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N e ws Albiglutide approved for type 2 diabetes

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DA and GlaxoSmithKline on April 15 announced the approval of albiglutide subcutaneous injection for the treatment of adults with type 2 diabetes mellitus. The once-weekly therapy is indicated, in conjunction with diet and exercise, to improve glycemic control. The drug may be used with or without other antidiabetic agents and has been studied in clinical trials as standalone therapy and in combination with metformin, glimepiride, pioglitazone, insulin, and other antidiabetic drugs. GlaxoSmithKline will market albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, under the brand name Tanzeum. The company expects the product to be available during the third quarter of this year. The labeling includes an FDA-required Medication Guide and several pages of instructions for preparing and injecting each dose. According to the labeling, albiglutide is not intended for use in patients with type 1 diabetes or diabetic ketoacidosis. Albiglutide is not suitable as first-line drug therapy for the treatment of type 2 diabetes that has not been controlled through diet and exercise. The drug has not been studied in conjunction with prandial insulin regimens. Patients with severe gastrointestinal disease should not use albiglutide. The labeling includes a boxed warning about a potential risk for the development of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in patients treated with GLP-1 agonists. The drug is contraindicated in patients with a personal or family history of MTC and patients with multiple endocrine neoplasia syndrome type 2, which increases the risk for MTC.

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A risk evaluation and mitigation strategy has been developed to communicate to prescribers the potential risk of MTC and the risk of acute pancreatitis associated with albiglutide. In clinical trials, the most common adverse events reported in patients treated with albiglutide included diarrhea, nausea, upper-respiratory-tract infection, and injection-site reactions. The recommended starting dosage of albiglutide is 30 mg once weekly injected subcutaneously in the abdomen, thigh, or upper arm. If additional glycemic control is needed, the dosage can be increased to 50 mg once weekly. The injections may be performed at any time of day without regard to mealtimes.

If the patient misses a dose, the drug may be administered as soon as possible within three days after the missed dose. If more than three days have passed since the missed dose, the patient should withhold that dose and resume injections on the regularly scheduled day. Albiglutide will be available in 30- and 50-mg single-dose pens in cartons of one and four each that should be refrigerated at 2–8 °C. Patients may store the product at room temperature for up to four weeks before use. Each pen contains lyophilized albiglutide and the diluent, water for injection. The final solution is yellow. —Kate Traynor DOI 10.2146/news140038

VA pharmacy aims high for clinical practice

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o see how the Department of Veterans Affairs (VA) envisions ambulatory care pharmacy practice, all one needs to do is read the description of clinical pharmacy specialist (CPS) duties in VA’s recent job listings. The descriptions include phrases like “will function at the highest level of clinical practice working independently as a mid-level provider performing comprehensive pharmaceutical care,” and “will manage patient medication therapy by initiating, modifying and discontinuing medication therapy in an ambulatory care setting.”

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Jannet M. Carmichael, pharmacy executive for the VA Sierra Pacific Network, said VA’s model for pharmaceutical care stems, in part, from the belief that pharma- Jannet M. Carmichael cists should be working directly with patients. “At VA, we actually believe that pharmacists are a practitioner that patients are going to want to see on an encounter basis in a similar way as they would come in to see their physician or their nurse practitioner or other practitioner who

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can independently manage patients,” Carmichael said. She said this means that when veterans need pharmaceutical care for a medical issue or a medication complication, “they’re scheduled in for a clinic visit to see a pharmacist.” Advanced practice. Advanced practice roles for pharmacists are supported through VA’s system of establishing scopes of practice for CPS practitioners. The vision for advancing clinical pharmacy practice comes from VA’s national Clinical Pharmacy Practice Office (CPPO) within the Pharmacy Benefits Management service. “We try to provide oversight and training to the field on all things clinical, even including policy and strategies to increase the deployment of clinical pharmacists into high scope-of-practice areas where we think that the pharmacists are underutilized,” said Anthony P. Morreale, assistant chief consultant for clinical pharmacy services and health care services research at CPPO. “We build all our strategies around that.” Julie Groppi, national program manager for clinical pharmacy practice policy and standards at CPPO, said the office has defined core elements for advanced scopes of practice. In addition, she said, CPPO has worked to “establish some standardized policy and consistency within the system so that pharmacists’ scope of practice was overseen in the same means by which the medical staff process was for other prescribers.” Carmichael estimated that as many as 95% of the pharmacists at some of the six VA medical centers in her region have an advanced scope of practice. But at others, that figure is around 30–40%. She said the region’s pharmacy directors are working to confer advanced scopes of practice on pharmacists who already provide advanced services. The credentials of all Veterans Health Administration (VHA) health care providers are documented through VetPro, VHA’s standardized online credentialing system. Groppi said privileging, or what VHA calls scope-of-practice oversight for clin-

