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Hospitals Address Compounding Concerns

Cheryl Clark, for HealthLeaders Media, November 11, 2013

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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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?