Automated compounding enhances safety and regulatory compliance

Posted on July 2, 2015

By Niels Erik Hansen, Ph.D.

In January, the Department of Health and Human Services’ Office of the Inspector General (OIG) issued a report about hospitals’ use of standalone compounding pharmacies to produce compounded sterile preparations (CSPs). The study was spurred by concerns about the quality of CSPs following the 2012 meningitis outbreak 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 standalone compounding pharmacies. For hospitals that participate in Medicare, the Centers for Medicare and Medicaid Services (CMS) and other monitoring agencies are responsible for overseeing the safety of CSPs as part of the hospital certification process. However, the OIG found, the majority of CMS oversight agencies don’t consistently review hospitals’ preparation and use of CSPs, nor their contracts with pharmacies that supply them.

Although the report didn’t speculate whether such inconsistencies may put patients at risk, the OIG recommended 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 healthcare providers and policy makers. 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.

But while DQSA was a step in the right direction, it still does not resolve several critical issues. Chain of custody documentation and more stringent inspections 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 missed. Putting aside the mold-covered equipment inspectors found at NECC, just misreading the label on an admixture vial can 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 very 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 room visit – although the label on the bag listed the medication that was ordered by her physician. More frequent inspections may not have prevented either of these errors, but automated compounding could have.

From a regulatory standpoint, automated compounding provides many advantages. Some systems – such as RIVA – already have features that would allow compliance with DQSA. For example, RIVA provides 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. The process is fully compliant with USP<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 compounded drugs are safe and comply with regulations, then providing incentives for outsourcing pharmacies (and, for that matter, hospital pharmacies) to implement automated compounding should be a priority.

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