Tag: Patient 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.

The impact of COVID-19 on Pharmacy Personal Protective Equipment (PPE)

COVID-19 has taught us many things, among them that our healthcare supply chain is poorly designed and flimsy. Just a few weeks into the pandemic and our supply chain for Personal Protective Equipment (PPE) has been completely disrupted. PPE is now in short supply, and I suspect that we will run out of PPE in just a few weeks if things continue on their current trajectory.

Are we using more PPE because of COVID-19? Of course! But we are unable to spin up production because a vast majority of the products we need are not made in the United States and the world is in lock down. An industry that is literally designed to provide care to others and save lives has no supply chain redundancy, no failover strategy for shortages, and no geographical diversity for equipment and supplies.

Any pharmacy that compounds sterile medications – intravenous antibiotics, for example – is required to wear a lot of PPE. Guidelines have lead to staff being required to wear a clean, low-lint gown, bouffant (head cover), mask, shoe covers, and sterile gloves when entering the buffer area of a pharmacy cleanroom; I also have to wear a beard cover, but most do not.

When leaving the area, a vast majority of the aforementioned PPE gets tossed, i.e. wasted. Up until about a week ago, much of the PPE worn by pharmacy personnel could not be reused. Now, because of the pandemic, regulatory agencies are lifting these restrictions. It’s an interesting shift in thinking.

In general – in theory? – the use of PPE during sterile compounding is designed to decrease risk of introducing bioburden into process. I suppose that makes sense. Unfortunately, the risk has never been quantified to any appreciable manner. There are no before and after statistics to determine whether or not strict adherence to PPE guidelines has done anything to improve sterile compounding safety, or lesson the risk of contamination. One thing is does, however, is generate a ton of waste and increase the cost of sterile compounding significantly .(1)

Current garbing practices are basically at the whim of groups like the United States Pharmacopeia (USP). The process by which USP creates these guidelines is not at all transparent. We have no idea what thought and/or research goes into their recommendations. Unfortunately, USP guidelines are frequently – almost universally – adopted in whole or part by other regulatory agencies like Boards of Pharmacy, Departments of Public Health, The Joint Commission (TJC), and so on. Few ever question the decisions because everyone is too busy trying to follow the rules and take care of patients to fight it.(2)

Over the past couple of weeks, organizations and regulatory agencies have been pulling back on the requirements for sterile compounding PPE, due in no small part to the disruption in the supply chain caused by COVID-19. It’s an evolving situation.

As we move through this crisis, I recommend the following:

  • Review your current PPE practices. Some folks are doing way more than is required. While noble on the surface, doing so is adding to the shortage and not necessarily benefiting anyone.  A prime example is pharmacies that use full PPE in anterooms.
  • Re-use PPE when allowed. See most recent USP recommendations here.
  • Do not place re-used PPE in plastic bags for safekeeping. I saw this recommendation somewhere and it makes no sense to me. People perspire in PPE, and zipping it up in a bag is akin to a makeshift incubator.
  • Sign up for USP, TJC, and local Board of Pharmacy email communications. Things are changing rapidly, at least they have been here in California. We’ve had to make several adjustments over the past 7-10 days, and I expect we’ll have to make even more in the coming weeks. It’s going to get weird.
  • Use common sense. Folks, pharmacists are highly trained, specialized professionals. Now is not the time to be averse to making judgement calls. It’s why we spent all those years in school and get paid the big bucks. Use your head. Be smart but be flexible.

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  1. It is not uncommon for large hospital pharmacies with busy cleanrooms to spend more than $10K per month on disposable PPE. Think about that the next time a hospital administrator complains about spending $3K on a “non-formulary” course of therapy
  2. Recently, a group successfully blocked the publication of new USP <797> guidelines. One of the reasons the group went after USP was due to lack of transparency in their process and failure to provide information when comments and requests were ignored.

Today’s sterile compounding climate is a lesson on availability cascades

I’ve been slowly reading ‘Thinking, Fast and Slow’, a best-selling book by Daniel Kahneman, a Nobel Prize winning psychologist and economist known for his work on the psychology of judgment and decision-making. 

