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December 2004
Thursday, December 30, 2004
In this Issue:
Cash donations sought in tsunami relief effort
Water key to averting epidemics
Emergency Filtration donates NanoMasks
Drug approved for lung disease
Kodak reports strong demand for KODAK DRYVIEW
8900 Laser Imager with mammography upgrade
Best wishes for a healthy and happy New Year
Humanitarian agencies say that only cash is needed in the relief effort for victims of the tsunami catastrophes. Only monetary donations to the American Red Cross International Response Fund are being sought, said Sam Tidwell, chief executive officer of a local South Florida Red Cross chapter. Donations can be made by calling 1-800-HELP-NOW; online at www.redcross.org; or mailed to PO Box 37243 Washington, D.C., 20013. “People want to give and sometimes say, ‘I have clothes in my closet. I have medicine.’ That's not a good way to help in this kind of situation,” Tidwell said. One reason is the time it would take to ship items that are needed immediately. Another is that the infrastructure for distribution in the affected area no longer exists. Other relief organizations are taking the same position. ''This is an urgent situation and a rapid response is needed,'' said James Cavnar, president of the Boca Raton-based Cross International, which will distribute resources through Christian ministries already operating in the hardest hit areas. Tax-deductible gifts can be sent to Cross International, Dept. PRH0501, 370 W. Camino Gardens Blvd., Boca Raton, FL 33432. Donations can also may be made by credit card using an online form at www.crossinternational.org or by calling 1-800-391-8545. A secondary benefit of the cash-only rule is purchasing aid items close to the region, Tidwell explained. The Red Cross has also set up a website at www.icrc.org to assist people in finding friends and relatives. (Source: The Miami Herald)
Water key to averting epidemics
Tsunami survivors are at risk from diseases spread by dirty water, mosquitoes and crowding, and are in desperate need of large quantities of clean water. While no epidemics have been confirmed, officials said they were most worried about diarrheal diseases as well as liver diseases like hepatitis A and E. Health organizations like the W.H.O. and Unicef recommend that each person be given about five gallons of clean water a day. Dr. David Nabarro, the director of crisis operations for the W.H.O., said in an interview that water shortages had already occurred in the Maldives and Sri Lanka, and that tanker trucks would be needed to provide clean water. In addition, water-purifying tablets are being rushed into the affected countries, along with medicines to treat dehydration. Another hazard to drinking water is contamination of wells by salt water. Martin Dawes, a regional spokesman for Unicef in Colombo, Sri Lanka, estimated that 1,000 drinking-water wells in the country's hard-hit eastern region had been contaminated and would have to be pumped out. He added that his agency was seeking pumps or money to buy them. Mr. Dawes said Unicef had also bought about 20 million gallons of drinking water in 1,500-gallon barrels, enough for 100,000 people, and was expecting them to be delivered to the affected areas today. Dr. Nabarro also said there had been unconfirmed reports of measles in Sri Lanka. Dr. Pino Annunziata, a member of the W.H.O. emergency team, said that within a few weeks, there could also be increases in mosquito-borne diseases like malaria and dengue fever, unless insecticide-spraying starts immediately. (Source: The New York Times)
Emergency Filtration donates NanoMasks
Emergency
Filtration Products Inc. (EFP) announced that it is making an
initial donation of 1,000 of its NanoMasks to the international
relief agencies International Committee of the Red Cross (ICRC) and
CARE. This donation is being made to assist with the emergency
response under way in countries affected by the recent tsunami
disaster that has to date resulted in a death toll of more than
100,000. The initial shipment will be sent from
Taipei,
Taiwan, where EFP
maintains an inventory of NanoMasks and a production line at Weise
Labs Inc.'s facilities. “One of the challenges that affect the
stricken countries will be to control the spread of diseases that
arise from handling the large number of corpses that have resulted
from this catastrophe,” said Douglas K. Beplate, president, EFP. For
more on the ICRC, www.icrc.org)
For more on CARE, www.care.org.
CoTherix, a biopharmaceutical development company, said that the
Food and Drug Administration had approved its inhaled drug solution
Ventavis for the treatment of a pulmonary disease. The drug was
approved to treat pulmonary arterial hypertension, a debilitating
and potentially fatal disease characterized by high blood pressure
in the pulmonary arteries of the lungs. Ventavis is
marketed by
Schering A.G.
in several European countries and
Australia, and will now be made available in the United States
through CoTherix.
Kodak reports strong demand for KODAK DRYVIEW
8900 Laser Imager with mammography upgrade
Eastman Kodak Company reported high customer demand for its Kodak DRYVIEW 8900 Laser Imaging System with a new software upgrade for printing digital mammography images. Available since April 2004, this new product is far exceeding expectations, said the Company. Numerous U.S. facilities have ordered this high-speed, high-quality laser imager equipped with innovative software that supports the printing of high-resolution digital mammography images from full-field digital mammography systems (FFDM) and other approved digital modalities (such as ultrasound and MRI) used for mammography. With this upgrade, healthcare providers can print patient mammography images captured by FFDM systems from a range of vendors including GE Medical Systems, Siemens Medical Solutions, Hologic and Fischer Imaging. The 8900 imager can produce output from general medical imaging modalities as well.
Best wishes for a healthy and happy New Year
We at Healthcare Purchasing News want to wish you a peaceful and prosperous 2005. As you celebrate the New Year please join us in remembering the victims of the earthquake and tsunami disasters. For a list of disaster aid resources, see our Update from Tuesday, Dec. 28.
We’ll see you again Monday, Jan. 3. We look forward to bringing you another year of the latest in healthcare news!
Thursday, December 23, 2004
In this Issue:
International agencies unite
in effort to limit
health risks of tsunami aftermath
Study of nurses shows being
physically active doesn’t negate risk of being overweight
FDA approves nerve channel
blocking pain reliever
JCAHO issues alert on patient controlled analgesia
Physical activity can offset some of the harmful health consequences of being overweight but cannot fully erase them, according to the largest study to examine the relative benefits of being fit vs. fat. The study of more than 115,000 female nurses found that weight and activity levels are both powerful predictors of longevity, and that being either overweight or sedentary independently increases the risk of death. But the study concluded that the healthiest people are those who are both thin and physically active. Women who were obese and inactive had the highest mortality rate, 2.4 times that of women who were thin and active. Those who were physically active despite being obese were still nearly twice as likely to die as those who were lean and active. “Physical activity reduces the effects of being overweight, but it's far from removing all the increased risk associated with obesity,” said Frank Hu, an associate professor of nutrition and epidemiology at the Harvard School of Public Health, who led the study being published in New England Journal of Medicine. Proponents of fitness welcomed the findings that physical activity is important but questioned the conclusion that being overweight and healthy were mutually exclusive. Other experts said the new findings provide the most compelling evidence to date that while physical activity helps, any excess weight carries risks. More than two-thirds of Americans are overweight, including one-third who are obese. The new study involved data collected between 1976 and 2000 on 116,564 women participating in the Nurses' Health Study, an ongoing project in which thousands of nurses are being tracked for years to study various factors affecting health. Those who were physically active for at least 3 1/2 hours each week were considered active, and therefore fit. Lean was defined as having a body mass index below 25. Women who were overweight and inactive had a 64 percent elevated risk of mortality, compared with 28 percent higher risk for those who were overweight but active. Thin women who were sedentary had a 55 percent increased risk of dying compared with thin women who were physically active. Even though the study involved only women, the researchers said previous data suggest the findings probably hold true for men, as well. Louis J. Aronne, president of the North American Association for the Study of Obesity, said that it is clear that both fitness and fatness are important. “It's clearly not either fit or fat that's important, but both,” he said. “They both carry value.” (The Washington Post)
JCAHO issues alert on patient controlled analgesia
The Joint Commission on Accreditation of Healthcare Organizations has issued an alert describing how hospitals and home-care organizations can help prevent errors involving patient controlled analgesia, a computerized pump that allows a patient to self-administer pain medication intravenously by pressing a button. Problems can arise when a well-intentioned family member or healthcare professional pushes the button for the patient in an effort to keep them comfortable, JCAHO notes, adding that some patients may not be appropriate candidates for PCA because of their age, mental state or level of consciousness. To reduce the risk of PCA medication errors, the alert recommends healthcare providers develop criteria for selecting appropriate PCA patients, teach patients and family members about the proper use of PCA, and alert staff to the dangers of administering a PCA dose outside of a nurse-controlled protocol.
Tuesday, December 28, 2004
In this Issue:
Immediate
aid needed to prevent typhoid, hepatitis,
and other disease epidemics for tsunami survivors
List of organizations or their affiliates providing aid to those affected by the tsunamis in Asia
The largest earthquake to strike since 1964 caused devastating tsunami waves that have killed thousands in south Asia. The 9.0-magnitude quake hit Sunday, December 26 off the coast of Indonesia, triggering extremely large waves that brought massive flooding, damage and loss of life in the region. Waves as high as 20 feet crashed into the coastal areas near the Bay of Benegal. Among the worst affected countries are Sri Lanka and India, as well as Indonesia, Maldives and Thailand. Reports are that thousands of people are missing, and it is possible that the number of dead will continue to rise in the coming days. Typhoid, diarrhea and hepatitis epidemics pose a major threat to tens of thousands of people who survived according to international relief agencies. “The biggest threat to survivors is from the spread of infection through contamination of drinking water and putrefying bodies left by the receding waters,” Jamie McGoldrick of the U.N.'s Office for the Coordination of Humanitarian Affairs (OCHA) told reporters Monday. Aid agencies around the world have rushed staff, equipment and money to southern Asia. In New York, U.N. Emergency Relief Coordinator Jan Egeland warned there could be epidemics of intestinal and lung infections within days unless health systems in the eight stricken countries were enabled to cope. In Geneva, spokeswoman Fadela Chaib of the World Health Organization (WHO) told Reuters that it was vital to get water purification tablets and anti-malarial first aid kits into the region, especially to the worst-hit countries. “When clean water systems are destroyed, as they almost always are in disasters of this type, you have the immediate threat of water-borne diseases like diarrhea, typhoid and hepatitis-E,” she said.
Governments and humanitarian agencies around the globe pledged cash funds and dispatched emergency medical and rehabilitation teams to the region around the Bay of Bengal and down to Indonesia. Yvette Stevens, top official in Geneva for OCHA, said it would allow countries wanting to contribute to hear what was needed from representatives of the affected nations — Sri Lanka, Thailand, Indonesia, India, the Maldives, Malaysia, Myanmar and Bangladesh. Experts said the top five issues to be addressed were water, sanitation, food, shelter and health. The United States on Monday pledged an initial $15 million in aid and dispatched “This is indeed an international tragedy, and we are going to do everything we can,” Secretary of State Colin Powell said Monday. American ambassadors have released $100,000 each to India, Indonesia, the Maldives and Sri Lanka, and Powell said $4 million would be given to the Red Cross. U.S. government specialists in disaster relief were sent to Thailand and Indonesia, and others will be spread out through the region.
In addition to the aid pledged by the U.S: Japan said Tuesday it will provide around $30 million in aid, and will send three navy vessels to waters off Thailand to help rescue survivors. An initial $4 million will be spent on medical supplies, power generators and temporary shelter for survivors. In Britain, three charities — Save the Children, World Vision and Christian Aid — were flying out teams to help workers already in Sri Lanka and India and sending money to the region. Australian Foreign Minister Alexander Downer pledged $7.7 million to international aid agencies. China was preparing to dispatch to Indonesia a team of more than 40 experts for relief and rescue work, the official Xinhua News Agency said. In Brussels, the 25-nation European Union’s executive Commission announced Monday that it could mobilize up to $40.6 million. Kuwait offered the stricken nations $1 million in supplies, and Israel sent a medical team to Sri Lanka. Germany said it was providing $1.3 million and had sent a team from its disaster relief body THW to Sri Lanka to help provide drinking water and work on restoring electricity supplies. If you are looking for information on a U.S. citizen feared missing, contact the U.S. State Department at 888-407-4747, or, from overseas, at 317-472-2328.(The Associated Press and Reuters and MSNBC contributed to this story)
Action Against Hunger
247 West 37th Street, Suite 1201
New York, NY 10018
212-967-7800
www.aah-usa.org
ADRA International
Asia Quake Fund
12501 Old Columbus Pike
Silver Spring, MD 20904
800-424-2372
www.adra.org
Air Serv International
6583 Merchant Place, Suite 100
Warrenton, VA 20187
www.airserv.org
American Jewish Joint Distribution Committee
JDC: South Asia Tsunami Relief
Box 321
847A Second Avenue
New York, NY 10017
212-885-0867
www.jdc.org
American Jewish World Service
45 West 36th Street, 10th Floor
New York, NY 10018
800-889-7146
www.ajws.org
American Red Cross
International Response Fund
PO Box 37243
Washington, DC 20013
800-HELP-NOW
www.redcross.org
AmeriCares
88 Hamilton Ave.
Stamford, CT 06902
800-486-4357
www.americares.org
Baptist World Aid
Asia Tidal Waves
405 North Washington St.
Falls Church, VA 22046
703-790-8980
www.bwanet.org/bwaid
B’nai B’rith International
B’nai B’rith Disaster Relief Fund
2020 K. St. NW
7th Floor
Washington, DC 20006
212-490-3290
www.bnaibrith.org
Brother’s Brother Foundation
1200 Galveston Ave.
Pittsburgh, PA 15233
412-321-3160
www.brothersbrother.org
CARE
151 Ellis Street, NE
Atlanta, GA 30303-2440
800-521-CARE
www.care.org
Catholic Relief Services
209 West Fayette St.
Baltimore, MD 21201
800-HELP-CRS
www.catholicrelief.org
Christian Children’s Fund
Child Alert Fund
PO Box 26484
Richmond, VA 23261
800-776-6767
www.christianchildrensfund.org
Christian Reformed World Relief Committee
South Asia Earthquake
2850 Kalamazoo Ave. SE
Grand Rapids, MI, 49560
800-55-CRWRC
www.crwrc.org
Church World Service
PO Box 968
Elkhart, IN 46515
800-297-1516
www.churchworldservice.org
Food for the Hungry
Asia Quake Relief
1224 E. Washington St.
Phoenix, AZ 85034
800-2-HUNGERS
Doctors Without Borders/Medecins
Sans Frontieres
PO Box 2247
New York, NY 10116-2247
888-392-0392
www.doctorswithoutborders.org
International Aid
17011 W. Hickory
Spring Lake, MI 49456
800-968-7490
www.internationalaid.org
International Federation of Red
Cross and Red Crescent Societies
PO Box 372
CH-1211 Geneva 19
Switzerland
41-22-730-4222
www.ifrc.org
International Medical Corps
Tsunami Emergency Response
1919 Santa Monica Blvd., Suite 300
Santa Monica, CA 90404-1950
800-481-4462
www.imcworldwide.org
International Orthodox Christian
Charities
PO Box 630225
Baltimore, MD 21263-0225
877-803-4622
www.iocc.org
International Relief Teams
Asia Earthquake/Floods
3547 Camino Del Rio South, Suite C
San Diego, CA 92108
619-284-7979
www.IRTeams.org
International Rescue Committee
PO Box 5058
Hagerstown, MD 21741-9874
877-REFUGEE or 733-8433
www.theIRC.org
Latter-Day Saint Charities
Welfare Services Emergency Response
50 East North Temple Street, Room 701
Salt Lake City, Utah, 84150-6800
801-240-3544
ldscharitiesldschurch.org
Lutheran World Relief
South Asia Tsunami
700 Light St.
Baltimore, MD 21230
410-230-2700
www.lwr.org
MAP International
PO Box 215000
Brunswick, GA 3121-5000
800-225-8550
www.map.org
Mercy Corps
Southeast Asia Earthquake
Dept. W
PO Box 2669
Portland, OR 97208
800-852-2100
www.mercycorps.org
Northwest Medical Teams
PO Box 10
Portland, OR 97207-0010
503-624-1000
www.nwmedicalteams.org
Relief International
11965 Venice Blvd. .405
Los Angeles, CA 90066
800-572-3332
www.ri.org
Operation USA
8320 Melrose Avenue, Ste. 200
Los Angles, CA 90069
800-678-7255
www.opusa.org
Oxfam America
Asia Earthquake Fund
P.O. Box 1211
Albert Lea, MN 56007-1211
800-77-Oxfam
http://www.oxfamamerica.org
Plan USA
Asia Disaster
155 Plan Way
Warwick, RI 02886
800-556-7918
www.planusa.org
Project Concern International
Asia Tsunamis Press List
5151 Murphy Canyon Road Suite 320
San Diego, CA 92123
858-279-9690
www.projectconcern.org
Project HOPE
Asia Tsunami Response
255 Carter Hall Lane
Millwood, VA 22646
800-544-4673
www.projecthope.org
SAWSO (Salvation Army World Service
Office)
South Asia Relief Fund
615 Slaters Lane
Alexandria, VA, 22313
800-SALV-ARMY
Save the Children
Asia Earthquake/Tidal Wave Relief Fund
54 Wilton Road
Westport, CT 06880
800-728-3843
www.savethechildren.org
Stop Hunger Now
SE Asia crisis
2501 Clark Ave, Suite 200
Raleigh, NC 27607
888-501-8440
www.stophungernow.org
US Fund for UNICEF
333 East 38th Street
New York, NY 10016
800-FOR-KIDS
www.unicefusa.org
World Concern
19303 Fremont Ave. N
Seattle, WA 98133
800-755-5022
www.worldconcern.org
World Emergency Relief
2270-D Camino Vida Roble
Carlsbad, CA 92009
760-930-8001
www.worldemergencyrelief.org
World Vision
PO Box 70288
Tacoma, Washington 98481-0288
888-56-CHILD
www.worldvision.org
Source: InterAction via AP
Thursday, December 23, 2004
In this Issue:
FDA says misleading Crestor ad should not run
New York City survey shows diabetes
gaining as a cause of death
AHRQ guide helps states assess and improve
diabetes care
HIMSS named to 2005
Associations
Advance America Honor Roll
Amerinet’s Allen Dunehew wins HIGPA Chairman’s
Award
FDA approves Smith & Nephew’s
ceramic hip
Happy Holidays from Healthcare Purchasing News!
