Pharmacy Technology Report (March 2020)

Best Practices in automation, informatics and patient safety

MARCH 2020 • Vol. 6. No. 1

THRIV coalition pushes for IV workflow management adoption Page 3

Hub brings anticoagulation care to underserved areas Page 6

A way to eliminate manual order entry Page 8

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PHARMACY TECHNOLOGY REPORT • MARCH 2020

Push Is On to Make IV-WMS Universal I

n December 2014, a 65-year-old woman was at home in Bend, Ore., recovering from brain surgery she had recently undergone in Seattle. After experiencing bouts of anxiety, she went to the ER at a local hospital, where the doctor ordered IV administration of fosphenytoin, a low-risk antiseizure medication that is also frequently used to treat anxiety. The order was sent to the pharmacy, where it was reviewed and sent to the cleanroom. The bag was prepared, labeled with a barcode, and checked by the pharmacist. It was then delivered to the ED, where the attending clinician scanned the patient’s wristband and the IV bag; they matched. The bag was hung, a drip was started, and 30 minutes later, Loretta McPherson was dead.

Forensic analysis revealed that instead of fosphenytoin, the pharmacy technician had accidentally pulled the paralytic agent rocuronium.

A few hours’ drive away, in Bellevue, Wash., medication safety technology expert Mark Neuenschwander read the headline about McPherson’s death with horror. For the past two decades, he had been a passionate advocate of bedside barcoding in hospitals, helping to lead the push for the FDA to require all immediate drug packages to be labeled with scannable barcodes. However, a scannable barcode could not save McPherson. “I realized that bedside barcoding can neither detect nor intercept

MUSC: An Early Adopter

O

ne enthusiastic supporter of THRIV’s efforts is Jeff Brittain, PharmD, the director of pharmacy support services at the Medical University of South Carolina (MUSC), in Charleston. “I’m 100% behind THRIV,” Dr. Brittain said. “It can be hard to understand the advantages of IV-WMS until you see them in your own pharmacy, because most pharmacies don’t realize how inaccurate they really are. You can do a lot of education, add manual steps, and put on high alert stickers, but those are not forcing functions. They don’t necessarily have that much effectiveness. There’s a better way.”

MUSC first began exploring IV workflow systems in late 2009 and early 2010, when the market was still in its infancy.

Dr. Brittain and his team reviewed the three different IV workflow products that were then on the market, and ultimately selected Baxter’s DoseEdge. (Other IV-WMS systems include Omnicell IVX Workflow, Grifols Kiro and PharmacyKeeper, ARxIUM’s RIVA, Equashield, ICU Medical’s Diana, ConsortiEx Assure-Trak, and BD Pyxis IV Prep. Some electronic health records also have introduced workflow modules, like Epic’s DispensePrep.)

MUSC went live with its IV-WMS in September 2011, rolling the technology out in the children’s hospital the first week,

preparation errors in the pharmacy,” Mr. Neuenschwander said.

This medication error inspired Mr. Neuenschwander to organize a new movement aimed at placing IV workflow management systems (IV-WMS) in all health care facilities where medications are compounded. After several years of organizational effort, the THRIV Coalition for IV Accuracy was officially formed in 2019, with its website (www.thrivcoalition.org) launched at the ASHP 2019 Midyear Clinical meeting in Las Vegas.

“We must use proven technologies that make it harder for pharmacy technicians to mix things wrong, and easier to mix them correctly, which don’t allow preparers to proceed to the next item on an order’s checklist until the previous item is fulfilled correctly,” Mr. Neuenschwander said.

Although the coalition advocates for health care institutions to voluntarily adopt IV-WMS, THRIV also is pushing for standards, compliance, and accrediting bodies to not only accept workflow management systems that meet or exceed criteria outlined in “THRIV’s Technology Checklist” (see page 4) but also to require health care providers to use them when preparing IVs.

Nearly 1 in 10 Preparations Incorrect How often do IV preparation errors occur? An observational study of accuracy in compounding IV formulations at see IV WORKFLOW, W page 4

the cancer center the second week, and then other areas of the hospital.

