For your own protection, before availing of said delivery service, demand a statement, in writing,from said company, that it will provide you with proof in writing that any package you send through said company has been received by the addressee.
Re Senator Loren Legarda.
According to a source, identified as columnist Ching M. Alano, Senator Loren Legarda has come up with her own prayer: "It goes something like this: "Dear Lord, in
addition to the prayers going around - of petitions that you hold Pepeng by your mighty hands - we pray that we learn to protect Mother Nature from now on. That we will each plant and nurture five trees or more a year; that we reduce, recycle and reuse; and know that you are God."
FDA Patient Safety News
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
New Colchicine Product and Dosing Regimen (Video, print, and e-mail functions)
FDA has approved the first single-ingredient oral colchicine product. The drug, called Colcrys, is approved to treat acute gout flares and familial Mediterranean fever. Oral colchicine has been used to treat gout in the past, but until now it had not been approved by FDA.
Colchicine has historically been given every hour for acute gout flares, either until the flare subsided or treatment had to be stopped because the patient developed gastrointestinal problems. But a dosing study conducted as part of the approval of Colcrys demonstrated that one initial dose and a single additional dose after one hour was just as effective and much less toxic. Healthcare professionals should use this lower recommended dosing regimen to treat acute gout flares.
Healthcare professionals should also be aware that colchicine interacts with other drugs, including P-glycoprotein and strong CYP3A4 inhibitors such as cyclosporine and clarithromycin. This can lead to serious or even fatal colchicine toxicity, particularly if a patient has renal or hepatic impairment. And so concomitant use of colchicine and P-glycoprotein or strong CYP3A4 inhibitors is contraindicated in these patients. For patients with normal renal and hepatic function, consider interrupting colchicine therapy or reducing the dose if the patient needs treatment with a P-glycoprotein or a strong CYP3A4 inhibitor.
Additional Information:
* FDA MedWatch Safety Alert. Colchicine (marketed as Colcrys). July 30, 2009.
* FDA Press Release. FDA Approves Colchicine for Acute Gout, Mediterranean Fever. July 30, 2009.
Potentially Fatal Errors with Certain Glucose Test Strips
FDA Patient Safety News: Show #91, October 2009
FDA is warning again that potentially fatal glucose monitoring errors can occur in patients who receive therapeutic products containing certain sugars other than glucose. These products include oral xylose, intravenous infusions that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin, such as Extraneal. A more specific product list can be found below.
The problem is that some glucose meters use a type of test strip (GDH-PQQ) that cannot distinguish between glucose and these other sugars, so the reading on one of these test strips will reflect both the patient's actual blood glucose and the other sugar the patient received. These falsely elevated readings can mask significant hypoglycemia, or they can lead to excessive insulin administration. This can result in severe hypoglycemia, coma and death. Other glucose test strip methodologies are not affected by the presence of non-glucose sugars.
FDA has received 13 reports of deaths associated with GDH-PQQ test strips that had documented interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Ten of the 13 patients were receiving Extraneal peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances. Patients were treated with insulin doses or insulin drips that were guided by falsely elevated blood sugar results. Six of the 13 deaths have occurred since 2008, despite previous warnings from FDA and others.
FDA is now recommending that healthcare facilities avoid using GDH-PQQ glucose test strips, which include several types of ACCU-CHEK, TRUEtest and Freestyle test strips.
If a facility does use GDH-PQQ test strips, FDA recommends additional precautions:
• Determine whether patients are receiving products that contain other sugars when they are admitted and periodically during their stay at the facility.
• If patients are receiving one of these interfering products, never use GDH-PQQ test strips to monitor their blood glucose. Instead, use only laboratory-based glucose assays. This also holds true for patients who are unresponsive or cannot communicate adequately.
• Educate the staff about this potentially fatal problem, and consider safeguards such as drug interaction alerts in computer order entry systems, patient profiles and charts. And for patients who are not receiving interfering products, periodically verify glucose meter readings with laboratory-based results.
