FDA Approves Viibryd to Treat Major Depressive Disorder

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.

"Major depressive disorder is disabling and prevents a person from functioning normally," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression."

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

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Surveys show significant proportions of hospitals and doctors already plan to adopt electronic health records and qualify for federal incentive payments

Four-fifths of the nation's hospitals, and 41 percent of office-based physicians, currently intend to take advantage of federal incentive payments for adoption and meaningful use of certified electronic health records (EHR) technology, according to survey data released today by the Office of the National Coordinator for Health Information Technology (ONC). The survey information was released as the registration period opened for the Medicare and Medicaid EHR Incentive Programs.

David Blumenthal, M.D., M.P.P., the National Coordinator for Health Information Technology, said the survey numbers represent a reversal of the low interest in EHR adoption in previous years. He credited leadership from the medical community and the federal government for the improved prospects for adoption and use of health information technology (health IT).

"For years we have known that electronic health records would improve care for patients and bring about greater cost effectiveness in our health sector, yet adoption rates by health care providers remained low," Dr. Blumenthal said. "In 2009, Congress and the President authorized major new federal support for EHR adoption and use, and in combination with medical professional and hospital leadership, I believe we are seeing the tide turn toward widespread and accelerating adoption and use of health IT."

The data released today comes from surveys commissioned by ONC and carried out in the course of regular annual surveillance by the American Hospital Association (AHA) and the National Center for Health Statistics (NCHS), an agency of HHS' Centers for Disease Control and Prevention (CDC).

The AHA survey found that 81 percent of hospitals plan to achieve meaningful use of EHRs and take advantage of incentive payments. About two-thirds of hospitals (65 percent) responded that they will enroll during Stage 1 of the Incentive Programs, in 2011-2012.

The NCHS survey found that 41 percent of office-based physicians are currently planning to achieve meaningful use of certified EHR technology and take advantage of the incentive payments. Four-fifths of these, or about a third of all office-based physicians (32.4 percent), responded that they will enroll during Stage 1 of the programs. Only 14 percent of respondents said they were not planning to apply for meaningful use incentives.

Additional survey data from NCHS show that significantly increasing numbers of primary care physicians have already adopted a basic EHR, rising by 50 percent from 19.8 percent of primary care physicians in 2008 to 29.6 percent in 2010. Basic EHRs provide a beginning point for use of electronic health records in physician offices, but most physicians would need to further upgrade their EHR systems or their use of the systems in order to qualify for meaningful use incentive payments.

Incentive payments for the adoption and meaningful use of certified EHR technology were authorized in the Health Information Technology Economic and Clinical Health Act (HITECH) in 2009. Incentive payments will be made through the Medicare and Medicaid programs. High rates of adoption and meaningful use could result in as much as $27 billion in incentive payments over 10 years.

Non-hospital-based physicians and other eligible professionals can obtain incentive payments of as much as $44,000 under Medicare or $63,750 under Medicaid. Under both Medicare and Medicaid, eligible hospitals may receive millions of dollars for implementing and meaningfully using certified EHR technology.

Provider registration for the Medicare EHR Incentive Program and some Medicaid EHR Incentive Programs opened Jan. 3, 2011. Most states will allow provider registration to begin for their Medicaid EHR Incentive Programs during the spring and summer of 2010.

"We are pleased to see this evidence of an enthusiastic early response, and we believe participation will continue to grow, especially as the Nation's physicians become more familiar with this one-time opportunity to improve care while helping to offset the costs of adopting EHR systems," said Donald Berwick, M.D., Administrator of the Centers for Medicare & Medicaid Services (CMS).

To qualify for incentive payments, under the Medicare EHR Incentive Program, providers must achieve meaningful use of certified EHR technology, under regulations issued by CMS and ONC. Medicaid providers can receive their first year's incentive payment for adopting, implementing, and upgrading certified EHR technology but must demonstrate meaningful use in subsequent years in order to qualify for additional payments.

Dr. Blumenthal said the meaningful use process has contributed to the increased willingness of providers to adopt EHR systems, especially because it guides providers through staged objectives for the productive use of EHRs, and because providers can now be assured that Complete EHRs and EHR Modules certified under ONC criteria by ONC-authorized testing and certification bodies can be relied upon to support the meaningful use objectives.

He also pointed to the technical support programs created under the HITECH Act and now operating under ONC, which offer support to providers as they switch from paper records to EHRs. In particular, 62 Regional Extension Centers (RECs) across the nation will offer customized, on-the-ground assistance, especially for smaller-practice primary care providers and for small hospitals and clinics.

"We know that adoption of EHRs and conversion to EHR-based care is expensive and challenging, especially for smaller providers," Dr. Blumenthal said. "With HITECH, we are able to provide unprecedented funding and technical support programs to help providers make the transition and to help our nation achieve the improvements in health care quality, safety and cost effectiveness EHRs will bring about."

Dr. Blumenthal also praised medical professional organizations and hospital leaders, who have encouraged members to act soon in taking advantage of HITECH support programs and adopting EHR systems.

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HHS Announces Health Center Planning Grant Opportunity

/PRNewswire/ -- HHS Secretary Kathleen Sebelius today announced up to $10 million in funding for a Health Center Planning Grant (HCPG) opportunity for organizations across the country that would like to become a Community Health Center. The HCPG opportunity is intended to support organizations in the future development of a health center and will support approximately 125 HCPGs in FY 2011.

The Health Resources and Services Administration (HRSA) administers the Health Center Program. Health centers improve the health of the Nation's underserved communities and vulnerable populations. They assure access to comprehensive, culturally competent, quality primary health care services at more than 7,900 service delivery sites around the country to patients regardless of their ability to pay; charges for services are set according to income.

"This funding opportunity in the Affordable Care Act will help nurture organizations that answer the noble call to assist those who are medically underserved, underinsured and uninsured," said Secretary Sebelius.

"The HCPG grants help organizations qualify to become CHCs, which increases HRSA's ability to serve more people," said HRSA Administrator Mary K. Wakefield , Ph.D., R.N. "From oral health, behavioral health, to maternal wellness and serving those in rural communities, community health centers increase access for those in need of high quality preventive and primary health care."

Eligible entities for the FY 2011 HCPG include public or nonprofit private entities, including tribal, faith-based and community-based organizations that currently do not receive the following section 330 funding awards:

* Planning Grants
* Community Health Centers
* Migrant Health Centers
* Health Care for the Homeless
* Public Housing Primary Care Programs
* Primary Care Associations


For more information about eligibility, guidance and application submission for the HCPG, visit www.grants.gov. For more information on HRSA's community health center program, visit http://bphc.hrsa.gov/. For more information about Affordable Care Act investments in community health centers, visit www.HealthCare.gov.

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HHS and EPA announce new scientific assessments and actions on fluoride

The U.S. Department of Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA) today are announcing important steps to ensure that standards and guidelines on fluoride in drinking water continue to provide the maximum protection to the American people to support good dental health, especially in children. HHS is proposing that the recommended level of fluoride in drinking water can be set at the lowest end of the current optimal range to prevent tooth decay, and EPA is initiating review of the maximum amount of fluoride allowed in drinking water.

These actions will maximize the health benefits of water fluoridation, an important tool in the prevention of tooth decay, while reducing the possibility of children receiving too much fluoride. The Centers for Disease Control and Prevention named the fluoridation of drinking water one of the ten great public health achievements of the 20th century.

“One of water fluoridation’s biggest advantages is that it benefits all residents of a community—at home, work, school, or play,” said HHS Assistant Secretary for Health Howard K. Koh, MD, MPH. “Today’s announcement is part of our ongoing support of appropriate fluoridation for community water systems, and its effectiveness in preventing tooth decay throughout one’s lifetime.”

