Inside the Current Issue
|
||
|
Cover Story Doing more with less - redefining inventory organization |
||
| Newswire | ||
 |
||
| Purchasing Connection | ||
| Resources | ||
| Show Calendar | ||
 |
||
| Classifieds | ||
| Issue Archives | ||
| Advertise | ||
| About Us | Home | |
| Subscribe | ||
| Special Event Photos | ||
|
KSR Publishing, Inc. Copyright © 2008 |
||
 |
|
People, Places, Processes & Products that Influence the Supply Chain |
|
hpnonline Daily Update |
||||||||
|
|
March 2008
March 7, 2008 Download print version German authorities report problems with blood thinner
Drugs like aspirin could reduce breast cancer and help existing sufferers
Cause of typhoid outbreak still a puzzle as cases rise New test for joint infection could spare some patients an unnecessary procedure Criminal charges filed over poisonous toothpaste Gettin' Jiggy with StyleView German authorities report problems with blood thinner Concerns about the safety of the blood thinner heparin spread to Germany on Thursday after drug authorities there received reports of patients being sickened after taking the drug. Meanwhile, Food and Drug Administration officials announced that they were asking all companies in the United States that produce heparin to test it with two new procedures. The complex tests, nuclear magnetic resonance spectroscopy and capillary electrophoresis, are the only ones that can uncover whether the drug contains a possibly counterfeit ingredient. Dr. Janet Woodcock, deputy F.D.A. commissioner, said that the agency would post instructions online for the tests. Food and Drug officials said Wednesday that a possibly counterfeit ingredient had been found in certain batches of heparin linked to at least 19 deaths in the United States and more than 700 severe allergic reactions. Federal officials said they could not yet say that the contaminant, which mimics real heparin, caused the reactions. Until Thursday, federal investigators had been focusing on heparin manufactured by Baxter International. But Dr. Woodcock said that German health authorities told the F.D.A. that Baxter did not make the heparin linked to two separate outbreaks of allergic reactions in that country. Germany has reported fewer than 100 cases of patients suffering severe allergic reactions and shock, and no deaths. F.D.A. officials declined to say whether the raw ingredients for the suspect German heparin came from China, the source of the starting materials used to make the contaminated heparin in the United States. Most of the world’s heparin supply is from China. In the last six months, more than 30 Chinese companies could be found selling heparin products on major business-to-business Web sites. “We are working as quickly as possible to analyze any potential impact on the U.S. market and worldwide,” said Deborah Autor, the director of compliance for the agency’s Center for Drug Evaluation and Research. In the first half of last year, China exported heparin products to 42 countries and regions, according to a September 2007 report by the China Chamber of Commerce for Import and Export of Medicines and Health Products. China exported the most heparin products, about 13 tons, to Germany. It also sent 11 tons to France and about 10 tons to the United States, the report said. Erin Gardiner, a spokeswoman for Baxter, said reports that her company was not responsible for making the suspect heparin in Germany would most likely point to a problem with the suppliers of crude heparin. “The news today indicates that the issue could be further back in the supply chain,” Gardiner said. Last week, Baxter withdrew from the market nearly all of its heparin products. Most supplies of heparin in the United States are now from APP Pharmaceuticals, of Schaumburg, IL. APP’s supplies have undergone the new tests. German authorities have identified Rotexmedica as a manufacturer of at least some of the suspect heparin there, F.D.A. officials said. F.D.A. officials said they were told that the German authorities had recalled an unspecified amount of heparin. (The New York Times) See THIS LINK  Drugs like aspirin could reduce breast cancer and help existing sufferers Anti-inflammatory drugs like aspirin may reduce breast cancer by up to 20 percent, according to an extensive review carried out by experts at London’s Guy’s Hospital and published in the March issue of IJCP, the International Journal of Clinical Practice. But they stress that further research is needed to determine the best type, dose and duration and whether the benefits of regularly using non-steroidal anti-inflammatory drugs (NSAIDs) outweigh the side effects, especially for high-risk groups. “Our review of research published over the last 27 years suggests that, in addition to possible prevention, there may also be a role for NSAIDs in the treatment of women with established breast cancer” said Professor Ian Fentiman from the Hedley Atkins Breast Unit at the hospital, part of Guy's and St Thomas' NHS Foundation Trust. “NSAID use could be combined with hormone therapy or used to relieve symptoms in the commonest cause of cancer-related deaths in women.” Professor Fentiman and Avi Agrawal reviewed 21 studies covering more than 37,000 women published between 1980 and 2007. Their review included 11 studies of women with breast cancer and ten studies that compared women who did and did not have the disease. “Having weighed up the findings from over 20 studies, we have concluded that NSAIDs may well offer significant protection against developing breast cancer in the first place and may provide a useful addition to the treatment currently available to women who already have the disease,” said Professor Fentiman. “Recent studies of NSAIDs use have shown about a 20 percent risk reduction in the incidence of breast cancer, but this benefit may be confined to aspirin use alone and not other NSAIDs.”
