Nicotine Replacement Therapy and Smoking Statistics

Smoking Cessation Pharmacotherapy

• Objectives: Understand tobacco use epidemiology, assess tobacco use using a patient-centered approach, apply pharmacotherapy principles for selection, and provide smoking cessation interventions.

Epidemiology of Tobacco Use

• Leading cause of preventable death and morbidity in the U.S.
• Approximately 14% of the U.S. population smokes (~30 million).
• Approximately 440,000 premature deaths annually.
• $96 billion in direct medical expenses annually.

Epidemiology of Smoking Cessation

• 70% of smokers desire to quit.
• 44% attempt to quit annually.
• Fewer than 10% of quit attempts are successful.
• With effective counseling: ~16% success rate.
• With effective pharmacotherapy: ~19-36% success rate.

Patient Assessment & Interventions

• Tobacco Cessation Treatment Pathway: Ask, Assess, Advise, Offer & Connect to Treatment, Follow-up.
• Ask about patient's smoking status.
• Assess the extent of nicotine dependence and willingness to quit. Methods include Fagerstrom Test and Heaviness of Smoking Index.
• Advise the patient about the importance of quitting and provide information on health benefits and risks.

Extent of Nicotine Dependence

• Fagerstrom Test: A questionnaire to assess nicotine dependence. Includes questions about cigarettes per day and time to first cigarette. Higher score indicates greater dependence.
• Heaviness of Smoking Index: Similar to Fagerstrom Test, assessing dependence based on cigarettes per day and time to first cigarette after waking. Higher score indicates greater dependence.

Transtheoretical Model of Change

• Stages of Change: Precontemplation, Contemplation, Preparation, Action, Maintenance, Relapse. Illustrates a patient's progress toward quitting.

Tobacco Cessation Treatment Pathway - Advise

• Consequences of not quitting: shortened lifespan, increased risk of cancer, COPD, cardiovascular disease, even light smoking is harmful.
• Health benefits of quitting: reduced risk of death by 90% within age 40, reduced lung and heart disease risk within 10 years.

Motivational Interviewing

• The 5 "Rs": Relevance (relate smoking to comorbidities), Risks (consequences of not quitting), Rewards (health and financial benefits), Roadblocks (factors hindering quitting), Repetition (ongoing support). Helps the patient determine the process of change.

• DARES: Develop discrepancy (highlighting the differences between behavior and goals), Reinforce patient's change talk (motivating patient to take action), and strengthen commitment and Avoid argumentation. Encourages action.

• Roll with resistance: Understanding and supporting resistance to change with empathy, questions, reflective listening, and patient choices.

Patient Accepts Treatment

• Set a quit date (2 weeks from now).
• Tell family and friends (support system).
• Anticipate barriers (develop a plan).
• Remove tobacco products from environment.
• Prescribe Rx pharmacotherapy.

Set a Quit Date

• Timeline: Specify medication start date and quit date.
• Disposal: Instructions for discarding cigarettes, ashtrays, and lighters.
• Alternatives: Availability of nicotine-free products as needed.
• Support: Contact information for the clinic regarding specific questions.

Tell Family & Friends

• Support system: Contact information for clinic or pharmacy.
• Support Groups: Referrals to quit lines (e.g., 1-800-QUIT-NOW), relevant organizations (e.g., American Lung Association).
• Technology: Websites (e.g., smokefree.gov, quitnet.com), Smartphone Apps (e.g., 553 apps).

Technology

• Resources: Variety of available tools for patient use.

Anticipate Barriers – Types

• Lifestyle Strategies: Stress management, healthy eating, exercise (to reduce weight gain). Reduce alcohol intake. Limit contact with other smokers. Address previous quitting routines/triggers.
• Cognitive Techniques: Mental rehearsal (visualization), Positive self-talk (managing thoughts), and Distractive thinking (substituting activities). Committing to stopping smoking.

Anticipate Barriers - Specifics

• Review commitment to quit consistently.
• Addressing mental rehearsal and recognizing and acknowledging obstacles.
• Identifying cognitive strategies to manage feelings that may cause relapse.