“Today both HHS and EPA are making announcements on fluoride based on the most up to date scientific data,” said EPA Assistant Administrator for the Office of Water, Peter Silva. “EPA’s new analysis will help us make sure that people benefit from tooth decay prevention while at the same time avoiding the unwanted health effects from too much fluoride.”

HHS and EPA reached an understanding of the latest science on fluoride and its effect on tooth decay prevention and the development of dental fluorosis that may occur with excess fluoride consumption during the tooth forming years, age 8 and younger. Dental fluorosis in the United States appears mostly in the very mild or mild form – as barely visible lacy white markings or spots on the enamel. The severe form of dental fluorosis, with staining and pitting of the tooth surface, is rare in the United States.

There are several reasons for the changes seen over time, including that Americans have access to more sources of fluoride than they did when water fluoridation was first introduced in the United States in the 1940s. Water is now one of several sources of fluoride. Other common sources include dental products such as toothpaste and mouth rinses, prescription fluoride supplements, and fluoride applied by dental professionals. Water fluoridation and fluoride toothpaste are largely responsible for the significant decline in tooth decay in the U.S. over the past several decades.

HHS’ proposed recommendation of 0.7 milligrams of fluoride per liter of water replaces the current recommended range of 0.7 to 1.2 milligrams. This updated recommendation is based on recent EPA and HHS scientific assessments to balance the benefits of preventing tooth decay while limiting any unwanted health effects. These scientific assessments will also guide EPA in making a determination of whether to lower the maximum amount of fluoride allowed in drinking water, which is set to prevent adverse health effects.

The new EPA assessments of fluoride were undertaken in response to findings of the National Academies of Science (NAS). At EPA’s request, in 2006 NAS reviewed new data on fluoride and issued a report recommending that EPA update its health and exposure assessments to take into account bone and dental effects and to consider all sources of fluoride. In addition to EPA’s new assessments and the NAS report, HHS also considered current levels of tooth decay and dental fluorosis and fluid consumption across the United States.

The notice of the proposed recommendation will be published in the Federal Register soon and HHS will accept comments from the public and stakeholders on the proposed recommendation for 30 days at CWFcomments@cdc.gov. HHS is expecting to publish final guidance for community water fluoridation by spring 2011. You may view a prepublication version of the proposed recommendation at ­­­­­­­­­­­­­­­­­­­ http://www.hhs.gov/news/press/2011pres/01/pre_pub_frn_fluoride.html. Comments regarding the EPA documents, Fluoride: Dose-Response Analysis For Non-cancer Effects and Fluoride: Exposure and Relative Source Contribution Analysis should be sent to EPA at FluorideScience@epa.gov. The documents can be found at http://water.epa.gov/action/advisories/drinking/fluoride_index.cfm

For more information about community water fluoridation, as well as information for health care providers and individuals on how to prevent tooth decay and reduce the chance of children developing dental fluorosis, visit http://www.cdc.gov/fluoridation. For information about the national drinking water regulations for fluoride, visit: http://water.epa.gov/drink/contaminants/basicinformation/fluoride.cfm


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CDC Unveils New Adult Vaccination Rates; nfid Surveys Illuminate Barriers to Vaccine Uptake

/PRNewswire/ -- New data from the Centers for Disease Control and Prevention (CDC) show that adults remain largely unvaccinated against preventable infectious illnesses. At a news conference convened today by the National Foundation for Infectious Diseases (NFID), experts in public health, infectious disease, oncology and other medical specialties discussed the data and the health consequences for adults who skip vaccines. They collectively called on all adults and health care providers to improve vaccination rates.

"For more than six decades, vaccines have protected us from infectious illnesses that have a wide range of consequences, from lost work days and inability to meet our daily obligations, to pain, discomfort, hospitalization, long-term disability and death," said Susan J. Rehm, M.D., NFID medical director. According to Dr. Rehm, by foregoing needed vaccines, adults not only leave themselves vulnerable to sickness, but they expose those around them to unnecessary risks, too.

This problem is evident right now, as pertussis (whooping cough) continues to claim the lives of infants in California, while adults, who are frequently responsible for transmitting the disease to infants, fail to get the one-time pertussis booster vaccine. The impact of other vaccine-preventable infections may not be as immediately apparent, but they are no less important. Other vaccines for adults protect against viruses that cause several types of cancer, reactivation of the chickenpox virus that causes shingles later in life, and infection with bacteria that are the leading cause of community-acquired pneumonia.

New survey results from NFID suggest that doctor/patient communication challenges may be at least part of the problem. While physicians perceive they are encouraging their adult patients to be vaccinated, patients say the topic of vaccination rarely comes up during their doctor visits.

Vaccination rates highest among seniors; lowest among minority groups

In unveiling the adult vaccination data from the 2009 National Health Interview Survey (NHIS), Melinda Wharton, M.D., M.P.H., deputy director of the National Center for Immunization and Respiratory Diseases at the CDC, noted that the highest immunization rates are among older Americans, who tend to be vaccinated against influenza and pneumococcal infections. She suggested that one reason for this might be that older persons tend to have more routine visits with health care providers, providing more opportunities to learn about and adopt good preventive care behaviors.

"A good ongoing relationship with your medical provider is positive for so many reasons," said Dr. Wharton, "not least of which is that you will have an ongoing opportunity learn about the best ways to stay healthy, including the best preventive care choices like vaccines."

While adult vaccination rates are showing slow improvement overall, one vaccination trend Dr. Wharton specifically noted is the 7.4 percent decrease in pneumococcal vaccination rate in high-risk adults 19 to 64 years of age. She pointed out that this is not because people are suddenly foregoing this vaccine. Rather, the decrease reflects the recent addition of new risk groups -- namely smokers and people with asthma -- increasing the pool of people who should get the vaccine. Dr. Wharton called on smokers and people with asthma to check with their physicians or other health care providers about this vaccine.

In addition to generally low adult vaccination rates, Dr. Wharton touched on the problem of racial and ethnic vaccination disparities. While strides have been made to close racial and ethnic gaps, some significant vaccination gaps continue to exist among Whites, Blacks and Hispanics.

Vaccine (age and/or risk status)	Non- Hispanic White (%)	Non- Hispanic Black (%)	Hispanic or Latino (%)
Tetanus, diphtheria, pertussis (19-64 years)	51	54	49
Pneumococcal (65 years and older)	65	45	40
Pneumococcal (19-64 years, high risk)	18	18	12
Hepatitis B (19-49 years, high risk)	43	44	37
HPV (19-26 years)	20	13	13
Shingles (60 years and older)	11	4	5
Influenza (65 years and older)	69	51	51
Influenza (50-64 years)	42	37	31

The NHIS survey also reported vaccination rates in health care professionals for influenza (up 7 percent, to 53 percent), hepatitis B (up 2.5 percent, to 65 percent) and Tdap (up 1.6 percent, to 58 percent). "It's gratifying to see health care worker vaccination rates continue to increase," said CDC's Melinda Wharton. "By modeling good preventive care behaviors our health care professionals are truly leading the way as good partners in their relationship with patients." The NHIS vaccination data include anyone employed in a health care occupation or setting. In contrast, physician-only vaccination rates are much higher (>90 percent for influenza) as reported in two separate NFID surveys fielded before and during the current influenza season.

Doctor/patient communication breakdown a factor in low vaccination rates

A dramatic physician-patient communication disconnect was revealed by new data from two NFID surveys. Nearly 90 percent of primary care physicians say they discuss vaccines with their patients, yet in a separate survey of consumers, almost half cannot recall ever discussing vaccines with their physicians. As further evidence of the communication gap between physicians and their patients, 99 percent of physicians say that they or their staff initiates vaccine discussions, but just 44 percent of patients say that is true.

"Busy primary care physicians think they're doing a good job recommending vaccines, but the survey indicates that patients aren't getting the message," suggested Dr. Rehm. "Consumers overwhelmingly said they look to physicians for vaccine recommendations and are likely to act on those recommendations, so it's clear that we physicians need to be more effective in communicating with our patients."

