Jerry Fahrni

Category: Pharmacy Practice

  • Recommendations for technology-assisted CSP preparation

    Both ISMP and ASHP are working on draft recommendations for technology in the IV room. ISMP’s version is an update to their ‘Guidelines for Safe Preparation of Sterile Compounds’ that was originally published in 2013. The proposed revision is open for public comment until April 10th. ASHP is also working on new recommendations for the use of IV Workflow automation technology for the preparation of compounded sterile products (CSPs)

    It feels a bit like running into a burning building to pull people out instead of taking action to prevent the building from catching fire in the first place, i.e. reactive instead of proactive. Many of us have known for years that there’s a problem in the IV room. It’s the dirty little secret of the industry. We’ve been saying that change is needed, but it has mostly fallen on deaf ears until now. What’s changed? I have an opinion, but that’s for another time.

    We’ve known for decades that the IV room is not only one of the busiest areas in a pharmacy but also one of the most dangerous. IVs present higher risks than most other medications and the literature presents abundant evidence of the prevalence of pharmacy compounding errors, (1, 2, 3, 4, 5, 6, 7) which result in patient harm or death. (8,9, 10, 11) These errors not only impact patients but caregivers and healthcare facility as well. The human and financial toll are staggering.

    While we may think we don’t make mistakes in the IV room, studies have shown that errors during CSP production are not uncommon. According to the frequently cited article by Flynn, Pearson, and Baker published in 1997: “A five-hospital observational study on the accuracy of preparing small and large volume injectables, chemotherapy solutions, and parenteral nutrition showed a mean error rate of 9%, meaning almost 1 in 10 products was prepared incorrectly prior to dispensing.” (7)

    Many of the errors found with CSPs can be easily prevented through the use of common, currently available technologies. While adoption of technology has been slow, pharmacies are increasingly moving toward the use of these systems. Guidelines from ISMP and ASHP will certainly help speed things up.

    Compliance with USP <797> Pharmaceutical Compounding—Sterile Preparations and ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products has certainly led to improved processes and safety in the IV room. Both address the need to accurate identify, measure, dilute, mix, package, and label CSPs. However neither of the guidelines is designed to drive adoption of CSP technologies to improve safety, accountability, and documentation.

    The quality and safety of CSPs goes beyond sterility, potency, and stability and must include accurately identified and measured ingredients, diluents, final solutions, and containers as well as identifying, tracking, and documenting the CSP from cleanroom to patient.  Current practices do not support or encourage the use of available automation and technologies to support these activities.

    Much has yet to be defined and there are currently no guidelines or governing entities to drive standardization for vendor development and design, nor is there anything to help healthcare systems make smart choices.* With that said, it appears that changes are just around the corner.

    During this time, it is important to understand the following:

    • Vendors must design – and users chose – systems that provide a clear advantage over manual systems in patient safety, workflow standardization, and documentation; are cost-effective; interoperable with existing systems; are simple to install, use, and maintain; and carry a high degree of certainty and reliability.
    • Minimum requirements** should include interoperability with pharmacy information systems and electronic health records, control of final product label, bar code verification of all ingredients and final containers, imaging for verification and documentation, documentation of master formula records, lot numbers, expiration dating, and products used, and basic dose tracking functionality.
    • While some of the products available today generate their own ISO class 5 compounding environment, these systems must function properly in cleanroom environments and comply with all USP <797> and <800> standards and recommendations.
    • And finally, technologies for CSP production must be correctly selected and utilized to effectively create a safe environment for both the healthcare provider and the patients they serve. There is no one-size-fits-all approach to these systems and each healthcare system is different. Proper selection will depend on several factors.

    It’s time for vendors and healthcare systems to wake up and get ready for what’s coming.

    References

    1. US Food and Drug Administration Website. Report: Limited FDA Survey of Compounded Drugs. Available online at: http://www.fda.gov/cder/pharmcomp/survey.htm. Accessed on January 3, 2004.
    2. United States Department of Justice, Federal Bureau of Investigation Website, April 22, 2002. Available online at: http://kansascity.fbi.gov/kcmostate042202.htm. Accessed on July 6, 2002.
    3. Trissel LA. “Compounding our problems–again.” Am J Health-Syst Pharm. 1 Mar. 2003: 432.
    4. Selenic D, Dodson DR, Jensen B et al. “Enterobacter cloacae bloodstream infections in pediatric patients traced to a hospital pharmacy.” Am J Health-Syst Pharm. 2003; 60:1440–6.
    5. Niedowski E, Bor J. State to probe Hopkins death: 2-year-old cancer patient died after receiving improper IV mixture. December 20, 2003. Baltimore Sun, Baltimore, MD.
    6. Flynn, EA, Pearson, RE, Barker, KN. “Observational study of accuracy in compounding IV admixtures at five hospitals.” Am J Health-Syst Pharm. 1997 Apr 15; 54: 904–912
    7. Solomon SL, Khabbaz RF, Parker RH, et al. “An outbreak of Candida parapsilosis bloodstream infections in patients receiving parenteral nutrition.” J Infect Dis 1984; 149:98–102.
    8. Hughes CF, Grant AF, Leckie BD, et al. “Cardioplegia solution: A contamination crisis.” J Thorac Cardiovasc Surg 1986; 91:296–302.
    9. Associated Press. Pittsburgh woman loses eye to tainted drug; 12 hurt. Baltimore Sun. November 9, 1990:3A.
    10. Dugleaux G, Coutour XL, Hecquard C, et al. “Septicemia caused by contaminated parenteral nutrition pouches: The refrigerator as an unusual cause.” J Parenter Enteral Nutr 1991; 15:474–475.
    11. Perrin J. “Unsafe activities of compounding pharmacists.” Am J Health-Syst Pharm 1995;52:2827–2828.

