Four Common Antipsychotic Drugs Found to Lack Safety and Effectiveness in Older Adults

Science Daily
Originally published November 27, 2012

In older adults, antipsychotic drugs are commonly prescribed off-label for a number of disorders outside of their Food and Drug Administration (FDA)-approved indications -- schizophrenia and bipolar disorder. The largest number of antipsychotic prescriptions in older adults is for behavioral disturbances associated with dementia, some of which carry FDA warnings on prescription information for these drugs.

In a new study -- led by researchers at the University of California, San Diego School of Medicine, Stanford University and the University of Iowa, and funded by the National Institute of Mental Health -- four of the antipsychotics most commonly prescribed off label for use in patients over 40 were found to lack both safety and effectiveness. The results will be published November 27 in The Journal of Clinical Psychiatry.

The study looked at four atypical antipsychotics (AAPs) -- aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) -- in 332 patients over the age of 40 diagnosed with psychosis associated with schizophrenia, mood disorders, PTSD, or dementia.

"Our study suggests that off-label use of these drugs in older people should be short-term, and undertaken with caution," said Dilip V. Jeste, MD, Estelle and Edgar Levi Chair in Aging, Distinguished Professor of Psychiatry and Neurosciences, and director of the Stein Institute for Research on Aging at UC San Diego.

The entire story is here.

Thanks to Tom Fink for this information.

Medical malpractice: Why is it so hard for doctors to apologize?

Fixing a system built on blame and revenge will require bold ways of analyzing mistakes and a radical embrace of openness.

By Dr. Darshak Sanghavi
The Boston Globe
Originally posted on January 27, 2013


DANIELLE BELLEROSE WENT THROUGH HELL for two years trying to conceive, undergoing nine rounds of fertility treatments before she finally got pregnant with twins in late 2003. Shortly thereafter, the then 28-year-old nurse and Massachusetts native developed a complication that required months of bed rest at home. Suddenly, on a June night nearly three months before her due date, Danielle’s uterus began bleeding profusely. At 4:56 a.m. she had an emergency caesarean section at Beth Israel Deaconess Medical Center. Her daughters, Katherine and Alexis, entered the world weighing only about 3 pounds each.

Everything seemed to go well until the end of the first week. When Danielle and her husband, John, visited the unit, Alexis looked fine, but Katherine appeared mottled and pale. Panicked, Danielle found a nurse, and testing confirmed that Katherine was in profound shock due to necrotizing enterocolitis, a devastating intestinal complication that affects premature babies. The infant’s blood had turned acidic. An X-ray indicated a tear in her bowel. Just after midnight, Katherine was taken by ambulance to Children’s Hospital Boston.

Extremely premature infants such as Katherine and Alexis are entirely unprepared to live outside their mother’s womb. After only 30 weeks of gestation, the newborn heart isn’t fully developed, and the intestines can’t easily digest breast milk or formula. At that age, a baby’s brain often doesn’t remember to breathe. In 1963, when President John F. Kennedy’s son, Patrick, was born prematurely, the only thing to do was “monitor the infant’s blood chemistry,” as a newspaper of the day put it. Patrick Kennedy died after two days. By the time Katherine Bellerose was being cared for in the same hospital, however, new treatments had increased survival rates in very low birth weight infants to 96 percent.

Still, at Children’s Hospital, Katherine struggled to survive. Surgeons made a last-ditch effort to save her life by removing her colon, in the hope that this would halt further damage. She failed to improve. Multiple rounds of CPR were performed.

The rest of the story is here.

Amgen Agrees to Pay $762 Million for Marketing Anemia Drug for Off-Label Use

By ANDREW POLLACK and MOSI SECRET
The New York Times
Published: December 18, 2012

The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.

The federal charges were made public as Amgen pleaded guilty to illegally marketing the drug and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.

Amgen was “pursuing profits at the risk of patient safety,” Marshall L. Miller, acting United States attorneyin Brooklyn, said in a telephone news briefing on Tuesday.

David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single misdemeanor count of misbranding the drug, Aranesp, meaning selling it for uses not approved by the F.D.A.

Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation.

The entire article is here.

EHRs could mean fewer malpractice claims

By Mike Milard
IT Health News
Originally published August 3, 2012

A study by Harvard Medical School-affiliated researchers, published in June in the Archives of Internal Medicine, showed that Massachusetts physicians who used electronic health records saw a reduction in malpractice claims.

Correlation does not imply causation, of course. But the report's authors say their findings suggest, "implementation of EHRs may reduce malpractice claims and, at the least, appears not to increase claims as providers adapt to using EHRs."

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"We found that the rate of malpractice claims when EHRs were used was about one-sixth the rate when EHRs were not used," the researchers write. "This study adds to the literature suggesting that EHRs have the potential to improve patient safety and supports the conclusions of our prior work, which showed a lower risk of paid claims among physicians using EHRs. By examining all closed claims, rather than only those for which a payment was made, our findings suggest that a reduction in errors is likely responsible for at least a component of this association, since the absolute rate of claims was lower post-EHR adoption."

The entire article is here.

Will Patient Safety Initiatives Harm Physicians?

By Brian S. Kern, Esquire
Medscape Today News
Originally published on March 12, 2012

Peer review, the patient safety method designed to identify ineffective, unethical, or impaired physicians, can help improve the delivery of medical care, provide risk-management lessons, and lead to improved policies and procedures. At the same time, some doctors and hospital administrators have expressed concern that peer review produces fodder for civil or criminal lawsuits against physicians and healthcare institutions.

The body of law on patient safety initiatives and their level of confidentiality has evolved considerably. Historically, case law, recognizing the importance of peer-review procedures -- and the need to keep them confidential -- has protected self-critical analysis and other forms of internal investigation.

For example, in Christy v. Salem (2004), a New Jersey appellate court addressed whether a hospital's peer-review committee report was discoverable in a medical malpractice case. In declining to "adopt the privilege of self-critical analysis as a full privilege," the court chose to rely on a "case-by-case balancing approach" and essentially held that facts contained within a report are subject to legal discovery, but "evaluative and deliberative materials" are not.

Shortly thereafter, the Garden State adopted the New Jersey Patient Safety Act (NJ PSA), which in large part codified Christy v. Salem. The measure was tested early when, during the discovery phase of a medical malpractice trial against an obstetrician, a plaintiff's attorney sought hospital reports related to patient safety. The defense objected, asserting that the information was privileged and thus legally protected against disclosure.

The entire story is here.