Jerry and Ray talk about the pharmacy IV room, specifically where we’ve been, where we’re at, and where we’re headed. Topics include workflow, the impact of USP <797> on pharmacy iv room operations, and thoughts on currently available iv workflow management system technologies.
You can learn more about Ray at his LinkedIn Profile here.
Short updates for the week ending March 26, 2016. I briefly touch on USP <800>, DrugCam semi-automated iv workflow management system, and the Grifols KIRO Robot
Both ISMP and ASHP are working on draft recommendations for technology in the IV room. ISMP’s version is an update to their ‘Guidelines for Safe Preparation of Sterile Compounds’ that was originally published in 2013. The proposed revision is open for public comment until April 10th. ASHP is also working on new recommendations for the use of IV Workflow automation technology for the preparation of compounded sterile products (CSPs)
It feels a bit like running into a burning building to pull people out instead of taking action to prevent the building from catching fire in the first place, i.e. reactive instead of proactive. Many of us have known for years that there’s a problem in the IV room. It’s the dirty little secret of the industry. We’ve been saying that change is needed, but it has mostly fallen on deaf ears until now. What’s changed? I have an opinion, but that’s for another time.
We’ve known for decades that the IV room is not only one of the busiest areas in a pharmacy but also one of the most dangerous. IVs present higher risks than most other medications and the literature presents abundant evidence of the prevalence of pharmacy compounding errors, (1, 2, 3, 4, 5, 6, 7) which result in patient harm or death. (8,9, 10, 11) These errors not only impact patients but caregivers and healthcare facility as well. The human and financial toll are staggering.
While we may think we don’t make mistakes in the IV room, studies have shown that errors during CSP production are not uncommon. According to the frequently cited article by Flynn, Pearson, and Baker published in 1997: “A five-hospital observational study on the accuracy of preparing small and large volume injectables, chemotherapy solutions, and parenteral nutrition showed a mean error rate of 9%, meaning almost 1 in 10 products was prepared incorrectly prior to dispensing.†(7)
Many of the errors found with CSPs can be easily prevented through the use of common, currently available technologies. While adoption of technology has been slow, pharmacies are increasingly moving toward the use of these systems. Guidelines from ISMP and ASHP will certainly help speed things up.
Compliance with USP <797> Pharmaceutical Compounding—Sterile Preparations and ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products has certainly led to improved processes and safety in the IV room. Both address the need to accurate identify, measure, dilute, mix, package, and label CSPs. However neither of the guidelines is designed to drive adoption of CSP technologies to improve safety, accountability, and documentation.
The quality and safety of CSPs goes beyond sterility, potency, and stability and must include accurately identified and measured ingredients, diluents, final solutions, and containers as well as identifying, tracking, and documenting the CSP from cleanroom to patient. Current practices do not support or encourage the use of available automation and technologies to support these activities.
Much has yet to be defined and there are currently no guidelines or governing entities to drive standardization for vendor development and design, nor is there anything to help healthcare systems make smart choices.* With that said, it appears that changes are just around the corner.
During this time, it is important to understand the following:
Vendors must design – and users chose – systems that provide a clear advantage over manual systems in patient safety, workflow standardization, and documentation; are cost-effective; interoperable with existing systems; are simple to install, use, and maintain; and carry a high degree of certainty and reliability.
Minimum requirements** should include interoperability with pharmacy information systems and electronic health records, control of final product label, bar code verification of all ingredients and final containers, imaging for verification and documentation, documentation of master formula records, lot numbers, expiration dating, and products used, and basic dose tracking functionality.
While some of the products available today generate their own ISO class 5 compounding environment, these systems must function properly in cleanroom environments and comply with all USP <797> and <800> standards and recommendations.
And finally, technologies for CSP production must be correctly selected and utilized to effectively create a safe environment for both the healthcare provider and the patients they serve. There is no one-size-fits-all approach to these systems and each healthcare system is different. Proper selection will depend on several factors.
It’s time for vendors and healthcare systems to wake up and get ready for what’s coming.
References
US Food and Drug Administration Website. Report: Limited FDA Survey of Compounded Drugs. Available online at: http://www.fda.gov/cder/pharmcomp/survey.htm. Accessed on January 3, 2004.
United States Department of Justice, Federal Bureau of Investigation Website, April 22, 2002. Available online at: http://kansascity.fbi.gov/kcmostate042202.htm. Accessed on July 6, 2002.
