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Vermont Cardiac NetworkFebruary 11, 2016

Tobacco Treatment 2016: An Evidence Based Approach

Elizabeth Maislen, APRN, CTTS

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Disclosures

None. I do not intend to discuss off label use of

any products. I don’t smoke and I don’t vape or

hookah. When patients ask, “Did YOU ever

smoke?” I tell them “It’s not about me today, it’s all about YOU.”

Thank you to Susanne Tanski, MD

Cessation Treatments are Underused!

The treatments recommended in the PHS guidelines are underused by smokers and health care providers.

About 70% of smokers want to quit smoking, and about half try to quit each year.

However, less than 10% succeed, in part because less than one-third of smokers who try to quit use proven cessation treatments.

In 2010, less than half of smokers (48.3%) who saw a health professional in the past year reported receiving advice to quit

The Surgeon General’s Report

Cigarettes and other tobacco products have evolved into highly engineered, addictive and deadly products, containing thousands of y p gharmful chemicals causing a wide range of diseases, cancers and premature deaths.

9 of 10 smokers regret ever having started. 60% of current smokers perceive themselves as

“very addicted.”

Health Consequences Smoking-50 years of Progress, UHDHHS, Report of Surgeon General 2014

What’s Different?Today’s cigarette smokers, especially women, have much higher risk for lung cancer, COPD and CVD, despite smoking fewer cigarettes.

The design of the cigarette is different.

More nicotine is absorbed when smoked.

Combinations of products in cigarettes.

International Tobacco Control Study S. Glantz et al, 2-8-14; 2002-2011 longitudinal study

PHS-Sponsored Clinical Practice Guideline Treating Tobacco Use and Dependence: 2008 Update

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NicotineNicotine

Where is it found?

– Tobacco plant

– Virtually all is from tobacco, even NRT

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Chemical structure

– Readily crosses cell membranes

– Binds in brain and muscle

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https://www.youtube.com/watch?v=nwVxu

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The Health Consequences of Smoking:50 Years of Progress

A Report of the Surgeon General

1964 2014

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The Grim Statistics

Between 1964 and 2014:

Over 20 million Americans died because of smoking, including 2.5 million nonsmokers

More than 100,000 babies

Smoking is still the leading cause of preventable disease and death in the United States.

What We’ve Learned

The Killer Cigarette

Smoking risks are more deadly than 50 years ago.

Smokers inhale over 7,000 chemical compounds.

At least 70 CAUSE CANCERCANCER.

What We’ve Learned

The Killer Cigarette

Smoking causes disease in nearly every organ.

Secondhand smoke kills more than 41,000 nonsmokers every year.

There is no safe level of SHS exposure and NO SAFE CIGARETTECIGARETTE.

21st Century Tobacco UseBetween 2010 and 2014 smoking caused

Nearly half a million premature deaths a year

More than 87% of all lung cancer deaths

61% of all pulmonary deaths

32% of all coronary deaths

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Smoking and Children Today about half of all children 3-18 years of age are

exposed regularly to cigarette smoke.

Every day over 3,200 kids try their first cigarette and another 2,100 youth and young adults become daily smokers.

Nearly 9 out of 10 smokers started before age 18.

Photo credit: Trinketsandtrash.org

Smoking and ChildrenEvery adult who dies early because of smoking is replaced by two new young smokers.

If they keep smoking, at least one of the two will also die early from smoking.

Smoking and Children The costs of smoking Annual smoking costs are more than $289 billion.

We spend at least $132 billion in yearly medical care for adults.

We lose at least $157 billion yearly in productivity costs when smokers get sick and die early.

The Power of Nicotine Addiction Nicotine is the primary addicting drug in cigarettes.

Nicotine keeps people smoking longer and that causes more damage to the body.

Nicotine patches, gum, and lozenges are safe when used as directed.

Nicotine

Nicotine is the primary addicting drug in cigarettes.

It can raise heart rate and blood pressure.

It can result in premature births and low birth weight babies in women who smoke during pregnancy.

It can be harmful to developing brains.

