Nursing Home Characteristics Associated with Antipsychotic Prescribing After Implementation of the National Antipsychotic Reduction Initiative (ARI).

OBJECTIVES: To describe nursing home (NH) characteristics associated with antipsychotic use and test whether associations changed after implementation of the National Partnership to Improve Dementia Care's antipsychotic reduction initiative (ARI). METHODS: Longitudinal quasi-experimental design using data from multiple sources and piecewise linear mixed models were used for statistical analyses. RESULTS: There was a significant decrease in monthly antipsychotic use across the study period (pre-ARI b = -0.0003, p <.001; post-ARI b = -0.0012, p <.001), which held after adjusting for NH characteristics. Registered nurse hours (b = -0.0026, p <.001), licensed practical nurse hours (b = -0.0019, p <.001), facility chain membership (b = -0.0013, p <.01), and health inspection ratings (b = -0.0003, p >.01) were associated with decreased antipsychotic use. Post-ARI changes in associations between NH characteristics and antipsychotic use were small and not statistically significant. CONCLUSIONS: Decreases in antipsychotic use were associated with most NH characteristics, and associations persisted post-ARI. Further research is warranted to examine the interactions between ARI policy and NH characteristics on antipsychotic prescribing, as well as other NH factors, such as facility prescribing cultures and clinical specialty of staff. CLINICAL IMPLICATIONS: Decreases in monthly antipsychotic use were observed following the ARI. The decreases in monthly antipsychotic use were associated with most NH characteristics, and these associations persisted during the post-ARI period.

Patient Outcomes After Delirium Screening and Incident Alzheimer's Disease or Related Dementias in Skilled Nursing Facilities.

BACKGROUND: The extent to which a positive delirium screening and new diagnosis of Alzheimer's disease or related dementias (ADRD) increases the risk for re-hospitalization, long-term nursing home placement, and death remains unknown. OBJECTIVE: To compare long-term outcomes among newly admitted skilled nursing facility (SNF) patients with delirium, incident ADRD, and both conditions. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study of Medicare beneficiaries who entered a SNF from hospital with a minimum 14-day stay (n = 100,832) from 2015 to 2016. MAIN MEASURES: Return to home, hospital readmission, admission to a long-term care facility, or death. KEY RESULTS: Patients with delirium were as likely to be discharged home as patients diagnosed with ADRD (HR: 0.63, 95% CI: 0.59, 0.67; HR: 0.65, 95% CI: 0.64, 0.67). Patients with both delirium and ADRD were less likely to be discharged home (HR: 0.49, 95% CI: 0.47, 0.52) and showed increased risk of death (HR: 1.30, 95% CI: 1.17, 1.45). Patients with ADRD, regardless of delirium screening status, had increased risk for long-term nursing home care transfer (HR: 1.66, 95% CI: 1.63, 1.70; HR: 1.76, 95% CI: 1.69, 1.82). Patients with delirium and no ADRD showed increased risk of transfer to long-term nursing home care (HR: 1.25, 95% CI: 1.18, 1.33). The rate of deaths was higher among patients who screened positive for delirium without ADRD compared to the no delirium and no ADRD groups (HR: 2.35, 95% CI: 2.11, 2.61). CONCLUSION: A positive delirium screening increased risk of death and transfer to long-term care in the first 100 days after admission regardless of incident ADRD diagnosis. Patients with delirium and/or ADRD also are less likely to be discharged home. Our study builds on the evidence base that delirium is important to address in older adults as it is associated with negative outcomes.

Examining transitions of care among nursing home residents with and without antipsychotic medication use.

