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

25 Years a Failed Career 

I recently took a job as the Director of Pharmacy for a medium sized – just over 400 beds – acute care hospital a couple of hours away from my home in Fresno. I never wanted to be a director. I always told myself that if I ended up working in a pharmacy, it was because I failed to use my degree to do something else. I knew after being a pharmacist for only a few years that I simply couldn’t spend my entire career doing it. But I’ve spent the last few years working in a hospital, and my clinical acumen has waned. It was either get out, i.e., find something else to do with my pharmacy degree or take an “administrative role.” I tried the former several times but could never make it stick. That left the latter. So here we are. At this point it’s highly unlikely I’ll do anything else.  

Reflecting on my career, I’ve had many jobs. It’s hard to think back on all of them, but it must be more than a dozen. I have worked as a staff pharmacist in multiple hospitals, obviously. I worked retail pharmacy a couple of times. Awful, simply awful. I worked in a compounding pharmacy. I worked for a few years as an IT pharmacist. I worked as both a Pharmacy Supervisor and Operations Manager. I worked for a pharmacy technology company as a product manager. I worked for a couple of years a s project manager. I’ve done some consulting work for a few companies. I spent some time doing presentations. I technically had my own company twice. Both times went down in flames. I joined a couple of start-ups. Cool, interesting, and engaging, but ultimately didn’t pay the bills. Crud, I even did a little writing.  

While most of my jobs have been forgettable, three stand out as my favorites. Why? Hard to say. Each had something unique to offer that I have been unable to replicate elsewhere. In no particular order, here they are: 

Compounding pharmacy: During my third year of pharmacy school, I went to work for a small compounding pharmacy in San Jose, strangely called Santa Clara Drug. I continued to work there for a couple of years after graduating pharmacy school and getting my license.  

The pharmacy was owned by a couple of older pharmacists that had been practicing community pharmacy for most of their careers, possible for the entirety of their careers. One pharmacist would be what I consider a silent partner. The other, Lionel was a great pharmacist and a great man. I learned a lot from him. His knowledge of non-sterile – previously extemporaneous – compounding was immense. His demeaner was that of a thoughtful parent. He knew his patients and treated them all with great dignity and kindness.  

The pharmacy specialized in preparing many different compounds for human patients such as capsules, troches, suspensions, elixirs, creams, ointments, gels, and suppositories in any number of combinations, flavors, colors, etc. Not to mention the hundreds of formulations for our non-human patients. I made concoctions for cats, dogs, birds, rats, snakes, and many other animals.  

Two things I loved about Santa Clara drug was working side by side with Lionel and working closely with veterinarians. Veterinarians, unlike human physicians, value a pharmacist’s input and advice. I cannot tell you how many times a veterinarian called the pharmacy and said something like “Hey Jerry, how can we get itraconazole into a rat?.” A conversation would ensue, and we would work together to come up with a solution.  

Product Manager: Around 2010, after working as an IT pharmacist for a few years, I had an opportunity to go to work for Talyst, a pharmacy technology company which is now part of Swisslog. I knew quite a bit about pharmacy but nothing about the inner workings of a company. I was so naïve. It was one of the most transformative times in my career. The work was invigorating. The people were driven and smart. It gave me the opportunity to grow my thinking in ways that would have never been possible if I had continued working as a pharmacist. Even today, I look around and see how constrained healthcare is by lack of thought and inability to deconstruct a problem into something more manageable.  

The other thing I liked about my time as a project manager was the travel. For reasons unknown to me, some people within the company thought I hated travel. Maybe it was because I had such terrible luck while traveling. Who knows. For me, it was an opportunity to go places I had never been. Until my visit to the company headquarters in Bellevue, WA in 2010 – besides some trips to Vegas – I had only been out of California a couple of times. One of those times was when I enlisted in the Army and was sent to Fort Jackson in South Carolina for basic training. Other than that, my travel had been extremely limited until joining the company.  

I grew so much personally from my time working at Talyst. From the people to the travel, I am profoundly grateful for my time there.  

Project Manager: Sometime in 2017, while I was working as a per diem staff pharmacist following another failed attempt to start a consulting business, I got a call from someone at Sutter Health in Northern California. The person on the phone said they had a great project that could use my expertise. My expertise? What expertise were we talking about? Well, it turns out that it was the culmination of years of learning about pharmacy and my involvement with sterile compounding.  

On paper, the project was simple enough: help manage the construction and licensing of several new IV rooms for Sutter Health. System wide, the overall number was something like 23 new construction projects. I had only eight. My job was to oversee everything from construction and equipment, to helping with policy design and meeting with inspectors and licensing agencies.  

The project itself may be the single largest one of its kind. I don’t know of any other organization that has taken on something so large and intricate. The learning curve was incredible. My limits were tested, but the knowledge I gained was invaluable. I used everything in my knowledgebase and then some. I learned things about HVAC systems, regulatory compliance, and finance that I would have never picked up anywhere else.  

As with the other two favorites, I am grateful for having had the opportunity to work with Sutter Health in this capacity.  

And there it is, the three best jobs I’ve had during my long and winding 25-year career. All of them great in their own respect. All of them I wish I still had.  

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.

=========================== 

*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.

———-

  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.

————————-

*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.

———–

  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”.