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 2â€. 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 citizensâ€.
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 involvementâ€. 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 citizensâ€. 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 probabilitiesâ€.
Full disclosure, anyone reading this should take it with a grain of salt. I used to work for Talyst as a product manager for their acute care product line, and I’ve recently been involved with a Pyxis Logistics implementation. With that said, forward.
In short, yes, BD Pyxis Logistics (“Logistics) is quite good. BD is doing something that pharmacy has needed for a long time, embracing the concept of “the enterprise†with integration across multiple areas in and out of the pharmacy. BD, as a company, has been busy over the past few years piecing together products to create a cohesive strategy. Someone has been paying attention.
Are they there yet? Not yet, but they are on their way. To paraphrase my brother, they’re currently the worst they’re ever going to be, i.e. their products and strategy are only going to get better and mature over time.
You’ve heard me talk about the four areas of pharmacy many times: standard storage, refrigerated storage, controlled substance storage, and the iv room.
Basic storage are those basic shelving units that most people think of when they walk into a pharmacy. It’s where you’ll find unit-dose and bulk room-temperature items. Logistics is squarely focused on this area of the pharmacy. It works well and, at least in my opinion, does a good job of addressing inventory across multiple pharmacies. Throw in that Logistics is web-based, and it’s compelling.
Refrigerated storage is, well, where you put things when you want to keep them cold. Same as basic storage, only refrigerated. BD doesn’t offer anything specific for this area, but Logistics handles refrigerated items just fine. It basically treats refrigerators the same way it treats static shelving and carousels. It’s just another storage area.
Cleanroom/IV Room is where you’ll find all the supplies for compounding sterile medications. The IV room has been getting a lot of attention lately, but that has nothing to do with inventory management. Most pharmacies treat the IV room as a black hole for inventory, i.e. they lose visibility of their inventory when it crosses the threshold into the land of sterility., BD has had a product called Cato for many years. It’s now called BD Pyxis IV Prep and I’ve always been a fan. Pyxis IV isn’t fully integrated with Logistics, but they’re working on it.
Controlled substance storage is where you’ll find all your opioids, benzodiazepines, and so on. Anything the DEA, Board of Pharmacy, and any other regulatory agency considers a diversion risk. I have a love-hate relationship with controlled substance management. This area is long overdue for improvement. With that said, I’m happy to report that BD is making inroads. The latest version of their CII safe software is integrated with Logistics, meaning no more disparate systems for controlled and non-controlled meds.
What I like about Pyxis Logistics
Multiple pieces of the pharmacy puzzle. When looking at the BD Pyxis lineup, the four areas of pharmacy are closer than ever.
Integration that is getting better and better all the time. BD not only has the pharmacy covered — Logistics, CII Safe, IV prep — but think about their dominance in the automated dispensing unit (ADU) market. Integration is hard, but getting ADUs and pharmacy inventory seamlessly talking to one another is something I’ve been pining after for a long time. Â
Handhelds. BD offers a handheld for Logistics. I haven’t had one in my hands but the device and functionality look good, shortening the inventory gaps even more. Talyst had a handheld device for AutoPharm years ago. Wonder what became of it?
Good folks to work with. I have nothing but good things to say about the people from BD that I’ve worked with. They want to do a good job.
Improvements are rapid and obvious. That’s the thing about most companies, they want to improve their products and keep customers happy. Improved products and happy customers equal increased adoption, which in turn leads to more sales, which leads to more money, and so on down the rabbit hole.
What I don’t like about Pyxis Logistics
Reports and analytics appear weak. The system offers many canned reports and access to the company’s Knowledge Portal, but overall, it feels like they’re behind in this area. From what I’ve seen, it’s just not there. When compared to something like the analytics software from Swisslog — still don’t know the name of the product…. Pharmacy Analytics? I mentioned it here — it feels miles behind. What’s worse is that what I saw at ASHP Midyear back in December doesn’t make me feel any better about it.
