“CIGARETTE SMOKING…rxforchange.ucsf.edu/file_downloads/CORE MODULES.pdf · Annual adult per capita cigarette consumption and major smoking and health events Centers for Disease

1

Copyright © 1999-2007 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved.

Rx for CHANGEClinician-Assisted Tobacco Cessation

TRAINING OVERVIEW

Epidemiology of Tobacco Use module

Nicotine Pharmacology & Principles of Addiction module

Drug Interactions with Smoking module

Assisting Patients with Quitting module

Hands-on workshop

Aids for Cessation module

Tobacco trigger tapes

Case scenarios

EPIDEMIOLOGY of TOBACCO USE is the chief, single,

avoidable cause of death in our society and the most

important public health issue of our time.”

C. Everett Koop, M.D., former U.S. Surgeon General

“CIGARETTE SMOKING…

Mackay & Erickson. (2002). The Tobacco Atlas. World Health Organization.

WORLDWIDE ADULT TOBACCO USE PREVALENCE (Men/Women)

Canada25.0 (27.0/23.0)

USA20.9 (23.9/18.1)

UK26.5

(27.0/26.0)

Australia19.5 (21.1/18.0)

China35.6 (66.9/4.2)

Russian Federation36.5 (63.2/9.7)

Japan33.1 (52.8/13.4)

India16.0 (29.4/2.5)Brazil

33.8 (38.2/29.3)Namibia

50.0 (65.0/35.0)

South Africa26.5 (42.0/11.0)

Sweden19.0 (19.0/19.0)

Yugoslavia47.0 (52.0/42.0)

Iran15.3 (27.2/3.4)

Guinea51.7 (59.5/43.8)

New Zealand25.0 (25.0/25.0)

Philippines32.4 (53.8/11.0)

France34.5 (38.6/30.3)

TRENDS in ADULT CIGARETTE CONSUMPTION—U.S., 1900–2005

Annual adult per capita cigarette consumption and major smoking and health events

Centers for Disease Control and Prevention. (1999). MMWR 48:986–993.Per-capita updates from U.S. Department of Agriculture, provided by the American Cancer Society.

0

1,000

2,000

3,000

4,000

5,000

1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000

1964 SurgeonGeneral’s Report

Great Depression

End of WW II

First modern reports linking smoking and cancer Federal cigarette

tax doubles

MasterSettlementAgreement; California first state to enact ban on smoking in bars

Broadcastad ban

Cigarette price drop

Nonsmokers’rights movement

beginsNum

ber o

f cig

aret

tes

Year

U.S. entry into WW I

20 states have > $1

pack tax

Marketing of filtered cigarettes

2


Adapted from NCI Smoking and Tobacco Control Monograph 8, 1997, p. 13. Data from U.S. Department of Agriculture. Reprinted with permission. Thun et al. 2002. Oncogene 21:7307–7325.

0

2

4

6

8

10

12

14

1880 1890 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000

Poun

ds o

f tob

acco

per

cap

ita

Cigarettes

Cigars

Chewing tobacco

Snuff

Pipe/roll your own

ADULT PER-CAPITA CONSUMPTION of TOBACCO, 1880–2005

All forms of

tobacco are

harmful.

Year

TRENDS in ADULT SMOKING, by SEX—U.S., 1955–2005

Trends in cigarette current smoking among persons aged 18 or older

Graph provided by the Centers for Disease Control and Prevention. 1955 Current Population Survey; 1965–2005 NHIS. Estimates since 1992 include some-day smoking.

Perc

ent

70% want to quit70% want to quit

0

10

20

30

40

50

60

1955 1959 1963 1967 1971 1975 1979 1983 1987 1991 1995 1999 2003

Male

Female 23.9%18.1%

20.9% of adults are current

smokers

Year

STATE-SPECIFIC PREVALENCE of SMOKING among ADULTS, 2005

California15.2%

New York 20.5%

Utah11.5%

Texas 20.0%

Illinois 19.9% Kentucky

28.7%

Nevada23.1%

Centers for Disease Control and Prevention. (2006). MMWR 55:1148–1151.

Florida 21.6%

Indiana27.3%

PREVALENCE of ADULT SMOKING, by RACE/ETHNICITY—U.S., 2005

0% 10% 20% 30% 40% 50%

13.3% Asian*

32.0% American Indian/Alaska Native*

21.5% Black*

21.9% White*

16.2% Hispanic


* non-Hispanic.

PREVALENCE of ADULT SMOKING, by EDUCATION—U.S., 2005

0% 10% 20% 30% 40% 50%

10.7% Undergraduate degree

25.5% No high school diploma

43.2% GED diploma

24.6% High school graduate

22.5% Some college

7.1% Graduate degree


TRENDS in TEEN SMOKING, by ETHNICITY—U.S., 1977–2006

Trends in cigarette smoking among 12th graders: 30-day prevalence of use

0

10

20

30

40

50

1977 1982 1987 1992 1997 2002Year

Institute for Social Research, University of Michigan, Monitoring the Future Projectwww.monitoringthefuture.org

Perc

ent

White

Hispanic

Black

3


PUBLIC HEALTH versus “BIG TOBACCO”

The biggest opponent to tobacco control efforts is the tobacco

industry itself.

In the U.S., for every $1 spent on tobacco prevention,the tobacco industry spends $28 to market its products.

The TOBACCO INDUSTRYFor decades, the tobacco industry has publicly denied the addictive nature of nicotine and the negative health effects of tobacco.

April 14, 1994: Seven top executives of major tobacco companies state, under oath, that they believe nicotine is not addictive.

Tobacco industry documents suggest otherwiseDocuments available at http://legacy.library.ucsf.edu

The cigarette is a heavily engineered product.Designed and marketed to maximize bioavailability of nicotine and addictive potentialProfits over people

An EFFECTIVE MARKETING STRATEGY: “LIGHT” CIGARETTES

The difference between Marlboro and Marlboro Lights…

an extra row of ventilation holesan extra row of ventilation holes

Image courtesy of Mayo Clinic Nicotine Dependence Center - Research Program / Dr. Richard D. Hurt

The Marlboro and Marlboro Lights logos are registered trademarks of Philip Morris USA.

TOBACCO INDUSTRY ADVERTISING

$15.15 billion spent in the U.S. in 200321.5% increase over 2002 figures35.0% increase over 2001 figures

0

5

10

15

1970 1997 1998 1999 2000 2001 2002 2003

Bill

ions

of d

olla

rs s

pent

YearFederal Trade Commission. (2005). Cigarette Report for 2003.

ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, 1997–2001


32%28%23%

9%8%

<1%

TOTAL: 437,902 deaths annually

1,828Other34,693Cancers other than lung38,112Second-hand smoke*

101,454Respiratory diseases123,836Lung cancer137,979Cardiovascular diseases

Percentage of all smoking-attributable deaths*

* In 2005, it was estimated that nearly 50,000 persons died due to second-hand smoke exposure.

ANNUAL SMOKING-ATTRIBUTABLE ECONOMIC COSTS—U.S., 1995–1999

0 10 20 30 40 50 60 70 80

Annual lost productivity

costs (1995–1999)

Medical expenditures

(1998)

Billions of dollars

Men, $55.4 billion

Ambulatory care, $27.2 billion

Prescription drugs,

$6.4 billion

Women, $26.5 billion

Nursing home, $19.4 billion

Other care, $5.4 billion


Hospital care, $17.1 billion

Societal costs: $7.18 per pack

4


COMPOUNDS in TOBACCO SMOKE

Carbon monoxideHydrogen cyanideAmmoniaBenzeneFormaldehyde

NicotineNitrosaminesLeadCadmiumPolonium-210

An estimated 4,800 compounds in tobacco smoke, including 11 proven human carcinogens

Gases Particles

Nicotine does NOT cause the ill health effects of tobacco.

2004 REPORT of the SURGEON GENERAL:HEALTH CONSEQUENCES OF SMOKING

Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general.

Quitting smoking has immediate as well as long-term benefits, reducing risks for diseases caused by smoking and improving health in general.

