Carol Southard, RN, MSN

1
Tobacco Cessation Practice Guidelines
Carol Southard, RN, MSN Tobacco Treatment
Specialist Northwestern Memorial Physicians
Group
2
Presentation Objectives

• At the conclusion of this program, the
  participant will be able to
• Describe trends and issues regarding smoking
  cessation
• Discuss tobacco cessation intervention
• Review treatment options in the management of
  smoking cessation
• Explain current guidelines on smoking cessation
  intervention
• Summarize appropriate cessation pharmacotherapy

3
The use of tobaccoconquers men with a certain
secret pleasure so that those who have once
been accustomed theretocan hardly be restrained
therefrom
Sir Francis Bacon

• Historica Vital et Mortis 1622

4
a custome lothsome to the Eye, hatefull to the
Brain, dangerous to the Lungs, and in the black
stinking fume thereof, nearest resembling the
horrible, stigian smoke of the pit that is
bottomlesseKing James I, 1604

• My position on the use of tobacco

5
6th principleIt is the imperative of every
lover of mankind, to unite in suitable efforts to
remove this rapidly increasing evil, by
exhibiting its injurious effects on the health,
its degrading consequences on the morals, and its
enslaving power on the habits, of its deluded
victims, and also, by seeking to deter others,
especially the young, from acquiring this
unnecessary, offensive and injurious practice.

• British Anti-Tobacco Society 1850s

6
(No Transcript)
7
Tobacco Facts

• 1 public health problem in the United States
• Most preventable cause of morbidity and mortality
• Causes more deaths each year than alcohol, motor
  vehicle accidents, suicide, AIDS, homicide,
  illicit drugs and fires combined
• Proven risk factor for heart disease, malignant
  neoplasms and stroke
• One-third of all tobacco users will die
  prematurely
• 90 of smokers begin smoking before age 21
• 75.5 billion in direct medical costs 92
  billion in lost productivity
• U.S. DHHS, CDC (2004) The Health Consequences of
  Smoking A Report of the Surgeon General.

8
Comparative Causes of Annual Deaths in the United
States
Number of Deaths (thousands)
AIDS Alcohol Motor Homicide
Drug Suicide Smoking
Vehicle
Induced
Source CDC
9
Impact of Smoking

• Conclusively linked to acute myeloid leukemia and
  cancers of the cervix, kidney, pancreas and
  stomach
• Known to cause pneumonia, abdominal aortic
  aneruysm, cataracts and periodontitis
• Harms nearly every organ of the body, damaging a
  smoker's overall health even when it does not
  cause a specific illness
• If current trends hold, tobacco will kill a
  billion people this century, 10 times more than
  the 20th century

10
Smoking Incidence Scope

• The annual toll on the nations health and
  economy is staggering 440,000 deaths, 8.6
  million people suffering from at least one
  serious illness related to smoking
• 75.5 billion in direct medical costs 92
  billion in lost productivity
• The Department of Health and Human Services has
  set a goal of reducing smoking prevalence to 12
  or less by 2010

11
ETS A Known Human Carcinogen

• ETS second hand smoke, or passive smoking
• The smoke generated from a single cigarette in a
  large room causes the air to fail the national
  minimum standard set by the Clean Air Act of 1994
• ETS is comprised of
• Sidestream smoke emitted by a burning tobacco
  product
• Mainstream smoke exhaled by the smoker
• 1986 Surgeon Generals Report
• ETS causes disease, including lung cancer, among
  healthy nonsmokers
• Separating smokers from nonsmokers in same space
  may reduce ETS exposure but does not eliminate it

12
Impact of Secondhand Smoke

• Many millions of Americans are still exposed to
  secondhand smoke
• Secondhand smoke exposure causes disease and
  premature death
• Children exposed to secondhand smoke are at an
  increased risk for sudden infant death syndrome
  (SIDS), acute respiratory infections, ear
  problems, and more severe asthma. respiratory
  symptoms and slows lung growth children
• Exposure of adults to secondhand smoke has
  immediate adverse effects on the cardiovascular
  system and causes coronary heart disease and lung
  cancer
• The scientific evidence indicates that there is
  no safe level of exposure to secondhand smoke
• Eliminating smoking in indoor spaces fully
  protects people from exposure to secondhand smoke
  - separating sections, air cleaning systems, and
  ventilating buildings cannot eliminate the risk
  of exposure

