Pharmacy Practice News - Special Edition June 2022 by McMahon Group

The 2022 Annual Compendium of Compounding

ISMP Releases New Sterile Compounding Guidelines A call to action on IV-WMS adoption Are BUD rules friendly to home infusion? 10 new building blocks of compounding safety The case for IV robotics Supplement to Pharmacy Practice News

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Important Safety Information HyperRAB is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products. *Store HyperRAB at 2 to 8ºC (36 to 46ºF). Do not freeze. Store at room temperatures not to exceed 25°C (77°F) for up to 6 months at any time prior to the expiration date, after which the product must be used or discarded. Do not return to refrigeration.1 References: 1. HyperRAB (rabies immune globulin [human]) Prescribing Information. Grifols. 2. Data on ﬁle, Grifols. 3. Cabasso VJ, Loofbourow JC, Roby RE, Anuskiewicz W. Rabies immune globulin of human origin: preparation and dosage determination in non-exposed volunteer subjects. Bull World Health Organ. 1971;45(3):303-315. 4. Aoki FY, Rubin ME, Fast MV. Rabies neutralizing antibody in serum of children compared to adults following post-exposure prophylaxis. Biologicals. 1992;20(4): 283-287. 5. Kuwert EK, Werner J, Marcus I, Cabasso VJ. Immunization against rabies with rabies immune globulin, human (RIGH) and a human diploid cell strain (HDCS) rabies vaccine. J Biol Stand. 1978;6(3):211-219. 6. Aoki FY, Rubin ME, Friesen AD, Bowman JM, Saunders JR. Intravenous human rabies immunoglobulin for post-exposure prophylaxis: serum rabies neutralizing antibody concentrations and side-effects. J Biol Stand. 1989;17(1):91-104.

Please see Important Safety Information and brief summary of Prescribing Information for HyperRAB on adjacent pages, or visit www.HyperRAB.com for full Prescribing Information.

Important Safety Information Indication and Usage HYPERRAB® (rabies immune globulin [human]) is indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred. Important Safety Information For infiltration and intramuscular use only. Severe hypersensitivity reactions may occur with HYPERRAB. Patients with a history of prior systemic allergic reactions to human immunoglobulin preparations are at a greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available for treatment of acute allergic symptoms, should they occur. HYPERRAB is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The most common adverse reactions in >5% of subjects during clinical trials were injection-site pain, headache, injection-site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal pain. Do not administer repeated doses of HYPERRAB once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine. Other antibodies in the HYPERRAB preparation may interfere with the response to live vaccines such as measles, mumps, polio, or rubella. Defer immunization with live vaccines for 4 months after HYPERRAB administration. Please refer to accompanying full Prescribing Information for complete prescribing details.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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Rabies Immune Globulin (Human) These highlights do not include all the information needed to use HYPERRAB® safely and effectively. See full prescribing information for HYPERRAB. HYPERRAB [rabies immune globulin (human)] solution for infiltration and intramuscular injection Initial U.S. Approval: 1974 -------------------------INDICATIONS AND USAGE ---------------------HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use Persons previously immunized with rabies vaccine that have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred. -------------------- DOSAGE AND ADMINISTRATION -----------------For infiltration and intramuscular use only. Administer HYPERRAB within 7 days after the first dose of rabies vaccine. Postexposure prophylaxis, along with rabies vaccine, after suspected exposure to rabies

HYPERRAB 20 IU/kg body weight OR 0.0665 mL/kg body weight Single-dose

Administer as soon as possible after exposure, preferably at the time of the ﬁrst rabies vaccine dose. Inﬁltrate the full dose of HYPERRAB thoroughly in the area around and into the wound(s), if anatomically feasible. Inject the remainder, if any, intramuscularly.

-------------------- WARNINGS AND PRECAUTIONS -----------------• Severe hypersensitivity reactions, including anaphylaxis, may occur with HYPERRAB. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. • HYPERRAB is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ----------------------------ADVERSE REACTIONS-------------------------The most common adverse reactions in >5% of subjects in clinical trials were injection site pain, headache, injection site nodule, abdominal pain, diarrhea, ﬂatulence, nasal congestion, and oropharyngeal pain. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ----------------------------DRUG INTERACTIONS ----------------------• Repeated dosing after administration of rabies vaccine may suppress the immune response to the vaccine. • Defer live vaccine (measles, mumps, rubella) administration for 4 months.

Grifols Therapeutics LLC Research Triangle Park, NC 27709 USA U.S. License No. 1871

3058814 Revised: 1/2021

CONTENTS

TABLE OF 6 10 14 16

Should IV-WMS Be Mandatory? Advocating for and Implementing IV-WMS BUD’s Impact on Home Infusion Products Kienle’s 10 New Building Blocks of Compounding Safety

18 56% Rate of Adherence to Sterile Compounding SOPs Is ‘Crazy’

22 ISMP Releases New Guidelines on Sterile Compounding

26 Making a Case for IV Robotics 30 Pharmacy Relies on IV Robots, Batch Compounding to Cope LEADERSHIP Ernest R. Anderson Jr., MS, RPh, Boston, MA Elaine Strauss, PharmD, MS, Atlanta, GA

