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.

Remdesivir, the pharmacy budget buster

I saw the discussion below in one of the pharmacy forums. Fact check true on this one.

Gilead would have everyone believe that remdesivir is a magic bullet for COVID-19 infection. Not true. Helpful? Useful tool? Maybe.

Remdesivir, while potentially beneficial, has limitations. For one, it should only be used on hospitalized patients that have falling oxygen saturation and chest infiltrates. Second, while it has been shown to potentially shorten the course of the disease, it has not been shown to reduce mortality.(1)

On the flipside, the drug is relatively expensive, has been overused, and contrary to data showing that it may shorten the course of the disease, may inadvertently lengthen hospital stays.

Based on the “Solidarity” trial, a WHO guideline committee went as far as to recommend against the use of remdesivir.(2)

“The Solidarity Trial published interim results on 15 October 2020. It found that all 4 treatments evaluated (remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon) had little or no effect on overall mortality, initiation of ventilation and duration of hospital stay in hospitalized patients… So far, only corticosteroids have been proven effective against severe and critical COVID-19. [see RECOVERY trial (3)]… The researchers determined the evidence quality to be low for remdesivir in regard to improving time to clinical improvement, hospitalization duration and mechanical ventilation duration.”

However, you won’t find physicians touting this particular WHO recommendation. Why not? Simply put, it doesn’t fit the narrative put forward by Gilead and the media. Nor does the WHO recommendation give practitioners access to this new therapeutic toy. A combination of marketing and fear has led to remdesivir rapidly evolving into “best practice”. It is basically spreading through hospitals unchecked.

But Jerry, no hospital could have predicted the pandemic and therefor the cost of remdesivir. True. However, if remdesivir truly cut hospital stays by a couple of days and reduced time on mechanical ventilation, the cost of the drug would be a wash. I have not seen any large-scale data to support this notion. As of today, hospitals have spent millions upon millions of dollars on remdesivir. Not to mention that there are reports of providers prolonging patient stays to complete remdesivir treatment courses even when patients have met criteria for discharge. Such practice spits in the face of common sense.

But Jerry, even if it saves one life it will have been worth it. Ah yes, the battle cry of people who want something done, regardless of the consequences. Such sentiment seems reasonable on the surface, but quickly fades with analysis and thought. A philosophical debate for another time. Suffice it to say that real life doesn’t work that way.  

Overall, the unfettered use of remdesivir, combined with failure of healthcare to provide clear, concise, science-based use criteria, has created a budget pitfall that will take years to climb out of, if at all. It’s this type of fiscal irresponsibility that makes the U.S. healthcare system so special.

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  1. Healio.com. 2021. Remdesivir shortens time to improvement, but has no significant mortality effect. [online] Available at: <https://www.healio.com/news/primary-care/20210331/remdesivir-shortens-time-to-improvement-but-has-no-significant-mortality-effect> [Accessed 29 April 2021].
  2. Who.int. 2021. “Solidarity” clinical trial for COVID-19 treatments. [online] Available at: <https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments> [Accessed 30 April 2021].
  3. New England Journal of Medicine, 2021. Dexamethasone in Hospitalized Patients with Covid-19. 384(8), pp.693-704.

Pharmacy – Relying on 503Bs is a mistake

What’s a 503B FDA outsourcing facility? Well, just sit right back and you’ll hear a tale, a tale of a fateful trip, that started from this tropic port, aboard this tiny ship…. just kidding, it’s what popped into my head when I started writing, but we really should define what a 503B is.

The 503B moniker is a designation created by the FDA that establishes a middle ground between manufacturers and facility-level compounding. In short, 503Bs are pharmacies that can “manufacture” compounded medications and sell them to other entities, like hospitals. Unlike hospital pharmacies, designated 503A pharmacies, 503Bs must comply with strict CGMP – current good manufacturing practices – which are the same standards that pharmaceutical manufacturers are held. Because 503Bs use CGMP and conduct lots of sterility and stability testing, they’re allowed to assign extended beyond-use-dates (BUDs) to products. It’s a tough gig to be sure, no one wants to be beholden to the douchebags at the FDA. More information on 503Bs can be found here.