OBJECTIVES: This study examines the association between antipsychotic (AP) medication use and care transitions in the nursing home (NH) population. METHODS: This cross-sectional study used data from a 5% random sample of Medicare beneficiaries between 2011 and 2015. Propensity score adjusted negative binomial regression was performed and conditional probabilities of having a first transition from the NH to specific locations were calculated. RESULTS: Among 150,284 eligible beneficiaries, the majority were female (67%), white (84%), and >75 years old (63%). Controlling for resident characteristics, the odds of having any transition was 5% lower among those with AP use [IRR (95% confidence interval (CI))=0.95(0.94-0.96)] relative to those with no AP use. Residents with AP use had higher proportions of transitions to hospital (22.7% vs. 19.5%, p < 0.01), emergency department (19.6% vs. 10.7%, p < 0.01), and different NH (1.5% vs. 0.4%, p < 0.01), and lower proportions of transition to non-healthcare locations compared to those without AP use. CONCLUSIONS: Findings demonstrate that residents with AP use had higher probabilities of transitions to more costly care settings such as the emergency department and hospital compared to those without AP use. Future longitudinal studies will help to inform clinical interventions aimed at improving the quality of care for this population.

Medication cost-reducing behaviors in older adults with atrial fibrillation: The SAGE-AF study.

BACKGROUND: As patient prices for many medications have risen steeply in the United States, patients may engage in cost-reducing behaviors (CRBs) such as asking for generic medications or purchasing medication from the Internet. OBJECTIVE: The objective of this study is to describe patterns of CRB, cost-related medication nonadherence, and spending less on basic needs to afford medications among older adults with atrial fibrillation (AF) and examine participant characteristics associated with CRB. METHODS: Data were from a prospective cohort study of older adults at least 65 years with AF and a high stroke risk (CHA2DS2VASc ≥ 2). CRB, cost-related medication nonadherence, and spending less on basic needs to afford medications were evaluated using validated measures. Chi-square and t tests were used to evaluate differences in characteristics across CRB, and statistically significant characteristics (P < 0.05) were entered into a multivariable logistic regression to examine factors associated with CRB. RESULTS: Among participants (N = 1224; mean age 76 years; 49% female), 69% reported engaging in CRB, 4% reported cost-related medication nonadherence, and 6% reported spending less on basic needs. Participants who were cognitively impaired (adjusted odds ratio 0.69 [95% CI 0.52-0.91]) and those who did not identify as non-Hispanic white (0.66 [0.46-0.95]) were less likely to engage in CRB. Participants who were married (1.88 [1.30-2.72]), had a household income of $20,000-$49,999 (1.52 [1.02-2.27]), had Medicare insurance (1.38 [1.04-1.83]), and had 4-6 comorbidities (1.43 [1.01-2.01]) had significantly higher odds of engaging in CRB. CONCLUSION: Although CRBs were common among older adults with AF, few reported cost-related medication nonadherence and spending less on basic needs. Patients with cognitive impairment may benefit from pharmacist intervention to provide support in CRB and patient assistance programs.

Association Between Perioperative Medication Use and Postoperative Delirium and Cognition in Older Adults Undergoing Elective Noncardiac Surgery.

