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ISSUE: JUNE 2014 | VOLUME: 41
Determined to cement access to reliable and safe sources for crucial IV drug admixtures, a
growing number of hospitals are bringing production of compounded sterile products (CSPs)
in-house and turning their backs on external compounding pharmacies. Such far-reaching
decisions reflect the lingering distrust of outsourced CSPs, according to several
administrators from hospitals that have made this move.
People were really pulled up short by the events related to the New England Compounding
Center [NECC], said Eric Kastango, MBA, RPh, FASHP, the president and CEO of Clinical
IQ and formerly a member of the United States Pharmacopeial Conventions (USP)
Compounding Expert Committee. Warnings issued by the FDA to other compounding
pharmacies have brought to light a lot of the ugly stuff that was going on.
That ugly stuff included a wide range of manufacturing and quality control issues that
resulted in a nationwide outbreak of severe meningitis cases caused by tainted steroid
injections. To date, about 750 people have developed the infections; 64 have died, according
to federal health officials.
As a result of this massive breakdown in drug safety, Mr. Kastango noted, hospitals are
looking for strategies to become self-sufficient and vertically integrated, and to decrease
reliance on these vendors.
A Wake-Up Call To Gain More Control
For some hospitals the decision was, by necessity, sudden. In March 2013, Yale-New Haven
Hospital, in Connecticut, received contaminated magnesium sulfate from a compounding
pharmacy. No patients were harmed, but the incident was a wake-up call, according to
Lorraine Lee, MHA, BS Pharm, the director of pharmacy. It was much too real because it
happened here, we didnt just read about it, Ms. Lee said. Something had to change.
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Lorraine Lee,
MHA, BS Pharm
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In the year before the Ameridose closing, the hospital produced about
200,000 CSPs. The following year, insourced production reached
320,000a 150% increase, according to Nathan Van Allen, PharmD, the
Erasmo A.
Mitrano, RPh, MS
pharmacy compounding manager. The hefty increase was made possible through increased
staffing (including pharmacy students, overtime and outside agency help) and around-theclock operation of compounding facilities. Were still using an additional 10 to 12 full time
equivalent staff positions than we were before, Dr. Van Allen said, noting that the added
stress on the pharmacy staff has meant increased sensitivity to burnout and health
problems.
Were still in the middle of this; it hasnt eased up, added Mr. Mitrano.
Just as at Yale-New Haven Hospital, the pharmacy leadership at MGH reached out to other
services, particularly nursing and anesthesia, to help fill the vast shortfall. Systems such as
Mini-Bag Plus (Baxter) allowed drugs to be reconstituted safely by nurses outside of a
cleanroom. Anesthesia providers, who had been receiving 13,000 syringes monthly from
Ameridose, began drawing up their own syringes in preparation forand duringsurgery.
That type of help had an enormous impact and took a lot of weight off our shoulders, Mr.
Mitrano said.
Making such a titanic transitioneither under the gun or more deliberatelyrequires
tremendous support from hospital administration, Mr. Mitrano stressed. You must have their
total commitment that this is the way the institution wants to go; it cant be a partial effort, he
said.
To keep up the momentum, the pharmacy is undergoing a build-out of its current facility and
has acquired additional IV workstations and robotics, Mr. Mitrano noted. He predicted that
automated production eventually will account for 75% of CSP preparation. Well essentially
have our own compounding facility within the hospital. Self-sufficiency is getting closer,
added Dr. Van Allen. The hospital now produces about 90% of its CSPs; for now, it will
continue to outsource TPN products.
BWH a Fan of Re-Insourcing
At Brigham and Womens Hospital (BWH) in Boston, CSP supply lines were
disrupted to a lesser extent than at other facilities during the IV compounding
crisis, because the hospital had already begun the process of ramping up
internal compounding of IV sterile products, according to Bill Churchill, MS,
RPh, the chief of pharmacy services. Although quality and safety were major
driving forces for re-insourcing (the term Mr. Churchill prefers for describing
the hospitals new direction), so were financial implications. The hospital
projected, and realized, major savings (estimated at $1.5 million; sidebar)
Bill Churchill,
over the past few years, which it attributes to the strategic shift. Bringing
MS, RPh
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production inside and having control of our own environment with our own staff was a much
better way for us to go, Mr. Churchill said.
The hospital also hired a microbiologist to work in the pharmacy department to coordinate all
IV compounding quality assessment, including end-product testing, staff testing and facility
testing, and to assure compliance with USP Chapter <797> standards. All CSP batches are
tested and quarantined until they are confirmed sterile and stable.
Only after they pass muster with my microbiologist do they move into circulation for
patients, Mr. Churchill explained. BWH also invested in upgrading on-site cleanroom
facilities. Once a new negative-pressure cleanroom is completed, the existing main
cleanroom will be upgraded and renovated to further increase capacity. BWH also has
purchased four IV compounding robots. A fifth one, dedicated to oncology, is expected in
June.
New workflow patterns and staff responsibilities also emerged. The changes were heavily
influenced by lean process redesign, a method for streamlining processes or systems by
eliminating as much waste and unnecessary work as possible. Some pharmacy technicians,
for example, have become automation experts, expanding their skill sets well beyond more
traditional tasks, like drawing up syringes in a laminar flow hood. Additionally, the BWH
pharmacy used to produce CSPs in batches to cover the following 18 hours of use, but that
was not efficient. Drug regimens change, orders get discontinued, doses get changed. A lot
of the labor and materials expended for long batch runs were being wasted, Mr. Churchill
said. Now, the restructured workflow, supported by newer technology and greater staff
expertise, allows batches to be produced every four hours. That was a huge step forward
for us.
Centralized Compounding?
The pharmacy now produces about 70% of the CSPs used at the hospitalup from about
40% two years ago. Going forward, Partners HealthCare, the umbrella system for both BWH
and MGH, is contemplating the feasibility of a centralized compounding facility to supply all
13 of its hospitals. In the interim, the steps taken have been challenging and progress
gradual. Its an ongoing process where you take things in bite sizes that you feel
comfortable with, Mr. Churchill said. To make the change, operationalize that change, go
back and re-evaluate it, then continue to evolve your process with the next change until you
finally get it where you want it, takes time and patience. The process simply cannot be
rushed.
Steve Frandzel
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Nathan Van Allen, PharmD, the pharmacy compounding manager at Massachusetts General
Hospital, in Boston, offered additional details on the type of sterile compounding technologies in play
at the facility. The systems are ones we have either added to our operation, are in the midst of
adding or investigating for the future, he noted:
i.v. Station (Health Robotics). These will be used for automated mixing and packaging either
by mixing each individual dose separately or repackaging a premixed solution in a repeatable
and controlled environment, Dr. Van Allen said.
i.v. Soft (Health Robotics). This technology can be used for documenting and verifying the
contents of compounded solutions.
Barcode scanning and point-of-service software. These programs allow for checking of
ingredients before preparation and stepwise checks throughout the compounding process.
Mini-Bag Plus (Baxter). Proprietary system allowing for powdered vial to be attached to diluent
bag on patient floor.
DoseEdge (Baxter). Dr. Van Allen and his colleagues are investigating this for documentation
and verification of solutions.
Biological Safety Cabinets (Baker Co.). Preparation of sterile solutions for packaging, syringes
for robotics automation, specialty preparations, etc.
Baxa Repeater Pump. Semi-automated syringe filler.
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