Everyone is talking about antipsychotic use in nursing homes…again. Ever since the Office of Inspector General (OIG) released a report on this issue last year, it has been on the minds of everyone, from administrators and medical directors to nurses and family members.

While the focus on antipsychotics has caused headaches for nursing facilities, it also has resulted in a renewed commitment to ensuring appropriate and limited use of these medications. Additionally, it has encouraged facilities to promote a culture where staff are empowered get to know residents and use this knowledge to resolve behavioral issues. When staff put their detective skills to work, their genius often rivals that of Sherlock Holmes, and they can solve behavioral issues without pharmacologic intervention.

Antipsychotics Take Center Stage

The OIG report, “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents,” evolved from a request by Congress to evaluate the extent to which elderly nursing facililty residents were prescribed antipsychotic medications and what it was costing Medicare. Specifically, there were concerns about the use of these drugs for off-label uses, especially for residents with dementia.

These concerns were not unwarranted. In 2006, one study found that 21 percent of antipsychotic prescriptions involved off-label uses. A 2007 Agency for Healthcare Research and Quality report indicated several off-label uses for antipsychotics, including treatment of depression, agitation in dementia, obsessive-compulsive disorder, post-traumatic stress and/or personality disorders, Tourette’s syndrome, and autism.In 2009, another study of antipsychotic use in the Veterans Affairs system concluded that 60.2 percent of patients receiving these medications had no recorded diagnosis that justified the prescription.

Elsewhere, the report found that 14 percent (more than 300,000) of elderly nursing home residents had at least one Medicare claim for atypical antipsychotics (from January through June of 2007). Additionally, it showed that these claims accounted for 20 percent of the total 8.5 million claims for atypical antipsychotics for all Medicare beneficiaries. More significant was the finding that 83 percent of these Medicare claims for atypical antipsychotics for nursing home residents were associated with off-label conditions; 88 percent were associated with dementia, which is specified in the Food and Drug Administration (FDA) boxed warning.

The vast majority of these residents showed signs of inconsolable or persistent distress, significant functional decline, and danger to themselves or others.

While these numbers may be alarming, it is important to note that physicians are not prohibited from prescribing medications for off-label conditions or when there is a condition specified in the boxed warning.

Challenging Validity Of Claims

Another finding from the report that has garnered attention involves the number of antipsychotic claims that were determined to be erroneous. More than 726,000 of the 1.4 million antipsychotic claims for nursing home residents didn’t comply with Medicare reimbursement criteria. Over 20 percent of the atypical antipsychotic claims weren’t administered in accordance with Centers for Medicare & Medicaid (CMS) standards regarding unnecessary drug use in nursing homes. This is significant, as failure to comply with CMS standards may impact Medicare participation.

The cost of these erroneous claims amounted to $116 million. The cost of all antipsychotic claims for elderly nursing home residents was $309 million.

Concerns about these costs, as well as the potentially dangerous effect of antipsychotics on elders, led
OIG to make several recommendations:
■ Assessing whether survey and certification processes offer adequate safeguards against unnecessary antipsychotic drug use in nursing homes;
■ Exploring alternative methods (beyond surveys) to promote compliance with federal standards regarding unnecessary drug use in nursing homes; and
■ Taking appropriate action regarding claims associated with erroneous payments identified in the report.
The report was not without its limitations. For instance, it didn’t take into consideration the potential harm from using conventional antipsychotics or benzodiazepines. It also failed to account for the risk versus
benefit evaluations on prescribers’ parts.

Jennifer Hardesty, PharmD, FASCP, clinical services manager of Baltimore-based Remedi SeniorCare, also observes, “There is an inherent conflict of interest when a government entity responsible for payment and interested in saving money issues a report critical of higher-cost atypical antipsychotics, but continues to pay for cheaper and more potentially dangerous drugs like traditional antipsychotics and benzodiazepines in the same population.”

CMS, Trade Groups Have Plans

CMS responded promptly to the report and announced plans for an education and awareness program. On May 30 of this year CMS Acting Administrator Marilyn Tavenner announced the establishment of a Partnership to Improve Dementia Care, an initiative to ensure appropriate care and use of antipsychotic medications for nursing home patients.

