Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings
Published: 2015-01-30T00:00:00

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Highlights:
section_title: Why GAO Did This Study
paragraphs: Dementia affects millions of older adults, causing behavioral symptoms such as mood changes, loss of communication, and agitation. Concerns have been raised about the use of antipsychotic drugs to address the behavioral symptoms of the disease, primarily due to the FDA's boxed warning that these drugs may cause an increased risk of death when used by older adults with dementia and the drugs are not approved for this use.
GAO was asked to examine psychotropic drug prescribing for older adult nursing home residents. In this report, GAO examined (1) to what extent antipsychotic drugs are prescribed for older adults with dementia living inside and outside nursing homes, (2) what is known from selected experts and published research about factors contributing to the such prescribing, and (3) to what extent HHS has taken action to reduce the use of antipsychotic drugs by older adults with dementia. GAO analyzed multiple data sources including 2012 Medicare Part D drug event claims and nursing home assessment data; reviewed research and relevant federal guidance and regulations; and interviewed experts and HHS officials.
section_title: What GAO Found
paragraphs: Antipsychotic drugs are frequently prescribed to older adults with dementia. GAO's analysis found that about one-third of older adults with dementia who spent more than 100 days in a nursing home in 2012 were prescribed an antipsychotic, according to data from Medicare's prescription drug program, also known as Medicare Part D. Among Medicare Part D enrollees with dementia living outside of a nursing home that same year, about 14 percent were prescribed an antipsychotic. (See figure.)
Experts and research identified patient agitation or delusions, as well as certain setting-specific characteristics, as factors contributing to the prescribing of antipsychotics to older adults. For example, experts GAO spoke with noted that antipsychotic drugs are often initiated in hospital settings and carried over when older adults are admitted to a nursing home. In addition, experts and research have reported that nursing home staff levels, particularly low staff levels, lead to higher antipsychotic drug use.
Agencies within the Department of Health and Human Services (HHS) have taken several actions to address antipsychotic drug use by older adults in nursing homes, as described in HHS's National Alzheimer's Plan; however, none have been directed to settings outside of nursing homes, such as assisted living facilities or individuals' homes. While the National Alzheimer's Plan has a goal to improve dementia care for all individuals regardless of residence, HHS officials said that efforts to reduce antipsychotic use have not focused on care settings outside nursing homes, though HHS has done work to support family caregivers in general. Stakeholders GAO spoke to indicated that educational efforts similar to those provided for nursing homes should be extended to other settings. Extending educational efforts to caregivers and providers outside of the nursing home could help lower the use of antipsychotics among older adults with dementia living both inside and outside of nursing homes.
section_title: What GAO Recommends
paragraphs: GAO recommends that HHS expand its outreach and educational efforts aimed at reducing antipsychotic drug use among older adults with dementia to include those residing outside of nursing homes by updating the National Alzheimer's Plan. HHS concurred with this recommendation.

section_title: Letter
paragraphs: Dementia affected almost 15 percent of older adults in the United States  in 2010, according to an estimate from the RAND Corporation. RAND  estimated that the total monetary cost for caring for individuals with  dementia was between $157 billion and $215 billion, of which the  Medicare program paid around $11 billion. Furthermore, RAND  estimated that dementia costs will more than double by 2040 due to the  aging of the American population. While dementia is most commonly  associated with a decline in memory, it can also cause changes in mood  or personality, loss of communication, and, at times, agitation or  aggression. These behavioral symptoms can become challenging for  caregivers, both at home and in institutions such as nursing homes. To  manage these behaviors, antipsychotic drugs are sometimes prescribed.  Although experts indicate that an appropriate rate of prescribing of  antipsychotic drugs cannot be determined given that the clinical decision  to prescribe antipsychotics is based on individual patient factors, many  believe that prescribing rates for these drugs, particularly for nursing  home residents with dementia, have been too high.
Concerns have been raised about the use of antipsychotic drugs to  address behavioral symptoms—such as agitation or aggression—in older  adults. While a large proportion of prescriptions for antipsychotic drugs in  this population are used to treat behavioral symptoms, these drugs are  not approved for this use, and antipsychotic drugs have health risks. In  2011, the Department of Health and Human Services (HHS) Office of  Inspector General (OIG) reported that a large percentage—88 percent— of a 2007 sample of 1.4 million Medicare claims for newer antipsychotic  drugs for older adult nursing home residents was associated with a  dementia diagnosis. The Food and Drug Administration (FDA)—tasked  with approving drugs to be marketed in the United States—has not  approved these drugs to treat the behavioral symptoms of dementia,  although it has generally approved antipsychotic drugs to treat  schizophrenia and bipolar disorder. Furthermore, these drugs have been  found to cause falls and other adverse events, including an increased risk  of death, among older adults with a diagnosis of dementia. All  antipsychotic drugs carry an FDA-required boxed warning stating that  they are associated with an increased risk of death when used to treat   Physicians are not  older adults with dementia-related psychosis.prohibited from prescribing antipsychotic drugs in the presence of  dementia despite the boxed warning, nor are they prohibited generally  from prescribing a drug for uses other than what the FDA has approved.  Otherwise known as off-label prescribing, this practice is common in the  United States, and Medicare Part D covers drugs prescribed off-label in  some cases.
Less is known about antipsychotic prescribing in settings outside of the  nursing home, but one study estimated that out of a sample of older  adults with dementia living outside of a nursing home, close to one in five  took an antipsychotic between 2002 and 2004. has an interest in improving dementia care for individuals living both  inside and outside nursing homes. The National Alzheimer’s Project Act,  enacted in January 2011, required HHS to establish the National  Alzheimer’s Project to create and maintain an integrated plan to  overcome Alzheimer’s disease, including related dementias. HHS  developed its first National Alzheimer’s Plan in 2012, and it includes a  number of actions to improve systems of care and service delivery to  individuals with dementia.
Y. Rhee, J. G. Cernansky, L. L. Emanuel, C. G. Chang, and J. W. Shega, “Psychotropic  Medication Burden and Factors Associated with Antipsychotic Use: An Analysis of a  Population-Based Sample of Community-Dwelling Older Persons with Dementia,” Journal  of the American Geriatrics Society, vol. 59, no. 11 (2011). research about factors contributing to the prescribing of antipsychotic  drugs to older adults with dementia; and (3) to what extent HHS has  taken action to reduce the use of antipsychotic drugs in older adults with  dementia.
