Tag: Medication Safety

Epic will eventually control IV workflow management

Pulling another article from the notebook archive, penned March 20, 2020.

I have seen the future of IV workflow management systems (IVWFMS). Spoiler alert, EPIC wins. And before people start calling me an Epic fanboy, I should make it clear that I do not like Epic, as a company or a product. I believe healthcare will rue the day they relinquished all their power to a single company. 

Those that know me or have read anything I have written in the past decade, know that I am an advocate for technology in the IV room. People are imperfect creatures, they make mistakes. Don’t believe me? Google Emily Jerry death or St Charles rocuronium. That will tell you all you need to know about the dangers associated with injectable medications. Compounded sterile preparations are the most dangerous medications within the four walls of a hospital. Seems logical that such dangers would receive the utmost attention. Inexplicably, they do not. Many reasons are given for ignoring the issues, but it boils down to poor planning and the inability to prioritize in the face of budgetary and political restraints. 

Technology, while far from perfect, adds a level of protection to a complex, error-prone, and dangerous process. Adding a little common-sense technology to the IV medication process, like an IVWFMS*, is the quickest and most cost-effective way to improve safety.

Implementing these systems is a no-brainer, but that hasn’t stopped people from ignoring them. The problem has been, at least from my perspective, a complete failure by pharmacy leadership to recognize and prioritize IV room safety and efficiency. Nowhere else but in the IV room can a single mistake result in significant harm or death. Yet the IV room seems to get a fraction of the attention it should. Unfortunately, it often takes a tragic error like those noted above before folks take notice. 

With that said, there is some good news. I have witnessed an uptake of IVWFMS in recent years. More hospitals seem to be adding these systems to their workflow. While a welcome trend, the increased numbers don’t appear to be secondary to some altruistic good will or common sense, but rather because of Epic. The monolithic EHR vendor has unwillingly changed the landscape of the IVWFMS market, forever. Big pharmacy technology companies refuse to admit it, but the writing is on the wall. When asked what technology a hospital is using in the IV room, I used to hear “nothing” or “DoseEdge” with an occasional “MedKeeper” thrown in. Now, more often than not, I hear “Dispense Prep”.**

Why the shift? No mystery here, the answer is simple: the barrier to entry is low and the integration within the platform is amazing. 

For healthcare systems already using Epic, it is as easy as flipping a switch. The implementation requires a bit of legwork, and some minor equipment, but nothing like that required when implementing a third-party system like DoseEdge, BD Cato, etc. I have been involved with both Epic and third party IVWFMS implementations, there is little comparison in time, energy, effort, and cost. Epic Dispense Prep (EDP) wins in all those areas, easily, every single time. 

The ease of EDP implementation is tied directly to the modularity and integration of the overall system. It shares databases, labels, user experience, dashboards, and so on. EDP is already part of the EHR, so it requires no additional contracts, no additional maintenance agreements, no third-party vendor helpdesks, no “integration” within the EHR, no crazy implementation schedule and checklists, no weird upgrade schedule or downtime, and so on. 

EDP implementation requires far fewer pharmacy resources than other IVWFMS and has the added benefit of being nearly transparent to pharmacy personnel. Most of the build is handled behind the scenes by dedicated IT resources — the ever present Epic Willow Build Team. Pharmacy resources are kept to a minimum, which decreases impact on the department. Contrast this to something like DoseEdge, which requires a significant investment in time and effort from pharmacy personnel. I can attest from personal experience that the overhead for a third party IVWFMS implementation can be hundreds of hours of dedicated pharmacist time. EDP, on the other hand, requires a fraction of that time. This alone makes it an easy choice for pharmacies strapped for resources, which describes nearly all inpatient pharmacies. 

None of this means that EDP is the best IVWMS on the market. Not even close. While it offers full integration across the entire enterprise, barcode scanning, image capture, robust tracking, and is seamlessly tied into the billing system — something I care little about but is a top priority for healthcare systems — it falls short in other areas. As I write this, I can think of at least three products off the top of my head that I believe are better than Dispense Prep. They are more flexible, more feature rich, have better hardware, have better software, and so on. Most even eclipse EDP in the quality of the basics, like image capture. But it doesn’t matter if they are never implemented. The best IVWFMS is the one you are using. While Dispense Prep may not be the best, it is better than nothing. Love the one you’re with, you know?

