ASHP Midyear 2018: Initial Thoughts

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

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

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

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

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

Building a sterile compounding space in California – Regulatory Hurdles

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

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

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

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

In a nutshell:

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

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

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

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

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

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

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

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

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

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

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

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

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

Final Thoughts

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

Cool pharmacy cleanroom tech: Altro Whiterock

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Germfree MCU has three distinct work zones:

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

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

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

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

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

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

Pros:

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

Cons:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

USP Announces Intent to Postpone Official Date of USP Chapter <800>

In a notice posted last Friday, USP announced its intention to postpone the official date of USP Chapter <800> — Hazardous Drugs — Handling in Healthcare Settings.

According to the notice: “The intent of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding — Sterile Preparations, to provide a unified approach to quality compounding. The next revision to General Chapter <797> is anticipated to be published in the Pharmacopeial Forum 44(5) September-October 2018 for a second round of public comment and is expected to become official on December 1, 2019. Sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard. ”

The original date for USP <800> to take effect was July 1, 2018.

This is good news for many as the July 1, 2018 date has created chaos in pharmacies across the country as they attempt to update their cleanrooms to become compliant. With that said, it’s a bit irresponsible for USP to wait this long to announce the postponement. Many acute care pharmacies are in the middle of lengthy and expensive cleanroom renovations.

Not to mention that many state boards of pharmacy have hung their hats on USP <800>. For example, California has already made significant changes to their regulations around hazardous drug compounding. As I’ve written previously, California made significant — and reckless — changes. Unfortunately, this postponement of USP <800> will make matters worse. It’ll be interesting to see how the California Board of Pharmacy handles the postponement.

It’s time to disrupt pharmacist order verification

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

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

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

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

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

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

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

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

Sutter Health partners with Qventus for real-time analytics

FierceHealthcare: “That’s what led them to invest in a new platform that went beyond algorithms and software to emphasize the data’s tangible impact on clinician workflow and hospital operations… Although Sutter Health has worked with the company [Qventus] on several other initiatives targeting patient throughput, the pharmacy pilot is the system’s first significant foray into leveraging real-time or near-real-time analytics to influence care decisions. Beyond the machine learning platform, Sutter was drawn to the workflow specialists dispatched by the company to follow pharmacy care teams in order to better understand the ideal format to deliver data-driven insights.” – Sutter is a big organization. They have the resources and the desire to do some pretty amazing things. I’ve had the opportunity to speak with them on a few occasions and found them open to things outside the traditional pharmacy box. That’s truly rare in pharmacy these days.

Sutter is planning to target cost and quality using the Qventus AI-based software platform. I’m not familiar with Qventus. I went to their website, but things were vague. Unfortunately, that’s not uncommon. I find a lot of technology vendors lack good information about their products on their own websites. Strange but true.

AI-based platforms are the future of pharmacy. We simply spend too much time looking for needles in haystacks. Imagine: no more “monitoring sheets”, no more time spent by pharmacists rummaging through every chart looking for that one thing out of place, improved antibiotic stewardship, directed therapy based on patient condition and need, optimized pharmacotherapy, improved inventory management, decreased waste, and so on and so forth. The possibilities are endless.

Let’s hope that Sutter shares their experience with the rest of the world so that we can all learn from their initiative.

Nonadherence to diabetes medications costly

This is follow-up commentary to an article I Tweeted about earlier this week.

JCP: “[Express Scripts] found that patients who were adherent to oral diabetes drugs had 235 fewer emergency department visits and 50 fewer inpatient hospitalizations per 1000 patients, resulting in an average of $500 saved per patients and a total decrease of $210 million in health care spending in 2016…Patients who were nonadherent were found to have 1.3 times higher medical costs and 4% higher total health care costs compared with adherent patients, a difference of $11,176 vs $10,683, respectively.” – No surprise. Poor control of chronic diseases like diabetes can lead to lots of complications, including admission to a hospital for advanced care.

Nonadherence to medication is tricky. Proposed solutions to the problem are many. Actual solutions to the problem are few. The issue is that there’s no one-size-fits-all approach to the problem. People behave like people. Some will do a great job managing their disease, while others won’t. The more complicated the disease management, the more likely that adherence will slip. And management of patients with diabetes can get very complicated.

