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

By | January 25, 2016

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)

2 thoughts on “Will the revised USP Chapter 797 include recommendations for automation and technology?

  1. Rayburn B Vrabel, PharmD

    The subtitle of the current USP regulation should be “Clean, but deadly”. It imposes GMP-like sterile manufacturing environmental requirements on hospital pharmacies, without (1) any requirements to ensure that the correct ingredients were used to prepare a given CSP (e.g., barcode scanning) or (2) that appropriate quality control measures were used to ensure that pharmacy technicians, who often operate independently in a pharmacy clean room, are preparing CSPs correctly (e.g., imaging and/or gravimetrics). In fact, the very USP requirements implemented to ensure CSP sterility and integrity have driven most pharmacists out of the pharmacy clean room, where they either remotely review the work of pharmacy technicians or they check the technician’s work after the fact by looking at the empty vials and syringes used to prepare a given CSP. The implementation of this regulation definitely has “unintended consequences”.

    An example of how this can go wrong occurred approximately 14 months ago (December 2014) in Bend, Oregon, where a patient received an IV that was supposed to contain the anti-convulsant, fosphenytoin, but instead contained a lethal dose of the neuromuscular-blocking agent, rocuronium. All because a simple human slip error in the pharmacy, by both a pharmacy technician and a pharmacist, missed the fact that the wrong vial of drug was used to prepare the patient’s IV admixture. Simple barcode scanning of the ingredients at the time of CSP preparation could have prevented this from occurring. The hospital’s gift shop probably used barcoding in their point-of-sale technology, but NOT the hospital pharmacy. Worse yet is that the nurse who scanned the barcode on that patient’s IV admixture supposedly containing fosphenytoin had no clue that this IV bag contained the wrong drug. Imagine what the nurse thought when the patient went into cardiac arrest a few minutes after starting the IV infusion.

    This case demonstrates the leap of faith nurses take when they hang a pharmacy-prepared IV admixture (CSP) that has been prepared in a pharmacy IV room where some form of IV Workflow Automation system using barcode scanning is NOT being used for the preparation of ALL IV admixtures. Even if pharmacists prepared IV admixtures, which they rarely do anymore, they would still be a risk of making a slip-type of medication error. Why, because they are human and humans make slip errors. The same is true for pharmacy technicians.

    If I were a nurse, and especially if I was in a nursing leadership position, I would want to know if the pharmacy was using any type of IV Workflow Automation to prevent the occurrence of human slip medication errors in the pharmacy IV preparation room. In the old days, when nurses did more medication preparation, the rule was “if you didn’t make it, you can’t administer it”. Nursing trusts pharmacy because they trust pharmacists, but pharmacists don’t make IVs. Therefore, the new nursing rule should be “if pharmacy didn’t scan it (during preparation), we won’t hang it!”

    When I have asked pharmacy directors about why they are NOT using any type of IV Workflow Automation systems (minimally barcode scanning), I have received answers ranging from “we are investigating it” to “we really don’t have a problem”. The first case (i.e., “investigating it”) is confirmed by a recent survey in AJHP found that more than 60% of pharmacies have NO PLANS to implement IV Workflow Automation within the next four years! In the latter case (i.e., “don’t have a problem”), I guess they are not using any humans in their IV preparation room; no robotic automation either! Additionally, one pharmacy system director in a senior national position told me, “Our IT plate is full for the next year or so”. I sure hope that whatever IT project they are working on is more important than preventing deadly, human slip errors originating in their pharmacy IV room. I also hope that their nursing administrator and hospital administrator have signed off on the low priority given for the use of IV medication safety technology.

    Fortunately, there are a couple of GOOD things happening on the “regulatory front” when it comes to IV preparation medication safety.

    (1) The ASHP House of Delegates is considering a policy statement that attempts to address the issue. Unfortunately, in my opinion, the statement that is currently being considered lacks actionable direction (see my ASHP Connect post of February 3rd, 2016 for more details).

    (2) More importantly, the ISMP has recently released a new list of “Best Practices” (http://bit.ly/1O9HhYv). Number 11 on that list effectively addresses this issue. See below:

    When compounding sterile preparations, perform an independent verification to ensure that the proper ingredients (medications and diluents) are added, including confirmation of the proper amount (volume) of each ingredient prior to its addition to the final container. This best practice also go on to state:  Use technology to assist in the verification process (e.g., barcode scanning verification of ingredients, gravimetric verification, robotics, IV workflow software) to augment the manual processes. 

    I wish I could make this and other ISMP Best Practices a basic hospital pharmacy requirement. Maybe ASHP and/or USP will embrace the language used within the ISMP best practice to further communicate the need to address this serious medication safety issue.

  2. Pingback: Placing equipment in the primary engineering controls (PECs) | Jerry Fahrni

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