Showing posts with label gwinnett. Show all posts
Showing posts with label gwinnett. Show all posts

Thursday, December 17, 2009

Park Springs to Expand Health Care Center at Retirement Community

Cobblestone to add two memory care rooms, 18 skilled nursing rooms, two prep kitchens

Park Springs, the Southeast’s premier continuing care retirement community announces that it is renovating Cobblestone, the community’s health care center, expanding the facility by 12 rooms. The expansion will include two phases of construction. Phase one is slated to begin in early January, while phase two is scheduled to begin in mid-February.

Renovations during phase one construction will include adjusting eight assisted living suites into 14 memory care suites. A new memory care dining area with a new warming and preparation kitchen will also be added. A new wandering control system is also planned to increase Members safety. Updated finishes in the new common area will also occur at this time.

Phase two will consist of renovating 12 memory suites into 18 skilled nursing rooms. Construction will also include the addition of a new preparation kitchen as well as upgrades to the existing skilled nursing preparation kitchen. Renovations to the common areas, a new skilled family area, and offices for the community’s physician and assistant director of nursing will also be added at this time.

“We are excited about expanding Cobblestone,” said Joan Carlson, Park Springs’ vice president of quality, innovation and culture. “We currently offer the highest quality services, medical care, nursing and rehabilitative care in a residential environment in the Southeast and our expansion will allow us to increase the level of care we provide. It will also allow us to provide outside short term admission to our Medicare skilled unit.”

Cobblestone’s Resident Centered model provides Members flexibility in their daily activities embracing individuality while focusing on all aspects of wellness. Staffing ratios are approximately two times greater than the state average. A full time doctor trained as a geriatrician whose sole responsibility is the health of our Members is employed on site. A clinic staffed by a full time Licensed Nurse Practitioner performs routine check ups, tests and lab work. The community doctor, clinic and skilled care are all Medicare certified. Home care services are provided by trained staff employed directly by the Park Springs and are licensed by the state, bonded and insured only after undergoing a strict screening process.

About Park Springs
The Southeast's premier CCRC, Park Springs enhances life for active seniors by providing independent residences alongside extensive amenities and on-site wellness and private health care facilities. The 398-home campus-style community is situated on 54 acres surrounded by Stone Mountain Park. A 64-suite health center provides assisted living, skilled nursing and dementia/Alzheimer's care. The campus style community boasts a 50,000 square foot Clubhouse serving meals in four themed dining rooms daily and a 12,000 square foot fitness center with an indoor swimming pool. The Seniors Housing Council of the National Association of Home Builders named Park Springs a Platinum winner. Park Springs is developed by Isakson Living and managed by Life Care Services LLC (LCS), a leader in senior living communities. LCS today serves more than 23,000 residents daily in over 80 communities nationwide. For more information on Park Springs, call 678-684-3300 or visit www.parkspringscommunities.com.
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Saturday, October 17, 2009

AseraCare Home Health Now Serving Atlanta

(BUSINESS WIRE)--AseraCare Home Health of Atlanta announced that it is now offering comprehensive home health services to the residents of DeKalb, Fulton and Gwinnett counties in Georgia — including skilled nursing and specialized rehabilitation therapy.

AseraCare Home Health’s experienced staff provides outstanding clinical services to patients within the comfort of their own homes, enabling patients to maintain greater independence and achieve a higher quality of life.

The agency’s caregivers excel in treating patients who need in-home care as a result of joint replacement and other surgery, injury (including sports or job-related injuries), cardiac conditions and major illnesses.

“We provide an important service for Atlanta-area patients who need care once they leave the hospital and return to their own homes,” said Bob Donovan, President of AseraCare Home Health. “And, by working in conjunction with our sister Golden Living companies in the Atlanta area — including seven Golden LivingCenters and AseraCare Hospice — we are able to provide a full range of post-acute care services. Our integrated approach enables patients to move seamlessly from one care setting to another as their conditions require, with a singular focus on their needs.

“We look forward to a vibrant future here as we continue to strengthen our presence in the Atlanta market,” Donovan added.

The AseraCare Home Health office is located at 30 Perimeter Park, Suite 100, in Atlanta, Georgia. This complex is also home to the Atlanta offices of AseraCare Hospice and the administrative offices of Golden LivingCenters and Aegis Therapies.

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Sunday, July 12, 2009

Cancer Wellness at Piedmont’s Programs and Services for July

Comprehensive Complimentary Services Offered to Anyone Affected by Cancer

Cancer Wellness at Piedmont offers comprehensive services and programs for anyone affected by cancer at any phase in his or her journey. All programs take place at Cancer Wellness at Piedmont, located in the Piedmont Hospital Cancer Center at Piedmont West Medical Office Park, 1800 Howell Mill Road, Suite 700, Atlanta, GA 30318. For more information please visit piedmontcancerconnection.org or, to make a reservation for one of the classes listed below, call 404-425-7944, and please indicate which classes you plan to attend.

Classes offered every month include: Cancer Wellfit©, Gentle Yoga, Art Therapy, Guided Imagery and Relaxation for Optimal Health, Mindfulness Training 101 & 201, Breast Cancer Support, Gynecological Cancer Support, and A Guy’s Group.
Some special events for July:

The Life Lessons and Sacred Truths of the Chakras – Level 1 – This experiential workshop will introduce you to the seven sacred chakras. Explore and practice gentle yoga poses, meditation, breathwork, mantras and energy psychology principles that help you open and balance your mind, body and spirit energetically. Join Angela Buttimer, LPC, RYT, and Jody D. Iodice, Ph.D., on Wednesday, July 1, from 9:45 a.m. to 1 p.m. (lunch provided) and on Tuesday, July 21, from 5 to 8:15 p.m.

