H1N1   Pandemic

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Objectives. Review epidemiology of H1N1 infectionPrepare Obstetricians and Gynaecologists in the counseling of pregnant woman on:Measures of preventionsTreatment of H1N1 suspect in infantImmunization against H1N1Up to date information on H1N1 available on SOGC website. Disease Characteristics

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H1N1 Pandemic

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1. H1N1 – Pandemic Andre Lalonde, MD EVP, SOGC

2. Objectives Review epidemiology of H1N1 infection Prepare Obstetricians and Gynaecologists in the counseling of pregnant woman on: Measures of preventions Treatment of H1N1 suspect in infant Immunization against H1N1 Up to date information on H1N1 available on SOGC website

3. Disease Characteristics and Burden How severe is the pandemic? Who is the most affected in terms of illness, complications and death? Who are the persons most likely to spread infection? 3

4. Ethical Considerations What ethical principles and values should be applied? How do they inform the decision? Are the recommendations fair and equitable? 4

6. Epidemic Curve – No Vaccination

8. Hospitalization Rate per 100 000 person years in healthy individuals

9. Hospitalization Rate per 100 000 person years in individuals with underlying conditions

10. Epidemiological curve for hospitalized cases and deaths 10 There is some impact of reporting delay Figure 3. Number of laboratory-confirmed Pandemic (H1N1) 2009 hospitalized cases and deaths in Canada by date of onset (or specimen collection date where date of onset is not available) as of 8 August 2009 (Please note that onset date/specimen collection date is available for 65/66 deaths and 1,294/1,341 hospitalized cases).There is some impact of reporting delay Figure 3. Number of laboratory-confirmed Pandemic (H1N1) 2009 hospitalized cases and deaths in Canada by date of onset (or specimen collection date where date of onset is not available) as of 8 August 2009 (Please note that onset date/specimen collection date is available for 65/66 deaths and 1,294/1,341 hospitalized cases).

11. 11 Purpose of Slide: To show the incidence of lab-confirmed H1N1 by age-group and gender June 15th was used as the cut-off point for this analysis because after this time there was substantial variation in the testing practices between different jurisdictions. Purpose of Slide: To show the incidence of lab-confirmed H1N1 by age-group and gender June 15th was used as the cut-off point for this analysis because after this time there was substantial variation in the testing practices between different jurisdictions.

12. Canadian Situation Total of 7,276 laboratory confirmed cases 1,315 cases were hospitalized (line-list info on 1282 (97%)) 239 (18.1%) of those hospitalized admitted to ICU 66 (5.0%) of those hospitalized died 12

13. 13 Slide contains data up to June 15 as after this point there was significant variation in the testing practices in different jurisdictions. PURPOSE: To show which Age Group would have the highest number of lab-confirmed clinical cases (A proxy for disease incidence in the community) if the situation continued as it did up to June 15,2009. The Extrapolated Number of Lab-Confirmed Clinical Cases per year was based on dividing the Number of Lab-Confirmed cases by 1.5 to obtain the number of cases per month. This number was then multiplied by 12 to obtain the estimated number of lab-confirmed cases per year and subsequently the Age-specific rates.Slide contains data up to June 15 as after this point there was significant variation in the testing practices in different jurisdictions. PURPOSE: To show which Age Group would have the highest number of lab-confirmed clinical cases (A proxy for disease incidence in the community) if the situation continued as it did up to June 15,2009. The Extrapolated Number of Lab-Confirmed Clinical Cases per year was based on dividing the Number of Lab-Confirmed cases by 1.5 to obtain the number of cases per month. This number was then multiplied by 12 to obtain the estimated number of lab-confirmed cases per year and subsequently the Age-specific rates.

14. Data Highlights - I Population incidence rates are highest for those 5-19 years and infants Hospitalization rates are highest in the under 15 years, pregnant women, those with underlying conditions and Aboriginal populations Presence of underlying condition is the greatest risk factor of admission to ICU or death Female gender is associated with higher risk of ICU admission and death 14

15. Data Highlights - II Rates in healthy individuals, Incidence: highest in 0-24 years Hospitalization: highest in 0-24 years ICU Similar between 1 and 64 y Death Similar between 1 and 64 y ICU+death Similar between 1 and 64 y Vaccinating 2-24 year olds would have a greater epidemiological impact compared to older age groups

16. Data Highlights - III H1N1 Vaccine characteristics : Many unknowns remain – first clinical trial results in mid-late September (CSL product); initial GSK results late Oct./early Nov. Unknowns: Need for second dose Vaccine safety –increased reactogenicity if adjuvanted, otherwise unknown Effect of adjuvant for dose-sparing, immunogenicity, cross-reactive immunity 16

17. Data Highlights - IV Vaccine logistical assumptions 3.5 million doses per week capacity – minimum level Production limited by fill line capacity First lots filled mid to late October probably including an unadjuvanted lot. HC authorization mid November (up to 17.5 m doses available) Projected 49 million doses produced by first week of February 17

