Integration no longer optional for pharmacy technology

I’ve written about the need for better integration and interoperability before. I’ve even written about the trend toward integrated systems. In January 2014, I wrote that “healthcare systems, and more specifically pharmacies, have started to understand the importance of having integrated systems.”

Here we are two years later, and to my surprise, we seem to be making great progress. There are obvious trends appearing in pharmacy.

  • While walking through the Exhibit Hall at ASHP Midyear, it was clear that integration was on the minds of many – people, healthcare systems, vendors. The term “integration” was being thrown around like confetti at Mardi Gras.
  • Companies like Baxter, Omnicell, and Aesynt are making a concerted effort to improve integration, each using a different approach. Baxter has a new EPIC interface, allowing DoseEdge to feed information directly into the EHR. Omnicell has made significant strides in creating a centralized database across their inventory management products for the central pharmacy. Aesynt is focusing on pulling data from several disparate sources for their data analytics tools, REINVENT and Formulary Tool Kit (FTK)
  • Acquisitions continue to be on everyone’s mind. Aesynt recently became part of Omnicell, and CareFusion is part of BD. Others are possible by year’s end.
  • Pharmacies want fewer disparate systems and are willing to sacrifice functionality for integration. I won’t go into specifics here, but several pharmacies that I’ve spoken with are opting for systems that are, in my opinion, missing key components, in favor of integration with their EHR or another system.

Looking over the landscape, it’s obvious that integration of systems will no longer be optional. The big boys are all in, and the little guys should take note as to not be left out in the cold.

Will the revised USP Chapter 797 include recommendations for automation and technology?

Whether or not future editions of USP General Chapter <797> will include recommendations for IV room automation and technology is a great question, and one that I’ve been pondering for quite some time. I’m torn as to whether or not I think adding such recommendations to a USP General Chapter is a good idea.

On one hand, I believe that pharmacy is over-regulated as it is. The amount of time spent by pharmacy personnel adhering to and documenting compliance to regulations currently in place is staggering. New regulations are frequently added to the process, but rarely, if ever taken away.

On the other hand, pharmacies refuse to utilize game-changing automation and technology even when they know it has the potential to improve operations, improve patient safety, and decrease cost. I’ve met many pharmacy directors and operations managers over the years that operate in a state of willful blindness when it comes to adoption of technology in the pharmacy.

While I don’t support adding, even more, regulatory requirements to pharmacy practice, I’m in favor of increased use of pharmacy automation and technology, especially in the IV room. It’s a conundrum.

With that said, it may become a moot point as it is possible that recommendations addressing the use of iv room automation and technology will find their way into the next revision of USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. Recent discussions with people close to the situation lead me to believe it could happen.

Should that occur, it would likely be a good thing for pharmacy practice in the long run as it would drive adoption of CSP preparation technology. Even if the Expert Compounding Committee were to recommend adoption and not mandate it, i.e. “should” versus “shall”, the industry would surely take note. Recommendations that show up in <797> have a way of trickling down into other regulatory agencies as well as into the minds of inspectors and pharmacy directors. For example, the 2015 California Lawbook for Pharmacy(1) states that “The board shall review any formal revision to General Chapter 797 of the United States Pharmacopeia and The National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary”. Regardless of whether or not the board takes action, they are sure to take notice.

It’s too early to say whether or not the revisions to Chapter <797> will include recommendations for CSP preparation technology, but I suspect we won’t have to wait long to find out. Chapter <797> is currently up for public comment until January 31, 2016. Based on recent changes to USP General Chapter <800>, I suspect revisions to Chapter <797> will become official in a similar timeframe so that the chapters can be properly harmonized. Only time will tell.

Something worth thinking about.

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(1) Article 7.5, Section 4127(c)

JerryFahrni.com Podcast | Episode 7: Virtual Reality and Pharmacy

Jerry talks about his experience with Virtual Reality and where there may be some potential for use in pharmacy.

Show Notes:
Host: Jerry Fahnri, Pharm.D.

0:00 Introduction
0:28 My experience with VR
1:59 VR tiers and products
5:05 Application of VR – General
5:50 Application of VR – Healthcare
7:51 Application of VR – Pharmacy
13:01 Application of VR – Vendors

Items discussed in podcast:
Google Cardboard
Samsung Gear VR
Oculus Rift
HTC Vive
Microsoft HoloLens

Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones

 

Traditional literature doesn’t work for evaluating pharmacy automation and technology, and here’s why

Recently a friend and colleague reached out to me looking for guidance on published studies showing positive ROI for IV room automation and technology. There’s precious little literature covering this practice are of pharmacy, much less getting into things like ROI.

