Accuracy and precision are central to ensuring positive outcomes in health care. To minimize the potential for error, it is crucial for pharmacists and pharmacy technicians to engage in a relentless pursuit of excellence throughout the medication management process.
Within the quality-driven health care climate, there is no doubt that the bar is set high for pharmacy performance. Thus, it may be surprising that sterile IV compounding, a common but critical pharmacy task that often is perceived to be precise, frequently demonstrates error rates between 5% and 15%.1-3 A study conducted at Brigham and Women’s Hospital (B&W) in Boston found that 12.5% of manually prepared CSPs failed accuracy measurements.4
Leadership Begins with Vision
Automated compounding processes, which leverage the proven advantages of bar code verification, workflow assistance devices, gravimetric measurement, robotic technology, and radio frequency identification, are rapidly evolving for pharmacy practice. While many hospital pharmacy leaders are embracing these advancements, the technology has yet to achieve widespread adoption. Pharmacy Purchasing & Products’ 2015 State of Pharmacy Automation Survey reports that just 5% of US hospital pharmacies utilize IV compounding robots.5
Multiple compounding incidents, including the 2012 meningitis outbreak that led to 64 people dying from contaminated epidural solutions,6 highlight the risks associated with manual compounding practices. The high profile nature of many of these cases has increased scrutiny at both the federal and state levels. Hence, pharmacy directors can expect increased regulatory activity, as well as pressure to perform at an even higher level.
The risks associated with manual sterile compounding processes must be addressed through improved standard operating procedures (SOPs) and the judicious use of technology. Although the cost of making these changes may seem high, the cost of not acting can be substantially higher. Preventable adverse events, including those associated with manual IV compounding, may be responsible for as many as 1.2 million hospitalizations and between $300 million and $600 million in medical professional liability costs.7
To enhance quality, safety, and cost-efficiency, B&W, which prides itself on being a leader in the progressive deployment and use of bar code verification and automation, made the strategic decision to re-engineer manual sterile compounding processes. In 2008, the pharmacy department began pioneering the use of IV robotics technology. In fact, B&W was one of the first hospitals in the US to implement a robotics platform for the preparation of IV chemotherapy. Thereafter, B&W evolved to a more comprehensive robotics platform and quality framework to insource the compounding of sterile products. Currently, B&W prepares approximately 600,000 sterile products annually; the only products that are outsourced are epidural admixtures, TPNs, and miscellaneous PCA admixtures. This platform includes multiple robotic systems and workflow assistance devices. The shift toward robotic compounding has significantly improved the accuracy of CSPs, reduced waste associated with IV batch compounding, and recouped millions of dollars in cost savings.
Opportunities in Sterile Compounding
While pharmacy operations have evolved to embrace the patient safety and workflow benefits of advanced medication safety technology, progress must continue in the effort to modernize sterile compounding processes, many of which have not significantly changed in decades. This is particularly concerning given the influx of new medications, increased pharmacy workloads, and the lack of formal credentialing processes for pharmacy specialists in the field of sterile compounding.
The already complex compounding process is further complicated by variation in the products used. For example, FDA-approved drug products contain a range of +/– 10% of the labeled drug product in the container, and syringes are accurate up to +/– 5%. Moreover, many commercially available IV bags contain overfill; there is considerable variation in the amount of the overfill volumes, which can differ by bag size and by manufacturer.8 Human variation in compounding practice introduces additional risks to the accuracy of the final product. Volumetric measurements rely on the ability of the compounding technician or pharmacist to accurately reconstitute, dilute, measure, and draw up the components used to prepare the CSP. Together, these risks may pose a considerable threat to patient safety. In addition, the risk of repetitive task injuries to staff who work in the sterile products room is another consideration that can help drive change.
The Impact of IV Automation
Advanced IV automation and robotics technology can increase the precision of compounding processes, eliminate the potential for human error, and improve the institution’s overall culture of safety. Specifically, consider the following elements:
In its first foray into the realm of IV robotics, B&W deployed an infrastructure to specifically address preparation of chemotherapy drugs and conducted the aforementioned study4 to determine its effectiveness. While 12.5% of manually compounded preparations failed accuracy measurements, the robotics infrastructure produced an error rate of only 0.9%, and these errors were detected and intercepted before the product left the pharmacy department.
