New recommendations on how to improve the safety of compounded, sterile drugs given in hospitals represent a step forward in the fight to prevent more patients from being sickened or killed by mishandled or improperly compounded drugs, experts say.
“You could never be 100% (sure) that you're not going to have an error occur, but I think these would go a long way,” Allen Vaida, executive vice president of the Institute for Safe Medication Practices, said of the recommendations.
HHS' Office of Inspector General released a report last Thursday showing significant gaps in oversight of hospitals' use of compounded, sterile drugs and urged the CMS to step up its regulatory efforts. Specifically, the OIG recommends the CMS ensure hospital surveyors—who assess whether hospitals are meeting the safety requirements necessary to participate in Medicare—receive training on safe compounding practices.
The CMS should amend its guidelines for hospital surveys to ensure they examine hospitals' contracts with stand-alone compounding pharmacies, according to the OIG report. Those contracts could address drug-safety issues such as recall procedures, proper storage while in transit and quality assurance related to sterility and potency.
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 OIG study found that 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. But only one of the five entities examined always reviews contracts between hospitals and stand-alone compounding pharmacies.
The oversight entities also may not have enough properly trained staff to thoroughly review hospitals' preparation and use of sterile compounded drugs, the study found. Additionally, 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.
The OIG studied the CMS and four hospital accreditors after a 2012 outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy in which 64 people died.
Erin Fox, director of drug information services at University of Utah Health Care, said it would be advisable for surveyors to make sure hospitals are doing their due diligence in selecting compounding pharmacies. But she appreciates that the recommendations don't demand hospitals only contract with FDA-registered pharmacies. Compounding pharmacies that register with the agency are subject to FDA inspection, but registration is voluntary.
Mark Chalos, an attorney for families of victims of the 2012 fungal meningitis outbreak, also called the recommendations a positive development.
“At the end of the day it's the providers' responsibility to ensure patient safety, and any steps that encourage providers and hold providers accountable for their conduct I think is a step toward protecting patient safety,” Chalos said.
The CMS, in a written response to the study, agreed with the recommendations. The agency pledged to explore creating online training materials for surveyors with state survey agencies.
Gabrielle Cosel, manager of the drug safety project at Pew Charitable Trusts, said it's important Congress and the FDA continue to work to improve safety. “I think this study is about one piece of the pie,” Cosel said.
