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Mass. fails to rein in sedating of seniors

Boston Globe

Nursing homes that overuse antipsychotics unpunished.

State regulators rarely take action against Massachusetts nursing homes that, contrary to federal guidelines, use powerful anti-psychotic sedatives to control unruly elderly residents, a Boston Globe investigation has found.

Just 27 homes were cited for unnecessary use of antipsychotics from 2009-11, and inspectors in each of those cases did not deem the incidents as serious. The homes were not fined.

Federal guidelines say that antipsychotics are intended for patients with severe mental illness and a handful of other conditions, but many nursing homes administer them more broadly to residents who punch, kick, or shove others. Often that includes residents with dementia, despite federal warnings about potentially fatal side effects in such patients.

Government data show that antipsychotics are overused more often in Massachusetts nursing homes than nationally, but only a small fraction of facilities with high rates of unnecessary use have been admonished by state regulators, the Globe found.

In the cases where homes were cited, inspection reports described residents who had been on antipsychotics for months, and sometimes years, without evidence that staff tried to wean them off — as required by federal law. And a few reports detailed instances in which residents were so overmedicated they were unable to open their mouths to eat, or do much of anything besides sleep.

Cites difficulties

One resident at Kindred Nursing and Rehabilitation-Goddard in Stoughton was hospitalized “with severe facial bruising” after a 2010 fall linked to overmedication. The resident had been given a cocktail of four psychoactive drugs, including antidepressant, anti-anxiety, and antipsychotic medications. The home’s executive director, Edith Mahoney, said in a statement that the facility addressed the state’s concerns and is participating in a program to help reduce use of psychoactive drugs.

In another case, a 94-year-old at Royal of Fairhaven Nursing Center in Fairhaven, depressed about the loss of her husband of 72 years, received no counseling, which had been recommended by a social worker, and instead was placed by the nursing home’s physician on an antidepressant and an antipsychotic. After she was hospitalized for a seizure, the physician doubled the woman’s antipsychotic dose, with no explanation.

When asked by state inspectors why the woman was on an antipsychotic for nearly a year with no symptoms of psychosis, nursing staff said the physician “liked the medication,” the documents show.

The home’s spokesman, Scott Wahle, said in an e-mail that the physician disagreed with inspectors’ 2009 conclusions, and that the facility has since added specialized training to significantly lower its unnecessary use of antipsychotics.

Dr. Madeleine Biondolillo, Massachusetts’ top nursing home regulator, said her inspectors “try hard to have a justification” to reprimand facilities for antipsychotic use they feel is unnecessary. But she said federal rules are ambiguous, and harm from inappropriate use of antipsychotics can be subtle, indirect, and come weeks after a patient is put on them — making it difficult to penalize a facility and make it stick when the homes appeal the citation to an independent review board.

“I desperately want these overuse numbers to come down,” she said.

Earlier this year, the Globe reported that antipsychotic overuse is prevalent in many of the nation’s 15,600 nursing homes, and that about 185,000 residents were given the drugs in 2010 without a valid reason. Documents obtained under the Freedom of Information Act revealed that in 21 percent of US nursing homes that year, at least one-quarter of the residents without illnesses recommended for antipsychotic use received the medications. In Massachusetts, the proportion was 28 percent.

The newspaper then requested from the Centers for Medicare & Medicaid Services, the federal agency that regulates nursing homes, a copy of state inspection reports for each Massachusetts facility cited for unnecessary drug use from 2009 through 2011. There were 425.

Among the findings:

■ State regulators cited homes for 199 instances of unnecessary medication use during this period, and antipsychotic overuse comprised just 36 of those cases, or fewer than one in five.

■ Five percent of all the unnecessary-medication cases were deemed serious enough to merit a mandatory fine. None of the antipsychotic cases fell into this category.

■ Roughly 4 percent of Massachusetts homes with above-median rates of unnecessary antipsychotic usage were reprimanded by state regulators in 2009. That fell to 2 percent in 2010. Federal regulators changed the way antipsychotic overuse was calculated in 2011, making it hard to compare that year with earlier ones. But there were fewer unnecessary drug citations in 2011 than in the two previous years.

■ Two-thirds of the cases of unnecessary antipsychotic use involved residents with dementia.

■ The most commonly cited overused medication was Seroquel, an antipsychotic that was the subject of a 2005 US Food and Drug Administration black-box warning — the agency’s most serious medication alert — about potentially lethal side effects for dementia patients.

Massachusetts’ lax enforcement of rules against unnecessary antipsychotic use has captured federal attention. The state is one of six, along with Georgia, Illinois, Missouri, Pennsylvania, and Texas, recently selected by the Centers for Medicare & Medicaid Services for a six-month study on the reasons for the overuse.

