When Medical Information Becomes a Drug Safety Issue

Jun 27, 2017
Chris O'Shaughnessy

Vice President

Medical information and drug safety will forever be intertwined. When someone calls the toll-free number listed on a drug package to ask a question about a product, it’s not uncommon for an adverse event (AE) to be uncovered in the course of a conversation between the caller and the agent. This means that the agent identifies a potential side effect or product safety issue from the details shared by a caller, either directly or indirectly.

The Continuity Advantage

Once the capture of the AE has taken place, a strictly regulated domino effect of processing and reporting that AE needs to occur. Ensuring a seamless transition to the drug safety or pharmacovigilance team from medical information is a priority.

Teams working side-by-side in medical information and drug safety departments offer a true “continuity advantage” to the pharmaceutical company, consumer and healthcare provider.

 

Benefits include:

  • Enhanced ability for quality control, because everyone on the medical information team is trained to capture and identify AEs. Teams include healthcare professionals who are highly trained (and receive ongoing training) and can draw from their own clinical experiences.
  • Mitigated risks and less potential for transmission errors, given that the teams are working closely together under one umbrella. This process avoids miscommunication between multiple vendors and partners.
  • Scalability, as linked medical information and drug safety programs can be customized to handle minimal calls for a single product or a large call volume, upwards to hundreds of thousands of calls for an entire product line.

 

The end result means that a consumer can feel assured that any issues are handled in a swift manner by trained professionals, and the pharmaceutical company receives accurate and important information at their fingertips — not only for regulatory reporting, but to inform of needed immediate product changes or future improvements.

 

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