Episodes
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Host:
Ken Perez, Vice President, Healthcare Policy and Government AffairsGuest Experts
Sarah Kester, PharmD, Pharmaceutical Program Manager, Omnicell Specialty Pharmacy ServicesMatt Manning, PharmD, Senior Director of Operations, Health Systems, Omnicell Specialty Pharmacy ServicesEpisode Highlights
Q: What does an advanced clinical adherence monitoring program entail and what does the Omnicell Specialty Pharmacy Services team do to impact adherence to XIFAXAN?
Sarah Kester:The process for our team starts at the very beginning of the lifecycle of the prescription. In a typical big box or PBM pharmacy scenario, when a prescription for XIFAXAN is received and prior authorization (PA) is needed, then the pharmacy would send that insurance rejection back to the provider and basically do nothing until they hear back from the provider that the prescription has been approved. Meanwhile, the patient languishes without their medication.
When you send your prescription to your health-system-owned pharmacy, as soon as we receive the referral and it's determined that a PA is needed, the pharmacy goes right to work on completing the PA. Our team members are very well versed in the requirements for PAs and we have a PA approval rate of over 92%.
Once your PA is approved, then our clinical team takes over and we contact the patients. We provide them with in-depth counseling, check for any drug interactions, and educate the patient on the medication and desired outcomes for treatment.
After the initial counseling and delivery of the medication, we continue to perform clinical follow up on a monthly basis for each patient. Seven to ten days before their refill is due, follow up calls are made to every patient. At that time, we monitor for side effects, efficacy of the medication, and any hospitalizations the patient may have experienced. We also provide monthly reminders that the patient should be on this medication for long-term maintenance and should not stop unless directed by their provider. We provide 36 months of follow up for the patient as part of our partnership with Bausch
Q: Now Sara, what benefits do you see from this intensive follow up with patients?
Sarah Kester: Our most important finding is the increase in days on therapy for our patients versus the national average. The average days on therapy for all XIFAXAN patients is around 5.4 months. However, patients that participate in our program are on therapy for about 9 months.
What's the importance of a patient getting a few more months of treatment? Quite simply, it results in patients living longer, having a better quality of life, and staying out of the hospital.
One of my favorite stories involves a patient who started on our program after being prescribed XIFAXAN after an episode of hepatic encephalopathy. This episode of HE resulted in him losing his driving privileges. When we started out, we had to speak with his caregiver because his cognitive deficit was too great for him to speak with us directly. But, after getting him established on treatment, his symptoms abated and now we're able to speak with him. He was even able to start driving again and every month he mentions that when we do our follow up. Getting his freedom to be independent back was such a great experience for him.
Q: Let's take this up a level. Patient adherence is just one of the many challenges associated with operating a specialty pharmacy and optimizing results. Matt, what are some other common core challenges that impact specialty pharmacies and how can health systems ensure they are positioned for success?
Matt Manning:There are a lot of considerations when it comes to launching and scaling a specialty pharmacy and we're energized to support health systems and position them for success. Let's start with manufacturer relations. Manufacturer limited drug distribution can be a huge barrier for a new specialty pharmacy. Many drugs today are distributed through a limited network of pharmacies at the discretion of the manufacturer. These drugs could be limited for a variety of different reasons — whether it's REMS considerations, storage considerations, or cost.
I recently read that 48% of the specialty pharmacy pipeline consists of products aimed to treat orphan disease states. When you include Oncology, that number is 80%. Those are the hallmark disease states that are going to be challenging to get access to. A new specialty pharmacy will need to validate its operation, providing manufacturers with confidence that they possess the capabilities and expertise necessary to handle their drug and serve patients.
Omnicell Specialty Pharmacy Services wants to ensure you gain access to limited distribution drugs as quickly as possible. We support this effort through our existing manufacturer relationships and SOPs. We’re able to have great conversations with manufacturers regarding their products anchored in the SOPs, policies, and programs we’ve developed to convince these drugmakers to grant LDD access to the specialty pharmacies we partner with.
Another core consideration is access to payment networks. Again, these are limited for a variety of different reasons. Payers will restrict certain products and medications and patients to be serviced through their preferred pharmacy operation.
We really take a unique approach to addressing the barriers of access to payer networks. Omnicell Specialty Pharmacy Services manages its own PSAO. This allows us to get into a majority of networks very quickly and allows our team to help support audits, payer relations, and negotiations.
