Pharmacotherapy for the Treatment of Nicotine Dependence
Donna Shelley, MD, MPH, Columbia University Mailman School of Public Health drs26@columbia.edu
Submitted by the NY/NJ AETC
Outline
System changes to increase tobacco use treatment Pharmacotherapy Referral sources
Why should I treat tobacco use?
I in 5 deaths in the US are due to smoking 1 in 3 cancer deaths are caused by smoking
70% of smoker want to quit
64% of New Yorkers who smoke tried to quit in the past 12 months NYC Community Health Survey
2001
Less than 10% succeed without assistance
ROLE OF THE HEALTH CARE TEAM
Multiple Influences on a Tobacco User
Family
Co-workers Faith Community Newspapers, Magazines TV, Radio Internet
MD assisted quit rates at one yr are 10-30%
Provider
Friends
Community
―Not enough time‖
“Minimal interventions
lasting less than 3 minutes increase overall tobacco abstinence rates.”
The PHS Guideline (Strength of Evidence = A)
―I can’t help patients stop.‖
Effective interventions exist:
Pharmacotherapy Brief
counseling changes
System
Guideline available at www.ahrq.gov
Tobacco use results in a true drug dependence
Tobacco dependence exhibits classic characteristics of drug dependence
Nicotine: Nicotine is as addictive as heroin Causes physical dependence characterized by withdrawal symptoms upon cessation Smokers use tobacco to regulate their moods and emotions
Tobacco dependence is a chronic disease
Tobacco dependence requires ongoing rather than acute care Relapse is a component of the chronic nature of the nicotine dependence — not an indication of personal failure by the patient or the clinician
The 5 A’s For Patients Willing To Quit
ASK about tobacco use. ADVISE to quit. ASSESS willingness to make a quit attempt. ASSIST in quit attempt. ARRANGE for follow-up.
Smoking as a vital sign (SVS) ASK: Ask every patient at every visit
“Do you currently use any tobacco products?”
Progress note vital signs BP: __________ Weight: _______ Ht: _______ Tobacco Use: Advise to quit Ready to quit? Rx given Referral made BMI:_____ Yes Y Y Y Y No N N N N Former
Impact of smoking status identification system on rates of clinician intervention:
Intervention rate (95% C.I.) OR (95% C.I.) Cessation Rates
No Screening System Screening system in place to ID smoking status
38.5 % 65.6%
1.0 3.1
3% 6.4%
BASED ON 9 RANDOMIZED STUDIES
AHRQ GUIDELINES, 2000
Progress Note
Vital signs
Date: ___________ Temp: __________ BP: ___________ Pulse: __________ Height: _______ Weight: ______ BMI: _______
Yes
No
□ □ □ □ □
Tobacco Use Advice Given Ready To Quit Referral Made Rx Given
□ □ □ □ □
ADVISE
Advice should be: clear, strong, personalized
Progress note vital signs BP: __________ Weight: _______ Ht: _______ Tobacco Use: Advise to quit Ready to quit? Rx given Referral made BMI:_____ Yes No Y N Y N Y N Y N Former
ADVISE
Even brief advice to quit results in greater quit rates
“As your health care provider, I must tell you that the most important thing you can do to improve your health is to stop smoking.”
Physician Advice can increase quit rates by 30%
Advice
Odds Ratio (95%) CI 1.0
Estimated Abstinence Rate 7.9%
No advice to quit (reference group)
Physician advice 1.3 to quit (1.1-1.6)
Fiore M, PHS guideline 2000
10.2%
Assess willingness to quit
“Are you willing to try to quit at this time? I can help you.”
Progress note vital signs BP: __________ Weight: _______ Ht: _______ Tobacco Use: Advise to quit Ready to quit? Rx given Referral made BMI:_____ Yes No Y N Y N Y N Y N Former
ASSIST
Help set a quit date Provide practical counseling (alcohol, other smokers in home) Past quit experiences Anticipate challenges
Counsel your patients to quit: Minimum advice increases quit rates by 30%
Level of contact Estimated Est. odds ratio abstinence rate 1.0 10.9 13.4
No contact
Min counseling < 3 min 1.3
Low intensity 3-10 min >10 minutes
1.6
2.3
16
22.1
Assist: Pharmacotherapy
Progress note vital signs BP: __________ Weight: _______ Ht: _______ Tobacco Use: Advise to quit Ready to quit? Rx given Referral made BMI:_____ Yes No Y N Y N Y N Y N Former
―Pharmacotherapy should be offered to all smokers trying to quit except where contraindicated.‖
Fiore 2000
First-line pharmacotherapy
Nicotine Replacement Therapy
Patch Gum Lozenge Inhaler Nasal spray
Non nicotine replacement Bupropion (Zyban)
Pharmacotherapy
Estimated odds ratio for long term abstinence
2.5 2 1.81 1.5 1 0.5 0 Patch
Fiore 2000
2.35 2.14 1.66 2.05 2.1
Gum
Inhaler
Spray
Lozenge Bupropion
Nicotine Replacement Therapy (NRT)