While not an accident per se, I believe Epic won the battle of IV workflow management systems without trying. Several large IDNS have already converted to Epic, giving them an obvious competitive edge in the IV room. As facilities with Epic gravitate toward Dispense Prep for the reasons outlined above, the market will inevitably begin to contract, forcing third party vendors to compete against one another for a smaller piece of the pie. It may take some time – things always do in healthcare – but companies marketing IVWFMS will feel the pressure. I believe some already have. I have personally witnessed facilities that have uninstalled DoseEdge in favor of EDP, and some that have elected to with Epic over an outside vendor. The pressure is on. 

To the IVWFMS out there, I wish you good luck. The long game is not in your favor.

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*Robotics has its place in the IV room. Products continue to get better every year. While it may not be for everyone, I can see use cases where robotics would be a viable option. 

**EPIC Dispense Prep (EDP) is the IVWFMS module inside the Epic EHR System. It is an incredibly well integrated piece of the overall Epic medication distribution model. Dispense Queue [a dashboard of everything waiting to be prepared] → Dispense Prep [capture all data during compounding] → Dispense Check [Pharmacist Review] → Dispense Tracking [track product from pharmacy to bedside]. While I do not care for Epic, in general, one has to admire the vision and design.

IV workflow management systems and workarounds

A large portion of the most recent issue of the ISMP Medication Safety Alert is dedicated to IV workflow management systems (IVWFM) and errors caused by workarounds. There are a few head-scratchers in the list to be sure. There are even some that had me speculating their authenticity, i.e. too wacky to believe.

“Data submitted to the ISMP National Medication Errors Reporting Program (ISMP MERP) have repeatedly shown that manual verification of intravenous (IV) admixture ingredients by pharmacy personnel who prepare solutions and pharmacists who inspect the final products is not particularly effective in detecting and correcting errors.” You can take this to the bank! Rule #1: people are people. They make mistakes and do crazy things sometimes. Rule #2: no amount of technology will eliminate rule #1.

“However, as with any new technology that introduces an element of change, we want you to know about the workarounds and errors we have learned about with WFMS and why they may be happening so you can be as prepared as possible to address the when you assess or implement this technology. Some of these workarounds or errors are common to many other forms of healthcare technology.”

This is no doubt true as I’ve witnessed workarounds with pharmacy technology on many occasions.The sad truth of the matter is that no amount of technology will prevent people from finding workarounds. Just like no amount of manual processes and double checking will prevent workarounds. Unfortunately, these workarounds can lead to mistakes, which is what we are ultimately trying to prevent.

Typically, it is a combination of well-defined processes with appropriate technology that creates the safest environment. It’s also the best way to prevent workarounds. That and opening a can of whoop ass on people that don’t follow the rules; figuratively speaking, of course.

Here are some of the potential workarounds and errors identified by ISMP, many of which are similar to those seen with bar-code medication administration (BCMA):

Inability to scan the barcode — This is a common problem with any bar-code scanning process, i.e. BCMA, etc. Barcodes are far from perfect and will never be 100% scannable.

Reluctance to scan the barcode — Human nature. Go figure.

Scanning just one vial — i.e. scanning a “representative vial” when using more than one vial during CSP prep. Happens all the time.

Using a decoy for scanning or image capture — the old barcode-in-the-pocket scam.

Using the syringe pull-back method — hard to imagine that this is still going on in pharmacies across the country. It should be banned. Any facility caught using the syringe pull-back method should be fined heavily and mocked openly for their laziness.

Blurry or missing digital images — I’ve experienced this personally. Here are some images from one popular IVWFM system that were given to me. Can you tell, without any doubt, what the volumes are in these syringes? [If anyone has any sample images, I would love to see them]

Lapses in technique. “Use of WFMS touch screens can lead to touch contamination, especially when handling hazardous drugs. This and other lapses in hazardous drug handling and aseptic technique are not easily captured by the WFMS and may go unnoticed.” — No doubt a problem. Regardless of what technology you add to your process, proper technique in the hood is a must.

