Disclosures

Drs. Hudmon and Corelli declare no conflicts of

interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

Assessing and Assisting Patient Tobacco Cessation Efforts in Pharmacy Practice

Karen Hudmon, DrPH, MS, RPh
Purdue University

Robin Corelli, PharmD

University of California, San Francisco

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 3

Pharmacist Learning Objectives

Target Audience: Pharmacists and
Technicians
Summarize the public health risks of nicotine addiction. Recall current and emerging behavior change theories
and resources appropriate for smoking cessation.

Describe motivational interviewing techniques that can be

ACPE#: 0202-0000-13-006-L04-P ACPE#: 0202-0000-13-006-L04-T Activity Type: Knowledge-based

used to assess a patients use of tobacco as well as their readiness to change tobacco-related health behaviors. List pharmacotherapies for treating nicotine dependence. Outline evidence-based medication regimens and behavioral strategies to address individual challenges in tobacco cessation. After viewing a video of a simulated clinical encounter, identify effective and ineffective counseling strategies for promoting behavior change related to smoking cessation.

Technician Learning Objectives

Summarize the public health risks of nicotine addiction. Recall current and emerging behavior change theories
and resources appropriate for smoking cessation. Describe motivational interviewing techniques that can be used to assess a patients use of tobacco as well as their readiness to change tobacco-related health behaviors. After viewing a video of a simulated clinical encounter, identify effective and ineffective counseling strategies for promoting behavior change related to smoking cessation.

Self-Assessment Questions
The most common cause of death attributable to smoking is: A. Cardiovascular disease B. Lung cancer C. COPD (chronic obstructive pulmonary disease) D. Pneumonia

With your guidance, a patient whom you are assisting with quitting smoking purchased nicotine patches and set a quit date in 2 weeks. What is the patients stage of change? A. B. C. D. E. Precontemplation Contemplation Preparation Action Maintenance

In general, use of a pharmaceutical method (nicotine replacement therapy, bupropion SR, or varenicline) increases patients chances of quitting smoking at 5 or more months by how much? A. B. C. D. 25% 50% Double Triple

With which of the following products does nicotine most rapidly reach the brain? A. B. C. D. Gum Inhaler Nasal spray Lozenge

Which of the following are true about tobacco quitlines?

A. They provide
prescription medications for quitting at no cost. B. Patients are charged a nominal fee for highquality services C. Up to 30% success rate for patients who complete the sessions D. Are appropriate for use only by patients who do not have health insurance.

10

11

CIGARETTE SMOKING
Much of this program was adapted, with permission, from the Rx for Change: ClinicianAssisted Tobacco Cessation program.

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

Copyright 1999-2013 The Regents of the University of California. All rights reserved.

http://rxforchange.ucsf.edu

19% of adults are current smokers

13

Annual U.S. Deaths Attributable to Smoking, 20002004

% of all smokingattributable deaths

Smoking Cessation: Reduced Risk of Death

Prospective study of 34,439 male British doctors Mortality was monitored for 50 years (19512001)
Years of life gained

Cardiovascular diseases Lung cancer Respiratory diseases Second-hand smoke Cancers other than lung Other
CDC. MMWR 2008;57:11261128.

128,497 125,522 103,338 49,400 35,326 1,512

29% 28% 23% 11% 8% <1%

14

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.
Age at cessation (years) 15

TOTAL: 437,902 deaths annually

Doll et al. (2004). BMJ 328(7455):15191527.

Nicotine Distribution
Arterial

Venous

Assisting Patients with Quitting: Counseling and Pharmacotherapy

Nicotine reaches the brain within 1015 seconds.

Henningfield et al. (1993). Drug Alcohol Depend 33:2329.

16

Clinical Practice Guideline for Treating Tobacco Use and Dependence

Update released May 2008 Sponsored by the U.S. Department
of Health and Human Services, Public Heath Service with:
Agency for Healthcare Research and Quality National Heart, Lung, & Blood Institute National Institute on Drug Abuse Centers for Disease Control and Prevention National Cancer Institute

Tobacco Dependence: A two-part problem

Behavioral
The habit of using tobacco
Treatment

Physiological
The addiction to nicotine
Treatment

Behavior change program

Medications for cessation

Treatment should address the physiological and the behavioral aspects of dependence.
18 19

www.surgeongeneral.gov/tobacco/

Effects of Clinician Interventions

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 1.72.2 times as likely to quit successfully for 5 or more months.

Why Should Clinicians Address Tobacco Use?

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.