Smoking cigarettes with lower machine-measured yields of tar and nicotine provides no clear benefit to health.

The list of diseases caused by smoking has been expanded.

U.S. Department of Health and Human Services. (2004). The Health Consequences of Smoking: A Report of the Surgeon General.

FOUR MAJOR CONCLUSIONS:

HEALTH CONSEQUENCES of SMOKING

CancersAcute myeloid leukemia Bladder and kidneyCervicalEsophagealGastricLaryngealLungOral cavity and pharyngealPancreatic

Pulmonary diseasesAcute (e.g., pneumonia)Chronic (e.g., COPD)

Cardiovascular diseasesAbdominal aortic aneurysmCoronary heart diseaseCerebrovascular diseasePeripheral arterial disease

Reproductive effectsReduced fertility in womenPoor pregnancy outcomes (e.g., low birth weight, preterm delivery)Infant mortality

Other effects: cataract, osteoporosis, periodontitis, poor surgical outcomes

U.S. Department of Health and Human Services. (2004). The Health Consequences of Smoking: A Report of the Surgeon General.

USDHHS. (2006). The Health Consequences of Involuntary Exposure to Tobacco Smoke: Report of the Surgeon General.

There is no safe level of second-hand

smoke.

Second-hand smoke causes premature death and disease in nonsmokers (children and adults)Children:

Increased risk for sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, and more severe asthma

2006 REPORT of the SURGEON GENERAL: INVOLUNTARY EXPOSURE to TOBACCO SMOKE

Respiratory symptoms and slowed lung growth if parents smokeAdults:

Immediate adverse effects on cardiovascular systemIncreased risk for coronary heart disease and lung cancer

Millions of Americans are exposed to smoke in their homes/workplacesIndoor spaces: eliminating smoking fully protects nonsmokers

Separating smoking areas, cleaning the air, and ventilation are ineffective

SMOKE-FREE WORKPLACE LAWS

Smoke-free offices, restaurants, and bars: California, Colorado, Connecticut, Delaware, Hawaii, Maine, Massachusetts, New Jersey, New York, Rhode Island, Vermont, Washington

Smoke-free offices and restaurants: Arkansas, District of Columbia (bars in 2007), Florida, Georgia, Idaho, Louisiana, Montana (bars in 2009), Nevada, North Dakota, Utah (bars in 2009)

Smoke-free offices: Maryland, South DakotaData current as of November 9, 2006.

QUITTING: HEALTH BENEFITS

Lung cilia regain normal functionAbility to clear lungs of mucus increasesCoughing, fatigue, shortness of breath decrease

Excess risk of CHD decreases to half that of a

continuing smokerRisk of stroke is reduced to that of people who have never smoked

Lung cancer death rate drops to half that of a

continuing smokerRisk of cancer of mouth,

throat, esophagus, bladder, kidney, pancreas

decrease

Risk of CHD is similar to that of people who have never smoked

2 weeks to

3 months1 to 9

months

1year

5years

10years

after15 years

Time Since Quit DateCirculation improves,

walking becomes easierLung function increases

up to 30%

5


BENEFICIAL EFFECTS of QUITTING: PULMONARY EFFECTS

Reprinted with permission. Fletcher & Peto. (1977). BMJ 1(6077):1645–1648.

Disability

Death

Smokedregularly and

susceptible to effects of smoke

Never smoked or not susceptible to smoke

Stopped smoking at 45 (mild COPD)

Stopped smoking at 65 (severe COPD)

25

FEV 1

(% o

f val

ue a

t age

25)

25

50

75

100

050 75

Age (years)

COPD = chronic obstructive pulmonary disease

AT ANY AGE, there are benefits of quitting.AT ANY AGE, there are benefits of quitting.

Reduction in cumulative risk of death from lung cancer in men

Reprinted with permission. Peto et al. (2000). BMJ 321(7257):323–329.

Cum

ulat

ive

risk

(%)

Age in years

0

5

10

15

30 40 50 60

Year

s of

life

gai

ned

Age at cessation (years)

Prospective study of 34,439 male British doctorsMortality was monitored for 50 years (1951–2001)

On average, cigarette smokers die approximately 10 years younger than do

nonsmokers.

Among those who continue smoking, at least half

will die due to a tobacco-related disease.

SMOKING CESSATION: REDUCED RISK of DEATH

Doll et al. (2004). BMJ 328(7455):1519–1527.

FINANCIAL IMPACT of SMOKING

Packsper day

Buying cigarettes every day for 50 years @ $4.26 per packMoney banked monthly, earning 1.5% interest

0 100 200 300 400

Hundreds of thousands of dollars lost

$342,729

$228,486

$114,243

EPIDEMIOLOGY of TOBACCO USE: SUMMARY

About one in five adults are current smokers; smoking prevalence varies by sociodemographic characteristics.

Nearly half a million U.S. deaths are attributable to smoking annually.

Smoking costs the U.S. $157.7 billion per year. Lifetime financial costs of smoking can exceed $300,000 for a heavy smoker.

At any age, there are benefits to quitting smoking.

The biggest opponent to tobacco control efforts is the tobacco industry itself.

NICOTINE PHARMACOLOGY and PRINCIPLES of ADDICTION

6


NICOTINE ADDICTIONU.S. Surgeon General’s Report (1988)

Cigarettes and other forms of tobacco are addicting.

Nicotine is the drug in tobacco that causes addiction.

The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine.

U.S. Department of Health and Human Services. (1988). The Health Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon General.

Nicotiana tabacumNatural liquid alkaloid

Colorless, volatile base pKa = 8.0

N

CH3N

H

Pyridine ring

Pyrrolidine ring

CHEMISTRY of NICOTINE

PHARMACOLOGY

Effects of the body on the drugAbsorptionDistributionMetabolism Excretion

Effects of the drug on the body

Pharmacokinetics

Pharmacodynamics

NICOTINE ABSORPTION

Absorption is pH dependentIn acidic media

Ionized ⇒ poorly absorbed across membranesIn alkaline media

Nonionized ⇒ well absorbed across membranesAt physiologic pH (7.3–7.5), ~31% of nicotine is unionized

At physiologic pH,nicotine is readily absorbed.

NICOTINE ABSORPTION: BUCCAL (ORAL) MUCOSAThe pH inside the mouth is 7.0.

Acidic media(limited absorption)

Cigarettes

Alkaline media(significant absorption)

Pipes, cigars,spit tobacco,

oral nicotine products

Beverages can alter pH, affect absorption.

NICOTINE ABSORPTION: SKIN and GASTROINTESTINAL TRACT

Nicotine is readily absorbed through intact skin.

Nicotine is well absorbed in the small intestine but has low bioavailability (30%) due to first-pass hepatic metabolism.

7


NICOTINE ABSORPTION: LUNG

Nicotine is “distilled” from burning tobacco and carried in tar droplets.

Nicotine is rapidly absorbed across respiratory epithelium.

Lung pH = 7.4

Large alveolar surface area

Extensive capillary system in lung

NICOTINE DISTRIBUTION

Henningfield et al. (1993). Drug Alcohol Depend 33:23–29.

0

10

20

30

40

50

60

70

80

0 1 2 3 4 5 6 7 8 9 10

Minutes after light-up of cigarette

Pla

sma

nico

tine

(ng

/ml) Arterial

Venous

Nicotine reaches the brain within 11 seconds.Nicotine reaches the brain within 11 seconds.

Metabolizedand excreted

in urine

NICOTINE METABOLISM

CH3N

H 10–20% excreted

unchangedin urine

Adapted and reprinted with permission. Benowitz et al. (1994). J Pharmacol Exp Ther 268:296–303.

70–80% cotinine

~ 10% other metabolites

N

NICOTINE EXCRETION

Half-lifeNicotine t½ = 2 hrCotinine t½ = 19 hr

ExcretionOccurs through kidneys (pH dependent;

with acidic pH)Through breast milk

NICOTINE PHARMACODYNAMICS

Nicotine binds to receptors in the brain and other

sites in the body.

