1. Pregnant & Breastfeeding Women CAN-ADAPTT Guideline Webinar Series March 15, 2011 Guideline Section Lead: Alice Ordean, MD, CCFP, MHSc

2. Bio and Disclosures  Alice Ordean is an Assistant Professor in the Department of Family & Community Medicine at the University of Toronto and Medical Director of the Toronto Centre for Substance Use in Pregnancy (T-CUP).  No disclosures.

3. Guideline Development Group  Peter Selby, MBBS, CCFP, MHSc, FASAM;  Gerry Brosky, MD, MSc, CCFP;  Charl Els, MBChB, FCPsych, MMed Psych (cum laude), Cert. ASAM, MRO;  Rosa Dragonetti, MSc;  Sheila Cote-Meek, BScN, MBA, PhD;  Jennifer O’Loughlin, PhD;  Paul McDonald, PhD, FRSPH;  Alice Ordean, MD, CCFP, MHSc;  Robert Reid, PhD, MBA

4. CAN-ADAPTT  Guideline development, dissemination and engagement project  Integrates practice, policy and research in a collaborative smoking cessation network  Goal: To inform the development of a Pan-Canadian clinical practice guideline (CPG) for smoking cessation Funded by the Drugs and Tobacco Initiative, Health Canada

5. Dissemination & Engagement National Network Practice-informed Research Agenda Knowledge Translation PRACTICE RESEARCH Clinical Practice Guideline

6. Appraisal: AGREE 4 independent reviewers (practicing physicians) All formally trained on AGREE instrument HIGH QUALITY CLINICAL PRACTICE GUIDELINES U.S. Department of Health and Human Services Public Health Service: Treating Tobacco Use and Dependence (2008 Update), New Zealand Smoking Cessation Guidelines (August 2007), Registered Nurses Association of Ontario: Integrating Smoking Cessation into Daily Nursing Practice (March 2007), Registered Nurses Association of Ontario: Integrating Smoking Cessation into Daily Nursing Practice (October 2003), Institute for Clinical Systems Improvement. Tobacco use prevention and cessation for infants, children and adolescents (June 2004), Institute for Clinical Systems Improvement Tobacco use prevention and cessation for adults and mature adolescents (June 2004). The CAN-ADAPTT program engaged the Guidelines Advisory Committee COMPREHENSIVE LITERATURE SEARCH 87 Guidelines Found 87 Guidelines Found Highest scoring CPG’s included 6 Guidelines Included Appraisal: AGREE Plus 8 Additional questions developed by CAN-ADAPTT to understand the applicability of the recommendations in the Canadian context Initial LITERATURE REVIEW for existing Clinical Practice Guidelines 5 Guidelines Included 5 Guidelines Included Version 1.0 February 2009 Version 1.0 February 2009

7. HIGH QUALITY CLINICAL PRACTICE GUIDELINES Clinical Approaches 7 clinical sections discussed Workshop held: November 1, 2009 100 CAN-ADAPTT members attended and provided feedback The Guideline Development Group (GDG) reviewed the section notes and determined revisions to the summary statements. Population Level approaches Sections: Population level approaches to tobacco cessation in Canada Workshop/AGM: Oct 1 st, 2010 Version 3.0 Release Date January 2011 Version 3.0 Release Date January 2011 Input from CAN-ADAPTT Network Spring – Summer 2010 Input from CAN-ADAPTT Network Spring – Summer 2010 Version 2.0 Currently Posted Version 2.0 Currently Posted Network input Network Input Levels of Evidence Attributed levels of evidence and grades of recommendation to each summary statement based on GRADE principles

8. Background/Overview of Evidence  Existing evidence included CPGs from Canada, USA, New Zealand, France and UK  Literature review in this specific subpopulation has a limited number of high quality trials with contradictory results especially in area of pharmacotherapeutic options

9. Background/ Overview of Evidence U.S. Department of Health and Human Services Public Health Service (2008)  Because of the serious risks of smoking to the pregnant smoker and the fetus, whenever possible pregnant smokers should be offered person-to- person psychosocial interventions that exceed minimal advice to quit. (Strength of Evidence = A)  Although abstinence early in pregnancy will produce the greatest benefits to the fetus and expectant mother, quitting at any point in pregnancy can yield benefits. Therefore, clinicians should offer effective tobacco dependence interventions to pregnant smokers at the first prenatal visit as well as throughout the course of pregnancy. (Strength of Evidence = B)

10. Background/ Overview of Evidence New Zealand Ministry of Health (2007)  Offer all pregnant and breastfeeding women who smoke multi-session behavioural smoking cessation interventions from a specialist/dedicated cessation service. (Grade=A)  All health care workers should briefly advise pregnant and breastfeeding women who smoke to stop smoking. (Grade = A)  NRT can be used in pregnancy and during breastfeeding following a risk-benefit assessment. If NRT is used, oral NRT products (for example, gum, inhalers, microtabs and lozenges) are preferable to nicotine patches. (Grade=C) Registered Nurses Association of Ontario (2007)  Nurses implement, wherever possible, intensive intervention with women who are pregnant and postpartum. (Strength of Evidence = A)

11. Gap in Practice and Barriers  Challenges in identification due to stigma associated with smoking during pregnancy  Pregnant & breastfeeding women frequently receive inaccurate advice from health care practitioners regarding the effects of smoking during pregnancy and the safety of smoking cessation interventions (e.g. NRT, bupropion)

