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

anthrax-exposed 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 (case-by-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 multi-agent therapy among pregnant/lactating women cannot be adequately assessed due to lack of data

Healthcare system issues– Background (2)

SNS antibioti

cs

Pre-designated RSS sites

PODs

Hospitals

Pharmacies

Individual homes

Healthcare system issues– Background (2)

SNS antibioti

cs

Pre-designated RSS sites

PODs

Hospitals

Pharmacies

Individual homes

Healthcare system issues– Background (2)

To recommend another setup for pregnant/lactating women is not feasible

SNS antibioti

cs

Pre-designated RSS sites

PODs

Hospitals

Pharmacies

Individual homes

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-to-date 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

For more information please contact Centers for Disease Control and Prevention1600 Clifton Road NE, Atlanta, GA 30333Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-mail: cdcinfo@cdc.gov 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.

Thank you!

National Center for Chronic Disease Prevention and Health Promotion

Division of Reproductive Health