By
Liz Highleyman
The
declaration allows the opening of triage, treatment,
and segregation facilities for flu management,
as well as waivers of certain federal Medicaid,
Medicare, and private insurance requirements (e.g.,
related to confidentiality and patient transfer)
to encourage quick treatment.
"Given
that the rapid increase in illness across the
nation may overburden health care resources and
that the temporary waiver of certain standard
federal requirements may be warranted in order
to enable U.S. health care facilities to implement
emergency operations plans, the 2009 H1N1 influenza
pandemic in the United States constitutes a national
emergency," Obama wrote.
Public
health officials estimate that more than 20,000
people in the U.S. have now been hospitalized
with H1N1 flu and more than 1000 have died, although
figures are imprecise because the CDC no longer
recommends laboratory testing of all suspected
flu cases to confirm the strain. At this early
point in the year, H1N1 is now widespread in 46
states, already reaching the level of a typical
seasonal flu at the peak of the winter flu season.
Peramivir
Emergency Authorization
In
response to a request from the CDC, the FDA notified
healthcare professionals that it has issued an
emergency use authorization (EUA) for the investigational
intravenous (IV) antiviral drug peramivir for
certain hospitalized adults and children with
confirmed or suspected 2009 H1N1 influenza infection.
Data
presented at the recent 49th Interscience
Conference on Antimicrobial Agents and Chemotherapy
(ICAAC 2009) showed that a single intravenous
injection of peramivir worked as well as the widely
used oral agent oseltamivir (Tamiflu) for relieving
symptoms of seasonal influenza.
IV
peramivir is authorized only for hospitalized
adult and pediatric patients for whom therapy
with an IV drug is clinically appropriate, based
on one or more of the following factors:
 |
The
patient is not responding to either oral or
inhaled antiviral therapy; |
|
Drug
delivery by a route other than an intravenous
route is not expected to be dependable or
feasible; |
|
For
adults only, when the clinician judges IV
therapy to be appropriate due to other circumstances.
|
Given
the limited safety data on peramivir, mandatory
reporting requirements are important for defining
the safety profile of this as yet unapproved drug.
As part of the conditions of the EUA, healthcare
providers (or designees) must report adverse events
and all medication errors associated with peramivir
to FDA's MedWatch program within 7 calendar days
from the onset of the adverse event. Additionally,
healthcare providers (or designees) must conduct
follow-up requested by FDA or CDC related to peramivir
adverse event or medication error reports.
For
more information see:
Other
H1N1 Flu Information
On
October 21, CDC updated its information for patients
and providers about H1N1 concerns for people with
HIV/AIDS:
|
CDC
Issues Updated Information about H1N1 Swine
Flu for People with HIV |
|
CDC
Updates Interim Recommendations for Clinicians
Concerning H1N1 Influenza in HIV Positive
Adults and Adolescents |
Flu.gov:
One-stop access to U.S. Government H1N1, avian
and pandemic flu information.
CDC
2009 H1N1 Flu (Swine Flu) web site.
10/27/09
Sources
Kaiser
Family Foundation. President Obama Declares H1N1
A National Emergency. Kaiser Daily Global Health
Policy Report. October 26, 2009.
U.S.
Food and Drug Administration. FDA Authorizes Emergency
Use of Intravenous Antiviral Peramivir for 2009
H1N1 Influenza for Certain Patients, Settings.
Press Release. October 23, 2009.