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Smoking and Lung Cancer

Today’s smokers are more likely to develop lung cancer than smokers 50 years ago.

Lung cancer is the #1 cause of cancer death for men and women.

Nearly 9 out of 10 lung cancers are caused by smokingsmoking.

Smoking – The Cancer Trigger

Smoking is now known to cause

13 different types of cancer—

almost everywhere in the body.

1 out of 3 U.S. cancer deaths are tobacco-related.

New Cancer FindingsTWO more cancers are caused by smoking:

Liver cancer

Colorectal cancer –the second deadliest behind lung cancer

SMOKING keeps cancer treatments from working as well as they should.

Smoking – The Breath Blocker COPD rates have risen steadily since 1964.

Nearly 8 out of 10 COPD deaths are from smoking.

COPD patients have higher risk for lung cancer and heart disease.

Women who smoke are now dying from COPD in the same numbers as men who smoke.same numbers as men who smoke.

Smoking – The Heart StopperCardiovascular Disease (CVD)

CVD is the biggest killer in the U.S.

It causes more than 800,000 deaths every year.

Smoking is a major cause of CVD.

SHS increases the risk for heart attack or stroke, SHS increases the risk for heart attack or stroke, even for nonsmokers.

Cardiovascular disease includes:

Coronary heart disease

High blood pressure

Heart attack

Stroke

Abdominal aortic aneurysm

P i h l t i l di Peripheral arterial disease

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Smoking – The Heart Stopper Smoking causes cells lining veins and arteries to

swell.

Narrower arteries mean reduced blood flow to the heart, brain, and organs.

Clots can block narrowed t i i h t tt karteries, causing heart attack,

stroke, and even sudden death.

Even occasional smoking damages blood vessels.

Smoking and ReproductionSmoking also causes reproductive issues for men:

Smoking can cause erectile dysfunction (ED).

Smoking damages DNA in sperm.

Smoking and DiabetesDiabetes is the 7th leading cause of death in the U.S.

Smoking causes type 2 diabetes.

Smokers are 30-40% more likely to develop type 2 diabetes than nonsmokers.

Smoking and DiabetesDiabetic smokers:

Have difficulty regulating insulin levels.

Have higher risk of heart disease, blindness, kidney failure, and nerve and blood vessel damage to feet and legs.

Smoking and the Immune System Smoking harms the immune system and causes

autoimmune disorders.

Smoking is a cause of rheumatoid arthritis (RA).

RA treatment can be less effective for smokers.

Smoking Today – The Persistent Epidemic

Cigarettes cause almost all tobacco-related disease and death.

Smoking claims nearly 500,000 lives every year.

More than 16 million people have at least one smoking-related disease.

88 million Americans continue to be exposed to SHS 88 million Americans continue to be exposed to SHS.

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Smoking Today – The Persistent Epidemic Lower smoking rates have saved 8 million lives and

added about three years to average life expectancy.

50 years after the first SG report, 18% of Americans smoke compared to 43% in 1965.

Today 42 million adults and 3 million middle and high school students are smokers.

W h d b t th i till h We have made progress, but there is still so much more to do.

Saving Millions of Lives – Doing Much MoreWe know what works to lower smoking rates:

Smokefree policies in public places

Make smoking the exception – not the norm

Easy-to-get affordable smoking cessation treatments

Cessation – Lifeline to a Tobacco-Free Life Most smokers want to quit and half already have.

Cessation therapies improve your chances of quitting successfully.

Talk to your doctor, and call 1-800-QUIT-NOW or go to http://www.SmokeFree.gov for free help.

We Can Be Tobacco-Free

The time is NOW to begin a tobacco-free future.

We can break the cycle of sickness, disability and death caused by smoking.

We can reduce the disease and death caused by smoking until the scourge of the tobacco use epidemic becomes a minor public health nuisance.

We Can Be Tobacco-Free

is the chief, single, avoidable cause of death

“CIGARETTE “CIGARETTE SMOKING…SMOKING…

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in our society and the most important public health

issue of our time.”C. Everett Koop, M.D., former U.S. Surgeon General

All forms of tobacco are harmful.

