Transcript TOBACCO CONTROL STRATEGIES for PHARMACISTS

NONPRESCRIPTION NICOTINE
REPLACEMENT THERAPY
“CIGARETTE
SMOKING…
is the chief, single,
avoidable cause of death
in our society and the most
important public health
issue of our time.”
C. Everett Koop, M.D., former U.S. Surgeon General
ADULT PER CAPITA CONSUMPTION
OF TOBACCO, 1880-2000
14
Pounds of tobacco per capita
12
10
Snuff
8
6
Chewing
tobacco
Pipe/roll
your own
All forms
of
tobacco
are
harmful
4
Cigarettes
2
Cigars
0
1880 1890 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000
Year
Adapted from NCI Smoking and Tobacco Control Monograph 8, 1997, p. 13. Data from U.S. Department of Agriculture.
Reprinted with permission. Thun et al. Oncogene 2002;21:7307–7325.
TRENDS in ADULT SMOKING, by SEX—
U.S., 1955–2002
Trends in cigarette current smoking among persons aged 18 or older, by sex
60
50
22.5% of adults
are current
smokers
Male
Percent
40
30
20
25.2%
Female
20.0%
10
0
1955 1959 1963 1967 1971 1975 1979 1983 1987 1991 1995 1999
Year
70% want to quit
Graph provided by the Centers for Disease Control and Prevention. 1955 Current Population
Survey; 1965–2001 NHIS. Estimates since 1992 include some-day smoking.
ANNUAL U.S. DEATHS ATTRIBUTABLE
to SMOKING, 1995–1999
Cardiovascular diseases
149,000
34%
Lung cancer
125,000
28%
Respiratory diseases
98,000
22%
Second-hand smoke
53,000
9%
Cancers other than lung
31,000
7%
Other
2,000 <1%
TOTAL: more than 440,000 deaths annually
Centers for Disease Control and Prevention. MMWR 2002;51:300–303.
2004 REPORT of the
SURGEON GENERAL
FOUR MAJOR CONCLUSIONS




Smoking harms nearly every organ of the body, causing many
diseases and reducing the health of smokers in general.
Quitting smoking has immediate as well as long-term benefits,
reducing risks for diseases caused by smoking and improving
health in general.
Smoking cigarettes with lower machine-measured yields of tar
and nicotine provides no clear benefit to health.
Numerous diseases are caused by smoking.
U.S. Department of Health and Human Services. The Health Consequences of Smoking:
A Report of the Surgeon General, 2004.
HEALTH CONSEQUENCES
of SMOKING

Cancers








Lung
Laryngeal, pharyngeal, oral
cavity, esophagus
Pancreatic
Bladder and kidney
Cervical and endometrial
Gastric
Acute myeloid leukemia
Reduce fertility in women,
poor pregnancy outcomes, low
birth weight babies, sudden
infant death syndrome

Cardiovascular diseases





Subclinical atherosclerosis
Coronary heart disease
Stroke
Abdominal aortic aneurysm
Respiratory diseases


Acute respiratory illnesses,
e.g., pneumonia
Chronic respiratory diseases,
e.g., COPD

Cataract

Periodontitis
U.S. Department of Health and Human Services. The Health Consequences of Smoking:
A Report of the Surgeon General, 2004.
CAUSALLY ASSOCIATED HEALTH
RISKS of SECOND-HAND SMOKE

Developmental effects


Carcinogenic effects


Lung cancer, nasal sinus cancer
Cardiovascular effects


Fetal growth retardation, SIDS
EVEN A LITTLE
SECOND-HAND
SMOKE IS
DANGEROUS
Heart disease mortality, acute and chronic CHD morbidity
Respiratory effects


