PREGNANT SMOKERS PREGNANT SMOKERS ––TREATMENT STRATEGIES TREATMENT STRATEGIES

Elyse R. Park, Ph.D., MPHElyse R. Park, Ph.D., MPHMassachusetts General Hospital Massachusetts General Hospital

Departments of Psychiatry & Institute Departments of Psychiatry & Institute for Health Policyfor Health Policy

Tobacco Research & Treatment CenterTobacco Research & Treatment Center

Faculty DisclosureFaculty Disclosure

Dr. Park has an Investigator initiated award from Dr. Park has an Investigator initiated award from Pfizer in which the medication, Pfizer in which the medication, VareniclineVarenicline, was , was provided for a pilot smoking cessation trial for provided for a pilot smoking cessation trial for lung cancer patients.lung cancer patients.

Learning ObjectivesLearning Objectives

Identify risk factors for prenatal smoking Identify risk factors for prenatal smoking and postpartum relapseand postpartum relapse

Review 3Review 3--levels of brief behavioral levels of brief behavioral smoking cessation interventionssmoking cessation interventions

Review pharmacological treatmentsReview pharmacological treatments

Health Risks of Tobacco Use Health Risks of Tobacco Use During and After PregnancyDuring and After Pregnancy

Smoking Smoking duringduring PregnancyPregnancySignificant evidence that smoking causes:Significant evidence that smoking causes:

StillbirthStillbirthPreterm birthPreterm birthPlacental abruptionPlacental abruptionSIDS SIDS

Associated with increased risks of:Associated with increased risks of:Spontaneous abortionsSpontaneous abortionsEctopic pregnanciesEctopic pregnanciesPlacenta Placenta previaprevia MMWR, 2004;Cnattingius, NTR, 2004MMWR, 2004;Cnattingius, NTR, 2004

Smoking during PregnancySmoking during PregnancyLow BirthweightLow Birthweight

0

5

10

15

20

25

30

35

LBW

(%)

0 1-5 6-10 11-15 16-20 21-30 31+Cigarettes per Day

Simpson, Am J OBGYN, 1957Simpson, Am J OBGYN, 1957

Smoking Smoking afterafter PregnancyPregnancy

Increased risk in children of smokersIncreased risk in children of smokersSudden Infant Death Syndrome (SIDS)Sudden Infant Death Syndrome (SIDS)Hospitalization in 1Hospitalization in 1stst year of lifeyear of lifeSerious respiratory infectionsSerious respiratory infections

(e.g., (e.g., bronchiolitisbronchiolitis, pneumonia), pneumonia)

OtitisOtitis mediamediaAsthmaAsthma

WHY DO SMOKERS KEEP SMOKING?

Pharmacologic addiction to nicotinePharmacologic addiction to nicotine

Psychological dependence on smokingPsychological dependence on smokingBehavioral cuesBehavioral cues (meals)(meals)Coping with stress, emotionsCoping with stress, emotions (anger)(anger)

Mood regulationMood regulation

NICOTINE WITHDRAWAL SYMPTOMSNicotine cravingNicotine cravingIrritability, anger, impatienceIrritability, anger, impatienceRestlessnessRestlessnessDifficulty concentrating Difficulty concentrating InsomniaInsomniaAnxietyAnxietyDepressed mood Depressed mood Increased appetiteIncreased appetite

FINANCIAL COSTS OF FINANCIAL COSTS OF PRENATAL SMOKINGPRENATAL SMOKING

SmokingSmoking--attributable costs by pregnant attributable costs by pregnant smoker = $880smoker = $880

For each pregnant women who quits For each pregnant women who quits smoking, Medicaid saves $1274smoking, Medicaid saves $1274

1% decrease in smoking prevalence 1% decrease in smoking prevalence would save U.S. $21 million in direct would save U.S. $21 million in direct medical costs in first yearmedical costs in first year

Clinical Practice Guideline, 2008Clinical Practice Guideline, 2008

Who Smokes in Pregnancy?Who Smokes in Pregnancy?

How prevalent is prenatal smoking?How prevalent is prenatal smoking?

