OIG: Improved oversight of standalone compounding pharmacies needed

January 26, 2015

The OIG found that almost all acute-care hospitals use compounded sterile preparations (CSPs) and most contract with standalone compounding pharmacies to provide at least some of their CSPs.

Compounding pharmacies providing medications to hospitals need better oversight, according to a new report from the Department of Health and Human Services’ Office of Inspector General (OIG).

The OIG decided to take a look at the issue after the 2012 nationwide meningitis outbreak was found to be caused by a standalone compounding pharmacy that produced contaminated steroids for injection. The OIG found that almost all acute-care hospitals use compounded sterile preparations (CSPs) and most contract with standalone compounding pharmacies to provide at least some of their CSPs.

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The Framingham, Mass.-based pharmacy, the New England Compounding Center, has since gone out of business.

Although oversight entities address most of the recommended CSP practices, the organizations may lack the human capital required to thoroughly review hospitals’ preparation and use of CSPs, according to the OIG report. Plus, only one oversight entity always reviews hospital contracts with standalone compounding pharmacies.

Another concern is that “surveyors receive limited training specific to compounding, and most oversight entities do not routinely include pharmacists on hospital surveys,” the report stated. The OIG is also concerned that, although most oversight entities are considering changes to how they oversee hospitals’ preparation and use of CSPs, none of them are considering changes to how they oversee hospitals’ contracts with standalone compounding pharmacies.

As a result, the Centers for Medicare and Medicaid Services (CMS) should ensure that hospital surveyors receive training on standards from nationally-recognized organizations related to safe compounding practices.

“We recognize that it is not reasonable to expect surveyors to be experts on the highly technical aspects of pharmaceutical compounding. However, CMS should work with experts and professional organizations, such as USP, ISMP, and ASHP, to develop surveyor training on standards for compounding from nationally-recognized organizations,” the report stated.

CMS should also amend its interpretive guidelines to address hospitals’ contracts with standalone compounding pharmacies. “Specifically, within guidance on the pharmaceutical services CoP [Medicare Conditions of Participaton], CMS could instruct surveyors to assess hospitals’ management of contracts with standalone compounding pharmacies,” the report stated.

In addition, CMS could require that, when surveyors assess hospitals’ management of contracts with standalone compounding pharmacies, they review whether these pharmacies have registered with the Food and Drug Administration