Tobacco Cessation Products Review
Amy Bachyrycz, Pharm.D. Shared Faculty, UNM COP
Walgreens Pa?ent Care Center
Objectives
• Tobacco cessa?on product review • Current clinical evidence regarding tobacco cessa?on
• Case based applica?on of tobacco cessa?on products
• Pharmacist role and perspec?ve in tobacco cessa?on efforts
Pathophysiology of Smoking • Repeated exposure develops neuroadapta?on of the receptors
• Develops tolerance to it’s own ac?on with repeated use • Pharmacotherapies reduce withdrawal symptoms and block the reinforcing effects of nico?ne • Without causing excessive adverse effects
• All FDA approved tobacco cessa?on products are safe for short and long term use
• Combina?on therapy may be indicated for pa?ents that may have failed monotherapy or with heavy chemical addic?on
Jiloha R. Pharmacotherapy of Smoking Cessation. Indian J of Psych. 2014.
Why Do We Smoke? • Rewards • Boredom • Habit • Addic?on
Neurobiology of Smoking • Tip of a lighted cigareNe, burns at 800 degrees Celsius • With each puff, draws into one’s mouth gases and many sized par?cles
• Of the 4000 chemicals iden?fied in tobacco smoke, nico?ne is responsible for a number of pathophysiological changes in the body
• Nico?ne remains dissolved in the moisture of the tobacco leaf as a water soluble salt, in a burning cigareNe it vola?lizes & remains suspended on minute droplets of tar as free nico?ne • Droplets reach smallest alveoli of the lungs
• About 90% of the nico?ne present in inhaled smoke is absorbed (11-‐15 seconds)
• Yields increase in dopaminergic ac?vity and euphoria/pleasure
FDA Approved Products
• NRT (also over-‐the-‐counter) • Patch, gum, lozenge
• NRT (prescrip?on only) • Inhaler, nasal spray
• Varenicline • Zyban and generic
Plasma Nicotine Concentrations
0
5
10
15
20
25
1/0/1900 1/10/1900 1/20/1900 1/30/1900 2/9/1900 2/19/1900 2/29/1900
Plas
ma
nico
tine
(mcg
/l)
Cigarette
Moist snuff
Nasal spray
Inhaler
Lozenge (2mg)
Gum (2mg)
Patch
0 10 20 30 40 50 60
Time (minutes)
Cigarette
Moist snuff
Review of 5A’S • 5A’s are part of NM Board of Pharmacy protocol • 5A’s will gather all necessary info for workup/SOAP note • 5A’s will determine what behavioral modifica?on you recommend for your pa?ent
• 5A’s will determine and jus?fy what product you chose to prescribe • Ask every pa+ent about tobacco use • Advise all smokers to quit • Assess smokers' willingness to quit • Assist smokers with treatment and referrals • Arrange follow-‐up
Fagerstrom • Smoking is a 2 part addic?on • Determines level of addic?on
• How soon aber waking do you smoke your first cigareNe? • Time less than 5 minutes: 3 points • Time 5 to 30 minutes: 2 points • Time 31 to 60 minutes: 1 point
• Interpreta?on • Heavy nico?ne dependence: 5-‐6 points • Moderate nico?ne dependence: 3-‐4 points • Light nico?ne dependence: 0-‐2 points
Steps to Case Work-‐up • Iden?fy pa?ent is in Stage 2 model for change • Sign consent form • Complete 5A’s • Complete Fagerstrom (op?onal) • Agree on behavioral modifica?ons to make • Agree on TC product, dose, side effects, contraindica?ons • Write brief work-‐up/SOAP to store in pharmacy using 5A’s • Write script, fill and dispense (charge pt for med/counseling) • No?fy PCP/healthcare team, w/ pa?ent consent, within 15 dys
SOAP • Subjec?ve
• HPI (chief complaint, stage in quiing process) • SH (age, gender, occupa?on, etoh, cpd) • PMH Medica?ons (prescrip?on, OTC, discon?nued meds)
• Objec?ve • Vitals • Lab Values
• Assessment • Triggers and associa?ons, readiness to quit, product jus?fica?on
• Plan • Quit date, 1800 Quit Now reference if appropriate • Specific pharmacotherapy and behavioral modifica?ons • PCP/healthcare team no?fied and date documented