The book summarizes behavioral science research conducted by Kahneman. The recurring theme of the book is what the author defines as two modes of human thought, “System 1” and “System 2”. System 1 is fast, instinctive, and emotional. System 2, as you might guess, is slower, deliberate, and logical. The author spends a lot of time discussing how System 1 and System 2 impact choices and judgment, creating an incredible amount of bias in our decision making process. The basic thesis being that people really don’t have as much control over their decisions as they believe. According to Kahneman, humans constantly fall into predictable thinking traps, often due to the fast and emotional System 1. The concept is philosophically interesting but practically devastating.[1] 

One section of the book that I found particularly compelling, and applicable to pharmacy, was Chapter 13, ‘Availability, Emotion, and Risk’. The chapter goes into great detail about how bias impacts decisions, even when presented with facts to the contrary. According to Kahneman, these biases are warped by media coverage, especially for emotionally charged issues. This creates problems because the average person is driven more by emotion than reason. [2] 

This area of the book hit home for me because of my current involvement in a massive project to bring hospital pharmacy cleanrooms into compliance with new USP <797> and <800> guidelines. The entire project is the direct result of decision bias surrounding sterile compounding. 

If one were to go back and research the impetus for developing current sterile compounding guidelines, one would be hard pressed to find anything concrete. Current USP Chapters <797> and <800> are based more on “expert opinion” than science. If it were the other way around, one would find more references for specific requirements and fewer reader comments. The guidelines would read more like a journal article and less like best practice recommendations. However, that’s not what we find in these chapters. 

While there’s nothing wrong with expert opinion, per se, they should not override common sense. Expert opinions should be considered recommendations and guidance, not requirements and law. The problem with expert opinion is that it can be influenced by emotion, the same as an average person. Emotional decision making can lead to problems. According to Kahneman, “…biased reactions to risks are an important source of erratic and misplaced priorities in public policy. Lawmakers and regulators may be overly responsive to the irrational concerns of citizens, both because of political sensitivity and because they are prone to the same cognitive biases as other citizens”. 

Consider this, Kahneman describes something in his book called an availability cascade. An availability cascade is “a self-sustaining chain of events, which may start from media reports … and lead up to public panic and large-scale government action. …[the] emotional reaction becomes a story in itself, prompting additional coverage in the media, which in turn produces greater concern and involvement”. This describes perfectly the current state of sterile compounding regulation in pharmacy. 

Remember a little thing in 2012 that caused outrage aimed at pharmacies across the country? For those of you that don’t recall, Google New England Compounding Center (NECC).  In summary, people died as the result of fungal meningitis caused by contaminated steroid injections compounded by NECC. It was pretty bad. The incident lead to congressional hearings, more power being granted to the FDA, increased scrutiny by regulatory and licensing agencies, and ultimately, more pharmacy regulation. Pharmacy is still reeling from the impact that the NECC tragedy had on the profession. 

Here’s the thing, it was a horrible, terrible, no good tragedy, but it had nothing to do with lack of regulation. The folks at NECC simply chose to ignore best practice and place profit ahead of common sense and standard safety precautions. Lest we forget, USP <797> was already on the books in 2012. Would NECC have followed standard sterile compounding processes in place at the time, we wouldn’t be having this discussion today.  

A single event, the NECC tragedy, was championed into significant changes without objective analysis. Why? According to Kahneman, we have “a basic limitation in the ability of our mind to deal with small risks, we either ignore them altogether or give them far too much weight…..biased reactions to risks are an important source of erratic and misplaced priorities in public policy. Lawmakers and regulators may be overly responsive to the irrational concerns of citizens, both because of political sensitivity and because they are prone to the same cognitive biases as other citizens”. That’s a perfect description of the current sterile compounding climate. Unfortunately, there’s no going back. As one prominent sterile compounding consultant told me, that ship has sailed. The only thing we can do now is be more prudent with decisions moving forward. 

Think of the resources that have gone into cleanroom construction, training, and testing since the NECC incident. It’s staggering. Now think of what other pharmacy initiatives could have been implemented with the same resources. Based on risk alone, patient safety would have been better served by putting the same effort toward improving sterile compounding accuracy instead of sterility.

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[1] Please read the book. It contains little tests and puzzles that will blow your mind. I thought I had solid command of my thinking. I thought my decisions were logical and well reasoned. I was wrong. 