BACKGROUND: Postoperative delirium is frequent in older adults and is associated with postoperative neurocognitive disorder (PND). Studies evaluating perioperative medication use and delirium have generally evaluated medications in aggregate and been poorly controlled; the association between perioperative medication use and PND remains unclear. We sought to evaluate the association between medication use and postoperative delirium and PND in older adults undergoing major elective surgery. METHODS: This is a secondary analysis of a prospective cohort study of adults ≥70 years without dementia undergoing major elective surgery. Patients were interviewed preoperatively to determine home medication use. Postoperatively, daily hospital use of 7 different medication classes listed in guidelines as risk factors for delirium was collected; administration before delirium was verified. While hospitalized, patients were assessed daily for delirium using the Confusion Assessment Method and a validated chart review method. Cognition was evaluated preoperatively and 1 month after surgery using a neurocognitive battery. The association between prehospital medication use and postoperative delirium was assessed using a generalized linear model with a log link function, controlling for age, sex, type of surgery, Charlson comorbidity index, and baseline cognition. The association between daily postoperative medication use (when class exposure ≥5%) and time to delirium was assessed using time-varying Cox models adjusted for age, sex, surgery type, Charlson comorbidity index, Acute Physiology and Chronic Health Evaluation (APACHE)-II score, and baseline cognition. Mediation analysis was utilized to evaluate the association between medication use, delirium, and cognitive change from baseline to 1 month. RESULTS: Among 560 patients enrolled, 134 (24%) developed delirium during hospitalization. The multivariable analyses revealed no significant association between prehospital benzodiazepine (relative risk [RR], 1.44; 95% confidence interval [CI], 0.85-2.44), beta-blocker (RR, 1.38; 95% CI, 0.94-2.05), NSAID (RR, 1.12; 95% CI, 0.77-1.62), opioid (RR, 1.22; 95% CI, 0.82-1.82), or statin (RR, 1.34; 95% CI, 0.92-1.95) exposure and delirium. Postoperative hospital benzodiazepine use (adjusted hazard ratio [aHR], 3.23; 95% CI, 2.10-4.99) was associated with greater delirium. Neither postoperative hospital antipsychotic (aHR, 1.48; 95% CI, 0.74-2.94) nor opioid (aHR, 0.82; 95% CI, 0.62-1.11) use before delirium was associated with delirium. Antipsychotic use (either presurgery or postsurgery) was associated with a 0.34 point (standard error, 0.16) decrease in general cognitive performance at 1 month through its effect on delirium (P = .03), despite no total effect being observed. CONCLUSIONS: Administration of benzodiazepines to older adults hospitalized after major surgery is associated with increased postoperative delirium. Association between inhospital, postoperative medication use and cognition at 1 month, independent of delirium, was not detected.

Opioid Use Increases the Risk of Delirium in Critically Ill Adults Independently of Pain.

Rationale: It is unclear whether opioid use increases the risk of ICU delirium. Prior studies have not accounted for confounding, including daily severity of illness, pain, and competing events that may preclude delirium detection.Objectives: To evaluate the association between ICU opioid exposure, opioid dose, and delirium occurrence.Methods: In consecutive adults admitted for more than 24 hours to the ICU, daily mental status was classified as awake without delirium, delirium, or unarousable. A first-order Markov model with multinomial logistic regression analysis considered four possible next-day outcomes (i.e., awake without delirium, delirium, unarousable, and ICU discharge or death) and 11 delirium-related covariables (baseline: admission type, age, sex, Acute Physiology and Chronic Health Evaluation IV score, and Charlson comorbidity score; daily: ICU day, modified Sequential Organ Failure Assessment, ventilation use, benzodiazepine use, and severe pain). This model was used to quantify the association between opioid use, opioid dose, and delirium occurrence the next day.Measurements and Main Results: The 4,075 adults had 26,250 ICU days; an opioid was administered on 57.0% (n = 14,975), severe pain occurred on 7.0% (n = 1,829), and delirium occurred on 23.5% (n = 6,176). Severe pain was inversely associated with a transition to delirium (odds ratio [OR] 0.72; 95% confidence interval [CI], 0.53-0.97). Any opioid administration in awake patients without delirium was associated with an increased risk for delirium the next day [OR, 1.45; 95% CI, 1.24-1.69]. Each daily 10-mg intravenous morphine-equivalent dose was associated with a 2.4% increased risk for delirium the next day.Conclusions: The receipt of an opioid in the ICU increases the odds of transitioning to delirium in a dose-dependent fashion.

Association Between Incident Delirium Treatment With Haloperidol and Mortality in Critically Ill Adults.

