Tobacco Cessation

Factors Contributing to Tobacco Use

Individual: Sociodemographic, Coexisting medical conditions, Genetic predisposition Environment: Tobacco advertising, Conditioned stimuli, Social interactions Pharmacology: Alleviation of withdrawal symptoms, Weight control, Pleasure/Mood modulation

Bupropion ADRs

Insomnia Dry mouth Tremor Skin rash

Symptoms of Withdrawal

Irritability/Frustration/Anger Anxiety Difficulty concentrating Restlessness/Impatience Depressed mood/Depression Insomnia Impaired task performance Increased appetite Weight gain Cravings

ADRs of chewing nicotine gum too fast

Lightheadedness N/V Irritation of throat and mouth Hiccups Indigestion

Deaths Attributable to Smoking

From most to least: Cardiovascular & Metabolic Diseases Lung Cancer Pulmonary Disease Second-Hand smoke Cancers other than lung

Dangerous Compounds in Tobacco Smoke

Gases: BENZENE, FORMALDEHYDE, Carbon Monoxide, Hydrogen Cyanide, Ammonia Particles: CADMIUM, POLONIUM-210, Nicotine, Nitrosamines, Lead

Follow Up

Pharmacist should follow up with patient within 2 weeks of initiating therapy and after completion of a course of therapy Pharmacists should also document record of the screening and prescription and keep hold of record for 7 years Must provide patients with record and notify the PCP of the prescription within 3 business days

Directions for Nicotine Lozenge Use

Place in mouth and allow to dissolve slowly Do not chew or swallow lozenge Occasionally rotate to different areas of the mouth Lozenges will dissolve completely in about 20-30 minutes

Where is nicotine best absorbed?

The lungs Can be absorbed through the skin First Pass Metabolism makes bioavailability low

How much nicotine is absorbed in each cigarette?

1mg

Generations of Electronic Cigarettes

1st: Mimic appearance, 1 time use 2nd: Larger, Rechargeable batteries 3rd: Device Customization 4th: Pod Mods, Nicotine salts

How many cigarettes in a pack?

20

How much weight do smokers gain on average?

9-11 pounds

Light Smoker Nicotine Patch Dosing

<10 cigarettes/day Step 2: 14mg x 6 weeks Step 3: 7mg x 2 weeks Same for generic

Heavy Smoker Nicotine Patch Dosing

>10 cigarettes/day Step 1: 21mg x 6 weeks Step 2: 14mg x 2 weeks Step 3: 7mg x 2 weeks Same for generic

Indiana Code 16-19-4-11

A state wide standing order for pharmacists to dispense FDA approved medications with an indication for smoking cessation Medications: Nicotine gum, Nicotine lozenges, Nicotine patch, Nicotine Inhaler, Nicotine nasal spray, Bupropion SR tablets, Varenicline

Nicotine Absorption

Absorption is pH-dependent In acidic media: Ionized which means it's poorly absorbed across membranes In alkaline media: Nonionized which means it will be will absorbed across membranes At physiologic pH (7.4), ~31% of nicotine is nonionized At physiologic pH, nicotine is readily absorbed

Qualifications for the Standing Order

Active Indiana pharmacists license Education and training in tobacco use disorder Complete continuing education on tobacco cessation each biennium Act in good faith and exercising reasonable care

Nicotine Nasal Spray

Aqeous Solutions of nicotine in a 10mL spray bottle Each metered dose actuation delivers: 50mcL spray and 0.5mg nicotine ~100 doses/bottle Rapid absorption across nasal mucosa

The 5 A's of Smoking Cessation

Ask: ASK about tobacco use Advise: ADVISE tobacco users to quit (clear, strong, personalized) Assess: ASSESS readiness to make a quit attempt Assist: ASSIST with the quit attempt Arrange: ARRANGE follow-up care

Stage 2 Three Key Elements of Counseling

Assess tobacco use history Discuss key issues Facilitate quitting process

Drug Interactions with Smoking

Bendamustine Haloperidol Tasimelteon Caffeine Olanzepine Theophylline Clozapine Riociquat Erlotinib Ropinerole Fluvoxamine Tacrine Irinotecan

Nicotine Gum Directions

Chew each piece very slowly several times Stop chewing at first sign of peppery taste or slight tingling in mouth "Park" gum between cheek and gum Resume slow chewing when taste or tingle fades When taste or tingle returns, stop and park gum in different place in mouth Repeat chew/park steps until most of the nicotine is gone

