I love pharmacy IV room workflow and technology, but I don’t get to talk about it much anymore. Most of my conversations these days are focused on IV room regulation, i.e. compliance with USP <797>/<800> and Board of Pharmacy rules. So you can imagine my surprise when two people approached me on two completely different occasions at two unrelated events asking my thoughts on IV room technology. Awesome! Then they asked me what I thought about using robots in the IV room. Bummer. Of all IV room technologies, robotics is my least favorite.
Image owned by Jerry Fahrni, Pharm.D. Taken February 12, 2014.
Ten years ago, I was optimistic about IV room robots. Today, not so much. If I could sum up my opinion in one sentence, it would be that highly-automated robotic systems for sterile compounding are not ready for prime time. Note that I said highly-automated and not fully-automated. Even though robots replace human hands for the actual compounding process, they are dependent on human hands for moving products in and out of the robot before, during, and after the compounding process. When considering IV robotics, one should always think about:
Patient safety – Can robots reduce CSP errors? Certainly, but so can most any IV room technology that utilizes bar-code scanning, gravimetrics, imaging, etc. Often times people will tout robotic systems for consistently compounding drugs within 5% of the prescribed dose. It’s not really a big deal. Doses slightly outside the 5% range are not clinically significant, and getting it within that range is not important enough by itself to warrant the investment in a robotic system. Given proper guidance and a system for compounding, particularly an IV workflow management system, humans can easily be as accurate.
Worker protection from hazardous drugs (HDs) – There is no question that IV robots have the potential to reduce worker exposure to HDs during the compounding process. Then again, new USP <800> guidelines do the same. Ever heard of a CSTD?
Workflow efficiency – Not sure a robot brings you increased efficiency unless you’re talking about single batch high-volume IV production. I sat for hours watching IV robots doing their thing in pharmacy cleanrooms across the country. I don’t think I ever thought to myself, “dude, that thing sure makes things easier/betterâ€.
Cost reduction from moving outsourced CSPs back in house, i.e. no longer having to purchase CSPs from a third party – Not specific to robots. Perhaps for single batch high-volume IV production, but doubtful.
Reduced waste from discontinued orders falling off work queues before they are filled – Sure, a robot can help with this, but the same is true for almost any IV workflow management system.
Comprehensive documentation for regulatory compliance – These systems certainly collect lots of data but how easy is it to use? Just because the system collects info doesn’t mean you can get it out when you need it. I’ve seen things. Just sayin’.
Return on investment (ROI) – What do these systems give back? There are few pharmacies where IV room robots will result in a positive ROI. I’ve seen pharmacies try. While their arguments may sound good on paper, in practice they are as thin as the paper they are written on. The only time these systems yield a real ROI, in my opinion, is when they are used to repetitively compound the same few items over and over again – in other words, batch compounding for high-volume items. All of the systems have roughly the same throughput, which is much lower than that of a highly skilled technician. IntelliFill i.v. is the fastest of all the robots I’ve seen, but it is limited in scope to syringes.
Formulary limitations – One of the major limitations of IV robots is the number of formulary items they can handle. During visits to facilities using IV robots — San Francisco, CA; Asheville, NC; Baltimore, MD; Madera, CA; and so on — I saw very few medication “line items†assigned to the robot. The largest number I witnessed was somewhere around 10, and the smallest number was two. Two! Someone had a million-dollar robot making CSPs out of two drugs. Hospital formularies are large and diverse. They include all kinds of IV products: piggybacks, large-volume parenterals, syringes, and so on. Not to mention that formularies change all the time. The inability of these systems to manage a large number of different CSPs at one time is definitely a limitation.
Maintenance – What does it cost to maintain these bad boys? They don’t operate on a zero cost. They also don’t maintain themselves. Operational resources required for things like robot maintenance, formulary maintenance, product changes, and so on are important considerations to keep in mind when purchasing a robot. Who is serving who…. or is that who is serving whom? I can never get that right. Anyway, the time, energy, and effort required to keep an IV robot at peak operational efficiency simple isn’t worth it. At least not in my opinion. In a nutshell, I’m just not a fan of the current crop of IV robots. Does that mean that there is no future for robots in sterile compounding? On the contrary, I think we must move toward a future where all CSPs are made by robots. It’s the only thing that makes sense. Unfortunately, that future is still far off. I’ve had the opportunity to peak behind the curtains at a few robots currently under development. There are some great products coming down the pike, but we are going to have to wait a while. Apparently, building robots with creative new features is hard.
