Sterile compounding optimization during COVID-19

From January 2020 until March of 2022, I was one of two inpatient pharmacy supervisors at Community Regional Medical Center (CRMC) in Fresno, California. CRMC is a big level one trauma center. They have about every imaginable service, minus only bone marrow and solid-organ transplants. The pharmacy is large and busy. The size and complexity of the place generated plenty of opportunities to make changes, test out new processes, and work through complicated patient care issues. 

Thinking back, you will note that COVID-19 was in full swing during my time at CRMC, especially during late 2020 and throughout 2021. The fallout from the virus created some interesting problems for pharmacy, namely supply chain issues and increased patient acuity, resulting in increased workload. One particularly troublesome issue was the strain that COVID-19 put on CRMC’s sterile compounding service. The inability to get product, combined with increased demand for certain types of infusions, wreaked havoc on the department.

In response, our team did some interesting things to simplify, streamline, and improve IV production during this time. The work was some of the best I had ever done. I felt so good about it that I thought others might like to review the process. I thought someone might be able to learn from our successes and failures. So, along with a couple of colleagues, I decided to write what I thought would be a publishable article. Turns out there’s a reason I started a blog more than a decade ago instead of trying to push information through mainstream publications.  

The article manuscript was uploaded to the AJHP portal and sat for quite some time. Once the review process began, it wasn’t long before it was summarily rejected. Not “hey, fix these things and we’ll publish it”. Nope, a straightforward “we regret to inform you…”. Apparently, the information wasn’t worth publishing. Some of the comments received from reviewers were valid, and worth consideration, but others were quite silly. Someday, I might post the reviewer comments here just to see what others think. However, right now I’m irritated, so it doesn’t seem like a great idea.  

Overall, I found the reviewers comments lacking in basic understanding of what goes on day-to-day in a large inpatient pharmacy. Some of the comments — “What type of inventory adjustment occurred when usage patterns changed?” – had me scratching my head. Had these folks ever worked in a real pharmacy? I mean, adjusting inventory isn’t rocket science. Ask yourself what happens when your family starts going through two gallons of milk every week instead of one. You buy more milk. Or, for empty nesters like me and my wife, when you hardly ever need milk anymore, you only buy it when you need it. Common sense, people. Common sense.

Anyway, my original intent for the article was to disseminate information to those that might find it useful. So, for those people, I’m including it here in its entirety, warts and all. With that said, the article is written in a more formal tone than my normal writing, which honestly makes it more difficult to fully understand. All told, the necessary information is probably a 1-page weblog. Regardless, I hope you get something out of it. Happy reading.  

Oh, one thing that I think is important but got left out of the article is how manual the processes were that we used to improve our sterile compounding. Shocking, really. My love of technology and automation offered no benefit here. Healthcare – and by association pharmacy – is so disjointed and fragmented that I quickly abandoned any attempt to automate this project. Simple, manual tasks continue to rule the day.

Sterile product optimization during the SARS-CoV-2 pandemic at a large academic medical center pharmacy

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.

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.

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

Building a sterile compounding space in California – Regulatory Hurdles

For almost a year, I’ve been working as a ‘Pharmacy Project Manager’ on a large healthcare system project to bring all their pharmacy sterile compounding spaces — a.k.a. Cleanrooms, SCA’s, C-SCA’s, etc. — into compliance with USP General Chapters <797> and <800>. Some areas have been remodeled while others have simply been scrapped in favor of a completely new space.

The time on this project has been one of the highlights of my 20-plus year career. I’ve learned so much in such a short period. You think you know something until you have to start doing it day in and day out. It’s only then that you realize you know nothing. Here I am a year later and my knowledge base on sterile compounding has increased tenfold. It’s been a great experience.

One of the things that I learned early on in this position is that no pharmacy project in California is easy. There are several state and local agencies that have to be involved. And as one might expect, when government agencies get involved, the paperwork, time, money spent, and frustration can escalate quickly.

The process for remodeling or building a new sterile compounding area, at least in California, involves at least three agencies: the Office of Statewide Health Planning and Development (OSHPD), the California State Board of Pharmacy (BoP), and the California Department of Public Health (CDPH).