To estimate the extent to which older adults residing inside and outside of  nursing homes are prescribed antipsychotic drugs, we first analyzed  Medicare Part D Prescription Drug Event (PDE) data for individuals with  dementia in 2012. We used the Medicare Part D PDE data because  Medicare is the primary source of insurance coverage for individuals over  the age of 65, and approximately 63 percent of Medicare beneficiaries  were enrolled in Medicare Part D in 2012. To identify individuals living in  nursing homes, we combined the PDE claims data with 2012 data from  the Long Term Care Minimum Data Set (MDS), which includes nursing  home assessments for all individuals living in nursing homes, regardless  of insurance coverage. We also used data from the Medicare Master  Beneficiary Summary File (MBSF), as well as the Medicare Part D Risk  File to identify diagnoses, including dementia diagnoses and diagnoses  for certain conditions for which FDA has approved the use of  antipsychotics drugs. We excluded from our estimates individuals with  dementia also diagnosed with one of these FDA-approved conditions for  antipsychotic drugs—schizophrenia and bipolar disorder. We define an  individual as having been prescribed an antipsychotic drug if they were  prescribed at least one prescription for an antipsychotic drug during the  year, regardless of how many days’ supply are covered by the  prescription. Within the nursing home population, our analysis of PDE  claims specifically identified those with a long stay in the nursing home— defined by the Centers for Medicare & Medicaid Services (CMS) as more  than 100 days—because drugs for individuals with short stays—100 days  or less—are generally covered under Medicare Part A, not Part D. We  identified antipsychotic prescriptions in the PDE claims data by examining  relevant national drug codes (NDC) using a list of generic names for  antipsychotic drugs. We disaggregated the data to examine certain  characteristics, such as gender, age, and geographic location.
To supplement our analysis of the Medicare Part D data for the nursing  home population, we also analyzed data on antipsychotic prescribing and  diagnoses among nursing home residents available in the MDS. This  allowed us to look at a more comprehensive population of nursing home  residents—all residents in a Medicare or Medicaid certified nursing  home—and to examine prescribing rates by length of stay. analysis, we determined an individual was prescribed an antipsychotic  drug if any nursing home assessment during 2012 indicated the resident  took an antipsychotic drug during the previous 7 days. In addition to  excluding residents with dementia also diagnosed with schizophrenia and  bipolar disorder, we also excluded residents with Tourette syndrome, a  condition for which FDA has approved the use of certain antipsychotics,  as well as Huntington’s disease, a condition for which CMS guidance has  recognized antipsychotics as an acceptable treatment.with dementia and at least one of these diagnoses accounted for about   7 percent of nursing home residents with dementia overall.
Nearly all of the 15,700 nursing homes providing long term care services in the United  States participated in the Medicare and Medicaid programs in 2012. antipsychotic drug claims under Medicare Part D in 2012 to calculate the  share of plan payments for prescriptions from the specialties with the  most antipsychotic prescribing for individuals with dementia.details on the data analyses, see appendix I.
We ensured the reliability of the MDS data, Medicare PDE claims data,  Medicare Part D Risk File data, MBSF data, and NPPES data used in this  report by performing appropriate electronic data checks, reviewing  relevant documentation, and interviewing officials and representatives  knowledgeable about the data, where necessary. We found the data were  sufficiently reliable for the purpose of our analyses.
To examine what is known from selected experts and published research  about factors contributing to the prescribing of antipsychotic drugs to  older adults with dementia, we interviewed experts in the field of dementia  care and conducted a literature review. We used a snowball sampling  approach to identify industry, provider, and advocacy groups, as well as  research experts, with experience or work on the subject of antipsychotic  drug use among older adults. We interviewed two to five groups within  each category of expert groups and asked them about contributing  factors. We also conducted a literature review to identify original research  on factors associated with prescribing antipsychotic drugs to older adults.  We searched for relevant articles published in peer-reviewed journals  from January 2009 through March 2014 and excluded international  research. We also included articles published within our timeframe that  were identified through our interviews. We found a total of 42 articles that  met our inclusion criteria; after reviewing those articles, we found  contributing factors cited in 18 articles. For more details on the literature  review and a list of the articles identified, see appendix II.
To identify the extent to which HHS has taken action to reduce  prescribing of antipsychotic drugs to older adults, we spoke with officials  from agencies within HHS, including CMS, FDA, the Administration for  Community Living (ACL), the National Institutes of Health’s (NIH)
National Institute on Aging and National Institute of Mental Health, and  the Agency for Healthcare Research and Quality (AHRQ). We also  reviewed relevant federal regulations, CMS nursing home guidance,  agency Web pages, and other federal documents, such as the National  Alzheimer’s Plan.
We conducted this performance audit from January 2014 through January  2015 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
subsections: section_title: Antipsychotic Drug Classification and FDA- Approved Uses
paragraphs: Antipsychotic drugs are classified into two sub-groups. The first group, or  generation, of antipsychotic drugs—also known as “conventional” or  “typical” antipsychotic drugs—was developed in the mid-1950s. Examples  include haloperidol (Haldol®) and loxapine (Loxitane®). The second  generation of antipsychotic drugs, known as “atypical” antipsychotics, was  developed in the 1980s. Examples include aripiprazole (Abilify®) and  risperidone (Risperdal®). Atypical antipsychotics became more popular  upon their entry into the market due to the initial belief that these drugs  caused fewer side effects than the conventional antipsychotics. Each  antipsychotic drug has its own set of FDA-approved indications. The  vast majority of antipsychotic drugs are FDA-approved for the treatment  of schizophrenia, and most atypical antipsychotic drugs are FDA- approved for the treatment of bipolar disorder. In addition, some  antipsychotics are FDA-approved for the treatment of Tourette syndrome.  CMS guidance to state nursing home surveyors also recognizes  antipsychotics as an acceptable treatment for conditions for which the  drugs have not been FDA-approved, such as for the treatment of  Huntington’s disease.
In 2005, FDA recognized the risks associated with atypical antipsychotic  drugs and required those drugs to have a boxed warning, citing a higher  risk of death related to use among those with dementia. In 2008, FDA  recognized similar risks for conventional antipsychotic drugs and required  the same boxed warning. Besides the risks described in the boxed  warning, use of antipsychotic drugs carries risks of other side effects,  such as sedation, hypotension, movement disorders, and metabolic  syndrome issues.
section_title: Treatment Approaches for Behavioral Symptoms of Dementia
paragraphs: Clinical guidelines consistently suggest the use of antipsychotic drugs for  the treatment of the behavioral symptoms of dementia only when other,  non-pharmacological attempts to ameliorate the behaviors have failed,  and the individuals pose a threat to themselves or to others. For  example, AMDA–The Society for Post-Acute and Long-Term Care  Medicine suggests first assessing the scope and severity of the behavior  and identifying any environmental triggers for the behavior. A medical  evaluation may determine whether the behavioral symptoms are  associated with another medical condition, such as under-treated arthritis  pain or constipation. In its clinical guideline, AMDA cited conflicting  evidence surrounding the effectiveness of antipsychotic drugs in treating  the behavioral symptoms of dementia.found significant improvement in symptoms with the treatment of certain  atypical antipsychotic drugs, but also noted that other reviews signaled  there were no significant differences attributable to atypical antipsychotic  drugs.