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TRENDS in ADULT TRENDS in ADULT SMOKING, by SEXSMOKING, by SEX——U.S., U.S., 19551955––20092009

Trends in cigarette current smoking among persons aged 18 or older

t

Male

20.6% of adults are current

smokers

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

Per

cen

t

70% want to quit70% want to quit

Female 23.5%17.9%

Year

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Henry Waxman 1994Henry Waxman 1994It is sometimes easier to invent fiction than to

face the truth. The truth is that cigarettes are the

single most dangerous consumer product ever

sold Nearly a half million Americans die every

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sold. Nearly a half million Americans die every

year as a result of tobacco. This is an

astounding, almost in- comprehensible statistic.

Imagine our Nation's outrage if two fully loaded

jumbo jets crashed each day, killing all aboard.

Yet that is the same number of Americans that

cigarettes kill every 24 hours.45

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VERMONTVERMONT

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NEW HAMPSHIRENEW HAMPSHIRE

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VERMONTVERMONT

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NEW HAMPSHIRENEW HAMPSHIRE

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Age-standardized total cigarette smoking prevalence, males, 1996 and 2012.

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Age-standardized total cigarette smokingprevalence, females, 1996 and 2012.

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“Smoking will retard wound healing, whether the wound is surgical or the result of trauma or burns”

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Silverstein P: Smoking and wound healing. Presented at the Medical Leadership Conference: Effects of Cigarette Smoking -- A Global Perspective,Washington, DC, July 18, 1991.

“Wound complications after breast reduction surgery or mastectomy are 30-50% higher in women who smoke”

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Silverstein P: Smoking and wound healing. Presented at the Medical Leadership Conference: Effects of Cigarette Smoking -- A Global Perspective,Washington, DC, July 18, 1991.

“Patients who smoked regularly before surgery had twice the risk of wound infections as non-smokers”

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Jones RM: Smoking before surgery: The case for stopping. BR Med J1985;290(6484):1763-1764

“Recovery room stays are 20% longerfor smokers than non-smokers”

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Handlin DS, Baker T, Woolwich J: Effect of smoking on duration in recovery room.Anesthesiology 1990;73(8):1052.

“Smoking slows the healing of peptic duodenal ulcers and increases the rate of ulcer relapse”

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Kuipers EJ, Hazenberg HJ, Quik RF, et al: Nizatidine versus ranitidine in the treatment of peptic ulcer disease: Report on the Dutch investigation as part of a European multi-centre trial. Neth J Med 1990;37(i-2):58-62.

“A smoker’s broken bones takealmost twice as long to healcompared to those of a non-smoker”

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USA Today, February 1995

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It pays to quit smokingIt pays to quit smoking--Literally!Literally!

Moderate smokers (1 ppd) = $8/day, $64/week,

$3328 a year, that’s $33,280 in 10 years!

H k (3 d) $24/d $168/ k

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Heavy smoker (3 ppd) = $24/day, $168/week,

$8736 a year, that’s $87,360 in 10 years!

Smokers may spend up to 8% of their annual

income a year on the purchase of cigarettes,

which can profoundly affect the financial well

being of their families.

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“Indeed it is difficult to identify any other condition that presents such a mix of lethality prevalence and

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lethality, prevalence, and neglect, despite effective and readily available interventions.”

Fiore et al, U.S. Department of Health and Human Services June 2000

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Peripheral Effects of NicotinePeripheral Effects of Nicotine Increased Heart rate

Increased Blood pressure

Vasoconstriction

Increased metabolic rate

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Increased metabolic rate

Lipolysis

Skeletal muscle relaxation

EEG desynchronization

Increased ACTH Adrenal steroids

Psychological Effects of Psychological Effects of NicotineNicotine Stimulation

Arousal

Memory

Attention

I d d f i

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Increased speed of processing

Relaxation

Anxiolytic/stress reduction

Analgesia

Mood improvement

Appetite suppression

Social facilitationPHS

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ANNUAL SMOKINGANNUAL SMOKING--ATTRIBUTABLE ECONOMIC ATTRIBUTABLE ECONOMIC COSTSCOSTS

Health-care expenditures

Lost productivity costs

T t l f d l t t

$96.7 billion

$97.6 billion

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0 50 100 150 200

Societal costs: $10.28 per pack of cigarettes smoked

Total economic burden of smoking, per year

Billions of US dollars

Centers for Disease Control and Prevention (CDC). (2008). MMWR 57:1226–1228.

