Jerry Fahrni

Author: Jerry Fahrni

  • More thoughts on USP <797> and pharmacy IV rooms [comment from reader]

    A friend and colleague, Ray Vrabel, left a comment on my post from April 20th. I thought what Ray had to say was too good not to post. He raises some good points, which are worth more discussion.

    Ray is a sharp guy, and he and I have had some good conversations over the past couple of years. He’s passionate about patient safety and pharmacy practice. While I don’t always agree with everything that Ray has to say, I definitely appreciate his thoughts and opinions.

    Make sure to read more of Ray’s thoughts here.

    Jerry,

    Your post has got me wondering about a number of things: Area 51, The Kennedy Assassination, Obama’s birth certificate, and now USP797.

    You raise the question which I have always wondered about: What was the problem that USP797 was attempting to solve? Was there documentation of significant problems associated with pharmacy-prepared IV admixtures by pharmacies who were following the ASHP Guidelines in place before USP797? Did anyone conduct a multi-hospital study to determine if hospitals following pre-USP797 ASHP Guidelines had any clinical problems associated with pharmacy IV admixtures? In other words, what is the science that drove the USP797 standards?

    We have effectively turned our pharmacy IV Rooms into GMP-like sterile manufacturing facilities. So now, if properly followed, we have hospital pharmacies preparing a very high quality product from a sterility standpoint. That’s a good thing, but we also have a number of unintended consequences:

    (1) Most IV admixtures are now prepared by pharmacy technicians, but they are no longer being directly supervised by pharmacists because of the onerous garbing requirements, making it inconvenient for the pharmacist to move into and out of the IV room.

    (2) While there is now a requirement that every pharmacy must follow UPS797 standards, we do not have a technician licensure/certification requirement for all technicians in all states.

    (3) While USP797 has required the use of all types of environmental, operational, and testing products, there is no requirement for pharmacies to use barcode checking of the IV admixture ingredients (i.e., Label, bag, and additives). Why do we have excellent sterility requirements with no requirement for accuracy of IV additive preparation?

    What’s wrong with this picture? We now have sterile IV admixtures, but we don’t have any standards to make sure that the IV admixture is made correctly (i.e., correct ingredients). I feel that barcode scanning during medication preparation (BCMP) should be the minimum standard for ALL IV admixtures in ALL pharmacies. For more on this, please see my LinkedIn post: https://www.linkedin.com/pulse/why-hospital-gift-shops-more-important-than-pharmacy-iv-vrabel.

  • Three CE Opportunities for Sterile Compounding and the IV room

    There’s little doubt in my mind that everyone’s eyes are on pharmacy IV rooms these days. Case in point, I’ve received several continuing education (CE) opportunities via email recently that are aimed squarely at the IV room and sterile compounding.

    • Achieving and Marinating Excellence in Sterile Compounding: Innovative Techniques to Ensures Competency (link)
    • IV Integration and a Culture of Safety: Reducing Complexity and Its Consequences (link)
    • Understanding the New Federal Framework for Oversight of Sterile Compounding (link)

    So if you’re in the market for a little free CE – and let’s face it, who isn’t – and want some great information on a timely subject, then simply click on the links above. Enjoy!

  • What practice area benefits most from increased sterile compounding regulation?

    I recently sat through a webinar that was recorded during a live symposium at ASHP Midyear in Anaheim on December 8, 2014. The symposium was entitled “Understanding the New Federal Framework for Oversight of Sterile Compounding” (1) and consisted of three separate presentations, one of which was given by Eric Kastango. (2)
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  • Do patients in the U.S. really own their healthcare data?

    Yesterday I was reading through my Twitter stream when I came across a brief exchange between Eric Topol (@EricTopol)  and Farzad Mostashari (@Farzad_MD). Both are big names in the digital healthcare space.


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  • Saturday morning coffee [April 11 2015]

    “This above all: to thine own self be true.” – William Shakespeare

    So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….

    The mug below comes straight from the bookstore on the UC San Diego campus. My youngest daughter, Mikaela and I attended Triton Day 2015 last Saturday on the UCSD campus. Mikaela will be attending UCSD starting in the Fall of this year as a NanoEngineering major. After sitting through the Chemical Engineering and NanoEngineering presentations at Triton Day I’m thinking about joining her. It’s a great time to be entering the nanotechnology field.

    UCSD Triton Mug
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  • Cool Pharmacy Technology – Kiro Oncology System

    I’ve recently had conversations with several companies outside the U.S. developing robotic technology for the i.v. room. One of those systems is the Kiro Oncology System. Check the video below.

