Too Many Antipsychotic Drugs?

Nursing homes where there is a record high rate of antipsychotic drug prescriptions in the previous year are more likely to prescribe antipsychotic agents to newly admitted older adult patients, even when there is no clinical indication that the patient needs this therapy.

In 2007, almost one-third of U.S. nursing home residents received antipsychotic drugs, raising serious concerns about the safety of their use. In 2005, the Food and Drug Administration issued warnings regarding the risk of death among older adults with dementia being given these agents to control behavioral symptoms. A large clinical trial recently concluded that the adverse effects of atypical antipsychotic drugs outweighed the benefits in patients with Alzheimer’s disease.

The study suggests that organizational culture at some nursing homes may encourage the prescribing of antipsychotics. “Future research is needed to determine why such a prescribing culture exists and whether there are adverse health consequences as a result of our observed facility-level antipsychotic prescribing rate,” they concluded. “This study may also inform future policies to target nursing homes with high antipsychotic prescribing rates to improve quality of care for nursing home residents.”

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Too Many Antipsychotic Drugs?

IL: Pushing for Stricter Rules for Antipsychotic Drugs in Nursing Facilities

Nursing home resident advocates in Illinois are pushing for new, stricter rules on the use of antipsychotic drugs among elderly nursing home residents, in order to prevent misuse of the drugs as a form of chemical restraint in nursing homes.
Illinois Citizens for Better Care, a grassroots organization that fights to improve nursing home care in the state, is pushing for new state laws and regulations that would prevent nursing homes and doctors from using antipsychotic and psychotropic drugs as a form of chemical restraint on the elderly, according to a report by the Chicago Tribune and ProPublica.

Concerns over the use of such drugs have increased considerably as the result of an ongoing series of in-depth nursing home investigative reports conducted by the Tribune on nursing home problems in Illinois. The stories have unveiled a series of critical failings in the Illinois nursing home system. In addition to investigations which uncovered unapproved use of antipsychotics on non-consenting elderly nursing home residents in order to control them, the stories have also found incidents of murder, rape and abuse, largely due to the housing of the criminally insane within the same facilities as elderly patients.

Illinois Governor Pat Quinn has established the Nursing Home Safety Task Force to address problems uncovered by the investigations, and Illinois Citizens for Better Care are pushing that task force to come up with a firm, durable solution that would prevent doctors and facilities from using antipsychotics to control and restrain nursing home residents.

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Restrictions sought in Illinois for Chemical Restraints in Nursing Homes

3 Nursing Facility Patients Killed by ‘Chemical Restraints’

California Attorney General Says Nursing Director Drugged Patients to Control Them.

What happened in a bucolic nursing home nestled in the California mountains starting in 2003 shocked investigators. When residents at the Kern Valley Nursing Home complained or annoyed nursing director Gwen Hughes, prosecutors say she chemically restrained them with powerful anti-psychotic drugs. Her methods were so severe, three residents died.

California Attorney General Jerry Brown says that Hughes ordered one patient drugged just for glaring at her, and another for throwing a carton of milk. Some residents were left drooling, dehydrated, and dangerously thin.

According to Brown, “In a couple cases, elderly people were actually held down, restrained against their will, and given excessive amounts of medicine to keep them quiet.”

Even more shocking — Hughes had been fired for over-drugging once before, from a nursing home in nearby Fresno, Calif. The administrator of that nursing home said they told her next employer only the dates she worked there, out of fear of lawsuits.

On Tuesday, three nursing home officials appeared at a hearing on charges of elder abuse at the Kern Valley facility from 2003 to 2007 — Gwen Hughes, as well as administrator Pamela Ott and staff physician, Dr. Hoshang Pormir. The three defendants each face up to 11 years in prison, and all have pleaded not guilty. A preliminary hearing is set for March 9, 2010.

Additionally, a former pharmacist at the facility, Debbi Gayle Hayes, accepted a plea bargain on the condition that she testifies for the prosecution.

What happened in the rural California nursing home may be an extreme case, but experts say over-drugging is common nationwide, and the number of nursing home residents who are given these drugs is rising.

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Three Nursing Home Patients Killed by ‘Chemical Restraints’

Compromised Care in IL Nursing Homes

Frail and vulnerable residents of nursing homes throughout Illinois are being dosed with powerful psychotropic drugs, leading to tremors, dangerous lethargy and a higher risk of harmful falls or even death, a Tribune investigation has found.