In general, 503Bs were born out of the crazy overregulation of pharmacy IV rooms. The adoption of USP General Chapter <797> by Boards of Pharmacy throughout the land created a void for most pharmacies that could not easily be filled. Unlike in the heyday of pharmacy practice, when pharmacists made sound, logical decisions based on science, education, and experience, the current landscape dictates when and how something can be made, its storage conditions, and ultimately how long it can be held prior to use. Before USP <797>, it was customary practice to compound “batches” of frequently used medications and store them for future use, whether that be a week or a month down the road. It was the lifeblood of many pharmacies as it gave them control of their own resources. During downtimes, staff would batch in anticipation of times when things were so busy you couldn’t take a piss. With adoption of USP guidelines as best practice, this all went away. Compounding on demand, with some low volume “anticipatory compounding”, became the norm.* It’s quite inefficient compared to older, better practices.

The issue above created a hole in the pharmacy supply chain that gave rise to 503Bs. It’s a service that no one asked for but became unavoidable for many. Don’t get me wrong, 503Bs have been of great benefit to many healthcare systems. They provide a vital service between pharmaceutical manufacturing and facility-level compounding. There are hospitals out there that would find it difficult to survive without 503Bs. On-demand compounding with small anticipatory batches is always preferred, but not always possible. Everybody needs help sometimes.

However, 503Bs are not perfect, and their shortcomings were amplified during peak pandemic. In general, one would have a need, place an order, and receive drug. But we all know that the pharmacy supply doesn’t always work this way. In fact, it’s all too common to have a need, place an order, and then sit around wondering what happened to the drugs that were supposed to be sitting in your receiving area. Things can get messy in a hurry. Think for a moment about when 503Bs are needed most. It’s when demand is high and pharmacies are running at peak capacity. Unfortunately, it’s during these times of critical need when 503Bs become a liability.  

In short, here are the reasons why using 503Bs is a mistake:

  1. Expensive – You pay for the convenience of purchasing products made by someone else. They have to pay for labor, testing, and infrastructure somehow. I don’t begrudge them their profit, but it has to come out of someone else’s pocket. For large facilities, this can easily add up to a number north of a million dollars per year. A million dollars isn’t exactly earth shattering for facilities with budgets in the multiple hundreds of millions of dollars, but it’s worth a moments consideration.
  2. Shortages, demands, delays – 503Bs suffer from the inability to spin up production during times of extreme need. Rest assured, when one pharmacy has increased need for a certain drug, they all do. This obviously creates issues with supply chain, and nowhere is this more evident than with 503Bs. It’s bit me on the rear more than once.
  3. Quality control issues – Unfortunately, 503Bs are subject to the same quality control issues that are found in many pharmacy IV rooms. One small error can force the destruction of an entire batch, which may represent orders for many pharmacies. Whoops, get ready for an Excedrin-sized headache.
  4. Customer support – My limited dealings with 503Bs has resulted in me wanting to deal with them even less. I’ve found customer support at 503B companies to be lacking, to put it kindly.**

In the end, it is at one’s own peril that they rely on 503Bs to provide a steady stream of products. They seem to let pharmacies down when they are needed the most. After much thought, I think it’s time for pharmacies to take back control of their compounded medication production. While not the easiest thing to do, USP guidelines – and by extension most regulatory agencies – do allow pharmacies to produce limited quantities of compounded products in anticipation of need. Given the potential expense of using 503Bs, it seems logical that one could find enough in cost savings to build out a new service line. This is especially true for facilities large enough to require such a service in the first place.  

And that brings us to robotics, which is a blog for another time.

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*one may technically compound large batches at the facility level, but it is limited by two factors: 1) it requires extensive testing that is time consuming and expensive, and 2) regulatory agencies like the CA Board of Pharmacy and the California Department of Public Health (CDPH) hate it, so they tend to crawl up every orifice you have searching for a problem if you do it. It’s the type of scrutiny facilities try to avoid.

**I believe this is due to the nature of their business model, i.e. razor thin margins made up by cranking out more product.

Pharmacy – Lessons from a pandemic

Quite some time ago I took to writing things down in a paper rather than digital notebook. This morning, as people will do when they are bored, I picked up one of those notebooks and began thumbing through the pages. Not too far in, I came across some notes dated Sunday, April 5, 2020 that form the foundation of this blog post.

As we enter year two of “two weeks to flatten the curve”, the notes I jotted down in April 2020 remain relevant. What I thought would be a short kneejerk overreaction, turned out to be quite long. Fortunately, at least in California, the predicted impact of COVID-19 never manifested. To date, our healthcare system has never been in danger of being overrun. In contrast, many facilities ran with patient loads less than average throughout most of 2020. The same remains true for the early months of 2021.

The “lessons” outlined below represent individual opinions, nothing more. They’re my thoughts from April 2020, with some updated experiences thrown in for good measure. Honestly, it is more about healthcare and people than it is “the virus”.