FDA says misleading Crestor ad should not run
A newspaper advertisement that touted the safety of the cholesterol drug Crestor was misleading and should no longer be published, regulators said in a letter. In the letter, dated Dec. 21, the Food and Drug Administration told the manufacturer, AstraZeneca, that it is particularly concerned that the advertisement played down risks associated with Crestor and wrongly suggested that the agency has “confidence” in the drug. The FDA cited one statement in the ad, “The FDA has confidence in the safety and efficacy of Crestor”, and said it “misleadingly suggests that the agency does not believe that Crestor poses safety risks.” “In fact, recent public statements made by the agency contradict that conclusion,” the FDA said. AstraZeneca spokesman Steven Lampert said the company maintains that the advertisement was not misleading, adding that it was a “one-time thing” that is no longer being published. The company has insisted that Crestor, whose chemical name is rosuvastatin, is as safe as other statin drugs used to lower cholesterol. The letter cited comments by Steven K. Galson, acting director of the FDA's drug division, who told The Washington Post in November that the agency was “very concerned about Crestor since the day it was approved.” The large advertisement ran in The Washington Post, the New York Times, USA Today and other papers Nov. 23 and 24, just days after veteran FDA scientist David J. Graham told a congressional hearing that Crestor was one of five drugs that could be unsafe. Immediately after the advertisement ran, the consumer watchdog group Public Citizen asked the FDA to prohibit its future publication. The group has cited reports that the drug can cause kidney damage and is calling for Crestor to be pulled from the market. (Reuters)
New York City survey shows diabetes
gaining as a cause of death
Diabetes killed an
increasing number of
New York City
residents last year, ranking for the first time among the five leading causes of
death in an annual summary of vital statistics released by the health
department. Diabetes was identified as the fourth-leading cause with 1,891
deaths in 2003, an 11 percent increase from the previous year, when the disease
was ranked sixth, according to the summary. Of those deaths, 1,024 were women
and 867 were men. Health officials attributed the increase to rising levels of
obesity among New Yorkers, and also to a higher risk of the disease in a
population that is living longer. Diabetes was the third-leading cause of death
among those between 55 and 74. Health Commissioner
Thomas R. Frieden warned that diabetes remained an underdiagnosed
condition that had been linked to heart disease. The 67-page vital statistics
survey (http://www.nyc.gov/html/doh/pdf/vs%20/2003sum.pdf)
showed that the top three causes of death among city residents remained the same
from the year before: Heart disease was again the leading killer, causing 23,875
deaths last year. Cancer was second with 13,826 deaths, and influenza and
pneumonia was third with 2,692 deaths. Alzheimer's disease was identified for
the first time as a leading cause of death in people over age 75. AIDS-related
deaths dropped two places to seventh last year, accounting for 1,656 deaths,
compared with 1,713 the year before. Health officials pointed out that it
remained the leading killer of residents between 35 and 44. Fewer teenagers gave
birth last year, continuing a long-term national and citywide trend. The total
number of deaths dropped once again this year to a historic low of 59,213
deaths, compared with 59,651 in 2002. In addition, the survey studied the
aftereffects of the August 2003 blackout and debunked at least one urban myth.
“People may have had fun in other ways, but there was no increase in births,”
Dr. Frieden said. Dr. Nathaniel Clark, a vice president with the American
Diabetes Association, said the increase in diabetes-related deaths in
New York City was not
surprising, since the disease had become more common. He said people could
reduce their risk of developing it by losing weight and exercising regularly.
(The New York Times)
AHRQ guide helps states assess and improve diabetes care
The Agency for Healthcare Research and Quality and Council of State Governments released a resource guide and workbook designed to help states assess the quality of diabetes care and develop improvement strategies. AHRQ Director Carolyn Clancy, M.D., said the tools “arm healthcare professionals, policymakers and local leaders with evidence-based information designed to facilitate improvements in diabetes care.” Daniel Sprague, executive director of the Council of State Governments, said the resource “contains a wealth of data on diabetes care quality as well as information on promising practices that states have implemented to improve diabetes care.” (AHA News Now)
HIMSS named
to 2005 Associations
Advance America Honor Roll
The Healthcare Information and Management Systems Society (HIMSS) has been named to the 2005 Associations Advance America Honor Roll, a national awards competition sponsored by the American Society of Association Executives (ASAE), Washington, DC. HIMSS received the award in the Citizenship and Enhancing Democracy category of the competition for its National Advocacy Outreach Program to advance the Society's public policy agenda. Realizing that federal policy directly affects the HIMSS membership, the Society introduced its advocacy outreach in 2000. Now, more than 14,000 HIMSS members have direct access to the federal government to proactively affect federal policy with specific enhancements introduced during 2004. “This award recognizes the strong commitment of our Board of Directors and HIMSS members and staff who have worked tirelessly and seamlessly together to create and implement this successful program,” said H. Stephen Lieber, HIMSS president and CEO. “Our members have provided ongoing leadership and support to address key initiatives and legislation affecting the healthcare industry.” Now in its 15th year, the prestigious Associations Advance America Awards program recognizes associations that propel America forward, with innovative projects in education skills training, standards setting, business and social innovation, knowledge creation, citizenship, and community service.
Amerinet’s Allen Dunehew wins HIGPA Chairman’s Award
Amerinet congratulates Allen Dunehew, RPh, MPA, vice president of pharmacy, on receiving the 2004 Health Industry Group Purchasing Association (HIGPA) Chairman’s Award. The award recognizes Dunehew’s outstanding contribution to the healthcare purchasing industry on behalf of the association, including his leadership of the HIGPA Pharmacy Working Group. This group produced a February 2004 report titled Integrity of the Pharmaceutical Supply Chain: Product Sourcing for Patient Safety. Dunehew also provided oral testimony to the Department of Health and Human Services (HSS) Drug Importation Task Force and was a member of the 2004 National Pharmacy Forum Steering Committee. He has led efforts to increase HIGPA collaboration with the American Society of Health System Pharmacists and participated in discussions with HHS’s Office of Pharmacy Affairs regarding the 340B program. Dunehew was one of two HIGPA representatives on the Healthcare Distribution Management Association’s Drug Availability Task Force that offered comments regarding the Food and Drug Administration’s counterfeit Drug Task Force Interim report. “I am honored to be recognized for my service to HIGPA and the industry,” said Dunehew. “HIGPA offers the opportunity for all industry organizations to work collectively to enhance patient care. I want to thank my fellow Pharmacy Working Group members for their dedication, time commitment and expertise in addressing critical healthcare issues.” The inaugural award was presented to Dunehew by HIGPA Chairman and Novation President Mark McKenna at the HIGPA 2004 International EXPO in Orlando, FL in October.
FDA approves Smith & Nephew’s ceramic hip
The U.S. Food and Drug Administration approved Smith & Nephew Inc's (Andover, MA) ceramic-on-ceramic hip, which will launch as an extension of the company's Reflection family of hip implants. The product complements Smith & Nephew's existing line of advanced bearing products for hip replacement surgery, including a hip product made of oxidized zirconium metal, branded oxinium.
Happy Holidays from Healthcare Purchasing News!
The entire staff of Healthcare Purchasing News sends you and your family warm wishes for a safe and happy holiday season! We’ll be back again on Tuesday with the latest in healthcare news.
Wednesday, December 22, 2004
In this Issue:
HealthSouth tentatively settles
civil charges for $325 million
Ex-drug company manager
arrested in fraud
Administration report gives drug
importation mixed reviews
General Data and TimeMed join
forces for bar code
labeling and identification solutions
Alliance Medical receives 510K clearance
for diamond drill burs
OSHA issues guidance for hospital-based first responders
HealthSouth tentatively settles
civil charges for $325 million
HealthSouth Corp., Birmingham, AL, will pay $325 million over the next two years under a tentative settlement of False Claims Act charges with the U.S. Justice Department and HHS' inspector general's office, reported Modern Healthcare. The 36-page global settlement resolves civil charges stemming from several whistleblower lawsuits against the company. It does not resolve a Securities and Exchange Commission investigation into securities fraud at HealthSouth or criminal charges against HealthSouth personnel, including founder and former Chief Executive Officer Richard Scrushy. A final agreement on the civil charges is expected to be announced by year's end, sources said. The civil allegations against HealthSouth include billing for unnecessary services, for services provided by uncredentialed providers and for individual physical therapy when group therapy was provided. HealthSouth also allegedly failed to report a $19.3 million gain from a 2001 sale of Caremark stock and allegedly falsified Medicare cost reports. The SEC, meanwhile, has accused HealthSouth of inflating earnings by $2.7 billion. And Scrushy is scheduled to go to trial in January on a 58-count criminal indictment alleging that he directed the fraud. Scrushy has pleaded not guilty. (Modern Healthcare)
The former manager of a controversial pharmacy contract at Jackson Memorial Hospital was charged Monday with taking fishing trips, enjoying lavish dinners and visiting strip clubs at the public's expense, reported The Miami Herald. Investigators with Miami-Dade County's Office of Inspector General and the State Attorney's Office said Kevin Reece, of Houston, disguised his pleasure outings as business meetings and added phantom guests to his expense reports to bilk the hospital out of more than $6,300. The questionable bills were first reported by The Herald in September following a complaint by a whistle-blower at the publicly owned hospital. Reece, 39, turned himself in Monday morning after prosecutors charged him with fraud and grand theft. He was released without bond. His lawyer says he is innocent. Reece was a manager with Cardinal Health Inc., an Ohio company that received a $3 million no-bid contract last year to run the pharmacy at Jackson Memorial. Reece, who is no longer with the company, was in charge of handling the transition of the pharmacy's management to Cardinal, a position that allowed him to bill expenses through Cardinal to the hospital. Reece's lawyer, Brian Tannebaum, said his client intended to have the bills covered by his Cardinal expense account, not the hospital. Records show that Reece submitted most expense reports to a former hospital vice president, Alson Cook, for approval. No charges have been filed against Cook. Investigators said Reece sometimes removed the records that verified his expenses before submitting them to the hospital. Cook said he did not review Reece's bills before approving them, the arrest report says. Cook told investigators he thought the fishing trips were being paid for privately. He and another guest paid Reece in cash for their shares of the costs, the arrest report says. After the investigation, Jackson canceled its management contract with Cardinal. The company remains the hospital's drug supplier until that contract, worth about $75 million a year, expires next year. Cardinal reimbursed the hospital for Reece's expenses, and Reece is no longer with the company, said a Cardinal spokesman. Marvin O'Quinn, Jackson's president and CEO, said the hospital has improved oversight of its billing procedures in recent months “to make sure this doesn't happen again,” O'Quinn said. (The Miami Herald)
Administration report gives drug
importation mixed reviews
The Bush administration said Tuesday that commercial importation of some low-cost prescription drugs from Canada might be feasible. But the savings to consumers would be small, it said, and the federal government would have to spend hundreds of million dollars a year to ensure the drugs' safety, reported The New York Times. The administration said in a report to Congress that legalizing imports would probably hurt the development of new drugs for Americans. The report catalogued many reasons why importing drugs from Canada would be risky. Americans could save more, it said, by increasing the use of generic drugs. The report, by a 13-member federal panel, ruled out legalizing individual imports of drugs for personal use as unworkable. But it said that commercial imports by wholesalers and pharmacies, under strict regulation, might be feasible. The report, from the Health and Human Services Department, said new technology, including radio frequency identification tags, could enhance safety by tracking imports as they moved from overseas to American pharmacies. In a letter sending the report to Congress, the administration said that any legalization plan “must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs” and that “Canada is the only country from which importation should be considered at this point.” The report provides authoritative estimates of the volume of imports. “Nearly five million shipments, comprising about 12 million prescription drug products with a value of approximately $700 million, entered the United States from Canada alone in 2003,” it said. The report said that a similar quantity of drugs was coming from the rest of the world, through the mail and couriers. In a study this year, the Congressional Budget Office said prices for brand-name prescription drugs were, on the average, 35 percent to 55 percent lower in other industrialized countries. The administration said that total savings to consumers from legalizing commercial imports “would be a small percentage relative to total drug spending in the United States - about 1 to 2 percent.” The savings, it said, would be $2 billion to $4 billion a year. Generic drugs, which account for slightly more than half of all prescriptions filled in the United States, are less expensive here than in Canada and other countries, the report said. Wholesalers and other middlemen, it added, would mark up prices on imported drugs. The Commerce Department on Tuesday issued a separate report saying price controls in other countries hurt consumers by reducing the revenues that drug companies need to finance research. In the letter to Congress, Tommy G. Thompson, the secretary of health and human services, and Commerce Secretary Donald L. Evans said these safeguards would be needed in any import program: Importers must establish pedigrees for imports, documenting the “chain of custody” and identifying everyone who handled the drugs. The government should limit ports of entry and distribution channels and should test a sample of imported drugs to confirm safety. Imports should be allowed only from foreign suppliers and wholesalers licensed by the United States. The government must not compel drug companies to ship products to the United States from abroad. Without such compulsion, “drug companies and even foreign governments may decide to restrict exports to the United States.” (The New York Times)
General Data and TimeMed join forces for bar code
labeling and identification solutions
General Data, a provider of specialized labeling and identification products, has signed a marketing and distribution agreement with TimeMed Labeling Systems, a provider of labeling products, systems and services for the healthcare industry. As part of the agreement, TimeMed will integrate into its solutions offerings General Data’s healthcare identification solutions, including the PersonalID patient identification wristbands, and StainerShield, a patent-pending bar code identification system designed for pre-stainer labeling of tissue and specimen slides. TimeMed has more than 45 years of labeling expertise in the healthcare industry. Together, the companies will be able to offer hospitals complete bar code labeling and identification solutions that will reduce patient identification and medical errors while increasing patient safety and quality patient care. General Data’s PersonalID wristbands are designed for error-free bar code and photo identification of patients in hospitals and other healthcare environments. General Data’s StainerShield solution allows lab technicians to print on-demand, patient-specific bar code labels and apply them to slides before specimens are exposed to harsh chemicals, solvents and stains.
Alliance Medical receives
510K clearance
for diamond drill burs
Alliance Medical Corporation (Alliance), a reprocessor of single-use medical
devices (SUDs), announced U.S. Food and Drug Administration (FDA) clearance of Alliance's
reprocessed diamond bur drill bits. This marks the first 510(k) clearance by the
FDA for a reprocessed device without the need for a supplemental validation
submission (SVS) as directed by the Medical Device User Fee and Modernization
Act of 2002 (MDUFMA). “The heightened review by the FDA is further evidence that
reprocessed devices are at least as safe as other medical devices and enable
Alliance to continue to provide desperately needed supply cost-savings for our
hospital partners,” said Rick Ferreira, President of Alliance Medical
Corporation. The new clearance covers models by Linvatec, MicroAire, Zimmer,
Anspach and Stryker. These drill bits are used in surgery to cut and shape
bones. The FDA's clearance to reprocess these drill bits allows Alliance Medical
to provide greater savings opportunities for their hospital partners.
OSHA issues guidance for hospital-based first responders
The Occupational Safety and Health Administration issued guidance designed to help hospitals safeguard their employees as they care for patients injured in incidents involving chemical, biological or radiological materials. The document was developed based on the best practices of hospitals of varying sizes and risk levels, an extensive literature search and stakeholder input. AHA Executive Vice President Rick Pollack commented, “The AHA believes that the guidance will be of great value to hospitals as they enhance their emergency management plans to address both the threat of terrorist attacks as well as the unintentional release of toxic substances that periodically occur. We especially applaud OSHA for the inclusive and deliberate process that the agency undertook in creating and seeking input and review of the guidance.”
Tuesday, December 21, 2004
In this Issue:
A fourth painkiller is linked to increases in
heart problems
Specialists speak out against DEA reversal on
pain drugs
Study shows embryonic stem cells
keep animal hearts beating
Study examines which
procedures
are better suited for ASCs
A fourth painkiller is linked to increases in heart problems
Naproxen, made by Bayer and sold under the brand name Aleve, appears to increase the risk of heart attacks and strokes, the government said Monday, making it the fourth major painkilling drug linked to heart problems in recent months. Officials suspended naproxen's use in a national study of whether the drug might help prevent Alzheimer's disease, after finding that those taking the drug had a 50 percent higher risk of heart problems than those taking a placebo, or dummy pill, according to a preliminary analysis. Doctors at the Food and Drug Administration recommended Monday that patients taking naproxen without a prescription limit usage to no more than 10 days and 440 milligrams a day unless they consult their doctor. Federal drug officials said that similar drugs, like Advil, might also increase heart risks. The study, sponsored by the National Institutes of Health, was intended to measure whether Aleve and Celebrex, made by Pfizer, might prevent Alzheimer's disease. Nearly 2,500 patients were given one of the two drugs or a placebo and were followed for three years. Those taking Aleve had a 50 percent greater rate of heart problems, including heart attacks and stroke, than those given a placebo. But the NIH study appeared to contradict a National Cancer Institute study last week that found that Celebrex users had a 240 percent increase in heart problems. The NIH did not find a higher likelihood of those problems in Celebrex users. Merck executives withdrew their painkiller Vioxx after a study found that it increased the risk of heart attack and stroke by more than 100 percent. Also, Pfizer announced recently that a study of Bextra found that it increased the risk of heart attacks in those who have had cardiac surgery. Federal drug officials said that the entire class of painkillers known as nonsteroidal anti-inflammatories could cause worrisome effects on the heart. A spokesman for the FDA said the agency was studying the results of this latest study and “will be assessing what regulatory actions are appropriate over the next day or two.” The NIH said it would review four dozen studies that it funds using the painkiller Celebrex. The agency said the fate of the other studies is unclear.
Specialists speak out against DEA reversal on pain drugs
Three medical associations representing pain specialists have sent the Drug Enforcement Administration a joint letter critical of its recently revised guidelines on prescribing pain medicines. The letter, signed by the presidents of all three groups, called a DEA policy statement published in November in the Federal Register “an unfortunate step backward” that encourages a return to “an adversarial relationship between [doctors] and the DEA.” Already concerned about what they saw as sometimes over-aggressive prosecutions of doctors, pharmacists and other health professionals who prescribe narcotic painkillers such as OxyContin, the specialists said the new DEA position threatens their ability to provide care to millions of patients. The presidents wrote that despite the DEA's assurances that it does not want to discourage doctors from providing proper narcotic medication to people in pain, the new guidelines “will undoubtedly have the exact opposite effect on any practitioner reading them.” DEA spokesman Bill Grant said in response that the agency “wishes to reassure the public that the withdrawal of the August [statement] does not represent any change in DEA's investigative emphasis or approach. Physicians acting in good faith and in accordance with established medical norms should remain confident that they may continue to dispense appropriate pain medications.” He said the DEA is working on a process to gather the views of the medical community as it refines its policy. The letter from the heads of the American Pain Society (APS), the American Academy of Pain Medicine (AAPM) and the American Society of Addiction Medicine (ASAM) is a response to a Nov. 16 DEA statement that repudiated some parts of a jointly negotiated set of guidelines that had been introduced in August. The August guidelines, in the form of answers to 29 frequently asked questions, were the result of two years of discussion and negotiation between pain specialists and the DEA. They were embraced by many doctors as a breakthrough in resolving a deepening conflict between law enforcement and pain management practitioners. But less than two months later, the agency took the document down and replaced it with a notice saying some of the earlier statement was inaccurate and did not represent a DEA policy statement. The pain specialists' letter took particular aim at the agency's new description of prescribing practices that can lead to a DEA investigation. The DEA said doctors who prescribe high dosages of opioid painkillers to patients for long periods of time are subject to investigation. It also said the government can open investigations on the suspicion that a doctor is diverting controlled drugs or to make sure there is no improper activity. (Washington Post)
Study shows embryonic stem cells
keep animal hearts beating
Researchers say they have transformed embryonic stem cells into heart cells that
could someday replace the electronic pacemakers now implanted to keep hearts
beating normally. “By transplanting these human heart cells into the ventricle
[heart chamber] of an animal, we can make them beat spontaneously,” said Ronald
Li, an assistant professor of medicine at Johns Hopkins Medical School and
leader of the group reporting the work in the Dec. 20 online issue of
Circulation. “The implication is that eventually we could make a biological
pacemaker to replace electronic pacemakers.” The
Hopkins
work avoids the controversy over the use of human stem cells because it was done
with a line of embryonic stem cells, designated ES, grown at the University of
Wisconsin, one of the few lines approved for use by the Bush administration.
