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Hospitals Address Compounding Concerns

Cheryl Clark, for HealthLeaders Media, November 11, 2013

The hospital couldn't afford "to install robotic pharmacy systems with the required state-of-the-art information and safety systems at each of our decentralized pharmacies. But by creating a centralized pharmacy, we could purchase and install those systems. In addition, we gained economy of scale and lower costs that create more value for the patient, and we can have better quality assurance and safety systems for the patient," he says.

Not all hospitals, however, have the capability of building their own central pharmacies to compound drugs for their patients.

But Brigham & Women's is doing the next best thing, says Churchill. Its team aggressively requests a lot of data and documentation, and then physically inspects the compounding pharmacy premises before signing the contract to purchase products, as well as in every year of the contract.

After the NECC outbreak, Brigham & Women's brought some operations in house. But it couldn't do that for everything it needed. It had to find another pharmacy to compound intrathecal pain pumps, for example, and it inspected three facilities, ultimately selecting one to replace NECC.

Brigham & Women's had hired or contracted with compounding pharmacy experts in quality management, microbiology, and pharmacy practice, and those conversant with the technicalities of U.S. Pharmacopeial Convention 797 safety and sterility standards. And it has also developed its own audit and inspection tool.

"We look for the facility's licenses, names of people who run the facility and their licenses, the pharmacists and their licenses," Churchill says. There are assessments of whether the facility has a separate negative pressure clean room, "so you don't get hazardous or toxic chemicals blowing around and contaminating another patient's drugs."

And there are inquiries about staff training and competency assessments as well as reviews of records, policy and procedure documents, and documents showing that the facility regularly tests for contamination in a variety of important preparation areas.

The process includes what Churchill calls a "system tracer."

"We ask them about a product we bought from them, the dates it was purchased, and we ask them to pull every record that was associated with that," including all testing and certification records, a list of all employees involved and their credentials, and continuing education requirements in the state they're licensed, Churchill says. "We want to see test results for fingertip touch testing and media growth testing. We want to see everything that employees have done to ensure that employees who worked on the product were competent to do so."

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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?