Pharmacotherapy for the Treatment of Nicotine Dependence

Donna Shelley, MD, MPH, Columbia University Mailman

School of Public Healthdrs26@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

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 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 heroinCauses physical dependence characterized by

withdrawal symptoms upon cessationSmokers use tobacco to regulate their moods and

emotions

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

The 5 A’sFor 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 signSmoking as a vital sign (SVS) (SVS) ASK ASK: :

Ask every patient at every visit

Progress note vital signs BP: __________ Weight: _______ Ht: _______ BMI :_____ Tobacco Use: Yes No Former Advise to quit Y N Ready to quit? Y N Rx given Y N Referral made Y N

“Do you currently use any tobacco products?”

Interventionrate (95% C.I.)

CessationOR Rates(95% C.I.)

38.5 % 1.0 3%

65.6% 3.1 6.4%

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

ProgressNote

Vital signs

Date: ___________ Temp: __________

BP: ___________ Pulse: __________

Height: _______ Weight: ______ BMI: _______

Yes No Tobacco Use □ □ Advice Given □ □ Ready To Quit □ □ Referral Made □ □ Rx Given □ □

ADVISEADVISE

Progress note vital signs BP: __________ Weight: _______ Ht: _______ BMI :_____ Tobacco Use: Yes No Former Advise to quit Y N Ready to quit? Y N Rx given Y N Referral made Y N

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%

AdviceAdvice

Odds RatioOdds Ratio(95%) CI(95%) CI

No advice to quit No advice to quit (reference group)(reference group)

Physician advicePhysician adviceto quitto quit

7.9%7.9%1.01.0

10.2%10.2%1.31.3(1.1-1.6)(1.1-1.6)

EstimatedEstimatedAbstinence RateAbstinence Rate

Fiore M, PHS guideline 2000

Assess willingness to quitAssess willingness to quit

Progress note vital signs BP: __________ Weight: _______ Ht: _______ BMI :_____ Tobacco Use: Yes No Former Advise to quit Y N Ready to quit? Y N Rx given Y N Referral made Y N

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

ASSISTASSIST

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 odds ratio

Est. abstinence rate

No contact 1.0 10.9

Min counseling < 3 min 1.3 13.4

Low intensity

3-10 min

1.6 16

>10 minutes 2.3 22.1

Assist: Pharmacotherapy

Progress note vital signs BP: __________ Weight: _______ Ht: _______ BMI :_____ Tobacco Use: Yes No Former Advise to quit Y N Ready to quit? Y N Rx given Y N Referral made Y N

“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

1.81 1.66

2.142.35

2.05 2.1

0

0.5

1

1.5

2

2.5

Patch Gum Inhaler Spray Lozenge Bupropion

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

0

5

10

15

20

25

30

0 20 40 60 80 100

120

Cigarette Patch Gum Nasal Spray

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 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)

Reimbursement

Medicare2 cessation attempts per year including max 4

sessions, up to 8 sessions per 12 monthsMust wait 11 months from the 1st of the 8

sessionsG0375 3-10 minutesG0376 >10 min1800 633 4227 (1 800 MEDICARE)

ASSIST: Next StepsASSIST: Next Steps

Progress note vital signs BP: __________ Weight: _______ Ht: _______ BMI :_____ Tobacco Use: Yes No Former Advise to quit Y N Ready to quit? Y N Rx given Y N Referral made Y N

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 Informationhttp://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/smoke2-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