The RxEvent system is designed to allow physicians to report adverse events via their electronic health records (HER) platforms. This data can then be passed directly to drug makers and the US Food and Drug Administration (FDA).
PDR, a distributor of FDA-approved labelling data, alerts and REMS information, developed RxEvent in partnership with Greenway Medical Technologies, American Pharmacists Association and athenahealth.
The firm explained that, according to some studies as physicians and pharmacists report as few as one in 10 of the adverse events they encounter “due to the time-consuming and inefficient processes involved.”
This may mean that as many as 4.5m ADEs each year go unreported, putting patients at risk, skewing drugmakers triage efforts and investigation strategies and potentially affecting decisions made by the FDA.