TOBACCO CESSATION: A REVIEW Discuss the 5 As model for treating - - PDF document

9/29/2016 1

TOBACCO CESSATION: A REVIEW OF CURRENT PRACTICES AND AN UPDATE TO E‐CIGARETTES

Jessica Kerwin, PharmD PGY‐2 Ambulatory Care Resident UNM College of Pharmacy jlkerwin@salud.unm.edu

Objectives

• Discuss the “5 A’s” model for treating tobacco use and

dependence.

• Given a patient case, identify a patient’s readiness to

quit smoking or using tobacco products.

• Evaluate a patient case to determine the best smoking

cessation product based on patient‐specific factors.

• Describe recent updates to the regulation of

electronic cigarettes and how these could impact smoking cessation.

Tobacco Use1

• Leading cause of preventable

and premature death

• Kills an estimated 443,000

Americans each year

• Costs $96 billion in direct

medical costs annually

• Every day in the US, 3,800 Americans under the

age of 18 smoke their first cigarette

• Decreases in smoking rates have stalled

Tobacco Use1

• Prevalence of cigarette smoking is highest

among lower socioeconomic youth

• Smokeless tobacco use is increasing among

white high school males

• Rates lower in women but gap is decreasing
• Concurrent use of multiple tobacco products is

common, with 50% of White and Hispanic males reporting using more than one product

• Nearly 7 out of every 10 adult cigarette users

reports that they want to quit smoking entirely

Benefits of Quitting2

• Lowered risk of lung cancer
• Reduced risk of heart disease, stroke, and peripheral

vascular disease

• Reduced heart disease risk within 1‐2 years of quitting
• Reduced respiratory symptoms
• Reduced risk of developing some lung conditions

(COPD)

• Women of child‐bearing age: reduced risk of infertility

9/29/2016 2

ASSESSING TOBACCO USE

Smoking Status Assessment3

• 1995: Smoking status is identified in 65% of clinic

visits

• 22% of patients received counseling on smoking cessation
• Treatment typically only offered to those with tobacco‐

related illness

• 2005: Smoking status is identified in 90% of clinic

visits

• 70% of patients received counseling on smoking cessation
• Among current smokers who attempted to stop

smoking in last year, only 21.7% utilized medication

Barriers to Smoking Status Assessment3

• Lack of knowledge
• How to identify smokers quickly and easily
• Which treatments are effective
• How treatments can be delivered
• Relative effectiveness of treatments
• Inadequate clinic support for assessment and treatment of

tobacco use

• Time constraints
• Limited training in tobacco cessation interventions
• Lack of insurance coverage for tobacco use treatment
• Inadequate payment for treatment

Readiness to Change4

Precontemplation Not ready – patient does not intend to take action in the foreseeable future (the next 6 months) Contemplation Getting ready – patient is aware of the pros and cons of change and intends to make a change in the next 6 months Preparation Ready – patient intends to take action in the immediate future (within the next month); making preparations for their change Action Patient has made specific, overt modifications to lifestyle within the last 6 months Maintenance Patient made specific, overt modifications to lifestyle >6 months ago and is working to prevent relapse

The Five A’s3

Ask Identify and document tobacco use in every patient at every visit Advise In a clear, strong, and personalized manner, urge every tobacco user to quit Assess Is the tobacco user willing to make a quit attempt at this time? Assist For the patient willing to make a quit attempt, offer medication and provide or refer for counseling or additional treatment to help the patient quit. For patients unwilling to quit at the time, provide interventions designed to increase future quit attempts. Arrange For the patient willing to make a quit attempt, arrange for followup contacts, beginning within the first week after the quit date. For patients unwilling to make a quit attempt at the time, address tobacco dependence and willingness to quit at next clinic visit.

The Five A’s – Ask

• Implement an office‐wide system that ensures

that every patient is asked about tobacco use status at every visit

• Incorporate into vital signs
• Add to clinic templates

9/29/2016 3 The Five A’s ‐ Advise

• Advise patient:
• Clear – upfront, to the point
• Strong – use your expertise, be a support

system

• Personalized – tie in current health, symptoms,

social, or economic concerns specific to the patient

The Five A’s ‐ Assess

• Are you willing to give tobacco cessation a try?
• If patient is willing, provide assistance
• Is patient is not willing to make a quit attempt at

this time, provide an intervention shown to increase future quit attempts

• Motivational interviewing techniques
• The Five R’s

The Five A’s ‐ Assist

• Set a quit date
• Tell family, friends, and

coworkers about quitting

• Anticipate challenges in

upcoming quit attempt, especially in initial period

• Remove tobacco products from your

environment

The Five A’s – Arrange

• Follow‐up contact should be soon after the scheduled

quit date

• Within first week
• Within first month
• During visit:
• Identify problems already encountered during quit attempt
• Assess medication use, medication related problems
• Determine tobacco use
• Congratulate on abstinence
• If patient relapsed, go over circumstances and strategies to

prevent in future

Motivational Interviewing – General Principles

• Express empathy
• Use open‐ended questions
• Reflective listening
• Develop Discrepancy
• Highlight differences in behavior and priorities
• Support “change talk” and “commitment” language
• Roll with Resistance
• Back off and reflect
• Ask permission
• Support self‐efficacy
• Point out previous successes
• Provide resources