Interference with the scale. “ISMP has received a report about a WFMS with gravimetric technology for which the scale would not work in a laminar airflow workbench/biological safety cabinet due to vibration. Every time the pharmacy technician needed to weigh a product, he or she had to turn off the hood [what the heck!].” — not all gravimetric solutions are equal. There are at least two IVWFM systems on the market that do a great job with their gravimetrics. There is at least one that doesn’t. Any facility considering this technology should make sure to do their homework.

Nonadherence to diabetes medications costly

This is follow-up commentary to an article I Tweeted about earlier this week.

JCP: “[Express Scripts] found that patients who were adherent to oral diabetes drugs had 235 fewer emergency department visits and 50 fewer inpatient hospitalizations per 1000 patients, resulting in an average of $500 saved per patients and a total decrease of $210 million in health care spending in 2016…Patients who were nonadherent were found to have 1.3 times higher medical costs and 4% higher total health care costs compared with adherent patients, a difference of $11,176 vs $10,683, respectively.” – No surprise. Poor control of chronic diseases like diabetes can lead to lots of complications, including admission to a hospital for advanced care.

Nonadherence to medication is tricky. Proposed solutions to the problem are many. Actual solutions to the problem are few. The issue is that there’s no one-size-fits-all approach to the problem. People behave like people. Some will do a great job managing their disease, while others won’t. The more complicated the disease management, the more likely that adherence will slip. And management of patients with diabetes can get very complicated.

The difficulty comes when multiple healthcare providers are involved. There are often multiple medications, complicated administration regimens, and so on. I witnessed this firsthand while caring for my mom during the last year of her life. She was a complicated patient, and her medication regimen changed frequently depending on the physician seen and which area of the disease was the focus of treatment; the old whack-a-mole approach to medicine. With that said, my mother was a best case scenario. Her ability to manage her medications was inspiration. However, even as a pharmacist I found it difficult to keep track of what was going on at times. There were times when I would re-sort and organize her weekly medications three times in a ten day period. Crazy.

My opinion is that adherence strategies are still in their infancy. There are simply too many variable when it comes to patients take their medications correctly. The most important thing, in my opinion, is getting people to take a stake in their own disease management. That should be the primary goal. The rest is window dressing at this point.

Does tall man lettering work?

First of all, is it tall man, tall-man, or tallman? And why is it called “tall man lettering” when none of the letters are actually taller than the others? Heck if I know. Just more questions in a mountain of questions piling up around tallMAN lettering.

Pharmacy Practice News: “[The study] found that there hasn’t been a substantial drop in drug name mix-ups since use of tall man lettering became widespread around 2007… “We saw no reassuring trend of declining rates of errors,” said study author Chris Feudtner, MD, PhD, MPH, a pediatrician at the University of Pennsylvania’s Perelman School of Medicine, in Philadelphia…If tall man lettering were working, the researchers expected to see a significant decrease in these types of errors after 2007 when the JC began recommending that hospitals implement tall man lettering and other typographic drug safety measures. No such drop was seen.”

The entire use of TaLlMaN lettering has always seemed odd to me. I could never understand how it would keep anyone from grabbing the wrong medication. I mean seriously, who in their right mind would confuse SUMAtriptan with ZOLMitriptan, or ARIPiprazole with RABEprazole. Crud, they’re not even remotely close when one considers the alphabet. When searching for the drug within a CPOE system one types “sum…” or “zol…”, not “…triptan. C’mon, people!

One classic mix up is hydrOXYzine and hydrALAzine. They definitely have similar names, but the former is an antihistamine used to treat itching, while the latter lowers blood pressure by exerting a vasodilating effect through a direct relaxation of vascular smooth muscle, i.e. it’s a blood pressure medication. Why the heck would anyone want to use a blood pressure medication to treat itching? They wouldn’t.