In a nutshell:

Office of Statewide Health Planning and Development (OSHPD): Part of the OSHPD mantra is to “ensure hospital buildings are safe”. They’re basically the organization that looks at your architectural and engineering plans and says yea or nay. My experience has mostly been nay on first glance followed by weeks of back and forth until all parties are satisfied. It’s an interesting process, to say the least. It’s also time-consuming.

OSHPD is a real stickler when it comes to anchoring equipment in place in case of an earthquake — noting that California has only had a few major quakes in the past few hundred years. A majority of our quakes are small and cause no damage. But don’t tell that to OSHPD. Their anchoring requirements are, shall we say robust; read that as overkill. The buildings around the anchored equipment will come crashing down long before the equipment will budge an inch. Just sayin’.

OSHPD is the first organization to sign off on a project. Once the plans are approved, a building permit may be issued and construction may begin. Once construction is complete, OSHPD inspects the area, and if everything meets code, they sign off and provide a Certificate of Occupancy (C of O) for the space.

I honestly don’t know a whole lot about OSHPD. The process is mostly handled by the architects, the project engineers, and the construction folks. I get informed with progress and sometimes provide snippets of information, but for me, the overall process is magic behind the curtains.

California State Board of Pharmacy (BoP): The BoP is responsible for ensuring that every pharmacy, or part of a pharmacy, conforms to the requirements set forth by the California Lawbook for Pharmacy. The BoP process starts with submission of an application, license sterile compounding or satellite pharmacy. The BoP reviews the document and either requests changes, which happens a lot, or approves the application and assigns an analyst. The analyst assigns an inspector to the project and a new set of back and forth begins. The inspector often asks for a lot of paperwork before their inspection: copy of sterile compounding PnP, testing and certification results for the room and hood, culture results, “QA” and competency results for staff, cleaning logs, etc. Once the inspector is satisfied with the paperwork — noting that each inspector is different and may ask for different things — they schedule a visit.

Assuming the BoP inspection goes smoothly, which is a hit and miss, the inspector will clear the site for licensing. Unfortunately, the inspector doesn’t actually license the space. All they do is notify the analyst assigned to your case that the space has been cleared for licensing. The actual license isn’t official until a new license number is assigned and posted to the BoP website. This can take anywhere from 2-6 weeks after the inspection. The BoP says “2 weeks” but I’ve found that to be inaccurate in almost all cases so far. The fastest I’ve had approval has been two weeks. The longest has been more than six weeks. If you haven’t heard from the BoP in two weeks, I recommend sending them a nudge, “hey, remember us?”.  It seems to help.

I recommend submitting your application to the BoP at least a couple of months before construction is complete.

California Department of Public Health (CDPH): If one were to assume that CDPH is a single organization, one would be only partly correct. For pharmacy projects, the organization is actually broken into multiple groups, each with its own set of requirements and approval processes for every single pharmacy sterile compounding project in California.

There’s the CDPH Central Application Unit (CAU), which works with each facility to ensure all necessary paperwork is in order: an HS Form 200 application form, along with a bunch of other paperwork like the OSHPD C of O and Form STD 850 Fire Safety Certificate. It’s quite a process. However, I’ve found that the CDPH CAU is easy to work with. They’re a friendly bunch that appears to want to help.

And there’s the CDPH Pharmaceutical Consultant Unit (PCU). As far as I can tell, the existence of the PCU in an official capacity is new. At least it feels new. The PCU requires its own laundry list of paperwork. Seriously, it’s a huge list of stuff.  The list includes the C of O for the space, even though the CAU requires it before they notify the PCU inspector; all sterile compounding PnP; temperature, pressure, and cleaning logs; a copy of the pharmacy plans, including HVAC system layout — even though this has already been approved by the engineers at OSHPD; test results for the room and hoods; employee competencies and QA testing; high-resolution photos of the space — even though CDPH PCU has no way to receive files this size and can’t use a file sharing service like Dropbox, Google Drive, or OneDrive from Microsoft.

Given my experience with the CDPH PCU, it’s difficult for me to understand their existence. They do almost exactly the same thing as the BoP. See above. It’s a duplication of efforts, to say the least. And in my humble opinion, the PCU doesn’t appear to provide any benefit to the overall health of the project. It doesn’t really matter as going through the PCU for approval of the space is required, so that’s what we do. Fortunately, the PCU inspectors are typically pretty easy to work with. They demand a lot but typically work with you to get it done.

