NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY. is the chief, single, avoidable cause of death in our...

NONPRESCRIPTION NICOTINEREPLACEMENT 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.

0

2

4

6

8

10

12

14

1880 1890 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000

Year

Po

un

ds

of

tob

ac

co

pe

r c

ap

ita

Cigarettes

Cigars

Chewing tobacco

Snuff

Pipe/roll your own

ADULT PER CAPITA CONSUMPTION OF TOBACCO, 1880-2000

All forms of tobacco

are harmful

TRENDS in ADULT SMOKING, by SEX—U.S., 1955–2002

Trends in cigarette current smoking among persons aged 18 or older, by sex

0

10

20

30

40

50

60

1955 1959 1963 1967 1971 1975 1979 1983 1987 1991 1995 1999

Year

Graph provided by the Centers for Disease Control and Prevention. 1955 Current Population Survey; 1965–2001 NHIS. Estimates since 1992 include some-day smoking.

Male

Female

Perc

en

t

25.2%

20.0%

70% want to quit70% 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: A Report of the Surgeon General, 2004.

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 Smoke: The Report of the California Environmental Protection

Agency, 1999.

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, UtahSmoke-free offices: Maryland

Exposure to second-hand smoke increases the risk of myocardial

infarction.

ANNUAL SMOKING-ATTRIBUTABLE ECONOMIC COSTS—U.S., 1995–1999

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

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

Centers for Disease Control and Prevention. MMWR 2002;51:300–303.

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 smokerRisk 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

1year

5years

10years

after15 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


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


Assess readiness to make a quit attemptASSESS

Assist with the quit attemptASSIST

Arrange follow-up careARRANGE


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 PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPTATTEMPT

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

YesNo

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.


PHARMACOTHERAPY

“All patients attempting to quit should be encouraged to use effective pharmacotherapies for cessation except in the

presence of special circumstances.”


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 patch1996

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 RATESIMPROVES 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

Hughes et al. Arch Gen Psychiatry 1991;48:52–59.

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

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

Pla

sma

nic

oti

ne

(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

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 LOZENGECommit (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 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

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 SmokerNicotrol 10 cigarettes/day

Not indicated>10 cigarettes/dayStep 1 (15 mg x 6 weeks)Step 2 (10 mg x 2 weeks)Step 3 (5 mg x 2 weeks)

Nicoderm CQ 10 cigarettes/dayStep 2 (14 mg x 6 weeks)Step 3 (7 mg x 2 weeks)

>10 cigarettes/dayStep 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/dayStep 2 (14 mg x 6 weeks)Step 3 (7 mg x 2 weeks)

>10 cigarettes/dayStep 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/day11 mg x 6 weeks

>15 cigarettes/day22 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


Remove patch from protective pouch


Peel off half of the backing from the patch


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


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

0

5

10

15

20

25

30

Nicotine gum Nicotine patch Nicotinelozenge

Nicotine nasalspray

Nicotineinhaler

Bupropion

Active drugPlacebo

Data adapted from Silagy et al. Cochrane Database Syst Rev, 2002 and Hughes et al., Cochrane Database Syst Rev, 2000

Per

cen

t q

uit 19.7

14.4

11.5

8.4

17.2

8.9

23.9

11.8

17.1

9.1

19.3

10.2

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 symptomsReserve for patients unable to quit using monotherapy.

COMPARATIVE DAILY COSTS of PHARMACOTHERAPY

Cost per day, in U.S. dollars

0 2 4 6 8

Nasal spray

Patch

Bupropion SR

Cigarettes (1 PPD)

Lozenge

Gum

Inhaler

$2.79 in KY $4.81 in NJ

$6.07

$5.81

$4.98

$4.30

$3.91

$3.40

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.

NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY. is the chief, single, avoidable cause of death in our...

Documents

Transcript of NONPRESCRIPTION NICOTINE REPLACEMENT THERAPY. is the chief, single, avoidable cause of death in our...