McKnight’s also ran an article about the recent studies that prove the off label use and over use of dangerous antipsychotics to elderly and vulnerable patients. Antipsychotic medication use is still widespread in nursing homes, even after the federal government issued a “black box” warning on the drugs in 2005 according to two new studies.

The drugs in question include clozapine, risperidone, olanzapine and paliperidone. Doctors prescribe these drugs, which are designed to treat bipolar disorder and schizophrenia, off-label for residents with dementia. Both studies appeared in Monday’s issue of the Archives of Internal Medicine.
 

As a follow up to yesterday’s blog entry, here is another article about the overuse of antipsychotic medications in nursing homes by Business Week.   The practice can threaten physical health. Since the U.S. Food and Drug Administration instituted a "black box" warning in 2005, one study found a 19 percent decrease in the prescription of atypical antipsychotics in elderly people with dementia.  But the researchers found that in 2008, antipsychotics still represented 9 percent of all prescriptions in this group.

"The [2005] safety warning pertained to an increased risk of death among individuals using these drugs, so the public health ramifications of use of these drugs in elderly people with dementia, often in nursing homes, which we consider a vulnerable population, is concerning," said Dr. E. Ray Dorsey, an assistant professor of neurology at the University of Rochester Medical Center and lead author of one of the studies in the Jan. 11 issue of the Archives of Internal Medicine.

Antipsychotics are widely used "off label" to control difficult behavior in elderly people with dementia. Indeed, Dorsey said he suspects that the vast majority of the use documented in his research is "off label." In the United States, no antipsychotics are approved to calm behavior.

The second study found that almost one-third of residents in nursing homes were prescribed antipsychotics and that one-third of that number did not have dementia or psychosis.  Newly arrived residents were more likely to receive this type of drug if they were in a nursing home that routinely prescribed such drugs, suggesting that organizational culture and not patients are driving the trend.

"If you enter a nursing home that has a higher proportion of people on antipsychotics, you are also likely to be put on antipsychotics," Briesacher said.
 

NY Times had a great article on the too common practice of overmedicating residents in nursing homes.  Nursing homes often chemically restrain residents because it is easier:  No complaints, no call bells, no requests.   Management can then staff less people on certain shifts especially at night.  Paula Spann wrote a great article.

Within three months of admission, a team of University of South Florida researchers determined, 71 percent of Medicaid residents in Florida nursing homes were receiving a psychoactive medication — an antidepressant or anti-psychotic, or dementia drugs — even though most were not taking such drugs in the months before they moved in and didn’t have psychiatric diagnoses. 15 percent of residents were taking four or more such medications.  Only 12 percent were getting nondrug treatments like behavioral therapy.

The article mentions Victor Molinari, a professor of aging at the University of South Florida and lead author of the study.  He wasn’t startled by those statistics. “They confirmed what I suspected,” he told me in an interview. “And people who work in nursing homes wouldn’t be surprised.  It seems the use of psychoactive medication is trumping the use of nondrug treatments,” Dr. Molinari said.   And given the possible interactions with the many other drugs most residents take, an average 10 or more prescriptions, “it could well be that we’re causing problems like falls, confusion and delirium, and hospitalizations,” he cautioned.

Nursing homes’ reliance on psychoactive drugs has troubled professionals in geriatrics for years.   In many states, residents being admitted directly from hospitals are exempt from screening.  As a result, federal data show, fewer than half of residents with major mental illnesses receive the mandated assessment.  Only half of nursing homes provide weekly patient consultations with psychiatrists, psychologists or other mental health experts; even fewer provide consultations with those who specialize in working with seniors. In addition, staffs are stretched thin and inadequately trained in mental health care. With a pill a quicker and simpler intervention than the alternatives, intentional overuse is the result.   If the aide had fewer patients to care for or if management increased staffing numbers, and more time to soothe one who was agitated, if she’d had better training in responding to behavioral problems, she might be able to handle behavioral issues.  

The Justice Department brought criminal charges against Eli Lilly, accusing the big pharmaceutical firm of illegally marketing its anti-psychotic Zyprexa to doctors who work in nursing homes and assisted living facilities, and encouraging them to prescribe it for sleep disorders and dementia. Its approved use is to treat schizophrenia and bipolar disorder. Lilly agreed to pay $1.4 billion in a related civil settlement.