[2] Paul Slovic, a professor of psychology at the University of Oregon and the president of Decision Research stated that people are “guided by emotion rather than by reason, easily swayed by trivial details, and inadequately sensitive to differences between low and negligibly low probabilities”.

ASHP Midyear 2018: Initial Thoughts

I recently returned from the 2018 ASHP Midyear Clinical Meeting, i.e. “Midyear” in Anaheim, CA. This year was a bit different for me as it was the first time in many years that I attended the meeting as a regular pharmacist, i.e. not tied to a pharmacy automation company as an employee or as a consultant. As such, I had no constraints on what I could see, do, or say. It was invigorating, to say the least.

I attended several educational sessions, mostly on USP <797> and <800>. However, most of my time was spent in the exhibit hall wandering from booth to booth checking out all the cool products. It was great.

As much as it pains me to say, not a lot has changed since the last ASHP Midyear Meeting I attended in December 2016.* Many of the products and vendors were exactly as I remember them. With that said, here are a few things that caught my attention:

  • The “Big 3”: Omnicell, BD, and Swisslog all had a big presence on the exhibit hall floor. All three companies appear to be vying for pharmacy supremacy as they continue to grow and gobble up small companies. The Omnicell booth was giant and seemed to always be full. Oddly, it was the only booth I walked into where someone from the company didn’t engage me in conversation.
  • IV workflow management (IVWFM): No longer a hot topic. It appears that the market is slowing as pharmacy leaders turn their attention to other things. Quite a dichotomy from what ISMP and ASHP continue to recommend, i.e. the use of technology during sterile compounding. Apparently patient safety is important, unless it’s inconvenient. Pharmacy is weird.
  • Drug Diversion: Unlike IV workflow management, drug diversion was a hot topic. It seems as though everyone has a software solution to help root out those pesky diverters.
  • Kiro Oncology by Grifols: I wrote about Kiro Oncology back in 2015. At that time, I didn’t think much of the product. It had some serious shortcomings, at least in my opinion.  The robot lacked speed and a drug dictionary that would make it useful. Now, not so much. I was impressed with how far Grifols has come with Kiro Oncology. The speed has significantly improved and they’ve worked with their partners to build an impressive oncology drug dictionary from which sterile compounds can be made. I spent quite a bit of time speaking with a Director of Pharmacy at a facility that is using Kiro. He mirrored my thoughts, i.e. not great to start but significantly better now. Given the new focus on hazardous drug compounding, my thoughts on Kiro have changed. There is great potential here. I may write more about this later.
  • PharmID: PharmID is a product that uses Raman Spectroscopy to identify drug waste. If you’ve been following my blog over the years then you know that I like Raman Spectroscopy. It makes a lot of sense when you want to know what’s in a clear fluid. Before PharmID, the company was trying to fit the technology into the sterile compounding space. That didn’t make sense to me, but this does. Given the focus on drug diversion and the inherent problems tracking waste in the OR, something like PharmID has great potential. Now all they need is something like the now defunct  BD Intelliport to automatically record the volume. If you can do that — identify the drug, measure the concentration and volume — you’re all set.
  • IntelliGuard: In the Summer of 2017, IntelliGuard got a new CEO and then abruptly went dark. The company disappeared from view. After visiting the IntelliGuard booth at Midyear, it was apparent why. They’ve completely revamped their image, created an entirely new marketing strategy, built some new products, improved on old products, and created an integrated platform message. I’ve always liked RFID technology for certain niches within healthcare, and IntelliGuard makes some great RFID products.
  • Swisslog: Some people feel that I’ve been a little hard on Swisslog over the past couple of years. I for one, am not one of the people. I call it like I see it. And my opinion is exactly that, my opinion. When Swisslog acquired Talyst, I was skeptical. Nothing has changed, I remain skeptical. However, Swisslog has two products that I really like. The first is their analytics software. I don’t know the name of the product and can’t seem to find it on their website. Regardless, I’m impressed by the vision that the company has with the product and the number of disparate systems they’ve managed to tie into it. I would love to see it in the wild. The second product is the Relay Robot. Love that little bot. I can see so much potential.
  • DrugCam: DrugCam is an IV workflow management system. I first saw the product at the ASHP Summer Meeting in Minnesota way back in 2013. DrugCam uses computer vision technology that automatically detects items and fluid volumes during the compounding process. As the user passes components in front of the cameras, the system automatically identifies them. If the system doesn’t recognize the item, the user is notified via visual cues on the screen. I’m not entirely sure how it works, but it is pretty interesting. The company had a presence in the exhibit hall but there was no hardware to look at, only a video set on a continuous loop in the background. I was really high on this technology when I first saw it. It would be good to see it in action. There’s an article from April 2016 in the International Journal of Pharmaceutics should you be interested in reading more about it.