Another consideration is capture rate. What I mean by that is the value of medications being sent to your pharmacy. We're thinking about helping a health system build a lucrative specialty pharmacy business. From this perspective, we work with health systems to examine the different clinicians and specialties driving specialty prescriptions in their organization. We determine which of these providers and operations should be prioritized, and we measure ourselves on that. Our goal is typically a 75% prescription capture rate, meaning referrals coming into the health system-owned specialty pharmacy. This translates to savings and revenue growth for our health system partners.
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Guest Host:
Dennis Wright, Senior Director, Product Marketing
Guest Expert
Berkley Sykes, Pharmacy Operations Manager, Huntsville Hospital
Episode Highlights
Q: Can you give an overview of Huntsville Hospital and some of your early experiences with IV robotics and how you're using them at Huntsville?
Berkley Sykes: Huntsville Hospital is a 971-bed community hospital. It's located in Huntsville, Alabama. We are the flagship of twelve hospitals within the Huntsville Hospital Health System. As the hospital pharmacy operations manager, I provide operational leadership and strategic guidance for inpatient and outpatient sterile compounding, centralized services, inventory management, and pharmacy. Most ops managers get to wear many hats, but my favorite is sterile compounding and IV robotics. For the past 20 years, I've been able to provide direction for sterile and hazardous compounding regulations, IV workflow, technology implementation, and IV robotics. Both of those journeys began for us back in 2013, as well as clean room design construction throughout the hospital system. I've been fortunate enough that I've been highly involved in seven to eight cleanroom builds over the years, which I enjoy. And most recently, I led the design and construction of a standalone IV robotics center that was established to add our new Omnicell IVX Station compounding robots.
Q: So, Berkeley talking about your experience with IV robotics, I know it goes back a long way. Can you take us back to the early days of why Huntsville Hospital started to go down this path and decided to leverage IV robotic technology as part of your pharmacy operation?
Berkley Sykes: I've been asked why we chose IV automation. Our main objectives have stayed the same since the beginning. They are safety, and they are savings. And while I would love only to say safety, the savings help us pay for the safety. But fortunately, these two go hand in hand. IV Robotics allows us to prepare medications without human inconsistency safely, and that, in turn, reduces our dependency on outsourcing. So, this provides a two-pronged result of saving us a significant amount of money by not purchasing these expensive 503B drugs. It also reduces our exposure to the quality assurance issues that we all know are inherent with the 503 D products.
It's been such a long, exciting road from when we first got IV robotics to now, we have the IVX Station, and one of the main reasons we made this change was based on regulations. I’m glad we've created this shift to IVX. It's going to be beneficial for us.
Q: When you implemented the brand new IVX station that you referenced, can you talk a little bit about what that transition looked like, the overall implementation process itself, and then any early impacts that you've seen?
Berkley Sykes: As with any significant go-live, I'm sure you can close your eyes and picture this. All the people running around and planning and working and making this happen. It was hectic, but many Omnicell people were involved in the project for weeks. We had engineers, and there was project management, a product team, and all kinds of people in and out who were helping us. They were fixing things and educating and teaching us what to do. And a big part, too, is that they were listening to us. The leaders and the developers at Omnicell are always thinking about our best interests. We've already had some releases of some new updates based on our program's needs, and they have our best interests in mind for future roadmap updates. That part has been just incredible for us.
Q: Do you have any other advice you would give to some of your peers at different hospitals and health systems around best practices for gaining that support and adoption with other stakeholders within your organization?
Berkley Sykes: It's such a good question, and it's something that hospital and pharmacy leaders struggle with. Robotics can be very complicated. Think about your pharmacy, where you want to be, how it elevates your pharmacy, and the safety it brings. And so, to be able to sell that, one of the big pieces is safety. And all those things you mentioned are so proper about removing the humans and how much safer the robot is just inherently in its design. So, looking at errors may be that you've had with manual preparations or errors that you've had from 503Bs, mainly if you outsource. If the question comes up, how will you pay for this? If you are outsourcing, that's number one because you can bring all that stuff in-house. IV robotics also helps manage waste, meet regulations, and have ready-to-use products that you do not have to outsource.
Q: You mentioned going live with the new IVX station earlier in 2022. Can you share metrics, wins, or successes you’ve had since implementing the brand-new IV robots?