“For years, I’ve had calls from family members saying, ‘Mom was completely lucid when she went into the nursing home, and a week later she no longer recognized us,’” said Janet Wells, public policy director of NCCNHR, formerly the National Citizens’ Coalition for Nursing Home Reform. “Families should question why drugs are prescribed, do some research. A lot of drugs are being used as restraints.”

Paula Span is the author of the recently published “When the Time Comes: Families With Aging Parents Share Their Struggles and Solutions.”

 

The Madison and St. Clair Record had an article about a lawsuit filed against a nursing home for giving a resident a blood thinner that caused rectal bleeding.  Ron Matikitis filed a lawsuit in Madison County Circuit Court on behalf of Ann Matikitis against Bravo Care of Edwardsville. Ron Matikitis claims nurses at Rosewood Care Center in Edwardsville – a nursing home licensed by Bravo Care – administered 4 milligrams of Coumadin to Ann Matikitis on Sept. 24, 2008, despite the fact that her physician had ordered her prescription to be held because of an elevated PT/INR lab result. The drug, usually used to prevent blood clots, ended up causing Ann Matikitis to experience massive rectal bleeding and to be hospitalized.

In addition to her injuries, Ann Matikitis suffered a marked deterioration of her prior physical condition, incurred substantial medical bills and suffered great pain and anguish. In addition she suffered a severe and permanent disability.

Ron Matikitis blames Bravo and its employees for failing to properly consult with Ann Matikitis’ physician and her family members about her deteriorating condition, for failing to timely report the medication error, for failing to provide appropriate general nursing, for failing to record the medication error and for failing to comply with a physician’s orders. In addition, employees negligently failed to record the care provided and Ann Matikitis’ reaction to the prescription and violated resident care policies, according to the complaint.

Ron Matikitis seeks a judgment of more than $50,000, plus costs and other relief the court deems just.

Robert H. Gregory of the Law Office of Robert H. Gregory in East Alton will be representing him.
 

The Star-Tribune had an interesting article about the massive stroke and death of a resident caused by a nursing home failing to give a medication despite a physician’s order.  State investigators say a woman recovering from spine surgery died of a massive stroke in June after a nursing home in Faribault, Minn., failed to give her a medication prescribed to prevent blood clots.

The doctor’s order was incorrectly transcribed by a nurse at Faribault Commons Nursing and Rehabilitation, and the home did not have adequate checks to spot the error, its administrator acknowledged Monday. The home was cited for neglect.

The report, made public last week by the department’s Office of Health Facility Complaints, said this is what happened:

The unidentified patient was moved from a hospital to Faribault Commons on June 2 for rehabilitation therapy with orders for the daily Lovenox injection.  She was given the drug for three days, mistakenly did not get it on the weekend, then got it again for four days.  Then the treatment was stopped because a nurse mistakenly had written that it was to end on June 11, instead of July 11 as ordered.  The patient had a massive stroke on June 17 and was sent to the hospital, but returned to the nursing home two days later for end-of-life care. She died on June 24.

 

The Chicago Tribune had a good article about the use of anti-psychotic medications being overprescribed and over used in nursing homes.  Health advocates are calling for tough new rules on the use of anti-psychotic drugs in Illinois nursing homes, including tighter controls on doctors who prescribe the powerful medications. "Medical care should help you get better, not get worse," said Wendy Meltzer of Illinois Citizens for Better Care, an advocacy group for nursing home residents.

A Tribune investigation recently showed how many frail and vulnerable Illinois nursing home residents have been unnecessarily dosed with anti-psychotics, leading to harm and an increased risk of death. One psychiatrist, the Tribune found in a joint investigation with ProPublica, provided assembly-line care to thousands of mentally ill patients.

The FDA has approved anti-psychotic drugs to treat serious mental illnesses, such as schizophrenia, but doctors also prescribe them to geriatric patients with other conditions, such as dementia, in a common but controversial practice called "off-label" use. Meltzer said one way to stop nursing home doctors from using the drugs to "chemically restrain" residents is for the state to refuse to pay for certain medications.  Documents show that hundreds of nursing residents have been given psychotropics without their permission since 2001. 

Nursing homes, Meltzer said, should have a formal process of explaining the benefits and risks of taking psychotropics. Right now, she said, the goal of many nursing homes is to simply get residents to sign the forms as opposed to explain the options.