Approximately 2,200 IV preparations go through the IVWMS across MUSC Health daily. Dr. Brittain reported that the scanning process identifies and rejects about 3% to 5% of items for dose preparation as inappropriate. “If you get into the hood where the scanner is, we assume you intend to use that ingredient to make the dose, so when an incorrect scan is recorded at that stage, we count it as a prevented error and attribute the prevention to the system,” he said. “At the pharmacist level, we now have less than 0.3% of scans rejected.

Before we had an IV-WMS, we saw roughly a 5% rejection rate when preparations came to the pharmacist for verification. So we are eliminating many potential errors before we even open the vial. That reduces waste as well.”

There have been other benefits, Dr. Brittain said. “We have used the data to narrow down the number of concentrations that we have. We get data out of the system on each step of the preparation, which provides a whole new world of metrics to help us adjust things like workflow, staffing and the times batches run.”

—Gina Shaw The sources reported no relevant financial relationships.

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PHARMACY TECHNOLOGY REPO RT • MARCH 2020

THRIV’s 5 Must-Have IV-WMS Technologies

IV WORKFLOW continued from page 3

five hospitals found a 9% error rate (Am J Health Syst Pharm 1997;54[8]:904-912), most involving wrong ingredients and/or volumes. “Imagine if Amazon fulfilled one in every 10 packages incorrectly, or Delta lost one of every 10 bags checked,” Mr. Neuenschwander said. “And nobody’s ever been killed by a late bag or getting the wrong package.”

A more recent systematic review of published evidence on IV admixture preparation errors found a substantial variation in error types and reported rates: wrong drug (approximately 0%-4.7%), wrong diluent solution (0%49.0%), wrong label (0%-99%), wrong dose (0%-32.6%), wrong concentration (0.3%-88.6%), wrong diluent volume (0.06%-49%), and inadequate aseptic technique (0%92.7%) (BMJ Open 2017;7:e015912).

Research consistently suggests that IV-WMS reduce errors. For example, evaluation of such a system at Boston Children’s Hospital found that 23% of the errors detected would not have been identified by the pharmacy’s previous practices (Am J Health Syst Pharm 2014;71[15]:1311-1317).

Meanwhile, only about 20% to 25% of hospitals report that they are now using IV-WMS. “Many of those either have systems that don’t meet THRIV’s minimum criteria or they are using the systems to prepare a low percentage of their IV medications,” Mr. Neuenschwander said. “In fact, the hospital in Bend had IV workflow technology in their pharmacy which faithfully intercepted errors, but had to suspend its use due to upgrading its hospital information system. The adoption rate is low and the utilization is shallow. THRIV’s goal is to get to the point where these safety systems are expected of hospitals by regulatory and accrediting bodies. We don’t believe we will get near universal adoption until [these systems] are required.”

According to ASHP’s 2019 hospital survey, cost is the No. 1 barrier to IV workflow management adoption. “This I do not understand, because IV-WMS are relatively inexpensive,” Mr. Neuenschwander said. “A 200-bed hospital could easily spend a million dollars or more to comply with USP’s Chapter <797> sterility requirements, while IV workflow technologies that meet or exceed THRIV’s standards could be obtained for considerably less than $100,000.”

The survey cited lack of space as the second barrier. “Perhaps respondents were thinking of large robotic workflow devices,” said Mr. Neuenschwander, but he noted that small, semiautomated tabletop components (tablets, scanners, camera, scales) can achieve all the same safety goals as large robotic systems.

Also, many pharmacists experience “sales fatigue” from requesting funding from institutional leadership to acquire these systems, he conceded. “I have not yet met a pharmacist who does not believe in IV workflow technology.

They know it’s the right thing, but they are weary from having their repeated requests routinely turned down. THRIV seeks to motivate, encourage and equip pharmacists to not

1. Workflow Management Software Software that guides compounders and/or robotics step-by-step through IV recipes: • Interfaced with medication order systems to populate user interfaces with up-to-date IV orders, which may be re-queued as urgency requires.

