May a physician continue to make adverse event reports to pharmaceutical manufacturers and/or the FDA?
Yes. The Privacy Rules expressly permit a physician to make adverse event reports to a person or entity subject to the FDA’s jurisdiction, such as a pharmaceutical manufacturer. As an added precaution to protect patient privacy, and to be sure a report is directed appropriately, physicians should make adverse event reports directly to the drug safety (or other appropriate department) of the manufacturer rather than to the sales representative. As with the majority of disclosures that are not for treatment purposes, physicians should disclose only the minimum amount of information that is necessary to make the report.
Related Questions
- Can covered entities continue to disclose adverse event reports that contain protected health information to the Department of Health and Human Services (HHS) Office for Human Research Protections?
- Where do I send adverse event reports or reports of unanticipated problems involving risk of harm to subjects?
- May a physician continue to make adverse event reports to pharmaceutical manufacturers and/or the FDA?
