Archive for January, 2012
A new federal report has found that only about 14 percent of all medical mistakes that harm patients in hospitals nationwide are ever actually reported.
Despite federal Medicare requirements that make reporting hospital accidents and mistakes mandatory, 86 percent of all harmful events go under the radar, according to a new report by the U.S. Department of Health and Human Services’ office of inspector general (DHHS-OIG).
In most cases, hospital staff appear not to have realized they should report the events, the study found.
Participation in the federal Medicare reimbursement program requires each participating hospital to track medical errors and adverse patient events and create incident reports for errors that result in patient harm. However, a review of 189 hospitals’ records nationwide by DHHS-OIG found that only one out of every seven patient harm incidents was properly reported. Most of the errors that did get reported were reported by nurses.
About 61 percent of the incidents were not reported due to staff members not knowing they should report them, hospital administrators told investigators. The remaining 25% that went unreported were cases where administrators claimed the staff commonly made a report, but failed in that particular instance.
Not only do the hospital error reports help the government track harm to patients caused by facilities nationwide, but they are also a key component in the development of new safety improvements to protect patients from future harm. However, the study also found that hospitals that successfully tracked such events rarely make changes to procedures to prevent a repetition of those events.
Hospital mistakes can include medication errors, allowing patients to develop bedsores, allowing hospital infections, wrong site surgery, leaving surgical tools and sponges in patients and other cases of medical malpractice.
The DHHS-OIG report recommends that the U.S. Centers for Medicare and Medicaid Services (CMS) work with the Agency for Healthcare Research and Quality (AHRQ) to create and promote a list of reportable events for hospital staff to reference. The report also urged CMS to strengthen hospital reporting system requirements and practices.
CMS reported that it is currently in development of guidance that would help assess patient safety improvement efforts in hospitals.
Nearly 90,000 BMW Mini Coopers sold in the United States have been recalled due to a risk of engine fire.
The National Highway Traffic Safety Administration (NHTSA) has announced a Mini Cooper recall (PDF) for certain model year 2007-2011 Mini Cooper, Mini Cooper S Clubman, Mini Cooper S Convertible, Mini Cooper JCW, Mini Cooper JCW Clubman, Cooper JCW Convertible and Cooper S Countryman passenger vehicles manufactured from 2006 through 2011.
The recall was issued after an analysis of dozens of cases involving overheating in the circuit board of an auxiliary water pump. At least four of those cases resulted in engine fires.
BMW first became aware of a potential Mini Cooper engine problem in June 2009, when they noticed electric auxiliary water pump failures on test vehicles with BMW 8-cylinder engines. The problem was first noticed among cars on the road in September 2009.
In November 2010, the company identified that electro-migration was causing circuit board and water pump overheating failures, by which time the first two reports of engine fires came in; one from the United Kingdom and another from Japan.
By November of last year there were 81 cases of known pump failures worldwide and four of them included burned engine compartments.
The NHTSA stepped in to investigate in October 2011. NHTSA investigators have concluded that the electric auxiliary water pump that cools the turbocharger has an electronic circuit board that can malfunction and overheat. The circuit board may smolder, which could cause a vehicle fire.
The recall is expected to affect 88,911 vehicles in the U.S. and nearly 300,000 around the world. They include some model year 2007-2011 Mini Cooper S, 2008-2011 Mini Cooper S Clubman, 2009-2011 Mini Cooper S Convertible, 2009-2011 Mini Cooper JCW, 2009-2011 Mini Cooper JCW Clubman, 2009-2011 Cooper JCW Convertible, and 2009-2011 Cooper S Country passenger cars.
BMW intends to begin notifying affected owners in February. Customers with vehicles included in the recall will be able to take the vehicle to a BMW dealer to have the water pump replaced free of charge. Owners with questions can contact BMW at (866) 275-6464.
The family of a Pennsylvania teenager killed in an ATV accident have reached a $2.7 million settlement with the driver of the vehicle, whom they allege was drunk at the time of the crash.
The family of Jonathon Byram, 19, filed a wrongful death lawsuit against Mark Renehan after their son died in an ATV crash at an Independence Day party in 2009.
Renehan was the driver of the all-terrain vehicle and, according to the lawsuit, he was drunk and speeding when it flipped over, killing Byram.
Byram was a college student in Maryland and Renehan was a college student in Connecticut. Both were home away from school for the summer at the time of the party. The party occurred at the home of Renehan’s family, which owns a group of houses in Manchester Township in Wayne County, Pennsylvania.
