0
   

selected adverse events ?

 
 
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.
  • Topic Stats
  • Top Replies
  • Link to this Topic
Type: Question • Score: 0 • Views: 316 • Replies: 2
No top replies

 
contrex
 
  1  
Reply Wed 4 Nov, 2009 10:25 am
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.
oristarA
 
  1  
Reply Wed 4 Nov, 2009 03:50 pm
@contrex,
Thank you
0 Replies
 
 

Related Topics

deal - Question by WBYeats
Let pupils abandon spelling rules, says academic - Discussion by Robert Gentel
Please, I need help. - Question by imsak
Is this sentence grammatically correct? - Question by Sydney-Strock
"come from" - Question by mcook
concentrated - Question by WBYeats
 
  1. Forums
  2. » selected adverse events ?
Copyright © 2024 MadLab, LLC :: Terms of Service :: Privacy Policy :: Page generated in 0.03 seconds on 10/10/2024 at 08:25:28