EDITORIAL BOARD

NUCLEAR PHARMACY

ADMINISTRATION Robert Adamson, PharmD, Livingston, NJ

Jeffrey Norenberg, PharmD, Albuquerque, NM

James A. Jorgenson, MS, RPh, St. Paul, MN

NUTRITION

Indu Lew, PharmD, Livingston, NJ

Beverly Holcombe, PharmD, BCNSP, FASHP, FASPEN, Chapel Hill, NC

AMBULATORY CARE Meghan D. Swarthout, PharmD, MBA, BCPS, Sallston, MD

Vanessa Kumpf, PharmD, BCNSP, Nashville, TN

STERILE COMPOUNDING Kristina N. Bryowsky, PharmD, MBA, BCPS, Fenton, MO

James O’Neill, Senior Systems Manager

TECHNOLOGY Thomas Van Hassel, RPh, Yuma, AZ

Rob Sinclair, Circulation Manager

Van Velle, President, Partner

David Bronstein, Editorial Director davidb@mcmahonmed.com

Matthew McMahon, General Manager, Partner

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Lauren Smith, Michael McMahon, Michele McMahon Velle, Partners

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Ray and Rosanne McMahon, Co-founders

ONCOLOGY

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CARDIOLOGY C. Michael White, PharmD, Storrs, CT

ORGAN TRANSPLANT PHARMACY

CNS/PSYCHIATRY Lawrence Cohen, PharmD, FASHP, FCCP, Fort Worth, TX

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Should IV-WMS Be Mandatory? By David Wild

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 see IV-WMS MANDATE, page 8

URMC’s Experience

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 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.”

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IV-WMS MANDATE continued from page 6

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.” Mr. Neuenschwander said the data underscore the efficacy of IV-WMS. Indeed, “barcode medication preparation [BCMP]-based technologies are to medication-use processes what order-fulfillment technologies are to Amazon—a company that realizes error rates below 0.1%,” he 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 gravimetric-based 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 patient safety benefits of IV-WMS 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.

Adoption Rates Still Low 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 barcode and image verification (ISMP; Oct. 22, 2020; bit.ly/3MTOCCC).

‘[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 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%). (For adoption rates in an ASHP survey, see page 10.) 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 medicationuse systems, and that institutions should use technologies that can prevent these types of errors—including IV-WMS. 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

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Advice from the experts

Advocating for and Implementing IV-WMS By Gina Shaw

ccording to a recent ASHP national survey of pharmacy practice in hospital settings, IV workflow management systems (IV-WMS) remain underused in U.S. hospitals, particularly at smaller institutions. Overall, 16.4% of hospitals reported having adopted IV-WMS; when broken down by size, 57.6% of the largest hospitals (≥600 staffed beds) are using the technology, versus 4.6% of hospitals with fewer than 50 beds. Only the largest group of hospitals broke the threshold of 50% or more using IV-WMS. However, IV-WMS adoption increased from 6.5% in 2014 to 12.8% in 2017, and the adoption rate of certain key components was higher than that of the systems overall. For example, 31.6% of all hospitals reported barcode scanning to verify the ingredients of sterile compounded IV preparations. (For adoption data from a 2020 ISMP report, see page 8.) “With most institutions having incorporated computerized physician order entry [CPOE] and barcoded medication administration [BCMA], the next area of safety is the pharmacy’s IV room,” said Dennis Killian, PharmD, the vice president of clinical operations for Peninsula Regional Health System, in Maryland. “There is a lot of risk associated with IV room processes; however, no authorities are saying that you have to adopt IV workflow management systems, whereas if you want to obtain incentives under meaningful use, you have to incorporate BCMA and CPOE. IV workflow technology takes effort to implement and costs money; without a mandate, some pharmacy practices just won’t do it. We’ve relied on pharmacy leaders and organizations such as the Institute for Safe Medication Practices to push this technology and say this is what we need to keep patients safe.” IV-WMS advocates are hopeful that calls for its implementation from pharmacy standard-setters will get louder. The THRIV Coalition for IV Accuracy, launched in 2019 to champion the “universal adoption ... of IV-WMS healthsystem pharmacies,” recently succeeded in getting several proposed resolutions accepted by USP for consideration to be adopted into USP’s 2020-2025 objectives and goals. “One proposal argues that IV-WMS should meet or exceed the criteria outlined in the coalition’s Technology Checklist,” said Mark Neuenschwander, THRIV’s founding director. “Another seeks to ensure that all medications, including those used for preparing IVs, have barcodes that include lot number and expiration date. Compounders need to know if the diluents and ingredients have been recalled or are out of date. Humans easily miss these things, but barcode scanners will not, and this is one more layer of safety that IV workflow can bring to the equation.”

“These resolutions have been incorporated into the formulation process for USP’s next five-year goals,” Mr. Neuenschwander added. “So we’re on their radar, and we are hopeful that we will be able to work with their scientific committees to formulate policy that will achieve those two goals.” A USP spokesperson confirmed that IV-WMS “is very much on the radar of the Compounding Expert Committee.” For more details, see page 6.)

Barriers and Considerations In addition to the often cited issue of cost, many institutions struggle with culture change and adaptation as a barrier to the adoption of IV-WMS. “They say, ‘What is it going to do to my process?’ Things to consider include, how do I have to restructure my room, do I need to change where I store drugs, and how would not having the final label before making a dose change the process?” said Thomas Moniz, PharmD, the director of pharmacy operations at Northern Light Eastern Maine Medical Center, in Bangor. “Yes, initially it will take time to adjust; depending upon the size of your operation, it may take a few weeks or a month. But you do hit your new normal, and there is evidence to suggest it is possible to achieve time savings.” Those increased efficiencies require a full walk-through of how your system will change. “If you slow people down in one area, they will find shortcuts in another, so you have to be careful about your impact on workflow, in the same way we couldn’t just turn on barcoded medication administration in nursing without understanding their workflow,” Dr. Moniz said. “For example, you will no longer have labels printing out that you’re putting on a tray with your vials and bags; in some systems, the labels don’t print until you’re almost done compounding.” Eastern Maine Medical Center designed its new sterile compounding space, which went live in November 2019, with its upcoming acquisition of IV-WMS in mind. “We made sure internet connections were available, and some of our hoods even have USB ports in them,” Dr. Moniz said.