13
(No Transcript)
14
U.S. Smoking Statistics

• About 43.4 million Americans are current smokers
  19.8 (first significant change since 2004
  first time below 20 since late 20s)
• 22.3 of men and 17.4 of women smoke in US
  (since 1974, the smoking prevalence in men has
  decreased by about 1 a year, in women 0.33)
• Prevalence
• Native Americans Alaskan Natives (32.4),
• Caucasians (21.4)
• African Americans (19.8)
• Hispanics (15.2 )
• Asians (10.4 )
• MMWR (2008).
• The Department of Health and Human Services
  has set a goal of reducing smoking prevalence to
  12 or less by 2010

15
Smoking-Related Disease Smoking Prevalence

• Smoking-related chronic disease - 36.9
• (without chronic disease - 19.3)
• Smoking-related cancers (other than lung) 38.8
• Stroke 30.1
• CHD 29.3
• Emphysema 49.1
• Chronic bronchitis 41.1
• MMWR (2006).

16
Tobacco is Not an Equal Opportunity Killer

• Affects young, the poor, depressed, uninsured,
  less educated, blue-collar, and minorities most
  in the US
• Addiction affects those with the least
  information about health risks, with the fewest
  resources to resist advertising, and the least
  access to cessation services
• Those below poverty line are gt40 more likely to
  smoke than those above poverty line
• Johnston, et. al. (2006)

17
(No Transcript)
18
Cessation Facts

• About 30 of patients are current smokers
• 70 of smokers say they are interested in
  quitting
• Only 10 to 20 plan to quit in the next month
• About 43 of smokers try to quit in a given year
• The majority of smokers try to quit on their own
• Overall, self-quitters have a success rate of 4
  to 5
• Half of all smokers eventually quit on average
  former smokers report 11 quit attempts over
  almost 19 years
• MMWR (2005).

19
Neurochemical Effects of NicotineNicotine
acts on nicotinic acetylcholine receptors in both
the central nervous system and the peripheral
nervous system resulting in a physical and
biologic basis for physical dependence

• Dopamine Pleasure
• Norepinephrine Appetite Suppression
• Acetylcholine Arousal, Cognitive Enhancement
• Vasopressin Memory
• Serotonin Mood Modulation
• ß-endorphin Anxiety Reduction

• Nicotine

Benowitz NL. Primary Care. 1999 26 619.
20
(No Transcript)
21
There is little doubt in my mind that if it were
not for nicotine, in tobacco smoke, people would
be little more inclined to smoke than they are to
blow bubbles or light sparklers
Philip Morris Researcher 1976
22
Unique Qualities of Nicotine Addiction Through
Smoking

• Cigarette is a highly engineered drug-delivery
  system
• Inhaling produces a rapid distribution of
  nicotine to the brain
• Drug levels peak within 10 seconds in the brain
• Acute effects dissipate within minutes, causing
  the smoker to continue frequent dosing throughout
  the day
• Average smoker takes 200-300 boluses to the brain
  per day
• Easy to get, easy to use, and it is legal!

23
DSM-IV Substance Dependence (includes Nicotine)

• CATEGORY DSM-IV (3 during 12 mo period)
• PHYSIOLOGICAL 1. Tolerance
• 2. Withdrawal symptoms
• LOSS OF CONTROL 3. Larger amounts taken, or
  over
• longer time than intended
• 4. Persistent desire control/cut down
• CONSEQUENCES 5. Great deal of time spent
• obtaining/using/recovering
• 6. Social, occupational, recreational
• activities given up/reduced
• 7. Continue to use despite knowing

24
Nicotine Withdrawal Symptoms

• Depression
• Difficulty concentrating
• Restlessness
• Decreased heart rate
• Increased appetite
• Anxiety

• Constant craving of cigarettes
• Insomnia
• Irritability
• Fatigue
• Frustration
• Anger

Withdrawal peaks within 24-48 hours and
diminishes over 1 to 3 months.
25
Tobacco Intervention

• US Public Health Service Clinical Practice
  Guideline Treating Tobacco Use and Dependence
  2008 Update
• Systematic review of almost 9000 publications,
  gt50 meta-analyses, expert summaries of relevant
  literature
• Clinicians and health care systems can
  significantly reduce prevalence by delivering
  evidence-based treatments
• 90 of managed health care plans cover tobacco
  dependence treatment
• 75 of states have Medicaid coverage for tobacco
  dependence treatment
• 2002, Joint Commission instituted treatment
  requirement for tobacco users with acute MI, CHF,
  or pneumonia
• Medicare, VA, US military provide coverage for
  treatment
• Every state has a quitline (Illinois 1 866
  QUITYES)
• JAMA, 2008.

