Transcript Title of Presentation Myriad Pro, Bold, Shadow, 28pt

Anthrax Special Considerations
for Pregnant and Postpartum Women:
Healthcare Planning Workgroup
Andreea Creanga, MD PhD
August 1, 2012
National Center for Chronic Health Promotion
Division of Reproductive Health
Workgroup members
 Martina
Badell
 William
Callaghan
 Deborah
Dee
 Jeff
Ecker
 Sue
Gorman
 Mirjan
Nesin
 Robbie
Prepas
Issues addressed by workgroup
 Clinical
issues
 Vertical transmission
 Breastfeeding
 Monitoring exposed/infected pregnant/lactating women
 Adherence to PEP & Tx
 Public
health response issues
 Clinical providers’ roles
 Workforce concerns
 Healthcare system issues
Vertical transmission – Key questions (1)
 What
is the evidence for vertical transmission of
anthrax (toxins)?
 Evidence of vertical transmission of anthrax bacilli in
animals exists
 B. anthracis identified in uterus, placenta, amniotic fluid &
fetal tissues in 5 cases of maternal cutaneous infection
(all 5 cases reported before 1923)
 Autopsies failed to demonstrate evidence of fetal
infection in 3 cases resulting in fetal deaths
Source: Meaney-Delman et al, 2012
Vertical transmission – Key questions (2)
 What
are the clinical & research implications of
potential vertical transmission of anthrax (toxins)?
 Maternal vaccination may benefit the woman & her infant
 PEP & Tx choices may need to include antibiotics with
known transplacental passage
 If mother infected  test the newborn & if pregnancy
results in fetal death  test fetal tissues
 Need to track pregnant/lactating anthrax cases to learn
more about vertical transmission potential
Breastfeeding – Key questions (1)
 What
is the evidence for transmission of anthrax
infection through breast milk?
 Few reports of isolation of B. anthracis from the milk of
affected animals (WHO, 2008)
 No evidence that anthrax bacilli are transmitted through
breast milk in humans
• 1 case report in a postpartum woman who continued
breastfeeding during Tx did not result in neonatal anthrax 
cutaneous anthrax lesion was not in close proximity to the breasts
• unclear whether anthrax lesions affecting the breast could lead to
maternal-to-infant transmission during breastfeeding
Breastfeeding – Key questions (2)
 Should women initiate
and/or continue
breastfeeding if exposed to anthrax?
 Based on available evidence, experts believe that anthraxexposed women can initiate or continue breastfeeding if
no cutaneous lesion is present on or near to the breasts
 If clinical anthrax, breastfeeding decision should be made
on a case-by-case basis
 “AVA is not a contraindication nor a precaution for
lactating women during or after an event with anthrax
exposure.” (ACIP, 2008)
Breastfeeding – Key questions (3)
 What
is the evidence regarding compatibility of
vaccines and antibiotics given to lactating women
and breastfeeding?
 Non-live vaccines are not contraindicated during
breastfeeding  “AVA is not a contraindication nor a
precaution for lactating women during or after an event
with anthrax exposure.” (ACIP, 2008)
 No data on the excretion of anthrax vaccine into breast
milk in humans
 AAP considers ciprofloxacin and tetracyclines to be usually
compatible with breastfeeding (AAP, 2001)
Monitoring of exposed/infected pregnant
and lactating women – Key questions (1)
 Should recommendations for routine pregnancy
care be altered in case of an anthrax attack?
 Recommendations for routine pregnancy care should not
be altered in healthy women -- there is need for usual
elements of prenatal care
 Standard contact isolation is appropriate for hospitalized
patients or patients with cutaneous lesions
Monitoring of exposed/infected pregnant
and lactating women – Key questions (2)
 Who should ensure monitoring
of exposed or
infected pregnant and lactating women?
 During pregnancy & after delivery monitoring of
exposed/infected pregnant/lactating women should be
the responsibility of a team of physicians to include
ObGyn, MFM, primary care & ID specialists
 Consultation by phone is an option since PEP/Tx should
not be delayed
Monitoring of exposed/infected pregnant
and lactating women – Key questions (3)
 Should temporary
separation of infants born to
anthrax exposed/infected women be considered?
 Temporary separation is not necessary, but should be
considered among women with cutaneous lesions (caseby-case assessment)
Adherence to PEP & Tx – Key question
 What
measures should be taken to monitor
adherence to PEP & Tx?
 Pregnant women are usually compliant to Tx
 Need to document compliance
• regular reporting by patients
• phone contact or home visits by nurses
 Regular contact will also address women’s concerns
regarding safety of PEP/Tx & breastfeeding
recommendations
Clinical providers’ roles– Key question (1)
 What
are the roles of OB care providers?
 Identify cases – exposure ascertainment is difficult
 Provide support to public health response (e.g. case
reporting, referrals to appropriate care or PODs)
 May be asked to provide PEP/Tx  should follow all
regulatory measures (e.g. Tx with investigational drugs
either under Investigational New Drug protocol or
Emergency Use Authorization)
 Should consult with ID colleagues and collaborate with
CDC if antitoxins are involved
Clinical providers’ roles– Key question (1 con’t)
 What
are the roles of OB care providers?
 Need to be well informed & understand clinical guidance
• actively seek up-to-date information
• attend pre- and/or post-event training
 Respond to queries from pregnant women about
recommendations made by public health authorities
 Reinforce recommendations for pregnant women & fully
inform patients of the risks/benefits of medications &
clinical recommendations
Workforce concerns – Key questions (1)