‘The Devil Is in the Details’ Marianne Ivey, PharmD, a professor emeritus at the University of Cincinnati James L. Winkle College of Pharmacy, stressed that hospitals considering IV-WMS need to “look

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see ADVOCATING, page 12

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ADVOCATING continued from page 10

carefully at the functionality of each system you’re considering; the devil is in the details.” As just one example, “do you want digital visualization at intervals or do you want it continuous? You should also get a feel for the vendor’s reputation, based on your own or colleagues’ experience with that vendor—how they represent the product and how they support it once it’s implemented,” said Dr. Ivey, a former pharmacy services vice president for a multihospital system. “In my experience working with pharmacy technology companies, there’s a pretty wide spectrum of quality in those who represent the company to help implement, utilize and maintain the systems you’re installing.” Gravimetrics to verify dose amount/volume is one of the least-adopted elements of IV-WMS: 5.4% of all hospitals and 21.2% of the largest hospitals are using it, according to the ASHP survey. But that may change; newer iterations of some IV-WMS products have improved on their integration of this function into the overall workflow.

IV-WMS MANDATE continued from page 8

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 As for nonregulatory bodies jumping into the fray, Mr. Neuenschwander noted that many have managed to boost implementation rates for several patient safety technologies, and he hopes THRIVE 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 have become de facto standards of practice,” he said. ISMP is yet another nonregulatory body that is a staunch advocate of IV-WMS, 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

“For some earlier systems, gravimetrics was kind of retrofitted in and never quite worked right, but newer technologies are incorporating gravimetrics from the ground up into a push-type system that makes the workflow easier, with fewer steps and actions required of the user,” said Peninsula Regional Health System’s Dr. Killian. “Once you weigh the product, you don’t need to click a button to say, ‘Hey, I’m weighing this.’ The system acknowledges the weight automatically and moves to the next step.” Although some hospitals have tried to incorporate IV workflow management into their electronic health record (EHR) systems, Dr. Killian said that the functionality still lags those built specifically for the purpose. “The jury is still out on EHRs and their ability to work in this space as a comprehensive offering,” he said. “Some sites seem to feel what they offer is good enough, but it can’t replace a true IV workflow system.” Dr. Ivey reported that she is on the advisory board of ConsortiEx and previously was a co-investigator of a study that was funded by Baxter. Dr. Killian reported that he has spoken for Baxter on IV workflow.

Hospitals includes a recommendation to employ IV-WMS (bit. ly/3pJa1kX). As for which specific vendor or IV-WMS technology to choose, one useful approach is to consider the experiences of other health systems that already have implemented an IV-WMS system (sidebar, “URMC’s Experience,” page 6).

‘People Respect What’s Regulated’ Although ISMP holds sway within the pharmacy community and among patient safety experts, Christina Michalek, BSPharm, RPh, FASHP, 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 reported no relevant financial disclosures.

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USP <797> proposed rule may change product storage requirements

BUD’s Impact on Home Infusion By Marcus Banks

Nashville, Tenn.—Storage requirements for many products used in home infusion services will change if proposed revisions to USP General Chapter <797> take effect, according to David Hughes, PharmD, who directs the home infusion service at the Yale New Haven Health System, in Connecticut. Speaking at the 2022 meeting of the National Home Infusion Association, Dr. Hughes detailed the potential changes. Most home infusion products would fall within “Category 2” of the proposed new USP <797> guidelines, Dr. Hughes said. Many of these products are aseptically produced, made entirely of sterile components and thus do not need to undergo sterility testing. Per the new guidelines, any compound meeting all those conditions could be stored for four days at a controlled room temperature: 10 days in a refrigerator or 45 days in a freezer. That’s a change from the 14 days in a refrigerator currently allowed for low-risk compounds in the current USP <797> guidelines, Dr. Hughes noted. (For a USP Fact Sheet on BUD, see bit.ly/3NhR6Lc.) The current USP <797> guidelines have been in effect since 2008. The public comment period about the new guidelines closed on March 17. In the new guidelines, USP proposes changing from a low-/medium-/high-risk model to one based on categories of risk. Category 1 compounds, which do not have to be prepared in a cleanroom suite, would have the shortest beyonduse dates (BUDs) in the new framework. Category 2 compounds would carry the storage limits described above, and Category 3 compounds could have BUDs of up to 180 days. “This change was proposed to avoid inaccurately conferring a level of risk to a particular compounded sterile product [CSP] without consideration for all factors that influence the quality of that CSP,” USP leaders explained in a 2021 overview of the rationale for the new BUDs and categories. Dr. Hughes noted that, according to the new guidelines, sterility testing is required for Category 2 compounds to have a BUD longer than 45 days. For example, an aseptically processed CSP that passes sterility testing can be stored in a freezer for 60 days, and a terminally sterilized CSP that

passes a sterility test can be in a freezer for up to 90 days. All Category 3 CSPs need to undergo sterility testing to achieve that 180-day mark, Dr. Hughes said. In general, he added, home infusion services should contract with labs that specialize in sterility testing rather than doing that work in-house.

