Smoking accounts for one of every five deaths in the US, and is the most modifiable cause of premature death. Tobacco use contributes to many cancers, cardiovascular disease, osteoporosis, hospitalizations, and poor fetal outcomes either directly or by passive (second hand) exposure. Twenty-five percent (25%) of all adults continue to smoke, and 3% use smokeless tobacco. Medical care costs and lost wages due to smoking-related morbidity and mortality amount to an estimated $100 billion annually in the US. Costs to employers have been estimated at $10, 000 per smoker yearly. One author (REF F) estimated a net employer benefit of $1,654 per successful quitter in the first year. Abstinence rates of 3-7% have been observed with clinician counseling and 8-25% with group counseling.
A recent DB, PC (9 week) study (NEJM, 1999, REF B) found abstinence rates at 12 months with placebo of 15.6%, nicotine patch 16.4%, bupropion 300mg/day 30.3%, and bupropion (300mg/d) and nicotine patch 35.5% (all patients received individual brief counseling). A 7 week dose comparison study (NEJM, 1997, REF A) found that 150 mg bupropion resulted in a 12 month quit rate of 22.9%, while 300mg/day resulted in 23.1% quit rate (placebo=12.4%).
The Tobacco Cessation program (TCP) at Eisenhower Army Medical Center will utilize the following process to ensure a standardized quality program is available to each patient enrolled in the program. This protocol was developed by the Tobacco Cessation Working Group. This multidisciplinary group includes representatives from the Department of Mental Health (Psychology), Department of Primary Care Services (Family Practice), Department of Preventative Medicine (Health and Wellness), and Department of Pharmacy.
Primary care providers (PCP) should identify patients who wish to quit smoking and consult them electronically “smokeless outpatient” to the TCP. Patients should be risk stratified for the TCP classes. The provider can assess this by asking the following questions:
Do you smoke more than 15 cigarettes daily?
Do you smoke within the first 30 minutes after awakening in the morning?
Those patients who answer “yes” to both questions are considered high-risk. Risk status (high or low) should be specified on their consult. Patients should also be requested to present to the Health and Wellness Center when the consult is generated. Patients may also self-refer to the Health and Wellness Center for the smoking cessation clinic.
-All patients who receive care at DDEAMC are eligible for the TCP.
Patients will attend four one-hour, small group sessions utilizing the “Fresh Start Program” of the American Cancer Society and facilitated by medical staff of EAMC. Classes will be offered during daytime and/or evening hours, interest and staffing permitting.
Current class meeting times and locations:
0900 Tuesday and Wednesday mornings at Community Mental Health 13th floor (Psychology).
1700 Tuesday evenings in the Family Practice Clinic (Family Practice)
Other classes to be announced as staffing available.
Patients will be risk-stratified into two groups: high risk or low risk based on their FTQ score. Patients who are candidates for bupropion SR 150mg (Zyban) will be offered a prescription for this cessation aid in session one. All patients prescribed Zyban must have a completed screening/intake questionnaire.
The facilitator will prescribe (or contact the authorized clinic provider/prescriber to initiate) bupropion SR (Zyban) per appropriate protocol, 14 day supply, with no refills. The class facilitator will enter the patient name, SSN, Fagerstrom Tolerance Questionnaire (FTQ) score, date and dose of therapy into the designated tobacco cessation program database for purposes of outcome monitoring. Printed drug information, including side effects, will be provided to each patient. EVIDENCE: Bupropion 150 mg QD has produced end-of treatment (EOT) quit rate of 38.6%, and one-year quit rate of 22.9% (vs. placebo: 19%, 12.4%). REF A. $$ Zyban150 mg QD x 8 weeks=$50.00.
Patients who have failed previous cessation programs may need higher initial therapy of bupropion (150 mg qam x 3 days, then 150 mg bid x 11 days # 25, no refills) or bupropion in combination with nicotine replacement products such as patches, gum, nasal spray or inhaler. High-risk patients who have failed other cessation programs may receive both bupropion SR bid AND nicotine transdermal patch. EVIDENCE: Bupropion alone and in combination with nicotine patch has produced an EOT abstinence rate of ~36%. At one year, the combination abstinence rate is slightly superior at 35.5% compared to bupropion alone at 30.3%. REF B.
$$Buproprion 150 bid & patch x 8 weeks = $212.00. Bupropion 150 bid x 8 weeks=$100.00.
Patients in whom bupropion/zyban is contraindicated will be offered nicotine transdermal patches and nicotine nasal spray (NNS) per protocol. This combination (with similar, but longer treatment protocol) has been shown to produce 1 year abstinence rates of 27% vs. 11% for patch and placebo spray. REF D. (In comparison, nicotine patch alone produces 1 year abstinence rates of 19% vs. 10% for placebo. REF C.) $$ Patch & NNS (10 doses/day = 6 bottles @ 35.69 each) x 8 weeks= $326.00.
In addition, patients who need further assistance for cravings or cannot tolerate the nasal spray may purchase 4 mg nicotine gum over-the-counter in retail pharmacies. Specific patient guidance will be given by facilitator as to which product and dose should be used. Patients will be counseled on the symptoms and risks of nicotine overdose. Printed patient education on the specific product(s) used will be given to each patient by facilitator.
Pharmacologic support (continued):
At session three, patients who have received pharmacologic therapy will be interviewed regarding efficacy and side effects. A second prescription will be initiated per protocol by an authorized provider for the remaining treatment period (6 weeks). This will be recorded in the TCP database by the facilitator or prescriber.
At session four, patients will be requested to make an appointment with their PCP for follow up on their cessation success in four weeks. Patients who are not smoke-free but still wish to quit should be re-consulted to the TCP as a “high risk” patient by PCP.
In addition, Health and Wellness center personnel will conduct a telephone survey at approximately 30 days after program completion, and again at 6 months and 12 months to assess abstinence as defined by the number of cigarettes smoked per day. (Zero = smoke free).
These protocols eliminate the need for the PCP to prescribe smoking cessation products. If the patient is smoke-free at their follow up visit (or call) at 60 days after starting the TCP, they should be congratulated and encouraged to maintain a tobacco-free lifestyle.
Patients who are not smoke-free but still desire cessation should be re-consulted to the TCP by their PCP, Health and Wellness Center staff, or by self-referral).
Data for each smoking cessation patient (beginning July 2001) will be entered into the “Tobacco Cessation” database site on the Local Area Network (LAN) Y drive. Outcome monitoring will be conducted by a designated authorized prescriber (or facilitator) on at least an annual basis and this information reported to the hospital via the Drug Use and Reaction (DURE) Committee. Involved parties may also utilize this information for purposes of resident research or local performance improvement initiatives (observing all confidentiality guidelines).
*Patients who need tobacco cessation therapy should not receive bupropion SR 150 mg (Wellbutrin SR) without any involvement in a formal cessation program as this is less likely to result in cessation success. (1 year abstinence rates of 12% with counseling alone vs. 23% with bupropion and counseling, REF A).
EAMC Tobacco Cessation Working Group Members:
Kathryn Koven, PharmD, Family Practice 787-9309 1137
Dr. Beauchamp, Allison K, Family Practice Resident 787-9355 1457
Dr. Earls, Jay E., Chief, Psychology 787-3780 1572
Maj. Marana, David, Chief, Health and Wellness 787-3547