Transcript TCCases2017 - New Mexico Pharmacists Association

Tobacco Cessation Products Review
Amy Bachyrycz, Pharm.D.
Shared Faculty, UNM COP
Walgreens Patient Care Center
Objectives
• Tobacco cessation product review
• Current clinical evidence regarding
tobacco cessation
• Case based application of tobacco
cessation products (practice)
• Pharmacist role and perspective in
tobacco cessation efforts
What Can I do upon
Graduation?
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Prescribe and FDA approved products for TC
Prescribe TC to those pts under 18 yrs of age
Charge pts for the cognitive services included in TC
Counsel/Recommend for pregnant female pts on Medicaid &
bill the state for the medication/counseling (via paper billing)
• Follow-up with patients as your clinical judgment deems is
necessary
Pathophysiology of Smoking
• Repeated exposure develops neuroadaptation of the
receptors
• Develops tolerance to it’s own action with repeated use
• Pharmacotherapies reduce withdrawal symptoms and block
the reinforcing effects of nicotine
• Without causing excessive adverse effects
• All FDA approved tobacco cessation products are safe for short
and long term use
• Combination therapy may be indicated for patients that may
have failed monotherapy or with heavy chemical addiction
Jiloha R. Pharmacotherapy of Smoking Cessation. Indian J of Psych. 2014.
Why Do We Smoke?
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Rewards
Boredom
Habit
Addiction
Neurobiology of Smoking
• Tip of a lighted cigarette, burns at 800 degrees Celsius
• With each puff, draws into one’s mouth gases and many sized
particles
• Of the 4000 chemicals identified in tobacco smoke, nicotine is
responsible for a number of pathophysiological changes in the
body
• Nicotine remains dissolved in the moisture of the tobacco leaf
as a water soluble salt, in a burning cigarette it volatilizes &
remains suspended on minute droplets of tar as free nicotine
• Droplets reach smallest alveoli of the lungs
• About 90% of the nicotine present in inhaled smoke is
absorbed (11-15 seconds)
• Yields increase in dopaminergic activity and euphoria/pleasure
FDA Approved Products
• NRT (also over-the-counter)
• Patch, gum, lozenge
• NRT (prescription only)
• Inhaler, nasal spray
• Varenicline
• Zyban and generic
New Improved FDA Approved
Products
Plasma Nicotine Concentrations
25
Cigarette
Cigarette
Moist snuff
Plasma nicotine (mcg/l)
20
Moist snuff
Nasal spray
15
Inhaler
10
Lozenge (2mg)
Gum (2mg)
5
Patch
0
1/0/1900
0
1/10/1900
10
1/20/1900
20
1/30/1900
30
Time (minutes)
2/9/1900
40
2/19/1900
50
2/29/1900
60
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 modification you
recommend for your patient
• 5A’s will determine and justify what product you chose to
prescribe
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Ask every patient 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 addiction
• Determines level of addiction
• How soon after waking do you smoke your first
cigarette?
• Time less than 5 minutes: 3 points
• Time 5 to 30 minutes: 2 points
• Time 31 to 60 minutes: 1 point
• Interpretation
• Heavy nicotine dependence: 5-6 points
• Moderate nicotine dependence: 3-4 points
• Light nicotine dependence: 0-2 points
Steps to Case Work-up
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Identify patient is in Stage 2 model for change
Sign consent form
Complete 5A’s
Complete Fagerstrom (optional)
Agree on behavioral modifications to make
Agree on TC product, dose, side effects, contraindications
Write brief work-up/SOAP to store in pharmacy using 5A’s
Write script, fill and dispense (charge pt for med/counseling)
Notify PCP/healthcare team, w/ patient consent, within 15 dys
SOAP
• Subjective
• HPI (chief complaint, stage in quitting process)
• SH (age, gender, occupation, etoh, cpd)
• PMH Medications (prescription, OTC, discontinued meds)
• Objective
• Vitals
• Lab Values
• Assessment
• Triggers and associations, readiness to quit, product justification
• Plan
• Quit date, 1800 Quit Now reference if appropriate
• Specific pharmacotherapy and behavioral modifications
• PCP/healthcare team notified and date documented
Case 1
• 65 y/o retired 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 and aspirin 81mg
• References a positive experience with Commit
lozenges
• Ready to quit in the next 30 days
Case 1 Possible Regimens
• CBT (lifestyle modifications)
• Smokers do not plan to fail they fail to plan
• Slip vs relapse plan of action
• Smoke break plan of action
• Crisis plan of action
• Avoid triggers and associations
• NRT (single or in combo)
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Avoid in MI, arrhythmia, angina
Once on, smoking must cease
Gum or bupropion: evidence of appetite 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 thereafter)
• Does not require taper to DC
• Avoid in eating 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:
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Varenicline was superior to NRT monotherapy
Varenicline was superior to bupropion
Varenicline was not superior to combination 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, after
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.