Among the positive findings, consumer familiarity with vaccine-preventable illnesses is rising, although still limited. Familiarity with specific vaccine-preventable diseases rose 4 to 12 percent compared with results from a 2009 survey, with the largest increase for pertussis vaccine. The only vaccine-preventable disease not to register an increase in familiarity is pneumococcal vaccine. Consumers also report that they rarely refuse vaccines if their physicians recommend them.

A realized consequence: disease resurgence

The ongoing pertussis epidemic in California demonstrates the danger still posed by diseases once thought to be gone in the U.S. There are reports of more than 6,400 cases so far in California this year, the most since 1958. While pertussis can affect people of any age and in fact, national rates have been rising in adults, it is the infants who adults pass this on to who bear the burden. Ten infants, all younger than three months, have died from whooping cough in California this year.

Patrick Joseph, M.D., a California infectious disease physician who is NFID's vice president, implored adults to get the one-time booster vaccine, "While the epidemic is in adults, the tragedy is in kids. The situation is grave when babies too young to be immunized are dying."

Dr. Joseph said this crisis means California doesn't have the luxury of bringing people along slowly. The time to increase vaccination rates for pertussis is now. The California Department of Public Health recommends pertussis boosters for all adults, including those over 65, a move supported by the CDC's Advisory Committee on Immunization Practices (ACIP). At its October meeting, ACIP voted to extend pertussis booster vaccination recommendations to include adults 65 and older nationwide.

While California has been hardest hit so far, many other areas have seen increased cases this year, including Ohio, South Carolina, Michigan, Texas, Idaho, upstate New York and the Philadelphia suburbs. Since pertussis knows no boundaries, Dr. Joseph voiced his hope that adults outside his home state would also take notice and seek a Tdap vaccine now to protect themselves and infants around them.

Importance of pneumococcal and influenza vaccines also highlighted

AARP board member Catherine Georges, R.N., Ed.D., reminded adults that the time to get an influenza vaccine is now. "We know it's important for Americans of all ages to go out now and get the flu vaccine, but it's even more critical for people 50-plus," said Dr. Georges, a registered nurse and professor and chair of the department of nursing at Lehman College and the Graduate Center at the City University of New York. "Older Americans are often caring for their children and for older loved ones. Getting vaccinated not only protects you, but also helps protect your family and friends." Dr. Georges echoed the universal recommendation from CDC for influenza vaccination of all Americans six months and older.

Since pneumococcal infection is an all too frequent complication of influenza, Dr. Georges reminded Americans that, "pneumococcal and influenza vaccines can be given at the same medical visit." Pneumococcal vaccine is recommended for everyone 65 and older and for younger adults with certain risk factors or conditions like asthma, smoking, heart disease and diabetes. For most people, pneumococcal is a one-time vaccination.

Alarmingly few Americans immunized against debilitating disease of shingles

The lowest vaccination rate for a routinely recommended vaccine is for the shingles vaccine, which is recommended for everyone starting at age 60. Only ten percent of eligible persons have received the shingles vaccine. Not only does the likelihood of getting shingles increase with age, so does the severity of shingles pain, which can last long after the shingles rash has disappeared (this pain is known as post-herpetic neuralgia, or PHN). This pain diminishes quality of life and functional capacity as much as congestive heart failure, a heart attack, type II diabetes or major depression.

Adults in the NFID survey say they are familiar with shingles, but further questioning reveals knowledge gaps; for instance, 42 percent do not know that anyone who has had chickenpox is at risk for shingles. Still, adults are aware of the pain of the disease; 55 percent say they "know someone who has had it and it was terrible." Unfortunately, only half of adults even know there is a shingles vaccine available and just 16 percent know it is currently recommended for everyone 60 and older.

"Shingles can be a terribly painful and debilitating disease, particularly in the elderly," said Jeffrey Cohen, M.D., chief of the Laboratory of Infectious Disease at the National Institute of Allergy and Infectious Diseases. "Shingles pain can be very difficult to treat. Current therapies are only somewhat effective and often associated with frequent and problematic side effects, especially in older people, which is why it is vitally important that we educate Americans about the vaccine."

Vaccines prevent cancer

"Human papillomavirus (HPV) not only causes cervical cancer, but also a growing portion of head and neck cancers," according to Maura Gillison, M.D., Ph.D, Jeg Coughlin Chair of Cancer Research at the Ohio State University College of Medicine. "Twenty years ago about 40 percent of these cancers were due to HPV; today that number is over 60 percent in the U.S. Even more alarming is that these cancers are happening in younger people without traditional risk factors—smoking and alcohol consumption."

The hepatitis B vaccine also protects against certain cancers. The hepatitis B virus causes 30 percent of all liver cancers in the U.S. and doubles the risk of non-Hodgkin's lymphoma. Both HPV and hepatitis B viruses are common. An estimated 70 percent of Americans will be infected with HPV in their lifetime and up to 1.4 million Americans have chronic hepatitis B infection.

CDC recommends HPV vaccine for all women 19 to 26 years of age if not previously vaccinated and recommends the hepatitis B vaccine for all sexually active adults who are not in a long-term, mutually monogamous relationship and others in more defined risk groups.

"I urge everyone to get the HPV and hepatitis B vaccines as recommended," said Dr. Gillison. "These vaccines are truly life-saving. As a cancer-specialist, I can tell you that prevention is a far better option than treatment. These are not cancers you want to have or want your kids to have."

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Study: Starting with Chiropractic Saves 40% on Low Back Pain Care

(BUSINESS WIRE)--A new study finds that low back pain care initiated with a doctor of chiropractic (DC) saves 40% on health care costs when compared with care initiated through a medical doctor (MD), the American Chiropractic Association (ACA) announced today. The study, featuring data from 85,000 Blue Cross Blue Shield beneficiaries, concludes that insurance companies that restrict access to chiropractors for low back pain treatment may inadvertently pay more for care than they would if they removed such restrictions.

Low back pain is a significant public health problem. Up to 85 percent of Americans have back pain at some point in their lives. In addition to its negative effects on employee productivity, back pain treatment accounts for about $50 billion annually in health care costs—making it one of the top 10 most costly conditions treated in the United States.

The study, “Cost of Care for Common Back Pain Conditions Initiated With Chiropractic Doctor vs. Medical Doctor/Doctor of Osteopathy as First Physician: Experience of One Tennessee-Based General Health Insurer,” which is available online and will also be published in the December 2010 issue of the Journal of Manipulative and Physiological Therapeutics, looked at Blue Cross Blue Shield of Tennessee’s intermediate and large group fully insured population over a two-year span. The insured study population had open access to MDs and DCs through self-referral, and there were no limits applied to the number of MD/DC visits allowed and no differences in co-pays.

Results show that paid costs for episodes of care initiated by a DC were almost 40 percent less than care initiated through an MD. After risk-adjusting each patient’s costs, researchers still found significant savings in the chiropractic group. They estimated that allowing DC-initiated episodes of care would have led to an annual cost savings of $2.3 million for Blue Cross Blue Shield of Tennessee.

“As doctors of chiropractic, we know firsthand that our care often helps patients avoid or reduce more costly interventions such as drugs and surgery. This study supports what we see in our practices every day,” said ACA President Rick McMichael, DC. “It also demonstrates the value of chiropractic care at a critical time, when our nation is attempting to reform its health care system and contain runaway costs.”

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New National Electronic Health Record Safety System Launched

/PRNewswire/ -- A new electronic health record (EHR) safety reporting system was announced today by the iHealth Alliance, a not-for-profit organization composed of medical society and professional liability carrier executives in collaboration with federal agencies and PDR Network. EHRevent.org establishes a national system where physicians and other health care providers can report issues related to the implementation and use of EHRs.