Berkley Sykes: We have been delighted with the progress we've made so far since our go-live. That was mid-July, and we've had about 7,900 preparations utilizing the IVX. Just last week, we started moving into our second phase, adding some new drugs, and we're just going to keep adding more preps, and we expect our volumes to continue to increase. We expected to have some high yields based on our experience with the IV robots, but these are just truly impressive and consistent. We've been at 98 percent for both the robot passes and the pharmacist quality checks. That's been fantastic. The technician and robot operators have been amazed by the throughput rate and speed.
Q: Sterile compounding has undergone significant technological, regulations, and oversight changes for years. With that said, where do you see the future of IV automation and where it may be heading?
Berkley Sykes: I've watched Omnicell adapt to the changes and stay a step ahead for the sake of their customers and our patients. And this includes improving old technology, listening to our requests and needs, for example, the faster speed and increased reliability, and helping us continually address how Ivy Robotics is different in terms of safety to regulatory agencies such as USP and FDA. And I hope it will all culminate in recognizing IV robotics compounding as vastly safer than human compounding.
Q: What would you like to say to others thinking about implementing IV robotics into their health system?
Berkley Sykes: I was exactly where many of our listeners were years ago. And I know what many of them may be thinking because I was thinking the same thing. And that is that Ivy robots. They seem scary. They are expensive, and they seem complicated. They are complicated. They are not toasters. That's what I like to tell everyone. But any hospital can overcome these fears.
With dedication and partnership, they can realize the value and potential of IV Robotics as a means to enhance patient safety and reduce costs. Like we've been talking just. As with any worthy effort, there will be growing pains, and you must be patient. But I have never once in all these years regretted having IV robotics. I'm passionate about it, and I hope to see a day when all IV preps are going through some technology, IV workflow, and robotics in the name of safety. I really, truly hope to see that one day.
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Episode Highlights
Q: Please tell our audience about your pharmacy background and experience leading key areas in pharmacy and respiratory care at Texas Children's Hospital.
Jeff Wagner: I oversee our pharmacy, respiratory care, and ECMO services across Texas Children's Hospital. Texas Children's has three hospitals in the greater Houston area with nearly 900 licensed beds. According to the U.S. News and World Report, the system consistently ranks among the top children's hospitals in the United States. Across the enterprise, we have close to 5 million patient encounters and 35,000 inpatient admissions annually, especially for our pharmacy operations and a team of over 600. We rely on automation and advanced technology to support safe and efficient medication use processes and provide care to our community's children and women. As an innovative leader, Texas Children's has sought the most advanced technology available, including automated medication dispensing systems and robotics to interface directly with automated dispensing cabinets.
Q: Can you please tell us more about how you use pharmacy technology and automation at Texas Children’s?
Gee Mathen: We can track every node within our environment within the visibility piece. So, this is the first step into a multi-layered process as we move forward. Our goal is to track individual doses from all seven stages of the medication management process, from procurement, storage, ordering, dispensing, administration, monitoring, and reporting. So, all of these pieces start with automation, and technology is a crucial component. The software aligns it as well to integrate the systems. I think that’s key to the success we’re trying to drive here.
Q: Can you tell us more about your role and how Texas Children’s has used automation to transform your pharmacy to benefit your patients?
Gee Mathen: My role here is the fun part. I get to put in the technology and ensure that we accomplish the vision and dreams that Texas Children's have set forth before us. We're a leading pediatric hospital, and super excited that we're number two this year in the U.S. News and World Report. We want to keep our patients safe, especially when the lives of children, mothers, and babies are at stake.
We chose a central pharmacy dispensing service, an automated central pharmacy system, and robotics to gain all the benefits, including increased medication safety through 100 percent barcode scanning, heightened inventory visibility, decreased redundant tasks, and reduced medication waste.
Texas Children's was already using automated dispensing cabinets to dispense about 1.3 million doses annually. Before we adopted the extra two automated central pharmacy systems from Omnicell, the hospital used a different solution to restock cabinets. The solution caused medication waste, was error-prone, and excessively relied on pharmacy personnel for manual labor and inconsistent practices. With the substantial use of automated dispensing cabinets, we needed to simplify the patient-specific dispensing process of the new automated central pharmacy system to improve the ADC restocking procedure to drive visibility and efficiency in drug dispensing throughout our healthcare system.
