PHARMACY

California gov signs e-pedigree bill, delaying track-and-trace requirements

BY Jim Frederick

SACRAMENTO, Calif. Gov. Arnold Schwarzenegger handed California pharmacies a major victory yesterday, signing into law a bill that gives the state’s drug retailers some breathing room in their effort to comply with electronic pedigree and track-and-trace technology requirements for prescription drugs.

Schwarzenegger signed into law SB 1307, which revised the technology requirements for establishing the origin and movement of prescription drugs through the supply chain. Included in the law is a provision that pushes back the deadline for compliance for California pharmacies from Jan. 1, 2011 to Jan. 1, 2017.

The decision reflects the recommendations of pharmacy leaders for a gradual and more workable implementation process for new e-pedigree requirements. A number of pharmacy representatives testified before the Enforcement Committee of the California State Board of Pharmacy, asking for an extension that would allow them enough time to adopt the track-and-trace technology needed to establish every drug’s pedigree.

Among those testifying was Dave Wilcox, owner of Northwest Medical Pharmacy in Fresno, Calif. Speaking on behalf of the National Community Pharmacists Association, Wilcox pointed out that community pharmacies need extra implementation time because the technologies are largely dictated to them by choices made by manufacturers and distributors.

NCPA executive vice president and chief executive officer Bruce Roberts praised Schwarzenegger for his recognition of the hurdles community pharmacies faced in trying to adapt to the changing track-and-trace requirements. He called the newly signed legislation “a common-sense bill delaying the implementation of e-pedigree, which gives California’s approximately 2,200 independent community pharmacies who are at the end of the distribution process a new deadline that is one year later than for manufacturers and distributors.”

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Independent pharmacy organization backs insurance coverage relief bill

BY Jim Frederick

ALEXANDRIA, Va. The National Community Pharmacists Association has joined with other groups representing smaller-scale employers to back new federal legislation that could ease the health insurance cost burdens on smaller businesses.

NCPA, the nation’s largest independent pharmacy organization, yesterday announced its endorsement of H.R. 6582, the Small Business Cooperative for Health Care Options to Improve Coverage for Employees [CHOICE] Act of 2008. The bill, introduced by U.S. House Small Business Committee chair Nydia Velazquez, D-N.Y., with support from both parties, is aimed at keeping smaller employers from falling prey to steadily rising health care and insurance costs.

To do so, the CHOICE bill creates private, voluntary purchasing cooperatives established under state insurance laws to provide excess claims insurance coverage to participating small businesses. The bill allows those employers to pool health risks over a larger number of insured plan participants, thus reducing costs and, ultimately, premiums.

H.R. 6582 also provides a refundable tax credit to small employers who purchase health insurance for their employees through the cooperative.

“With the cost of health insurance for small businesses rising 80 percent in the past eight years, the time for action has clearly arrived,” responded NCPA executive vice president and chief executive officer Bruce Roberts. The CHOICE bill, he added, “expands access to high-quality, affordable health insurance access for American small businesses and the self-employed. This bill provides the common-sense solutions to improve economic growth and productivity by promoting a healthier work force.”

Among other groups supporting the legislation: the American Optometric Association, American Rental Association, Coca-Cola Bottlers’ Association, Computing Technology Industry Association, International Franchise Association, National Association for Self-Employed, National Association of Home Builders, National Association of Realtors, National Black Chamber of Commerce, National Community Pharmacists Association, National Funeral Directors Association, National Gay & Lesbian Chamber of Commerce, National Restaurant Association, National Roofing Contractors Association, National Utility Contractors Association, U.S. Chamber of Commerce, U.S. Women’s Chamber of Commerce, and Women in Public Policy.

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No connection between Lou Gehrig’s disease and statins, FDA says

BY Alaric DeArment

WASHINGTON Cholesterol-lowering drugs do not increase the risk of Lou Gehrig’s disease, an analysis by the Food and Drug Administration has found.

The analysis, reported Monday in the journal Pharmacoepidemiology and Drug Safety, used data from 41 long-term controlled clinical trials involving statins. The FDA conducted the analysis after receiving an unusually large number of reports of Lou Gehrig’s disease in patients using the drugs in its Adverse Event Reporting System, but did not find an increase in the number of statin patients with the disease compared with those taking a placebo.

“The FDA’s review, which began in 2007, is an example of the agency working to analyze products [throughout their lifecycle] to keep healthcare professionals and patients informed of new and emerging safety data,” said Dr. Mark Avignan, director of the Division of Pharmacovigilance I at the FDA’s Center for Drug Evaluation and Research.

Lou Gehrig’s disease is the common name for amyotrophic lateral sclerosis, or ALS. It causes a gradual weakening of the muscles and impairment of speech ability.

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