This year’s ASHP Midyear Clinical Meeting was held at the Ernest N. Morial Convention Center in New Orleans, Louisiana on December 6 through December 10, 2015. For many, the Midyear Meeting is about the latest in clinical advances, but for me, it’s an opportunity to see all the new pharmacy automation and technology. And the best place to see the latest and greatest technology is in the exhibit hall.
Below you will find my thoughts on what I saw while roaming the exhibit hall. By no means is this an exhaustive list, but rather items that I think are worth mentioning and thinking about.
PHARMACY CLEAN ROOM
“Sterile compounding is a significant but perilous core pharmacy process in dire need of improvement.†– ISMP Jan 2015
The pharmacy clean room (a.k.a. iv room) continues to get a lot of attention, and rightly so. With the introduction of USP Chapter <800> and proposed changes to USP Chapter <797>, the clean room is on everyone’s mind. This year’s exhibit hall was a direct reflection of this.
The clean room automation and technology space is It was bound to happen. Over the past few years, several vendors have introduced products designed to help pharmacists with compounding sterile products or meeting clean room regulatory requirements.
Aesynt is now part of Omnicell and CareFusion is part of BD. BD has had more time to ramp up their messaging and it was obvious in their exhibit this year.
The Plus Delta Technologies booth was empty. Plus Delta’s products include PD, a medication tracking system, and IVTtrac, a semi-automated iv workflow management system. It is unclear whether the company has been sold, has gone belly up, or is simply keeping a low profile
APOTECA was not present in the Midyear Exhibit Hall this year. If you recall, APOTECA is the company responsible for APOTECAchemo, a robot for compounding hazardous drugs. Last year about this time they introduced APOTECAps, a semi-automated iv workflow management system. The company was conspicuously absent.
There was a good number of booths offering clean room consulting. More than I’ve seen in past years.
Aesynt – previously McKesson Automation, now part of Omnicell – was focused on data analytics in the clean room with two new products: REINVENT and Formulary Tool Kit (FTK). I wrote about REINVENT after the ASHP Summer Meeting in Denver. FTK is a tool designed to help pharmacies extend BUD in the cleanroom.
BD and Baxter seem to be running parallel races. Baxter had a press release at the meeting that focused on DoseEdgeBD did the same for Cato. Baxter will be pushing their Epic integration in the coming year.
Baxter was showing off their DoseEdge scales for the first time ever at a Midyear event. DoseEdge has had gravimetric functionality for quite some time, but the concept has never been popular with their customers. Apparently that has all changed. Based on conversations with insiders, this appears to be a direct result of pressure from BD’s gravimetric-centric approach.
Imaging platform and scales from DoseEdge (left) and BD Cato (right)
MedKeeper showed off a new booth at Midyear with Verification front and center. Verification is MedKeeper’s semi-automated iv workflow management system. Something that caught my eye while I was in the MedKeeper booth was the images captured by Verification. They’re really quite good. I was especially surprised to find that some of the images I was looking at were taken from outside an isolator. That’s right, the device was mounted outside the isolator, thus limiting the hardware in the hood.
Verification by MedKeeper – images shown on screen taken from outside an isolator
Talyst had Talyst IV Room on display. Talyst IV Room is part of the company’s mobile inventory management solution and offers users the ability to build IV kits utilizing barcode scanning for verification, as well as the ability to track sterile preparations throughout the compounding process.
Talyst IV Room product on display
Grifols introduced a new hazardous drug compounding hybrid robot, Kiro Oncology. Kiro is a bit different from previous robots as it uses two robotic arms to compound sterile preparations. It’s an interesting concept.
