Pharmacotherapy for the Treatment of Nicotine Dependence

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Pharmacotherapy for the Treatment of Nicotine
Dependence
Donna Shelley, MD, MPH, Columbia University
Mailman School of Public Health drs26_at_columbia.edu
Submitted by the NY/NJ AETC
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Outline

• System changes to increase tobacco use treatment
• Pharmacotherapy
• Referral sources

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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

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ROLE OF THE HEALTH CARE TEAM Multiple Influences
on a Tobacco User
Family
Provider
Co-workers
Faith Community
Friends
Newspapers, Magazines
Community
TV, Radio
Internet
MD assisted quit rates at one yr are 10-30
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Not enough time
Minimal interventions lasting less than 3
minutes increase overall tobacco abstinence
rates. The PHS Guideline (Strength of Evidence
A)
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I cant help patients stop.

• Effective interventions exist
• Pharmacotherapy
• Brief counseling
• System changes

Guideline available at www.ahrq.gov
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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

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Tobacco dependence is achronic 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

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The 5 AsFor 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.

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Smoking as a vital sign (SVS) ASK Ask every
patient at every visit
Do you currently use any tobacco
products?
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Impact of smoking status identification system on
rates of clinician intervention
Cessation OR Rates (95 C.I.)
Intervention rate (95 C.I.)
No Screening System
38.5
1.0 3
Screening system in place to ID smoking status
65.6
3.1 6.4
BASED ON 9 RANDOMIZED STUDIES AHRQ
GUIDELINES, 2000
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ProgressNote
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• Vital signs
• Date ___________ Temp __________
• BP ___________ Pulse __________
• Height _______ Weight ______ BMI _______
• Yes No
• Tobacco Use ? ?
• Advice Given ? ?
• Ready To Quit ? ?
• Referral Made ? ?
• Rx Given ? ?

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ADVISE
Advice should be clear, strong, personalized
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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.
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Physician Advice can increase quit rates by 30

Odds Ratio (95) CI
Estimated Abstinence Rate
Advice
No advice to quit (reference group)
7.9
1.0
Physician advice to quit
1.3 (1.1-1.6)
10.2
Fiore M, PHS guideline 2000
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Assess willingness to quit
Are you willing to try to quit at this time? I
can help you.
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ASSIST

• Help set a quit date
• Provide practical counseling (alcohol, other
  smokers in home)
• Past quit experiences
• Anticipate challenges

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Counsel your patients to quit Minimum advice
increases quit rates by 30
Level of contact Estimated odds ratio Est. abstinence rate
No contact 1.0 10.9
Min counseling lt 3 min 1.3 13.4
Low intensity 3-10 min 1.6 16
gt10 minutes 2.3 22.1
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Assist Pharmacotherapy
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Pharmacotherapy should be offered to all smokers
trying to quit except where contraindicated.
Fiore 2000
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First-line pharmacotherapy

• Nicotine Replacement Therapy
• Patch
• Gum
• Lozenge
• Inhaler
• Nasal spray
• Bupropion (Zyban)

Non nicotine replacement
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Pharmacotherapy
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Estimated odds ratio for long term abstinence
Fiore 2000
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Nicotine Replacement Therapy (NRT)

• No evidence that nicotine causes cancer
• No evidence of increased cardiovascular risk with
  NRT
• Medical contraindications
• immediate myocardial infarction (lt 2 weeks)
• serious arrhythmia
• serious or worsening angina pectoris
• accelerated hypertension

Joseph 1996, Ford 2005, Working Group 1994 Arch
Int Med
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Plasma nicotine levels after a cigarette vs.
different types of pharmacotherapy
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Withdrawal Symptoms

• Anxiety/Irritability
• Poor concentration
• Restlessness
• Craving
• Headaches
• Drowsiness
• Depression
• Hunger

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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

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NRTs Patches Need to be Individualized

• lt10 CPD may consider 7mg
• 10-15 CPD 14-21 mg/day patch
• 15-20 CPD 21 mg/day
• 21mg21 cigs/d
• 14mg14 cigs/d

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NRT Nicotine gum

• 2 mg (lt25 cigs) vs 4 mg (gt24 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

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Nicotine Lozenge (OTC)

• 2 mg smoke cig gt30 minutes on waking
• 4 mg smoke lt30 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

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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

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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

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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

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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)

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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

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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)

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Reimbursement

• ICD9 305.1 AND
• CPT code 99401 (15-minute physician-provided
  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)

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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 gt10 min
• 1800 633 4227 (1 800 MEDICARE)

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ASSIST Next Steps

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http//www.nysmokefree.com/newweb/fax/ReferFormRV1
-05-05II.pdf
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Resources

• www.nysmokefree.org

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Resources

• Smoking cessation programs in NYC
• http//www.nyc.gov/html/doh/html/smoke/quit.shtml

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How do I treat tobacco users who are not willing
to make a quit attempt?
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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.

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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.p
  df
• Patient websites/materials
• www.quitnet.com, www.smokeclinic.com
• http//www.nyc.gov/html/doh/html/smoke/smoke2-cess
  1.html

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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