• Guiding compounders step-by-step through each recipe with specific instructions and forcing functions that do not allow proceeding to next steps until previous steps have been completed and verified.

2. Barcode Scanning • Scanning barcodes to ensure all components/ingredients are correct.

3. Volume Verification Employing a combination of proven technologies that verify volumes of base solutions and additives are correct, which include: • In-process image capture (or live video): requiring and enabling a second set of eyes to verify right drugs and right volumes were used.

• Gravimetrics: weighing ingredients before and after draws and fills to verify volumes and final products.

• Flowmetrics: technologies that automatically release, measure and verify delivered volumes.

• Optical volume recognition: employing technological eyes to auto-verify syringe draws.

4. Auto Labeling • Barcoded labels produced or verified and activated for final preparations.

5. Auto Documentation • Concurrently auto documenting and time-stamping each preparation step.

let up, to influence their hospitals to voluntarily implement these systems now, and not wait until they are mandatory.”

The Institute for Safe Medication Practices (ISMP) is an organizational member of THRIV. “Barcode verification and gravimetrics coupled with real-time alerts created by workflow management systems can detect and prevent many potentially serious medication errors that would not have been recognized with traditional verification methods,” said Michael R. Cohen, RPh, the president of ISMP. “We strongly support their use, but ISMP doesn’t have any enforcement power. We need an organization that has the force of law to take this up and [mandate compliance].’

“Realistically, it will take time to make these standards mandatory,” Mr. Cohen said. “But IV workflow errors are among the most dangerous errors we see in hospitals. In the meantime, I would really hope that people would go to the THRIV website, download the guidelines, and make sure they are compliant.”

—Gina Shaw The sources reported no relevant financial relationships.

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PHARMACY TECHNOLOGY REPO RT • MARCH 2020

Hub Enables ‘Virtual’ Anticoagulation LAS VEGAS—A pilot program by the Department of Veterans Affairs to provide pharmacist-directed, centralized anticoagulation services is helping streamline care for patients in some rural areas and free up time for clinicians ns in regional VA centers to manage other patients.

The Centralized Anticoagulation Services Hub b (CASH) provides warfarin management services es for about 1,100 patients in four Veterans Integrated Service Networks comprising 11 states in the upper midwestern United States, according to the VA’s Heather L. Ourth, PharmD. Three VA medical centers are active participants, with a fourth scheduled to join at press time. e.

Dr. Ourth presented a poster (1-013) about the work k at a the ASHP 2019 Midyear Clinical Meeting.

CASH is based at the Edward Hines, Jr. VA Hospital in n Chicago. There, clinical pharmacy specialists and technicians work together to manage patients. Pharmacists, some of whom work remotely, call patients by phone to address nontherapeutic international normalized ratios (INRs), and complete education and risk–benefit assessments. Some patients who are more stable may receive

‘If we can use pharmacists and pharmacy technicians in a way that supports more of the patient population who receives [anticoagulant and antiplatelet therapy] and keeps them out of harm’s way, that’s a huge step forward.’

—John Fanikos, RPh letters instead of calls. Pharmacists also review and co-sign pharmacy technician notes when needed. Pharmacy technicians who are based on-site review new patient requests, address therapeutic INRs, triage patients to pharmacists when necessary, and review incoming calls and messages, retrieve lab results and contact no-shows. A dashboard database helps assist with identifying patients to contact, and tracks metrics and quality monitors.

Now one year into a two-year pilot, the program has increased the percentage of time in therapeutic range from 70.7% to 77% over a 14-month enrollment period.

The program initially hired three clinical pharmacy specialists and two technicians, with plans to hire additional staff as the program grows.

CASH was created to streamline care for patients, especially those in rural areas, and to better use health

professionals’ time in regional cente ers, Dr. Ourth told Pharmacy Technology Report. rt While the majority of patients taking warfarin were cared for in pharmacist-run anticoagulation clinics, c others in rural areas were being managed by physicians and nurses, or by clinical pharmacy specialists working in primary care settings.