1.7 1.0 1.1

2.2

n = 29 studies

Failure to address tobacco use tacitly implies that quitting is not important.
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

20

Barzilai et al. (2001). Prev Med 33:595599.

21

The 5 As Framework for Cessation Interventions

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

The 5 As (contd)
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 usebecause its important.

Condition X often is caused or worsened by

smoking. Do you, or does someone in your household smoke?

Medication X often is used for conditions

linked with or caused by smoking. Do you, or does someone in your household smoke?
22 23

The 5 As (contd)
ADVISE tobacco users to quit (clear, strong, personalized)
Its important that you quit as soon as possible, and I
can help you.

The 5 As (contd)
ASSESS readiness to make a quit attempt

Cutting down while you are ill is not enough. Occasional or light smoking is still harmful. 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 can work with you to design a specialized treatment plan.
24

ASSIST with the quit attempt

Not ready to quit: foster motivation (the 5 Rs) Ready to quit: design a treatment plan Recently quit: relapse prevention
25

The 5 As (contd)
ARRANGE follow-up care
Number of sessions 0 to 1 2 to 3 4 to 8 More than 8 Estimated quit rate* 12.4% 16.3% 20.9% 24.7%
* 5 months (or more) postcessation

The 5 As: REVIEW

ASK ADVISE ASSESS ASSIST ARRANGE
about tobacco USE tobacco users to QUIT READINESS to make a quit attempt with the QUIT ATTEMPT FOLLOW-UP care
27

Provide assistance throughout the quit attempt.

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

26

Helping Patients Quit is a Clinicians Responsibility

TOBACCO USERS DONT 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. THE DECISION TO QUIT LIES IN THE HANDS OF EACH PATIENT.

Promoting Change
Key concepts for helping patients quit:

Stages of Change and Decisional Balance Self-efficacy Ambivalence/resistance READS (motivational interviewing)

28

29

Assessing Readiness to Quit

Patients differ in their readiness to quit.

Assessing Readiness to Quit

STAGE 1: Precontemplation STAGE 2: Contemplation STAGE 3: Preparation STAGE 4: Action STAGE 5: Maintenance
Assessing a patients readiness to quit enables clinicians to deliver relevant, appropriate counseling messages.
30 31

STAGE 1: Not thinking about changing STAGE 2: Considering changing, but not yet STAGE 3: Getting ready to change soon STAGE 4: In the process of changing STAGE 5: Changed a while ago

Stages of Change: A Linear View

Quit date
- 6 months - 30 days

Assessing Readiness to Quit

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

+ 6 months Action
Precontemplation

Precontemplation

Contemplation

Not ready to quit

Preparation

Action

Contemplation

Preparation

Assess readiness to quit (or to stay quit) at each patient contact. 33

32

Staging Patients for Quitting

Never

Decisional Balance
Patients perception of the PROS and CONS of
making the change

Do you use tobacco? Yes Are you intending to quit smoking in the next month? No Are you intending to quit in the next 6 months? No

Quit 6m ago Quit < 6m ago

Congratulate patient Maintenance Action

As people move from precontemplation (CONS

outweigh the PROS) through to maintenance, there is a shift in the decisional balance (PROS outweigh the CONS)

Yes

Preparation

The balance is both qualitative (salience or

importance of the item) and quantitative (number of items)

Yes

Contemplation
34

Stage and decisional balance are measured to target

specific interventions
35

Precontemplation

Self-efficacy
A patients confidence in being able to
accomplish a recommended behavior E.g., taking the medicine as prescribed in a variety
of situations/circumstances

Ambivalence / Resistance
Ambivalence:
the coexistence of opposing or confusing
attitudes or feelings

Does the patient know what to do, how to do it,

and does he/she believe s/he has the resources (internally and externally) to make the change?

primary factor impeding behavioral change If patients (a) are not sure what to do, (b) are not
sure how to do it, or (c) do not believe in the accuracy of the diagnosis or efficacy of the recommendation, they will be unlikely to change.

Self-efficacy increases as a patient moves

forward through the stages of change
36

Ambivalence must be assessed and addressed 37 if change is to occur.

Ambivalence / Resistance
Resistance:
When patients are faced with change, they are
often resistant to doing what is needed.

READS
Five Principles of Motivational Interviewing
Roll with resistance instead of confronting or opposing patients resistance to change Express empathy through use of reflective listening Avoid argumentation by assuming that it is patients decision as to whether s/he chooses to change Develop discrepancies between patient goals and the problematic behavior through use of reflective listening and provision of objective feedback Support self-efficacy as well as optimism for change
39

Resistance can take many forms:

Patients can negate things a HCP says by
disagreeing, excusing, and minimizing. They may argue with a HCP by challenging, discounting what is said, or becoming hostile/agitated. Interrupting frequently or ignoring what is said.

