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providers do for their privileging,” Maroyka said. For example, he said, one pharmacist in a patient-centered medical home setting specializes in diabetes care and is able to prescribe medications, monitor patients, and educate them about their drug therapy. “She handles newly diagnosed diabetics and type 2 diabetics without complications,” Maroyka said. “If it’s more complex, like they need to be set up on [an insulin] pump or some other advanced regimen, then they would see the endocrinologist.” Maroyka said credentials for supplemental privileges may include PGY2 residency training or the completion of a fellowship or other recognized educational activity. For one pharmacist, he said, completion of the ASHP Research and Education Foundation’s three-part traineeship program in pain management and palliative care supported the attainment of advanced privileges to treat patients in need of such services. The Council on Credentialing in Pharmacy, a coalition consisting of ASHP and nine other national pharmacy organizations, recognizes several groups that may credential or certify pharmacists in advanced practice areas. These include the Board of Pharmacy Specialties, the National Asthma Educator Certification Board, the American Heart Association, the National Certification Board for Diabetes Educators, the Commission for Certification in Geriatric Pharmacy, the American Academy of HIV Medicine, and the American Board of Applied Toxicology. Resources that describe credentialing opportunities and related documentation are available at the council’s website, www.pharmacycredentialing.org. William Greene, chief pharmaceutical officer at St. Jude Children’s Research Hospital in Memphis, Tennessee, said 11 clinical pharmacists have been granted advanced privi- William Greene leges by the St. Jude governing board.

“These individuals have the authority to order and monitor laboratory tests and other items related to medication therapy and to adjust medication therapy [for] a broad number of medications,” Greene said. He said most pharmacists practicing at this level have completed a PGY2 residency program and are board certified in oncology pharmacy. But he said the system includes enough flexibility to allow some highly qualified, experienced pharmacists who lack those credentials to perform advanced functions. Greene said the decision to privilege pharmacists through the medical staffing process grew out of his concern that an auditor could potentially decide that clinical pharmacists were providing medication therapy services without a valid medication order. The problem, he said, is that although Tennessee’s pharmacy practice act allows pharmacists and physicians to establish patient care relationships, the act doesn’t define collaborative drug therapy management. Greene said that the hospital’s medical executive committee determined

that clinical pharmacists are functioning as “midlevel practitioners” and should be credentialed and privileged as such. He noted that the determination coincided with the Centers for Medicare and Medicaid Services 2012 revision of its conditions of participation that allowed pharmacists to be considered part of a hospital’s medical staff. “It was perfect timing,” Greene said. ASHP’s Council on Education and Workforce Development recently recommended that the Society support the use of postlicensure credentialing, privileging, and competency assessment to establish qualifications for providing direct care to patients. The council agreed that credentialing programs should meet guiding principles established by the Council on Credentialing in Pharmacy. ASHP’s House of Delegates, when it meets this summer, will consider these positions for adoption as an official ASHP policy. —Kate Traynor DOI 10.2146/news140031

Specialty pharmacy presents opportunities for hospitals, health systems

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s the nation’s spend on specialty medications continues to grow, hospitals and health systems are pursuing the patient care and revenue opportunities that come from integrating a specialty pharmacy. Kevin Colgan, corporate director of pharmacy for Rush University Medical Center in Chicago, gives partial credit to accountable care organizations. Kevin Colgan

“It’s not only the big financial opportunity,” he said of specialty pharmacy’s appeal to hospitals and health systems. A health care organization that operates a specialty pharmacy, Colgan explained, can collect robust data and determine which of the expensive medications work best. “That would be a game-changer for an accountable care organization,” he predicted.

