Iâ€™m sure youâ€™re all familiar with USP <797> requirements for ceilings, wall, and floors in a pharmacy cleanroom, a.k.a. IV room.Â According to the current chapter:
The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate. The surfaces shall be resistant to damage by disinfectant agents. Junctures of ceilings to walls shall be coved or caulked to avoid cracks and crevices where dirt can accumulate… Walls may be constructed of flexible material (e.g., heavy gauge polymer), panels locked together and sealed, or of epoxy-coated gypsum board.
Itâ€™s common to see pharmacies meet these requirements with hardened drywall and epoxy paint. Recently, I was exposed to an alternative solution: Altro Whiterock.
Altro Whiterock is made from a food-safe PVCu polymer that can handle temperatures up to 140Â°F /60Â°C. It’s impact resistant, grout-free and has a smooth surface, which makes it easy to clean. It’s also resistant to a host of chemicals and cleaning agents.
Iâ€™ve had the opportunity to use Altro Whiterock on a few projects. It looks fantastic once installed and really is quite resistant to damage. Itâ€™s not completely impervious to damage — I mean you could scratch it if you try — but it’s definitely resistant to routine dings and scratches from stray carts crashing into walls.
The only potential downsides are cost and installation. Whiterock is more expensive than drywall and epoxy paint. In addition, only certified installers can install Whiterock. While a bit of a hassle, itâ€™s understandable why youâ€™d want a qualified professional doing the work. And in regards to the cost, you know the saying, you get what you pay for. Â
If youâ€™re thinking about remodeling your pharmacy IV room, you owe it to yourself to give Altro Whiterock a look.
TheÂ EvolveÂ line of compressor-free, medical grade refrigerators* are quite impressive. Powered by SilverCoreâ„¢ Technology, they have no compressor. And because they have no compressor, they have no mechanical parts, run quiet, use less electricity, and generate less heat.
The system “absorbs heat energy from the storage cabinet using a non-toxic, non-hazardous refrigerant embedded in the walls. Heat energy is channeled up to a high-performance thermoelectric heat pump that cools the refrigerant and transfers the heat into the ambient environment“. Science!
Evolve refrigerators meet CDC vaccine storage guidelines as well as requirements for use in a clean room. In addition, the units provide alerts for temperature, door, battery, memory, loss of WiFi, and loss of power via local and remote monitoring options.
Because the refrigerators utilize solid-state technology, the company is able to squeeze more storage capacity into a unit compared to a similar sized non-solid state refrigerator. Up to 25% more storage capacity according to the company.
Iâ€™m not sure if youâ€™re aware of how much noise refrigerators can add to a pharmacy, but it’s lot. This is especially true in the IV room where PECâ€™s (hoods) already make the environment less than friendly to oneâ€™s ears.
Not only does the Evolve line of refrigerators look pretty cool — no pun intended — their ability to reduce noise pollution in the pharmacy is a welcome bonus.
* I first wrote about Evolve back in December 2015 after seeing the product at ASHP Midyear.
Hereâ€™s an interesting article from the January 13 issue of the Journal of Medical Internet Research (JMIR): Digital Pills To Measure Opioid Ingestion Patterns In Emergency Department Patients With Acute Fracture Pain: A Pilot Study (1)
A group of researchers out of Boston utilized digital pills (eTectRx, Newbury, FL, USA) to observe the ingestion patterns of oxycodone for patients discharged from the hospital following an acute extremity fracture.
Eighteen patients met inclusion criteria for the study, but only ten consented and were enrolled. Of the ten, eight had usable data. Not exactly a large number, but you gottaâ€™ start somewhere.
Study drug was dispensed in capsule form. The digital pill was compounded with oxycodone tablets using a standard capsule-filling machine by the hospital’s investigational drug services pharmacy. Compounded digital pills were dispensed in blister packages.
When ingested, the gastric chloride ion gradient in the stomach activates the digital pill, transmitting a unique radiofrequency signal that is captured by a hip-worn receiver. The ingestion data is then transmitted to a cloud-based server where it can be viewed and analyzed. Because each digital pill emits a unique frequency, the system can record multiple simultaneous ingestion events, which is very cool.
It turns out that the digital pill did a pretty good job of recording the patientâ€™s ingestion of their pain meds. It wasn’t perfect, and they had some technological issues along the way, but overall it results look promising. Imagine being able to see how your patients are taking their medication in real-time. You could even use the data coming from the digital pill to determine if a patient had ingested too many capsules at once.
The use of digital pills definitely has potential.
From the abstract:
Results: We recruited 10 study participants and recorded 96 ingestion events (87.3%, 96/110 accuracy). Study participants reported being able to operate all aspects of the digital pill system after their training. Two participants stopped using the digital pill, reporting they were in too much pain to focus on the novel technology. The digital pill system detected multiple simultaneous ingestion events by the digital pill system. Participants ingested a mean 8 (SD 5) digital pills during the study period and four participants continued on opioids at the end of the study period. After interacting with the digital pill system in the real world, participants found the system highly acceptable (80%, 8/10) and reported a willingness to continue to use a digital pill to improve medication adherence monitoring (90%, 9/10).
Conclusions: The digital pill is a feasible method to measure real-time opioid ingestion patterns in individuals with acute pain and to develop real-time interventions if opioid abuse is detected. Deploying digital pills is possible through the ED with a short instructional course. Patients who used the digital pill accepted the technology.
Chai, Peter R et al. “Digital Pills To Measure Opioid Ingestion Patterns In Emergency Department Patients With Acute Fracture Pain: A Pilot Study”. Journal of Medical Internet Research1 (2017): e19.
Needle sticks happen. Iâ€™ve actually stuck myself a few times during my career while compounding in the IV room. Fortunately for me, it never involved anything hazardous. Still, it was aÂ pain. No pun intended.