Becoming Grounded By Going Around in Circles – A Mandala Workshop - Join Edna Bacon, ATR, to examine the use of mandalas all over the world through the ages. A mandala is an artistic representation of the cosmos and a focus for meditation consisting of geometric designs and circles. Create mandalas individually and as a group with a variety of materials and consider the meaning they have for you. Friday, July 17, from 10 a.m. to 2 p.m. (lunch provided)

Plan Your Escape! – In collaboration with Pink Heals Foundation, Inc., Lisa Vingerling guides you on an evening of escape. Sip cocktails and enjoy worldly tapas and beautiful scenery. A guest photographer will show you how to take beautiful photographs with your own camera. Prepare to be inspired and leave ready to Plan Your Escape! Thursday, July 30, from 6:45 to 8 p.m. Please register by e-mailing RSVP@pinkheals.org.

For more information and a full list of classes please visit piedmontcancerconnection.org.
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Thursday, July 9, 2009

Kaiser Permanente of Georgia Continuing Medical Education Receives Recognition from Medical Association of Georgia

CME Program Becomes First in State to Receive This Honor

The Southeast Permanente Medical Group of Georgia, Inc. (TSPMG) has been honored with the highest possible accreditation status by the Medical Association of Georgia. TSPMG, which exclusively treats Kaiser Permanente patients in Georgia, was honored with “accreditation with commendation” for a 6-year term.

In garnering the honor, the TSPMG Office of Continuing Medical Education (CME) demonstrated excellence in all 15 basic criteria areas plus the seven optional criteria required for accreditation with commendation.

Kaiser Permanente is the first in the state to receive accreditation with commendation for a 6-year term under new, more stringent criteria. MAG is granted authority to accredit intrastate CME providers by the Accreditation Council for Continuing Medical Education (ACCME). Nearly 50 Georgia health care organizations apply for accreditation.

“The Office of CME strives to offer quality continuing medical education activities and considers it an honor to be recognized as one of the best in the state of Georgia”, said Sandra Gauthier, manager of Continuing Medical Education for TSPMG.

“We feel it is not enough to only have excellent CME activities, but also to be able to measure whether or not they make a difference in patient care,” she added. “The participation of CME Committee members, medical group leadership and the support and hard work of our dedicated staff made this recognition possible.”
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Wednesday, July 8, 2009

Governor Appoints Jewel Norman Mental Health Ombudsman

Governor Sonny Perdue announced today that he has appointed Jewel Norman as the State Disability Services Ombudsman. Norman will assume the position on July 16.

“Along with creating a stand alone agency for developmental disabilities, the appointment of Jewel Norman as the mental health ombudsman is another step in improving the state’s care and delivery of services to the mental health community,” said Governor Perdue. “Ms. Norman has a wealth of public and private experience managing human services.”

The mental health ombudsman is a five year appointment. In January, the Governor organized a committee to nominate candidates for ombudsman. Member of the committee included Mary Burns, Nora Haynes, Tommy Hills, Vernon Keenan, Sharon McDaniel, Don Meck and Gwen Skinner.

“I look forward to working with the advocacy and provider community to promote system-wide improvements in mental health, developmental disabilities and addictive disease,” said Norman.
The ombudsman will investigate and make recommendations to the department and other agencies, establish a uniform state-wide complaint process, collect and record data relating to complaints with regard to service providers, recommend law and policy changes, and make a biennial written report documenting types of complaints reported by consumers.

“This is a great day for people with mental illness and co-occurring disorders and their families,” said Nora Haynes, President of the Georgia chapter of the National Alliance on Mental Illness.

Jewel Norman has served as Chief Operating Officer and Chief Executive Officer of a large private for profit residential treatment facility. She has also served as a regional vice president of a psychiatric hospital corporation and served as interim CEO for a number of larger comprehensive psychiatric hospitals. Norman received her undergraduate degree from the University of Mary Washington and master’s degree from the University of Virginia.
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Rollins School of Public Health Names New Chair of Biostatistics and Bioinformatics

Lance Waller, PhD, has been named Rollins Professor and Chair of the Department of Biostatistics and Bioinformatics at Emory University's Rollins School of Public Health. His appointment was effective July 1.

Waller will also serve as associate director of biostatistics and bioinformatics in the Emory Center for Comprehensive Informatics, a multi-disciplinary center that supports translational, clinical or deep integrative studies combining biostatistics and high-performance computing techniques.

Waller joined Emory in 1998 as an associate professor of biostatistics. He was promoted to a professor of biostatistics in 2003 and was elected the same year to the Fellowship in the American Statistical Association. Waller was recently tapped as chair of the department after an extensive national search.

"Dr. Waller is taking the helm of the biostatistics and bioinformatics department at a very exciting time," says James W. Curran, MD, MPH, dean of the Rollins School of Public Health. "Emory researchers in a range of disciplines, including predictive health, oncology and HIV/AIDS, are increasingly turning to biostatistics to aid their bioscience research efforts. Dr. Waller's expertise will be an asset to the department and his colleagues."

Waller's research involves the assessment of spatial clustering of disease, linking spatial statistics and geographic information systems, statistical assessments of environmental justice, and hierarchical methods for modeling small-area health statistics. His recent analyses have included spatial point process methods in alcohol epidemiology and conservation biology (sea turtle nesting patterns), and hierarchical models in disease ecology.

“I look forward to building on the department’s strong base in biostatistical research, training and collaboration," says Waller. "The most effective programs in biostatistics grow and adapt in concert with new methods of measurement and the new research possibilities enabled by them. I’m especially excited about new opportunities in the analysis of high-dimensional data, which link information from multiple sources in a variety of applications from across the health sciences. Making sense of these complex data in accurate, reliable, and interpretable ways is our primary goal."