It noted one evidence review that  Other non-pharmacological interventions that can be attempted prior to  the use of antipsychotic drugs may focus on emotions, sensory  stimulation, behavior management, or other psychosocial factors. An  example of an emotion-oriented approach is Reminiscence Therapy,  which involves the recollection of past experiences through old materials  with the intention of enhancing group interaction and reducing  depression. An example of a sensory stimulation approach is Snoezelen  Therapy, which typically involves introducing the individual to a room full  of objects designed to stimulate multiple senses, including sight, hearing,  touch, taste, and smell. This intervention is based on the theory that  behavioral symptoms may stem from sensory deprivation. A 2012 white  paper published by the Alliance for Aging Research and the  Administration on Aging, a part of the ACL, noted that advancements  have been made with regards to the evidence base supporting some non- pharmacological interventions, but that evidence-based interventions are   Experts referenced in the white paper identified  not widely implemented.the need for clearer information about the interventions, such as a system  to classify what interventions exist and who might benefit from those  interventions. Experts also noted that additional research is needed to  develop effective interventions.
section_title: Federal Nursing Home Standards and Regulations
paragraphs: Federal law requires nursing homes to meet federal quality and safety  standards, set by CMS, to participate in the Medicare and Medicaid  programs. CMS regulations require nursing homes to ensure that  residents’ drug therapy regimens are free from unnecessary drugs, such  as medications provided in excessive doses, for excessive durations, or   Nursing facility staff must assess  without adequate indications for use.each resident’s functional capacity upon admission to the facility and  periodically thereafter, and provide each resident a written care plan.  Based on these assessments, nursing homes must ensure that  antipsychotics are prescribed only when necessary to treat a specific  condition diagnosed and documented in the patient’s record, and that  residents who use antipsychotic drugs receive gradual dose reductions  and behavioral interventions, unless clinically contraindicated. Part of the  nursing home survey process, otherwise known as nursing home  inspections, involves audits of these care plans and assessments.
section_title: Approximately 33 Percent of Older Adult Medicare Part D Enrollees with Dementia Who Resided in a Nursing Home, and 14 Percent Outside of a Nursing Home, Were Prescribed Antipsychotic Drugs in 2012
paragraphs: About one-third of older adult Medicare Part D enrollees with dementia  who spent over 100 days in a nursing home were prescribed an  antipsychotic drug in 2012. Among those Medicare Part D enrollees with  dementia who spent no time in a nursing home in 2012, we found that  about 14 percent were prescribed an antipsychotic. In total, Medicare   Part D plans paid roughly $363 million in 2012 for antipsychotic drugs  prescribed for older adult Medicare Part D enrollees with dementia.
subsections: section_title: Roughly One-third of Older Adult Nursing Home Residents with Dementia Were Prescribed an Antipsychotic Drug in 2012
paragraphs: We found that about 33 percent of Medicare beneficiaries with dementia  who were enrolled in a Part D plan and had a long stay in a nursing  home—defined as over 100 cumulative days—were prescribed an  antipsychotic in 2012. (See table 1.) We also found that prescribing  rates for Medicare Part D enrollees with dementia who were nursing  home residents varied somewhat by resident characteristic:
Male enrollees were slightly more likely to have been prescribed   an antipsychotic drug than female enrollees—about 36 percent and  32 percent, respectively.
The prescribing rate declined as Medicare Part D enrollee age  increased. For example, about 41 percent of those Medicare Part D  enrollees aged 66 to 74 received an antipsychotic prescription,  compared to 29 percent of those enrollees aged 85 and older who  were prescribed an antipsychotic drug.
The prescribing rate for antipsychotic drugs was highest for enrollees  in the South, and lowest for enrollees in the West.
We found slightly lower rates of antipsychotic drug prescribing when we  restricted our analysis to those enrollees with three or more 30-day  supply prescriptions during 2012. Specifically, about 28 percent of long- stay Medicare Part D enrollees with dementia were given three or more  30-day supply prescriptions for an antipsychotic drug over the course of  2012. We also found that the majority of prescriptions given to those long- stay Medicare Part D enrollees with dementia—about 68 percent—were  for seven or more 30-day supplies of the drug, while only 3 percent were  for less than one 30-day supply.
Consistent with the findings for Medicare Part D enrollees, our analysis of  MDS data showed that approximately 30 percent of all older adult nursing  home residents—regardless of enrollment in Medicare Part D—with a  dementia diagnosis were prescribed an antipsychotic drug at some point  during their 2012 nursing home stay. (See fig. 1.) Residents with  dementia accounted for a significant proportion of all nursing home  residents. In 2012, about 38 percent, or almost 1.1 million of the   2.8 million nursing home residents that year, were diagnosed with  dementia.
Examining this more comprehensive database of nursing home residents  also allowed us to compare the antipsychotic drug prescribing rates of  long-stay residents and short-stay residents—those residents who spent  100 days or less in the nursing home. The proportion of residents  diagnosed with dementia who were prescribed an antipsychotic drug   was greater for long-stay residents than for short-stay residents (about   33 percent versus 23 percent, respectively). (See table 2.) Variation in  prescribing rates across resident characteristics was similar to the  variation found in the Medicare Part D enrollee long-stay nursing home  population.
section_title: One in Seven Older Adult Medicare Part D Enrollees with Dementia Living Outside of Nursing Homes Were Prescribed an Antipsychotic Drug in 2012
paragraphs: Of those Medicare Part D enrollees with dementia in settings outside of  the nursing home, about one in seven (14 percent) were prescribed an  antipsychotic. (See fig. 2.) Roughly 1.2 million of the 20.2 million older  adult Medicare Part D enrollees living outside of a nursing home in 2012  had a diagnosis of dementia—just above 6 percent.
The rate of antipsychotic drug prescribing among older adult Medicare  Part D enrollees with dementia was lower for those living outside of  nursing homes, compared to those living in nursing homes, given that  residents of nursing homes are generally sicker than those living outside  of nursing homes. We also found that the pattern of variation in  antipsychotic drug prescribing for Medicare Part D enrollees outside of a  nursing home for certain characteristics was different from the pattern of  variation found in the nursing home population.
The proportion of Medicare Part D enrollees outside of nursing homes  diagnosed with dementia who were prescribed an antipsychotic drug  was higher for older enrollees—the opposite of the pattern found in  the nursing home setting. (See table 3.)
The prescribing rate was also higher for female enrollees outside of  the nursing home than for male enrollees, whereas the opposite was  true in the nursing home setting.
The prescribing rate for enrollees with dementia outside of the nursing  home changed less depending on enrollee location than those in  nursing homes.
We found slightly lower rates of antipsychotic drug prescribing for  Medicare Part D enrollees outside of the nursing home when we  restricted our analysis to those enrollees with three or more 30-day  supply prescriptions. Specifically, about 11 percent of enrollees outside of  the nursing home received three or more prescriptions for antipsychotic  drugs over the course of 2012. About 58 percent of antipsychotic  prescriptions for Medicare Part D enrollees with dementia living outside of  a nursing home were for seven or more 30-day supplies of the drug, while  only 3 percent were for less than a 30-day supply.
section_title: Medicare Part D Plan Payments for Antipsychotic Drugs Prescribed to Older Adult Enrollees with Dementia Totaled $363 Million in 2012
paragraphs: Medicare Part D plans paid roughly $363 million in 2012 for antipsychotic  drugs used by Medicare Part D enrollees with dementia aged 66 and  older. (See table 4.) Medicare Part D spending on antipsychotic drugs  for Medicare Part D enrollees living outside of a nursing home with a  dementia diagnosis totaled almost $171 million in 2012, the same as  spending for long-stay nursing home enrollees with dementia. Payments  for short-stay nursing home enrollees may be low because often  Medicare Part A covers drugs administered during short, post-acute stays  in nursing homes. Medicare Part D plans consistently spent more than  double on antipsychotic prescriptions for female enrollees than for male  enrollees; as reported in table 1, the number of female Medicare Part D  enrollees using antipsychotic drugs was also over two times that of  males.