OBJECTIVES: Haloperidol is commonly administered in the ICU to reduce the burden of delirium and its related symptoms despite no clear evidence showing haloperidol helps to resolve delirium or improve survival. We evaluated the association between haloperidol, when used to treat incident ICU delirium and its symptoms, and mortality. DESIGN: Post hoc cohort analysis of a randomized, double-blind, placebo-controlled, delirium prevention trial. SETTING: Fourteen Dutch ICUs between July 2013 and December 2016. PATIENTS: One-thousand four-hundred ninety-five critically ill adults free from delirium at ICU admission having an expected ICU stay greater than or equal to 2 days. INTERVENTIONS: Patients received preventive haloperidol or placebo for up to 28 days until delirium occurrence, death, or ICU discharge. If delirium occurred, treatment with open-label IV haloperidol 2 mg tid (up to 5 mg tid per delirium symptoms) was administered at clinician discretion. MEASUREMENTS AND MAIN RESULTS: Patients were evaluated tid for delirium and coma for 28 days. Time-varying Cox hazards models were constructed for 28-day and 90-day mortality, controlling for study-arm, delirium and coma days, age, Acute Physiology and Chronic Health Evaluation-II score, sepsis, mechanical ventilation, and ICU length of stay. Among the 1,495 patients, 542 (36%) developed delirium within 28 days (median [interquartile range] with delirium 4 d [2-7 d]). A total of 477 of 542 (88%) received treatment haloperidol (2.1 mg [1.0-3.8 mg] daily) for 6 days (3-11 d). Each milligram of treatment haloperidol administered daily was associated with decreased mortality at 28 days (hazard ratio, 0.93; 95% CI, 0.91-0.95) and 90 days (hazard ratio, 0.97; 95% CI, 0.96-0.98). Treatment haloperidol administered later in the ICU course was less protective of death. Results were stable by prevention study-arm, predelirium haloperidol exposure, and haloperidol treatment protocol adherence. CONCLUSIONS: Treatment of incident delirium and its symptoms with haloperidol may be associated with a dose-dependent improvement in survival. Future randomized trials need to confirm these results.

Cost-related Medication Nonadherence and Its Risk Factors Among Medicare Beneficiaries.

BACKGROUND: Unaffordability of medications is a barrier to effective treatment. Cost-related nonadherence (CRN) is a crucial, widely used measure of medications access. OBJECTIVES: Our study examines the current national prevalence of and risk factors for CRN (eg, not filling, skipping or reducing doses) and companion measures in the US Medicare population. RESEARCH DESIGN: Survey-weighted analyses included logistic regression and trends 2006-2016. SUBJECTS: Main analyses used the 2016 Medicare Current Beneficiary Survey. Our study sample of 12,625 represented 56 million community-dwelling beneficiaries. MEASURES: Additional outcome measures were spending less on other necessities in order to pay for medicines and use of drug cost reduction strategies such as requesting generics. RESULTS: In 2016, 34.5% of enrollees under 65 years with disability and 14.4% of those 65 years and older did not take their medications as prescribed due to high costs; 19.4% and 4.7%, respectively, experienced going without other essentials to pay for medicines. Near-poor older beneficiaries with incomes $15-25K had 50% higher odds of CRN (vs. >$50K), but beneficiaries with incomes <$15K, more likely to be eligible for the Part D Low-Income Subsidy, did not have significantly higher risk. Three indicators of worse health (general health status, functional limits, and count of conditions) were all independently associated with higher risk of CRN. CONCLUSIONS: Changes in the risk profile for CRN since Part D reflect the effectiveness of targeted policies. The persistent prevalence of CRN and associated risks for sicker people in Medicare demonstrate the consequences of high cost-sharing for prescription fills.

Adequacy of Prescription Drug Coverage in Long-term Care.

RESEARCH OBJECTIVE: Affordable access to medications is important to Medicare enrollees in long-term care (LTC), yet, it is unknown if prescription drug coverage is universal and adequate to meet their high medication needs. STUDY DESIGN: We assessed enrollment in prescription drug coverage, out-of-pocket (OOP) payments and medication use in a nationwide LTC database of prescription-level, resident-level, and facility-level data for the period 2011-2013. Inadequate drug coverage was defined as ≥50% medications paid for OOP. Risk-adjusted generalized estimation equations models were estimated to identify predictors of inadequate drug coverage and total prescription fills. POPULATION STUDIED: A nationwide sample of 332,087 Medicare enrollees observed >100 days in LTC. PRINCIPAL FINDINGS: We found Medicare Part D was the main source of drug coverage (82.4%), followed by private insurance (8.5%), and Veterans Administration (0.2%). No drug coverage could be detected for 8.9% (n=29,378) who paid for all of their medications OOP or received only temporary drug payment assistance. Inadequate drug coverage was identified in another 2721 persons. LTC Medicare enrollees without drug coverage or who had private insurance received significantly fewer prescriptions than if they had been enrolled in Medicare Part D. CONCLUSION: A substantial proportion of Medicare enrollees in LTC have inadequate or no drug coverage and are receiving less medication than indicated by their health needs. POLICY IMPLICATIONS: Medicare Part D is an important policy for ensuring affordable access to medications in LTC. However, expansions are needed to increase enrollment and decrease inadequate drug coverage.