Children: acute lower respiratory tract infections, asthma
induction and exacerbation, chronic respiratory symptoms,
middle ear infections
Adults: eye and nasal irritation
National Cancer Institute. Health Effects of Exposure to Environmental Tobacco
Smoke: The Report of the California Environmental Protection Agency, 1999.
SMOKE-FREE
WORKPLACE LAWS
Exposure to second-hand smoke increases
the risk of myocardial infarction.
Smoke-free offices, restaurants, and bars:
Delaware, California, Connecticut, Maine, Massachusetts, New York, Rhode Island
Smoke-free offices and restaurants:
Smoke-free offices:
Maryland
Florida, Idaho, Vermont, Utah
ANNUAL SMOKING-ATTRIBUTABLE
ECONOMIC COSTS—U.S., 1995–1999
Prescription
drugs,
$6.4 billion
Medical
expenditures
(1998)
Ambulatory care,
$27.2 billion
Hospital care,
$17.1 billion
Other care,
$5.4 billion
Nursing home,
$19.4 billion
Societal costs:
$7.18 per pack
Annual lost
productivity
costs
(1995–1999)
Men,
$55.4 billion
0
Women,
$26.5 billion
5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85
Billions of dollars
Centers for Disease Control and Prevention. MMWR 2002;51:300–303.
QUITTING: HEALTH BENEFITS
Time Since Quit Date
Circulation improves,
Lung cilia regain normal
walking becomes easier 2 weeks
to
function
Lung function increases
up to 30%
Excess risk of CHD
decreases to half that of a
continuing smoker
Lung cancer death rate
drops to half that of a
continuing smoker
Risk of cancer of mouth,
throat, esophagus,
bladder, kidney, pancreas
decrease
3 months
1 to 9
months
Ability to clear lungs of mucus
increases
Coughing, fatigue, shortness of
breath decrease
1
year
5
years
Risk of stroke is reduced to that
of people who have never
smoked
after
15 years
Risk of CHD is similar to that of
people who have never smoked
10
years
CLINICAL PRACTICE GUIDELINE for
TREATING TOBACCO USE and DEPENDENCE


Released June 2000
Sponsored by the AHRQ (Agency for Healthcare
Research and Quality) of the USPHS (US Public
Heath Service) with:
 CDC (Centers for Disease Control)
 NCI (National Cancer Institute)
 NIDA (National Institute for Drug Addiction)
 NHLBI (National Heart Lung & Blood Institute)
 RWJF (Robert Wood Johnson Foundation)
http://www.surgeongeneral.gov/tobacco/
The 5 A’s
ASK
ADVISE
ASSESS
ASSIST
ARRANGE
The 5 A’s

(cont’d)
ASK about tobacco use
Ask

“Do you ever smoke or use any type of tobacco?”

“I take time to ask all of my patients about tobacco
use—because it’s important.”
The 5 A’s

(cont’d)
ADVISE tobacco users to quit (clear, strong,
personalized, sensitive)


“It’s important that you quit as soon as possible, and I
can help you.”
“I realize that quitting is difficult. It is the most
important thing you can do to protect your health now
and in the future. I have training to help my patients
quit, and when you are ready, I will work with you to
design a specialized treatment plan.”
The 5 A’s
(cont’d)

ASSESS readiness to make a quit attempt
Assess

Assist
ASSIST with the quit attempt
The 5 A’s

(cont’d)
Arrange
ARRANGE follow-up care
Number of sessions
Estimated quit rate*
0 to 1
12.4%
2 to 3
16.3%
4 to 8
More than 8
20.9%
24.7%
* 5 months (or more) postcessation
PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPT
Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline.
Rockville, MD: USDHHS, PHS, 2000.
THE 5 A’s: REVIEW
ASK
about tobacco USE
ADVISE
tobacco users to QUIT
ASSESS
readiness to make a QUIT attempt
ASSIST
with the QUIT ATTEMPT
ARRANGE
FOLLOW-UP care
IS a PATIENT READY to QUIT?
Does the patient now use tobacco?
Yes
Is the patient now
ready to quit?
No
Promote
motivation
No
Did the patient once
use tobacco?
Yes
Yes
Provide
treatment
The 5 A’s
Prevent
relapse*
No
Encourage
continued
abstinence
*Relapse prevention interventions not necessary
if patient has not used tobacco for many years
and is not at risk for re-initiation.
Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline.
Rockville, MD: USDHHS, PHS, 2000.
PHARMACOTHERAPY
“All patients attempting to quit
should be encouraged to use
effective pharmacotherapies
for cessation except in the
presence of special
circumstances.”
Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline.
Rockville, MD: USDHHS, PHS, 2000.
PHARMACOLOGIC METHODS:
FIRST-LINE THERAPIES
Two general classes of FDA-approved
drugs for cessation:
1. Nicotine replacement therapy
 Nicotine gum, patch, lozenge, nasal spray, inhaler
2. Psychotropics
 Sustained-release bupropion
FDA APPROVALS:
SMOKING CESSATION
2002
Rx transdermal
nicotine patch
1997
1996
Rx
nicotine
gum
1991
Rx nicotine
inhaler;
Rx bupropion SR
OTC nicotine gum & patch;
Rx nicotine nasal spray
1984
OTC nicotine
lozenge
NRT: RATIONALE for USE


