PHARMACY

Summit held to address California’s health outlook

BY Drew Buono

LOS ANGELES The California Endowment hosted a summit Tuesday entitled Diabetes, Obesity and Heart Diseases: Changing the Paradigm to Care. The summit is being held to address the widespread threat to the state’s health and, more importantly, the effect of chronic diseases, which have crippled the state physically and economically.

More than 16.3 million cases of such chronic diseases as cancer, diabetes, heart disease, hypertension, stroke and mental disorders were reported in California in 2003, according to the Milken Institute. These chronic conditions can shorten lives, reduce quality of life and place a significant burden on caregivers. In addition, these diseases cost Californians approximately $133 billion dollars per year in direct treatment costs and lost productivity, according to the Milken Institute. These diseases account for 75 percent of healthcare spending, yet are often preventable and increasingly treatable, according to the Center for Disease Control.

“We must look at healthcare by finding solutions and implementing them, not by continuing the status quo” said Liz Helms, chair of the California Chronic Care Coalition. “California—and the rest of the nation—must focus on preventing chronic diseases and conditions through better disease management and appropriate medical intervention. Healthy living and continuing development of innovative treatments will ensure that quality of life is as high as possible.”

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FDA to open office in India

BY Drew Buono

KOCHI The Food and Drug Administration is planning on opening an office of its agency in India, in an effort to ensure the quality of the food and drugs being imported by the U.S., according to published reports.

Health and Human Service secretary Michael Leavitt and FDA commissioner Andrew von Eschenbach are in the country presently assessing the manufacturing practices existing at drug and food processing units.

According to Leavitt, he set up the mission because, “there was a serious apprehension among the consumers in this country on the quality of food and drugs being imported.” “We are trying to ensure the quality in the entire system of supply chain, right from the seed to the last outlet from where people buy the goods,” he said.

The U.S. imports about $56 million worth of food and drug products from India.

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BioDelivery works on risk management plan for dissolving fentanyl patch

BY Drew Buono

RALEIGH, N.C. BioDelivery Services International is planning on developing a safety plan for its new BEMA fentanyl patch, which the Food and Drug Administration accepted for review last week, according to published reports.

In December, a public health advisory from the FDA was released following reports of life-threatening side effects and even death associated with inappropriate prescriptions or use of the patches. So, to be safe, BioDelivery has developed a Risk Minimization Action Plan, or RiskMap, for its patch, which dissolves in the mouth and is placed on the walls of the cheek, unlike other fentanyl patches, which are placed on the skin and have to be disposed of.

Fentanyl is a narcotic pain medication more powerful than morphine. It has been in use for years. The FDA first issued a public health advisory for fentanyl skin patches in July 2005 following reports of the deaths of some patients.

BioDelivery’s vice president of marketing stated that the company is more confident as to the differences between its patch and other fentanyl patches, and believes the confidence is extended to how the drug is meant to be used and how the drug is delivered in the body.

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