Roadblocks/Barriers to Quitting

• Withdrawal symptoms: irritability, anger, depressed mood, anxiety, restlessness, difficulty concentrating, insomnia, chest tightness, increased appetite, constipation, gas, stomach pain, dizziness, fatigue.

Follow-up

• Contact within 1 week and 1 month of quit date.
• Assess for lapses ("slips") or relapse.
• Encourage recommitment to abstinence.
• Address barriers to quitting.
• Assess medication adherence/tolerability.

Rx Pharmacotherapy: Principles for Selecting Pharmacotherapy

Pharmacotherapy Efficacy

• Table with FDA-approved options and their odds ratios (OR) for smoking cessation, comparing them to a placebo. Includes nicotine gum, patch, lozenges, bupropion SR (Zyban), inhaler, nasal spray, combination therapy.

Combination Therapy

• Combination therapy options, OR (95% Confidence Interval) for quitting. Includes examples like nicotine patch + gum/spray, patch + inhaler, etc.

Pharmacotherapy 1st Line Options

• Nicotine Replacement Therapy (NRT) is a common 1st line option
• Varenicline is another possible 1st line choice
• Combination therapies like patch + gum are possible

Combination NRT

• Various combinations of nicotine replacement therapy (NRT) products.

Nicotine Replacement Therapy Precautions/Contraindications/Warnings

• All NRT: Hypersensitivity, pregnancy (category D), recent myocardial infarction, serious arrhythmias, worsening angina.
• Additional Formulation-based: Severe eczema or psoriasis, temporomandibular joint (TMJ) disease, caution in denture wearers, hypersensitivity to menthol, bronchospastic disease, severe reactive airway disease, chronic nasal disorders.
• Recent myocardial infarction and other precautions are important.

Nicotine Replacement Therapy - Nicotine Transdermal Patch

• Directions: Daily use. Hairless areas, rotation of placement. Skin irritation avoidance.
• Dosing Regimen: Vary based on smoking history (light vs heavy smoker). Decreasing patch strength over time.
• Adverse Effects: Local skin reactions, insomnia, vivid dreams, headache.
• Advantages: Slow nicotine release, once daily dosing, adherence.
• Disadvantages: Cannot titrate dose to cravings/withdrawal.

Nicotine Replacement Therapy - Nicotine Lozenges

• Directions: Don't use within 15 minutes of eating/drinking. Don't chew or swallow. Lozenge use limit each day.
• Dosing Regimen: Vary based on dependence (heavy versus low). Gradual decrease in strength over weeks.
• Advantages: Ease of use & titration to control cravings. Can be used in those with dental challenges
• Disadvantages: Frequent dosing required..

Nicotine Replacement Therapy - Nicotine Gum

• Directions: Avoid usage within 15 minutes of meals. Chewing then allowing the stimulation to cease (parking). Limit usage to 24 pieces daily
• Dosing regimen: Based on weeks 1-6, 7-9, 10-12 dependence, increasing per day.
• Advantages: Easy to use, address cravings. Can be used in smokers with poor dentition.
• Disadvantages: Frequent dosing, May need proper chewing technique, May stick to teeth.

Nicotine Replacement Therapy - Nicotine Inhaler

• Directions: Do not use within 15 minutes of eating. Inhale into the back of the throat. Limit puffs to 20 minutes of puffing (duration). No more than 16 cartridges daily
• Dosing Regimen: Initial dose based on smoking history. Gradually decreasing cartridges over time.
• Adverse Effects: Mild irritation in mouth or throat (initially), unpleasant taste or cough (initially), runny nose, upset stomach, and hiccups.
• Advantages: Ease of use & titration to control cravings. Hand-to-mouth routine is mimicked.
• Disadvantages: Need for frequent dosing and puffing. Visible during use. Device assembly may be difficult.