This partnership, which involves federal and state partners, nursing homes and other providers, advocacy groups, and caregivers, has set a national goal of reducing the use of antipsychotic drugs in nursing home residents by 15 percent by year end.

CMS has developed several steps to achieve this lofty goal. These include:
■ Enhanced training. CMS has developed Hand in Hand, a training series for nursing homes that emphasizes person-centered care, prevention of abuse, and high-quality care for residents. CMS is also providing training focused on behavioral health to state and federal surveyors.
■ Increased transparency. CMS is making data on each nursing home’s antipsychotic drug use available on Nursing Home Compare starting in July of this year and will update these data.
Alternatives to antipsychotic medication. CMS is emphasizing non-pharmacological alternatives for nursing home residents, including potential approaches such as consistent staff assignments, increased exercise or time outdoors, monitoring and managing acute and chronic pain, and planning individualized activities.

CMS also is conducting research to better understand the decision to use or not to use antipsychotic drugs in residents with dementia. A study to evaluate this decision-making process is under way in several nursing homes. Findings will be used to target and implement approaches to improve the overall management of residents with dementia, including reducing the use of antipsychotics in this population.

Earlier this year, the American Health Care Association and the National Center for Assisted Living had set a 15 percent reduction in off-label antipsychotic use by the end of 2012 as part of its new program, The Quality Initiative. The effort builds on existing work in long term care by setting specific, measurable targets to further improve quality care throughout the long term care continuum.

The Facts About Atypical Antipsychotics

It is important to understand a little about the drugs that are causing so much controversy.

There are several atypical antipsychotics: aripiprazole, clozapine, olanzapine, olanzapine/fluoxetine, paliperidone, quetiapine, risperidone, and ziprasidone. While these medications were developed and approved to treat psychiatric illnesses such as schizophrenia, using atypicals off-label may help patients with mental health conditions for which there aren’t any FDA-approved options.

However, these drugs hold a great risk for elderly patients, especially those with dementia. All atypicals increase the risk of death in these patients and may put elders with dementia at greater risk for stroke.
They also have many side effects, such as weight gain, agitation, sleepiness, gastrointestinal problems, dry mouth, cognitive problems, and fatigue.

There are times when these medications are appropriate and necessary. According to regulations, antipsychotic medication should be used only for specific diagnoses identified in the “Diagnostic and Statistical Manual-IV.”

These include schizophrenia, schizo-affective disorder, delusional disorder, mood disorders such as mania or bipolar disorders, schizophreniform disorder, psychosis, brief psychotic disorder, medical illness or delirium with manic or psychotic behavior, and—most significant in long term care—dementing illnesses that are with associated behavioral symptoms.

However, antipsychotics can’t be used casually for any of these conditions. According to the regs, the symptoms must be identified as being due to mania or psychosis, the behaviors pose a danger to the resident or others, or the symptoms are severe enough that the resident exhibits inconsolable or persistent distress or significant function decline. These drugs must help stabilize or improve the person’s clinical outcomes, quality of life, and functional capacity.

There are numerous issues—many of which are common in people with dementia—for which antipsychotic use is inappropriate and unacceptable.

The regulations indicate that these drugs cannot be used simply for the behaviors of wandering, poor self-care, restlessness, impaired memory, mild anxiety, insomnia, unsociability, fidgeting, nervousness, uncooperative behavior, verbal outbursts, and behaviors that don’t endanger the resident or others.

Matthew Wayne, CMDEven when the use of antipsychotics is necessary and appropriate, they should be used only at the lowest effective dose and for the shortest possible time.

They should be used to treat an enduring condition only when target behaviors are clearly and specifically identified and monitored, and usage must be documented carefully over time. The behavioral issues must be re-evaluated periodically to determine if medication dose reduction or discontinuation are viable options.

As Matthew Wayne, MD, CMD, chief medical officer, CommuniCare Family of Companies in Ohio, says, “Sometimes, it is cruel not to do something with medications. In the right circumstances, they can provide a significant benefit.”

