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H1N1 Influenza Management Issues for Pregnant Women and Newborns Elliott Main, MD Chair, Dept OB/GYN California Pacific Medical Center San Francisco (Revised October 29, 2009) H1N1: Pregnancy Issues Epidemiology-Current CDC numbers Pregnancy-specific Concerns with H1N1 Recommendations for Triage and Treatment of Possibly Infected or Exposed Mothers – Prior to Labor – During Labor – Recommendations for Prophylaxis – Safety of Medications H1N1 Flu Vaccine – Safety of other Influenza Vaccines – How to Order and Use Free Vaccine from the State 1. Late June: Widespread activity on both coasts. 1. 2 months later, shows less geographic influenza activity. 2. California is no longer in the “widespread” group. 1. By September, the South East is particularly hard hit. 1. By mid-October, the entire nation has widespread flu outbreak. 1. Adult deaths from influenza are not increased this year or this summer. www.cdc.gov/flu/weekly Oct. 17, 2009 1. Pediatric deaths due to flu are highly unusual at this time of year and are equal to the level seen in the height of winter. 2. The absolute numbers are small. www.cdc.gov/flu/weekly Oct. 17, 2009 Summer Fall Winter 1. Basically ALL influenza this summer and fall is H1N1 (Type A, not H3). 2. Rate declined as the summer progressed. But…. www.cdc.gov/flu/weekly Oct. 17, 2009 Epidemiology Summary: Large US and California peak in May/June 2009, faded and then came back in fall Currently nationwide, worst in the East Children and pregnant women are at greater risk than with usual influenza strains and therefore are highest priority groups for the vaccine Most illness is mild but these high risk groups are at risk for serious M/M What Will Happen When School Opens? Pregnant Women are a High-Risk Population for H1N1 6x more likely to get infected with H1N1 4x more likely to be hospitalized (Jamieson et al, Lancet July 29, 2009) 6x more likely to die than other adults Deaths related to pneumonia with subsequent ARDS requiring mechanical ventilation At least 6 maternal deaths in Northern CA General Recommendations If sick with an influenza-like illness (ILI): Fever (>100F, 37.8C) plus at least cough or sore throat and possibly other symptoms like runny nose, body aches, headaches, chills, fatigue, vomiting and diarrhea Should stay home and keep away from others as much as possible, for at least 24 hours after fever is gone (without the use of fever-reducing medicine). www.cdc.gov/flu/weekly/ Sept. 1, 2009 Telephone Triage Do NOT want patients with ILI to come to an OB/GYN’s office Phone triage: – If fever plus symptoms then consider treatment (see recommendations) – BUT, If respiratory concerns (dyspnea, chest pain, tachypnea) NEEDS TO BE EVALUATED with O2 sat and exam (? Primary care/Urgent care/ER) ACOG / CDC Released Oct 15, 2009 Usable for office, clinic or OB Triage ACOG websitehttp://www. acog.org/departments/resour ceCenter/2009H1N1TriageT reatment.pdf Key Points for ILI Triage Screen for significant respiratory problems – History/symptoms – O2 sat, CXR, ABGs as clinically indicated Patients who improve and then worsen are at high risk Assess for OB, social and medical co-morbidities – PTL – Asthma, HIV – Inability to care for self Follow-up within 24-48hrs! Influenza A Testing Treatment decisions should NOT be based on test results High rates of false negatives for rapid assays—depending on specific test, sensitivity ranges from 10-70% for H1N1 Specific tests for H1N1 are send outs, many Health Departments are no longer offering them except for severe cases,but some hospital labs will be getting rapid and specific tests in the next 6 weeks Treatment for Pregnant Women Early treatment recommended for suspected cases without waiting for laboratory confirmation Tamiflu® (oseltamivir) is now the drug of choice for its systemic activity: 75mg bid for 5 days – Class C: based on limited human safety studies but to date no human fetal injury has been reported – All experts conclude that treatment is supported by overwhelming evidence of benefit compared to serious risk of harm from the virus Even if symptoms started more than 48hrs prior to presentation to care, treatment is still indicated Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season. CDC October 16, 2009 http://www.cdc.gov/h1n1flu/recommendations.htm Prophylaxis for Pregnant Women Infected persons may shed virus beginning ONE DAY before they develop symptoms and up to 7 days after they become ill. Prophylaxis is indicated for pregnant women with close contact with