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Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

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Page 1: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to
Page 2: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Smoking Out Tobacco Use:

Tobacco Cessation

Treatment

Updates

Roxane Took, PharmD

Assistant Professor, Pharmacy Practice Department

St. Louis College of Pharmacy

Golden L. Peters, PharmD, BCPS

Associate Professor, Pharmacy Practice Department

St. Louis College of Pharmacy

Page 3: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Drs. Took and Peters 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.

Disclosures and Conflict of Interest

Page 4: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

At the conclusion of the program, the pharmacists will be able to:

1. Discuss over-the-counter (OTC) and prescription treatment options for

tobacco cessation

2. Describe the role of combination therapy for tobacco cessation

3. Explain recommendations and precautions for using electronic cigarettes

Pharmacist Objectives

Page 5: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

At the conclusion of the program, the pharmacy technician will be able to:

1. Discuss over-the-counter (OTC) and prescription treatment options for

tobacco cessation

2. Describe the role of combination therapy for tobacco cessation

3. Explain recommendations and precautions for using electronic cigarettes

Technician Objectives

Page 6: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

A customer is at your pharmacy and would like help choosing the right OTC

product for smoking cessation. She smokes ½ pack per day (ppd) with her first

cigarette when she wakes up each morning (about 15 minutes after waking).

Which is the best produce and initial dose for this patient?

a. Nicotine lozenge 4 mg (Nicorette)

b. Nicotine lozenge 2 mg (Nicorette)

c. Nicotine patch 21 mg (Nicoderm CQ)

d. Nicotine patch 7 mg (Nicoderm CQ)

Pre-Test Questions

Page 7: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

What is an advantage of the nicotine patch (Nicoderm CQ) over the nicotine gum

when used for combination therapy?

a. Has flexible dosing based on cravings

b. Is readily accessible since it is OTC

c. Has more consistent and faster delivery of nicotine

d. May help reduce morning cravings for a cigarette

Pre-Test Questions

Page 8: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Which of the following is a contraindication for use with bupropion SR (Zyban)?

a. History of myocardial infarction

b. History of seizures

c. Uncontrolled depression

d. Concurrent use of SSRI (selective serotonin reuptake inhibitors within 14 days)

Pre-Test Questions

Page 9: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

True/False: Specific brands of e-cigarettes are recommended by the FDA for

smoking cessation.

Pre-Test Questions

Page 10: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Background

Page 11: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Epidemiology

1.3 billion smokers worldwide

Estimated that 38 million American adults smoke

Male: 17.5%

Female: 13.5%

Smoking has declined in the United States

1965: 42.5% of adults smoked

2010: 19.3% of adults smoked

2016: 15.5% of adults smoked

CDC. Smoking & tobacco use. 2018.

Page 12: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Health Risks

Tobacco use is the leading cause of preventable morbidity and

mortality in the United States

Smoking leads to ~480,000 deaths/year in the United States

1 in 5 deaths/year in the United States

Nearly 6 million deaths worldwide

Roughly half of smokers will die from a tobacco-related illness

On average, smokers die 10 years earlier than nonsmokers

CDC. Smoking & tobacco use. 2018.

Page 13: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Background

Economic Impact

Cigarette smoking causes $300 billion in health care cost

Direct medical expenses – $170 billion

Indirect costs – $156 billion

Tobacco companies spent $8.9 billion in marketing

CDC. Smoking & tobacco use. 2018.

Page 14: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Benefits of Smoking Cessation

Smokers who quit around age of 30 gain approximately 10 years of life

expectancy

Smokers who quit after age 40 also gain life expectancy

Smokers who quit after age 80 also reduces mortality

CDC. Smoking & tobacco use. 2018.

Page 15: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Benefits of Smoking Cessation

Smoking cessation is associated with substantial reduction in:

Myocardial infarction

Sudden cardiac death

Stroke

Improved coagulation parameters

Reversal of endothelial dysfunction

Slowing or reversal of atherosclerosis

Progression of peripheral artery disease

CDC. Smoking & tobacco use. 2018.