Waller has authored or coauthored more than 100 articles and one book. His research is actively supported by seven federal grants, including four National Institutes of Health (NIH) grants on which he currently serves as principal investigator. In addition, Waller serves on numerous national advisory committees and has actively taught and mentored graduate and professional students during his tenure at Emory. Waller is also an alumnus of the Emory Woodruff Leadership Academy.

Waller earned his master's of science and doctoral degree in operations research from Cornell University. Before coming to Emory, he was an associate professor of biostatistics at the University of Minnesota and the University of Alabama at Birmingham.

Emory's biostatistics and bioinformatics faculty collaborate with researchers in a variety of disciplines, developing and applying statistical methodology in search of solutions to medical and public health problems. Specific research projects include a five-year, NIH-funded grant to develop powerful computer modeling techniques to analyze and respond to infectious disease outbreaks; efforts to apply biostatistical methods to the analysis of genetic data to further understanding of complex disorders such as Parkinson’s disease and schizophrenia; and the development of statistical methods to analyze the distribution of the burdens of environmental hazards between different socioeconomic groups.

The Rollins School of Public Health enrolls over 900 graduate students in masters' and doctoral programs, has more than 5,000 alumni, and employs 180 full-time faculty who work throughout Georgia, the United States, and in more than 100 countries around the globe. The Department of Biostatistics and Bioinformatics consists of more than 30 full-time and 20 adjunct faculty members.

To learn more about the Rollins School of Public Health, visit www.sph.emory.edu, and to learn more about the Emory Center for Comprehensive Informatics, visit http://cci.emory.edu/cms/index.html.
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Obesity Among U.S. Adults Continues to Rise

Obesity Prevalence 25 Percent or Higher in 32 States

The proportion of U.S. adults who are obese increased to 26.1 percent in 2008 compared to 25.6 percent in 2007. The data come from CDC's Behavioral Risk Factor Surveillance System (BRFSS), a state-based phone survey that collects health information from adults aged 18 and over.

In six states - Alabama, Mississippi, Oklahoma, South Carolina, Tennessee and West Virginia - adult obesity prevalence was 30 percent or more. Thirty-two states, including those six, had obesity prevalence of 25 percent or more. Only one state, Colorado, had a prevalence of obesity less than 20 percent. But no state showed a significant decrease in obesity prevalence from 2007 to 2008.

More than 400,000 U.S. adults were surveyed in the 2008 BRFSS, which is the world's largest telephone health survey. To assess obesity prevalence, survey respondents are asked to provide their height and weight, which is used to calculate their body mass index (BMI). A person is considered obese if they have a BMI of 30 or above.

"Obesity is a major risk factor for many chronic diseases such as heart disease and diabetes. As obesity increases among all age groups, we are seeing chronic diseases in much younger adults compared to a few decades ago," said Dr. William Dietz, director, CDC's Division of Nutrition, Physical Activity and Obesity.

"For example, we now see young adults who suffer from heart disease risk factors and other conditions such as type 2 diabetes that were unheard of in the past."

The 2008 BRFSS obesity data indicate that none of the 50 states or the District of Columbia has achieved the Healthy People 2010 goal of reducing obesity prevalence to 15 percent or less.

"The latest BRFSS survey data show that the obesity problem in this country is getting worse," said Liping Pan, CDC epidemiologist and lead author of the 2008 BRFSS obesity map analysis. "If this trend continues we will likely see increases in health care costs for obesity related diseases."

For more information on obesity trends, including an animated map, visit
www.cdc.gov/obesity/data/trends.html.
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Tuesday, July 7, 2009

Isakson, Chambliss Praise Albany Non-Profit Founder as CNN Hero

U.S. Senators Johnny Isakson, R-Ga., and Saxby Chambliss, R-Ga., today praised the work of Pamela Green Jackson, founder and CEO of The Youth Becoming Healthy Project, whose work has led to her selection as a CNN ‘Hero of the Week.’

Jackson will appear on CNN’s Larry King Live and American Morning this week to discuss her accomplishments with The Youth Becoming Healthy Project.

Jackson founded the non-profit organization in February 2004 in memory of Bernard Green, her only brother, who lost his battle to complications of obesity-related illnesses on February 11, 2004. Since that time, The Youth Becoming Healthy Project has worked with countless numbers of students in Dougherty County’s middle schools by placing fitness centers, staff and wellness programs in each school to help combat childhood obesity. Jackson has also expanded her work to include elementary schools.

“Not only does The Youth Becoming Healthy Project work directly with students and schools to provide fitness and nutrition education and healthier menu choices, but Pamela Green Jackson serves as an inspiration to the community as she took a personal tragedy and turned it into a victory for her community,” said Isakson.

“I applaud Pamela Green Jackson for her tremendous work in the Albany community,” said Chambliss. “The obesity rate among children has dramatically increased over the past 20 years and these nutrition education and wellness programs are an important step in teaching our young students how to live healthy lifestyles.”

CNN Heroes, now in its third year, recognizes individuals around the world who are making a difference in their communities and beyond. Thousands of individuals are nominated by people from around the world in various categories. Jackson was chosen from a pool of viewer-submitted nominees and will be featured on Larry King Live this Thursday, July 9, at 9:00 p.m. and on CNN Heroes beginning Friday, July 10, 2009, on CNN, CNN International and CNN En Espanol.
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Monday, June 29, 2009

Study Shows Multifaceted Inpatient Psychiatry Approach Can Reduce Readmissions

According to a new study conducted by staff at Mayo Clinic and Austin Medical Center — part of Mayo Health System, patients treated at a rural hospital utilizing a multifaceted inpatient psychiatry approach (MIPA) had lower odds of readmission within 30 days.