Clinical Leaders Chime In

For many medical directors, directors of nursing, and consultant pharmacists, ensuring appropriate antipsychotic prescribing has been a priority for some time. In many ways, they actually have welcomed the focus on this issue as an opportunity to share their experiences and best practices.

David Smith, MD, CMD, president of Geriatric Consultants in Brownwood, Texas, says, “This has been my topic for a long time. As medical director, I look at every patient on an antipsychotic.” He gets regular lists of patients on antipsychotics and watches to see who is prescribing these drugs, how they are documenting the diagnosis/treatment goals, what non-pharmacologic interventions were attempted, and what follow-up was done or scheduled.

Smith won’t hesitate to have a talk with physicians who are on the outliers of prescribing, or who aren’t documenting what they have done, or why they aren’t following up or making efforts to reduce dosages or eliminate antipsychotics.

Karyn Leible, RNSuch physician-to-physician communication is key, agrees Karyn Leible, RN, MD, CMD, senior vice president of medical services at Jewish Senior Life of Rochester, N.Y. She notes that at one of her facilities, “we made sure that there was a physician-to-physician communication whenever there were any medication changes or recommendations. This made it feel more like a peer review aimed at benefiting resident care.”

Creating a culture where physicians and nurses don’t immediately make a connection between behaviors and medications can be challenging. However, as Smith says, “We have set an expectation for our nurses to compile all of the information before they call about a behavioral problem. ‘Agitation’ by itself is never an acceptable description of the problem. I want a full description of what is happening and what led up to it.

Are they hitting people? Who are they seeking out to hit—someone weaker? If they are yelling or shouting, what are they saying? If they are wandering, is it aimless or shadowing wandering? The answers to these questions help us understand what is going on in the resident’s head and what we need to do for him or her. I wholeheartedly endorse the ABC process [What are the antecedents to the behavior? What is the behavior? What are the consequences of the behavior?] for evaluation of behavioral and psychiatric symptoms of dementia [as outlined in the AMDA clinical practice guideline on delirium and acute problematic behaviors].”

Robin Arnicar, RN, CDONA,FACDONA, director of nursing at Erickson Living’s Renaissance Gardens at Riderwood Village, a continuing care retirement community in Silver Spring, Md., encourages staff to start at the beginning and understand that many behaviors in residents with dementia are the result of unmet basic needs. By going through a list of possibilities—hunger, pain, cold, hot, wet, lonely, and so on—staff can resolve the behavior or rule out the possible reason for it.

Nurses need to be trained to do this, she says, because many of them have been taught that they should call the physician right away when there is any change in condition or a problem.

“We need to take the fear out of nurses’ actions. We need to teach them that it’s okay to say, ‘I’ve identified a problem, and I’m going to apply this intervention.’ Not all behaviors require a physician’s intervention. There is a lot nurses can do before they pick up the phone,” she says.

Look For Behavioral Clues

Creating such a culture isn’t easy, Leible admits. In many ways, it is human nature to seek an immediate solution or response, she observes. “I challenge nurses to show me what they’ve done to understand and address the problem,” she says. She works with her team to help them find clues in the patient’s chart.
For example, she says, “We recently had a resident who was highly agitated. Looking at her chart, we saw that she was sick with a respiratory illness. That is why she was anxious—she was having trouble breathing.”

One way to motivate staff is to “harp on their successes,” she says. “They need to hear what they do well. We need to help them see more options.”

Wayne notes the value of getting staff used to thinking in terms of taking the steps necessary to understand the behavior, its triggers and circumstances, and what might be done to address it before resorting to medications. “When staff feel overwhelmed and call requesting a prescription, this is an opportunity to walk them through these steps,” he says.

Monthly team meetings with a focus on dementia and behavioral issues are good opportunities to help staff hone their problem-solving skills, work together to utilize everyone’s strengths and knowledge, and increase their confidence in their abilities to address behavioral issues, he says.

