16 October 2008
N-95 Respirator fit-testing required for US postal carriers to recei=
ve a
"Household Antibiotic Kit" (doxycycline) for use during an Anthrax
attack
On October 3, 2008 a letter was
sent from the Food and Drug Administration (FDA)/HHS Deputy Commissioner for
Policy (Randall Lutter, Ph.D.) to the Director of the Biomedical Advan=
ced
Research and Development Authority (BARDA)/HHS (Robin Robinson, Ph.D) in
response to BARDA's request for the FDA "to issue an Emergency Use
Authorization (EUA) for the pre-event provision and potential use of
doxycycline hyclate tablet emergency kits for inhalational
anthrax...specifically for eligible United States Postal Service (USPS)
participants in the Cities Readiness Initiative (CRI)...and their household
members." The complete 17-page pdf can be accessed via the FDA website=
at:
www.fda.gov/Cder/drugprepare/
A brief but critically importa=
nt
reference in the letter from the FDA to BARDA appears on page 9, and i=
n a
footnote (#20) on page 12, stating the requirement for successful N=
-95
respirator fit-testing in order for US Postal Service (USPS) postal
carriers to be eligible to receive the Household Antibiotic Kit (HAK):
Page 9: "Policies and
procedures must also include screening for fitness to receive OSHA-required
personal protective equipment (PPE) (i.e., N-95 masks) and provision of PPE=
to
eligible USPS participants. "
Page 12: "USPS postal
carriers are not eligible to receive a doxycycline hycalte tablet emergency=
kit
if they have not passed their N-95 mask fit test."
The explicit rationale for
successful N-95 fit-testing is not stated in this letter. Given that
inhalational anthrax is NOT transmitted from person-to-person, however, the
rationale is most likely due to concern that anthrax spores in the
environment following an aerosolized release (attack) might put the po=
stal
carriers at risk of infection when they are delivering preventive antibioti=
cs
to persons in their homes.
If this is the actual rationale
for use of N-95 respirators as part of the PPE to be worn by postal workers
delivering antibiotics to the homes of persons who were possibly exposed to
aerosolized anthrax spores as part of the Cities Readiness Initiative,
then a key part of the associated risk communication will
need to focus on explaining this rationale to the general public, who
are unlikely to have N-95 respirators for their own use. =
Such risk communication could =
be a
formidable challenge.
Daniel R. Lucey, MD, MPH
EROne Institutes,
Adjunct Professor of Microbiol=
ogy
and Immunology
websi=
te for =
this
posting: www.BePast.org=
e-mai=
l: DRL23@Medstar.net