State, Justice Department Reach Agreement on Mental Health Plan

Agreement avoids direct federal control, lays out measurable benchmarks

Governor Sonny Perdue today announced that the State of Georgia and the US Department of Justice (DOJ) have reached a settlement agreement that avoids direct federal control of the state’s services for people with developmental disabilities and mental illness and adds concrete goals to Georgia’s current plans to expand services in communities. Under the agreement, the state will stop admitting people whose primary diagnosis is a developmental disability into state hospitals by July 2011 and instead place them directly into community services. By July 2015 it will attempt to place any who remain in state hospitals into community services as well. The agreement also provides for expanded community-based services for approximately 9,000 individuals with mental illness. The new agreement lays aside a DOJ lawsuit brought earlier this year under the Americans with Disabilities Act.

“We’re happy that, after long and frequent negotiations, we now have an agreement with measurable goals that preserves Georgia’s ability to make decisions on how best to serve Georgians,” said Governor Perdue. “I have always said the state needed to provide better services to our most vulnerable citizens, and the Department of Justice has played a helpful role in spurring change in Georgia. I am confident we finally have an agreement that moves us towards our common goals of recovery and independence for people with mental illness and developmental disabilities”

The new agreement is part of a series of actions that have sought to reform Georgia’s behavioral health and developmental disability services. In its 1999 Olmstead decision, the US Supreme Court found that people with mental illness and developmental disabilities in Georgia and other states have a right to receive services in community settings instead of being segregated into state hospitals. The new settlement agreement furthers the State’s commitment to comply with the Olmstead agreement, replacing and expanding upon an existing voluntary compliance agreement that was entered into in 2008. It reaffirms, and does not replace, a separate agreement that seeks to improve the safety and effectiveness of the state’s psychiatric hospitals.

“The staff members at our hospitals and regional offices have worked long and hard to make the people we serve safer,” said Dr. Frank Shelp, Commissioner of the Georgia Department of Behavioral Health and Developmental Disabilities (DBHDD). “This agreement would not have been possible without their dedication, and it’s that commitment to the people we serve that will make it a success.” In 2009, Governor Perdue and the Georgia General Assembly created DBHDD to focus solely on policies and programs for people with mental illness, developmental disabilities, and substance use disorders. In its first year of operations, the agency improved the safety and effectiveness of the seven state hospitals, expanded community-based services, built innovative partnerships with several medical schools in Georgia, and forged strong alliances with Georgia advocacy and consumer groups.
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FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

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FDA Moves Forward on Implementation of Tobacco Law

The U.S. Food and Drug Administration today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee (TPSAC).

The Tobacco Products Scientific Advisory Committee is tasked with providing advice, information, and recommendations to the Commissioner of Food and Drugs on health and other issues relating to tobacco products. The committee will be asked to consider a variety of topics including:

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o identifying the effects of the alteration of the nicotine yields from tobacco products;
o reporting on the impact of the use of menthol in cigarettes on the public health; and
o advising on an application for modified risk (use of descriptors such as “light”) tobacco product.

The TPSAC will consist of 12 members, including the Chair to be selected by the Commissioner of Food and Drugs, from among experts knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation or use of tobacco products. There will be nine voting and three non-voting members. Of the nine voting members, seven will be health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. One member will be an officer or employee of a state or local government or the federal government, and the final member will be a representative of the general public.

The three non-voting members will be identified with industry interests. These members will include one representative of the tobacco manufacturing industry, one representative of the tobacco growers, and one representative of the small business manufacturing industry.

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FDA Launches New Center for Tobacco Products

The U.S. Food and Drug Administration today launched its new Center for Tobacco Products in an historic effort to curb the hundreds of thousands of deaths caused by those products each year.

The Center will oversee the implementation of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in June 2009. The FDA’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, and establishing and enforcing advertising and promotion restrictions.

Lawrence Deyton, M.D. M.S.P.H., an expert on veterans’ health issues, public health, tobacco use, and a clinical professor of medicine and health policy at George Washington University School of Medicine and Health Sciences, will serve as the Center’s first director.

“We are thrilled to announce Dr. Deyton’s appointment as director of the Center for Tobacco Products and look forward to him joining the agency,” said FDA Commissioner Margaret A. Hamburg, M.D. “He is the rare combination of public health expert, administrative leader, scientist, and clinician.”

Before coming to the FDA, Deyton was Chief Public Health and Environmental Hazards Officer for the U.S. Department of Veterans Affairs. His responsibilities there included oversight of the VA’s public health programs including tobacco use, the health of women veterans, the long-term health consequences of military service, and the VA’s emergency preparation and response. He was selected after a national search.

The FDA’s Center for Tobacco Products, located on the FDA’s White Oak Campus in Silver Spring, Md., will use the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products.

