Significant gaps remain in ensuring the safety of compounded drugs given in hospitals, reports a study (PDF) released to Modern Healthcare early Thursday morning by HHS' Office of Inspector General.
To improve the situation, the OIG is recommending the CMS ensure hospital surveyors receive training on safe compounding practices. The CMS should amend its guidelines for hospital surveys to address hospitals' contracts with stand-alone compounding pharmacies, the OIG said.
Also, the CMS could require surveyors to take into account, when reviewing hospitals, whether the stand-alone pharmacies contracting with those hospitals have registered with the Food and Drug Administration, the OIG suggested.
The CMS and the accreditors follow most of the recommended practices for ensuring the safety of sterile compounded drugs, at least some of the time, OIG found. But only one of the five entities examined always reviews contracts between hospitals and stand-alone compounding pharmacies—contracts that could address drug safety issues such as recall procedures; proper storage while in transit; and quality assurance related to sterility and potency.
The oversight entities may not have enough properly trained staff to thoroughly review hospitals' preparation and use of sterile compounded drugs, the study found. Pharmacists are not routinely involved in most hospital surveys, even though only a trained pharmacist would likely be able to perform a comprehensive review of recommended practices, according to the study.
“Surveyors need the appropriate knowledge of this highly technical aspect of hospital operations,” according to the study. “However, we found that oversight entities provide limited training specific to compounding to their surveyors.”
Additionally, three of the five oversight entities do not look at whether the stand-alone compounding pharmacies a hospital uses are registered with the FDA, according to the study. Compounding pharmacies that register with the agency are subject to FDA inspection, though registration is voluntary.
“Because most hospitals do not inspect the stand-alone pharmacies with which they contract, a satisfactory FDA inspection might be the only indicator of the conditions at a stand-alone pharmacy,” according to the study.
The OIG performed the study of the CMS and four hospital accreditors following a deadly 2012 outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy. The FDA and state agencies typically handle oversight of stand-alone compounding pharmacies such as the one involved in the meningitis outbreak, but the CMS oversees the safety of sterile compounded drugs prepared and used in Medicare participating hospitals. It oversees them through a hospital certification process in which state survey agencies or the CMS-approved accreditors assess hospital compliance with drug compounding requirements.
Most hospitals contract with at least one stand-alone compounding pharmacy, especially for high-risk drugs such as the steroid that became tainted and led to 64 deaths in the 2012 fungal meningitis outbreak. Fourteen individuals, including two pharmacists, were indicted in December in connection with that outbreak.
“Despite outsourced compounded injections' being responsible for the 2012 fungal meningitis outbreak, none of the oversight entities plan to change how their oversight addresses hospital contracts with stand-alone compounding pharmacies,” the study also noted.
The accreditors looked at include the Joint Commission, the American Osteopathic Association, Det Norske Veritas Healthcare and the Center for Improvement in Healthcare Quality.
The CMS, in a written response to the study, largely agreed with the recommendations. The CMS pledged to explore developing online training materials for surveyors with state survey agencies.
The CMS also said it would look into revising guidelines to make surveyors aware that hospitals often contract with outside compounders for higher-risk compounded drugs. But the CMS stopped short of promising to require surveyors to take into account whether stand-alone compounders contracting with hospitals are registered with the FDA.
“Since Medicare regulations do not require hospitals and (critical-access hospitals) to use only those compounding pharmacies that have voluntarily registered with the FDA, surveyors would limit their assessment of the contracts with stand-alone compounding pharmacies to how the facility assures that its contracted services comply with the regulations,” the CMS wrote in its response from Administrator Marilyn Tavenner.
The CMS also noted in its response that it “relies on the Food and Drug Administration oversight of manufacturers to ensure safety of commercially available prescription drugs.”
Attempts to reach the CMS for further comment Wednesday were unsuccessful.
When Congress passed the legislation making FDA registration voluntary for compounding pharmacies, some advocates and lawmakers were disappointed the reporting was not mandatory as it had been in drafts of the bill.
Follow Lisa Schencker on Twitter: @lschencker
