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Strategies for optimizing IV-WMS
Optimizing IV Workfl ow Mgmt at Your Institution
After you have gotten buy-in from the departmental and/or institutional leadership at your hospital to invest in an IV workflow management system (IV-WMS) for your sterile compounding, all your worries about compounding errors are over, right? Not so fast.
Leading medication safety experts, such as the Institute for Safe Medication Practices (ISMP), advocate for the widespread adoption of IV-WMS in compounding to detect and intercept the errors that humans—even when they are highly trained, experienced and vigilant—can unwittingly commit and fail to catch. Even though research and real-world experience have shown that IV-WMS can significantly reduce these errors, it’s up to the people who put this technology in place to use it most effectively.
“Automation, even a tool as advanced as IV-WMS, doesn’t remove the potential or substitute for human work,” said Charlene Hope, PharmD, the chief pharmacy quality and medication safety officer at the University of Chicago Medicine. “Rather, it creates new human work and changes the kinds of errors that people can make. There may be data overload, workload bottlenecks and new demands on your attention. You can maximize the benefits of your IV-WMS by addressing workarounds and errors.”
The University of Chicago began rolling out IV-WMS in July 2018, beginning with its off-site freestanding chemotherapy clinics and then adding inpatient chemotherapy services a month later.
“This phased-in approach involves fewer staff in the initial phase, so you can put in the workflow, train them and observe glitches with the system in a limited formulary,” Dr. Hope said. “You’re taking a complex, high-demand area and introducing software that’s going to impose constraints, which then start to reveal a lot of challenges.”
For example, if you have an IV formulary that has limited standardization, now is the time when you may realize that you can no longer accommodate Free CE/CME now available!
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Head of Pulmonary and Critical Care Medicine MedStar Washington Hospital Center Professor of Medicine Georgetown University Washington, DC
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four different standard concentrations and should move to two, Dr. Hope noted. “Once everything is loaded into the software, there needs to be testing and validation because this becomes the source of truth,” she said.
By early February 2019, IV-WMS had been rolled out for all IV preparation at the University of Chicago. Soon Dr. Hope and her team observed that there were several challenges to making the most of the new system, including adding new products, expectations around turnaround time, STAT dosing and bypasses.
“We had a medication event that was a good catch by one of our nurses,” Dr. Hope said. “She was about to give an intrathecal injection and realized that the wrong drug had been made. Investigating what happened, I reviewed the IV-WMS images and saw that the product had been bypassed.”
It turned out that IV room practices on the use of bypass were inconsistent: Technicians might decide when to bypass a product on their own. There was a verbal understanding that a technician should get a pharmacist’s approval before bypassing, but no standard protocol was in place. Subsequently, the institution developed policies and procedures outlining when drugs can be bypassed in the IV-WMS and when they cannot be, and indicating that pharmacists must always approve any bypass.
Turnaround Times a Sore Point
Changes in turnaround times can be frustrating when an institution has just adopted IV-WMS. “What might have previously been a three-minute process may now double in time, so you need to educate your nursing and medical staff as to why this may happen and that it is safer for their patients,” Dr. Hope said. “We have also established a threshold at which [when] the number of IVs in our verification queue reaches an overwhelming level, the pharmacist is to send out an all-bulletin page to the rest of the department to say that we’re backed up so other pharmacists can jump in and help to check product, to remove that pressure of engaging a workaround to get through the queue.”
Turnaround times also should be less of an issue with newer IV-WMS, said Derek Gillespie, BSPharm, MBA, an advocate for patient safety in pharmacy. “I had an early version of Baxter’s DoseEdge, and they readily admitted it took longer to process, on the order of 20 to 30 seconds, which can add up if you start multiplying. If you’re in a small hospital with 50 to 100 admixtures a day, that’s not a big issue; but at a huge hospital, that’s a significant amount of time to add to your day.”
More recent versions of the systems from vendors such as BD Cato, Omnicell and DoseEdge have streamlined their operations. “The newer integrated machines don’t ask the user to take the photo, weigh the product or read the barcode using a foot pedal or a touch screen; they do those steps automatically,” Mr. Gillespie said. “You follow the instructions on how to admix a product and the machine will do the rest.”
