a provider talking to a patient -- is effective.

There is a strong dose response relationship between the intensity of tobacco-dependence counseling and its effectiveness. Treatments involving person-to-person contact (via individual, group, or proactive telephone counseling) are called consistently effective, and effectiveness increases with treatment intensity.

Three types of counseling and behavioral therapies were found to be especially effective and should be used with all patients attempting tobacco cessation: provision of practical counseling, provision of social support as part of treatment, and help in securing social support outside of treatment.

Smoking Cessation Modalities

Behavioral Modifications

Lifestyle modification and behavioral modification are important. Patient education should be given during the initial visit and revisited over the course of a year during follow-up visits for each patient. Suggestions could include counter-conditioning such as waiting an additional 5 minutes before lighting up, smoking a cigarette only halfway, and/or reducing smoking by 1 cigarette per day every other day. Patients should be encouraged to keep a "cigarette diary" from the time of the initial visit to the specified quit date to track tapering of tobacco use. In reality, few patients taper tobacco use (cigarette fading) significantly during this preparation phase, but the point of becoming "mentally" ready is reinforced with this exercise. Instruction should also include suggestions about stimulus control, such as removing visual cues and staying away from situations that make them want to smoke. For example, patients may be encouraged to remove ashtrays from the home and workplace and to avoid alcohol and bars where smoking commonly occurs. Each patient's family, friends, and significant others should be encouraged to provide support. It is believed that a support system could assist the smoking cessation candidate through the preparation, action, and maintenance phases.

The biggest concern that many patients have is weight gain. The average person gains only 5-10 pounds when attempting to stop smoking. Patients may not gain any weight, or they may gain significantly more than the average. Patients should be instructed to not try to diet and stop smoking at the same time. Start with smoking cessation, and after 3 months of being smoke-free, a diet can be discussed. Additional patient information pertaining to healthy snacks and food choices should be made available for interested patients.

Transtheoretical Model

The 5 stages of the transtheoretical model (precontemplation, contemplation, preparation, action, and maintenance) are described in detail in Table 1.

Table 1. Transtheoretical Model for Smoking Cessation

  • Patients are unaware, unwilling, or are too discouraged to alter their smoking behavior.
  • Few negative consequences have occurred from smoking.
  • Patients may feel that the negatives of smoking may not outweigh the positives.
  • Patients are not seriously considering smoking cessation in the next 6 months.
  • The process of social liberation (eg, recognizing situations such as smoke-free workplaces) peaks in precontemplation and decreases gradually as one moves through the remaining stages.
  • To move into contemplation, precontemplators must:
    • Be prompted to accept ownership of the behavior problem
    • Increase their awareness of the negative consequences of smoking
    • Evaluate the effects of smoking on others and the environment
    • Recognize how certain situations affect smoking behavior
    • Accurately assess the resources available to facilitate smoking cessation
  • Active consideration of change
  • Patients are currently smoking, but are considering stopping within the next 6 months.
  • Individuals seek relevant information, re-evaluate smoking behavior, and enlist support of others.
  • It is common for individuals to remain in this stage for extended periods, often years at a time.
  • Current smokers who are ready to stop smoking in the next 30 days
  • Smoker has made at least one 24-hour quit attempt in the past year (this is not absolutely necessary for a smoker to be in the preparation stage)
  • Although self-liberation does not peak until maintenance, it is a key process in this stage.
  • Individuals must have the confidence that they can change.
  • Patients are actively modifying their habits and environment.
  • They have quit smoking within the past 6 months.
  • Stimulus-control and counter-conditioning are necessary to prevent relapse.
  • Behavior change may be accompanied by feelings of guilt, fear of failure, and limited personal freedom. Support from others is vital during this stage.
  • Patients are making major lifestyle changes during this stage and may be faced with challenging situations.
  • Individuals undergo re-evaluation that results in moving from "smoker" to "nonsmoker" status.
  • Former smokers who have not smoked for at least 6 months
  • Counter-conditioning and self-liberation, which peak early during this stage, are most likely to prevent a relapse.
  • Patients in this stage remain highly susceptible to relapse.
  • Must be aware of environmental and internal stimuli that can trigger a return to smoking.
  • Relapse can be viewed as part of the learning process, and knowing cues for relapse is useful for future attempts at smoking cessation.

Fagerstrom Test

When an attempt to stop smoking is initiated, withdrawal symptoms such as irritability, drowsiness, anxiety, hunger, sleep disturbances, and difficulty concentrating reach maximal intensity 1 to 2 days after cessation and gradually decrease in intensity over a period of 2 weeks.[19,20] However, the desire to smoke may persist for a lifetime in the patient who has successfully stopped smoking.

