PPN Insourcing IV Sterile Compounding 6_2014

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ISSUE: JUNE 2014 | VOLUME: 41

Technology

Insourcing IV Sterile Compoundingby Steve Frandzel

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 Convention’s (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 didn’t just read about it,” Ms. Lee said. “Something had to change.”

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Lorraine Lee, MHA, BS Pharm

The hospital’s multiphase transition to insourcing—still a work in progress—began with cutting off the pharmacy responsible for the contaminated drugs. Producing enough CSPs internally then required a 260% increase in staff hours and far greater use of existing infrastructure.

“The bulk of the CSP deficiencies were counteracted without the acquisition of additional equipment,” Ms. Lee said. Other adjustments included re-evaluating the use of previously outsourced CSPs. For example, tightening use restrictions for magnesium sulfate, as recommended by a group of physicians at the hospital, reduced demand for the drug by 30%. Help also came from nursing, which increased its use of closed systems that allow nurses to reconstitute IV drugs in patient care areas safely. Ideally, the second phase will be to divest all third-party CSPs, including total parenteral nutrition (TPN) products. The hospital is considering construction of a new 5,000- to 8,000-square-foot cleanroom at a cost upward of $1 million. Phase 3 would be construction of a centralized compounding service to supply all three of the system’s hospitals.

Ms. Lee noted that insourcing changes the equation for beyond-use dating (BUD). One attraction of outsourcing has been that compounding pharmacies offered extended BUD for the drugs they ship to the hospital, which potentially reduces wasted doses and allows hospitals to stock up on high-volume admixtures. But Ms. Lee became skeptical after her experience with contaminated products. “They tell you they can provide CSPs that have extended beyond-use dates [without compromising stability or sterility of the products] and they have the studies to back that up, but do they really? That’s a big red flag to me now,” she said.

Hospitals that decide to do a higher percentage of sterile compounding in-house must be ready to commit to the added time, training and testing necessary to comply with USP standards for BUD, Ms. Lee stressed. “Operationally, it’s hard to manage and comes at a high cost, and that’s why hospital pharmacies typically don’t put beyond-use dates on the drugs they make,” she noted.

Mass General Pivots Quickly

Massachusetts General Hospital (MGH), in Boston, decided to fast-track CSP insourcing after the FDA shut down Ameridose (a sister company of NECC) for multiple manufacturing violations in fall 2012. The company, which delivered about 68,000 doses to MGH monthly, had been the hospital’s primary CSP supplier, according to Erasmo A. Mitrano, RPh, MS, MGH’s associate chief of pharmacy. “We needed very quickly to change gears to take care of patients,” he said.

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Erasmo A. Mitrano, RPh, MS

Bill Churchill, MS, RPh

In the year before the Ameridose closing, the hospital produced about 200,000 CSPs. The following year, insourced production reached 320,000—a 150% increase, according to Nathan Van Allen, PharmD, the pharmacy compounding manager. The hefty increase was made possible through increased staffing (including pharmacy students, overtime and outside agency help) and around-the-clock operation of compounding facilities. “We’re 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.

“We’re still in the middle of this; it hasn’t 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 for—and during—surgery. “That type of help had an enormous impact and took a lot of weight off our shoulders,” Mr. Mitrano said.

Making such a titanic transition—either under the gun or more deliberately—requires 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 can’t 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. “We’ll 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 Women’s 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 hospital’s new direction), so were financial implications. The hospital projected, and realized, major savings (estimated at $1.5 million; sidebar) over the past few years, which it attributes to the strategic shift. “Bringing

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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 hospital—up 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. “It’s 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

Mass General’s Growing Menu Of Sterile Compounding Technology

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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.

At Brigham and Women’s, A Suite Of Robots Lends a Helping Hand

The Pharmacy Department at Brigham and Women’s uses a variety of robotic technologies to assist in its transition toward bringing sterile compounding in-house. Bill Churchill, MS, RPh, the hospital’s chief of pharmacy services, said the technologies have significantly boosted workplace efficiency and patient safety—and saved scarce health care dollars in the process.

Until the latter part of 2013, three primary robotics systems were in use at Brigham and Women’s, Mr. Churchill noted: Health Robotics’ i.v. Station, which is used to compound batch-prepared drugs, as well as patient-specific IV bags and syringes; an Intellifill syringe robot, from Baxter, that prepares bulk batches of ready-to-use syringes (primarily for anesthesia and nursing staff); and Health Robotics’ CytoCare robot for preparing chemotherapy products.

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Bill Churchill observes the IntelliFill robot sort syringes.

Since that time, “in our efforts to continually evaluate our technology, BWH has moved toward standardizing our robotic technology,” Mr. Churchill said. As a result, “we’ve moved away from the Intellifill and the CytoCare units, by bringing in two additional i.v. Station robots, and we are awaiting delivery of an i.v. Station Onco robot that will replace the CytoCare [unit].”

He added that BWH also is using Aesynt’s i.v. Soft Assist system to streamline workflow related to manual compounding. “This basically helps us to supplement robotic production with manual processes as efficiently as possible,” Mr. Churchill explained.

The gain in volume and efficiency that occurred as a result of these technologies has been significant, Mr. Churchill noted. The systems can aid in the preparation of more than 400,000 doses annually, all of which were previously done off-site and shipped to the hospital at significantly higher costs, he noted. Moreover, the robots have contributed to approximately $1.5 million in savings, Mr. Churchill said. The cost savings, he noted, were largely a result of shifting from higher-cost outsourced products to less expensively prepared products made at the hospital. “The calculation was a straightforward business analysis that was performed to get approval for the robotic devices, and then revalidated to prove ROI [return on investment] savings,” he said.

Mr. Churchill stressed, however, that the importance of cost savings pales in comparison to the safety gains that occur as a result of increased automation. “IV medications that are prepared by humans are approximate—USP standards allow a range of plus or minus 10% of what the label amount says, but there can be much greater range of variability in the accuracy of preparation.” He added that the robots measure these medications not only by volume, but also by specific gravity, with an accuracy of plus or minus 5%.

“That higher level of accuracy makes a difference for many patient populations, including elderly [patients], patients with renal or liver disease, as well as neonates and pediatric patients, to name a few.”

—Steve Frandzel, David Bronstein

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More on the Web

To read an expert’s take on the pros and cons of insourcing, “To Insource or Outsource? That Is the Question!”, visit http://bit.ly/ 1lnKIiD.

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PPN Insourcing IV Sterile Compounding 6_2014

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