FDA is working with glucose monitoring manufacturers to address problems with GDH-PQQ glucose test strips, and will continue to monitor adverse events associated with these products.
Additional Information:
FDA MedWatch Safety Alert. GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology. August 13, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177295.htm
FDA Patient Safety News is available at www.fda.gov/psn
Certain Lots of Teva Propofol Recalled
FDA Patient Safety News: Show #91, October 2009
Teva Pharmaceuticals is recalling certain lots of Propofol Injectable Emulsion 10 mg/mL because some of the vials in these lots contain elevated endotoxin levels.
The company says that it has received over 40 reports of patients treated with propofol who experienced fever, chills and other flu-like symptoms post-operatively. Based on available information, these febrile or flu-like reactions were self-limited and spontaneously resolved. However, patients exposed to high endotoxin levels could experience serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death.
The recall affects lot numbers 31305429B and 31305430B, which contain 100 mL vials. Anyone with propofol from these lots should not use it and return it to the distributor. For more information, contact Teva Pharmaceuticals at 1-866-262-1243.
Additional Information:
FDA MedWatch Safety Alert. Propofol Injectable Emulsion, 10 mg/mL 100 mL vials. July 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172507.htm
FDA Patient Safety News is available at www.fda.gov/psn
Alaris (Medley) Infusion Systems Recalled
FDA Patient Safety News: Show #91, October 2009
CareFusion is alerting healthcare professionals about a number of safety problems with several models of Alaris infusion systems. These problems could cause patients to be over or under-infused, which could lead to serious injury or death.
Certain units of the following Alaris devices are affected:
• Point-of-care Units, Models 8000 and 8015
• Pump Module, Model 8100
• Patient-Controlled Analgesia Module, Model 8120
• Inter-Unit Interface Connectors for the Alaris System
These devices were formerly sold under the "Medley" name.
The company notified customers about these potential problems in June, and described its plans to provide software and hardware corrections over the next several months. Until then the company's notice advises pump users to take certain steps to mitigate the problems.
For example, one failure can affect the Alaris PC unit when it is used with the PCA module. The pump is supposed to verify that the volume of medication in the syringe will deliver the infusion that is programmed. But if the infusion rate exceeds the volume of therapy in the syringe, a warning is displayed. If the pump user confirms the infusion and the patient presses the button on his handset to deliver medication, the pump may deliver the entire contents of the syringe to the patient, which could cause serious injury or death.
The company says that if the syringe volume warning appears, you must first take the dose request handset from patients to keep them from pressing the button. Then, press the “CONFIRM” key, then the “PAUSE” key to halt the infusion. Remove the syringe, verify the concentration, and reprogram the infusion. Do not return the handset to the patient until you have reprogrammed the infusion and confirmed that it's been programmed properly.
Another example involves the possible failure of the circuitry that protects against electrostatic discharge in certain Alaris PC units. Because of this, there could be problems with the entry keypad, including the possibility that the keypad could not respond to key presses, or that key entries could register incorrectly or could occur without keys being pressed. Pump users should always verify the drug name, concentration, and programmed infusion parameters before starting an infusion. If a keypad does not perform correctly, take the pump out of service and return it to the company.
You can get more information about the Alaris System recall by calling the CareFusion recall center at 888-562-6018.
Additional Information:
FDA MedWatch Safety Alert. Alaris System (Cardinal Health). August 5, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174797.htm
Cardinal Health/CareFusion Customer Letter. Urgent: Medical Device Recall Notification – Update to Previous Recall Information. July 29, 2009.
http://www.carefusion.com/Images/Recall_Update_29July2009_tcm10-5320.pdf
Cardinal Health Customer Letter. Urgent: Medical Device Recall Notification. June 12, 2009.
http://www.carefusion.com/Images/CustomerLetter-Signed_tcm10-5325.pdf
FDA Patient Safety News is available at www.fda.gov/psn
Recall of Certain Hospira Devices
FDA Patient Safety News: Show #91, October 2009
Hospira, Inc. has issued an alert about a number of the company's medical devices that have defective AC power cords. These devices include infusion pumps, compounders, monitoring devices and printers.