Advocates also said Illinois should require drugmakers to publicly disclose payments to doctors so that their patients can be aware of possible conflicts of interest. One pharmaceutical company gave Reinstein nearly $500,000 to promote a drug that Medicaid records suggest he prescribed 41,000 times.

 

The Eagel Tribune had an article about a criminal organization running out of a nursing home.  Visitors to Rockingham County Jail brought prescription drugs, including OxyContin and Suboxone, to the county nursing home, where they exchanged the drugs with low-security inmates who worked in the nursing home. Those inmates hid the drugs in their bodies and brought them back for distribution to the jail’s general population, U.S. Attorney Kacavas said.  15 people were arrested for forging prescriptions for controlled drugs and smuggling some of those drugs into the Rockingham County Jail in Brentwood. At least four of those arrested were inmates at the county jail.  An investigation that began at the county jail broke up a drug ring yesterday that federal authorities described as a "sophisticated criminal organization."

Nicknamed "Operation Jail House Rock," the investigation was a joint endeavor between county, state and federal law enforcement agencies, Kacavas said. It began when county jail workers overheard conversations during which the drug smuggling was discussed. Through interviews with other inmates and listening in on county jail phone lines, county investigators were able to uncover how the drugs were being brought into the jail, and eventually catch those involved in the act, Rockingham County Deputy Attorney Tom Reid said yesterday.

The drugs involved were OxyContin, Oxycodone, Suboxone, Lorazepam and Ativan, all narcotics.

 

As a follow up to recent posts regarding the kickback scheme involving OmniCare and Murray Forman and Leonard Grunstein, today I am going to post a well written article from the Chicago Breaking News about a doctor prescribing dangerous medications to nursing home residents.

Inside Chicago’s Maxwell Manor nursing home, Dr. Michael Reinstein’s patients suffered from side effects so severe that they trembled, hallucinated or lost control of their bladders. Staffers told state investigators that so many patients were clamoring to complain to Reinstein about their medications that a security guard was assigned to accompany him on his visits. In addition, staffers said Reinstein had induced patients to take powerful antipsychotic drugs with the promise of passes to leave the home.

Today he is one of the most prolific providers of psychiatric care in Chicago-area nursing homes and mental health facilities, even as he is trailed by lawsuits and complaints like the ones at Maxwell Manor.  An investigation by ProPublica and the Tribune found that Reinstein has compiled a worrisome record, providing assembly-line care with a highly risky drug.  Reinstein has been accused of overmedicating his mentally ill patients. His unusually heavy reliance on the drug clozapine — a potent psychotropic medication that carries five "black box" warnings — has been linked to at least three deaths.

In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together. Records also show he is getting government reimbursement for seeing an improbably large number of patients. Documents filled out by Reinstein suggest that if each of his patient visits lasts 10 minutes, he would have to work 21 hours a day, seven days a week.  Reinstein sees 60 patients each day, he wrote in an audit report in 2007.

Working from a strip-mall office in Uptown, Reinstein says he is psychiatric medical director at 13 nursing facilities, seeing patients with chronic mental illness. Those include people with schizophrenia.

Autopsy and court records show that three patients under Reinstein’s care died of clozapine intoxication. Alvin Essary died at age 50 at the Somerset Place nursing home on the North Side in 1999.  Medical records show that when he died his blood contained five times the toxic level of clozapine.

The "black box" warnings — the FDA’s strongest — on clozapine’s label detail serious potential side effects, from enlargement of the heart to rapid drops in blood pressure to increased seizure risk.   Doctors also are required to take regular blood samples to ensure patients’ immune systems aren’t shutting down.

The FDA approved the drug two decades ago for only a sliver of the population: the actively suicidal or the quarter of schizophrenic patients who do not improve on medications with lesser side effects. Yet Reinstein last year said under oath that his practice once had more than 300 patients among 415 in one Chicago nursing home on clozapine.

Read More →

Chicago Tribune had an article that is a good follow-up or counter balance to yesterday’s blog entry.  The article discusses the overmedication of nursing home residents including Delores Fleming.  She moved into Heritage Manor of Mount Zion and scored 23 out of 30 on a mental exam and was deemed to be "moderately impaired," state inspection records show.  Fleming had few problems her first week in the nursing home, according to her medical records, which her family provided to the Tribune.  But after she repeatedly had crying spells and tried to wander away, the nursing home doctor prescribed two anti psychotic drugs, even though she was not psychotic. Her family had given consent for the Seroquel, but the medical records show the permission sheet erroneously described the drug as an anti-anxiety medication. Seroquel is an anti psychotic drug intended for serious mental illnesses, such as schizophrenia.