Page 16: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Benefits of Smoking Cessation

After smoking cessation for…

24hrs 48hrs 2-12 wks 1 yr 5 yrs 10 yrs 15 yrs

BP

drops

Carbon

monoxide

level

in blood

returns to

normal

Circulation

and lung

function

improves

Risk of CHD is

half that of a

smoker’s

Risk of

cardiac death

is decreased

significantly

Risk of lung

cancer is half

that of a

smoker’s

Risk of CHD

and stroke is

same as

nonsmoker’s

CDC. Smoking & tobacco use. 2018.

Page 17: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Therapeutic Options for

Tobacco Cessation

Source: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm

Page 18: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Behavioral counseling

Nicotine replacement therapies (NRT)

Over-the-counter products

Nicotine gum

Nicotine patch

Nicotine lozenge

Prescription products

Varenicline

Bupropion SR

Nicotine inhaler

Nicotine nasal spray

Tobacco Cessation Therapies

Treating Tobacco Use and Dependence: 2008 Update.

Page 19: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Pharmacotherapy is recommended for all those trying to quit

EXCEPT for:

Pregnant/breastfeeding

Children/adolescents (restricted to > 18 years old)

Minors require a prescription

Medical contraindications

Smoking <10 cigarettes/day

Except for nicotine patch, FDA approval for light smokers, < 10

cigarettes/day

Smokeless tobacco and cigar users

No FDA indication

Tobacco Cessation Therapies

Treating Tobacco Use and Dependence: 2008 Update.

Page 20: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Nicotine gum

Dosing based on time to first cigarette (TTFC)

First cigarette is within 30 minutes of waking

Nicotine 4 mg

First cigarette is greater than 30 minutes of waking

Nicotine 2 mg

Special considerations

Avoid with significant dental problems

“Chew and Park”

Smoking Cessation TherapiesTobacco Cessation Therapies

Lexicomp Online, Wolters Kluwer Clinical Drug Information, Inc.:2013; Accessed May 8, 2018.

Page 21: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Nicotine lozenge

Dosing based on time to first cigarette

First cigarette is within 30 minutes of waking

Nicotine 4 mg

First cigarette is greater than 30 minutes of waking

Nicotine 2 mg

Special considerations

Do not chew or swallow, allow to dissolve

Smoking Cessation TherapiesTobacco Cessation Therapies

Lexicomp Online, Wolters Kluwer Clinical Drug Information, Inc.:2013; Accessed May 8, 2018.

Page 22: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Nicotine patch

Dosing based on number of cigarettes/day

> 10 cigarettes/day

Start with 21 mg patch

< 10 cigarettes/day

Start with 14 mg patch

Special considerations

Precautions/CI – skin disease (e.g. psoriasis, eczema, atopic dermatitis)

ADRs – skin irritation, insomnia, abnormal dreams

Vivid dreams

Smoking Cessation TherapiesTobacco Cessation Therapies

Lexicomp Online, Wolters Kluwer Clinical Drug Information, Inc.:2013; Accessed May 8, 2018.

Page 23: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Nicotine inhaler

Precautions/CI

Reactive airway disease

Special considerations

Hand-to-mouth action

Nicotine nasal spray

Precautions/CI

Chronic nasal disorders

Severe reactive airway

disease

Special considerations

Fastest nicotine delivery

system

Most addictive NRT

Passive administration

Smoking Cessation TherapiesTobacco Cessation Therapies

Lexicomp Online, Wolters Kluwer Clinical Drug Information, Inc.:2013; Accessed May 8, 2018.

Page 24: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Bupropion SR

Precautions

Boxed warning – serious neuropsychiatric events

Contraindications

Seizure disorder

Bulimia/anorexia

History of head trauma

Dosing

150 mg daily x 3 days; then 150 mg BID x 7 – 12 weeks

Special considerations

Initiate 1 week prior to quit date

Smoking Cessation TherapiesTobacco Cessation Therapies

Lexicomp Online, Wolters Kluwer Clinical Drug Information, Inc.:2013; Accessed May 8, 2018.