Using a standardized online format, EHRevent will collect reports from physicians and other health care providers who use EHRs and create reports that medical societies, professional liability carriers and government agencies, such as the U.S. Food and Drug Administration (FDA), will use to help educate providers on the potential challenges that EHR systems may bring. The system will be available directly via the Internet at www.EHRevent.org and also integrated into the web sites of participating liability carriers, medical societies, PDR Network and other partners, including EHR system vendors.

EHRevent was modeled after other national reporting systems, including the system used in the aviation industry, and its reports include issues related to software problems, inadequate user training, security breaches and near-misses. Reports will be confidential but used to better understand challenges associated with the adoption and implementation of EHRs and to improve patient safety.

"Electronic health records are being adopted at record rates and present an opportunity to advance patient care," said Nancy Dickey, M.D., iHealth Alliance chair and former president of the American Medical Association. "As with any new system, there is a learning curve for the software providers and for the doctors who use these systems. EHRevent will help us all get smarter about EHRs and assure that patient care advances are also patient-safe advances."

Professional liability carriers who insure doctors against malpractice claims are among the strongest supporters of EHRevent.

"EHRs can impact both the care that is delivered and the record of that care," explained David Troxel, M.D., medical director for The Doctors Company, which is the country's largest professional liability carrier. "EHRs can play a major role in advancing the practice of good medicine, but there are often unanticipated consequences when new technologies are deployed and it is important to collect and disseminate EHR user experience as these powerful systems are adopted."

Alan Lembitz, M.D., vice president of Patient Safety and Risk Management for COPIC Insurance Company, added, "Our experience indicates that EHRs have the capacity either to induce or to reduce medical errors in very unique ways, and we have seen data that indicates that EHR adoption may reduce physician liability. It will be increasingly important to understand best practices to improve patient safety for EHRs and for their users, and EHRevent will help both."

EHRevent is also working directly with EHR vendors as well as Regional Extension Centers (RECs), which are federally designated groups that assist physicians with EHR selection and adoption. Participating EHR vendors and RECs will help educate physicians regarding the importance of EHR event reporting and will receive reports as EHRevent partners.

"Patient safety is at the core of our mission to assist in the adoption of EHRs," explained Kathy Mechler, co-director and chief operating officer for the Texas A&M Health Science Center Rural and Community Health Institute, which includes the CentrEast REC. "We look forward to working with the many EHRevent partners to help educate providers and drive safe EHR adoption."

Michael Stearns, M.D., president and CEO of e-MDs, Inc., a leading EHR vendor, and board president of the Texas e-Health Alliance said, "EHRs have tremendous potential to improve the quality and efficiency of healthcare, but like any tool they must be designed and implemented in a way that uses best practices that strive to eliminate medical errors. We are anxious to collaborate with the EHRevent effort and we encourage all EHR vendors to participate because we believe that EHRevent can be an important communication platform to improve patient safety related not only to EHRs but to medical devices and drugs."

Data collected by EHRevent will also be used by the FDA to help evaluate any safety issues that may arise during the widespread implementation of this technology.

"We applaud the efforts of the iHealth Alliance to help assure the safety of EHRs," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "We look forward to working with the iHealth Alliance to encourage physicians and EHR vendors to report information on their experiences with electronic health records to EHRevent and other appropriate reporting systems."

EHRevent and a similar service for reporting adverse drug events via EHRs will be governed by the iHealth Alliance, with network operations provided by PDR Network. PDR Network CEO, Edward Fotsch, M.D. explained, "EHRevent, and RxEvent for adverse drug events, will collect information using online forms that include the Common Format developed by the Agency for Healthcare Research and Quality (AHRQ) and will keep the information confidential through PDR Secure, a Patient Safety Organization, allowing only participating organizations to access the reports.

"We know that clinicians and health care organizations want to participate in efforts to improve patient care," said William Munier, M.D. Director for the Center for Quality Improvement and Patient Safety, AHRQ. "Patient Safety Organizations (PSOs) facilitate a shared-learning approach that supports effective interventions to reduce risk of harm to patients and improve quality. We are collaborating in efforts to facilitate reporting to PSOs those adverse events that are related to EHRs and other health information technology, in order to facilitate the development of safer health information technology solutions."

Starting today, U.S. physicians and other healthcare professionals will learn about and be encouraged to use EHRevent by their medical societies, liability carriers, the FDA, PDR Network and other participating groups.

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Patients Who Survive Sepsis Infections Are More Than Three Times as Likely to Develop Cognitive Problems

/PRNewswire/ -- Older adults who survive severe sepsis are at higher risk for long-term cognitive impairment and physical limitations than those hospitalized for other reasons, according to researchers from the University of Michigan Health System.

Research to be published Oct. 27 today in the Journal of the American Medical Association showed that 60 percent of hospitalizations for severe sepsis were associated with worsened cognitive and physical function among surviving older adults. The odds of acquiring moderate to severe cognitive impairment were 3.3 times higher following an episode of sepsis than for other hospitalizations.

Severe sepsis also was associated with greater risk for the development of new functional limitations following hospitalization, says lead author, Theodore (Jack) Iwashyna, M.D., Ph.D., assistant professor of internal medicine at U-M.

Among patients who had no limitations before sepsis, more than 40% developed trouble with walking. Nearly 1 in 5 developed new problems with shopping or preparing a meal. Patients often developed new problems with such basic things as bathing and toileting themselves.

"We used to think of sepsis as just a medical emergency, an infection that you get sick with and then recover," said Iwashyna, "But we discovered a significant number of people face years of problems afterwards.

"Those problems are bigger and more common than we expected. Most older Americans suffer real brain and body problems. We need new treatments, not just for the sepsis infection, but to prevent these new disabilities afterwards."

Sepsis is an overwhelming infection that can result in failure of multiple organ systems. The initial infections are often common problems, such as pneumonia or a urinary tract infection. About 40 percent of those with severe sepsis die from the infection.

Anyone can get sepsis, but older people and those with weakened immune systems are most vulnerable. Sepsis is probably the most common cause of critical illness in the United States.

The best data available are from the 1990s, when it was estimated that 750,000 people each year were diagnosed with sepsis. Researchers believe that number has doubled each decade.

"These new data show a majority of older patients suffer with real life-changing burdens after beating sepsis. This is an underrecognized public health problem with major implications for patients, families and the health care system," Iwashyna says.

"We need to make sure families have the resources they need to care for survivors of sepsis when they go home. It's not enough just to get them through the acute episode. We need to start preparing them for the years of problems they may have afterwards."

"This research underscores the need for physicians who care for older adults to focus early on preventing infections that can lead to sepsis," says study co-author Kenneth M. Langa, M.D., Ph.D., a core investigator for the Ann Arbor Veterans Administration Health Services Research and Development Service's Center of Excellence and professor of internal medicine at U-M.

Older patients need to get their flu and pneumonia vaccines in order to decrease their risk for infections, and physicians need to be aware of the long-term risk for cognitive and physical disabilities that many patients may face, Langa said.

"In contrast to Alzheimer's disease and other forms of dementia, the cognitive impairment associated with sepsis is likely at least partially preventable through better acute care of the sepsis episode and better rehabilitation efforts afterwards," Langa says.

"We need to start working early – from the beginning of the hospitalization – to make sure patients do not develop new disability. There are innovative new ways to care for people that might help prevent this disability," Iwashyna says.

The research was supported primarily by the National Institute on Aging and the National Heart, Lung and Blood Institute.

The researchers used data from the NIA-supported Health and Retirement Study , a long-term study that collects information on the health, economic, and social factors influencing the health and well-being of a nationally representative sample Americans over age 50.

"This research makes clearer how acute medical problems in older adults may have an important lasting impact and contribute to a downward trajectory in both cognitive and physical function," says Richard Suzman, Ph.D., director of the NIA's Division of Behavioral and Social Research, which supports the HRS.

"The unique nature of the rich HRS dataset that links both survey data and Medicare administrative data made this innovative study possible and will also facilitate future studies of the long-term impact of critical illness on older adults and the family members that care for them."

