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Jim Thigpen, PharmD, BCPS ETSU Bill Gatton College of Pharmacy Describe the pharmacotherapy used in smoking cessation Determine the appropriate therapy to recommend for a specific patient Describe patient expectations when using smoking cessation products Extent of harms to children caused by tobacco use and secondhand smoke exposure Relationship of pediatric tobacco use and exposure to adult tobacco use Existence of effective interventions to reduce the use Documented underuse of those interventions Policy Statement – Tobacco Use: A Pediatric Disease, Pediatrics 124(5), Nov 2009 Provide counseling to expectant parents to quit using tobacco products and avoid SHS exposure during and after pregnancy Assist new parents in their efforts to continue their tobacco use-abstinence or –cessation efforts after delivery Counsel parents to reduce or eliminate children’s exposure to SHS Counsel preadolescents and adolescents to prevent initiation Counsel adolescents and parents to quit using tobacco 85% of parents who smoke consider it acceptable for their child’s pediatrician to prescribe a smoking-cessation medication for them1 In 2005, the American Medical Association adopted a policy statement supporting the practice of pediatricians addressing parental smoking2 American Medical Association H-490.917 Physician Responsibilities for Tobacco Cessation. Adopted June 2005, Chicago IL 18.4% will quit if you do nothing 23.1% will quit if you intervene Families with children ages 4-17 more likely Interventions whose primary goal was cessation Interventions that offered medications Interventions with high follow-up rates Rosen LJ, Noach MB et al. Parental smoking cessation to protect young children: a systematic review and meta-analysis. Pediatrics 129(1) Jan 2012 Cessation rates are ↑ when smokers attended two or more sessions of ≥ 20 minutes Motivating the unwilling patient The five Rs Relevant reasons to quit Risks associated with continued smoking Rewards for quitting Roadblocks to successful quitting Repetition of the counseling of subsequent visits There is a consistent relationship between more intensive counseling and abstinence from smoking No counseling (11%) 1 – 3 minutes (14%) 4 – 30 minutes (19%) 31 – 90 minutes (27%) Counseling should be sympathetic and supportive, not confrontational 1-800-QUIT-NOW (1-800-784-8669 Cold turkey 5% success Unassisted tapering 5% success Assisted tapering QuitKey® Computer-assisted behavior modification ▪ 19-24% abstinence rate 1 year after quitting Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS Nicotine is carried by tar particles to the lung alveoli and then to the brain Nicotine binds with to nicotinic cholinergic receptors in the brain, leading to neurotransmitter release Tolerance develops with chronic smoking, resulting in the proliferation of nicotine receptors and permitting higher levels of self-administration of nicotine A lack of binding to these receptors due to decreased smoking results in withdrawal symptoms About half of phenotypic variance in tobacco dependence is attributable to genetic influence Fiore MC, Baker TB. Treating smokers in the health care setting NEJM 2011;365:1222-31 Three general classes of FDA-approved drugs for smoking cessation: Nicotine Replacement Therapy (NRT) ▪ Gum, patch, lozenge, nasal spray, inhaler Psychotropics ▪ Sustained-release bupropion (Zyban®) Partial nicotinic receptor agonist ▪ Varenicline (Chantix®) The clinical practice guideline states that pregnant smokers should be encouraged to quit without medication based on insufficient evidence of effectiveness and hypothetical concerns NRT products are category D Bupropion is category C Varenicline is category C Smokeless tobacco users No FDA indication Individuals smoking < 10 cigarettes per day Adolescents OTC sales are restricted to ≥ 18 NRT use in minors requires a prescription Reduces physical withdrawal from nicotine Eliminates the immediate, reinforcing effects of nicotine that is rapidly absorbed via tobacco smoke Allows patient to focus on behavioral and psychological aspects of tobacco cessation Use of NRT approximately doubles long-term quit rates relative to placebo Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS Polacrilex gum Nicorette®, generics Lozenge Nicorette® Lozenge Nasal Spray Nicotrol ® NS Inhaler Nicotrol ® Nicorette ® Mini Lozenge Generics Transdermal Patch Nicoderm CQ ® Generics Patients should stop using all forms of tobacco upon initiation of NRT Patients with underlying cardiovascular disease Recent myocardial infarction Serious arrhythmias Serious or worsening angina NRT products may be appropriate for these patients if they are under medical supervision Resin complex Nicotine Polacrilin Sugar-free chewing gum base Contains buffering agents to enhance buccal absorption of nicotine Available in 2mg, 4mg; original, cinnamon, fruit, mint (various), and orange flavors Dosage based on current smoking patterns: If patient smokes Recommended strength ≥ 25 cigarettes (1 pack)/day 4 mg < 25 cigarettes/day 2 mg Recommended Usage Schedule for Nicotine Gum Weeks 1 - 6 Weeks 7-9 Weeks 10 - 12 1 piece q 1 – 2 h 1 piece q 2 – 4 h 1 piece q 4 – 8 h Do not use more than 24 pieces per day Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS Chew each piece slowly several times Stop chewing at first sign of peppery taste “park” gum between cheek and gum Resume chewing when taste or tingle fades Return to “park” when taste or tingle resumes Repeat chew/park until most of the