Internal medicine, family medicine, and psychiatry or neurology  physicians prescribed the greatest proportion of antipsychotic drug  prescriptions for older adult Medicare Part D enrollees with dementia— about 82 percent in total. Antipsychotic drugs prescribed by these  specialties also made up about 82 percent of the Medicare Part D plan  payments for antipsychotic drugs—almost $298 million in plan payments.  Antipsychotic prescriptions from internal medicine physicians comprised  36 percent of Medicare Part D plan payments for antipsychotic drugs,  while family medicine and psychiatry or neurology prescriptions  comprised about 30 and 16 percent, respectively. Nurse practitioner and  physician assistant prescriptions collectively accounted for almost   5 percent of antipsychotic drug claim payments, while the remaining   13 percent encompassed many specialties.
Quetiapine Fumarate, Risperidone, and Olanzapine were the most  commonly prescribed antipsychotic drugs for older adult Medicare Part D  enrollees with dementia in 2012, comprising approximately $246 million in  plan payments. (See table 5.) Haloperidol and Aripiprazole were also  commonly prescribed; these two drugs were prescribed to almost 9 and   6 percent of Medicare Part D enrollees with dementia, respectively.
section_title: Experts and Research Commonly Cited Certain Patient and Setting-Specific Factors Contributing to the Prescribing of Antipsychotic Drugs to Older Adults
paragraphs: Experts we spoke with and research we reviewed commonly identified  certain factors that are specific to the patient that contribute to  antipsychotic prescribing, such as patient agitation or delusions. Experts  and research also identified certain contributing factors that are specific to  settings, such as to nursing homes or hospitals.
subsections: section_title: Experts and Research Identified Patient-Specific Factors, Such As Agitation or Delusions, That Contribute to the Decision to Prescribe Antipsychotic Drugs
paragraphs: The majority of experts we spoke with and some research articles we  reviewed highlighted agitation, aggression, or exhibiting a risk to oneself  or others as factors that contribute to the decision to prescribe  antipsychotics. For example, in a study examining the MDS from 1999 to  2006 in eight states, 51 percent of aggressive nursing home residents  diagnosed with dementia were prescribed antipsychotic drugs in 2006, as  opposed to 39 percent of residents with behavioral symptoms but who  were not aggressive during that same time period. The study suggested  that aggressive residents may have been more likely to be prescribed  antipsychotics because of the greater risk of injury associated with the  aggressive behavior. This is consistent with findings from our analysis of  nursing home assessment data; we found that, of residents diagnosed  with dementia and documented as being a risk to themselves or others,  61 percent had an antipsychotic drug prescription in 2012.
Many experts we interviewed identified other situations that may warrant  the use of antipsychotics despite their risk, such as patients experiencing  frightening delusions or hallucinations that cause the patient to act out in  ways that may be violent or harmful. Several experts noted that  individuals experiencing these psychotic and other behaviors may be  suffering from distress and are more likely to be prescribed antipsychotic  drugs to ease their distress and improve their quality of life. For  example, individuals may injure themselves or strike another resident or  staff member because of delusions that these people intend to kill them.  A few research articles identified psychotic behaviors as a contributing  factor. For instance, one study that examined medical records of more  than 200 nursing home residents with dementia found that 47 percent of  residents who were on an antipsychotic also had a diagnosis of  psychosis.
The research we reviewed also cited other specific patient characteristics  associated with higher antipsychotic use in dementia patients. Patient  characteristics such as age, gender, race or ethnicity, and psychiatric  diagnoses were associated with higher antipsychotic prescribing in  several articles. For example, in one study of nursing home assessments  and Medicaid drug claims from seven states, researchers found that  nursing home residents with psychiatric co-morbidities, such as anxiety  and depression without psychosis, were more likely to be prescribed   Male gender was also mentioned as a patient  antipsychotic drugs. characteristic associated with higher antipsychotic prescribing in three  research articles. In our analyses of 2012 Medicare data, males had a  higher prescribing rate in the nursing home, while females had a higher  rate outside of the nursing home. Finally, one article found that black  nursing home residents were more likely to be prescribed antipsychotic  drugs, while another article found that black residents were less likely to  receive them when compared to white residents.
section_title: Experts and Research Identified Setting-Specific Factors That Contribute to Antipsychotic Prescribing
paragraphs: Experts and research identified factors within the setting that an individual  visits or resides in, such as nursing homes or hospitals, as contributing to  the decision to prescribe antipsychotic drugs to older adults. Among  nursing homes, experts and research cited factors, including the culture  of the facility, the level of staff training and education, and the number of  staff at the nursing home, as contributing to the decision to prescribe  antipsychotic drugs to older adults. Specifically, nursing home  leadership—such as administrators and medical directors—and culture  were cited by half of the experts and two of the research articles. An  expert told us that when the leadership of the nursing home believes it is  broadly acceptable to provide antipsychotic drugs to residents with  dementia, this belief spreads throughout the facility. One study examining  variation in antipsychotic use in nursing homes looked at the pharmacy  claims and nursing home assessments of more than 16,000 residents in  1,257 nursing homes.admitted to facilities with high antipsychotic prescribing rates were   1.4 times more likely to receive antipsychotics, even after controlling for  patient-specific factors.
The study found that new nursing home residents  In addition to nursing home culture and leadership, many experts and two  research articles identified staff or prescriber education and training on  antipsychotic prescribing for individuals with dementia as affecting  antipsychotic drug prescribing. One industry group we spoke with  indicated that physician training specifically regarding older adults with  dementia in nursing homes and knowledge of related federal regulations  are often lacking. Similarly, a study in 68 nursing homes in Connecticut  examining knowledge of nursing home leaders and staff, who often set  the tone for prescribing antipsychotic drugs and observing patients’  behavioral symptoms, found most of the certified nursing assistants—  96 percent—were not aware of the serious risks to residents that can  result from antipsychotic use. The study also found that 56 percent of  direct-care staff believed medications worked well to manage resident  behavior. Another article reported that antipsychotic drug prescribing for  individuals with dementia decreased from 20.3 to 15.4 percent in one  nursing home after the implementation of an educational in-service  training designed to reduce the inappropriate use of antipsychotic  prescribing and increase documentation of non-pharmacological  interventions.factor that can contribute to minimizing unnecessary antipsychotic  prescribing. One provider group noted that, in order to reduce  antipsychotic use, a facility would need to invest in professional training  for staff in a way that provides information about adequate alternatives to  antipsychotic drugs.