Reduces physical withdrawal from nicotine
Allows patient to focus on behavioral and
psychological aspects of tobacco cessation
IMPROVES SUCCESS RATES
SYMPTOMS of NICOTINE
WITHDRAWAL

Anger/irritability

Restlessness

Anxiety

Drowsiness

Cravings

Fatigue

Difficulty concentrating


Hunger/weight gain
Impaired task
performance

Nervousness

Sleep disturbances

Impatience
Hughes et al. Arch Gen Psychiatry 1991;48:52–59.
NRT: PRODUCTS
Polacrilex Gum


Nicorette (OTC)
Generic nicotine gum (OTC)
Lozenge

Commit (OTC)
Transdermal Patches



Nicoderm CQ (OTC)
Nicotrol (OTC)
Generic nicotine patches
(OTC, Rx)
Nasal Spray

Nicotrol NS (Rx)
Inhaler

Nicotrol (Rx)
PLASMA NICOTINE CONCENTRATIONS
for NICOTINE-CONTAINING PRODUCTS
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
NRT: PRECAUTIONS

Patients with underlying cardiovascular disease

Recent myocardial infarction

Life-threatening arrhythmias

Severe or worsening angina
NRT: PRECAUTIONS

(cont’d)
Patients with other underlying conditions

Active temporomandibular joint disease (gum only)

Pregnancy

Lactation
Minimum age for
FDA-approved NRT use: 18 years
NICOTINE GUM: Nicorette;
generic
(GlaxoSmithKline; Watson Labs)

Approved for Rx use in 1984; OTC in 1996

Resin complex





Nicotine
Polacrilin
Sugar-free chewing gum base
Buffering agents to enhance buccal absorption of
nicotine
Available: 2 mg, 4 mg; regular, mint, orange
NICOTINE GUM: DOSING
Dosage based on current smoking patterns:
If patient smokes
Recommended strength
25 cigarettes/day
4 mg
<25 cigarettes/day
2 mg
NICOTINE GUM: DOSING (cont’d)
Recommended Usage Schedule for Nicotine Gum
Weeks 1–6
Weeks 7–9
1 piece q 1–2 h 1 piece q 2–4 h
Weeks 10–12
1 piece q 4–8 h
DO NOT USE MORE THAN 24 PIECES PER DAY
NICOTINE GUM:
DIRECTIONS for USE




Use gum according to recommended dosing
schedule (to decrease cravings & withdrawal
symptoms)
Chew each piece very slowly several times
Stop chewing at first sign of peppery, minty, or
citrus taste or of slight tingling in mouth (~15
chews, but varies)
“Park” gum between cheek & gum (to allow
absorption of nicotine across buccal mucosa)
NICOTINE GUM:
DIRECTIONS for USE



(cont’d)
Resume slow chewing when taste or tingle fades
When taste or tingle returns, stop and park gum in
different place in mouth
Repeat chew/park steps until most of the nicotine is
gone (taste or tingle does not return; generally 30
minutes)
NICOTINE GUM:
CHEWING TECHNIQUE SUMMARY
Chew slowly
Chew again
when the taste
or tingle fades
Stop chewing at
first sign of peppery,
minty, or citrus
taste or tingle
Park
NICOTINE GUM:
GRADUAL REDUCTION of DOSE
Recommended strategies for discontinuing use of
nicotine gum:



Chew gum for 10–15 minutes instead of 30 minutes
Chew each piece for more than 30 minutes but
reduce the number of pieces used daily
Substitute ordinary chewing gum for nicotine gum
NICOTINE GUM: ADDITIONAL
PATIENT EDUCATION


To improve chances of quitting, use at least nine
pieces of gum daily
The effectiveness of nicotine gum may be reduced
by some foods and beverages:
 Coffee
 Juices
 Wine
 Soft drinks
Do NOT eat or drink for 15 minutes BEFORE
or while using nicotine gum.
NICOTINE GUM:
ADD’L PATIENT EDUCATION


(cont’d)
Chewing gum will not provide same rapid
satisfaction that smoking provides
Chewing gum too rapidly can cause excessive
release of nicotine, resulting in

Lightheadedness

Nausea/vomiting

Irritation of throat and mouth

Hiccups

Indigestion
NICOTINE GUM:
ADD’L PATIENT EDUCATION


(cont’d)
Side effects of nicotine gum include

Mouth soreness

Hiccups

Dyspepsia

Jaw muscle ache
Nicotine gum may stick to dental work

Discontinue use if excessive sticking or damage to
dental work occurs
NICOTINE GUM: SUMMARY
ADVANTAGES