“We felt there could be operational efficiencies that could be gained by piloting this virtual care model that optimizes the role of both the pharmacist and the technician,” she said, “and free up physician providers, nurses and primary care pharmacists to be able to see more patients and address chronic disease state management, mental health needs and pain management.”

Although the program hasn’t yet done formal patient satisfaction surveys, “the patients like it and it’s convenient for them,” Dr. Ourth said. “They still have to get their labs done, but they don’t have to make another appointment. They know the pharmacists are going to call them with their results and any further instructions.”

‘A Huge Step Forward’ In anticoagulation therapy, management by phone, telemedicine and related tools has been proven to be as successful as face-to-face encounters, commented John Fanikos, RPh, the executive director of Pharmacy Services at Brigham and Women’s Hospital, in Boston.

“The important part of this study was the inclusion and expansion of the role of pharmacy technicians, which is a wonderful advancement,” Mr. Fanikos said. “There are lots of patients on anticoagulant and antiplatelet therapy, and if we can utilize pharmacists and pharmacy technicians in a way that supports more of the patient population who receives these drugs and keeps them out of harm’s way, that’s a huge step forward.”

—Karen Blum The sources reported no relevant financial relationships.

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PHARMACY TECHNOLOGY REPO RT • MARCH 2020

Saying Goodbye to Manual Entry B

y virtually eliminating manual order entry at its automated compounding device (ACD), Cook Children’s Medical Center, in Fort Worth, Texas, significantly reduced the risk for transcription errors associated with patient-specific parenteral nutrition and sterile IV fluids.

No relevant events occurred after a four-month implementation phase of the initiative, compared with two such events in four months leading up to the go-live date.

The pharmacy team also described an unexpected rise in ACD productivity. Ja ason M. Evans, PharmD, said IV fluids compounded pounded on the Exactamix ACD increased from about 500 in the first months after implementation to about 800 in the final month of the yearlong study. The increase occurred, he said, because “we found it more efficient” to use the ACD for patient-specific IV fluids that previously were compounded manually. He estimated that 75% or more of the fluids were compounded for patients in the neonatal ICU. Still, “we didn’t go from the Stone Age to the Jetsons in one move,” Dr. Evans said. “We had a different electronic health record [EHR] before this, and we added pieces here and there to make the process safer.”

Moving to the Epic EHR system allowed the team to construct a comprehensive database containing IV fluid options that satisfied a range of pediatric needs while making it easier for providers to select appropriate therapies.

Creating the database took hours of discussions among pharmacists, providers and an expert team from the EHR supplier. Dr. Evans said the supplier team “spent a lot of time optimizing infusion builders, so that if a provider wanted to order a complex IV fluid” every ingredient would be in the right field, and the pharmacist would not have to do any modifications or transcription. “For the most part, the order would be 100% ready to go,” he said.

The process proceeds quickly from the point where the provider enters the order and it’s verified by a pharmacist.

An interface sends the order electronically in two directions to separate systems: 1) full order details are sent to a workstation queue next to the ACD, and 2) formula ingredients and volumes are saved in a discrete file, which can later be accessed by the ACD. When ready to compound, a pharmacy technician uses the workstation queue to print the preparation label containing a unique barcode delineating the name of the discrete file containing the patient-specific formula. The label is scanned and the information uploaded to the ACD. “The ACD doesn’t actually communicate directly with the EHR, but we found an indirect way to pass pertinent

Cook Children’s Medical Center uses DoseEdge pharmacy workflow technology in its approach to automated IV compounding.

order details to the ACD for safe and efficient compounding of patient-specific orders,” Dr. Evans said. When the compounder finishes pumping the admixture, a mixed-check report is transmitted to the DoseEdge pharmacy workflow management system terminal with details including user name, ingredients, weight variance, and date and time. The workvariance flow technology also will prompt if any manual additions are necessary before the order can be completed and sent to a pharmacist for the final check.

