PHARMACY

Roundtable examines ‘go-to’ retail resources for diabetes

BY Drew Buono

NEW YORK The Fifth Annual Diabetes Roundtable, which was sponsored exclusively by Drug Store News, took place today with a panel of 10 key figures from the pharmaceutical retail and supply industry. The panel included: Mark Doerr, vice president of the Kmart Pharmacy Corp., Rachel Sosalski, manager of trade operations for Novo Nordisk, Robb Ayshford, Kmart’s director of pharmacy administration, Brian Hille, director of pharmacy for Safeway, Neil Luckianow, director of sales and marketing for Bayer Diagnostics, Ernest Richardsen, vice president of pharmacy programs at Rite Aid, Suzanne Eastman, executive director of clinical services for Catalina Health Resource, Chrissy Ellegood, director of diabetes care at Medicine Shoppe, John Fegan, senior vice president of pharmacy operations for Ahold USA, and Kaliroi Brodin, director of health and wellness services for Duane Reade.

The roundtable was the second event of the day, following the Ninth Annual Industry Issues Summit that took place in the morning. David Wendland of Hamacher Resources, who was taking part in his fourth roundtable, moderated the diabetes event. Wendland opened up the discussion by asking the retailers of the panel if they considered their respective companies as the “go-to resource” for patients for information on diabetes.

Each member agreed that his or her respective company was represented well to provide customers with diabetic information. Fegan pointed out that Ahold was partnering with healthcare professionals to make itself the “go-to resource.” He believed the company was on the right track. Richardsen and Ayshford told of their respective companies’ partnership with the American Diabetes Association to make themselves more prepared to be that resource for customers. The follow-up question, which then targeted both the retailers and suppliers was: Where would patients first go after hearing from their doctors that they had pre-diabetes?

Brodin said that Duane Reade had a diabetes resource center in the store where customers can receive free advice. She was also quick to point out that customers would go to someone they trust first to find answers, such as a friend who has diabetes. The Internet is also a key piece for people looking for information according to Brodin. Hille, Eastmann and Brodin each made reference to the pharmacist as the key giver of information. Hille said that Safeway encourages face-to-face contact between the patient and the pharmacist. Eastmann believed that a customer would go to his or her pharmacist first for answers and that, afterward, the information on Catalina’s Web site, as well as newsletters and telephone calls would make up the necessary information a customer would be looking for. Some features, though, were considered underutilized by the panel, namely clinics and nurse practitioners.

Kaliroi and Doerr both agreed that clinics would grow and nurse practitioners would be increasingly utilized to give diabetic screenings—and more information for patients—when a pharmacist wasn’t available. Richardsen also noted that Medication Therapy Management collaborations with clinics would be very useful. The point, according to the panel, was to provide their customers with the resources they need for diabetes awareness. Customers are key for these companies and if their staff or technology can make a person feel more secure and knowledgeable about a given circumstance, such as diabetes, these companies will invest the money to make themselves that “go-to resource.”

The panel summed up their discussion with a group vote that was unanimous in its decision; all ten members agreed that electronic medical records were key to have for their respective businesses.

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PHARMACY

Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue

BY Allison Cerra

NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.

While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.

At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.

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PHARMACY

Caraco receives tentative FDA approval for generic Lexapro

BY Allison Cerra

WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.

“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”

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