Nations advance systems to flag bad drug reactions

In the ongoing battle to spot adverse drug or medical product reactions as early as possible, groups in Canada, Europe and the U.S. are advancing new programs to protect patients and inform health officials.

Experts recently convened in Boston and provided updates on the programs to boost the ability of regulators and others to monitor the safety of treatments, Sara Gambrill, a contributor to Life Science Leader magazine, reported. The efforts involve the use of electronic systems, public-private partnerships, and networks of organizations working together.

  • Harvard Medical School's Richard Platt gave an overview of a pilot project within the Sentinel Initiative, an electronic system in the U.S. for speedy safety monitoring, which aims to pinpoint "previously unsuspected" adverse reactions to drugs, Gambrill writes.
  • In Europe, the PROTECT Project is advancing with public and private support to pull data from such sources as clinical trials, observational studies and spontaneous reports to provide timely detection of adverse events. The pharmacovigilance effort has advanced with funds from the Innovative Medicine Initiative. 
  • Canada's answer to calls for providing better information on drug safety is a program called DSEN. Created by the Canadian Institutes of Health Research and Health Canada, DSEN's goal is to be "an independent source of real-world drug safety and effectiveness information to inform regulators, policy makers, healthcare providers and patients," Gambrill writes.

These programs and others were discussed during Cambridge, MA-based Outcome's Post-Approval Summit in Boston last month.

- check out Gambrill's report