Page 25: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Varenicline

Precautions

Renal impairment – CrCl < 30mL/min

Boxed warning – serious neuropsychiatric events REMOVED!!!

Dosing

Days 1 – 3: 0.5 mg daily

Days 4 – 7: 0.5 mg BID

Days 8 – on: 1 mg BID

Duration of treatment = 12 weeks

Special considerations

Initiate 1 week prior to quit date

Smoking Cessation TherapiesTobacco Cessation Therapies

Lexicomp Online, Wolters Kluwer Clinical Drug Information, Inc.:2013; Accessed May 8, 2018.

Page 26: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Second-line treatment options

Clonidine

Drowsiness, dry mouth, dizziness, sedation

Lower BP due to antihypertensive effect

Rebound hypertension with abrupt discontinuation

Nortriptyline

Dry mouth, light headedness, blurry vision, sedation, urinary retention

Complementary or alternative

Hypnosis

Acupuncture

Auriculotherapy

Smoking Cessation TherapiesTobacco Cessation Therapies

Lexicomp Online, Wolters Kluwer Clinical Drug Information, Inc.:2013; Accessed May 8, 2018.

Page 27: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Combination therapy for

tobacco cessation

Page 28: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Nicotine patch + PRN NRT (nicotine gum, lozenge, or nasal spray)

NRT + bupropion *FDA approved

Alternatives:

Varenicline + bupropion

Varenicline + NRT

Varenicline+ nortriptyline

Combination therapy options for tobacco

cessation

REFERENCES: Clinical Guidelines for Prescribing Pharmacotherapy for Smoking Cessation. Content last reviewed December 2012. Agency for Healthcare Research and Quality,

Rockville, MD. http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/tobacco/prescrib.html

U.S. Public Health Service. Treating Tobacco Use and Dependence. Clinical Practice Guideline. U.S. Department of Health and Human Services. 2008. Available at

www.ncbi.nlm.nih.gov/books/NBK63952/. Accessed May 4, 2018.

The Journal of Family Practice. Smoking Cessation: What Should You Recommend? https://www.mdedge.com/jfponline/article/105467/addiction-medicine/smoking-cessation-what-

should-you-recommend/page/0/2 2016. Available at: Accessed May 11, 2018.

Page 29: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Better for highly dependent smokers or those with history of severe

withdrawal

Long-acting products provide constant level of nicotine replacement, while

short-acting products provide breakthrough relief from cravings and prevents

severe withdrawal symptoms

Benefits of combination therapy for

tobacco cessation

Source: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm

Page 30: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Evidence for combination therapy for

tobacco cessation

Source: Report of the Surgeon General. The Health Consequences of Smoking – 50 Years of Progress. Available at

www.surgeongeneral.gov/library/ reports/50-years-of-progress/exec-summary.pdf. 2014. Accessed May 11, 2018.

Page 31: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Evidence for combination therapy for

tobacco cessation

Source: Veterans Health Administration Pharmacy Benefits Management Services, Medical Advisory Panel, Tobacco Use Cessation

Technical Advisory Group, and Public Health Strategic Healthcare Group. Recommendations for Use of Combination Therapy in

Tobacco Use Cessation. April 2009. https://www.healthquality.va.gov/guidelines/CD/mtu/tuc_combination_therapy.pdf. Accessed

April 6, 2018.

Page 32: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

A 56-year old African American male presents to clinic asking for help in his first

quit attempt.

Social history: smoked ~15 cigarettes per day x 36 years (no previous attempts to

quit smoking); smokes first cigarette after breakfast (~1 hour after waking up)

Past Medical History (PMH): type 2 diabetes, hypertension, dyslipidemia,

glaucoma

Current med list: metformin 1000 mg po BID, lisinopril 10 my po daily,

fenofibrate 145 mg po daily, latanoprost 0.005% 1 drop in OS QHS

Allergies: none, intolerant to statins

What is/are the most appropriate therapy for him?