This action comes after reports of sparking, charring and fires on the plug of the power cord. Hospira has determined that the power cord's prongs may crack and fail at or inside the plug. That could lead to fire, electrical shock, device failure, and interference with therapy. Depending on the device and the type of therapy, these failures could cause potentially serious injury or death.
Hospira is working with its customers to replace the power cords on all the affected devices, regardless of their condition. The complete list of these devices can be found below.
In the meantime, Hospira is advising users of the affected devices to inspect their power cords. The defective cords have a prong and ground-pin insert design, with a black plastic bridge connecting the terminal prongs on the plug. Devices with power cords that don't have this black bridge connecting the terminal prongs are not affected.
Anyone who finds a cord with bent or cracked prongs, burnt plastic, or excessive wear and tear should immediately stop using the device and contact Hospira to find out how to get replacement parts or devices. The company can be contacted at 1-800-241-4002. Power cords that don't show any of these potentially dangerous characteristics should be monitored regularly until they can be replaced.
Additional Information:
Hospira Press Release. Hospira Issues Urgent Device Recall For AC Power Cords. August 14, 2009.
http://www.fda.gov/Safety/Recalls/ucm178158.htm
FDA Patient Safety News is available at www.fda.gov/psn
“Nuby” Gel-filled Teethers Recalled
FDA Patient Safety News: Show #91, October 2009
Parents and other caregivers of small children should be aware that the company Luv N' Care Ltd. has recalled almost 20 styles of gel-filled teethers because they might be contaminated with bacteria.
The gel inside these teethers may contain Bacillus subtilis and Bacillus circulans. Adults exposed to these bacteria generally do not get sick. However, if the teether is punctured and infants or children with weakened immune systems ingest the gel containing these bacteria, they could suffer stomach pain, vomiting, diarrhea, and occasionally more serious disease.
The recall affects 15 styles of gel-filled teethers sold under the brand name "Nuby", two sold under the "Cottontails" name and one sold under the "Playskool" name. UPC codes for these styles can be found below. Consumers who have these teethers should stop using them immediately and either throw them away or return them to the place of purchase for a refund. For questions, contact the company at 1-800-256-2399, ext. 3106.
Additional Information:
FDA MedWatch Safety Alert. Nuby Gel Filled, Cottontails, and Playskool Teethers. August 12, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172712.htm
FDA Patient Safety News is available at www.fda.gov/psn
U.S. Department of Health & Human Services National Institutes of Health Research Matters
http://www.nih.gov/news/research_matters/index.htm
NIH Research Matters is a review of NIH research from the Office of Communications and Public Liaison, Office of the Director, National Institutes of Health.
Cocaine Vaccine Shows Promise for Treating Addiction
http://www.nih.gov/news/health/oct2009/nida-05.htm
Embargoed for Release
Monday, October 5, 2009
4:00 p.m. EDT
Cocaine Vaccine Shows Promise for Treating Addiction
NIDA Study Suggests Harnessing the Immune System Against Cocaine Addiction May Prove Effective
Immunization with an experimental anti-cocaine vaccine resulted in a substantial reduction in cocaine use in 38 percent of vaccinated patients in a clinical trial supported by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health. The study, published in the October issue of the Archives of General Psychiatry, is the first successful, placebo-controlled demonstration of a vaccine against an illicit drug of abuse.
"The results of this study represent a promising step toward an effective medical treatment for cocaine addiction," said NIDA Director Dr. Nora Volkow." Provided that larger follow-up studies confirm its safety and efficacy, this vaccine would offer a valuable new approach to treating cocaine addiction, for which no FDA-approved medication is currently available."