Kiro Oncology robot from Grifols
Compounding robots were out in full force: Aesynt with v.STATION, ARxIUM with RIVA, and Grifols with Kiro Oncology.
RFID-ENABLED TECHNOLOGY
RFID-enabled technology was more prevalent at this year’s ASHP Midyear than I can recall in previous years. Booths that had RFID-enabled products on display were typically busy, and the people in those booths were engaged in conversation.
Does this mean that pharmacy has finally turned the corner on RFID? Perhaps, but the technology still has some barriers, both real and perceived to overcome. It is clear to me, however, that RFID has niches in pharmacy and vendors are finding those niches.
Three booths that I thought were particularly busy were MEPS Real-Time, Inc., Kit Check and FFF Enterprises.
MEPS Real-Time, Inc. was showing off their Intelliguard RFID system, which includes an RFID-enabled medication tray management system, controlled temperature cabinets (CTCs) – both refrigerated and room temperature – and a virtual logbook for tracking medication trays.
Kit Check had their “Little Blue Box†scanning station in the booth, which is part of their RFID-enabled medication tray management system. In addition, Kit Check was showing off their RFID-enabled Anesthesia Check system, which I thought was pretty cool. The design is well thought out and offers some nice functionality.
FFF Enterprises is a distributor of plasma products, vaccines, biopharmaceuticals, and biosimilars. Part of their product line includes Verified Inventory Program-Consignment (VIPc), which includes RFID-enabled refrigerators that offer automatic track and replenishment for their product line. Cardinal Health does something similar.
SencorpWhite was on hand with a small booth providing information on their RFID capable carousels. They didn’t have a physical carousel in the booth as in previous years, but instead opted for literature and a looping video to support their product offering.
PharMEDium announced that they will be making pre-filled syringes with RFID tags embedded in the labels. This is big, but the announcement went unnoticed by many. I wouldn’t have known about the move had I not been speaking to one of the vendors mentioned above. I verified this with one of the PharMEDium executives and was informed that the RFID-enabled pre-filled syringes will not be proprietary to any single company, and will be made available to anyone looking for pre-filled syringes with embedded RFID tags.
COLD CHAIN TECHNOLOGY
It has been clear for quite some time that refrigeration is going to be important for the next generation of pharmaceuticals, including biologicals. Pharmacies will need to invest in and utilize better security, as well as real-time monitoring for temperature, humidity, and inventory.
The exhibit hall was full of vendors offering real-time monitoring. Have a data connection, i.e. “the internet� If so, then you have everything you need to use many of these systems. Vendors are offering cloud-based storage of information, which means anytime, anywhere access to data. Real-time monitoring and alerts mean that pharmacy directors will have peace of mind that their pricey inventory is in date, properly stored, and in stock. It’s a win-win.
All the major pharmaceutical grade refrigerator vendors had a presence in the exhibit hall: Helmer, Follett, Migali Scientific. Not to mention seeing many other vendors with one of these brands in their booth. Partnerships and alliances appear to be the most efficient method of ensuring that you can offer a refrigerated solution to your customers.
Some items that I felt were particularly interesting in the cold chain area:
RFID-enabled refrigerators. See the section on RFID for more detail.
The Evolve line of pharmacy-grade refrigerators from Phononic were quite impressive. These refrigerators are powered by SilverCoreâ„¢ Technology. They have no compressor, meaning they have no mechanical parts, run quiet, use less electricity, and generate less heat. The refrigerators use solid-state heat pump technology coupled with a non-hazardous, non-toxic refrigerant. In addition, the units provide alerts for temperature, door, battery, memory, loss of Wi-Fi, and loss of power. Check the image below showing the solid-state “pumpâ€.
Phononic compressor-free refrigeration technology
Vaccine Smart-Fridge. I wrote about this back in September. The Smart-Fridge is an interesting concept. The system offers single-point access to vaccines, providing real-time alerts on inventory shortages and temperature. Automated temperature monitoring ensures that things stay within their appropriate temperature range, and analytics and historical dispensing data are collected and made available to the user.