Patient Case

Page 33: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

• Behavioral counseling

• Nicotine replacement therapy

• Nicotine patches 21 mg x 4-6 wks, 14 mg patch/day x 2 wks, then 7 mg

patch/day x 2 wks OR

• Nicotine lozenges 2 mg: 1 lozenge every 1-2 hrs in wks 1-6; 1 every 2-4 hrs

in wks 7-9 and; 1 every 4-8 hrs in wks 10-12)

• Varenicline 0.5mg daily (days 1-3), 0.5mg BID (days 4-7) and 1 mg BID for the

remainder of 12 wks (started 1 week prior to quit date)

• Bupropion 150mg daily x 3 days; then 150mg BID x 7 – 12 weeks (started 1

week prior to quit date)

• Combination therapy, nortriptyline, clonidine

• E-cigarettes???

Patient Case

Page 34: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Electronic Cigarettes

https://www.fda.gov/tobaccoproducts/labeling/productsingredientscomponents/ucm456610.htm

Page 35: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

First introduced in the United States in 2007

Electronic cigarettes

E-cig

E-cigarette

ENDS (electronic nicotine delivery system)

E-hookahs

Vape pens

Tank systems

Background

PL Detail-Document. Pharmacist’s Letter. 2014.

e-cigarettes.surgeongeneral.gov/

Wynn WP III, et al. J Pharm Pract. 2012;25(6):591-9.

Drew AM, et al. Am Fam Phys. 2014.

smokefree.gov/quitting-smoking/e-cigs-menthol-dip-more/what-we-know-about-e-cigarettes

Page 36: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

There are more than 250 e-cigarette brands available

Major tobacco companies have entered into the e-cigarette market

Using an e-cigarette is sometimes called “vaping”

E-cigarettes can be used to deliver marijuana and other drugs

Background

Page 37: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Estimated 2.5 million e-cigs users

E-cigarette sales

2011 – $250 million

2012 – $500 million

2013 – $1 billion

2014 – $1.5 billion

2015 – $1.9 billion

2016 - $2.35 billion

2017 – $2.9 billion

2018 estimated $3.6 billion

Background

Palazzolo DL. Front Public Health. 2013;1(56):1-20.

Wynn WP III, et al. J Pharm Pract. 2012;25(6):591-9

https://www.statista.com/statistics/285143/us-e-cigarettes-dollar-sales/

Page 38: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Many smokers use e-cigarettes for smoking cessation

E-cigarettes are gaining popularity

Novel approach to smoking cessation

Data is currently lacking regarding safety and efficacy

E-cigarettes lack FDA approval for smoking cessation aids

Background

Bullen C, et al. Lancet. 2013;382(9905):1629-37.

Drew AM, et al. Am Fam Phys. 2014.

Page 39: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Epidemiology

MMWR Morb Mortal Wkly Rep 2017;66:597–603.

CDC. MMWR. 2013;62(35):729-30.

https://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes

Page 40: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarettes are still fairly new

Long-term health effects is undetermined

While e-cigarettes may be less harmful than regular cigarettes, this does not

mean that they are harmless

Early evidence suggests that e-cigarette use may serve as an introductory

product for preteens and teens who then go on to use other tobacco products

E-cigarette use exposes the lungs to a variety of chemicals, including those

added to e-liquids, and other chemicals produced during the

heating/vaporizing process

Precautions

smokefree.gov/quitting-smoking/e-cigs-menthol-dip-more/what-we-know-about-e-cigarettes

https://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes

Page 41: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Studies have shown:

Some e-cigarette products contain

Carcinogens

Toxins

Toxic metals

Nickel

Chromium

Cadmium

Precautions

smokefree.gov/quitting-smoking/e-cigs-menthol-dip-more/what-we-know-about-e-cigarettes

https://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes

https://www.cdc.gov/tobacco/basic_information/e-cigarettes/index.htm

Page 42: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Poison Control Center

E-cigarette Device and Liquid Nicotine Reported Exposures to Poison Centers

Most frequent calls – related to persons 0 to 5 years old

Background

PL Detail-Document. Pharmacist’s Letter. 2014.

http://www.aapcc.org/alerts/e-cigarettes/

Page 43: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarette Components

Common components of e-cigarettes

Battery

Cartridge containing solution

Atomizer (heating element, creates vapor)

Source: http://www.icig.ca/

Page 44: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarette Mechanism

Air is drawn through the device

Activating the airflow sensor

Heating element is activated in the atomizer

Solution is heated to create water vapor

Small light is at the end of some devices to simulate a flame

Source: http://starfocal.com/category/electronic-cigarette/

Page 45: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarette Design

There are 4 common styles of e-cigarettes

Disposable e-cigarette

Rechargeable e-cigarette

Pen-style, medium sized rechargeable e-cigarette

Tank-style, large sized rechargeable e-cigarette

Grana R, et al. Circulation. 2014:129:1972-86.