Thousands of elderly and disabled people have been affected, many of them drugged without their consent or without a legitimate psychiatric diagnosis that would justify treatment, state and federal inspection reports show.

In all, the Tribune identified 1,200 violations at Illinois nursing homes involving psychotropic medications since 2001. Those infractions affected 2,900 patients.

The actual numbers are likely far higher because regulators inspect some facilities just once every 15 months, and even then they usually check only a small sample of residents for harm.

The Tribune’s unprecedented review of more than 40,000 state and federal inspection reports found that nursing homes ranging from “five-star” establishments on the North Shore to run-down facilities in urban neighborhoods have been cited for improperly administering psychotropic drugs.

The paper’s review took into account violations for “chemical restraint” and “unnecessary drugs” as well as cases involving dosages that exceeded safety standards or falls in which psychotropics possibly played a role.

While some nursing home residents suffer from major mental illnesses, such as schizophrenia, the inspection reports show that many patients harmed by antipsychotic drugs had not been diagnosed with psychosis. They were disabled by Alzheimer’s disease, cancer or Parkinson’s disease. Some were blind or so frail that they could not breathe without the aid of an oxygen tank.

The findings come at a difficult time for Illinois nursing homes, which are already under fire for housing violent felons alongside geriatric patients and for failing to accurately assess the risk posed by the most serious offenders.

The misuse of psychotropics, which some experts say is a nationwide problem in nursing homes, suggests a troubling future for many seniors.

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Compromised Care: Psychotropic Drugs Given to Nursing Home Patients Without Cause

Antipsychotic Drug Profits

Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.

On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.

On the other, some worried that his research findings might be too good to be true.

As Reinstein grew irritated with what he perceived as the company’s slights, a top executive outlined the scenario in an e-mail to colleagues.

“If he is in fact worth half a billion dollars to (AstraZeneca),” the company’s U.S. sales chief wrote in 2001, “we need to put him in a different category.” To avoid scaring Reinstein away, he said, the firm should answer “his every query and satisfy any of his quirky behaviors.”

Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.

During that period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.

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Doctor-Drugmaker Ties: Psychiatrist Dr. Michael Reinstein Received Nearly $500,000 From Antipsychotic Drug’s Manufacturer

One Patient: Sixty Seven Different Drugs

The scariest wrinkle in the Omnicare kickback case is just how vulnerable old people in nursing homes are to schemes in which drug companies allegedly induce pharmacies to prescribe drugs they otherwise wouldn’t.

One patient cited by the government’s complaint received 67 — sixty-seven! – different drugs under Omnicare’s “care”. Those drugs included Cipro, Neurontin, Heparin, Pepcid, Oxycodone and Seroquel or their generics, according to the complaint.

Omnicare, the country’s largest nursing home pharmacy chain, paid $98 million to settle the case.

There’s no suggestion that these drugs were prescribed needlessly (some patients are indeed very sick), however this patient seems to have been “cycled” through various drug categories — hence Seroquel and Neurontin, and Pepcid and Zantac. (Ironically, Risperdal seems to be the only drug the patient didn’t get.)

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In Risperdal Kickback Case, One Nursing Home Patient Received 67 Different Drugs

<a href="
http://www.phillipsandcohen.com/CM/NewsSettlements/NewsSettlements551.asp”>Download the Complaint from the Phillips and Cohen Website

SC Reaches Settlement With Eli Lilly Over Zyprexa

Attorney General Henry McMaster said Friday that South Carolina reached a $45 million settlement with pharmaceutical giant Eli Lilly over the company’s marketing of the anti-psychotic drug Zyprexa.

Eli Lilly confirmed it is the largest monetary settlement any state has won from the company. McMaster also said it was the second-largest state settlement in South Carolina history, behind the multibillion dollar settlement the state received from the 1998 tobacco agreement.

“This is a victory for South Carolina’s taxpayers who were forced to bear the financial costs of Eli Lilly’s unlawful conduct,” McMaster said in a statement. “Our case was sound. The evidence we presented was overwhelming. And I am pleased to say justice has been served.”

As part of the settlement, Eli Lilly didn’t admit to any wrongdoing.

Spokeswoman Marni Lemons said Eli Lilly felt it was in the best interests of the company, patients and physicians “who rely on Zyprexa as a lifesaving medication to put this issue behind us.”

