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)

If you don’t know Eric, you should. He’s well known in the industry for his knowledge and expertise in all things related to sterile compounding. I consider Eric the foremost authority in this area, if not in the world, certainly in the U.S. I enjoy speaking with Eric and have always come away smarter and better informed from our discussion. So whenever I see an article or presentation from Eric, I do my best to set aside some time to walk through the material.

In the presentation Eric included several slides giving examples of “compounding incidents” since 1990. According to Eric, there have been “over 25 pharmacy compounding incidents with 1,049 adverse events, including 89 deaths” reported since 2001. That’s a striking number, although one has to wonder what the total number of CSPs administered to patients were during the same time period. Millions? Hundreds of millions? A billion? I’ve never seen those numbers so I can’t really say. Rest assured, it’s a lot.

As I studied the slides something jumped out at me: of the 28 examples of “compounding incidents” provided, only six occurred in acute care pharmacies, i.e. hospital pharmacies. The rest were divided among community pharmacy, outsourced compounders, homecare, and “compounding pharmacy”. Of the six examples given for hospital pharmacy only three were the result of contamination of a sterile preparation. The other three were the result of a compounding mistake: 1,000-fold zinc overdose in 2005, use of hypertonic saline in place of normal saline in 2006, and a compounding error that resulted in a patient received a serious overdose of sodium chloride in 2010.

I do not assume that these are all the sterile compounding incidents that have occurred in hospital pharmacies over the years, but they are definitely the high profile cases. I remember the zinc overdose in 2005 and the hypertonic saline incident in 2006. Both were tragic.

Given all the interest in “improving sterile compounding” in hospital pharmacies over the past several years, don’t you find it interesting that we’ve put so much time, effort, energy, and money into regulating the sterility of sterile compounding and not in ensuring accuracy? Based on the data alone it would seem that pharmacies would be rushing to improve accuracy. I’m not saying that one should ignore aspects of compounding that ensure sterility, I’m simply stating that patient’s might be better served if we spend some time developing and implementing more automation and technology in the i.v. room to prevent compounding errors.

As things sit now, hospitalized patients benefit least from hospital pharmacies putting all their eggs in one basket. Something to think about.

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(1) The symposium content is great. I highly recommend it. Definitely worth 90 minutes of your time.
(2) Kastango, Eric. ‘How Did You Get Here? Review Of The Compounding Legislation And The Previous Contamination Incidents That Have Occurred Over The Last 25 Years’. 2014. Presentation at Midday Symposium at the 49th ASHP Midyear Clinical Meeting and Exhibition.

One thought on “What practice area benefits most from increased sterile compounding regulation?”

  1. 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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