The Five R’s

• Relevance
• Risks
• Rewards
• Roadblocks
• Repetition

9/29/2016 4 Patient Case

• JG is a 27 yo male who presents to your clinic for medication
• management. He states he has smoked 1 pack per day for the

last 7 years. He mentions that he has noticed that it has become increasingly more difficult for him to exercise because he spends a lot of time coughing and trying to catch his breath. It is his personal goal to run a marathon before the age of 30 and he feels that he has to stop smoking in order to achieve this goal. He plans to quit by Halloween this year.

• Assess JG’s readiness to quit smoking
• What support can you provide during this time?

Patient Case

• ML is a 67 yo female with past medical history of HTN, CAD,

T2DM, and a recent diagnosis of COPD. She states that she has smoked since she was 13 years old and smokes anywhere from 1‐2 packs per day. She has recently increased her daily smoking because her daughter and grandkids moved out of state and she has been lonely. She states that she is not willing to stop smoking because she has tried to in the past and it is too hard. Also, she says that because she now has COPD, there is not point in quitting because “the damage is already done”.

• Assess ML’s readiness to quit
• What are some strategies you can use to motivate patient?

MEDICATIONS FOR TOBACCO CESSATION

FDA Approved Medications for Tobacco Cessation

• Nicotine Replacement

Therapy (NRT)

• Patch, gum, lozenge,

inhaler, nasal spray

• Varenicline
• Bupropion SR

Nicotine Replacement3,5

• MOA: deliver nicotine with the intent to replace, at

least partially, the nicotine obtained from cigarettes and reduce the severity of nicotine withdrawal symptoms

• Use with caution in patients with significant

cardiovascular risk or recent history of cardiovascular disease

• Pregnancy Category: D

Nicotine Patch3,5

• Dosing
• Available in 21 mg/day, 14 mg/day, and 7 mg/day transdermal patch
• For patients smoking >10 cigarettes per day:
• Begin with 21 mg/day patch x 6 weeks, followed by 14 mg/day patch x 2 weeks,

followed by 7 mg/day patch x 2 weeks

• For patients smoking < 10 cigarettes per day:
• Begin with 14 mg/day patch x 6 weeks, followed by 7 mg/day patch x 2 weeks
• Remove at bedtime if patient experiences sleep

disturbances

• Apply to clean, dry, relatively hairless area
• Rotate sites to avoid skin reactions; use steroid cream to

treat local reactions

9/29/2016 5 Nicotine Gum3,5

• Dosing
• First cigarette < 30 minutes after waking: use 4mg strength
• First cigarette > 30 minutes after waking: use 2mg strength
• Chew one piece of gum when urge to smoke occurs
• May repeat once if urge persists within the hour
• Initial 6 weeks: Chew 1 piece of gum every 1‐2 hours

(NTE 24 pieces/day)

• Chew using “chew and park” method over ~30

minutes per piece

Nicotine Lozenge3,5

• Dosing
• First cigarette < 30 minutes after waking: use 4mg strength
• First cigarette > 30 minutes after waking: use 2mg strength
• Use one lozenge when urge to smoke occurs
• Do not use more than one lozenge at a time
• Initial 6 weeks: Use 1 lozenge every 1‐2 hours (NTE 5

in 6 hours or 20 lozenges/day)

• Allow to dissolve slowly in mouth

Nicotine Inhaler3,5

• Initial dosing: 6‐16 cartridges per day
• One cartridge = 4 mg = 80 puffs
• Frequent puffing achieves best results
• NTE 16 cartridges per day
• Typical use: 3‐6 months
• Use beyond 6 months not studied
• Inhale deeply into the back of throat or puff in short breaths

Nicotine Nasal Spray3,5

• Initial dosing
• 1‐2 sprays in each nostril per hour
• NTE 5 doses (10 sprays) in an hour or 80 sprays in 24 hours
• NTE 3‐6 months of normal dosing
• How supplied
• 10mg/mL, 10 mL (200 sprays/unit)
• Each spray delivers 0.5mg nicotine
• Prime before first use and if not used >24 hours

Varenicline3,5

• MOA
• Partial nicotinic receptor agonist; stimulates dopamine activity but to a

lesser degree than nicotine, resulting in reduced craving

• Dosing
• Initial: 0.5mg daily x 3 days, then 0.5mg BID x 4 days, then 1mg BID

thereafter

• Started 7 days prior to quit date
• Boxed Warning: severe neuropsychiatric events can occur, even

in patients without a history of psychiatric illness

• May increase CV events in those with preexisting CV illness
• Requires renal adjustment for CrCl < 30 ml/min

