Medical Information Teams Responsible for Tracking Off-Label Questions

Medical Information Teams Responsible for Tracking Off-Label Questions

Cutting Edge InformationCassie Demeter, 919-403-6583

Nine out of ten of surveyed pharmaceutical medical information teams document incoming inquires and medical information requests. At the remaining 10% of companies, these inquiries are likely documented by compliance or knowledge management teams.

A Cutting Edge Information’s study, “Medical Information Teams and Call Center Management,” found that for compliance purposes, companies typically store all unsolicited inquiries within the company’s medical information system. Companies document inquiries from all parts of the organization, including the field force and the call center. Documenting inquiries allows companies to monitor in their response processes. They also provide accurate assessments of fulfilled unsolicited inquiries and off-label questions.

Medical information documentation systems have been in use for many years now. Often, companies develop proprietary software to capture key elements of unsolicited . Customizable documentation systems track the caller’s name, the type of healthcare provider or patient, the caller’s question and the standard response provided to the caller. They also track the status of follow-up information that the medical information team sent to the caller and the nature of any follow-up information sent.

“The final piece of information that a complete documentation system includes is a link to the company’s adverse events system,” said Ryan McGuire, research team leader at Cutting Edge Information. “Any inquiry that includes information about an adverse event is typically tagged with a linking ID in the system. The linking ID helps identify the call within the adverse events system as well. But once the medical information database tags the call and transfers the information to the adverse event system, drug safety and pharmacovigilance teams are typically responsible for following up.”

“Medical Information Teams and Call Center Management” ( explores documentation systems for medical information teams. It also includes data on staffing, resources and call center management at company headquarters and affiliate offices. Use this report to:

For more information about medical information and , contact Cassie Demeter at 919-403-6583.