FDA Clarifies “Unexpected” Adverse Event Reporting
The FDA issued a notice last week clarifying that any adverse event not included on a compounded drug’s labeling should be considered “unexpected” and reported to the agency.
The notice, published in the Federal Register, is in response to issues raised in seven comments to a February draft guidance on when outsourcing facilities must report adverse drug events.
Stakeholders complained that if an adverse event couldn’t be linked to a specific drug, the outsourcing facility would have to list all medications the patient was taking that might be suspect. The FDA clarified that this requirement applies to known suspect products and the agency will consider relevant facts including how the drug was administered and the patient’s medical history.
The agency also clarified that the 10-year period for maintaining adverse event records begins as soon as the outsourcing facility receives the information. The records should include four key elements: an identifiable patient, an identifiable reporter, a suspect drug and a serious adverse event. If any of these elements is missing, the facility should have records of its efforts to obtain the information.
As a result of the comments, the FDA plans to add a statement in the final guidance recommending that outsourcing facilities report all serious adverse events, even if not required. Laboratory data, hospital discharge summaries and other important information about an event should be provided to the agency, if available.
The FDA estimates that about 55 outsourcing facilities will submit adverse event reports annually.