  • The pharmacy supply chain is broken. With hospital census numbers falling throughout most of 2020, the struggle to keep up with basic supplies became a real grind. Shortages are nothing new, but the problem was amplified during the pandemic. Personal Protective Equipment (PPE) became especially problematic, particularly for large facilities with cleanrooms. PPE was worth more than gold in the early months on the pandemic. Everyone scrambled to provide basic gear for IV room personnel. Reasons for the extreme shortage were many. A majority of PPE being made outside the country, fewer people available to work in production plants secondary to illness, and increased use were all factors. However, hoarding cannot be overlooked. Facilities were buying “as much as they could get” and stockpiling. It was a real problem.
  • Patient care became political. At no point in my career have I seen such a draconian dictation of what therapies could or could not be used. Historically, medication selection is based on physician’s professional judgement coupled with experience. That all changed in 2020. Legitimate, potentially beneficial treatments became political hotbeds. Physicians have always been the tip of the spear when caring for patients. They see things the rest of us don’t, which often gives them insight into treatment approaches. I’ve seen things throughout my career that I thought should never have been used but were. It often boiled down to “what they doctor wanted”. Not in 2020. Providers were denied therapies that were not “mainstream”. Normally, I’d get immense pleasure out of watching a physician turn into a 3-year-old that’s been told they can’t have a popsicle for dinner, but not this time.
  • 2020 exposed pretenders. I was shocked at the panic displayed by many healthcare providers. When things got tough, instead of rising up, they folded. The metal of which people are made becomes clear when the pressure is on. It’s often not pretty.
  • The approach for treating any disease evolves over time. Some things work, some don’t. Experience counts. COVID-19 has proven no different. Patients are doing better now because treatment has evolved. With that said, COVID-19 became the first disease in memory to have treatment dictated by reasons other than data. That’s a precedent no one should be celebrating.
  • Scientific literature died in 2020, and it will never be the same again. Instead of sharing information and ideas, it became political. In 2020, open discussion and thoughtful debate was traded for political correctness. Studies or opinions that dissented from mainstream political views were simply not tolerated. Articles were pulled. Commentary was written. Pop-up warnings were added to online journal articles that proposed alternate theories.
  • Healthcare systems were not prepared. The pandemic exposed many weaknesses in hospital practice. So much for “mass casualty preparedness” lauded by hospitals everywhere. See what I said above about the metal from which people are made. It became obvious in the early days of the pandemic that many in healthcare leadership have no metal at all. I saw much panic, flailing, paralysis, and poor decision making throughout 2020.
  • Healthcare forgot that other diseases existed. I simply stopped reading pharmacy forums and gave up on healthcare related websites. There was no reason to visit. Everything written was related to COVID-19. The same questions and commentary, day in and day out. It was monotonous and unnecessary. It’s a good thing all other illnesses and healthcare-related issues took a hiatus in 2020.
  • Media in general, but more specifically social media, replaced idea sharing, science, and data with politics. What a mess. I gave up on social media in 2020 – ironic that I’m sharing this online, right? There is no intellectual value left in social media, only hate-spewing, intolerant individuals.
  • Healthcare systems are technologically inept. No surprise here, I’ve been saying this for years. The arrival of COVID-19 exposed healthcare’s technology-last approach. Nowhere was this more evident than when “remote work” became a thing. Excluding telehealth, “remote work” for many healthcare systems was a joke. As someone that spent the better part of his career “working remotely”, I can tell you that it can be done, given the right equipment and infrastructure. Not in healthcare. “Here’s a laptop, you’ll be working remotely”. Good luck with that. Not everyone is cut out for remote work. Many lack the focus, attention, and discipline to make it work. 
  • Over regulation. Does anyone doubt that healthcare is a regulatory nightmare? I cannot speak about other states, but the California Board of Pharmacy and Department of Public Health (CDPH) proved themselves inept and tone-deaf during the pandemic. I could go into details, but it would probably cost me my job, so I’ll just leave it at that.
  • Waste. I will never again worry about “the environment”. Why bother? Given the millions of tons of unnecessarily wasted PPE that is surely piling up in landfills somewhere, I will never worry about what I toss in the trash. Day after day, I walked past trash receptacles full of used masks, booties, goggle, and gowns. Daily! The waste generated by any large facility in a week far exceeds my lifetime allotment of garbage. So please don’t pander to me about “saving the planet”.