Single Patient or Batch? “In the 2008 version of chapter <797>, the beyond-use dates are largely based on the starting ingredients,” said Patricia Kienle, RPh, MPA, BCSCP, FASHP, the director of accreditation and medication safety at Cardinal Health. “So a key question is, are those ingredients sterile or non-sterile?” Another important consideration, she noted, “is the number of patients you’re going to make these medications for. Is it a single patient or a batch? That’s an oversimplification, but it tends to be how people think about it.” In the proposed revisions to <795> and <797>, Ms. Kienle said, BUDs derive instead from the location where compounding occurs; that is, different standards apply depending on whether compounding occurs in a cleanroom or segregated compounding area. “Some of the reasons for these changes have gotten lost in the revision process,” Ms. Kienle added. Ms. Kienle said she doesn’t think the 10-day BUD for refrigeration of Category 2 products proposed in the new revisions will have much practical impact, even if it seems that it should because the current standards allow for 14 days of refrigeration. That 14-day BUD only applies to a medication made for a single patient, Ms. Kienle noted, whereas a batch of the same medication intended for multiple people can only be refrigerated for nine days, per current USP guidelines. The new rules—if adopted—would allow 10 days of storage of a batched medication, which is more generous, she said. “I’m sure there are situations where people are going to have to back it off from 14 days to 10,” Ms. Kienle added. “But I think the vast majority are going to say, ‘Wow, I used to do it for nine and now I can do it for 10.’” Ms. Kienle is an employee and shareholder of Cardinal Health. These comments are her own and neither affiliated with nor endorsed by USP.

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Kienle’s 10 New Building Blocks of Compounding Safety Each year, Patricia Kienle, RPh, MPA, BCSCP, FASHP, the director of accreditation and medication safety at Cardinal Health, shares 10 points that she believes pharmacists need to consider to ensure compounding safety and compliance with USP, state boards of pharmacy, and other regulatory bodies and accreditation organizations. Follow the USP compounding-related chapter revision process. The 2019 proposed revisions of USP General Chapter <795> (nonsterile compounding) and USP <797> (sterile compounding) were appealed, but USP published updated revisions in September 2021. The 2019 appeals of the USP chapters were primarily about beyonduse dates (BUDs) and the ability to extend them. The information added to the proposed revised 2021 chapter <797>, particularly information in the boxes supplementing the text, is valuable to incorporate into policies. To keep up to date, institutions should subscribe to the USP Compounding Compendium (www.usp.org/ products/usp-compoundingcompendium) and follow the USP compounding page (www.usp.org/compounding). USP <800> (handling hazardous drugs) has been an official chapter since 2016. It was not appealed, but its federal enforceability is tied to its mention in the revised chapters. Some states have already chosen to incorporate all or portions of the requirements in their review. USP <825> (radiopharmaceuticals) has been an official chapter since 2020. It applies both to nuclear pharmacies and nuclear medicine departments in hospitals and clinics. Read the FDA document concerning unsanitary conditions and hospital/health-system compounding. Be sure to monitor the FDA website (bit.ly/ 3LGEX0A) for new and revised compounding-related documents, including those related to unsanitary conditions (bit.ly/2PvYQQe), which were updated in November 2020, and a revised draft version of hospital and healthsystem expectations, which were updated in October 2021. Other documents concern repackaging, compounding from bulk substances and outsourcing facilities. These documents may be in draft or final form, so be vigilant and make sure you have the most recent revision. Stay current with state rules and regulations. State regulations may be more stringent than USP standards, and some states already have incorporated aspects of the revised USP chapters into their inspections. Because of ongoing confusion about which standards to adhere to—USP or state regulations—especially around BUDs and frequency of personnel requalification, pharmacies should follow the more stringent regulations, which may be on the state side.

Be familiar with the expectations of your urr health nd d other system’s accreditation organization and ccreditaprofessional organizations. The four hospital ac accreditaedicare & tion organizations deemed by the Centers for Me Medicare o (TJC), on Medicaid Services include the Joint Commission reeditation DNV Healthcare, Healthcare Facilities Accreditation ealthcare Program and the Center for Improvement in He Healthcare errile comQuality. All of these organizations focus on sterile pounding, as they survey facilities. a the TJC’s most recent information discussed at ib bition ASHP 2021 Midyear Clinical Meeting and Exhibition nd d duridentified several problem areas TJC has found ing surveys: competency assessments, properr facilin nmental ties, and response to certification and environmental clluded monitoring reports. Specific issues have included r rgen pre-spiking IV bags and preparation of allergen ake extracts in practitioner offices and clinics. M Make h hese sure you have these items addressed before these diitaorganizations visit your site. Whatever accreditarent tion organization you use, be sure to stay current with its guidance. th hey When accreditation organizations survey, they gu ulaexpect compliance with applicable laws and regulaliitions, their standards, your organizational poligaacies, and best practices. Several professional orgahaat nizations provide best-practice documents that ed d supplement the minimum standards established maaby USP. For more details, check out informaon n tion at the ASHP, Institution for Safe Medication o or Practices (ISMP), and American Society for Parenteral and Enteral Nutrition websites. Be aware of allowances and restrictions when unusual circumstances occur. The COVID-19 pandemic created situations that no one anticipated. ASHP, the CDC, the FDA, ISMP and USP developed documents with allowances during the public health emergency. These included adjustments for BUDs, garb and personal protective equipment, as well as other components of compounding regulations and best practices, assuming appropriate oversight. As the situation evolved, the documents were updated.