Total Medicare program costs

Total federal-state Medicaid program costs $30.9 billion

$18.9 billion

$194 billion

2008 PHS Clinical Practice 2008 PHS Clinical Practice Guideline: Treating Tobacco Use Guideline: Treating Tobacco Use and Dependence Updateand Dependence UpdateHistory:

1. 1996—Initial Guideline published;

literature from 1975–1995;

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approximately 3,000 articles

2. 2000—Revised Guideline published;

literature from 1995–1999;

approximately 6,000 articles

3. 2008—Updated Guideline published;

literature from 1999–2007;

approximately 8,700 total articles

Combinations: Medication and Combinations: Medication and CounselingCounseling

Effectiveness of and estimated abstinence rates for the combination of counseling and medication versus counseling alone (n = 9 studies)

Estimated Estimated

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TreatmentNumber

of arms

Estimated

odds ratio

(95% C.I.)

Estimated

abstinence

rate (95% C.I.)

Counseling

alone11 1.0 14.6

Medication

and

counseling

131.7

(1.3, 2.1)

22.1

(18.1, 26.8)

ProPro--Active QuitlinesActive QuitlinesEffectiveness of and estimated abstinence rates for quitline counseling compared to minimal interventions, self-help or no counseling (n = 9 studies)

InterventionNumber

of arms

Estimated

odds ratio

Estimated

abstinence rate

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of arms(95% C.I.) (95% C.I.)

Minimal or

no counseling

or self-help

11 1.0 8.5

Quitline

counseling 11

1.6

(1.4, 1.8)

12.7

(11.3, 14.2)

Effectiveness of and estimated abstinence rates for quitline counseling and medication compared to medication alone (n = 6 studies)

InterventionNumber

of arms

Estimated

odds ratio

Estimated

abstinence rate

ProPro--Active QuitlinesActive Quitlines

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of arms(95% C.I.) (95% C.I.)

Medication alone 6 1.0 23.2

Medication and

quitline counseling 6

1.3

(1.1, 1.6)

28.1

(24.5, 32.0)

Medications are effective, but they are just one component of comprehensive treatment for tobacco cessation.

Behavior change is equally important.

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CLOSE TO HOME © 2000 John McPherson. Reprinted with permission of UNIVERSAL PRESS SYNDICATE.

All rights reserved.

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TOBACCO TOBACCO TREATMENTTREATMENT MedicationMedication

Seven first-line medications shown to be effective and recommended for use by the Guideline Panel:

– Nicotine Patch

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– Nicotine Gum– Nicotine Lozenge– Nicotine Inhaler– Nicotine Nasal Spray– Bupropion SR – Varenicline

Absorption of NicotineAbsorption of Nicotine

Nicotine is carried on tar droplets

Absorption depends on pH

Most cigarette smoke is acidic and absorbed

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Most cigarette smoke is acidic and absorbed by the lungs, 1-2 mg nicotine/cigarette

Some tobacco smoke (pipe, cigar) is alkaline and absorbed through the mouth, amount absorbed is then highly variable.

TTS Course U Mass Medical School

Nicotine Patches1mg /1cigarette

21 mg14 mg7 mg7 g

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Nicotine InhalerNicotine Inhaler

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Medication RecommendationMedication RecommendationRecommendation: Certain combinations of first-line medications have been shown to be effective smoking cessation treatments. Therefore, clinicians should consider using these combinations of medications with their patients who are willing to quit. Effective combination medications are:

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combination medications are:

* Long-term (> 14 weeks) nicotine patch + other NRT (gum and spray)

* The nicotine patch + the nicotine inhaler

* The nicotine patch + bupropion SR.