The HRS, now in its 18th year, follows more than 22,000 people over the age of 50, collecting data every two years, from pre-retirement to advanced age.

The NIA leads the federal effort supporting and conducting research on aging and the medical, social and behavioral issues of older people. For more information on research and aging, go to www.nia.nih.gov.

Additional authors: E. Wesley Ely, M.D., M.P.H. of the Tennessee Valley Veteran's Affairs (VA) Healthcare System and Vanderbilt University; Dylan M. Smith, Ph.D., of Stony Brook University Medical Center.

Journal reference: Journal of the American Medical Association, 2010; 304(16): 1787-1794.

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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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Therapeutic Benefits of Bariatric Surgery on Diabetes Translate Into Significant Economic Benefits

/PRNewswire/ -- New data presented today at Obesity 2010, the 28th annual scientific meeting of The Obesity Society, find that bariatric surgery is associated with reduced healthcare costs for diabetes patients who are morbidly obese. The study, conducted by Washington University School of Medicine in St. Louis, Universite du Quebec a Montreal (UQAM), and Analysis Group, Inc., shows that costs associated with bariatric surgery are fully recovered in two to three years post-surgery, and a significant reduction in diabetes diagnostics claims and diabetes medication claims occurs post-surgery. The study, Economic Impact of the Clinical Benefits of Bariatric Surgery in Diabetes Patients With BMI greater than or equal to 35 kg/m2, also was published in last month's online edition of Obesity ( link to abstract of study in Obesity ).

Diabetes mellitus is a major public health concern in the United States—and other parts of the world—because of its prevalence, considerable morbidity and mortality and economic burden. Diabetes is associated with serious complications, including coronary heart disease, kidney failure, neuropathy, blindness and amputation, and was the seventh leading cause of death in 2006, accounting for more than 72,000 deaths.(1)

Type 2 diabetes accounts for 90 to 95 percent of all diagnosed cases.(1) Obesity is a major risk factor for Type 2 diabetes,(2) and the risk of diabetes increases directly with body mass index (BMI).(3) Results of a 2004 meta-analysis of more than 20,000 patients who had bariatric surgery showed that diabetes was completely resolved in 76.8 percent of patients, and resolved or improved in 86 percent, following surgery.(4)

"Weight loss is an important therapeutic goal in obese patients with type 2 diabetes, because even moderate weight loss—5 percent—improves hepatic insulin sensitivity and reduces glucose production by the liver(5)," says Samuel Klein, M.D., director, Center for Human Nutrition, Washington University School of Medicine, St. Louis. "Bariatric surgery is the most effective available weight-loss therapy and has considerable beneficial effects on diabetes and other obesity-related comorbidities."

Diabetes-related costs represent a disproportionate share of healthcare costs among the obese.(6) The estimated yearly costs of managing a patient with diabetes ($13,243) are more than five times that of a patient without diabetes ($2,560), and this number is expected to reach $350 billion total by 2025. With the addition of productivity lost, this number increases to $2.6 trillion in the next 15 years.(7)

"The purpose of this study was to estimate the economic impact of the clinical benefits of bariatric surgery on medical costs and return on investment of the surgery in patients with diabetes who are morbidly obese (BMI greater than or equal to 35 kg/m2)," says Pierre Cremieux, Ph.D., a health economics expert and Managing Principal at Analysis Group. "We identified obese patients with diabetes who were treated with bariatric surgery and compared their post-surgery healthcare costs, diabetes diagnosis claims, and diabetes medication claims with matched non-surgery control patients. The data show surgical therapy to be clinically effective, and ultimately less expensive, than leaving these patients on standard therapy."

Using an administrative claims database of privately insured patients covering 8.5 million lives 1999–2007 at 40 large nationwide companies, the researchers identified obese patients with diabetes, 18 to 65 years old who were treated with bariatric surgery, using Healthcare Common Procedure Coding System codes. These patients were matched with non-surgery control patients on demographic factors, comorbidities and healthcare costs. The overall return on investment associated with bariatric surgery was calculated using multivariate analysis, and surgery and control patients were compared post-index with respect to diagnostic claims for diabetes, diabetes medication claims, and adjusted diabetes medication and supply costs. Specific findings of the study include:

* At six months post-surgery, 28 percent of surgery patients had a diabetes diagnosis, compared to 74 percent of control patients (P <0.001).
* At three months post-surgery, insulin use (among pre-index insulin users) dropped to 43 percent for surgery patients vs. 84 percent for controls (P < 0.001).
* At one month post-surgery, medication and supply costs were significantly lower for surgery patients (P < 0.001).


This research comes in the wake of Analysis Group's 2008 research, "A Study on the Economic Impact of Bariatric Surgery," which also demonstrated that healthcare costs for morbidly obese patients receiving bariatric surgery dropped while costs for morbidly obese patients who did not have surgery continued to rise. That study also provided evidence that insurers recover their costs for bariatric surgery in two to four years, depending on the type of surgery performed.

The study was co-authored by Samuel Klein, M.D., (Wash. U), Pierre Cremieux, Ph.D., (UQAM and Analysis Group), Arindam Ghosh, Ph.D., Sara Eapen, Ph.D. and Tamara J. McGavock (all of Analysis Group). The study was funded by Ethicon Endo-Surgery, Inc., a manufacturer of minimally invasive and traditional surgical devices and instruments for bariatric surgery.

Analysis Group provides economic, financial, and business strategy consulting to leading law firms, corporations, and government agencies. The firm has more than 500 professionals, with offices in Boston, Chicago, Dallas, Denver, Los Angeles, Menlo Park, New York, San Francisco, Washington and Montreal (www.analysisgroup.com).

(1) National Diabetes Fact Sheet: United States, 2007. CDC Diabetes, 2007.

(2) Ford ES, Williamson DF, Liu S. Weight change and diabetes incidence: findings from a national cohort of US adults. Am J Epidemiol 1997;146:214–222.

(3) Colditz GA, Willett WC, Rotnitzky A, Manson JE. Weight gain as a risk factor for clinical diabetes mellitus in women. Ann Intern Med 1995;122:481–486.

(4) Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004;292(14):1724-37.

(5) Wing RR, Koeske R, Epstein LH et al. Long-term effects of modest weight loss in type II diabetic patients. Arch Intern Med 1987;147:1749–1753.

(6) Cawley J, Rizzo J, Gunnarsson C, Haas K. The health care cost effects of diabetes among obese and morbidly obese adults in the United States. Poster presented at International Society of Pharmacoeconomic Outcomes Research (ISPOR) 13th Annual International meeting, Toronto, ON, Canada.

(7) Campbell RK, Martin TM. The chronic burden of diabetes. Am J Manag Care 2009;15:S248–S254.

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Radiotherapy Centers of Georgia in Partnership with Northside Hospital Present Breast Health & Cancer Awareness Day

Educating the Community on Breast Cancer Awareness October 2, 2010

Have you checked your breasts today? In 2009, the American Cancer Society estimated approximately 40,170 women died from breast cancer. In Georgia, an estimated 5,840 women will be diagnosed with breast cancer and 1,140 women will die from the disease this year. October is Breast Cancer Awareness Month and Radiotherapy Centers of Georgia – Cherokee County, in partnership with Northside Hospital-Cherokee, is presenting the 2nd Annual Breast Health & Cancer Awareness Day on Saturday, Oct. 2, 2010 at the Northside Hospital–Cherokee Conference Center, located at 1130 Bluffs Parkway in Canton, GA 30114.

“Breast Cancer is the leading cause of cancer death in women behind lung cancer,” said Sandra Gregory, M.D., radiation oncologist of Radiotherapy Centers of Georgia – Cherokee County. “It is a disease which is 100 percent treatable if caught early, so it is important to be educated and aware.”