1111--22% of U.S. women smoke throughout 22% of U.S. women smoke throughout pregnancy pregnancy

State prevalence range 26% (WV)State prevalence range 26% (WV)-- 6% (AZ6% (AZ))

42% of females < 12 years of school smoke 42% of females < 12 years of school smoke during pregnancy during pregnancy

25% of pregnant Medicaid recipients are 25% of pregnant Medicaid recipients are smokerssmokers

Risk Factors For Smoking in Risk Factors For Smoking in PregnancyPregnancy

Less educationLess education

Young Young

White White

MedicaidMedicaid

Partner who smokesPartner who smokes

Smoking Cessation Smoking Cessation MethodsMethods

PHARMACOLOGICAL PHARMACOLOGICAL TREAMENTTREAMENT

SMOKING CESSATION METHODS2008 US Public Health Service Guidelines

Effective treatments exist Effective treatments exist

More is better but brief intervention worksTreating tobacco is highly cost-effective

Counseling (individual / group / telephone)- Effective for adolescents

Pharmacotherapy – use combinationsCombination is better than either one alone

SSmoking Cessation during Pregnancymoking Cessation during PregnancyPharmacologic InterventionsPharmacologic Interventions

The efficacy and safety of these The efficacy and safety of these pharmacological approaches during pharmacological approaches during pregnancy is unknown pregnancy is unknown

No medication has been observed in a No medication has been observed in a sufficiently large pregnant population to sufficiently large pregnant population to determine what might occur with largedetermine what might occur with large--scale usescale use

PHARMACOLOGIC TREATMENT2008 U.S. Public Health Service Guideline

Nicotine replacement (Class D)Gum Skin patch Nasal spray Inhaler Lozenge (no category rating)

Bupropion SR (Zyban,Wellbutrin SR) (Class C)

Varenicline (Class C)

In nonIn non--pregnant smokers, NRT and pregnant smokers, NRT and buproprionbuproprioneach double cessation compared to behavioral each double cessation compared to behavioral methods alone.methods alone.

In very limited studies in pregnant women, NRT In very limited studies in pregnant women, NRT was not associated with adverse outcomes, but was not associated with adverse outcomes, but did have a shortdid have a short--term influence on fetal breathing term influence on fetal breathing movements and fetal heart rate variability.movements and fetal heart rate variability.

Nicotine most likely has adverse effects on the Nicotine most likely has adverse effects on the fetus; smoking exposes women to nicotine plus fetus; smoking exposes women to nicotine plus other chemicals that are injurious.other chemicals that are injurious.

PHARMACOLOGIC TREATMENT2008 U.S. Public Health Service Guideline

VARENICLINEVARENICLINE

NonNon--nicotine medication; interferes with nicotine medication; interferes with nicotine receptorsnicotine receptorsAgonist & antagonist function; reduces Agonist & antagonist function; reduces pleasure gained from smoking as well as pleasure gained from smoking as well as withdrawal symptomswithdrawal symptomsFDA approval FDA approval –– 20062006

VARENICLINEVARENICLINE

Unknown safety with pregnant womenRecent safety warningsRecent safety warnings–– Warnings of use in individuals with Warnings of use in individuals with

serious psychiatric illnessserious psychiatric illness–– FDA public health advisory (2/2008)FDA public health advisory (2/2008)(http://www.fda.gov/bbs/topics/NEWS/2008/NEW(http://www.fda.gov/bbs/topics/NEWS/2008/NEW

01788.html)01788.html)

CHOOSING THE RIGHT CHOOSING THE RIGHT PHARMACOLOGICAL TREATMENT PHARMACOLOGICAL TREATMENT

FOR PATIENTSFOR PATIENTS

Oral substitutes good for cravingsOral substitutes good for cravings

Nasal spray works quicklyNasal spray works quickly

Nicotine inhalers mimic smokingNicotine inhalers mimic smoking

Patches are convenientPatches are convenient

Prescription pros & consPrescription pros & cons

DepressionDepression

BEHAVIORAL TREATMENTBEHAVIORAL TREATMENT

2008 U.S. DHHS CLINICAL 2008 U.S. DHHS CLINICAL PRACTICE GUIDELINESPRACTICE GUIDELINES

Because of the serious risks of smoking to the Because of the serious risks of smoking to the pregnant smoker and fetus, whenever possible pregnant smoker and fetus, whenever possible pregnant smokers should be offered personpregnant smokers should be offered person--toto--person psychosocial interventions that exceed person psychosocial interventions that exceed minimal advice to quit.minimal advice to quit.–– Psychosocial interventions are twice as effective Psychosocial interventions are twice as effective

than usual carethan usual care

Clinicians should offer effective tobacco Clinicians should offer effective tobacco dependence interventions to pregnant smokers dependence interventions to pregnant smokers at the 1at the 1stst prenatal visit as well as throughout prenatal visit as well as throughout the course of pregnancy. the course of pregnancy.