An effective strategy the University of Chicago group employed to support IV-WMS use was the designation of a “super user” for each shift. “Managers may be working during the day, but what if you encounter issues on the overnight shift?” Dr. Hope asked. “You need to ensure that you have trained staff who are competent at problem solving and critical thinking who can help other team members on every shift. For example, new drugs and new concentrations: About 90% of your compounds will be standardized in the system, but sometimes patients have a special need and you may need to work outside the confines of the system. Often it’s those special orders where there is a high risk of error, and having a super user on the team to help out is a great safety strategy.”
Another recent caught mistake at the University of Chicago illustrates this point. An overnight pharmacist noticed that the vial the technician used for a preparation for a pediatric patient was the wrong concentration, which would have produced a 10-fold dosing error. “We found out that the new strength was not yet built into the program,” Dr. Hope said. “So although you have the IV workflow system, and yes, it builds in that level of checking, you can’t be complacent, either. You know that gut feeling when you think something doesn’t look quite right? Stop and check again.”
Strategies such as super users and stricter bypass policies and procedures had their intended effect. During the first week of full IV-WMS implementation at the University of Chicago, Dr. Hope reported, there were 3,920 bypasses out of a total of approximately 8,500 doses. By the fifth week, bypasses were down to 476, with approximately the same doses compounded. Meanwhile, between 3,000 and 4,000 incorrect doses were caught and canceled by the IV-WMS each week.
“I have not spoken to a single person that has done the work of adopting IV-WMS who would consider going back,” Mr. Gillespie said. “Once you get those reports and you see what the system is intercepting—and it’s a larger volume than you would have imagined, with greater seriousness than you would have imagined—how could you go back?”
He noted that there are many errors intercepted by IV-WMS that occur repeatedly over extended periods of time without change. “At one hospital I worked with, we had a certain number of insulin mis-dispenses that were caught,” he said. “I reported this back to the staff, but the numbers stayed pretty much the same. That’s a measure of the human condition. If I were to go into an IV room and had to check one thing occasionally, I’m probably not going to make an error on that because it’s not what I do every day. When I’m asked to check something in those circumstances, I’m going to make sure it’s completely accurate. But if I’m signing 1,000 labels a day, No. 954 might get by me—not because people don’t care, don’t want to do a good job, don’t want to protect the public, but because we’re human beings and our brains are created in ways that teach us to take shortcuts we don’t even understand.”
—Charlene Hope, PharmD
—Gina Shaw
Mr. Gillespie reported serving as a consultant to Omnicell for Central Rx Solution Design. The remaining sources reported no relevant fi nancial disclosures.
Allegheny Makes a Case for IV Robotics
Outsourcing sterile IV medications can put a big dent in a hospital’s drug budget.
Allegheny General Hospital, in Pittsburgh, for example, had been paying 503B outsourcing facilities about $2.6 million per year for compounded IV products, according to Arpit Mehta, PharmD, MPH, MHA, the director of pharmacy. But that was before the hospital’s first compounding robot recently went fully live.
Now with the arrival of a second Omnicell IV robot, which will double the hospital’s automated nonhazardous dose output to around 100,000 bags and syringes per year, Dr. Mehta expects the outsourcing bill to drop to $500,000,
saving more than $2 million. (Chemotherapy and other hazardous drugs are compounded manually for specific patients, he said.)
It’s not just cost reduction that has elevated the robots’ value, Dr. Mehta said. “From a patient safety perspective and error prevention in general, it has been fantastic. Leveraging the IV robotic technology has truly allowed us to have full visibility of the compounded medications we’re using in our critical care units and operating rooms [ORs]. And it gives us the flexibility to make the quantity we need on time, without running into any shortages or quality assurance issues.”
Compounded IV bags include vasopressin, norepinephrine, phenylephrine, fentanyl and hydromorphone, he said, and neostigmine, ephedrine and ketamine are among the syringe-containing medications compounded for the OR. “From a patient safety perspective, [using compounding robots] is leaps and bounds ahead of where we were before,” he said. “And from the viewpoint of employee safety, it eliminates touch contamination and it makes our process much more efficient.”
Dr. Mehta said he didn’t have baseline safety or error data because the robotically compounded drugs were all previously acquired from a 503B facility. But according to Dennis Wright, MBA, Omnicell’s senior director of central pharmacy product marketing, the literature makes a strong case for the risks inherent in manual compounding. He pointed to one widely cited study showing a 9% error rate for manually prepared admixtures (Am J Health Syst Pharm 1997;54[8]:904-912).