Perhaps it would make more sense to simply put the drug class or use on the packaging. You know, hydroxyzine [antihistamine/itching] or hydralazine [vasodilator/blood pressure]. Better yet, let’s require prescribers to place an indication on all orders: hydroxyzine 25mg PO Q6H PRN ITCHING versus hydralazine 25mg PO Q6H FOR BLOOD PRESSURE. Might even be educational for some prescribers.(1)

How about we spend a little time creating smart EHR’s that know when something is amiss?(2) A system that won’t let the provider select a medication for an inappropriate indication without jumping through some hoops. Something like “You sure about this, bruh? Hydralazine isn’t typically used for itching. Were you trying to prescribe hydroxyzine?”(3)

Now combine smart prescribing practices like those above with safety measures in the pharmacy like barcode scanning for verification. Selecting the wrong medication in the pharmacy is always possible and happens for a host of reasons, regardless of t.a.l.l.m.a.n lettering. Barcode scanning is a pretty good way to help ensure that you have the prescribed medication in hand.

Overall, I’m not surprised that T-A-L-L-M-A-N lettering didn’t make much of a difference in the study. Even though it’s become a standard of practice, I don’t know that I’ve ever bought into it. My preference would be to use better technology with a little common sense.

If you’re interested in reading the article (BMJ Qual Saf 2016;25[4]:213-217; BMJ Qual Saf 2015 Dec 16. [Epub ahead of print]), it can be found here.

 

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(1)    You might be surprised to find out how little some practitioners know about the medications they prescribe. I constantly appalled by the prescribing practices that I see in the acute care setting.

(2)    Something like AI or ML, perhaps. Hmm…

(3)    That’s kind of how the call goes when you have to let a prescriber know they may have inadvertently selected the wrong drug.

Microneedle patch for monitoring drug levels

Medgadget: “A collaboration between researchers at the University of British Columbia and Paul Scherrer Institut in Switzerland has developed a microneedle device for drug monitoring. The device is in a form of a patch that’s stuck onto the skin, painlessly pushing microneedles through to sample the interstitial fluid…The proof-of-concept device reported by the team was used to measure the concentration of vancomycin.”

microneedle-optofluidic biosensor

This is something that has been sorely needed for a long time. As a pharmacist, I can confidently state that we spend entirely too much time looking at drug levels that are within normal limits versus evaluating those that are not. It would seem much more efficient, at least in the acute care environment, to ignore “normal” levels and spend our time investigating those that are out of whack.

In the outpatient environment this makes even more sense as a patient safety measure. Imagine never again having a patient urgently admitted to the hospital for a drug level that’s way too high. Think of all the medications that require at least intermittent drug levels: carbamazepine, phenytoin, digoxin, tacrolimus, and so on.

Side note, my mother was taking tacrolimus around the time of her liver transplant. An EHR charting error occurred that resulted in her receiving 10 mg orally twice a day instead of 1 mg orally twice a day; yep, a 10-fold error. True story. Almost killed her. The small-town hospital where she lived didn’t recognize the symptoms and failed to get a drug level when she was admitted for “dehydration”. Several days of pleading with physicians and calls to UCSF resulted in a level being drawn. It was off the charts. She was subsequently transferred to UCSF where she spent the next six weeks in the ICU. The entire ordeal could have been avoided with real-time drug monitoring. Just sayin’.

Cool technology for pharmacy – ProteXsure Safety Capsule System

Needle sticks happen. I’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 a 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. “no-recapping” to physical barriers like safety syringes. The ProteXsure Safety Capsule System falls into the latter category.

ProteXsure

medGadget: “[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.”

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 “One Hand Recapping”
  • Accepts both “Bent & Straight” 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.

Witnessing errors in the iv room

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.

Syringe pull-back method

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.  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.  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) 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.

(3) Am J Hosp Pharm 1997;54:904-912

Initial reaction to FDA stance on syringes as standalone storage container

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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  1. There’s much more to this statement, but for the sake of brevity let’s just leave it at that.

Pros and cons of IV workflow management systems

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.
Continue reading Pros and cons of IV workflow management systems