Other:Neuromuscular junctionSensory receptorsOther organs

Central nervous system

Exocrine glands

Adrenal medulla

Peripheral nervous system

Gastrointestinal system

Cardiovascular system

Nicotine has predominantly stimulant effects.

NICOTINE PHARMACODYNAMICS (cont’d)

Central nervous systemPleasureArousal, enhanced vigilanceImproved task performanceAnxiety relief

OtherAppetite suppressionIncreased metabolic rateSkeletal muscle relaxation

Cardiovascular system↑ Heart rate↑ Cardiac output↑ Blood pressureCoronary vasoconstrictionCutaneous vasoconstriction

8


NEUROCHEMICAL and RELATED EFFECTS of NICOTINE

Dopamine

Norepinephrine

Acetylcholine

Glutamate

Serotonin

β-Endorphin

GABA

N

I

C

O

T

I

N

E

Benowitz. (1999). Nicotine Tob Res 1(Suppl):S159–S163.

Pleasure, reward

Arousal, appetite suppression

Arousal, cognitive enhancement

Learning, memory enhancement

Mood modulation, appetite suppression

Reduction of anxiety and tension

Reduction of anxiety and tension

WHAT IS ADDICTION?

”Compulsive drug use, without medical purpose, in the face of

negative consequences”

Alan I. Leshner, Ph.D.Former Director, National Institute on Drug Abuse

National Institutes of Health

BIOLOGY of NICOTINE ADDICTION: ROLE of DOPAMINE

Nicotinestimulates

dopamine release

Repeat administration

Tolerance develops

Discontinuation leads towithdrawal symptoms.Pleasurable feelings

Nicotine addiction is not just a bad habit.

Nicotine entersNicotine entersbrainbrain

Stimulation of Stimulation of nicotine receptorsnicotine receptors

Dopamine releaseDopamine release

DOPAMINE REWARD PATHWAYPrefrontal

cortex

Nucleus accumbens

Ventral tegmental

area

CHRONIC ADMINISTRATION of NICOTINE: EFFECTS on the BRAIN

Perry et al. (1999). J Pharmacol Exp Ther 289:1545–1552.

Nonsmoker Smoker

Human smokers have increased nicotine receptors in the prefrontal cortex.

High

Low

Image courtesy of George Washington University / Dr. David C. Perry

Depression

Insomnia

Irritability/frustration/anger

Anxiety

Difficulty concentrating

Restlessness

Increased appetite/weight gain

Decreased heart rate

Cravings*

NICOTINE PHARMACODYNAMICS: WITHDRAWAL EFFECTS

American Psychiatric Association. (1994). DSM-IV. Hughes et al. (1991). Arch Gen Psychiatry 48:52–59.

Hughes & Hatsukami. (1998). Tob Control 7:92–93.

Most symptoms peak 24–48 hr

after quitting and subside within

2–4 weeks.

* Not considered a withdrawal symptom by DSM-IV criteria.

HANDOUT

9


NICOTINE ADDICTION CYCLE

Reprinted with permission. Benowitz. (1992). Med Clin N Am 2:415–437.

NICOTINE ADDICTION

Tobacco users maintain a minimum serum nicotine concentration in order to

Prevent withdrawal symptomsMaintain pleasure/arousalModulate mood

Users self-titrate nicotine intake bySmoking/dipping more frequentlySmoking more intenselyObstructing vents on low-nicotine brand cigarettes

ASSESSINGNICOTINE DEPENDENCE

Fagerström Test for Nicotine Dependence (FTND)Developed in 1978 (8 items); revised in 1991 (6 items)

Most common research measure of nicotine dependence; sometimes used in clinical practice

Responses coded such that higher scores indicate higher levels of dependence

Scores range from 0 to 10; score of greater than 5 indicates substantial dependence

Heatherton et al. (1991). British Journal of Addiction 86:1119–1127.

HANDOUT

FACTORS CONTRIBUTING toTOBACCO USE

PhysiologyGenetic predispositionCoexisting medical conditions

EnvironmentTobacco advertisingConditioned stimuliSocial interactions

PharmacologyAlleviation of withdrawal symptomsWeight controlPleasure

Tobacco Use

TOBACCO DEPENDENCE:A 2-PART PROBLEM

Tobacco DependenceTobacco Dependence

Treatment should address the physiological and the behavioral aspects of dependence.

PhysiologicalPhysiological BehavioralBehavioral

Treatment Treatment

The addiction to nicotine

Medications for cessation

The habit of using tobacco

Behavior change program

NICOTINE PHARMACOLOGY and ADDICTION: SUMMARY

Tobacco products are effective delivery systems for the drug nicotine.

Nicotine is a highly addictive drug that induces a constellation of pharmacologic effects.

Nicotine activates the dopamine reward pathway in the brain, which reinforces continued tobacco use.

Tobacco users who are dependent on nicotine self-regulate tobacco intake to maintain pleasurable effects and prevent withdrawal.

10


NICOTINE PHARMACOLOGY and ADDICTION: SUMMARY (cont’d)

Nicotine dependence is a form of chronic brain disease.

Tobacco use is a complex disorder involving the interplay of the following:

Pharmacology of nicotine (pharmacokinetics and pharmacodynamics)

Environmental factors

Physiologic factors

Treatment of tobacco use and dependence requires a multifaceted treatment approach.

DRUG INTERACTIONS with SMOKING

Drugs that may have a decreased effect due to induction of CYP1A2:

CaffeineFluvoxamineOlanzapineTacrineTheophylline

Absorption of inhaled insulin is 2- to 5-fold higher in smokers than in nonsmokers

Use is contraindicated in current smokers and patients who quit less < 6 months prior to treatment

PHARMACOKINETIC DRUG INTERACTIONS with SMOKING

HANDOUTSmoking cessation will reverse these effects.

PHARMACODYNAMIC DRUG INTERACTIONS with SMOKING

Smokers who use combined hormonal contraceptives have an increased risk of serious cardiovascular adverse effects:

StrokeMyocardial infarctionThromboembolism

This interaction does not decrease the efficacy of hormonal contraceptives.

Women who are 35 years of age or older AND smoke at least 15 cigarettes per day are at significantly elevated risk.

DRUG INTERACTIONS with SMOKING: SUMMARY

Clinicians should be aware of their patients’smoking status:

Clinically significant interactions result not from nicotine butfrom the combustion products of tobacco smoke.

These tobacco smoke constituents (e.g., polycyclic aromatic hydrocarbons; PAHs) may enhance the metabolism of other drugs, resulting in a reduced pharmacologic response.

Smoking might adversely affect the clinical response to the treatment of a wide variety of conditions.

ASSISTING PATIENTS with QUITTING

11


Released June 2000

Sponsored by the Agency for Healthcare Research and Quality of the U.S. Public Heath Service with

Centers for Disease Control and PreventionNational Cancer InstituteNational Institute for Drug AddictionNational Heart, Lung, & Blood InstituteRobert Wood Johnson Foundation

www.surgeongeneral.gov/tobacco/

CLINICAL PRACTICE GUIDELINE for TREATING TOBACCO USE and DEPENDENCE

EFFECTS of CLINICIAN INTERVENTIONS

Fiore et al. (2000). Treating Tobacco Use and Dependence. Clinical Practice Guideline.Rockville, MD: USDHHS, PHS.

0

10

20

30

No clinician Self-helpmaterial

Nonphysicianclinician

Physicianclinician

Type of Clinician

Esti

mat

ed a

bsti

nenc

e at

5+

mon

ths

1.0 1.1(0.9,1.3)

1.7(1.3,2.1)

2.2(1.5,3.2)

n = 29 studies

Compared to smokers who receive no assistance from a clinician, smokers who receive such assistance are 1.7–2.2 times as likely to quit successfully for 5 or more months.

Tobacco users expect to be encouraged to quit by health professionals.

Screening for tobacco use and providing tobacco cessation counseling are positively associated with patient satisfaction (Barzilai et al., 2001).

Barzilai et al. (2001). Prev Med 33:595–599.

Failure to address tobacco use tacitly implies that quitting is not important.