In expert interviews, education of staff was identified as a  Nursing home staffing levels, specifically low staff levels, were also cited  as a contributing factor to antipsychotic drug use in one research article  and by a few experts. For example, one study examined more than 5,000  nursing homes and 561,000 residents by linking 2009 and 2010  prescription drug claims to the Nursing Home Compare database to  identify a nationwide pattern of antipsychotic drug use. The study found  the nursing homes with the highest quintiles of antipsychotic drug use had  significantly less staff than those with the lowest quintiles. An expert  group noted that nursing homes with less staff may not have enough  activities and oversight for the patients, which in turn may make the  nursing home residents susceptible to higher antipsychotic drug use.
In addition, the majority of experts we spoke with told us that entering a  nursing home from a hospital is a factor leading to higher antipsychotic  prescribing in the nursing home. These experts agreed that antipsychotic  drugs are often initiated in hospital settings and carried over to nursing  home settings. One industry group we spoke with noted that individuals  with dementia go to the hospital frequently and can be prescribed an  antipsychotic drug if they exhibit disruptive behavior. Another industry  group attributed the actual prescribing of antipsychotic drugs to hospital  care culture and stated that the prescribing of antipsychotics is a common  practice in hospitals for treating individuals with dementia. A research  study that examined the medical charts of 73 residents in seven nursing  homes found 84 percent of the residents that had been admitted to the  nursing home from the hospital were admitted on at least one  psychoactive medication—including antipsychotics.
Finally, experts we spoke with indicated that caregivers’ frustration with  the behavior of individuals with dementia can lead to requests for  antipsychotic drugs. For example, an advocacy group we spoke with  mentioned that a caregiver may request an antipsychotic drug for an  individual with dementia in an effort to keep them in the home. The  individual with dementia may not recognize their relative, which can  cause them agitation. To keep the individual calm so that they can stay in  the home and not be placed in a nursing home, an antipsychotic  medication may be prescribed. Representatives from another provider  group explained that when an individual with dementia has an unmet  need, they may also appear to be in distress, which may cause the  caregiver to become frustrated because they do not know how to relieve  this distress.
section_title: HHS Agencies’ Actions Focused on Reducing Antipsychotic Drug Use by Older Adults with Dementia Target Nursing Home Residents, Not Those in Other Settings
paragraphs: HHS agencies, including CMS, AHRQ, and NIH, have taken actions to  address antipsychotic drug use by older adults with dementia in nursing  homes. However, HHS has done little to address antipsychotic drug use  among older adults with dementia living in settings outside of the nursing  home.
subsections: section_title: HHS Has Several Initiatives Focused on Reducing Antipsychotic Drug Use by Older Adult Nursing Home Residents
paragraphs: Under the National Plan to Address Alzheimer’s Disease, HHS has a goal  to expand support for people with Alzheimer’s disease and their families  with emphasis on maintaining the dignity, safety, and rights for those  suffering from this disease. To reach this goal, HHS outlined several  actions, including monitoring, reporting, and reducing the use of  antipsychotics drugs by older adults in nursing homes. CMS has taken  the lead in carrying out this work. Other HHS agencies have also done  work related to reducing antipsychotic drug use in nursing homes.
subsections: section_title: CMS Actions
paragraphs: In 2012, CMS launched the National Partnership to Improve Dementia  Care in Nursing Homes with federal and state agencies, nursing homes,  providers, and advocacy organizations. This was in response to several  reports dating back to 2001 published by the HHS Inspector General and  advocate concerns about the persistently high rate of antipsychotic drug  use and quality of care provided to nursing home residents with dementia.
The National Partnership began with an initial goal of reducing the  national prevalence of antipsychotic drug use in long-stay nursing home  residents by at least 15 percent by December 31, 2012. CMS used  publicly reported measures from the Nursing Home Compare website to  track the progress of the National Partnership and, according to officials,  to reach out to those states and individual facilities with high prescribing  rates. In the fourth quarter of 2011, which was deemed the baseline,   23.8 percent of long-stay nursing home residents nationwide were  prescribed an antipsychotic drug. While the National Partnership did not  reach its target reduction in 2012, by the end of 2013 the national use  rate decreased to 20.2 percent, a 15.1 percent reduction. The majority  of states showed some improvements in their rates; however some states  showed much more improvement than others. For example, Delaware  showed a 27 percent reduction—from 21.3 to 15.5 percent—in the  prevalence of antipsychotic drug use from 2011 through 2013, while  Nevada saw a smaller reduction of 2.7 percent—from 20.3 to   19.7 percent—during the same period. The National Partnership is  working with state coalitions, as well as nursing homes to reduce this rate  even further. In September 2014, CMS established a new set of national  goals to reduce the use antipsychotic drugs in long-stay nursing home  residents by 25 percent by the end of 2015 and 30 percent by the end of  2016, which, assuming a baseline of 23.8 percent, would lead to a  prescribing rate of 16.7 percent. Beginning in January 2015, CMS’s Five- Star Quality Rating System for nursing homes will be based, in part, on  this measure of the extent to which antipsychotic drugs are used in the  nursing home. The Five-Star Quality Rating System provides a way for  consumers to compare nursing homes on the Medicare Web site.  Previously, the measure was displayed, but not included in the calculation  of each nursing home’s overall quality score.
Person-centered care is an approach to care that focuses on residents as individuals  and supports caregivers working most closely with them. It involves a continual process of  listening, testing new approaches, and changing routines and organizational approaches  in an effort to individualize and de-institutionalize the care environment.
Medicare beneficiaries, and Advancing Excellence in America’s Nursing  Homes Campaign, a major initiative of the Advancing Excellence in Long  Term Care Collaborative. The National Partnership includes regular  conference calls with states, regions, and advocates, and presentations  by experts in the field, to share best practices and brainstorm ways to  improve dementia care in their facilities.
In addition, CMS has taken four additional actions that aim to reduce  antipsychotic drug use among older adults in nursing homes:
CMS provided additional guidance and mandatory training around  behavioral health and dementia care from 2012 through 2013 to the  state surveyors responsible for reviewing and assessing nursing  homes. This was done in order to improve surveyors’ ability to identify  the use of unnecessary drugs, including inappropriate use of  antipsychotic drugs.
QIOs have focused some of their efforts on reducing antipsychotic  drug use in nursing homes. For example, beginning in 2013, the QIOs  provided training to nearly 5,000 nursing homes on the appropriate  use of antipsychotic medications.
CMS recently concluded pilots of a new dementia-focused survey that  examines the use of antipsychotic drugs to older adults with dementia  living in nursing homes. CMS reported that the focused survey pilot  results will allow the agency to gain new insight about the current  survey process, including how the process can be streamlined to  more efficiently and accurately identify and cite deficient practices as  well as to recognize successful dementia care programs. The pilot  consisted of onsite, targeted surveys of dementia care practices in  five nursing homes in each of five states.