The entire CDPH process is a bit convoluted. Once the CAU has everything they need for your new pharmacy sterile compounding area, i.e. they have all the paperwork, they notify the PCU that you’re clear for inspection. The PCU inspector contacts the facility via email or phone and works with them to schedule a field inspection. The inspector comes out, inspects the space, and if it’s good to go — almost never in my experience — they clear the space for use. However, the PCU clearance doesn’t mean you can use the space. The PCU inspector must first notify the local CDPH office with a “recommendation” to approve the space for use. The local office reviews the PCU inspectors report and if they agree with the inspector’s recommendation, which they always do, they notify the inspector of the approval. The inspector then notifies the facility that they’re good to go. Simple, right? Riiiight.

I recommend submitting your CAU application 4-6 months in advance of your construction completion date. I recommend contacting the PCU 2-3 months out. It’s better to be on their radar.

Final Thoughts

Building a new sterile compounding space is expensive, time-consuming, and disruptive. Even with the best planning, the regulatory processes in California are going to make you want to pull your hair out and scream. But there’s nothing you can do about it. I’ve found that being informed about the process is the best weapon in your arsenal, and can only help you in the long run. Get educated on the process. Reach out to all the agencies involved and find out what you have to do well in advance of your project. And don’t be afraid to reach out to the inspectors — BoP and CDPH PCU — because they’re there to help you.

Cool pharmacy cleanroom tech: Altro Whiterock

I’m sure you’re all familiar with USP <797> requirements for ceilings, wall, and floors in a pharmacy cleanroom, a.k.a. IV room. According to the current chapter:

The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate. The surfaces shall be resistant to damage by disinfectant agents. Junctures of ceilings to walls shall be coved or caulked to avoid cracks and crevices where dirt can accumulate… Walls may be constructed of flexible material (e.g., heavy gauge polymer), panels locked together and sealed, or of epoxy-coated gypsum board.

It’s common to see pharmacies meet these requirements with hardened drywall and epoxy paint. Recently, I was exposed to an alternative solution: Altro Whiterock.

Altro Whiterock is made from a food-safe PVCu polymer that can handle temperatures up to 140°F /60°C. It’s impact resistant, grout-free and has a smooth surface, which makes it easy to clean. It’s also resistant to a host of chemicals and cleaning agents.

I’ve had the opportunity to use Altro Whiterock on a few projects. It looks fantastic once installed and really is quite resistant to damage. It’s not completely impervious to damage — I mean you could scratch it if you try — but it’s definitely resistant to routine dings and scratches from stray carts crashing into walls.

The only potential downsides are cost and installation. Whiterock is more expensive than drywall and epoxy paint. In addition, only certified installers can install Whiterock. While a bit of a hassle, it’s understandable why you’d want a qualified professional doing the work. And in regards to the cost, you know the saying, you get what you pay for.  

If you’re thinking about remodeling your pharmacy IV room, you owe it to yourself to give Altro Whiterock a look.

Mobile compounding units, a.k.a. sterile compounding trailers

Image owned by Jerry Fahrni, Pharm.D. Taken June 28, 2018

Construction on pharmacy cleanrooms is at an all-time high in California. Every hospital I know is either renovating a sterile compounding area —  cleanroom or SCA — or building a new one. Why? Because of USP General Chapter <800>, of course. Never have I seen so little cost so much. That little 19-page document has sent shock waves throughout the pharmacy world and created more chaos than anything I’ve witnessed in my 20 plus year career. Whether or not the changes called for in the new chapter will improve patient care and worker safety remains to be seen. That’s a blog post for another time.

As pharmacies begin renovating existing sterile compounding areas, or building new ones, there may be a time when they find themselves without a suitable area to make Compounded Sterile Preparations (CSPs). Some pharmacies have the physical space and financial resources to build new sterile compounding areas without vacating their existing space. Others do not.

For those that don’t, there are few options. They can potentially get someone else to handle their CSP production while under construction, or they could give everything an immediate-use BUD. Neither is a great option, but options they are.

Enter the Mobile Sterile Compounding Unit (MSCU) built by Germfree — aka Mobile Compounding Unit (MCU), “Pharmacy Trailer”, “Rx Trailer”, “the trailer” or as the manufacturer likes to call it, “Rental Compounding Trailer”. I prefer MCU.