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 thereafter
• Continuing Pack
• Take 1mg bid
• Counseling Points
• Take with food
• Take at least 8 hrs apart, but not after 6pm
• If side effects occur, immediately discontinue
Nicotine Gum Suggested Dosing
If patient smokes
Recommended strength
25 cigarettes/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.
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
1 lozenge
1 lozenge
q 1–2 h
q 2–4 h
q 4–8 h
DO NOT USE MORE THAN 20 LOZENGES
PER DAY.
Nicotine Patch Suggested Dosing
Product
Nicoderm CQ
Generic
Light Smoker
Heavy Smoker
10 cigarettes/day
>10 cigarettes/day
Step 2 (14 mg x 6
weeks)
Step 1 (21 mg x 6 weeks)
Step 3 (7 mg x 2 weeks)
Step 3 (7 mg x 2 weeks)
10 cigarettes/day
>10 cigarettes/day
Step 2 (14 mg x 6
weeks)
Step 1 (21 mg x 4 weeks)
Step 3 (7 mg x 2 weeks)
Step 3 (7 mg x 2 weeks)
Step 2 (14 mg x 2 weeks)
Step 2 (14 mg x 2 weeks)
Nicotine Nasal Spray
• Aqueous solution in a 10-ml spray bottle
• 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 additional 4–6 weeks needed
Nicotine Inhaler
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Start with 6 cartridges/day (4mg/cartridge delivered)
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Increase prn to maximum of 16 cartridges/day
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Use for minimum of 3 weeks, maximum of 12 weeks
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Gradual dosage reduction over additional 6–12 weeks
Please write your script now!
• Switch scripts
• Please call out a piece of info. you are missing as the
dispensing pharmacist or may be hard to interpret
• Confirm you have all of the required information
• Patient name, address, and DOB
• Address must be on script per BOP law, so if you do not write it, the
dispensing pharmacy must write it
• Drug, strength, and instructions
• Not generally acceptable includes:
• Use as directed or as needed
• See package directions
• Quantity and number of refills
• Difficult to interpret includes:
• One box
• Doctor signature and one other identifier (phone number)
Please re-write your script now!
• Switch scripts
• Re-confirm you have all of the required information
• Patient name, address, DOB
• Address must be on script per BOP law, so if you do not write it, the
dispensing pharmacy must write it
• Drug and instructions (must have a strength)
• Not generally acceptable includes:
• Use as directed or as needed
• See package directions
• Quantity and number of refills
• Difficult to interpret includes:
• One box (large or small, what package size?)
• Doctor signature and one other identifier (phone number)
Product Success Rates
• JAMA, January 2014 compiled results from 267 studies
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NRT, 17.6% success rate
Bupropion, 19.1% success rate
Placebo, 10.6% success rate
Varenicline, 27.6% success rate
Combination, NRT 31.5% success rate (patch plus inhaler)
Cahill K, et al. Pharmacological treatments for tobacco cessation. Jama. 2014.
Case 2
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Female Jonah Smith DOB 3/15/1980, owns a restaurant
No PMH and no medications
Smokes 15 cpd, mostly while at work
Interested in quitting to encourage her restaurant staff to
quit
• Failed NRT (patch alone) in past due to numbness in the
arm
Case 2 Possible Regimens
• CBT (lifestyle modifications)
• 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))
• Identified that it is unclear if varenicline plus NRT is effective
and safe
• Nicotine patch plus varenicline vs. varenicline alone
• Combination therapy was associated with higher abstinence
rates at week 12 (55.4% vs. 40.9%) and week 24 (49.0% vs.
32.6%)
• Combination therapy was associated with adverse events
• Nausea, sleep disturbance, skin reactions, constipation,
depression,
• Only skin reaction reached statistical significance (P=0.03)
Coenraad F, et al. Efficacy of varenicline combined with NRT vs. varenicline alone for smoking cessation. JAMA. 2014.