nicotine is gone (≈ 30 minutes) Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS Use at least nine pieces per day Do not eat or drink anything for 15 minutes before or while using nicotine gum Nicotine polacrilex is buffered to pH 8.5 Acidic beverages may reduce the pH of the saliva, reducing the buccal absorption of nicotine ▪ Coffee, wine, juices, soft drinks Chewing gum too rapidly can cause excessive nicotine release Lightheadedness, N/V, irritation, hiccups, reflux Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS Advantages Disadvantages Satisfy oral cravings Need for frequent Might delay weight dosing Dental work Must use proper technique Gum might not be socially acceptable gain (4 mg) Therapy can be titrated to manage withdrawal symptoms Flavors Dosage is based on “time to first cigarette” as an indicator of nicotine dependence Use the 2 mg strength if you smoke the first cigarette more than 30 minutes after waking Use the 4 mg strength if you smoke the first cigarette less than 30 minutes after waking Use is essentially identical to gum Dosing intervals, titration, use, etc Nicotine is well absorbed across the skin Delivery to systemic circulation avoids hepatic first pass effect Plasma nicotine levels are lower and fluctuate less than with smoking Treatment Estimated abstinence rate Placebo 13.8% Nicotine patch (6-14 weeks) 23.4% Nicotine patch (> 14 weeks) 23.7% Product Light Smoker Heavy Smoker Nicoderm® CQ ≤ 10 cigarettes/day Step 2 (14 mg X 6 weeks) Step 3 (7 mg X 2 weeks) 10 cigarettes/day Step 1 (21 mg X 6 weeks) Step 2 (14 mg X 2 weeks) Step 3 (7 mg X 2 weeks) Generic ≤ 10 cigarettes/day Step 2 (14 mg X 6 weeks) Step 3 (7 mg X 2 weeks) 10 cigarettes/day Step 1 (21 mg X 4 weeks) Step 2 (14 mg X 2 weeks) Step 3 (7 mg X 2 weeks) Choose an area of skin on the upper body or upper outer part of the arm Make sure the skin is clean, dry, hairless, and not irritated Apply patch to different area each day Do not use same area again for at least 1 week Side effects to expect in first hour: Mild itching Burning Tingling Additional possible side effects: Vivid dreams or sleep disturbances Headache Up to 50% will have local skin reactions Aqueous solution of nicotine (10 ml) Each metered dose delivers 50 mcl spray 0.5 mg nicotine ≈ 100 doses/bottle Rapid absorption across nasal mucosa More rapid onset compared to gum, patch, or inhaler 26.7% 6-month abstinence rate One dose = 1 mg nicotine (2 sprays, one 0.5 mg spray in each nostril) Start with 1-2 doses per hour Increase prn to maximum dosage of 5 doses per hour or 40 mg (80 sprays; ½ bottle) daily For best results, patients should use at least 8 doses daily for the first 6-8 weeks Gradual tapering over an additional 4-6 weeks Start with at least 6 cartridges/day during the first 3-6 weeks of treatment Increase to a maximum of 16 cartridges per day In general, use 1 cartridge every 1-2 hours Recommended duration of therapy is 3 months Gradually reduce daily dosage over the following 6-12 weeks During inhalation, nicotine is vaporized and absorbed across oropharyngeal mucosa 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 Open cartridge retains potency for 24 hours Mouthpiece is reusable; clean regularly Side effects associated with the nicotine inhaler include: Mild irritation of mouth or throat Cough Headache Rhinitis Dyspepsia Severity generally rated as mild, and frequency of symptoms declined with use Non-nicotine Sustained release antidepressant Oral only Estimated abstinence rate is 24.2% Atypical antidepressant thought to affect levels of dopamine and norepinephrine Clinical effects ↓ craving for cigarettes ↓ symptoms of nicotine withdrawal Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS Contraindications/Precautions History of epilepsy Other sources of bupropion (Wellbutrin®) MAO inhibitors in preceding 14 days Prior diagnosis of anorexia, bulemia, other psychiatric disorders (suicide risk) Abrupt discontinuation of benzodiazepines, sedatives, or alcohol (↑ seizure risk) Hepatic disease Patients should begin therapy 1 – 2 weeks prior to their quit date to ensure target plasma levels 150 mg once daily for 3 days, then BID Duration is 7-12 weeks Common side effects include: Insomnia, dry mouth Less common Tremor, skin rash Binds with high affinity and selectivity to α4β2 neuronal nicotinic acetylcholine receptors Stimulates low-level agonist activity Competitively inhibits binding of nicotine Clinical effects ↓ symptoms of nicotine withdrawal Blocks dopaminergic stimulation responsible for reinforcement & reward associated with smoking Neurophychiatric symptoms and suicidality Changes in mood Psychosis/hallucinations/paranoia/delusions Homicial ideation/hostility Agitation/anxiety/panic Suicidal ideation or attempts Completed suicide Patients should begin therapy 1 week prior to their quit date Treatment Day Dose Day 1 to day 3 0.5 mg daily Day 4 to day 7 0.5 mg BID Day 8 to end of treatment 1 mg BID Adverse Effects (> 5% and x2 higher than placebo) Nausea Sleep disturbances Constipation Flatulance Vomiting Vivid dreams (< 5%) Clonidine α2-adrenergic agonist that reduces sympathetic outflow that reduces the autonomic symptoms of withdrawal May be beneficial Nortriptyline TCA May be beneficial Nasal Spray 25 Bupropion 23.9 20 Patch 15 18 15.8 16.1 17.1 19 20.2 10 5 0 Gum Lozenge Inhaler Verenicline Combination NRT Patch + gum/inhaler/nasal spray Bupropion + Nicotine patch Gum Lozenge Patch Inhaler Nasal Spray Bupropion Verencline $4.68 $4.95 $3.89 $7.02 $3.92 $7.78 $4.70 $2.16 $3.24 $1.90 $3.62