FierceHealthcare by Dan Bowman
Despite a constant barrage of statistics showing how checklists and other safety measures can help hospitals to avoid costly preventable errors, many administrators apparently aren’t getting the message. According to a study published in last Thursday’s New England Journal of Medicine, harm to patients remains relatively common at hospitals, especially procedural and medication issues.
Dr. Christopher P. Landrigan, an assistant professor at Harvard Medical School and the study’s lead author, and his colleagues examined 10 hospitals in North Carolina from 2002 to 2007, choosing the Tar Heel State because of a “high level of engagement in efforts to improve patient safety.” They believe that more needs to be done to assimilate safety efforts into the day-to-day routines of doctors and nurses, specifically with regard to keeping an eye on mistakes.
“Until there is a more coordinated effort to implement those strategies proven beneficial, I think that progress safety will be very slow….We need a monitoring system that is Mandatory,” Landrigan told the New York Times. “There has to be some mechanism for federal-level reporting, where hospitals across the country are held to it.”
In all, more than 2,300 patient records were reviewed, with “harms” identified roughly 25 percent of the time (588 cases). Nearly 43 percent of the harms led to “prolonged hospitalization,” with permanent damage occurring 2.9 percent of the time (17 cases) and death occurring 2.4 percent of the time (14 cases). Sixty-three percent of harms (364 cases) were deemed “preventable.”
“Since North Carolina has been a leader in efforts to improve safety, a lack of improvement in this state suggests that further improvement is also needed at the national level,’ the authors concluded. “[A]chieving transformational improvement in the safety of healthcare will require further study of which patient-safety efforts are truly effective across settings and a refocusing of resources, regulation, and improvement initiatives to successfully implement proven interventions.”
Source: US Food and Drug Administration
The FDA has now approved Eribulin mesylate injection (Halaven; Eisai, Inc) yesterday for the treatment of metastatic breast cancer. The drug is for patients who have received at least 2 prior chemotherapy regimens for late-stage breast cancer.
Eribulin is a synthetic analog of halichondrin B, a novel microtubule dynamics inhibitor extracted from the marine sponge Halichondria okadia.
A phase 3 study of 762 women with metastatic breast cancer who were heavily pretreated with a median of 4 chemotherapy regimens including an anthracycline and a taxane was conducted in advance of approval. Results showed that eribulin significantly improved overall survival. The 1-year survival rate was 53.9% for eribulin-treated patients and 43.7% for those given other drugs.
“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, in an agency news release. “Halaven shows a clear survival benefit and is an important new option for women.”
Adverse events most commonly reported the study patients included neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, asthenia, peripheral neuropathy, and constipation.
Some promising news as we head into another holiday season.
~Posted by D.M. Schwadron, Esquire
Civil Suits Uncover Nursing Home Abuse
Civil suits help uncover abuses by nursing home and insurance companies. Where regulatory and legislative bodies have been unable to cope with this distressing rise of neglect and abuse of our elderly, the civil justice system has stepped into the breach. A report, “Standing Up for Seniors: How the Civil Justice System Protects Elderly Americans,” reveals that litigation is critically important to protect nursing home residents.
According to the report, the vast majority of the nursing facilities that house more than 1.5 million elderly Americans are owned by private corporate chains, making it difficult for consumers to hold them accountable for abuse. The report also asserts that insurance companies are more likely to take advantage of older patients with practices like miscalculating mortality rates, denying claims and cutting off benefits for needed treatments.
The report outlines how, through litigation, trial attorneys across the country have uncovered evidence of corporate programs aimed at terminating seniors’ benefits as well as evidence of nursing home abuse and neglect. The report warns that efforts to combat nursing home abuses through civil suits are hampered by the use of mandatory arbitration clauses in nursing home and insurance contracts.
Gayle R. Lewis, Esquire
The Food and Drug Administration made a mistake in approving a knee implant against the advice of its scientific reviewers. It has now admitted that it shouldn’t have approved the device. The announcement comes a year after the agency first acknowledged that is decision to approve the Menaflex implant, made by ReGen Biologics, was influenced by outside pressure, including lobbying by four lawmakers from the company’s home state of New Jersey. The 2008 decision to approve the implant was made despite protests by FDA scientists that Menaflex – which reinforces damaged knee tissue – provides little, if any, benefit to patients. The FDA says it’s taking steps to revoke Menaflex’s approval.
Gayle R. Lewis, Esquire
The company’s chief executive says that Johnson & Johnson disappointed consumers when it recalled millions of bottles of popular children’s medicines. William Weldon admitted that the company had let the public down, saying:
We let the public down. We did not maintain our high quality standards, and as a result, children do not have access to our important medicines. I accept full accountability for the problems at McNeil and I will take full accountability for fixing them.
Since the April 30th recall that saw 40 popular medicines such as Children’s Tylenol pulled from store shelves, J&J has “undertaken significant improvements as McNeil’s facilities,” Weldon said, adding that the company is spending $100 million to do so. J&J has said its Fort Washington, Penn. Plant, which made the 135 million bottles recalled in April, would not reopen until the second half of next year.
As far as the controversial so-called “phantom” recall last year of a faulty adult version of Motrin, Weldon said the company “should have handled things differently.” Regardless of how badly J&J has acted in the past, the company must do more than talk. It must recognize its safety responsibility and take all steps necessary to correct all problem areas.
The U.S. Food and Drug Administration has warned doctors and patients about an increased risk of thigh fractures with a widely-used group of bone-strengthening drugs. The agency said patients taking bisphosphonate drugs such as Fosamax and Boniva appear more likely to suffer a rare type of fracture of the femur. The factures occurred just below the hip joint and make up less than 1% of all femur fractures.
In more than half the cases reported to the FDA, patients experienced pain or aching of the groin before the fracture. The FDA is updating the drugs’ labels about the fracture risk. Drugmakers will also be required to distribute pamphlets about the risks to patients. Bisphosphonates work by slowing the loss of bone cells that lead to osteoporosis. Prescription drugs in that class include Merck & Co.’s Fosamax and Roche’s Boniva, as well as Warner Chilcott’s Actonel and Atelvia and Novartis’ Reclast. More than 5 million prescriptions for the drugs were written last year, according to the FDA. The drugs are mainly prescribed to women after menopause. The FDA says patients should continue taking the treatments unless directed to stop by their doctor. The agency said it will continue reviewing safety information on the drugs and eventually make recommendations on their use.