Bupropion SR3,5

• MOA:
• Blockade of neuronal reuptake of dopamine and

norepinephrine

• Blockade of nicotinic acetylcholinergic receptors
• Contraindicated in patients taking MAO‐inhibitors

within 14 days, eating disorder, or seizure disorder

• Dosing
• Start 1‐2 weeks prior to quit date
• Initial: 150mg daily x 3 days, then 150mg BID thereafter

9/29/2016 6 Patient Case

• KM is a 72 yo female with PMH significant for HTN,

atrial fibrillation, and seizure disorder. She was recently diagnosed with COPD and is motivated to quit smoking to slow the progression of COPD. She currently smokes 2 packs per day.

• What would be a good medication option for her?
• What medication would you consider avoiding in this

patient?

Patient Case

• TG is a 45 yo male with PMH significant for GERD,

HTN, PTSD, and a history of depression, which he receives counseling for. He has smoked since he was 19 yo and has recently cut back to ½ pack per day. He is having trouble with overall smoking cessation and would like to try a medication.

• What would be a good medication option for him?
• What medication would you consider avoiding in this

patient?

E‐CIGARETTE REGULATIONS

E‐Cigarette Background6,7

• Introduced to US market in 2007
• Increasing in popularity
• 12% of US adults have tried e‐cigarettes
• <4% of US adults are regular e‐cigarette users
• Increasing popularity among

adolescents

• 2011: 1.5% prevalence in

high school students

• 2016: 16% prevalence in

high school students

• Use may lead to cigarette smoking

E‐cigarette Efficacy and Safety8

• Conflicting evidence to say that e‐cigarettes increase likelihood
• f smoking cessation
• Smokers seem more interested in buying e‐cigarettes for smoking

cessation

• Lacking data on how many smokers switch from cigarettes to e‐cigarettes

for purposes of quitting altogether

• Dozens of carcinogens in traditional cigarettes – most are not

present in e‐cigarettes

• E‐cigarette vapor contains carbonyl compounds (formaldehyde,

acetaldehyde) which can be carcinogens

• Urine levels of these toxin significantly lower in e‐cigarette use
• Unclear what effect of inhaling flavor liquids is – under investigation

FDA Increases E‐Cigarette Regulations8

9/29/2016 7

Effect of FDA Regulation of E‐Cigarettes6,8

• Illegal to sell e‐cigarettes online or in person to anyone < 18

years old

• Age verification via photo ID required
• Tobacco products cannot be sold in vending machines unless adult only

location

• Distribution of free samples no longer allowed
• Manufacturers must show that products meet applicable public

health standard set forth in law to receive authorization to market product

• Allow FDA to prevent misleading claims regarding e‐cigarettes
• Help FDA evaluate ingredients of tobacco products and how they are

made

• FDA better able to communicate potential risks of use

Concerns with FDA Regulation of E‐Cigarettes8

• Consolidation of e‐cigarette market
• Costly application process through FDA
• May push out smaller competitors, leaving big players only
• Less options for consumers
• Clinical research may become more difficult
• FDA requirement for investigational new drug application is

time‐consuming and expensive

• Fear that researchers will be less willing to perform well‐

designed trials under new regulations

References

1.

Preventing tobacco use among youth and young adults: A report of the Surgeon

• General. US Dept of Health and Human Services. Rockville, MD: 2012. Available from:

http://www.surgeongeneral.gov/library/reports/preventing‐youth‐tobacco‐use/exec‐ summary.pdf

2.

Quitting Smoking: Smoking and Tobacco Use. Centers for Disease Control and

• Prevention. 17 Feb 2016. Available from:

http://www.cdc.gov/tobacco/data_statistics/fact_sheets/cessation/quitting/index.ht m

3.

Guidelines

4.

The Transtheoretical Model. Pro‐Change Behavior Systems, Inc. 2016. Available from: http://www.prochange.com/transtheoretical‐model‐of‐behavior‐change

5.

• Lexicomp. Updated periodically. 2016.

6.

FDA takes significant steps to protect Americans from dangers of tobacco through new

• regulation. FDA News Release. US Food and Drug Administration. 5 May 2016.

Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm

7.

Leventhal AM, Strong DR, Kirkpatrick MG, et al. Association of Electronic Cigarette Use With Initiation of Combustible Tobacco Product Smoking in Early Adolescence.

• JAMA. 2015 Aug 18;314(7):700‐7.

8.

Abbasi J. FDA extends authority to e‐cigarettes: implications for smoking cessation?

• JAMA. 2016;316(6):572‐574.

TOBACCO CESSATION: A REVIEW OF CURRENT PRACTICES AND AN UPDATE TO E‐CIGARETTES

Questions?

Jessica Kerwin PGY‐2 Ambulatory Care Resident UNM College of Pharmacy jlkerwin@salud.unm.edu