Last year reminded me of all the reasons I left hospital pharmacy and spent a chuck of my career exploring other options. Healthcare is a mess and COVID-19 did nothing to improve it.

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.

Pharmacy Integration is Starting to Make Sense

I’ve been writing about the need for pharmacy integration for years. Most of it negative, and deservedly so because it’s been lousy.

With that said, things appear to have changed in recent years. Integration, it seems, has slowly become a thing. Maybe because I’ve been out of general pharmacy practice for so long that it seems decent, or maybe it’s getting better. Hard to tell, honestly.

Pharmacy systems aren’t really talking to each other better than before, per se, but the number of disparate systems seem to have decreased over the years. Once there were many, now there are seeming few. Once, everything was “best-of-breed”, now things are moving to one system to rule them. Case in point, electronic health records. (EHRs).

I always thought pharmacy integration would take place from the inside out, i.e. pharmacy systems would integrate with other systems and drive information sharing across the hospital. Not even close. Instead, pharmacy systems have become more integrated by being consolidated and sucked into the EHR.

The advent of EHRs has done more for system integration in healthcare than just about anything else. I have plenty of negative things to say about EHRs, but it’s clear that they’ve changed the way we practice, forever.

The way I see things – at least now – most healthcare systems have fallen into two large buckets: 1) documentation – clinical and other; and 2) operational logistics.

Clinical Documentation: Clinical documentation used to take place in “the chart”, among many other places. The chart was nothing more than a binder filled with dividers, separating one bit of information from another. Think of a Trapper Keeper, minus the cool picture on the cover. Paper was everywhere. If you wanted to read something about a patient, like a progress note or radiology report, you had to go to the chart, which wasn’t always easy. They had a way of walking away with physicians and not making their way back to the nursing station.

This all changed when EHRs hit the scene. Everything from demographic data to notes, lab values, medication information, and so on is at your fingertips. If you need information, all you do is log into the EHR and go hunting. Admittedly, it’s not as easy to navigate as a paper chart, but it’s a heck of a lot more data rich and never walks away.

Most of the information coming out of hospital pharmacies these days can be found in EHRs. That includes medication distribution information, pharmacist notes, barcode archives, and so on.

Operational Logistics: Think Amazon warehouse. That’s the easiest way I can explain pharmacy logistics. You buy something from a third party, store it in the pharmacy for a period of time, and send it to a patient when it’s ordered. Simple, really. We’re still not very good at it, but that’s the gist.

For the most part, pharmacy logistics has maintained its distance from the influence of EHRs. Instead, inventory management has been driven largely by a other, non-EHR companies: CareFusion, Omnicell, and to a lesser extent, Swisslog. These companies have grown and expanded over the years, increasing their portfolios to cover more and more areas of the pharmacy.

I’ve mentioned the “four areas of pharmacy” many times: standard storage, refrigerated storage, controlled substance storage, and the iv room. The first three areas are still dominated by these companies. Carousels, inventory software, refrigerators, various cabinets controlled by remote locks, and automated packagers can be found in most large pharmacies. All of which are offered by the aforementioned companies. There was a time when it was common for any number of these products to be supplied by different vendors. Not so much anymore.

These days, it’s all about integrated systems from a single vendor. When given a choice, pharmacies are deciding to purchase from a vendor that can “do it all”. For example, CareFusion offers Pyxis ES ADUs for medication distribution at the point of care; Pyxis Logistics software and hardware for medication distribution from the pharmacy; Pyxis CII safe to manage controlled substances; BD Cato for the IV room; and so on.

With that said, the IV room is in a state of flux. The nature of this area lends itself to both operational logistics and documentation, the latter of which seems to be more important now more than before. It may be the only area of the four where inventory management means less than documentation. I expect this trend to continue.  

Surprisingly, I really have seen better integration amongst pharmacy systems these days. I fully expect it to improve even more as EHRs expand and eventually creep into operational logistics. At least one EHR vendor has already made a significant impact in the IV room. Eventually, pharmacy will be just another department within the EHR’s web of control. I see both good and bad in such a future, but that’s a blog post for another time.

Rethinking Chromebooks

A couple of years ago, I tried switching from a Windows laptop to a Chromebook. It didn’t work. At the time, I was simply too entrenched in my specific needs to make the switch. Things have changed since then. For over a year, I’ve been using an ASUS Chromebook Flip C302 as my primary computing device. Besides having a mouthful of a name, it’s a great little machine. The combination of it plus my Samsung Note 9 has been nearly perfect. I say nearly perfect because I recently ran into an issue where my Chromebook couldn’t cut it. Some will call it an edgecase, but it created a problem nonetheless.