Hardesty suggests psychiatric rounds, where team members, including the physician, pharmacist, and others, get together and review all psychiatric medications monthly.

“This is a great forum that enables you to track changes and what has worked or not worked,” she says. When such rounds aren’t possible, she suggests doing a quick antipsychotic review during Quality Assurance Committee meetings. “This is a good opportunity to bring this issue to the surface and develop an action plan,” she says.

Involve Nurse Assistants

J. Kenneth Brubaker, MD, CMD, staff/faculty member of the Lancaster General Geriatric Specialists and chief medical director for the Pennsylvania Department of Aging, emphasizes the importance of involving certified nurse assistants (CNAs) in addressing behavioral issues. He says, “When I make rounds, I go to CNAs first. I will go over issues about particular patients with them and ask about any problems or concerns they have or have observed.” Because they know residents well and understand their personalities and behaviors, they often know what to do before anyone else does, he says.

Brubaker gives an example: “A resident became agitated and picked up a chair. A CNA just took the chair from him and then diverted his attention to something else. She knew that this was a better approach than trying to talk him into putting down the chair.”

Arnicar agrees that CNAs can be a wealth of information. The problem is, she says, that they don’t always realize the value of the information they have. “We need to educate them about how to use the information they have and tell them how important their observations are to the team,” she says.

It is important for staff to understand the relationship between physical illness or discomfort and behaviors.
Wayne says, “When a patient exhibits a behavioral issue, he or she should be evaluated medically. This needs to be done before we jump to treatment. If we rule out a medical change of condition, then we can move toward determining it’s a dementia-related condition. If we determine that it is, we then need to look at nonpharmacologic interventions before we jump to medications.”

Pain actually is a common cause of a behavioral issue and often can be resolved easily. As Arnicar says, “On one dementia unit, we applied Tylenol BID, and we experienced a 60 percent reduction in [agitated] behaviors.”

Painting A Personal Portrait

Knowing residents as individuals is essential to understanding their behavior. It can provide clues that lead to an effective—and often easy—non-pharmacologic solution. For example, Smith says, “We need to understand the person’s personality quirks and propensities. That can explain their behavior because dementia tends to disinhibit things like obsessive-compulsive traits.”

He adds that the same is true of a culture of violence. People with a violent background might have been able to keep a reasonable check on it before, but once they become more demented, they lose control. “You can’t fix socialization with drugs,” Smith says.

Leible agrees that knowing residents can make all the difference. “We actually had a family request that we put their loved one on medication. The woman kept asking to go home, and the family thought she was fearful about being in the facility. However, as we talked more, we found out that she had lived alone and was used to having peace and quiet, Leible says. From then on, when the resident would get agitated and ask to go home, the caregiver would take her someplace quiet, and she would calm down.

Understanding a person’s coping mechanisms also can be an important clue. As Smith notes, “Most of us use intellectualization as a coping mechanism. So when we get dementia, we lose the tools to solve problems. The frustration that results from this loss often is missed in our evaluation of dementia patients.”
Smith knows this from experience. When he was young—before he was a physician—his grandmother developed dementia. She began losing things around the house. Her explanation was that the neighbors were sneaking into her home and moving or stealing things.

“On the surface, that sounds like an appropriate indication for an antipsychotic. However, looking back, I realize that she was a fiercely independent woman who couldn’t deal with the fact that she was losing control of her faculties. So she manufactured a rationale that supported her denial,” Smith explains. Instead of medications, he suggests, patients like this can benefit from efforts to support their self-reliance and confidence and enable them to get help without losing their pride.

It can be challenging to get residents and families to talk about personal issues and histories that may be painful or embarrassing, Smith admits. “The tactics I have for this are imperfect, and they sometimes leave me short. However, I make sure [family members] understand that anything they tell me is private,” he says.

“You don’t have to write all the nuances in your notes—just enough to help craft an answer, and you don’t need them to tell you all the details, just the circumstances.” He adds, “You need to explain that this is not the time to keep things under wraps and that what they share can help you craft a solution for their loved one.” Building trust isn’t easy or quick. “It doesn’t happen on the first day. You need to wait for your moment,” Smith says.