Trissel LA. “Compounding our problems–again.†Am J Health-Syst Pharm. 1 Mar. 2003: 432.
Selenic D, Dodson DR, Jensen B et al. “Enterobacter cloacae bloodstream infections in pediatric patients traced to a hospital pharmacy.†Am J Health-Syst Pharm. 2003; 60:1440–6.
Niedowski E, Bor J. State to probe Hopkins death: 2-year-old cancer patient died after receiving improper IV mixture. December 20, 2003. Baltimore Sun, Baltimore, MD.
Flynn, EA, Pearson, RE, Barker, KN. “Observational study of accuracy in compounding IV admixtures at five hospitals.†Am J Health-Syst Pharm. 1997 Apr 15; 54: 904–912
Solomon SL, Khabbaz RF, Parker RH, et al. “An outbreak of Candida parapsilosis bloodstream infections in patients receiving parenteral nutrition.†J Infect Dis 1984; 149:98–102.
Hughes CF, Grant AF, Leckie BD, et al. “Cardioplegia solution: A contamination crisis.†J Thorac Cardiovasc Surg 1986; 91:296–302.
Associated Press. Pittsburgh woman loses eye to tainted drug; 12 hurt. Baltimore Sun. November 9, 1990:3A.
Dugleaux G, Coutour XL, Hecquard C, et al. “Septicemia caused by contaminated parenteral nutrition pouches: The refrigerator as an unusual cause.†J Parenter Enteral Nutr 1991; 15:474–475.
Perrin J. “Unsafe activities of compounding pharmacists.†Am J Health-Syst Pharm 1995;52:2827–2828.
**Minimum requirements. This is not to say that this should be the end game, but rather a place to start. Overreaching in the beginning of this process is sure to dampen development and adoption.
Not being involved with long-term care (LTC) pharmacies much over the years, I sometimes forget that there’s technology to help with some of the day-to-day operations.
I recently came across an advertisement for a company called Manchac Technologies. The reason it caught my eye is because I had a chance to visit with Manchac several years ago when they were still in their development stage.
Manchac is a company out of Alexandria, LA that specializes in technology designed to automated blister card packaging called DOSIS. “DOSIS products are designed to enhance efficiencies in your pharmacy operations while reducing the opportunities for errors…a robotic solution that fully automates blister cards (filled, sealed, and patient-labeled)â€.
Blister cards – aka punch cards, blister packs, etc. – are still prominent in nursing homes and, therefore, a huge part of LTC pharmacies. Large operations will do thousands of blister cards daily. According to information on the DOSIS site, the companies new BP198 machine is “capable of producing 40-55 filled and sealed cards per hourâ€.
Image of a typical “blister pack”
I wonder how that production stacks up to a pharmacy technician, in both numbers of cards per hour and error rate? Maybe it’s just me, but those numbers appear to be low compared to what a good technician could do.
The video below shows the BP198 technology from behind the scenes. The actual BP198 product appears to be contained in a cabinet about the size of a large high-speed packager, as you can see about 0:14 into the video.
Recently a friend and colleague reached out to me looking for guidance on published studies showing positive ROI for IV room automation and technology. There’s precious little literature covering this practice are of pharmacy, much less getting into things like ROI.
Why is that? As I see it, the problem comes down to these three things:
Bias. Some of what is written, especially in the “throw-away journals†is sponsored content, and as a result, presents a lop-sided view to the reader. It’s still worth reading, but always with a grain of salt.
One-size fits all. Nope. There are too many approaches to compounded sterile product (CSP) production in pharmacies across the U.S. I’ve been in more than 20 acute care pharmacies over the past few years looking at operations, and it’s clear that we’re all doing exactly the same thing completely differently. The solution for a 200-bed community hospital may or may not be a good fit for a 600-bed level 1 trauma center, or a healthcare system with centralized IV admixture servicing several facilities. It all depends on your needs. One must look at several variables and the specific needs of the pharmacy, patient, and healthcare system. Doing anything less is a recipe for wasted time, energy, and resources.