Q: Recognizing the difficulties in previous restocking workflows, what solution did you identify and implement?
Jeff Wagner: We partnered with our medication management technology partner to employ the automated central pharmacy system to fit our institution's specific requirements by dispensing patient-specific and cabinet restock medications to address the problems with previous restocking processes.
Q: How did you prepare to deploy the pioneering workflow at your hospital?
Gee Mathen: Over two years ago, Texas Children's and Omnicell collaborated on the automated central pharmacy system and robotics, which was improved to restock ADCs. Jeff and I had the privilege of going and taking a look at this in the early inception stages. When we saw it, we said, hey, our future will be different. It was a light bulb moment. Our pharmacy informatics teams ran several tests to ensure a smooth transition. When we finally moved forward with our new robots. They developed a workflow to restock the ADCs from the automated central pharmacy system. We also had interdepartmental cooperation amongst the executives, pharmacy informatics team, pharmacy inventory team, and other participants. They were all essential to the workflow's success.
Q: When and where did you begin the new workflow? And can you walk our listeners through a typical day of that workflow?
Gee Mathen: The cabinets are organized by the areas they service. The automated central pharmacy system is notified each morning via automated restock notifications for the cabinet groups. It creates medication bags with one cabinet's worth of drugs in each and then processes requests for those cabinets one group at a time. Medication bags are dispensed and sorted into bins for each cabinet. Once the bin's contents have been transferred, they are scanned using an in-house barcode program to confirm that they go into the right cabinet.
Q: Can you please describe the following steps and areas of the workflow?
Jeff Wagner: The XR2 dispenses medications and groups by the automated dispensing cabinet. The pharmacy inventory technicians use these bar-coded cabinet bags to restock each ADC with the required amount of medication. Pharmacy technicians then scan the medication barcodes to double-check the accuracy of transferring the medications from the bag to the ADC bin. An in-house dashboard keeps track of progress in real-time all day long. And we analyze this data from each process step to identify opportunities to improve the process and its safety and efficiency.
Q: It sounds like automation and the central pharmacy that fills cabinets have made a big difference for Texas Children’s. What benefits could our listeners experience in their health systems and pharmacies?
Gee Mathen: Industry-wide doses dispensed from cabinets grew from approximately 25 percent to over 75 percent from 2002 to 2020. There are now more cabinet-filling workflows in hospitals driven by automation and robotics. Other advantages to central filling are safety scanning and verification and the efficiency of pulling medications from a single location instead of all over the pharmacy.
Q: What automation solution exists now that is different from the past?
Jeff Wagner: After 30 years of manual and inefficient processes to fill cabinets, we now have access to automated central pharmacy systems. Some of the ones we have in use at Texas Children's provide the efficiency and safety necessary to distribute medications to patient care areas in larger quantities. The central pharmacy dispensing service and associated processes ensure our pharmacy automated robotics run at the highest level throughout the technologies lifecycle. The automated central pharmacy system offers many benefits when handling cabinet filling. It supports picking larger sizes and weights that accommodate cards and strips of doses, as well as boxes of vials. The system does not require repackaging medications by supporting manufacture, and packaging, including 90 percent of non-IV form factors. And when we remove the need for repackaging, we remove a step that creates an opportunity for human error, further supporting a safe environment.
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Because of high demand and limited supply, there is a nursing shortage in the United States. COVID-19 has reminded us of the importance of nurses in our lives and why we must invest in them. Learn from prominent healthcare experts how to limit the impact of nursing shortages by leveraging intelligent infrastructure, automation, and data intelligence.
Participants
Lisa Smithgall, Senior Vice President and Chief Nursing Executive, Ballad HealthTrish Tanner, Vice President and Chief Pharmacy Officer, Ballad HealthGuest Host
Sabrina Cole, Director, Autonomous Pharmacy Advisory Board, Omnicell -
Find out how pharmacy leaders break down these data silos with advanced analytical tools that provide visibility, insight, and workflow enhancements, leading to inventory optimization and cost reduction.
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As retail pharmacy continues to expand its critical role in the patient’s healthcare journey, it has become increasingly important to streamline and automate inefficient pharmacy operations to free up pharmacists’ time to focus on patient care. Learn how pharmacies are leveraging advanced digital technologies that enable them to improve patient engagement, optimize revenue performance, and deliver high-value clinical services.