STRIP PACKAGING FOR AMBULATORY CARE
Strip packagers have been around for a long time. They were popular in acute care for a while, but not so much anymore. However, there appears to be renewed interest in the technology for use in ambulatory care pharmacy, especially as a method of improving medication adherence. I spoke to several strip packaging vendors that are seeing renewed interest in the technology. Most attribute this to the introduction of strip packaging as a medication adherence platform made popular by recent coverage of PillPack.
DYNALABS DVxâ„¢ Onsite Drug Verification System. DVx allows users to quickly and easily verify drug identity and strength (concentration) in real-time. The demo was impressive. The representative that I spoke with said that DYNALABS currently had a limited reference library, but were adding new drugs all the time.
ScriptCenter by Asteres. Think of ScriptCenter as something similar to the Amazon Locker model. Pharmacies fill medications, place them in the ScriptCenter kiosk, and allow users to pick them up at their convenience. Kind of an ATM-style solution to medication refill pickup. The system sends messages to patients when their prescription is loaded and ready. Users can pay with credit card or payroll deduction. You can even load OTCs into ScriptCenter. I spoke to Dana Darger, Director of Pharmacy at Regional Health in Rapid City, SD about ScriptCenter. He has been using the unit to provide employees with 24/7 access to medication refills. So far he’s been pretty happy with the results. Dana commented that ScriptCenter has helped alleviate congestion in the outpatient pharmacy as well as give hospital employees easy access to their refills.
ScriptCenter by Asteres
Cactus Smart Sink. I wrote about the Cactus Smart Sink while attending Midyear. The Smart Sink is a pharmaceutical waste disposal container that renders its contents “unrecoverable, non-retrievable and unusableâ€. It’s small and unassuming. I thought it was pretty slick.
Swisslog Nexus Station. One has to wonder how a tube station can be exciting. Well, if you’ve ever worked in a pharmacy where items are queued up due to volume, then you’ll appreciate the Swisslog Nexus Station. The Nexus allows users to load up to five tubes at a time in a Lazy Susan-like configuration. Tubes can be loaded as non-secure or secure and the Nexus will keep track. Much more efficient than a “one-up†tube station.
Nexus Station by Swisslog
A PDF version of this report may be downloaded here.
“To be idle is a short road to death and to be diligent is a way of life; foolish people are idle, wise people are diligent.” – Buddha
So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….
The mug below comes straight from the Hula Daddy Coffee Plantation in Kona, HI. My family and I recently spent a week in Kona on vacation. The island isn’t what I expected, but we had a great time. There are so many interesting things to do, and the differences in landscape and climate are crazy in such a small area.
“An error doesn’t become a mistake until you refuse to correct it.” – Orlando A. Battista
So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….
The mug below was sitting next to my laptop filled with chocolate covered espresso beans last Saturday morning, Valentine’s Day. A gift from my lovely wife. Apparently she’s aware of my addiction. It made me smile.
The promise of a future where robots handle pharmacy distribution has been around for quite some time. It seems to always be “just a few years awayâ€. I’ve seen my share of robotic distribution systems implemented in pharmacy operations, and the expectation has always been better than the reality.
But what about using robotic systems in the i.v. room to help make sterile preparations? It seems like the perfect place for this type of tool. Activities in i.v. rooms are dangerous and expensive. If one could utilize a robot to increase safety and decrease cost, then it would seem like a no brainer. Unfortunately it’s not as simple as that.
Over the past 16 months I’ve observed several different robots – INTELLIFILL I.V. by Baxter, APOTECAchemo by APOTECA, i.v.STATION by Aesynt, and RIVA by IHS – in several different pharmacy environments – inpatient batch processing for multiple hospitals, inpatient patient specific production for single hospital, inpatient chemotherapy, and outpatient chemotherapy. During that time I’ve formed several opinions about the current crop of i.v. room robots; some good, some not so good. (more…)
“A man who lives right, and is right, has more power in his silence than another has by his words.†~Phillips Brooks
So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….
A package arrived on my doorstep Christmas Eve. That’s not unusual this time of year. However, neither my wife nor I were expecting a package. When I opened it I found two coffee mugs inside with a note that said “We were inspired by your blog post the other dayâ€. Very cool. The mugs were sent by MEPS Real-Time, Inc. A very big thank you to the generous people at MEPS.