(Strength of Evidence = A)

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VareniclineVareniclineEffectiveness and abstinence rates for various medications and medication combinations compared to placebo at 6-months post-quit (n = 86 studies)

M di tiNumber

Estimated

dd ti

Estimated

b ti t

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Medicationof arms

odds ratio

(95% C. I.)

abstinence rate

(95% C. I.)

Placebo 80 1.0 13.8

Varenicline

(2 mg/day)5

3.1

(2.5, 3.8)

33.2

(28.9, 37.8)

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Treatment Efficacy and Treatment Efficacy and Number of SessionsNumber of Sessions

0-1 sessions 12.4% est. abstinence

2-3 sessions 16.3%

4-8 sessions 20.9%

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>8 sessions 24%

No difference in outcome between group and individual counseling

Telephone counseling is effective

PHS Guidelines 2000,Commonwealth Fund Report

Electronic CigaretteElectronic CigaretteA SMOKING CESSATION A SMOKING CESSATION DEVICE?DEVICE?

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ELECTRONIC CIGARETTESELECTRONIC CIGARETTES Battery operated devices that deliver vaporized nicotine

– Cartridges contain nicotine, flavoring agents, and other chemicals

Battery warms cartridge; user inhales nicotine vapor or

‘smoke’

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Available on-line and in shopping malls

– Not labeled with health warnings Preliminary FDA testing found some

cartridges contain carcinogens and impurities (e.g., diethylene glycol)

No data to support claims that these products are a safe alternative to smoking

Other forms of Tobacco Cigars Blunts Hookah or Water Pipe Hookah or Water Pipe Vaping products Smokeless tobacco

Chewing tobacco Snuff- moist and dry, sachel or Snus “Dip” Dissolvables

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Dual Tobacco Use

Combustible plus non combustible tobacco types

Convenient packaging facilitates Convenient packaging facilitates availability and ease of using both types of products.

Snus package can fit just about anywhere, can be used in places where you cannot smoke.

From Cigarette to Vapor Pen, an evolution in technology

PHS-Sponsored Clinical Practice Guideline Treating Tobacco Use and Dependence: 2008 Update

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Roll Your Own Cigarettes

Roll in rolling machine or by hand “rollies” Use increases when branded cigarette prices go up Pipe tobacco Pipe tobacco Greater tar and nicotine yields/cigarette Likely inhale differently or more deeply, depositing

smoke, nicotine and toxins in lungs Greater urinary concentrations of toxins Increases risks for lung and oral cancers Low cost=more affordable

Addict Biol, 14, 2009, page 315 Tobacco Control, June 1998, Darrall & Figgins, page 168.

Cloud Vape Pen

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The Electronic Cigarette

http://www ispot tv/ad/7fnS/njoy e http://www.ispot.tv/ad/7fnS/njoy-e-cigarette-return-the-favor-song-by-avicii

What are the public health harms?

Re-normalizing the image of smokingAllowed in places where smoking is not

allowedAdvertising is completely unrestricted, with TV

ads for the first time since 1971 Largely indistinguishable from cigarettes

Second-hand vapor is NOT just water vaporEmit variable levels of nicotine

So what to do?

Research is imperative to assess second hand vapor effects (of all kinds), addiction potential and dual-use maintenance

Must have a regulated product for an informed consumer, with fully disclosed labeling

Until we know more about “e-anything” and cessation, we can still recommend medicinal NRT, quit lines and support while people are becoming non-tobacco users

Carbon Monoxide MonitorCarbon Monoxide MonitorCPT Code 94250CPT Code 94250

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Type: PNG

•660 × 396 (Same size), 154KB•Search by imageImages may be subject to copyright.

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Type: PNG

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Ask Ask about tobacco use. Identify and document tobacco use status for every patient at every visit.

AdviseAdvise to quit. In a clear, strong and personalized manner urge every tobacco user to quit.

AssessAssess willingness to make a quit attempt Is the tobacco user

The "5 A's" Model for Treating The "5 A's" Model for Treating Tobacco Use and Dependence Tobacco Use and Dependence --20002000

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AssessAssess willingness to make a quit attempt. Is the tobacco user willing to make a quit attempt at this time?