Nicotine Replacement Therapy - Nicotine Nasal Spray

• Directions: Do not use within five minutes of driving. Prime. Tilt head back and spray. Don’t inhale. Do not blow nose soon after.
• Dosage: Weeks 1-8 / Weeks 9-12/14. 1 dose = 2 sprays, 1 spray per nostril; 0.5 mg/spray. Maximum of 40 doses/day.
• Advantages: Easy to use; can be titrated to cravings, rapid nicotine delivery.
• Disadvantages: Addiction potential, frequent dosing, visible during usage.

Varenicline (Chantix®)

• Contraindications/Warnings: Serious skin reactions, angioedema, accidental injury (somnambulism), severe renal impairment, pregnancy category C, serious psychiatric disorders. Risk of suicidal behavior/thoughts, cardiovascular events. Black-box neuropsychiatric warning removed in 2016, newer guideline/warning statement remains. EAGLES trail.
• Directions: Take with a full glass of water after meals. Stop varenicline and call the doctor if symptoms arise, like abnormal behavior, thoughts of suicide, or extreme changes in mood. Use caution while operating heavy machinery.
• Dosage Regime: 7 days before quit date. Daily dosing varies over weeks.
• Side Effects: Nausea (~33%), Insomnia, abnormal dreams, vomiting, and flatulence.
• Advantages: Dual action, easy use (twice daily). Combination use with nicotine patch is a possibility.
• Disadvantages: Serious adverse events possible.

Bupropion SR (Zyban®)

• Contraindications/Cautions/Warnings: Seizure disorder, concomitant use of Wellbutrin, anorexia/bulimia, recent discontinuation of sedatives/alcohol, CNS tumor, hepatic cirrhosis, MAO inhibitors, pregnancy (Category C), glaucoma, increased risk of suicide, neuropsychiatric adverse events.
• Directions: Take doses more than 8 hours apart, not at bedtime. Do not crush, divide or chew. If there are changes in mood, behavior or thoughts of suicide, contact a doctor immediately.
• Dosage Regimen: 7 days before quit date (initial dose). Dosage increases over time.
• Side Effects: Insomnia (~35-40%), tremor (rare), rash (rare), and constipation.
• Disadvantages: Drug interactions.
• Advantages: Easy to use (twice daily). May delay some weight gain, suitable addition to nicotine replacement therapy.

Combination Therapy

• If single-agent therapy isn’t effective, combining varenicline or bupropion with one NRT product can be considered

Pharmacotherapy for Patients with CVD

• Preference of therapy. Categorizing what is effective depending on the status of the patient's CVD. Table of first, second, and third lines.

Gradual Reduction & Medication Preloading

• Gradual reduction strategies like varenicline-assisted gradual therapy for a 3-month period.
• Preloading pharmacotherapy: Starting pharmacotherapy while still smoking to reduce smoking satisfaction and the amount of cigarettes per day.

Duration of Smoking Cessation Therapies

• Table of suggested durations for various therapies, like nicotine patch, gum, lozenges, inhaler, nasal spray, Bupropion SR, Varenicline.

NRT Duration & Use While Smoking

• April 2013 FDA Update: remove warnings against using NRT while still smoking, remove the specific duration use limit. The recommendation is now to consult healthcare providers regarding longer usage times to prevent relapse.

Vaping and e-Cigarettes

• Safety concerns related to battery-operated devices containing nicotine and flavors.
• Regulatory status: E-cigarettes were regulated by the FDA as of 2016.
• Public health concerns: Significant increase in youth vaping and associated disease risks.

Clinician Resources

• List of helpful websites/resources for clinicians.

Patient Resources

• Websites and phone numbers to help patients access cessation support.

Smoking Cessation Case Scenarios

• Detailed case scenarios for patients with differing histories, including medical issues, smoking history and readiness to quit, along with detailed summaries and notes. The case scenarios are for use in class study.

Test your knowledge on nicotine replacement therapy, smoking statistics, and the economic costs associated with smoking in the U.S. This quiz covers various methods of nicotine replacement and their advantages and disadvantages. Challenge yourself to see how much you know about smoking cessation techniques.