    *Actually, I would argue that IN THE CLEAN ROOM: A review of technology-assisted sterile compounding systems in the US (Jerry Fahrni, Pharm.D. and Mark Neuenschwander) would be a great tool for helping pharmacies make smart choices, but most seem averse to the information.

    **Minimum requirements. This is not to say that this should be the end game, but rather a place to start. Overreaching in the beginning of this process is sure to dampen development and adoption.

  • Novel formulation of ethanol for glove decontamination to prevent Clostridium difficile contamination

    Clostridium difficile is a major problem in hospitals across the U.S. According to the CDC, it is estimated that C. difficile caused almost half a million infections in the U.S. in 2011, and approximately 83,000 of the patients who developed C. difficile experienced at least one recurrence and 29,000 died within 30 days of the initial diagnosis.  Staggering numbers.

    C. difficile is a nasty spore-forming bacteria that produces toxins. The main clinical symptoms of C. difficile infection include watery diarrhea, fever, nausea, abdominal pain, and loss of appetite. More serious infections can result in pseudomembranous colitis, perforations of the colon, and in extreme cases sepsis.

    For the reasons cited above, I found this Pharmacy OneSource article quite interesting. According to the OneSource article: “A concise communication recently published in the Infection Control & Hospital Epidemiology (ICHE) journal provides effectiveness data on a novel formulation of ethanol used for glove decontamination to prevent Clostridium difficile (spores) hand contamination during glove removal… Test solutions included the novel, sporicidal ethanol formulation (70% ethanol adjusted to pH 1.3 with hydrochloric acid), as well as, 1:10 and 1:100 dilutions of sodium hypochlorite (bleach), and 70% ethanol with no pH adjustment/additives… [the] sporicidal ethanol formulation was effective in rapidly reducing C. difficile spores by approximately two logs, with a further reduction when applied as a wipe.” This was equivalent to 1:100 dilution of bleach solution.

    While there are no studies that I’m aware of linking C. difficile infection to pharmacy cleanroom practices, such a novel anti-C. difficile solution has potential wide sweeping application throughout acute care facilities as well as long-term care facilities.

    The abstract for the article cited in the OneSource piece can be found here states: “Decontamination of gloves before removal could reduce the risk for contamination of hands of personnel caring for patients with Clostridium difficile infection. We demonstrated that a novel sporicidal formulation of ethanol rapidly reduced C. difficile spores on gloved hands without adverse odor, respiratory irritation, or staining of clothing.” – Infect. Control Hosp. Epidemiol. 37.03 (2015): 337-339.

  • Cost of cancer drug waste isn’t as simple as it seems

    New York Times: “The federal Medicare program and private health insurers waste nearly $3 billion every year buying cancer medicines that are thrown out because many drug makers distribute the drugs only in vials that hold too much for most patients, a group of cancer researchers has found. …  “Drug companies are quietly making billions forcing little old ladies to buy enough medicine to treat football players, and regulators have completely missed it,” said Dr. Peter B. Bach… co-author of the study.”

    I read this article with great interest. While it’s true that “cancer drugs”, i.e. chemotherapy can be costly, the reasons are many and this article speaks about only a single issue that overly simplifies the problem and vilifies the manufacturers. It’s not that simple.

    Before I discuss items not mentioned in the NYT article, let me give you a bit of background. As a practicing pharmacist for nearly twenty years, I’ve been involved with my fair share of sterile preparations, including chemotherapy. In the early years of my career pharmacies would frequently hold onto vials of medications that had only small amounts removed to make a patient dose. These vials with the remaining drug were affectionately called “partials”, and were often stored for later use in the refrigerator for periods of up to a week. Partials were then combined to make additional doses, thus minimizing waste. In addition, pharmacy as a whole would often utilize the “overfill” found in many medication vials to stretch inventory. As a specific example, I recall 50mcg/mL, 20mL vials of fentanyl routinely containing more than a full milliliter of overfill, i.e. more than 21mL of the solution. Sometimes, depending on the number of CSPs of a specific medication prepared, the overfill from several vials would be enough to generate another complete dose for a patient.

    It’s important to understand that the two use cases described above were standard practices and were in no way meant to endanger patients or cheat anyone out of anything. At the time, they were considered strategies to minimize drug waste. Period.