Experiments have been done in guinea pigs, and the work needs to be repeated in
large animals such as pigs, said Li. (HealthDayNews)
Study examines which procedures
are better suited for ASCs
According to risk assessment researcher Lee Fleisher, procedures less advisable in the Ambulatory Surgical Center (ASC) setting include operations lasting more than two hours and those that will require general anesthesia. Fleisher's study on ASC safety, published this year in the journal Archives of Surgery, found that higher rates of death and disability correlated with “greater invasiveness.” He listed prostate removal, laparoscopic gallbladder operations, radical mastectomy and umbilical hernia repair as among the more problematic operations. He also cautioned against certain plastic surgeries that take so long anesthesia can wear off, and certain orthopedic surgeries that produce a lot of bleeding, among others. “Laparoscopic gallbladder removal is on the edge of how far I would go” in an ASC setting, Fleisher said. The Center for Medicare and Medicaid Services (CMS) authorizes reimbursement for some 2,500 procedures, from cataract surgery to breast reduction, at ASCs. Last month, it revised the list of approved procedures, adding 25, including knee arthroscopy, chin reconstruction and bladder repair, and deleting 105. Among the items deleted as too risky: muscle and skin grafts, reconstructive cleft palate surgery, excision of the parotid gland, draining ovarian abscesses, repair of facial nerves and eardrum revision. Publication of the list is closely watched by private insurers and HMOs, which use it to decide what procedures to cover. That, in turn, affects ASC conduct. Medicare's decision last year against reimbursing laparoscopic gallbladder removal in the ASC setting, for example, effectively stopped many ASCs from performing it. CMS gave no explanation for its removal this year of two popular urology procedures: prostate biopsies carried out with needles; and cystoscopy, a telescopic inspection of the bladder and the urethra. ASCs, professional societies and individuals have until January 25 to challenge the changes. (Washington Post)
Mobile Aspects unveils RFID healthcare system
The healthcare industry RFID solutions provider Mobile Aspects announced the availability of its new ‘One System of CARE’, comprising RFID hardware and software solutions to enable healthcare providers to automatically track medical supplies, assets, and patients in real-time for safer and more efficient patient care. The system creates and monitors real-time data, providing healthcare providers with reliable data instantly for reporting, searching, and for patient/drug alerts. The system updates existing care systems by adding automatic identification and information technologies. By automatically tracking patients, product usage, and medicine usage, it enables healthcare providers to deliver safer patient care while bringing about more accurate inventory management and billing. From the system's web-based (thin client) interface, authorized medical staff can receive and monitor real-time data and evaluate any medicinal, asset-related, or patient data at any time. Integrated seamlessly into a hospital's existing information management systems, such as billing, electronic medical records, and ADT systems, Mobile Aspects’ RFID tracking solutions include the company's iRIS inventory management system, an RFID-enabled anaesthesia workstation, a medicine delivery workstation, and both patient and asset tracking systems.
Monday, December 20, 2004
In this Issue:
Administration wants to curb state Medicaid
spending
Pfizer will stop advertising Celebrex to
consumer
CDC expands priority groups for flu shots
Lung-cancer drug shows unfavorable trial
results
IsoTis sells wound management
unit
to DFB Pharmaceuticals Inc.
Administration wants to curb state Medicaid spending
Federal
officials are sending auditors to state capitals across the country to
investigate techniques used by states to shift hundreds of millions of dollars
in Medicaid costs to the federal government. Also, under a proposed federal
rule, the Bush administration will require states to prepare annual estimates of
total improper payments and calculate payment error rates for Medicaid and the
State Children's Health Insurance Program. States will have to identify the
cause of each error, address it and recover any overpayments to healthcare
providers. The moves come as the administration is considering a wide range of
other new initiatives to curb the growth of Medicaid spending, crack down on
improper payments and help states save money by restricting eligibility and
benefits, reported The New York Times. Federal investigators said
Medicaid wasted hundreds of millions of dollars a year by overpaying for
prescription drugs. Many states pay on the basis of inflated, fictitious list
prices reported by drug companies. One of the initiatives would link payments to
actual market prices, which are often much lower. Federal health officials said
the nomination of Michael O. Leavitt as secretary of health and human services
signaled the administration's desire to make big changes in Medicaid, like those
Mr. Leavitt made as governor of Utah. Under one proposal, states would be
allowed to make many changes like increasing co-payments and limiting
eligibility without having to get federal waivers. Local officials would also be
allowed to provide different benefits in different parts of a state. In a letter
to President Bush last week, 47 Democratic senators expressed “opposition to any
Medicaid reform proposal that seeks to impose a cap on federal Medicaid spending
in any form or eliminates the fundamental guarantee to Medicaid coverage for our
nation's must vulnerable citizens.” Medicaid spending shot up 63 percent in the
last five years. With more than 50 million beneficiaries and more than $300
billion a year in combined federal and state outlays, Medicaid is now bigger
than Medicare. For prescription drugs alone, Medicaid spending soared to $34
billion in 2003, from $13.6 billion in 1998. Mr. Bush has vowed to cut the
federal budget deficit by half in five years, and Republican leaders in Congress
say that goal will be virtually impossible without touching Medicaid. Gary R.
Karr, a spokesman at the Centers for Medicare and Medicaid Services, said the
administration would work with Congress to come up with “a long-term solution
that helps state budgets while improving health outcomes for beneficiaries.” The
growth of Medicaid has outstripped the growth of state revenues and is putting
pressure on other state programs. This year, for the first time, Medicaid was a
larger component of state spending than elementary and secondary education
combined, the governors association said.
http://www.nytimes.com/2004/12/20/politics/20
medicaid.html?ex=1104548448&ei=1&en=204ce310e20ec1a0
Pfizer will stop advertising Celebrex to consumer
Pfizer said that it would immediately stop advertising Celebrex, its best-selling arthritis pain reliever, to consumers after a study showed that high doses were associated with an increased risk of heart attacks. The suspension of advertising, which is indefinite, includes television, radio, newspaper and magazine ads and other promotions to consumers, said a Pfizer spokesperson, according to the New York Times. The Food and Drug Administration said Friday that it was considering regulatory measures that could include severe label warnings or even requiring that the drug be withdrawn in the United States. Although consumer advertising will be suspended, Pfizer plans to continue marketing Celebrex to doctors, said the spokesperson. The FDA's acting commissioner, Dr. Lester M. Crawford, said Friday that doctors should consider moving patients on Celebrex to other drugs. Pfizer maintains that Celebrex has not been shown to be dangerous when taken at the usual dose levels for arthritis patients. The heart risk in the study disclosed on Friday occurred only when patients took Celebrex at two to four times the usual dose for long periods. In addition, Celebrex had not been linked to heart attacks before Friday, although other studies have shown comparable problems with Bextra, as well as Vioxx, the similar drug that Merck has withdrawn. (The New York Times)
CDC expands priority groups for flu shots
A federal advisory panel Friday recommended the government ease restrictions on the nation's supply and make shots available to everyone 50 and older. The move was prompted by worries that tens of thousands of doses of flu vaccine might go to waste. Some states are reporting a surplus of flu vaccine. One reason is that many of the elderly or chronically ill people who were given top priority for flu vaccinations did not try to obtain a shot. Also, the flu season has been mild so far. The recommendation from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices came during an emergency meeting. On Friday, the advisory panel said the CDC should focus first on helping state and local health departments reallocate supplies to any facing shortages, and then work to allow more people to get flu shots. Under the panel's recommendation, the elderly, infants and the chronically ill would still be given the highest priority, but shots would also be made available to a second-tier group of people ages 50 to 64 as well as those who are in close contact with high-risk individuals, depending on vaccine availability in each state. Effective January 3rd, in locations where state and local health authorities judge vaccine supply to be adequate to meet demand, the priority groups for inactivated influenza vaccine will include adults age 50-64 and out-of-home caregivers and household contacts of persons in high-risk groups. People in the high-risk groups for serious complications from influenza include persons aged 65 years or older, children aged less than 2 years, pregnant women, and people of any age who have certain underlying health conditions such as heart or lung disease, transplant recipients, or persons with AIDS. The emergency meeting was scheduled after a CDC study released Thursday found that more than half of all elderly or chronically ill adults have not yet gotten a flu shot. The committee concluded that those people in the high-risk groups who have not already sought a flu shot are unlikely to do so this season. More than four out of five states report having sufficient supplies of flu shots, and at least six states have reported a surplus, the CDC reported. The committee also voted Friday to immediately recommend allowing children ages 2 to 18 to get the vaccine if they are in close contact with high-risk patients. (The Associated Press) For more, visit www.cdc.gov/flu.
Lung-cancer drug shows unfavorable trial results
The Food and Drug Administration said on Friday that it would consider whether to remove Iressa, a product from AstraZeneca, from the market after the drug failed to prolong the lives of people with advanced lung cancer in a clinical trial. AstraZeneca said that while the drug would remain available to patients for now, the company would not promote it to physicians. Iressa was one of the first cancer drugs created to disrupt a particular molecular mechanism that spurs tumor cells to grow and to avoid some of the most serious side effects of conventional chemotherapy. In May 2003, the F.D.A. approved Iressa as a last-ditch treatment for lung cancer, under rules intended to speed the introduction of drugs for life-threatening diseases. The drug was approved because it shrank tumors in about 10 percent of patients for whom other treatments had been unsuccessful. But the approval was contingent on the company running a trial to show that the drug actually prolonged lives, the FDA's preferred benchmark. On Friday, AstraZeneca announced that Iressa had not prolonged lives in the 1,700-patient trial by a meaningful amount. Those taking the drug had a median survival of 5.6 months compared with 5.1 months for those taking a placebo. The Iressa finding is expected to mean much larger sales of Tarceva, a very similar lung cancer drug that was approved in November. That drug prolonged lives in a clinical trial, providing a median survival of 6.7 months compared with 4.7 months with a placebo. If Iressa is to be saved, it might be by using genetic tests to identify in advance which patients would benefit from the drug. Earlier this year, after the Iressa trial had already begun, two teams of scientists in Boston reported finding genetic mutations in tumor cells that correlate with benefit from the drug. (The New York Times)
IsoTis sells wound management unit
to DFB Pharmaceuticals Inc.
IsoTis OrthoBiologics announced it has sold its wound management activities to DFB Pharmaceuticals Inc. of Fort Worth, TX, for an undisclosed amount. DFB Pharmaceuticals, through its subsidiary Healthpoint Ltd., is a US-based market leader in advanced wound care, dermatology, and surgical products. In August 2003, IsoTis OrthoBiologics and DFB Healthpoint entered into a worldwide exclusive licensing agreement for Allox, a cell-based product for the treatment of chronic skin wounds. In 2003, IsoTis announced the establishment of EpiSource SA to create an independent vehicle and a potential spin-off company for its wound management portfolio. Pieter Wolters, Chief Executive Officer of IsoTis OrthoBiologics, said, “Today's agreement concludes IsoTis' transformation over the past two years. It allows us to focus for the full 100 percent on orthobiologics.” H. Paul Dorman, Chairman and CEO of DFB/Healthpoint added, “We believe that the future of advanced wound care will include more pharmaceutical and cell-based biologic products. We are very committed to this future and believe that Allox will be a tremendous addition to our product portfolio.”
Friday, December 17, 2004
In this Issue:
Johnson & Johnson to acquire Guidant
States more fiscally fit, but
health costs
prevent full recovery
Novation awards separate
surgical products
to multiple manufacturers
Internal FDA survey shows lack
of confidence in oversight
FCC acts to expand
availability of
rural telemedicine funding
GE Healthcare introduces FDA
approved adaptable
critical care respiratory carestation
Amerinet renews contract with
Tyco Healthcare Group
Johnson & Johnson to acquire Guidant
Johnson & Johnson (J&J) has said that it would acquire
Indianapolis-based interventional device firm
Guidant for $25.4 billion. The deal will result in a new
cardiovascular device unit for J&J. The unit will bear the Guidant
name and will include Cordis, a J&J company that was first to
receive Food and Drug Administration approval to market a
drug-eluting stent. The Cordis name will be retained for certain
products within the franchise, Guidant said. J&J said its offer to
acquire Guidant was made up of 60% stock and 40% cash to give J&J
the financial latitude to pursue additional deals should it choose
to do so. In a conference call with analysts, J&J Executive Vice
President and Chief Financial Officer Robert Darretta said the
acquisition of Guidant, a leader in the fast-growing defibrillator
and stent markets, would diversify J&J's revenue stream, reducing
the company's reliance on pharmaceuticals, reported Modern
Healthcare. The boards of directors of Johnson & Johnson and
Guidant have given their respective approvals to the transaction,
which is subject to clearance under the Hart-Scott-Rodino Antitrust
Improvements Act, the European Union merger control regulation, and
other closing conditions. The agreement will require the approval of
Guidant's shareholders. Officials said they hoped to complete the
deal by the third quarter of 2005. Guidant, a 1994 spinoff of Eli
Lilly and Co., capitalized on breakthroughs in heart stents and
pacemaker- defibrillator technology to become one of the world's top
medical device makers with $3.6 billion in revenue. The deal would
be the largest in J&J's 118-year history, the Associated Press said.
(Modern Healthcare)
States more
fiscally fit, but health costs
prevent full recovery
The fiscal condition of the states improved this year, but soaring health costs have made it difficult for them to recover from the worst fiscal crisis in six decades, the National Governors Association said Thursday. States ended the 2004 fiscal year with balances totaling $25.3 billion, equal to 4.8 percent of state spending. That represents a significant increase from the previous year, when balances totaled $16.4 billion, or 3.2 percent of state spending. Such balances provide a financial cushion for states, with a 5 percent cushion considered healthy. Twenty-three states had balances of 5 percent or more, up from 12 in 2003. A recession in 2001 sharply reduced state revenues for two years. Now, the governors said, tax collections are more stable, but still not sufficient to pay for the growth of Medicaid and other health costs. “We have just come through a tremendously difficult fiscal period,” said Raymond C. Scheppach, executive director of the governors association. Scott D. Pattison, executive director of the National Association of State Budget Officers, noted that while the latest nationwide survey showed “relative improvement from the fiscal malaise of the past few years, the states' fiscal situations will remain difficult for the foreseeable future.” Spending from state general funds increased by 3 percent this year to $523.5 billion, after two years of hardly any growth. Despite the signs of a recovery, states are keeping a tight lid on spending, and nine states reported a decline in general fund spending from 2003 to 2004. They were Alaska, Colorado, Maryland, Michigan, Minnesota, Nebraska, South Carolina, Texas and Wisconsin. One mystery of the last recession is why welfare rolls continued to decline even as unemployment increased. States have poured money into education, training and child care to help welfare recipients get and keep jobs. Forty-four states said they would maintain cash assistance benefits in 2005 at the levels in effect this year. Five states - California, Illinois, Michigan, South Dakota and Texas - said they planned to increase cash assistance benefits next year, while West Virginia said it was planning a substantial cut. Collections of sales, personal income and corporate income taxes equaled or exceeded projections in 45 states this year. But, the report said, revenues came in lower than expected in five states: Colorado, Georgia, Kentucky, Ohio and Oregon. States had two favorite sources of new revenue. They increased cigarette and tobacco taxes by a total of $888 million, and they approved sales tax increases totaling $710 million. In 2002, the governors association reported that “nearly every state is in fiscal crisis,” with the worst budget problems since World War II. Congress provided $20 billion in fiscal relief to the states last year. But the aid expired in June, and Congress has no plans to renew it. (Source: The New York Times)
Novation awards separate surgical products
to multiple manufacturers
Novation, the supply company of VHA Inc. and the University HealthSystem Consortium, has awarded 17 separate contracts to six companies for Endoscopic Instruments, Ligation, Mechanical Stapling and Cutting, Skin Staplers, Sutures, Topical Skin Closure, Trocars, and Ultrasonic Cutting and Coagulation. These products, historically awarded together as suture and endomechanicals, are being awarded individually and will offer greater overall value to healthcare organizations. The agreements take effect on April 1, 2005, and run through March 31, 2008. The total potential for VHA and UHC member purchases across all product categories covered by the new Novation contracts is $900 million, although Novation does not anticipate that members will purchase all that is available through the new contracts. The agreements could provide up to a 25 percent savings for VHA and UHC members over the previous offering. “The new Novation agreements include the following companies and products: 3M (St. Paul, MN), Skin Staplers; Aesculap (Bethlehem, PA), Sutures; Applied Medical (Rancho Santa Margarita, CA) Endoscopic Instruments, Ligation, Trocars: Ethicon (Somerville, NJ), Mechanical Stapling and Cutting, Topical Skin Closure, Trocars; Genicon (Winter Park, FL), Trocars; and United States Surgical (Norwalk, CT), a business unit of Tyco Healthcare—Syneture and Autosuture divisions, Endoscopic Instruments, Ligation, Mechanical Stapling and Cutting, Skin Staplers, Sutures, Topical Skin Closure, Trocars, Ultrasonic Cutting and Coagulation. The agreements were awarded based on the results of Novation's public competitive bid process, member surveys and the recommendation of the Novation Suture and Endomechanical Task Force, which includes clinicians and purchasing executives from member hospitals. Their decision measured both financial and non-financial criteria, such as clinical acceptability, product breadth and depth, value added, and ability to supply and service. “Consistent with Novation's heritage of being 'member-driven,' these new contract awards reflect member preferences and the changing dynamics in the marketplace," said Bob Majors, director of materials management, Bloomington Hospital & Healthcare System in Bloomington, Ind. “The new awards will provide members access to more choices and new technology, and increase the competitive environment for future bids across all products and services.”
