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.

(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.

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