The 2nd Annual Breast Health & Cancer Awareness Day will begin at 10 a.m. and run until 2 p.m., with featured lectures from renowned female physicians and breast specialists -- moderated by Sandra Gregory, M.D. The day’s activities will feature three panels addressing three crucial topics for women: Wellness and Prevention, Latest Treatment and Technology and Recent Developments in Breast Cancer.

Each panel consists of some of the best and brightest in their field. Peahen Gandhi, M.D., OB/GYN, Courtney Sinclair, M.D., GYN and Angela Falany, M.D. will discuss wellness and prevention; Anita Johnson, M.D., Breast Surgeon, Angela Robbins, M.D., Breast Surgeon and Lynn Baxter, M.D., Diagnostic Radiologist will speak towards the latest treatment and technology; and the third panel on recent developments in Breast Cancer will feature Rosa Langella, M.D., Breast Surgeon, Kathleen Long, M.D., Medical Oncologist, Gena Volas-Redd, M.D., Medical Oncologist and Sandra Gregory, M.D., Radiation Oncologist.

This free education event is an opportunity for women of the community to learn about genetic testing, partial breast irradiation, diet and nutrition, changes in surgical management of breast disease and breast cancer prevention. Northside Hospital’s ScreenAtlanta mobile mammography van will be onsite performing mammograms and attendees will also have an opportunity to sign up with StoryCorps Atlanta to go in-studio and record their personal experiences with Breast Cancer.

“Women who have been diagnosed or have loved ones who have been diagnosed are always the most eager to learn every last detail about Breast Cancer. But it is just as important, if not more important for those who are not as aware to be educated and proactive in getting screened,” said Dr. Gregory.

Breakfast, a survivor program and luncheon will be provided with a special butterfly release to honor all those who have fought and won the cancer battle. The 2nd Annual Breast Health and Cancer Awareness Day is free and open to the public. Registration is recommended, but only required for those requesting mammograms. To register, please call 404-845-5555 and press “0,” Monday through Friday from 8:30 a.m. to 4 p.m.

Sponsorship opportunities are still available. For more information on Breast Cancer Symposium 2010 or sponsorship opportunities, contact Toni Karasik at 678-965-4756 x. 115 or e-mail tkarasik@rccancercenters.com.
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FDA approves first oral drug to reduce MS relapses

The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).

“Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Gilenya is the first in a new class of drugs that block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS.

MS is a chronic, often disabling, disease that affects the central nervous system—the brain, spinal cord, and optic nerves. According to the National Multiple Sclerosis Society, there are about 400,000 people in the United States and 2.1 million people worldwide with MS.

The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision.

Patients using Gilenya should be monitored for a decrease in heart rate upon starting the drug. Gilenya may also increase the risk of infections. Cases of serious eye problems (macular edema) have occurred in patients taking the drug and an ophthalmologic evaluation is recommended.

The most frequent adverse reactions reported by patients taking Gilenya in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes and cough.

The drug will be available in 0.5 milligram capsules. Gilenya is made by Novartis, Basel, Switzerland.

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Sebelius announces $42.5 million for public health improvement programs through the Affordable Care Act

$399,836 to Georgia State Department of Community Health

U.S. Department of Health and Human Services Secretary Kathleen Sebelius today (September 20) announced that the Centers for Disease Control and Prevention (CDC) has awarded funding for 94 projects totaling $42.5 million to state, tribal, local and territorial health departments to improve their ability to provide public health services. This funding, made possible through the new Prevention and Public Health Fund created by the Affordable Care Act, will be distributed through cooperative agreements to 49 states, eight federally recognized tribes, Washington, D.C., nine large local health departments, five territories, and three Affiliated Pacific Island jurisdictions to maximize public health efforts.

“These funds will help health departments around the country to improve the quality and effectiveness of the critical health services that millions of Americans rely on every day,” said Secretary Sebelius. “Strengthening our public health system through better coordination and collaboration will help to deliver higher quality health care more efficiently.”

This new 5-year cooperative agreement program entitled, Strengthening Public Health Infrastructure for Improved Health Outcomes, will provide health departments with needed resources to make fundamental changes in their organizations and practices, so that they can improve the delivery of public health services including:

- Building and implementing capacity within health departments for evaluating the effectiveness of their organizations, practices, partnerships, programs and use of resources through performance management

- Expansion and training of public health staff and community leaders to conduct policy activities in key areas and to facilitate improvements in system efficiency

-Maximizing the public health system to improve networking, coordination, and cross-jurisdictional cooperation for the delivery of public health services to address resource sharing and improve health indicators

-Disseminating, implementing and evaluating public health’s best and most promising practices

- Building a national network of performance improvement managers that share best practices for improving the public health system.

“Investing in public health builds a foundation for a strong and healthy society and contributes to lowering the cost of health care. Investing in proven preventive services and strong policies helps us to avoid unnecessary costs later,” said CDC Director Thomas R. Frieden, M.D., M.P.H.

“These funds are a down payment on improving public health services across the nation,” said Dr. Judith A. Monroe, CDC’s deputy director for state, tribal, local and territorial support. “With these funds, we will help our nation’s public health departments work more effectively and efficiently to detect and respond to public health problems. This program will strengthen the nation’s public health system and our ability to improve the health and well being of all Americans.”

In response to the CDC’s original funding announcement Public Health Systems and Infrastructure projects in July 2010, CDC received more than 140 applications from health departments seeking funds through this cooperative agreement. For more information, please visit http://www.cdc.gov/ostlts

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HHS awards $130 million to boost health professions workforce

Georgia to receive over $2.6 million in grants

HHS Secretary Kathleen Sebelius today announced $130.8 million in grants to strengthen and expand the health professions workforce. Six areas are targeted: primary care workforce training, oral health workforce training, equipment to enhance training across the health professions, loan repayments for health professionals, health careers opportunity programs for disadvantaged students, and patient navigator outreach and chronic disease prevention in health disparity populations. The grants include $88.7 million in funding from the American Recovery and Reinvestment Act of 2009.

"An adequate health care workforce is the linchpin for reforming our health care system to ensure greater access, improve the quality of health care and cut overall costs in the long term," said Secretary Sebelius. "Today's awards not only will provide more training opportunities for people interested in a health professions career, but also will support equipment purchases and faculty development to expand and enhance the quality of training."

"With an aging and increasingly diverse population, we need to prepare our health professionals to meet the challenges of providing health care in the twenty-first century," noted Mary K. Wakefield, Ph.D., R.N., administrator of HHS' Health Resources and Services Administration (HRSA), which oversees the programs. "This includes ensuring diversity in the workforce, and that well-trained professionals practice in areas of severe need."

Expanding the Primary Care Workforce

Training Programs in Primary Care - $42.1 million ($31.5 million Recovery Act)
Grants will support family medicine, general internal medicine, and general pediatrics programs, including curriculum development, faculty development, didactic and community-based education, and training in underserved areas for primary care residents, pre-doctoral students, interdisciplinary and inter-professional graduate students, and physician assistant students.

Oral Health - $23.9 million ($6.7 million Recovery Act)
Funding will target workforce development programs for pre- and post-doctoral training for dental residents; dental faculty; loan repayment for faculty who teach primary care dentistry; and training for practicing dentists, or other approved dental trainees in general, pediatric, and public health dentistry and dental hygiene programs. Funding also includes $4.3 million to states to provide 9 new grantees the opportunity to address their states' unique oral health workforce needs in underserved urban and rural areas. Grants are designed to strengthen the delivery of multidisciplinary comprehensive oral health care, integral to quality primary care.

Equipment for State-of-the-Art Learning

Equipment to Enhance Training for Health Professionals - $50.5 million (Recovery Act)
Funding from the Recovery Act will provide 208 awards to assist with purchasing equipment for training current and future health professionals across disciplines at the undergraduate, graduate, and post- graduate education levels. Awardees include academic health centers, area health education centers, centers of excellence, and other educational institutions that serve underserved and uninsured patient populations, rural communities, and minorities. Equipment purchases will expand current training capabilities by replacing outdated equipment and technology or purchasing equipment that previously was unaffordable.