Why is that? As I see it, the problem comes down to these three things:

  1. Bias. Some of what is written, especially in the “throw-away journals” is sponsored content, and as a result, presents a lop-sided view to the reader. It’s still worth reading, but always with a grain of salt.
  2. One-size fits all. Nope. There are too many approaches to compounded sterile product (CSP) production in pharmacies across the U.S. I’ve been in more than 20 acute care pharmacies over the past few years looking at operations, and it’s clear that we’re all doing exactly the same thing completely differently. The solution for a 200-bed community hospital may or may not be a good fit for a 600-bed level 1 trauma center, or a healthcare system with centralized IV admixture servicing several facilities. It all depends on your needs. One must look at several variables and the specific needs of the pharmacy, patient, and healthcare system. Doing anything less is a recipe for wasted time, energy, and resources.
  3. Traditional literature doesn’t work. The typical literature cycle doesn’t work for pharmacy technology. Even though pharmacy automation and technology moves slowly, it still changes at a much more rapid pace than therapeutics and/or best practices. Changes in clinical approaches to the use of medication takes time, and once established typically last until something better comes along. We’re talking years here, sometimes decades. That doesn’t work for pharmacy automation and technology. Research on an IV room robot that was purchased in 2009, installed in 2010, and published about in 2015(1) is of little use to pharmacists looking for relevant information in 2016. It’s doubtful that the technology is still in a form today that could be easily compared to that presented in the article. It’s also entirely likely that the product no longer exists. An article like that offers little to those considering investing in pharmacy automation and technology, perhaps except for general interest or curiosity.

There is clearly a lack of literature on the subject, but there is also clearly no one size fits all approach. If you’re truly looking for the best way to implement automation and technology in your pharmacy, I recommend the following:

  1. Go ahead and do a literature search, focusing on the “throw-aways”. I know, I just spent a page telling you this doesn’t work. You won’t find enough to make a decision, but it will, at least, give you an idea of what products are on the market.
  2. Get some boots on the ground. There is no substitute for seeing the technology in action. Go visit people that are using the product. Don’t be cheap. If you’re going to drop a million dollars on a compounding robot, be willing to spend some money traveling around and looking at these things in real-world environments.
  3. Take your time. This is one area where making a snap decision will cost you. Not only will you spend resources on something that might not be the best fit, you’re likely to be stuck with it for a while.
  4. If you can’t do the above yourself, hire a consultant. Sounds a bit self-serving, but it’s true. Consultants will cost you upfront, but will save you several-fold the cost in the long run.

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  • Nurgat, Z., Faris, D., Mominah, M., Vibar, A., Al-Jazairi, A., Ewing, S., … Al-Jedai, A. (2015). A three-year study of a first-generation chemotherapy-compounding robot. American Journal of Health-System Pharmacy, 72(12), 1036–1045. http://doi.org/10.2146/ajhp140256

Webinar alert – The Missing Link: Practical Tips for Preparing for USP 800

I mentioned previously that USP General Chapter <800> – Hazardous Drugs—Handling in Healthcare Settings has been approved and will be published February 1, 2016. Thankfully, the Compounding Expert Committee approved a delayed official implementation until July 1, 2018. Obviously, the committee felt that enforcing Chapter <800> sooner would create a hardship on systems that aren’t close to being ready and need the added time to make changes.

There is going to be a lot of confusion around USP <800>, and for that reason, I will be proactively learning about its impact on healthcare systems and how it differs from the current version of USP <797>.

First up on my learn-about-USP<800> list for 2016 is a webinar – The Missing Link: Practical Tips for Preparing for USP 800 – sponsored by Pharmacy OneSource. According to the webinar site: “In this webinar, Patricia C. Kienle, RPh, MPA, FASHP and Eric S. Kastango, MBA, BSPharm, FASHP will provide practical tips to assure compliance with upcoming USP Chapter 800 Hazardous Drugs: Handling in Healthcare Settings. Facilities, PPE, personnel training, and environmental monitoring will be discussed. The link between USP Chapters 795, 797, and 800 will be explained.”  Patricia and Eric are both leading experts in this field and typically have great insight into sterile compounding regulation. It’s definitely worth an hour of your time.

The webinar is scheduled for on Wednesday, January 13.

You can get more information on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings to be Published in USP 39–NF 34, First Supplement here.

Is nearly universal prospective order review (NUPOR) really necessary?

Several years ago there was a group of pharmacists taking a serious look at the long-time practice of having pharmacists review virtually all drug orders, sometimes referred to as nearly universal prospective order review (NUPOR). The argument for NUPOR is that it is needed to ensure complete, accurate orders. The argument against NUPOR is that it’s expensive, time-consuming, and unnecessary in many instances. I fall into the latter category of pharmacists, i.e. NUPOR is an antiquated practice that needs to be done away with.

There are those that argue that doing away with NUPOR is dangerous and removes the pharmacist from the medication use process. Nothing could be further from the truth. By making NUPOR a requirement you have taken pharmacists out of the healthcare discussion. NUPOR forces pharmacists to be tied to a terminal when they could be doing other things. 

The introduction of Electronic Health Records (EHRs) and Computerized Provider Order Entry (CPOE) have created a perfect opportunity to change the concept of NUPOR.