The Fagerstrom Test for Nicotine Dependence (FTND) is a 6-item questionnaire designed to assist the healthcare professional in determining the likelihood of nicotine dependence.[21] A score of 6 or greater (maximum score of 10) on the FTND indicates a high level of nicotine dependence (see Table 2). The FTND, along with a history of prior attempts to quit, is a valuable tool for determining a course of action for smoking cessation. Therapeutic interventions are based on the FTND, previous attempts to quit, and patient preferences.

Table 2. Fagerstrom Test

Questions and Possible Answers Score
How soon after you wake up do you smoke your first cigarette?
≤ 5 min 3
6-30 min 2
31-60 min 1
≥ 61 min 0
Do you find it difficult to refrain from smoking in places where it is forbidden (eg, in church, at the library, in a cinema)?
Yes 1
No 0
What cigarette would you hate most to give up?
The first in the morning 1
Any other 0
How many cigarettes per day do you smoke?
≤ 10 (≤ 0.5 pack) 0
11-20 (0.5 -1 pack) 1
21-30 (1 - 1.5 packs) 2
≥ 31 (≥ 1.5 packs) 3
Do you smoke more frequently during the first hours after waking than during the rest of the day?
Yes 1
No 0
Do you smoke when you are so ill that you are in bed most of the day?
Yes 1
No 0
TOTAL SCORE: _____ (Max. Score = 10)*
*Scores of 6 or greater generally are interpreted as indicating a high degree of dependence, with more severe withdrawal symptoms, greater difficulty in quitting, and possibly the need for higher doses of medication.

Smoking Cessation Therapies: Cold Turkey

The cold turkey method of smoking cessation is a feasible initial option, as well as the least expensive option for the smoking cessation candidate. The best candidates for this method are those who smoke fewer than 10 cigarettes (half a pack) per day, have a relatively low level of nicotine dependence per the FTND (score lower than 6 out of the possible 10 points), and individuals who don't feel they need the "extra help" an NRT or bupropion could provide. Even those who smoke more than 10 cigarettes per day, or who have a high score on the FTND, can try the cold turkey method. If that method is unsuccessful in assisting the patient to long-term smoke-free status, then pharmacologic therapy can be initiated.

Smoking Cessation Therapies: Nicotine Patch

The nicotine patch is first-line pharmacotherapy to be recommended in the smoking cessation clinics due to long-term success rates, safety, ease of patient use, and cost associated with this method.[14] Pharmacist information on the use of the nicotine patch can be found in Table 3. The 24-hour patch is associated with an increase of adverse events (eg, skin irritation, vivid dreams) but is definitely indicated in patients who get up at night to smoke or those who smoke first thing in the morning (within 30 minutes of awakening) due to the pharmacodynamics of this delivery system.[22] It is recommended to limit duration of therapy with the patch to no longer than 6-8 weeks, because little benefit of a longer duration has been reported in the literature.[23] Tapering of the patch is also discouraged based on reports from the literature.[22,23] Recommendations secondary to the wants and needs of each patient should be created.

Table 3. Information for Nicotine Patches

Recommendations for Dosing of Nicotine Patches:
Transdermal System Dosing Regimen
Nicoderm Light smokers (≤ 10 cigarettes/day): one 14-mg/24-hr patch for 16 or 24 hr/day for 6 weeks, then one 7-mg/24-hr patch for 16 or 24 hr/day for 2 weeks
Heavier smokers (> 10 cigarettes/day): one 21-mg/24-hr patch for 16 or 24 hr/day for 6 weeks, then one 14-mg/24-hr patch for 16 or 24hr/day for 2 weeks, then one 7-mg/24-hr patch for 16 or 24hr/day for 2 weeks.
Nicotrol Patients who smoke 10 or more cigarettes/day: 15 mg/day for 6 weeks
  • Eight weeks of treatment has been shown to be as effective as longer treatment periods.
  • Individualize treatment based on specific patient characteristics such as previous experience with the patch, number of cigarettes smoked/day, and degree of addiction (Fagerstrom test).
  • Tapering (step-down dosages) may benefit some patients but is not required with nonprescription patches.
  • Pregnancy: Smoking cessation without pharmacologic treatment should first be encouraged. Use during pregnancy and breast feeding only if benefits of smoking cessation outweigh the risks.
  • Heart disease: Use patch in patients less than 4 weeks post-myocardial infarction (MI), those with cardiac arrhythmias, those with severe or worsening angina, or those with uncontrolled hypertension -- CONTACT PHYSICIAN FIRST!
  • Local reactions to the patch: Up to 50% of patients who use the patch will experience a local skin reaction (burning, pruritis, erythema). The 16-hour systems have a lower incidence of these types of reactions. Treatment with hydrocortisone or triamcinolone cream +/- an oral antihistamine will usually help. Rotating patch sites will also help. Less than 5% will need to discontinue the patch because of local irritation.
  • In patients who smoke fewer than 10 cigarettes/day, either pharmacologic treatment or "cold turkey" may be appropriate.
  • A 24-hour regimen may benefit those patients with severe nighttime/early morning cravings.
Patient Consultation
  1. Patches should be applied once daily to a hairless location between the neck and waist as soon as the patient awakens. Use a different site daily. The same site should not be used more than once a week. Remove the 16-hour system at bedtime.
  2. If adverse reactions occur, contact the pharmacist. Adverse reactions include local skin reactions, nicotine withdrawal, nicotine excess, and sleep disturbances.
  3. Use only 1 patch at a time, 1 patch per day.
  4. Do not smoke while wearing the patch.
  5. Weight gain: Patients usually gain less than 10 pounds. Deal with smoking cessation first, then with the weight issue.
  6. There are no activity restrictions while wearing the patch.
  7. Disposal of used patches: Keep both new and used systems away from children and pets. Even a used patch may contain up to 60% of the original nicotine content.

