Pharmacotherapy for the Treatment of Nicotine Dependence Donna Shelley, MD, MPH, Columbia University Mailman School of Public Health 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

Provider Friends Internet Family TV, Radio Faith Community Community Newspapers, Magazines Co-workers ROLE OF THE HEALTH CARE TEAM Multiple Influences on a Tobacco User MD assisted quit rates at one yr are 10-30%

“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  System changes Guideline available at

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: Smoking as a vital sign (SVS) ASK: Ask every patient at every visit “Do you currently use any tobacco products?”

Intervention rate (95% C.I.) Cessation OR Rates (95% C.I.) 38.5 % 1.0 3% 65.6% % No Screening System Screening system in place to ID smoking status Impact of smoking status identification system on rates of clinician intervention: 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

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 No advice to quit (reference group) Physician advice to quit 7.9% % 1.3( ) Estimated Abstinence Rate Fiore M, PHS guideline 2000

Assess willingness to quit “Are you willing to try to quit at this time? I can help you.”

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 contactEstimated odds ratio Est. abstinence rate No contact Min counseling < 3 min Low intensity 3-10 min >10 minutes

Assist: Pharmacotherapy

“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 Bupropion (Zyban ) Non nicotine replacement

Pharmacotherapy

Estimated odds ratio for long term abstinence Fiore 2000

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

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 1 st dose-taper over 4-6 weeks Side effects: Insomnia, local rash

NRTs: Patches Need to be Individualized <10 CPD may consider 7mg CPD = mg/day patch CPD = 21 mg/day 21mg=21 cigs/d 14mg=14 cigs/d

NRT: Nicotine gum 2 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)

Multiple Pharmacotherapy Bupropion SR may be combined with any of the NRTs Combination NRT:  Abstinence rate single NRT: 17.4 vs two NRT 28.6 (21.7, 35.4)  patch + gum or patch + nasal spray is more effective than a single NRT  encourage in patients unable to quit using single agent  caution patients on risk of nicotine overdose  combined NRT not currently FDA approved

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: AND CPT code (15-minute physician- provided counseling) OR CPT code (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 1 st of the 8 sessions  G minutes  G0376 >10 min  (1 800 MEDICARE)

ASSIST: Next Steps

Resources

Resources Smoking cessation programs in NYC

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 or www.ahrq.gov  Physician guides  Patient tear sheets free NYCDOH: City Health Information Patient websites/materials cess1.html

Medication – Daily Cost Bupropion 150 SR$3.00 /day Transdermal 7 to 21$4.00 / patch ($40/box 14) Lozenge 2mg or 4 mg$7.00 / 10 pieces Gum 2 mg or 4 mg$5.00 / 10 pieces Nasal Spray$6.00 / 12 sprays Inhaler$11.00 / 10 cartridges