Jerry Fahrni

Tag: IV ROOM

  • USP soliciting comments for proposed changes to Chapter <797> Pharmaceutical Compounding—Sterile Preparations

    The USP Compounding Expert Committee has published a Notice of Intent to Revise for General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.

    I knew this was coming. I’ve talked to several people this year that indicated that revisions to Chapter <797> were imminent, especially with the introduction of USP <800> Hazardous Drugs—Handling in Healthcare Settings.

    According the USP notice:

    The General Chapter has been under review since 2010 and has been significantly revised to clarify requirements, and reflect stakeholder feedback and learnings since the last revision became official in 2008.

    Major revisions of the General Chapter include:

    1. Reorganization of existing sections and placement of procedural information in boxes
    2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.
    3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings
    4. Introduction of the terminology “in-use time” to refer to the time before which a conventionally manufactured product used to make a CSP must be used after it has been opened or punctured, or a CSP must be used after it has been opened or punctured.

    Items #2 and #3 are significant.

    Most hospitals do not currently make CSPs that fall into the microbial high-risk category. Altering these categories could have significant impact on acute care pharmacies.

    The introduction of USP Chapter <800> Hazardous Drugs – Handling in Healthcare Settings will make any mention of hazardous drugs in the current Chapter <797> obsolete. I suspect that the Compounding Expert Committee will likely remove management of hazardous drugs from Chapter <797> and simply defer to USP <800>, which has yet to be published in anything other than draft form.

    I will be spending the next week or so going through the proposed changes to better understand what the USP Committee is thinking. Remember, these revisions aren’t final.

    Revisions to General Chapter <797> will be published for public comment in Pharmacopeial Forum (PF) 41(6) [Nov.–Dec. 2015] on November 2, 2015. You can view the proposed revisions with line numbers in advance of publication here [PDF].

  • Pros and cons of IV workflow management systems

    Pondering the need for an IV workflow management system (IVWMS)? You’re not alone if you are. According the most recent PP&P State of Pharmacy Automation Survey, 15% of facilities have already implemented something and another 29% plan to do so in the next few years. The only surprise is the relatively low percentage of facilities planning on implementation in the near future.
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  • JerryFahrni.com Podcast | Episode 4: UCSF Mission Bay Pharmacy

    Show Notes:
    Host: Jerry Fahrni

    PillPick by Swisslog1
    BoxPicker by Swisslog1
    RIVA by ARxIUM (formerly Intelligent Hospital Systems)

    ———————
    1. Make sure to check out the videos for both PillPick and BoxPicker at the Swisslog website.

  • Saturday morning coffee [August 8 2015]

    “Power is like being a lady… if you have to tell people you are, you aren’t.” – Margaret Thatcher

    The mug below comes from Six Flags Magic Mountain down in Valencia, California. If you like roller coasters, then this is the place for you. They have some of the best in the business, and my kids love to ride them. We used to go down there a few times a year, but haven’t had the opportunity in a while. It was nice to have a little reckless fun for a change. One of the longtime landmark rides at Magic Mountain was the Colossus, billed as the tallest and fastest wooden roller coaster in the world. Something happened in 2014 and Six Flags did some major work on the coaster. It’s no longer the wooden beast it was, but rather a hybrid wood and steel roller coaster called Twisted Colossus. The new ride features barrel roll inversions, and a near-vertical drop. And when I say near-vertical drop, I mean near vertical. It got my heat racing. Should have brought the GoPro.

    Twisted Colossus MUG
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  • JerryFahrni.com Podcast #3: Semi-automated IV Workflow Management Systems

    Show Notes:
    Host: Jerry Fahnri

    New Equipment:
    Blue Microphones Yeti USB Microphone – Blackout Edition
    Dragonpad Pop Filter

    IVWFM systems discussed:
    APOTECAps1
    BD Cato
    DoseEdge
    EPIC Dispense Prep2
    i.v.SOFT
    IVTrac1
    Meditech1,2
    PharmQ-ITH – No longer available. IP sold to BD
    Phocus Rx
    PyxisPrep – No longer available. Killed following acquisition by BD
    RxADMIX1
    ScriptPro
    Verification

    1. I have not reviewed these systems in a live environment, i.e. non-beta customer site. I have had a live demo of IVTrac.
    2. These systems are part of an already existing EHR platform, i.e. they are not standalone

  • What USP <797> has to say about beyond-use dating of stock bags

    Nothing. It says nothing, which leaves things open to interpretation. That’s bad.

    Beyond use dating (BUD) in USP <797> is pretty straightforward, but there’s really no language in there describing stock bags.

    Here are some things to think about. When performing routine compounding, USP <797> states that in the absence of sterility testing, the assigned BUD must not exceed the following:

    USP 797 BUD for temp and risk
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  • JerryFahrni.com Podcast #2: Sterile Compounding Robots

    Show notes:
    Host: Jerry Fahrni

    Robots discussed:
    i.v.STATION by Aesynt
    RIVA by Intelligent Hospital Systems (IHS)
    INTELLIFILL I.V. by Baxter
    APOTECAchemo® by Loccioni Group

  • More thoughts on the ASHP national survey results for informatics and pharmacy practice

    On Monday I spoke briefly about two articles in AJHP that summarize two recent ASHP surveys. The first covers Pharmaccy Informatics in U.S. Hospitals(1), while the second focuses on pharmacy practice in acute care hospitals(2).

    Both surveys contain a wealth of information, and provide a snapshot of what pharmacies in the U.S. are doing. While conducted at different times by different groups, I think it’s more interesting to look at the two surveys together. As I mentioned in my podcast, the adoption of automation and technology goes hand in hand with pharmacy operations. You can no longer have one without the other.
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  • Cool Pharmacy Technology – Aesynt REINVENT [it’s about the data]

    Data surrounds us. We’re deluged by it in every facet of our lives, from the bank statements we receive in our personal life to the mountains of data collected in healthcare. Regardless of the data collected, there are basically three things that can be done with the information. It can be ignored, archived, or used. Unfortunately only one of those three things is truly meaningful, using it.

    Many, especially in pharmacy, chose to ignore or archive data rather than use it. That’s not because the information isn’t valuable, but rather because they are overwhelmed with the amount of information they receive and simply have no idea what to do with it. Throw in the fact that the more data we collect, the more useful it becomes, and things get weird. Seems counterintuitive, but data collected from a single source, say one pharmacy i.v. room, offers little value.

    Single source data creates several problems, such as potential bias, the inability to find trends that may be available in larger data sets, and failure to create usable comparisons to others that may offer insight into improved operations. Only when data is collected from several different sources does one truly begin to understand its value.
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  • Pharmacy – entrenched in outdated dogma

    Dogma: belief or set of beliefs that is accepted by the members of a group without being questioned or doubted (Merriam-Webster)

    I have opinions, lots of opinions. And like most, I believe my opinions are valid; it’s human nature. It’s not uncommon for me to find people within a group that agree and disagree with my opinions. However, once in a while I come across an entire group of people that stand in disagreement with my thoughts. That’s not crazy to imagine, but when that happens I’m forced to re-evaluate. Let’s face it, if everyone thinks I’m wrong, it’s possible that I am.

    Such is the case with my thoughts on the use of technology and personnel in the i.v. room, which are on record at this site and are quite transparent. In a nutshell I believe that:
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