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)
Continue reading What practice area benefits most from increased sterile compounding regulation?

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.


Continue reading Do patients in the U.S. really own their healthcare data?

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
Continue reading Saturday morning coffee [April 11 2015]

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.