Case 3
• Female Debbie Juniper DOB 12/15/1985, is a nurse
• You see her smoking in the designated smoke areas where you are
on your rotation
• No PMH and no medications
• Smokes 5 cpd while at work and 15 cpd while at home (1ppd)
• Interested in quitting because she knows it is not healthy and you
get to know her well that month and mention it to her
• Also interested in quitting because her health insurance rate is
higher as a smoker
• Willing to try any available therapy as long as it is covered by her
insurance or not to expensive
Case 3 Possible Regimens
• CBT (lifestyle modifications)
• NRT (single or in combo)
• Gum and lozenge are not generally covered
because of OTC status
• Nasal and inhaler are expensive and not
generally covered or need a prior authorization
• Bupropion (with or without NRT)
• Varenicline (ALONE)
Case 4
• 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 patient
• He reports NKDA, however, he has HTN and
hyperlipidemia
• You notice a box of Marlboro lights in his left
chest pocket, but he is NOT ready to quit
Case 4 Possible Suggestions
• 5 R’s
• Not ready to quit
• Motivational counseling
• Plan or Assist & Arrange
• 1-800-QuitNow card
• Free gum/patches if no current condition
• Possible phone call in 30 days
Smokeless Tobacco
• Clinical evidence is limited
• All tobacco cessation products may be used
Varenicline in Smokeless
Tobacco
• Systematic review, meta-analysis
• Evaluated 3 published randomized clinical trials involving 744
users comparing varenicline vs. placebo
• Abstinence at 12 weeks (48.0% vs. 33.0%)
• Abstinence at 26 weeks (49.0% vs. 39.0%)
• Overall, no statistically significant differences in the incidence
of adverse events
Schwartz J, et al. Use of varenicline in smokeless tobacco cessation. Nicotine & Tobacco Research. 2015.
MM
Medical Marijuana
• Protocol does not allow you to prescribe TC products for
medical marijuana patients trying to quit
• Extraction of marijuana is done with toxic chemicals like
butane, propylene glycol which become inhaled by patients
• As marijuana reaches legalization status in NM:
• Patients may be interested in cessation
• Patients may find long term studies prove respiratory diseases
increase
• Patients may be on concurrent medications that interact with the
MM
• Patients may be interested in safer options such as edibles
• Patients may turn to their pharmacist for advice
Pharmacists Prescriptive Authority
Protocol Highlights
• Counseling x 90 minutes/patient
• * You may charge for each visit
• Must get some work-up of patient (PMH, SH)
• Approved training (RX F C curriculum)
• 2 Live CE’s Q 2 yrs
• Prescribe FDA approved medications
• Informed Consent w/ approval to notify PCP in
15 dys of Rx if identified
• Pt F/u
• * Group sessions are allowed
Patient Info. For Group Session
 Benefits to quitting
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Cough may resolve
Exercise tolerance improves rapidly
Bladder cancer: 50% reduction in 5 years
Lung cancer: 50% reduction in 10 years
Heart disease: 50% reduction in 1 year
Vascular disease: 50% reduction in 5 years
Mortality: improves lifespan by appx. 10-15 yrs
Pharmacists Must Refer…
• For bupropion prescribing only
• Seizure disorder/Eating disorder
• Alcoholism
• Liver cirrhosis
• Contraindication to specific therapy
• NRT
• Arrhythmias
• MI (h/o)
• Angina, worsening
• Varenicline
• Depression/anxiety
• Risks are greater than benefits
Barriers to Increased
Pharmacist Intervention
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Lack of federal provider status
Lack of third party payer coverage for products or visits
Lack of federal funds (excludes pregnant patients)
Lack of corporate support from employers
Workload difficult to manage with remote activity
F/u difficult (e.g. phone numbers disconnected, no-shows)
Pharmacists may not be comfortable prescribing to children
<18 years of age
• Pharmacists have limited info. to other PMH, lab values, etc.
Summary
• Tobacco cessation product review includes products that may
be more suitable for individual patients
• Clinical evidence is limited (e.g. e-cigarettes, smokeless
tobacco) and tobacco cessation efforts
• All healthcare professionals have a role in tobacco cessation
advocating
• Pharmacist prescriptive authority exists, but barriers exist in
NM