Most hospitals obtain compounded drugs from outsourcing facilities, which must meet FDA quality standards
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Report in brief
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2019
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Compounding -- standards Medicare Outsourced Services Purchasing, Hospital Quality Control Chemistry, Pharmaceutical -- standards Humans United States United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- Why OIG Did This Review. 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. Only compounders registered with FDA as outsourcing facilities can legally compound and distribute non-patient-specific drugs. In response to deaths from an outbreak of fungal meningitis caused by contaminated compounded injections, Congress passed the Drug Quality and Security Act in November 2013. This legislation enhanced FDA's authority over facilities that perform large-scale compounding of non-patient-specific drugs. It distinguished the work of these facilities from traditional pharmaceutical compounding, which is done on a patient-specific basis. The Drug Quality and Security Act allows compounders that are registered as outsourcing facilities with FDA to compound and distribute drugs without a patient-specific prescription. FDA must inspect such facilities according to a risk-based schedule. How OIG Did This Review. 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 the hospitals detailed questions about where they obtain non-patient-specific compounded drugs and the factors they considered in choosing where to obtain them. To determine the registration status of the compounding facilities that the hospitals identified, we compared those facilities' names to FDA's list of registered outsourcing facilities as of January 2018. What OIG Found. Most hospitals that obtained non-patient-specific compounded drugs from outside compounders obtained them from what the Food and Drug Administration (FDA) calls outsourcing facilities—compounders that are registered with FDA. In fact, 89 percent of hospitals that obtained non-patient-specific compounded drugs did so exclusively from outsourcing facilities, 9 percent of such hospitals obtained at least some from outsourcing facilities, and just 2 percent obtained them exclusively from unregistered compounders. We provided FDA with a list of compounders sorted by registration status, which it can use to prioritize followup. Hospitals reported that quality considerations--including FDA registration; State and Federal enforcement actions; product recalls; and quality assurance documentation--drive their decisions on where to obtain non-patient-specific compounded drugs. Hospitals rated quality considerations as extremely important when choosing compounders. One expert told us, "… I would be very hesitant to purchase from a nonregistered facility." Of hospitals that compounded non-patient-specific drugs in their own pharmacies, only 2 percent had considered registering those pharmacies with FDA as outsourcing facilities, and only one hospital had actually registered its compounding facility. Cost, as well as equipment and facility design limitations, were extremely important factors for hospitals in deciding whether to register their pharmacies as outsourcing facilities. What OIG Recommends and How the Agency Responded. OIG recommends that FDA further communicate with hospitals about the importance of obtaining their non-patient-specific compounded drugs from outsourcing facilities. We also recommend that FDA take appropriate followup actions with the unregistered compounding facilities on the list that we provided; these facilities may not be in compliance with Federal law. FDA's followup could include for-cause inspections and any advisory or enforcement actions that are warranted. FDA concurred with our recommendations.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (35 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101757561 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101757561