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
I mentioned previously that USP General Chapter <800> – Hazardous Drugs—Handling in Healthcare Settings has been approved and will be published February 1, 2016. Thankfully, the Compounding Expert Committee approved a delayed official implementation until July 1, 2018. Obviously, the committee felt that enforcing Chapter <800> sooner would create a hardship on systems that aren’t close to being ready and need the added time to make changes.
There is going to be a lot of confusion around USP <800>, and for that reason, I will be proactively learning about its impact on healthcare systems and how it differs from the current version of USP <797>.
First up on my learn-about-USP<800> list for 2016 is a webinar – The Missing Link: Practical Tips for Preparing for USP 800 – sponsored by Pharmacy OneSource. According to the webinar site: “In this webinar, Patricia C. Kienle, RPh, MPA, FASHP and Eric S. Kastango, MBA, BSPharm, FASHP will provide practical tips to assure compliance with upcoming USP Chapter 800 Hazardous Drugs: Handling in Healthcare Settings. Facilities, PPE, personnel training, and environmental monitoring will be discussed. The link between USP Chapters 795, 797, and 800 will be explained.â€Â Patricia and Eric are both leading experts in this field and typically have great insight into sterile compounding regulation. It’s definitely worth an hour of your time.
The webinar is scheduled for on Wednesday, January 13.
You can get more information on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings to be Published in USP 39–NF 34, First Supplement here.
I spent a short time observing iv preparation in two separate, distinctly different pharmacy environments in the weeks leading up to the new year.
One was a traditional iv room in a large acute care pharmacy with multiple pharmacy technicians and pharmacists putting out hundreds of compounded sterile preparations (CSPs) per day. The second was a segregated compounding area in a satellite pharmacy with one pharmacy technician and one pharmacist using a glove box to prepare STAT and first dose CSPs to critical care areas.
Neither area utilized technology for CSP preparation, instead opting for the good ole fashioned syringe pull-back method (1). In the case of the traditional iv room, I observed instances of up to twenty different CSPs with empty vials and syringes laid out awaiting pharmacist verification. In the segregated compounding area with glove box, CSPs were typically prepared one at a time or in small batches.
During my short time observing CSP preparation in the two areas I witnessed errors that would have easily been caught with the use of readily available technology. Â Here are two examples:
Wrong drug selection – This may be the most common error seen in iv rooms. In this particular case, the technician used a vial of potassium phosphate (KPhos) for a CSP that called for sodium phosphate (NaPhos). The use of bar code scanning for verification during the compounding process would have prevented this error.
Calculation error resulting in an incorrect dilution – A patient-specific order called for 20 mg of hydrocortisone in a total volume of 2 mL to be placed in a syringe for iv administration. The technician started by first making a stock hydrocortisone syringe from which to draw the dose. This is a common practice. The resulting stock syringe should have contained 100 mg of hydrocortisone in 10 mL of solution, i.e. final concentration of 10 mg/mL. Instead, the technician calculated the final volume as 25 mL, resulting in a final concentration of 4 mg/mL in the stock syringe. So when the patient-specific dose of 2 mL was drawn into the syringe the final dose was only 8 mg. The pharmacist almost let it go, but something made him take a second look. It was only when he asked the technician to explain the process that the error was discovered. The use of bar code scanning for verification during the compounding process would not have prevented this error. But, the use of step-by-step instructions with intermediary step checks during the stock syringe prep, or the use of gravimetrics, would have.
The number of CSPs prepared in iv rooms daily in the United States is unknown, at least to me, but has to be somewhere in the neighborhood of a million. (2) Combine that with published literature that puts sterile compounding errors around 11%, (3) and that’s some scary stuff. With numbers like these, I wonder how many mistakes make their way to the patient?
The iv room is a busy place with a lot of dangerous medications. It’s also a place where a lot of errors occur. Â With the availability of commercially available products that can easily prevent these types of errors, there’s really no excuse for continuing to use a completely manual process.
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(1) Syringe pull-back method is when the empty syringe used for each drug or electrolyte is left alongside the item with its plunger pulled back to the volume that was added. The pharmacist looks at the empty syringe with plunger pulled back and compares volume to the volume necessary to accurately prepare the CSP. This is common practice in many pharmacies even though it has been declared unsafe. I continue to be surprised that pharmacies use the syringe pull-back method.
(2)Â Using a number of 1.5 CSPs per patient, per day in acute care hospitals, and using 795,603 licensed Community Hospital beds in the United States (1999 – 2013 AHA Annual Survey, Copyright 2015 by Health Forum, LLC, an affiliate of the American Hospital Association), the number of CSPs produced per day in the United States exceeds 1 Million.
I’m sure that most of you are aware, but just in case, I thought I would pass this little tidbit along.
The Compounding Expert Committee announced on November 20, 2015, that USP has approved a new General Chapter USP <800> – Hazardous Drugs—Handling in Healthcare Settings. The revised chapter will be published February 1, 2016, in the first supplement to USP 39-NF 34. USP standards typically become official 6 months after publication, but the Expert Committee approved a delayed official implementation date of July 1, 2018 to prevent any undue hardship on systems that need to make major changes.