Assist Assist in quit attempt. For the patient willing to make a quit attempt, use counseling or pharmacotherapy to help him or her quit.

ArrangeArrange followup. Schedule followup contact, preferably within the first week after the quit date.

BRIEF COUNSELING: BRIEF COUNSELING: ASK, ADVISE, REFERASK, ADVISE, REFER

ASK about tobacco USE

ADVISE tobacco users to QUIT

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REFER to other resources

ASSIST

ARRANGE

Patient receives assistance, with follow-up counseling

arranged, from other resources such as the

tobacco quitline

Brief interventions have been shown to be

effective

In the absence of time or expertise:

BRIEF COUNSELING: BRIEF COUNSELING: ASK, ADVISE, REFER ASK, ADVISE, REFER (cont’d)(cont’d)

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In the absence of time or expertise:

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

intervention can be achieved in less than 3 minutes.

30

ence

at

s

n = 29 studies

With help from a clinician, the odds of quitting approximately doubles.

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

CLINICIANS CAN MAKE a CLINICIANS CAN MAKE a DIFFERENCEDIFFERENCE

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0

10

20

No clinician Self-helpmaterial

Nonphysicianclinician

Physicianclinician

Type of Clinician

Esti

mat

ed a

bsti

ne5+

mon

ths

1.0 1.11.7

2.2

Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

WHAT ARE WHAT ARE “TOBACCO QUITLINES”?“TOBACCO QUITLINES”?

Tobacco cessation counseling, provided at no

cost via telephone to all Americans

Staffed by trained specialists

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Staffed by trained specialists

Up to 4–6 personalized sessions (varies by

state)

Some state quitlines offer pharmacotherapy at

no cost (or reduced cost)

Up to 30% success rate for patients who

complete sessionsMost health-care providers, and most patients,

are not familiar with tobacco quitlines.

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Insurance Coverage of Cessation Treatments is Cost Effective

Cessation treatments are both clinically effective and highly cost-effective relative to interventions for other clinical disorders.

Cost-effectiveness analyses have shown that tobacco dependence treatment that tobacco dependence treatment compares favorably with routinely reimbursed medical interventions such as the treatment of hypertension and high cholesterol, as well as preventive screening interventions such as periodic mammography and PAP tests.

Current Status of Cessation Coverage

Nine states have laws or regulations in place requiring at least some private insurance plans to cover certain cessation treatments.

(Colorado, Illinois, Maryland, New Jersey, New Mexico, North Dakota, Oregon, Rhode Island, and Vermont)

Medicaid Coverage and the ACA

Section 4107 of the Affordable Care Act requires all state Medicaid programs to provide a comprehensive tobacco cessation benefit as defined by the USPHS guidelines to pregnant women who are enrolled in Medicaid, effective October 2010

As of January 2014, Section 2502 of the law bars state Medicaid programs from excluding cessation medications, including over-the-counter medications, from coverage.

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Medicare Coverage Medicare recipients have access to individual

cessation counseling and prescription cessation medications.

Th b fit t it tt t d The benefit covers two quit attempts a year and four counseling sessions per quit attempt.

Medicare copayment, coinsurance, and deductibles for cessation treatments are waived under the Affordable Care Act, effective January 1, 2011.

HELPING PATIENTS QUIT HELPING PATIENTS QUIT IS a CLINICIAN’S IS a CLINICIAN’S RESPONSIBILITYRESPONSIBILITY

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

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

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

plan for their quit attempts.

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FIVE YEAR SURVIVAL65 year old patients with:

• Early stage non-small cell lung CA33% for continued smokers70% for smokers who quit

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70% for smokers who quit

• Limited stage small cell lung CA29% for continued smokers63% for smokers who quit

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Tobacco Dependence Tobacco dependence is a chronic disease,

with most smokers making multiple quit attempts before succeeding.

Many of these smokers require repeated intervention.

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THANK YOU!(For not smoking)(For not smoking)