Traditional literaturedoesn’t work. The typical literature cycle doesn’t work for pharmacy technology. Even though pharmacy automation and technology moves slowly, it still changes at a much more rapid pace than therapeutics and/or best practices. Changes in clinical approaches to the use of medication takes time, and once established typically last until something better comes along. We’re talking years here, sometimes decades. That doesn’t work for pharmacy automation and technology. Research on an IV room robot that was purchased in 2009, installed in 2010, and published about in 2015(1) is of little use to pharmacists looking for relevant information in 2016. It’s doubtful that the technology is still in a form today that could be easily compared to that presented in the article. It’s also entirely likely that the product no longer exists. An article like that offers little to those considering investing in pharmacy automation and technology, perhaps except for general interest or curiosity.
There is clearly a lack of literature on the subject, but there is also clearly no one size fits all approach. If you’re truly looking for the best way to implement automation and technology in your pharmacy, I recommend the following:
Go ahead and do a literature search, focusing on the “throw-awaysâ€. I know, I just spent a page telling you this doesn’t work. You won’t find enough to make a decision, but it will, at least, give you an idea of what products are on the market.
Get some boots on the ground. There is no substitute for seeing the technology in action. Go visit people that are using the product. Don’t be cheap. If you’re going to drop a million dollars on a compounding robot, be willing to spend some money traveling around and looking at these things in real-world environments.
Take your time. This is one area where making a snap decision will cost you. Not only will you spend resources on something that might not be the best fit, you’re likely to be stuck with it for a while.
If you can’t do the above yourself, hire a consultant. Sounds a bit self-serving, but it’s true. Consultants will cost you upfront, but will save you several-fold the cost in the long run.
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Nurgat, Z., Faris, D., Mominah, M., Vibar, A., Al-Jazairi, A., Ewing, S., … Al-Jedai, A. (2015). A three-year study of a first-generation chemotherapy-compounding robot. American Journal of Health-System Pharmacy, 72(12), 1036–1045. http://doi.org/10.2146/ajhp140256
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.
Acute care pharmacies generate a lot of pharmaceutical waste, and it’s not always clear what you should do with it.
Yesterday I came across The Cactus Smart Sink while roaming through the exhibit hall at ASHP Midyear. The Smart Sink is a pharmaceutical waste disposal container that renders its contents “unrecoverable, non-retrievable and unusable”.
Some key features of The Smart Sink include:
A two cartridge system, one for liquid waste and one for solid waste, including patches.
It runs on batteries
Has a small footprint, measuring only 15.5†W x 12.5″ H x 9.5†D.
Uses audible alarms and alert lights to notify users when cartridges are full, have expired, or when the unit has been accessed.
I thought the it was pretty cool. Obligatory video below.
The Vaccine Smart-Fridge is an interesting concept for ambulatory care. It appears to be a consignment vaccine distribution system. Reminds me of a refrigerated single-point automated dispensing cabinet (ADC).
There’s a lot to like here.
By using a consignment model, the vendor offers an ambulatory care clinic low cost, low risk access to vaccines. It also decreases the chance of something sitting in the cabinet beyond it expiration date, or going bad because the temperature is out of range. The company supplying the items has a vested interested in making sure that everything inside those refrigerators is ready for use, and that waste is kept to a minimum.
I believe that the consignment model for pharmaceuticals will only continue to grow. The largest budget item in many pharmacy is inventory, by a wide margin. Refrigerated medications seem to be the main target for consignment, but it’s possible that the model could creep into other spaces as well, especially with the introduction of biosimilars.
The system provides real-time alerts on inventory shortages and temperature. Automated temperature monitoring ensures that things stay within their appropriate temperature range. Heat is bad for lots of medications, especially vaccines. This information can be viewed from a computer or mobile device. I like that it’s proactive.
Single-item access is a great concept for an ADC. This style of distribution is frequently used for controlled substances – morphine, fentanyl, etc. It provides better security than open access trays, drawers, and bays, thus minimizing opportunity for diversion. Does it make sense for everything? No, not really, but in this case it fits.
The system provides access to real time analytics and historical dispensing data. This information could be linked to other systems for easy access to vaccination records.
Pharmaceutical refrigeration is in need of a little disruption, so when I see something like this I’m encouraged that someone is thinking about it. There’s nothing new about this technology, but it does provide a new paradigm to think about.
Pondering the need for an IV workflow management system (IVWMS)? You’re not alone if you are. According the most recent PP&P State of Pharmacy Automation Survey, 15% of facilities have already implemented something and another 29% plan to do so in the next few years. The only surprise is the relatively low percentage of facilities planning on implementation in the near future. (more…)
Jerry talks about the use of RFID technology in pharmacies, specifically the use of RFID in refrigerated consignment programs and medication tray management.