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Table. Tab b Sterile Compounding Resources Source Sou u of guidance

Website navigation

ASHP ASH H Connect

www.ashp.org Æ Member Center Æ ASHP Connect

CDC C Medication Pre p Preparation

www.cdc.gov/injectionsafety/providers/provider_faqs_med-prep.html

FDA A Compounding

www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

ISM ISMP M Sterile Com Compounding m

www.ismp.org Æ Sterile Compounding

USP P Compounding

www.usp.org Æ Compounding

ASP ASPEN P

www.nutritioncare.org Æ Parenteral Nutrition Safety Consensus Recommendations and Clinical Guidelines

‘Because of ongoing confusion about which standards to adhere a to—USP or state regulations—especially around BUDs and frequency of personnel requalification, pharmacies should follow the more stringent regulations, which may be on the state side.’ —Patricia Kienle, RPh, MPA We h have seen similar situations when weather or other naturall disasters affected supply of drugs and supplies. The COVID-19 CO O crisis allowances were obviously lengthier and mo o comprehensive, but we need to be prepared for more futuree emergency management needs. Com m Compounding pharmacists should monitor key sources of inf f information: ASHP Connect, USP compounding pages, IS S ISMP’s website and newsletters, the CDC, and FDA guida a guidance pages. It’s important to remember that these allow w allowances are usually only meant for the duration of a publi ic health emergency and not intended to be permapublic nentt policies. Given the potential for new COVID-19 vari i variants and an uptick in cases, it’s important to bec o become familiar with these resources (Table). St t States also have issued alerts concerning their compou u pounding expectations during a public health emergen n gency, and many state health-system pharmacy societies provide summaries and notices to their members. It’s critically important to keep current with state-level cha a changes by monitoring your state’s board of pharmacy web b website. Limit exposure to hazardous drugs. USP <800> is designed to protect healthcare workers, so work toward full compliance with the chapter. One piece of guidance in the chapter is to ensure your assessment of risk reflects best practices as well as how you handle hazardous drugs used in your institution. This practice requires a team-based, interprofessional effort to ensure your practices are appropriate throughout the health system.

Use the right technology/safety practices. Two key strategies are to use closed system drug-transfer devices (CSTDs) and surface sampling. CSTDs are required in the chapter for administration of National Institute for Occupational Safety and Health Table 1 antineoplastic agents and recommended for compounding. Evaluation of CSTD use needs to be part of your assessment of risk evaluation and review. As for sampling for hazardous drug contamination, this practice is a form of environmental monitoring and is growing as a way to monitor for contamination and mitigate potential exposure to personnel and patients. Read and react to your daily monitors and certification reports. Surveyors and state board inspectors often tell me that when they ask for the most recent certification and environmental monitoring reports, they find that the person supervising compounding operations hasn’t even reviewed the report. Now is the time to evaluate what’s in the reports and take action based on the results. Nonviable monitors aren’t limited to your twice-yearly certification. You also need to record daily temperature, humidity and pressure differentials of your compounding areas. Be sure you have a process to react to excursions and correct them when necessary. Make sure your certification reports summarize all the key required elements, and have your certifier review the areas that pass, fail or need attention after their evaluation. Be sure you receive a written report within a few days of the certifier’s visit, and schedule the return visit within six months to be sure you will have the certification completed before six months elapses, per USP requirements. see BUILDING BLOCKS, page 18

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ISMP survey reveals major compliance gaps

56% Rate of Adherence to Sterile Compounding SOPs Is ‘Crazy’

By Bruce Buckley

he USP’s sterile compounding standards have been in place for nearly two decades, and most large health systems now employ technological tools to safeguard the sterile drug workflow process. But have health systems reached the optimal level of compliance? That’s what the Institute for Safe Medication Practices (ISMP) wanted to know. So ISMP launched a Pulse Check survey. More than 600 pharmacists, technicians and others allied with pharmacy responded.

BUILDING BLOCKS continued from page 17

Read and react to your environmental monitoring reports. Environmental monitoring results get even more scrutiny than certification elements. Your microbial environmental monitoring program must be designed to adequately detect excursions. The minimum elements need to include staff training and competency, frequency of monitoring at least as much as defined in the USP chapters, and reaction to results. (Remember: The USP chapters are minimum standards; many best practices exceed the minimum frequency.) Many organizations have their certifiers perform the semiannual electronic air and surface sampling, but the proposed frequency of monthly surface sampling is unlikely to be able to be consistently supported by your certifier if the revision requires that. In any case, your ability to do your own surface sampling—either every month or just those months when the certifier isn’t at your facility—will enhance the ability to react to concerns.

The answer, detailed in survey results described at a virtual Omnicell Illuminate meeting, was that although progress in achieving compounding safety has been made, significant gaps remained. Three-fourths of respondents, for example, reported being aware of at least one pharmacy compounding error in the past 12 months, said Christina Michalek, BSPharm, RPh, FASHP, the ISMP medication safety specialist who presented the findings. The errors ranged from incorrect dose or concentration to faulty labeling to wrong see SOP ADHERENCE, page 20

Benchmark your practices. Much of USP’s guidance focuses on existing best practices in compounding, including the requirements for master formulation records, compounding allergenic extracts, procedures for media fill and gloved fingertip testing, procedures for air and surface sampling, cleaning procedures, evaluation of environmental monitoring excursions, and certification of facilities. Review those procedural aspects and explanations and incorporate them into your own policies and procedures. To ensure that your practices meet the USP minimum standards as well as changes that evolve as practices mature, conduct gap analyses at least annually. Gap analysis tools are available at the ASHP Compounding Resource Center (www.ashp.org/Pharmacy-Practice/ Resource-Centers/Compounding), CriticalPoint (www. criticalpoint.info) and other sources. Ms. Kienle is an employee of Cardinal Health and a member of the USP Compounding Expert Committee. The comments in this article are her own.

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Table. Sterile Compounding Errors

continued from page 18

drug used (Table). Some were found and corrected before dispensing, Ms. Michalek said, while others came to light only after leaving the pharmacy. Ms. Michalek noted that the well-documented risks of sterile compounding were not just confined to the pharmacy. “It begins with the products we decide to bring into an organization,” she said. The risks involve when and how medications are prescribed and the processes of verification and communication, she added; they also extend to the workplace environment, the lack of standardized practices, production pressures and the absence of technology. “These are all risks,” she said. An even more complete picture of compounding safety challenges emerged from an open-ended question that drew more than 600 responses. By far the biggest barrier, she said, “was the inability of pharmacists to accurately verify compounded sterile preparations using indirect processes like the syringe pull-back method.” Closely following was the difficulty in complying with USP General Chapter <797> and <800> standards. Rounding out the list were staff training and competency issues, a lack of technology, not enough workspace and heavy workloads. Insufficient leadership support and work supervision also came under fire. The survey also addressed technology. A total of 361 respondents (57%) reported using at least some technological tools in sterile compounding. They included barcode verification with and without images, multiple ingredient compounding devices, gravimetric verification and robotic compounding.

