Q&A with Stephen F. Eckel, PharmD, MHA, BCPS
Pharmacy Purchasing & Products: What are some of the primary challenges with ensuring IV safety?
Stephen F. Eckel: One of the most significant challenges to improving compounding safety is the lack of awareness of the existing risk for errors in the IV production process. Because it is difficult to quantify the number of errors or near misses that occur in our current systems, it is similarly challenging for some facilities to grasp the value proposition of investing in technology to minimize medical errors during compounding.
The first step to improving IV safety is to appreciate how risky manual processes are. A number of potential errors can begin in the IV room. Among the most frequently occurring are:
In addition to direct observation of staff practices, root cause analysis and failure mode effects analysis (FMEA) are critical strategies for identifying the points in the IV process with the highest risk and probability for error. Those staff members most knowledgeable about the IV preparation process—ie, those compounding and verifying IVs—must be involved in conducting these analyses. Building redundancies into the process can offset the points of high risk and avert patient harm. For example, ISMP believes that the selective, proper use of independent double checks can play a significant role in medication safety, provided the process is standardized and the checks are conducted independently, used judiciously, are not relied upon as the only risk-detection strategy, and are conducted using a cognitive review (ie, purposeful thought to prevent the double-check from becoming a superficial, rote task).1 However, implementing independent double-checks may add time and cost to the IV preparation process, so it is crucial that staff has a clear understanding that potentially deadly errors occur in order to gain their buy-in for this important safety step.
Finally, it is vital that the pharmacist have a policy and procedure or checklist to refer to when verifying the accuracy of compounded products.
PP&P: What are some considerations for investing in compounding?
Eckel: In today’s capital-constrained environment, any time a new technology or automation solution is considered for implementation, a return-on-investment (ROI) analysis should be conducted. Implementing IV automation affects workflow and costs, so a pharmacy director must have access to data demonstrating appropriate ROI to make an informed decision and to make the case to administration when considering investing in this technology. Regrettably, too often there is not sufficient data available to quantify the ROI from such technologies. Looking forward, pharmacy would benefit from those hospitals that have prioritized IV safety sharing their experiences and reporting on their ROI results.
Unfortunately, while some organizations are conducting these reviews, they are in the minority. The time is right for more pharmacy leaders to champion this approach. Moreover, few published clinical studies, posters, and presentations evaluating ROI for these technologies exist. Clearly, additional research is needed.
Likewise, the technology companies creating these automation tools have an obligation to demonstrate the value of their technology via a robust analysis of data outlining compounding process weaknesses in addition to detailing the value their solution delivers. While IV compounding automation has undoubtedly increased safety in the drug preparation process, there is still significant room for improvement. When pharmacists evaluate a medication for inclusion on formulary, we review not only information from the manufacturer, but also comprehensive clinical evidence of the drug’s effectiveness and safety, including peer-reviewed research studies, and require a high level of evidence. However, oftentimes we adopt automation solutions without the same level of clinical evidence. More robust clinical data quantifying the safety benefits, and including an ROI analysis, would greatly assist pharmacy decision-makers when evaluating and selecting automation.
Request this level of clinical data from potential automation vendors. If peer-reviewed clinical data is not available, pharmacy directors should work with the leadership team to undertake in-house studies to quantify the safety benefits and conduct an ROI analysis of implementing the technology at their institutions.
Finally, when evaluating IV compounding automation, it is important that those with direct experience and knowledge be involved to ensure informed decision-making. It is not uncommon for pharmacy administration to wield significant sway in the selection of automation, despite possibly not having worked in the compounding area for some time. For this reason, it is vital for the pharmacists who routinely work in the IV room to be active in the selection process.
PP&P: What is the role of IV workflow technology in the IV preparation process?
Eckel: IV workflow technology helps ensure IV medications are prepared safely and correctly utilizing digital imaging and gravimetric verification, while reducing waste by enabling compounding in a just-in-time manner. At UNC Hospitals, the goal for IV workflow automation is to limit the number of bags that are wasted due to the altering or discontinuation of a medication. Moreover, the technology allows us to plan batch compounding at appropriate times to ensure a smooth workflow.