CMS began reporting the rate of chronic use of atypical antipsychotic  drugs by older adult Medicare beneficiaries living in nursing homes for   This information is publicly available  Medicare Part D plans in 2013.on the Medicare Part D Compare Website, which is used by Medicare  beneficiaries comparing Medicare Part D plans. The measure used for  Medicare Part D plans differs in a few respects from the measure  used to assess nursing homes. First, the Medicare Part D measure  examines chronic use, defined as having at least 3 months or more of  a prescription for an atypical antipsychotic drug, whereas the nursing  home measure includes any use. Additionally, the Medicare Part D  measure only includes atypical antipsychotic drugs, compared to the  nursing home measure, which includes all antipsychotic drugs. Of the  421 Medicare Part D plans reporting in 2012, the rate of use among  Medicare Part D enrollees residing in nursing homes ranged from 0 to  almost 64 percent. The average among all Medicare Part D plans in  2012 was approximately 22 percent of enrollees residing in nursing  homes having at least 3 months or more of a prescription. CMS told  us that variation in antipsychotic prescribing among Medicare Part D  plans may be explained by the prescribing practice in the plan’s  service area, nursing home willingness to allow the use of  antipsychotic drugs for the behavioral symptoms of dementia, resident  need, and success in implementing interventions to reduce the  inappropriate use of antipsychotic drugs.
section_title: Actions of Other HHS Agencies
paragraphs: In addition to CMS actions, AHRQ and NIH have awarded research  grants for work related to antipsychotic drug use by older adults with  dementia in nursing homes.
AHRQ has funded individual grants for work related to antipsychotic  drug use in nursing homes through its Center for Evidence and  Practice Improvement and the Centers for Education & Research on  Therapeutics (CERT) program. For example, in 2011, CERT funded  several project centers for a 5-year period to study a broad range of  health care issues, including Rutgers University, which studied  patterns of antipsychotic drug use, along with the safety and  effectiveness of antipsychotic drug use for individuals living in nursing  homes.
Within the NIH, the National Institute on Aging and the National  Institute of Mental Health have also funded related research, including  a number of studies examining the safety of antipsychotic drugs in  older adults.
Some stakeholders and other provider groups we spoke with expressed  overall support of HHS’s efforts, while others cautioned that the emphasis  should not curtail access to those individuals who need antipsychotic  drugs. Specifically, stakeholders indicated that the collaboration between  public and private organizations, as part of the National Partnership,  along with the sharing of practices aimed at reducing antipsychotic drug  use, contributed to the campaign’s success. Stakeholders also mentioned  that the National Partnership allowed nursing homes to pay attention and  start talking about issues related to antipsychotic drug use. Some  stakeholders further indicated that HHS’s initiatives have brought focus to  the issue of antipsychotic drug use in older adults in nursing homes.  Conversely, other groups and individuals involved in HHS’s efforts  expressed concern that the emphasis on reducing antipsychotic drug use  in nursing homes could result in some individuals who need these  medications not receiving them. One researcher we spoke with noted that  because nursing homes’ use of antipsychotic drug use is measured and  publicly reported, these facilities may be worried about their antipsychotic  drug rate and focus on the bottom-line number instead of what is good for  the individual. CMS officials told us that they are careful in their  messaging to acknowledge that antipsychotic drugs have a useful  prescribing purpose and therefore will never be totally eliminated. They  are working with providers to develop a comprehensive view of what a  patient potentially needs, emphasizing that using antipsychotic drugs  should not be the first-line intervention.
section_title: HHS Has Taken Little Action to Educate and Provide Outreach to Reduce Antipsychotic Drug Use among Older Adults Residing Outside of Nursing Homes
paragraphs: While the National Alzheimer’s Plan was established to improve care for  all individuals with dementia regardless of the setting where they reside,  HHS efforts related to reducing antipsychotic drug use among older  adults have primarily focused on those living in nursing homes with less  activity geared toward those living outside of nursing homes. HHS  officials noted that the focus has been on reducing antipsychotic drug use  rates in nursing homes for a variety of reasons, including the severity of  dementia among nursing home residents and the agency’s responsibility  to ensure appropriate training of nursing home staff. However, the risk of  antipsychotic drugs to older adults is not specific to those in nursing  homes. Furthermore, we found that 1 in 7 Medicare Part D enrollees with  dementia outside of the nursing home were prescribed an antipsychotic  drug in 2012.
We identified one activity by HHS’s ACL that examined a topic related to  the use of antipsychotic drugs, specifically the use of non- pharmacological interventions in the treatment of individuals with  dementia. In 2012, ACL partnered with a research group to conduct a  study on non-pharmacological treatments and care practices for  individuals with dementia and their caregivers. The study results were  presented in a white paper and disseminated on the ACL’s Web page.  ACL also included the study results in a newsletter distributed to state  organizations on aging. ACL officials also told us that they participate in  the National Partnership as a stakeholder organization, including  reviewing the training materials that were distributed to nursing homes.  However, ACL officials told us that none of their other past activities have  dealt specifically with reducing antipsychotic drug use among older adults  outside of nursing homes.
While ACL has not focused on reducing antipsychotic drug use among  older adults outside of nursing homes, ACL is responsible for other parts  of the National Alzheimer’s Plan related to improving dementia care in the  community. ACL partners with national groups to share information on  dementia-related issues such as caring for minority populations with  dementia and preventing elder abuse and neglect. As part of this work,  ACL works with organizations, such as the Alliance for Aging Research  and the National Family Caregiver Alliance, to share research, host  webinars and presentations, and promote issues through social media.  ACL also funds grants for state long-term care ombudsmen that are  responsible for advocating for older adults living in nursing homes,  assisted living facilities, and other residential settings for older adults.
Stakeholder groups we spoke to indicated that educational efforts similar  to those provided under the National Partnership should be extended to  those providing care to older adults in other settings, such as hospitals  and assisted living facilities. Some stakeholders noted that some of the  same material regarding non-pharmacological interventions could be  shared with caregivers in these other care settings.
Many experts we spoke with said that many nursing home residents  come to the nursing home already on an antipsychotic drug. Extending  educational efforts to caregivers and providers outside of the nursing  home could help lower the use of antipsychotics among older adults with  dementia living both inside and outside of nursing homes.
section_title: Conclusion
paragraphs: The decision to prescribe an antipsychotic drug to an older adult with  dementia is dependent on a number of factors, according to experts in the  field, and must take into account the possible benefits of managing  behavioral symptoms associated with dementia against potential adverse  health risks. In some cases, the benefits to prescribing the drugs may  outweigh the risks. HHS has taken important steps to educate and inform  nursing home providers and staff on the need to reduce unnecessary  antipsychotic drug use and ways to incorporate non-pharmacological  practices into their care to address the behavioral symptoms associated  with dementia. However, similar efforts have not been directed toward  caregivers of older adults living outside of nursing homes, such as those  in assisted living facilities and private residences. Targeting this segment  of the population is equally important given that over 1.2 million Medicare  Part D enrollees living outside of nursing homes were diagnosed with  dementia in 2012 and Medicare Part D pays for antipsychotic drugs  prescribed to these individuals. While the extent of unnecessary  prescribing of antipsychotic drugs is unknown, older adults with dementia  living outside of nursing homes are also at risk of the same dangers  associated with taking antipsychotics drugs as residents of nursing  homes. In fact, the National Alzheimer’s Project Act was not limited to the  nursing home setting, but calls upon HHS to develop and implement an  integrated national plan to address dementia. HHS’s National Alzheimer’s  Plan addresses antipsychotic drug prescribing in nursing homes only,  however, and HHS activities to reduce such drug use have primarily  focused on older adults residing in nursing homes. Given that HHS does  not specifically target its outreach and education efforts relating to  antipsychotic drug use to settings other than nursing homes, older adults  living outside of nursing homes, their caregivers, and their clinicians in  these settings may not have access to the same resources about  alternative approaches to care. By expanding its outreach and  educational efforts to settings outside nursing homes, HHS may be able  to help reduce any unnecessary reliance on antipsychotic drugs for the  treatment of behavioral symptoms of dementia for all older adults  regardless of their residential setting.