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S.C. Reaches Settlement With Company Eli Lilly

Lilly Paid Doctors to Prescribe Zyprexa

Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa, and used golf bets to get more patients on the drug, according to notes by sales representatives.

During a golf game, one doctor agreed to start new patients on Zyprexa for each time a sales representative parred, or put the ball in a hole within a predetermined number of strokes, according to the notes.

“I got four pars out of nine holes,” Lilly salesman Vince Sullivan said in a February 2002 note. “I said I wanted my four new patients.”

The notes were made public for the first time in a court hearing today in South Carolina in the state’s lawsuit against Lilly over Zyprexa marketing practices. State officials contend Indianapolis-based Lilly marketed the drug for unapproved uses. A trial is set to begin Sept. 14.

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Lilly Paid Doctors to Prescribe Zyprexa

Criminal Charges Filed Against Former Nursing Home Admin.

Attorney General Edmund G. Brown Jr. announced that Kern Valley Hospital administrator Pamela Ott was charged on eight felony counts of elder abuse Tuesday, for allowing staff to forcibly administer psychotropic medications to patients for their own convenience, rather than for their patients’ therapeutic interests. These actions are alleged to have resulted in the deaths of three nursing home residents.

“As hospital administrator, Pamela Ott, was ultimately responsible for safeguarding the welfare of her patients,” Brown said. “Instead, Ott abdicated her responsibility and allowed the staff of the Kern Valley Hospital to foricibly sedate patients who questioned their care.”

Brown the charges against Ott in Kern County Superior Court. She surrendered herself in court this morning and pled not guilty. She was released on her own recognizance on the condition that she not run a skilled nursing facility.

A preliminary hearing is set for November 4, 2009. Tuesday’s charges are in addition to those filed in February 2009 against:

•Gwen Hughes, the former Director of Nursing at the skilled nursing facility of the Kern Valley Healthcare District in Lake Isabella, Kern County on charges of elder abuse and assault with a deadly weapon.

•Debbi Hayes, the former pharmacist at the Valley Healthcare District, on charges of elder abuse and assault with a deadly weapon. On August 14, 2009, Hayes pled no contest to a felony charge of conspiracy to commit an act injurious to public health. She is a cooperating witness for the people.

•Dr. Hoshang Pormir, a staff physician at Kern Valley Healthcare District, who was serving as the medical director of the skilled nursing facility, on charges of elder abuse.

As the Administrator of the Kern Valley Health Care District, Ott hired and supervised Director of Nursing Gwen Hughes.

Upon taking over in Sept. 2006, Hughes ordered that Alzheimer’s and other dementia patients be given high doses of psychotropic medications to make them more tranquil and easy to control. She ordered the administration of these medications to patients who argued with her, were noisy, or who were otherwise disruptive. Two patients who resisted were held down and forcibly given injections. Ms. Ott was informed of these actions and allowed them to continue.

Hughes is also alleged to have directed Debbi Hayes, the hospital pharmacist, to fill prescriptions for psychotropic medications. Hayes wrote and filled these prescriptions without first obtaining a doctor’s approval.

Dr. Pormir approved these psychotropic medications only some time after they had been administered and without examining the patients first and determining whether these psychotropic medications were medically necessary.

Several of these patients are alleged to have had medical complications as a result of being given these psychotropic medications, including lethargy and the inability to eat or drink properly. It is believed that three patients died and one patient suffered great bodily injury as a result.

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Charges Filed Against Former Nursing Home Admin.

>Eli Lilly and Zyprexa

>

Eli Lilly & Co. urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn’t work for such patients, according to unsealed internal company documents.

In 1999, four years after Lilly sent study results to the U.S. Food and Drug Administration showing Zyprexa didn’t alleviate dementia symptoms in older patients, it began marketing the drug to those very people, according to documents unsealed in insurer suits against the company for overpayment.

Regulators required Lilly and other antipsychotic drug- makers in April 2005 to warn that the products posed an increased risk to elderly patients with dementia. The documents show the health dangers in marketing a drug for an unapproved use, called off-label promotion, said Sidney Wolfe, head of the health research group at Public Citizen in Washington.

Wolfe: “By definition, off-label means there is no clear evidence that the benefits of a drug outweigh the risks. The reason why off-label promotion is illegal is that you can greatly magnify the number of people who will be harmed.”

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Lilly Sold Drug for Dementia Knowing It Didn’t Help, Files Show

See also:
Bitter Pill