Tagged Articles

deficiencies 17 articles

FDA stands by decision to ban import of drugs from Ranbaxy’s India plant

Ranbaxy Laboratories Inc.’s drugs manufactured at its plant in India were banned from entering the United States by the Food and Drug Administration (FDA) due to quality concerns, but European regulators say the plant does not pose a risk to public health. The FDA’s ban came after the agency in January announced it had uncovered drug safety violations at the pharmaceutical company’s India plant. FDA investigators found that employees at the plant had re-tested some of the drugs to gain more favorable results after the drugs failed initial tests. They also found that the facility lacked appropriate controls over computerized ... Read More

New diabetes drug gets positive review from European drug advisors

An advisory committee for the European drug authority is recommending the approval of empagliflozin, a new type 2 diabetes drug made by Boehringer Ingelheim and Eli Lilly and Company. Empagliflozin is in a new class of diabetes drugs known as sodium glucose co-transporter 2, or SGLT-2, inhibitors. It works by targeting glucose directly and works independently of B-cell function and insulin resistance. The drug produces increased urinary glucose excretion, with a consequent lowering of plasma, glucose levels, and weight loss. If approved, the empagliflozin would be marketed under the name Jardiance. Earlier this month, the U.S. Food and Drug Administration ... Read More

Dialysis clinic closes following two infection-related deaths

Bessemer Kidney Center, one of about a dozen dialysis clinics owned by Fresenius Medical Care North America, recently was shut down after a report by the Alabama Department of Public Health (ADPH) noting multiple infection-control deficiencies and citing two infection-related deaths. The report also referenced infection-controlled deficiencies during the past two years at 11 other Fresenius-owned dialysis clinics throughout the state. The majority of deficiencies were related to infection control, disinfection, hand washing or glove use. The Bessemer Kidney Center was cited in an inspection report dated May 15, 2012, which found deficiencies for infection control, glove use and disinfection ... Read More

Mass. shuts down 11 pharmacies in wake of fungal meningitis outbreak

Massachusetts health inspectors have issued cease-and-desist orders on 11 compounding pharmacies and cited 21 others for minor deficiencies following a deadly outbreak of fungal meningitis linked to contaminated steroid shots made by New England Compounding Center (NECC), a Massachusetts specialty pharmacy. The shutdown orders and citations were issued after unannounced inspections of 40 pharmacies across the state. Compounding pharmacies custom-mix FDA-approved drug ingredients based on doctors’ prescriptions for individual patients. However some specialty pharmacies, like NECC, mass produce custom drugs and distribute them across state lines. Drug companies are regulated by the FDA and must undergo routine inspections, but the ... Read More

Roche questioned about unreported possible drug side effects, deaths

Roche, maker of drugs such as the cancer drug Avastin, flu medicine Tamiflu, antianxiety drug Klonopin, and the diet pill Xenical, is being investigated by European drug regulators because of potential deficiencies in the way the drug company reported possible side effects in patients in the United States. The European Medicines Agency identified the problems during a routine inspection of Roche, during which they found about 80,000 reports of possible side effects in drugs sold in the U.S. that had not been followed up on to determine if they were actual adverse reactions that should be reported to drug authorities. The ... Read More

Advocate wants federal nursing home database to include abuse cases

Nursing home advocate Wes Bledsoe wants the federal government to change the way it rates nursing homes on its Web site Medicare. gov, to accurately reflect the quality of care at nursing homes, according to the Albert Lea Tribune. Bledsoe, founder of the watchdog group A Perfect Cause, returned to Albert Lea, Minnesota, to rally support for his efforts. Bledsoe has been to Albert Lea numerous times in response to news reports about the “abuse-for-thrills” case at Good Samaritan Society nursing home where two nursing aides have been charged with a linty of crimes including disorderly conduct, assault and criminal ... Read More

OK nursing home closes amid allegations of abuse, neglect

Silver Lake Care Center of Bartlesville, Oklahoma, voluntarily closed its doors earlier this month after mounting complaints of physical and verbal abuse, financial woes, unresolved staffing issues, and numerous lawsuits alleging neglect and wrongful death, according to the News Examiner-Enterprise. Investigators cited the nursing home in February saying it failed “to screen for, prevent, identify, report and investigate abuse.” Former director of nursing Terri Conley said she resigned from the home in January because the home was severely understaffed. “If you don’t have enough staff, the residents are not going to get the care they need,” she told the newspaper. ... Read More

Tennessee nursing home cited, residents in immediate jeopardy

The news took the staff at Quality Care Health Center in Lebanon, Tennessee by surprise. The Tennessee Department of Health issued a ban on new admissions, claiming those at the home are in immediate jeopardy, according to News Channel 5. The announcement was spurred by a recent state and Federal Center for Medicare-Medicaid Services inspection that found the center in violation of physician services, nursing services and medical records. The inspection also raised questions about several patients whose weight had dropped dramatically. A spokesperson for the home says weight fluctuation among the elderly is not uncommon and oftentimes is unavoidable. ... Read More

Nursing home corporation faces manslaughter charges

No one disputes that 74-year-old Julia McCauley, a resident at Life Care Center of Acton in Massachusetts rolled her wheelchair outside the front door of the home where she had lived five years. She had done it on more than one occasion. But in August of 2004, her trip through the exit resulted in her tumbling down a flight of stairs. She died shortly after the fall. Had McCauley been wearing the doctor-prescribed bracelet that would sound an alarm and lock the doors if she wandered too close to the home’s exit, perhaps her story wouldn’t have ended so tragically. ... Read More

Veterans home cited for putting residents at risk of harm

A U.S. Justice Department report claims that residents at William F. Green State Veterans Home in Bay Minette, Alabama, suffered significant harm and risk from the facility’s inadequate medical and nursing services, accoding to the Mobile Press Register. The report was released last month and is based on the outcome of a February inspection and interviews at the nursing home. It alleges that the home had “inadequate nutritional and hydration services; improper and dangerous psychotropic medication practices; inadequate pressure-sore treatment and skin care; inadequate restorative care and specialized rehabilitation services; failure to protect residents from harm due to falls; failure ... Read More