According to allegations raised in the ATV accident lawsuit, the Renehan family handed out alcoholic beverages throughout the party for several hours before the crash, and Renehan admitted to police that he had been drinking. Renehan was tried on charges of involuntary manslaughter and vehicular homicide while under the influence, but was acquitted. Renehan refused to take a blood alcohol test at the time of the accident, invoking his Fifth Amendment rights.
The civil lawsuit accused Rehanan of intoxication and speeding while driving the ATV, resulting in the crash and Byram’s death. According to a report by The Scranton Times Tribune, a resolution to the case, filed in federal court in Scranton, was reached sometime last week for $2.7 million.
Salmonella contamination has been detected in some packages of LEASA alfalfa sprouts, resulting in a recall of the products in five states.
The FDA announced a LEASA sprouts recall on January 19, after inspectors detected salmonella in the Winn-Dixie label’s alfalfa sprouts. The company is recalling all of its LEASA sprout products, although there have been no reports of salmonella food poisoning in connection with the recalled sprouts.
Winn-Dixie Stores, Inc. said it decided to pull all types of LEASA sprouts from all of its grocery stores out of an abundance of caution, but noted that recalling the alfalfa sprouts was made mandatory by the FDA. Winn-Dixie has grocery stores in Alabama, Florida, Georgia, Louisiana and Mississippi.
The recall affects LEASA Alfalfa Sprouts, sold in a 6 oz. package with a UPC Code of 7546555912; LEASA Broccoli Sprouts, sold in a 4 oz. package with a UPC Code of 7546555636; LEASA Gourmet Sprouts, sold in a 6 oz. package with a UPC Code of 7546555633; LEASA Spicy Sprouts, sold in a 6 oz. package with a UPC Code of 7546555635; and LEASA Onion Sprouts, sold in a 6 oz. package with a UPC Code of 7546555634. All of the affected sprouts were sold between January 7 and January 18 of this month and have expiration dates between Feb. 1, 2012, and March 15, 2012.
Salmonella is a type of bacteria that attacks the gastrointestinal tract, causing mild to severe food poisoning. For most healthy adults, symptoms of food poisoning from salmonella typically resolve after a few days or weeks. However, young children, the elderly, and individuals with compromised immune systems have an increased risk of suffering severe food poisoning after ingesting the bacteria. If not properly treated, some cases of salmonella food poisoning can lead to hospitalization, dehydration or death.
Winn-Dixie recommends consumers discard affected sprouts in a sealed garbage container and take either the packaging label or receipt to a Winn-Dixie grocery store for a full refund. Consumers with questions can call the Winn-Dixie Guest Service Center at (866) 946-6349.
Pennsylvania legislators are attempting to impose new limits on punitive damage awards leveled against elderly care facilities in lawsuits over nursing home neglect and abuse.
Last week, the Pennsylvania House of Representatives voted 103-89 to approve HB 1907, an addition to the Medical Care Availability and Reduction of Error Act, which seeks to shield nursing homes from large punitive damage awards in cases where juries find that residents were injured as a result of neglect or abuse.
The cap would limit punitive damages to double that of the compensatory damages awarded in any Pennsylvania nursing home lawsuit.
As opposed to compensatory damages, which are design to provide compensation for injuries, punitive damages are designed to punish a defendant for their conduct. In many states, punitive damages start at triple the compensatory damages. T
he bill does, however, contain a provision which would nullify the cap in cases where the plaintiff allege intentional misconduct, as opposed to gross negligence.
Republican proponents of the bill say that it aims to curb frivolous lawsuits, but by limiting punitive damages it would affect only those lawsuits where juries have already determined that a nursing home acted egregiously.
Opponents of the bill argue that the ability for the elderly to recover economic and compensatory damages is very limited and the law would defang the legal system’s ability to punish abusive nursing homes in Pennsylvania. In addition, some question the constitutionality of an arbitrary carte blanche legislative limit, which overrules the decision of a lawfully selected jury.
In addition to nursing homes, the cap would apply to health care professionals working in personal care homes, assisted living facilities, long-term care centers, hospices and other health care agencies.
The bill must still be approved by the state senate and the governor before it would go into effect.
European and U.S. regulators are reviewing Novartis AG’s (NOVN) Gilenya pill for multiple sclerosis after reports of 11 deaths among patients who took the drug. The shares fell the most in more than five months.
The reports raise concern that Gilenya, the first oral treatment for the debilitating neurological disease, may harm the heart, the European Medicines Agency said in a statement today. The U.S. Food and Drug Administration said it’s also reviewing data on the medicine.
Novartis said last month a patient died Nov. 23 after starting treatment with Gilenya. Ten other deaths have been reported among patients who began taking the drug, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm, the London-based EMA said. It isn’t clear what role if any Gilenya had in the deaths, it said.