I recently found myself in need of a resume. I have one, sort of. It’s been years since I actually needed a resume, so I haven’t really stayed on top of it. I tried building one from scratch, but quickly realized that it was garbage, so I hired a professional. This particular professional, like many others, uses Microsoft Office, specifically Microsoft Word to create documents. I wasn’t concerned. As a Chromebook user and Microsoft Office 365 subscriber, I assumed everything would be seamless. I mean, I could simply use the web version of Word, right? Yes and no. It turns out that the online version of Word doesn’t play all that well with all desktop versions of Word.

The resume contained a lot of formatting that didn’t translate well from the desktop to the web version. My attempts to make edits and leave comments from within the web version were a disaster. Formating got destroyed, things disappeared from the page, and I quickly became frustrated. Within a day of going back and forth with the author of my new resume, I realized that I had found an instance where a Chromebook simply wouldn’t cut it.

Sooo, what’s a guy to do? I haven’t purchased a Windows laptop for myself in nearly five years. I literally started digging through my computer graveyard, i.e. the closet for one of my old machines. There were plenty to choose from. In the end, I ended up using an old 15.6-inch Sony VAIO to edit and complete the resume. The VAIO is a bit long in the tooth, but it’s a nice big machine to type on. I appreciate the screen real estate for going back and forth between documents, notes, etc. It worked out quite well.

In the end, I received a new resume and went on my merry way. However, it made me realize that as much as I like my Chromebook, the platform still “isn’t there” yet. At least not for me. For Chromebooks to be truly mainstream, this type of thing can’t happen. At least not as long as such a large number of folks continue to use Microsoft Office as their content creation suite of choice. I understand that this is as much Microsoft’s fault as Googles, but when given the option, it seems logical to stick with a Windows machine for the immediate future.

Consider this, I can use Chrome on a Windows machine to seamlessly do everything I can do on a Chromebook. I can’t do the opposite, at least not seamlessly. I’m sure the Chromebook zealots — and Microsoft haters — will disagree, but it doesn’t change the fact that my struggles were real. As PC laptops continue to get better, and Chromebooks continue to become more expensive, a decision that used to simple is much more complicated now. This is especially true now that Microsoft has embraced Chromium in their new Edge browser.

Given that one can purchase a nice Windows laptop from Lenovo, Dell, HP, or Microsoft for around the $1000 price point, it makes spending $800-$1000 on a nice Chromebook a tough sell. I’ll continue to use my Flip for now — as I said above, it’s a great little machine — but I’m currently on the hunt for a new Windows laptop. I’ve narrowed my search down to a select few machines from Microsoft and Lenovo.

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.

—————————————-

[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”.

Is BD Pyxis Logistics inventory management any good?

Full disclosure, anyone reading this should take it with a grain of salt. I used to work for Talyst as a product manager for their acute care product line, and I’ve recently been involved with a Pyxis Logistics implementation. With that said, forward.

In short, yes, BD Pyxis Logistics (“Logistics) is quite good. BD is doing something that pharmacy has needed for a long time, embracing the concept of “the enterprise” with integration across multiple areas in and out of the pharmacy. BD, as a company, has been busy over the past few years piecing together products to create a cohesive strategy. Someone has been paying attention.

Are they there yet? Not yet, but they are on their way. To paraphrase my brother, they’re currently the worst they’re ever going to be, i.e. their products and strategy are only going to get better and mature over time.

You’ve heard me talk about the four areas of pharmacy many times: standard storage, refrigerated storage, controlled substance storage, and the iv room.

Basic storage are those basic shelving units that most people think of when they walk into a pharmacy. It’s where you’ll find unit-dose and bulk room-temperature items. Logistics is squarely focused on this area of the pharmacy. It works well and, at least in my opinion, does a good job of addressing inventory across multiple pharmacies. Throw in that Logistics is web-based, and it’s compelling.

Refrigerated storage is, well, where you put things when you want to keep them cold. Same as basic storage, only refrigerated. BD doesn’t offer anything specific for this area, but Logistics handles refrigerated items just fine. It basically treats refrigerators the same way it treats static shelving and carousels. It’s just another storage area.

