16 minute read
TECHNOLOGY
Technology Can Help With Vancomycin Dosing
Houston Methodist Hospital (HMH) is leading a shift this September toward AUC (area under the curve) vancomycin dosing in all eight facilities of the Houston Methodist health system, said William L. Musick, PharmD, BCIDP, a clinical specialist in infectious diseases at HMH’s 1,200-bed flagship location.
“We knew for almost two years this would be the direction of the new vancomycin guidelines, and the direction we had to move,” Dr. Musick said.
Still, to validate this dosing strategy, HMH analyzed target blood attainment levels and patient safety data of approximately 3,500 courses of vancomycin administered in 2018 and 2019, roughly one-third via the newer AUC approach and two-thirds by the traditional trough level–guided method. “We [achieved] a 30% relative reduction in AKI [acute kidney injury] events and a 20% relative reduction in the likelihood of abnormally high or low vancomycin trough levels when guided by AUC,” said Dr. Musick, citing the yearlong research and quality project largely done by Joshua Knight, PharmD, a pharmacy infectious diseases resident at HMH.
HMH’s AUC study predated the new vancomycin guidelines issued in March 2020 by ASHP, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society and the Society of Infectious Diseases Pharmacists (Am J Health Syst Pharm 2020;77[11]:835- 864; bit.ly/3hIFl0c).
Software Help
To help make the AUC shift more effective, the health system has become an early adopter of integrated software—VigiLanz precision dosing powered by Tabula Rasa Healthcare’s DoseMeRx—to handle the complex calculations of the AUC approach. This integrated software became available in April 2020, after the HMH analysis.
“Knowing that AUC leads to more favorable outcomes, it has to be our
—William L. Musick, PharmD
primary method for making dosing decisions. This integrated software eliminates hurdles of complicated math I can’t ask my pharmacists to do,” said Dr. Musick, who heads a team of five infectious disease pharmacists.
HMH has used VigiLanz to aggregate data on antimicrobial usage, dosing and microbiology, and to alert pharmacists about potential antibiotic stewardship issues requiring intervention for the past decade; it has used DoseMeRx to optimize patient-specific dosing for the past five years. Both ran as stand-alone software products, but DoseMeRx will now operate within the VigiLanz platform, which sits atop HMH’s Epic pharmacy management system and Epic electronic health and medication administration records systems, Dr. Musick noted.
This means that patient-specific demographics, laboratory results, medication orders and antibiotic doses administered populate DoseMeRx fields so the software can quickly calculate optimal dosing for adult and pediatric patients. “This expedites dose changes as needed, eliminates the possibility of data entry errors by end users, and saves a lot of labor time. I think we’ll see better patient outcomes,” he added.
The software is cloud-based, accessible to pharmacists via browser, and issues patient-specific alerts by emails and pagers.
COVID-19 Drives Need For Efficiency
The COVID-19 pandemic increased the need for streamlining vancomycin dosing, Dr. Musick noted. The infectious diseases pharmacy team at HMH “easily faced a 25% increase in patients monitored daily on antibiotics, plus the additional workload on investigational agents for COVID-19 because we’re involved in the day-to-day maintenance and screening of all patients in clinical trials for potentially new COVID medications,” he explained in mid-August, when Houston was a hot spot and HMH was caring for between 160 and 170 COVID-19 inpatients.
The added COVID-19 workload made it “quite timely for us getting to speed on this technology, though combining
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two former stand-alone systems also required more IT [information technology] support and infrastructure, new trials, and a huge push by us for metrics,” Dr. Musick said. The HMH beta testing of the technology over the past six months hasn’t yielded data that could be disclosed, because “we’re still validating implementation.”
VigiLanz and Tabula Rasa do not have access to HMH’s outcomes data. But Dr. Musick is seeking a possible collaborative project with both companies to share such data. The goal, he noted, would be to customize use of the programs based on HMH’s patient population rather than generalized patterns of infection and treatment.
Asked to comment, Ronak Gandhi, PharmD, a senior clinical pharmacist in infectious diseases at Massachusetts General Hospital (MGH), in Boston, said, “What Houston Methodist Hospital is doing is a novel, innovative approach. It may provide alternative options to other hospitals that may use both of these software products. Quickly assessing dosing is absolutely of the essence if a patient has sub- or supratherapeutic levels of vancomycin.”
