PHARMACY

APhA reports interim success of Diabetes Ten City Challenge

BY Drew Buono

WASHINGTON According to an interim study by the American Pharmacists Association Foundation, patients enrolled in the APhA’s Diabetes Ten City Challenge appears to be changing their attitude towards their diabetes care.

The program is designed to eliminate co-payments for diabetes medications and supplies if patients work with a pharmacist to monitor and manage their condition.

Some of the improvements highlighted in the interim study include an increase in the percentage of patients enlisting in preventative health services. Participants receiving flu vaccinations increased from 43 to 61 percent, eye examinations increased from 60 to 77 percent and foot examinations increased from 38 to 68 percent. Patients with nutrition goals rose from 22 to 66 percent; those with exercise goals increased from 24 to 72 percent, and those with weight management goals increased from 23 to 64 percent.

Also, 87 percent of the patients said that their overall diabetes care was excellent, a huge jump from the pervious 39 percent.

The areas included in the program are Charleston, S.C., Chicago, Colorado Springs, Colo., Cumberland, Md., Honolulu, Milwaukee, Northwest Georgia, Pittsburgh, Los Angeles and Tampa Bay, Fla.

The foundation looks to release a full report based on clinical outcomes and patient satisfaction in early 2009.

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PHARMACY

FDA to review ulcer gel, HIV medications

BY Drew Buono

WASHINGTON The Food and Drug Administration is conducting two safety reviews of the drugs Regranex gel, used for leg and foot ulcers and the HIV medications Ziagen and Videx.

Diabetic patients using Johnson & Johnson’s Regranex face an increased risk of cancer from using the gel.

Data analyses from another study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking GlaxoSmithKline’s Ziagen or Bristol-Myers Squibb’s Videx as part of their drug therapy.

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FDA OKs Dendreon’s phase III Provenge trial

BY Drew Buono

SEATTLE The Food and Drug Administration has agreed to allow Dendreon to get the final results from its phase III trial for its prostate cancer drug Provenge.

Last May, the FDA requested additional clinical data from Dendreon to support its effectiveness claim for Provenge despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13 to 4 that the product was effective and 17 to 0 that it was safe.

That request led three congressmen: Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, to point accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved. One of the members of the committee is a lead investigator for a competing cancer drug made by Novacea.

According to the company, interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010.

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