No evidence that nicotine causes cancer No evidence of increased cardiovascular risk with NRT Medical contraindications: immediate myocardial infarction (< 2 weeks) serious arrhythmia serious or worsening angina pectoris accelerated hypertension
Joseph 1996, Ford 2005, Working Group 1994 Arch Int Med
Plasma nicotine levels after a cigarette vs. different types of pharmacotherapy
30 25 20 15 10 5 0
0
0 10
20
40
60
80
Cigarette
Patch
Gum
Nasal Spray
12
0
Withdrawal Symptoms
Anxiety/Irritability Poor concentration Restlessness Craving Headaches Drowsiness Depression Hunger
NRT: Nicotine patch
24 hr (21, 14, 7mg) Nicoderm/generic or
16 hr (15, 10, 5 mg) Nicotrol Available OTC A new patch is applied each morning Rotating placement site can reduce irritation 6 weeks for 1st dose-taper over 4-6 weeks
Side effects: Insomnia, local rash
NRTs: Patches Need to be Individualized
<10 CPD may consider 7mg 10-15 CPD = 14-21 mg/day patch 15-20 CPD = 21 mg/day
21mg=21 cigs/d 14mg=14 cigs/d
NRT: Nicotine gum
2 mg (<25 cigs) vs 4 mg (>24 cigs) 1-2 per hour for first 6 weeks-taper Chew (release peppery taste) and park, continue for 30 minutes Absorbed in a basic environment, avoid acidic beverages 15 minutes pre and during dose (coffee, soda, juice) Use enough pieces each day (max 24) Side effects: dyspepsia, mouth soreness
Nicotine Lozenge (OTC)
2 mg smoke cig >30 minutes on waking 4 mg smoke <30 minutes Allow to dissolve 30 min Cannot drink or eat 15 minutes before using First 6 weeks take one q1-2 hr (9-20 /day) than taper up to 6 weeks
NRT: Nicotine inhaler
Available by prescription
Continuous puffing over 20 minutes per dose (80 puffs per dose delivers 4 mg)
6-16 cartridges per day for 12 weeks
Eating or drinking before and during administration should be avoided
NRT: Nicotine nasal spray
Available by prescription
Patient should not sniff, swallow, or inhale the medication
A dose is 2 squirts, one to each nostril Initial dosing should be 1 to 2 doses per hour, increasing as needed up to 6-8 weeks and than taper Dosing should not exceed 40 doses per day
Bupropion SR (Zyban®)
Mechanism of action: presumably blocks neural reuptake of dopamine and/or norepinephrine
Dosing:
start
2 weeks before quit date 150 mg orally once daily x 3 day 150 mg orally twice daily x 7-12 weeks no taper necessary at end of treatment
Maintenance - efficacious as maintenance medication for 6 months post-cessation
Bupropion SR (Zyban®)
Contraindications
Seizure
disorder Current use of Wellbutrin Bulimia/anorexia MAO inhibitor in past 14 days Heavy alcohol use
Side effects:
Dry
mouth Insomnia (avoid bedtime dose)
Factors to Consider When Choosing a Pharmacotherapy
Patient
preference Clinician familiarity with the medications Contraindications for selected patients Previous patient experiences with a specific agent (positive or negative) Patient characteristics (concern about weight gain, history of depression)
Reimbursement
ICD9: 305.1 AND
CPT code 99401 (15-minute physicianprovided counseling) OR CPT code 99211 (nurse counseling) NYS Medicaid benefit: NRT, Zyban are reimbursed (two 3 mo courses per year, may prescribe more than one medication)
Reimbursement
Medicare
2
cessation attempts per year including max 4 sessions, up to 8 sessions per 12 months Must wait 11 months from the 1st of the 8 sessions G0375 3-10 minutes G0376 >10 min 1800 633 4227 (1 800 MEDICARE)
ASSIST: Next Steps
Progress note vital signs BP: __________ Weight: _______ Ht: _______ Tobacco Use: Advise to quit Ready to quit? Rx given Referral made BMI:_____ Yes No Y N Y N Y N Y N Former
http://www.nysmokefree.com/newweb/fax/ReferFormRV1-05-05II.pdf
Resources
www.nysmokefree.org
Resources
Smoking cessation programs in NYC
http://www.nyc.gov/html/doh/html/smoke/quit .shtml
How do I treat tobacco users who are not willing to make a quit attempt?
Treating patients who are not ready to make a quit attempt
RELEVANCE: Tailor advice and discussion to each patient.
RISKS: Outline risks of continued smoking. REWARDS: Outline the benefits of quitting.
ROADBLOCKS: Identify barriers to quitting.
REPETITION: Reinforce the motivational message at every visit.
Resources
Physician resources
AHRQ www.ahrq.gov or 800-358 9295 Physician guides Patient tear sheets free NYCDOH: City Health Information http://www.nyc.gov/html/doh/html/smoke/smoke.html http://www.nyc.gov/html/doh/pdf/chi/chi21-6.pdf
Patient websites/materials
www.quitnet.com, www.smokeclinic.com http://www.nyc.gov/html/doh/html/smoke/smoke2cess1.html
Medication – Daily Cost
Bupropion 150 SR Transdermal 7 to 21 Lozenge 2mg or 4 mg Gum 2 mg or 4 mg Nasal Spray Inhaler $3.00 /day $4.00 / patch ($40/box 14) $7.00 / 10 pieces $5.00 / 10 pieces $6.00 / 12 sprays $11.00 / 10 cartridges