Advantages of Nasal Spray

Can be titrated to rapidly manage withdrawal symptoms Can be used in combination with other agents to manage situational urges

Warning and Precautions of Bupropion

Changes in mood Psychosis/Hallucinations/Paranoia/Delusions Homicidal ideation Aggression/Hostility/Anxiety/Panic Suicidal ideation, suicide attempt, completed suicide If these are noticed stop medication immediately and contact PCP Use in caution in pts with elevated risk for seizures and patients with underlying neuropsychiatric conditions

Varenicline Warnings and Precautions

Changes in mood Psychosis/Hallucinations/Paranoia/Delusions Homicidal tendencies Agression/Hostility/Anxiety/Panic Suicidal ideation, Suicide Attempt, Completed suicide Seizures Enhanced effects of alcohol Accidental injury Cardiovascular event Angioedema and hypersensitivity reactions Serious skin reactions

Directions for Use of Nicotine Patch

Choose an area of skin on the upper body or upper outer part of the arm Make sure skin is clean, dry, hairless, and not irritated Remove patch from protective pouch Peel off half of the backing from the patch Apply adhesive side of patch to skin Peel remaining protective covering Press firmly with palm of hand for 10 seconds Make sure patch sticks well to skin, especially around the edges Apply patch to different area each day Do not use same area again for at least 1 week Wash hands: Nicotine on hands can get into eyes or nose and cause stinging or redness Do not leave patch on skin for more than 24 hours - Doing so may lead to skin irritation Adhesive remaining on skin may be removed with rubbing alcohol or acetone Dispose of used patch by folding it onto itself completely covering adhesive area

Nonpharmacologic Methods

Cold Turkey Unassisted tapering Assisted Tapering: Formal Cessation Programs Acupuncture Hypnotherapy Massage therapy

Combination Pharmacotherapy

Combination NRT: Long acting (patch)+ Short acting (Gum, Inhaler, Spray) Bupropion SR + Patch

Drug with Additive Effect with smoking for CV disease

Combined hormonal contraceptives

Nicotine Inhaler

Consists of: Mouthpiece, Cartridge with porous plug containing 10mg nicotine and 1mg menthol Delivers 4mg nicotine vapor, absorbed across buccal mucosa

Tobacco Use log

Continue regular tobacco use for 3 or more days Each time any form of tobacco is used, log the following information: Time of day, Activity or situation during use, "Importance" rating (Scale of 1-3) Review log to identify situational triggers for tobacco use; develop patient-specific coping strategies

Behavioral Strategies

Control environment: Tobacco-free home and workplace, Remove cues to tobacco use; actively avoid trigger situations, Modify behaviors that you associate with tobacco Substitutes for smoking: Water, Sugar-free chewing gum or hard candies Minimize stress where possible, obtain social support, take a break, and alleviate withdrawal symptoms

Neurochemical in Nicotine

Dopamine: Pleasure, Appetite Suppression Norepinephrine: Arousal, Appetite suppression Acetylcholine: Arousal, Cognitive enhancement Glutamate: Learning, Memory enhancement Serotonin: Mood manipulation, Appetite suppression B-Endorphin: Reduction of anxiety and tension GABA: Reduction of anxiety and tension

ADRs of Nicotine Nasal Spray

Hot peppery feeling in back of throat or nose Sneezing Coughing Watery eyes Runny nose Side Effects should lessen over a few days. If they do not decrease after a week contact health care providers

5 R's

Method for enhancing motivation Relevance Risks Rewards Roadblocks Repetition

Advantages of Nicotine Inhalers

Might serve as an oral substitute for tobacco Can be titrated to manage withdrawal symptoms Mimics the hand-to-mouth ritual of smoking Can be used in combination with other agents to manage situational urges

Advantages of Lozenges

Might serve as an oral substitute for tobacco Use might delay weight gain Can be titrated to manage withdrawal symptoms Can be used in combination with other agents to manage situational urges

Advantages of Nicotine Gum

Might serve as an oral substitute for tobacco Might delay weight gain Can be titrated to manage withdrawal symptoms Can be used in combination with other agents to manage situational urges

ADRs of Nicotine Inhaler

Mild irritation of the mouth or throat Cough HA Rhinitis Dyspepsia Generally mild and decline with use

ADRs of Nicotine Patch

Mild itching Burning Tingling Vivid dreams or sleep disturbances HA

Withdrawal Information

Most symptoms pass within 2-4 weeks after quitting Cravings can last longer, up to several months or years Most symptoms manifest with the first 1-2 days, peak within the first week, and subside with 2-4 weeks.