Internal FDA survey shows lack of confidence in oversight
About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold, according to an internal survey, reported the Associated Press. More than one-third of those scientists have some doubts about the process for approving new drugs, the survey found. Complete results of the survey, conducted by the Health and Human Services Office of Inspector General, were released after an advocacy group filed a Freedom of Information Act request. The survey sought the opinions of about 400 agency scientists about the process of evaluating and approving prescription drugs. A majority said they were “completely confident” or “mostly confident” about decisions concerning the safety and efficacy of drugs approved for sale. But 31 percent were only “somewhat confident” and 5 percent had no confidence in the safety decisions. About 66 percent of those surveyed said they were not at all confident or somewhat confident that the FDA adequately monitors the safety of drugs once they are on the market. (AP)
FCC acts to
expand availability of
rural telemedicine funding
The
Federal Communications Commission took steps to
expand a program that provides telemedicine funding to healthcare providers
serving rural communities. The Rural Health Care Support Mechanism program
provides discounts on monthly telecommunications charges, satellite services for
mobile medical clinics and Internet access. With program expenditures below the
annual limit of $400 million, the commission adopted changes to redefine what
constitutes a rural area to better target small towns and villages, increase
discounts available for the purchase of mobile satellite telecommunications
services, and streamline the application process by setting an annual June 30
deadline for applications. The commission also launched a further rulemaking
examining whether a flat 25% discount for Internet services is sufficient, and
whether network infrastructure should be funded under the program.
GE
Healthcare introduces FDA approved adaptable
critical care respiratory carestation
GE Healthcare, a division of General Electric Company, has received FDA 501(k) clearance for the Engström Carestation, a critical care respiratory carestation offering integration throughout the care process. The Engström Carestation offers integration of ventilation with monitoring modules, capable of measuring advanced parameters, and is designed to make the job of the respiratory therapist easier, faster and more accurate. The Engström Carestation was introduced in the U.S. at the annual meeting of the American Association of Respiratory Care (AARC). Clinicians can easily adapt the Engström Carestation to their facility standards; ventilator defaults, from alarm and mode settings to the desired user interface configuration, can all be adjusted. Aerogen's OnQ aerosol generator, the Aeroneb Pro Micropump Nebulizer integrates directly into the Engstrom Carestation. This advanced nebulization system produces a fine droplet, low-velocity aerosol without requiring propellants, compressors or ultrasonic elements. The Engström Carestation system includes network and integration capability, patient care documentation, plug-and-play modules and the ability to provide patient spirometry and metabolic measurement. The Engstrom Carestation also includes a Paramagnetic O2 sensor, which is maintenance-free, comes standard and never needs to be replaced.
Amerinet renews contract with Tyco Healthcare Group
Amerinet has renewed an agreement with Tyco Healthcare Group, delivering member savings on electronic thermometry products. The renewed agreement extends the contract for an additional 36 months through November 1, 2004. Tyco Healthcare manufactures a diverse menu of healthcare products and is a leading developer and distributor of medical products worldwide.
Thursday, December 16, 2004
In this Issue:
FDA under scrutiny over flawed devices
American Medical Group
Association
membership continues steady climb
Comptroller General to appoint
members of
new citizens' healthcare working group
DJ Sullivan Healthcare
Consulting
announces new staff member
FDA under scrutiny over flawed devices
A report
in The New York Times examines possible shortcomings in the Food and Drug
Administration’s (FDA’s) regulation of high-risk medical devices such as
defibrillators, citing the example of Access Cardiosystems (Concord, MA), which
recalled all 18,500 defibrillators it had produced since going into business two
years earlier. The company insists that actual product failures were few and
that most patients were never endangered. But according to The Times, an
executive of the company acknowledged there was a component failure in one of
the company’s devices that failed to revive a 72-year-old man following a heart
attack. A look at the history of Access Cardiosystems raises questions about its
products, said The Times. Formed in 2000, the company received FDA
approval in 2002 to sell its device through a commonly used regulatory procedure
for devices that allows a manufacturer, rather than running clinical trials,
only to show that its product is “substantially equivalent” to ones already
offered for sale. An executive of the company, which ceased operating last
month, said that more than 50 percent of the units might have defects. Months
earlier, in January, Access Cardiosystems' former chief executive, wrote the FDA
and accused Access of shipping potentially defective units. When FDA inspectors
visited the factory days later, they found no major defects and cleared the
company of serious problems. But as complaints about the device, and deaths
possibly associated with it, began to increase over the summer, the inspectors
never returned to learn what they might have missed. Already under scrutiny for
what some critics say is lax oversight of prescription drugs, the FDA may have
similar problems with medical device regulation, said The Times. Each
year, the agency approves hundreds of devices, including dozens of so-called
high-risk products, such as defibrillators, whose failure is life-threatening.
With the sales of such devices soaring, especially in settings such as offices,
schools and homes which are outside of the agency’s problem-reporting system,
some experts say that the FDA may soon have an even bigger problem on its hands.
Under FDA rules, only manufacturers and healthcare facilities are required to
report patient deaths or serious injuries that are potentially related to device
defects. But individual consumers and even many emergency units like police and
fire department rescue squads are not covered by the rule. As a result, some
faulty equipment may go undetected and uncorrected. “We are depriving the
regulatory system and the manufacturers of critical input,” said Mark E. Bruley,
a vice president at ECRI Inc., a company which evaluates medical devices. Dr.
Daniel G. Schultz, the director of the FDA's Center for Devices and Radiological
Health, disputed any suggestion that the agency failed to aggressively regulate
medical devices, saying that the agency “responded appropriately to the
information” it had about Access Cardiosystems. But, Dr. Schultz did acknowledge
that the growing use of emergency defibrillators in public places and homes was
likely to create new challenges. The agency, while demanding that manufacturers
of some high-risk devices follow their products' performance, has permitted the
sale of devices before receiving study proposals from companies on how they
intend to do this. In September, the FDA approved for the first time the
over-the-counter sale of emergency defibrillators, but it has yet to receive an
after-sale study proposal from the manufacturer, a unit of Royal Philips
Electronics. A Philips spokeswoman said her company planned to submit a study
proposal soon, according to The Times. For the full story, visit
http://www.nytimes.com/2004/12/15/business/15device.
html?ex=1104120874&ei=1&en=2618444d9847b465
American
Medical Group Association
membership continues steady climb
The American Medical Group Association (AMGA) announced another strong year of membership growth. As of November 30, AMGA has experienced a net growth of more than 5,000 physician members in 2004 and has added 30 new medical group members, bringing the total current membership to nearly 70,000 physicians in 257 medical groups. This growth is even better than 2003, when AMGA had a net growth of 3,900 physicians and gained 28 new member medical groups. “Our new members continue to cite AMGA’s focus on the specific needs of physicians and administrative leaders in multispecialty medical groups and integrated delivery systems as one of the main reasons they are turning to AMGA,” said Donald Fisher, Ph.D., President and CEO of AMGA. In the past three years, AMGA’s group membership has grown 13.2 percent and the number of physicians represented has grown nearly 25 percent, from 226 members with approximately 50,000 physicians in 2001 to 257 members with nearly 67,000 physicians in 2004. Retention has also been stronger in 2004 than in past years, with only 8 medical groups dropping membership in the association, representing 448 physicians or 3.1 percent of the total membership. AMGA is a not-for-profit trade organization that represents medical groups, including some of the nation’s largest integrated healthcare delivery systems. AMGA advocates for the multispecialty medical group model of healthcare delivery and for the patients served by medical groups through innovation and information sharing, benchmarking, leadership development, and continuous striving to improve patient care. To learn more about AMGA, visit www.amga.org.
Comptroller
General to appoint members of
new citizens' healthcare working group
Comptroller General of the United States David M. Walker will appoint 14 individuals, including a chairperson, to serve as members of the Citizens' Health Care Working Group, as required by the Section 1014 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). The secretary of Health and Human Services also serves as a member of the working group and is required by the MMA to establish the working group. The group will lead a nationwide public debate on ways to improve the healthcare system to provide every American with the ability to obtain quality and affordable healthcare coverage. The working group will make recommendations to the President and the Congress. Individuals interested in serving for the two-year term will have an opportunity to apply online at GAO's website (www.gao.gov) beginning in mid-December. The comptroller general will announce his appointments by late February 2005.
DJ Sullivan Healthcare Consulting
announces new staff member
DJ Sullivan Healthcare Consulting, Inc. (SHC) announces the addition of William (Bill) Bailey to its staff. As Vice President of SHC, Mr. Bailey will head the surgery materials management and sterile processing programs within the SHC consulting repertoire. Mr. Bailey has 25 years of experience in surgery and sterile processing in both clinical and managerial positions, including more than 11 years in surgery management consulting and implementation. The addition of Bill Bailey to the SHC staff represents a significant expansion in focus and expertise concerning surgery materials, i.e., supply chain logistics, comprehensive materials cost management, sterile processing operations, CSP facility design, and staffing allocation. These are all critical elements in achieving a “Best Practice Surgery Program,” the cornerstone consultation/design/implementation offering of the SHC practice.
Wednesday, December 15, 2004
In this Issue:
Medicare payment errors nearly $20 billion
How to report problems with
device
manufacturers to the FDA
Report: US still not ready for bioterrorism
Thompson names hospital leaders to AHRQ
advisory council
Catholic Health east joins
Consorta
Consorta awards Medline with
wound care
products agreement
Misys Healthcare Systems
launches
Misys Pharmacy solution
Medicare payment errors nearly $20 billion
Medicare wants to cut the rate of questionable payments by more than half, to 4 percent, by 2008, administrator Mark McClellan said. Medicare reported Monday that private companies that process health claims from its beneficiaries made nearly $20 billion in erroneous or questionable payments last year, an error rate of 9.3 percent. That performance was a slight improvement over the previous year. The error rate measures claims that were paid despite being medically unnecessary, inadequately documented or improperly coded. In some instances, Medicare asked healthcare providers for medical records to back up their claims and got no response. The survey does not document instances of alleged fraud, McClellan said. More extensive payment reviews and other quality controls will help the agency achieve the 4 percent goal, he said. Medicare contracts with private insurers to pay more than 1 billion claims each year. Monday's report was based on a survey of 160,000 claims, Medicare said. Last year, Medicare reported the error rate as 5.8 percent, but that figure had been adjusted to factor out a high proportion of claims for which the healthcare provider did not respond to Medicare's request for documentation. The unadjusted rate was 9.8 percent, using the same criteria that produced this year's 9.3 percent rate. Medicare said it abandoned the adjustment because its analysis was larger and more detailed. The review found that doctors and other providers were paid $900 million less than they should have received because of errors made by insurers. By contrast, there were $20.8 billion in questionable overpayments, Medicare said. Medicare report: http://www.cms.hhs.gov/CERT (Associated Press)
How to report problems with device
manufacturers to the FDA
Many of IAHCSMM’s members have reported, through the Discussion Forum and at IAHCSMM Meetings, that they are having problems with manufacturers. For instance, some manufacturers are not providing adequate instructions for cleaning and/or sterilization; some are calling for unusual cycles that are unavailable on standard hospital sterilizers, etc. According to the FDA, the only way the FDA can take any action is to receive complaints, properly filed on MEDWATCH Form 3500. To make the reporting easier, the FDA has provided a website that goes directly to the Form. They also provide instructions on exactly how the Form should be completed. The website is: https://www.accessdata.fda.gov/scripts/medwatch.
Report: US still not ready for bioterrorism
The nation's public health system remains woefully unprepared to respond to a crisis, despite repeated government warnings about the possibility of bioterrorism or another health emergency such as a flu pandemic, a new report shows. The federal government has spent $3 billion to improve public health preparedness since 2001, but little progress has been made toward tracking disease outbreaks, preparing for mass distribution of antidotes and equipping labs to identify and test for deadly pathogens, the non-profit Trust for America's Health found in its second annual report on public health preparedness. “More than three years after 9/11 and the anthrax tragedies, we've only made baby steps toward better bioterrorism preparedness, rather than the giant leaps required to adequately protect the American people,” said Lowell Weicker, board president for the Trust and a former senator and governor from Connecticut. The report detailed weaknesses nationwide. Among them: •Only six states are fully capable of distributing life-saving vaccines and antidotes from a federal stockpile in an emergency. Florida, Illinois and Louisiana are among them; three other states have chosen not to make their status public. •Twenty states still don't have a public response plan to deal with a flu pandemic. Scientific models show that in the USA, a major flu outbreak could result in 89,000 to 207,000 deaths and cost the economy up to $166.5 billion. Health officials warn that such an outbreak could happen at any time. •Only five public health labs have the equipment and space necessary to handle a chemical terrorism threat. •Two-thirds of states don't electronically track disease outbreak information according to national standards. Without such tracking, delays in reporting make crucial early warnings and treatment impossible. Despite the influx of money after 9/11, the report said it's not enough. Federal bioterrorism funding decreased by more than $1 million per state in 2004, and nearly a third of the states cut their public health budgets between fiscal years 2003 and 2004, the report said. Government officials have praised the progress made updating the public health system, pointing to the creation of the national stockpile, which barely existed before 9/11. Von Roebuck, spokesman for the federal Centers for Disease Control and Prevention, which controls the national stockpile, said CDC officials “feel comfortable that any state in the nation could respond” to a bioterrorist attack. Overall, he said, “there's been a lot of really good progress that's been made” on public health preparedness, but “there is work that still needs to be ongoing.” (USA Today)
Thompson names hospital leaders to AHRQ advisory council
HHS Secretary Tommy Thompson has appointed seven new members to the National Advisory Council for Healthcare Research and Quality, which advises the Health and Human Services secretary and the director of HHS’ Agency for Healthcare Research and Quality on priorities for a national health services research agenda. The new members, who will serve through 2007, include hospital leaders Patrick Charmel, president and CEO of Griffin Health Services Corp., Derby, CT; Daniel Varga, M.D., chief medical officer at Norton Healthcare, Louisville, KY; and Andrew Brown, M.D., associate vice chairman for primary care at the University of Mississippi Medical Center, Jackson, MS. For more, visit http://www.ahrq.gov/about/council.htm.
Catholic Health east joins Consorta
Consorta Inc. announced that Catholic Health East (CHE) has become a Consorta Shareholder. With the addition of CHE, Consorta’s 13 Shareholder systems now represent 60% of the Catholic acute care hospitals in the United States. Consorta’s ability to foster a growing collaboration of Catholic systems under a single GPO is unprecedented. Consorta has consistently delivered the highest rate of return in the industry and this year will hit a new high with the return of 75 cents for every revenue dollar collected. Catholic Health East is headquartered in Newtown Square, PA. CHE is the ninth largest health system in the United States, as ranked by net patient revenue. The Catholic Health East annual spend on supplies and pharmaceuticals approximates $600 Million. With Consorta, CHE executives will have the opportunity to establish a distinctive supply chain strategy for their organization.
Consorta awards Medline with wound care
products agreement
Consorta, Inc. has awarded Medline Industries Inc., a sole source agreement for traditional wound care products. The three-year agreement, valued at more than $18 million, will provide wound care products at significant savings to Consorta’s membership of more than 2000 health care facilities in the U.S. The agreement solidifies Medline’s position as the second leading provider of traditional wound care products to the U.S. health care marketplace with a 23% share of the market. The agreement, which begins January 1, 2005, covers a multitude of products, including a variety of gauze sponges, abdominal (ABD) pads and gauze bandages used in practically every type of patient care procedure. In addition, Medline has a similar contract with Consorta’s largest member, Ascension Health, the largest not-for-profit healthcare system in the U.S. The agreement is part of Consorta’s Custom Contracting Program.
Misys Healthcare Systems launches
Misys Pharmacy solution
Misys
Healthcare Systems launched Misys Pharmacy IMM at the American Society of Health
System Pharmacists (ASHP) 2004 conference. Misys Pharmacy IMM is a
patient-centered, integrated, browser-based pharmacy information system that
manages every aspect of medication management. Part of the Misys Optimum product
family, as a departmental solution, Misys Pharmacy IMM can reduce medication
errors, significantly improving patient safety. When used with Bar Code
Medication Administration (BCMA) and computerized physician order entry (CPOE),
this integrated medication management process achieves maximum reduction in
medication errors and adverse affects to patients.
Tuesday, December 14, 2004
In this Issue:
Bush nominates EPA Administrator
Leavitt for health secretary
Cardinal Health announces global restructuring
plan
Oracle to acquire PeopleSoft for $10.3 billion
IHI launches national campaign to save 100,000
lives in U.S. hospitals
FDA issues additional recall for medical
ventilator
Bush nominates EPA Administrator
Leavitt for health secretary
President Bush has nominated EPA Administrator Mike Leavitt to replace Tommy Thompson as Health and Human Services secretary. Before joining the Environmental Protection Agency in November 2003, Leavitt, 53, was governor of Utah for 11 years. “He has managed the EPA with skill and with a focus on results,” said President Bush. Bush said he plans to implement the first prescription drug benefit for seniors and has called for expanding the services provided by faith-based groups and continuing medical research “always ensuring that the work is carried out with vigor and moral integrity.” “I look forward, as the president said, to the implementation of the Medicare prescription drug program in 2006, medical liability reform and finding ways to reduce the cost of healthcare,” said Leavitt. “I am persuaded that we can use technology and innovation to meet our most noble aspirations and not compromise our other values that we hold so dear.” The Department of Health and Human Services is the biggest in the federal government. The department oversees Medicare and Medicaid for senior citizens, the safety of drugs and the nation's food supply through the Food and Drug Administration and it administers the National Institutes of Health and the Centers for Disease Control and Prevention. Thompson was the ninth member of Bush’s Cabinet to tender his resignation, marking the largest second-term Cabinet overhaul in more than 30 years. Thompson said he intends to serve until February 4 or until the Senate confirms his successor. (CNN)
Cardinal Health announces global restructuring plan
Cardinal Health Inc. announced details of a previously disclosed three-year restructuring plan expected to improve annual operating earnings by $500 million. The company also announced that its board of directors has authorized the purchase up to $500 million of its common shares as management deems appropriate. The restructuring supports “One Cardinal Health,” a long-term program launched by the company to increase the value it provides customers through better integration of existing businesses and improved efficiency from a more disciplined approach to procurement and resource allocation. The restructuring will be implemented in two phases over a three-year period, the company said. The cost to execute the first phase of restructuring is estimated to be $300 million to $350 million, for asset impairment, employee severance and other costs. Cost savings and profit improvements from this phase are expected to add $125 million to operating earnings in fiscal 2005 and reach an annualized amount of $200 million for fiscal 2006. The company expects to reduce its 58,000 global workforce by 4,200 during this phase, primarily through business consolidations and process improvements, resulting in the closing of approximately 25 facilities worldwide. More than 100 profit-improvement actions underway include rationalizing and discontinuing overlapping or underperforming product lines and improving product pricing. The second phase of the restructuring will focus on longer term integration to drive top line growth and create greater productivity, including; Company-wide, world-class shared services for administrative functions such as finance, human resources and information technology, Strategic sourcing to better leverage Cardinal Health’s global scale and purchasing power; an integrated go-to-market strategy for the company’s hospital and pharmaceutical manufacturer customers; efficiency and quality improvement plans across Cardinal Health’s manufacturing and logistics operations.
