HHS WEEKLY REPORT
16-22 March 2003

THIS ISSUE AVAILABLE ONLINE WITH EXPANDED INFORMATION AND PHOTOS AT:
http://www.hhs.gov/news/newsletter/weekly

IN THIS ISSUE:
1) Secretary Thompson announces steps to reduce medication errors
2) Bush Administration acts to help America's uninsured
3) Helping Americans Climb the Career Ladder
4) Secretary Thompson announces the creation of the "Su Familia" bi-lingual helpline
5) FDA approves first drug in new class of HIV treatments
6) President's Council Chairman Lynn Swann testifies before Congress
7) Surgeon General receives smallpox vaccine

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Secretary Thompson announces steps to reduce medication errors

HHS Secretary Tommy G. Thompson announced two proposed rules from the Food and Drug Administration (FDA) that will improve patient safety by reducing medication errors and by more quickly identifying potential errors that may occur.

"These proposals are key steps in reducing medication problems through using state-of-the-art technology," Secretary Thompson said. "We will build a medical patient protection system for the 21st Century."

In addition to the human suffering they cause, medication errors represent a significant economic cost to the United States. According to the Institute of Medicine, thousands of deaths and millions of hospitalizations result from medication errors. The expected annual benefit from preventing adverse events due to medication errors is equivalent to $3.9 billion.

The new rules, part of FDA's strategic initiative to reduce adverse events involving the products it regulates, will require bar coding on medications and will improve reporting requirements for safety problems involving medicines.

The proposed requirement for bar codes adopts a technology that is widely used in other industries to reduce the number of medication errors in hospitals and other health care settings. The required bar code would contain the National Drug Code (NDC) number, unique identifying information about the drug that is to be dispensed to the patient, in a linear bar code as part of the drug label.

"When you check out at the grocery store you use barcodes, why wouldn't you use it for your prescription drugs?" Secretary Thompson said. "With this technology we will save lives, simple as that."

The second action the agency is announcing will revamp the safety reporting requirements to enhance FDA's ability to effectively monitor and improve the safe use of medications.

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Bush Administration acts to help America's uninsured

Secretary Tommy G. Thompson highlighted the President's comprehensive approach to improving access to health care and helping America's uninsured in a speech to the National Managed Health Care Congress on Tuesday, March 11.

"Lack of health insurance is a problem that has many facets and many causes, so we need to attack it on many fronts," Secretary Thompson said. "With more than 40 million Americans lacking health insurance, the President is aggressively pursuing a comprehensive approach to providing health coverage for Americans."

Since taking office, Secretary Thompson has expanded access to care by more than 2.2 million people and expanded benefits to 6.7 million other Americans by giving states significantly more flexibility in running state health care programs.

Actions proposed by President Bush include:

Expanding Direct Care Services

· Spend $169 million to increase the number of Community Health Centers across the country.
· Provide direct services in critical health areas.

Improving State Programs for Low-Income Americans

· Strengthen and modernize Medicaid.
· Allow states with flexibility by efficiently approving their SCHIP and Medicaid waiver requests.
· Extend availability of SCHIP funds.
· Extend transitional medical assistance.

Providing Individual Tax Supports for Insurance Costs

· Health credits to families and small businesses who provide health insurance
· Expanding and extending Medical Savings Accounts.

Supporting Availability of Affordable Health Care Coverage

· Support state efforts to provide access to insurance by supporting high-risk insurance pools.
· Allow small businesses to work together through Association Health Plans to provide health insurance to their employees.
· Help displaced workers retain health insurance.

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Helping Americans Climb the Career Ladder

Secretary Thompson testified before the Senate Finance Committee on March 12, to promote reauthorization of the 1996 Temporary Assistance for Needy Families (TANF) law to help millions of Americans continue to climb the career ladder and build a better life for themselves and their families

"President Bush is committed to the millions of Americans who are beginning and continuing to climb the career ladder thanks to welfare reform," Secretary Thompson said. "We will work with the Senate to take the next step in welfare reform and help families break the cycle of dependence and create a culture of independence."

President Bush's TANF proposal takes the next step in welfare reform by strengthening work requirements, providing the assistance families need to advance in their careers and granting states more flexibility to run successful programs.