Still, Dr. Gandhi noted that buying third-party software for such initiatives is not the only option, as evidenced by his own experience at MGH. He is part of an antimicrobial stewardship team at MGH that augmented its electronic health record system to monitor patients with positive blood cultures in real time last year, without incurring the expense of third-party surveillance software. “Many hospitals of all sizes could emulate our DIY approach if their stewardship team is large enough and the number of positive blood cultures per day isn’t too great,” Dr. Gandhi said.
If, however, a hospital chooses to partner with a vancomycin dosing software vendor, he suggested a few key factors to consider (box). —Al Heller
The sources reported no relevant fi nancial relationships.
WATCH: Guideline author Michael J. Rybak, PharmD, discusses vancomycin monitoring (bit.ly/33PxPL7-PPN).
4 Tips for a Good Vendor Match
Hospitals need to consider many factors before using third-party software to manage vancomycin dosing. Here’s a good place to start:
1. Size matters. How great is the need for third-party software, judging by how many patients are in the hospital, how many get vancomycin, and which ones get area under the curve-based dosing? There are no definitive benchmark numbers to determine this; rather, base the decision on a hospital’s usage patterns.
That said, hospital and antimicrobial stewardship leadership teams ought to address how to optimize the monitoring of patients on vancomycin. If, for example, there is a good pharmacist-to-patient ratio with a pharmacist on every floor, then the need for third-party software is lower. If there is just one pharmacist for multiple floors, then the need for third-party software to boost efficiency is higher. If a hospital uses a lot of vancomycin, even with a good pharmacist-topatient ratio, it could still require third-party software.
2. Ensure programs are validated. There are several validation steps, but the overall goal is to determine whether a vancomycin software program pulls in the correct data, uses the right pharmacokinetic profiles, can be individualized as needed, and integrates optimally into electronic medical records.
3. Optimize maintenance costs. If your hospital is part of a health system, you may be able to negotiate better contract prices for ongoing maintenance of vancomycin dosing software, although it may require payment of multiple contracts. If your health system has both large and small institutions, is it worth the contract price for smaller institutions that have lower patient volumes that are less acute, compared with focusing efforts on larger institutions with larger volumes of more acute patients?
4. Don’t skimp on education. Expect to educate staff to properly use the software, and count on vendors to be available to help with this.
The ROI on IV-WMS study showing that 23% of the errors detected by a new IV-WMS implecontinued from page 1 were undetectable by the pharmacy’s respectively (P<0.001), for a cost savthat is highly customized,” he said. previous verification practices (Am ings of $144,019 over three months, and “When you are dealing primarily with J Health Syst Pharm 2014;71[15]:1311- a projected annual savings of $576,076 adults, there is much more standard 1317). Of those errors, 167 were judged (Int J Med Inform 2018;115:73-79). dosing, often in premade bags that to pose the potential for adverse drug
There were 1,160 errors detected are frozen and can be reused, so your events resulting in moderate (n=146) during the post-implementation peridollar losses from wasted or missing or severe (n=21) harm. od, with the IV-WMS intercepting 983 errors (84.74%) and pharmacists ‘[With IV-WMS], everybody does everything the detecting 177 errors (15.26%).
The hospital’s total number of doses same way, step-by-step, so you get the same dispensed declined from 110,963 in the pre-implementation study period output. That consistency of process results in a very to 101,765 in the post-implementation consistent product.’ study period, and that decline has —John Hingl, BSPharm remained consistent, said co-author John Hingl, BSPharm, the pharmacy manager at Cincinnati Children’s. “We have not done further calculations of cost savings since we completed the study, but numbers of doses dispensed, if we use that as a metric, have remained proportionally lower. So the cost savings should be continuing,” Mr. Hingl told Pharmacy Practice News .
Some of the savings generated by the new system stem from the ability to efficiently implement changes to the batch schedule. “Although this could be achieved in a manual system, this would be labor intensive as personnel would need to manually sort and print labels required for each batch while real time orders were being created and cancelled,” Mr. Hingl and his co-investigators wrote. “In a large hospital, this can result in wasted doses being compounded IV-WMS Successesssses and new doses being missed unless personnel are continuously dedicated to monitoring which orders are being Reduced wasted and missing IV doses by 14,176 ses by 14,176d b 14 176 cancelled and created. and 2,268 doses, respectively.