Case 1 • 65 y/o re?red pt John Smith, DOB 10/22/48 • Appears depressed, no work-‐up or diagnosis • Smokes 1 ppd x 15 yrs • PMH: open heart surgery several years back • Meds: metoprolol • References a posi?ve experience with Commit
• Ready to quit in the next 30 days
Case 1 Possible Regimens • CBT (lifestyle modifica?ons)
• Smokers do not plan to fail they fail to plan • Slip vs relapse plan of ac?on
• Smoke break plan of ac?on • Crisis plan of ac?on • Avoid triggers and associa?ons
• NRT (single or in combo) • Avoid in MI, arrhythmia, angina • Once on, smoking must cease • Gum or bupropion: evidence of appe?te suppression • Nasal spray: avoid in asthma, COPD, URI
Case 1 Possible Regimens • Bupropion (with or without NRT)
• Taper (150mg daily x 3-‐7 dys, then bid thereaber) • Does not require taper to DC • Avoid in ea?ng d/o, seizures, alcoholism, meds that lower seizure threshold, liver failure or elevated lipid panel, currently on Wellbutrin
• Varenicline (USE ALONE) • Avoid in underlying anxiety/depression • Discuss side effects clearly
• Nausea, dreams, neuropsych symptoms • Banned in commercial drivers, pilots, air traffic contr. • Careful in renal failure & underweight individuals
Varenicline and combination NRT, found most effective • Evidence Based Medicine Journal reported findings from 12 treatment specific reviews of high methodological quality: • Varenicline was superior to NRT monotherapy • Varenicline was superior to bupropion • Varenicline was not superior to combina?on NRT • NRT and bupropion were of equal efficacy
• The reviews did not find an increase of neuropsychiatric events with either varenicline or bupropion compared to placebo
• The reviews had compelling evidence that varenicline, aber proper screening, does not cause an increase in serious adverse effects
Ebbert J. Varenicline and combination nicotine replacement therapy are the most effective pharmacotherapies for treating tobacco use. Evid Based Med. 2013.
Nicotine Gum Suggested Dosing
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.
If patient smokes Recommended strength
≥25 cigarettes/day 4 mg
<25 cigarettes/day 2 mg
Nicotine Lozenge Dosing Dosage is based on the “time to first cigarette” (TTFC) as an indicator of nicotine addiction
Use Commit Lozenge 2 mg: If you smoke your first cigarette more than 30 minutes after waking up
Use Commit Lozenge 4 mg: If you smoke your first cigarette of the day within 30 minutes of waking up
Nicotine Lozenge Suggested Dosing
Recommended Usage Schedule for Commit Lozenge
Weeks 1–6 Weeks 7–9 Weeks 10–12
1 lozenge q 1–2 h
1 lozenge q 2–4 h
1 lozenge q 4–8 h
DO NOT USE MORE THAN 20 LOZENGES PER DAY.
Nicotine Patch Suggested Dosing
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)
Nicotine Nasal Spray • Aqueous solu?on in a 10-‐ml spray boNle
• Start with 1–2 doses per hour • Increase prn to max. dosage of 5 doses per hour
• For best results, use at least 8 doses daily for the first 6–8 weeks
• Gradual tapering over an addi?onal 4–6 weeks needed
Nicotine Inhaler n Start with 6 cartridges/day (4mg/cartridge delivered)
n Increase prn to maximum of 16 cartridges/day
n Use for minimum of 3 weeks, maximum of 12 weeks
n Gradual dosage reduction over additional 6–12 weeks
Varenicline Dosing Instructions • Starter Pack
• Take 0.5mg daily on days 1 through 3 • Take 0.5mg bid on days 4 through 7 • Take 1mg bid thereaber
• Con?nuing Pack • Take 1mg bid
• Counseling Points • Take with food • Take at least 8 hrs apart, but not aber 6pm • If side effects occur, immediately discon?nue
Product Success Rates • JAMA, January 2014 compiled results from 267 studies
• NRT, 17.6% success rate • Bupropion, 19.1% success rate • Placebo, 10.6% success rate • Varenicline, 27.6% success rate • Combina?on, NRT 31.5% success rate (patch plus inhaler)
Cahill K, et al. Pharmacological treatments for tobacco cessation. Jama. 2014.
