Don Featherstone, Bashas' pharmacy manager for Southern Arizona, holds the two medications that will be studied: Atrovent on the left and Spiriva on the right. Customers who take the drugs will report on side effects they experience. Each participant will receive a $20 Bashas' gift card.

Benjie Sanders / Arizona Daily Star

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The FDA is taking some of its first steps to reform the drug-approval process in Arizona, with a pilot drug-safety study to be launched at Bashas' pharmacies in January.

The program, which will gather data about the side effects of two drugs to treat lung disease, is among the first initiatives of the Tucson-based Critical Path Institute,, a nonprofit partnership of the University of Arizona, the Food and Drug Administration and the technology development firm SRI International Inc.

In addition to the Bashas' drug study, C-Path has won a $750,000 FDA grant to study heart failure using data from the University of Utah.

C-Path was set up in 2004 to help speed the approval of promising new medicines by using new technologies and approaches to test drugs and screen patients. Backers say the institute, which has raised more than $10 million in local donations to seed operations for the first five years, could help drive economic development in the area by attracting drug developers.

C-Path CEO Dr. Raymond Woosley said the pharmacy initiative is an effort to demonstrate how increased tracking can boost safety, as regulators look to speed drug approval.

"We need to speed drugs to market, and we can never do that without an effective safety net," said Woosley, who spent much of his career studying drug safety.

The initial program will study patients on two drugs that treat lung disease: Atrovent, which was approved a decade ago, and Spiriva, which was approved in 2004.

The Bashas' program will serve as a model for a new drug-safety-monitoring system, Woosley said, adding that he hopes to expand the program to major pharmacy chains. The 54 pharmacies that Chandler-based Bashas' operates statewide are part of United Drugs, a co-op of independent drugstores.

"It just seemed like a very interesting program that's necessary for our country," said Don Featherstone, pharmacy district manager for Bashas' in Southern Arizona. "Every industrialized country has a post-marketing (drug) surveillance system in place except for the United States."

The program will work like this: Each Bashas' pharmacy will have fliers explaining the program, to be handed out to customers filling prescriptions for the subject drugs.

Customers who enroll in the study will be asked to submit to an initial phone interview and to sign a federally required disclosure form, Featherstone said. All patient information will be kept confidential.

Participants will be asked to report any side effects — good or bad — within 30 days to the Arizona Poison Control Center and will be called for a follow-up interview at the end of the monitoring period. As a reward for helping, each participant will get a $20 Bashas' gift card.

The initial goal of the six-month program is to study 50 patients taking the lung drugs. C-Path will add other drugs to the study at a rate of about two per month, with input from the FDA, Woosley and Featherstone said.

The study is being funded with about $100,000 from the Agency for Healthcare Research and Quality, through the UA Center for Education and Research on Therapeutics, said Lisa Higgins, assistant director for Safe Path, one of four program areas at C-Path.

Higgins said she believes consumers will step up to help. "Safety is a big concern in the public consciousness right now, and people are going to be supportive," she said.

The program to study heart-failure patients in Utah will involve the UA, the University of Utah and the Translational Genomics Research Institute, or TGen, in Phoenix, Woosley said.

Using medical and genetic data, researchers will try to determine genetic markers that determine the effectiveness of certain heart drugs, Woosley said.

"We need a way to determine who will have a good response or a bad response," he said.

The $750,000 appropriation for the study is particularly significant because it's "new money" to the FDA, Woosley said.

TECH FILE