Oracle to acquire PeopleSoft for $10.3 billion
The Oracle Corporation announced Monday that it would acquire PeopleSoft for $10.3 billion, ending a bitter takeover fight that had lasted more than 18 months, reported The New York Times. The merger is another step in the consolidation of the information technology industry as it matures, according to many industry analysts and Oracle's founder and chief executive, Lawrence J. Ellison. The deal would make Oracle, which is the leader in the corporate database business, the second-largest maker of software that companies use to manage their finances, human resources, sales and customer relations. SAP of Germany is the No. 1 company in the $25 billion a year business software industry. PeopleSoft, which acquired J. D. Edwards in August 2003, is No. 2, and Oracle has been third in the market. By acquiring PeopleSoft, Oracle hopes to move closer to becoming the Microsoft of corporate data centers, said The Times. Just as Microsoft has expanded its dominant position in desktop computing by offering word processing and spreadsheet programs that run on its Windows operating system, so Oracle hopes to add layers of software that are tied to its mainstay product, the Oracle database systems, reports The Times. The bid of $26.50 a share was the sixth offer Oracle had made since June 6, 2003, and was 10 percent higher than its earlier bid of $24 a share, which it had insisted was final. PeopleSoft's board had rejected the $24-a-share bid as inadequate on Nov. 1. The shares of both PeopleSoft and Oracle rose sharply yesterday. (The New York Times)
IHI launches national
campaign to save 100,000
lives in U.S. hospitals
The Institute for Healthcare Improvement (IHI) announced that it is launching the first ever national campaign to save 100,000 lives in the next 18 months, and every year thereafter, in U.S. hospitals. The “100,000 Lives Campaign” aims to enlist thousands of hospitals across the country, at no charge, in a commitment to implement changes in care that have been proven to prevent avoidable deaths. The campaign was formally unveiled today by Dr. Donald Berwick, President and CEO of IHI, during his keynote address at IHI’s National Forum in Orlando, FL. Joining Dr. Berwick on stage to endorse this Campaign were leaders of The American Medical Association (AMA), The American Nurses Association (ANA), Ascension Health, The Centers for Medicare & Medicaid Services (CMS), The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), North Carolina State Hospital Association, SSM Health Care, and The Veterans Health Administration. Hospitals that choose to participate in the Campaign commit to implement some or all of the following six quality improvement changes: •Deploy Rapid Response Teams – by allowing any staff member, regardless of position in the chain of command, to call upon a specialty team to examine a patient at the first sign of decline; •Deliver Reliable Evidence-Based Care for Acute Myocardial Infarction – by consistently delivering key measures - including early administration of aspirin and beta-blockers – that prevent patient deaths from heart attack; •Prevent Adverse Drug Events – by implementing medication reconciliation, which requires that a list of all of a patient’s medications (even for unrelated illnesses) be compiled and reconciled to ensure that the patient is given (or prescribed) the right medications at the correct dosages - at admission, discharge and before transferring a patient to another care unit; •Prevent Central Line Infections – by consistently delivering five interdependent, scientifically grounded steps collectively called the “Central Line Bundle”; •Prevent Surgical Site Infections – by reliably delivering the correct perioperative antibiotics, maintaining glucose levels and avoiding shaving hair at the surgical site; •Prevent Ventilator-Associated Pneumonia – by implementing five interdependent, scientifically grounded steps, such as elevating the head of the hospital bed by 30 degrees, thereby dramatically reducing mortality and length of stay in the Intensive Care Unit. “I invite every healthcare facility in the United States to join with IHI and our partner organizations in this Campaign to make these proven, life-saving techniques standard practice,” said Donald Berwick, President and CEO of IHI. “Together, we can literally save 100,000 lives by June 14, 2006!” Hospitals can learn more about the campaign’s proven life-saving improvement techniques and join the 100,000 Lives Campaign at: http://www.ihi.org/ihi/programs/campaign.
FDA issues additional recall for medical ventilator
The Food and Drug Administration has revealed a malfunction in an adaptor meant to correct a potentially deadly defect in a medical ventilator it approved several years ago, reported Newsday. In a statement released Friday, the FDA stated that the manufacturer of a medical ventilator had recalled 1,129 cable adaptors intended to fix an earlier life-threatening problem linked to the device. Instead, the adaptors posed new hazards for respiratory patients. A news release issued by manufacturer Pulmonetic Systems of Minneapolis, said use of the adaptors could lead to “serious injury or death” because they might prevent the ventilator from working. However, Pulmonetic said it had received no death or injury reports connected to the adaptors. The adaptors were meant to correct an earlier power supply defect. But the adaptors apparently compounded the problem in some cases. Earlier this year, a Newsday investigation of Pulmonetic's ventilators found reports of 18 deaths associated with the devices had been filed with the FDA. At the time, Pulmonetic officials said that the ventilators were in use when problems occurred, but that the devices didn't actually cause incidents in which patients turned blue from lack of oxygen and alarms failed to sound when the machines stopped working. In its latest announcement, the FDA stated: “Customers have been asked by the firm to remove the adaptors according to instructions provided to them and return the adaptors to the company.” The FDA approved Pulmonetic's ventilators in 1998, under a streamlined approval process. Pulmonetic Systems' permanent resolution of the ventilator malfunction will be to replace the power circuit board for all affected ventilators made by the company, the FDA announcement stated. (Newsday, Inc.)
Monday, December 13, 2004
In this Issue:
HDMA receives CMS Clarification on treatment
of service fees in Medicare ASP
Genetic test can predict
breast cancer relapse,
help women avoid chemotherapy
Heart Rhythm Society relocates to
Washington
eClinicalWorks announces
strategic partnership
with Clinical Pathology Laboratories
Healthlink Inc. appoints new
president
Artromick introduces new
integrated
mobile computing medication cart
Freedom Medical awarded
Premier contract
HDMA receives CMS Clarification on treatment
of service fees in Medicare ASP
HDMA President and CEO John Gray today received clarification from the Centers for Medicare and Medicaid Services (CMS) that bona fide service fees paid by pharmaceutical manufacturers to wholesale distributors, which are not passed on in whole or in part to customers, should not be included in the calculation of Average Sales Price (ASP). This is an important clarification that addresses uncertainty that was present in the marketplace for pharmaceutical distribution services. “Our wholesale distributor members are extremely pleased that CMS has clearly stated that manufacturers should not include fees for bona fide distributor services, negotiated at fair market value, in their ASP submissions for purposes of Medicare Part B reimbursement,” said John Gray, HDMA President and CEO. “Wholesale distributors provide a wide range of important services to pharmaceutical manufacturers, and it is essential that Medicare reimbursement policy not impede the market for those services.” Gray added, “This clarification puts any uncertainty to rest.” For more than 125 years, HDMA has worked with members to secure a safe, efficient and reliable healthcare distribution system that is able to provide life-saving health products and services.
Genetic
test can predict breast cancer relapse,
help women avoid chemotherapy
A new genetic test that can identify which breast cancer patients are unlikely to suffer recurrences could potentially spare tens of thousands of women from unnecessarily undergoing chemotherapy, researchers reported. The test could help many of the 50,000 to 100,000 U.S. women who are diagnosed each year with breast cancer that has not yet spread elsewhere in the body. Many of these women undergo chemotherapy after getting surgery and radiation, but only a small proportion would actually suffer a recurrence without additional treatment. Previously there was no reliable way to know who was considered low risk. Researchers said the new test, which measures the activity of more than a dozen genes, indicates that as many as half of these women are at low risk for recurrence and could forgo chemotherapy. The $3,450 test, called OncotypeDX, was developed by researchers at the National Surgical Adjuvant Breast and Bowel Project (NSABP) in Pittsburgh, a large, ongoing federally funded research program, and Genomic Health Inc., a Redwood City, CA, biotech company. The Food and Drug Administration has already approved the test. In a study that will be published in the Dec. 20 issue of the New England Journal of Medicine, the researchers used the test to screen stored tumor tissue from 668 patients who had undergone treatment in the NSABP program from 1982 to 1988. All had malignancies that were sensitive to estrogen but had not yet spread outside the breast. The test accurately predicted which patients were most likely to have gone on to suffer a recurrence in the next decade, with 51 percent scoring in the low-risk group, 22 percent at intermediate risk and 27 percent at high risk, the researchers found. The findings correlated with actual rates of recurrence. Only 6.8 percent of the low-risk group suffered a recurrence, compared with 14.3 percent of the intermediate-risk group and 30.5 percent of those at high risk. The journal released the study online to coincide with a presentation at a scientific meeting in San Antonio of additional research involving 651 similar women that showed the test could also predict which women were most likely to benefit from chemotherapy.
Heart Rhythm Society relocates to Washington
The Heart Rhythm Society (formerly NASPE) announces its plans to relocate its headquarters to Washington, DC. The organization, representing physicians and allied specialties in cardiac pacing and electrophysiology, moves into its new offices at 1400 K St., NW on Dec. 13. "Being in Washington will help us forge stronger alliances with governing agencies and healthcare groups whose work complements ours," says Stephen C. Hammill, MD, president of the Heart Rhythm Society, the leading professional society for cardiac arrhythmia professionals and the primary information resource on heart rhythm disorders. The Centers for Medicare and Medicaid Services (CMS) recently asked the Heart Rhythm Society to be the lead organization in developing a national registry called for in CMS' recent draft coverage decision on implantable cardioverter defibrillators (ICDs). “Our goal of moving to Washington was to raise the profile and image of the organization, especially since DC is home to the largest number of nonprofit organizations," said James Youngblood, CEO of the Society. The Society's new offices will also house the Heart Rhythm Foundation, which focuses on educating the public about heart rhythm disorders as well as fundraising for the Society. The Foundation was founded in 2004 and has initiated important pilot programs to raise public awareness about Sudden Cardiac Arrest, targeting those patients at most risk with information on how to determine risk and treatment options. The Heart Rhythm Society will have a staff of approximately 30 in Washington. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Based in Natick, Mass. since 1979, it has a membership of over 3,500 physicians and associated professionals in over 65 countries around the world.
eClinicalWorks announces strategic partnership
with Clinical Pathology Laboratories
eClinicalWorks, a provider of integrated end-to-end ambulatory electronic medical records (EMR) and practice management systems for multi-location, multi-specialty medical practices, has announced a product integration with Clinical Pathology Laboratories (CPL), one of the five largest laboratories in the U.S. Under the terms of the agreement, eClinicalWorks will integrate its award-winning EMR and PM solution with CPL’s leading clinical and anatomical laboratory testing services, offering its laboratories the opportunity to seamlessly integrate critical patient information into their medical file. Under the terms of the agreement, eClinicalWorks will be integrating its EMR solution and practice management solution with CPL’s clinical and anatomical laboratory testing services. The integrated solution is already in production and being used by CPL’s five laboratories in the following states: Texas, Oklahoma, Arkansas and Louisiana and will soon offer eClinical Works in its Mid Atlantic and Midwest divisions. eClinical Works supports open standards and systems architecture including CCR, HL7, HTTP, XML, SQL and J2EE.
Healthlink Inc. appoints new president
Healthlink Incorporated, a Houston-based, provider focused, privately held,
healthcare information systems consulting firm, announced the appointment of
Dana Sellers as President of the company. Mrs. Sellers will also continue as
COO, an appointment she received last year. In addition to managing the
company’s operations, Mrs. Sellers has responsibility for business development
as well as many of the administrative services of the company. Ivo Nelson will
remain as CEO of Healthlink. Mrs. Sellers has a track record of more than 24
years’ experience in the healthcare and information technology industries. Her
experience previous to Healthlink includes positions with the IBM Corporation,
Trinity Computing Systems, and DuPont.
Artromick introduces new integrated
mobile computing medication cart
Artromick International Inc. announced the release of its new Avalo IMC Medication Cart line featuring mobile computing technology for point-of-care medication control. In a development partnership with Rioux Vision, Artromick has melded its innovative Avalo medication cart platform with the latest mobile computing solutions to facilitate and manage wireless data systems in a variety of healthcare settings. The new Avalo IMC Medication Cart line also features a self-locking security system that permits wireless control and administration of all carts from a single remote location. This advanced security is coupled with advanced computing solutions by Rioux Vision to distinguish the line as truly unique in the mobile medication workstation product category. As part of its cooperative partnership, Artromick also offers the full line of Rioux Vision mobile computing workstations for point-of-care information and medical records management.
Freedom Medical awarded Premier contract
Freedom Medical Inc. has been awarded an agreement as a supplier for Biomedical Equipment Rental with Premier Inc. This is the third major GPO rental contract that Freedom Medical Inc has received in the past 12 months. Freedom Medical has already received agreements with Novation and Consorta.
Friday, December 10, 2004
In this Issue:
New tuberculosis drug shows promise
VHA survey shows shortage of
infection
control staff can lead to costly infections
FDA: Pfizer's Bextra to carry heart risk
warning
Data storage management
solutions essential
to meet HIPAA recommendations
Cardinal Health sponsors
fourth annual
small business procurement conference
Amerinet announces new
agreement
with Fujisawa Healthcare Inc.
New tuberculosis drug shows promise
For the first time in 40 years, researchers have discovered a new drug that may help fight tuberculosis. Known as R207910, the drug belongs to a class of compounds called diarylquinolones (DARQs) that work by cutting off the bacteria's energy supply, reports HealthDayNews. Among infectious diseases, tuberculosis is second only to AIDS as the leading cause of death worldwide. The disease sickens more than 8 million people every year and kills 2 million to 3 million annually. Also, as many as 400,000 cases a year are caused by microbial strains that are resistant to current drug treatments. R207910 has been given to about 50 healthy people for safety testing so far. Studies of its effectiveness in people infected with TB will begin “very soon,” said lead researcher Koen Andries of Johnson & Johnson Pharmaceutical Research & Development in Beerse, Belgium, reported The Washington Post. In animal studies described in the journal Science, the compound easily overcame the two biggest hurdles facing TB therapies today: their ineffectiveness against resistant strains and the long period of treatment required to achieve a cure. TB today is treated with a cocktail of three drugs that must be taken every day for six to nine months. The new drug was discovered through a search of the Johnson and Johnson chemical "library" that catalogs compounds the company has developed. R207910 was originally designed as an inflammation treatment but when it failed in its original purpose, researchers found an unexpected benefit. Lab tests in culture showed the compound was effective against several different mycobacteria, even against drug-resistant strains of M. tuberculosis. But the drug appears to leave other bacteria unharmed, which means that it won't contribute to the growing problem of drug resistance with other bacteria, the researchers said.
VHA survey shows shortage of infection
control staff can lead to costly infections
VHA Inc. has surveyed infection control specialists at member organizations and discovered several factors that may contribute to an increased likelihood of patients developing infections while in the hospital. “We found that in some hospitals infection control resources are stretched very thin,” said John Hitt, M.D., vice president of clinical improvement for VHA. Industry experts say that hospital-acquired infections cost the nation $7 billion annually. “Devoting more staff to infection control activities in hospitals will reduce infections and have a significant clinical and financial benefit, given that healthcare-associated infections have a significant economic, social and clinical cost,” Hitt said. VHA's survey indicated: Approximately one in three hospitals had less than the recommended ratio of infection control staff to patient beds. Four areas consumed 64 percent of the infection control staff members' time: surveillance (26 percent), communications/management issues (14 percent), transmission prevention (12 percent) and education and training (13 percent). Surveillance was mostly frequently conducted monthly for catheter-related bloodstream infections, catheter-related urinary tract infections and ventilator-associated pneumonia, and less frequently for antimicrobial use and resistance. The most common areas of focus for infection control teams were: surgical infection prevention, hand hygiene, catheter-related bloodstream infection and ventilator-associated pneumonia. The two biggest obstacles to performing better were insufficient resources and lack of physician support. Hitt estimates that costs for a single patient developing a hospital-acquired infection costs the hospital and the U.S. healthcare system from several thousand dollars to more than $50,000 per case.
FDA: Pfizer's Bextra to carry heart risk warning
The U.S. Food and Drug Administration (FDA) said on Thursday that Pfizer's new pain drug Bextra will carry a labeled warning about a risk of cardiac and blood-clotting problems. Bextra's updated labeling will say that patients who have recently had artery bypass graft surgery are especially at risk for heart and blood-clotting complications when taking the drug. Bextra's new label will also warn of the pain therapy's link to two potentially fatal skin reactions: Steven-Johnson Syndrome and toxic epidermal necrolysis. Pfizer's drug, in a class of painkillers known as Cox-2 selective non-steroidal anti-inflammatory drugs (NSAIDS), is approved to treat the symptoms of osteoarthritis and rheumatoid arthritis, and menstrual pain. FDA said it strengthened Bextra's labeling because the agency is still getting reports of serious skin reactions in patients taking Bextra, and that the condition seems to occur more often in patients on Pfizer's drug than in patients on other COX-2 therapies. In addition, a new study of 1,500 patients showed that people who were treated with Bextra after having cardiac surgery had a higher incidence of heart attack, stroke, and clotting in the veins and lungs, the agency added. However, the new labeling also notes that, based on what FDA knows now, Bextra's benefits still appear to outweigh its risks when used properly.
Data storage management solutions essential
to meet HIPAA recommendations
Healthcare facilities in the U.S. are currently in a rush to meet the Health Insurance Portability and Accountability Act (HIPAA) deadline for security compliance. Data storage management solutions are likely to play a key role in preparing these facilities to meet the HIPAA recommendations regarding keeping patient record in a timely, secure, and organized manner. New analysis from Frost & Sullivan (http://www.healthcare.frost.com), “Data Storage Management Markets for U.S. Healthcare Settings”, reveals that revenue in this industry totaled $845.2 million in 2004 for storage hardware solutions, and projects to reach $1,329.6 million in 2008. The market is already showing a marked increase in IT spending on security system upgrades. Investment in picture archiving and communication systems (PACS), electronic medical records (EMR), and computerized physician order entry (CPOE) solutions expects to be among the top priorities. For successful implementation, storage vendors have to coordinate not only with HIPAA consultants, but also with providers of clinical information systems, right from the product development stage. They can also conduct pilot projects at the healthcare centers to check security compliance. Most of the demand for high storage requirements expects to come from medical images, patient records, and hospital administration-related data. In fact, the healthcare data is increasing by more than four times every two years. Since data types are not homogeneous, integration between digital imaging and communications in medicine (DICOM) and extensible mark-up language (XML) standards plays an important role for successful implementation.