26
Treatment Facts

• The efficacy of several smoking cessation
  therapies is well established
• All proven treatments appear to be equally
  effective quit rates are doubled
• Early evidence suggests allowing smokers to
  choose treatment produces better outcomes
• The Agency for Health Care Policy and Research
  (AHCPR) published updated smoking cessation
  guidelines in 2008 for primary care clinicians

27
Practice Guideline

• All tobacco products exact devastating costs on
  the nations health and welfare
• For most users, tobacco use results in true drug
  dependence comparable to opiates, amphetamines
  and cocaine
• Chronic tobacco use warrants repeated clinical
  intervention just as do other addictive disorders
• Health care administrators, insurers, and
  purchasers should institutionalize guideline
  findings

28
Efficacy of Counseling

• Meta-analysis of 56 studies Cessation rates
• lt 3 minutes of counseling 10.7
• 3-10 minutes 12.1
• gt 10 minutes 18.7

Fiore MC, Wetter DW, Bailey WC, et al. Smoking
Cessation Clinical Practice Guideline. Rockville,
Maryland Agency for Health Service, U.S. Dept.
of Health and Human Services, 1996.
29
Evidence-based smoking treatments

• Medications
• Nicotine Replacement (gum, patch, inhaler, spray,
  lozenge)
• Bupropion (Zyban , Wellbutrin )
• Varenicline (Chantix)
• Counseling
• Group or individual, focus on behavioral,
  cognitive skills to prevent relapse
• NO EFFICACY NOT HELPFUL
• Hypnosis, acupuncture, herbs, lasers, etc.

UDHHS Treatment Practice Guidelines (2008)
30
Nicotine Replacement Therapy

• Goal is to replace nicotine from cigarettes in
  order to reduce or eliminate physical withdrawal
  symptoms
• Pharmacokinetic properties differ but none
  deliver nicotine to the circulation as fast as
  does inhaling cigarettes
• Effectiveness of all are broadly similar
• Few health interventions have such overwhelming
  evidence of effectiveness
• Self-administered products should be used on
  scheduled basis initially before tapered to ad
  lib use and eventual discontinuation

31
Plasma Nicotine ConcentrationsCigarettes versus
NRT

• Cigarettes
• 1 cigarette produces rapid surge of plasma
  nicotine
• ? by about 25 ng/ml in minutes declines rapidly
• NRT
• No form achieves plasma nicotine concentrations
  as high as those from smoking 20 cigarettes/day
• Does not reproduce immediate effect of smoking

Tang JL, Law M, Wald N. BMJ. 1994 308 22.
32
Nicotine Replacement Therapy

• No evidence of increased cardiovascular risk with
  NRT except with acute disease
• Medical contraindications
• Immediate myocardial infarction (lt 2 weeks)
• Serious arrhythmia
• Serious or worsening angina pectoris
• Accelerated hypertension

33
Nicotine Gum

• Available since 1984
• OTC 1995
• 2 mg recommended for patients smoking less than 1
  pack per day
• 4 mg for patients smoking over 1 pack/day
• Full dose absorbed in about 20 minutes
• Cost 6.00 per day

34
Nicotine Patch

• Available since 1994
• OTC 1996
• 21 mg recommended for patients smoking 1 pack per
  day
• 14 mg for patients smoking 1/2 pack/day
• 7 mg for patients smoking 5 or less cigarettes a
  day
• Full dose absorbed in about 2 hours
• Cost 4.00 per day

35
Nicotine Inhaler

• Available since 1998 - Rx
• Each cartridge delivers 4 mg of nicotine over 80
  inhalations
• Full dose absorbed in about 20 minutes
• Cost 10.00 per day
• Designed to combine pharmacological and
  behavioral substitution

36
Nicotine Nasal Spray

• Available since 1996 - Rx
• Each spray delivers 0.5 mg of nicotine
• Full dose absorbed in less than 5 minutes
• Minimum recommended treatment is 8 doses per day
• Cost 5.00 per day

37
Nicotine Lozenge

• Available since 2002 - OTC
• 2 mg recommended for patients who smoke more than
  30 minutes after waking
• 4 mg for patients who smoke within 30 minutes of
  waking
• Full dose absorbed in about 20 minutes