    A couple of things worth noting:

    • The system uses dual robotic arms during the compounding process. This is something that is important for the next generation of i.v. room robots. The current crop of i.v. room robots here in the U.S. use a single arm. Think about the inefficiency of one-armed sterile compounding.
    • The Kiro Oncology System is self-cleaning. This is a concept that appears to be more popular “in Europe” than it is here in the U.S. Kiro Oncology isn’t the first overseas group I’ve dealt with that is pushing the idea of self-cleaning. None of the U.S. vendors have ever mentioned it.

  • Managing medication trays in acute care pharmacy

    Medication trays – a.k.a. med trays, code trays/kits/boxes/bags, transport trays/kits/boxes/bags, intubation kits, C-section trays, anesthesia trays, and so on ad infinitum – are common in acute care pharmacies.  I’ve seen them in every variation you can imagine in every pharmacy I’ve ever been in.

    Depending on the situation, med trays can contain a large number of injectable medications. For example: code trays may contain several different neuromuscular blockers like vecuronium, rocuronium, succinylcholine; pressors like epinephrine, norepinephrine, phenylephrine;  other code drugs like atropine, vasopressin; reversal agents like naloxone and neostigmine; antibiotics, etc, while a C-section tray may contain local anesthetics in various shapes and sizes (lidocaine with or without EPI, SDV or MDV, bupivacaine of various concentrations, etc). The list goes on. It’s pretty crazy.

    Anesthesia_Tray
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  • Automated intravenous fluid monitoring at the bedside

    Over the years I’ve had a lot of ideas, some good and some not. When an idea comes to me, I typically record it in a notebook that I have sitting on my desk. Occasionally I return to the notebook and review the ideas to see how many of the ideas still have merit. Sometimes an idea has become outdated, and rarely an idea will have materialized as a product of similar design built by a company. And then there’s a group of ideas and concepts that still hold value but haven’t been seen in the market.

    Today I was rummaging through some of my old ideas. One of them from 2010 caught my attention. In 2010 I thought it would be cool if someone could use technology to analyze the IV fluid being administered to a patient in real-time. Basically, such a system would prevent the wrong IV medication from being hung on a patient, thus preventing a medication error.
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  • Cleanroom technology for pharmacy – DRUGCAM

    DRUGCAM is an interesting piece of pharmacy cleanroom technology. On one hand it falls into the semi-automated systems category because the person using it has to manually manipulate all the components of the sterile compound they’re making. In other words, it’s not a robot. On the other hand DRUGCAM uses some interesting technology and software to automate some of the steps in the process.

    DRUGCAM uses multiple cameras(1) to automatically detect the items being used during the compounding process. As the user passes components in front of the cameras, the system automatically identifies them. No bar code scanning required. That’s probably a good thing outside the U.S. as I’ve learned that not all countries require manufacturers to place a bar code on their drug containers. If the system doesn’t recognize the item, the user is notified via visual cues on the screen.

    DRUGCAM uses the same technology to automatically detect the volume of fluid pulled into syringes, and also detect when the same syringe is empty following addition of the contents to the final container. I’m not sure how the system determines the correct syringe position, but it’s pretty interesting.

    One other thing that makes DRUGCAM unique is that it takes video of the entire compounding process. I’ve mentioned this idea to several vendors over the past few years, but no one really seemed interested in the idea of using video.(2) I think it offers potential advantages over still photos. For one, if something looks weird you can always move forward or back in the compounding process to see what went wrong.

    Check the video below. It shows DRUGCAM being used in a glovebox.

    DRUGCAM is not currently available in the U.S. If you’d like more information just follow the link to the DRUGCAM website.

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    (1) When I saw DRUGCAM at the ASHP Summer Meeting back in June 2013 the engineer told me that the system utilized two cameras, but I can’t find that information on the product website.
    (2) Everyone I’ve talk with was concerned about the storage requirements for the video. My brother works for a company that designs security cameras, software, etc. Those companies have been dealing with high-definition video storage for years.

  • Saturday morning coffee [March 21 2015]

    “Life is a dream for the wise, a game for the fool, a comedy for the rich, a tragedy for the poor.” – Sholom Aleichem

    So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….

    I was sitting in The Main Street Café in Visalia, CA having breakfast with my brother when I saw the sign below hanging on the wall. Perk ‘Em Up….would make a great name for a coffee shop, no? Just in case you were wondering, the staff was great, but the food was mediocre. The pancakes weren’t very good at all. No flavor. Bacon was good though.

    MUG_CoffeeShop
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