Food and Drug Administration (FDA)

• • The FDA has a variety of reporting options:
    • • Complete voluntary Form FDA 3500 online. FDA Form 3500 should be used by health care professionals and consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care. Events that occur during clinical trials under an Investigational New Drug application are mandatory reports and are submitted to FDA as specified in the investigational new drug/biologic regulations or investigational device exemptions. Do not submit vaccine reporting, veterinary medicine and Internet fraud via this form.
      • Call 1-800-332-1088 to report by telephone
      • Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-332-0178 (send only page 1 plus any continuation pages; do not send instruction pages)
      • MedWatch: The FDA Safety Information and Adverse Event Reporting Program
        This FDA safety information and adverse event reporting program provides clinically important safety details and resources that allow people to report a serious issue with a medical product, medication or device; report unlawful sales of medical products online; and sign up for MedWatch alerts via e-mail, Twitter or RSS feeds.
  • Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program (MERP) and Vaccine Errors Reporting Program (VERP)
    ISMP operates two national error-reporting programs: the National Medication Errors Reporting Program and the National Vaccine Errors Reporting Program. Both are confidential, voluntary programs that provide expert analysis of system-based causes of medication and vaccine errors. Both health care practitioners and consumers/patients can report errors.