Mr. Wright said Omnicell’s “whole goal is to remove humans from those areas
where they can introduce risk, either by making mistakes or introducing potential contamination, and apply robotics, which [provides] automated safety checks and a standardized compounding workflow in a completely isolated ISO Class 5 environment.”
Striking a Balance Between Manual and Robotics
At Allegheny General Hospital, about 30% of the 360,000 IV doses administered each year are compounded by the robot, Dr. Mehta noted. Most of the balance still needs to be compounded manually, he said, because Allegheny’s Omnicell robots are not equipped to handle individual dose variations. Small quantities are still outsourced “from strategic partners whom we have visited and know the quality of their products meets the standards,” he added. But even for manually compounded medications, Dr. Mehta said the pharmacy is bolstering preparation accuracy and safety by converting to the Omnicell IVX Workflow system, which integrates barcode scanning, gravimetric or volumetric verification, multispectral imaging, photo documentation and label printing into the compounding process.
Robotics also enhance Allegheny’s ability to meet the documentation standard of USP General Chapter <797>. “That process is now 100% automated,” he said, “so we don’t have to have a person manually tracking any information. If there’s a recall or other concern, we can pull data pretty much all the way to the individually compounded bag or syringe level and assess it for any concerns.”
For Allegheny General Hospital, the conversion to robotics and IV automation paralleled the opening of new stateof-the-art pharmacy on the third floor of its landmark “skyscraper” building in Pittsburgh. The move doubled the size of the old pharmacy on the floor below and allowed the installation of a new larger and better- equipped cleanroom facility that adheres to USP <797> safe compounding standards.
In its automation startup, Allegheny has relied on what amounts to a partnership with Omnicell. Mr. Wright explained that the company had “changed the traditional model of just selling an IV robot and having the customer figure out how to optimize it to where we now bundle it into a complete service offering” that provides “the technology, tools and resident expert operators who are colocated with the technology.”
After-installation services include a formulary tool kit that provides a beyond-use dating (BUD) library. The tool “allows our health system and hospital partners to extend beyond-use dating,” Mr. Wright said.
Allegheny fully uses that extended BUD opportunity, Dr. Mehta said. “We follow the normal routine of quarantining the product and sending a sample out to a third-party lab for testing because we want that extended BUD for these products. Once the results come back, the product is released from quarantine and it becomes generally available. The majority of medications that we compound in the robot are stored in our automated dispensing cabinets on the nursing units as well as in our anesthesia carts in the OR.”
Although robots can seem prohibitively expensive, Dr. Mehta said he expects a net savings of $1.6 million per year once they are both fully operational. That includes, he said, the cost of the medications, the technology, the third-party testing and even the salary of a pharmacist dedicated to managing the program.
“It’s not necessarily about the finances,” he said. “There is a safety component and the drug shortage component, and we have control of our inventory. But at the end of the day we do need to justify the investment. And this is a huge financial saving and a benefit to the organization.”
Uptake Still Slow
Despite technological advances, hospital adoption of robotic IV compounders has remained relatively limited. According to a recent Institute for Safe Medication Practices survey, only about 8% of hospital pharmacies use a robot to prepare sterile medications (bit.ly/3qN37fF). That rate may be expected to increase, however, as the technology continues to progress and vendor competition makes the return on investment more attractive to hospital executives.
“Robotic compounding systems are improving all the time,” said Jerry Fahrni, PharmD, a health information technology expert. “They offer improved safety for both employees and patients by removing human hands from many of the steps in the compounding process. This is especially true for hazardous drugs compounding.
“Although these robots don’t completely automate the entire CSP [compounded sterile product] process,” he added, “they have automated safety features such as object recognition, barcode scanning, image capture of critical steps and plus/minus scales.”
Those scales refer to a measurement of accuracy obtained via gravimetrics, a technology that is one of the main advantages of IV robotics, Dr. Fahrni noted. Gravimetrics can be used to precisely weigh the ingredients of a prepared drug dose. The final product is considered acceptable by the robot if it falls between plus or minus 5% of the expected weight (J Oncol Pract 2012;8[6]:344-349).
“I’ve always liked the idea of using robots for CSP production,” added Dr. Fahrni, a member of the Pharmacy Technology Report advisory board. “But in my opinion they were never quite ready for prime time. Five years ago, I don’t think I would have had much good to say. But times changes and things get better. Overall, one could argue that there is a potentially positive return on investment for compounding robots in specialized situations. They’re not for everyone, but for those situations where they fit, I think they hold value.” —Bruce Buckley