Records show that Fleming briefly improved on the Seroquel, but over the next three months she had episodes of extreme anxiety.  The doctor doubled the dosage of one medication no fewer than four times, putting her above the recommended limit.  Once she thought she was possessed, nursing notes state. Another time she thought her brother had left her $50 million.

Her doctor ordered multiple injections of the anti psychotic drug Haldol and the anti-anxiety medication Ativan, state inspection records show. Fleming’s dose of Seroquel also was repeatedly doubled, putting her above the recommended limit for that drug.

After Fleming’s family complained that she had grown lethargic, the staff referred her to a neurologist. According to a state inspection report, the neurologist found her catatonic and believed she had developed tremorlike "Parkinson’s symptoms, due to the Haldol."  When he gave her the same mental exam she had previously taken, she scored zero out of 30. The neurologist recommended that her drugs be curtailed, and her condition dramatically improved. When she retook the test, she scored a 30 out of 30.

Both her family and the facility decided she should live elsewhere. The family wanted her in a home that specialized in Alzheimer’s care; Heritage Manor believed Fleming was endangering other residents, records show, and gave her 30 days to leave.

When the Tribune reviewed 40,000 state and federal inspection reports filed since 2001 on 742 Illinois nursing homes, numerous instances emerged in which regulators cited facilities for misusing psychotropics even though the patients’ doctors had created the problems.

When physicians or psychiatrists prescribe a drug for a patient, facilities must administer it as long as the order is consistent with state and federal nursing home regulations. If inspectors determine a violation occurred, they cite the nursing facility, not the doctor.

The Tribune found that inspectors documented many cases in which doctors prescribed powerful anti psychotic drugs without adequate justification or in doses that were too high.  The doctors also sometimes failed to provide adequate follow-up care, the inspection records show. They are required to see their nursing home patients only once every 60 days, though some do not visit even that often.  Several nursing home owners interviewed by the Tribune said they have struggled with doctors who rarely make time to visit patients.

Nursing homes are required to have pharmacists visit the facilities regularly and review prescriptions. If they discover irregularities, such as a patient placed on a drug without cause, they notify the nursing staff and doctor. But the Tribune found that when pharmacists recommended that a psychotropic be discontinued or the dosage reduced, physicians sometimes ignored the advice.

The difficult task of monitoring for side effects is left to nurses who are poorly trained in the use of psychotropic drugs. Experts say the situation can affect quality of care, and the Tribune’s review of inspection reports shows that is true — sometimes with tragic consequences.

The Chicago Tribune has done a great job researching, investigating, and writing about the use and abuse of anti-psychotics in nursing homes. See full article here.
 

The Washington Post had an ainteresting article about the effect of drug enforcement on nursing home residents receiving pain medications.  Efforts by the Drug Enforcement Administration to crack down on narcotics abuse are producing a troubling side effect by denying some hospice and elderly patients needed pain medication.

Tougher enforcement of the Controlled Substances Act, which tightly restricts the distribution of pain medicines such as morphine and Percocet, is causing pharmacies to balk and is leading to delays in pain relief for those patients and seniors in long-term-care facilities.  The DEA has sought to prevent drug theft and abuse by staff members in nursing homes, requiring signatures from doctors and an extra layer of approvals when certain pain drugs are ordered for sick patients.

Most nursing homes do not have pharmacies or doctors on site, adding to delays for patients who fall ill late at night or in transition from a hospital.  The pharmacies face tens of thousands of dollars in fines if they deviate from strict controls that require doctors to sign paper prescriptions and fax them to a pharmacy before a nurse can administer them in the nursing home setting.

"The system is broken. It isn’t working, and patients are suffering," said Claudia Schlosberg, director of policy and advocacy for the American Society of Consultant Pharmacists. "While we need to ensure there are proper controls on the medications, the overall law enforcement concern has to be compatible with meeting patients’ needs, and right now it’s not."

Doctors in nursing homes say the restrictions do not take into account that many more patients, with higher levels of illness and pain, are moving into long-term-care sites and out of hospitals.