Cardinal
Health sponsors fourth annual
small business procurement conference
More than 100 representatives from small, minority, and women-owned businesses from across the country attended Cardinal Health's fourth annual Small Business Procurement Conference to learn about opportunities for diverse small businesses to serve as Cardinal Health's supply partners and to help fulfill the company's procurement needs. Held at The NorthPointe Conference Center in Lewis Center, Ohio, this year's conference titled "Helping small businesses to think big" brought together Cardinal Health business representatives, suppliers and customers to identify additional opportunities for partnering with the small business community. Cardinal Health customers also attended the conference to learn more about the company's Supplier Diversity program and how it can best support customers' own initiatives to drive spending opportunities with small, woman, veteran and minority-owned companies. The two-day conference kicked-off with Corris Boyd, vice president of Triad Hospitals, discussing the importance of embracing supplier diversity and incorporating supplier diversity programs into core values and business objectives. The conference included several industry-related workshops designed to further educate attendees on relevant supply chain, business development, finance, and strategic alliance opportunities, as well as information on selling to federal and private sector hospitals.
Amerinet announces new agreement
with Fujisawa Healthcare Inc.
Fujisawa and Amerinet have added a new program to their current agreement. The new program creates a new opportunity for savings by offering member Amerinet hospitals or integrated delivery networks (IDNs) enhanced pricing for Fujisawa's antifungal agent AmBisome (amphotericin B) liposome for injection. The agreement became effective on August 1, 2004 for acute care only.
Thursday, December 9, 2004
In this Issue:
Capgemini forecasts healthcare’s top business
issues for 2005: Focus on clinical IT, EHRs, pay-for-performance
AMA delegates address
possibility
of medical personnel draft
S. Jersey man charged with
vaccine smuggling
New study says wait before implanting
defibrillators
CDC issues
draft TB prevention guidelines
for public comment
During 2005, the healthcare industry will continue to deal with recurring issues, including financial pressure on profit margins, limited access to capital, increased competition, rising medical costs and a growing number of uninsured, said Capgemini US LLC. What is new is the extent to which health providers and payers are likely to respond to these and other challenges by using information technology, particularly to support data-driven clinical care. Specifically, health organizations will use technology to improve patient safety through evidence-based medicine programs, control costs through disease management programs, develop new measurement tools to facilitate pay-for-performance compensation models and create consumer directed health products. A forecast of healthcare's top issues in 2005 published by Capgemini, draws on the collective experience of the firm's clinicians and other experts in healthcare IT, strategic planning, revenue management and supply chain to help prepare providers and payers for the coming year. "With a national focus on the benefits that can accrue from greater use of IT in healthcare, the industry is poised for a significant increase in IT spending," said Lewis Redd, national leader of Capgemini's health practice. "Increasingly, the focus for technology will broaden from administrative efficiency to improving the quality of clinical care and customer relationships." The Capgemini report identifies the top 10 areas that healthcare organizations are likely to focus on in the coming year. 1. Enhanced reporting capabilities which will be needed to facilitate decision-making for such activities as pay-for-performance, cost management and training. 2. Accelerating technology implementations will become increasingly important. Finding smart ways to reduce the time frame will help reduce the total cost of ownership of new systems. 3. Health organizations will increase their investments in clinical information systems and begin to evolve towards electronic health records. 4. Payers and providers will increasingly leverage the Web to empower consumers, through self-service portals that enable consumers to perform administrative functions, access some of their medical information online and manage their benefits in the case of consumer directed health plans. 5. Collaboration between payers and providers will grow in order to find new ways to reduce administrative costs for both groups. 6. Payers and providers will consolidate back office operations to reduce overhead. 7. Managing capacity will be critical. Hospitals challenged by increasing demand and limited ability to expand will look at creative solutions to increase their patient flow, reduce waiting time and minimize diversions, in order to provide room for growth. 8. Payers will work to address new markets by developing a range of new products and customer services. These will include meeting employer demands for cost control through new consumer driven health products, tiered benefits and customizable services. 9. More payers and providers will recognize the problem of obesity with tailored disease management programs and clinical treatments. 10. Outsourcing solutions will need to be managed more carefully and viewed as strategic investments, rather than a "quick fix" in order to yield full financial advantages.
AMA delegates
address possibility
of medical personnel draft
In addition to discussing medical practice insurance, American Medical Association (AMA) delegates meeting in Atlanta also addressed the possibility of a draft of medical personnel. AMA voted in favor of monitoring the possibility of medical personnel being drafted and working with the Selective Service “to address ... questions and concerns regarding implementation of the draft program,” the Wall Street Journal reports. Congress in 1987 authorized the Health Care Personnel Delivery System, a contingency plan for drafting medical professionals, “to handle an emergency need for medical personnel during a conflict,” the Journal reports. If activated by the president and approved by Congress, the plan would require about 3.4 million male and female healthcare workers ages 20 to 44 to register with the Selective Service. About 36,000 healthcare professionals could then be selected in a draft. The Journal reports that the Department of Defense has reiterated that “the military health system has performed ‘superbly’ in Iraq and Afghanistan and there is no need for a medical draft.” A Selective Service newsletter last year and a paper published earlier this year in the Wisconsin Medical Journal both indicated that a medical draft could happen sometime in the future. Some physicians are concerned that a medical draft would weaken hospitals and clinics and exacerbate physician and nurse shortages, said the Journal. (Kaiser Daily Health Report)
S. Jersey man charged with vaccine smuggling
A convenience store owner from South Jersey has been charged with smuggling flu vaccine into the United States in an effort to cash in on the national shortage of the inoculations, reported The Associated Press. The man’s lawyer says Mahmoud A. Abuarqoub, 37, thought it was legal to try to import the drug from Saudi Arabia and sell it to a hospital near his home in Somers Point, Atlantic County. Abuarqoub was arrested Saturday as he landed at Philadelphia International Airport after a trip to Jordan. If convicted of smuggling, Abuarqoub could face up to five years in prison, a federal prosecutor said. "We have not seen anything like this where someone was so brazen to approach a hospital" to offer to sell black-market vaccine, said Kyle Hutchins, special agent in charge of the federal Immigration and Customs Enforcement agency's Newark office, AP reports. According to court documents, Abuarqoub, who owns a 7-Eleven store in Villas, Cape May County, contacted Shore Memorial Hospital in Somers Point on Oct. 27 with an offer to sell up to 20,000 doses of flu vaccine. Hospital officials notified authorities of the unusual offer and agreed to take part in a sting. On Oct. 28, Abuarqoub and a hospital employee met and agreed he would supply 5,000 doses of the vaccine for $275,000, or $55 per dose, through the Safad Corp., which he owns. The hospital later signed a contract on the deal. On Nov. 17, authorities intercepted 810 doses of the vaccine, shipped through DHL, at John F. Kennedy International Airport in New York. At the time, Abuarqoub was out of the country. The government contends Abuarqoub told his contact at Shore Memorial that he was concerned that the vaccine was not being shipped at the right temperature and that he would bring some back himself. Assistant U.S. Attorney Renee M. Bumb said Abuarqoub also contacted other hospitals and medical offices with offers to sell them the black-market vaccine. (The Associated Press)
Implanting defibrillators in patients just weeks after a heart attack does not improve their chances of survival, according to an international study. The researchers suggested instead that patients wait several months before having one of the devices inserted in the chest, reported The Associated Press. The findings could have big implications for Medicare, which is about to expand coverage for the $25,000 devices to more people, said AP. Research has shown that implanted defibrillators save lives, but those studies were done almost exclusively on patients six months to several years after a heart attack. The new study found that defibrillators offered little benefit in the early days after a heart attack, when patients with damaged and weakened heart muscle were most likely to die, said AP. In the study, reported in The New England Journal of Medicine, lives saved among patients who suffered abnormal rhythms were basically canceled out by deaths from heart problems unrelated to rhythm. For doctors, this finding will complicate deciding exactly when to install the devices, and in which patients. "We recommend that you wait at least six months after the heart attack," said the lead researcher, Dr. Stefan Hohnloser, professor of medicine and cardiology at J. W. Goethe University in Frankfurt. The study, financed by St. Jude Medical of St. Paul, a defibrillator manufacturer for which Dr. Hohnloser serves as a consultant, involved patients who suffered a muscle-damaging heart attack just 6 to 40 days earlier, a group at high risk of death from another heart attack or gradual heart failure, or from abnormal rhythms. Currently, Medicare covers implantation of a defibrillator as little as a month after a heart attack. The program is expected to adopt a plan by the end of the month to pay for the devices for many more patients, including people who have not had a heart attack but whose hearts are so damaged that they cannot pump enough blood. (The Associated Press)
CDC issues
draft TB
prevention guidelines
for public comment
The Centers for Disease Control and Prevention has released for public comment revised guidelines for preventing the transmission of tuberculosis in healthcare settings. The agency said the document updates CDC guidelines published in 1994 to reflect shifts in the epidemiology of the disease, advances in scientific understanding and changes in health care practice. The 1994 guidelines presented recommendations for TB infection control based on a risk assessment process that classified health care facilities according to categories of TB risk, with a corresponding series of administrative, environmental and respiratory protective control measures. The revised guidelines continue that focus. They also note that the federal Occupational Safety and Health Administration recently applied its General Industry Respiratory Protection Standard to respirators used for occupational exposure to TB, requiring annual fit testing of TB respirators for health care workers. However, Congress’ omnibus appropriations bill for fiscal year 2005 included an AHA-backed provision blocking OSHA from using funds to administer or enforce the requirement. AHA is reviewing the draft CDC guidelines and plans to submit comments before the Feb. 4 deadline.
Wednesday, December 8, 2004
In this Issue:
Thompson issues national diabetes plan
Smiths Medical acquires Medex
for $925 million
AMA sets standards for expert
witnesses
in medical malpractice cases
New Jersey hospitals cut heart-bypass deaths by nearly half
Miami medical school receives $100 million
donation for biomedical research
Stryker Corporation adds
Revolution System
to Amerinet contract
Thompson issues national diabetes plan
The Department of
Health and Human Services has released a national plan for fighting
diabetes focused on prevention, detection and treatment of the
disease, which affects more than 18 million Americans. The plan
outlines specific steps individuals, businesses, schools, civic
groups and government organizations can take to prevent and control
the disease. HHS Secretary Tommy Thompson also named 11 winners of
the 2004 “Innovation in Prevention” awards, recognizing
organizations that have implemented innovative health promotion and
chronic disease prevention programs. For more on the diabetes action
plan and a list of award recipients, visit
www.hhs.gov/news/press/2004
pres/20041207b.html.
(AHA News Now)
Smiths Medical acquires Medex for $925 million
Smiths Group announced Tuesday that it has agreed to acquire the privately-held
US medical device company, Medex Inc, in a transaction
which will greatly enhance the presence of Smiths Medical in the
US and international markets
for devices used in critical care. Smiths will pay the current owners of Medex
$625m in cash for the company’s equity, subject to any closing adjustment, and
will assume some $300m of net debt. Medex is a leading supplier of infusion
equipment used in critical care, specializing in intravenous infusion catheters,
which prevent needle-stick injuries. Headquartered in Carlsbad, CA, Medex has US
operations in Ohio, Illinois, Connecticut and Georgia, with additional plants in
Mexico, Germany, Italy and the UK. Smiths Medical is a leading supplier of
devices used during critical and intensive care, surgery, postoperative care
during recovery, and in a series of high-end home infusion therapies.
AMA sets standards for expert witnesses
in medical malpractice cases
The American Medical Association has ruled that expert witnesses should be board certified as well as recent practitioners in the same field as defendant physicians. The new AMA policy, which was approved by a vote of 284 to 196, states that the requirements for expert witnesses include: comparable education, training, and occupational experience in the same field as the defendant within 5 years of the date of the incident that gave rise to the malpractice claim and board certification. In a related action, the AMA House is again asking the AMA board to develop and maintain an electronic registry of expert witnesses in malpractice cases. The request for an online registry came from the Florida delegation, which maintains that establishing and maintained such a registry would cost about $3000. The AMA board said in a report that such a registry would cost closer to $100,000 and would be onerous to maintain. As a result the board concluded that the AMA should not pursue an online registry. Following the vote the Chairman of the Board of Trustees J. James Rohack, MD, a cardiologist from Temple, Texas said, the Board will "look at it again and try to determine if there is a less costly way to maintain a site that will be useful to our members." (Reuters Health)
New Jersey hospitals cut heart-bypass deaths by nearly half
Patient deaths from heart bypass surgery in New Jersey dropped roughly 45 percent between 1994 and 2001, representing the largest single decline since state reporting of the procedure began, a new state report card showed. The 16 hospitals in the report achieved an average statewide death rate of 2.51 percent in 2001. That represented an improvement over the 2000 death rate of 2.68 percent and was far better than the 4.14 percent that New Jersey hospitals rated in the first report card in 1994-95. It takes the state about three years to accumulate all the data. State Health Commissioner Clifton Lacy attributed the dramatic turnaround to factors such as improved technology, doctors employing better and often less-invasive surgical techniques and hospitals doing a better job of assessing patients for what can still be a risky operation. He said the public reporting of outcomes also has pushed hospitals to make investments in their heart programs. The sixth annual report, released by the Department of Health and Senior Services, included statewide and hospital-by- hospital data on 8,045 bypass procedures performed in 2001. A total of 202 deaths were recorded, including deaths occurring 30 days after surgery. All data were risk-adjusted to allow for fair comparison among hospitals and surgeons treating diverse patient populations. In the report, rankings also were provided for heart surgeons who performed at least 100 procedures in one hospital during 2000 and 2001 combined. Two surgeons, David Johnson at Jersey Shore and Eric Somberg at Hackensack, had mortality rates significantly lower than the statewide average. Nationwide, studies have demonstrated, in general, that higher-volume surgeons and hospitals have better outcomes, although that is not always the case. (The Star Ledger)
Miami medical school receives $100 million
donation for biomedical research
The University of Miami medical school announced that it had received a $100 million donation, the second-largest amount ever given to a Florida university, and that the money would be used for biomedical research. The donation, a gift from the family of the late construction magnate Leonard M. Miller, who was treated for cancer there, means the University of Miami now has $800 million toward its goal of raising $1 billion by 2007. The funds will be used to establish four professorships, to recruit the next generation of biomedical scientists and for research. It also raises expectations that the medical school will be able to compete with the best in the nation. As thanks for the gift, the medical school will be renamed the Miller School of Medicine. The gift is significant not just for its size but also because it brings South Florida one step closer to becoming a world-class center for biotech research. Some area universities are spending millions to expand their bioscience departments. And California-based Scripps Research Institute plans to open a satellite center in northwest Palm Beach County by September 2006. Miller spent his final years being treated for liver cancer by medical school doctors at Jackson Memorial Medical Center, a battle he ultimately lost in 2002 at age 69. Sue Miller described how doctors would call the family from airports on their way back from seminars with the latest research on the disease, reported the South Florida Sun-Sentinel.
Stryker Corporation adds Revolution System
to Amerinet contract
Amerinet has renewed an agreement for orthopedics and orthopedic supplies with Stryker Corporation. Effective August 1, 2004 through July 31, 2007, members can continue saving on heavy duty and micro power tools, irrigation and cement systems, cast room supplies and accessories. Stryker is also adding the Revolution Cement Mixing and Delivery System to their contracts. Revolution represents the latest in advanced cartridge mixing and delivery systems.
Tuesday, December 7, 2004
In this Issue:
FDA announces new food-tracking rules
Johnson & Johnson may acquire heart device
maker
More flu shots on the way
U.S. selects regions for Medicare drug benefits
Massachusetts launches electronic medical record initiative
Tri-anim buys surgical company
FDA announces new food-tracking rules
New rules announced Monday by the Food and Drug Administration will make it easier to investigate a bioterror attack on the U.S. food supply by helping to trace sources of contamination in the supply chain. The rule requires that any company that manufactures, processes, packs, transports, distributes, receives, holds or imports food must keep records showing where it obtained the food and where it shipped it. Farms, restaurants, food banks and individuals preparing food in the home are exempt. Companies must retain records, from six months to two years, depending on the shelf life of the food. Larger companies have a year to comply with the new regulations. Smaller companies have 18 months to two years. The regulation is the fourth in a series of FDA rules implementing a 2002 bioterrorism law, passed after the 2001 anthrax attacks by mail. Last week, Health and Human Services Secretary Tommy Thompson pointed out the possibility that infected food could be imported from the Middle East, but specialists say the threat is equally serious for food produced domestically. “There are any number of threats, and they range from what's done across the oceans to what's done in the kitchen in the restaurant that you're eating in,” said Michael Osterholm, associate director of the National Center for Food Protection and Defense at the University of Minnesota, a project of the Department of Homeland Security. Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, said that while the rules will help FDA trace the source of contamination, they don't do anything to prevent attacks. Also needed, she said, were more FDA inspections of food coming into the country and the authority for the agency to inspect foreign plants. The agency responded that it is doing a better job picking which food to inspect once it arrives at US ports, using newly mandated data filed by companies that import into the country. “We don't need and can't inspect every article of food,” says Lester Crawford, acting FDA commissioner Crawford said. Still, he said, something lethal could slip through. “We have a long, long border that is not wired and not fenced,” he said, while adding, “We are far better off than we were three years ago.” On Monday, Thompson said, “Publication of this record-keeping rule represents a milestone in U.S. food safety and security.”