To implement the program, the FDA will start with $5 million from the fiscal year 2009 budget to establish the necessary administrative functions for the Center. As set forth in the Family Smoking Prevention and Tobacco Control Act, funding for the Center and other activities related to the regulation of tobacco will come from user fees paid by manufacturers and importers of tobacco products.

According to the Centers for Disease Control and Prevention, cigarette smoking causes an estimated 438,000 deaths, or about 1 of every 5 deaths, each year. On average, adults who smoke cigarettes die 14 years earlier than nonsmokers.

“As many Americans know, freedom from tobacco dependence is the key to a healthy future,” said Assistant Secretary for Health Howard Koh, M.D., M.P.H. “Dr. Deyton’s public health and tobacco cessation experience will be invaluable as the Department of Health and Human Services and the Food and Drug Administration take on this challenge.”

One of Deyton’s priorities had been revitalization of the VA’s smoking and tobacco use cessation programs. Under his leadership, current smoking among veterans enrolled in the cessation program fell from 33 percent in 1999 to 22 percent in 2007. The VA health care system is the largest integrated provider of health care and medical services in the United States, with more than 1,400 sites serving nearly 6 million veterans in fiscal year 2008.

“I am eager for the challenge of leading the tobacco team at FDA,” said Deyton. “This is a tremendous opportunity for us at FDA to work hand-in-hand with the CDC, researchers at the National Institutes of Health, and public health leaders in the states to make progress in combating tobacco use – the leading cause of preventable death in the United States.”

In 2002, Deyton established the VA’s Public Health Strategic Health Care Group, which encompassed responsibilities for HIV, hepatitis C, tobacco use cessation, bioterrorism, and issues such as SARS, pandemic influenza, and other emerging public health threats. He became Chief Officer in January 2006 and since then has been successful in efforts to address the health needs of veterans.

Deyton has served for 11 years in leadership positions in the National Institute of Allergy and Infectious Diseases at NIH, six years in the Office of the Assistant Secretary for Health at HHS, and as a legislative aide with the House of Representatives Subcommittee on Health and the Environment in the 1970s.

He was a founder in 1978 of the Whitman Walker Clinic, a community based AIDS service organization in Washington, D.C. He is a graduate of Kansas University, the Harvard School of Public Health and the George Washington University School of Medicine. Deyton’s post-doctorate medical training was at the University of Southern California/Los Angeles County Medical Center. He is board certified in Internal Medicine and continues to care for patients on a regular basis.

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Taking Control of Your Diabetes Conference Heads to Augusta to Bring Answers, Advocacy and Hope - February 28, 2009

/PRNewswire/ -- Taking Control of Your Diabetes (TCOYD) conference and health fair will be held February 28, 2009 at the Augusta Marriott Hotel, bringing national and local medical experts in diabetes care to people with all types of diabetes, those at risk for diabetes, and their loved ones for a day of highly informative and motivational programs.

Leading specialist will discuss practical advice and developments in the treatment of diabetes, the complications of the disease, psychological barriers to controlling diabetes, prevention, nutritional issues and much more. Health professionals from the Medical College of Georgia, University Primary Care, University Hospital, Augusta Foot and Ankle, Veterans Administration Medical Center, University Medical Associates, and a host of other diabetes specialists have partnered with Taking Control of Your Diabetes to hold this premier conference and health fair.

TCOYD participants can hear lectures, participate in screenings, and speak one-on-one with diabetes specialists including physicians, pharmacists, dieticians, certified diabetes educators and podiatrists.

A health fair with 35 informational exhibits from national and local diabetes-related companies and organizations will be open throughout the day. A banquet lunch is included and will feature special guest speaker All-Star Hawks player Dominique Wilkins who will share his inspiring story, living well with diabetes.

"With the increase in obesity, more and more Georgians are being diagnosed every day with diabetes. This conference and health fair is a great way to learn as much as you possibly can in one day and in one location from a variety of diabetes experts. We want to help individuals and families living with diabetes to be educated, motivated and empowered to take control of their diabetes," says Charles Shaefer, Jr., MD, conference co-director.

Pre-registration is recommended and financial aid is available for those who need assistance. Early registration fees are $15 per person. Registration fees include breakfast, lunch, all conference activities and materials. FINANCIAL ASSISTANCE IS AVAILABLE BY CALLING TCOYD. Onsite registration begins at 9 a.m. and costs $20. The conference is from 10:00 a.m. to 4:00 p.m. To register or get more information, call 800-998-2693 or visit www.tcoyd.org, or www.AugustaDiabetes.org.

TCOYD founder and director Steven Edelman, MD, an internationally recognized leader in diabetes treatment, research and education, who has lived with diabetes for 37 years, says, "Diabetes is demanding and people's daily decisions have an immediate impact on their health. At the same time, information about living with diabetes is complex. Education is critical to staying on top of this disease."

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