Reply
Wed 4 Nov, 2009 08:25 am
I think all adverse events should be reported to FDA, not just selected ones. What do you say, please?
Context:
Prescribing under the EUA is different from prescribing FDA-approved drugs (see table). Health care providers need to recognize that peramivir is an unapproved drug authorized for use only because of and during the 2009 H1N1 public health emergency. Although review by an institutional review board is not required, health care providers who prescribe the drug must fulfill certain requirements. These requirements are detailed in the "Peramivir Fact Sheet for Health Care Providers"2 and include documentation in the medical record that the patient and caregivers have been given the "Peramivir Fact Sheet for Patients and Parents/Caregivers," informed of alternatives to receiving peramivir, and told that peramivir is an unapproved drug to be used only under the EUA. Providers must also report all medication errors and selected adverse events to the FDA's MedWatch program (www.fda.gov/medwatch/report.htm), after which the FDA may contact the provider for additional information.
A selected adverse event is one which is of a type selected by the FDA for reporting. Therefore there is no need or requirement to report other adverse events.