Piecemeal products. It’s obvious what BD is doing. However, buying products and folding them into your portfolio can make things feel like they’re bolted on instead of feeling like they’re an integral part. It’s only going to get better, but one has to be willing to ride through the rough patches to get to the smooth road.
Lack of product maturity. “Pyxis”, the ADUs, is a very mature product that’s used in thousands of facilities. Logistics and IV Prep, not so much, and it feels like it.
Overall, it seems as though BD is heading in the right direction. It will be interesting to see where the company ultimately goes with their strategy.
Several years ago,
shortly after I was let go from Talyst, I found myself with some free time on
my hands. I started writing a book. The book was titled ‘Making the right
choice: Helping pharmacies make smart decisions about automation and technology’.
Like many books I’ve started, it remains unfinished. I don’t think I’ve touched
it since 2016. At least that’s the date I have listed as the last time I edited
it. However, I recently had reason to go back and review some things I included
in the book. Kind of a retrospective review of advice to myself.
Specifically, I was interested in my thoughts on putting together a project team and managing a project. And there, in Chapter 8: First things first, I found what I was looking for. Some of the information is outdated, specifically the final page called Cautionary Tale**, but overall the information still rings true.
Here it is,
Chapter 8 in it’s draft form. Maybe one day I’ll get around to finishing the
book. One never can tell.
Chapter 8: First things first
“You can do anything…but before you can do anything, you have to do something.†— Clifford Cohen
You can’t get
to the end of a project if you never start, and getting started can often seem
like the most difficult part of any project. I can’t pinpoint why it’s so hard
to get started, but it is. Perhaps it’s fear of the unknown, or unwillingness
to move away from comfort zones. Or maybe it’s because we don’t want to do the
work. Who knows? The only thing I know for sure is that once the ball gets
rolling, no matter how slowly, it always seems to roll forward. The key is to
stop putting it off and get started.
With that
said, it’s important that one is truly ready to move forward. Understanding the
reason(s) for doing something is key. Seems simple, but it might surprise you
to learn how often people do things without understanding why. Begin the process
with eyes wide open. Never do anything simply for the sake of doing something.
One must be
able to justify all projects, regardless of their purpose. Simply put, the
project must worthwhile, viable and affordable, bring a reasonable return on
investment (ROI), and be within acceptable tolerances and risks.
Ask yourself these three questions:
What do I hope to accomplish?
Does the technology make sense?
Does the technology fit my operations
If you’ve
answered the above questions to everyone’s satisfaction, it’s time to get
busy.
Below are the
things that I think are important to ensuring a successful technology implementation
in a pharmacy. While it may seem like a lot of work, the end result will be
worth the time and energy.
Gauge user
beliefs and feeling. Is
it going to be an uphill battle? Are the pharmacists and technicians open to
the idea of implementing new technology? Is the pharmacy morale where it should
be? Does your department fear change? The success of your implementation will
rely heavily on how well you and your department are prepared. The
implementation of new technology can often pose a threat of reduced control
over one’s work. This can create pushback from the staff. Helping them
understand what it is you hope to accomplish, how it will help them, and
offering opportunities for staff to become involved and have a vested interest
in the project can go a long way to ensuring a successful implementation.
Get
support / buy-in for the project.
The need for support for any project is a must, and this is especially true for
pharmacy projects. Success depends on support from the top of the organization
to the bottom. Lack of support will result in a failure to launch. If and when
possible, it is best to start with an executive sponsor, or someone from the
Hospital Board of Directors, if you have one. This person, or persons, will be
your champion during high-level meetings within the organization.
Once you have
executive level support, it’s time to consider support from other areas. If the
project will impact nurses, find a nurse. If a physician, find a physician.
And, so on. You don’t want to launch a project that will impact a group of
people without getting their support. Trust me, it’s not a good idea. Call it
politics if you must, but peer-to-peer communication works wonders. Having
support from a variety of areas and disciplines will improve communication and
go a long way in generating support for a project.
Create a
buzz. Create some
excitement. Don’t act like the project is required, but rather a choice that’s
going to make things better.