At a remote workflow terminal, the pharmacist performs the final on-screen check of the IV fluid with a stand-alone, high-definition camera that can be zoomed in from different angles to detect any particulate matter that may be floating in the fluid. “If everything checks out, the pharmacist clicks a button verifying that the product can be dispensed and sent to its final destination,” Dr. Evans said.

He noted that if an order is “simply for a commercially available fluid (i.e., premix), the EHR guides the provider to these selections, so we don’t have to compound it. However, if the IV fluids need to be compounded—for instance, the addition of 10 or 20 milliequivalents of potassium—the infusion builder in the EHR allows them to make that choice, and the order can be appropriately routed.”

Dr. Evans said the question of commercially available solutions often comes up. Citing federal and state laws, he emphasized that “we do not compound anything that’s commercially available. We won’t touch it if we can buy it. But if it has to be compounded at all, we will consider making it on the compounder.”

Jared Cash, BS, PharmD, the pharmacy director at Intermountain Healthcare Primary Children’s Hospital, in Salt Lake City, commented that “those unfamiliar with pediatrics do not appreciate the increased complexity in these situations and how significant reducing manual steps can be. I applaud Cook Children’s [ability to] significantly reduce a human error–prone activity— manual order entry.”

—Bruce Buckley

The sources reported no relevant financial relationships.

The data were first presented at the ASHP 2019 Summer Meetings and Exhibition, in Boston.

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PHARMACY TECHNOLOGY REPORT • MARCH 2020

Patient-Powered Networks Gain Traction DALLAS—Hospitals, insurers and other stakeholders are partnering with patient-powered research networks to glean insights into how patients experience their diseases and treatments.

“The information that members of these networks offer is invaluable, because it improves the industry’s knowledge of their diseases, helps bridge the gap between how providers and patients understand their illnesses, and helps create a common language that all stakeholders can use,” said Maria Lowe, PharmD, a health data and drug information clinical specialist at PatientsLikeMe, a patient network that provides data to patients and partner organizations in the health care field, with headquarters in Cambridge, Mass.

Data Gathering Easier Than Ever The proliferation of wearable devices and online patient forums has made collecting information directly from patients easier than ever, Dr. Lowe said. Those data serve as important complements to information from claims databases and electronic health records, she explained, adding that “patient-generated data can tell us things clinical data can’t, such as how patients are doing between clinical encounters, what matters to them, and how they experience health care and their condition on a daily basis.”

PatientsLikeMe has more than 600,000 members living with roughly 2,800 conditions, according to the website (www.patientslikeme.com). The demographic information, medication histories, symptom reports and patient narratives that members have provided have helped professional associations like the American

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College of Cardiology, governmental organizations such as the National Institute of Mental Health, and payors, such as Aetna, better understand patients’ needs, according to the company. For example, Merck turned to PatientsLikeMe’s membership to help clarify what patients mean when they say, “I can’t sleep.” Dr. Lowe said, “They found that even when they say they can’t sleep, many patients leave out a variety of sleep disturbances that are symptoms of insomnia.” The insights helped shape Merck’s patient education materials and also aided the company in launching a specific product.

‘Patient-generated data can tell us things clinical data can’t, such as ... how they experience health care ... on a daily basis.’

—Maria Lowe, PharmD Another partnership, with AstraZeneca, helped inform that company’s research priorities for a clinical trial of a lupus drug, Dr. Lowe noted. “AstraZeneca turned to our members to help them understand what symptoms matter most to them,” she said. After analyzing data from 183 PatientsLikeMe members with lupus, they concluded that fatigue and body pain were the most important symptoms in their lives. “The company ultimately adjusted the trial design to modify the selected end points to better align with what patients cared about.”

In yet another partnership that demonstrates how patients’ insights can improve health care, Walgreens now includes a web-based patient dashboard that presents the frequency of adverse events related to specific drugs and the efficacy of those drugs, as reported by PatientsLikeMe network members.

For a list of other patient-powered research networks, visit the National Patient-Centered Clinical Research Network (PCORnet.org).

—David Wild Dr. Lowe reported no relevant financial relationships.

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