You can get more information on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings to be Published in USP 39–NF 34, First Supplement here.
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.
Like many others, I received a press release from BD while attending the 2015 ASHP Midyear Clinical Meeting in New Orleans. The press release touted the introduction of “a simplified way for hospitals to manage intravenous (IV) medication to help improve safety and reduce wasteâ€. The press release goes on to explain how BD has combined their technology with that of CareFusion, which they acquired last year.
I didn’t think much of it at the time. I get lots of these throughout the year, especially during conferences like ASHP Midyear. I always approach them with a heavy dose of skepticism, and for good reason. Announcements like these often describe a Picasso when in reality you’re getting something closer to Dogs Playing Poker.
However, Medgadget Tweeted about BD’s “simplified comprehensive IV management†earlier today. I found that interesting as it didn’t really seem to fit Medgadget’s typical fare. When I clicked on the link in the Medgadget Tweet I was taken to the official BD press release. Hmm.
Here’s the plan laid out by BD in the press release:
Starting in the IV room of a hospital pharmacy, BD Cato™ Medication Workflow Solutions have been integrated with the CareFusion SmartWorks platform to seamlessly integrate with pharmacy IT systems to receive IV orders. Throughout the medication preparation process, the BD Cato System helps detect potential errors optimize drug utilization, simplify preparation steps and improve documentation compliance.
If preparing hazardous drugs, clinicians may use a closed system drug transfer device (CSTD), and BD’s Hazardous Drug Safety portfolio of solutions can help minimize the risk of hazardous drug exposure for health care workers and patients through products like the BD PhaSealâ„¢
After the medication has been safely prepared and is ready to deliver to the patient floor, the Track and Deliver module of Pyxis® ES Link enables the pharmacy and nurses to see exactly where the medication is during transport and when and where it is delivered. This helps nurses better manage their time and reduces calls to the hospital pharmacy inquiring about status and whereabouts of medication.
Once the medication makes it to the patient bedside, the Alaris® System with bi-directional electronic medical record (EMR) interoperability bridges the gap between an EMR and an infusion pump. With only one additional barcode scan to a nurse’s workflow, the pharmacist-verified physician’s order can pre-populate the Alaris System, reducing manual keystrokes and infusion programming errors.
EMR interoperability also enables automated documentation back to the patient’s EMR, where the nurse validates the data in the EMR and commits it to the patient record, eliminating the need for manual documentation and ensuring that documentation is complete and accurate. In addition, Alaris® Viewer Suite for Charge Capture takes all of the data from the Alaris System and displays it in a patient-specific report, making it easier for billers and coders to make an accurate claim for reimbursement.
Finally, through Pyxis ES Link, a nurse can submit an IV refill request that will be displayed in the Med View Dashboard and enable pharmacists to proactively plan for IV replenishment needs, reducing the risk of interrupted therapy and waste. The refill order is sent to the BD Cato Medication Workflow Solutions and the process begins again.
The concept is interesting, but before passing ultimate judgment I need to see the entire process at a live site. I will contact BD next week to see if I can get more information and find a customer using the entire system.
Someone asked me the other day where they could read up on what’s going on in the world of pharmacy sterile compounding. It’s a good question. The simple answer is to get your hands on a copy of the USP Compounding Compendium and read it over and over again. That’s where I started. Unfortunately, that will make you about $150 lighter in the wallet. Not to mention that it’s not the most entertaining of documents.
ASHP offers several training courses that include written material as well as video. I’ve gone through many of them myself. They’re good, but expensive. You can see a list of them here.
I’ve found Pharmacy Practice News and Pharmacy Purchasing & Products to have lots of good, timely content pertaining to sterile compounding. The best part about these two publications is that they provide free access after a one-time registration process.
If you’re just looking for general reading material, a Google search for sterile compounding, compounded sterile preparations (CSPs), primary engineering controls, beyond-use dating (BUD), USP <797>, or pharmacy compounding will give you more than you can handle.
Anyone else have any recommendations for where to find information on sterile compounding? If you do, feel free to leave a comment below.
USP <800> is still in draft form. The official date of the chapter has not yet been determined and is dependent on several factors, but expect it to become official some time in mid to late 2016. And while USP <797> is in the process of being updated, the current version is still the one everyone has to live with.
Information contained in USP <800> is in addition to information found in USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations and USP Chapter <795>Â Pharmaceutical Compounding – Nonsterile Preparations.
In its current iteration, USP <797> and USP <800> requirements for hazardous drugs (HDs) differ. However, HD compounding in the upcoming revision to <797> will be harmonized with Chapter <800>. Actually, it looks like USP will simply defer all HD compounding to USP <800>, which makes sense.
