Transcript Alcohol and Tobacco Interventions 101” for Primary Care

Tobacco Cessation
Interventions
Lunch and Learn Seminar
Series for Physicians,
Family Health Teams, and
other Health/Allied Health
Practitioners
Session 7:
Pharmacotherapies
(3): Prescription
Medications
Faculty: Claudia Mariano, MSc, NP-PHC, CDE
Housekeeping
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Lunch & Learn Series 2012/2013 Curriculum Needs Assessment
Claudia Mariano, MSc, NP-PHC, CDE
[email protected]
Claudia Mariano graduated from the University of Toronto in 1986 with an
Honours BScN in Nursing. After working for several years on a surgical
floor and then in public health, she returned to U of T and graduated with
her MSc in Nursing in 1993, followed by graduation from the Primary
Health Care Nurse Practitioner program in 1999.
Following the completion of the NP program, Claudia worked for 10 years at
East End Community Health Centre in Toronto before moving to her
current position three years ago at the West Durham Family Health Team
in Pickering. Claudia provides comprehensive health care across the
lifespan, with a focus on diabetes and smoking cessation. Claudia is
TEACH certified and vice-chair of the Central East Association for
Smoking Elimination. Claudia is currently the President-Elect of the Nurse
Practitioners’ Association of Ontario.
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Disclosures
Claudia Mariano
Honorarium from Pfizer (2011, 2010)
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The recipient of the funding is in
compliance with the CMA and the
CPA guidelines / recommendations
for interaction with the
pharmaceutical industry.
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Disclaimer
These materials (and any other materials provided in
connection with this presentation) as well as the
verbal presentation and any discussions, set
out only general principles and approaches to
assessment and treatment pertaining to tobacco
cessation interventions, but do not constitute
clinical or other advice as to any particular
situations and do not replace the need for
individualized clinical assessment and treatment
plans by health care professionals with knowledge
of the specific circumstances.
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TEACH Curriculum Development
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The TEACH Curriculum and slides were developed and compiled with funding
from the Government of Ontario, Ministry of Health Promotion. Content of
slides are primarily based on evidence based guidelines including:
CAN-ADAPTT Canadian Practice Guidelines Initiative – developed in
collaboration with national experts in tobacco cessation and health behaviour
change (www.can-adaptt.net)
US Guidelines Treating Tobacco Use and Dependence: Clinical Practice
Guideline 2008 Update. US Department of Health and Human Services,
Public Health Service
Rethinking Stop-Smoking Medications: Treatment Myths and Medical
Realities OMA Position Paper, January 2008.
The development and delivery of the TEACH curriculum is not influenced or funded in any part by
tobacco industry. TEACH has not received funding from the tobacco industry. The development of
the TEACH curriculum has not been influenced by pharmaceutical industry. TEACH project
received a $10 000 unrestricted grant from Pfizer, to develop video vignettes that are used in our
training. Information presented on pharmacotherapy refers to generic products only, and
recommendations are based on existing research, including the CAN-ADAPTT and US
guidelines. An algorithm is provided to help practitioners determine if and which pharmacotherapy
is appropriate for a smoker.
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Session 7: Learning Objectives
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Describe the types of prescription medication
available for smoking cessation
Apply evidence-based guidelines in
prescribing/recommending prescription
medications for smoking cessation
Apply new knowledge and skills to your
practice with your patients
Why medication?
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Behaviour is the motor manifestation of
thoughts and feelings based on responses to
internal and/or external stimuli
There are underlying brain changes in
smokers as a result of repeated
exposure to tobacco smoke
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This leads to a “new normal” but requires the
smoker to keep smoking to feel normal. Or else
Withdrawal
Mood modulating effects= antidepressant
effects
Learning= habit and over learned behaviour
The role of medications
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Psychological or placebo effects
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Increase motivation to stop or make a quit attempt
Increase confidence when making a quit attempt
Act as a deterrent to smoking
The role of medications
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Pharmacological effects
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Induction of remission
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Maintain remission/prevent relapse
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Eliminate/reduce withdrawal symptoms
Interrupt cravings and habitual responses to cues and
triggers.
What is successful quitting?
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Outcome measures:
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Self report
Biochemical validation
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Not smoking a puff for 7 days, 30 days ( point prevalence)
Continuous abstinence= not smoking at all.