Smoking Cessation Therapies: Nicotine Gum

Nicotine gum is also adequate first-line therapy, but it is recommended to patients only if relapse occurred with the nicotine patch or bupropion or if patients did not want to use the patch. The reasons for this are the extensive patient education that is required for proper use of the nicotine gum and the higher cost of the gum than the nicotine patch. Information about the use of nicotine gum is provided in Table 4. Nicotine gum should be scheduled (eg, 1 piece every hour while awake) instead of used on an as-needed basis. This is due to the pharmacodynamics of the nicotine gum, as it takes up to 30 minutes for the nicotine from the gum to reach the central nervous system via buccal absorption.[24] Tapering of the nicotine gum is also strongly encouraged, as patients may become addicted to this cessation modality. Incorrect use of the nicotine gum is evidenced by hiccups, dyspepsia, and rapid chewing motion by the patients. Rotation of the buccal site where the nicotine gum is "parked" is done to minimize mouth sores commonly associated with the use of this agent.

Table 4. Information for Nicotine Gum

Recommendations for Dosing of Nicotine Chewing Gum:
Chewing Gum Dosing Regimen
Nicorette The gum is available in doses of 2 mg and 4 mg per piece (the 4-mg dose is for highly dependent patients, patients who request it, or patients who failed on 2mg). One piece of Nicorette should be chewed and "parked" between the cheek and gum intermittently over 30 minutes every 1-2 hours for 6 weeks, then every 2-4 hours for 3 weeks, then every 4-8 hours for 3 weeks. Patients using the 2-mg strength should not exceed 30 pieces/day. Patients using the 4-mg strength should not exceed 20 pieces/day.
  • Patients who smoke 25 or more cigarettes/day or score at least 6 on the Fagerstrom test may receive additional benefit from the 4-mg dose.
  • 10-12 doses of the 2-mg or 4-mg nicotine gum provide one third to one half of the usual daily nicotine intake of the patient who smokes 30 cigarettes/day.
  • Because of delayed absorption (up to 30 minutes before effects are felt), recommend that patients use the gum on a regular scheduled basis (eg, 1 piece/hr) instead of when the patient has the urge to smoke.
  • Tapering may be beneficial with nicotine gum.
  • Clinical studies found greater efficacy in patients who chewed more than 9 pieces/day.
  • Side effects include mouth irritation, sore jaw muscles, dyspepsia, nausea, and hiccups. Many of these may be related to improper use.
  • Individualize treatment based on specific patient characteristics such as previous experience with the patch, number of cigarettes smoked per day, and degree of addiction (Fagerstrom test).
  • Pregnancy: Smoking cessation without pharmacologic treatment should first be encouraged. Use during pregnancy and breast feeding only if benefits of smoking cessation outweigh the risks.
  • Heart disease: Use the gum in patients less than 4 weeks post-MI, those with cardiac arrhythmias, those with severe or worsening angina, or those with uncontrolled hypertension -- CONTACT PHYSICIAN FIRST!
  • In patients who smoke less than 10 cigarettes per day, either pharmacologic treatment or "cold turkey" may be appropriate.
Patient Consultation
  1. Chewing technique: The gum should be chewed until a peppery taste emerges, then parked between cheek and gum to facilitate nicotine absorption through the oral mucosa.
  2. Gum should be slowly/intermittently chewed for about 30 minutes.
  3. Acidic beverages (eg, coffee, juices, soft drinks) interfere with the buccal absorption of nicotine, so eating/drinking anything except water should be avoided for 15 minutes before and during chewing.
  4. Many patients do not chew enough gum to get the maximum benefit (too few pieces/day or not enough weeks of therapy). USE THE GUM ON A SCHEDULED BASIS OF 1 PIECE EVERY 1-2 HOURS FOR AT LEAST 1 MONTH. After 1 month, discuss tapering.
  5. Do not smoke while using the gum.
  6. Use with caution in patients with recent major dental work or in those with dentures.
  7. Weight gain: Patients usually gain less than 10 pounds. Deal with smoking cessation first, then with the weight issue.
  8. There are no activity restrictions while chewing nicotine gum.
  9. Keep both used and unused gum away from children and pets.
  10. Side effects include mouth irritation, sore jaw muscles, dyspepsia, nausea, and hiccups. Many of these may be related to improper use. Also counsel on nicotine excess/withdrawal.