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Commercial insurers spent 18.4% more on specialty medications in 2012 than in 2011 and 1.5% less on traditional medications, according to the Express Scripts Drug Trend Report update for October 2013. Medicare’s spend on specialty medications increased by 24.1% during that time. Prognosticators at the pharmacy benefit management company expect specialty medications to represent half of commercial insurers’ and Medicare Part D plan sponsors’ expenditures for pharmaceuticals by the end of this decade. Scott Knoer said he started proposing a specialty pharmacy for the Cleveland Clinic immediately after arriving as the chief pharmacy officer in 2011. With a decade of experiScott Knoer ence at Fairview Health Services, which has operated its specialty pharmacy since 1992, initially serving only transplant patients, Knoer said he knew well the opportunity for revenue. “It took three years to get the capital approved, but I got $6.5 million for a 20,000-square-foot specialty pharmacy facility,” he said. The “go-live” date for the facility is in August, Knoer said, noting that his design incorporates the existent mail-order pharmacy. A full build-out will occur in a couple years. At that time, he said, there will be 66 full-time equivalents dedicated to the specialty pharmacy. “I was able to convince my C-suite that this was a good investment,” Knoer said of Cleveland Clinic’s highest-level executives. “But every organization has different thresholds for ROIs. . . . I had to put together a business plan that demonstrated that the return on this [investment] was better” than that projected for the other multimillion-dollar projects under consideration. Rush’s specialty pharmacy started operating in mid-January just as a clinical pharmacist started working in the hepatology clinic, Colgan said. The next week, clinical pharmacists started working at the multiple sclerosis and neurology clinics, he said. In week 3, a

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clinical pharmacist started at the rheumatology clinic; in week 4, a clinical pharmacist started at the gastroenterology clinic. “In those first four weeks, we had 50 referrals for new starts,” Colgan said, referring to the clinical pharmacists and the groundwork they—rather than the clinics’ physicians and staff—laid for patients new to the prescribed medication. Rush’s specialty pharmacy, part of a 44-site pilot program for the University HealthSystem Consortium, filled the initial prescriptions for 28 of those 50 patients, Colgan reported at the end of February. Of the 22 other patients, 12 had prior-authorization paperwork under review at their insurance company. For the remaining 10 patients, he said, “we had to do warm transfers [of prescriptions] to a preferred pharmacy.” Breakeven for the specialty pharmacy was reached “in months, not years,” Colgan said. The University of Illinois Hospital and Health Sciences System started its specialty pharmacy in the 1990s to serve the growing number of patients who received transplants at the Chicago hospital, said JoAnn Stubbings, assistant director for specialty pharmacy services. Transplant pharmacy services for these patients consisted of managing their prescriptions every JoAnn Stubbings month and sending supplies by mail, Stubbings said. Additional experience at the oncology pharmacy, one of several outpatient pharmacies, put the department of ambulatory care pharmacy services in a good position to dispense specialty medications as drug therapy became more complex, she said. The oncology pharmacy provides onsite infusion services and dispenses take-home medications. When the medication assistance program became fully staffed in 2001, Stubbings said, “We had all of these elements to be able to grow our specialty pharmacy business.” Growth came after the department began capitalizing on opportunities in

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the health system’s gastroenterology, multiple sclerosis, and rheumatology clinics, she said. “You have to make this extra effort in the clinics to actually offer your services,” Stubbings said. “You offer your pharmacy as a choice to the patient” for filling the prescription. She pointed to the assignment of a clinical pharmacist to the gastroenterology clinic, which treats inflammatory bowel disease, as “kind of the beginning of our new specialty pharmacy business.” The department built a call center in 2012 and staffs it with a technician, two pharmacists, and several pharmacy students, she said. That staff, she explained, lays much of the groundwork for the specialty pharmacy to dispense medications efficiently and not get bogged down in handling clinical issues and other matters. Yet, not all the efforts by the clinical pharmacists and call center staff result in business for the health system’s specialty pharmacy, Stubbings said. The dispensing of specialty medications for pulmonary hypertension is an example. “We can’t fill [those prescriptions] because they’re restricted,” she said. “So we do all the workup—we do everything—and then we just turn it over to the specialty pharmacy” contracted by the drug company. Finding a way to pay for a pharmacist to help a patient when the revenue for handling the drug product goes to another pharmacy is, in Stubbings’ opinion, probably the biggest challenge there is in health system–based specialty pharmacy. St. Jude Children’s Research Hospital in Memphis just started the “planning stages” for its specialty pharmacy, Steve Pate, director of home infusion and specialty pharmacy services, said at the end of February. Pate said he came to the facility to develop its home infusion pharmacy Steve Pate first and then the specialty pharmacy after working for a home infusion company that had a specialty pharmacy branch.