    Fast forward to today and neither partial vials nor overfill are routinely used. Why? Well, new regulatory requirements and standards of practice like USP <797> have made it increasingly difficult to hang onto partials secondary to beyond-use-dating, lack of stability and sterility data, and so on. In addition, insurance companies laid down the boom several years ago and mandated that pharmacies no longer use overfill because it was considered “fraudulent billing”. I’ve been in several pharmacies over the past several years where the complexity of regulatory compliance and insurance billing has made partials and overfill too risky and complex to deal with. Instead, any leftover drug is discarded, i.e. wasted. Wasting partials and overfill are now considered standard practice.

    This is not to say that drug companies aren’t trying to maximize their profits. Of course they are. I’m not completely oblivious to the fact. However, as a pharmacist, I think about what healthcare would look like without the billions of dollars’ drug companies spend on research and development. It would be a sad, desperate place. Several medications brought to market during the past decade have saved countless lives.

    What does it all mean? It means we have some work to do. It means that we need to find a way to extend the shelf life of partial vials, especially chemotherapy. It also means that we need to find common ground with payers that allow pharmacies to utilize the entire contents of vials. It’s not rocket science, but it’s certainly no walk in the park either.

  • UPMC pilots pharmacogenomics program for heart patients

    Twenty years ago pharmacogenomics was supposed to revolutionize the way we practice pharmacy. Unfortunately, the revolution has been slow to evolve. That’s why this pilot program at UPMC is so exciting.

    UPMC is piloting a program to perform genetic testing on patients to determine medication response. “At UPMC, doctors are testing for that gene before prescribing medications to patients who receive a stent.” This is one of only a handful of healthcare systems in the country openly performing pharmacogenomic testing.

    “UPMC’s goal is to use clinical pharmacogenomics knowledge to individualize patient treatments – part of a broader program at UPMC that officials say could eventually include a wide variety of drugs to improve outcomes for patients…..The genetic and clinical information that is gathered for the PreCISE-Rx program, also feeds UPMC’s data analytics program, which is expected to lead to new scientific insights into how and why drugs work for some patients but not others, and to identify new drug targets.”As

    As pharmacists, we should be excited about this. We should also make sure that we’re waist deep in it. My hope is that UPMC has included clinical pharmacists in the program.

    This is a great step toward personalized medication.

    Source: UPMC pilots pharmacogenomics program, uses gene tests to target medications for heart patients

  • Placing equipment in the primary engineering controls (PECs)

    Can you place items in the primary engineering control (PEC, aka “the hood”)? I get this question from time to time with regards to IV workflow management systems (IVWFMs). Most (all?) IVWFMs currently on the market utilize various hardware components – cameras, stands, scales, tablets, etc. – inside the hood.

    Hardware in the PEC

    Things may change in the future, but the bottom line is that there is nothing in the current USP General Chapter <797> that directly addresses the use of automation and technology inside the hood.

    However, <797> does, in a general way, address the use of items inside the direct compounding area [DCA], which is where compounding equipment is typically found. Nothing found within the DCA can impact first air, and the equipment needs to be cleanable.

    USP Chapter <797> states: “After proper introduction into the DCA of supply items required for and limited to the assigned operations, they are so arranged that a clear, uninterrupted path of HEPA-filtered air will bathe all critical sites at all times during the planned procedures. That is, no objects may be placed between the first air from HEPA filters and an exposed critical site.”

    Further guidance may be found in Chapter <797> in a section titled Suggested Standard Operating Procedures (SOPs): “Supplies used in the DCA for the planned procedures are accumulated and then decontaminated by wiping or spraying the outer surface with sterile 70% IPA or removing the outer wrap at the edge of the DCA as the item is introduced into the aseptic work area…. All supply items are arranged in the DCA so as to reduce clutter and provide maximum efficiency and order for the flow of work… After proper introduction into the DCA of supply items required for and limited to the assigned operations, they are so arranged that a clear, uninterrupted path of HEPA-filtered air will bathe all critical sites at all times during the planned procedures.”

    If the items being placed in the hoods meet both requirements, i.e. they do not obstruct HEPA-filtered air and can be properly cleaned, then there shouldn’t be an issue.

    To ensure that the items are being used appropriately I recommend that users: 1) perform appropriate surface sampling to ensure sterility, and 2) perform a smoke study. Smoke studies are the only way to ensure that items in the hood are not impeding airflow. Take the time to do one for each hood where hardware is used.

  • General Chapter 800 Commentary posted

    Just in case anyone was interested and wanted to get a jump on the upcoming USP Chapter <800>.

    The USP-NF Compendial Update for February included General Chapter <800> Commentary, which was posted on February 1, 2016. It’s a PDF document that includes all the comments that were submitted for consideration to the Expert Compounding Committee. The document can be found here.

    If you want to get a sense of what’s going to be in the chapter, just open it up and search for ‘comment incorporated’. There are just over 100 items. On the flipside, if you want to see what was rejected search for ‘comment not incorporated’. My search found more than 200 items that were rejected. Too bad, really. I thought some of the items that were kicked to the curb were pretty good ideas.

  • 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