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C-Path, FDA and Arizona Coalition Kick Off the Community Pharmacy Safety Network

Posted on: Wednesday, 18 January 2006, 12:00 CST

The Critical Path Institute (C-Path), the U.S. Food and Drug Administration (FDA), Bashas' United Drug (Bashas'), the Arizona Poison and Drug Information Center and The University of Arizona Center for Education and Research on Therapeutics (AzCERT) have begun a partnership to create a statewide Community Pharmacy Safety Network (CPSN). Funded jointly by C-Path, AzCERT and a grant from the Agency for Healthcare Research and Quality (AHRQ), the CPSN will be the first-of-its-kind active drug surveillance system in the nation.

The CPSN's first project will compare the safety and effectiveness of two commonly prescribed asthma disease medications (one old, one new). Bashas' customers who fill prescriptions for either of the two medicines will be asked to register with a call center that has been created by the Arizona Poison and Drug Information Center and will later report how well their medicines worked and any side effects they experienced. Participants will receive a Bashas' gift card as an incentive for their participation. The data will be summarized and analyzed by C-Path and AzCERT and sent to the FDA for review. The CPSN's goal is to detect side effects from new medicines within weeks after they enter the market instead of, oftentimes, years. C-Path's president, Dr. Raymond Woosley, predicts that the CPSN, now operating only in Arizona, will expand to a nationwide scale over the next few years.

Lisa Higgins, director of CPSN, noted, "This is a wonderful opportunity that brings together the FDA and some of Arizona's leading institutions to address a pressing public health issue, the need for early assessment of the safety of new medications." Don Featherstone, pharmacy district manager for Bashas' Southern Arizona, added, "The C-Path partnership is important to Bashas' since our pharmacies will be the first to work with C-Path in their goal of developing a safety system that will ultimately be implemented throughout the country at multiple pharmacy chains." C-Path and the FDA plan to track and compare the safety of many other medicines as the CPSN reaches its full potential.

The FDA announced in late December its first-of-its-kind partnership with C-Path as part of its Critical Path Initiative, FDA's premier program to improve the efficiency and safety of medical product development. "We are encouraged by C-Path's efforts to improve the way medicines are used, improve the interaction between patients and pharmacists, both having the potential to provide important information to the FDA, the medical and pharmacy communities, and to patients," said Dr. Paul Seligman, director of FDA's Office of Pharmacoepidemiology and Statistical Science. Dr. Carolyn M. Clancy, director of the Agency for Healthcare Research and Quality (AHRQ), said, "This unique federal-state-private partnership will help improve the way we assess the safety of new medications and monitor their safe use. The Community Pharmacy Safety Network will help ensure that the pharmaceuticals used in this nation will help and not harm."

C-Path was established in July of 2005 as a publicly funded non-profit research and education institute by its founding partners, the U.S. Food and Drug Administration, The University of Arizona, and SRI International. Its mission is to help implement the Critical Path Initiative of the FDA with the objective of developing faster, safer and smarter pathways to new medical products. The CPSN is one of C-Path's first projects and is designed to evaluate the safety of newly marketed pharmaceuticals.

Bashas' is one of Arizona's leading businesses, with 54 pharmacies throughout Arizona. Bashas' United Drugs pharmacists are dedicated professionals working actively to raise public awareness of the importance of taking care of health.

The Arizona Poison and Drug Information Center provides poison and medication-related emergency treatment advice, referral assistance and comprehensive information on poisons and toxins, poison prevention and the safe and proper use of medications. Calls are taken 24/7 by registered pharmacists with certified training in poison information. These pharmacists play a major role in patient care and in the prevention of unnecessary emergency medical utilization.

The mission of the network of federally funded Centers for Education and Research on Therapeutics (CERTs) is to conduct research and provide education that will advance the optimal use of drugs, medical devices and biological products. The Arizona CERT's specific aim is to improve therapeutic outcomes and reduce adverse events caused by drug interactions, especially those that result in harm to women. The Arizona CERT is funded by the Agency for Healthcare Research and Quality.

Source: Business Wire

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