Access to psychiatric services in rural areas, particularly inpatient psychiatric care, is limited and care may not be as comprehensive as in metropolitan areas. The purpose of the study, published in the Summer 2009 issue of The Journal of Rural Health, evaluated the impact of the MIPA approach to psychiatric inpatient care on readmission rates in a rural hospital setting.

"The primary treatments for patients who enter inpatient psychiatric hospitals include medication management, group psychotherapy and brief inpatient hospital stays. However, research has shown that this standard of care can result in high numbers of readmissions within 30 days," according to Timothy Lang, Psy.D., a clinical psychologist at Austin Medical Center and one of the study's authors. "To the extent that readmissions may be avoidable, they can be characterized as overutilization of services which can place a strain on both inpatient facility staff and the patient. Approaches like MIPA need to be explored as a practice innovation for inpatient psychiatric facilities."

The MIPA model of inpatient psychiatric care emphasizes a comprehensive diagnosis of the patient's condition with that diagnosis driving treatment and more effective interventions. Austin Medical Center incorporated many of the MIPA best practices that had been reported in the literature, including targeted psychopharmacology; psychological and cognitive testing; occupational therapy; chemical dependency evaluations, smoking cessation group therapy; dietary group therapy; family meetings; contacts with friends and/or family to provide input for improving diagnosis reliability; and relapse prevention.

The study utilized data on psychiatric inpatient readmissions data gathered from 1999 to 2005 at Austin Medical Center. The study's authors compared readmissions within 30 days for patients who were admitted to an inpatient psychiatric unit using a MIPA model of care to readmissions of a comparison group of patients admitted prior to Austin Medical Center's adoption of MIPA in July 2002.

The findings showed that prior to Austin Medical Center's implementation of MIPA, 12 of 37 patients, or 32.4 percent, were readmitted within 30 days. In contrast only seven of 147 patients, or 4.8 percent, were readmitted following MIPA implementation. In addition, significant increases in the percentage of patients' utilization of services following MIPA implementation were noted. These services include psychological testing; occupational therapy; chemical dependency evaluations; smoking cessation counseling; dietary counseling; family meetings; collateral contacts; relapse prevention and follow-up outpatient visits. While specific services that may have caused a reduction in readmission rates cannot be determined from this study, services are regarded as a bundle that is believed to have a collective impact.

"This study indicates the impact of MIPA is positive for patients," according to another study author, James Rohrer, Ph.D., Mayo Clinic Department of Family Medicine. "The results support cautious optimism that the MIPA of inpatient psychiatric care has reduced readmission rates. The implementation of this model in a rural hospital demonstrates that access to high-quality inpatient psychiatric care is achievable in rural settings."

Another study author is Pierre Rioux, M.D., medical director of Austin Medical Center's psychiatric inpatient unit and an instructor in psychiatry at Mayo Clinic.
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Saturday, June 13, 2009

The Secret Lives of Sneezes and Coughs

Like people, coughs come in all shapes and sizes. They can be deep or shallow, long or short, or forced or stifled. Scientists who study the ways we cough and sneeze are shedding light on how viruses like influenza spread.

To follow the evolution of cough, scientists use elaborate setups that reveal how much saliva is expelled and where it goes. They ask people to cough into masks that are carefully weighed before and after the coughs. They illuminate the flows of coughs with powerful lasers and fancy photo techniques and use powerful computers to model this flow of thousands of tiny particles. They use heated manikins and cough machines in rooms filled with tiny droplets of olive oil or theatrical smoke to track how air moves, where breath goes, and how exposed we are to someone else's cough.

A typical cough starts with a deep breath, followed by a compression of air in the lungs and then a crackling burst as that air is forced out in a fraction of a second. The average human cough would fill about three-quarters of a two-liter soda bottle with air -- air that shoots out of the lungs in a jet several feet long. Coughs also force out thousands of tiny droplets of saliva. About 3,000 droplets are expelled in a single cough, and some of them fly out of the mouth at speeds of up to 50 miles per hour.

Sneezing is even worse. It starts at the back of the throat and produces even more droplets -- as many as 40,000 -- some of which rocket out at speeds greater than 200 miles per hour. The vast majority of the droplets are less than 100 microns across -- the width of a human hair. Many of them are so tiny that they cannot be seen with the naked eye.

"What happens to these droplets depends on their size," said fluid dynamicist Bakhtier Farouk of Drexel University in Philadelphia. He is working on software that models how microscopic droplets move around a room.

Most of the larger, heavier drops fall quickly to the floor under the influence of gravity. The smaller and lighter particles (those that are five microns or less across) are less affected by gravity and can stay airborne almost indefinitely as they are caught up in and dispersed by the room's airflow.

Movements in a room can cause the heavier droplets to become airborne again after they have fallen to the ground or another surface. Making a hospital bed can kick up viruses on the covers. Opening a door can dramatically alter the airflow in the room and pull up viruses on the floor. Even walking through a room can spread droplets in a person's wake.

If a person is sick, the droplets in a single cough may contain as many as two hundred million individual virus particles. The number varies dramatically and changes over the course of an infection as the immune system clears out the virus. Generally, a sick person is most infectious as soon as the first symptoms appear and less infectious as his or her immune system clears the virus.

Once airborne, viruses in these tiny droplets can survive for hours. Even if the droplets hit a surface, the viruses can survive and still spread disease if the droplets become airborne later. When a droplet lands on paper, its virus particles can survive for hours. On steel or plastic they can survive for days.