Resistance can occur because patients are 38 ambivalent or for other reasons.

Integrating Tobacco Cessation Activities into Practice

Minimal (<3 minutes):
Ask-Advise-Refer

THE 5 As: Brief Intervention for Tobacco Cessation in 10 Minutes or Less

ASK [<1 minute]

Do you smoke or use any type of tobacco? How much do you use daily?

Low-intensity (3 to 10 minutes):
Individual counseling and MTM activities Algorithm Checklist Handouts Higher intensity (>10 min): Individual counseling and group programs

ADVISE [<1 minute]

I strongly advise you to quit. It is the most important thing you can do for your health.

ASSESS [<1 minute]

Are you willing to make a quit attempt at this time?

40

41

THE 5 As: Brief Intervention for Tobacco Cessation in 10 Minutes or Less (contd)

ASSIST [5 to 7 minutes]
Assist with establishing a quit date Assist with choosing medication and provide counseling Assist with cognitive-behavioral counseling

Brief Counseling: Ask-Advise-Refer

ASK ADVISE REFER
Patient receives assistance, with follow-up counseling arranged, from other resources such as the tobacco quitline about tobacco USE tobacco users to QUIT to other resources

ARRANGE [<1 minute]

Arrange for follow-up care

ASSIST ARRANGE
43

42

Brief Counseling: Ask-Advise-Refer (contd)

Brief interventions have been shown to be
effective

What are Tobacco Quitlines?

Tobacco cessation counseling, provided at no cost
via telephone to all Americans

In the absence of time or expertise:

Ask, advise, and refer to other resources, such as local group programs or the toll-free quitline 1-800-QUIT-NOW

Staffed by trained specialists Up to 46 personalized sessions (varies by state) Some state quitlines offer nicotine replacement
therapy at no cost (or reduced cost)

Up to 30% success rate for patients who complete

sessions

Most health-care providers, and most patients, are not familiar with tobacco quitlines.
44 45

Tobacco Dependence: A two-part problem

Behavioral
The habit of using tobacco
Treatment

Pharmacologic Methods: First-line Therapies

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

Physiological
The addiction to nicotine
Treatment

Nicotine replacement therapy (NRT)

Nicotine gum, patch, lozenge, nasal spray, inhaler

Psychotropics
Sustained-release bupropion

Behavior change program

Medications for cessation

Partial nicotinic receptor agonist

Varenicline

46

47

Pharmacotherapy
Clinicians should encourage all patients attempting to quit to use effective medications for tobacco dependence treatment, except where contraindicated or for specific populations* for which there is insufficient evidence of effectiveness.
* Includes pregnant women, smokeless tobacco users, light smokers, and adolescents.

Pharmacotherapy: Special Populations

Pharmacotherapy is not recommended for:

Smokeless tobacco users

No FDA indication for smokeless tobacco cessation

Individuals smoking fewer than 10 cigarettes per day Adolescents

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

NRT use in minors requires a prescription Recommended treatment is behavioral counseling.

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

Medications significantly improve success rates.

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

48

49

NRT: Products NRT: Rationale for Use

Reduces physical withdrawal from nicotine Eliminates the immediate, reinforcing effects of
nicotine that is rapidly absorbed via tobacco smoke
Gum
Nicorette (OTC) Generic nicotine gum (OTC)

Nasal spray
Nicotrol NS (Rx)

Lozenge
Nicorette (OTC) Generic nicotine lozenge (OTC)

Inhaler
Nicotrol (Rx)

Allows patient to focus on behavioral and

psychological aspects of tobacco cessation
Transdermal patch
NicoDerm CQ (OTC) Generic nicotine patches (OTC, Rx)

NRT products approximately doubles quit rates.

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

50

Patients should stop using all forms of tobacco 51 upon initiation of the NRT regimen.

Plasma Nicotine Concentrations for Nicotine-Containing Products

Cigarette Moist snuff

NRT: Precautions
Patients with underlying cardiovascular
disease
Recent myocardial infarction (within past 2 weeks) Serious arrhythmias Serious or worsening angina

10

20

30 Time (minutes)

40

50

60

From: Rx for Change: Clinician-Assisted Tobacco Cessation Program. http://rxforchange.ucsf.edu

52

NRT products may be appropriate for these patients 53 if they are under medical supervision.

