Automated Compounding Enhances Safety and Regulatory Compliance

Several recent events point to glaring problems in ensuring the safety of compounded sterile preparations (CSPs)—problems that technology might be able to solve.

In January, the Department of Health and Human Services’ Office of Inspector General (OIG) issued a report about hospitals’ use of stand-alone compounding pharmacies for CSPs. The study was spurred by concerns about the quality of CSPs after the 2012 meningitis outbreak and deaths caused by contaminated injections from the New England Compounding Center (NECC), an independent compounding pharmacy.

According to the OIG, most acute care hospitals use CSPs and get at least some of them from stand-alone compounding pharmacies. For hospitals that participate in Medicare, the Centers for Medicare & Medicaid Services (CMS) and other agencies are responsible for overseeing the safety of CSPs as part of the hospital certification process. However, the OIG found, most CMS oversight agencies do not consistently review hospitals’ preparation and use of CSPs, nor their contracts with the pharmacies that supply them.
Although the report did not speculate whether such inconsistencies could put patients at risk, the OIG recommended that CMS inspectors receive more training on safe compounding standards and regularly review hospital contracts with compounding pharmacies.
Clearly, the NECC meningitis outbreak continues to resonate among health care providers and policymakers. The Drug Quality and Security Act (DQSA), passed by the U.S. Congress in 2013 in response to the NECC tragedy, provides enhanced rules for preparing and tracking compounded medications. The law allows compounding pharmacies to voluntarily register with FDA as outsourcing facilities (hospitals that participate in Medicare are required to purchase CSPs only from registered outsourcing facilities) and undergo enhanced inspections.
Although DQSA was a step in the right direction, it still does not resolve several critical issues. Chain of custody documentation and inspections that are more stringent are improvements, but neither addresses the biggest risk to the safety of CSPs: manual compounding.
The fact is manual compounding is fraught with risks from human error and contamination. Instituting extra process steps, including checks and rechecks, may be reasonable, but each extra step adds another opportunity for errors to be made. Putting aside the mold-covered equipment that inspectors found at NECC, just misreading the label on an admixture vial could be hazardous.
In 2007, actor Dennis Quaid’s twin infants received adult doses of a blood thinner–1,000 times stronger than a pediatric dose–because a pharmacy technician drew medication from a vial whose label was similar to the vial that should have been used (both infants survived). Last December, a woman in Oregon died after receiving an IV containing the wrong medication during an emergency department visit, although the label on the bag listed the medication that was ordered by her physician. Inspections that are more frequent may not have prevented either of these errors, but automated compounding could have done so.
From a regulatory standpoint, automated compounding provides many advantages. Some systems already have features that would allow compliance with DQSA; for example, an electronic audit trail documenting the details of every dose dispensed, including every vial used, an aseptic compounding chamber with ISO Class 5 air and much more. Some systems are also fully compliant with USP Chapter <797> compounding standards, also required by DQSA.
As the population ages and more people rely both on hospitals and compounded medications provided by their doctors (such as in the NECC case), ensuring the safety of CSPs is going to be even more important. If Congress and the FDA really want to ensure the safety of compounded drugs, as well as assure that compounding pharmacies comply with regulations, then they must provide incentives for outsourcing pharmacies (and, for that matter, hospital pharmacies) to implement automated compounding.

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