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The Operating Room is a dynamic setting. The medications used are high risk and need immediate monitoring and oversight. At any moment, a patient’s condition can turn critical. Find out how pharmacy and anesthesia leaders at Atrium Wake Forest Baptist implemented solutions to help them ensure patient safety, drug availability, and compliance.
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Health systems are continuously being challenged to ensure IV preparations are prepared safely and accurately while complying with increasingly complex regulations. As a result, many rely on 503B outsourcing pharmacies to provide the vast majority of their pre-mixed compounded sterile products. But as product shortages and pricing fluctuations in the supply chain become more acute, rather than provide relief, 503Bs actually can put more pressure on pharmacy staffs and budget.
Joining host Ken Perez to discuss are pharmacy leaders who met those challenges by going against the trend – by insourcing their sterile compounding, with a twist.
Joseph J. DiCubellis, RPh, MPH, Senior Director of Pharmacy Services for the University of Maryland Medical System and Senior Director of Pharmacy, University of Maryland Medical CenterYevgeniya Kogan-Hardesty, PharmD, BCSCP, Sterile Compounding, Pharmacy Manager, University of Maryland Medical Center -
Persistent labor shortages are forcing health system pharmacy leaders to rethink their operational and clinical choices. Learn how innovative leaders at Owensboro Health are sidestepping labor issues, up-leveling clinical programs, and optimizing medication management processes with advanced robotics and software operated by a dedicated resident expert.
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You can’t manage what you can’t see. When pharmacy leaders at St. Jude Children’s Research Hospital and their teams made their medication inventories visible through intelligent data solutions, they were able to make better decisions for their patients, workflow, compliance, and financial performance.
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Medication compounding practices are again under scrutiny from authoritative bodies. And also focusing attention on the benefits of IV workflow and robotic technology. Special guest Kevin Hansen, Assistant Director of Pharmacy at Moses Cone Memorial Hospital, sits down for a far-reaching interview. Kevin call for barcode scanning of compounding ingredients as a minimum required standard. And he explains how changing perspectives can lead to greater adoption of compounding technology across health systems.
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Anesthesia providers need easy access to medications in the operating room. Pharmacy needs to keep medications secure. Achieving that delicate balance in the OR pressure cooker between access and accountability requires an aligned vision, dynamic communications, and enabling, closed-loop technology.
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Central pharmacy is the hub of care that patients and providers depend on. Which is why pharmacy leaders follow a deliberative, collaborative approach when choosing a medication distribution model. Hear how two pharmacy leaders approached the matter of distribution models, but arrived at very different destinations.
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The 340B Drug Pricing Program continues to prove itself as a vital source of billions of dollars of funding for much needed patient care. Yet, aspects of the program today are facing significant challenges that threaten the very foundation of the program and our safety-net providers. To sort out these legal, policy, and financial complexities, we’re joined by the definitive 340B Program insider, Ted Slafsky.
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Pharmacy dashboards are no longer enough. To manage organizational complexity and make better informed decisions, pharmacy leaders need dynamic intelligence tools. Learn how emerging technologies, including predictive and prescriptive analytics, can take medication management to the next level.
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The Autonomous Pharmacy Advisory Board has launched a free, self-assessment tool to help health system pharmacy leaders determine their current state performance against five key dimensions: safety, efficiency, regulatory compliance, financial performance, and human resource management. Learn how pharmacy leaders from Baptist Health are using their self-assessment results as a strategic tool to chart a pathway to achieving a fully autonomous pharmacy.
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Pharmacy leaders continue to be frustrated by pharmacy technician shortages. In some cases, the labor issues are getting so severe that – ironically – leaders face having to postponing automation projects because they don’t have enough qualified technicians to manage the technology.
Learn how pharmacy innovators are overcoming technician turnover headaches with new, subscription models, helping them to realize the full benefits of pharmacy automation.
Guests:
Matt Baldwin, PharmD, System Pharmacy Director, Aultman Health Foundation Dave Young, PharmD, Network Director of Inpatient Pharmacy, Einstein Healthcare NetworkHost:
Ken Perez, Vice President, Healthcare Policy and Government Affairs, Omnicell
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Learn how health systems can leverage a vibrant, pharmacy-finance partnership to drive successful 340B programs, and allow pharmacy staff more time to focus on patient care. Find out why 340B program management has evolved, the program challenges that health systems still face, and the data and operational complexities that necessitate a cross-functional approach.