Previous studies have suggested that NSAIDs like aspirin and ibuprofen,
which have traditionally been used as mainstream non-prescription
analgesics, may provide protection against coronary heart disease and some
malignancies, such as colorectal cancer. But Professor Fentiman is urging
caution until further research fully weighs up the pros and cons of using
NSAIDs to prevent and treat breast cancer.
GAO: Issues and challenges related to how hospitals submit quality data and how CMS ensures data reliability Hospitals submit data on a series of quality measures to the Centers for Medicare & Medicaid Services (CMS) and receive scores on their performance. CMS instituted the Reporting Hospital Quality Data for Annual Payment Update Program (APU program) to collect the quality data from hospitals and report their rates on the measures on its Hospital Compare Web site. For hospital quality data to be useful to patients and other users, they need to be reliable, that is, accurate and complete. The Deficit Reduction Act of 2005 directed CMS to implement a value-based purchasing program for Medicare that beginning in fiscal year 2009 would adjust payments to hospitals based on factors related to the quality of care they provide. This statement provides information on (1) how hospitals collect and submit quality data to CMS and (2) how CMS works to ensure the reliability of the quality data submitted. This statement is based primarily on Hospital Quality Data: HHS Should Specify Steps and Time Frame for Using Information Technology to Collect and Submit Data (GAO-07-320, Apr. 25, 2007) and Hospital Quality Data: CMS Needs More Rigorous Methods to Ensure Reliability of Publicly Released Data (GAO-06-54, Jan. 31, 2006). In preparing these reports, GAO conducted case studies of eight hospitals, and reviewed documents of, and interviewed officials at CMS. What GAO found: GAO reported in April 2007 that the eight case study hospitals visited used six steps to collect and submit quality data, two of which (steps 2 and 3) involved complex abstraction—the process of reviewing and assessing all relevant pieces of information in a patient’s medical record to determine the appropriate value for each data element. The six steps were (1) identify patients for whom the quality data should be submitted, (2) locate needed information in the medical records, (3) determine the appropriate value for each data element, (4) transmit the data to CMS, (5) review reports to ensure acceptance of the data by CMS, and (6) supply copies of selected medical records to CMS for data validation. Several factors account for the complexity of the abstraction process (steps 2 and 3), including the content and organization of the medical record, the scope of information and clinical judgment required for certain data elements, and frequent changes by CMS in its data specifications. GAO’s case studies also showed that existing information technology (IT) systems help hospitals gather some quality data but are far from enabling hospitals to automate the abstraction process. For more information see THIS LINK.
Vaccine could offer protection against high blood pressure A vaccine that protects against high blood pressure by mopping up a hormone that makes blood vessels constrict has been developed by a team of scientists. A trial of the jab showed it significantly reduced blood pressure in 72 people with mild to moderate hypertension, and was particularly effective in the early hours of the morning, when people are most at risk of strokes and heart attacks. Dr. Martin Bachmann and colleagues from University hospital, Lausanne, developed the vaccine to target a hormone, angiotensin 2, which causes blood vessels to tighten and so raise the pressure of blood flowing through them. Angiotensin-blocking drugs are the most common hypertension treatments today. To make the vaccine, the researchers attached molecules of angiotensin 2 to artificial viruses, harmless bundles of protein created in the lab which look like viruses but cannot replicate or cause damage. The researchers have formed a company, Cytos Biotechnology. In the trial, volunteers were injected with either a placebo, 100 micrograms or 300 micrograms of the vaccine. Each person received three jabs, one on the first day of the trial, with the others following one and three months later. The blood pressure of each volunteer was taken one day before the trial and two week after the last injection. According to a report in the Lancet, systolic blood and diastolic blood pressure fell by 9mm and 4mm respectively in patients given 300 micrograms of the vaccine. Those given a placebo showed no change in blood pressure. "What was quite remarkable and unexpected was the biggest falls in blood pressure were between 5am and 8am, when most strokes and heart attacks happen," said Bachmann. "This time is particularly risky because blood pressure surges in the morning as the body wakens, before patients have taken their medication ... With a vaccine, we hope they would only need an injection every six months." (The Guardian)