Types of equipment to be purchased include e-learning tools such as video, audio and interactive learning systems that provide more distance learning opportunities; human patient simulators that give students the opportunity to improve clinical judgment and critical thinking; and mobile dental vans that provide training in delivering care to diverse segments of the population while bringing basic routine dental treatments to families unable to access care. It is estimated that more than 200,000 individuals will be trained, including health professions students, faculty and clinical practice providers.

Priming the Workforce Pipeline

Loan Repayment ($8.3 million) - 29 grants will be made to states that provide matching funds to assist health professionals in repaying their educational loans. In return, these individuals agree to provide full-time primary health services in federal health professional shortage areas for a minimum of two years. Health professionals eligible to receive funding include physicians, dentists, nurse practitioners, nurse midwives, physician assistants, psychologists, and social workers.

Health Careers Opportunity Program ($2.1 million) - Three grantees will receive funding to increase diversity in the health professions by developing an educational pipeline to enhance the academic performance of economically and educationally disadvantaged students, and prepare them for careers in the health professions. Eligible applicants included schools of medicine, public health, dentistry, pharmacy, allied health, and graduate programs in behavioral or mental health.

Patient Navigator ($3.8 million) - Funding will support 10 grants for patient navigator outreach and chronic disease prevention programs to develop and operate patient navigator services that improve health care outcomes for individuals with cancer or other chronic diseases, with specific emphasis on health disparity populations. Grant recipients recruit, train, and employ patient navigators with direct knowledge of the communities they serve to coordinate care for patients with chronic illnesses. Eligible applicants include federally qualified health centers, health facilities operated through Indian Health Service contracts, hospitals, rural health clinics, and academic health centers.

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HHS Awards $31 million more for prevention and wellness projects

Funded by the Affordable Care Act of 2010

The U.S. Department of Health and Human Services (HHS) today announced $31 million for awards to ten communities in eight states and one award to a state health department to support public health efforts to reduce obesity and smoking, increase physical activity and improve nutrition.
The awards funded by the Prevention and Public Health Fund included in the Affordable Care Act are part of the HHS Communities Putting Prevention to Work (CPPW) program, a comprehensive prevention and wellness initiative administered by the Centers for Disease Control and Prevention.

"As I've seen throughout the year in my work with Let's Move!, prevention works when it comes to improving the health of our families," said First Lady Michelle Obama. "These critical investments will help more communities across America tackle serious health challenges like childhood obesity, while promoting physical activity and healthy eating."

Today's announcement follows the release in February and March 2010 of more than $491.8 million in Communities Putting Prevention to Work funds to states, U.S territories and communities. Those projects are supporting statewide and community based policy and environmental changes in nutrition, physical activity, tobacco control, expanded tobacco quit lines, and cessation media campaigns.

"To realize our goals of improving the health of Americans and lowering our nation's health care costs, we must address the underlying factors that influence our families' health - factors like the foods we eat and the conditions that exist in our homes, neighborhoods and workplaces," said HHS Secretary Kathleen Sebelius. "With Communities Putting Prevention to Work, we're creating evidence-based models that we can replicate on a large scale to permanently reduce the chronic diseases plaguing so many of our communities."

These Communities Putting Prevention to Work awards will provide communities with the resources to create healthy choices for residents, such as increasing availability of healthy foods and beverages, improving access to safe places for physical activity, discouraging tobacco use, and encouraging smoke-free environments. Of the 11 new awards, ten are dedicated to obesity prevention efforts and one to tobacco cessation.

Currently, seven of ten deaths among Americans each year are caused by chronic diseases such as heart disease, cancer, stroke and diabetes. These same chronic diseases account for more than 75% of our nation's health care spending.

HHS also announced $10 million in additional funding for six communities - all of which were part of the original 44 Communities Putting Prevention to Work communities funded by the American Recovery and Reinvestment Act of 2009 (ARRA) - to provide mentoring to less experienced communities based on their previous success in specific policy strategies. Funding for the "Community Mentoring" initiative comes from ARRA.

Awards:

Communities Putting Prevention to Work Community Initiative

. $3.0 Million to Alabama Department of Health: Mobile County, Alabama for tobacco prevention
. $2.3 Million to Arkansas Department of Health: City of North Little Rock, Arkansas for obesity prevention; and Independence County, Arkansas for obesity prevention
. $5.8 Million to Children's Memorial Hospital / City of Chicago, Illinois for obesity prevention
. $2.35 Million to DeKalb County Board of Health, Georgia for obesity prevention
. $3.7 Million to North Carolina Division of Public Health: Appalachian District Health Department, North Carolina for obesity prevention; and Pitt County, North Carolina for obesity prevention
. $4.85 Million to Pinellas County Health Department, Florida for obesity prevention
. $3.6 Million to Santa Clara County Public Health Department, California for obesity prevention
. $3.8 Million to Southern Nevada Health District, Nevada for obesity prevention

Note: The five small city/rural awards are administered through three state departments of health (Alabama, Arkansas, and North Carolina).

Communities Putting Prevention to Work States and Territories Competitive Special Policy and Environmental Change Initiative

. $1.6 Million to South Carolina Department of Health and Environmental Control for obesity prevention

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'Legacy of Katrina' Report Details Impact of Stalled Recovery on Mental Health Status of Children

/PRNewswire/ -- Five years ago Hurricane Katrina and the flooding of New Orleans caused the evacuation of 1.5 million Gulf Coast residents. After a year, 500,000 people remained displaced, many residing in highly transitional shelters, including the notorious FEMA trailer parks. Now at the five-year mark, substantial consequences from this prolonged displacement have resulted in widespread mental health issues in children living in the region, according to a new study by the National Center for Disaster Preparedness (NCDP) at Columbia University's Mailman School of Public Health and a related white paper from the Children's Health Fund (CHF). Together, these documents indicate that although considerable progress has been made in rebuilding the local economy and infrastructure, there is still an alarming level of psychological distress and housing instability. Investigators believe that housing and community instability and the uncertainty of recovery undermine family resilience and the emotional health of children. These factors characterize what researchers are calling a failed recovery for the Gulf region's most vulnerable population: economically disadvantaged children whose families remain displaced.

The CHF report, "Legacy of Katrina: The Impact of a Flawed Recovery on Vulnerable Children of the Gulf Coast," expands upon on a study by NCDP researchers, who have followed a cohort of more than 1,000 families affected by Katrina and the ensuing disruption. According to the Gulf Coast Child & Family Health Study, funded by the Children's Health Fund and published in the current issue of American Medical Association's Journal of Disaster Management and Public Health Preparedness, the widespread mental health problems still experienced by Gulf Coast children serve as a barometer for the failed recovery of their families and their communities. Over one-third of the children in displaced families have been clinically diagnosed with at least one mental health problem since Katrina -- with behavioral and conduct disorders the most common of these problems. Yet fewer than 50% of parents seeking needed mental health counseling for their children were able to access professional services. Furthermore, nearly half of the households in the study were still living in unstable conditions and, five years later, 60% of respondents still report their situation as being unstable or worse than it was before Katrina.

"This study points to a major crisis facing the children of the post-Katrina Gulf Region," says Irwin Redlener, M.D., director of the National Center for Disaster Preparedness at Columbia's Mailman School of Public Health and president of the Children's Health Fund. "From the perspective of the Gulf's most vulnerable children and families, the recovery from Katrina and the flooding of New Orleans has been a dismal failure."

"Previous studies have demonstrated a significant increase in the prevalence of anxiety, depression, and post-traumatic stress disorder, following Hurricane Katrina, as well as a rise in violence and suicide," said Italo Subbarao D.O., MBA, deputy editor of AMA's Disaster Medicine and Public Health Preparedness Journal. "This study adds further credence to widely accepted views that adults and children affected by catastrophic emergencies can experience up to a 40% increase in mental and behavioral illness."