The MCU is basically a semi-truck trailer with a fully functional pharmacy cleanroom inside. Germfree describes it as a “turnkey rental pharmacy/cleanroom for hospital facility renovations”.  I wouldn’t go as far as to call it turnkey, but it’s close.

The Germfree MCU has three distinct work zones:

1) ISO Class 7/8 anteroom with a small area for personnel to don Personal Protective Equipment (PPE). The area has lockers for storing PPE, a hand washing sink, and a gowning bench.

2) ISO Class 7 Negative Pressure Buffer Room (HD room) with Class II, Type A Biological Safety Cabinets, storage space, and integrated refrigerator and freezer. Preparation areas are all stainless steel.

3) ISO Class 7 Positive Pressure Buffer Room (non-HD room) with Laminar Airflow Workstations, storage and integrated refrigerator and freezer. As with the HD room, preparation areas are stainless steel.

The trailer has a dedicated HVAC system for temperature and humidity control, an auxiliary generator should you require emergency power, on-board fresh water to provide for a sink, a gray water tank to collect water for disposal, data ports for computers and phones, and a host of cameras with a digital video recorder (DVR) for security.

I’ve had the opportunity in my current position to oversee the implementation of a MCU from purchase to fully-operational cleanroom. I’m a few weeks from signing off on the project. Only a bit of regulatory paperwork remains.

During my time with the MCU I’ve formed some opinions, which I present to you here.

Pros:

  • Ready-to-use, sort of. While it takes a little bit of work to get a MCU up and running, they truly are close to being a “turnkey cleanroom”.
  • ISO compliant HD and non-HD buffer rooms. Unlike an SCA, there is no limitation to what can be made in the MCU. It is fully capable of handling any type of CSP.
  • Self-contained, mostly. Once the MCU is tied to water and electricity, pharmacy personnel can work as if they were in any other pharmacy cleanroom.
  • It’s quicker and cheaper than many remodels. I don’t mean to say that MCUs are inexpensive, but I would wager that the cost is less than most major pharmacy remodels or the cost of building a completely new cleanroom.
  • The MCU is nice. Regardless of how you feel about the idea, one thing is for sure, the Germfree MCUs are nice and well-built. Honestly, the HD and non-HD buffer rooms inside the trailer are nicer than many pharmacy cleanrooms I’ve been in. Don’t take my word for it, go visit one yourself.
  • Same hoods that you find in the pharmacy. The same Germfree BZ and BBF hoods you find in pharmacy cleanrooms can be found in the MCU.
  • Lease or buy. Depending on your needs, Germfree offers both.

Cons:

  • One-year maximum use in California. This has nothing to do with Germfree but rather the state I live in. California will only give permission to use these trailers for 12 months. This seems a bit silly to me. Don’t people use trailers as permanent homes? I believe so. As mentioned above, the MCUs from Germfree are nicer than some cleanrooms I’ve been in. Meh, when in Rome…
  • Requires a “flex” or “alternate means of compliance (AMOC)” from state agencies, at least in California. It’s a bit of extra paperwork.
  • Regulatory scrutiny, again California specific. All the state agencies — OSHPD, CDPH, Board of Pharmacy — have taken an aggressive approach to these trailers, which makes getting them up and running a bit of a hassle. Be prepared to do a lot of extra paperwork, including extended policies and procedures, additional trailer-specific training and training, and so on.
  • Requires water, electricity, and internet. This is where calling the trailer self-contained becomes strained. Yes, the trailer has a fresh-water tank and a generator, but those are temporary solutions. Should you need the trailer for an extended period, you will have to find more permanent water and electricity options.
  • Gray water tank. Water used to wash hands has to go somewhere. In this case, it’s a gray water holding tank. Obviously, the tank has to be emptied when it gets full. Depending on how prolific your CSP production is, that could be more than once a week.
  • No restroom. Cross your legs or leave the trailer because there is no bathroom.
  • Customer support/service. I’m sure this will improve over time, but it’s been less than optimal.
  • Limited availability. Apparently, it takes a while to build an MCU, so if you’re in the market for one you should look into it as soon as possible.