Cause of typhoid outbreak still a puzzle as cases rise As cases of typhoid fever continued to escalate and an already crowded government hospital had started putting patients under a tent, government and health officials in Calamba City, Philippines, were still uncertain of the cause of the outbreak. As of Thursday, the number of persons afflicted with typhoid fever in the community had increased from 1,041 to 1,149 and the confinement in six hospitals had risen from 426 to 522, Dr. Dennis Labro, city health office's spokesperson, told the Philippine Daily Inquirer, parent company of INQUIRER.net. Labro said the CHO, with the help of sanitary inspectors in the provincial level, was conducting an investigation and water sampling. He added that the test would take some time because their staff members were going from house to house in every village, including unaffected areas. The team also probed the possibility that there were leaks in the water facilities of the Calamba Water District (CDW). CDW earlier denied the allegations that the water it supplied to villages was contaminated. CDW general manager Alberto M. Cervancia said they had met the Department of Health's bacteriology standards for drinking water. CDW had also sought the assistance of the Aqua Laboratory Center, an accredited agency of DoH for water testing, he added. The Aqua Lab reported through physiochemical test on February 27 that the water sample from CWD passed the DOH standards and was negative for Salmonella typhi, the bacteria which causes typhoid fever. "There could be other causes aside from water," Cervancia said. From 155 people, the hospital was accommodating 170 typhoid patients as of Thursday. Dr. Gonzalo Lavarias Jr., chief of hospital, said they would be setting up another makeshift tent to shelter the other patients as the hallways had become even more congested. An open makeshift tent near the hospital's chapel, which set up Sunday, is housing around 58 patients. Labro however clarified that typhoid cases might not really be increasing because some of the patients might have just sought hospitalization recently but had been enduring the disease for days. "There were also days with lower hospital admission but last Wednesday was one of the peak days," he said, adding: "This is because of the long incubation period of the disease." "The city government is both alarmed and concerned in what is happening. In declaring state of calamity, it would be easy to disburse calamity funds for medical supplies," Labro said. He said city residents were also alarmed and facing difficulties in terms of the water source. "Some residents are already thinking to move out of Calamba temporarily until the outbreak subsides," he said. (Inquirer.net) See THIS LINK
New test for joint infection could spare some patients an unnecessary procedure A potential diagnostic test that could help surgeons confirm or rule out the presence of infection-causing bacteria in prosthetic joints that require surgical revision has been developed by researchers at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health (NIH). Such a test could spare a subgroup of people who need the surgery a time-consuming and costly treatment for infection, while helping to ensure that people who need the procedure get it. The test is described in the March issue of the Journal of Bone and Joint Surgery. Each year, hundreds of thousands of joint replacement surgeries are performed in this country. And each year, thousands of them must be revised (the prosthetic joint must be removed and replaced) due to severe pain and swelling. These symptoms are often due to infection, said Rocky S. Tuan, Ph.D., chief of NIAMS' Cartilage Biology and Orthopaedics Branch. The standard treatment for suspected infection is to remove the joint prosthesis and replace it with a spacer that has been impregnated with antibiotics. After about six weeks, patients must undergo another surgery to remove the spacer. Only then can the surgeon implant the new prosthesis. The problem with this approach is that confirming the presence of infection-causing bacteria is an inexact science. Currently, doctors check for infection by culturing a sample of the joint fluid. A positive culture confirms live bacteria, making spacer surgery a certainty. A negative culture, however, does not necessarily mean there is no infection. In fact, Tuan says that estimates of the false negative rate for joint cultures in revision surgeries range from 27 percent to 50 percent. But because failure to treat an infected joint could lead to severe infection and limb amputation, spacer surgery is sometimes performed for safety's sake even when infection test results are inconclusive. To get around the false-negative problem, Tuan and his colleagues developed a way to test for joint infections using polymerase chain reaction (PCR), which detects the presence of bacterial DNA. However, this approach proved to have pitfalls, too. It picked up all bacteria, even dead or dying bacteria that cannot perpetuate infection, thereby giving false positives. Tuan says this new problem led them to expand their PCR approach by testing for bacterial messenger ribonucleic acid (mRNA). "When bacteria are dying, their mRNA is one of the first things to go," he said. As a result, the researchers hypothesized that a good mRNA test would not only detect bacteria, but would likely tell them if any bacteria they detected were still viable. Unlike DNA, mRNA is not directly quantifiable by known techniques, so the mRNA test that Tuan's group developed employs a process called reverse transcription PCR (RT-PCR) to convert the mRNA into DNA for measurement. Now Tuan's team is recruiting 50 people who need joint revision for a clinical trial that will involve testing patients' joint fluid for bacteria and then following them for 6 months to a year after surgery. They hope that the results from this study will validate the protocol to identify or rule out infections before a person begins a surgical revision. Tuan would like to be able to tell patients who need infection treatment, "There is a really bad infection and we know what to do." "But we also want to tell the person without infection that it's O.K. to put in a revision joint. That saves the spacer, the additional surgery and its associated risk, and 6 weeks of being laid up," Tuan said.