Nicotine Gum
Nicorette; generics

Nicotine Gum: Summary

ADVANTAGES DISADVANTAGES

Resin complex
Nicotine Polacrilin

Might satisfy oral

cravings

Need for frequent dosing

can compromise compliance

Might delay weight

gain (4-mg strength) therapy to manage withdrawal symptoms are available

Might be problematic for

patients with significant dental work

Sugar-free chewing gum base Contains buffering agents to enhance

buccal absorption of nicotine

Patients can titrate A variety of flavors

Patients must use proper

chewing technique to minimize adverse effects socially acceptable

Available: 2 mg, 4 mg; original, cinnamon,

fruit, mint (various), and orange flavors
54

Gum chewing might not be

55

Nicotine Lozenge
Nicorette Lozenge, Nicorette Mini Lozenge; generics

Nicotine Lozenge: Summary

ADVANTAGES
Might satisfy oral cravings Might delay weight gain (4-mg strength) Easy to use and conceal Patients can titrate therapy to manage withdrawal symptoms Several flavors are available

Nicotine polacrilex formulation

Delivers ~25% more nicotine than equivalent gum dose

DISADVANTAGES
Need for frequent dosing can compromise compliance Gastrointestinal side effects (nausea, hiccups, and heartburn) may be bothersome
57

Sugar-free mint (various), cherry flavor Contains buffering agents to enhance buccal
absorption of nicotine

Available: 2 mg, 4 mg
56

Nicotine Patch
NicoDerm CQ; generic

Nicotine Patch: Summary

ADVANTAGES DISADVANTAGES
Patients cannot titrate the dose to acutely manage withdrawal symptoms Allergic reactions to the adhesive may occur Patients with dermatologic conditions should not use the patch
59

Nicotine is well absorbed across the skin Delivery to systemic circulation avoids
hepatic first-pass metabolism

Provides consistent nicotine levels Easy to use and conceal Once daily dosing associated with fewer compliance problems
58

Plasma nicotine levels are lower and

fluctuate less than with smoking

Nicotine Nasal Spray

Nicotrol NS

Nicotine Nasal Spray: Summary

ADVANTAGES
Patients can easily titrate therapy to rapidly manage withdrawal symptoms

Aqueous solution of nicotine in

a 10-ml spray bottle

DISADVANTAGES
Need for frequent dosing can compromise compliance Nasal/throat irritation may be bothersome Higher dependence potential Patients with chronic nasal disorders or severe reactive airway disease should not use the spray
61

Each metered dose actuation

delivers
50 mcL spray 0.5 mg nicotine

~100 doses/bottle Rapid absorption across nasal

mucosa
60

Nicotine Inhalation System

Nicotrol Inhaler

Nicotine INHALER: Summary

ADVANTAGES
Patients can easily titrate therapy to manage withdrawal symptoms The inhaler mimics the hand-to-mouth ritual of smoking

Nicotine inhalation
system consists of:
Mouthpiece Cartridge with porous plug containing 10 mg nicotine and 1 mg menthol

DISADVANTAGES
Need for frequent dosing can compromise compliance Initial throat or mouth irritation can be bothersome Patients with underlying bronchospastic disease must use the inhaler with caution

Delivers 4 mg nicotine
vapor, absorbed across buccal mucosa
62

63

Bupropion SR
Zyban; generic

Bupropion: Mechanism of Action

Atypical antidepressant thought to affect levels
of various brain neurotransmitters
Dopamine Norepinephrine

Nonnicotine cessation aid Sustained-release antidepressant Oral formulation

Clinical effects
craving for cigarettes symptoms of nicotine withdrawal

64

65

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

Bupropion: Warnings and Precautions

Neuropsychiatric symptoms and suicide risk
Changes in mood (depression and mania) Psychosis/hallucinations/paranoia/delusions Homicidal ideation/hostility Agitation/anxiety/panic Suicidal ideation or attempts Completed suicide
66 Patients should stop bupropion and contact a health care provider immediately if agitation, hostility, depressed mood or changes in 67 thinking or behavior (including suicidal ideation) are observed

Patients undergoing abrupt discontinuation of

alcohol or sedatives (including benzodiazepines)

Bupropion: Warnings and Precautions (contd)

Bupropion should be used with 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 Patients with depressive or psychiatric disorders
68

Bupropion SR: Summary

ADVANTAGES
Easy to use oral formulation Twice daily dosing might reduce compliance problems Might delay weight gain Bupropion might be beneficial for patients with depression
69

DISADVANTAGES
The seizure risk is increased Several contraindications and precautions preclude use in some patients