Cotinine ( urine, serum, saliva)
CO ( carbon monoxide- end tidal expired CO in ppm)
Consider this an indicator of the truth NOT the truth
Costs of Smoking vs. Pharmacotherapy
Options:
Approx. Cost
Cheap brand of cigarettes (7 packs)
(e.g., Native, DK’s, etc.)
$40.00
Name-brand cigarettes (7 packs)
(e.g., DuMaurier, Players, etc.)
$66.00
Name-brand patch
$30.00/week
No-name patch
$20.00/week
Name-brand gum (15 pieces/day)
$35.00/week (105 pieces, 2mg)
$38.00/week (105 pieces, 4mg)
Name-brand inhaler (6 cartridges/day)
$40.00/week (42 cartridges)
Contraband Cigarettes
$7.00 - $15.00
Varenicline
$58.00 starter kit (2 weeks);
$64.00 for continuation pack (2 weeks)
Buproprion
$74.00/month
Note: Dispensing fees vary between pharmacies and costs may slightly differ
between chains
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Smoking Cessation Medications
1st Line
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Nicotine patch, gum,
lozenge, inhaler
Bupropion SR
Varenicline
2nd Line
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Clonidine
Nortriptyline
Recap from Session #1:
Nicotine Replacement Therapy (NRT)
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Provides the body with nicotine to help
minimize withdrawal symptoms and
cravings
Eliminates toxic substances one gets
from cigarettes
Shown to almost double quit rates
Most effective when combined with
therapy
Can be used to help “reduce” smoking
– Can start before quit date
Prescription
Medications
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Bupropion
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Antidepressant
Doubles chances of quitting
Shown to minimize weight gain associated with
quitting smoking
Contraindications
– Seizure history
– Active eating disorder
– MAOI Medications
– Using bupropion, sensitivity to bupropion
How To Use Bupropion
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Prescribed by Physician, Nurse Practitioner or Dentist
Dose 150mg once daily for 3 days, increase to 150mg
twice daily on day 4
8 hours between doses
Take as early in evening as possible
Monitor closely for changes in mood, suicidal ideations
Can be used alone or in combination with NRT
Bupropion may assist those with depression
to quit smoking
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RCT conducted with cancer patients with and without depression
symptoms
Bupropion
NRT
Behavioural
Counselling
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Placebo
NRT
Behavioural
Counselling
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Patients with depressive
symptoms had lower abstinence
rates
Patients with depressive sx who
received bupropion experienced
increased abstinence and quality
of life, and reduced withdrawal sx
However, those with depressive symptoms had lower overall abstinence rates
than those without depressive symptoms who received bupropion
Schnoll et al. (2010)
Varenicline
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Oral medication
Reduces withdrawal and
craving
Prevents pleasurable effects
of smoking
α42 nicotinic acetylcholine
receptor partial agonist
Varenicline – Cessation Studies
Both studies used carbon monoxide to confirm continuous abstinence rates
9 – 12
9 - 52
Varenicline
43.9%
23%
Bupropion
29.8%
Placebo
17.6%
Weeks
9 – 12
9 - 52
Varenicline
44%
21.9%
14.6%
Bupropion
29.5%
16.1%
10.3
Placebo
17.7%
8.4
B. Jorenby el al. 2006
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Weeks
Gonzales et al. 2006
Varenicline
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Potential benefit for long-term relapse prevention
– Abstinent patients following 12 weeks of open label
use, randomized to further 12 weeks treatment. 64%
abstinent at 12 weeks
Weeks 13 to 24
varenicline 70.5% vs placebo 49.6%
Weeks 13 to 52
varenicline 43.6% vs placebo 36.9%
Tonstad et al. 2006
Varenicline: Side Effects
Nausea
– 1mg bid 30%
– Placebo 10%
– Often mild to moderate, transient, early in treatment
– Minimized by taking the dose with food or water
– If nausea is intolerable, dose reduction is advised.
– 2-3% discontinue due to nausea
 Insomnia, abnormal dreams
 Constipation, flatulence, vomiting
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Varenicline: Dosing
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Initiation phase
– 0.5mg daily days 1 to 3
– 0.5mg bid days 4 to 7
– 1.0mg bid thereafter
– TQD should be day 7. However, smokers may quit up to 4
weeks after the medication is started.