Criminal charges have been filed against a company that prosecutors say imported and distributed nearly 90,000 tubes of Chinese toothpaste containing a poisonous substance, Los Angeles City Attorney Rocky Delgadillo announced Thursday. A wholesaler that supplied local stores with the tubes was also charged. Selective Imports sold the toothpaste containing diethylene glycol to distributors nationwide between December 2005 and May 2007, prosecutors said. Vernon Sales is accused of buying some of the tubes and reselling them to Los Angeles stores. Diethylene glycol is a chemical used in antifreeze and as a solvent. Chinese manufacturers have used the chemical, known as DEG, as a cheaper alternative to glycerin, which thickens toothpaste. Exposure to DEG, however, can cause kidney and liver damage over time. Vernon Sales President Kamyab Toofer and Vice President Pejman Mossay were charged with 14 criminal counts each of receiving, selling and delivering an adulterated drug. Selective Imports President Frahad Nazarian and Vice President Yones Ghermezi were charged with two criminal counts each of receiving, selling and delivering products containing DEG. Each count carries a maximum penalty of one year in jail and a $1,000 fine. The companies are liable for distributing the tainted product even if they had no direct knowledge of the risk because they were negligent in not ensuring the toothpaste was safe, Supervising Deputy City Attorney Jerry Baik said. Ghermezi said he had not seen the charges but was shocked by the filing. All the adulterated toothpaste was voluntarily pulled from shelves and from his Vernon, CA, company's inventory eight months ago and destroyed by the U.S. Food and Drug Administration last month, he said. "Everything we had was destroyed by the FDA," Ghermezi said. "I thought the file had been closed." Ghermezi said he supplied the toothpaste to Vernon Sales, also based in Vernon. He said his company never knowingly sold adulterated toothpaste and thought the product had FDA approval. "We didn't know of the ingredients of the toothpaste," he said. "We don't [have] any intention of hurting people." The charges stem from an inquiry after the FDA confiscated some 70,000 tubes of toothpaste delivered to the Port of Long Beach in May, Baik said. (Washington Post) See THIS LINK
Ergotron introduces all new powered and non-powered point-of-care computing carts, StyleView 31 and StyleView 32 that bring forward today’s most essential functionality features in a lightweight, highly maneuverable form factor. Ever wonder what happens in those medical product testing labs when no one is around? Well take an entertaining, one-minute-and-thirty-second break from your busy day to find out what interesting things can happen when the Ergotron tester guy literally falls for his test subject. Click this link: http://www.youtube.com/watch?v=8mpFJF8ao2M
March 6, 2008 Download print version
improve MRSA treatment
Email
your nomination to
editor@hpnonline.com with “Critical Care Supply Innovator” in the
subject line.
A significant amount of an unidentified foreign substance contaminated Baxter International Inc.'s blood-thinning drug heparin, the U.S. Food and Drug Administration said Wednesday, raising the possibility of intentional tampering in a supply chain that begins with pig farms in China. The mysterious substance, which has a chemical makeup similar to heparin, comprises as much as 20 percent of the active ingredient in nine suspect lots produced by Baxter since September, the FDA said Wednesday. The suspect lots are connected to at least four deaths reported nationwide since Baxter noted a spike in adverse reactions to the drug in late December. The FDA on Wednesday said heparin is connected to as many as 19 deaths and 785 serious illnesses since Jan. 1, 2007. But the FDA timeline extends well beyond the period from September to November, when Baxter's Cherry Hill, NJ, plant produced the heparin connected to the recent rash of serious allergic reactions. The suspect active ingredient in heparin originated at a Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, WI. "We don't know whether the introduction of the contaminant was accidental, as part of the biological process, or if it was deliberate," said Dr. Janet Woodcock, acting director of the FDA's center for drug evaluation and research. At least one former top FDA official who helped lead the fight against counterfeit drugs indicated that some Chinese suppliers in the past have introduced foreign substances to boost production when supplies are tight. "The obvious question is, 'Are these plants back-dooring their supply in order to supplement their capacity?' " asked Benjamin England, who chaired the FDA's Counterfeit Drug Working Group before leaving for a private law practice in Washington, DC, in 2003. Heparin is produced from an enzyme in the mucous lining of pig intestines. The suspect lots of heparin were made beginning in September, just after the peak in an epidemic of an often-fatal disease known as "blue ear" that afflicted more than 250,000 pigs throughout China. An FDA official at the press conference said it is possible supplies of the adulterated ingredient came from pig intestines. But FDA officials emphasized they have not pinpointed the source. Conventional quality and safety testing typically does not discover a foreign substance, England added, because the tests are not designed for that purpose. Scientific Protein's plant obtains heparin from bulk providers of raw material. From its plant in Changzhou, Scientific Protein ships raw heparin to the company's headquarters outside Madison, WI, then on to Baxter's Cherry Hill plant for final processing, packaging and shipping. |