The CLINICIAN’s ROLE in PROMOTING CESSATION

ASK

ADVISE

ASSESS

ASSIST

ARRANGE

The 5 A’s


HANDOUT

The 5 A’s (cont’d)

Ask about tobacco use

“Do you ever smoke or use any type of tobacco?”

“I take time to ask all of my patients about tobacco use—because it’s important.”

“Medication X often is used for conditions linked with or caused by smoking. Do you, or does someone in your household smoke?”

“Condition X often is caused or worsened by smoking. Do you, or does someone in your household smoke?”

ASK


tobacco users to quit (clear, strong, personalized, sensitive)

“It’s important that you quit as soon as possible, and I can help you.”

“I realize that quitting is difficult. It is the most important thing you can do to protect your health now and in the future. I have training to help my patients quit, and when you are ready, I will work with you to design a specialized treatment plan.”

ADVISE

12



Assess readiness to make a quit attemptASSESS

Assist with the quit attempt

Not ready to quit: provide motivation (the 5 R’s)

Ready to quit: design a treatment plan

Recently quit: relapse prevention

ASSIST

Arrange follow-up careARRANGE


20.9%4 to 824.7%More than 8

16.3%2 to 3 12.4%0 to 1

Estimated quit rate*Number of sessions

* 5 months (or more) postcessation


PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPTPROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPT

The 5 A’s: REVIEW

ASK about tobacco USE

ADVISE tobacco users to QUIT

ASSESS READINESS to make a quit attempt

ASSIST with the QUIT ATTEMPT

ARRANGE FOLLOW-UP care

Faced with change, most people are not ready to act.

Change is a process, not a single step.

Typically, it takes multiple attempts.

HOW CAN I LIVE WITHOUT TOBACCO?

The (DIFFICULT) DECISION to QUIT

HELPING SMOKERS QUIT IS a CLINICIAN’S RESPONSIBILITY

THE DECISION TO QUIT LIES IN THE HANDS OF EACH PATIENT.

TOBACCO USERS DON’T PLAN TO FAIL.MOST FAIL TO PLAN.

Clinicians have a professional obligation to address tobacco use and can have an important role in helping patients

plan for their quit attempts.

STAGE 1: Not ready to quit in the next month

STAGE 2: Ready to quit in the next month

STAGE 3: Recent quitter, quit within past 6 months

STAGE 4: Former tobacco user, quit > 6 months ago

ASSESSING READINESS to QUIT

Patients differ in their readiness to quit.

Assessing a patient’s readiness to quit enables clinicians to deliver relevant, appropriate counseling messages.

13


Former tobacco

user

Recent quitter

Ready to quit

Not ready to quit

Relapse

Not thinking about it

Thinking about it, not ready

For most patients, quitting is a cyclical process, and their readiness to quit (or stay quit) will change over time.

Assess readiness to quit (or to stay quit) at each patient

contact.

ASSESSING READINESS to QUIT (cont’d) IS a PATIENT READY to QUIT?

Does the patient now use tobacco?

Is the patient now ready to quit?

Provide treatmentThe 5 A’s

Promote motivation

Yes

YesNo

Did the patient once use tobacco?

Prevent relapse*

Encourage continued abstinence

Yes

No

No

*Relapse prevention interventions not necessary if patient has not used tobacco for many years and is not at risk for re-initiation.


STAGE 1: Not ready to quit

Not thinking about quitting in the next monthSome patients are aware of the need to quit.Patients struggle with ambivalence about change.Patients are not ready to change, yet.Pros of continued tobacco use outweigh the cons.

GOAL: Start thinking about quitting.

ASSESSING READINESS to QUIT (cont’d)

STAGE 1: NOT READY to QUITCounseling Strategies

DON’TsPersuade

“Cheerlead”

Tell patient how bad tobacco is, in a judgmental manner

Provide a treatment plan

DOsStrongly advise to quit

Provide information

Ask noninvasive questions; identify reasons for tobacco use

“Envelope”

Raise awareness of health consequences/concerns

Demonstrate empathy, foster communication

Leave decision up to patient

The 5 R’s—Methods for increasing motivation:

Relevance

Risks

Rewards

Roadblocks

Repetition


Tailored, motivational messages

STAGE 1: NOT READY to QUITCounseling Strategies (cont’d)

STAGE 1: NOT READY to QUITA Demonstration

CASE SCENARIO:MS. STEWART

You are a clinician providing care to Ms. Stewart, a 55-year-old patient with emphysema.

She uses two different inhalers to treat her emphysema.

VIDEO #1

14


Ask about tobacco useLink inquiry to knowledge of disease

Assess readiness to quitAware of need to quit; not ready yet

Advise to quitDiscuss implications for disease progression

“I will help you, when you are ready”

STAGE 1: NOT READY to QUITCase Scenario Synopsis

The clinician hasEstablished a relationship

Established herself as a resource

Planted a seed to move patient forward

Opened a door to facilitate further counseling

STAGE 1: NOT READY to QUITCase Scenario Synopsis (cont’d)

Ready to quit in the next monthPatients are aware of the need to, and the benefits of, making the behavioral change.

Patients are getting ready to take action.

STAGE 2: Ready to quit

GOAL: Achieve cessation.


Assess tobacco use history

Discuss key issues

Facilitate quitting process

STAGE 2: READY to QUITThree Key Elements of Counseling

STAGE 2: READY to QUITAssess Tobacco Use History

Praise the patient’s readinessAssess tobacco use history

Current use: type(s) of tobacco, brand, amountPast use: duration, recent changesPast quit attempts:

Number, date, lengthMethods used, compliance, durationReasons for relapse

Reasons/motivation to quit (or avoid relapse)

Confidence in ability to quit (or avoid relapse)

Triggers for tobacco useWhat situations lead to temptations to use tobacco?What led to relapse in the past?

Routines/situations associated with tobacco use

STAGE 2: READY to QUITDiscuss Key Issues

When drinking coffeeWhile driving in the car When bored or stressedWhile watching televisionWhile at a bar with friends

After mealsDuring breaks at workWhile on the telephoneWhile with specific friends or family members who use tobacco

15


“Smoking gets rid of all my stress.”

“I can’t relax without a cigarette.”

There will always be stress in one’s life.

There are many ways to relax without a cigarette.

THE MYTHS

STRESS MANAGEMENT SUGGESTIONS:Deep breathing, shifting focus, taking a break.

Smokers confuse the relief of withdrawal with the feeling of relaxation.

STAGE 2: READY to QUITDiscuss Key Issues (cont’d)

THE FACTS

Stress-Related Tobacco Use

Patients who receive social support and encouragement are more successful in quitting.

ADVISE PATIENTS TO DO THE FOLLOWING: Ask family, friends, and coworkers for support, for example, not to smoke around them and not to leave cigarettes out

Talk with their health care provider

Get individual, group, or telephone counseling


Social Support for Quitting

HERMAN ® is reprinted with permission from LaughingStock Licensing Inc., Ottawa, Canada

All rights reserved.

Most smokers gain fewer than 10 pounds, but there is a wide range.

Discourage strict dieting while quittingRecommend physical activityEncourage healthful diet, planning of meals, and inclusion of fruitsSuggest increasing water intake or chewing sugarless gumRecommend selection of nonfood rewards

Maintain patient on pharmacotherapy shown to delay weight gain

Refer patient to specialist or program


Concerns about Weight Gain

Most pass within 2–4 weeks after quitting

Cravings can last longer, up to several months or years

Often can be ameliorated with cognitive or behavioral coping strategies

Refer to Withdrawal Symptoms Information Sheet

Symptom, cause, duration, relief

Most symptoms peak 24–48 hours after quitting and

subside within 2–4 weeks.