Availability
– Starter Pack: 11 tablets of 0.5mg, 14 tablets of 1.0mg
– Continuation Pack: 2-week blister pack 28 tablets of 1.0mg
– Loose packaging 0.5 mg tablets: 56 per bottle
Varenicline: Pooled Analysis
• Efficacy and tolerability of Varenicline reflected in
randomized, double-blind, placebo trial
• 5096 men and women smoking >/=10
cigarettes/day
•18-75 yrs old, no psychiatric disorders
• Neuropsychiatric symptoms were seen, but
incidence and causal relationship is not known
•No cases of suicidal ideation or behaviour
•No evidence of dose-responsivity, other than
some sleep disorders/disturbances
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Tondstad, S, Davies, S et al. Drug Saf. 2010; 33(4) 289-301.
Outcomes of Varenicline exposure
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Recent retroactive study conducted in California to
assess varenicline-related events reported to
poison control centre
Among cases where varenicline was
unintentionally ingested, most common side
effects were gastrointenstinal and neuropsychiatric
Vast majority did not require admission to hospital
Kreshak et al., 2009
What about concerns regarding
varenicline and increased suicidality?
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Varenicline and Suicidality: Study
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Study of 80,660 people comparing bupropion,
varenicline, and NRT assessing for increases in fatal
and non-fatal self harm, suicidal thoughts and
depression (1)
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No clear evidence associated with depression or suicidal
thoughts, however twofold increase of self harm cannot be
ruled out (1)
Varenicline may be associated with increased
aggression and acts of violence towards others (2)
1, Gunnell, Irvine, Wise, Davies & Martin (2009)
2. Moore, Glenmullen, Furberg (2010)
Important Safety Information Regarding
Varenicline
Boxed Warning:
 Highlights important recommendations for healthcare
professionals regarding information related to neuropsychiatric
adverse events.
 A warning regarding rare reports of hypersensitivity reactions,
such as angioedema and serious skin reactions, including
Stevens-Johnson syndrome and erythema multiforme.
Unintentional Varenicline Exposure:
 Recent retroactive study assessed cases where varenicline
was unintentionally ingested, most common side effects were
gastrointenstinal and neuropsychiatric
 Vast majority did not require admission to hospital
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Safety Continued
Varenicline and Suicide
 No clear evidence associated with depression or suicidal
thoughts, however twofold increase of self harm cannot be
ruled out.
 Varenicline may be associated with increased aggression
and acts of violence towards others
Varenicline and Cardiovascular Events
 Results of a recent meta-analysis suggest that varenicline
may be associated with increased risk of adverse
cardiovascular events. Further evidence is needed in order
to substantiate this claim.
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Current Studies Exploring Expansion of
Uses for Varenicline
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Pilot study indicates that varenicline may be effective
for smokeless tobacco users to reduce use and
achieve abstinence (1)
Varenicline has been used to eliminate dependency on
nicotine gum (2)
Cigarettes per day reduced in cocaine users treated
with methadone, when given varenicline (3), also tested
with methamphetamine dependence (4) with no
adverse events along with alcohol dependence in
heavy drinking smokers (5)
1.) Ebbert, Crogham, North & Schroeder, 2010 2.) Garelik,
2010 3.) Poling, Roundsaville, Gonsai, Severino et al. 2010
4.) Zorick, Sevak, Miotto, Shoplaw et al. 2009 5.)
Hendrickson, Zhao-Shea, Pang, Gardner et al. 2010
Pharmacotherapy for smoking cessation
Nicotine replacement therapy
Medication
Bupropion
Gum
Treatment
Length[1]
8-12 weeks
(up to 1 year)
Lozenge
8-12 weeks
(up to 1 year)
Patch
Varenicline*
Inhaler
8-12 weeks
(up to 1 year)
8-12 weeks
(up to 1 year)
8 weeks
(up to 1 year)
12 weeks
(up to 24
weeks)
Disturbed
sleep
(insomnia,
abnormal / vivid
dreams)
Headache
Site irritation
Coughing
Dry
Bad
Irritation
GI
Constipation
Dizziness
Main Side
Effects[2],[3]
Dosage
Efficacy at six
months or
later (RR [95%
CI])[4],[5],[6]
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Dyspepsia
Diarrhea
Hiccups
Flatulence
Mouth
Heartburn
irritation
Nausea /
vomiting
Sore jaw /
throat
Hiccups
2 mg
4 mg
2 mg
4 mg
5, 10, 15 mg or
7, 14, 21 mg
6-12 cartridges
per day
150-300 mg/day
0.5 mg qd to 1
mg bid
1.43
[1.33-1.53]
(53 trials)
2.00
[1.63 to 2.45]
(6 trials)
1.66
[1.53 to 1.81]
(41 trials)
1.90
[1.36-2.67]
(4 trials)
1.69
[1.53-1.85]
(36 trials)
2.31
[2.01-2.66]
(10 trials)
Mouth
irritation
Nausea
Sore jaw
of
throat and
nasal
passages
Stomatitis
mouth
disturbance
Insomnia
Jitteriness
Nausea
Seizure
taste
Flatulence
Nausea
Sleep
disturbances
[1] Le Foll & George, Treatment of tobacco dependence: integrating recent progress into practice. CMAJ. Vol. 177, No. 11; 1373-1380. (November 2007).