Gum use may satisfy
oral cravings.
Gum use may delay
weight gain.
Patients can titrate
therapy to manage
withdrawal symptoms.
DISADVANTAGES



Gum chewing may not
be socially acceptable.
Gum is difficult to use
with dentures.
Patients must use proper
chewing technique to
minimize adverse
effects.
NICOTINE LOZENGE
Commit (GlaxoSmithKline)


Approved for OTC use in
2002
Nicotine polacrilex
formulation


Delivers ~25% more nicotine
than equivalent gum dose
Available: 2 mg, 4 mg
NICOTINE LOZENGE: DOSING
Dosage based on the “time to first cigarette”
(TTFC) as an indicator of nicotine addiction.
NICOTINE LOZENGE:
DOSING (cont’d)
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 LOZENGE:
DIRECTIONS for USE (cont’d)



Do not chew or swallow the lozenge
Occasionally rotate the lozenge to different areas of
the mouth
Lozenge will completely dissolve in about 2030
minutes
NICOTINE LOZENGE: ADDITIONAL
PATIENT EDUCATION



To improve chances of quitting, use at least nine
lozenges daily during the first 6 weeks
The lozenge will not provide same rapid
satisfaction that smoking provides
The effectiveness of nicotine lozenge may be
reduced by some foods and beverages:
 Coffee
 Wine
 Juices
 Soft drinks
Do NOT eat or drink for 15 minutes BEFORE
or while using nicotine lozenge.
NICOTINE LOZENGE:
ADD’L PATIENT EDUCATION

Side effects of nicotine lozenge include

Nausea

Hiccups

Cough

Heartburn

Headache

Flatulence

Insomnia
(cont’d)
NICOTINE LOZENGE: SUMMARY
ADVANTAGES



Lozenge use may
satisfy oral cravings.
The lozenge is easy to
use and conceal.
Patients can titrate
therapy to manage
withdrawal symptoms.
DISADVANTAGES

Gastrointestinal side
effects (nausea, hiccups,
and heartburn) may be
bothersome.
TRANSDERMAL NICOTINE PATCH

Approved for Rx use in 1991; OTC in 1996

Current products include



Nicoderm CQ PatchOTC (GlaxoSmithKline)
Nicotrol PatchOTC (Pharmacia)
Generic ProductsRx, OTC
TRANSDERMAL NICOTINE PATCH



Nicotine is well absorbed across the skin
Delivery to systemic circulation avoids
hepatic first-pass metabolism
Plasma nicotine levels are lower,
fluctuate less than with smoking


Relieve nicotine withdrawal
Low potential for dependence (compared to
rapid delivery systems)
TRANSDERMAL NICOTINE PATCH:
PREPARATION COMPARISON
Product
Nicotrol
Nicoderm CQ
Generics
Nicotine
delivery
16 hours
24 hours
24 hours
5 mg patch
10 mg patch
15 mg patch
7 mg patch
14 mg patch
21 mg patch
7 mg patch
14 mg patch
21 mg patch
Availability
11 mg patch
22 mg patch
TRANSDERMAL NICOTINE
PATCH: DOSING
Product
Light Smoker
Heavy Smoker
10 cigarettes/day
Not indicated
>10 cigarettes/day
Step 1 (15 mg x 6 weeks)
Step 2 (10 mg x 2 weeks)
Step 3 (5 mg x 2 weeks)
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)
10 cigarettes/day
Generic
(formerly Habitrol) 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)
15 cigarettes/day
Generic
(formerly ProStep) 11 mg x 6 weeks
>15 cigarettes/day
22 mg x 6 weeks
Nicotrol
Nicoderm CQ
TRANSDERMAL NICOTINE PATCH:
DIRECTIONS for USE




Choose an area of skin on the
upper body or the upper outer part
of the arm
Make sure the skin is clean, dry,
and hairless
Hair will interfere with application
of the patch
Do not shave; this may irritate the
skin
TRANSDERMAL NICOTINE PATCH:
DIRECTIONS for USE (cont’d)



Do not apply patch to skin that is inflamed, burned,
or irritated in any way (these conditions may alter
nicotine absorption)
Apply patch to a different area each day
The same area should not be used again for at
least 1 week
TRANSDERMAL NICOTINE PATCH:
DIRECTIONS for USE (cont’d)