Cleanroom/IV Room is where you’ll find all the supplies for compounding sterile medications. The IV room has been getting a lot of attention lately, but that has nothing to do with inventory management. Most pharmacies treat the IV room as a black hole for inventory, i.e. they lose visibility of their inventory when it crosses the threshold into the land of sterility., BD has had a product called Cato for many years. It’s now called BD Pyxis IV Prep and I’ve always been a fan. Pyxis IV isn’t fully integrated with Logistics, but they’re working on it.

Controlled substance storage is where you’ll find all your opioids, benzodiazepines, and so on. Anything the DEA, Board of Pharmacy, and any other regulatory agency considers a diversion risk. I have a love-hate relationship with controlled substance management. This area is long overdue for improvement. With that said, I’m happy to report that BD is making inroads. The latest version of their CII safe software is integrated with Logistics, meaning no more disparate systems for controlled and non-controlled meds.

What I like about Pyxis Logistics

  • Multiple pieces of the pharmacy puzzle. When looking at the BD Pyxis lineup, the four areas of pharmacy are closer than ever.
  • Integration that is getting better and better all the time. BD not only has the pharmacy covered — Logistics, CII Safe, IV prep — but think about their dominance in the automated dispensing unit (ADU) market. Integration is hard, but getting ADUs and pharmacy inventory seamlessly talking to one another is something I’ve been pining after for a long time.  
  • Handhelds. BD offers a handheld for Logistics. I haven’t had one in my hands but the device and functionality look good, shortening the inventory gaps even more. Talyst had a handheld device for AutoPharm years ago. Wonder what became of it?
  • Good folks to work with. I have nothing but good things to say about the people from BD that I’ve worked with. They want to do a good job.
  • Improvements are rapid and obvious. That’s the thing about most companies, they want to improve their products and keep customers happy. Improved products and happy customers equal increased adoption, which in turn leads to more sales, which leads to more money, and so on down the rabbit hole.

What I don’t like about Pyxis Logistics

  • Reports and analytics appear weak. The system offers many canned reports and access to the company’s Knowledge Portal, but overall, it feels like they’re behind in this area. From what I’ve seen, it’s just not there. When compared to something like the analytics software from Swisslog — still don’t know the name of the product…. Pharmacy Analytics? I mentioned it here — it feels miles behind. What’s worse is that what I saw at ASHP Midyear back in December doesn’t make me feel any better about it.
  • Piecemeal products. It’s obvious what BD is doing. However, buying products and folding them into your portfolio can make things feel like they’re bolted on instead of feeling like they’re an integral part. It’s only going to get better, but one has to be willing to ride through the rough patches to get to the smooth road.
  • Lack of product maturity. “Pyxis”, the ADUs, is a very mature product that’s used in thousands of facilities. Logistics and IV Prep, not so much, and it feels like it.

Overall, it seems as though BD is heading in the right direction. It will be interesting to see where the company ultimately goes with their strategy.

Chapter 8: First things first

Several years ago, shortly after I was let go from Talyst, I found myself with some free time on my hands. I started writing a book. The book was titled ‘Making the right choice: Helping pharmacies make smart decisions about automation and technology’. Like many books I’ve started, it remains unfinished. I don’t think I’ve touched it since 2016. At least that’s the date I have listed as the last time I edited it. However, I recently had reason to go back and review some things I included in the book. Kind of a retrospective review of advice to myself.

Specifically, I was interested in my thoughts on putting together a project team and managing a project. And there, in Chapter 8: First things first, I found what I was looking for. Some of the information is outdated, specifically the final page called Cautionary Tale**, but overall the information still rings true. 

Here it is, Chapter 8 in it’s draft form. Maybe one day I’ll get around to finishing the book. One never can tell.

Chapter 8: First things first

“You can do anything…but before you can do anything, you have to do something.” — Clifford Cohen

You can’t get to the end of a project if you never start, and getting started can often seem like the most difficult part of any project. I can’t pinpoint why it’s so hard to get started, but it is. Perhaps it’s fear of the unknown, or unwillingness to move away from comfort zones. Or maybe it’s because we don’t want to do the work. Who knows? The only thing I know for sure is that once the ball gets rolling, no matter how slowly, it always seems to roll forward. The key is to stop putting it off and get started.

With that said, it’s important that one is truly ready to move forward. Understanding the reason(s) for doing something is key. Seems simple, but it might surprise you to learn how often people do things without understanding why. Begin the process with eyes wide open. Never do anything simply for the sake of doing something.

One must be able to justify all projects, regardless of their purpose. Simply put, the project must worthwhile, viable and affordable, bring a reasonable return on investment (ROI), and be within acceptable tolerances and risks.

