Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir Under EUA

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What selected adverse events must be reported?

• Deaths
• Neuropsychiatric events
• Renal adverse events
• Serious skin adverse events
• Hypersensitivity reactions adverse events
• Severe intravenous site or intravenous administration adverse events (e.g., septic phlebitis, infiltrated IV)
• Other serious adverse events*

*Serious adverse event is defined as: any life-threatening adverse drug experience that may prolong existing hospitalization, result in a persistent or significant disability/incapacity or a congenital anomaly or birth defect or an event that may jeopardize the patient to an extent that may require medical/surgical intervention to prevent one of the outcomes above including death.

What information should be included in the report?
It is important that the information reported to FDA be as detailed and complete as possible.  Information to include:

• Patient Demographics (e.g., peramivir request number, patient initials, date of birth)
• Pertinent medical history
• Pertinent details regarding admission and course of illness
• Concomitant medications
• Timing of adverse event(s) in relationship to administration of IV peramivir
• Pertinent laboratory and virology information
• Outcome of the event and any additional follow-up information if it is available at the time of the MedWatch report. Subsequent reporting of follow-up information should be completed if additional details become available (use the same peramivir request number when completing the report).

How do I report medication errors and adverse events?
Health care providers (or designees) should follow the instructions below to ensure proper reporting of adverse events and medication errors associated with peramivir use. 

• Adverse events or medication errors should be submitted to FDA using MedWatch Form 3500. FDA will conduct compliance audits of the MedWatch forms to make sure they are completed and returned.
• The FDA Form 3500 can be completed online at www.fda.gov/medwatch/report.htm or submitted by using FDA’s pre-paid postage Form 3500 available at www.fda.gov/medwatch/safety/FDA-3500_fillable.pdf. This form can be returned by faxing (1-800-FDA-0178) or by mailing to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
• If you are unable to access the FDA’s Form 3500 through the internet, you may contact FDA at 1-800-FDA-1088 to report any medication errors of adverse events.

Special instructions for filling out required sections of FDA Form 3500 for peramivir:

• Section A, Box 1: Include the peramivir request number and the patient’s initials in the Patient Identifier box. This step is essential to facilitate follow-up and tracking of the adverse event report.
• Section A, Box 2: Provide the patient’s date of birth.
• Section B, Box 5: Describe the event:
  • Make certain to write “Peramivir EUA” in the first line.
  • Provide a detailed report of the medication error and/or adverse event(s).
• Section G, Box 1: Provide name, address, phone number, and e-mail address of the reporter who is responsible for the MedWatch report. Make certain to also list the address of the treating institution (NOT the healthcare professional’s office address).

If you have additional questions regarding FDA Form 3500 or submitting adverse events reports, please contact FDA’s Division of Drug Information at 1-888-463-6332 or druginfo@fda.hhs.gov