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*I skipped the 2017 meeting due to scheduling conflicts with my new job

It’s time to disrupt pharmacist order verification

Several years ago there was a debate over the long-time practice of having pharmacists review all medication orders prior to administration; referred to as nearly universal prospective order review (NUPOR).(1) At the heart of the debate was whether or not such a process was still relevant in the changing face of healthcare, i.e. do pharmacist really need to see every single medication order prior to that medication being administered to a patient?(2)

The argument in favor of universal medication order review is obvious: ensure complete, accurate orders. The argument against universal medication order review is that it’s expensive, time-consuming, and unnecessary in most instances. My own personal belief is that the practice is antiquated and should be changed.

The introduction of electronic health records (EHRs) has changed the medication order entry landscape. No longer do pharmacists interpret and enter orders from hand-written orders on paper faxed to the pharmacy. Those days are mostly behind us. These days, medication orders are generated electronically from pre-defined, pre-built entries in the EHR. Providers simply check a box and bam, order entered. Or as one pharmacist put it in a discussion forum recently “I mean an order set that has been checked by pharmacy, checked by a physician, checked by nursing, approved by P&T / Medical Ethics ….how many times do we need to verify it?”. I feel the same way.

In the rare case that no checkbox is available, today’s EHRs are intelligent enough to provide directions for the user. Not to mention that a majority of medication orders processed in a hospital are simple, routine, and require no critical thought. It is the exception rather than the rule to see an order that requires any deep thought or intervention.

There are those that argue that taking pharmacists out of the order verification role is dangerous, but nothing could be further from the truth. Having pharmacists verify orders is retroactive, at best. What percentage of orders require a pharmacist’s intervention? 10%? 5%? Hard to say, but the percentage is small.(3) The same pharmacist mentioned above said it best: “I did a cursory look and for one month out of 150,000 orders verified, only 5,000 had an intervention performed on them. So 3% of the time we are actually doing something significant enough to warrant an intervention.” So current best practice has pharmacists — a highly trained, expensive professional — looking at 100% of orders in an attempt to find the 3% that have problems. Seems kind of silly.

I often look to the model used in poison control centers for support of my opinion. Non-pharmacists screen calls at poison control centers. If the call can be handled via a well-thought-out algorithm, then it’s handled. If not, the call is escalated to a pharmacist. In other words, pharmacists are only getting the calls that require their particular brand of expertise. That’s poison control! Think about it.

The days of having a pharmacist look at each and every medication order entered into an EHR are over. It’s an antiquated process that’s long overdue for an overhaul. The time has come for healthcare systems to make better use of their personnel.

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  1. People love their acronyms. I’ve always called it “order verification”.
  2. The answer is obviously no, pharmacists do not need to review every single medication order before that medication is given to a patient. But, people like to argue.
  3. I’ve said many times that a monkey could do my job. While my comments are flippant, the sentiment rings true. I could train an intelligent teenager to do 80% of my job in a couple of short weeks. On a side note, I’ve never had a single person challenge me regarding my monkey comment. Seems odd, don’t you think? I mean, it’s insulting.

Saturday morning coffee [September 16 2017]

“Why do you look at the speck of sawdust in your brother’s eye and pay no attention to the plank in your own eye?” — Matthew 7:3 (NIV)

So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts…

‘It’ was #1 at the box office last weekend, bringing in more than $120 million. Expect it to stay there for at least one more weekend. I won’t be seeing it any time soon. Not my kind of movie. Expect more scary movies to hit the box office as we approach Halloween.  

