The U.S. Food and Drug Administration (FDA) is the oldest consumer protection agency in the nation. The modern era of the U.S. Food and Drug Administration (FDA) dates to 1906 with the passage of the Federal Food and Drugs Act -- this added regulatory functions to the agency's scientific mission in the interest of public health and safety. FDA ensures that products are: Safe and effective Represented honestly, accurately, and informatively Compliant with laws and regulations
The FDA has jurisdiction over twenty-five cents of every consumer dollar, focusing on six key areas: Foods (except meat and poultry) Biologics (such as blood products and vaccines) Human drugs (all medicines and over-the-counter drugs) Cosmetics Medical devices (such as contacts and pacemakers) and radiological health (such as X-rays and microwaves) Animal drugs, feed, and testing
Advocates and forms partnerships to advance women’s health Promotes research studies on a wide range of topics to enhance the understanding of women’s health Provides reliable women’s health information on a range of topics such as: Safe medication use Diabetes Mammography Heart disease HIV/AIDS Botox, tattoos, and permanent make-up Today, we will be talking about diabetes.
Over 20 million Americans have diabetes; almost 10 million are women. Diabetes is a serious chronic illness that affects women in all life stages. Women live longer than men. Diabetes increases risk of cardiovascular disease. Diabetes cost about $132 billion in 2002, that includes direct (medical expenditures) and indirect costs (loss work days). The number of women at risk for diabetes and its complications will continue to increase.
When we think about minority populations and diabetes, we know that this group is the hardest hit by type 2 diabetes. The prevalence is 2-4 higher among ethnic minority women in comparison to their white counterparts. 3.2 million African Americans over age 20 have diabetes. American Indians and Alaska Natives have the highest rates of diabetes of all ethnic/racial groups. Mexican Americans are 1.7 times more likely to have diabetes than non-Hispanic whites. There is insufficient data available for each of the Hispanic groups, however, many Hispanics are at increased risk for diabetes.
Prediabetes: impaired glucose tolerance and impaired fasting glucose People with prediabetes have higher than normal blood glucose levels, but not high enough to be classified as diabetes. Prediabetes is a condition that raises the risk of developing type 2 diabetes, heart disease, and stroke. Progression to diabetes among those with prediabetes is not inevitable. Studies have shown that people with prediabetes who lose weight and increase their physical activity can prevent or delay diabetes, and even return their blood glucose levels to normal.
Problems for the mother: Women with a history of GDM have a 20-50% chance of developing type 2 diabetes 5 to 10 years after the pregnancy. Diabetic complications can progress. Preeclampsia—a hypertensive disorder , or high blood pressure, occurring only during pregnancy and postpartum, and affecting both the mother and the baby. Problems for the baby: Large for Gestational Age (LGA): Diabetes during pregnancy causes the mother's increased blood glucose (sugar) to circulate to the baby. In response, the baby's body makes insulin. All the extra sugar and the extra insulin production can lead to excessive growth and deposits of fat, thus, a larger baby. Prematurity. Neonatal complications: low glucose, jaundice. 10x increased risk for obesity during childhood and adolescence; and therefore is also at risk for developing type 2 diabetes later in life. Intrauterine death. Congenital abnormalities.
In 1994, 14 states had an age-adjusted prevalence of diagnosed diabetes of less than 4%, and only two states had an age-adjusted prevalence of 6% or greater.
However, by 2004, no state had an age-adjusted prevalence of diagnosed diabetes of less than 4%, and 39 states had an age-adjusted prevalence of 6% or greater.
This side-by-side comparison shows the increasing prevalence (existing cases) of diagnosed diabetes among the adult populations of states between 1994 and 2004. Among the 49 states having data for 1994 and 2004, the age-adjusted prevalence of diagnosed diabetes was at least 50% higher in 2004 than in 1994 in 23 states (Alabama, Florida, Georgia, Idaho, Indiana, Kentucky, Maine, Mississippi, Montana, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Virginia, Washington, West Virginia, Wyoming).
Methodology The percent of U.S. adults who are obese or who have diagnosed diabetes was determined by using data from the Behavioral Risk Factor Surveillance System (BRFSS, available at http://www.cdc.gov/brfss ). An ongoing, yearly, state-based telephone survey of the non-institutionalized adult population in each state, the BRFSS provides state-specific information on behavioral risk factors for disease and on preventive health practices. Respondents who reported that a physician told them they had diabetes (other than during pregnancy) were considered to have diagnosed diabetes. Self reported weight and height were used to calculate body mass index (BMI): weight in kilograms divided by the square of height in meters. A BMI greater than or equal to 30 was considered to be obese. Rates were age-adjusted using the 2000 U.S. Standard Population.
Diabetes is associated with an increased risk for a number of serious, and sometimes life-threatening complications. Certain populations experience an even greater threat. Heart disease and stroke account for about 65% of deaths in people with diabetes. Diabetes is the leading cause of new cases of blindness. Diabetes is the leading cause of kidney failure Amputations are 10 times higher. Can cause complications during pregnancy. Diabetes can affect any part of your body. Adults with diabetes have heart disease death rates about 2 to 4 times higher than adults without diabetes and the risk of stroke is 2 to 4 times higher. In women with diabetes, deaths from heart disease have increased 23% over the past 30 years compared to a 27% decrease in women without diabetes. About 73% of adults with diabetes have blood pressures greater than or equal to 130/80 or use prescription medications for hypertension. Diabetic retinopathy causes 12,000 to 24,000 new cases of blindness in adults 20-74 years of age each year. Diabetes is the leading cause of kidney failure, accounting for 44% of new cases in 2002. The rate of amputation for people with diabetes is 10 times higher than for people without diabetes. Poorly controlled diabetes before conception and during pregnancy can cause major complications, posing a risk for both mother and child. Many people are not aware they have diabetes until they develop one of its complications.