ical pharmacists, involves peer review of the practitioner’s knowledge, skills, and experience. In some cases, a pharmacist who does not meet all of the established requirements for a scope of practice will complete a proctorship before applying for advanced privileges. Morreale said 72% of VA pharmacists with an advanced scope of practice are board certified, residency trained, or both. “It’s a pretty well-trained work force,” he said. In the field. A total of 28 CPS practitioners whose advanced scopes of practice include prescribing privileges work at the W. G. Hefner VA Medical Center (VAMC) in Salisbury, North Carolina, and its affiliated community-based outpatient clinics in Charlotte, Hickory, and Winston– Salem, said Glen Albracht, chief of pharmacy at the medical center. These pharmacists are Glen Albracht authorized to initiate, continue, discontinue, and adjust therapy; order consultations with other health care providers; and order lab tests that are necessary to support drug therapy. Albracht said that although most pharmacists at his sites don’t yet have an advanced scope of practice, the medical center benefits from establishing CPS practitioners on the staff. “There is a lot of paperwork associated with the administrative oversight of a professional practice evaluation program for CPS practitioners with an advanced scope of practice, and it does take a lot of extra time,” he said. But he said it’s important to follow the medical model to establish credibility and recognition of pharmacists as prescribers. “The physicians embrace pharmacy and use us as often as possible,” Albracht added. “It saves considerable time for the physicians if the pharmacist has the time and ability” to care for patients with, for example, diabetes or other chronic conditions. Jon E. Folstad, associate chief of clinical pharmacy services at W. G. Hefner Jon E. Folstad

VAMC, said garnering support from health care professionals outside of pharmacy remains critical to optimize pharmacy’s role in providing health care for veterans. Continued on page 893

New drugs and dosage forms Ceritinib capsules (Zykadia, Novartis): The kinase inhibitor is indicated for the treatment of patients with metastatic non-small-cell lung cancer who test positive for anaplastic lymphoma kinase gene rearrangement and whose disease has progressed while receiving crizotinib therapy or are intolerant to it. Mercaptopurine oral suspension (Purixan, Rare Disease Therapeutics): The raspberry-flavored liquid is indicated as part of a combination regimen for the treatment of patients with acute lymphoblastic leukemia. Omega-3-acid ethyl esters A capsules (Omtryg, Trygg Pharma): The combination product, containing ethyl esters of eicosapentaenoic acid, docosahexaenoic acid, and other omega-3 fatty acids, is indicated as an adjunct to diet to reduce the serum triglyceride concentration in adults with severe hypertriglyceridemia. Ramucirumab injection (Cyramza, Eli Lilly): The vascular endothelial growth factor receptor 2 antagonist is indicated for the treatment of patients with advanced or metastatic gastric cancer whose disease has progressed during or after fluoropyrimidine- or platinumcontaining chemotherapy. Short ragweed pollen allergen extract sublingual tablets (Ragwitek, Merck Sharp & Dohme): The allergen extract is indicated as immunotherapy for the treatment of short ragweed pollen–induced allergic rhinitis in patients 18–65 years of age who test positive for immunoglobulin E antibodies to short ragweed pollen. The biological is subject to FDA Medication Guide requirements. Siltuximab for injection (Sylvant, Janssen Biotech): The interleukin-6 antagonist is indicated for the treatment of patients with multicentric Castleman disease who test negative for HIV and human herpesvirus 8. Timothy grass pollen allergen extract sublingual tablets (Grastek, Merck Sharp & Dohme): The allergen extract is indicated as immunotherapy for the treatment of grass pollen–induced allergic rhinitis in patients 5–65 years of age who test positive for immunoglobulin E antibodies to Timothy grass or cross-reactive pollens. The biological is subject to FDA Medication Guide requirements.

