Tuesday, October 1, 2013

Who Is Taking the Compounding Crisis Seriously?

Tom Van Hassel, RPh, the pharmacy director at Yuma Regional Medical Center, in Yuma, Ariz., is no stranger to the crisis of confidence in compounding triggered by the NECC debacle. For the past several months, he has been working in his capacity as the president of the Arizona State Board of Pharmacy to draft new guidelines intended to make the practice safer for patients and hospitals.
Given the intensive level of activity those efforts require, does Mr. Van Hassel take issue with Mr. Kastango’s claim that there is a lack of urgency among some elements in pharmacy to fix what’s broken in the admixture arena?

“I actually agree with Eric on this—there does need to be a lot more effort than I am seeing, at least in health systems,” he told Pharmacy Practice News. “And remember, there’s no one right solution: some facilities will decide to bring compounding in-house to boost safety, which is fine—if they do it right and can guarantee USP [Chapter] <797> compliance. Other facilities will decide to continue to outsource, which is also OK—but again, only if they do it correctly, by thoroughly vetting vendors to ensure the companies take good manufacturing practices and patient safety seriously.
“The problem is I don’t see a groundswell of hospitals stepping up and implementing these important quality improvement strategies.”

Help may be at hand from recent actions taken by the National Association of Boards of Pharmacy (NABP), which recently decided that USP Chapter <797> has to be the common nationwide source for guidance on compounding policies and procedures. Mr. Van Hassel said he has been working with his own state chapter to make that happen, even though it’s something of a departure from previous policy. “We used to pick and choose the parts of <797> that we thought would work for hospitals in our state,” he said. “Frankly, we did that because we felt <797> and the related USP materials on beyond-use-dating and other safety issues were way too complicated to follow. But after the NABP meeting, we saw that kind of cherry-picking may have led to some confusion and an uneven playing field among the states in terms of safe compounding expertise and compliance. So we are working hard to redraft our guidelines and get everyone on the same page.”

Mr. Van Hassel said he hopes the current pharmacy compounding bill doesn’t work at cross purposes to the proactive steps boards of pharmacy are taking to boost compounding safety. If the Senate version of the bill gets passed, he noted, the section that excludes health systems from some of its provisions could impede action. “Some hospitals may be looking at that exclusion and feeling as though they will get a pass,” he said. “Well, even if the Senate version does get signed into law, nobody gets a pass from USP Chapter <797> when it comes to in-house compounding. And we all need to handle outsourcing of compounding in a responsible fashion. That’s an important safety message that can’t be lost.”

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