Deadline Hollywood: “It’s an age-old excuse, but, yes, blame this summer’s box office depression on too many tired tentpoles that underperformed. That’s what happens in a product-driven business.” – I feel like this is true. Some of this year’s franchise movies weren’t very good, i.e. Pirates of the Caribbean: Dead Men Tell No Tales, Alien: Covenant, and Transformers: The Last Knight to name a few.  

The FDA recently released a safety alert calling for “separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least 3 hours…  A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines.”. Sodium polystyrene sulfonate (SPS) is commonly used to treat hyperkalemia — a potassium level that’s too high. It’s kind of an odd alert as I would have thought this was common sense. It’s a freaking binding agent that preferentially exchanges sodium ions for other ions for Pete’s sake!

MedicalXpress: “In recent years, researchers have identified substances in coffee that could help quash the risk of developing Type 2 diabetes. But few of these have been tested in animals. Now in study appearing in ACS’ Journal of Natural Products, scientists report that one of these previously untested compounds [cafestol ] appears to improve cell function and insulin sensitivity in laboratory mice.” – It’s coffee time! Coffee, coffee, coffee, coffee…

Bloomberg: “Here’s a fact you have to write down to believe: Over the past 10 years, during which the world has adopted smartphones and social media, sales of fountain pens have risen… Retail sales, in particular, have grown consistently. In 2016 they were up 2.1 percent from the year before, making fountain pens a $1 billion market, according to a report by Euromonitor International.” — I enjoy using fountain pens, and have several. My most recent acquisition is a Pilot Vanishing Point. Neat pen. Retractable nib. 

Jalopnik: “Tesla briefly sold a 60 and 60D trim level of its Model S and Model X vehicles. These models had 75 kWh battery packs installed, but were software limited to have less range to artificially create a more affordable entry-level tier for buyers….With category four Hurricane Irma headed straight for Florida, Tesla unlocked the full capacity of 60 and 60D model owners in Florida to give them about a 30 mile range boost while evacuating.” – Tesla is getting a lot of praise for doing this. On the surface that makes sense, but why would you put an artificial limit on the car straight off the production line. Can you imagine if Chevy or Ford said, “here’s our new V6. It gets 30 miles per gallon, but we tune it down to 22 miles per gallon unless you pay us more”. Think about it.

Xiaomi announces the Mi Mix 2 and Mi Note 3, a better bezel-less flagship and mid-ranger for the end of 2017. With the price of smartphones at or above $1000, it’s time to search for an alternative. 

Looks like Google is ready to drop the curtain on the Pixel 2. “Google hasn’t yet sent out invitations to its next event, but it is beginning to tease it. After sightings of a billboard in Boston suggested that we “ask more of our phone,” Google has thrown up a homepage for the entire world with the same notion — the Pixel 2s are coming.” (source: Android Central). I have to admit, the Pixel and Pixel XL just didn’t do it for me. My wife and daughter both carry the Pixel XL. Meh.

Healthcare IT News: “AMA demands EHR overhaul, calls them ‘poorly designed and implemented’…Latest study confirms typing and clicking consume more than half the workday for doctors.” – Ya think?

Ars Technica: “The situation at Cooley Dickinson is not unique; patients nationwide are being potentially misled about the quality of their care. According to data collected by the [Wall Street] Journal, hundreds of hospitals with federal safety violations continue to boast accreditation and a “Gold Seal of Approval” from the Joint Commission, a nonprofit that the government relies on to accredit almost 80 percent of US hospitals.” – This really isn’t a surprise. The Joint Commission is a joke. They give hospitals tons of warning prior to their “inspections”. And of course, they do a superficial job of looking around. I think they should just pop in without warning and do a deep dive. I could certainly tell them where to look. 

I watched a slew of college football games last weekend. A couple of minor surprises, like Oklahoma over Ohio State — for which I am eternally grateful — and how much trouble Washington State had with Boise State. The PAC-12 looks pretty solid as does the SEC, as usual. Looking forward to watching a few this weekend as well: USC vs. Texas and Louisville vs. Clemson, for starters.

As far as NFL games from last weekend, I didn’t watch a single one. That’s the first time that I can remember that I didn’t sit down on a Sunday and watch the NFL. You want to know something? I don’t really miss it.