18. Who’s at Risk for a Severe Outcome? Analysis based on cases who were hospitalized or died

19. Hospitalized cases by PTs 19

20. Overall Hospitalization Rates by Age Group Age not available for all cases Age Group Population Number with Non-Severe Disease (%) Population Hosp (non-ICU)/ ICU or Death (%) <1 370,299 83 (89.8) 10 (10.8) 1-4 1,433,682 134 (91.8) 12 (8.2) 5-14 3,799,717 225 (91.8) 20 (8.2) 15-24 4,553,335 116 (82.3) 25 (17.7) 25-44 9,388,602 158 (72.1) 61 (27.9) 45-64 9,295,026 177 (69.1) 79 (30.9) 65+ 4,600,616 71 (74.7) 24 (25.3) Total Canadian Population 33,441,277 964 (80.7) 231 (19.3) Age not available for all cases Age Group Population Number with Non-Severe Disease (%) Population Hosp (non-ICU)/ ICU or Death (%) <1 370,299 83 (89.8) 10 (10.8) 1-4 1,433,682 134 (91.8) 12 (8.2) 5-14 3,799,717 225 (91.8) 20 (8.2) 15-24 4,553,335 116 (82.3) 25 (17.7) 25-44 9,388,602 158 (72.1) 61 (27.9) 45-64 9,295,026 177 (69.1) 79 (30.9) 65+ 4,600,616 71 (74.7) 24 (25.3) Total Canadian Population 33,441,277 964 (80.7) 231 (19.3)

21. Hospitalized cases by gender and pregnancy status

22. Pregnant Women 48 women hospitalized were pregnant 11 Admitted to ICU of which 2 died ~4% of all hospitalized cases were pregnant Information about trimester was available for 26 pregnant women: 1st Trimester: 3 women 2nd Trimester: 4 women 3rd Trimester: 19 women Of the 7 women in their 1st or 2nd trimester all had non-severe hospitalizations 4 (21%) out of 19 women in their 3rd trimester were admitted to ICU or Died Total of 56 women had lab confirmed influenza 2 deaths among pregnant womenTotal of 56 women had lab confirmed influenza 2 deaths among pregnant women

23. Hospitalized Women and Pregnancy NOTE: This slide likely underestimates the proportion of non pregnant women not admitted to ICU since the analysis was done on a more recent available subset of the data. Information on pregnancy trimester was available for 24 hospitalized women: 19 (79.2%) were in their third trimester. Two pregnant cases resulted in death. Information on pregnancy trimester was available for only 1 woman: she was in her third trimester. Pregnancy with focus on reproductive age (15-49 female) I took out all males and partially took out females (<15 y or >44 years), there are 219 hospitalized H1N1 females in this subset. There is no significant difference in severity between pregnant women and non-pregnant women (OR=0.727, 95%CI=0.350 -1.513, P=0.3941) This result is coherent to my previous results. It means pregnant status is not a significant risk factor for the severity.NOTE: This slide likely underestimates the proportion of non pregnant women not admitted to ICU since the analysis was done on a more recent available subset of the data. Information on pregnancy trimester was available for 24 hospitalized women: 19 (79.2%) were in their third trimester. Two pregnant cases resulted in death. Information on pregnancy trimester was available for only 1 woman: she was in her third trimester. Pregnancy with focus on reproductive age (15-49 female) I took out all males and partially took out females (<15 y or >44 years), there are 219 hospitalized H1N1 females in this subset. There is no significant difference in severity between pregnant women and non-pregnant women (OR=0.727, 95%CI=0.350 -1.513, P=0.3941) This result is coherent to my previous results. It means pregnant status is not a significant risk factor for the severity.

24. Signs & Symptoms of H1N1 Infection fever cough runny nose sore throat body aches fatigue lack of appetite

25. Prevention Stay away from people infected or suspected of “Flu like” disease Ask people around you at home or work to wear protection mask if they have the “flu” Use antiseptic soaps in your home or office in case of “flu” epidemic In case large number of people at work are infected, stay home Do not shake hands Avoid crowded public areas

26. Treatment of H1N1 All Health Care Professionals should provide their pregnant patien with a Tamiflu prescription in readiness, in case symptoms develop. Pregnant women with onset of “flu like” symptoms Send someone immediately to get the prescription filled Take medication immediately Do not go to the emergency room or your doctors - start taking medication ASAP Go to the hospital if you have breathing difficulties with or without medication

27. Vaccination – 2 types Unadjavent vaccine: Adjavent vaccine (ASO3): available in mid november

28. Vaccine Characteristics Any expected population differences in protection from the pandemic vaccine? Any people who do not need the vaccine? Need for a second dose? Are dose-sparing strategies possible, e.g. intradermal administration? Are there any vaccine safety concerns? What is the proposed indication for use and what indication/market authorization has been granted by the Health Canada regulator? What pre-market assessment has been performed, and what post-market surveillance requirements are imposed?