Smoking Cessation Therapies: Bupropion

Bupropion is first-line therapy for those who have failed other NRTs, in combination with the nicotine patch, or in those who specifically request this modality to facilitate a quit attempt. Information on the use of bupropion is provided in Table 5. Drug interactions with bupropion are important to be aware of, and one should avoid this agent in patients with a history of seizures. Patients could be started on bupropion 1-2 weeks prior to the quit date, and total duration of therapy should last no longer than 12 weeks with no tapering of the medication.[25] Commonly reported side effects are headache, insomnia, and dry mouth.[25,26] Combination therapy with bupropion and the nicotine patch are considered to be an option in patients based on prior quit attempts, number of cigarettes per day (> 30 cigarettes per day), and Fagerstrom test (score of 6 or greater). Because of the higher cost of bupropion, nicotine patches were often more attractive to consumers as first-line therapy.

Table 5. Information for Bupropion

Recommendations for Dosing of Bupropion:
Brand Name Dosing Regimen
Zyban Start therapy 1-2 weeks prior to the quit date. Begin with 150 mg daily for 3 days; if this is tolerated, the dosage should be increased to 150 mg twice daily. Treatment should be continued for 7-12 weeks.
  • First non-nicotine product marketed for smoking cessation
  • Zyban modulates the level of dopamine and norepinephrine, 2 chemicals associated with craving and withdrawal symptoms.
  • Individualize treatment based on specific patient characteristics such as previous experience with the patch and gum, number of cigarettes smoked per day, and degree of addiction (Fagerstrom test).
  • Zyban can be used with the nicotine patch.
  • Pregnancy: Smoking cessation without pharmacologic treatment should first be encouraged. Use during pregnancy and breast feeding only if benefits of smoking cessation outweigh the risks.
  • Heart disease: in patients less than 4 weeks post-MI those with cardiac arrhythmias, those with severe or worsening angina, or those with uncontrolled hypertension -- CONTACT PHYSICIAN FIRST! (if Zyban is used concomitantly with the patch)
  • Must be started prior to the quit date.
  • In patients who smoke fewer than 10 cigarettes per day, either pharmacologic treatment or "cold turkey" may be appropriate.
  • The most common complaints with Zyban are insomnia and dry mouth.
  • Zyban is a weak inducer of cytochrome P-450 enzymes. Monitor closely when used with phenobarbital, phenytoin, and carbamazepine. Contact physician if bupropion is used in any patient with a known seizure history.
Patient Consultation
  1. Therapy should be initiated 1-2 weeks prior to designated quit date.
  2. Most common adverse effects are headache, insomnia, dry mouth, and rhinitis.
  3. Weight gain: Patients usually gain less than 10 pounds. Deal with smoking cessation first, then with the weight issue.
  4. There are no activity restrictions while using bupropion.
  5. Keep this and all medications away from children and pets.

Smoking Cessation Therapies: Nasal Spray Inhaler and Nicotine Inhaler

The nicotine nasal spray is an alternative for patients who have failed to stop smoking through nicotine patch or nicotine gum therapy, but bupropion is an equally effective and more convenient method for this group. Because of its quick onset of action, the nicotine nasal spray may benefit heavy smokers (those smoking 2 packs or more per day) and patients with higher levels of nicotine addiction. Frequent dosing and patient education is vital to success with the nicotine nasal spray. The method of delivery may cause bothersome adverse effects, limiting the use of this product by many patients.

The Nicotrol Inhaler is a very expensive alternative that adds no added efficacy over the other methods. Patients who rely on the hand-to-mouth ritual may derive the greatest benefit from the nicotine inhaler. See Table 6 for information on the nicotine nasal spray and nicotine inhalation system.