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“Find a medical staff champion. That’s what we’ve had to do any time we want to initiate or expand services,” he advised. He said that several years ago, the medical staff supported pharmacists’ work in anticoagulation management so strongly that a decision was made to have pharmacy “own the complete process of initiating and monitoring anticoagulation therapy.” Under the previous system, he said, each anticoagulation visit resulted in patients seeing multiple health care providers and waiting for test results and decisions about changes to therapy. Now, he said, pharmacists do pointof-care testing, take a medication history, counsel the patient, and make any necessary changes to therapy. “It’s improved significantly since pharmacy has owned the process,” Folstad said. “We demonstrated more efficient and effective care, and patient satisfaction improved by having one person doing complete care rather than having a fragmented process.” Albracht said CPS practitioners at his VAMC work in primary care, acute care, long-term care, home-based primary care, mental health, infectious diseases, and pain management, and some have a limited scope of practice in hematology– oncology. Morreale said nearly 3000 of VA’s 7000 pharmacists have an advanced scope of practice that confers prescribing privileges in a variety of practice areas. But much of the recent advancedpractice action within VA is focused on pharmacists with a global scope of practice who support patient-centered care in primary care settings. “There’s a movement for pharmacists with a scope of practice to move from disease-based scopes of practice to actually have more practice area–based scopes,” Groppi said. She said CPS practitioners in primary care settings must demonstrate expertise and experience in the management of patients with a spectrum of diseases

commonly encountered in this care environment. “Even though the patient may have been referred to the pharmacist primarily for their diabetes management, the pharmacist is really reviewing all of the medications and the appropriateness of medications and really assessing other disease states, such as the patient’s blood pressure control or their lipid control,” Groppi said. Morreale said the number of CPS practitioners with an advanced scope of practice has more than doubled since 2010, when the VA began its implementation of the patient-centered medical home model of care. Dubbed the patientaligned care teams (PACT) initiative, this care model is being rolled out at all VHA facilities. PACT strongly supports the use of CPS practitioners, and the official PACT handbook includes specific staffing

recommendations for pharmacists on patient care teams. According to the handbook, the teams should include one CPS for every three “patient panels” to perform disease management and one anticoagulation CPS for every five patient panels to manage anticoagulation. Morreale said each panel consists of approximately 1200 patients. He said VA facilities, including community–based outpatient clinics that operate under contract, are hiring pharmacists to meet the standards specified in the handbook. And that bodes well for pharmacists and for patient care, he said. “Systemwide, I think we’re moving to a place where pharmacists really have the opportunity to use what they’ve learned. And that kind of was our goal,” Morreale said. —Kate Traynor DOI 10.2146/news140039

Iowa pharmacists fill allergy testing niche

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or more than a decade, a pharmacistrun service at an Iowa hospital that tests patients for penicillin sensitivity has faced ups and downs, but the hospital has ultimately remained committed to the program. The service, at Iowa Methodist Medical Center, a 670-bed community-based teaching hospital in Des Moines, was described in the June 15, 2004, issue of AJHP. “We were looking for ways to, basically, improve the ability to use antimicrobials,” recalled Geoffrey C. Wall, internal medicine clinical pharmacist and lead author of the report. “As with most hospitals, I think, we realized that we were using a whole lot of alternative medications for patients with supposed penicillin allergies.”

According to the report, pharmacists evaluated 26 patients for penicillin allergy, and skin test results were negative in all but one of the 23 patients who met the criteria for testing. The test result was indeterminate for the remaining patient, and all 26 were subsequently treated with penicillin without incident. Wall said the idea for the allergy testing service was inspired by two events—his periodic occupational tuberculin skin test and a report published in 2000 in the journal Chest that described a penicillin allergy test pilot program administered by allergy fellows. “We don’t require a pulmonologist to read a [tuberculin test], so why do you have to be an allergist to do penicillin skin tests?” Wall recalled of his thinking at the time.

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VA pharmacy aims high for clinical practice.

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