Johnson & Johnson may acquire heart device maker
Johnson & Johnson is in advanced negotiations to acquire Guidant, one of the nation's largest makers of devices to treat heart and circulatory illnesses, for more than $24 billion, executives said Monday, reported The New York Times. The deal would give Johnson & Johnson a strong foothold in the fast-growing market for products like defibrillators and pacemakers, said The Times. Guidant ranks a strong second in that market to the leader, Medtronic. The transaction would also strengthen Johnson & Johnson's position in the multibillion-dollar market for stents. If completed, the transaction would be the third-largest deal in the nation this year behind J.P. Morgan Chase's $58 billion acquisition of Bank One and Cingular's $41 billion purchase of AT&T Wireless. The executives said they were hoping to reach a final agreement within the next week, said The Times. Ronald W. Dollens, Guidant's president and chief executive, announced last May that he would retire at the end of this month. Johnson & Johnson, based in New Brunswick, NJ, reported net income of $2.07 billion on revenue of $11.6 billion in its third quarter. Guidant, based in Indianapolis, had net income for the quarter of $154 million on revenue of $925 million. Guidant's sales of implantable defibrillators have jumped 16 percent to $445 million in the third quarter. Recent clinical studies have suggested that hundreds of thousands of patients suffering from progressive heart failure might be able to avoid deadly heart attacks if such devices were implanted, and the federal government has begun to expand its Medicare coverage for the implants. Guidant is also a major manufacturer of angioplasty systems. Johnson & Johnson's Cordis unit and Guidant have been competitors in the stent business. Guidant has been the leader in the market for bare metal stents, but Cordis took leadership of the overall stent market in 2003 when it introduced Cypher, a drug-coated stent that was more effective at preventing new blockages from forming. Cordis then lost its position when Boston Scientific entered the market this year with Taxus, a competing drug-coated stent that cardiologists say is easier to insert. Clearance for Guidant to sell its own drug-coated stents in the United States is not expected before 2007. It signed an agreement this year to market Cypher while it develops its own drug-coated stent. But Guidant remains a leader in those areas of cardiac care where bare metal stents are used, reported The Times. It recently became the first company cleared to sell stents for use in the carotid artery that carries blood to the brain, creating an alternative to surgery for patients suffering blockages in that major artery. Guidant is also thought to be a leader in the development of absorbable stents, which researchers say may be an improvement on the permanently implanted drug-coated metal devices. (The New York Times)
The Food and Drug Administration has certified the safety of a portion of 5 million doses of flu vaccine that are available from plants in Canada and Germany. Health and Human Services Secretary Tommy Thompson was scheduled to announce the vaccine purchase Tuesday. The FDA has inspected the facilities where the vaccines were made, and has also tested that they would be effective against the dominant flu strain expected in the United States and made sure the vaccines have been stored properly since they were made, HHS officials said Monday, according to the Associated Press. At the American Medical Association (AMA) conference in Atlanta on Monday, Dr. Julie Gerberding, director of the Centers for Disease Control (CDC), cautioned healthcare officials to remain alert even though the flu season has begun slowly, with no widespread outbreak reported. “The most common month of peak activity is February,” she said. Officials declined to say how much vaccine was being purchased now. In separate efforts, Illinois, New Mexico and New York City have located another 650,000 doses from drug wholesalers, but have not yet gotten FDA approval to purchase the vaccine for their residents, reported AP. The vaccine shortage was a major concern to physicians at the AMA meeting who complained that the flu vaccine was at times available on a first-come basis instead of reaching high-risk patients as a top priority, said AP. However, Gerberding said, “volunteerism works” as most Americans followed CDC guidelines for reserving the vaccine for those in greatest need. Geberding said that she does not endorse penalizing healthy patients who are taking the vaccine. (The Associated Press)
U.S. selects regions for Medicare drug benefits
The Bush administration announced Monday that it would divide the nation into 34 regions to administer the new Medicare prescription drug program for the elderly, which begins in January 2006. Medicare will rely on private insurers, subsidized by the government, to deliver drug benefits. Premiums for each drug plan will be uniform throughout its region, but they could vary widely between neighboring states in different regions. The configuration of the regions will be a significant factor in the success or failure of the law, reported The New York Times. The regional boundaries will, to a large degree, determine how many insurers participate in the new program, said The Times. Leslie V. Norwalk, acting deputy administrator of the Centers for Medicare and Medicaid Services, said the boundaries had been drawn to maximize participation by private insurers in each region. The White House had originally wanted to establish large multistate regions. Administration officials said that larger regions would force health plans to serve rural areas that they had previously avoided. But many insurers told the administration that it would be difficult or impossible to serve such large areas. Tommy G. Thompson, the secretary of health and human services, settled on what he described as a compromise, designating 34 regions. Some of the drug plan regions are very large. One, covering all of California, has 4.3 million Medicare beneficiaries. Other large single-state regions include Florida, with 3 million beneficiaries, New York (2.8 million) and Texas (2.5 million). New Mexico, with just 260,000 beneficiaries, is a separate region, as are Mississippi, with 460,000 beneficiaries, Arkansas (470,000) and Oklahoma (540,000). Maine and New Hampshire, with a total of 420,000 beneficiaries, are one region, while the other four New England states, with 1.8 million Medicare patients, are a separate region. Geographically, the largest region consists of seven states in the upper Midwest and northern Plains. The states, Iowa, Minnesota, Montana, Nebraska, North and South Dakota and Wyoming, have 1.9 million Medicare beneficiaries. (The New York Times)
Massachusetts launches electronic medical record initiative
Within five years, physicians in Massachusetts could access patients' records from any hospital or doctors' office in the state under a new “eHealth” initiative. Blue Cross Blue Shield of Massachusetts is providing $50 million in funding toward the project. Gov. Mitt Romney said switching from paper records to electronic records could save the state millions of dollars while improving patient safety and quality of care. The project, which will begin as a pilot program in three communities, could make Massachusetts the first in the nation to have a statewide electronic medical record system. Medicine is one of the few modern business sectors that has yet to embrace information technology, mainly because of a lack of incentive on the part of physicians and hospitals and the difficulty and expense of making computer systems compatible, according to Mickey Tripathi, who will lead the Massachusetts e-Health Collaborative. Indiana has launched a pilot program, but Tripathi, who led that effort for eight months before becoming leader of the Massachusetts project, said that program doesn't have the funding or the industry buy-in that exists here. The Massachusetts e-Health Collaborative is a nonprofit consortium of 34 institutions statewide, including hospitals, insurers, business associations, and physician groups. Romney said the system would have strict controls to allow patients to control who sees their records. The Massachusetts Public Interest Research Group, a consumer advocacy organization, said patients should have individual personal identification numbers by which they would control access to their records.
Tri-anim buys surgical company
Tri-anim, a specialty products sales company for respiratory, anesthesia and EMS, has expanded into the surgical market by purchasing Charles Polo & Co. from SurgiNex Inc. This acquisition is the first step in an aggressive expansion plan that calls for Tri-anim to grow to $500 million in sales over the next three to five years. The current Charles Polo & Co. sales staff will form the foundation for Tri-anim’s new surgical division. This acquisition will help hospitals and surgery centers reduce their supply chain process costs through consolidation of multiple purchase orders, JIT delivery and e-commerce, said Dan Pearson, Tri-anim Vice President, Sales and Marketing. According to Pearson, this is the first of several expected moves into the surgical market and will be followed closely by moves into other specialty areas where Tri-anim could bring value to the customer through consolidation and efficiencies.
Monday, December 6, 2004
In this Issue:
Health secretary Thompson resigns, issues
warnings
Whooping cough alert
New warnings for Bextra label
Study shows leukemia pill has 86 percent
remission rate
Philips introduces advanced
technologies at RSNA
GE Healthcare unveils 'Vision
of Healthcare
in the Year 2015' at RSNA
Planar introduces new console
application,
the Dome Dashboard
Health secretary Thompson resigns, issues warnings
Tommy G. Thompson, the secretary of health and human services, announced Friday that he was resigning, and he expressed grave concern about the threat of a global flu epidemic and the possibility of a terrorist attack on the nation's food supply, reported The New York Times. “For the life of me,” he said, “I cannot understand why the terrorists have not attacked our food supply because it is so easy to do.” At a news conference at his department, Mr. Thompson said he wished Congress had given him the power to negotiate with drug manufacturers to secure lower prices for Medicare beneficiaries. Mr. Thompson also said he tended to favor creation of an independent office to monitor the safety of prescription drugs after they are approved for sale to the public. Dr. Mark B. McClellan, the federal official in charge of Medicare and Medicaid, is the leading candidate to succeed Mr. Thompson, administration officials said. Dr. McClellan, a physician and an economist, worked at the White House in the first two years of the Bush administration and was commissioner of food and drugs from November 2002 to February of this year. Mr. Thompson said Dr. McClellan “would be a great secretary.” But Mr. Thompson said that the deputy secretary, Claude A. Allen, and Senator John B. Breaux of Louisiana, a Democrat, were also qualified. In addition, Mr. Thompson said he had heard that Newt Gingrich, the former speaker of the House, was interested in the job. Mr. Thompson, 63, the eighth member of the Bush cabinet to resign since the election, said he tried to resign a year ago but agreed to stay at the White House's request. Now, he said, after 20 years in the Wisconsin Legislature, 14 years as governor and four years as secretary, “it's time for me and my family to move on to the next chapter in our life.” He said he wanted to work in the private sector, but would stay in office until Feb. 4 or until the Senate confirmed a successor. A spokesman for Mr. Thompson, said that before he leaves office he wants to issue a plan to “beef up our ability to review the safety of drugs after they have been approved.” Asked what worried him most, Mr. Thompson cited the threat of a human flu pandemic caused by mutations in a strain of avian influenza virus, or bird flu. “This is a really huge bomb that could adversely impact on the health care of the world,” killing 30 million to 70 million people, he said. Although the government has increased inspections of imported food, Mr. Thompson said he worried “every single night” about threats to the food supply. “We are importing a lot of food from the Middle East and it would be easy to tamper with that,” he said. He called for better technologies to detect contamination. Mr. Thompson said his greatest accomplishment was to secure passage of a bill adding prescription drug benefits to Medicare. Asked if he might run for governor of Wisconsin, Mr. Thompson said: “It's entirely possible. I happen to love politics. Why would I say no?” Also, “there's a Senate seat open,” he said, in reference to the seat now held by Herb Kohl, a Democrat. (The New York Times)
Health officials from Fairfax County, VA, warned principals at all county public schools to be on the lookout for students or staff with symptoms of whooping cough after several students were found to have the highly contagious respiratory disease. County Health Department officials are asking that students or employees with symptoms of the illness, which is characterized by a persistent cough, stay out of school until they have taken antibiotics for five days. Officials recommend that people who have symptoms but don't take antibiotics stay away from school for 21 days, which would ensure that they are no longer contagious. Whooping cough, or pertussis, is usually relatively mild when contracted by older children or adults but can be serious, and even life-threatening, for infants. The bacterial illness is easily spread through coughing and sneezing. Although young children can be vaccinated against the disease, those vaccinations wear off over the years, and there is no adult vaccination. The alert in Fairfax comes as officials nationwide have been reporting an increase in pertussis cases in recent years, reports the Washington Post. John Moran, an epidemiologist with the Centers for Disease Control and Prevention in Atlanta, said there were 11,647 cases reported in 2003, the most in 40 years. As of last week, 15,206 cases had been reported in 2004, including 16 deaths. Moran said health officials attribute the rise, in part, to increased reporting and recognition of the disease and the development of a more accurate test to confirm a diagnosis. (Washington Post)
The new prescribing information for Pfizer's arthritis drug Bextra contains a warning to avoid prescribing the drug in patients undergoing open-heart surgery. As previously reported, the Bextra label also includes a “black box” warning for a dangerous skin condition called Stevens-Johnson Syndrome. Bextra is an anti-inflammatory medicine that works by the same mechanism as Vioxx. The drug's label gives a clear look at the drug's negative open-heart surgery safety data. Patients on Bextra had significantly more side effects. When they also received parecoxib, essentially an injectible form of Bextra, there was a statistically significant increase in heart attacks and strokes. Cautions about heart risk appear in three places. First, a table reprints data from the studies that showed the risk. Second, there is an underlined and bolded warning not to use Bextra in patients undergoing heart bypass. A third section repeats that doctors should not use the drug in patients who have undergone heart surgery. The exact language on the label says: Patients treated with BEXTRA for pain following coronary artery bypass graft surgery have a higher risk for cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications. BEXTRA is therefore contraindicated for the treatment of postoperative pain following CABG surgery. (Forbes)
Study shows leukemia pill has 86 percent remission rate
A next-generation leukemia pill designed to help patients not cured by the successful drug Gleevec works even better than doctors had hoped, researchers said Sunday. The new drug, made by Bristol-Myers Squibb put 86 percent of patients who tried it into remission, the researchers said. Although this was only a Phase I trial meant to show the drug was safe, the effects were dramatic, the doctors told a meeting in San Diego of the American Society of Hematology. The Leukemia and Lymphoma Society helped sponsor the study. Oncologists hope the approach may work in many other cancers, too. The new drug is being tested in patients with chronic myeloid leukemia, which affects about 4,400 Americans a year and 10,000 people around the world. The drug is known by its experimental name BMS-354825. During the trial, also financed by Bristol-Myers, 31 of 36 patients with advanced CML who had not been helped by Gleevec had a complete hematologic response, meaning their bodies stopped producing leukemia cells. This translates to an 86 percent remission rate, said Dr. Charles Sawyers, a Howard Hughes Medical Institute investigator at the University of California Los Angeles who is helping test the drug. Gleevec, made by Swiss drug company Novartis, targets an enzyme called BCR-ABL that leukemia cells use to proliferate. It attaches to the cancerous cells and stops them from growing and spreading. (Reuters)
Philips introduces advanced technologies at RSNA
At the 90th annual meeting of the Radiological Society of North America (RSNA), Royal Philips Electronics introduced new technologies to enhance radiologists' ability to provide advanced patient care. Among the new products showcased: the Philips Panorama 1.0T, an open high-field MR scanner with active shielding; the Philips GEMINI GXL, an open PET/CT scanner that delivers exceptional image quality with entirely new levels of throughput using line of response (LOR); the Philips Brilliance 64-channel CT scanner; and the new enterprise-ready Philips Xtenity Radiology Information System (RIS).
GE Healthcare unveils 'Vision of Healthcare
in the Year 2015' at RSNA
GE Healthcare, a unit of General Electric Company, unveiled its 2015 Future Technology Pavilion at the 2004 Radiological Society of North America (RSNA) conference. During the conference, GE showcased technologies to help enable personalized healthcare in the future, resulting in the earlier detection of disease and treatments tailored to individual patients. GE's Technology Pavilion highlights healthcare research and development including the new, targeted diagnostics, as well as information technologies solutions and imaging equipment that will enable physicians to predict, diagnose, inform and treat disease earlier than ever before. The company featured a new 64-slice PET/CT scanner, a portable digital radiography system, and new high-definition MRI technology, along with new technologies in PACS, CT, ultrasound, and women's imaging.
Planar introduces new console application,
the Dome Dashboard
Also at RSNA, Planar Systems Inc. introduced the Dome Dashboard, a new console application for the maintenance and monitoring of medical imaging displays. Developed specifically for the needs of medical imaging in the PACS environment, Planar's Dome Dashboard is a software console application which enables PACS administrators and IT managers to centrally manage, control and report on their entire line of Dome medical imaging displays. Centralized management enables increased PACS uptime and productivity for hospitals that are deploying imaging displays throughout the healthcare system, from the radiology suite, to operating rooms, nursing stations and doctors' offices. With the Dome Dashboard, Planar fulfills hospitals' medical imaging display needs for both hardware and software, with solutions designed to function together seamlessly.
Friday, December 3, 2004
In this Issue:
CDC report shows steady HIV rate, racial
disparities
Antidepressant use triples
Patient identification aided by
picture wristbands
ASHES elects 2005 board members
ISMP error alert on unlabeled
containers during surgery
CDC report shows steady HIV rate, racial disparities
Despite the government's promise to “break the back” of the AIDS epidemic by 2005, about 40,000 Americans test positive for the HIV infection every year, the same number as a decade ago, reported the Associated Press. The figure is double the annual goal of 20,000 new HIV cases laid out by the Centers for Disease Control and Prevention nearly four years ago. Nearly a million people in the United States now have the AIDS virus. CDC released the new data Wednesday as part of the federal health agency's commemoration of World AIDS Day. The rate of HIV diagnoses in the United States increased slightly, by 1 percent, between 2000 and 2003, from 19.5 people per 100,000 population to 19.7 per 100,000 in the 32 states surveyed by the CDC. Rates of HIV/AIDS diagnosis among non-Hispanic African-Americans in the United States were significantly higher than among other racial and ethnic groups. The rate of HIV/AIDS diagnosis among African-American females in 2003 (53 cases per 100,000 population) was more than 18 times higher than among white women and almost five times higher than among Latina women. In addition, African-American women accounted for 69 percent of female HIV diagnoses during 2000-2003. Men who have sex with men continued to account for the largest proportion of diagnoses, 44 percent of all HIV diagnoses during the four-year period, and 61 percent of diagnoses among men. The CDC also issued new data on HIV testing trends in the U.S. from two national surveys conducted in 2002 with more than 100,000 people. The National Health Interview Survey (NHIS) showed that 10 percent of adults reported HIV testing in the previous year. The Behavioral Risk Factor Surveillance System (BRFSS) reported that about 12 percent of adults were tested in the previous 12 months. Greater use of the rapid HIV tests approved in 2002 is expected to continue to increase the number of persons who get tested. Testing rates were higher among groups for whom HIV testing is recommended by CDC than among the general population. The reports on HIV/AIDS diagnoses and HIV testing are available at www.cdc.gov/mmwr.
Antidepressant use triples
One in 10 American
women takes an antidepressant drug such as Prozac, Paxil or Zoloft, and the use
of such drugs by all adults has nearly tripled in the last decade, according to
the latest figures on American health released by the federal government. The
report said that prescription drug costs are rising faster than any other area
of medical care. In 2002, the latest year for which data were available, total
healthcare spending
climbed 9.3 percent in
2002 to $1.6 trillion,
of which prescription drugs accounted for $162 billion, the report found. Drug
costs rose by 15 percent over the year before, driven by a combination of more
expensive medicines and increased use. Antidepressant drugs called selective
serotonin reuptake inhibitors (SSRIs) showed some of the largest increases in
use. By 2000, the proportion of adults using such drugs had nearly tripled,
compared with the data set that ended in 1994. In 2002, more than one in three
doctor's office visits by women involved a prescription for an antidepressant,
said Amy Bernstein, project director for the report issued by the Center for
Mental Health Services of the Centers for Disease Control and Prevention. The
number of children getting psychiatric drugs also soared. In 2002, about 6
percent of all boys and girls were taking antidepressants, triple the rate in
the period 1994-96. And about 14 percent of boys, nearly one in seven, were on
stimulant drugs in 2002, double the number in 1994-96, the report found. The
number of adults taking cholesterol-lowering statin drugs nearly quadrupled from
1995-96 to 2001-02, said the report. Overall, 44 percent of all Americans,
including children, were taking at least one prescription drug in 1999-2000, a 5
percent increase since 1994. One-in-six Americans takes at least three
prescription drugs.
Nearly half of all women
were taking prescription drugs, 49 percent, compared to 39 percent of men. Drug
usage peaked at 84 percent for people aged 65 and over, with the top rate at 89
percent for black women over 65.