Once they are breathed in, the droplets settle onto cells at the back of the throat, where the virus attempts to enter these cells and begin replicating. This may or may not cause an infection. The body's natural defenses are designed to eliminate infections, and whether someone will fall ill depends on how much virus is breathed in and whether the person's immune system has encountered that virus previously, said Julian Tang, a clinical virologist in Singapore.

When people do get sick, the body tries to deal with the infection by bringing up mucus to help clear it. Some of this mucus is swallowed, carrying the virus down to be destroyed by stomach acid. Some viruses in the throat, though, will be expelled when we cough, and this coughing expels the mucus (and new virus) out of the body, thus beginning the whole process anew.

By Jason Socrates Bardi
Inside Science News Service

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FDA Issues Public Health Advisory Regarding Levemir Insulin

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.
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Tuesday, June 9, 2009

FDA Requires Boxed Warning for All Botulinum Toxin Products

Prompted by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.

The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

These symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The agency also took the action because of the potential for serious risks associated with the lack of interchangeability among the three licensed botulinum toxin products.

“Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Botulinum toxin products have benefits but can cause serious health problems and it is important that anyone who administers or uses these products understands these risks.”

Product Names

The products required to add the new label and a REMS are Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.

Botox, Myobloc, and Dysport are approved by the FDA for the treatment of a condition marked by repetitive contraction of the neck muscles (cervical dystonia). Botox Cosmetic and Dysport are approved by the FDA for dermatologic use in the temporary improvement in the appearance of frown lines between the eyebrows called glabellar lines. In addition, Botox is approved for the treatment of severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm).

Recommendations for Health Care Professionals

The FDA has notified the manufacturers of Botox and Myobloc that label changes and a REMS are necessary to ensure that the benefits of the product outweigh the risks. The FDA approved a REMS for Dysport as part of the product approval. The REMS for each of these products will include a Medication Guide and a Communication Plan. Medication Guides are FDA-approved handouts given to patients, or their families and caregivers, when a medicine is dispensed. The Medication Guides will contain information about the risks associated with botulinum toxin products. The FDA is also requiring the manufacturers to collect safety data in children and adults with muscle spasticity to assess the signal of risk regarding distant spread of toxin effects.

Treatment of muscle spasticity is not an FDA-approved use of botulism toxin products. The doses used in treatment of muscle spasticity are often much higher than the doses for uses described in FDA-approved product label. Symptoms consistent with spread of toxin effects have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label.

The companies that make Botox and Myobloc are required to submit the requested safety label changes, including the boxed warning and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions the agency is allowed to issue an order directing the label change as deemed appropriate to address the new safety information.

Health care professionals who use botulinum toxins should do the following:

Understand that dosage strength (potency) expressed in “Units” is different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one product to another.

Be alert to and educate patients and caregivers about the potential for effects following administration of botulinum toxins such as: unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
Understand that these effects have been reported as early as several hours and as late as several weeks after treatment.

Advise patients to seek immediate medical attention if they develop any of these symptoms.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.--Online --Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787--Fax: 800-FDA-0178--Phone: 800-FDA-1088

Today’s action updates a February 2008 announcement that the FDA was conducting an ongoing safety review of botulinum toxin products.The FDA also issued a response to a citizen petition related to the risk of spread of botulinum toxin effects from the site of injection. This response provides additional detail regarding the FDA’s analysis of this safety issue. The FDA’s response to the Citizen Petition can be found at http://www.fda.gov/cder/drug/early_comm/botulinum_CP_response.pdf
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Wednesday, May 27, 2009

Sinusitis and Allergies: What You Need to Know Living in Atlanta

Spring has sprung and summer is just around the corner. While much of the tree pollen has come and gone, the sniffling and sneezing associated with grass pollen is just getting underway. Those suffering from grass pollen will continue battling their allergies from May through the summer months. Seasonal allergens can also trigger sinus attacks or sinusitis.

Emory experts will host a free seminar for the community called “Sinusitis and Allergies – What You Need to Know Living in Atlanta” on May 28 at 6:30 p.m. at Emory University Hospital Midtown. This is an opportunity for allergy and sinus sufferers to hear about the latest treatments, therapies and research, as well as to ask the physicians questions on the topics.

“This seminar will give participants a chance to learn more about the nose and sinuses, conditions commonly experienced, as well as environmental and food allergies and their treatments,” says John DelGaudio, MD, director of the Emory Sinus, Nasal and Allergy Center. “Participants will also hear about the latest ideas about these conditions.”

While Atlanta is known for its desirable spring and summer months, it comes with side effects for many.

“This is the time of the year when we see patients feeling the effects of the pollen and mold season,” says C. Sekhar Ghosh, MD, private practice internist at Emory University Hospital Midtown. “Patients come to our office for first-line treatment related to their seasonal allergies, sinusitis and asthma attacks. Over the counter remedies work for some, but others may need more intervention.”

Join us as four experts in the field talk sneezing, sniffling and stuffy nose. Details are below:

WHAT: Sinusitis and Allergies - What You Need to Know Living in
Atlanta Seminar
WHEN: Thursday, May 28, 2009, 6:30 – 8 p.m.
WHERE: Emory University Hospital Midtown
Glenn Auditorium
550 Peachtree St., NE
Atlanta, Ga., 30308
COST: Free. Call Emory HealthConnection to 404-778-2000 to register.
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Tuesday, May 26, 2009

Mayo Study Finds That Team Preop Briefing Improves Communication, Reduces Errors

A short, preoperative team briefing prior to cardiac surgery - where each person on the team speaks - improves communication and reduces errors and costs, according to a pilot study conducted at Mayo Clinic.

Mayo researchers believe this is the first such study to use real-time observations to measure the effect of preoperative briefings on specific disruptions to surgery. Disruptions were categorized as patient-related issues, equipment or resource issues, procedural knowledge issues and miscommunication events. Results from the Mayo Clinic pilot are published online in the Journal of the American College of Surgeons.