Normal ADRs of Nicotine Gum

Mouth soreness Hiccups Dyspepsia Jaw muscle ache May stick to dental work

ADRs of Lozenges

N Hiccups Coughs Heartburn HA Flatulence Insomnia

Varenicline ADRs

Nausea Sleep disturbance Constipation Flatulence Vomiting

Disadvantages of Nicotine Inhalers

Need for frequent dosing can compromise adherence Cartridges might be less effective in cold environments (60F)

Disadvantages of Lozenges

Need for frequent dosing can compromise adherence Gastrointestinal side effects

Disadvantages of Nasal Spray

Need for frequent dosing can compromise adherence Nasal administration might not be acceptable/desirable for some patients; nasal irritation often problematic Not recommended for use by patients with chronic nasal disorders or severe reactive airway disease

Disadvantages of Nicotine Gum

Need for frequent dosing can compromise adherence Might be problematic for patients with significant dental work Proper chewing technique is necessary for effectiveness and to minimize adverse effects Gum chewing might not be acceptable or desirable for some patients

Nicotine Patches Available

NicoDerm CQ (OTC): 7mg, 14mg, 21mg. Available as generic

3 General Classes of FDA-Approved Drugs for Smoking Cessation

Nicotine Replacement Therapy (NRT) Psychotropics Partial nicotinic receptor agonists

Transdermal Nicotine Patch

Nicotine is well absorbed through the skin Delivery to systemic circulation avoids hepatic first-pass metabolism Plasma nicotine levels are lower and fluctuate less than with smoking Water will not harm the nicotine patch if it is applied correctly; patients may bathe, swim, shower, or exercise while wearing the patch DO NOT CUT PATCHES TO ADJUST DOSE Keep new and used patches out of the reach of children and pets Remove patch before MRI procedures After patch removal, skin may appear red for 24 hours. If skin stays red more than 4 days or if it swells or a rash appears, contact health provider - do not apply another patch Local skin reactions (redness, burning, itching): Usually caused by adhesive, Up to 50% of patients experience this reaction, Fewer than 5% of patients discontinue therapy, Avoid use in patients with dermatologic conditions Lowest cessation rate

Nicotine Lozenge

Nicotine polacrilex formulation delivers ~25% more nicotine than equivalent gum dose Sugar-free mint, cherry flavors Contains buffering agents to enhance buccal absorption of nicotine Available as 2mg or 4mg Use 2mg lozenge if you smoke your first cigarette more than 30 minutes after waking Use 4mg lozenge if you smoke your first cigarette within 30 minutes of waking Use at least 9 lozenges daily during first 6 weeks Will not provide the same rapid satisfaction that smoking provides Effectiveness will be affected by coffee, juices, wine, and soft drinks DO NOT EAT OR DRINK FOR 15 MINUTES BEFORE OR WHILE USING THE LOZENGES

Varenicline (Chantix)

Nonnicotine cessation aid Partial nicotinic receptor agonist Oral formulation MOA: Binds with high affinity and selectivity at A4B2 neuronal nicotinic ACh receptors. Stimulates low-level agonist activity. Competitively inhibits binding of nicotine Clinical Effects: Decreases symptoms of nicotine withdrawal, Blocks dopaminergic stimulation responsible for reinforcement and reward associated with smoking Doses should be taken after eating, with a full glass of water Nausea and insomnia are usually temporary side effects May experience vivid, unusual or strange dreams during treatment Use caution driving, drinking alcohol, and operating machinery until effects of quitting smoking with varenicline are known Highest Cessation rate

Bupropion SR

Nonnicotine cessation aid Sustained-released antidepressant Oral formulation MOA: Atypical antidepressant thought to affect levels of various brain neurotransmitters (DA and NE) Clinical Effects: Decreased cravings and decreased symptoms of nicotine withdrawal

Advantages of Nicotine Patches

Once daily dosing associated with fewer adherence problems Of all NRT products, its use is least obvious to others Can be used in combination with other agents; delivers consistent nicotine levels over 24 hours