Case 2 • Female Jonah Smith DOB 3/15/1980, owns a restaurant • No PMH and no medica?ons • Smokes 15 cpd, mostly while at work • Interested in quiing to encourage staff to quit • Failed NRT (patch) in past due to numbness in the arm
Case 2 Possible Regimens • CBT (lifestyle modifica?ons) • NRT (single or in combo)
• Wants to quit today • Bupropion (with or without NRT) • Varenicline (ALONE)
Varenicline with NRT • South Africa, JAMA 2014 (24 week trial, n=446)) • Iden?fied that it is unclear if varenicline plus NRT is effec?ve and safe • Nico?ne patch plus varenicline vs. varenicline alone
• Combina+on therapy was associated with higher abs+nence rates at week 12 (55.4% vs. 40.9%) and week 24 (49.0% vs. 32.6%)
• Combina?on therapy was associated with adverse events • Nausea, sleep disturbance, skin reac?ons, cons?pa?on, depression,
• Only skin reac?on reached sta?s?cal significance (P=0.03)
Coenraad F, et al. Efficacy of varenicline combined with NRT vs. varenicline alone for smoking cessa?on. JAMA. 2014.
Case 3 • You have an appt. with Mr. Bradshaw, a 46 y/o man who is 50lbs overweight
• He is agitated because he had to wait while you finished up with a pa?ent
• He reports NKDA, however, he has HTN and hyperlipidemia
• You no?ce a box of Marlboro lights in his leb chest pocket, but he is NOT ready to quit
Case 3 Possible Suggestions • 5 R’s
• Not ready to quit • Mo?va?onal counseling
• Plan or Assist & Arrange • 1-‐800-‐QuitNow card
• Free gum/patches if no current condi?on • Possible phone call in 30 days
Smokeless Tobacco • Clinical evidence is limited • All tobacco cessa?on products may be used
Varenicline in Smokeless Tobacco • Systema?c review, meta-‐analysis • Evaluated 3 published randomized clinical trials involving 744 users comparing varenicline vs. placebo
• Abs?nence at 12 weeks (48.0% vs. 33.0%) • Abs?nence at 26 weeks (49.0% vs. 39.0%) • Overall, no sta?s?cally significant differences in the incidence of adverse events
Schwartz J, et al. Use of varenicline in smokeless tobacco cessation. Nicotine & Tobacco Research. 2015.
Pharmacists Prescriptive Authority Protocol Highlights • Counseling x 90 minutes/pa?ent • Must get some work-‐up of pa?ent (PMH, SH) • Approved training (RX F C curriculum) • 2 Live CE’s Q 2 yrs • Prescribe FDA approved medica?ons • Informed Consent w/ approval to no?fy PCP in 15 dys of Rx if iden?fied
• Pt F/u • * Group sessions are allowed
Patient Info. For Group Session § Benefits to quiing
§ Cough may resolve § Exercise tolerance improves rapidly § Bladder cancer: 50% reduc?on in 5 years § Lung cancer: 50% reduc?on in 10 years § Heart disease: 50% reduc?on in 1 year § Vascular disease: 50% reduc?on in 5 years § Mortality: improves lifespan by appx. 10-‐15 yrs
Pharmacists Must Refer… • For bupropion prescribing only
• Seizure disorder/Ea?ng disorder • Alcoholism • Liver cirrhosis
• Contraindica?on to specific therapy • NRT
• Arrhythmias • MI (h/o) • Angina, worsening
• Varenicline • Depression/anxiety
• Risks are greater than benefits
Barriers to Increased Pharmacist Intervention • Federal provider status • Lack of third party payer coverage for products • Lack of federal funds (excludes pregnant pa?ents) • Lack of corporate support • Workload difficult to manage • F/u difficult (e.g. phone numbers disconnected, no-‐shows)
Summary • Tobacco cessa?on product review includes products that may be more suitable for individual pa?ents
• Clinical evidence is limited (e.g. e-‐cigareNes, smokeless tobacco) and tobacco cessa?on efforts
• All healthcare professionals have a role in tobacco cessa?on advoca?ng
• Pharmacist prescrip?ve authority exists, but barriers exist in NM