“The IV-WMS assists this process by automatically queuing the medicaSaved $144,019 over three months; $576,076 tions to be compounded, discontinues cancelled orders in real time, and annually (projected). prints each label immediately prior to preparation.” Flagged 1,160 errors post-implementation; 983
Mr. Hingl cautioned, however, that intercepted (84.74%). Pharmacists detected 177 implementing batch schedule changes can reach a point of diminishing errors (15.26%). returns. “We started with batches every two hours, and that just overwhelmed Source: Int J Med Inform 2018;115:73-79. our delivery capacity,” he said. “At our institution, we’ve found that between mented at Boston Children’s Hospital two and three IV batches per day is the doses will likely be less. Nevertheless, “Barcode medication administration ‘sweet spot,’ but that will be institutionyou could adopt the methodology from and dispensing have already been provspecific. But regardless of the interval, our study to assess savings from IVen to decrease medication errors, and by using IV-WMS to cut errors and WMS at any institution.” this is now a standard from which nursstreamline your batching, you can still ing shall not deviate,” Dr. Moniz said. reduce 90% of IV drug waste.” Barcoding Function a Major Plus “Pharmacy compounding and
General hospitals and health sysThe primary value of IV-WMS lies manipulation of drugs is often more tems may not find quite the same level in its barcoding function, said Thomas complex than administration with fewof savings from IV-WMS as did CinMoniz, PharmD, the director of pharer safeguards. For me to grab a wrong cinnati Children’s, Mr. Hingl noted. macy operations at Northern Light vial that is a look-alike or sound-alike “In a pediatric institution, we do all Eastern Maine Medical Center, in is so much easier in the pharmacy IV of our doses in a patient-specific way Bangor, and a co-author of a seminal 2014 room, since controls such as profiled
Pyxis Cubie [System; BD] usually don’t exist within the pharmacy.”
Beyond merely detecting IV preparation errors, IV-WMS adoption, with its detailed, barcode-based reports, also aids hospitals and health systems in identifying underlying factors contributing to those errors, said Dr. Lin, an assistant professor of pharmacy at the James L. Winkle College of Pharmacy.
In another study, Dr. Lin and Mr. Hingl and their colleagues found that analysis of the hospital’s IV-WMS error reports identified four significant predictors of error risk (Am J Health Syst Pharm 2016;73[12]:887- 893). One was site of care: According to the investigators, critical care areas
had more errors, which they attributed to the urgency of dosing. Other predictors included staff shift, with the night shift actually having fewer errors than day/evening shifts; day of week, with Sundays and Mondays having higher error rates; and compounding staff type, with technicians having a higher risk than pharmacists, perhaps because of their higher compounding workload. “Risk-factor analysis offers another potential benefit to institutions adopting these systems,” Dr. Lin said.
“But the greatest benefit by far is safety,” Mr. Hingl stressed. With IV-WMS, he explained, “everybody does everything the same way, step-bystep, so you get the same output. That consistency of process results in a very consistent product.” —Gina Shaw
Practical Considerations for Implementation of Biosimilars in Oncology Biosimilar Information Technology Integration:
DOUGLAS HACKENYOS, PHARMD, BCOP
Part 2 of 33
Oncology Pharmacy Clinical Coordinator Department of Pharmacy UConn Health Farmington, Connecticut
As of August 2020, the FDA has approved 9 antineoplastic biosimilars—biologics that are highly similar to and have no clinically meaningful differences from an approved reference product with respect to safety, purity, and potency. 1
As additional biosimilars hit the market, health care institutions face growing challenges in appropriately managing their use. This article is the second in a 3-part series focusing on management and uptake of biosimilars in oncology practice. Biosimilar product selection was reviewed in the first installment, and this article focuses on biosimilar information technology integration. The third article will highlight the role of the pharmacist in provider and patient education about biosimilars. (Part 1 is available at bit.ly/3iVAkSi-PPN.)