Dosing of Nicotine Nasal Spray

One dose = 1mg nicotine (2 sprays) Start with 1-2 doses per hour Increased prn to maximum dosage of 5 doses per hour or 40mg daily For best results, patients should use at least 8 doses daily for the first 6-8 weeks NEEDS GRADUAL TAPERING OVER AN ADDITIONAL 4-6 WEEKS

Advantages of Bupropion

Oral dosing is simple and associated with fewer adherence problems Might delay weight gain Bupropion mightbe beneficial in patients with depression Can be used in combination with NRT agents

Advantages of Varenicline

Oral dosing is simple and associated with fewer adherence problems Offers a different mechanism of action for persons who have failed other agents

What two things should treatment address?

PHYSIOLOGICAL AND BEHAVIORAL

Bupropion SR Dosing

Patient should start 1-2 weeks before quit date Initial: 150mg PO q AM for 3 days Then: 150mg PO BID for 7-12 weeks Doses must be administered at least 8 hours apart Tapering not necessary when discontinuing therapy

Bupropion CIs

Patients with seizure disorders Patients with a current or prior diagnosis of bulimia or anorexia nervosa Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs Patients taking MAO inhibitors (within 14 days of initiating or discontinuing therapy)

NRT Precautions

Patients with underlying cardiovascular disease Recent MI within the last 2 weeks Serious arrhythmias Serious or worsening angina

Stage 1 Counseling Strategy Don'ts

Persuade "Cheerlead" Tell patient how bad tobacco is, in a judgmental manner Provide a treatment plan

Assess Tobacco Use History

Praise the patients readiness Assess: Current type of tobacco and amount used Past use: Duration, Recent changes Past quit Attempts: Number, date, length, Methods/Medications used, adherence, duration, reasons for relapse Reasons/Motivation to quit Confidence in ability to quit Triggers for tobacco use Routines/Situations associated with tobacco use Discourage strict dieting while quitting Discuss methods for quitting Set quit date Recommend tobacco use logs Provide medicaiton counseling Discuss concept of "slip" versus relapse Offer to assist throughout quit attempt Congratulate patient

Effects of Nicotine

Predominantly Stimulatory CNS: Pleasure, Arousal, Enhanced vigilance, Improved task performance, Anxiety relief Cardiovascular: Increased HR, Increased cardiac output, Increased blood pressure, Coronary vasoconstriction, Cutaneous vasoconstriction Other: Appetite suppression, Increased metabolic rate, Skeletal muscle relaxation

When must patients be referred for smoking cessation?

Pregnant or planning to become pregnant Heart attack in past 2 weeks, history of arrhythmias or irregular heartbeat Unstable angina or chest pain with strenuous activity History of mental health disorder and currently not stable

Pharmacotherapy is not guideline recommended for these populations

Pregnant patients Smokeless tobacco users Individuals smoking fewer than 10 cigarettes per day Adolescents

Directions for Nasal Spray

Press in circles on sides of bottle and pull to remove cap Prime the pump (before first use). Reprime if spray not used for 24 hours Blow nose Tilt head back slightly and insert tip of bottle into nostril as far as comfortable Breathe through mouth, and spray once in each nostril Do not sniff or inhale while spraying If nose runs, gently sniff to keep nasal spray in nose Wait 2-3 minutes before blowing nose Avoid contact with skin, eyes, and mouth (If contact occurs, rinse with water immediately)

Electronic Cigarettes Health Risks

Propylene glycol may cause respiratory irritation and increase the risk for asthma Glycerin may cause lipoid pneumonia on inhalation Nicotine is highly addictive and can be harmful Carcinogenic substances are found in some aersols Use of e-cigarettes leads to emission of propylene glycol, particles, nicotine, and carcinogens into indoor air

Varenicline Dosing

Pts should begin 1 week prior to quit date Day 1-3: 0.5mg QD Day 4-7: 0.5mg BID Day 8 Onwards: 1mg BID

Directions for Nicotine Inhalers

Pull and separate mouthpiece into two parts Press nicotine cartridge firmly into bottom of mouthpiece until it pops down into place Line up the markings on the mouthpiece again and push the two pieces back together so they fit tightly Twist top to misalign marks and secure unit During inhalation, nicotine is vaporized and absorbed across oropharyngeal mucose Inhale into back of throat or puff in short breaths Nicotine in cartridges is depleted after about 20 minutes of active puffing (cartridge does not have to be used all at once - try different schedules)(open cartridge retains potency for 24 hours) Mouthpiece is reusable; clean regularly with mild detergent