Page 46: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarette Design

Disposable e-cigarette

Cigarette shaped devices

Not rechargeable or refillable

Discarded after solution runs out

Brand names

NJOY, OneJoy, FlavorVapes

Grana R, et al. Circulation. 2014:129:1972-86.

Source: http://www.cia-on-campus.org/disposables/flavor-vapes/

Page 47: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarette Design

Rechargeable e-cigarettes

Cigarette shaped device

Rechargeable

Refillable

Regulator for puff duration and frequency

Brand names

Blu, GreenSmoke, EonSmoke

Grana R, et al. Circulation. 2014:129:1972-86.

Source: http://store.blucigs.com/rechargeables/

Page 48: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarette Design

Pen-style, medium-sized rechargeable e-cigarette

Larger than a cigarette

Higher capacity battery

Prefilled or refillable cartridge

Regulator for length and frequency of puffs

Brand names

VaporKing, Storm, Wicked, Tornado

Grana R, et al. Circulation. 2014:129:1972-86.

Source: http://www.bestecig.com/product_view.asp?id=2

Page 49: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarette Design

Tank-style, large sized rechargeable e-cigarettes

Much larger than a cigarette

High capacity battery

Large, refillable cartridge (tank)

Regulator for length and frequency of puffs

Easily modified/customized

Brand names

Volcano, LavaTube

Grana R, et al. Circulation. 2014:129:1972-86.

Source: http://www.volcano-ecigs.dk/

Page 50: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Juuling = vaping

Juul is a manufacturer of an e-cigarette

Makes up ~33% of the e-cigarette market

Don’t look like traditional e-cigarettes

Difficult for parents and teachers to identify

1Juul cartridge = nicotine in 1 pack of cigarettes

Intended for adults per Juul CEO

Statement from FDA Commissioner (April 24, 2018):

New enforcement actions and a Youth Tobacco Prevention Plan to stop

youth use of, and access to, JUUL and other e-cigarettes

Electronic Cigarettes

Juul ®

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm605432.htm

Page 51: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

Source:

www.juul.com

https://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes

Page 52: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarette Components

E-cigarette solution (e-juice)

Concentrations can vary

Toxins

Nicotine

Nicotine-free

E-cigarettes can contain:

Flavors

Chocolate, caramel,

strawberry, bubble gum,

menthol, tobacco, coffee, cola,

Belgian waffle

Nicotine

Additives

Nicotine free

Herbal extracts

Vitamin supplements

Benowitz NL, et al. JAMA. 2013;310(7):685-6.

Drew AM, et al. Am Fam Phys. 2014.

Page 53: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

FDA Tobacco Regulations

FDA now regulating:

Electronic cigarettes

Hookah

Cigars

Pipe tobacco

New requirements:

Must be > 18 y.o.

No free samples

No vending machine sales (except in adult only locations)

www.fda.gov/downloads/TobaccoProducts/AboutCTP/UCM580536.pdf

Page 54: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

FDA Tobacco Regulations

Specific requirements for manufacturers:

Register establishment and list of products manufactured

Report ingredients

Place warning statements on packages and advertisements

No modified risk claims

i.e. “light”, “low”, or “mild”

Future Regulations (2019):

Premarket application and review for all new tobacco products

Report quantities of harmful or potentially harmful contents

https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Manufacturing/default.htm

Page 55: Smoking Out Tobacco Use: Tobacco Cessation Treatment ......Health Risks Tobacco use is the leading cause of preventable morbidity and mortality in the United States Smoking leads to

E-cigarettes

www.cdc.gov/tobacco/basic_information/e-cigarettes/index.htm

Grana R, et al. WHO. 2013.

who.int/fctc/cop/cop7/FCTC_COP_7_11_EN.pdf

WHO Tobacco Free Initiative Statement. Accessed 7/14/14.

