Regulatory round-up

In an effort to keep you up-to-date on the latest regulatory requirements, we've rounded up some important developments that are in the news this month. Read on to learn about a recent FDA ruling on the use of niacin and fenofibric acid with statins – and new quality measures for skilled-nursing providers.

  • FDA rescinds approval of niacin, fibrate in combination with statins. According to the American Pharmacists Association, the FDA is removing its approved indication for coadministration with a statin for niacin and fibrate combination products due to a lack of cardiovascular benefit. This decision affects the indication of niacin extended-release (Niaspan) and fenofibric acid (Trilipix) as well as Advicor and Simcor, which combine niacin with a statin. Read article

  • Nursing Home Compare to include data about use of antianxiety/hypnotic medications. The S4 Group recently reported that CMS is posting data for six new quality measures (QMs) on Nursing Home Compare, including the percentage of long-stay residents who received an antianxiety or hypnotic drug. However, the new antianxiety/hypnotic medication measure will not affect Five-Star Quality Rating QM ratings. Learn more

If you have any questions or concerns about these regulatory requirements, please contact Director of Pharmacy Derek Brown at This email address is being protected from spambots. You need JavaScript enabled to view it..


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