COUNSELING MODEL - ACOG (2000)

ASK

ADVISEASSESSASSISTARRANGE

COUNSELING MODEL – 1-3 minute brief intervention

ASK

ADVISEREFER with self-help material

ASKASK about smoking at every visitabout smoking at every visit

HOWHOW you ask mattersyou ask matters……

Deception rates, confirmed by comparing Deception rates, confirmed by comparing results of biochemical tests with selfresults of biochemical tests with self--reports, reports, are high. They reach 50% in some populations. are high. They reach 50% in some populations.

Alabama SCIP, 1998Alabama SCIP, 1998

Recommended QuestionRecommended QuestionWhich best describes your cigarette smoking? Which best describes your cigarette smoking?

I have NEVER smoked or smoked less than 100 I have NEVER smoked or smoked less than 100 cigarettes in my lifetimecigarettes in my lifetimeI stopped smoking BEFORE I found out I was pregnant I stopped smoking BEFORE I found out I was pregnant and I am not smoking nowand I am not smoking nowI stopped smoking AFTER I found out I was pregnant I stopped smoking AFTER I found out I was pregnant and I am not smoking nowand I am not smoking nowI smoke some now, but CUT DOWN since I found out I I smoke some now, but CUT DOWN since I found out I was pregnantwas pregnantI smoke regularly now, about the same as before I I smoke regularly now, about the same as before I found out I was pregnant.found out I was pregnant.

Mullen, Am Mullen, Am JlJl ObstetObstet GynecolGynecol, 1991, 1991

ADVISE every smoker to stop

“Quitting smoking is the most important action you can take for your health and your baby’s health”

Strong and clearBe positive - benefits of quitting

REFER smokers

Face-to-face counseling – group or individualTelephone counseling

New York State Smokers' Quitline: New York State Smokers' Quitline: 11--866866--NYNY--QUITS QUITS (1(1--866866--697697--8487)8487)

Hospital-based smoking cessation consultsWebsites:

www.nysmokefree.com

COUNSELING MODEL – 4-10 minutes

ASK

ADVISEASSESSASSISTARRANGE

ASSESS

Patient’s motivation to quit smoking

Risk perceptions

Social support

ASSESS readiness to quit

“If we give you some help, are you willing to try?”

Precontemplation “I like to smoke…”

Contemplation “I want to quit, but…”

Preparation “I’m ready to quit”

Assess Assess –– risk perceptionsrisk perceptions

““Can you tell me what you think about Can you tell me what you think about the risks of smoking for yourself?the risks of smoking for yourself?””

“…“…your baby?your baby?””

Assess Assess –– supportsupport

Emotional supportEmotional support

Smoking specific supportSmoking specific support

ASSISTSMOKERS READY TO QUIT

Set a quit date

Help make a treatment planGive a pregnancy-tailored bookletOffer social supportIdentify trigger situations

ASSISTSMOKERS NOT READY TO QUIT

Review health risks to mother and fetus

Educate about quitting process

Recommend no smoking around family

Address smoking at every prenatal visit

Assure follow-up during the first week of a quit; this is the critical periodSet follow-up appointmentRemember to address postpartum!

ARRANGE follow-up

COUNSELING MODEL – 10-30 minutes

ASK ADVISEASSESSASSISTARRANGE

ASSESS & ASSIST

Motivation to quit smoking

Risk perceptionsSocial support

Smoking environment

Confidence & importance

Pros & cons of smoking

Other health behaviors

Precontemplation: “I don’t want to quit”

Cognitive ProcessesKnowledge & AttitudesPerceived riskSmoking environment & support

• Elicit patient’s attitudes and beliefs about smoking• Provide information and personalized feedback• Increase patient’s perception of risks due to

current behavior

→DON’T GIVE ADVICE ABOUT WHAT THE PATIENT CAN DO TO MAKE CHANGES

Contemplation: “I’d like to quit, but I really like smoking”

Cognitive ProcessesKnowledge & Perceived riskSmoking environment & supportPros and ConsBarriersConfidence & importance

• Try to tip balance in favor of change• Try to strengthen confidence

→ BEHAVIORAL CHANGES ARE UNLIKELY TO WORK

Preparation: “I’m ready to quit, butI’m not sure how to do it”

