PHARMACY

AHRQ contest winners announced

BY Alaric DeArment

NEW YORK — The Agency for Healthcare Research and Quality has announced the winners of a competition it sponsored to increase awareness and use of evidence-based healthcare tools in retail health settings, the government agency said.

The Evidence-Based Care Challenge took place between June 18 and Oct. 19, 2012 and enlisted nurse practitioners, physician assistants, researchers and other professionals to find ways to translate existing AHRQ research reports into provider-friendly resources for use in retail settings. Participants could also use the Otitis Media or the Screening for Obesity in Children and Adolescents.

In first place was the QR Medica Team, which used a beta-version website featuring evidence-based content on Otitis Media for healthcare providers and patients. The team included team leader and nurse practitioner Kelly McGee, Takecare Health Services, New Albany, Ohio; nurse practitioner Melinda McGaughy, Takecare Health Services, Health, Ohio; Paul Vineyard, a freelance information technology specialist; Janet Schmittgen, Walgreens Pharmacy, Heath, Ohio; Christine Lake, ADN nursing student, the American Institute of Alternative Medicine; Jordan McGaughy, ADN nursing student, Central Ohio Technical College; and Amanda McGaughy, BSN nursing student, Ohio State University.

In second place was the PAWS Team, which used a double-sided brochure on Otitis Media to help patients navigate treatment decisions with their provider at the point of care. The team, whose members were all from Lexington, S.C., included team leader and clinical practice manager Janette Capaci, pharmacist Larry Powers, pharmacist Patti Langston, pharmacist Kristy Clark, store manager Amanda Matthews, shift supervisor Deborah Boland, photo supervisor Brandon Batchelor, photo clerk Coulton Giles, shift supervisor Maria Taylor and shift supervisor Cheryl Lee. With exception to Capaci, who came from Minute Clinic, all the team members worked at the Lexington CVS.

In third place was the Tympanic Trio, whose members all came from a Tampa, Fla., Minute Clinic and who used a paper brochure "flipbook" with images on both sides of every page on Otitis Media. The team comprised nurse practitioner Nicola Archie, nurse practitioner Tara Jones and medical doctor Richard Kuehne.

The AHRQ said that by launching the EBC Challenge, it successfully encouraged development of relevant and useful resources that can be adopted for use by nurse practitioners and physician assistants in the convenience-care setting; introduced and expanded usage of evidence effort the EHC program to an important clinician audience; increased awareness of the EHC program and its products among the retail NP and physician assistant communities; and learned about effective ways to communicate with the retail NP and physician assistant communities.


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FDA turns down two Novo Nordisk insulin products

BY Alaric DeArment

BAGSVÆRD, Denmark — The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

Novo Nordisk said it received complete response letters from the FDA for Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). The FDA issues a complete response letter when it has finished reviewing an application for a drug, but determines that the application can’t be approved in its current form.

Reuters reported Monday the FDA had requested additional clinical trial data before it would consider approving Tresiba and Ryzodeg, but the company would not able able to provide the data in 2013 or 2014.


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Shire to pay Impax $48 million in authorized generic Adderall XR case

BY Alaric DeArment

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

Impax began selling its authorized generic version of Adderall XR (dextroamphetamine and amphetamine) in October 2009 under contract with Shire, but the generic drug maker filed suit against Shire in November 2010 for breach of contract and other related claims, alleging that Shire had failed to fill Impax’s orders for the drug. Shire responded with a counterclaim concerning Impax’s ordering practices under the agreement.

An authorized generic is a branded drug marketed under its generic name at a reduced price, usually under a contract between the branded drug’s manufacturer and a third-party company.

Under the settlement, Impax’s claims and Shire’s counterclaims will be dismissed, and Shire will make a one-time cash payment to Impax of $48 million. Impax will still have the right to sell its products on hand or owed to it under the agreement after the supply agreement expires, in September 2014.


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