More oversight needed for compounded drugs, says OIG

the Clinical Advisor take:

Medicare-approved hospital accreditors still are not properly overseeing contracts hospitals have with compounding pharmacies to ensure the safety of their drugs, a report issued by the Office of Inspector General concluded.

More than two years after fungus-contaminated drugs killed 64 patients and caused illnesses in another 687 across 20 states, the Office of Inspector General (OIG) found that much still needs to be done to assure the safety of these drugs. The report suggests CMS consider requiring more than 50 practices for accreditors to use to oversee compounded sterile preparations (CSPs).

"Contracting with standalone pharmacies for CSPs gets limited attention from the oversight entities," noted the report’s authors.

"Only one in five oversight entities always review hospitals' contracts with standalone pharmacies.” These reviews could attend to issues in recall procedures, proper storage, and quality assurance, added the report authors.

CMS agreed with two big-picture recommendations the OIG report made:

1. Train hospital surveyors using nationally recognized organizations related to safe compounding practices

2. Amend the interpretive guidelines to highlight hospitals’ contracts with standalone compounding pharmacies

Although the report did not disclose which of the five agencies failed to engage in recommended accreditation practices, the report noted that CMS-approved accreditors "may lack human capital required to thoroughly review hospitals' preparation and use of CSPs.”

CMS issued a response, stating that “while it is not reasonable to expect hospital surveyors to be experts on the highly technical aspects of compounding, surveyors could benefit from more training to ensure their basic competencies in assessing compounding practices in hospitals"