Give
everyone fair warning of what you plan to do. People fear change. Give them plenty of time to get
used to the idea. This will go a long way in gaining support for a project.
Being aware of what’s coming is always preferable to being surprised by what
has already been done.
Involvement
and participation. When
individuals believe that a project is relevant, they are much more likely to have
a positive attitude toward it. And the best way to get individuals to believe
is to get them involved. Allow them to participate in all phases of the
project. “Increasing user participation … enhances post-development user
involvement and attitude†(Vaughan PJ. System implementation success factors;
it’s not just the technology. Internal Report of Information Technology
Services. University of Colorado at Boulder. 2000), which is what you
want.
Involve as
many as you can as often as often as you can. When people are involved, it
gives them a sense of ownership and a vested interest in making a project
successful. It also helps deal with negative vibes from others. Include
multiple disciplines, depending on the technology and departments affected.
It is also
important that all participants be volunteers. Mandated participation has been
shown to be ineffective and potentially detrimental to the success of this type
of project. (Hunton, James E., and Jesse
D. Beeler. “Effects of User Participation In Systems Development: A
Longitudinal Field Experiment”. MIS Quarterly 21.4 (1997): 359.
Web. 8 Apr. 2016.)
Champions.
Champions are those people
that go above and beyond the general participant. Champions believe in the project
and the benefits it will provide. They can often have a contagious zeal about
the project, and are sometimes referred to as “evangelistsâ€, or in extreme
cases “zealotsâ€. Whatever you call them, when it comes to implementing new
technology in the pharmacy, Champions can be your best source of support. They
can be useful in putting a spotlight on the project in a positive way and
swaying the negative feelings of others.
Finding
Champions shouldn’t be too difficult. They’re usually early adopters and will
take the initiative to learn more about a project without being asked.
Develop rules for participation. This is really quite simple. It is important that the rules for participation be laid out well in advance, and that each member of the team sign off on them. There should be no surprises for what’s expected from participants once the project is underway. The following rules are examples:
Be willing and able to engage in the
project
Be willing to be positive about the
project
Be willing to work with others to
advance the project toward accomplishing the goal
Be willing to commit to attending
meetings
Be willing to commit to handling extra
work, even if it means staying late or doing some reading at home in the
evenings or on weekends. I understand that no one wants to put in a bunch of
unpaid overtime on these projects. However, on occasion, a little extra work may
need to be done to keep things moving forward. One should enter into
participation with the understanding that this could happen.
Be willing be engage in every aspect
of the project, not only the items that are assigned. It is vitally important
that each participant have at least a basic understanding of the overall scope
of the project and what each member of the team is assigned. Things happen.
People get sick, quit their jobs, move to another state, and so on. Unforeseen
events should not completely derail the project timeline or goals.
Find
naysayers and sway them over to your side. Every project has its opposition. As the saying goes,
you can’t please everyone all the time. Unfortunately, naysayers tend to have vocal
personalities. They’re not afraid to say what’s on their mind. These two things
– being negative and outspoken – tend to go hand-in-hand. The downside to
naysayers is that outwardly negative comments about a project have a way of
spreading like wildfire. They can be caustic, seeping into the minds of even
the staunchest supporter. And once there, negative thoughts can grow like a
cancer. With that said, naysayers and their negative comments have their place.
Because they’re not afraid to speak up, they can sometimes point out things
that others fail to see, helping avoid potential pitfalls. The trick is to use
the information to your advantage. Allow naysayers to offer up their thoughts
in a controlled environment where their comments can be contained. Give them
space to vent. Listen to what they have to say. Use what you can and toss the
rest. Showing naysayers that you’re willing to listen and take their concerns
seriously can go a long way. In rare cases, you might even make a convert out
of one, which would be a huge victory for the project. However, never try to
force change on a naysayer. Forcing change, or mandating them to join your side,
rarely works. It’s like dealing with a donkey, the harder you pull, the harder
they resist.