Like vaccines against infectious diseases such as measles and influenza, the anti-cocaine vaccine stimulates the immune system to produce antibodies. Unlike antibodies against infectious diseases, which destroy or deactivate the disease-causing agents, anti-cocaine antibodies attach themselves to cocaine molecules in the blood, preventing them from passing through the blood-brain barrier. By preventing the drug’s entry into the brain, the vaccine inhibits or blocks the cocaine-induced euphoria.
This study included 115 patients from a methadone maintenance program who were randomly assigned to receive the anti-cocaine vaccine or a placebo (inactive) vaccine. Participants were recruited from a methadone maintenance program because their retention rates are substantially better than programs focused primarily on treatment for cocaine abuse. Participants in both groups received five vaccinations over a 12-week period and were followed for an additional 12 weeks. All participants also took part in weekly relapse-prevention therapy sessions with a trained substance abuse counselor, had their blood tested for antibodies to cocaine, and had their urine tested three times a week for the presence of opioids and cocaine.
Participants differed in the levels of antibodies generated in response to vaccination. Thirty-eight percent attained blood levels of anti-cocaine antibodies thought to be sufficient to block cocaine's euphoric effects. During weeks 9 to 16 (when antibody levels peaked), these participants had significantly more cocaine-free urines than those who received the placebo or those with active vaccine but low levels of anti-cocaine antibodies. Participants with the highest antibody levels had the greatest reductions in cocaine use. No serious adverse effects were associated with vaccine treatment.
"Fifty-three percent of participants in the high-antibody group were abstinent from cocaine more than half the time during weeks 8 to 20, compared with only 23 percent of participants with lower levels of antibodies," said Thomas Kosten, M.D., of Baylor College of Medicine in Houston, the study's principal investigator.
"In this study immunization did not achieve complete abstinence from cocaine use," added Dr. Kosten. "Previous research has shown, however, that a reduction in use is associated with a significant improvement in cocaine abusers’ social functioning and thus is therapeutically meaningful."
Dr. Kosten led the study in collaboration with colleagues from Yale University School of Medicine, the Connecticut Veterans Administration (VA) Healthcare System, Baylor College of Medicine, and the Michael E. DeBakey VA Medical Center.
FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
Tuesday, October 6, 2009 4:07 AM
From:
"U.S. Food & Drug Administration (FDA)"
FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
Mon, 05 Oct 2009 15:53:00 -0500
The U.S. Food and Drug Administration today ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect clinical data on a number of potential safety issues, including fusion rates and frequency of additional surgeries.
U.S. ATTORNEY NEWS RELEASE: VEAL COMPANY CHARGED IN CASE OF TAINTED FEED
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm185288.htm
Wed, 30 Sep 2009 00:00:00 -0500
United States Attorney Michael L. Levy today announced the filing of an Information1 against Select Veal Feeds, Inc., and its owner Wayne A. Marcho, charging the defendants with one count of misbranding, in violation of the Food, Drug and Cosmetic Act. The charge arises from the shipment of formaldehyde and potassium permanganate, between 1998 through 2005, which the defendants directed their contract farmers to use as part of the veal calves’ feeding routine. Defendant Select Veal Feeds, Inc. is also charged with one count of obstructing an agency proceeding based on false statements to inspectors from the Food and Drug Administration (“FDA”) in January 2004.
For a copy of the news release, visit the U.S. Attorney's web site.
US cert gov web site
Cyber Security Tips
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* Why is Cyber Security a Problem?
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General security
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Attacks and threats
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* Identifying Hoaxes and Urban Legends
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Email and communication
* Understanding Your Computer: Email Clients
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* Benefits and Risks of Free Email Services
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* Protecting Portable Devices: Physical Security
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Privacy
* How Anonymous Are You?
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* Understanding Your Computer: Web Browsers
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Software and applications
* Understanding Patches
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* Reviewing End-User License Agreements
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