HANDOUT


Concerns about Withdrawal Symptoms Discuss methods for quittingDiscuss pros and cons of available methodsPharmacotherapy: a treatment, not a crutch!Importance of behavioral counseling

Set a quit date

Recommend Tobacco Use LogHelps patients to understand when and why they use tobaccoIdentifies activities or situations that trigger tobacco useCan be used to develop coping strategies to overcome the temptation to use tobacco

STAGE 2: READY to QUITFacilitate Quitting Process

HANDOUT

16


Continue regular tobacco use for 3 or more days

Each time any form of tobacco is used, log the following information:

Time of day

Activity or situation during use

“Importance” rating (scale of 1–3)

Review log to identify situational triggers for tobacco use; develop patient-specific coping strategies

STAGE 2: READY to QUITFacilitate Quitting Process (cont’d)

Tobacco Use Log: Instructions for useDiscuss coping strategies

Cognitive coping strategiesFocus on retraining the way a patient thinks

Behavioral coping strategies

Involve specific actions to reduce risk for relapse


HANDOUT

Review commitment to quit

Distractive thinking

Positive self-talk

Relaxation through imagery

Mental rehearsal and visualization

Cognitive Coping Strategies


Thinking about cigarettes doesn’t mean you have to smoke one:

“Just because you think about something doesn’t mean you have to do it!”Tell yourself, “It’s just a thought,” or “I am in control.”Say the word “STOP!” out loud, or visualize a stop sign.

When you have a craving, remind yourself:“The urge for tobacco will only go away if I don’t use it.”

As soon as you get up in the morning, look in the mirror and say to yourself:

“I am proud that I made it through another day without tobacco.”

Cognitive Coping Strategies: Examples


Control your environmentTobacco-free home and workplace

Remove cues to tobacco use; actively avoid trigger situations

Modify behaviors that you associate with tobacco: when, what, where, how, with whom

Substitutes for smokingWater, sugar-free chewing gum or hard candies (oral substitutes)

Take a walk, diaphragmatic breathing, self-massage

Actively work to reduce stress, obtain social support, and alleviate withdrawal symptoms

Behavioral Coping Strategies


Provide medication counselingPromote complianceDiscuss proper use, with demonstration

Discuss concept of “slip” versus relapse“Let a slip slide.”

Offer to assist throughout quit attemptFollow-up contact #1: first week after quittingFollow-up contact #2: in the first monthAdditional follow-up contacts as needed

Congratulate the patient!


17


Actively trying to quit for goodPatients have quit using tobacco sometime in the past 6 months and are taking steps to increase their success.

Withdrawal symptoms occur.

Patients are at risk for relapse.

STAGE 3: Recent quitter

GOAL: Remain tobacco-free for at least 6 months.


STAGE 3: RECENT QUITTERSEvaluate the Quit Attempt

Status of attemptAsk about social supportIdentify ongoing temptations and triggers for relapse(negative affect, smokers, eating, alcohol, cravings, stress)Encourage healthy behaviors to replace tobacco use

Slips and relapseHas the patient used tobacco at all—even a puff?

Medication compliance, plans for terminationIs the regimen being followed?Are withdrawal symptoms being alleviated?How and when should pharmacotherapy be terminated?

Congratulate success!Encourage continued abstinence

Discuss benefits of quitting, problems encountered, successes achieved, and potential barriers to continued abstinenceAsk about strong or prolonged withdrawal symptoms (change dose, combine or extend use of medications)

Promote smoke-free environments

Social supportDiscuss ongoing sources of supportSchedule additional follow-up as needed; refer to support groups

STAGE 3: RECENT QUITTERSFacilitate Quitting Process

Relapse Prevention

Tobacco-free for 6 monthsPatients remain vulnerable to relapse.

Ongoing relapse prevention is needed.

STAGE 4: Former tobacco user

GOAL: Remain tobacco-free for life.


STAGE 4: FORMER TOBACCO USERS

Assess status of quit attempt

Slips and relapse

Medication compliance, plans for terminationHas pharmacotherapy been terminated?

Continue to offer tips for relapse prevention

Encourage healthy behaviors

Congratulate continued success

Continue to assist throughout the quit attempt.

READINESS to QUIT: A REVIEW

Recent quitterNot ready to quit Former tobacco user

Quit date

Ready to quit

- 30 days + 6 months

Promote motivationThe 5 R’s

Behavioral counselingPharmacotherapy

The 5 A’s

Behavioral counseling

Relapse prevention

Behavioral counseling

PharmacotherapyRelapse

prevention

18


Routinely identify tobacco users (ASK)Strongly ADVISE patients to quitASSESS readiness to quit at each contactTailor intervention messages (ASSIST)

Be a good listenerMinimal intervention in absence of time for more intensive intervention

ARRANGE follow-upUse the referral process, if needed

COMPREHENSIVE COUNSELING: SUMMARY

Brief interventions have been shown to be effective

In the absence of time or expertise:

Ask, advise, and refer to other resources, such as local programs or the toll-free quitline1-800-QUIT-NOW

BRIEF COUNSELING: ASK, ADVISE, REFER

This brief intervention can be achieved in 30 seconds.

WHAT IF…

a patient asks you about your use of tobacco?

The RESPONSIBILITY of HEALTH PROFESSIONALS

It is inconsistent

to provide health care and

—at the same time—

remain silent (or inactive)

about a major health risk.TOBACCO CESSATION

is an important component ofTHERAPY.

DR. GRO HARLEM BRUNTLAND, FORMER DIRECTOR-GENERAL of the WHO:

“If we do not act decisively, a hundred years from now our grandchildren and their children will look back and seriously question how people claiming to be committed to public health and social justice allowed the tobacco epidemic to unfold unchecked.”

USDHHS. (2001). Women and Smoking: A Report of the Surgeon General. Washington, DC: PHS.

AIDS for CESSATION &CASE SCENARIO OVERVIEW

19


METHODS for QUITTING

Nonpharmacologic

Pharmacologic

Combination therapy is preferred.

NONPHARMACOLOGIC METHODS

Cold turkey: Just do it!

Unassisted tapering (fading) Reduced frequency of useLower nicotine cigarettesSpecial filters or holders

Assisted taperingQuitKey

NONPHARMACOLOGIC METHODS (cont’d)

Formal cessation programsSelf-help programsIndividual counselingGroup programsTelephone counseling

1-800-QUITNOW 1-800-786-8669

Web-based counselingwww.smokefree.govwww.quitnet.com

Aversion therapy

Acupuncture therapy

Hypnotherapy

Massage therapy

SCHEDULED GRADUAL REDUCTION of SMOKING

Gradual reduction of the total number of cigarettes smoked per day

Computerized unit facilitates reduction:QuitKey

Tapering curve developed based on patient’s smoking level19–24% abstinent at 1 yearIncludes telephone counseling support

QuitKeySMOKING CESSATION PROGRAM

QuitKey SMOKING CESSATION PROGRAM

Stage 1 (7 days)Push the SMOKE button every time you smoke, to record smoking habits

Turn unit on every morning and off every night

Stage 2 (14–34 days)Smoke only when you hear the tone or see the SMOKE SIGNAL; tapers smoking over time

Press the SMOKE button every time you smoke

Turn unit on every morning and off every night

20


SCHEDULED GRADUAL REDUCTION (cont’d)

Who is a candidate for scheduled gradual reduction?

Anyone who wants to quit smokingParticularly useful in persons for whom medications might not be a first-line choice, such as pregnant women or teensSpit tobacco users (18.4% abstinent after 1 year)

Ordering informationwww.quitkey.com or 1-800-543-3744 ($59.95)

PHARMACOTHERAPY

“All patients attempting to quit should be encouraged to use effective pharmacotherapies for smoking cessation except in the presence of special

circumstances.”

Fiore et al. (2000). Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS.

PHARMACOLOGIC METHODS: FIRST-LINE THERAPIES

Three general classes of FDA-approved drugs for smoking cessation:

Nicotine replacement therapy (NRT)Nicotine gum, patch, lozenge, nasal spray, inhaler

PsychotropicsSustained-release bupropion

Partial nicotinic receptor agonistVarenicline

Currently, no medications have an FDA indication for use in spit tobacco cessation.

FDA APPROVALS: SMOKING CESSATION

1984

Rx nicotine

gum 1991

Rx transdermal nicotine patch

1996

OTC nicotine gum & patch;Rx nicotine nasal spray

1997

Rx nicotine inhaler;

Rx bupropion SR

2002

OTC nicotine lozenge

2006

Rx varenicline

NRT: RATIONALE for USE

Reduces physical withdrawal from nicotine

Allows patient to focus on behavioral and psychological aspects of tobacco cessation

NRT APPROXIMATELY DOUBLES QUIT RATES.NRT APPROXIMATELY DOUBLES QUIT RATES.