“In my view this is highly unlikely to be related to the drug, but of course they have to check that,” Karl Heinz Koch, an analyst at Helvea SA in Zurich, said in a telephone interview today. “With all the experience we have with the drug, my comfort level is relatively high, but you can never be 100 percent sure. It certainly doesn’t help the share price.”
Novartis fell 3.9 percent to 52.05 Swiss francs in Zurich trading, the biggest decline since Aug. 10.
‘Possible Label Changes’
“We have been in touch with EMA, and similar to what they are doing, the FDA is conducting an analysis of available data and has not made any definitive conclusions,” Erica Jefferson, a spokeswoman for the U.S. regulator, said in an e-mail. “We will notify the public once our review is complete to communicate any recommendations or possible label changes.”
Novartis said it’s working with the EMA on the review and is notifying doctors of the agency’s recommendation to increase monitoring of patients’ hearts after the first dose.
“The role of Gilenya in the reported cardiovascular events has not been fully established and the cause of this patient’s death is still unexplained,” Novartis said in an e-mailed statement, referring to the first reported death. It didn’t mention the other deaths reported by the EMA. “Novartis continues to believe that Gilenya provides an important health benefit.”
Julie Masow, a spokeswoman for Novartis, said in an e-mail the death rate is in line with the broader expected death rates based on the 30,000 multiple sclerosis patients who have been treated with Gilenya to date. She also said no significant differences in death rates were detected during clinical trials between patients on the medicine and controls.
First Oral Treatment
Gilenya was approved in the U.S. in 2010 as the first oral treatment for multiple sclerosis, and cleared for sale in Europe in March. With sales of $291 million for the first nine months of 2011, it’s among the products Novartis is depending on as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan.
Biogen Idec Inc. (BIIB) plans to submit its oral MS drug, called BG-12, to regulators during the first half of this year after it was safe and effective in a late-stage trial, the Weston, Massachusetts-based company said in October.
“Increased alertness to toxicities is not what Novartis needs,” said Andrew Weiss, an analyst at Bank Vontobel AG in Zurich, in an e-mail. “Will the tox profile become Gilenya’s Achilles’ heel?”
The risk of slow heart rate, or bradycardia, after the first dose was known when the drug was approved, EMA said. The agency’s committee on human medicines expects to complete its review in March, the regulator said.
Doctors should increase patient monitoring after the first dose is given, the EMA said. That includes electrocardiograms before treatment and for the first six hours after the first dose, and then checking blood pressure and heart rate every hour, the EMA said. After six hours, patients with a slow heart rate or problems with electricity conduction in the heart should be watched until their condition has improved.
More than 30,000 patients worldwide have now taken the medicine, according to the EMA statement.
Separately, the EMA’s Committee for Medicinal Products for Human Use recommended approval of Novartis’s Signifor, the first treatment for Cushing’s disease in patients who can’t have surgery or for whom surgery hasn’t worked.
Cushing’s is a rare and deadly condition in which a small tumor produces too much of a certain hormone, resulting in weight gain in the face and neck, easy bruising and excessive growth of facial hair. It affects about 4 people in every 100,000 in the European Union, or about 20,000, the EMA said.
The European Commission usually follows the committee’s recommendations and delivers a final decision within three months, Novartis said in a statement.
The committee also recommended that Novartis’s cancer drug Gleevec be approved to treat patients with gastrointestinal stromal tumors for as much as three years, compared with one year now.
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Tysabri: Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)
ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn’s disease.
A patient’s anti-JCV antibody status may be determined using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional. The Stratify JCV Antibody ELISA test2 was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past.
BACKGROUND: Tysabri (natalizumab) is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn’s disease since January 2008.
RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users. See the Drug Safety Communication Data Summary section for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
- Download form2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
FDA NEWS RELEASE
For Immediate Release: January 20, 2012
Media Inquiries: Erica Jefferson, 301-796-4988, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).
The Stratify JCV Antibody ELISA test, when used with other clinical data from the patient, can help health care providers determine the risk for developing PML in MS and CD patients.
The John Cunningham virus (JCV) is a common virus that many people have been exposed to at some point in their lives, and is generally harmless. However, people with weakened immune systems, such as patients using immunomodulatory therapies like Tysabri, have an increased chance of developing PML from JCV. PML usually causes death or severe disability.