Build your team. According to Harvard Business Review’s (HBR’s) 10 Must Reads On Emotional Intelligence[(HBR’s 10 Must Reads On Emotional Intelligence. Print.), a source of great team success lies with teams that can achieve high levels of participation, cooperation, and collaboration among members. Sounds logical, but oh so difficult to do.
Note: HBR’s 10 Must Reads On Emotional Intelligence is a great collection of previously written articles pulled together into a single book. Each article is informative and interesting in its own right. However, when combined, they create a great collection that any person involved in a project should read. I highly recommend it. It’s a short book and an easy read.
Team
members must be chosen carefully and meet three basic conditions:
Mutual
trust of one another
Have
a sense of group identity: a feeling that they belong and the project is
worthwhile
Have
a sense of group efficiency: belief that the team can perform well and that the
group is better than the individual members.
Collectively,
HBR refers to this as the groups “emotional intelligence†(EI). While intelligence
and experience among group members is important, EI may be more important
still. Keep that in mind when you begin building your project team.
Chose
a project leader. Ah,
the leader. The captain. Thy person in charge. It’s a burden that many well
qualified individuals shy away from. Someone has to be in charge. Someone has
to be given authority over the group and be willing to make the tough decisions
and hold people accountable.
Not
everyone is cut out to be a leader. Everyone reading this has worked for both
great and terrible leaders. While I cannot tell you exactly how to identify a
great leader, I know one when I see one.
According to HBR’s10 Must
Reads On Emotional Intelligence
what distinguishes good leaders from great ones is their EI. For individuals,
EI is “a group of five skills that enable the best leaders to maximize their
own and their followers’ performanceâ€.
The
EI skills are:
Empathy
Motivation
Self-regulation:
controlling negative impulses [side note: this is really hard to do, especially
during high-stress times]
Self-awareness:
knowing strengths and weaknesses
Social
skill: being able to build a rapport with others to get desired results {side
note: especially tough if you’re a natural introvert]
Find
yourself a project manager. As
ridiculous as this may sound, the project manager is an often overlooked
position when discussing project teams. Let me go on record now as saying that
a good project manager is absolutely vital to the success of any project, and
could arguably be considered the linchpin to the success of the entire project.
It
is the job of the project manager to manage all aspects of the project,
including the scope, timeline, cost, quality, and people. They apply their
knowledge, skills, tools, and techniques to help projects be successful.
“The
role of the project manager is that of an enabler. Her job is to help the team
get the work completed, to “run interference†for them, to get scare resources
that they need, and to buffer them from outside forces that would disrupt the work.â€
(Lewis, James P. Fundamentals Of Project Management. New York: American
Management Association, 2007. Print.)
Things
to consider when selecting a project manager:
The
person must have leadership qualities, have good self-management and time
management skills, and be a taskmaster.
The
project manager cannot serve two masters. Individuals
that serve as a project manager must not be required to do any of the actual
work in the project. According to James Lewis, “as team sizes increase,
it becomes impossible to work and manage both [the work and the team], because
you are constantly being pulled away from the work by the needs of your team
membersâ€. Having project managers attempt to manage the project and perform
work in the project is a recipe for disaster.
The
person must have a proven track record. We all know people that can’t manage
the paper piles in their office much less a multi-faceted project requiring
meticulous attention to detail.
I
encourage everyone involved in a large project to read a book or two on project
management. Being a project manager is not as easy as it sounds and should be
given the respect it deserves.
**Cautionary Tale. Since drafting this section of
the book, I have been involved in another amazing project. One that had me
working with large teams to remodel or construct new pharmacy cleanrooms for
several hospitals. The project spanned well over a year and was simply
incredible.
There was an interesting thread in one of the ASHP practice forums recently. Someone asked whether or not pharmacists were “ready for the future that the opportunities these disruptive technologies offerâ€. This in reference to technologies that they saw in the exhibit hall at ASHP Midyear.
The simple answer is no. Pharmacists are barely ready for technology that’s 20 years old, much less anything that is disruptive. In support of my quick answer, I give you a brief conversation I had with one of the most progressive pharmacy operations people I’ve ever known (paraphrased, of course):
Me: “See anything cool in the exhibit hall?”