Delving Into Best Practices Respondents were asked to rate the implementation level of nine ISMP-defined compounding best practices. The greatest extent of implementation (73%) related to cleanroom/ sterile compounding area practices, including having enough workbenches to support only one staff member at a time per primary engineering control—laminar airflow workbench, biological safety cabinet, compounding aseptic isolator or compounding aseptic containment isolator. The survey also focused on standard operating procedures (SOPs). Were they defined and what was the level of compliance? More than half of respondents (56%) reported that SOPs were “defined and always followed.” About onethird (34%) said they were defined and “often followed,” while 10% said they were “never, rarely or sometimes” defined and followed.

‘Alarming’ Results Patricia Kienle, RPh, MPA, BCSCP, FASHP, the director of accreditation and medication safety at Cardinal Health, found this result “pretty alarming.” “Only 56% said always? That’s crazy,” Ms. Kienle told Pharmacy Practice News. “It shows that some people still aren’t doing what they should have been doing for decades.

Error

Percentage of mentions

Incorrect dose or concentration

Incorrect base solution

Incorrect base solution volume

Issue or error with labeling of CSP (including omission)

Incorrect reconstitution of drug (volume or diluent)

Incorrect drug

Wrong preparation technique (e.g., improper filtering, wrong tubing)

Expired drug, base solution or CSP

Wrong timing (e.g., preparing antineoplastic on wrong date)

Omission of a drug

CSP, compounded sterile preparation.

People need to have procedures that match what they actually do and that are compliant with USP <797> and <800> standards, state regulations and best practices.” Ms. Kienle also said these procedures need to be in place in health-system areas “outside of the pharmacy where sterile compounds are mixed, like procedural areas, operating rooms, imaging and infusion centers—places that have been under the radar for years. “Pharmacy supports those areas, too,” she added. “This is a team sport. It’s not limited to the silo of the pharmacy.” Although COVID-19 appears to have played little part in the survey results, Ms. Kienle said she is worried that the COVID-19 pandemic’s practice pressures might have caused people to become “even more lax on things like certification of their areas and maintaining and really upgrading the environmental pieces” that are fundamental to USP <797> and <800> standards. Ms. Michalek ended on an upbeat note. “Pharmacists and technicians have done some amazing work to continually improve the care and delivery of sterile injectable medication,” she said. “As stewards of medication use, they are really in the best position to move forward with more improvements and more safety around compounded sterile preparations.” A print version of the ISMP Pulse Check survey report can be found at bit.ly/3qN37fF. For ISMP’s new guidelines on sterile compounding, see page 22. Ms. Kienle is a member of the USP Compounding Expert Committee, but her comments are her own and neither affiliated with nor endorsed by USP. Ms. Michalek reported no relevant financial disclosures.

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ISMP Releases New Sterile Compounding Guidelines By Bruce Buckley

ow to drive the odds of sterile compounding errors to nearly zero through advanced technology: That’s the challenge taken on by the newly published compounding safety guidelines from the Institute for Safe Medication Practices (ISMP). “We have sophisticated technology and automation available on the market today that can prevent or catch compounding errors and provide safe patient care. However, the adoption of this technology throughout the nation is extremely low, leaving our patients vulnerable to harm from preventable errors,” said Kevin Hansen, PharmD, MS, BCPS, BCSCP, the systemwide director of pharmacy at Cone Health in Greensboro, N.C. “It has become inexcusable to not use some extent of compounding technology or automation in most pharmacy practice settings that perform sterile compounding,” said Dr. Hansen, who was a member of the expert panel that paerticipated in ISMP’s virtual summit last September to revise the organization’s existing compounding guidelines with a new focus on evolving technology. Implementing sterile compounding technology has been shown to greatly reduce the risk for medication errors. A 2019 multicenter study, for example, found that the use of technology-assisted IV workflow management systems (IV-WMS) were associated with a 14-fold increase in error detection compared with nonuse of such technology (Am J Health Syst Pharm 2019;76[15]:895-901).

‘The data have definitely proven that adding technology can prevent errors that we are not as good at capturing when we only have manual systems.’ —Christina Michalek, BSPharm, RPh, FASHP “The data have definitely proven that adding technology can prevent errors that we are not as good at capturing when we only have manual systems,” said Christina Michalek, BSPharm, RPh, FASHP, the director of membership and patient safety organization for ISMP, and one of the architects of the new guidelines.

The 24-page document is packed with concise bullet points—more than 160 in total—all designed to boil down complex advisory information into the most essential and practicable form possible: the essential technology attributes, safe pharmacy processes, safety gaps and best practices for automated compounding devices, IV-WMS and IV robots. The guidelines also specify nearly three dozen general best practices for sterile compounding safety, and take a look at what technology vendors and designers, moving forward, can do to advance compounding safety. One example of the latter is a recommendation to investigate the feasibility of developing a common language among technologies so that practitioners do not need to reenter data into each system. The guidelines also stress the need for collaboration, advising use of the document “in concert” with other sources, including guidelines and recommendations from the American Society for Parenteral and Enteral Nutrition, ASHP and USP. And, indeed, representatives of those organizations showed up in force for the three-day virtual summit, along with others from the FDA, the Joint Commission, the THRIV Coalition for IV Accuracy and ECRI, ISMP’s parent organization. Also in attendance were representatives from 15 health systems and hospitals and nine leading tech vendors.