Guests:
Eric Iorfido, PharmD, 340B Program Manager, Penn Highlands DuBois, PA
Charles Hirner, RPh, Senior Director, Omnicell 340B Operations
Host: Ken Perez, Vice President, Healthcare Policy and Government Affairs, Omnicell
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Host: Ken Perez, Vice President, Healthcare Policy and Government Affairs, Omnicell
Guest Expert: Arpit Mehta, PharmD, MPH, MHA, Director of Pharmacy, Allegheny General Hospital
Episode Highlights
What were some of the supply chain issues you experienced with compounded sterile products (CSPs)?
Arpit Mehta: Similar to other facilities across the country, we outsourced a lot of our ready-to-use medications from 503B vendors, primarily critical care drips, such as norepinephrine, phenylephrine, and vasopressin. Also some OR syringes like ephedrine, neostigmine, phenylephrine, succinylcholine, and others.
The challenge was balancing demand with inventory on hand to reduce waste.
For example, during the winter months, our vasopressin and norepinephrine usage would increase significantly but we couldn’t get the supply that we need. We would compound the medications in our clean rooms, but were constrained by beyond-use dating. This prevented us from putting medications at room temperature in automatic dispensing cabinets or anesthesia carts.
How did these supply chain issues impact operational and clinical decisions?
Arpit Mehta: This became a huge inventory management concern. It was a constant struggle to keep up with the demand that we had. Certainly, shortages played a huge role in in hindering our day to day operations—trying to balance inventory versus what we needed, when we needed it.
When our 503B vendor went out of business, we switched to another 503B vendor. That company also ultimately went out of business.
I would go to our hospital nursing huddle on a daily basis and have to discuss the shortages. I remember seeing the look on their faces when I told them, “Today we have fentanyl, tomorrow we have dilaudid.”
We knew we needed to get ahead of the problem, that we needed to get control over our inventory. After conversations with the VP of Pharmacy and the hospital CEO, we started exploring solutions.
What other challenges did you uncover during your analysis?
Arpit Mehta: It’s important for us to have standardization in our cleanrooms, so that we are consistently using the same compounding processes, not only in the hospital, but across the health system. That we follow the same beyond-use dating procedures, completing all documentation the same way, and so forth. Standardization allows us to run reports and do data analytics on the back end to improve efficiency, and to ensure safety and quality for all preps across the network.
Why did you choose the IV robotics service solution?
Arpit Mehta: We were struggling to fill our regular technician positions. We didn’t want an automation solution that required us to rotate a group of technicians through to learn the technology and to compound the medications. We decided on the Omnicell service program that provides the staff to help run the robotics compounding program.
The experience has been amazing. It really helped us focus, prioritize, and have technicians dedicated to the robot. They know the robot inside and out. They know the capacity, they can push the capacity to the limits. It’s helped us really expand the program quite a bit.
How did your operational processes change with IV robotics?
Arpit Mehta: “If you don’t measure, you don’t know.” That’s the challenge with manual compounding – there’s no way to measure accuracy. With our automated solutions, each prep is measured with gravimetric / volumetric verification. It gives us 100% confidence that everything we compounded in cleanrooms is accurate.
Another key is having a dedicated cleanroom supervisor and a well-trained team. It’s helped us to ensure appropriate processes are followed for checking the medications for robot compounding, for the quarantine process, for controlled substance management, and for tracking all production, minimizing waste, and things of that sort.
What has IV robotics solution enabled you to do?
Arpit Mehta: The operational benefits have been tremendous. We’re saving a great amount of time because we no longer are trying to figure out what we have on hand and what to compound. Just the shortage management piece has been huge. We’ve been able to produce what we want, when we want, and to reduce waste.
From a financial perspective, it’s been a huge success for us. We used to spend about $2.5 million with 503B vendors. By insourcing with the robot and service technicians, just in the last year—and really, it’s only six months of production—we’ve saved almost $700,000. And that’s after paying for the robot and service.
Clinically, it’s great because we don’t have to decide whether we were going to use fentanyl today or dilaudid. The clinical team can make that decision, without operational challenges dictating that patient decision.
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