Medical Information Call Centers: Processes for AE Reporting
68 TW Alexander Dr. RTP, NC 27709
+1 (919)-403-6583
+1 (919)-433-0220

Medical Information Call Centers: Establish Clear Processes for Adverse Event Reporting

Pharma medical information call centers bear a number of responsibilities beyond answering stakeholder questions about products.  For instance, call center agents may recruit for clinical trials and respond to internal literature requests.  Another vital call center role — conducted by 63% of surveyed teams — is reporting adverse events (AEs).

Industry regulations have stringent requirements about adverse event reporting and documentation, so it is crucial for call centers to develop clear protocols for handling adverse events and to train call center agents to follow the step-by-step process.

Oftentimes, the most crucial first step in AE reporting is determining if the person on the phone is discussing an adverse event or merely asking a question.  A physician might ask an agent if there is a study about anemia relating to a particular product.  The call center agent will then have to ask the physician, “Do you have a patient with this problem?”  If so, the agent will proceed via the AE reporting protocols.

One interviewed medical information team executive explained that the initial call is the call agent’s best opportunity to learn the most about the adverse event.  For this reason, the agent will immediately log the AE in the medical information system as soon as he or she identifies it as an adverse event.  This interviewed team has an integrated IT system that generates the necessary FDA forms when an agent logs the AE.  The IT system also gives the AE a call code and simultaneously reports the event to both the company’s pharmacovigilance and quality control groups, which will conduct their own investigations into the adverse event.

An integrated process like this both expedites and reduces errors in AE reporting.  But — since the crux of these protocols relies on call center agents to accurately identify and report adverse events — the onus is on call center teams to thoroughly train their agents.  As a result, AE reporting protocols are only as good as the training the agents provide.

Natalie DeMasi
Research Team Leader

Toolkit for Diabetes MSL Programs cover
The Toolkit for Diabetes MSL Programs
Pharmaceutical Continuing Medical Education cover
Pharmaceutical Continuing Medical Education
Pharmaceutical Key Opinion Leaders Management cover
Pharmaceutical Key Opinion Leader Management

Related Posts