Table 6. Recommendations for Dosing of Nicotine Nasal Spray and Nicotine Inhalation System

Nasal Spray Dosing Regimen
Nicotrol NS (10 mg/mL) One or two 1-mg doses (each dose is two 0.5-mg sprays, 1 in each nostril) per hour initially, increased as needed. Do not exceed 5 doses per hour or 40 doses per day. Use full dose for up to 8 weeks, then gradually decrease dose over 4-6 weeks.
Nicotine Inhaler Dosing Regimen
Nicotrol Inhaler Patients should be titrated to the appropriate dose (10 mg nicotine cartridge -- 4 mg delivered). Initially, patients should use 6-16 cartridges throughout the day to relieve withdrawal symptoms. After 12 weeks of treatment, a gradual reduction in dosage is recommended.

A Smoking Cessation Clinic in a Chain Community Pharmacy Practice

VCU School of Pharmacy has collaborated with Target Pharmacies in Virginia to advance patient-care oriented clinical pharmacy services. Smoking cessation was chosen as the first disease state to be implemented because of the nonprescription availability of NRT products and the numerous inquiries the Target pharmacists were receiving about them. Fifteen pharmacists at 7 Target Pharmacies in Virginia participated in the smoking cessation demonstration project from April 1997 to December 1999.

Training of the Target pharmacists was conducted using a smoking cessation training manual developed by the VCU School of Pharmacy. Throughout the manual, the transtheoretical model for smoking cessation is applied to individuals who wish to quit smoking.[18] Pharmacist training consisted of an explanation of the transtheoretical model for smoking cessation, essential components required for documentation in the patient chart, appropriate behavioral modification techniques for smoking cessation, and categorization of smokers regarding their stage of change (precontemplation, contemplation, preparation, action, and maintenance). Use of the FTND was demonstrated as an important tool for selecting a treatment modality for smoking cessation.[21] A workshop approach was used for education about both nonprescription and prescription smoking cessation therapies, demonstration on the use of nonprescription NRTs (nicotine patch and gum), patient counseling techniques for smoking cessation therapies, and the method for developing an individual action plan to assist the patient with smoking cessation. The Target pharmacists were also instructed on physical assessment skills, such as blood pressure and pulse monitoring, to be used in the smoking cessation clinic. The training sessions were conducted at both the pharmacy and off-site locations based on scheduling and pharmacist convenience.

Following the training session, the Target pharmacists were prepared to incorporate the smoking cessation program into the pharmacy sites. Patient recruitment involved a pharmacist asking every pharmacy customer if they smoked, and if so, would they like to quit. Patients were also referred to the pharmacy from local family practice physicians and nurse practitioners. Marketing materials consisted of signs and displays in the pharmacy and informational pamphlets describing the smoking cessation program. The pamphlets were distributed to interested individuals and available in brochure holders on the nonprescription shelves containing NRTs. The Target patient profile sheet was also used for identifying new patients to the pharmacy who were smokers.

Interested patients met individually with a trained Target pharmacist during scheduled clinic times at the semiprivate counseling area in the Target pharmacies. Patient education about behavioral modification and smoking cessation pharmacotherapy was discussed, and if appropriate, a quit date was established. A patient chart was maintained at the site and updated after each visit. Each patient was followed for 1 year from the determined quit date. Information collected about abstinence from smoking was self-reported by each patient during follow-up. Pharmacist follow-up with patients making a quit attempt was strongly emphasized. A random subset of 30 patients, 63% of the total population, was asked to complete a questionnaire on the third visit to the smoking cessation clinic (Table 7). This questionnaire was developed at the VCU School of Pharmacy for the smoking cessation clinic, and was used to assess patient satisfaction with both the pharmacist and the overall program. Patients were asked to complete the questionnaire outside of the pharmacy and to mail it to VCU upon completion. All survey responses were confidential, and patient anonymity was maintained.

Table 7. Patient Questionnaire

Directions: The following set of statements relates to your feelings about pharmacy services. For each statement, please show the extent to which you believe the pharmacy or pharmacist has the feature described by the statement. Circling a "1" means that you strongly disagree that they have that feature, and circling a "10" means that you strongly agree. There are no right or wrong answers -- please indicate your true perceptions.*