Robots in the IV room, still not ready for prime time

I love pharmacy IV room workflow and technology, but I don’t get to talk about it much anymore. Most of my conversations these days are focused on IV room regulation, i.e. compliance with USP <797>/<800> and Board of Pharmacy rules.
So you can imagine my surprise when two people approached me on two completely different occasions at two unrelated events asking my thoughts on IV room technology. Awesome! Then they asked me what I thought about using robots in the IV room. Bummer. Of all IV room technologies, robotics is my least favorite.

Image owned by Jerry Fahrni, Pharm.D. Taken February 12, 2014.

Ten years ago, I was optimistic about IV room robots. Today, not so much. If I could sum up my opinion in one sentence, it would be that highly-automated robotic systems for sterile compounding are not ready for prime time.
Note that I said highly-automated and not fully-automated. Even though robots replace human hands for the actual compounding process, they are dependent on human hands for moving products in and out of the robot before, during, and after the compounding process.
When considering IV robotics, one should always think about:

Patient safety – Can robots reduce CSP errors? Certainly, but so can most any IV room technology that utilizes bar-code scanning, gravimetrics, imaging, etc. Often times people will tout robotic systems for consistently compounding drugs within 5% of the prescribed dose. It’s not really a big deal. Doses slightly outside the 5% range are not clinically significant, and getting it within that range is not important enough by itself to warrant the investment in a robotic system. Given proper guidance and a system for compounding, particularly an IV workflow management system, humans can easily be as accurate.

Worker protection from hazardous drugs (HDs) – There is no question that IV robots have the potential to reduce worker exposure to HDs during the compounding process. Then again, new USP <800> guidelines do the same. Ever heard of a CSTD?

Workflow efficiency – Not sure a robot brings you increased efficiency unless you’re talking about single batch high-volume IV production. I sat for hours watching IV robots doing their thing in pharmacy cleanrooms across the country. I don’t think I ever thought to myself, “dude, that thing sure makes things easier/better”.

Cost reduction from moving outsourced CSPs back in house, i.e. no longer having to purchase CSPs from a third party – Not specific to robots. Perhaps for single batch high-volume IV production, but doubtful.

Reduced waste from discontinued orders falling off work queues before they are filled – Sure, a robot can help with this, but the same is true for almost any IV workflow management system.

Comprehensive documentation for regulatory compliance – These systems certainly collect lots of data but how easy is it to use? Just because the system collects info doesn’t mean you can get it out when you need it. I’ve seen things. Just sayin’.

Return on investment (ROI) – What do these systems give back? There are few pharmacies where IV room robots will result in a positive ROI. I’ve seen pharmacies try. While their arguments may sound good on paper, in practice they are as thin as the paper they are written on. The only time these systems yield a real ROI, in my opinion, is when they are used to repetitively compound the same few items over and over again – in other words, batch compounding for high-volume items. All of the systems have roughly the same throughput, which is much lower than that of a highly skilled technician. IntelliFill i.v. is the fastest of all the robots I’ve seen, but it is limited in scope to syringes.

Formulary limitations – One of the major limitations of IV robots is the number of formulary items they can handle. During visits to facilities using IV robots — San Francisco, CA; Asheville, NC; Baltimore, MD; Madera, CA; and so on — I saw very few medication “line items” assigned to the robot. The largest number I witnessed was somewhere around 10, and the smallest number was two. Two! Someone had a million-dollar robot making CSPs out of two drugs. Hospital formularies are large and diverse. They include all kinds of IV products: piggybacks, large-volume parenterals, syringes, and so on. Not to mention that formularies change all the time. The inability of these systems to manage a large number of different CSPs at one time is definitely a limitation.

Maintenance – What does it cost to maintain these bad boys? They don’t operate on a zero cost. They also don’t maintain themselves. Operational resources required for things like robot maintenance, formulary maintenance, product changes, and so on are important considerations to keep in mind when purchasing a robot. Who is serving who…. or is that who is serving whom? I can never get that right. Anyway, the time, energy, and effort required to keep an IV robot at peak operational efficiency simple isn’t worth it. At least not in my opinion.
In a nutshell, I’m just not a fan of the current crop of IV robots. Does that mean that there is no future for robots in sterile compounding? On the contrary, I think we must move toward a future where all CSPs are made by robots. It’s the only thing that makes sense. Unfortunately, that future is still far off.
I’ve had the opportunity to peak behind the curtains at a few robots currently under development. There are some great products coming down the pike, but we are going to have to wait a while. Apparently, building robots with creative new features is hard.