Looking to Automated Compounding Systems to Remove Human Error

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The 2012 meningitis outbreak linked to contaminated steroid injections continues to be a tragic reminder of the risks inherent in manual medication compounding. Unsanitary conditions at a Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. This sickened more than 750 patients and killed 64 patients across 20 states.

Although the outbreak is an extreme example of medication compounding gone awry, it is hardly an isolated incident. Subsequent compounding pharmacy product recalls in Georgia, Florida, Indiana, Nevada, New Jersey, and Texas, among others, are further evidence of how sterility can be compromised by manual production techniques.

In response, last fall Congress passed the Drug Quality and Security Act (DQSA) to regulate medication compounding and pharmacies that do it. Nonetheless, some may wonder if the law goes far enough since it does not address how technology can make medications safer. The fact is, automated compounding technology is proven to enhance the accuracy, safety, and repeatability of IV medication preparation. Automated systems have been available for more than a decade but too few pharmacies use them.

Medication compounding is a common practice in both hospitals and pharmacies. Physicians prescribe combinations of medicines that are mixed in a single syringe or IV bag for a specific patient. To make these compounds accurately and safely, pharmacists must measure and combine drugs with meticulous care; for example, diluting a few milliliters of one drug and adding an equally small quantity of another. But despite the best efforts of pharmacy workers to mix medications perfectly, humans are not perfect.

One of the biggest advantages automated pharmacy compounding technology provides is removing the primary source of contamination and error--humans--from the compounding process. Automated compounding systems also deliver many more benefits than the ability to make highly precise sterile compounds exactly right every time. They have an aseptic chamber where medications are mixed. Vials are photographed and their barcodes are scanned; both are then matched to a product database to ensure the right product is being used in each step. As compounding progresses, pulsed UV light provides extra disinfection to critical puncture sites, needles are automatically capped, and the finished product is dispensed in a syringe or IV bag with an electronic barcode label for documentation. The result is a sterile and accurate medication compound that is verifiably safe for the patient.

By increasing safety, the technology also saves money. Automation lowers the cost-per-dose of medication and reduces waste. Equally important, automated compounding minimizes the risk of medication errors that can result in patient injury, emergency intervention, hospitalization, and tort liability--critical considerations for a healthcare system already burdened by high costs that continue to rise rapidly.

Some will say that automated compounding systems are expensive, but that's relative. CT scanners, MRI machines, and many other types of healthcare technology can be considered expensive, but they are an investment in a higher standard of patient care. And, as those affected by the NECC tragedy might rightly ask, how much is too much to spend to ensure the safety and sterility of medicines injected into a patient’s body? Fortunately, through enhanced safety and lower medication costs, even the most expensive automated compounding systems have paid for themselves in less than three years.

Although new federal regulations should help address some of the breakdowns in the system, the rules still don’t address one of the most critical factors in pharmacy compounding: available technology that is proven to make it safer. If we are truly serious about preventing another outbreak linked to compounded medications, perhaps it’s time to put medical technology to its highest and best use, not just improving the quality of patients' lives, but saving them. 

 

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Guest contributors submit their opinions and knowledge about the Medical Design space

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Ruthann Browning

Ruthann Browning is a 28-year veteran of process equipment and automation. She currently handles Technical Sales in Automation in Comco’s western division and spearheads sales and marketing for...

Steve Schubert

Steve Schubert is VP, Business Development, for Advanced Machine & Engineering in Rockford, Ill. He has been with the company for more than 30 years.
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