An important issue to explore is how the automation impacts the production timeline as this question has not been well studied and requires additional investigation. One reason clear evidence is not available is that the time required to produce an IV using manual methods has not been definitively elucidated. Each hospital has a different pharmacy layout, space constraints, and resources, and each pharmacist managing the process has a unique skill set. A manager who has been trained in both workflow operations and IV management has additional strengths than one without such a background. Therefore, significant variability exists in how each organization compounds IVs, making it difficult to compare the efficiency of manual IV preparation with IV workflow technology-assisted preparation between different facilities.
In addition, depending on how the IV workflow technology is set up, after the technician is finished compounding they may have to wait to move on to the next task until after pharmacist review. Depending on the pharmacist’s workload, this process may require additional time. Finally, additional variation is inherent to the process based on differing state board of pharmacy requirements. For example, some states allow telepharmacy and/or remote pharmacist verification, and some do not.
Another metric yet undefined is the overall cost of producing an IV manually compared with the cost of producing an IV using workflow automation technology. To gain an accurate understanding of costs, critical information, such as how many pharmacists and technicians are required to produce the IV manually, and how much time each spent compounding and checking the IV, are required. Ultimately, with an understanding of the risks inherent in manual IV production, a quantification of the amount of rework required, and an evaluation of the time required for IV production, the case for incorporating automation into the IV process becomes quite clear.
PP&P: What are the inherent problems in ensuring safety for manual IV preparation?
Eckel: Consider the syringe pullback method; this is often seen as a more efficient practice for pharmacist verification because a pharmacist is not required to be in the cleanroom at the time the drug is compounded. However, ISMP discourages reliance on this method, especially for chemotherapy, complex electrolyte solutions, pediatric/neonatal solutions, and other high-alert CSPs, which should never be verified using this method.2,3 Indeed, ISMP has called this method of verification weak in comparison to manual or automated checking of products and volumes in syringes prior to addition to the admixture container.2
The method is prone to errors that may occur when pulling back the plunger to the volume of product one believes was included in the admixture, as well as when placing the syringes near the corresponding vials. Moreover, for the person checking the product, an error may occur if it is unclear which syringe accompanies which vial. So, a tremendous amount of trust is required when using this process because there is no way to verify that the medication has been made accurately beyond a doubt. Simply put, using the syringe pullback method requires too great a leap of faith to ensure patient safety.
When using manual methods, ensuring that medications with special compounding requirements are prepared correctly is another challenge for pharmacy. Using an IV workflow management system provides a significant advantage, as special instructions can be embedded in the software. Examples of special requirements include:
When IV automation is not in use, special instructions must be communicated visually, either posted in list format on the wall where IVs are made, placed in the bin from which the technician procures the drug, or on the drug label. These manual options are far from ideal as there is no forced function to ensure the technician has seen the instructions and no recording of whether they have been appropriately followed. Whether communicating important drug preparation information using a manual or automated method, be sure to delineate the steps for preparing these drugs during formal staff training.
Incorporating automation into the compounding process brings the safety of bar code checks, gravimetric checks, and video/photography checks to IV production—ultimately improving patient safety. While there is certainly room for improvement in the automation that is available today, manual IV production introduces a risk for error that is simply too high to accept.
Stephen F. Eckel, PharmD, MHA, BCPS, is an associate director of pharmacy at UNC Hospitals, as well as a clinical associate professor in the division of practice advancement and clinical education and the division’s vice chair for graduate and postgraduate education. In addition, he is director of graduate studies and is in charge of the 2-year MS in pharmaceutical sciences with a specialization in health-system pharmacy administration. Stephen received both his BS and PharmD from the UNC Eshelman School of Pharmacy and his MHA from the UNC Gillings School of Global Public Health.