Them: “Yeah, a change in software that will allow me to capture more 340B costs in the OR.”
Me: “Really? What about Kiro, IntelliGuard, and PharmID?”
Them: “That stuff? I don’t care about that stuff. It’s meaningless to me because it doesn’t help me. Not to mention that my organization will never go for it.”
The ASHP forum thread produced some interesting responses. One pharmacist pointed out that healthcare disruption will come from outside of healthcare. I agree with that opinion 100%. However, someone responded that they didn’t think this was “… a foregone conclusion†because they think that “…in the short to medium term, in order to actually make meaningful improvements in outcomes, healthcare needs to be disrupted from withinâ€. I almost snorted coffee out of my nose when I read that. It was that funny.
I’ve been a pharmacist for more that 20 years. In that time, pharmacy hasn’t disrupted anything. Nothing. Nada. Pharmacy departments are so busy keeping up with regulatory requirements and chasing elusive “clinical activities” that they don’t have time to innovate and disrupt.
I went back through some of my posts from the past few years. Here’s what I found:
03/02/15: 5 years later, my thoughts on pharmacy practice — “Pharmacy is the same as it was when I left. It’s the same chaotic, messy thing that it’s always been…. Five years out of the game and I don’t feel like I’ve missed much.”
06/04/15: Pharmacy – entrenched in outdated dogma — “…you should be using the most complete solution possible in the i.v. room, and you need to get over the idea that a PharmD is required for a “final checkâ€.”
09/20/15: Will healthcare disruption come easy and fast? — “There are many things being developed to improve healthcare, but the innovation is coming from outside sources. People are literally leaving healthcare to innovate things for healthcare.”
11/10/16: Someone please disrupt controlled substance storage technologies — “Management of controlled substances inside acute care pharmacies is a mess… Based on my observations, the technology is outdated, difficult to use, and has failed to improve the process in any appreciable way. It remains unclear to me what advantage these systems offer.”
09/21/17: It’s time to disrupt pharmacist order verification — “It’s an antiquated process that’s long overdue for an overhaul. The time has come for healthcare systems to make better use of their personnel.”
And that’s just flipping through my posts from the past few years. I can’t imagine what I’d find if I went all the way back to the birth of this weblog in 2009.
I used to think about disrupting healthcare all the time. I recorded my ideas in notebooks and spent years pitching my ideas to companies in the hopes of building a new and exciting pharmacy practice. But it went nowhere, and became nothing more than an exercise in futility.(1)
Is there a healthcare company out there that will disrupt pharmacy? Not likely. As a really smart lady once told me, no one wants to be in this space because it’s hard and you can’t make any money. What about companies from the outside? Also not likely for the same reason.
If it sounds like I’m bitter about all this, it’s because I am. Pharmacy practice could be so much more if we’d just crawl out of our holes and do something different from time to time.
Here’s the bottom line, pharmacy needs to be disrupted — desperately. However, it’s not going to happen. The best we can hope for are iteratvie changes, at best.
=============== (1) I’ve actually had a few ideas turn into real products. Nothing earth shattering, but cool nonetheless.
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 3â€: 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
A week or so ago a colleague tagged me on Twitter in reference to a Reddit post in which my name, or rather my site jerryfahrni.com came up. The thread was basically pharmacists listing places to go to get pharmacy related “informatics†information. My site popped up as a place to go. However, someone correctly pointed out that the blog has been quiet for a while now.
This got me thinking, why haven’t I written anything? Or more accurately, why haven’t I posted anything that I’ve written? I sat in my thinking chair and gave this question my full attention.
Three things came to mind: 1) lack of something new to write about, 2) a correlation between interest in my job and volume of written material, and 3) content creation and ownership.
Nothing New Under the Sun
First and foremost, there’s nothing new and exciting in the world of pharmacy automation and technology. As I have mentioned many, many times before, pharmacy moves at a glacial pace. That hasn’t changed. I’ve racked my brains over the past week to come up with something new and exciting in pharmacy that would be worth putting pen to paper. I came up empty. Nothing, nada, zilch.
