Report: Add REMS to Sentinel System

Risk Evaluation and Mitigation Strategies could become part of the solution to a pharma supply-chain nosebleed: Tainted chemicals from overseas.

The Sentinel System for drug side-effect tracking, being developed by the FDA, should be integrated with REMS to mitigate drug risks, urge the authors of a report, Optimal Futures for Risk Evaluation and Mitigation Strategies, by the Society for Women's Health Research.

They cite the FDA response to the 2008 case of adulterated heparin when the agency worked with Baxter Healthcare and academia to analyze suspect products and develop tests for manufacturers and suppliers to use in identifying contaminated product. The regulator also issued a public health advisory and, via Import Alert, requiring testing of samples from all heparin shipments coming into the U.S. from China. "FDA was able to marshal existing resources and authority but was also required to obtain the voluntary cooperation of industry to control the situation," the authors write.

REMS and the Sentinel System together would allow the FDA "to prevent or rapidly detect drugs that may be contaminated and to rapidly implement risk communication strategies," according to the report. The FDA has the "greatest potential to improve drug safety" if REMS policies incorporate the real-life experiences of patient advocates, prescribers, pharmacists, academics, payers and sponsors.

The FDA decided two years ago to form partnerships with Medicare, Medicaid and private insurers to develop a database of patient prescription-drug use to mine for adverse-event patterns. The regulator in January signed a contract with Harvard Pilgrim Health Care to develop a pilot of the system.

- see the FDA's Harvard Pilgrim Sentinel pilot release
- here's the 23-page free report