Most Hospitals Obtain Compounded Drugs From Outsourcing Facilities, Which Must Meet FDA Quality Standards

WHY WE DID THIS STUDY

To provide FDA with insights to improve its oversight of compounders and enhance patient safety, OIG determined the extent to which hospitals purchase non-patient-specific compounded drugs from outsourcing facilities.

In response to deaths from an outbreak of fungal meningitis caused by contaminated compounded injections, Congress passed the Drug Quality and Security Act (DQSA) in November of 2013. This legislation enhanced FDA's authority over facilities that perform large-scale compounding of non-patient-specific drugs. It distinguished these facilities, called outsourcing facilities, from traditional pharmaceutical compounding. It allows compounders that are registered with FDA as outsourcing facilities to compound and distribute drugs without a patient-specific prescription.

HOW WE DID THIS STUDY

We selected a stratified random sample of 601 Medicare-participating hospitals and sent them a questionnaire, achieving an overall 94 percent response rate. We asked detailed questions about where they obtain NPS compounded drugs and the factors they considered in choosing where to obtain them. We determined the registration status of the compounders the hospitals identified by comparing the facilities' names to FDA's list of outsourcing facilities as of January 2018.

WHAT WE FOUND

Most hospitals that obtained non-patient-specific compounded drugs from outside compounders obtained them from compounders registered with the Food and Drug Administration (FDA), known as outsourcing facilities. Factors associated with quality, including registration with FDA as an outsourcing facility, are among the most important factors considered when hospitals decide where to obtain their non-patient-specific compounded drugs. Few hospitals consider registering their own pharmacies as outsourcing facilities.

WHAT WE RECOMMEND

In light of our findings, we recommend that FDA further communicate with hospitals about the importance of obtaining their NPS compounded drugs from outsourcing facilities. We also recommend that it take appropriate followup actions with a list of unregistered compounding facilities that we identified from our survey of hospitals and provided to FDA. FDA concurred with our recommendations.