Electronic Health Record Build
Successful incorporation of biosimilars into the electronic health record (EHR) begins with well-constructed building blocks: electronic prescriptions or medication records. It is important to recognize that biosimilar products have distinct National Drug Codes (NDCs), billing codes, and names that will not allow them to be interchanged as are conventional brand-name and generic medications. Biosimilar electronic medication records (eMARs) should include the unique NDC, HCPCS J code, generic name (with 4-letter suffix), and brand name associated with each unique product. Comprehensive biosimilar builds minimize look-alike/sound-alike (LASA) errors that may arise with order entry, verification, preparation, and administration (Table). LASA warnings also may be added to each build so they appear on the eMAR and drug labels.
Biosimilar Order Sets
In addition to their many other benefits, electronic order sets and oncology treatment pathways can aid biosimilar uptake substantially. A preferred formulary biosimilar may be set as the default agent in a plan to bolster use and prevent provider confusion at order entry. Statements added to treatment plans and electronic consent forms can be used to further highlight formulary preferences and promote patient education related to biosimilars. Defaulted treatment plans also may assist in streamlining the prior authorization referral process and make the preferred biosimilar selection clear to authorization staff.
Default selection of a preferred formulary product within a treatment plan also must be balanced with a need for flexibility. Ideally, plans should be designed to accommodate third-party payor preferences and nonpreferred products supplied by specialty pharmacies or manufacturer assistance programs. Sophisticated EHRs may allow for “ toggling” between biosimilars and reference products within a treatment plan to allow pharmacist substitution of the required product. Efforts to minimize or avoid use of brand names in oncology treatment pathway titles, plan parameters, and other order set fields outside of the specific medication order may make future substitutions or product conversions more efficient.
Dispensing Technology
Technology within the pharmacy can drastically improve an institution’s ability to incorporate biosimilars into practice. Inventory management systems with electronic barcode scanning can help pharmacy staff differentiate between biosimilars
Table. Tips for Minimizing Look-Alike/Sound-Alike Medication Errors With Biosimilars
Order Entry
Verification
Preparation
• Discrete medication records for each biosimilar with full generic name, 4-letter suffix, and brand name • Default order sets/treatment pathways to formulary product preference • Discrete medication records for each biosimilar with full generic name, 4-letter suffix, and brand name • Minimize need for substitution upon verification
• Barcode scanning • Segregated inventory locations for reference, biosimilar, and subcutaneous product formulations and reference products as soon as medications enter the pharmacy. Biosimilar products may be assigned segregated locations using inventory management technology to avoid confusion during stocking and picking of physical inventory. Barcode scanning, image capturing, and dose compounding verification technology also can minimize preparation errors that may result from LASA biosimilar products. Dose preparation and verification technology also may help prevent preparation errors that may result from differences in the preparation of specific products. For example, vial sizes, reconstitution instructions, and the need for sterile water for injection (SWFI) versus bacteriostatic SWFI vary between singleand multidose trastuzumab products. 2,3 Inventory management and dose preparation may be further complicated by the need to stock multiple biosimilars as well as subcutaneous formulations for any given reference product; barcoding technology is essential to avoid errors in such scenarios.
Medication Administration Technology
Technology greatly facilitates safe administration of all medications including biosimilars. The use of barcode scanning and smart infusion pumps can reduce errors that may come with multiple product options. Many institutions are opting to minimize build and maintenance work for their smart pump libraries by using a single entry under a generic name to address both reference and biosimilar products with identical administration instructions. Some eMARs also may allow the addition of intranet links to drug information and patient education resources for biosimilar products for easy access at the point of care.
Conclusion
Implementation of a preferred oncology biosimilar product is a complex process that benefits greatly from the use of information technology systems. Comprehensive eMAR builds and technology involved in dispensing and administration will support uptake and minimize errors related to biosimilar use. With third-party payor preference being a major factor in determining biosimilar product selection, it is essential to maintain flexibility in eMAR and oncology treatment pathway design.
References
1. FDA. Biosimilar product information: FDA-approved biosimilar products. bit.ly/2G3Pnes-PPN. Accessed September 17, 2020. 2. Kanjinti (trastuzumab-anns) [prescribing information].
Amgen, Inc; 2019. 3. Herceptin (trastuzumab) [prescribing information].
Genentech, Inc; 2018.
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