29. H1N1 and the Aboriginal Population

30. Access to Care Nursing stations, health stations, health centres , health offices-heavy orientation to nursing provided care and a lot of community health representatives More limited scope of services than urban health services Nursing station-field unit located in an isolated/remote community where there is no year round road access to other health care facilities. A nursing station houses field unit staff of two or more community health nurses and primary care staff organized to carry out primary health care services. Access to urgent care is available on a 24 hour basis. Health station-field unit in a small building or trailer in an isolated or semi-isolated community. Health station houses field unit staff consisting of community health nurses and other health care support staff to carry our disease prevention and health promotion. May include primary care services but only on weekdays, not 24 hours Health centre-field unit staffed by one or more community health nurses and support personnel to carry out disease . Non isolated and semi isolated. Primary care m.d. on visiting basis. Potential uses-flu centres? Health office-leased space for a multi-purpose building (band office). Supports the work of community health representatives and visiting community health nurses and transient health care providers. -Palliative care and rehab care (post trach) are areas of needNursing station-field unit located in an isolated/remote community where there is no year round road access to other health care facilities. A nursing station houses field unit staff of two or more community health nurses and primary care staff organized to carry out primary health care services. Access to urgent care is available on a 24 hour basis. Health station-field unit in a small building or trailer in an isolated or semi-isolated community. Health station houses field unit staff consisting of community health nurses and other health care support staff to carry our disease prevention and health promotion. May include primary care services but only on weekdays, not 24 hours Health centre-field unit staffed by one or more community health nurses and support personnel to carry out disease . Non isolated and semi isolated. Primary care m.d. on visiting basis. Potential uses-flu centres? Health office-leased space for a multi-purpose building (band office). Supports the work of community health representatives and visiting community health nurses and transient health care providers. -Palliative care and rehab care (post trach) are areas of need

31. Population Rates by Aboriginal Status 31 Estimated hospitalization rate= Total number hospitalized past (3 months X 4) / PopulationEstimated hospitalization rate= Total number hospitalized past (3 months X 4) / Population

32. Risk of ICU Admission or Death by Aboriginal or First-Nations Status amongst those hospitalized 32 Conduct Risk Analysis on those with First-Nations Status only because Metis and Inuit are much less likely to go to ICU or Die than the non-aboriginal population Compare risk of ICU or Death vs. Being hospitalized only as per usualConduct Risk Analysis on those with First-Nations Status only because Metis and Inuit are much less likely to go to ICU or Die than the non-aboriginal population Compare risk of ICU or Death vs. Being hospitalized only as per usual

33. H1N1 – Aboriginal Population on Reserves Risk factors for severe H1N1: younger population, higher rates of underlying disease that are associated with higher risk, more pregnancies among younger mothers. Difficulties: access to appropriate medical care for early treatment given geographic isolation and lack of health human resources Operational factors make rapid spread and infection control difficult: higher housing density and lack of running water in several communities All of these issues relate to equity, which is also an ethical consideration.

35. Primary Targets Canada Persons with chronic conditions (NACI list) under the age of 65 - at higher risk of complications; 65+ less affected to date Pregnant women - at higher risk of complications and to potentially protect their infants Healthy Children 6 to 23 months of age - at higher risk of severe disease; children identified as a priority by the public 35

36. Primary Targets (cont.) Remote and isolated communities (First Nations, Inuit and other communities) - limited access to medical care, potential for development of herd immunity and prevention of infection, logistically easier to target whole community; equity, high concentration of persons with chronic conditions, observed morbidity/mortality

37. Summary of findings Population incidence rates are highest for those 5-19 years and infants Hospitalization rates are highest in the under 15 years, pregnant women, those with some underlying conditions and Aboriginal populations Increasing age, presence of underlying condition, female gender are associated with higher risk of admission to ICU or death Presence of an underlying condition and increasing age have the greatest impact on risk of ICU admission or death

38. What is SOGC Doing: Guidelines Update website regularly (www.sogc.org) Patient information tear out pad Posters

39. What you should do Advise all patients about H1N1 and their risk Give each pregnant woman a prescription Keep checking SOGC website and provincial health announcements Protect yourself and your staff: - medication to treat H1N1 information - immunization of you, your family and staff Consider providing immunization to your patients. If you want to do so make yourself aware of how to immunize and register with Public health to receive vaccine.

40. The Executive Committee of the SOGC adopted the following motions regarding H1N1 and pregnancy during the September 4th, 2009 meeting held in Ottawa. SOGC Members should: Promote the yearly influenza vaccine to all pregnant women. Inform, counsel, and promote to all pregnant women the availability and benefits of H1N1 vaccination. Inform pregnant women of the risks, signs, symptoms, severity and management of a possible H1N1 infection.

41. SOGC Members should: Provide pregnant women with a prescription for Tamiflu® (75mg bid for 5 days) during their antenatal visit, to be used when a suspected H1N1 infection occurs. Inform all pregnant women of the benefits and risks associated with the use of Tamiflu®, and its follow-up, such as the side effects, when to use the medication, and in case of serious respiratory difficulties to report to the nearest hospital. Be aware that Tamiflu® should NOT be used as a prophylaxis drug.

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