confirmed, probable or suspected H1N1 influenza during the period above The drug of choice for prophylaxis during pregnancy is not clear. Either/or: – Tamiflu® (oseltamivir): 75mg once daily for 10 days – Relenza® (zanamivir): two 5mg inhalations once daily for 10 days Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season. CDC October 16, 2009 http://www.cdc.gov/h1n1flu/recommendations.htm Medication Summary Antiviral medication dosing recommendations for treatment or chemoprophylaxis of novel influenza A (H1N1) infection Treatment Chemoprophylaxis Oseltamivir (Tamiflu®) 75-mg capsule twice per day for 5 days* 75-mg capsule once per day for 10 days* Zanamivir (Relenza®) Two 5-mg inhalations (10 mg total) twice per day for 5 days Two 5-mg inhalations (10 mg total) once per day for 10 days* *Currently recommended first choice medications. CDC: Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season. 10/16/2009 Given this Morbidity…The Key is Vaccination! 6x more likely to get infected with H1N1 4x more likely to be hospitalized (Jamieson et al, Lancet July 29, 2009) 6x more likely to die than other adults Deaths related to pneumonia with subsequent ARDS requiring mechanical ventilation At least 6 maternal deaths in Northern CA H1N1 Vaccine Strongly recommended for – Pregnant women – Parents of children under 6mos (i.e. partners!) – Health care providers with direct patient contact Safety – Use “Flu Shot” (fragments of killed/inactivated virus) not “nasal spray” (live-attenuated virus), – Thimerosol free vials – No adjuvents are used – Field tested in July/August in >4,000 people, tests in pregnant women underway in September, no ill effects – Produced with same techniques as prior flu vaccinessafe in pregnancy 2009 H1N1 Influenza Vaccine and Pregnant Women. CDC September 3, 2009 http://www.cdc.gov/h1n1flu/vaccination/pregnant_qa.htm H1N1 Vaccine (as of 10/28/09) Will be distributed free by the State: – www.CalPanFlu.org National delay in vaccine production so local distribution also dealyed – Kaiser and County Clinics this week – Hospitals and offices in midNovember… Single dose will generate immunity in 8-10 days rather than 2-3 weeks 2009 H1N1 Influenza Vaccine and Pregnant Women. CDC September 3, 2009 http://www.cdc.gov/h1n1flu/vaccination/pregnant_qa.htm H1N1 Vaccine 1. Live Attenuated Influenza Vaccine (LAIV) (aka Flu-Mist)—NOT TO BE GIVEN TO PREGNANT WOMEN -- OK for Postpartum women, healthcare workers (even those on L&D) 2. H1N1 Flu Shot (killed) Vaccine, two types: -- Multi-dose vial with the preservative Thimerosal (contains ethyl-mercury) -- Single-dose vial without Thimerosal California Law requires that pregnant women and children under 3 receive the Thimerosal– free vaccine Thimerosal There is a national shortage of Thimerosal-free vaccine (even less than regular vaccine) CDC, ACOG, IOM have all said strongly that Thimerosal is NOT a problem in pregnancy Autism-worriers in California had succeeded in getting the State Legislators (2006) to write a law that pregnant women should not get Thimerasol Given the shortages, on October 15, 2009 Director of California DPH issued an order suspending the ban on Thimerosal… (temporarily: Oct 12 to Nov 30) What about the risks from the last Swine Flu vaccine? In 1976 there was a national effort to immunize everyone to prevent an earlier (very different) swine flu. (BTW, only a single person died in that entire outbreak) – Guillon-Barre Syndrome (GBS) occurred in 1/100,000 persons with multiple deaths – Ever since, influenza vaccines have been made quite differently and the annual seasonal flu vaccines have NOT been associated with GBS (<1/1,000,000). H1N1 is made the same way. Each vaccine is subjected to safety trials including pregnant women H1N1: Isolation Issues Mother Newborn Staff Protection Family Members Visitors Caring for Mother/Infants CDC--July 6, 2009 Written Guidelines Infants of Moms who are confirmed or probable H1N1 – Consider separating mom and infant until • Mother has been on antiviral medication for 48 hours • Fever has fully resolved • Cough and secretions are controlled – Breast milk can be expressed When conditions are met mom can be united with infant but should wear facemask Infant should be cared for by a well family member Most mothers have rejected this approach! Considerations Regarding Novel H1N1 Flu Virus in Obstetric Settings. CDC July 6, 2009. http://www.cdc.gov/h1n1flu/guidance/obstetric.htm Excellent YouTube Video for Pregnancy Questions at Flu.gov August 27, 2009 CDC, ACOG, ACNM, NIAD, HHS Leaders Wide range