Ask yourself these three questions:

  • What do I hope to accomplish?
  • Does the technology make sense?
  • Does the technology fit my operations

If you’ve answered the above questions to everyone’s satisfaction, it’s time to get busy. 

Below are the things that I think are important to ensuring a successful technology implementation in a pharmacy. While it may seem like a lot of work, the end result will be worth the time and energy.

Gauge user beliefs and feeling. Is it going to be an uphill battle? Are the pharmacists and technicians open to the idea of implementing new technology? Is the pharmacy morale where it should be? Does your department fear change? The success of your implementation will rely heavily on how well you and your department are prepared. The implementation of new technology can often pose a threat of reduced control over one’s work. This can create pushback from the staff. Helping them understand what it is you hope to accomplish, how it will help them, and offering opportunities for staff to become involved and have a vested interest in the project can go a long way to ensuring a successful implementation.

Get support / buy-in for the project. The need for support for any project is a must, and this is especially true for pharmacy projects. Success depends on support from the top of the organization to the bottom. Lack of support will result in a failure to launch. If and when possible, it is best to start with an executive sponsor, or someone from the Hospital Board of Directors, if you have one. This person, or persons, will be your champion during high-level meetings within the organization.

Once you have executive level support, it’s time to consider support from other areas. If the project will impact nurses, find a nurse. If a physician, find a physician. And, so on. You don’t want to launch a project that will impact a group of people without getting their support. Trust me, it’s not a good idea. Call it politics if you must, but peer-to-peer communication works wonders. Having support from a variety of areas and disciplines will improve communication and go a long way in generating support for a project.

Create a buzz. Create some excitement. Don’t act like the project is required, but rather a choice that’s going to make things better.

Give everyone fair warning of what you plan to do. People fear change. Give them plenty of time to get used to the idea. This will go a long way in gaining support for a project. Being aware of what’s coming is always preferable to being surprised by what has already been done.

Involvement and participation. When individuals believe that a project is relevant, they are much more likely to have a positive attitude toward it. And the best way to get individuals to believe is to get them involved. Allow them to participate in all phases of the project. “Increasing user participation … enhances post-development user involvement and attitude” (Vaughan PJ. System implementation success factors; it’s not just the technology. Internal Report of Information Technology Services. University of Colorado at Boulder. 2000), which is what you want. 

Involve as many as you can as often as often as you can. When people are involved, it gives them a sense of ownership and a vested interest in making a project successful. It also helps deal with negative vibes from others. Include multiple disciplines, depending on the technology and departments affected.

It is also important that all participants be volunteers. Mandated participation has been shown to be ineffective and potentially detrimental to the success of this type of project.  (Hunton, James E., and Jesse D. Beeler. “Effects of User Participation In Systems Development: A Longitudinal Field Experiment”. MIS Quarterly 21.4 (1997): 359. Web. 8 Apr. 2016.)

Champions. Champions are those people that go above and beyond the general participant. Champions believe in the project and the benefits it will provide. They can often have a contagious zeal about the project, and are sometimes referred to as “evangelists”, or in extreme cases “zealots”. Whatever you call them, when it comes to implementing new technology in the pharmacy, Champions can be your best source of support. They can be useful in putting a spotlight on the project in a positive way and swaying the negative feelings of others.  

Finding Champions shouldn’t be too difficult. They’re usually early adopters and will take the initiative to learn more about a project without being asked. 

Develop rules for participation. This is really quite simple. It is important that the rules for participation be laid out well in advance, and that each member of the team sign off on them. There should be no surprises for what’s expected from participants once the project is underway. The following rules are examples:

  • Be willing and able to engage in the project
  • Be willing to be positive about the project
  • Be willing to work with others to advance the project toward accomplishing the goal
  • Be willing to commit to attending meetings
  • Be willing to commit to handling extra work, even if it means staying late or doing some reading at home in the evenings or on weekends. I understand that no one wants to put in a bunch of unpaid overtime on these projects. However, on occasion, a little extra work may need to be done to keep things moving forward. One should enter into participation with the understanding that this could happen.
  • Be willing be engage in every aspect of the project, not only the items that are assigned. It is vitally important that each participant have at least a basic understanding of the overall scope of the project and what each member of the team is assigned. Things happen. People get sick, quit their jobs, move to another state, and so on. Unforeseen events should not completely derail the project timeline or goals.

