Using a nationally representative sample of U.S. nursing homes and residents, our results document the prevalence and appropriateness of antipsychotic and benzodiazepine use among nursing home residents. More than one quarter of all nursing home residents received an antipsychotic medication in 2004; nearly 40% had no appropriate indication for such use. A smaller percentage of residents in our sample took benzodiazepines (13%); a similar portion (42%) did not seem to have an appropriate indication for such use. Our results demonstrate that antipsychotics and benzodiazepines are commonly used in nursing homes and seem to be frequently prescribed to residents who lack an appropriate diagnosis to substantiate their use.
Based on our findings, receipt of these drug classes without an appropriate indication for use is significantly more likely for residents with two characteristics—younger age and any behavioral symptoms. In fact, the results from our logistic regression model show that among those with no appropriate indication for use, having any behavioral symptom nearly doubles the odds of antipsychotic use and increases the odds of benzodiazepine use by almost 70%. Our results also show that having dementia and depression raise the odds of antipsychotic use without an appropriate indication by 80% and >30%, respectively, though these characteristics are not significantly associated with the odds of benzodiazepine use without an appropriate indication. The odds of benzodiazepine use without an appropriate indication are significantly increased among female residents and white residents, though this pattern is not found for antipsychotic use. The reasons for these patterns are unclear and merit further research.
In addition to resident characteristics, our analysis examined the association between facility characteristics and receipt of psychotropic drugs. Based on previous work related to nursing home quality of care and to nursing home prescribing in particular,
7,26,28,37 our hypotheses were that larger, for profit, lower staffed, more Medicaid-dependent facilities would have higher levels of psychotropic use of questionable appropriateness. However, we found that only a greater facility share of Medicaid residents was associated with greater odds of antipsychotic use among those without any indication for appropriate use. Being located in a metropolitan area was also associated with greater use of antipsychotics without an appropriate indication but not benzodiazepines.
This study has limitations worthy of comment. First, our analysis is based on cross-sectional data, making it difficult to draw any causal inferences. For instance, it is difficult to discern any causality concerning the associations between potentially inappropriate prescribing and adverse outcomes, such as ED visits, hospitalizations, or falls/fractures. Second, medication information in the 2004 NNHS is limited to medication names; the data do not include information about dosing, duration of use (including whether use was regular or emergent), or other medications tried previously (i.e., we are unable to determine compliance with dosing standards, overall duration of use, or previous receipt of other agents among current users). Third, by basing appropriateness coding on documented diagnoses and behavioral symptoms, it is possible that our analytic approach missed potential indications for use that were not documented in the survey data (e.g., CMS guidelines allow for exceptions to survey standards if medical necessity is established) or oversimplified clinical decisions for which there is no clear gold standard. Thus, we categorize some residents as having no appropriate recorded indication for antipsychotic or benzodiazepine use based on the published literature and standard clinical guidelines but cannot necessarily conclude that use is inappropriate. Finally, although based on a large, nationally representative sample, 2004 NNHS data are now 5 years old and may not reflect more recent initiatives and research findings related to use of these drugs in the nursing home.
Several policy and practice changes have occurred since the 2004 NNHS data were collected that could impact utilization of antipsychotics and benzodiazepines. In April 2005, the U.S. Food and Drug Administration issued a “black-box warning” of increased mortality risk in elderly patients with dementia-related psychosis who are treated with atypical antipsychotics. This warning may well provide further impetus for clinicians to seek alternative treatments for patients who received these medications without appropriate indications, especially when accompanied by effective medication review and educational interventions.
38A related development subsequent to the 2004 NNHS is the publication of results from the Clinical Antipsychotic Trials of Intervention Effectiveness—Alzheimer’s Disease study, the impact of which is more difficult to predict. A 2006 report of Phase 1 results showed no difference between medication and placebo in the primary outcome measure (i.e., time to discontinuation of the medication), challenging the effectiveness of these medications when used for psychosis, aggression, or agitation.
39 However, a subsequent 2008 report from the study did show improvement in some of the clinical outcome measures for some of the antipsychotic medications studied.
40Another development is CMS’s December 2006 revision to survey guidance for Pharmacy Services and Unnecessary Medications regulations for Medicare-and Medicaid-certified nursing homes. These guidelines require facilities to attempt gradual dose reduction for “psychopharmacological” medications—including antipsychotics and benzodiazepines—unless these changes are documented to be clinically contraindicated. More broadly, revised guidelines signal renewed scrutiny of psychotropic drug use in nursing homes and, if effective, could lessen inappropriate use of psychotropic drugs.
Finally, the Medicare Part D drug benefit fundamentally altered the nursing home pharmacy market in 2006. The most significant changes concerning nursing homes centered on residents dually eligible for Medicare and Medicaid; the new benefit shifts their drug coverage from Medicaid to Medicare and requires that they enroll in private prescription drug plans. The new benefit treats antipsychotics and benzodiazepines quite differently. Benzodiazepines were explicitly excluded from coverage under Part D guidelines. Although recent federal legislation requires that benzodiazepines be covered beginning January 2013, the initial exclusion of these drugs could reduce their utilization. In contrast, antipsychotics have been a “protected class” under Part D, requiring that plans cover all or substantially all medications in this class, and thus, antipsychotic use may be less impacted than benzodiazepines by Part D. However, it should be noted that several factors make the impact of Part D on use unclear for both classes, including the impact of utilization management strategies for antipsychotics by private plans, the provision of wrap-around coverage for benzodiazepines by states, and the requirement that nursing homes provide all needed services (including medications listed in residents’ care plans) regardless of financial coverage.
In the context of our findings and the policy changes in the nursing home pharmacy environment that have occurred subsequently, it is important that psychotropic prescribing in nursing homes be monitored closely, especially as our population ages and the number of nursing home residents with dementia and behavioral symptoms increases. Whether the shift of drug coverage for dually eligible nursing home residents from Medicaid to Medicare, along with the increased scrutiny of psychotropic drug use by the frail elderly more generally, will reduce the receipt of these medications by individuals without appropriate indications is unclear. Importantly, the addition of the PM module to NNHS in 2004 will allow these prescribing patterns to be tracked with subsequent survey waves, thus providing a useful barometer of change.