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Pandemic Influenza Plan - Questar III

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Section 6: Vaccine Procurement, Distribution, and Use<br />

3. Vaccine Safety Monitoring<br />

Interpandemic and <strong>Pandemic</strong> Alert Periods<br />

State Health Department:<br />

• Establish an adverse event monitoring system.<br />

• Designate an adverse event coordinator.<br />

• Monitor adverse events if pre-pandemic vaccine is used.<br />

• Consider how vaccine efficacy studies would be conducted and coordinate<br />

within DOH, especially with researchers and Wadsworth laboratories.<br />

• Disseminate information to LHDs and health care partners on the adverse<br />

event monitoring system.<br />

• Identify those health care providers that would provide medical<br />

consultation on adverse events on the state level.<br />

• Consider how the implementation of active surveillance would be done.<br />

• <strong>Plan</strong> for the use of an IND or Emergency Use Authorization protocol is<br />

needed.<br />

Local Health Departments:<br />

• Establish an adverse event monitoring system based on the requirements<br />

of the statewide system.<br />

• Identify which staff would be responsible for adverse event monitoring.<br />

• Identify which staff would provide medical consultation for adverse<br />

events on the local level.<br />

• Disseminate information on the adverse event monitoring system to local<br />

health care partners.<br />

• Work with the NYSDOH to plan for IND or Emergency Use<br />

Authorization protocols.<br />

Healthcare Partners:<br />

• Establish an adverse event monitoring system within health care facilities<br />

and practices.<br />

• Identify staff that would be responsible for adverse event monitoring.<br />

• Identify staff that would be responsible for medical consultation for<br />

adverse events.<br />

• Disseminate information on adverse event monitoring to staff.<br />

• Work with NYSDOH and LHDs to plan for IND or Emergency Use<br />

Authorization protocols.<br />

February 7, 2006 6-10

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