of practical maternity related questions (60min long) (check out minute 35 for intrapartum discussion) Can be recommended for ALL pregnant women and ALL providers www.flu.gov/news/knowwhattodo.html Know What to Do About the Flu Webcast Archive: Pregnant Women and New Moms. CDC August 27, 2009 http://www.flu.gov/news/knowwhattodo.html Caring for Infants-II CDC Webinar—August 27, 2009 Stresses a “Case-by-case, Common Sense” approach to isolation issues of H1N1 infected mothers with newborns If mother “really sick”, then separation is best If mother on treatment and doing “ok”, then they can be together based on clinical judgment. Use recommendations for seasonal flu: – – – – Surgical mask and hand washing for mother Breast feeding recommended Isolette for infant when not at breast vs nursery (?) The difficulty is that the CDC has never put this in writing… Know What to Do About the Flu Webcast Archive: Pregnant Women and New Moms. CDC August 27, 2009 http://www.flu.gov/news/knowwhattodo.html (min 34 of 60) Staff Protection-Mask Contoversy Surgical v. N95 – Many experts v. Cal OSHA – Not much data with H1N1, lots of opinions – Surgical masks appears to be effective for seasonal flu On Sept 3, 2009: IOM report to US OSHA and CDC made a strong recommendation for fit-tested N95… Liverman et al. Respiratory Protection for Healthcare Workers in the Workplace Against Novel H1N1 Influenza A: A Letter Report. Institute of Medicine Full PDF available at: http://www.nap.edu/catalog.php?record_id=12748#toc Recent RCT of N95 v. Surgical Masks for H1N1 1,936 ED/Resp Ward RN and MDs in Beijing Cluster randomized: surgical masks v. N95 Consistent use for 4 consecutive weeks Controls-”usual practice” at 9 hospitals Consistent surgical mask use was no better than controls for prevention of clinical respiratory illness (6.7% versus 9.2%, P=0.159) or of influenza-like illness (0.6% versus 1.3%, P=0.336). MacIntyre C, et al "The first randomised, controlled clinical trial of surgical masks compared to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in hospital health care workers in Beijing, China" ICAAC 2009; Oral session K-1918b. (September 16, 2009) Recent RCT of N95 v. Surgical Masks for H1N1--con’t Compared with controls, N95 respirators reduced the rate of clinical respiratory illness 60% (3.9% versus 9.2%, P<0.001) and the rate of influenzalike illness by 75% (0.36% versus 1.3%, P=0.035). The advantage of N95 respirators was substantial compared with surgical masks (RR 0.58 for clinical respiratory illness, P=0.019). MacIntyre C, et al "The first randomised, controlled clinical trial of surgical masks compared to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in hospital health care workers in Beijing, China" ICAAC 2009; Oral session K-1918b. (September 16, 2009) Recent RCT of N95 v. Surgical Masks for H1N1--con’t Does it work as well in hospitals with higher levels of hand hygiene? Adjustment for differences between hospitals in the level of handwashing, vaccination, and other factors that would impact infection risk only increased the apparent effectiveness of the N95 mask in staving off influenza to 96% (OR 0.04, 95% CI 0.01 to 0.15). So Mask AND Hand Hygiene give best results! MacIntyre C, et al "The first randomised, controlled clinical trial of surgical masks compared to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in hospital health care workers in Beijing, China" ICAAC 2009; Oral session K-1918b. (September 16, 2009) National Shortage of N95 Masks California is releasing N95 masks from their “strategic Stockpile” Given the shortage, a number of hospitals are reverting to surgical masks, as recommended for seasonal influenza Visitors—This will Change as the Season Goes On! Individualized by hospital based on local Flu incidence, likely in step-wise manner. Difficult balance between Family-Friendly and Infection Control. Some examples given below, in stages: All visitors must be well. No visitor children except well siblings to PP(?) No children at all in NICU(?) No visitor children under 16 in ALL units in hospital No visitors of all ages except partners/parents/guardians How are visitors being screened at entrance, in lobby, at nursing station? Stay Tuned…! Changes Every Week “The only thing that’s certain is uncertainty.” Dr Thomas Frieden Director CDC On the difficulties of preparing for swine flu... Additional Resources Visit www.CMQCC.org for more information, many documents and links to state, national and ACOG resources This website pulls together pregnancy H1N1 information from many sites