According to David M. Abramson, Ph.D., MPH, director of research at the NCDP and senior author of the study which looked at the roles of parents and communities in children's recovery, "Children are completely dependent upon others in their lives to provide the security and stability that will help them recover. This suggests that the many support systems in children's lives - their parents, their communities, and their schools - are not yet functioning properly. The slow recovery of children's mental health in Gulf Coast populations is a bellwether indicator of how well the region is recovering."

Additional key findings:

-- Even as long as four and a half years after the event, about 45% of
parents report that their children are experiencing emotional or
psychological problems that they hadn't experienced prior to Katrina.

-- Children post-Katrina are 4.5 times more likely to have serious
emotional disturbance than pre-Katrina. For the purposes of this
study, such disturbances were defined as emotional issues,
hyperactivity, conduct and problems relating to peers.

-- Nearly half of people who had been displaced for over a year by
Katrina are still living in unstable conditions.


The study findings are supported by clinical data from the Children's Health Fund, which provides mobile clinics that travel to underserved areas in the Gulf Coast to provide care for families and children. In the period of June 2009 through June 2010, despite improvement in housing conditions in Louisiana, psychiatric, developmental or learning-related disorders in children were diagnosed as frequently as respiratory illness. And in New Orleans alone, approximately 30,000 school children were not able to return to public school. However, data also shows that children who were relocated sooner did better in school than students with longer periods of displacement and those who were enrolled in higher performing schools did the best, thus highlighting the importance of social systems in a child's post-disaster recovery.

Both the study and the clinical reports from the Children's Health Fund's Gulf Coast pediatric programs paint a clear picture of how insufficient government response and recovery efforts continue to take a toll on children's welfare, especially those who are the most underserved. Dr. Redlener, a pediatrician and professor at Columbia University's Mailman School of Public Health, outlined a number of implications for policymakers and others: "Affected families need urgent assistance to return to a state of 'normalcy' characterized by safe communities and stable housing. Nearly two out of three children affected by Katrina continue to experience serious mental and behavioral problems or the stress of unstable housing or both, with children living in poverty over two times as susceptible to serious emotional disorders. We believe that this represents at least 20,000 children affected by Katrina--and perhaps considerably more. Immediate action needs to be taken to increase mental health services in the region."

Dr. Redlener continues, "And it's not just clinical services that are needed by these marginalized families. Every effort must be made to rapidly bring back a 'state of normalcy', that is, stable safe housing for every family in communities with appropriate access to essential services and economic stability."

The Gulf Coast Child & Family Health Study has collected mental health data in the Gulf Coast since January 2006 and covers a random sample of 1,079 households in Louisiana and Mississippi, including 427 children. Face-to-face interviews were conducted by trained interviewers, and the key outcome variable was Serious Emotional Disturbance, based upon the Strengths and Difficulties Questionnaire (SDQ), a widely validated diagnostic screener. The data were collected in four waves over the course of four years with the majority of data for this analysis drawn from the fourth round of data, collected through March 2010.

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FDA Proposes Withdrawal of Low Blood Pressure Drug

/PRNewswire/ -- The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA's accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.

To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug's clinical benefit, for example, by showing that use of the drug improved a patient's ability to perform life activities.

Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.

"We've worked continuously with the drug companies to obtain additional data showing the drug's clinical benefits to patients," said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research. "Since the companies have not been able to provide evidence to confirm the drug's benefit, the FDA is pursuing a withdrawal of the product."

The FDA today issued a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to the companies that manufacture midodrine. This is the first time the agency has issued such a notice for a drug approved under the FDA's accelerated approval regulations. Shire, the maker of the brand name drug, must respond to the FDA in writing within 15 days to request a hearing. If the company fails to do so, the opportunity for a hearing will be waived. Sponsors of generic versions of midodrine will have 30 days to submit written comments on the notice. If, after considering any relevant submissions, the FDA continues to believe that withdrawal of approval is warranted, approval of all midodrine products, including generic versions, will be withdrawn.

Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.

Under accelerated approval, a drug company may obtain approval of a drug used to treat a serious or life-threatening disease or condition based upon a surrogate endpoint. A surrogate endpoint is a clinical marker, such as a positive effect on blood pressure, believed to predict actual clinical benefits such as improved survival or decreased severity of the disease.

Drug companies that obtain approval under this program are required to conduct additional clinical trials after approval to confirm the drug's benefit. If those trials fail to confirm clinical benefit to patients, or if the companies do not pursue the required confirmatory trials with due diligence, the FDA can withdraw approval of the drug using expedited procedures.

According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009.

The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options.

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CDC: Two-Thirds of Emergency Visits Occur During Non-Business Hours; Percentage of Non-Urgent Emergency Patients Drops To Less than 8 Percent

/PRNewswire/ -- A new report from the Centers for Disease Control and Prevention once again debunks the myth that emergency departments are crowded with non-urgent patients, a finding noted by the American College of Emergency Physicians (ACEP).

"The percentage of non-urgent patients dropped to only 7.9 percent in 2007 [from 12.1 percent in 2006]," said Dr. Angela Gardner, president of ACEP. "The report also makes the excellent point that non-urgent does not imply unnecessary. As we have said repeatedly, our patients are in the ER because that's where they need to be.

There were approximately 222 visits to U.S. emergency departments every minute in 2007 (http://bit.ly/9B5kHJ) and the number of visits increased by 23 percent between 1997 and 2007, according to the report. Preliminary data for 2008 indicate that emergency visits will increase to a record high of more than 123 million (http://bit.ly/ak6oRx).

The report, "National Hospital Ambulatory Medical Care Survey: 2007 Emergency Department Summary" offers far more detail than the data brief released by the Centers for Disease Control and Prevention (CDC) in May. The U.S. Department of Health and Human Services, of which the CDC is a part, has indicated that this is the last fully detailed report of its kind to be issued about emergency department visits.

Dr. Gardner is urging the CDC to reconsider:

"It is essential to know what is happening in our emergency departments as we implement health care reform. This report is rich in data about who our patients are, how old they are and why they are seeking care in the ER. From a planning perspective, this information is invaluable. It would be a mistake for the CDC to discontinue tracking what is happening on the front lines of healthcare, the nation's emergency departments."

Babies under 12 months old had the highest visit rate at 88.5 visits per 100 infants. The second highest visit rate was by adults age 75 and older, with 62 visits per 100 people.

Approximately one-quarter of all visits were by patients insured by either Medicaid or the State Children's Health Insurance Program. The uninsured represented about 15 percent of all visits.

"Most doctors' offices are open for around 45 hours a week, as opposed to the 168 hours a week emergency departments are open," said Dr. Gardner. "That nearly two-thirds of emergency patients came to the ER between 5 p.m. and 8 a.m. during the week or on weekends highlights the unpredictable nature of health emergencies. When you are the one who has a sick child, the last thing you want is a 'closed' sign or after-hours message."

The report also notes that only 0.1 percent of patients die in the emergency department.

"We do an excellent job of stabilizing and treating our patients, but the persistent problems of overcrowding, ambulance diversion and boarding admitted patients in the ER are not going away," said Dr. Gardner. "We know from the Massachusetts experience that visits will continue to rise with health care reform. We also know that as Baby Boomers age, a tsunami of patients in need of emergency care is just around the corner. We need help and we need it now."

The report says the main issue contributing to overcrowding has been delays in moving the sickest patients to inpatient beds. Admitted patients have often been boarded in the emergency departments or hospital hallways for hours to days, resulting in overcrowding and diversion of incoming ambulances to other hospitals.

ACEP is a national medical specialty society representing emergency medicine. ACEP is committed to advancing emergency care through continuing education, research and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies.

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