Association between incident delirium and 28- and 90-day mortality in critically ill adults: a secondary analysis.

BACKGROUND: While delirium prevalence and duration are each associated with increased 30-day, 6-month, and 1-year mortality, the association between incident ICU delirium and mortality remains unclear. We evaluated the association between both incident ICU delirium and days spent with delirium in the 28 days after ICU admission and mortality within 28 and 90 days. METHODS: Secondary cohort analysis of a randomized, double-blind, placebo-controlled trial conducted among 1495 delirium-free, critically ill adults in 14 Dutch ICUs with an expected ICU stay ≥2 days where all delirium assessments were completed. In the 28 days after ICU admission, patients were evaluated for delirium and coma 3x daily; each day was coded as a delirium day [≥1 positive Confusion Assessment Method for the ICU (CAM-ICU)], a coma day [no delirium and ≥ 1 Richmond Agitation Sedation Scale (RASS) score ≤ - 4], or neither. Four Cox-regression models were constructed for 28-day mortality and 90-day mortality; each accounted for potential confounders (i.e., age, APACHE-II score, sepsis, use of mechanical ventilation, ICU length of stay, and haloperidol dose) and: 1) delirium occurrence, 2) days spent with delirium, 3) days spent in coma, and 4) days spent with delirium and/or coma. RESULTS: Among the 1495 patients, 28 day mortality was 17% and 90 day mortality was 21%. Neither incident delirium (28 day mortality hazard ratio [HR] = 1.02, 95%CI = 0.75-1.39; 90 day mortality HR = 1.05, 95%CI = 0.79-1.38) nor days spent with delirium (28 day mortality HR = 1.00, 95%CI = 0.95-1.05; 90 day mortality HR = 1.02, 95%CI = 0.98-1.07) were significantly associated with mortality. However, both days spent with coma (28 day mortality HR = 1.05, 95%CI = 1.02-1.08; 90 day mortality HR = 1.05, 95%CI = 1.02-1.08) and days spent with delirium or coma (28 day mortality HR = 1.03, 95%CI = 1.00-1.05; 90 day mortality HR = 1.03, 95%CI = 1.01-1.06) were significantly associated with mortality. CONCLUSIONS: This analysis suggests neither incident delirium nor days spent with delirium are associated with short-term mortality after ICU admission. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier NCT01785290 Registered 7 February 2013.

Nursing homes underreport antipsychotic prescribing.

Objective: Determine the accuracy of nursing home self-reported antipsychotic prescribing before and after implementation of a Medicare campaign to reduce use.Methods: Quasi-experimental study comparing trends in self-reported antipsychotic prescribing relative to claims-based prescribing. Setting is a nationwide sample of 11,912 facilities, 2011-2013. Participants are long-stay nursing home residents (n = 586,281) with prescribing data in Medicare Minimum Data Set 3.0 and Medicare Part D claims database. Verified with a pharmacy dispensing database. Main outcomes are the discrepancies in quarterly prevalence of antipsychotic prescribing between nursing home self-reports and claims data and the characteristics of facilities and residents where discrepancies were identified.Results: Nursing homes underreport their antipsychotic prescribing levels, on average, by 1 percentage point per quarter relative to Medicare Part D claims (0.013, 95% confidence interval (CI), 0.012-0.015; p<.001). After the Medicare campaign, the underreporting gap increased by another half a percentage point (0.004, 95% CI .003-.005; p = .012). Nursing home residents with dementia, Alzheimer's disease or bipolar disorders were at the highest risk for underreported antipsychotic prescribing before the campaign (Adjusted Odds ratio (AOR) 1.385, 95% CI: 1.330-1.444; AOR 1.234, 95% CI: 1.172-1.300; AOR 1.574, 95% CI: 1.444-1.716, respectively) and afterwards. After the launch of the Medicare campaign, underreported antipsychotic prescribing occurred most in for-profit nursing homes (AOR 1.088, 95% CI: 1.005-1.178) and facilities in the US South (AOR 1.262, 95% CI: 1.145-1.391). Agreement was high between claims and dispensing data (99.7%).Conclusion: Nursing homes did not identify up to 6,000 residents per calendar quarter as having received antipsychotics despite these prescriptions being paid by Medicare and dispensed by a pharmacy. Nursing home rates of antipsychotic prescribing from self-reported data may be biased.

