viernes, 25 de diciembre de 2009
Adverse Event Reporting for Emergency Use of Peramivir IV Under EUA
Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir IV Under EUA
[10-23-2009, Updated 12/18/2009] This Healthcare Professionals sheet describes the mandatory adverse event reporting requirements for the emergency use of Peramivir IV, an unapproved drug. Peramivir IV is currently being studied in clinical investigations and has been authorized for emergency use under an Emergency Use Authorization (EUA: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM187800.pdf) during the 2009 H1N1 influenza public health emergency. Given there are limited safety data on Peramivir IV, these mandatory reporting requirements are important to defining the safety profile of this unapproved drug.
See the Peramivir IV Fact Sheet for Health Care Providers for additional information about the emergency use of Peramivir IV [http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm187710.htm].
As part of the conditions of the EUA, health care providers (or designee) must report adverse events and all medication errors that occur during treatment with Peramivir IV, irrespective of causality, to FDA’s MedWatch program within 7 calendar days from the onset of the adverse event. Additionally, healthcare providers (or designee) must conduct follow-up requested by FDA or CDC related to Peramivir IV adverse event or medication error reports submitted to FDA.
Please note that an existing standard form, Voluntary MedWatch Form 3500, is being utilized for the mandatory reporting requirements for Peramivir IV administration under EUA. The Voluntary MedWatch 3500 form was not developed specifically for Peramivir IV adverse event reporting. Therefore, please follow the special instructions below for filling out the required sections of the form for Peramivir IV.
What selected adverse events must be reported?
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 IV request number, patient initials, date of birth)
Pertinent medical history
Pertinent details regarding admission and course of illness
Timing of adverse event(s) in relationship to administration of IV Peramivir IV
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 IV 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 IV use.
Adverse events or medication errors should be submitted to FDA using the Voluntary MedWatch Form 3500. FDA will conduct compliance audits of the MedWatch forms to make sure they are completed and returned.
Health Care Providers should not use the Mandatory MedWatch Form 3500A; these forms are used by manufacturers only.
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.
The following are special instructions for filling out the required sections of FDA Form 3500 for Peramivir IV:
Section A, Box 1: Include the Peramivir IV 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.
The instructions for completing the MedWatch Form FDA 3500, state under Box B2 – to NOT check death if no association between the drug and event is thought to exist. Healthcare providers completing the MedWatch Form FDA 3500 under the EUA for Peramivir IV should check death, for any death that occurred during treatment with Peramivir IV.
Section B, Box 5: Describe the event:
Make certain to write “Peramivir IV 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).
What about deaths and other adverse events that occur after treatment with Peramivir IV has been completed/discontinued?
FDA encourages reporting of all adverse event reports, including reports of death, that occur with the use of FDA regulated medical products. However, the specific mandatory reporting requirement in the EUA applies only to medication errors and the selected adverse events above that occur during treatment with Peramivir IV, irrespective of causality.
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 email@example.com