Polacrilex gumNicorette (OTC)Generic nicotine gum (OTC)

LozengeCommit (OTC)Generic nicotine lozenge (OTC)

Transdermal patchNicoderm CQ (OTC)Generic nicotine patches (OTC, Rx)

Nasal sprayNicotrol NS (Rx)

InhalerNicotrol (Rx)

NRT: PRODUCTS

21


PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS

0

5

10

15

20

25

1/0/1900 1/10/1900 1/20/1900 1/30/1900 2/9/1900 2/19/1900 2/29/1900

Plas

ma

nico

tine

(mcg

/l)

Cigarette

Moist snuff

Nasal spray

Inhaler

Lozenge (2mg)

Gum (2mg)

Patch

0 10 20 30 40 50 60

Time (minutes)

Cigarette

Moist snuff

NRT: PRECAUTIONS

Patients with underlying cardiovascular disease

Recent myocardial infarction (within past 2 weeks)

Serious arrhythmias

Serious or worsening angina

NRT products may be appropriate for these patients if they are under medical supervision.

NRT: PRECAUTIONS (cont’d)

Patients with other underlying conditions

Active temporomandibular joint disease (gum only)

Pregnancy

Lactation

NRT products may be appropriate for these patients if they are under medical supervision.

NRT: OTHER CONSIDERATIONS

NRT is not FDA-approved for use in children or adolescents

Nonprescription sales (patch, gum, lozenge) are restricted to adults ≥18 years of age

NRT use in minors requires a prescription

Patients should stop using all forms of tobacco upon initiation of the NRT regimen

NICOTINE GUMNicorette (GlaxoSmithKline); generics

Resin complexNicotine Polacrilin

Sugar-free chewing gum base

Contains buffering agents to enhance buccal absorption of nicotine

Available: 2 mg, 4 mg; regular, FreshMint, Fruit Chill, mint, & orange flavor

NICOTINE GUM: DOSING

Dosage based on current smoking patterns:

2 mg<25 cigarettes/day

4 mg≥25 cigarettes/day

Recommended strengthIf patient smokes

22


NICOTINE GUM: DOSING (cont’d)

Recommended Usage Schedule for Nicotine Gum

DO NOT USE MORE THAN 24 PIECES PER DAY.

1 piece q 4–8 h1 piece q 2–4 h1 piece q 1–2 h

Weeks 10–12Weeks 7–9Weeks 1–6

NICOTINE GUM:DIRECTIONS for USE

Chew each piece very slowly several times

Stop chewing at first sign of peppery, minty, or citrus taste orslight tingling in mouth (~15 chews, but varies)

“Park” gum between cheek and gum (to allow absorption of nicotine across buccal mucosa)

Resume slow chewing when taste or tingle fades

When taste or tingle returns, stop and park gum in different place in mouth

Repeat chew/park steps until most of the nicotine is gone (taste or tingle does not return; generally 30 minutes)

NICOTINE GUM:CHEWING TECHNIQUE SUMMARY

Park between cheek & gum

Stop chewing at first sign of peppery taste or tingling sensation

Chew slowly

Chew again when peppery taste or tingle fades

NICOTINE GUM: ADDITIONAL PATIENT EDUCATION

To improve chances of quitting, use at least nine pieces of gum daily

The effectiveness of nicotine gum may be reduced by some foods and beverages:

• Coffee • Juices• Wine • Soft drinks

Do NOT eat or drink for 15 minutes BEFORE or while using nicotine gum.

NICOTINE GUM:ADD’L PATIENT EDUCATION (cont’d)

Chewing gum will not provide same rapid satisfaction that smoking provides

Chewing gum too rapidly can cause excessive release of nicotine, resulting in

Lightheadedness

Nausea/vomiting

Irritation of throat and mouth

Hiccups

Indigestion

NICOTINE GUM:ADD’L PATIENT EDUCATION (cont’d)

Side effects of nicotine gum includeMouth soreness

Hiccups

Dyspepsia

Jaw muscle ache

Nicotine gum may stick to dental workDiscontinue use if excessive sticking or damage to dental work occurs

23


NICOTINE GUM: SUMMARY

DISADVANTAGESGum chewing may not be socially acceptable.

Gum is difficult to use with dentures.

Patients must use proper chewing technique to minimize adverse effects.

ADVANTAGESGum use may satisfy oral cravings.

Gum use may delay weight gain.

Patients can titrate therapy to manage withdrawal symptoms.

NICOTINE LOZENGECommit (GlaxoSmithKline); generics

Nicotine polacrilex formulationDelivers ~25% more nicotine than equivalent gum dose

Sugar-free, mint or cherry flavor (boxed or POP-PAC)

Contains buffering agents to enhance buccal absorption of nicotine

Available: 2 mg, 4 mg

NICOTINE LOZENGE: DOSING Dosage is based on the “time to first cigarette”(TTFC) as an indicator of nicotine addiction

Use Commit Lozenge 2 mg:If you smoke your first cigarette more than 30 minutes after waking up

Use Commit Lozenge 4 mg:If you smoke your first cigarette of the day within 30 minutes of waking up

NICOTINE LOZENGE: DOSING (cont’d)

Recommended Usage Schedule for Commit Lozenge

DO NOT USE MORE THAN 20 LOZENGES PER DAY.

1 lozengeq 4–8 h

1 lozengeq 2–4 h

1 lozengeq 1–2 h

Weeks 10–12Weeks 7–9Weeks 1–6

NICOTINE LOZENGE:DIRECTIONS for USE

Use according to recommended dosing schedule

Place in mouth and allow to dissolve slowly (nicotine release may cause warm, tingling sensation)

Do not chew or swallow lozenge.

Occasionally rotate to different areas of the mouth.

Lozenge will dissolve completely in about 20−30 minutes.

NICOTINE LOZENGE: ADDITIONAL PATIENT EDUCATION

To improve chances of quitting, use at least nine lozenges daily during the first 6 weeks

The lozenge will not provide the same rapid satisfaction that smoking provides

The effectiveness of the nicotine lozenge may be reduced by some foods and beverages:

• Coffee • Juices• Wine • Soft drinks

Do NOT eat or drink for 15 minutes BEFORE or while using the nicotine lozenge.

24


NICOTINE LOZENGE:ADD’L PATIENT EDUCATION (cont’d)

Side effects of the nicotine lozenge includeNausea

Hiccups

Cough

Heartburn

Headache

Flatulence

Insomnia

NICOTINE LOZENGE: SUMMARY

DISADVANTAGES

Gastrointestinal side effects (nausea, hiccups, and heartburn) may be bothersome.

ADVANTAGESLozenge use may satisfy oral cravings.

The lozenge is easy to use and conceal.

Patients can titrate therapy to manage withdrawal symptoms.