[2] Le Foll & George, November 2007.2
[3] e-CPS [Internet]. Ottawa (ON): Canadian Pharmacists Association; c2007 [cited 2011 Sept 14]. Available from: http://www.e-cps.ca.
[4] Stead LF, et al. Nicotine replacement therapy for smoking cessation (Review) The Cochrane Collaboration. Issue 1. Published by John Wiley & Sons, Ltd. (2008)
[5] Hughes JR, et al. Antidepressants for smoking cessation. Cochrane Database of Systematic Reviews: Issue 1 John Wiley & Sons, Ltd (2007)
[6] Cahill K, et al. Nicotine receptor partial agonists for smoking cessation. Cochrane Database of Systematic Reviews: Issue 2 John Wiley & Sons, Ltd (2011)
2nd Line Medications
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Use at physicians discretion (first- line
medications unsuccessful)
Not approved as smoking cessation aids
Clonidine
– Anti-hypertensive
– Helps to reduce withdrawal
Nortriptyline
– Antidepressant
– Two studies demonstrated
increased
abstinence rates
The Future
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Selegiline – Parkinson
treatment
Vaccines – prevent nicotine
from reaching the brain
Transcranial Magnetic
Stimulation
Comments!
Questions?
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Case Discussion
Stan is a 27 year old web designer who came to the
clinic 3 weeks ago after his mother was hospitalized
for a stroke, related to his daily heavy smoking. In his
assessment, he stated that seeing his mother so
incapacitated “has scared me into quitting.” Since
then, however, Stan has been struggling with NRT
(patch and gum), and states that he wants to try oral
snus. He says that a friend of his has been using it,
and that his investigation on the internet shows that it
is a much safer alternative to smoking.
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Snus – Background Info
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aThe
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Moist smokeless tobacco,
snuff
Although used worldwide,
the highest consumption of
snus is in Sweden
Associated with an
increased risk of pancreatic
cancer
(RR 2.0; 95% CI, 1.2-3.3a)
probability of an event (developing a disease) occurring in exposed
people compared with the probability of the event in nonexposed people.
Luo et al. Lancet. 2007. Epub ahead of print;
http://www.arnestadphotography.com/stock_photos/albums/concept/snuff_
tobacco_black.jpg. Accessed October 19, 2007.
Snus – Background Info
Different from other chew tobacco – it is sterilized,
decreasing the number of nitrosamines (cancer-causing
agents)
 Reduced risk of lung cancer
 No emphysema
 2x risk of pancreatic cancer
(down from 3x risk with smoking)
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Discussion Questions
1.
2.
3.
4.
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What do you think may be some of the reasons for Stan’s
“struggle” with NRT?
How would you respond to his wanting to try oral snus, and
his reasons for doing so?
What are some of the larger issues with respect to cessation
that this case raises?
If you were the therapist, how would you respond to Stan’s
statement:
“The patch and the gum aren’t working for me, and I
don’t want any of those other drugs [Buproprion,
Varenicline]. I think I’d like to give snus a try – it
sounds really good and I think it might help me.”
Resources
https://www.oma.org/Resources/Documents/2008RethinkingStopSmokingMedications.pdf
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Varenicline for Smoking Cessation: efficacy, safety,
and treatment recommendations (Ebbert et al. 2010)
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Placebo-Controlled Trial of Cytisine for Smoking
Cessation (West et al. 2011)
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Remember …
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A link to the Online Course Evaluation will be sent by
e-mail.
A link to Learning Assessment 2 will also be sent by email. This must be completed by October 26 in order
to receive your Letter of Completion
Next session: November 23, 2011:
Tobacco Interventions for Patients with
Mental Health Issues
**Application period will open Monday October 24, 2011**
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Thank
you!
Copyright
Copying or distribution of these materials is
permitted providing the following is noted on
all electronic or print versions:
© CAMH/TEACH
No modification of these materials can be
made without prior written permission of
CAMH/TEACH.
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