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Secretary Thompson announces the creation of the "Su Familia" bi-lingual helpline

HHS Secretary Tommy G. Thompson announced the creation of the "Su Familia" National Hispanic Family Health Helpline (at 866-783-2645 / 866-SU-FAMILIA). Su Familia will help Hispanic families get basic health information to help them prevent and manage chronic conditions, and refer them to local health providers and federally supported programs including the State Children's Health Insurance Program (SCHIP).

"Hispanics continue to face health disparities. This is unacceptable," Secretary Thompson said. "That's why we are committed to getting information and resources to those communities where the health gap exists. By establishing the Su Familia helpline, we are helping families get access to the best health information."

Su Familia bilingual information specialists refer callers to one of over 16,000 local health providers, including community and migrant health centers, just by providing the callers' zip code. Callers can also request basic health information, referrals to information sources, or receive consumer-friendly, bilingual Su Familia fact sheets. Fact sheets are currently available for a wide variety of topics including: asthma, cancer screening, cardiovascular disease, child and adult immunizations, diabetes, domestic violence and HIV/AIDS.

Leading up to Diabetes Alert Day (March 25), Secretary Thompson will raise awareness of simple steps to combat the growing diabetes epidemic facing Hispanic Americans. Hispanics are nearly two times more likely to have diabetes that non-Hispanic whites. In launching the Su Familia helpline at La Clinica del Pueblo in Washington, D.C., Secretary Thompson also encouraged Hispanic Americans to commit to preventative steps against diabetes that will to lead to a healthier future.

Su Familia is supported by HHS' Health Resources and Services Administration and HHS' Office of Minority Health, and was developed and is operated by the National Alliance for Hispanic Health. The toll-free helpline is open Monday through Friday, 9 a.m. to 6 p.m. Eastern Time.

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SCIENCE IN THE NEWS

FDA approves first drug in new class of HIV treatments

The Food and Drug Administration (FDA) announced the accelerated approval of Fuzeon (enfuvirtide) for use in combination with other anti-HIV medications to treat advanced HIV-1 infection in adults and children ages 6 years and older.

"The accelerated approval of this new drug should provide new hope for those suffering from advanced HIV infection," Secretary Tommy G. Thompson said. "While we work aggressively to prevent new HIV infections across the country, we also will continue to review potential new treatments so that drugs which are proven safe and effective are made available as quickly as possible to those Americans who could benefit from them."

FDA's accelerated approval of Fuzeon makes it the first product in a new class of medications called fusion inhibitors to receive marketing approval anywhere in the world. Drugs in this class interfere with the entry of HIV-1 into cells by inhibiting the fusion of viral and cellular membranes. This inhibition blocks the virus' ability to infect certain components of the immune system.

According to the U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 850,000 to 950,000 people currently living with HIV in the U.S., with approximately 40,000 new HIV infections occurring in the U.S. every year. A significant percentage of patients with chronic HIV have developed infection resistant to many of the existing medications.

Accelerated approval is a regulatory mechanism that speeds approvals of drugs for people with serious or life-threatening illnesses. FDA bases accelerated approval for a product on laboratory markers such as CD4 cell counts and viral load, rather than on clinical endpoints such as delay in death or reduction in opportunistic infections. FDA may withdraw the approval of products granted accelerated approval if post-marketing studies fail to verify clinical benefits.

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President's Council Chairman Lynn Swann testifies before Congress

Chairman of the President's Council and Physical Fitness and Sports Lynn Swann testified before the Senate Select Committee on Aging's Hearing on Physical Activity and Nutrition on March 11.

"You're never too old to begin exercising," Chairman Swann said. "And you're never too old to reap the benefits exercise has to offer."

The President's Council is encouraging Americans of all ages to participate in at least 30 minutes of physical activity five days a week. By doing this Americans will decrease their risks of heart disease, high blood pressure, colon cancer, and type 2 diabetes.

"Building physical activity into your daily routine can help add years to your life and can make your older years a high quality time of life," Swann said.

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Surgeon General receives smallpox vaccine

U.S. Surgeon General Richard Carmona received his smallpox vaccine on March 12, to demonstrate to doctors the importance of bioterrorism preparedness.

"Today, I rolled up my sleeve to show doctors that the first step in preparedness begins with the docs," Surgeon General Carmona said. "By preparing ourselves, that takes one more weapon off the table for the terrorists to use."

Dr. Carmona was vaccinated in Washington. Over the following days, Centers for Disease Control and Prevention Director Julie Gerberding, advisor to Secretary Thompson Dr. D.A. Henderson, and Senator Bill Frist, M.D., also were vaccinated.

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