Should special considerations be given to
providers caring for pregnant/lactating women?
 No -- “No data suggest that the risk for developing anthrax
is greater for pregnant [than nonpregnant women] who
have been exposed to B. anthracis.”
 “Pre-event vaccination is not recommended for medical
personnel.”
 In case of an anthrax attack, encouraging providers to get
PEP would ensure adequate workforce available to care for
pregnant/lactating women
Source: CDC/MMWR, 2010
Workforce concerns – Key questions (2)

What infection control measures should be
considered by OB care providers?
 Anthrax-infected patients do not generally pose a
transmission risk
 Need to ensure standard infection control precautions for
infection prevention within L&D, recovery/postpartum,
ICU/NICU settings
 If cutaneous anthrax -- transmission through non-intact
skin contact with draining lesions is possible  use
contact precautions (Siegel, 2007)
Workforce concerns – Key questions (3)

Should employers of pregnant/lactating women
in high-risk professions involving direct contact
with infected patients or animals be considered
for lower-risk activities?
 Yes -- they may need to be considered for lower-risk
activities (e.g. triage rather than direct patient care)
Healthcare system issues– Background (1)

Anthrax infection poses at least the same risk for
pregnant/lactating women as for the general population

Severity of illness among pregnant/lactating women &
whether anthrax infection is a factor promoting onset of
labor are unknown

Effects of antibiotic therapy timing & long-term use of multiagent therapy among pregnant/lactating women cannot be
adequately assessed due to lack of data
Healthcare system issues– Background (2)
PODs
SNS
antibiotics
Predesignated
RSS sites
Hospitals
Pharmacies
Individual
homes
Healthcare system issues– Background (2)
PODs
SNS
antibiotics
Predesignated
RSS sites
Hospitals
Pharmacies
Individual
homes
Healthcare system issues– Background (2)
PODs
SNS
antibiotics
Predesignated
RSS sites
Hospitals
Pharmacies
Individual
homes
 To
recommend another setup for pregnant/lactating
women is not feasible
Healthcare system issues– Key questions (1)

How can PODs best address specific needs of
pregnant/lactating women?
 PODs need to have adequate supplies of antibiotics for
PEP for pregnant/lactating women
 POD staff should receive adequate training & have up-todate information on PEP guidelines for pregnant/lactating
women easily available to them (e.g. fact sheet, pocket
guide)
Healthcare system issues– Key questions (2)

How can individual hospitals best address
specific needs of pregnant/lactating women?
 Appropriate medications for pregnant/lactating women should
be available in all hospitals designated to provide anthrax
PEP/Tx
 Providers need adequate training & up-to-date knowledge of
clinical guidelines for pregnant/lactating women
 A multidisciplinary team to include at least ObGyn & ID
specialists should be involved in care of all pregnant women
• consultation by phone is acceptable, but should not delay PEP/Tx
• transfer to a more appropriate care may be recommended
Healthcare system issues– Key questions (2 con’t)

How can individual hospitals best address
specific needs of pregnant/lactating women?
 Obstetric & neonatal care should be specifically
considered in anthrax attack preparedness plans
 Hospitals should anticipate potential higher need for ICU
& NICU services
 Visitor policies for pregnant/postpartum women should
be consistent with visitor policies for the general
(hospitalized) population
Healthcare system issues– Key questions (3)

What should community hospital systems do?
 Rapidly disseminate clinical guidance to local providers &
ensure that specific guidance for pregnant/lactating
women is well understood
• pre- & post-attack training
• webinars
• fact sheets / pocket guides
 Contribute data to local and state anthrax surveillance
activities in a timely & comprehensive fashion
Healthcare system issues– Key questions (4)

Should there be need to prioritize care for
pregnant/lactating women, what criteria should
be used to do so?
 We cannot make recommendations to prioritize care for
certain categories of pregnant/lactating women based on
existing evidence
 As more data on anthrax transmission, related morbidity
and mortality become available, such recommendations
could be considered
Healthcare system issues– Key questions (5)

What will the major barriers to implementing
CDC anthrax guidance regarding pregnant/
lactating women be?
 Providers’ knowledge of CDC guidance & PREP Act coverage
 Lack of evidence regarding safety & efficacy of CDC guidance
 Providers’ attitudes & past practices – unwillingness, low
demand by patients
 Racial/ethnic & socioeconomic disparities in prenatal &
postnatal care coverage of pregnant /lactating women
 Logistical – not part of usual practice, staffing issues
Healthcare system issues– Key questions (6)

What will the major facilitators to implementing
CDC anthrax guidance regarding pregnant/
lactating women be?
 Providers’ training and PREP Act coverage awareness
 Standing orders for providers
 Rapid release of available epi data on PEP and Tx among
pregnant/lactating women early during the anthrax attack
 Public awareness of designated POD locations through media
campaigns , including social media
 Assessment of racial/ethnic & SES disparities in PEP/Tx
 Financial – SNS materials will be distributed free of charge
Top-3 healthcare planning recommendations

Ensure OB providers receive up-to-date information and
coordinate with multidisciplinary spectrum of clinicians and
public health authorities so that PEP/Tx is not delayed

Stock PODs and hospitals with appropriate medications and
fact sheets with guidance for pregnant/lactating women

Develop plan to conduct anthrax surveillance, monitor PEP/Tx
in pregnant/lactating women & provide epi data on:
 Transplacental & breast milk transmission of anthrax (toxins)
 Benefit of vaccination/PEP during pregnancy/breastfeeding period for
both mother & newborn
 Safety & efficacy of PEP & Tx among pregnant/lactating women
Thank you!
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333
Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348
E-mail: [email protected]
Web: www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
National Center for Chronic Disease Prevention and Health Promotion
Division of Reproductive Health