Bhatnagar A, et al. Circulation. 2014 Aug 24. [Epub ahead of print]

heart.org/idc/groups/heart-public/@wcm/@global/documents

lung.org/e-cigarettes. May 10, 2018.

Organization Position

CDC • E-cigarettes have the potential to benefit adult smokers that

substitute use of cigarettes

WHO • “Until deemed safe, effective and of acceptable quality by a

regulatory body, “consumers should be strongly advised not to

use… electronic cigarettes.”

AHA • Clinicians should recommend proven smoking cessation therapies

first line; if patients fails, rejects or is intolerant to conventional

therapy consider using.

• Must set quit date for e-cigarettes

ALA • E-cigarettes are tobacco products

• Patients that want to quit should use proven safe and effective

methods, not electronic cigarettes

ALL:

• More research is needed regarding: characteristics of e-cigarettes, environmental

health, public health, safety and efficacy.

• Concerned about the impact on public health in youth

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Place in Therapy

Patients seeking advice on e-cigarettes

Sign of patient’s readiness to quit

Provide support for the quit attempt

Advice should not undermine their motivation

Encourage evidence-based treatments

Smoking cessation counseling

Approved prescription products

Approved NRT

Grana R, et al. Circulation. 2014;129:e490-2.

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Place in Therapy

Patients using e-cigarettes for smoking cessation

Support the quit attempt

Encourage patient to quit all tobacco products

Inform patient about e-cigarettes

Not FDA-approved for smoking cessation

Insufficient safety and efficacy data

No conclusive scientific evidence on the effectiveness of e-cigarettes for

long-term smoking cessation

Not enough data exists on the safety of e-cigarettes

Grana R, et al. Circulation. 2014;129:e490-2.

www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes

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A 56-year old African American male presents to clinic asking for help in his first

quit attempt.

Social history: smoked ~15 cigarettes per day x 36 years (no previous attempts to

quit smoking); smokes first cigarette after breakfast (~1 hour after waking up)

PMH: type 2 diabetes, hypertension, dyslipidemia, glaucoma

Current med list: metformin 1000 mg po BID, lisinopril 10 mg po daily,

fenofibrate 145 mg po daily, latanoprost 0.005% 1 drop in OS QHS

Allergies: none, intolerant to statins

Can we recommend e-cigarettes?

Patient Case

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Questions??

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A customer is at your pharmacy and would like help choosing the right OTC

product for smoking cessation. She smokes ½ ppd with her first cigarette when

she wakes up each morning (about 15 minutes after waking). Which is the best

produce and initial dose for this patient?

a. Nicotine lozenge 4 mg (Nicorette)

b. Nicotine lozenge 2 mg (Nicorette)

c. Nicotine patch 21 mg (Nicoderm CQ)

d. Nicotine patch 7 mg (Nicoderm CQ)

Pre-Test Questions

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What is an advantage of the nicotine patch (Nicoderm CQ) over the nicotine gum

when used for combination therapy?

a. It has flexible dosing based on cravings

b. It is readily accessible since it is OTC

c. It has more consistent and faster delivery of nicotine

d. May help reduce morning cravings for a cigarette

Pre-Test Questions

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Which of the following is a contraindication for use with bupropion SR (Zyban)?

a. History of myocardial infarction

b. History of seizures

c. Uncontrolled depression

d. Concurrent use of SSRI (selective serotonin reuptake inhibitors within 14 days)

Pre-Test Questions

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True/False: Specific brands of e-cigarettes are recommended by the FDA for

smoking cessation.

