Thursday December 1, 2011 Industry Headlines: Gov't Inspector Says Penalties Needed to Curb Use of Psychiatric Drugs in Nursing Homes (11/30/11 Associated Press) By Matthew Perrone Government inspectors told lawmakers Wednesday that Medicare officials need to do more to stop doctors from prescribing powerful psychiatric drugs to nursing home patients with dementia, an unapproved practice that has flourished despite repeated government warnings. So-called antipsychotic drugs are designed to help control hallucinations, delusions and other abnormal behavior in people suffering from schizophrenia and bipolar disorder, but they're also given to hundreds of thousands of elderly nursing home patients in the U.S. to pacify aggressive behavior related to dementia. Drugs like AstraZeneca's Seroquel and Eli Lilly's Zyprexa are known for their sedative effect, often putting patients to sleep. But the drugs can also increase the risk of death in seniors, prompting the Food and Drug Administration to issue multiple warnings against prescribing the drugs for dementia. Antipsychotics raise blood sugar and cholesterol, often resulting in weight gain. An inspector for the U.S. Department of Health and Human Services told the Senate Committee on Aging that the federal government's Medicare program should begin penalizing nursing homes that inappropriately prescribe antipsychotics, according to written testimony obtained by the Associated Press. The Centers for Medicare and Medicaid Services provides health coverage to nearly 80 million senior, poor or disabled Americans. HHS Inspector General Daniel Levinson proposed that Medicare force nursing homes to pay for drugs that are prescribed inappropriately, and potentially bar nursing homes that don't use antipsychotics appropriately from Medicare. A report by Levinson's office issued in May found that 83 percent of Medicare claims for antipsychotics were for residents with dementia, the condition specifically warned against in the drugs' labeling. Fourteen percent of all nursing home residents, nearly 305,000 patients, were prescribed antipsychotics. The HHS Inspector General's office Medicare claims during a 2007 six month period. Doctors are permitted to prescribe drugs for off-label uses, though it is illegal for drug companies to promote uses that haven't been cleared by the FDA. In recent years several pharmaceutical companies have paid huge fines to the Department of Justice in cases involving off-label marketing of antipsychotics. In January 2009, Eli Lilly & Co. Inc. agreed to plead guilty and pay $1.4 billion for illegal promotion of Zyprexa, including marketing to nursing home doctors. The company told its sales representatives to use the slogan "5 at 5," to persuade doctors that giving 5 milligrams of the drug at 5 p.m. would make dementia patients sleep through the night. AstraZeneca PLC has paid nearly $600 million in two separate settlements with federal and state prosecutors over alleged off-label promotion of its drug Seroquel.
D I A R I O O F I C I A L 4 6 6 1 1 D E 2 0 0 7 MINISTERIO DE LA PROTECCIÓN SOCIAL RESOLUCION NÚMERO 0676 (marzo 9 de 2007) Por la cual se establece el reglamento técnico de emergencia a través del cual se adopta el Plan Nacional de Control de Residuos de Medicamentos Veterinarios y otras Sustancias Químicas 2007 que deben cumplir los productos acuícolas para consumo h
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