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Hospitals Address Compounding Concerns

Cheryl Clark, for HealthLeaders Media, November 11, 2013

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."

Reprint HLR1013-8


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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2 comments on "Hospitals Address Compounding Concerns"


John Barton (1/21/2014 at 4:33 PM)
Compounding pharmaceutical activities are coming under rapidly accelerating scrutiny from the FDA and USP797 due to the unfortunate fungal meningitis out break at The New England Compounding Pharmacy and others such as Francks Compounding Pharmacy in Ocala, Fla., that also experienced a serious fungal outbreak.Direct regulation of the industry is inexorable and inevitable. Forward thinking, innovative companies are strategically planning for this scenario by implementing comprehensive decontamination protocols to preempt outbreaks at their facilities. Studies have shown that even the best terminal manual cleaning protocols only achieve a 40-60% reduction in residual bioburden. Many companies are turning to hydrogen peroxide fogging systems such as the Sanosil Halo Fogging System. Med Effect, Inc. offers the Sanosil Halo Hydrogen Peroxide Fogging System, which can be used for room/area or equipment decontamination. The Sanosil Halo Hydrogen Peroxide Fogging System is lightweight, portable, colorless, odorless, quiet, eco friendly, effective, and economical.The Halo Fogging System assures a homogeneous mist of ionized particles that migrates to areas that regular cleaning can't or don't reach, to include high touch areas around doors, behind window treatments , and even under desks and beds. The Halo Fogging System will kill 99.99 % of bacteria, viruses, and fungi on pre-cleaned surfaces, without harming sensitive electronics, surfaces or substrates. The Sanosil Halo Fogging System is EPA Registered, No. 84526-1. For additional information, please refer to our website at http://www.medeffect360.com and our industrial video at http://www.youtube.com/medeffect .

Dr. Brent S. Stogdill PharmD, BS, RPh (11/12/2013 at 11:50 AM)
I will never disagree that patient safety is paramount and I commend the institutions in this article for their efforts to achieve just that. Based on this article though, are your efforts and money being used wisely? Consider the following: First, lets address the elephant in the room. This article and so many like it sensationalize the deaths and illnesses from the fungal infections in the context that the New England pharmacy was COMPOUNDING the medication. This is dragging our whole healthcare system through the mud. It is FACT that the New England pharmacy was engaged in illegal MANUFACTURING not compounding. They were breaking rules and the board of pharmacy in that state and the FDA knew it or should have known it. Neither entity (BOP or FDA) needed more authority, they were just negligent in performing procedures they already had authority and obligation to do. Drag the BOP and the FDA through the mud not legitimate, law abiding compounding pharmacies (my profession). Second, lets address this article's statistics. It states that since 2001 (12 years) there have been 77 deaths linked to compounding pharmacies, and it says 60 of those deaths are from the New England pharmacy incident. That leaves 17 deaths caused by compounding pharmacies in the last 12 years. Now, how many of those deaths can be linked to compounding pharmacies that were engaged in similar or the same practices as the New England pharmacy? And, just for fun, lets also determine, in those same cases, whether the BOP and FDA did or did not properly inspect and follow through with procedures that they already have the authority and obligation to do? I am certain that will leave us with a number of deaths less than 17 in the last 12 years attributed to legitimately run compounding pharmacies. Now, compare that number to the number of hospital deaths caused by medication errors in that same 12 year period. Which issue needs the healthcare system to spend more time and money on? If the healthcare system does not already know the answer to that question I have pity on the whole system. This countries healthcare system desperately needs some good, old-fashioned common sense, politically and professionally?