Pre-Test Questions

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NRT should not be used in the following scenarios:

o Pregnant patients

o < 18 years old

o Medical contraindications

o < 10/cigs per day (except nicotine patch)

o Smokeless tobacco or cigar users

OTC NRT products:

o Nicotine gum – dosed based on TTFC

o Nicotine lozenge – dosed based on TTFC

o Nicotine patch – number of cigs/day

Prescription products:

o Bupropion and varenicline

TAKE HOME POINTS

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Combination therapy options

o Patch + nicotine gum or lozenge or spray

o NRT + Bupropion

Electronic cigarettes

o Long term effects have not been established

The FDA now regulates electronic cigarettes

Statements regarding electronic cigarettes have been made by

numerous organizations (CDC, WHO, AHA, and ALA) with the consensus that

not enough data is available regarding e-cigarette use for tobacco cessation

TAKE HOME POINTS

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CDC. Smoking & tobacco use. 2018.

https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm

Treating Tobacco Use and Dependence: 2008 Update.

Lexicomp Online, Wolters Kluwer Clinical Drug Information, Inc.:2013; Accessed May 8, 2018.

Clinical Guidelines for Prescribing Pharmacotherapy for Smoking Cessation. Content last reviewed December 2012.

Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/clinicians-

providers/guidelines-recommendations/tobacco/prescrib.html

U.S. Public Health Service. Treating Tobacco Use and Dependence. Clinical Practice Guideline. U.S. Department of

Health and Human Services. 2008. Available at www.ncbi.nlm.nih.gov/books/NBK63952/. Accessed May 4, 2018.

The Journal of Family Practice. Smoking Cessation: What You Should You Recommend?

https://www.mdedge.com/jfponline/article/105467/addiction-medicine/smoking-cessation-what-should-you-

recommend/page/0/2 2016. Available at: Accessed May 11, 2018.

Report of the Surgeon General. The Health Consequences of Smoking – 50 Years of Progress. Available at

www.surgeongeneral.gov/library/ reports/50-years-of-progress/exec-summary.pdf. 2014. Accessed May 11, 2018.

Resources & References

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Veterans Health Administration Pharmacy Benefits Management Services, Medical Advisory Panel, Tobacco Use

Cessation Technical Advisory Group, and Public Health Strategic Healthcare Group. Recommendations for Use of

Combination Therapy in Tobacco Use Cessation. April 2009.

https://www.healthquality.va.gov/guidelines/CD/mtu/tuc_combination_therapy.pdf. Accessed April 6, 2018.

PL Detail-Document. Pharmacist’s Letter. 2014.

https://e-cigarettes.surgeongeneral.gov/

Palazzolo DL. Front Public Health. 2013;1(56):1-20.

Wynn WP III, et al. J Pharm Pract. 2012;25(6):591-9

Bullen C, et al. Lancet. 2013;382(9905):1629-37.

Drew AM, et al. Am Fam Phys. 2014.

WHO Tobacco Free Initiative Statement. Accessed 7/14/14.

Bhatnagar A, et al. Circulation. 2014 Aug 24. [Epub ahead of print]

heart.org/idc/groups/heart-public/@wcm/@global/documents

http://www.lung.org/stop-smoking/smoking-facts/e-cigarettes-and-lung-health.html. Accessed May 10, 2018.

Resources & References

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MMWR Morb Mortal Wkly Rep 2017;66:597–603.

CDC. MMWR. 2013;62(35):729-30.

https://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes

https://smokefree.gov/quitting-smoking/e-cigs-menthol-dip-more/what-we-know-about-e-cigarettes

https://www.cdc.gov/tobacco/basic_information/e-cigarettes/index.htm

PL Detail-Document. Pharmacist’s Letter. 2014.

http://www.aapcc.org/alerts/e-cigarettes/

Wynn WP III, et al. J Pharm Pract. 2012;25(6):591-9.

Drew AM, et al. Am Fam Phys. 2014.

Grana R, et al. Circulation. 2014:129:1972-86.

Benowitz NL, et al. JAMA. 2013;310(7):685-6.

www.fda.gov/downloads/TobaccoProducts/AboutCTP/UCM580536.pdf

Resources & References

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Speaker Contact InformationRoxane Took, PharmD

[email protected]

Golden Peters, PharmD, BCPS

[email protected]