Pandemic Influenza Plan - Questar III

Section 7: Antiviral Medication Procurement, Distribution, and Use
• Local campaigns to educate health care workers about the recognition and
reporting of adverse events, and
• Distribution of MedWatch forms and descriptions of known adverse events to
each provider and user of antiviral drugs.
In addition, CDC and the FDA will explore the use of existing drug-monitoring system
that have access to individual health utilization records that many allow active,
population-based surveillance for adverse events following the use of antivirals for
treatment or prophylaxis.
E. Contingency Planning for Use of an Investigation New Drug Protocol
It may be necessary to use an unlicensed antiviral drug under the FDA’s Investigational
New Drug (IND) provisions. IND provisions require completion of a signed consent form
from each person who receives the medication, and mandatory reporting of specified
types of adverse events. They also require strict inventory control and record-keeping,
and approval from Institutional Review Boards (IRBs) in hospitals, health departments,
and other venues. The FDA regulations permit use of a national or “central” IRB.
As an alternative to IND use of an unapproved antiviral drug, HHS may utilize the drug
product under Emergency Use Authorization procedures as described in the FDA draft
guidance “Emergency Use Authorization of Medical Products” available on the FDA
website at www.fda.gov/cber/gdlns/emeruse.pdf.
VII.
Data Collection
The NYSDOH will develop a strategy for monitoring antiviral drug distribution by public
health. Data elements that may be collected include:
• The distribution of state or federal supplies of antiviral drugs:
o where antivirals are shipped;
o who has received them;
o type of administration: treatment, prophylaxis, PEP;
o dose and number of doses administered by person and in the aggregate;
o relevant medical history.
• Adverse events following administration of antivirals.
• Priority groups reached.
• Rates of severe influenza illness and death among those treated and untreated.
February 7, 2006 7-10