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Even information about which laminar hood was used is reviewed, including when it was cleaned, certified, and tested, and those test results.
Inspectors need to be savvy to know how to interpret a compounding organization's information. "We have seen cases in the past where pharmacies we've inspected did not show us the real data," Churchill says. "Getting the truth is something you have to really insist on."
Another area to be aware of is to make sure that a compounding company has not made the FDA's so-called 483 list indicating the agency had an issue with the company during a recent inspection.
"We routinely check the FDA 483 list to see if any of our pharmacies are on it, and one of them was recently. We contacted them right away, and said, 'We need to know why you were cited and what you're doing about it, and how the case was resolved.' "
This is not the optimal way to ensure safety and quality, however, Churchill acknowledges. What is needed, he and others say, is a "national, unbiased" organization that would operate like The Joint Commission, specifically reviewing standards, inspecting and certifying compounding pharmacies in every state for hospital and other health provider use.
No such appropriate organization has come forward to fill that role as yet, Churchill says.
The hospital's executives say it's important to give Churchill's division as much support as it needs.
Angela W. Yaniv, PharmD, assistant director of pharmacy for sterile products for the 1,300-licensed-bed Cleveland Clinic, agrees the issue of compounding pharmacy safety presents "a very scary situation," but say it's one that hasn't affected the clinic because it outsources products rarely.
"But you need to be aware of who you're purchasing from and do your research, and not accept whatever marketing materials are offered. I've seen some that look very professional and claim the organization is compliant with USP 797—but you have to dig deeper to really know if that's the case."
Yaniv recommends that hospitals that must rely on outsourced compounding pharmacies might use a tool provided free by the American Society of Health-System Pharmacists Foundation, which ASHPF officials say has been downloaded more than 1,000 times since September 2012. The tool includes nearly 100 questions that a provider using products might reasonably be expected to find out.
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