Currently, there is no treatment, prevention, or cure for PML, and no certain way to predict who will develop it. This test in conjunction with other factors listed below will allow the physicians and patients to carefully assess the risks and benefits of continuing Tysabri treatment depending on the complete clinical information for the particular patient. The following risk factors have been identified that increase the chance of Tysabri-treated patients developing PML:
• the presence of anti-JCV antibodies, which reflects prior exposure to JCV
• treatment with Tysabri for a significant period of time (longer than 2 years)
• treatment with certain medicines that can weaken a patient’s immune system (immunosuppressants such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide, and mycophenolate mofetil) before receiving Tysabri.
The risk of getting PML is greatest (about 11/1000 patients treated) if the patient has all three of these risk factors.
“PML is a fatal infection reported in patients undergoing immunomodulatory therapy,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics in FDA’s Center for Devices and Radiological Health. “This test gives doctors an additional means to determine if MS or CD patients undergoing Tysabri therapy are at increased risk for developing PML.”
The FDA reviewed data for the Stratify JCV Antibody ELISA test through the de novo reclassification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not comparable to an already legally marketed device.
In a separate action, the FDA also announced updates to the drug label for Tysabri. The change includes information that testing positive for anti-JCV antibodies is a recently identified risk factor for developing PML in patients treated with Tysabri for MS or CD.
The Stratify JCV Antibody ELISA test should not be used on its own as a basis for determining the risk for developing PML in patients on immunomodulatory therapy or for making clinical decisions. The test cannot be used to diagnose PML.
The test is for professional use and by prescription only and is to be performed only at Focus Diagnostics’ Reference Laboratory. The test is not intended for blood donor screening. The performance of this test has not been established for use in neonates, pediatric patients or any other immunocompromised patient populations.
The Stratify JCV Antibody ELISA test is manufactured by Focus Diagnostics of Cypress, Calif.
Tysabri is co-marketed by Cambridge, Mass.-based Biogen Idec and Elan Pharmaceuticals whose U.S. operations are based in South San Francisco, Calif.
For more information:
About 43,700 Big Lots floor lamps have been recalled because of reports that they may generate excessive heat and cause the lamp shades to melt.
The floor lamp recall was announced by the U.S. Consumer Product Safety Commission (CPSC) on January 12, after Big Lots received at least four reports where the lamp shades had melted.
Although there have been no injuries associated with the melting lamp shades, this could pose a risk for consumers.
The CPSC has determined that the melting was caused by the use of the recommended standard 40 watt light bulb with the lamp, which may generate too much heat.
The CPSC also discovered that the wiring for the lamp’s light socket can become exposed, putting consumers at an additional risk of being shocked.
The recall affects Classic Quarters Five Light Floor Lamps. The lamps have a model number of G-1843-5 on the underside of the base, and SKU numbers of 612007239, 612007829 or 612008982 at the beginning of the instructions. The lamps are about five feet tall and have gunmetal or chrome colored poles and five adjustable lights mounted on flexible tubes. Some have dark plastic shades while others are multicolored.
The lamps were sold exclusively at Big Lots stores nationwide for between $30 and $50 from April 2010 through November 2011.
The CPSC recommends that consumers stop using the lamps immediately and return them to a Big Lots store to receive a full refund. Consumers with questions can contact Big Lots by calling (866) 244-5687 or by visiting the company’s website at www.biglots.com.
About 19,000 Honeywell portable electric heaters have been pulled from stores because they could burn consumers.
The Honeywell Surround Select portable electric heater recall was announced on January 12 by the U.S. Consumer Product Safety Commission (CPSC).
According to the CPSC, the heater’s internal housing, which includes the fan, heating element and circuitry, is able to detach, which can expose consumers to a burn hazard. However, there have been no injuries reported in connection to the defective portable heaters.
The affected heaters include the Honeywell Surround Select Series portable electric heaters. They are black or white and cylindrical shaped, with a handle on top. The affected heaters have the model numbers HZ-420, HZ-430, and HZ-440. They also have five-digit date codes that have 11 as the last two digits. The model number is located on the bottom of the heater and stamped into the plastic, while the date code is located on the metal prongs of the heater’s electric plug. The heaters have “Honeywell” and “Surround Heat” located on the front of the heaters.
The heaters were distributed by Kaz USA Inc., under license from Honeywell. They were manufactured by Ningbo SMAL Electrics Co. Ltd., located in China.
The heaters were sold at Best Buy, Meijer and Wal-Mart stores nationwide for between $50 and $70 from July 2011 through December 2011.
The CPSC recommends that consumers who have heaters affected by the recall unplug them immediately and stop using them. Consumers can contact Kaz for a full refund. Consumers with questions can contact Kaz by calling (800) 370-8137 or by visiting the website at www.kaz.com/recall.