12. Table 1 – Negative Effects Associated with Cigarette Smoking During Pregnancy and Breastfeeding Pregnancy Complications Neonatal Effects Long-Term Effects  Subfertility (female and male)  Ectopic pregnancy (outside the uterus)  Spontaneous abortion (miscarriage)  Preterm labour  Premature rupture of membranes  Placental problems (previa & abruption)  Growth restriction  Low birth weight (on average ~200 grams smaller)  Increased perinatal mortality  Increased admission to the neonatal intensive care unit (NICU)  Sudden infant death syndrome (SIDS)  Decreased volume of breast milk and duration of breastfeeding  Childhood respiratory illnesses (asthma, pneumonia, bronchitis)  Other childhood medical problems (ear infections)  Learning problems (reading, mathematics, general ability)  Behavioral problems  Attention deficit hyperactivity disorder (ADHD) Cigarette smoking during pregnancy and breastfeeding is associated with numerous negative effects on mother, fetus, infant and adolescent. [1] [1] Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation, 7th edition. Philadelphia: Lippincott Williams & Wilkins, 2005

13. Summary Statement #1 Smoking cessation should be encouraged for all pregnant, breastfeeding and postpartum women. GRADE: 1A

14. Clinical Considerations  Smoking cessation interventions should be considered for the full spectrum of care from preconception visit to 1 year postpartum.  Smoking cessation counselling and care of pregnant smokers may be conducted by physicians, allied healthcare professionals (e.g. social worker, pharmacist, community health representatives), midwives, doulas, prenatal advisors, postpartum supports, family home visitors, and others.

15. Summary Statement #2 During pregnancy and breastfeeding, counselling is recommended as first line of treatment for smoking cessation GRADE: 1A

16. Summary Statement #3 If counselling is found ineffective, intermittent dosing nicotine replacement therapies (such as lozenges, gum) are preferred over continuous dosing of the patch after a risk-benefit analysis GRADE: 1C

17. Clinical Considerations  There is limited evidence on harms associated with the use of nicotine replacement therapy (NRT) during pregnancy. Until further information is available, the risks and benefits of smoking versus the use of NRT during pregnancy must be considered when counselling about smoking cessation options

18. Clinical Considerations  NRT can be considered as a second line option for individuals who cannot quit after counselling interventions.  There is some evidence from RCTs that NRT may be efficacious in pregnancy in terms of decreasing tobacco use and improving pregnancy outcomes. No safety concerns identified in these trials. Therefore, benefits of NRT seems to outweigh potential risks; therefore, NRT should be considered when counselling has been ineffective.

19. Depression during pregnancy is a common occurrence and the use of Zyban (bupropion) may be appropriate to treat both smoking and depression. There is limited evidence on the effectiveness of bupropion for smoking cessation during pregnancy. In addition, there is no evidence of harm related to the use of bupropion during pregnancy and therefore, it may be considered for use as an alternative to NRT for a subpopulation of pregnant smokers. Clinical Considerations

20. Summary Statement #4 Partners, friends and family members should also be offered smoking cessation Interventions. GRADE: 2B

21. Clinical Considerations  Despite preliminary evidence that continued smoking and relapse are more likely among pregnant women who have a smoking partner, there is limited data regarding the benefits of partner involvement in smoking cessation interventions for pregnant smokers. In non- pregnant populations, interventions to increase support did not find increased quitting rates.

22. Summary Statement #5 A smoke-free home environment should be encouraged for pregnant and breastfeeding women to avoid exposure to second-hand smoke GRADE: 1B

23. Evidence from a recent systematic review and meta-analysis demonstrated negative perinatal outcomes (e.g. trend towards lower birth weight, smaller head circumference and congenital anomalies) associated with second-hand smoke exposure. Therefore, pregnant and breastfeeding women should avoid this environmental risk. Clinical Considerations

24. Research Gaps  Relationship between smoking and infertility remains uncertain  Lack of information regarding use of pharmacological agents such as Bupropion and Varenicline as a smoking cessation aid – need more research on the effectiveness and safety  Need more evidence of risk/benefit analysis of various smoking cessation aids

25. Research Gaps  Role of partners, family in smoking cessation interventions needs to be defined  Knowledge gaps of health care providers needs to be addressed

26. Have additional feedback? 1.Join the network 2.Review the current version of the guideline 3.Provide your feedback online Clinical considerations; tools/resources

27. For more information CAN-ADAPTT Centre for Addiction and Mental Health 175 College St. Toronto, ON M5T 1P7 T: 416-535-8501 ext. 7427 www.can-adaptt.net Note : These presentation slides may be used or reproduced for educational purposes only. Please acknowledge authorship of this content to CAN-ADAPTT and CAMH.

28. Webinar Discussion: Suggested Resources  Medications and Mothers’ Milk by Dr. Thomas Hale (2010)  Drugs in Pregnancy and Lactation by GG Briggs, RK Freeman and SJ Yaffe (2009)  STARSS (Start Thinking About Reducing Second- hand Smoke) http:aware.on.ca/starss  TEACH course “Helping Pregnant Women Quit Smoking: A Woman-Centred Approach” www.teachproject.ca/courses