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Hospitals Address Compounding Concerns

Cheryl Clark, for HealthLeaders Media, November 11, 2013

In the wake of incidents in which compounding pharmacies have released contaminated products, hospital leaders are developing strategies and protocols to ensure patient safety.

This article appears in the October issue of HealthLeaders magazine.

It's a safe bet the fungal outbreak affecting patients who received contaminated steroid products prepared by the New England Compounding Center last fall has placed hospital leaders on a nervous edge, regardless of whether they were ever among that pharmacy's customers.

Though alarming for its size and scope—the outbreak led to the deaths of at least five dozen patients and sickened about 700 more in 20 states—it was not the first, or the last, such incident to cause harm on a large scale.

Some 20 serious errors involving preparation of products from compounding pharmacies since 2001 have resulted in 982 patients becoming ill, including at least 77 deaths in at least 32 states, according to a spring report from the Pharmacy Sterile Compounding Summit organized by the Pew Charitable Trusts and the American Hospital Association.

The harm caused blindness or vision loss, bloodstream infections, meningitis, and even strokes from drugs used for chemotherapy, parenteral nutrition, IV flushes, eye and spinal injections, and IV sedative solutions.

While state and federal legislators and regulators are looking at the issue and considering changes, leading healthcare providers are not waiting around.

"Until that time comes, we in hospital pharmacies have to do our own diligence to determine if the partners that we're using or want to use to provide outsourced products for our patients are going to meet our needs," says Bill Churchill, chief of pharmacy services at 747-bed Brigham & Women's Hospital in Boston.

"Every hospital that has the capability needs to drive its own bus on this. You need to take the bull by the horns."

Partly out of recognition that purchasing drugs from outside compounding pharmacies poses an avoidable risk, the 1,409-bed Scripps Health system in San Diego took steps two years ago to launch its own $3.5 million facility to serve as a centralized compounding pharmacy for its five hospitals, unifying smaller operations at each facility.

The move was facilitated by state legislation that set up a special pharmacy category under state licensing purview a year ago, and Scripps officials hoped to become one of the first health systems in the state to take advantage of the new law.

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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?