Until all the USP Chapters are on the same page, here are some highlighted differences between Chapters <800> and <797>:
Requirement of compounding supervisor
Applies to sterile as well as non-sterile compounding
No longer allowed to store, unpack, or manipulate HDs in positive pressure areas
Elimination of exemption that allowed low volumes of HDs to be compounded in a non-negative pressure room. All quantities of HDs must be compounded in a separate, negative pressure room
C-SCAs may be used to compound low- and medium-risk HDs
CSTDs are recommended for compounding and required for administration
Perhaps the greatest impact will come from elimination of the current USP <797> exemption for small volumes of HDs to be compounded in a positive pressure room. USP <800> handles this by allowing low- and medium-risk HDs to be compounded in a containment segregated compounding area (C-SCA). C-SCA is a new concept, and is defined as “a separate, negative pressure room with at least 12 air changes per hour (ACPH) for use when compounding HDs. Low- and medium-risk HD compounded sterile preparation (CSP) may be prepared in a BSC or compounding aseptic containment isolator (CACI) located in a C-SCA, provided the beyond-use date of the CSP does not exceed 12 hours“.
Jerry talks about the problem with storing medications in plastic syringes and potency loss. Recently the FDA notified ASHP that no plastic syringe is approved for use as a final storage device. Jerry discusses the issue and how it will impact pharmacies in the near future.
This morning I woke to the news that No Syringe Is Approved as a Standalone Storage Container, FDA Says. This I’m sure is in response to the recent issue with BD syringes and drug stability. I need to think about this more, but my gut reaction is that this is huge and will have a significant impact on many acute care pharmacy practices across the country.
There are three factors to consider when making and dispensing compounded sterile products (CSPs): accuracy, sterility, and stability.
Accuracy. Self-explanatory. When you make a CSP you want it to be as accurate as possible. This is where I believe automation and technology come into the equation. My thoughts on the subject can be found in many essays/articles published on this site.
Sterility is covered ad nauseam by USP General Chapter <797>. CSPs should be free of microbial contamination. This, of course, is for the safety of patients receiving treatment with CSPs. If you have any questions regarding how long something can be stored following compounding, and still be considered “sterile†then you should look no further than the beyond-use dating (BUD) guidelines found in <797>.
Stability. When you store something in a container, i.e. a syringe, bag, bottle, etc. you want the drug to remain active for as long as necessary to administer to the patient. We know that some drugs are sensitive to light, temperature, type of storage device, etc. However, pharmacy has long used syringes as a method of distribution, and as long as the drug was considered unaffected by light and temperature, not much consideration was given to stability.(1) This is a holdover from the days when we, i.e. pharmacy used to draw everything up in glass syringes. Glass was an awesome storage medium, but we didn’t really change out practice when glass syringes became too expensive to be practical and we went to plastic. While addressed in USP General Chapter <797>, stability is not given the same detailed coverage as sterility. USP <797> was never meant to address stability in great detail.
Recently I’ve seen an upward trend in pre-drawn syringes. I’ve spent the better part of the last three months immerging myself in what goes on with medication distribution and use in the O.R. That is to say I’ve been educating myself on processes and paradigms of how anesthesiologists and pharmacy work together to ensure safe, accurate and responsible medication use during surgery.
One of the major trends I found in O.R.’s was the use of pre-drawn syringes. Pharmacy likes them because it gives them more control over drug usage and waste, and anesthesiologists like them because they don’t have to draw medications from vials prior to administration. Anesthesiologists are more concerned with monitoring the patient then they are with having to deal with medication labeling, etc.; and rightly so.
This desire to supply anesthesiologists with pre-drawn syringes has created an interesting side effect in CSP automation – there is a renewed interested in CSP robots in the clean room. Robots are good at batch production. Pulling several hundred syringes filled with the same drug is an ideal use for a compounding robot.
This of course, doesn’t include pediatric facilities that use pre-drawn syringes to stock their shelves to meet the needs of their patient population. I remember when I was a pediatric pharmacist back in the early 2000’s. We pulled thousands of syringes each and every day to replenish stock not only on our shelves in the pharmacy, but to place in ADCs for easy access to medication for nurses and physicians.
Some pharmacies will use third party vendors like PharMEDium for their pre-drawn syringes. I bet companies like PharMEDium already have data on the stability of drugs stored in syringes. Will they share this information with the rest of the pharmacy world? My gut reaction is that they won’t. By sharing  information they’re basically cannibalizing their own sales. What’s this do for them? Uptake of customers and bigger sales in the immediate future. It’ll be interesting to see how they handle it. Not to mention potential liability snafus.
Like I mentioned above, I need to think on this more deeply. However, at this moment I’m thinking that the FDA’s stance on syringes as stand-alone storage devices is going to create a lot of headaches for pharmacies across the country over the next several weeks. It’ll be interesting to see how organizations like ISMP, ASHP, USP, etc. respond to the FDA’s statement.
Grab some popcorn folks, this should be good.
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There’s much more to this statement, but for the sake of brevity let’s just leave it at that.