Sensory changes, such as vision, hearing, smell, and taste Poor dentition, such as difficulties in food consumption Decreased exercise and mobility due to arthritis, etc. Cognitive and psychological problems such as depression, cognitive impairment and dementia Effects of other chronic diseases, such as increased frailty, toxic effects of poly-pharmacy
While diabetes is an extremely serious condition, there are steps women can take to manage the disease under a doctor's supervision. We'll go into more detail in a moment on each of these points: Watch what you eat and get exercise. Use medicines wisely. Check your blood sugar and know your “ABCs.” The FDA food label can help you.
The first step in managing diabetes: Watch what you eat and get exercise. There is no one diet for people with diabetes. Work with your health care team to come up with a plan for you. Be active at least 30 minutes a day, most days of the week. Exercise helps your body use insulin better.
The next step in managing diabetes: Use medicines wisely. Sometimes people with diabetes need to take pills or shots. Follow the directions. Ask your doctor, nurse, or pharmacist how your medicines work. Ask when to take them and if they have any side effects.
The third step in managing diabetes: Check your blood sugar and know your “ABCs.” Talk to your health care team about your “ABCs”...an easy-to-remember acronym that stands for: A-1-C blood sugar level (you want a score of less than 7). Blood pressure (should be maintained at less than 130/80). Cholesterol (less than 200 overall; LDL less than 100; HDL greater than 60). Improved control of cholesterol or, blood lipids, (for example, HDL, LDL, and triglycerides) can reduce cardiovascular complications by 20-50%. Blood lipid is the fat in the bloodstream; it's measured with a lipid profile blood test. The lipid profile test measures: Total cholesterol: the fat produced by the liver and found in some foods. Triglycerides: the storage form of fat in the body. HDL cholesterol: the fat that takes extra cholesterol from the blood to the liver for removal (&quot;good cholesterol&quot;). LDL cholesterol: the fat that takes excess cholesterol in the body to where it’s needed, but too much of it collects on the inside of artery walls (&quot;bad cholesterol&quot;). Keep your blood sugar, blood pressure, and cholesterol under control to help prevent heart disease and stroke. Ask your doctor for an A-1-C (“A-one-see”) blood test, which checks blood sugar levels over 2-3 months.
The TTTC outreach program has a number of goals: Discuss the need for a national public health agenda on diabetes and women’s health Prevent or delay diabetes whenever possible Provide needed support to women at risk Promote appropriate care and medical product use Prevent, delay, and minimize occurrence of complications Highlight strategies for action Discuss personal involvement opportunities
Many other organizations have partnered with the FDA OWH to assist in delivering the TTTC message. Among the most involved include … (Read the list.)
TTTC delivers three key messages to women with diabetes. We keep repeating them because they are so important. Watch what you eat and exercise. Use medicines wisely. Check blood sugar and know your “ABCs:” A -1-C Level B lood Pressure C holesterol
Publications comprise a key element of the TTTC educational process. Publications include: My Medicines brochure. Diabetes brochure. Diabetes fact sheet . Diabetes recipes cards (includes Hispanic/Latino culturally-appropriate recipes). The My Medicines and diabetes brochures are available in English, Spanish, and several Asian languages.
The My Medicines brochure has been a very effective tool in educating women and their families about the basics of safe medication use. It was developed by FDA’s Office of Women’s Health and the National Association of Chain Drug Stores. The brochure is available in many languages, including Chinese, Hmong, Japanese, Korean, Laotian, Samoan, Tagalog, Thai, Russian, Polish and Spanish. The key messages are simple: Read the label Avoid problems Ask questions Keep a record
This is the newly designed diabetes fact sheet. We updated the information and it replaces the diabetes brochure. The fact sheet covers the following topics: What is diabetes? Are you at risk? What can you do?
The diabetes recipes card was developed by FDA’s Office of Women’s Health, the National Association of Chain Drug Stores, and the American Diabetes Association. The recipes are: Tasty Healthy There are also recipes that are culturally appropriate for Hispanic/Latino communities .
Phase I focused more on clinical assessments. Here are highlights of the results: Conducted 4,000 clinical assessments in 240 drug stores. 1,900 of the 4,000 had already been diagnosed with diabetes. 1,800 people were given the American Diabetes Association risk assessment. 46% of the 1,800 assessed scored above the target number of 7 on the A-1-C test. Phase II emphasized public awareness. As you can see, the effort reached millions of people: Distributed 5 million brochures nationwide via 3,200 drug store outlets. 58% reached were female; 42% male. 89% were over 40 years old. Reached 50,000 through nurses in high-risk minority communities.
The final message of TTTC and of my presentation to you today is simple: Join us! Your involvement is crucial in successfully raising awareness of diabetes among women and their families throughout the U.S. We encourage you to join our team and to develop your own Take Time To Care activity about diabetes. To join us as a partner, or for more information about our office and the Take Time To Care program, go to our website at http://www.fda.gov/womens. I hope you will make the most of all these FREE resources: To download free information: http://www.fda.gov/womens To order free materials: http://www.pueblo.gsa.gov/cic_shop/orderinfo.htm Questions: 1-800-DIABETES (1-800-342-2383) More information is available online: http://www.diabetes.org http://www.fda.gov/womens http://www. fda.gov/womens/taketimetocare/diabetes
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Diabetes for keiro (Japanese)
糖尿病 <ul><li>敬老ヘルシー・エイジング </li></ul><ul><li>研究機関 </li></ul>Take Time To Care