High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them

WHY WE DID THIS STUDY

A recent nationwide meningitis outbreak caused by contaminated injections, which were compounded by the New England Compounding Center, raised major concerns about the use of drugs supplied by compounding pharmacies. Hospitals may have sourcing arrangements with multiple outside compounding pharmacies and may also compound drugs within their own pharmacies. The meningitis outbreak and its aftermath revealed a gap in information about hospitals' use of compounded drugs supplied by outside pharmacies and the steps that hospitals take to ensure the quality of compounded drugs.

HOW WE DID THIS STUDY

This study focused on hospital use of compounded sterile preparations (CSPs). CSPs are sterile compounded drugs that are generally administered to patients via injection or infusion. We surveyed a nationally representative sample of 298 acute-care hospitals operating in 2012 that participated in Medicare. We developed and used an online questionnaire to determine the extent and nature of hospital use of CSPs and outsourcing, including the extent to which hospitals outsource versus prepare onsite, and challenges in outsourcing and preparing CSPs. We received responses from 236 hospitals, an overall response rate of 79 percent. In addition, we interviewed stakeholders, including four practicing hospital pharmacists and officials of the trade association that represents hospital pharmacists.

WHAT WE FOUND

In 2012, 92 percent of hospitals used CSPs. Almost all hospitals (92 percent) used sterile-to-sterile CSPs and only 25 percent of hospitals used higher risk nonsterile-to-sterile products. Of the hospitals that used nonsterile-to-sterile CSPs, 85 percent outsourced at least some of these products (i.e., purchased them from outside pharmacies). Factors related to ensuring an adequate supply of CSPs were very important to hospitals when determining whether to outsource CSPs. Also, hospitals took limited steps to ensure the quality of outsourced CSPs but had few problems with the quality of products from outside pharmacies. Finally 56 percent of hospitals made changes or planned to make changes to CSP sourcing practices in response to the fall 2012 meningitis outbreak.

RECOMMENDATIONS

This report does not contain recommendations. OIG will pursue additional work to further examine the safety and quality of pharmaceutical compounding in hospitals, including work examining Federal oversight mechanisms.