Vendors Add Value The presence of the vendor group was one key to the summit’s success, according to Rita K. Jew, PharmD, MBA, BCPPS, FASHP, who was named the president of ISMP in January, succeeding Michael R. Cohen, RPh, MS, ScD (hon.), FASHP, who became ISMP’s president emeritus.

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GUIDELINES continued from page 22

“The pharmacy cannot achieve what we want to achieve in optimizing safety without the help of the vendors,” Dr. Jew told Pharmacy Practice News in an interview that followed an ISMP symposium at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Dr. Hansen and Ms. Michalek also participated in the symposium. “In my previous experience with implementing a lot of different technologies,” Dr. Jew said, “the biggest problem was that vendors create technology but rarely think through the workflow. And even though there were a lot of safety features in place, they weren’t providing enough guidance for the pharmacy folks to implement them.” She added: “We know that learning a new technology is always difficult. Folks tend to try to fit their old practices into the new technology, which never works. It can even make the new practice worse.” Dr. Jew said the vendors create training programs to get people to learn how to use the software and hardware, but don’t really train on the new workflow, and “what ends up happening is that people start creating workarounds, which a lot of times bypass the technologies’ safeguards.” Dr. Jew added that teamwork is key. “The biggest message for vendors is to collaborate with pharmacy teams to design the new workflow to maximize safety so that it can be implemented from the very beginning,” she explained. “That’s why human factor engineering is such an important focus as we implement technology.” Although ISMP’s sterile compounding guidelines (first published in 2013 and revised in 2016) touched on IV workflow and automated compounders, they didn’t “really dive into some of the safety gaps and robotic technology out there,” Dr. Jew said. “So, the goal of the new guidelines was to focus on the safety of compounding technology, explore some of the safety gaps and come to a consensus on what the best practices should be.” Sterile compounding technology also can help to reduce the impact of drug shortages, Cone Health’s Dr. Hansen noted. He described how his organization had used IV robotics to lessen the impact of the shortage of heparin sodium premixed bags. “Heparin is a high-alert medication with a narrow therapeutic range,” he said, “so it’s really important to have the right drug in the bag at the right concentration.” By working with its robotic technology vendor, he said, Cone Health was able to accomplish that end, and “now our robots are producing heparin infusions to meet patient needs across our health system and have had no patient care disruptions as a result of this national shortage.”

Gravimetrics Brings Accuracy to a New Level The use of gravimetric verification also ensured drug concentration accuracy, Dr. Hansen noted. Since bringing the robotic–gravimetric approach into action, he said, “not a single report has been brought to my attention” of any differences in therapeutic effect of the robot-produced heparin compared with the conventionally manufactured premixed bags, which some organizations have reported seeing using manual preparation of heparin infusions.

‘The biggest message for vendors is to collaborate with pharmacy teams to design the new workflow to maximize safety ... from the very beginning. That’s why human factor engineering is such an important focus as we implement technology.’ —Rita K. Jew, PharmD “For many of these compounders who don’t think they need technology or automation,” Dr. Hansen added, “what happens when you have a shortage? Who is going to make it, and how can you make sure it’s still as sterile, safe and potent as the FDA conventionally manufactured premix? That’s where there is a strong case for using IV robotics and automation in practice settings.” At a minimum, he said, hospitals that do sterile compounding need to acquire barcode scanning technology for compounding that can “ensure that the right drug, diluent, and fluid is used for the right patient.” He further acknowledged, “It is our obligation for safe patient care to provide barcode medication preparation for compounded medications, similar to how barcoding has been adopted by nurses with barcode medication administration.” Ms. Michalek said the response from people who took part in the summit showed that “we addressed the issues that needed to be addressed. We know that there are others out there—practitioners and organizations—that are trying to drive these safety practices and the use of better compounding systems, and all of us together are going to improve the safe care that we provide to our patients.” Dr. Hansen reported that he provides educational talks for Omnicell. He also disclosed that he is a member of the USP Compounding Expert Committee, but his statements are neither affiliated with nor endorsed by USP. Dr. Jew and Ms. Michalek reported no relevant financial disclosures.

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Making a Case for IV Robotics By Bruce Buckley

utsourcing 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 state-ofthe-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

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IV ROBOTICS continued from page 26

‘IV robotic technology ... gives us the flexibility to make the quantity we need on time, without running into any shortages or quality assurance issues.’

