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.
This article is presented for informational purposes only and is not intended to constitute legal advice.