1. Pharmacy informational materials are helpful. 1 2 3 4 5 6 7 8 9 10
2. The pharmacist is dependable. 1 2 3 4 5 6 7 8 9 10
3. The pharmacist does things promptly. 1 2 3 4 5 6 7 8 9 10
4. The pharmacist spends the right amount time with me to meet my needs. 1 2 3 4 5 6 7 8 9 10
5. The pharmacist is willing to help me. 1 2 3 4 5 6 7 8 9 10
6. The pharmacist is consistently courteous with me. 1 2 3 4 5 6 7 8 9 10
7. The pharmacist has the knowledge to answer my questions. 1 2 3 4 5 6 7 8 9 10
8. The pharmacist explains things in a way that I can understand. 1 2 3 4 5 6 7 8 9 10
9. The pharmacist listens to what I have to say. 1 2 3 4 5 6 7 8 9 10
10. The pharmacist gives me individual attention. 1 2 3 4 5 6 7 8 9 10
11. The pharmacist is easily accessible by phone. 1 2 3 4 5 6 7 8 9 10
12. The pharmacy offers appointment times that are convenient to me. 1 2 3 4 5 6 7 8 9 10
13. The pharmacist makes me feel that my well-being is important. 1 2 3 4 5 6 7 8 9 10
14. I feel comfortable asking my pharmacist questions. 1 2 3 4 5 6 7 8 9 10
15. I feel I understand the risks of smoking much better than before I started this program. 1 2 3 4 5 6 7 8 9 10
16. I better understand what education resources areavailable to quit smoking than before I started. 1 2 3 4 5 6 7 8 9 10
17. I would recommend this program to friends and family. 1 2 3 4 5 6 7 8 9 10
18. Overall, I am satisfied with my experience. 1 2 3 4 5 6 7 8 9 10

*Results: Analysis of the 19 questionnaires that were completed and returned revealed that 82% (279/342) of the possible responses by patients were "10" and 94% (320/342) were "8" or higher.

Upon completion of the training session, the role of the VCU faculty was to make periodic visits to the sites to assist with the smoking cessation clinics and to observe the pharmacists in the clinics. The observations were performed to maintain quality control in the smoking clinics and provide feedback on individual pharmacist performance. The faculty also served as a readily accessible source of drug information for the Target pharmacists. Fourth-year PharmD candidates from VCU who were completing clerkship rotations were available during scheduled clinic times to assist the Target pharmacists, maintain patient charting, and coordinate data collection via patient questionnaires. These individuals also played an active role in recruiting new patients for the smoking cessation clinic. The student participants received the same training as the pharmacists prior to contributing at the sites. The Target pharmacists were responsible for scheduling clinic times, meeting individually with patients in the smoking cessation clinic, and maintaining patient charts. Additional information about this smoking cessation program in the chain pharmacy setting has been previously described in the literature.[27,28]

For the purposes of this project, relapse is defined as smoking on a daily basis after abstaining from tobacco products for at least 24 hours, and refers to individuals who did not achieve long-term cessation. Long-term cessation is defined as at least 12 months (1 year) of abstinence from tobacco products. Descriptive statistics were used to describe patient demographics and smoking cessation rates. Nominal data were evaluated using chi-squared and Fisher's exact tests where appropriate, and continuous data were evaluated using 2-tailed T-tests. The statistical analyses were conducted using Microsoft Excel 1997 software (Microsoft, Redmond, Wash.) and SAS System for Windows release 6.12 (SAS Institute, Cary, NC). Data were deemed significant at P ≤ .05.

Smoking Cessation Clinic: Results

The results for the evaluation of a smoking cessation clinic in community pharmacy practice are shown in Table 8. Forty-eight patients were followed for at least 1 year after their determined quit date in the smoking cessation program. Of these, 12 patients (25%) abstained from smoking cigarettes for 12 months or more beyond their determined quit dates. These patients were considered to be abstinent for at least 1 year, achieving long-term cessation. Abstinence rates for 1, 3, and 6 months were 43.8% (21/48), 31.3% (15/48), and 25% (12/48), respectively. Thus, 6- and 12-month cessation rates were unchanged at 25%. Women were nearly 5 times more successful in attaining long-term abstinence than men (33.3% and 6.7%, respectively). Statistical analysis of gender and abstinence from smoking was statistically significant (P = .047). Adults ranging in age from 21 years to 70 years were included into the 1-year analysis. The highest cessation rate of 33.3% was observed in patients 20-29 years of age and those greater than 50 years of age. Participants aged 30-39 years and 40-49 years had lower 1-year smoking cessation rates of 15.8% and 22.2%, respectively. However, no statistically significant difference was observed for obtaining long-term cessation status and a particular age cohort.