Add Behavioral ProcessesOvercoming barriersIncreasing social support

• Strengthen commitment/motivation for change• Help patient to develop a feasible change plan• Discuss potentially difficult situations• Refer to behavioral or pharmacological treatment

→ CONSIDER DEVELOPING SMALL BEHAVIORAL CHANGES

Action & Maintenance: “I’ve quit/I’m a nonsmoker”

Continue cognitive & behavioral processes

•Strengthen commitment/motivation to change (review motivation & confidence)

• Review behavioral plan (check barriers, support)• Refer to behavioral or pharmacological treatment

if needed to stay quit• Discuss positive changes observed since quitting

(review pros & cons)

→ IDENTIFY RELAPSE RISKS

THE ROLE OF PROVIDERSTHE ROLE OF PROVIDERS

Obstetric providers often miss opportunities to Obstetric providers often miss opportunities to counsel smokers during prenatal & postnatal counsel smokers during prenatal & postnatal care care

www.TalkToYourPatients.orgwww.TalkToYourPatients.org

PROVIDER INTERVENTIONSPROVIDER INTERVENTIONS

MOMS STUDY & MEDICATIONSMOMS STUDY & MEDICATIONS

Cessation medications were not discussed Cessation medications were not discussed or recommended in the trial protocol. or recommended in the trial protocol.

EndEnd--ofof--pregnancy assessment asked pregnancy assessment asked subjects about subjects about

–– Use of smoking cessation methods Use of smoking cessation methods during that pregnancyduring that pregnancy

–– Whether prenatal provider discussed Whether prenatal provider discussed cessation methods during the pregnancycessation methods during the pregnancy

OB PROVIDER ADVISE & ASSISTOB PROVIDER ADVISE & ASSIST90

79

0102030405060708090

100

% of prenatal sm

okers reporting action

Advised to stop Assist

Park et al., SRNT, 2004

OB PROVIDER ASSISTANCE TO QUIT

101915

2737

66

0102030405060708090

100

Counseled

Given

materials

Methods

Gum

Patch

Zyban

% of prenatal sm

okers reportingaction

Park et al., SRNT, 2004

CESSATION MEDICATION DISCUSSED CESSATION MEDICATION DISCUSSED AND USED DURING PREGNANCYAND USED DURING PREGNANCY(End of pregnancy survey, N=296)(End of pregnancy survey, N=296)

29.3

10.1

0

10

20

30

40

%

Prenatal providerdiscussedmedication use

Smoker usedmedication inpregnancy

Rigotti, Park et al, 2007

Postpartum RelapsePostpartum Relapse

Postpartum Smoking CessationPostpartum Smoking Cessation

0102030405060708090

100

0 1 2 3 4 5 6

Months from Delivery

% A

bsta

inin

g

Mullen, AJPH, 1990Mullen, AJPH, 1990

77--DAY POINT PREVALENCE SMOKINGDAY POINT PREVALENCE SMOKING

0

2738

49

60

0

10

20

30

40

50

60

70

BL 6 week 12 week 18 week 24 week

Time Period

Perc

enta

ge

% smoking/Study N

Park et al., 2008

Mean Support by Smoking Status at 24 weeks

3BL 6 12 24Weeks Postpartum

Supp

ort S

core

smokers' emotional support nonsmokers' emotional supportsmokers' smoking-specific support nonsmokers' smoking-specific support

OB PROVIDER DISCUSSED MOOD OB PROVIDER DISCUSSED MOOD & SMOKING& SMOKING

54 52

42

24

0102030405060708090

100

% of prenatal quitters reporting action

Mood Smoking Mood Smoking

Park et al., 2008PRENATAL POSTPARTUM

CONCLUSIONSCONCLUSIONSPrenatal smoking can cause significant health Prenatal smoking can cause significant health and financial consequencesand financial consequences

The efficacy & safety of pharmacological The efficacy & safety of pharmacological smoking cessation treatment for pregnant women smoking cessation treatment for pregnant women is unknownis unknown

Brief obstetricianBrief obstetrician--delivered behavioral treatment delivered behavioral treatment can be effective at helping pregnant smokers quitcan be effective at helping pregnant smokers quit

Obstetricians can play an important role in Obstetricians can play an important role in helping their pregnant and postpartum patients to helping their pregnant and postpartum patients to quit & stay quitquit & stay quit