United States: OIG Report Examines High-Risk Compounded Sterile Preparations Last Updated: June 6 2013 Article by Nancy Sheliga Reed Smith

The OIG has released a study entitled "High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them," triggered by concerns caused by the recent outbreak of meningitis among patients receiving contaminated injections from a compounding center. The report found that 92% of hospitals used compounded sterile preparations (CSPs) in 2012, prepared either onsite at the hospitals themselves or outsourced to compounding pharmacies. Among these, higher-risk nonsterile-to-sterile compounding composed less than 1% of CSPs used in hospitals, but 85% of hospitals outsourced at least some nonsterile-to-sterile compounding. Among the reasons hospitals cited for outsourcing CSPs were the need to ensure an adequate supply of CSPs in the event of shortages, the need to obtain more stable CSPs and products with extended shelf lives, the ability to have products on hand when needed with less waste, and insufficient resources to prepare all CSPs on site at some hospitals.
Overall, hospitals reported few problems with the quality of CSPs obtained from outside pharmacies and they took few steps to ensure the quality of outsourced CSPs. However, over half of hospitals indicated that they have made changes or plan to make changes to CSP sourcing practices due to the recent meningitis outbreak, including decreasing CSP outsourcing, requesting more information on product quality from outside pharmacies, contracting with different outside pharmacies, changing the way CSPs are prepared in hospital facilities, increasing quality controls in hospital pharmacies, and expanding the capacity to prepare CSPs in-house.
The OIG notes that hospitals largely remain confident about the quality of outsourced CSPs, but "the meningitis outbreak raises questions about whether this confidence is well placed." The OIG observes that vigilance is needed in this area and indicates that it plans to pursue additional work relating to the safety and quality of pharmaceutical compounding in hospitals, including work examining federal oversight mechanisms.
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