Here are some scenarios to think about:

  1. Setting, a large acute care hospital with a busy Emergency Department (ED). Physicians frequently order boluses of NS, or other fluid. Does a 1L bolus of NS ordered for an adult patient in the ED really require verification by a pharmacist prior to administration? Ask yourself, as a pharmacist, what set of circumstances would cause you to reject such an order and call the physician?
  2. Setting, hospital OB-GYN unit. Adult patient comes in for delivery. Physician orders 50 mg of IV meperidine x1 for pain. The patient is in good health, labs are normal, and has no allergies to the medication. Is there any reason that such an order needs verification? What would cause you to reject it and call the physician?
  3. Setting, general medicine floor of a hospital. Elderly patient admitted following a minor surgical procedure. The patient is experiencing constipation secondary to the procedure and medication for pain. Physician orders a bisacodyl suppository or MOM x1 to help get things moving. Labs are ok, the patient has no allergies to the medication, and there are no significant drug interactions. Is there any reason that such an order would require a pharmacist’s blessing?

The list goes on and on. I suppose one could argue that there could be potential for a physician to blow through a catastrophic problem with the drug order that would harm the patient. Sure, that could happen. However, I would argue that a good system would allow the healthcare system to place hard stops in places where there is genuine concern or potential for a problem.

I just don’t see NUPOR as necessary in today’s healthcare environment, especially for those healthcare systems using EHRs and CPOE. Don’t agree? That’s cool. Use the comment section below to convince me I’m wrong, but make sure you have a good reason, because if you don’t, I’ll mock you in front of the other children. 

Witnessing errors in the iv room

I spent a short time observing iv preparation in two separate, distinctly different pharmacy environments in the weeks leading up to the new year.

One was a traditional iv room in a large acute care pharmacy with multiple pharmacy technicians and pharmacists putting out hundreds of compounded sterile preparations (CSPs) per day. The second was a segregated compounding area in a satellite pharmacy with one pharmacy technician and one pharmacist using a glove box to prepare STAT and first dose CSPs to critical care areas.

Syringe pull-back method

Neither area utilized technology for CSP preparation, instead opting for the good ole fashioned syringe pull-back method (1). In the case of the traditional iv room, I observed instances of up to twenty different CSPs with empty vials and syringes laid out awaiting pharmacist verification. In the segregated compounding area with glove box, CSPs were typically prepared one at a time or in small batches.

During my short time observing CSP preparation in the two areas I witnessed errors that would have easily been caught with the use of readily available technology.  Here are two examples:

Wrong drug selection – This may be the most common error seen in iv rooms. In this particular case, the technician used a vial of potassium phosphate (KPhos) for a CSP that called for sodium phosphate (NaPhos). The use of bar code scanning for verification during the compounding process would have prevented this error.

Calculation error resulting in an incorrect dilution – A patient-specific order called for 20 mg of hydrocortisone in a total volume of 2 mL to be placed in a syringe for iv administration. The technician started by first making a stock hydrocortisone syringe from which to draw the dose. This is a common practice. The resulting stock syringe should have contained 100 mg of hydrocortisone in 10 mL of solution, i.e. final concentration of 10 mg/mL. Instead, the technician calculated the final volume as 25 mL, resulting in a final concentration of 4 mg/mL in the stock syringe. So when the patient-specific dose of 2 mL was drawn into the syringe the final dose was only 8 mg. The pharmacist almost let it go, but something made him take a second look. It was only when he asked the technician to explain the process that the error was discovered. The use of bar code scanning for verification during the compounding process would not have prevented this error. But, the use of step-by-step instructions with intermediary step checks during the stock syringe prep, or the use of gravimetrics, would have.

The number of CSPs prepared in iv rooms daily in the United States is unknown, at least to me, but has to be somewhere in the neighborhood of a million. (2) Combine that with published literature that puts sterile compounding errors around 11%, (3) and that’s some scary stuff. With numbers like these, I wonder how many mistakes make their way to the patient?

The iv room is a busy place with a lot of dangerous medications. It’s also a place where a lot of errors occur.  With the availability of commercially available products that can easily prevent these types of errors, there’s really no excuse for continuing to use a completely manual process.

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(1) Syringe pull-back method is when the empty syringe used for each drug or electrolyte is left alongside the item with its plunger pulled back to the volume that was added. The pharmacist looks at the empty syringe with plunger pulled back and compares volume to the volume necessary to accurately prepare the CSP. This is common practice in many pharmacies even though it has been declared unsafe. I continue to be surprised that pharmacies use the syringe pull-back method.

(2) Using a number of 1.5 CSPs per patient, per day in acute care hospitals, and using 795,603 licensed Community Hospital beds in the United States (1999 – 2013 AHA Annual Survey, Copyright 2015 by Health Forum, LLC, an affiliate of the American Hospital Association), the number of CSPs produced per day in the United States exceeds 1 Million.

(3) Am J Hosp Pharm 1997;54:904-912