In addition to scouring inspection reports, researchers will interview state inspectors, said Toby Edelman, a senior policy lawyer at the Center for Medicare Advocacy who is one of the leaders of the study.

Advocates for nursing home residents say facilities need to employ nondrug methods for controlling unruly behavior.

More than half of nursing home residents have dementia, and many are no longer able to articulate their pain or needs, which often prompts them to strike caregivers or other residents out of frustration, fear, and confusion.

Federal regulators are finalizing new guidelines that will more clearly define the approaches nursing homes must first try with agitated or combative residents, ruling out other reasons for their behavior — such as infections, hunger, thirst, or pain — before using antipsychotics.

Biondolillo’s agency is crafting new dementia care regulations, to go into effect by April 1, that will require enhanced training for Massachusetts nursing home staff on alternative techniques to calm agitated residents without resorting to antipsychotics.

Scott Plumb, senior vice president of Massachusetts Senior Care, a trade association, said nursing homes are improving, but relentless public criticism combined with continual state budget cuts threaten to reverse the progress.

“It kills morale, and it makes it that much harder to attract and retain quality people,” Plumb said. “We are taking care of sicker people with fewer resources. To do this right, you have to put in more staff.”

Industry leaders and advocates have joined state regulators to help design the pending rules on dementia care, which are likely to require that homes add more meaningful activities, in addition to training.

Biondolillo said more financial backing will be needed for her department and for increasing nursing homes’ Medicaid reimbursement rates.

“It will be important that everyone, the Legislature included, recognize that improvement will take [money],” she said.

Biondolillo’s department, the Bureau of Health Care Safety and Quality, also is responsible for regulating pharmacies, and it has come under heavy criticism for inadequate oversight of the Framingham compounding company blamed for the national fungal meningitis outbreak. The outgoing state health secretary, Dr. JudyAnn Bigby, told lawmakers last month that her agency, which includes Biondolillo’s bureau, needs more money to do its job.

Over the past four years, since the recession started squeezing state budgets, the safety and quality bureau has shouldered a 26 percent cut, losing roughly $4.7 million (adjusted for inflation), according to an analysis by the Massachusetts Budget and Policy Center.

The Globe reported earlier this year that unnecessary use of antipsychotics in Massachusetts nursing homes has decreased since 2005, and in August 2011, a yearlong pilot program called OASIS was launched by the industry’s nonprofit organization, Massachusetts Senior Care Foundation, in 11 Massachusetts nursing homes to hasten that trend. It aims to lower antipsychotic use by teaching staff how to better communicate with residents.

Nursing home staffers have been enthusiastic and some homes have reported lowering antipsychotic rates, but an analysis of the data has not been completed, said Laurie Herndon, the foundation’s director of clinical quality.

Without waiting for the final results, state regulators and the industry expanded the program this fall to 104 nursing homes, including 63 with the highest rates of antipsychotic overuse. The state is using $182,000 in federal funds.

The anecdotal feedback “was so powerful,” Biondolillo said, “we don’t want to lose the momentum.”

The experience at Southpointe Rehabilitation & Skilled Care Center in Fall River, one of the homes in the pilot program, suggests change may take time.

Southpointe’s overuse of antipsychotics has been below the state median, but during its annual inspection last December, three months into the OASIS training, the home was cited for unnecessary use of the sedatives.

Inspection records indicate that a resident was prescribed Seroquel by her primary care physician after a family member had mistaken “anxiety issues” for hallucinations. The woman’s physician kept her on the antipsychotic despite a psychiatric evaluation that recommended it be replaced with an antianxiety medication.

Christopher Hannon, Southpointe’s administrator, said the home’s medical director, the unit manager, and a social worker all questioned the physician’s decision, but ultimately went along with it because they felt they could not challenge it.

But if the same scenario were to be repeated, Hannon said he believes the additional OASIS training has emboldened staff members to speak up for residents.

“My hope is that it would not happen again because of all the education we have done, and also because we have tried to bring in the nurse practitioners and the physicians, all the prescribers, so they fully understand the implications,” Hannon said.

Records indicate the physician finally discontinued the Seroquel — after the facility was cited for unnecessary use.

A nationwide push by the Centers for Medicare & Medicaid Services to slash inappropriate antipsychotic use in nursing home residents by 15 percent by the end of this year may not hit its mark, said Alice Bonner, director of the agency’s nursing home division. Bonner said the results probably won’t be known until March or April because consultants need several months to analyze the data.

Her agency announced a multiyear education initiative in May, noting that nearly 40 percent of residents with dementia nationwide were receiving antipsychotics though they did not have a condition that would warrant it. Since then, anecdotal reports indicate progress in reducing residents’ doses of the medications, she said, but it can take time to wean them off entirely.

“We took on this initiative without much in the way of additional resources,” Bonner said, “and I am starting to actually see forward momentum.”