Following the success of the initial effort with oncology drugs, B&W began insourcing sterile compounding processes on a more widespread level. Before B&W began the insourcing program, nearly 350,000 bags and syringes were outsourced to various IV compounders. Now, the vast majority of batch needs are produced in-house. Pharmacy leaders presented the return to insourcing to hospital management as a way to reduce outsourcing costs and strengthen quality control and oversight of IV compounding processes. New robotic technology was deployed to address high-volume syringe preparation for the OR. Initially, robots were used to prepare up to 300,000 syringes annually, incorporating standard concentrations, extended beyond-use dating, and color-coded labeling. Ultimately, the in-house compounding initiative achieved a high level of quality, producing sterile, accurate, clearly labeled products that resulted in a net savings (after investments) to the organization of $1.2 million in the first year and resulted in similar annual cost avoidances thereafter.
Recognizing the potential of expanding CSP insourcing, the organization identified the elements and functionality needed to implement a complete compounding platform. Specifically, B&W’s ideal technology array needed to provide for:
Presently, B&W’s robotics compounding workflows have evolved to include four IV robots for general use, one robot devoted to the preparation of hazardous medications, and three workflow-assistance devices for sterile IV preparations that are compounded manually. Nearly 20% of our monthly volume is prepared using robotic technology, and robotic volume continues to grow.
Pharmacy managers continue to work closely with the robot vendor to optimize the interface between the robotic systems and the hospital’s EHR. In fact, B&W’s pharmacy and IT staff are completing a bidirectional interface that will greatly enhance workflow and productivity in the sterile products suite. Once the interface is complete, we expect robotic compounding volume to continue to increase. The ultimate goal is to transition our batch compounding to a centralized 503B-registered compounding facility that will service the entire Partners Healthcare Network. We anticipate going online with this facility within the next 18 months. Once this occurs, the hospital intends to repurpose the robotic and workflow assistance devices to shift the compounding operations away from batch compounding processes to a system that is focused on patient-specific, just-in-time compounding. We believe that this shift will dramatically reduce IV waste and improve the utilization of pharmacy resources.
B&W has learned valuable lessons in the process of moving from manual to automated compounding. Hospitals contemplating a similar move should consider the following:
Conduct a thorough review of manual sterile compounding processes. Evaluate what is being prepared, how it is being prepared, and at what time of day compounding occurs. Conducting a thorough review of manual processes allows pharmacy staff to garner a complete understanding of the drugs that can be transitioned to robotic compounding.
Build a comprehensive drug database at the outset. When seeking to incorporate a broad diversity of medication brands, upfront work is critical. Robots must be programmed to recognize and manipulate currently used brands, as well as secondary ones that may be needed in the event of drug shortages.
Train, train, train. Training IV technicians is paramount to success. B&W trained specific staff members to become IV robotics technician specialists. These staff members are experts on how the IV robot works; they understand basic cleaning and preventative maintenance protocols, conduct calibration of the robotic device, and recognize when the robot is malfunctioning.
Design and implement a comprehensive quality control program. Effective SOPs ensure that quality remains a top priority. B&W established comprehensive environmental monitoring of the sterile product facilities, staff, robots, laminar flow hoods, and products. Along with thorough product testing, extended beyond-use studies, and the hiring of a full-time microbiologist to oversee quality control, the organization implemented a quarantine program, which requires that all products be quarantined until they are tested and the results are approved.
Develop a strong change-control process. To prevent errors and system breakdowns, effective change-control processes must be in place, including protocols to ensure that the device is functioning based on operating specifications after it has been down for maintenance, undergone repair, or had software upgrades installed. Implement testing strategies to validate the system before going live.
Choose robust technology. The ability to interface bidirectionally with other informatics platforms, such as the EHR, to streamline workflows and ensure successful outcomes, is essential.
Partner with an experienced vendor. When making a dramatic workflow change, the support of a knowledgeable vendor is vital. Hospital pharmacies often need assistance with training, building competencies, workflow process design, and the development of SOPs to ensure compliance with regulatory agencies. In addition, developing strong partnerships is instrumental in ensuring two-way communication occurs, which is necessary for the development of next-generation technology.
Today’s quality-driven landscape demands a higher standard of care. Fortunately, advanced technology exists to support compounding goals. This technology should be leveraged to its fullest capacity. Hospital pharmacies have already realized the benefits of automation and technology on many fronts; IV robotics is the next step on this journey. Hospitals should take steps to pioneer these new workflows with the goal of improving overall outcomes. As this technology continues to dramatically evolve, industry will rely on pharmacy’s feedback to improve IV compounding technologies and continue advancing patient care.
William W. Churchill, MS, RPh, received a BS in pharmacy and his MS in hospital pharmacy from Northeastern University’s College of Pharmacy and Allied Health, and earned a certificate in health care management from Boston University’s Graduate School of Management. In addition to serving as the chief pharmacy officer for Boston’s Brigham and Women’s Healthcare, Bill is also a clinical professor of pharmacy practice at Northeastern University’s Bouve College of Health Sciences.