One of the unexpected benefits of writing In the Clean Room has been the interest that it has generated outside the U.S. Mark and I have had some interesting conversations with people from all over the world as a result.
One of our colleagues from Germany shared these interesting new developments from overseas. All three of the “robots” listed below are designed for compounding hazardous drugs, i.e. chemotherapy. The number of different approaches and concepts used for robotic sterile preparation is amazing.
PharmaHelp from Fresenius Kabi
Basically a hood with built-in automated compounded technology. The concept appears to be focused on batch preparation driven by workflow management software. The process is aided by RFID and gravimetric technology.* PharmHelp reminds me of a combination of the EXACTAMIX Compounder and INTELLIFILL I.V. There is a video at the site, but I couldn’t find a way to embed it here.
KIRO Oncology from KIRO (Mondragon)
Two things of interest with KIRO Oncology: 1) Dual-armed approach. The use of two robotic arms makes sense as one of the current limitations to the compounding robots I’ve seen in the U.S. is the use of a single arm. The use of a single arm creates a rate-limiting step, 2) It is “self-cleaning”. Check the video below, “self-cleaning” starts at about 1:35.
MOTOMAN from YASKAWA (Japan)
A MOTOMAN dual arm robot from YASKAWA. Again, dual-arm approach. I’d like to see more video on this guy as the video below isn’t very good. When I do a web search for MOTOMAN I find mostly industrial use robots. Not sure how far they are with using their technology in the IV room.
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*It’s important to note that not all countries utilize bar code scanning technology like we do in the U.S. The FDA did us a big favor when they required drug manufacturers to place bar codes on medications. Not so in other countries. Many drug products in other countries do not contain bar codes.
Business Wire: “Aesyntâ„¢ announced it has completed the acquisition of Health Robotics, the leading global supplier of automated technology for intravenous (IV) medication preparation, compounding and dispensing.”
For those of you that have short memories, Aesynt is basically a spin-off of the acute care pharmacy side of McKesson. It’s a big group that specializes in things like automated carousels, inventory management software, packaging and bar-coding technology, controlled substance management hardware and software, and a robotic distribution system, i.e. “the McKesson robotâ€.
Health Robotics is a company that specializes in IV room automation and technology. They have two robots: i.v.STATION for non-hazardous compounding and i.vSTATION ONCO for hazardous compounding, i.e. chemotherapy. Their robots compete with both Intelligent Hospital Systems – the RIVA robot – and APOTECAchemo. They also have i.v.SOFT, a workflow management system that competes against the likes of DoseEdge by Baxter, among others.
Someone at Aesynt has been paying attention. Interest in IV room technology has been steadily growing for the past few years, basically telegraphing the demand that we’re seeing today. This definitely puts Aesynt in a unique position in the acute care pharmacy space, especially when you consider that they also offer a point of care distribution system and something for anesthesia.
The acquisition of Health Robotics by Aesynt is sure to send some ripples through the world of pharmacy automation and technology. Grab some popcorn and settle back in your chair. As interest in the IV room continues to grow, and as companies begin to fight for market share, things are surely going to get interesting. Exciting stuff.
The December 2013 issue Pharmacy Purchasing & Products features a Q&A session with Anne McDonnell, PharmD, BCOP; Caryn Belisle, RPh; and Josephine Leung, PharmD, MBA from Brigham and Women’s Hospital, Department of Pharmacy
I had the opportunity to visit Brigham and Women’s Hospital earlier this year while doing some research for a project I’m working on. It’s a very interesting facility that makes use of a lot of pharmacy automation and technology. Based on what you read below you’d think that everything was perfect. What I saw was interesting, but far from perfection.
Worth noting in the Q&A session is that the products being used are never defined, i.e. what technology is being used. There’s mention of a robot, but which robot? They speak of gravimetic analysis, but don’t say what system they’re referring to. I know because I’ve been there, but other people might like to know as well don’t you think?
Here are some of the questions and responses I found particularly interesting in the PP&P article. (more…)