Perceptions vs. evidence: therapeutic substitutes for antipsychotics in patients with dementia in long-term care.

OBJECTIVE: To compare differences between clinician perceptions of therapeutic substitutes for antipsychotics prescribed to patients with dementia in long term care (LTC) and published evidence. METHODS: A mixed-methods approach that included a drug information search, online survey of 55 LTC clinicians and a comprehensive literature review was used. For 41 pharmacologic antipsychotic substitute candidates identified, LTC clinicians rated the likelihood they would substitute each for patients with dementia and identified non-pharmacologic antipsychotic substitutes. The quality of evidence supporting the most likely antipsychotic substitutes was assessed using a modified GRADE approach. RESULTS: Among 36 (65%) of LTC clinicians responding, the pharmacologic candidates deemed likely or somewhat likely to be substituted for an antipsychotic were: valproic acid, serotonin modulator antidepressants, short-acting benzodiazepines, serotonin reuptake inhibitor antidepressants, alpha-adrenoceptor antagonist, buspirone, acetaminophen, serotonin-norepinephrine reuptake inhibitor antidepressants, memantine, and a cholinesterase inhibitor. High quality evidence supporting these substitutions existed for only memantine and cholinesterase inhibitors, while high quality evidence cautioning against this substitution existed for valproic acid. Activities and music therapy were the most commonly cited non-pharmacologic substitutes but the supporting evidence for each is sparse. CONCLUSION: Perceptions of LTC clinicians regarding substitutes for antipsychotics in LTC patients with dementia vary widely and are often discordant with published evidence.

Did Medicare Part D Affect National Trends in Health Outcomes or Hospitalizations? A Time-Series Analysis.

BACKGROUND: Medicare Part D increased economic access to medications, but its effect on population-level health outcomes and use of other medical services remains unclear. OBJECTIVE: To examine changes in health outcomes and medical services in the Medicare population after implementation of Part D. DESIGN: Population-level longitudinal time-series analysis with generalized linear models. SETTING: Community. PATIENTS: Nationally representative sample of Medicare beneficiaries (n = 56,293 [unweighted and unique]) from 2000 to 2010. MEASUREMENTS: Changes in self-reported health status, limitations in activities of daily living (ADLs) (ADLs and instrumental ADLs), emergency department visits and hospital admissions (prevalence, counts, and spending), and mortality. Medicare claims data were used for confirmatory analyses. RESULTS: Five years after Part D implementation, no clinically or statistically significant reductions in the prevalence of fair or poor health status or limitations in ADLs or instrumental ADLs, relative to historical trends, were detected. Compared with trends before Part D, no changes in emergency department visits, hospital admissions or days, inpatient costs, or mortality after Part D were seen. Confirmatory analyses were consistent. LIMITATIONS: Only total population-level outcomes were studied. Self-reported measures may lack sensitivity. CONCLUSION: Five years after implementation, and contrary to previous reports, no evidence was found of Part D's effect on a range of population-level health indicators among Medicare enrollees. Further, there was no clear evidence of gains in medical care efficiencies.

Approaches to Gradual Dose Reduction of Chronic Off-Label Antipsychotics Used for Behavioral and Psychological Symptoms of Dementia.