“Factors affecting the
recent increase in utilization of medications include the growth of third-party
insurance coverage for drugs, the availability of successful new drugs,
marketing to physicians and increasingly directly to consumers, and clinical
guidelines recommending increased utilization of medications for conditions such
as high cholesterol, acid-reflux disease, and asthma,” the report concluded. The
report, “Health, United States 2004,” presents the latest data collected by CBC,
the National
Center for Health Statistics and dozens of other Federal health agencies,
academic and professional health associations, and international health
organizations. (The Washington Post)
Patient identification aided by picture wristbands
Combining individualized picture wristbands with DICOM modality worklist capability can ensure positive patient identification and yield patient safety dividends, according to researchers from the University of Texas M.D. Anderson Cancer Center (MDACC) in Houston. While there has been expanded attention by healthcare institutions and publicity in the popular media on patient safety issues relating to medication or surgical errors, there has been little focus on errors in diagnostic imaging departments, and those can be just as important, according to Rebecca Downs. She presented the MDACC's experience Wednesday at the 2004 RSNA meeting. “If you have an inappropriately labeled film or digital image, that can be just as detrimental as a misadministered medication,” Downs said. To ensure positive identification of patients, MDACC began outfitting all patients that enter the radiology department with individualized wristbands, which feature a color picture of the patient, medical record number (MRN), date of birth, sex, and MRN barcode. Pictures are taken with a digital camera upon arrival, and a polyester wristband is then printed and placed on the patient, Downs said. The photos are stored as JPEG files for reuse and later retrieval, if necessary. The barcode on the wristband is then scanned at the time of the imaging procedure using a barcode scanner attached to the modality. At that point, the imaging modality queries the RIS for the DICOM worklist using the standard's modality worklist function, she said. The RIS then returns to the modality a list of procedures that patient has scheduled for that day. As a result, the risk of data-entry error is greatly reduced, Downs said. Images are then identified correctly for that patient. Response has been overwhelmingly positive from both patients and other specialty areas in the hospital, Downs noted. In the future, MDACC is planning to roll out the system to 35 diagnostic imaging patient reception and nursing areas. The institution is also evaluating the possibility of adding radiofrequency identification (RFID) technology to the wristband, allowing for automatic tracking of patient movement throughout the division, Downs said. (AuntMinnie.com)
ASHES elects 2005 board members
The American Society for Healthcare Environmental Services (ASHES), an AHA personal membership group, has elected two new members to its board of directors. They are Rose Hamann, ARRT, CHESP, director of environmental services at Blessing Hospital in Quincy, IL, and James Connors, CHESP, director of environmental and textiles services at Rhode Island Hospital in Providence, RI. Hamann has 39 years experience in healthcare with 28 years in radiology and 11 years as Environmental Services and Security Director. Connors has over 34 years in the healthcare EVS and textile care fields. Both board members will serve a three-year term, beginning Jan. 1, 2005.
ISMP error alert on unlabeled containers during surgery
A recent tragic medication error that claimed the life of a 69-year old Seattle
woman serves as a compelling example of why unlabeled medications and solutions
in the sterile field are dangerous, said the Institute for Safe Medication
Practices (ISMP). During surgery, a technician accidentally injected the patient
with an antiseptic skin prep solution, chlorhexidine, instead of contrast media
as indicated. Both solutions were clear and in unlabeled cups. There have been
many other similar errors reported, and the Institute for Safe Medication
Practices (ISMP) hopes this most recent tragedy will act as a wake-up call. A
detailed account of the circumstances surrounding the error was published in the
December 1 issue of the ISMP Medication Safety Alert! newsletter. The hospital’s
decision to switch antiseptics from a brown providine-iodine solution to a clear
chlorhexidine solution resulted in a two look-alike solutions on the sterile
field. Recent findings from the 2004 ISMP Medication Safety Self-Assessment for
Hospitals, which represent data from more than 1,600 respondents, show that less
than half of our nation’s hospitals (41%) always label containers on the sterile
field, including syringes, basins, or other vessels used to store drugs.
Eighteen percent do not label medications and solutions on the sterile field at
all, and another 42% apply labels inconsistently. Although this represents an
improvement from the 2000 medication safety self-assessment findings (25%
reported full labeling, 24% reported no labeling), it still points to an area
that needs significant improvement. To reduce the risk of errors, ISMP suggests
that healthcare delivery sites develop and implement policies and procedures for
safe labeling of medications and solutions used in perioperative settings,
including traditional ORs, labor and delivery rooms, ambulatory surgery units,
physicians’ offices, cardiac catheterization suites, endoscopy suites, radiology
departments, and other areas where operative and invasive procedures may be
performed. The ISMP has issued recommendations, many of which were mentioned in
a recently published Association of Perioperative Registered Nurses (AORN)
guidance document (http://www.aorn.org/About/positions/pdf/7f-safemeds-2004.pdf).
These include providing and requiring labels, differentiating look-alike
products, labeling medication one at a time, confirming medications and labels,
re-verifying with relief staff, discarding unlabeled medications, and conducting
walk-arounds.
Thursday, December 2, 2004
In this Issue:
FDA takes action against
company
for illegal drug importation
Anthem-WellPoint merger
finalized after
Georgia funding deal
Ricin vaccine ready for human
trials
Wall Street Journal examines
new strategies
by hospitals to decrease mortality rates
Brown named JCAHO chairman for
2005
Healthcare providers report
fraudulent invoices
Spectrum Surgical Instruments
announces repair
agreement with Lake Erie Regional Cooperative
FDA takes action against company
for illegal drug importation
The U.S.
Attorney's Office, Southern District of New York, has on behalf of
the Food and Drug Administration (FDA), filed a civil complaint
against Canada Care Drugs, Inc., Claire Ruggiero, and Christine
Ruggiero for the illegal importation of prescription drugs into the
U.S. Canada Care was previously affiliated with Rx Depot Inc., a
company that was engaged in the illegal importation of prescription
drugs until November 6, 2003, when the U.S. District Court for the
Northern District of Oklahoma entered an order of preliminary
injunction against the company and its affiliates to stop their
illegal activity. According to the complaint filed in the Southern
District of New York on Monday, Canada Care severed its relationship
with Rx Depot, but continued illegal activity in violation of the
Food, Drug and Cosmetic Act (FDCA). FDA's investigation of Canada
Care's illegal importation operations has revealed several products
that pose a risk to the public health. In February and August 2004,
FDA made two undercover purchases of the FDA-approved drugs Sporanox
and Neurontin through Canada Care. Instead of Neurontin, FDA
received unapproved drugs called APO-Gabapentin and Novo-Gabapentin.
Also alleged in the complaint, the manner in which the Sporanox
shipment was sent by the foreign pharmacy posed a potentially
serious health threat to the patients who received it. Patients
should take it in treatment “pulses” of one week, and then wait
three weeks before resuming another pulse treatment, consulting
their doctor between treatments, however the foreign pharmacy sent
three packages of Sporanox at one time.
Anthem-WellPoint merger finalized after Georgia funding deal
Georgia Insurance Commissioner John Oxendine (R) on Tuesday approved
a $16.4 billion merger between California-based WellPoint Health
Networks and Indiana-based Anthem after Anthem agreed to provide a
total of $126.5 million for healthcare programs, the Atlanta
Journal-Constitution reports. The
approval by Oxendine completes the merger Anthem and WellPoint
shareholders and a number of entities with direct regulatory
authority, such as the
Department of Justice,
nine other states and
Puerto Rico, previously approved the merger.
The merger,
which was announced in October 2003, will combine the companies
under the corporate name WellPoint and establish headquarters in
Indiana. The merger creates the largest U.S. health insurer, with 28
million members in 13 states. Oxendine decided to approve the merger
after Anthem agreed to contribute about $100 million to Georgia over
the next 20 years. Under the agreement, Georgia for the next 20
years will receive 2% of the Anthem investment portfolio to purchase
bonds to expand and improve rural health centers in the state. In
addition, Anthem will provide Georgia with $26.5 million to allow
patients in rural areas to telecommunicate with specialists in other
areas of the state. Anthem agreed to build, supply and finance
telemedicine centers at 36 rural hospitals, clinics and four
teaching hospitals in Georgia. Under the agreement, health insurance
policies issued by the new company will cover all procedures
conducted at the telemedicine centers, according to Oxendine. In
addition, WellPoint and Anthem promised that they would not increase
premiums for Georgia BCBS members. (Kaiser Daily Health Policy
Report).
Ricin vaccine ready for human trials
Texas researchers will begin clinical trials of a candidate vaccine against the deadly toxin ricin, a biological agent that can only be tested in select labs. University of Texas Southwestern Medical Center in Dallas received approval from the Food and Drug Administration to conduct the safety trial in humans. According to the Centers for Disease Control and Prevention, as little as 500 micrograms of ricin is enough to kill an adult. Lethal doses depend on how the poison is delivered: by powder, mist, pellet or dissolved in water. The poison can be made from waste left over from processing castor beans. Because castor beans are easy to obtain and the poison remains potent despite exposure to temperature extremes, government officials worry that it could become a tool of terrorists. Unless treated quickly, there is no antidote. The Texas researchers will test the safety of a genetically engineered protein vaccine, RiVax, developed by a team led by UT Southwestern's Dr. Ellen Vitetta. The team developed the experimental RiVax vaccine for the deadly poison as an offshoot of its cancer research. The National Institutes of Health funded research to turn the discovery into a product that may soon help protect Americans against a bioterrorism attack. In past trials, the vaccine protected mice against 10 lethal doses of ricin and had no side effects even when given at 100 times the dose needed to prompt an antibody response. (The Associated Press)
Wall Street Journal examines new strategies
by hospitals to decrease mortality rates
The Wall Street Journal on Wednesday looked at a new strategy U.S. hospitals are adopting that involves the use of a “SWAT team concept” to decrease mortality rates by “eliminating red tape that causes delays in assisting critically ill patients.” The so-called rapid response teams, which often include a critical-care nurse, intensive-care specialist and a respiratory therapist, are mobilized by pager as soon as a patient's condition exhibits “worrisome changes,” such as elevated blood pressure or a negative reaction to medication, according to the Journal. The teams, which are authorized to act without contacting the patient's physician, are designed to prevent cardiac arrest and other medical crises at the first indication of a potential problem, rather than resuscitating patients after the heart already has stopped. The concept, which was pioneered in Australia, is supported by the not-for-profit Institute for Healthcare Improvement, which aims to enlist 1,000 hospitals in a campaign it is launching this month that will promote using the teams and employing other methods to reduce the occurrence of avoidable deaths (Wall Street Journal, Kaiser Daily Health Report).
Brown named JCAHO chairman for 2005
Fred Brown, a healthcare executive and past AHA chairman, has been elected 2005 chairman of the Joint Commission on Accreditation of Healthcare Organizations. The founding president and CEO of BJC Healthcare in St. Louis, Brown most recently was a visiting scholar and executive-in-residence at the George Washington University School of Public Health and Health Services. He currently serves as JCAHO vice chair and as chairman of the National Kidney Foundation and is an international consultant.
Healthcare providers report fraudulent invoices
Healthcare providers are being cautioned to be on the lookout for suspicious invoices, following reports that hospitals and nursing homes in several states have received invoices from a Missouri-based company for “solid waste consulting” services that were never performed. According to the Kansas City Better Business Bureau, the invoices from WasteCheck Consulting Programs in Kansas City were dated Nov. 12 and have ranged from $279.50 to $8,359. Bureau spokesperson Julie Martin said an attorney representing WasteCheck claims the invoices were a marketing piece. However, she said the documents are marked “invoice” and do not include a clearly written statement indicating that they are a solicitation and not a request for payment, as required by the Federal Trade Commission. She said her organization has received eight complaints from nursing homes and hospitals in Ohio, Iowa, Missouri, Nebraska and Texas, and has “notified the proper authorities.” Some healthcare providers in South Dakota and Kentucky also have received the invoices. Martin advised companies that have paid the invoice in error to contact her organization immediately at (816) 421-7800. For more, visit www.spokane.bbb.org/alerts/alerts.html?newsid=537&newstype=1. (Source: AHA NewsNow)
Spectrum Surgical Instruments announces repair
agreement with Lake Erie Regional Cooperative
Spectrum Surgical announces a three year Repair Agreement with Lake Erie Regional Cooperative (LERC). Effective October 1, 2004, Spectrum Surgical Repair Services Division will be contracted for general instrument repair and specialty instrument repair. These integrated services include daily service plus a dedicated fleet of on-location repair lab vehicles. LERC is a sub-chapter T purchasing cooperative, which consists of 25 acute-care members, over 400 physician practices, and a number of non-acute care organizations. This contract agreement will give members access to a 25-30% savings on surgical instrument repair.
Wednesday, December 1, 2004
In this Issue:
MRSI could help diagnose
bipolar disorder
CDC report: Birth rates for
women aged 40-44 up
Consorta and R2 Technology extend agreement
for
computer-aided detection for mammography
Quality Medical Professionals offers temporary
medical staffing for the holidays
Ochsner Clinic Foundation selects MedAssets
for
supply chain and revenue cycle solutions
Amerinet announces new labeling
contracts
with TimeMed and Shamrock
MRSI could help diagnose bipolar disorder
Because diagnosis
of bipolar disorder requires documentation of at least two distinct
episodes, mania and depression, patients are often undiagnosed or
misdiagnosed for years. But preliminary research suggests that
magnetic resonance spectroscopy imaging (MRSI) could aid diagnosis
by providing a “chemical fingerprint of bipolar disorder,” according
to Dr. John D. Port, Ph.D., assistant professor of radiology at the
Mayo Clinic in Rochester, MN. Dr. Port presented the study findings
at the Radiological Society of North America (RSNA) conference in
Chicago on Tuesday. The MRSI study included 19 patients with bipolar
disorder confirmed by psychological testing who were not being
treated with medication. MRSI was performed on a 3-tesla long-bore
scanner (GE Healthcare) using PRESS-MRSI. The scan analyzed
metabolites of five brain chemicals, and produced a graph
illustrating region-by-region variations in the metabolites. In
comparing the images from the 19 patients to scans done in 19 age-
and sex-matched healthy volunteers, distinct and different patterns
emerged. According to Port, the next research step will be a study
of patients undergoing medical treatment for bipolar disorder to
determine if MRSI can detect changes in brain chemistry in response
to medication. About 2.3 million Americans suffer from bipolar
disorder, according to the National Institute of Mental Health. (AuntMinnie.com)
CDC report: Birth rates for women aged 40-44 up
Preliminary birth data for 2003 indicate that the birth rate for women aged 40-44 increased in 2003 while the rate for women aged 45-54 remain unchanged, according to a new report by the Centers for Disease Control and Prevention. The report, “Births: Preliminary Data For 2003,” shows that birth rates for women aged 40-44 rose 5 percent between 2002 and 2003 from 8.3 to 8.7 births per 1,000 women. The rate for women aged 45-54 remained unchanged at 0.5. This is the first time that births to women over 40 topped 100,000 in a single year. Other findings in the report include: Birth rates for women aged 30-34 increased by 4 percent (91.5 per 1000 in 2002 versus 95.2 in 2003) from 2002 to 2003, while the rate for women aged 35-39 rose 6 percent (41.4 per 1000 in 2002 to 43.8 in 2003). The teen birth rate fell for the 12th straight year, from 43.0 births per 1,000 teens aged 15-19 in 2002 to 41.7 in 2003. The report includes other important health information, such as: The percent of mothers who smoked during pregnancy decreased from 11.4 percent in 2002 to 11.0 in 2003. The percent of women who received prenatal care within the first three months of pregnancy increased between 2002 and 2003, continuing a pattern that began in the early 1990’s. Slightly over 84 percent of women received early prenatal care in 2003. The cesarean delivery rate rose for the seventh straight year. Preliminary 2003 data show that 27.6 percent of all births were cesarean deliveries, a 6 percent increase from 2002. The percent of babies born preterm (less than 37 weeks of gestation) rose from 12.1 in 2002 to 12.3 in 2003, continuing its steady increase since the mid-1990’s. The percent of babies born at low birth weight (under 2,500 grams) rose from 7.8 percent in 2002 to 7.9 percent in 2003. Low birth weight has gradually increased since the mid-1980’s. Preliminary Data For 2003 was prepared by CDC’s National Center for Health Statistics. The data was based on over 95 percent of birth records reported to vital statistics offices in all 50 states as part of the National Vital Statistics System. The report is available at www.cdc.gov/nchs.
Consorta and R2 Technology extend agreement for
computer-aided detection for mammography
Consorta Inc. announced a one-year extension of its contract with R2 Technology Inc., a maker of computer-aided detection (CAD) for medical imaging. Through the agreement, R2 Technology provides Consorta members with CAD systems designed to assist radiologists in the early detection of breast cancer. ImageChecker was the first CAD system approved by the Food and Drug Administration for use with mammography. Since 1998, R2 Technology has received 17 supplemental approvals for technological and clinical advances. Computer-aided detection is increasingly used by radiologists as a “second pair of eyes” when reading a mammogram. The ImageChecker system has the potential to detect findings that might otherwise be overlooked during the review process, thus improving cancer detection capabilities. Clinical trials demonstrated that use of the ImageChecker system could result in earlier detection of up to 23.4 percent of the cancers currently detected with screening mammography.
Quality Medical Professionals offers temporary
medical staffing for the holidays
Quality
Medical Professionals (QMP) announced it is ready to provide qualified and
affordable temporary medical professionals during the coming holiday season.
Industry statistics show that qualified nursing and allied medical labor
shortages continues to grow, and the holiday season could mean even greater
staffing shortages in the healthcare sector. In addition to injury, illness, and
turnover are healthcare administrators must manage the Influenza vaccine
shortage, plus scheduled and “unscheduled” holiday vacations. QMP provides
healthcare managers the required floor coverage during busy holidays to ensure
highest quality services and contain recruitment, qualification, and
administrative costs.
Ochsner Clinic Foundation selects MedAssets for
supply chain and revenue cycle solutions
Ochsner Clinic Foundation (New Orleans, LA), has selected MedAssets to implement supply chain and revenue cycle solutions. Ochsner Clinic Foundation has a total annual supply spend of $130 million. The multi-year relationship is effective January 1, 2005. Ochsner Clinic Foundation is one of the nation's big six clinics and is the Gulf South's premier healthcare delivery network. Ochsner's close collaboration between its clinicians and scientists brings medical discoveries from the laboratory to the bedside. In addition to providing a complete revenue cycle tool suite, supply contract portfolio, custom catalog, and strategic information technology, MedAssets, through its business partner Aspen Healthcare Metrics will focus on reduction of supply costs related to high cost medical devices and pharmaceuticals.
Amerinet announces new labeling contracts
with TimeMed and Shamrock
Amerinet has signed a three-year renewal for tapes, labels and labeling systems with TimeMed Labeling Systems Inc. The agreement, effective November 1, 2004 through October 31, 2007, enables Amerinet’s healthcare provider members to save on pressure sensitive labeling products from TimeMed. The TimeMed product offering includes stock and custom pressure sensitive tapes, labels, labeling systems, and laser and thermal wristbands. Amerinet has also renewed a contract with Shamrock Scientific Specialty Systems for tapes, labels and labeling systems. Effective November 1, 2004 through October 31, 2007, Shamrock will provide Amerinet members with discounted pricing on blank and pre-printed labels, stock and custom labels with special materials. Members can also access Shamrock’s design assistance to produce the precise labels needed for their procedures.