38
Combination Nicotine Replacement Therapy

• Combining the nicotine patch and a
  self-administered NRT (either nicotine gum or
  nicotine nasal spray) is more efficacious than a
  single form of NRT

39
Nicotine Delivery SystemsPlasma Concentrations
Cigarette
Gum (4 mg)
Gum (2 mg)
Inhaler
Nasal spray
Patch
Reprinted with permission from Schneider et al.,
Clinical Pharmacokinetics 200140(9)661684.
Adis International, Inc.
40
Representative Long-Term Quit Rates

• Type
• Combined Treatment
• NRT Alone
• Behavior Therapy
• Not Treatment

• Abstinent
• 35 40
• 20 25
• 20 25
• 5

41
Non-Nicotine MedicationsBupropion

• An atypical antidepressant with dopaminergic and
  noradrenergic activity
• First FDA approved non-NRT
• Risk of seizure is 0.1 or less
• Can be used in combination with NRT
• Is effective in those with no current or past
  depressive symptoms

42
Bupropion SR

• Available by prescription only (USA)
• Dosing
• Start 1-2 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 consider as a maintenance therapy
  for up to 6 months post-cessation
• Side effects
• Dry mouth and insomnia
• Risk of seizure approximately 1 in 1,000
• Contraindicated for patients with seizure
  disorder or predisposing factors that increase
  seizure risk (head injury, active substance
  abuse)

43
Multiple Pharmacotherapy

• Bupropion SR may be combined with any of the NRTs
• Combination NRT
• Patch gum or patch nasal spray is more
  efficacious than a single NRT
• Encourage in patients unable to quit using single
  agent
• Combined NRT not currently FDA approved

44
Non-Nicotine MedicationsVarenicline

• A partial nicotinic acetylcholine receptor
  agonist
• Specifically indicated for use as an aid in
  smoking cessation
• Provides some nicotine effects to ease withdrawal
  symptoms
• Blocks effects of nicotine

45
Varenicline (Chantix)

• Recommended dosage
• Start 1 week before quit date
• 0.5 mg for 3 days
• Then 0.5 mg BID for 4 days
• Then 1 mg BID for up to 12 weeks

46
Varenicline (Chantix)

• Efficacy
• Six clinical trials N3659
• Self-report verified by CO measurement
• 1 in 5 quit at 1 year
• Precautions
• Nausea reported by 1/3
• Pregnancy Category C
• NO Contraindications

47
Extended Use of Pharmacotherapy

• First-line tobacco dependence medications may be
  considered for extended use, especially in
  patients with persistent withdrawal symptoms
• Evidence shows that a minority of patients
  continue ad libitum NRT agents
• Does not present known health risks
• FDA has approved bupropion SR for a long-term
  maintenance indication
• FDA has approved varenicline for a 3-month term
  indication may be repeated as necessary

48
Psychosocial Therapies

• Behavioral therapy is the only proven
  psychosocial treatment for smoking cessation
• Can be administered in a group setting or can
  also be conducted on an individual basis
• Major disadvantage is limited availability and
  acceptability
• Quitlines use behavioral/cognitive approach

49
State of the Art Programs

• Setting of specific quit date
• Interruption of conditioned responses
• Identification and preparation of plans for
  coping
• Attention to relapse episodes
• Encouragement of continued nonsmoking
• Follow up contact
• Social support for quitting and abstinence

50
Elements of a Counseling Intervention

• Quit date
• Set a stop date, preferably within 2 weeks
• Starting on the quit date, total abstinence is
  essential
• Past quit experience
• Identify what helped and what hurt in previous
  quit attempts
• Anticipate triggers or challenges in upcoming
  attempt
• Discuss challenges/triggers and how patient will
  successfully overcome them

51
Elements of a Counseling Intervention (continued)

• Alcohol
• Since alcohol can cause relapse, the patient
  should consider limiting/abstaining from alcohol
  while quitting
• Other smokers in the household
• Quitting is more difficult when there is another
  smoker in the household
• Patients should encourage housemates to quit with
  them or not smoke in their presence

52
Ambivalence
Patients task to articulate and resolve
ambivalence.
Clinicians role to help him/her examine and
resolve ambivalence
53
Pregnant Smokers

• Augmented interventions approximately doubles
  abstinence rates relative to usual care
• Greatest health benefits result from cessation
  early in pregnancy, however, pregnant women
  should be encouraged to quit anytime during
  pregnancy
• Pharmacotherapy should be considered when a
  pregnant woman is otherwise unable to quit, and
  when the likelihood of quitting, with its
  potential benefits, outweighs the risks of the
  pharmacotherapy and potential continued smoking

