Risk For Untoward Outcomes Research Articles

Hospital inspectors eye black-box warnings

The federal government expects hospitals participating in the Medicare and Medicaid programs to have systems in place to minimize adverse events from medications that carry a higher-than-usual risk for untoward outcomes. In addition, some states require hospitals’ pharmacy and therapeutics committees to have written policies and procedures establishing safe medication-use systems. California is one such state. The California department in charge of hospital inspections expects facilities to have in place appropriate safeguards to manage the risks inherent to medications whose labeling has a boxed, or black-box, warning. That expectation, explained officially in a November 2007 notice from the inspecting agency, is based on Medicare’s conditions of participation (see sidebar on page 894) and California’s regulations covering general acute care hospitals. The penalty for not meeting the expectation may be a declaration of “immediate jeopardy,” which can result in a hospital losing its certification to participate in Medicare and Medicaid. But regardless of what the federal government decides to do, a California law that went into effect at the start of 2007 allows the state to take action. By law, the Department of Public Health can assess a fine of $25,000 if inspectors identify a deficiency “constituting an immediate jeopardy to the health or safety of a patient.”