PHARMACY

Pharmacy organizations in California request CMS examination of Medi-Cal cuts

BY Adam Kraemer

SACRAMENTO, Calif. The National Association of Chain Drug Stores, the California Pharmacists Association and the California Retail Association called on federal regulators Friday to carefully examine a state plan amendment for a 10 percent “across-the-board” cut to Medi-Cal reimbursements.

In a joint letter to the administrator of the Centers for Medicare and Medicaid Services, Kerry Weems, the groups highlighted potential consequences of the reduction, which was enacted last month.

“We urge that CMS ensure that DHCS and the Medi-Cal program have performed their statutorily required due diligence under the Medicaid statute in evaluating the impact of each component provider reduction on beneficiary access. If they have not done so, we urge that the SPA be rejected,” the groups stated.

“Maintaining pharmacy access is important not only to Medi-Cal beneficiaries’ health and safety, but also to the Medicaid program’s overall ability to constrain costs at the ‘macro’ level,” they noted, citing studies that have found reduced access to prescriptions can result in increased emergency room visits and prolonged hospital stays, which are more costly forms of healthcare.

Pharmacies fill over 22 million prescriptions for Medi-Cal patients every year, and NACDS, CPhA, and the CRA represent approximately 5,000 pharmacies operating in California.

“Many California providers—and particularly pharmacy providers—have experienced repeated reductions in Medi-Cal reimbursement over the last few years,” the groups wrote. “[It] it is crucial that any additional cuts be performed in a measured and rational manner that takes beneficiary access levels into consideration. We trust that if the supportive documentation submitted by the state with the proposed SPA fails to meet the federal statutory standard, CMS will reject that submission and insist that the federal standard be met through a provider-by-provider evaluation of beneficiary access levels.”

The full text of the letter is available here.

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St. Charles Pharmaceuticals receives grant for research on new analgesic

BY Diana Alickaj

NEW ORLEANS St. Charles Pharmaceutical has announced that it has received funding for the first year of three for a research grant from the National Institute of Neurological Disorders and Stroke.

St. Charles Pharma is a Louisiana based company that will use the award, technically a Cooperative Small Business Phase II SBIR Grant for Translational Research, to fund the research of SCP-123, which the company is working hard to place into clinics. The award will also work in funding the preparation of the application to be submitted to the FDA.

SCP-123 is an analgesic that treats neuropathic pain, and according to published reports, offers greater pain reduction, reduced side effects and has the potential to also treat acute, migraine, post-operative and pediatric pain.

“We are excited. Dr. Narducy and his research team have now raised $6 million in NIH grant funding to support the Company’s drug development efforts,” John Koerner, St Charles’ chairman, stated. “If all goes well, SCP-123 could fill a large, unmet medical need and become a drug of first choice—a blockbuster—for the treatment of neuropathic pain. This grant award is a big plus toward mitigating development risk and making it all happen.”

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FDA issues warnings to makers of misbranded STD drugs

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Thursday issued six warning letters to five U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet indicated for the prevention and treatment of sexually transmitted diseases.

“The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective,” stated Janet Woodcock, deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. “STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs.”

Some of these products, directed at U.S. consumers, falsely claim to have “FDA Approval” and some claim to be “more effective” than conventional medicine, the regulatory agency stated. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus.

Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.

The products claim to prevent or treat a variety of STDs, including herpes, chlamydia, human papilloma virus, cervical dysplasia and HIV/AIDS.

Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products, the agency stated. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

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