I gotta’ go to work now. Have a great weekend, everyone.

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.

A “no-mistakes sponge system” — bar-coded sponges in the OR

While not directly related to pharmacy, the SurgiCount Safety-Sponge System is kinda’ cool. The system uses low-tech barcode technology to prevent surgical sponges from being left behind in patients. Simple yet effective.

“The system uses sterile bar-coded sponges and a computer tablet loaded with proprietary software to ensure that all sponges are tracked. After approximately 11 million surgical procedures over the last five years, which involved the use of more than 200 million sponges, the system boasts zero sponges left behind.” source: MLive

The lowly barcode gets a bum wrap sometimes. It’s far from perfect, but overall I believe the use of barcodes has improved safety throughout the healthcare environment. I remember just a few short years ago when barcode scanning was uncommon. Now, not so much. “Overall, 92.6% of hospitals have barcode-assisted medication administration (BCMA) systems to verify patient identity and electronically check doses administered by nurses (Table 2). Over the past 13 years, the percentage of hospitals having BCMA has increased from 1.5% in 2002.“(1) I get calls in the pharmacy from nurses refusing to administer medication because they’re unable to scan the medication barcode. We’ve come a long way.

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(1) Pedersen C, Schneider P, Scheckelhoff D. ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing—2016. American Journal of Health-System Pharmacy. 2017;74(17):1336-1352. doi:10.2146/ajhp170228.

Compounding Today: state board of pharmacy concerns with USP <800>

Each Friday the CompoundingToday Newsletter faithfully appears in my inbox. The newsletter features commentary by Lloyd V. Allen, Jr., Ph.D., RPh, Editor-in-Chief of the International Journal of Pharmaceutical Compounding. Dr. Allen is a legend in the pharmacy compounding world for both sterile and non-sterile products. He was someone that I looked up to during my early years as a pharmacist; still do, as a matter of fact.

Long before USP <795> and <797> existed, he was preaching the gospel of proper compounding technique and the need for specialized training. Truly a visionary man ahead of his time. I hope to meet him in person someday.

So it should come as no surprise that I take seriously every thought and opinion he has. In last week’s Compounding Newsletter, Allen tackled an interesting topic with some thoughtful commentary.

From the newsletter:

Numerous state boards of pharmacy have concerns about United States Pharmacopeia (USP) Chapter <800> Hazardous Drugs-Handling in Healthcare Settings.

– The official chapter goes beyond the walls of the pharmacy and into healthcare settings, including physician offices, clinics, hospitals, treatment centers, etc. where state boards of pharmacy don’t generally have authority for enforcement.

– The requirements of <800> are very strict and extremely costly; many smaller pharmacies will no longer be able to serve their patients who depend upon compounded medications so they will simply cease compounding patient-specific medications, including some hospitals.

– There are some aspects of <800> that should be the burden of manufacturers and distributors, not pharmacies. As an example, no package should be delivered to a pharmacy contaminated with hazardous drug (HD) contents on the package surfaces that exposes pharmacy personnel upon opening. This is the responsibility of the manufacturer and distributor…

– Many of the requirements of <800> are based upon “opinion” and not necessarily upon science as demonstrated by documented, prospective studies.

It’s interesting to note that USP <800> extends into all areas where HD’s may be used, including physician offices. Where will that oversight come from? Will pharmacies be held accountable?

Dr. Allen has always been an advocate for “the little guy” and been cognizant of the balance between practical regulation and overbearing regulation. This is clear in his assessment of many areas within USP <800>. While I don’t necessarily agree with everything he says, I believe that his commitment to pharmacy practice and patient care deserve our attention. As he states, it is possible that the new regulation will simply be too much for some, resulting in the closure of compounding facilities. The greater concern, at least for me, is what impact the new requirements will have on hospital pharmacies where budgets drive change. A shift in budgetary requirements will likely mean that important projects will be postponed or canceled in favor of meeting USP <800>. The untoward consequences could be felt for years to come.(2)

Dr. Allen’s zinger about the lack of science is understandable and shared by many, but I don’t believe that prospective studies are always necessary to begin a process. For example, would you really want a 10-year pilot study showing that healthcare workers in the U.S. exposed to HDs are 10 times more likely to die of cancer than those that don’t before implementing these guidelines?(1) No, of course not. As I’ve said many times before, some fields – clean room procedure and pharmacy technology, for example – cannot be studied and scrutinized in the same manner as therapeutics. We simply can’t wait 5-10 years to change operational practices. With that said, USP <800> probably goes too far too fast in certain aspects of the regulation. Only time will tell whether the new guidelines will have the same impact as USP <797> did back when they were introduced.

