Serious Adverse Event Reports: The Basics

When it comes to product-related complaints from consumers, one question that I’m often asked is how to tell the difference between an adverse event report (AER) and a serious adverse event report (SAER). It’s an important distinction as the latter requires the responsible party– the company listed on the dietary supplement label–to do some fast footwork to inform the FDA.

Companies can manage their own product complaints, have a third party handle them, or arrange to have another company in the supply chain handle them (e.g., a private label retailer may have their manufacturer handle complaints). Whatever the arrangement, one thing is clear: Companies with good procedures and training in place can tackle this with ease.

Rules of the road

In general, a relatively minor product-related complaint such as mild digestive upset would trigger a company’s standard operating procedure for consumer complaints. Staff would then earmark this as an AER, collect the relevant information, and send it on for internal tracking, documentation, and trend analysis as required under regulation.

When a product-related complaint is more serious, however, it becomes an SAER (more on that later), and the company must notify the FDA quickly … within 15 business days after receipt of the complaint. So, with the clock ticking, it’s important to be able to identify and process SAERs fast. A little training can go a long way to helping staff meet this short deadline.

Let’s get serious

What is an SAER? It’s a product-related event that results in one of the circumstances below. Under regulation, a company must report it to the FDA using the MedWatch 3500A Mandatory Reporting Form. Did I mention the clock is ticking?

The SAER circumstances that require notifying the FDA are:

1. Death
2. Life-threatening circumstance
3. Hospitalization--initial or prolonged
4. Disability or permanent damage
5. Congenital anomaly or birth defect
6. Requires medical intervention, based on appropriate medical judgment, to prevent any of the above

Is that really hospitalization?

Of the six SAER circumstances listed above, “hospitalization” tends to be the most confusing. It’s specific to inpatient hospitalization rather than any care received in a hospital setting. That is, the consumer must be formally admitted to a hospital—with a doctor’s order—or have a current hospital stay prolonged.

So, simply using a hospital-based service as an outpatient would not qualify as “hospitalization.” Neither would an emergency room visit to the extent that the consumer is released to go home (e.g., not admitted to a hospital) or unless one of the other circumstances above is met (e.g., treated in the emergency room for a life-threatening condition). Likewise, a visit to a doctor’s office, an outpatient clinic, a retail healthcare clinic or similar facility, even when affiliated with a hospital, would not meet the requirement for “hospitalization.”

Efficiency at the speed of training

Customer service representatives are typically the front line staff that initially receive and process product-related complaints. With proper training, they can quickly identify and process complaints related to AERs and SAERs. Is it an AER? Check. Begin internal tracking and follow up. Is it an SAER? Check. Prepare or notify others to prepare to file a MedWatch form within the 15-day window and, if needed, initiate further investigation. (The SAER notice to the FDA is just that: a notice. It is not an admission of cause. Further investigation would be needed to determine a causal link, if any.)

Bottom line

Whether tracking AERs internally or meeting the FDA’s notification requirement for SAERs, a company that combines a good standard operating procedure with regular staff training has a clear advantage for handling these types of consumer complaints quickly, accurately, and with ease.