section_title: Recommendation for Executive Action
paragraphs: We recommend that the Secretary of HHS expand its outreach and  educational efforts aimed at reducing antipsychotic drug use among older  adults with dementia to include those residing outside of nursing homes  by updating the National Alzheimer’s Plan.
section_title: Agency Comments
paragraphs: We provided a draft of this report to HHS for comment. In its written  response, reproduced in appendix III, HHS concurred with our  recommendation, stating that the agency will support efforts to update the  National Alzheimer’s Plan through continued participation on the Federal  National Alzheimer’s Project Act Advisory Council. HHS also provided  technical comments that we incorporated as appropriate.
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If you or your staffs have any questions about this report, please contact  me at (202) 512-7114 or iritanik@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this report  are listed in appendix IV.
section_title: Appendix I: Scope and Methodology for Data Analyses
paragraphs: This appendix describes our methodology for analyzing the 2012  prescribing of antipsychotic drugs for older adults with dementia in  nursing homes and other settings, as well as for analyzing Medicare   Part D plan payments for these antipsychotic drug prescriptions. It also  describes our efforts to ensure the reliability of the data.
subsections: section_title: Analyses of Antipsychotic Drug Prescribing for Older Adults with Dementia
paragraphs: We used two primary data sources to examine antipsychotic drug  prescribing for older adults with dementia: the Medicare Part D  Prescription Drug Event (PDE) data to identify antipsychotic drug  prescribing for Medicare Part D enrollees in and outside of the nursing  home, and the Long Term Care Minimum Data Set (MDS) to identify  antipsychotic drug prescribing for all nursing home residents, regardless  of Medicare Part D enrollment.
subsections: section_title: Medicare Part D Prescription Drug Event data analyses
paragraphs: To estimate the extent to which older adults residing inside and outside of  nursing homes are prescribed antipsychotic drugs, we first analyzed 2012  PDE data for individuals with dementia. We used the Medicare Part D  PDE data because Medicare is the primary source of insurance coverage  for individuals over the age of 65 and approximately 63 percent of  Medicare beneficiaries were enrolled in Medicare Part D in 2012. To  identify individuals living in nursing homes, we combined the PDE claims  data with data from the MDS, which includes nursing home assessments  for all individuals living in nursing homes, regardless of insurance  coverage. We also used data from the Medicare Master Beneficiary  Summary File (MBSF), as well as the Medicare Part D Risk File to  identify diagnoses, including dementia diagnoses and diagnoses for  certain conditions for which the Food and Drug Administration (FDA) has  approved the use of antipsychotics drugs. We excluded from our  estimates individuals with dementia also diagnosed with one of these  FDA-approved conditions for antipsychotic drugs—schizophrenia and  bipolar disorder. The Medicare Part D Risk File contains diagnoses based  on claims from the previous year for each enrollee, so our diagnosis  categories may be conservative estimates as they did not take into  account longer-standing or newer diagnoses. We also excluded enrollees  with outlier data, enrollees with less than 12 months of Medicare Part D  enrollment in 2012, and those enrollees who died in 2012 because they  did not have complete Medicare Part D data for the entire year. Finally,  we excluded enrollees who resided outside of the 50 states and the  District of Columbia.
For these analyses, we define an individual as having been prescribed an  antipsychotic drug if they were prescribed at least one prescription for an  antipsychotic drug during the year, regardless of how many days supply  are covered by the prescription. We identified relevant national drug  codes (NDC) using a list of generic names for antipsychotic drugs, and,  using those codes, we determined the number and percent of Medicare  Part D enrollees who were prescribed an antipsychotic drug in 2012. The  specific drugs included are listed in table 6.
Within the nursing home population, our analysis of PDE data specifically  identified those with a long stay in the nursing home—defined by the  Centers for Medicare & Medicaid Services (CMS) as more than   100 days—because drugs for individuals with short stays—100 days or  less—are generally covered under Medicare Part A, not Part D. We  disaggregated the data to examine certain characteristics, such as  gender, age, and geographic location.
section_title: Long Term Care Minimum Data Set analysis
paragraphs: To supplement our analysis of the Medicare Part D data for the nursing  home population, we also analyzed 2012 data on antipsychotic  prescribing and diagnoses among nursing home residents available in the  MDS. This allowed us to look at a more comprehensive population of  nursing home residents—all residents in a Medicare or Medicaid certified  nursing home—and to examine prescribing rates by length of stay, using  steps identified by CMS based on dates reported in the nursing home  assessments. In addition to excluding residents with dementia also  diagnosed with schizophrenia and bipolar disorder, we excluded residents  with Tourette syndrome, a condition for which FDA has approved the use  of certain antipsychotics, as well as Huntington’s disease, a condition for  which CMS guidance has recognized antipsychotics as an acceptable  treatment. Individuals with both dementia and at least one of these  diagnoses accounted for about 7 percent of nursing home residents with  dementia overall. We also excluded residents with outlier identification  codes or other outlier data, residents under the age of 65, and residents  in facilities outside of the 50 states and the District of Columbia. We  included only those residents that lived through 2012 so that there was a  complete year of data for each resident and because antipsychotic drugs  can be used in a hospice setting to make residents more comfortable at  the end of their lives. For this analysis, we determined an individual was  prescribed an antipsychotic drug if any nursing home assessment during  2012 indicated the resident took an antipsychotic drug during the previous  7 days, and we include any instance where antipsychotic use is   We disaggregated the data to examine certain  documented.characteristics, such as gender, age, and geographic location.
section_title: Medicare Part D Plan Payments
paragraphs: To identify what Medicare Part D plans paid for antipsychotic drugs  prescribed to older adults with dementia in 2012, we identified individuals  with dementia using the Medicare Part D Risk File, and calculated plan  payments for those enrollees using the PDE claims data. We also  calculated plan payments for the most commonly prescribed antipsychotic  drugs, and used the National Plan and Provider Enumeration System  (NPPES) to identify the breakdown of prescriber specialties listed on  antipsychotic drug claims under Medicare Part D in 2012 to calculate the  share of plan payments for prescriptions from the specialties with the  most antipsychotic prescribing for individuals with dementia.
section_title: Data Reliability and Audit Standards
paragraphs: We ensured the reliability of the MDS data, Medicare PDE data, Medicare  Part D Risk File data, MBSF data, Red Book data, and NPPES data used  in this report by performing appropriate electronic data checks, reviewing  relevant documentation, and interviewing officials and representatives  knowledgeable about the data, where necessary. We found the data were  sufficiently reliable for the purpose of our analyses.
