PHARMACY

NACDS, NCPA commend Reps. Rogers, Braley for concern over draft FUL lists

BY Antoinette Alexander

ALEXANDRIA, Va. — The National Association of Chain Drug Stores and National Community Pharmacists Association issued a statement on Thursday announcing that they commend Reps. Bruce Braley, D-Iowa; Mike Rogers, R-Mich.; and 38 of their colleagues who expressed concerns with draft Federal Upper Limits lists that recently have been published by the Centers for Medicare and Medicaid Services.

“We are concerned that these lists contain flawed information that is not reliable for use in establishing pharmacy reimbursement in Medicaid. We ask that you direct states not to use these draft lists for reimbursement purposes until they can be improved and finalized through a formal notice of proposed rule,” the members of Congress wrote in a letter to CMS.

NACDS and NCPA also have expressed concern with the draft FUL lists in written comments to CMS. “We are heartened that our arguments have been given further credibility by a large bipartisan group of representatives,” stated NACDS president and CEO Steve Anderson and NCPA CEO B. Douglas Hoey. “We want to especially thank Representatives Braley and Rogers for their leadership on this important issue.”

In addition to urging CMS to cease publication of draft FUL lists until a final AMP rule is in place, the representatives also urged the agency to be mindful of comprehensive pharmacy reimbursement. “When setting pharmacy reimbursement rates, both components of reimbursement — product cost and cost to dispense — must be taken into consideration when determining whether pharmacies are paid adequately,” the members of Congress wrote.

Click here to view the Braley-Rogers letter.
 

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GPhA proposes new initiative to target drug shortages

BY Alaric DeArment

WASHINGTON — The Generic Pharmaceutical Association proposed Thursday the creation of a new initiative to combat the problem of drug shortages.

Calling it a multistakeholder initiative to accelerate the recovery of critical drugs in short supply, the GPhA said the Accelerated Recovery Initiative would call for an independent third party to gather current and future supply information from stakeholders for products; use the information to identify current and potential supply gaps, focusing on products with an expected shortage time longer than 90 days; and involve a high-level "SWAT team" within the Food and Drug Administration to respond quickly to shortages.

The ARI would bring together manufacturers, wholesalers, distributors, group purchasing organizations and the FDA.

"The generic industry has taken a leading role in responding to this crisis, and the ARI marks a significant step in those efforts," GPhA president and CEO Ralph Neas said. "This type of multistakeholder collaboration is exactly what is required to respond to this crisis. While this remains a complex issue that cannot be solved overnight, the ARI would significantly enhance our ability to reverse the drug shortages currently afflicting patients and prevent further ones from occurring."

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Study: Dapagliflozin added to existing glimepiride therapy helps Type 2 diabetics reduce blood-glucose levels

BY Allison Cerra

DUBAI — A study conducted by Bristol-Myers Squibb and AstraZeneca found that adding an investigational compound to an existing Type 2 diabetes treatment may help reduce blood-glucose levels among patients.

The drug makers said that in its phase-3 study — which was conducted over a 24-week period and consisted of 592 adults (ages 18 years and older) with Type 2 diabetes — a mean change in blood-glucose levels was recorded in patients that had dapagliflozin (2.5 mg, 5 mg or 10 mg per day) added to their glimepiride (4 mg/day) therapy, compared with placebo added to glimepiride. The study period then was extended by an additional 24 weeks — 519 of 546 patients initially enrolled completed the extension — to measure the efficacy of dapagliflozin over a longer period of time. Bristol and AstraZeneca found that in addition to maintaining reductions in blood-sugar levels, the 48-week study reported that patients taking dapagliflozin added to glimepiride maintained reductions in fasting plasma glucose levels, post-prandial glucose and total body weight.

The data were presented at the International Diabetes Federation 2011 World Diabetes Congress in Dubai last week.

“Given that patients with Type 2 diabetes often need multiple therapies to help manage blood-sugar levels over the course of this progressive disease, it is important to assess the ability of new compounds to work in combination with commonly prescribed anti-diabetic treatments,” said Krzysztof Strojek of the department of internal diseases, diabetology and nephrology at Silesian Medical University (Poland). “This study demonstrated that the addition of dapagliflozin to existing glimepiride therapy maintained reductions in blood-sugar levels over 48 weeks.”

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