"The goal of the briefings was to get everyone used to talking when there wasn't a problem, so they would be more likely to speak up when problems occur," says Thoralf Sundt, M.D., Mayo Clinic cardiac surgeon who volunteered his surgery team for the study. "We know that miscommunication is a major cause of sentinel events, an unexpected death or serious injury."

Fifty-six surgical staff members filled out questionnaires and participated in focus groups to develop the format for the briefings. Among the participants were surgical assistants and technicians, registered nurses, nurse anesthetists, and perfusionists, who operate the heart-lung machine during most cardiac surgeries.

The briefings were conducted in the operating room immediately prior to the first surgical procedure of the day, before the patient arrived in the room. Each team member discussed his or her role in the procedure and any concerns specific to the patient. The briefings lasted from one to eight minutes.

"The briefing was not a checklist review," says Dr. Sundt. Checklists are most helpful in preventing predictable errors, such as confirming if and when medications are administered prior to surgery. No checklist can cover the unexpected scenarios that might occur in surgery.

"Because of the complexity of what we do, errors do happen," says Dr. Sundt. "Each team member needs to feel comfortable enough to identify errors. Then we catch them and correct them."

Pre-procedure briefings are not common in operating rooms, but they are standard in other high-risk industries such as aviation and in the military, according to Douglas Wiegmann, Ph.D., the lead researcher on the Mayo study.

"This approach reflects a change in culture in the surgical field - that everyone has a unique contribution to the outcome and care of the patient," says Dr. Wiegmann, who has since moved to the University of Wisconsin as an associate professor of human factors engineering.

While staff are expected to speak up during surgery, they don't or don't always, according to Dr. Wiegmann. Other research has shown that information conveyed in the operating room is often shared in a tense, ad hoc manner that is not conducive to comfortable communication. Previous Mayo Clinic research found that only 32 percent of nonphysician caregivers in cardiovascular surgery thought that surgeon communication was effective. In the same study, 59 percent of nonphysician respondents thought that surgeon attitudes and personalities negatively impacted teamwork.

To measure the briefings' effectiveness, a trained observer monitored six surgeries where briefings were conducted and 10 surgeries where no briefing occurred. The observer was a medical student who was familiar with cardiac surgery and trained to record errors and flow disruptions.

When the briefings were conducted:

Miscommunication events were reduced by 53 percent. None of the miscommunication events observed during the study resulted in adverse events. Examples include the surgeon asking for a medication to be given the anesthesiologist not hearing the request. There were significantly fewer delays, with fewer interruptions to clarify procedures. And, nurses made fewer trips outside the operating room to retrieve supplies.

Waste of medical supplies was reduced because the team better anticipated specific needs for each surgery.

Dr. Sundt says his team has embraced the briefings and continues to conduct them prior to the first procedure of the day. Other surgical teams have since requested implementation of the briefings.

"It's time well spent that tunes us in to the specific patient's needs," says Dr. Sundt. In addition to specific concerns about the surgery, the briefings include information about the patient's prior procedures, other diagnoses, risks and emotional concerns, such as the patient's biggest worry regarding surgery.

"It sets the tone for the day. Now, I'm uncomfortable when we don't do it," says Dr. Sundt, who was initially skeptical about the benefits of the briefings.

There are barriers to conducting briefings for every procedure. "The structure of the operating room is not conducive to this," says Dr. Sundt. With multiple surgical suites, surgery times overlap, creating difficulty in assembling the team prior to each procedure. During long, complex surgeries, shift and staff changes occur.

Additional study and pilots are needed to determine ways to incorporate the briefings more broadly, researchers say.
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Piedmont Mountainside Hospital Encourages Community to Check Their Bones

May is Osteoporosis Awareness Month

May is Osteoporosis Awareness Month and Piedmont Mountainside Hospital (PMH) is encouraging members of the community to learn more about osteoporosis and bone health. According to the National Osteoporosis Foundation, an estimated 10 million Americans are afflicted with osteoporosis and another 34 million are estimated to have low bone mass.

Osteoporosis, or porous bone, is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures of the hip, spine, and wrist. It is referred to as the “silent disease” since many patients are often not aware of their condition until after a fracture occurs.

“Osteoporosis can have a debilitating effect on the lives of patients, if not properly treated. We are here to help our patients develop a personalized treatment plan that will help them to lead an active lifestyle,” says Linda Stead, Chief Nursing Office, PMH. “In fact, my mother has osteoporosis and had a spontaneous fracture of her pelvis due to the osteoporosis before it was discovered. We are now careful to make sure she has her screening exams and has follow-up check-ups with her physician to monitor her medications he prescribed for osteoporosis."

This preventable and treatable disease affects women and men. However, women are more susceptible to osteoporosis due to changes that occur during menopause. This disease can only be diagnosed with a physician administering a bone mineral density (BMD) screening.

Warning signs may include collapsed vertebra which may initially be felt or seen in the form of severe back pain, loss of height, or spinal deformities such as kyphosis, or severely stooped posture. Taking the time to meet with your physician and to get a BMD screening can help to decrease your risk of developing osteoporosis. Knowing your risk and taking essential steps to prevent the disease can have a major effect on treating or even preventing the disease. Some common risk factors of osteoporosis include age, gender, family history and certain medications.

While many risk factors are non-modifiable, there are a few lifestyle changes that can be made to lower your personal risk for osteoporosis:

· Feel the burn: Adapting a regular exercise routine improves bone health and increases muscle strength, coordination and balance.
· Take your vitamins: Calcium and Vitamin D help build strong bones.
· Stop Smoking : Smoking is bad for your bones as well as for your heart and lungs.

