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Compounding Concerns

Cheryl Clark, for HealthLeaders Media, October 14, 2013
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For example, one of the questions in the ASHPF tool asks whether the pharmacy has "disclosed any disciplinary or punitive action by any regulatory agency, [e.g., FDA, state board of pharmacy] within the past 36 months."

She also suggests that through their group purchasing organizations, smaller hospitals might "find resources to periodically inspect outsourcing vendors that they're using."

J. Eric Morgan, PharmD, pharmacy director of 85-licensed-bed Prattville (Ala.) Baptist Hospital, echoes those concerns. And while his hospital uses a large compounding pharmacy company that so far has not had quality problems, he worries what might happen down the road when and if new regulations take effect, imposing requirements that curtail his ability to outsource drugs.

He says it's fine for larger hospitals to bring their compounding operations in-house, or even create their own elaborate pharmacy inspection system. But his is a much smaller organization.

"I have pharmacists here eight hours a day, but there are 16 hours a day that I physically do not have a pharmacist in the building," he says. Two sister hospitals 10 miles away in Montgomery have 24-hour pharmacies and manage orders remotely.

But that doesn't help him when he needs a compounded drug right away.

"I firmly believe that something needs to be done to clarify regulatory oversight, but it needs to be mindful of the fact that compounding pharmacies are a tremendous resource that small community hospitals badly need."

In the meantime, hospital leaders and pharmacy chiefs continue the struggle to ensure purity, dosage, and safety of these important drugs.

"In my 39-year career, this was the single most difficult situation that I've ever faced," says Churchill. "It was the one that caused me the greatest concern, the one that occupied the vast majority of my time. There were days upon days that went by where I didn't do anything but work on the
IV compounding situation and we're still doing things to refine our processes, do things better, bring in more robots, and change practices in a continual way.

"It isn't something where you take 10 minutes, fix it. This will linger until things sort out at the state and national level on who will have direct oversight."

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This article appears in the October issue of HealthLeaders magazine.


Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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