There are technologies that I still find interesting, like RFID and IV room stuff, but they remain basically unchanged from when I first became interested in them nearly ten years ago. Yes, a decade ago, at least.
I continue to stay abreast of many healthcare-related technologies, but most of the effort inside companies these days is focused on integration and electronic health records (EHRs). Good things for healthcare to be sure, but I have almost no interest in EHR’s. And for companies trying to create integrated systems, they’re only kidding themselves. Several companies have been telling me for years that they are “working on a bi-directional interface with [insert system here]â€. Some are close or appear to be close, but none that I’m aware of have completed the task. By the time these companies get a completely functional bi-directional interface up and running, it won’t matter. The ship will have sailed, as the saying goes.
Case in point, one of my favorite pharmacy technologies five years ago — IV workflow management systems — is dying a slow, painful death. Yes, adoption rates for these systems is the highest it has ever been. However, not only is there a lack of interest in these systems from inside the profession, but companies like EPIC are building many of the same features directly into the EHR. The IV workflow functionality that I’ve seen inside EHRs is limited and poorly designed, but it doesn’t matter because it’s readily available and free. Soon, acute care pharmacies will be using substandard IV workflow management software without giving it a second thought. And once it takes hold, it will almost certainly spell the end for many, if not most, of the companies competing in this space.
Interest in My Job
I found an interesting correlation between my writing and my job. The more interested and engaged I was in my job, the less I wrote. I suppose that makes sense. When I’m bored, I go in search of something to do, hence reading and writing about stuff.
For example, for the last 14 months I’ve been working on a project like no other I’ve ever been involved with. From the outside, much of the work would seem mundane and boring. However, it’s work that I had not previously done and the learning curve for the first few months was steep. My interest was held by learning new things about the job. I wasn’t actively seeking anything outside my job to hold my attention.  Simple, really.
With that said, interest in my job is only a minor reason for the lack of blog posts. The real killer is below.Â
Content Creation and Ownership
When I started jerryfahrni.com, I never thought that I would have to worry about the things I wrote. But the world is a strange place.
When I write something and post it, I’m putting it out there for the world to use however they see fit. Basically, I believe it’s open source. Take it and do whatever you want with it. Some companies, however, wanted to “own†my content, i.e. my thoughts. So I stopped putting my ideas in writing on the web. Not that I was ever going to do anything with them, but it felt wrong that a company could do such a thing. As a result, many of my ideas remain on the pages of notebooks sitting on my bookshelf.
Others companies preferred that I not post anything about any of the technologies or processes that they used. And by preferred, I mean they threatened me. That made things difficult. At times, I had to significantly limit what I wrote for fear of reprisal. This was a killer for me.
Finally, when I started consulting full time I found it increasingly difficult to be completely frank with my readers. I sometimes worked for companies that made the products I was writing about. I had to be careful not to offend anyone that was or could potentially be a client. Composing blog posts became akin to walking through a virtual minefield.
Parting Thoughts
For the most part, I couldn’t find a way around the obstacles described above. Over time, it became so difficult to create content that it was no longer interesting or fun. And when that happens, it’s time to put on the brakes and re-evaluate.
I remain interested in pharmacy, especially automation, technology, and workflow design. I still write from time to time, but not often. I still love to talk about this stuff, so if you see me out and about, please engage me in conversation.
I am planning to attend ASHP Midyear in December. I’m truly looking forward to it as it will be the first time in many years that I will be attending as “just another pharmacy”. I can see and say whatever I like (smile).
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 safeâ€. 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?â€.  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):Â 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.
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. Â
If you’re thinking about remodeling your pharmacy IV room, you owe it to yourself to give Altro Whiterock a look.
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 Trailerâ€, “Rx Trailerâ€, “the trailer†or as the manufacturer likes to call it, “Rental Compounding Trailerâ€. 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 renovationsâ€.  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 cleanroomâ€.
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.
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/betterâ€.
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.