All of these changes will not only help you to decrease your risk for osteoporosis, but they will also aid your overall health. For more information about preventing and treating osteoporosis, call Piedmont Mountainside Hospital at 706-692-2441 or visit www.piedmontmountainsidehospital.org.
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Specialty Care Costs for Patients With Bipolar Disorder are Higher Than Diabetes and Other

Mayo Clinic researchers have found that bipolar disorder is more costly than other chronic conditions such as diabetes, depression, asthma or coronary artery disease. These findings are based on a review of health care claim costs. Specialty care costs (the costs of seeing any specialist and all tests ordered) were especially higher for bipolar patients. Results of this review are being presented today at the Annual Meeting of the American Psychiatric Association in San Francisco.

"Psychiatric care costs represented only a portion of the specialty care costs for these chronic conditions," explains Mark Williams, M.D., a Mayo Clinic psychiatrist and lead researcher. "This suggests that many of the specialty costs for bipolar patients are not directly related to seeing a mental health provider."

A data review of health care claims over a four-year period, showed patients with bipolar disorder had significantly higher total per member per month costs compared with patients who had the other conditions. Only patients with both coronary artery disease and diabetes had higher costs than patients with bipolar disorder. Total costs, specialty care visits, specialty care costs, outpatient psychiatric costs, and outpatient psychiatric visits were compared. "The goal of this study is to drive practice changes that improve the efficiency and value of care for bipolar disorder with hopes to improve care while reducing costs," explains Dr. Williams.

Other authors on the Mayo Clinic study include Nilay Shah, Ph.D.; Mark Frye, M.D.; Jeanette Ziegenfuss, Ph.D.; Amy Wagie; and Douglas Wood, M.D.

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Maternity Center at Piedmont Fayette Hospital Offers Classes for Expecting Parents

Parents and expectant parents are invited to attend several informative classes offered by the Maternity Center at Piedmont Fayette Hospital (PFH). For more information on the Maternity Center at PFH, visit www.fayettehospital.org. Community members are invited to take part in the following classes:

Prepared Childbirth Class - This course, recommended for women 20 to 28 weeks into pregnancy, provides an eight hour childbirth education class that teaches mom and her partner about what to expect during labor and delivery. The instructor will discuss the stages of labor, relaxation, breathing techniques, common concerns, comfort measures and much more. Participants will need to bring two pillows and a blanket or towel. The fee for the course is $85 and includes light refreshments. The class will be held Saturday, June 20 from 9 a.m. to 5 p.m. in the 1279 Building, Conference Room C. To register, call Link2Health toll-free at 1-866-900-4321. For more information call 770-719-6005.

Breastfeeding Basics - The Maternity Center at Piedmont Fayette Hospital offers a three hour group participation discussion on the benefits and how-to's of breastfeeding. This class includes preparing for breastfeeding and getting started in the hospital and at home, special situations and growing a breastfeeding family. The class is best if done prior to delivery, but participants are welcome at any time. Fathers and grandparents are welcomed and encouraged to attend also. This class is now offered every month, and the next class is Saturday, June 13 from 9 a.m. to noon in the Dietary Conference Room on the ground floor of the hospital. For more information or to register, call 770-719-6005.

Moms in Motion - “Moms in Motion” is a fitness program designed to prepare women for the physiological changes that occur during pregnancy and postpartum. The class combines low impact aerobics, toning exercises, relaxation and breathing techniques and appropriate warm-ups/cool-downs perfect for both pregnant and postpartum women. The program provides not only a safe and effective exercise regime, but also provides valuable information on pregnancy, postpartum and child safety. Participants may register for this ongoing program at any time during or after pregnancy. Classes are held every Tuesday and Thursday from 5:15 to 6:15 p.m. in Suite 200 of the Piedmont Fayette Hospital Fitness Center at 1250 Hwy 54 West. Space is limited. The classes are FREE to fitness center members and $25 per month for non-members. Written approval from a physician is required. For more information or to register, call 770-719-7290.

Maternity Center Tours - The Maternity Center at Piedmont Fayette Hospital welcomes expectant mothers and their families to take a tour of the facility. The tour will be offered on Monday, June 1 at 6 p.m.; Saturday, June 13 at 12:30 p.m.; and Saturday, June 20 at 6 p.m. The tour will provide information on the hospital's approach to maternity care and how physicians and staff help new mothers and their babies before and after delivery. Families, including siblings, are welcome. Please meet in the Maternity Center lobby (third floor, enter through the West Entrance). For more information call 770-719-6005.

Fayette County Safe Kids Child Passenger Safety Training Class - Fayette County Safe Kids will offer a car seat safety class to teach parents how to keep children safe, especially while traveling by car. The course will be offered Monday, June 8 from 2 to 3:40 p.m. in Conference Room A on the third floor of the hospital's 1279 Building. This class is offered the second Monday of each month. For additional information contact Debbie Straight, 770-305-5148.

Sibling Class - Siblings ages three to ten, accompanied by a parent, are welcome to attend. The class includes a brief tour of the hospital, and will cover the adjustments of becoming a big brother or big sister, as well as what happens to the mother while she is in the hospital. The course will be offered Saturday, June 13 from 2 to 3 p.m. This class is offered the second Saturday of each month. Please meet in the Maternity Center lobby (third floor, enter through the West Entrance) and sign in. For more information or to register, call 770-719-6005.
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Thursday, May 21, 2009

Emory Eye Center Starts Study for Infants with Blocked Tear Ducts

Highlights:

• No consensus exists on the optimal time to treat congenital nasolacrimal duct obstruction with nasolacrimal duct probing.
• Study researchers will determine whether there is any advantage to early probing, since many of these obstructions go away on their own.
• Researchers will determine the percentage of infants’ eyes that have resolution on their own by looking at the group that will receive no immediate probing.