Pharmacists determined each patient's smoking history. Forty-four (91.7%) of the patients smoked 30 cigarettes (1.5 packs) per day or less, with 47.9% of all patients smoking 11-20 cigarettes, or a half to 1 pack per day. Long-term cessation rates were similar for those who smoked 1-10 cigarettes, 11-20 cigarettes, and 21-30 cigarettes per day (33.3%, 26.1%, and 22.2%, respectively; NS). A smoker's level of nicotine dependence was categorized by the calculation of a Fagerstrom addiction scale score.[21] A score of 6-10 indicated a high level of nicotine dependence, and a score lower than 6 was associated with a lower level of dependence. A mean Fagerstrom score of 5.1 was observed for all patients attempting to quit smoking. The 12 patients abstaining for at least 1 year had a mean Fagerstrom score of 4.2. Statistical analysis revealed that patients considered to be of high nicotine dependence (Fagerstrom scores of 6-10) achieved long-term cessation status at a rate nearly equal to those with lower nicotine dependence (23.81% and 26.92%, respectively). Most patients (87.5%) had attempted to quit smoking at least 1 time before entering the program. Ten of the smoke-free patients had a history of 1 previous quit attempt. Statistical analysis revealed no significant difference in 1-year abstinence status rates between those smokers with 1 previous quit attempt and those who had never attempted to quit.

Forty-five percent of patients with prior diagnoses of hypertension, coronary artery disease, or dyslipidemia quit smoking for the duration of follow-up. Long-term cessation was also achieved in patients with known psychiatric disorders, respiratory disease, and thyroid disease (13.3%, 25.0%, and 66.6%, respectively). Only 1 diabetic patient was followed for 12 months and did not ultimately quit smoking.

A comparison of smoking cessation methods is described in Figure 1. Twenty-five patients attempted to quit smoking using transdermal nicotine replacement patch therapy. Six of these patients achieved long-term cessation status. Other successful therapies included "cold turkey," nicotine gum, and combination patch with bupropion therapy. Four patients used bupropion and 1 patient used nicotine nasal spray to assist with the quit attempt, but none of these patients refrained from smoking for the 1-year follow-up period. Statistical analysis of those employing a pharmacologic agent vs those who did not showed no statistically significant difference between the strategies and long-term cessation. The mean time until relapse for all methods of smoking cessation was 41.7 days. Patients quitting "cold turkey" relapsed at a mean of 23 days, while those using nicotine replacement dosage forms and/or bupropion had a mean relapse time of 46.6 days; however, this difference was not statistically significant.

Figure 1.

Increased appetite and weight gain were the most frequently reported smoking cessation withdrawal symptoms at a rate of 16.7% across the sample population. Tobacco cravings and feelings of anxiety, nervousness, and jitteriness were reported by 12.5% of the patients. Anger, frustration, irritation, drowsiness, fatigue, and headache were reported by less than 10% of the population during follow-up. None of the patients reported a depressed mood upon smoking cessation.

Smoking cessation clinic patients reported few adverse drug reactions (ADRs). Mild skin reactions from nicotine replacement patches were the most frequently reported ADR, experienced by 20% of patch users. Users of these cessation methods reported nasal irritation from nicotine nasal spray, insomnia and vivid dreams from bupropion and nicotine replacement patch therapy, and jaw aches from nicotine gum.

Thirty patient questionnaires were distributed and 19 (63%) were completed and returned. Patients were instructed to evaluate each of the 18 statements on a 0-10 scale, with a score of "10" indicating strong agreement. Analysis of the questionnaire revealed that 82% (279/342) of the possible responses by the patients were "10" and 94% (320/342) were "8" or higher. Results of the patient questionnaires are detailed in Table 7.

Smoking Cessation Clinic: Discussion

A Centers for Disease Control and Prevention (CDC) survey of 20,000 people in 1994 found that 2.5% to 7.5% of the smokers were able to maintain long-term abstinence after a quit attempt.[29] It has been estimated that only 3% of patients abstain from smoking for 6 months when they attempt to quit on their own, without the assistance of a healthcare provider.[30] The community pharmacist-managed smoking cessation clinic model presented here resulted in 25% of clinic enrollees being able to maintain smoking cessation for at least 1 year.

Factors such as gender, age, number of cigarettes smoked per day, level of nicotine dependence, a history of previous quit attempts, and method of cessation were examined for their association as predictors of achieving long-term smoking cessation. The percentage of women who abstained from smoking for 1 year was much higher than that of men enrolled in the clinic, and data analysis revealed these gender differences to be statistically significant. The reason for this difference is unclear, but the investigators and pharmacists felt that women seemed more enthusiastic about the program and were more willing to follow-up.

Achievement of a successful outcome from the clinic was not influenced by a smoker's age. Long-term cessation from smoking was achieved by patients of ages greater than 20 years, with no observable differences in 1-year abstinence rates among the 10-year age cohorts examined.