Nicotine Distribution

Reaches the brain with 10-20 seconds Mostly is located in the arteries although some does go into the venous system

2013 NRT Label Changes

Removed abuse or dependence label Removed label warning not to be used with smoking products

Nicotine Gum

Resin complex of nicotine and polacrilin Sugar-free chewing gum base Contains buffering agents to enhance buccal absorption of nicotine Available: 2mg, 4mg, original cinnamon, fruit and mint flavors Use 2mg if you smoke your first cigarette more than 30 minutes after waking Use 4mg if you smoke your first cigarette within 30 minutes of waking DO NOT EAT OR DRINK FOR 15 MINUTES BEFORE OR WHILE USING NICOTINE GUM Effectiveness of nicotine gum may be reduced by some foods and beverages: Coffee, Juices, Wine, Soft drinks To improve chance of quitting, use at least 9 pieces of gum daily Chewing gum will NOT provide same rapid satisfaction that smoking provides

Cognitive Coping Strategies

Review commitment to quit Distractive thinking Positive self-talk Relaxation through imagery Mental rehearsal and visualization

Fixed QUIT Approach

Set quit date for 1 week after starting varenicline Continue treatment for 12 weeks

Disadvantages of Bupropion

Several CIs and precautions preclude use in some patients

Disadvantages of Varenicline

Should be taken with food or a full glass of water to reduce the incidence of nausea Post-marketing surveillance data indicate potential for neuropsychiatric symptoms

Readiness to quit Stages

Stage 1: Not ready to quit in the next month. GOAL: Start thinking about quitting. Stage 2: Ready to quit in the next month. GOAL: Achieve cessation. Stage 3: Recent quitter, quit within past 6 months. GOAL: Remain tobacco-free for at least 6 months. Stage 4: Former tobacco user, quit >6 months ago. GOAL: Remain tobacco-free for life

Flexible QUIT Approach

Start taking varenicline and pick a quit date between 8-35 days from treatment initiation Continue treatment for 12 weeks

Gradual QUIT Approach

Start taking varenicline and reduce smoking by 50% within the first 4 weeks, an additional 50% in the next 4 weeks, and continue until complete abstinence by 12 weeks

Nicotine Inhaler Dosing

Start with at least 6 cartridges/day during the first 3-6 weeks of treatment Increase PRN to maximum of 16 cartridges/day In general, use 1 cartridge ever 1-2 hours Recommended duration of therapy is 3 months Gradually reduce daily dosage over the following 6-12 weeks

Stage 1 Counseling Strategy Do's

Strongly advise to quit Provide information Ask noninvasive questions; identify reasons for tobacco use Raise awareness of health consequences/concerns Demonstrate empathy, foster communication Leave decision up to patients

Stage 3 Evaluate the Quit Attempt

Tailor interventions to match each patient's needs Status of attempt: Ask about social support, Identify ongoing temptations and triggers for relapse, Encourage healthy behaviors to replace tobacco use Slips and Relapse: Has the patient used tobacco/inhaled nicotine at all? Medication adherence, plans for termination Congratulate on success Encourage continued abstinence Schedule additional follow-up as needed

Why should clinicians address tobacco?

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 Failure to address tobacco use tacitly implies that quitting is not important

E-Cigarette or Vaping Use Associated Lung Injury (EVALI)

Vitamin E Acetate is strongly linked Emergency room visits are not declining as fast they had originally risen All EVALI patients have reported e-cig use

Nicotine Lozenge Schedule

Weeks 1-6: 1 lozenge q 1-2 h Weeks 7-9: 1 lozenge q 2-4 h Weeks 10-12: 1 lozenge q 4-8 h MAX 20 LOZENGES

Recommended Nicotine Gum Schedule

Weeks 1-6: 1 piece q 1-2 h Weeks 7-9: 1 piece q 2-4 h Weeks 10-12: 1 piece q 4-8 h MAXIMUM 24 PIECES PER DAY

Disadvantages of Nicotine Patches

When used as monotherapy, cannot be titrated to acutely manage withdrawal symptoms Not recommended for use in patients with dermatological conditions