Dr. Allen goes on to state: “As state boards of pharmacy have options other than accepting USP <800> in its entirety… The purpose of this document is to simply provide a resource from which state boards of pharmacy can “pick and choose” items to include for their respective state.” While this may be true, it is one area where I disagree with Allen. Giving each state the ability to “pick and choose” how to implement and use USP <800> makes things incredibly difficult. California, for example, has made a complete mess out of their new regulations. Other states will do the same, creating chaos. In Allen’s scenario, moving ten feet across a state boundary could mean following a completely different set of rules. How does that make sense? I recommend developing USP <800> to a point that everyone can live with and use it. Period.

I encourage you to read through the most recent issue of the CompoundingToday Newsletter. I also recommend that you “click subscribe” as well. The information is good and thought-provoking.

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  • This is a fictitious example.
  • As my friend and colleague, Ray Vrabel likes to say, the clean room is “clean, but deadly”, referring to the fact that we spend all our money on regulation and virtually nothing on technology to improve safety.

Automated detection of LASA medication errors

 

Look-alike/sound-alike (LASA) medications – also referred to as sound-alike, look-alike drugs (SALAD) (1) — have been a thorn in the side of healthcare professionals for as long as I’ve been a pharmacist.

Many solutions to the LASA problem have been proposed, including Tall Man Lettering (2), physical separation of look-alike drugs, printing of both brand and generic names on packaging and storage bins, use of colorful warning labels, and so on and so forth. The problem with all these solutions is that they involve humans. Working in acute care pharmacy has taught me over and over again that as long as humans are involved there will be errors.

Technologies can help. Automated carousel technology and robotics can help manage physical separation of the medications and eliminate visual bias generated by human eyes. Bar-code scanning can certainly aid in identifying medications correctly. Bar-codes don’t care that medications have similar names, they’re either right or wrong.

In a recent article by Rash-Foanio (3) et al. the authors use an algorithm to flag potential errors from LASA drugs when an order meets the following criteria:

  1. a medication order is not justified by a diagnosis documented in the patient’s record
  2. another medication whose orthographic similarity to the index drug exceeds a specified threshold exists
  3. the latter drug has an indication that matches an active documented diagnosis.

In the study the authors perform a retrospective analysis to identify errors that involved cyclosporine and cycloserine. The algorithm wasn’t perfect. Sixteen orders involving unique patients were found. Additional chart review of the errors discovered that 5 (31%) identified by the algorithm did not involve a medication error, i.e. the intended medication was correct. However, the algorithm correctly identified 11 (69%) LASA errors.

While it may not catch all LASA errors, it seems that EHRs should give AI and some deep learning serious considerations for items like this. Preemptively catching greater than 50% of LASA errors is better than catching zero. (5)

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  1. I came out of pharmacy school having learned the phrase “sound-alike, look-alike drugs” (SALAD). At some point it changed to look-alike/sound-alike (LASA). Not sure when, how, or why it changed, but them’s the breaks. Just go with it. Adapt or die, I suppose.
  2. I’ve never been a fan of tall-man lettering, and it isn’t even clear that it works to reduce errors.
  3. Rash-Foanio, Christine et al. “Automated Detection Of Look-Alike/Sound-Alike Medication Errors”. American Journal of Health-System Pharmacy7 (2017): 521-527. Web.
  4. Kondrak, Grzegorz, and Bonnie Dorr. “Automatic Identification Of Confusable Drug Names”. Artificial Intelligence in Medicine1 (2006): 29-42. Web. 28 Apr. 2017.
  5. Honestly, one of the simplest things we can do is force providers to select an indication when ordering LASA medications. That simple act has the potential to significantly reduce these errors.