Making the family part of the care team can strengthen relationships. Brubaker says, “I spend time talking to family and tell them how important their input is.”

Sometimes, as a result, miracles happen. He tells the story of one very sweet resident with dementia who suddenly stopped eating. “She was just dying in front of us,” he says. The team couldn’t find anything wrong with her. However, they thought she might be depressed, so they put her on an antidepressant. But they also got her daughter involved, and she began spending more time at the facility. Before long, the resident was eating and back to her old sweet self.

“I suspect the daughter and the antidepressant were equally responsible. You can’t have too much family involvement,” says Brubaker.

Arnicar agrees. “We had a resident who would get agitated every afternoon at about 2 or 3 p.m.,” she says.

“We talked to her family and found out she used to have a cocktail every day at that time.” The facility got an order for her to get a cocktail, and her agitation disappeared.

Establish Resident Profiles Early

While establishing these relationships can be time-consuming, it is well worth the effort. As Brubaker says, “We had a patient who couldn’t communicate because of a stroke. She became territorial, and staff couldn’t figure out what to do. So we contacted her family and found out that she had run a business before she got ill. She had been in control and used to giving orders.” Everyone agreed that she was acting out because she was frustrated that she had lost control. So her son told staff to call him anytime she acted up, and he would pretend to be taking orders from her. This resolved her behavior and created a bond between staff and family.

Obtaining and documenting information about the resident’s personality, history, interests, and pet peeves is important, and Smith is working on developing a form that family members or other responsible parties can complete.

“Written in fifth-grade language, it should include questions that help us get an idea of who this person was before he or she got dementia,” he says. If staff have this information early on, it can make all the difference in the world in terms of preventing triggers or responding effectively and quickly when there is a sentinel event. As Smith explains, “Knowing someone is intensely bigoted because he was a POW of the Japanese can help you understand why he goes on a tirade when a person of any ethnicity goes into his room.”

If it ultimately is determined that a resident needs antipsychotic medications, Wayne stresses the importance of communicating with the family members about why the drugs are being prescribed, what the advantages and risks are, and what specific behaviors are being targeted. Even though this is not required by law, he says, “When we prescribe these medications, there should be a consistent form to enable us to gain the understanding and buy-in of family members.”

During these or any conversations with family regarding behavioral or other dementia-related issues, Wayne says, “We always need to look for common ground. We need to communicate what we are trying to do and how it is in the best interest of the resident. If you couch these discussions in these terms, it gets everyone on the same page.”

Brubaker agrees that these conversations are valuable. “We call the family and explain to them why we want to use the medication,” he says. “Sometimes, they will say ‘no.’ But more often, they agree that it is important to do what is best for their loved one.”

Slow But Steady Journey

Hardesty hopes that the focus on antipsychotics will help create a more consistent approach to prescribing and using these drugs. “In the past, different facilities had different philosophies and approaches. There wasn’t always strong documentation around toxicity, diagnosis, goals, or outcomes,” she says.

Facilities now see that they need to have a template for an ongoing plan to make sure the diagnosis is correct, documentation is consistent and includes descriptions of behaviors and their circumstances, what non-pharmacologic interventions were attempted, target behaviors and treatment goals, results of monitoring (including side effects), and what dosage reduction efforts were pursued, Hardesty says.

“Facilities should keep a flow chart of when they last attempted a dose reduction. This should be clearly outlined so that surveyors have no questions,” she says, stressing that clear, concise, detailed, and consistent documentation will save the facility a lot of headaches.

Changing the way antipsychotics are viewed and used in long term care isn’t an easy puzzle to solve. Not every team player is Sherlock Holmes or even Dr. Watson.

It’s a process of change, and it won’t happen overnight. We have to redo our thinking,” says Leible.
Wayne suggests, “This really isn’t about antipsychotics. It’s about good quality, person-centered dementia care. For people to look at this as an antipsychotic issue is missing the point.”

Joanne Kaldy is a freelance writer and communications consultant based in Harrisburg, Pa.