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It’s no secret that the compounding industry is under greater scrutiny these days. A number of high-profile cases, including recent deaths linked to outsourced intravenous (IV) compounding at a Texas hospital, have moved patient safety concerns front and center.1 In the wake of ongoing fallout and a 2-year crackdown on compounding centers by FDA, many hospitals are analyzing their current strategy and rethinking the pros and cons of outsourced IV compounding.
Mr BarickmanIt’s no secret that the compounding industry is under greater scrutiny these days. A number of high-profile cases, including recent deaths linked to outsourced intravenous (IV) compounding at a Texas hospital, have moved patient safety concerns front and center.1 In the wake of ongoing fallout and a 2-year crackdown on compounding centers by FDA, many hospitals are analyzing their current strategy and rethinking the pros and cons of outsourced IV compounding.
Historically, outsourcing portions of the IV compounding process such as batch compounding has been attractive for these reasons:
· Outsource centers effectively address the expense and resource challenges associated with managing complex compounding operations; and
· Outsourcers are recognized for their ability to secure product in an era of problematic drug shortages.
Although these benefits present notable opportunities for resource-strapped hospital pharmacies, the reality is that hospitals can better mitigate patient safety risks and control costs by maintaining full control over the process.
Third-party compounding centers have not faced the same high-level regulation and oversight as manufacturers, leaving room for error and compromised patient safety, as evidenced in recent media reports on the continuing succession of quality problems.1 The regulatory landscape is evolving to address this issue, but new requirements are increasing the costs of doing business for outsourcers. These added expenses are being passed on as higher premiums to hospital customers, diminishing the cost advantages of the outsourcing option that may have been realized in the past.
Moving forward, hospitals should consider the advantages of in-house batch compounding as a viable option. Successful transition strategies that promote patient safety at the highest level entail an approach that leverages best-practice procedures and an automated infrastructure.
Bringing the batch IV compounding function in-house can be a costly and time-intensive endeavor as organizations update facilities and implement new procedures to ensure compliance with industry guidelines and state requirements. Staff training and fully developed education programs are needed to ensure the production of IV admixtures that meet the required high standards of safety and quality.
Although insourcing the batch IV compounding function can be a daunting task for lean pharmacy departments, when done correctly, the benefits far outweigh the effort. Hospitals can actually realize a huge financial advantage, saving as much as 60% to 80% over outsourcing in some cases.
Patient safety is a top concern for hospital pharmacies, and IV admixture is particularly challenging. Two critical types of errors are associated with IV compounding: microbiologic contamination or compromised sterility, typically associated with inadequacies of facilities, equipment, and aseptic procedures; and accuracy. Simply put, if the correct drugs are not selected or standard formulas and calculations are not executed accurately, patients can get hurt. Errors can be as simple as drawing the wrong amount of the correct drug or as dangerous as using the wrong drug or wrong strength entirely. As well, the most common method pharmacists use to check IVs is a manual IV process that can miss these errors entirely.
Because IV rooms are notoriously labor-intensive and aseptic protocols require extra procedural time, it is more efficient for hospital pharmacies to conduct IV compounding in batch mode for the most commonly used products. Running batches, however, introduces greater procedural complexities and raises the USP risk level and requirements for maximizing the product beyond-use dates. Manual-only processes should not be used for batch compounding, because these have an inherent error rate that is multiplied geometrically throughout the batch process, leading to unacceptable errors and patient adverse drug events.
Studies consistently show manual work processes are most often the culprit when compounding issues occur-not the facilities or the environment. In fact, manual compounding errors occur frequently and range from 1.5% to 9%. For this reason, the best solution for all sterile medication compounding is to deploy and leverage an automation infrastructure that ensures medication and dose accuracy as well as sterility. For batch IV compounding, in which each error is multiplied many times, the case for automation is even stronger.
The resource and workflow impact of moving IV compounding in-house should not be underestimated. It is substantial. The potential to positively impact patient safety and the bottom line is equally great, however.
To ensure success and maximize the safety and financial benefits of IV insourcing, hospital pharmacies should consider some form of automation, even if the initial investment only produces semiautomated workflows to address documentation and bar code verification. A more ideal model would be to deploy fully automated solutions, such as modern IV robots, to address sterility and accuracy at the highest level.
Accuracy and procedural adherence is critical to IV compounding safety. Although human factors will always result in procedural variances, even with partially automated solutions, hospital pharmacies can rely on fully automated solutions to follow the same preprogrammed protocol every time with a precise end result.
The other critical safety factor is sterility. IV compounding robots operate in an aseptic containment environment that eliminates the most unsanitary component of the typical compounding process, humans. This level of aseptic process control can provide the sterile products that consistently meet the requirements for extending beyond-use dating.
As hospitals look to ensure safe, cost-efficient compounding practices, high-quality in-house IV compounding departments allow them to have greater control over these processes. Automation is an important component of state-of-the-art IV programs, as it has proven safety benefits over manual systems.
When making the move toward in-sourced compounding, organizations should consider technology as an essential part of their strategy, because only automation can provide the accuracy and sterility required for batch IV compounding medication safety.
1. Eisler P, Schnaars C. Safety, sanitary problems prompt scores of drug recalls. USA Today. October 7, 2014. http://www.usatoday.com/story/news/nation/2014/10/07/compounding-pharmacy-recalls-inspections-contamination/16472741/. Accessed January 9, 2015.
Mr Barickman is a senior executive pharmacy consultant at Aesynt, Cranberry Township, PA.