Find naysayers and sway them over to your side. Every project has its opposition. As the saying goes, you can’t please everyone all the time. Unfortunately, naysayers tend to have vocal personalities. They’re not afraid to say what’s on their mind. These two things – being negative and outspoken – tend to go hand-in-hand. The downside to naysayers is that outwardly negative comments about a project have a way of spreading like wildfire. They can be caustic, seeping into the minds of even the staunchest supporter. And once there, negative thoughts can grow like a cancer. With that said, naysayers and their negative comments have their place. Because they’re not afraid to speak up, they can sometimes point out things that others fail to see, helping avoid potential pitfalls. The trick is to use the information to your advantage. Allow naysayers to offer up their thoughts in a controlled environment where their comments can be contained. Give them space to vent. Listen to what they have to say. Use what you can and toss the rest. Showing naysayers that you’re willing to listen and take their concerns seriously can go a long way. In rare cases, you might even make a convert out of one, which would be a huge victory for the project. However, never try to force change on a naysayer. Forcing change, or mandating them to join your side, rarely works. It’s like dealing with a donkey, the harder you pull, the harder they resist.

Build your team. According to Harvard Business Review’s (HBR’s) 10 Must Reads On Emotional Intelligence[(HBR’s 10 Must Reads On Emotional Intelligence. Print.), a source of great team success lies with teams that can achieve high levels of participation, cooperation, and collaboration among members. Sounds logical, but oh so difficult to do.

Note: HBR’s 10 Must Reads On Emotional Intelligence is a great collection of previously written articles pulled together into a single book. Each article is informative and interesting in its own right. However, when combined, they create a great collection that any person involved in a project should read. I highly recommend it. It’s a short book and an easy read.

Team members must be chosen carefully and meet three basic conditions:

  1. Mutual trust of one another
  2. Have a sense of group identity: a feeling that they belong and the project is worthwhile
  3. Have a sense of group efficiency: belief that the team can perform well and that the group is better than the individual members.

Collectively, HBR refers to this as the groups “emotional intelligence” (EI). While intelligence and experience among group members is important, EI may be more important still. Keep that in mind when you begin building your project team.

Chose a project leader. Ah, the leader. The captain. Thy person in charge. It’s a burden that many well qualified individuals shy away from. Someone has to be in charge. Someone has to be given authority over the group and be willing to make the tough decisions and hold people accountable.

Not everyone is cut out to be a leader. Everyone reading this has worked for both great and terrible leaders. While I cannot tell you exactly how to identify a great leader, I know one when I see one.

According to HBR’s 10 Must Reads On Emotional Intelligence what distinguishes good leaders from great ones is their EI. For individuals, EI is “a group of five skills that enable the best leaders to maximize their own and their followers’ performance”.

The EI skills are:

  • Empathy
  • Motivation
  • Self-regulation: controlling negative impulses [side note: this is really hard to do, especially during high-stress times]
  • Self-awareness: knowing strengths and weaknesses
  • Social skill: being able to build a rapport with others to get desired results {side note: especially tough if you’re a natural introvert]

Find yourself a project manager. As ridiculous as this may sound, the project manager is an often overlooked position when discussing project teams. Let me go on record now as saying that a good project manager is absolutely vital to the success of any project, and could arguably be considered the linchpin to the success of the entire project.

It is the job of the project manager to manage all aspects of the project, including the scope, timeline, cost, quality, and people. They apply their knowledge, skills, tools, and techniques to help projects be successful.

“The role of the project manager is that of an enabler. Her job is to help the team get the work completed, to “run interference” for them, to get scare resources that they need, and to buffer them from outside forces that would disrupt the work.” (Lewis, James P. Fundamentals Of Project Management. New York: American Management Association, 2007. Print.)

Things to consider when selecting a project manager:

  1. The person must have leadership qualities, have good self-management and time management skills, and be a taskmaster.
  2. The project manager cannot serve two masters. Individuals that serve as a project manager must not be required to do any of the actual work in the project. According to James Lewis, “as team sizes increase, it becomes impossible to work and manage both [the work and the team], because you are constantly being pulled away from the work by the needs of your team members”. Having project managers attempt to manage the project and perform work in the project is a recipe for disaster.
  3. The person must have a proven track record. We all know people that can’t manage the paper piles in their office much less a multi-faceted project requiring meticulous attention to detail.

I encourage everyone involved in a large project to read a book or two on project management. Being a project manager is not as easy as it sounds and should be given the respect it deserves.


**Cautionary Tale. Since drafting this section of the book, I have been involved in another amazing project. One that had me working with large teams to remodel or construct new pharmacy cleanrooms for several hospitals. The project spanned well over a year and was simply incredible.