Varenicline Chantix
Nonnicotine
cessation aid

Varenicline Mechanism of Action:

Binds with high affinity and selectivity at 42
neuronal nicotinic acetylcholine receptors
Stimulates low-level agonist activity Competitively inhibits binding of nicotine

Partial nicotinic
receptor agonist

Clinical effects
symptoms of nicotine withdrawal Blocks dopaminergic stimulation responsible for
reinforcement & reward associated with smoking
71

Oral formulation
70

Varenicline: Warnings and Precautions

Neuropsychiatric symptoms and suicide risk
Changes in mood (depression and mania) Psychosis/hallucinations/paranoia/delusions Homicidal ideation/hostility Agitation/anxiety/panic Suicidal ideation or attempts Completed suicide
Patients should stop varenicline and contact a health care provider immediately if agitation, hostility, depressed mood or changes72 in thinking or behavior (including suicidal ideation) are observed

Varenicline: Summary
ADVANTAGES
Easy to use oral formulation Twice daily dosing might reduce compliance problems Offers a new mechanism of action for persons who have failed other agents

DISADVANTAGES
May induce nausea in up to one third of patients Post-marketing surveillance data indicate potential for neuropsychiatric symptoms

73

Long-term (6 month) Quit Rates for FDA-Approved Smoking Cessation Medications

30

Combination Pharmacotherapy
Regimens with enough evidence to be recommended as first-line treatment

28.0
Active drug Placebo

Combination NRT
Long-acting formulation (patch)
Produces relatively constant levels of nicotine
12.0

25

23.9 18.9

Percent quit

20

18.0 15.8 16.1 11.8 9.9 8.1

17.1

15

PLUS Short-acting formulation (gum, inhaler, nasal spray)

Allows for acute dose titration as needed for nicotine withdrawal symptoms

11.3
10

10.6 9.1

0 Nicotine gum Nicotine patch Nicotine lozenge Nicotine nasal spray Nicotine inhaler Bupropion Varenicline

Bupropion SR + Nicotine Patch

75

Data adapted from Cahill et al. (2012). Cochrane Database Syst Rev; Stead et al. (2008). Cochrane Database Syst Rev; Hughes et al. (2007). Cochrane Database Syst Rev

74

Compliance is Key to Quitting

Promote compliance with prescribed
regimens needed

Comparative Daily Costs of Pharmacotherapy

Average $/pack of cigarettes, $5.98

Use according to dosing schedule, NOT as Consider telling the patient:

It is important to read all the directions thoroughly before using the product. The products work best when used according to the recommended dosing schedule.
$/day
76
Average wholesale acquisition price from Red Book Online. (2012, September).

77

Interventions for Quitting: Summary

To maximize success, interventions should include
counseling and one or more medications

Key Points
Tobacco use is the leading known preventable cause of
disease and death in the United States.

Pharmacists can have a positive impact on patients

78

Clinicians should encourage the use of effective

medications by all patients attempting to quit smoking
Exceptions include medical contraindications or use in specific populations for which there is insufficient evidence of effectiveness

First-line medications that reliably increase long-term

smoking cessation rates include:
Bupropion SR Nicotine replacement therapy (gum, inhaler, lozenge, patch, nasal spray) Varenicline

Use of effective combinations of medications should

be considered

ability to quit and should assess and address tobacco use tobacco use status at each encounter. There are effective methods for quitting, and these should be used by all patients attempting to quit. Interventions for cessation should include behavioral counseling in combination with one or more FDAapproved medications. Tobacco quitlines are an effective and accessible resource for all patients who are ready to quit. Routine implementation of tobacco cessation interventions is feasible for all pharmacy practice settings. 79

With your guidance, a patient whom you are assisting with quitting smoking purchased nicotine patches and set a quit date in 2 weeks. What is the patients stage of change?

In general, use of a pharmaceutical method (nicotine replacement therapy, bupropion SR, or varenicline) increases patients chances of quitting smoking at 5 or more months by how much?

A. B. C. D. E.

Precontemplation Contemplation Preparation Action Maintenance

A. B. C. D.

25% 50% Double Triple

80

81

With which of the following products does nicotine most rapidly reach the brain?

Which of the following are true about tobacco quitlines? A. They provide
prescription medications for quitting at no cost. B. Patients are charged a nominal fee for highquality services C. Up to 30% success rate for patients who complete the sessions D. Are appropriate for use only by patients who do not have health insurance.

A. B. C. D.

Gum Inhaler Nasal spray Lozenge

82

83