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

Comments

2 responses to “Will the revised USP Chapter 797 include recommendations for automation and technology?”

1. February 4, 2016

   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. February 11, 2016

   Placing equipment in the primary engineering controls (PECs) | Jerry Fahrni

   […] 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. […]

This site uses Akismet to reduce spam. Learn how your comment data is processed.