OBJECTIVE: Little is known about how to best taper antipsychotics used in patients with dementia. To address this gap, we reviewed published antipsychotic discontinuation trials to summarize what is known about tapering strategies for antipsychotics used with older adults with dementia. We further developed pharmacokinetic-based gradual dose reduction (GDR) protocols based on antipsychotic half-lives. DATA SOURCES: MEDLINE, EMBASE, and International Pharmaceutical Abstracts were searched up to October 2014 to identify intervention studies reporting the behavioral and psychological symptoms of dementia outcomes resulting from discontinued off-label use of antipsychotics in nursing facility populations. Recently published pharmacokinetic reviews and standard pharmacology texts were used to determine antipsychotic drug half-lives for the pharmacokinetic-based GDR protocols. STUDY SELECTION: For the review, studies with an intervention resulting in antipsychotic medication discontinuation or tapering were eligible, including randomized controlled trials and pre- and post-intervention studies. DATA EXTRACTION: When available, we extracted the protocols used for antipsychotic GDR from each study included in the review. DATA SYNTHESIS: We found that clinical trials used different approaches to antipsychotic discontinuation, including abrupt discontinuation, slow tapers (more than two weeks), and mixed strategies based on drug dosage. None of the published trials described an approach based on pharmacokinetic principles. We developed a two-stage GDR protocol for tapering antipsychotic medications based on the log dose-response relationship; each stage was designed to result in a 50% dose reduction prior to discontinuation. This pharmacologically based strategy for patients chronically prescribed antipsychotics resulted in recommendations for slow tapers. CONCLUSION: Our theoretically derived GDR recommendations suggest a different approach than previously published in clinical trials. Further study is needed to evaluate the effect of this approach on patients.

Antipsychotic use in nursing homes varies by psychiatric consultant.

BACKGROUND: The relationship between psychiatric consultation and antipsychotic prescribing in nursing homes (NH) is unknown. OBJECTIVE: To identify the association between psychiatric consultant groups and NH-level antipsychotic prescribing after adjustment for resident case-mix and facility characteristics. RESEARCH DESIGN AND SUBJECTS: Nested cross-sectional study of 60 NHs in a cluster randomized trial. We linked facility leadership surveys to October 2009-September 2010 Minimum Data Set, Nursing Home Compare, the US Census, and pharmacy dispensing data. MEASURES: The main exposure is the psychiatric consultant group and the main outcome is NH-level prevalence of atypical antipsychotic use. We calculated annual means and interquartile ranges of NH-level antipsychotic use for each consultant group and arrayed consultant groups from lowest to highest prevalence. Generalized linear models were used to predict antipsychotic prescribing adjusting for resident case-mix and facility characteristics. Observed versus predicted antipsychotic prescribing levels were compared for each consultant group. RESULTS: Seven psychiatric consultant groups served a range of 3-27 study facilities. Overall mean facility-level antipsychotic prescribing was 19.2%. Mean prevalence of antipsychotic prescribing ranged from 12.2% (SD, 5.8) in the lowest consultant group to 26.4% (SD, 3.6) in the highest group. All facilities served by the highest-ranked consultant group had observed antipsychotic levels exceeding the overall study mean with half exceeding predictions for on-label indications, whereas most facilities served by the lowest-ranked consultant group had observed levels below the overall study and predicted means. CONCLUSIONS: Preliminary evidence suggests that psychiatric consultant groups affect NH antipsychotic prescribing independent of resident case-mix and facility characteristics.

Persistent medication affordability problems among disabled Medicare beneficiaries after Part D, 2006-2011.