The difficulty comes when multiple healthcare providers are involved. There are often multiple medications, complicated administration regimens, and so on. I witnessed this firsthand while caring for my mom during the last year of her life. She was a complicated patient, and her medication regimen changed frequently depending on the physician seen and which area of the disease was the focus of treatment; the old whack-a-mole approach to medicine. With that said, my mother was a best case scenario. Her ability to manage her medications was inspiration. However, even as a pharmacist I found it difficult to keep track of what was going on at times. There were times when I would re-sort and organize her weekly medications three times in a ten day period. Crazy.

My opinion is that adherence strategies are still in their infancy. There are simply too many variable when it comes to patients take their medications correctly. The most important thing, in my opinion, is getting people to take a stake in their own disease management. That should be the primary goal. The rest is window dressing at this point.

[Article] Evaluation of real-time data obtained from gravimetric preparation…

I am currently reading an article on the use of gravimetrics in the preparation of hazardous CSPs published in the Journal of Clinical Pharmacy and Therapeutics.*

The article addresses data collected from a large-scale, retrospective analysis of medication errors identified during the preparation of antineoplastic drugs, aka chemotherapy. The paper looks at 759 060 doses prepared in 10 pharmacy services in five European countries (Austria, Czech Republic, Denmark, Germany, and Switzerland) between July 2011 and October 2015. While the sheer number of CSPs made over that period of time isn’t impressive, the fact that they’re all chemotherapy is. I believe this is the first article of its kind. I can’t think of another article that looks at the use of an IV workflow management system across such a large number of facilities, much less the use of gravimetrics during the compounding of sterile hazardous drugs.

The authors of the paper do a good job of: (1) addressing the use of gravimetrics versus image-assisted volumetrics, (2) covering the weaknesses of using syringes to measure small volumes (take a look at FIGURE 2 Tolerances of 1- and 5-mL syringes), and presenting a solid case for why gravimetrics is important for preparing hazardous CSPs. It also has some good images and tables, which I plan to refer to in future presentation.

In a nutshell “[e]rrors were… identified during weighing stages of preparation of chemotherapy solutions which would not otherwise have been detected by conventional visual inspection“. I find that this is the key benefit of using a system with gravimetrics, i.e. the accuracy of the dose doesn’t rely on human inspection. Overall, the gravimetric system caught errors in 7.89% of the 759 060 antineoplastic doses prepared. This percentage is consistent with other studies looking at CSP error rates.

A total of 13 831 errors for doses that deviated by more than 10% were caught by the system. That may not sound like a lot, but it can be, depending on the situation. Worse yet, 4 467 errors were off by 20% or more. Regardless of the situation, a 20% deviation in a dose is unacceptable. The significance, of course, is that a deviation this large could result in unintended toxicity or under treatment, depending on the direction of the error, i.e. 80% – 120% of the prescribed dose.

The article concludes that the “Introduction of a gravimetric preparation system for antineoplastic agents detected and prevented dosing errors which would not have been recognized with traditional methods and could have resulted in toxicity or suboptimal therapeutic outcomes for patients undergoing anticancer treatment.” I agree in principle with the sentiment, but believe that the authors overstate the significance of the gravimetric system while understating the importance of secondary checks. By stating that the system “prevented dosing errors which would not have been recognized with traditional methods” they are assuming that all errors would have made it past a pharmacist or other secondary verification method. It’s possible — maybe even likely — that some of the errors would have made their way past a secondary check, but not all. In many cases, chemotherapy preparations go through several step-checks during the compounding process. Typically, one of those step-checks is verifying the dose — volume in the syringe — prior to injecting it into the final container. Errors are often discovered at this point in the process. With that said, the author’s overzealous conclusion shouldn’t take away from the importance of gravimetrics in preparing CSPs.

Do yourself a favor and go get a copy of the article. It’s worth a few minutes of your time.

The online article is here.

A PDF copy can be downloaded here.

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Notes:

The system used in all the pharmacies was BD Cato.

BD funded the project. While this can raise some red flags, I don’t think it’s enough to disqualify the data. Other companies, like Baxter, sponsor half of the sessions on compounding safety at ASHP Midyear. I for one am happy they do it. Support from companies like BD and Baxter go a long way in bringing important topics like compounding safety to the masses. So, focus on the use of gravimetrics, not on the company that sponsored the paper.

*Terkola R, Czejka M, Bérubé J. Evaluation of real-time data obtained from gravimetric preparation of antineoplastic agents shows medication errors with possible critical therapeutic impact: Results of a large-scale, multicentre, multinational, retrospective study. J Clin Pharm Ther. 2017;00:1–8. https://doi/org/10.1111/jcpt.12529