We conducted this performance audit from January 2014 through January  2015 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
section_title: Appendix II: Literature Review
paragraphs: To identify what is known from published research about factors  contributing to the prescribing of antipsychotic drugs to older adults with  dementia, we conducted a literature search among recently published  articles; specifically, we searched for relevant articles published from  January 1, 2009, through March 31, 2014. We conducted a structured  search of various databases for relevant peer reviewed and industry  journals including MEDLINE, BIOSIS Previews, and ProQuest. Key terms  included various combinations of “antipsychotic,” “dementia,” “elderly,”  “older adults,” “nursing homes,” “community,” “assisted living,” “home  health,” “medication management,” and “medication monitoring.” From all  database sources, we identified 386 articles. We first reviewed the  abstracts for each of these articles for relevancy in identifying contributing  factors related to the use of antipsychotic drugs both inside and outside of  nursing homes. For those articles we found relevant, we reviewed the full  article and excluded those where the research (1) was conducted outside  the United States; (2) included individuals less than 65 years of age; or  (3) was an editorial submission. We added one article that could be linked  to original research outside of the research cited in the article. After  excluding these articles and including others, 42 articles remained: 22  focused on nursing homes; 11 focused on settings outside of nursing  homes; 7 focused on both settings; and in 2 articles, the settings were  either unclear or undetermined. Articles were then coded by analysts  according to whether they identified contributing factors for use of  antipsychotic drugs. We found 18 that contained detailed reasons that  contribute to antipsychotic drug use among older adults:  Bowblis, J. R., S. Crystal, O. Intrator, and J. A. Lucas. “Response to  Regulatory Stringency: The Case of Antipsychotic Medication Use in  Nursing Homes.” Health Economics, vol. 21 (2012).
Briesacher, B. A., J. Tjia, T. Field, K. M. Mazor, J. L. Donovan,   A. O. Kanaan, L. R. Harrold, C. A. Lemay, and J. H. Gurwitz. “  Nationwide Variation in Nursing Home Antipsychotic Use, Staffing   and Quality of Care.” Abstracts of the 28th ICPE 2012, (2012).
Briesacher, B. A., J. Tjia, T. Field, D. Peterson, and J. H. Gurwitz.  “Antipsychotic use Among Nursing Home Residents.” The Journal of  American Medical Association, vol. 309, no. 5 (2013).
Chen, Y., B. A. Briesacher, T. S. Field, J. Tjia, D. T. Lau, and   J. H. Gurwitz. “Unexplained Variation across U.S. Nursing Homes in  Antipsychotic Prescribing Rates.” Archives of Internal Medicine, vol. 170,  no. 1 (2010).
Crystal, S., M. Oflson, C. Huang, H. Pincus, and T. Gerhard. “Broadened  Use of Atypical Antipsychotics: Safety, Effectiveness, and Policy  Challenges: Expanded Use of these Medications, Frequently Off-label,  Has Often Outstripped the Evidence Base for the Diverse Range of  Patients Who Are Treated with Them.” Health Affairs, vol. 28, no. 5  (2009).
Department of Health and Human Services – Office of Inspector General,  Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home  Residents,” OEI-07-08-00150, May 2011.
Fung, V., M. Price, A. B. Busch, M. B. Landrum, B. Fireman,   A. Nierenberg, W. H. Dow, R. Hui, R. Frank, J. P. Newhouse, and   J. Hsu. “Adverse Clinical Events among Medicare Beneficiaries Using  Antipsychotic Drugs: Linking Health Insurance Benefits and Clinical  Needs.” Medical Care, vol. 51, no. 7 (2013).
Healthcare Management Solutions, LLC and the Meyers Primary Care  Institute at the University of Massachusetts Medical School. Antipsychotic  Drug Use Project Final Report (Columbia, Md.: January 2013).
Kamble, P., J. Sherer, H. Chen, and R. Aparasu. “Off-Label Use of  Second-Generation Antipsychotic Agents among Elderly Nursing Home  Residents.” Psychiatric Services, vol. 61, no. 2 (2010).
Kamble, P., H. Chen, J. T. Sherer, and R. R. Aparasu. “Use of  Antipsychotics among Elderly Nursing Home Residents with Dementia in  the United States: An Analysis of National Survey Data.” Drugs & Aging,  vol. 26, no. 6 (2009).
Lemay, C. A., K. M. Mazor, T. S. Field, J. Donovan, A. Kananaan,   B. A. Briesacher, S. Foy, L. R. Harrold, J. H. Gurwitz, and J. Tjia.  “Knowledge of and Perceived Need for Evidence-Based Education   about Antipsychotic Medications among Nursing Home Leadership   and Staff.” The Journal of American Medical Directors Association,   vol. 14, no. 12 (2013).
Lucas, J. A., S. Chakravarty, J. R. Bowblis, T. Gerhard, E. Kalay,   E. K. Paek, and S. Crystal. “Antipsychotic Medication Use in Nursing  Homes: A Proposed Measure of Quality.” International Journal of  Geriatric Psychiatry (2014).
Molinari, V. A., D. A. Chiriboga, L. G. Branch, J. Schinka, L. Shonfeld,   L. Kos, W. L. Mills, J. Krok, and K. Hyer. “Reasons for Psychiatric  Medication Prescription for New Nursing Home Residents.” Aging &  Mental Health, vol. 15, no.7 (2011).
Rhee, Y., J. G. Cernansky, L. L. Emanuel, C. G. Chang, and J. W. Shega.  “Psychotropic Medication Burden and Factors Associated with  Antipsychotic Use: An Analysis of a Population-Based Sample of  Community-Dwelling Older Persons with Dementia.” The Journal of  American Geriatrics Society, no. 59 (2011).
Saad, M., M. Cassagnol, and E. Ahmed. “The Impact of FDA’s Warning  on the Use of Antipsychotics in Clinical Practice: A Survey.” The  Consultant Pharmacist, vol. 25, no. 11 (2010).
Sapra, M., A. Varma, R. Sethi, I. Vahia, M. Chowdhury, K. Kim, and   R. Herbertson. “Utilization of Antipsychotics in Ambulatory Elderly with  Dementia in an Outpatient Setting.” Federal Practitioner, (2012).
Tjia, J., T. Field, C. Lemay, K. Mazor, M. Pandolfi, A. Spenard, S. Ho,   A. Kanaan, J. Donovan, J. H. Gurwitz, and B. Briesacher. “Antipsychotic  Use in Nursing Homes Varies By Psychiatric Consultant.” Medical Care,   vol. 52, no. 3. (2014).
Watson-Wolfe, K., E. Galik, J. Klinedinst, and N. Brandt. “Application of  the Antipsychotic Use in Dementia Assessment Audit Tool to Facilitate  Appropriate Antipsychotic Use in Long Term Care Residents with  Dementia.” Geriatric Nursing, vol. 35 (2014).
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Lori Achman, Assistant   Director; Todd D. Anderson; Shaunessye D. Curry; Leia Dickerson;   Sandra George; Kate Nast Jones; Ashley Nurhussein-Patterson;   and Laurie Pachter made key contributions to this report.