Over the years a lot of attention has been given to methods for preventing needle sticks in healthcare, ranging from things like procedures, i.e. â€œno-recappingâ€ to physical barriers like safety syringes. The ProteXsure Safety Capsule System falls into the latter category.
medGadget: â€œ[The ProteXsure Safety Capsule System] prevents needle stick injuries by offering an easy way to snap on a protective cap to the tip of a needle. Once a syringe is finished with, the needle is simply pushed into a slot on the side of the ProteXsure. This can be done with one hand. A cap immediately grabs onto the needle, readying the syringe for safe disposal.â€
The ProteXsure Safety Capsule System gets high marks for ease of use and design. It appears to be a simple, yet elegant solution to the problem of blunting the end of a needle to prevent accidental sticks. Check the video below to see how simple the product is to use.
From the ProteXsure site:
First device to safely address recapping the Front & Back end of all dental syringes
Fits all size needles and gauges in most medical and healthcare settings
Meets all OSHA guidelines of mandated â€œOne Hand Recappingâ€
Accepts both â€œBent & Straightâ€ needles
Quick and easy to use
Non skid gel pads adhere to any surface without leaving marks or residue
100 safety capsules inside every system
Fully automatic (Insert needle and remove)
Once completely dispensed, simply dispose in a normal waste bin & replace
Additional downstream needle protection should original needle cap come off (capsule covers needle tip in addition to the syringe cap)
No information on cost and availability in the U.S.
This yearâ€™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.Â For many, the Midyear Meeting is about the latest in clinical advances, but for me, itâ€™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
â€œSterile compounding is a significant but perilous core pharmacy process in dire need of improvement.â€ â€“ 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 everyoneâ€™s mind. This yearâ€™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 Deltaâ€™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 Iâ€™ve seen in past years.
Aesynt â€“ previously McKesson Automation, now part of Omnicell â€“ 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 BDâ€™s gravimetric-centric approach.
MedKeeper showed off a new booth at Midyear with Verification front and center. Verification is MedKeeperâ€™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. Theyâ€™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. Thatâ€™s right, the device was mounted outside the isolator, thus limiting the hardware in the hood.
Talyst had Talyst IV Room on display. Talyst IV Room is part of the companyâ€™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.
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. Itâ€™s an interesting concept.
Compounding robots were out in full force: Aesynt with v.STATION, ARxIUM with RIVA, and Grifols with Kiro Oncology.
RFID-enabled technology was more prevalent at this yearâ€™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) â€“ both refrigerated and room temperature – and a virtual logbook for tracking medication trays.
Kit Check had their â€œLittle Blue Boxâ€ 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 didnâ€™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 wouldnâ€™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. â€œthe internetâ€? 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. Itâ€™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 â€œpumpâ€.
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 heâ€™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.
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 â€œunrecoverable, non-retrievable and unusableâ€. Itâ€™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 youâ€™ve ever worked in a pharmacy where items are queued up due to volume, then youâ€™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 â€œone-upâ€ tube station.
A PDF version of this report may be downloaded here.
Acute care pharmacies generate a lot of pharmaceutical waste, and itâ€™s not always clear what you should do with it.
Yesterday I came across The Cactus Smart SinkÂ while roaming throughÂ the exhibit hall at ASHP Midyear. The Smart Sink is a pharmaceutical waste disposal container that renders its contents â€œunrecoverable, 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 15.5â€ W x 12.5″ H x 9.5â€ 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.
This was all over the web yesterday, so Iâ€™m not telling you anything you donâ€™t already know, but this is huge. 3D printing is one of those technologies that has the potential to disrupt just about every industry it touches. Itâ€™s not often that you can say that. The most recent technologies that I can think of that had that kind of impact was the explosion of smartphones and tablets, which are now ubiquitous across every industry you can imagine.
Iâ€™ve recently had conversations with several companies outside the U.S. developing robotic technology for the i.v. room. One of those systems is the Kiro Oncology System. Check the video below.
A couple of things worth noting:
The system uses dual robotic arms during the compounding process. This is something that is important for the next generation of i.v. room robots. The current crop of i.v. room robots here in the U.S. use a single arm. Think about the inefficiency of one-armed sterile compounding.
The Kiro Oncology System is self-cleaning. This is a concept that appears to be more popular â€œin Europeâ€ than it is here in the U.S. Kiro Oncology isnâ€™t the first overseas group Iâ€™ve dealt with that is pushing the idea of self-cleaning. None of the U.S. vendors have ever mentioned it.
Over the years I’ve had a lot of ideas, some good and some not. When an idea comes to me I typically record it in a notebook that I have sitting on my desk. Occasionally I return to the notebook and review the ideas to see how many of the ideas still have merit. Sometimes an idea has become outdated, and rarely an idea will have materialized as a product of similar design built by a company. And then there’s a group of ideas and concepts that still hold value, but haven’t been seen in the market.
Today I was rummaging through some of my old ideas. One of them from 2010 caught my attention. In 2010 I thought it would be cool if someone could use technology to analyze the IV fluid being administered to a patient in real-time. Basically such a system wouldÂ prevent the wrong IV medication from being hung on a patient, thus preventing a medication error. Continue reading Automated intravenous fluid monitoring at the bedside
Drug and concentration information is presented to the user via audio and visual feedback. The system pulls information from the bar code on the syringe as itâ€™s inserted into the Intelliport injection port.
Drug identification, dose measurement and drug allergy alerts in real-time. The allergy information is pulled directly from the patientâ€™s EHR record.
Automated documentation of medication delivery. The system wirelessly captures drug, dose, time, and route of administration. The information is fed directly back into the EHR