Emory Eye Center will participate in third phase of a National Eye Institute (NEI)-sponsored multicenter clinical trial, the Nasolacrimal Duct Obstruction (NLDO) Study in late winter. The trial will evaluate which of two approaches is optimal in treating young infants with blocked tear duct: probing the obstruction immediately or waiting to see if the condition goes away on its own after six months, as is often the case.

Co-investigators Amy Hutchinson, MD, and Scott Lambert, MD, pediatric ophthalmologists, will enroll the first patients this spring. Infants must be between six and 10 months old. Half the group of children eligible for enrollment in the study will undergo immediate probing. The other half will wait six months for probing. The later group may receive eye massage at home, which in itself can be helpful.

An antibiotic eye drop may also be prescribed if necessary. At six months, if the obstruction persists, probing will be done within a month. Assignment to either of the two groups is randomly picked via computer.

“This trial will give important information that will help physicians provide the best, safest and most cost effective treatment to children with this very common disorder,” says Hutchinson.

“Doctors are trying to find the most cost-effective ways to treat diseases,” says Lambert. “This study should help us better understand where it is more cost-effective to treat blocked tear ducts during infancy or to wait until children are older.”

NLDO is common in infants and toddlers and presents in the first few months of life. It is caused by a blockage of the duct that drains the tears from the eye to the nose. NLDO often goes away on its own, but when it does not, the condition is often treated with a procedure called probing.

During probing, the physician passes a probe through the tear duct, typically clearing the blockage. In children one year and older, the procedure is performed in a hospital or surgery center using anesthesia. In children less than a year old, some doctors will perform the procedure in the office without putting the child to sleep.

More than 220 children will participate in the study throughout the country. The study is a part of the Pediatric Eye Disease Investigator Group of NEI of the National Institutes of Health. The NEI provides funding for the study.

The Department of Ophthalmology and Emory Eye Center have a mission to conduct pioneering research into blinding eye diseases, to educate and train eye professionals, and to provide excellent patient care. The Department includes 35 ophthalmologists, seven optometrists, nine basic scientists, 11 post-doctoral fellows, and nine researchers in other Emory departments who hold joint appointments in the Department of Ophthalmology. Ophthalmology research is supported by $6 million in NIH funding. The Department remains in the top rankings (#9 – 2008) by U.S. News & World Report for the 12 years the magazine has held a ranking for Ophthalmology. It also ranks in the Top Ten in all four categories surveyed by Ophthalmology Times annual report. http://eyecenter.emory.edu
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Monday, May 18, 2009

Turmeric Extract Suppresses Fat Tissue Growth in Rodent Models

Curcumin, the major polyphenol found in turmeric, appears to reduce weight gain in mice and suppress the growth of fat tissue in mice and cell models. Researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (USDA HNRCA) studied mice fed high fat diets supplemented with curcumin and cell cultures incubated with curcumin.

“Weight gain is the result of the growth and expansion of fat tissue, which cannot happen unless new blood vessels form, a process known as angiogenesis.” said senior author Mohsen Meydani, DVM, PhD, director of the Vascular Biology Laboratory at the USDA HNRCA. “Based on our data, curcumin appears to suppress angiogenic activity in the fat tissue of mice fed high fat diets.”

Meydani continued, “It is important to note, we don’t know whether these results can be replicated in humans because, to our knowledge, no studies have been done.”

Turmeric is known for providing flavor to curry. One of its components is curcumin, a type of phytochemical known as a polyphenol. Research findings suggest that phytochemicals, which are the chemicals found in plants, appear to help prevent disease. As the bioactive component of turmeric, curcumin is readily absorbed for use by the body.

Meydani and colleagues studied mice fed high fat diets for 12 weeks. The high fat diet of one group was supplemented with 500 mg of curcumin/ kg diet; the other group consumed no curcumin. Both groups ate the same amount of food, indicating curcumin did not affect appetite, but mice fed the curcumin supplemented diet did not gain as much weight as mice that were not fed curcumin.

“Curcumin appeared to be responsible for total lower body fat in the group that received supplementation,” said Meydani, who is also a professor at the Friedman School of Nutrition Science and Policy at Tufts. “In those mice, we observed a suppression of microvessel density in fat tissue, a sign of less blood vessel growth and thus less expansion of fat. We also found lower blood cholesterol levels and fat in the liver of those mice. In general, angiogenesis and an accumulation of lipids in fat cells contribute to fat tissue growth.”

Writing in the May 2009 issue of The Journal of Nutrition, the authors note similar results in cell cultures. Additionally, curcumin appeared to interfere with expression of two genes, which contributed to angiogenesis progression in both cell and rodent models.

“Again, based on this data, we have no way of telling whether curcumin could prevent fat tissue growth in humans.” Meydani said. “The mechanism or mechanisms by which curcumin appears to affect fat tissue must be investigated in a randomized, clinical trial involving humans.”

This study was funded by a grant from the United States Department of Agriculture. Asma Ejaz, a graduate student who worked on this project received a scholarship grant from the Higher Education Commission of Pakistan.

Ejaz A, Wu, D, Kwan P, and Meydani M. Journal of Nutrition. May 2009; 139 (5): 1042-1048. “Curcumin Inhibits Adipogenesis in 3T3-L1 Adipocytes and Angiogenesis and Obesity in C57/BL Mice. 919-925.”
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Wednesday, May 13, 2009

Bloomberg - Video: In-Depth Look - Health Care Reform

An interview with Republican Senator John Cornyn of Texas saying that we need a deal with health-care costs. (Bloomberg News)




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