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 a
Related Questions
- I report adverse drug reactions (ADRs), but another pharmacist reports medication errors. Should we continue collecting data about errors or focus strictly on adverse drug events and patient harm?
- When does a user facility report information about adverse events?
- How do I report medication errors and adverse events?