TRANSDERMAL NICOTINE PATCHNicoderm CQ (GlaxoSmithKline); generic

Nicotine is well absorbed across the skin

Delivery to systemic circulation avoids hepatic first-pass metabolism

Plasma nicotine levels are lower and fluctuate less than with smoking

TRANSDERMAL NICOTINE PATCH:PREPARATION COMPARISON

7-mg patch14-mg patch21-mg patch

7-mg patch14-mg patch21-mg patch

Strengths

Rx/OTCOTCAvailability

24 hours24 hoursNicotine delivery

GenericNicoderm CQProduct

TRANSDERMAL NICOTINE PATCH: DOSING

>10 cigarettes/day

Step 1 (21 mg x 4 weeks)



≤10 cigarettes/day



Generic

(formerly Habitrol)

>10 cigarettes/day




≤10 cigarettes/day



Nicoderm CQ

Heavy SmokerLight SmokerProduct

TRANSDERMAL NICOTINE PATCH:DIRECTIONS for USE

Choose an area of skin on the upper body or upper outer part of the arm

Make sure skin is clean, dry, hairless, and not irritated

Apply patch to different area each day

Do not use same area again for at least 1 week

25


TRANSDERMAL NICOTINE PATCH:DIRECTIONS for USE (cont’d)

Remove patch from protective pouch


Peel off half of the backing from patch


Apply adhesive side of patch to skin

Peel off remaining protective covering

Press firmly with palm of hand for 10 seconds

Make sure patch sticks well to skin, especially around edges


Wash hands: Nicotine on hands can get into eyes or nose and cause stinging or redness

Do not leave patch on skin for more than 24 hours—doing so may lead to skin irritation

Adhesive remaining on skin may be removed with rubbing alcohol or acetone

Dispose of used patch by folding it onto itself, completely covering adhesive area

TRANSDERMAL NICOTINE PATCH:ADDITIONAL PATIENT EDUCATION

Water will not harm the nicotine patch if it is applied correctly; patients may bathe, swim, shower, or exercise while wearing the patch

Do not cut patches to adjust doseNicotine may evaporate from cut edgesPatch may be less effective

Keep new and used patches out of the reach of children and pets

Remove patch before MRI procedures

TRANSDERMAL NICOTINE PATCH:ADD’L PATIENT EDUCATION (cont’d)

Side effects to expect in first hour:Mild itchingBurningTingling

Additional possible side effects:Vivid dreams or sleep disturbancesHeadache

26


TRANSDERMAL NICOTINE PATCH:ADD’L PATIENT EDUCATION (cont’d)

After patch removal, skin may appear red for 24 hours

If skin stays red more than 4 days or if it swells or a rash appears, contact health care provider—do not apply new patch

Local skin reactions (redness, burning, itching)Usually caused by adhesiveUp to 50% of patients experience this reactionFewer than 5% of patients discontinue therapyAvoid use in patients with dermatologic conditions (e.g., psoriasis, eczema, atopic dermatitis)

TRANSDERMAL NICOTINE PATCH: SUMMARY

DISADVANTAGESPatients cannot titrate the dose.

Allergic reactions to the adhesive may occur.

Patients with dermatologic conditions should not use the patch.

ADVANTAGES

The patch provides consistent nicotine levels.

The patch is easy to use and conceal.

Fewer compliance issues are associated with patch use.

NICOTINE NASAL SPRAYNicotrol NS (Pfizer)

Aqueous solution of nicotine in a 10-ml spray bottleEach metered dose actuation delivers

50 µl spray0.5 mg nicotine

~100 doses/bottleRapid absorption across nasal mucosa

NICOTINE NASAL SPRAY:DOSING & ADMINISTRATION

One dose = 1 mg nicotine (2 sprays, one 0.5 mg spray in each nostril)

Start with 1–2 doses per hour

Increase prn to maximum dosage of 5 doses per hour or 40 mg (80 sprays; ~½ bottle) daily

For best results, patients should use at least 8 doses daily for the first 6–8 weeks

Termination:

Gradual tapering over an additional 4–6 weeks

NICOTINE NASAL SPRAY: DIRECTIONS for USE

Press in circles on sides of bottle and pull to remove cap

NICOTINE NASAL SPRAY: DIRECTIONS for USE (cont’d)

Prime the pump (before first use)

Obtain facial tissue or paper towelHold bottle and press on bottom with thumbPump into tissue until fine spray is observed (6–8 times)

If pump is not used for 24 hours, prime the pump 1–2 times

27


NICOTINE NASAL SPRAY:DIRECTIONS for USE (cont’d)

Blow nose (if not clear)

Tilt head back slightly and insert tip of bottle into nostril as far as comfortable

Breathe through mouth, and spray once in each nostril

Do not sniff or inhale while spraying

NICOTINE NASAL SPRAY:DIRECTIONS for USE (cont’d)

If nose runs, gently sniff to keep nasal spray in nose

Wait 2–3 minutes before blowing nose

Wait 5 minutes before driving or operating heavy machinery (spray may cause tearing, coughing, and sneezing)

Avoid contact with skin, eyes, and mouth

If contact occurs, rinse with water immediately

Nicotine is absorbed through skin and mucous membranes

NICOTINE NASAL SPRAY:ADDITIONAL PATIENT EDUCATION

What to expect (first week):Hot peppery feeling in back of throat or noseSneezingCoughingWatery eyesRunny nose

Side effects should lessen over a few daysRegular use during the first week will help in development of tolerance to the irritant effects of the spray

If side effects do not decrease after a week, contact health care provider

NICOTINE NASAL SPRAY:SUMMARY

DISADVANTAGESNasal/throat irritation may be bothersome.Nasal spray has higher dependence potential.Patients with chronic nasal disorders or severe reactive airway disease should not use the spray.

ADVANTAGESPatients can easily titrate therapy to rapidly manage withdrawal symptoms.

NICOTINE INHALERNicotrol Inhaler (Pfizer)

Nicotine inhalation system consists of

MouthpieceCartridge with porous plug containing 10 mg nicotine

Delivers 4 mg nicotine vapor, absorbed across buccal mucosa

May satisfy hand-to-mouth ritual of smoking

NICOTINE INHALER: DOSING

Start with 6 cartridges/day

Increase prn to maximum of 16 cartridges/day

Use for minimum of 3 weeks, maximum of 12 weeks

Gradual dosage reduction: if needed over additional 6–12 weeks

28


Air in

Aluminum laminatesealing material

Porous plug impregnated with nicotine

Mouthpiece

Nicotine cartridge

Air/nicotine mixture out

Sharp point that breaks the seal

Sharp point that breaks the seal

NICOTINE INHALER:SCHEMATIC DIAGRAM

Reprinted with permission from Schneider et al. (2001). Clinical Pharmacokinetics 40:661–684. Adis International, Inc.

NICOTINE INHALER:DIRECTIONS for USE

Align marks on the mouthpiece

NICOTINE INHALER:DIRECTIONS for USE (cont’d)

Pull and separate mouthpiece into two parts


Press nicotine cartridge firmly into bottom of mouthpiece until seal breaks


Put top on mouthpiece and align marks to close

Press down firmly to break top seal of cartridge

Twist top to misalign marks and secure unit

During inhalation, nicotine is vaporized and absorbed across oropharyngeal mucosa

Inhale into back of throat or puff in short breaths

Nicotine in cartridges is depleted after about 20 minutes of active puffing

Cartridge does not have to be used all at once

Open cartridge retains potency for 24 hours

Mouthpiece is reusable; clean regularly with mild detergent


29


NICOTINE INHALER:ADDITIONAL PATIENT EDUCATION

Patients may experience mild irritation of the mouth or throat, and an unpleasant taste or cough when first using the inhaler

Patients will adapt to these effects in a short time

Other (less common) side effects includeRhinitisDyspepsiaHiccupsHeadache

NICOTINE INHALER:ADD’L PATIENT EDUCATION (cont’d)

The inhaler may not be as effective in very cold (<59°F) temperatures—delivery of nicotine vapor may be compromised

Use the inhaler longer and more often at first to help control cravings (best results are achieved with frequent continuous puffing over 20 minutes)

Effectiveness of the nicotine inhaler may be reduced by some foods and beverages

Do NOT eat or drink for 15 minutes BEFORE or while using the nicotine inhaler.

NICOTINE INHALER: SUMMARYDISADVANTAGES

The initial throat or mouth irritation can be bothersome.

Cartridges should not be stored in very warm conditions or used in very cold conditions.

Patients with underlying bronchospastic disease must use the inhaler with caution.

ADVANTAGES

Patients can easily titrate therapy to manage withdrawal symptoms.

The inhaler mimics the hand-to-mouth ritual of smoking.