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“We’ve been very purposeful in seeking out the skill mix” for the two pharmacies, he said. Some of the new staff members have a background in home infusion; others have a background in specialty pharmacy, particularly prior authorization and cold-chain management. As for conversations with third-party payers and the drug companies with a limited or restricted distribution model for specialty medications, Pate said St. Jude emphasizes its patients’ reliance on the facility for care. “There’s not another pharmacy out there, there’s not another clinical staff out there, that’s going to manage our patients any better than we do,” he said. To date, Pate said direct conversations with drug companies have been successful regarding a few medications that normally have restricted distribution. “We want to be able to dispense everything that our patients need so that we can fully manage their medication

needs,” Pate said. “When things start getting fragmented off, that makes the process much more difficult on our side.” St. Jude, which is in the same city as the airport hub for FedEx Express, plans to ship medications worldwide to its patients, Pate said. “We’re already able to FedEx medications to multiple states because we’re already licensed in those states as a pharmacy provider.” The pediatric facility, according to its 2013 annual report, treats patients from the 50 states and around the world and never sends a bill to a child’s family. Knoer, at the Cleveland Clinic, advised anyone trying to decide between building a specialty pharmacy practice or partnering with one to first understand the opportunity for the particular hospital or health system. “You have to mine your prescribers’ data,” he said. First, Knoer advised, determine the medications that are prescribed for such

CDC says pharmacist–leaders crucial for antimicrobial stewardship

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he Centers for Disease Control and Prevention (CDC) recently highlighted inappropriate antimicrobial use in hospitals as a major public health problem that pharmacists can help solve. CDC Director Tom Frieden, during a March 4 press teleconference, said a pharmacist’s “drug expertise” and leadership are among the seven critical components of an effective antimicrobial stewardship program. Other critical components include a commitment from hospital leadership, the appointment of a leader who is accountable for outcomes, the implementation of at least one recommended action to improve antimicrobial use, and the tracking and reporting of antimicrobial use data.

These recommendations were described in the online early release of CDC’s March 7 “Vital Signs” report, a monthly publication that draws attention to critical public health issues in the United States. Along with the report, CDC released a Vital Signs fact sheet to help hospitals better manage antimicrobial use. Cynthia Reilly, ASHP’s director of medication safety and quality, said the report and fact sheet provide “great tips for raising awareness and encouraging involvement in steward- Cynthia Reilly ship programs.” The report examined the antimicrobial prescribing and medication-use proc-

diseases as cancer, hepatitis C, multiple sclerosis, and rheumatic disease— conditions that tend to be treated with specialty medications. Then, he urged, determine the number of physicians who specialize in treating each of those diseases and identify the specialty medications that those physicians prescribe and the volumes. With the opportunity understood, Knoer said, the next consideration is whether the manufacturers of those specialty medications limit their distribution. Knoer also suggested working with the people at the hospital or health system who negotiate contracts with third-party payers. The goal, he said, is to have the specialty pharmacy “carved in” and thus able to fill the prescriptions for specialty medications. —Cheryl A. Thompson DOI 10.2146/news140032

ess in hospitals and found wide variation among different facilities, indicating that some use is not optimal. Frieden said inappropriate use of antimicrobials puts patients at unnecessary risk for drug-resistant infections and allergic reactions as well as gastrointestinal infections caused by Clostridium difficile. He said that effective antimicrobial stewardship programs in hospitals can have “a direct and almost immediate impact” in reducing antimicrobial resistance and C. difficile infections. According to the report, which was based on 2010 data from 183 U.S. hospitals, 56% of 11,282 randomly selected inpatients received antimicrobials during their hospital stay, and 29% received at least one dose of a broadspectrum agent. The report noted that the use of broad-spectrum antimicrobials is a known risk factor for C. difficile infection.

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Specialty pharmacy presents opportunities for hospitals, health systems.

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