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 —Arpit Mehta, PharmD, MPH 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.” Gravimetrics can be used to precisely weigh the ingredients of a Although robots can seem prohibitively prepared drug dose. The final product is considered acceptable by the expensive, Dr. Mehta said he expects a net savrobot if it falls between plus or minus 5% of the expected weight. ings of $1.6 million per year once they are both “Although these robots don’t completely automate the fully operational. That includes, he said, the cost entire CSP [compounded sterile product] process,” he addof the medications, the technology, the third-party testing ed, “they have automated safety features such as object recand even the salary of a pharmacist dedicated to managing ognition, barcode scanning, image capture of critical steps the program. and plus/minus scales.” “It’s not necessarily about the finances,” he said. “There Those scales refer to a measurement of accuracy obtained is a safety component and the drug shortage component, via gravimetrics, a technology that is one of the main advanand we have control of our inventory. But at the end of the tages of IV robotics, Dr. Fahrni noted. Gravimetrics can be day we do need to justify the investment. And this is a huge used to precisely weigh the ingredients of a prepared drug financial saving and a benefit to the organization.” dose. The final product is considered acceptable by the Uptake Still Slow robot if it falls between plus or minus 5% of the expected Despite technological advances, hospital adoption of weight (J Oncol Pract 2012;8[6]:344-349). robotic IV compounders has remained relatively lim“I’ve always liked the idea of using robots for CSP producited. According to a recent Institute for Safe Medication tion,” added Dr. Fahrni, a member of the advisory board for Practices survey, only about 8% of hospital pharmaPharmacy Technology Report, a supplement to Pharmacy cies use a robot to prepare sterile medications (bit. Practice News. “But in my opinion they were never quite ly/3qN37fF). That rate may be expected to increase, howready for prime time. Five years ago, I don’t think I would ever, as the technology continues to progress and vendor have had much good to say. But times changes and things competition makes the return on investment more attracget better. Overall, one could argue that there is a potentive to hospital executives. tially positive return on investment for compounding robots “Robotic compounding systems are improving all the in specialized situations. They’re not for everyone, but for time,” said Jerry Fahrni, PharmD, a health information those situations where they fit, I think they hold value.” technology expert. “They offer improved safety for both employees and patients by removing human hands from Dr. Fahrni reported that he sits on the Omnicell IV Automation many of the steps in the compounding process. This is espeInnovation Group. Dr. Mehta reported no relevant financial disclosures. cially true for hazardous drugs compounding.

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Pharmacy Relies on IV Robots, Batch Compounding to Cope By Karen Blum, Bruce Buckley and Gina Shaw

s the COVID-19 pandemic surged in spring 2020, the pharmacy at the University of Maryland Medical Center, in Baltimore, faced several challenges affecting inventory management and pharmacy operations. By tweaking its in-house IV robot compounding process and transitioning to making some highly used products in batches instead of patient-specific doses, the pharmacy team quickly accommodated emerging inventory needs. The main challenge was to come up with solutions that worked for both under- and overstocked medications—both of which occurred, paradoxically, as a result of the panemic. For example, inventory for many normally used medications such as succinylcholine and phenylephrine accumulated because of a fall-off in patient admissions and surgical procedures, Yevgeniya Kogan, PharmD, the hospital’s sterile compounding operations manager, said during the ASHP annual meeting. Other drugs, such as hydromorphone IV bags, went into critical shortages because they were being purchase from 503B vendors, many of which had supply chain issues. The pandemic itself both increased demand for critical care products and generated staffing problems, as some employees stayed home to provide child care or because of a need to quarantine after potential exposure to the SARS-CoV-2 virus. To overcome these challenges, Dr. Kogan and her colleagues quickly learned to adapt, turning to systems already in place for in-house IV compounding processing by robots, an inventory batch management analysis strategy and a prescribing trends review. First, Dr. Kogan reviewed the pharmacy’s production schedule to make sure all compounds were still needed, flagging neostigmine for potential removal. The medical center typically used 700 syringes of the drug per month, but only 243 syringes were being used at the height of the pandemic. As COVID-19 evolved, the medical center was seeing a high demand for IV infusions of azithromycin 500 mg, cefepime 6 g, epinephrine 8 mg, furosemide 200 mg, hydromorphone 20 mg, pantoprazole 80 mg and rocuronium 400 mg. She and her colleagues determined they needed an estimated 600 weekly doses of these drugs combined and created a new schedule to batch the medications, in which hydromorphone and epinephrine would be produced by the IV robots while the remaining five products would be made manually by pharmacy technicians. They produced more than 20,000 doses of these medications over three months. During this period, the pharmacy team continued to carefully monitor inventory of these and other needed medications produced by the robots, such as heparin and vancomycin, including what was on hand and what was expected to

be released from their quarantine process each week. They tried to keep three weeks’ worth of extended-dated IV robot products available at all times to account for any increase in demand or production issues. From June through July, the pharmacy had steady use of azithromycin, pantoprazole and furosemide, and decreases in the need for cefepime as the number of COVID-19 patients began to fall, and in rocuronium as the preferred paralytic agent shortage resolved. Among the robotic compounded products, hydromorphone remained in high use. In contrast, the team temporarily stopped production of hydromorphone because one vendor shipped four weeks’ worth of back-ordered product that had been on shortage. Among other robotically made products, rocuronium syringes also experienced a significant shortage due to insufficient vial supply, so the pharmacy had to be wise in managing inventory, Dr. Kogan said. They were able to get one of their vendors to outsource the product to stay ahead of the need, she noted. When the vial shortage stabilized, the pharmacy quickly resumed production. By using these strategies, the pharmacy estimated a cost savings of more than $95,000 over four months from producing drugs as needed and not having them sit on the shelf and expire. “It’s important to develop a dynamic inventory review to adjust quickly to whatever is thrown your way,” Dr. Kogan advised. “And an IV robot compounding program may help buffer the pharmacy department from 503B vendor product shortages.” It’s also important to be adaptable. During one of the surges in COVID-19 cases, she noted, the Maryland team had to take another careful look at all of their compounding and inventory management strategies and make the necessary adjustments to ensure proper stocks. “It hasn’t been easy to balance that with surging patient care needs, but at least we have tools in place from our experiences in the spring,” Dr. Kogan said. “So far, we are managing to stay about one step ahead of the flood.” The sources reported no relevant financial disclosures.

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Pharmacy Practice News - Special Edition June 2022

Articles inside

Advocating for and Implementing IV-WMS

Kienle’s 10 New Building Blocks of Compounding Safety

56% Rate of Adherence to Sterile Compounding SOPs Is ‘Crazy’

ISMP Releases New Guidelines on Sterile Compounding

Pharmacy Relies on IV Robots, Batch Compounding to Cope

BUD’s Impact on Home Infusion Products