54
Hospitalized Smokers

• Smoking cessation treatments were found to be
  efficacious when delivered to hospitalized
  smokers
• Hospitalized smokers should be identified on
  admission and offered treatments to minimize
  withdrawal and maintain abstinence after
  discharge

55
Smokers with Comorbidities

• Smokers with a psychiatric comorbidity or
  chemical dependency should be offered
  guideline-based treatments
• Psychiatric disorders are more common in smokers
  than the general population and carry a higher
  rate of relapse
• Bupropion SR or nortriptyline should be
  considered in smokers with a history of
  depression
• Smoking cessation does not appear to interfere
  with recovery from chemical dependency

56
Weight Gain

• Clinicians should openly address postcessation
  weight gain concerns
• Acknowledge weight gain is likely but typically
  limited
• Encourage concentration on smoking cessation now,
  weight control later
• Recommend healthy diet and physical activity
• Consider pharmacotherapy, particularly bupropion
  SR and nicotine gum, shown to delay (but not
  prevent) weight gain

57
Coding for Treatment of Tobacco Use and
Dependence

• Record
• ICD-9 Code 305.1 Tobacco Dependence

58
Program Agenda

• Session 1
• Session 2
• Session 3
• Session 4

• Orientation Introductions
• Understanding addiction
• Preparation_________________
• Benefits of Quitting
• Withdrawal Symptoms
• Cessation Strategies__________
• QUIT DAY_________________
• Motivation Reinforcement
• Support Systems

59
Program Agenda

• Session 5
• Session 6
• Session 7
• Session 8

• Lifestyle issues
• Nutrition/Weight
• Exercise____________________
• Stress Management
• Relaxation Skills
• New Self-image______________
• Ex-smokers panel_____________
• Graduation Celebration
• Relapse Prevention

60
Power of Intervention

• The costs of providing brief interventions is 3
  per smoker
• Implementing such interventions could quadruple
  the national annual cessation rate, translating
  to roughly 4.8 million quitters
• Adding brief behavioral counseling and medication
  can increase the cessation rate sixfold,
  translating to roughly 7.2 million quitters

61
Health professionals shouldnt grade themselves
on how many people they can get to quit, but
rather how many times they give the message when
the opportunity arises.
Under these criteria, there is no reason not to
have an intervention success approaching 100
62
Surgeon Generals Web site

• The full text of the guideline documents and the
  meta-analyses references for online retrieval are
  available at www.surgeongeneral.gov/tobacco/defau
  lt.htm
• The Clinical Practice Guideline
• The Quick Reference Guide
• Consumer Version

63
Naltrexone reduces smoking desire
VAS rating Desire to Smoke
N22
0 (pill) 2 hr rest cig 1
1 hr rest
single cigarette
King Meyer (2000) Pharm Biol Behav 66 563-572
64
Chicago STOP Smoking Research Project II

• 2006-2009 Chicago area goal is to enroll n324
  smokers 260 smokers currently enrolled
• Naltrexone vs. placebo for 3 months
  All receive nicotine patch and individual
  therapy
• Quit rates up to 12-month follow-up
• Weight, urges, withdrawal scores taken at each
  visit
• Detailed weekly reports appetite, food
  consumption, and eating hedonics
• Web site http//stopsmoking.uchicago.edu
• Email stopsmoking_at_uchicago.edu

65
Other Chicago area options

• Intensive Group Programs (with med options)
• NW Wellness Institute (Southard)
• Respiratory Health Association (Courage to
  Quit)
• Individual Program (with med options)
• TCP at UC (Hogarth, Krishnan) fax to referral
• Less intensive
• Illinois Quitline 1-866-QUITYES
• Websites becomeanex.com, etc.

66
Conclusions

• Nicotine dependence is a chronic condition
• Every patient who uses tobacco should be offered
  treatment
• It is essential that clinicians and health care
  delivery systems institutionalize the consistent
  identification, documentation and treatment of
  every tobacco user
• Brief tobacco dependence treatment is effective
• There is a strong dose-response relationship
  between the intensity of tobacco dependence
  counseling and its effectiveness
• Numerous effective pharmacotherapies now exist
• Tobacco dependence treatments are both clinically
  effective and cost-effective relative to other
  medical and disease-prevention interventions

67
What about Joe Camel?