More thoughts on USP <797> and pharmacy IV rooms [comment from reader]

By | April 27, 2015

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.

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