On September 4, 2013, the Department of Health and Human Services ("HHS") released a report entitled "National Action Plan for Adverse Event Prevention" ("Plan"). The 176-page report purports to "engage all stakeholders in a coordinated, aligned, multi-sector, and health literate effort to reduce ADEs [adverse drug events] that are most common, clinically significant, preventable, and measurable." For this effort, the Plan focused on the intended end-users, "policymakers, health care professionals, public and private sector organizations, and communities who can organize and take action toward preventing high-priority ADEs." The high priority targets identified to prevent ADEs are the drug classes of anticoagulants, diabetes agents, and opioids. The four-pronged approach includes: surveillance, prevention, incentives and oversight, and research.
ADEs may occur in both inpatient (hospital) and outpatient and long-term settings. According to statistics cited in the Plan, ADEs account for about two million hospital stays annually and prolong hospital stays by about 1.7 to 4.6 days. ADEs in outpatient settings account for reportedly over 3.5 million emergency department visits, resulting in 125,000 hospital admissions each year.
The Plan acknowledges that a certain amount of passive (voluntary) reporting of ADEs comes via FDA's Adverse Event Reporting System ("FAERS") as well as FDA's Sentinel Initiative that monitors over 125 million lives but, the Plan says, "which do[es] not constitute a nationally representative sample, but for specific studies, FDA's Sentinel Initiative has the potential to access health records to confirm coded data or provide additional data." FDA's Sentinel Initiative was established in response to the FDA Amendments Act ("FDAAA") passed in 2007, which mandated that FDA establish an active surveillance system for monitoring drugs, using electronic data from healthcare information holders. The goal of the Sentinel Initiative is a new active surveillance system that could be used to monitor all FDA-regulated products. In particular, the Sentinel System draws on existing automated healthcare data from multiple sources to actively monitor the safety of medical products continuously and in real time.