Remove patch from protective pouch
TRANSDERMAL NICOTINE PATCH:
DIRECTIONS for USE (cont’d)

Peel off half of the backing from the patch
TRANSDERMAL NICOTINE PATCH:
DIRECTIONS for USE (cont’d)




Apply adhesive side of
patch to the skin
Peel off remaining
protective covering
Press firmly with palm of
hand for 10 seconds
Make sure the patch sticks
well to skin, especially
around the edges
TRANSDERMAL NICOTINE PATCH:
DIRECTIONS for USE (cont’d)




Wash hands (nicotine on hands can get into eyes or nose
and cause stinging or redness)
Do not leave the patch on skin for more than 16 hours
(Nicotrol) or 24 hours (Nicoderm, generic patches—doing
so may lead to skin irritation
Adhesive remaining on skin may be removed with rubbing
alcohol or acetone
Dispose of a used patch by folding onto itself, completely
covering the adhesive area
TRANSDERMAL NICOTINE PATCH:
ADDITIONAL PATIENT EDUCATION



Water will not harm the nicotine patch if it is
applied correctly; patients may bathe, swim,
shower, or exercise while wearing the patch
Do not cut patches to adjust dose

Nicotine will evaporate rapidly

Patch will be rendered useless
Keep new and used patches out of the reach of
children and pets
TRANSDERMAL NICOTINE PATCH:
ADD’L PATIENT EDUCATION (cont’d)

Side effects to expect in first hour:





Mild itching
Burning
Tingling
After patch removal, the skin may appear red for
the next 24 hours
If skin stays red more than 4 days or swells, or if a
rash appears, contact health care provider; do not
put on a new patch
TRANSDERMAL NICOTINE PATCH:
ADD’L PATIENT EDUCATION (cont’d)
Additional possible side effects:

Vivid dreams or sleep disturbances

Headache

Local skin reactions (erythema, burning, pruritus)





Usually caused by adhesive
Up to 50% of patients experience this reaction
Incidence may be higher with 24-hour products
Less than 5% of patients discontinue therapy
Avoid use in patients with dermatologic conditions
(e.g., psoriasis, eczema, atopic dermatitis)
TRANSDERMAL NICOTINE PATCH:
SUMMARY
ADVANTAGES



The patch provides
consistent nicotine
levels.
The patch is easy to
use and conceal.
Fewer compliance
issues are associated
with the patch.
DISADVANTAGES




Patients cannot titrate the
dose.
Allergic reactions to
adhesive may occur.
16-hr patch may lead to
morning nicotine cravings.
Patients with dermatologic
conditions should not use
the patch.
LONG-TERM (6 month) QUIT RATES for
AVAILABLE CESSATION MEDICATIONS
30
Active drug
Placebo
Percent quit
25
20
23.9
19.7
19.3
17.2
17.1
14.4
15
11.8
11.5
10
8.4
8.9
9.1
10.2
5
0
Nicotine gum
Nicotine patch
Nicotine
Nicotine nasal
Nicotine
Bupropion
lozenge
spray
inhaler
Data adapted from Silagy et al. Cochrane Database Syst Rev, 2002
and Hughes et al., Cochrane Database Syst Rev, 2000
COMBINATION NRT
Long-acting formulation (patch)

Produces relatively constant levels of nicotine
PLUS
Short-acting formulation (gum, lozenge, inhaler, nasal
spray)

Allows for acute dose titration as needed for
withdrawal symptoms
Reserve for patients unable to
quit using monotherapy.
COMPARATIVE DAILY COSTS
of PHARMACOTHERAPY
Inhaler
$6.07
Gum
$5.81
Lozenge
$4.98
Cigarettes (1 PPD)
$2.79 in KY $4.81 in NJ
Bupropion SR
$4.30
Patch
$3.91
Nasal spray
$3.40
0
2
4
6
Cost per day, in U.S. dollars
8
The RESPONSIBILITY of
HEALTH PROFESSIONALS
It is inconsistent
to provide health care and
—at the same time—
remain silent (or inactive)
about a major health risk.
TOBACCO CESSATION
is an important component of
THERAPY.
DR. GRO HARLEM BRUNTLAND,
DIRECTOR-GENERAL of the WHO:
“If we do not act decisively, a hundred
years from now our grandchildren and
their children will look back and seriously
question how people claiming to be
committed to public health and social
justice allowed the tobacco epidemic to
unfold unchecked.”
US Department of Health and Human Services. Women and Smoking: A Report of
the Surgeon General. Washington, DC: Public Health Service, 2001.