NONPRESCRIPTION NICOTINE
REPLACEMENT THERAPY
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
“CIGARETTE
SMOKING…
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.
ADULT PER CAPITA CONSUMPTION OF TOBACCO, 1880-2000
All forms of
tobacco
harmful are
TRENDS in ADULT SMOKING, by SEX
—U.S., 1955–2002
Trends in cigarette current smoking among persons aged 18 or older, by sex
Graph provided by the Centers for Disease Control and Prevention. 1955 Current Population
Male
Female
Percent
25.2%
20.0%
70% want to quit 70% want to quit
22.5% of adults are current
smokers
ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, 1995–1999
Centers for Disease Control and Prevention. MMWR 2002;51:300–303.
Second-hand smoke 53,000 Respiratory diseases 98,000 Cancers other than lung 31,000
Lung cancer 125,000
Cardiovascular diseases 149,000
Other 2,000
34%
28%
22%
9%
7%
<1%
TOTAL: more than 440,000 deaths annually
2004 REPORT of the SURGEON GENERAL
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:
FOUR MAJOR CONCLUSIONS
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
Fetal growth retardation, SIDS
Carcinogenic effects
Lung cancer, nasal sinus cancer
Cardiovascular effects
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
EVEN A LITTLE SECOND-HAND
SMOKE IS
DANGEROUS
SMOKE-FREE
WORKPLACE LAWS
Smoke-free offices, restaurants, and bars:
Delaware, California, Connecticut, Maine, Massachusetts, New York, Rhode Island
Smoke-free offices and restaurants: Florida, Idaho, Vermont, Utah
Smoke-free offices: Maryland
Exposure to second-hand smoke increases
the risk of myocardial infarction.
ANNUAL SMOKING-ATTRIBUTABLE ECONOMIC COSTS—U.S., 1995–1999
Annual lost productivity
costs (1995–1999)
Medical expenditures
(1998)
Billions of dollars
Men,
$55.4 billion Ambulatory care,
$27.2 billion
Prescription drugs,
$6.4 billion
Women,
$26.5 billion Nursing home,
$19.4 billion
Other care,
$5.4 billion
Hospital care,
$17.1 billion
Societal costs:
$7.18 per pack
QUITTING: HEALTH BENEFITS
Lung cilia regain normal function
Ability to clear lungs of mucus increases
Coughing, fatigue, shortness of breath decrease
Excess risk of CHD decreases to half that of a continuing smoker
Risk of stroke is reduced to that of people who have never
smoked Lung cancer death rate
drops to half that of a continuing smoker Risk of cancer of mouth,
throat, esophagus, bladder, kidney, pancreas decrease
Risk of CHD is similar to that of people who have never smoked
2 weeks to 3 months
1 to 9 months
1 year
5 years
10 years
after 15 years
Time Since Quit Date Circulation improves,
walking becomes easier Lung function increases
up to 30%
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/
CLINICAL PRACTICE GUIDELINE for
TREATING TOBACCO USE and DEPENDENCE
ASK ADVISE ASSESS ASSIST ARRANGE
The 5 A’s
The 5 A’s (cont’d)
Ask about tobacco use
“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.”
ASK
The 5 A’s (cont’d)
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.”
ADVISE
The 5 A’s (cont’d)
Assess readiness to make a quit attempt ASSESS
Assist with the quit attempt ASSIST
Arrange follow-up care ARRANGE
The 5 A’s (cont’d)
Number of sessions Estimated quit rate*
0 to 1 12.4%
2 to 3 16.3%
4 to 8 20.9%
More than 8 24.7%
* 5 months (or more) postcessation
Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline.
Rockville, MD: USDHHS, PHS, 2000.
PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPT
PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPT
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?
Is the patient now ready to quit?
Provide treatment
The 5 A’s Promote
motivation
Yes
Yes No
Did the patient once use tobacco?
Prevent
relapse* Encourage
continued abstinence
Yes No
No
*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
1984
Rx nicotine
gum
1991
Rx transdermal nicotine patch
1996
OTC nicotine gum & patch;
Rx nicotine nasal spray
1997
Rx nicotine inhaler;
Rx bupropion SR
2002
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
IMPROVES SUCCESS RATES
Anger/irritability
Anxiety
Cravings
Difficulty concentrating
Hunger/weight gain
Impatience
Restlessness
Drowsiness
Fatigue
Impaired task performance
Nervousness
Sleep disturbances
SYMPTOMS of NICOTINE
WITHDRAWAL
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)
NRT: PRODUCTS
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
0 10 20 30 40 50 60 Time (minutes)
Cigarette
Moist snuff
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 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 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
Park
Stop chewing at first sign of
peppery, minty, or citrus taste or tingle Chew slowly
Chew again
when the taste
or tingle fades
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
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.
ADVANTAGES
Gum use may satisfy oral cravings.
Gum use may delay weight gain.
Patients can titrate
therapy to manage
withdrawal symptoms.
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
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 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 2030
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 Juices
Wine Soft drinks
Do NOT eat or drink for 15 minutes BEFORE
or while using nicotine lozenge.
NICOTINE LOZENGE:
ADD’L PATIENT EDUCATION (cont’d)
Side effects of nicotine lozenge include
Nausea
Hiccups
Cough
Heartburn
Headache
Flatulence
Insomnia
NICOTINE LOZENGE: SUMMARY
DISADVANTAGES
Gastrointestinal side
effects (nausea, hiccups, and heartburn) may be bothersome.
ADVANTAGES
Lozenge use may satisfy oral cravings.
The lozenge is easy to use and conceal.
Patients can titrate
therapy to manage
withdrawal symptoms.
TRANSDERMAL NICOTINE PATCH
Approved for Rx use in 1991; OTC in 1996
Current products include
Nicoderm CQ Patch
OTC(GlaxoSmithKline)
Nicotrol Patch
OTC(Pharmacia)
Generic Products
Rx, OTCTRANSDERMAL 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 Availability 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
11 mg patch
22 mg patch
TRANSDERMAL NICOTINE PATCH: DOSING
Product Light Smoker Heavy Smoker
Nicotrol 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) 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
(formerly Habitrol) 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) Generic
(formerly ProStep) 15 cigarettes/day
11 mg x 6 weeks >15 cigarettes/day
22 mg x 6 weeks
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
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.
ADVANTAGES
The patch provides consistent nicotine levels.
The patch is easy to use and conceal.
Fewer compliance
issues are associated
with the patch.
LONG-TERM (6 month) QUIT RATES for AVAILABLE CESSATION MEDICATIONS
Data adapted from Silagy et al. Cochrane Database Syst Rev, 2002 and Hughes et al., Cochrane Database Syst Rev, 2000
P er ce n t q u it
19.714.4 11.5
8.4
17.2
8.9
23.9
11.8
17.1
9.1
19.3
10.2
