behind IV-WMS

Should IV-WMS Be Mandatory?

By David Wild

Medication 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%), 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 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

URMC’s Experience

When 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 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.” ‘[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

A URMC pharmacy technician compounds a sterile product using an IV-WMS employing barcoding, digital image capture and gravimetric verification.

IV-WMS

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barcode and image verification (ISMP; October 22, 2020; bit.ly/3MTOCCC).

Moreover, 74% said they knew of at least one pharmacy sterile compounding error occurring within the previous 12 months. The top three compounding errors reported by respondents were incorrect dose or concentration (58%), incorrect base solution (51%) and incorrect base solution volume (43%).

Although the majority of the errors cited in the ISMP survey did not reach the patient, that is not a reason for complacency, noted medication safety expert Dan Degnan, PharmD, MS, an associate director of professional skills laboratories at Purdue University College of Pharmacy, in West Lafayette, Ind. Even a small number of errors reaching the patient should be concerning, given that “compounding errors have a high potential to harm a patient,” he told Pharmacy Practice News.

Such errors “can be difficult to detect, and we probably would not know the true incidence of IV medication errors that may have reached a patient," Dr. Degnan noted, explaining that voluntary error reporting rates are “notoriously unreliable for determining the true incidence of error.” He cited, as an example, an early, seminal study on voluntary error reporting that found as few as 1.5% of all adverse events in the hospital are reported voluntarily (Ann Intern Med 1993;119[5]:370-376).

Dr. Degnan added that any errors detected by an institution should be used to drive improvements to medication-use systems, and that institutions should use technologies that can prevent these types of errors—including IV workflow management technologies.

But according to Mr. Neuenschwander, many health systems aren’t getting the message. “Too many pharmacy departments, convinced that BCMP technologies are as critical, if not more critical than barcode medication administration [BCMA] technologies, find their repeated budget requests for IV workflow technologies rejected,” he lamented. Although he acknowledged that price can be a concern, he stressed that compounding workflow systems cost a fraction of medication-use technologies, such as automated dispensing cabinets, computerized physician order entry (CPOE) systems and BCMA systems.

The Regulatory Gap

The most common reason that Mr. Neuenschwander has heard for IV-WMS funding being denied is the lack of any regulatory body requiring the technology. Pharmacy Practice News contacted USP and the Joint Commission to ask whether they have considered requiring use of IV-WMS. In a response from USP, Anne Bell, the group’s senior communications manager, said the “topic is very much on the radar of the Compounding Expert Committee, and is one of the considerations being discussed for the proposed revisions to the compounding chapters.” Robert Campbell, PharmD, the clinical director of standards interpretation and director of medication management at the Joint Commission, Oakbrook Terrace, Ill., wrote in an email that “with exception to the National Patient Safety Goal requiring the use of smart pumps for the IV infusion of heparin, The Joint Commission standards focus on processes of care and do not identify a technology that must be used to achieve desired outcomes.”

Not Necessarily Regulatory

Mr. Neuwenschwander noted that nonregulatory bodies have managed to boost implementation rates for several patient safety technologies, and he hopes his group can convince them to do the same with IV-WMS.

For example, although neither CPOE nor BCMA systems are mandated, both technologies are part of the Leapfrog Group’s grading structure, “which is no small reason why using these two technologies has become de facto standards of practice,” he said.

ISMP is yet another nonregulatory body that is a staunch advocate of IVWMS, arguing in an online article (bit. ly/3tdDrg3) that the technology should be “both a leadership and regulatory mandate.” Furthermore, the organization’s 2022-2023 Targeted Medication Safety Best Practices for Hospitals

includes a recommendation to employ IV-WMS (bit.ly/3pJa1kX).

As for which specific vendor or IVWMS technology to choose, one useful approach is to consider the experiences of other health systems that already have implemented an IV-WMS system (sidebar, page 21).

‘People Respect What’s Regulated’

Although ISMP holds sway within the pharmacy community and among patient safety experts, Christina Michalek, RPh, a medication safety specialist at ISMP and the administrative coordinator for the Medication Safety Officers Society at the organization, said “the bottom line is that people respect what’s regulated.”

“People in the pharmacy community look to ISMP and other professional organizations, and they follow the literature in pharmacy, so they have a sense of the value of this technology,” she added. “But it’s people outside of pharmacy that need to see the value, and that is most effectively done if it’s required.”

Administrators “might question the value of these systems because they might not see a clear association between IV compounding errors and patient safety.”

If compounding errors occur and go undetected, they may not be linked directly with a patient’s change in condition, Ms. Michalek said. “Errors are happening; administrators just might not know about them.”

The sources in the main article and sidebars reported no relevant fi nancial disclosures.

More on the Web

UNC Health recently adopted an IVWMS and achieved significant operational and cost benefits. To read about its experience, see expanded version of article at www.pharmacypracticenews.com.

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