BUPROPION SRZyban (GlaxoSmithKline); generic

Nonnicotine cessation aid

Sustained-release antidepressant

Oral formulation

BUPROPION:MECHANISM of ACTION

Atypical antidepressant thought to affect levels of various brain neurotransmitters

Dopamine

Norepinephrine

Clinical effects

↓ craving for cigarettes

↓ symptoms of nicotine withdrawal

BUPROPION:PHARMACOKINETICS

AbsorptionBioavailability: 5–20%

MetabolismUndergoes extensive hepatic metabolism (CYP2B6)

EliminationUrine (87%) and feces (10%)

Half-lifeBupropion (21 hours); metabolites (20–37 hours)

30


BUPROPION:CONTRAINDICATIONS

Patients with a seizure disorder

Patients taking

Wellbutrin, Wellbutrin SR, Wellbutrin XL

MAO inhibitors in preceding 14 days

Patients with a current or prior diagnosis of anorexia or bulimia nervosa

Patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines)

BUPROPION:WARNINGS and PRECAUTIONS

Bupropion should be used with extreme caution in the following populations:

Patients with a history of seizure

Patients with a history of cranial trauma

Patients taking medications that lower the seizure threshold (antipsychotics, antidepressants, theophylline, systemic steroids)

Patients with severe hepatic cirrhosis

BUPROPION:USE in PREGNANCY

Category C drug

Use only if clearly indicated

Attempt nondrug treatment first

BUPROPION SR: DOSING

Initial treatment150 mg po q AM x 3 days

Then…150 mg po bid Duration, 7–12 weeks

Patients should begin therapy 1 to 2 weeks PRIOR to their quit date to ensure that therapeutic plasma

levels of the drug are achieved.

BUPROPION:ADVERSE EFFECTS

Common side effects include the following:Insomnia (avoid bedtime dosing)

Dry mouth

Less common but reported effects:Tremor

Skin rash

BUPROPION: ADDITIONAL PATIENT EDUCATION

Dose tapering not necessary when discontinuing treatment

If no significant progress toward abstinence by seventh week, therapy is unlikely to be effective

Discontinue treatmentReevaluate and restart at later date

31


BUPROPION SR: SUMMARYDISADVANTAGES

The seizure risk is increased.

Several contraindications and precautions preclude use.

ADVANTAGESBupropion is an oral formulation with twice-a-day dosing.

Bupropion might be beneficial for patients with depression.

VARENICLINE Chantix (Pfizer)

Nonnicotinecessation aid

Partial nicotinic receptor agonist

Oral formulation

VARENICLINE:MECHANISM of ACTION

Binds with high affinity and selectivity at α4β2neuronal nicotinic acetylcholine receptors

Stimulates low-level agonist activity

Competitively inhibits binding of nicotine

Clinical effects

↓ symptoms of nicotine withdrawal

Blocks dopaminergic stimulation responsible for reinforcement & reward associated with smoking

VARENICLINE:PHARMACOKINETICS

Absorption

Virtually complete after oral administration; not affected by food

Metabolism

Undergoes minimal metabolism

Elimination

Primarily renal through glomerular filtration and active tubular secretion; 92% excreted unchanged in urine

Half-life

24 hours

VARENICLINE :USE in PREGNANCY and LACTATION

Category C drug

Use only if potential benefit justifies potential risk

Attempt nondrug treatment first

Unknown if drug excreted in human breast milk

VARENICLINE: DOSINGPatients should begin therapy 1 week PRIOR to theirquit date. The dose is gradually increased to minimize

treatment-related nausea and insomnia.

1 mg bidDay 8 to end of treatment*

0.5 mg bidDay 4 to day 7

0.5 mg qdDay 1 to day 3

DoseTreatment Day

Initial dose titration

* Up to 12 weeks

32


VARENICLINE:ADVERSE EFFECTS

Common side effects (≥5% and twice the rate observed in placebo-treated patients) include:

Nausea

Sleep disturbances (insomnia, abnormal dreams)

Constipation

Flatulence

Vomiting

VARENICLINE: ADDITIONAL PATIENT EDUCATION

Doses should be taken after eating, with a full glass of water

Nausea and insomnia are side effects that are usually temporary.

If symptoms persist, notify your health care provider

Dose tapering not necessary when discontinuing treatment

VARENICLINE: SUMMARYDISADVANTAGES

May induce nausea in up to one third of patients.

Post-marketing surveillance data not yet available.

ADVANTAGESVarenicline is an oral formulation with twice-a-day dosing.

Varenicline offers a new mechanism of action for persons who previously failed using other medications.

PHARMACOLOGIC METHODS: SECOND-LINE THERAPIES

Clonidine (Catapres transdermal or oral)

Nortriptyline (Pamelor oral)

HERBAL DRUGS for SMOKING CESSATION

LobelineDerived from leaves of Indian tobacco plant (Lobelia inflata)

Partial nicotinic agonist

No scientifically rigorous trials with long-term follow-up

No evidence to support use for smoking cessation

Illustration courtesy of Missouri Botanical Garden ©1995-2005. http://www.illustratedgarden.org/

LONG-TERM (≥6 month) QUIT RATES for AVAILABLE CESSATION MEDICATIONS

0

5

10

15

20

25

30

Nicotine gum Nicotinepatch

Nicotinelozenge

Nicotinenasal spray

Nicotineinhaler

Bupropion Varenicline

Active drugPlacebo

Data adapted from Silagy et al. (2004). Cochrane Database Syst Rev; Hughes et al., (2004). Cochrane Database Syst Rev.; Gonzales et al., (2006). JAMA and Jorenby et al., (2006). JAMA

Perc

ent q

uit 19.5

14.6

11.5

8.6

16.4

8.8

23.9

11.8

17.1

9.1

20.0

10.2 9.3

22.4

33


COMBINATION PHARMACOTHERAPY

Combination NRTLong-acting formulation (patch)

Produces relatively constant levels of nicotine

PLUSShort-acting formulation (gum, lozenge, inhaler, nasal spray)

Allows for acute dose titration as needed for withdrawal symptoms

Bupropion SR + NRT

The safety and efficacy of combination of varenicline with NRT or bupropion has not been established.

Reserve for patients unable to quit using monotherapy.

COMPLIANCE IS KEY to QUITTING

Promote compliance with prescribed regimens.

Use according to dosing schedule, NOT as needed.

Consider telling the patient:“When you use a cessation product it is important to read all the directions thoroughly before using the product. The products work best in alleviating withdrawal symptoms when used correctly, and according to the recommended dosing schedule.”

COMPARATIVE DAILY COSTS of PHARMACOTHERAPY

Cost per day, in U.S. dollars0 2 4 6 8

Nasal spray

Patch

Varenicline

Cigarettes (1 pack/day)

Lozenge

Bupropion SR

Gum

Inhaler $6.07

$5.81

$5.73

$5.26

$3.91

$3.67

$4.22

$4.26

WORKSHOP: CASE SCENARIOS

LEARNING FORMAT

Case scenarios

Range of 1–15 minutes for each interaction

Two rolesClinicianPatient

LEARNING FORMAT (cont’d)

Break into groups of two

Alternate roles as the clinician and the patient

Class discussion following each case

34


The CLINICIAN

Brief description of the patient and the setting

Tailor your messages based on each patient’s needs and readiness

Step 1: ASK about tobacco useStep 2: ADVISE patient to quit

Clear, strong, personalized, sensitive

Step 3: ASSESS readiness to make a quit attempt

The CLINICIAN (cont’d)

Step 4: ASSIST with the quit attemptAssess tobacco use history

Assess key issues for the upcoming or current quit attempt

Help patient to choose methods for quitting and facilitate the quitting process

Step 5: ARRANGE follow-up careSchedule a time to either meet or call patient

The CLINICIAN (cont’d)

A few helpful hints…

Use ACTIVE listening and open-ended questions

Show EMPATHY

EXPLORE patients’ history, beliefs, motivations, and perceived barriers prior to making recommendations; consider cost issues

RESIST temptation to move patients too quickly

Refer to TOBACCO CESSATION COUNSELING GUIDESHEET

The PATIENT

Brief description of the patient and the setting

General guidelines for responses to clinician’s queries

SUMMARY: CASE SCENARIOS

Use this class time to apply your new knowledge and practice your new counseling skills.

Many of the counseling skills learned in the Rx for Change program can be applied to behaviors other than tobacco use

Don’t wait too long to apply your new skills in the “real world”