Technology
Pharmacy Practice News • April 2022
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Medication Safety
Should IV-WMS Be Mandatory? By David Wild
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edication safety experts are urging various regulatory bodies to make IV workflow management systems (IV-WMS) mandatory, based on the technology’s track record for preventing catastrophic medication errors. “Most hospitals today are using the same manual compounding verification processes used back in the previous millennium,” said Mark Neuenschwander, the founding director of THRIV Coalition, a group of healthcare stakeholders based in Bellevue, Wash., that advocates for wider use of IV workflow technologies (THRIVcoalition.org.) That manual verification process can result in up to 9% of IV preparations being compounded with errors, and in 2% of cases, the errors can be potentially clinically significant, because they involve antineoplastics or other drugs requiring pharmacokinetic monitoring (Am J Health Syst Pharm 1997;54[8]:904-912). In fact, “too many
of these errors can cause patient harm and death,” Mr. Neuenschwander said. But the errors don’t have to happen. In a study published in 2019, researchers investigated the impact of IV-WMS technology that employed barcoding, digital image capture and, in some cases, gravimetric verification. They compared error detection rates at four hospitals that used these technologies with four hospitals that used manual workflows. The investigators found that facilities with IV-WMS technologies had an error detection rate of 3.13%, compared with 0.22% among those using a manual compounding process (P<0.05) (Am J Health Syst Pharm 2019;12[15]:895-901). The most common errors caught when an IV-WMS was used were incorrect medication (63%), incorrect base fluid volume (11%) and incorrect medication volume (6%), while the most common errors detected when these technologies were not used included incorrect medication volume (18%),
‘[IV-WMS] should definitely be a requirement for compounded product preparation, at least for oncology and pediatric medications, because of the high risk to patients if they don’t get an accurate dose.’ —Lindsey Amerine, PharmD incorrect base fluid volume (17%) and incorrect medication (17%). The authors speculated that there is likely “underreporting of errors in [compounded sterile products] when using non–[technology-assisted workflow], potentially leading to an increased number of medication errors that go undetected and reach the patient.” “Barcode medication preparation [BCMP]-based technologies are to medication-use processes what orderfulfillment technologies are to Amazon—a
URMC’s Experience
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hen David Webster, RPh, MSBA, the director of pharmacy - acute care operations at the University of Rochester Medical Center (URMC), in New York, and his colleagues purchased an IV workflow management system (IV-WMS), they had a good sense of what they were looking for in a vendor. “We wanted something with a robust safety system that includes barcode verification of ingredients, digital image capture and integrated gravimetric checking, because it allows confirmation of the correct amount of each ingredient being added to the compound,” Mr. Webster said. Today, all three of the cleanrooms at URMC where patient-specific IV formulations are compounded incorporate IV workflow technologies. In the two oncology compounding rooms, nearly all doses are processed through IV Dispense Prep, a system built into their Epic electronic medical record system (EMR) that includes barcoding and digital imaging. Meanwhile, at the main non-oncology cleanroom, staff compound 30% of their doses using the Omnicell IVX system, which includes the additional step of gravimetric verification in a single integrated device located in the hood. “More than 90% of all patient-specific doses compounded across all three cleanrooms are processed through our IV workflow systems, and we intend to continue to increase and maximize the use of the IVX system, with gravimetrics,” he said. Mr. Webster’s team has not formally analyzed its error detection rate before and after implementation of the systems, but he said he believes “there has been a significant decrease in errors, and we have confirmed the accuracy of all doses produced on the IVX system prior to dispensing.” He added several other criteria that his team looked for while evaluating IV-WMS vendors. “It was important for us to have a system with hard stops, so that any failure point at a critical step stops the process altogether, rather than allowing the user to acknowledge the error but then complete the product,” he said. Flexibility in handling both hazardous and nonhazardous products and in compounding complex mixtures that require multiple compounding steps was also important to Mr. Webster. “For example, gravimetric analysis may not be possible for some very low-volume additions, but the
A URMC pharmacy technician compounds a sterile product using an IV-WMS employing barcoding, digital image capture and gravimetric verification. system we chose was configurable to allow us to use the other safety checks built into the device.” Other priorities they had when looking for a vendor included the ability to integrate the device with their EMR so that they could fully use tools such as dose tracking and rate-based infusion replacement, and to be able to expand the number of devices in the system as the workload grows. For those considering an IV-WMS, Mr. Webster suggested first developing a clear understanding of the resources needed to implement and maintain the system. “Some costs that might not come to mind include developing the interface with your EMR and maintaining protocols and medication libraries within the system,” he said. Although every system has its limitations—for example, some might not have hard stops or may not be as flexible in allowing for custom workflow designs—“no system is perfect,” he said. “You have to understand your priorities and find the vendor that best fits your needs.” —D.W.
company that realizes error rates below 0.1%,” Mr. Neuenschwander said.
Switching to Gravimetrics Lindsey Amerine, PharmD, the executive director of pharmacy at UNC Health, in Chapel Hill, N.C., said her organization switched to a gravimetricbased IV-WMS after finding deep faults in its manual syringe pull-back verification technique—the method most often employed in the absence of IV-WMS. Specifically, 28.3% of UNC’s sterile products were outside of the ±5% range in volume, and almost 13% were over ±10% off the prescribed dose, a range outside of which there is considered to be a risk for suboptimal clinical responses and toxicity (J Oncol Pharm Pract 2016;22[1]:3-9). “Every patient deserves an accurate dose, and we wanted to make sure we were sending out accurate preparations,” Dr. Amerine told Pharmacy Practice News. After settling on an IV-WMS (BD Pyxis IV Prep) that included barcoding, digital imaging and gravimetric verification, they found the percentage of finished doses outside the ±5% range dropped to 0.4%, with a negligible number of doses outside the ±10% range (Am J Health Syst Pharm 2018;75[17]:1286-1292). Seeing the benefit of IV-WMS to patient safety has left Dr. Amerine with a clear opinion on the necessity for some type of regulatory forcing function to promote more widespread IV-WMS adoption. “This technology should definitely be a requirement for compounded product preparation, at least for oncology and pediatric medications, because of the high risk to patients if they don’t get an accurate dose,” she said.
Implementation Gap Despite the incidence of compounding errors and the ability of IV-WMS technologies to mitigate those risks, most institutions do not use these systems, as a 2020 survey by the Institute for Safe Medication Practices (ISMP) showed. ISMP surveyed 634 pharmacists and pharmacy technicians, mostly from hospital settings, and found that only 47% used IV-WMS technologies with see IV-WMS, page 22