All of the abstinent patients smoked 1.5 packs of cigarettes or less per day. Clinic enrollees who smoked more than 1.5 packs per day were unsuccessful, but only accounted for 8.3% of the follow-up population. According to the Fagerstrom addiction scale, the clinic population was considered to possess a lesser nicotine dependence on average (mean = 5.1). Also, those smokers who quit smoking for at least 1 year had an even lower mean score of 4.2. However, the clinic was successful in achieving long-term cessation for both the higher and lower nicotine-dependent groups, as the outcome differences were statistically insignificant. Clinic patients with a history devoid of prior quit attempts achieved long-term cessation status similar to those with at least 1 previous quit attempt.

Notably, 3 of the 12 patients who achieved long-term cessation had a "slip" (relapsed to smoking for a short period of time), and then went on to be smoke-free for at least 1 year from the date of the "slip." This may suggest that more quit attempts can lead to long-term cessation, although this factor was not found to be statistically significant in this project. The employment of a smoking cessation strategy that did not use an NRT and/or bupropion was as successful in maintaining abstinence for 1 year as the use of a pharmacologic agent. Although relapse occurred later for patients using drug therapy than those trying a "cold-turkey" approach, the difference was not statistically significant.

The statistically insignificant differences among many of the various predictors are interesting. For example, the use of an NRT and/or bupropion has been shown to prevent relapse and increase smoking cessation rates vs a quit attempt not using a pharmacologic agent.[14] Though outcome differences between the factors examined were observed, a larger sample size would be needed to provide enough statistical power to reveal significant differences between the variables. It also should be noted that duration of NRT therapy varied among participants in the program. For example, patients applying nicotine patches used the therapy from 7 days to 12 weeks, and both 16- and 24-hour patch regimens were used. These decisions were made following the initial intervention based on patient medical history, prior quit attempts, Fagerstrom test score, and patient preference. This emphasizes the importance of an individualized smoking cessation plan vs a "one size fits all" program. After gathering information and providing education, the pharmacists who participated in the project empowered each patient to make an appropriate decision.

The clinic patients tolerated their quit attempt well and were generally satisfied with the pharmacy service. Only 12.5% of the patients experienced tobacco cravings and anxiety associated with nicotine withdrawal. Drug therapy also appeared to be well tolerated, as the most common ADR was an expected mild skin reaction experienced by 20% of nicotine transdermal patch users. According to the patient questionnaire results, the educational materials, counseling, and pharmacist service were very well received. It is noteworthy that clinic enrollees who did not maintain their quit attempt for 1 year still responded favorably to the pharmacy service.

Smoking Cessation Clinic: Conclusion

A community pharmacist-managed smoking cessation clinic can achieve long-term smoking cessation rates that exceed those for patients who do not use a healthcare provider during a quit attempt. The chain pharmacy model presented here can be readily implemented into a community pharmacy after initial pharmacist training and at minimal cost. The benefits that may be achieved are improved patient health outcomes and increased patient satisfaction with pharmacist-managed clinical services.

Table 8. Demographics and One-Year Abstinence Outcomes

Number No. Abstinent Percent
Men 15 1 6.7
Women 33 11 33.3
Total 48 12 25
20-29 11 4 33.3
30-39 19 3 15.8
40-49 9 2 22.2
50+ 9 3 33.3
Smoking History
1-10 cigs/day 12 4 33.3
11-20 cigs/day 23 6 26.1
21-30 cigs/day 9 2 22.2
31-40 cigs/day 3 0 0
41+ cigs/day 1 0 0
Fagerstrom Test†
Fagerstrom 0-5 26 7 26.9
Fagerstrom 6-10 21 5 23.8
Prior Quit Attempts
Prior Quit = 0 6 1 16.7
Prior Quit = 1 40 10 25
Prior Quit = 2 1 0 0
Prior Quit = 3 1 1 100
Disease State
HTN, CAD, dyslipidemia 11 5 45.5
Psychiatric disorder 15 2 13.3
Asthma, COPD 4 1 25
Diabetes mellitus 1 0 0
Thyroid disease 3 2 66.7

*P = .047, Fisher's exact test
Fagerstrom test score not reported in 1 patient
Total number does not equal 48, as patients may have multiple or no disease states
HTN = hypertension; CAD = coronary artery disease; COPD = chronic obstructive pulmonary disease


Tobacco-dependence treatments are both clinically effective and cost-effective relative to other medical and disease-prevention interventions. As such, insurers and purchasers should ensure that all insurance plans include as a reimbursed benefit the counseling, clinic fees, and pharmacotherapeutic treatments identified as effective in the new guidelines. Clinicians should be reimbursed for providing tobacco-dependence treatments just as they are reimbursed for treating other chronic conditions.


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