BACKGROUND: Disabled Americans who qualify for Medicare coverage typically have multiple chronic conditions, are highly dependent on effective drug therapy, and have limited financial resources, putting them at risk for cost-related medication nonadherence (CRN). Since 2006, the Part D benefit has helped Medicare beneficiaries afford medications. OBJECTIVE: To investigate recent national trends in medication affordability among this vulnerable population, stratified by morbidity burden. DESIGN AND SUBJECTS: We estimated annual rates of medication affordability among nonelderly disabled participants in a nationally representative survey (2006-2011, n=14,091 person-years) using multivariate logistic regression analyses. MEASURE: Survey-reported CRN and spending less on other basic needs to afford medicines. RESULTS: In the 6 years following Part D implementation, the proportion of disabled Medicare beneficiaries reporting CRN ranged from 31.6% to 35.6%, while the reported prevalence of spending less on other basic needs to afford medicines ranged from 17.7% to 21.8%. Across study years, those with multiple chronic conditions had consistently worse affordability problems. In 2011, the prevalence of CRN was 37.3% among disabled beneficiaries with ≥ 3 morbidities as compared with 28.1% among those with fewer morbidities; for spending less on basic needs, the prevalence was 25.4% versus 15.7%, respectively. There were no statistically detectable changes in either measure when comparing 2011 with 2007. CONCLUSIONS: Disabled Medicare beneficiaries continue to struggle to afford prescription medications. There is an urgent need for focused policy attention on this vulnerable population, which has inadequate financial access to drug treatments, despite having drug coverage under Medicare Part D.

Reported racial discrimination, trust in physicians, and medication adherence among inner-city African Americans with hypertension.

OBJECTIVES: We sought to determine if reported racial discrimination was associated with medication nonadherence among African Americans with hypertension and if distrust of physicians was a contributing factor. METHODS: Data were obtained from the TRUST project conducted in Birmingham, Alabama, 2006 to 2008. All participants were African Americans diagnosed with hypertension and receiving care at an inner city, safety net setting. Three categories of increasing adherence were defined based on the Morisky Medication Adherence Scale. Trust in physicians was measured with the Hall General Trust Scale, and discrimination was measured with the Experiences of Discrimination Scale. Associations were quantified by ordinal logistic regression, adjusting for gender, age, education, and income. RESULTS: The analytic sample consisted of 227 African American men and 553 African American women, with a mean age of 53.7 ± 9.9 years. Mean discrimination scores decreased monotonically across increasing category of medication adherence (4.1, 3.6, 2.9; P = .025), though the opposite was found for trust scores (36.5, 38.5, 40.8; P < .001). Trust mediated 39% (95% confidence interval = 17%, 100%) of the association between discrimination and medication adherence. CONCLUSIONS: Within our sample of inner city African Americans with hypertension, racial discrimination was associated with lower medication adherence, and this association was partially mediated by trust in physicians. Patient, physician and system approaches to increase "earned" trust may enhance existing interventions for promoting medication adherence.

A critical review of methods to evaluate the impact of FDA regulatory actions.

PURPOSE: To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions and identify best practices for future evaluations. METHODS: We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations. RESULTS: We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions. CONCLUSIONS: Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies.

The incident user design in comparative effectiveness research.

Comparative effectiveness research includes cohort studies and registries of interventions. When investigators design such studies, how important is it to follow patients from the day they initiated treatment with the study interventions? Our article considers this question and related issues to start a dialogue on the value of the incident user design in comparative effectiveness research. By incident user design, we mean a study that sets the cohort's inception date according to patients' new use of an intervention. In contrast, most epidemiologic studies enroll patients who were currently or recently using an intervention when follow-up began. We take the incident user design as a reasonable default strategy because it reduces biases that can impact non-randomized studies, especially when investigators use healthcare databases. We review case studies where investigators have explored the consequences of designing a cohort study by restricting to incident users, but most of the discussion has been informed by expert opinion, not by systematic evidence.

Unintended impacts of a national antipsychotic reduction initiative among nursing facility residents with and without Alzheimer's disease.

BACKGROUND: In July 2012, the Centers for Medicare & Medicaid services launched an antipsychotic reduction initiative (ARI) to improve care for nursing facility residents with Alzheimer's disease and related dementias (ADRD). We examined the impact of this policy on antipsychotic and psychotropic medication (PM) utilization and diagnosis patterns in long-stay nursing facility residents with ADRD and other conditions in which antipsychotics are indicated. METHODS: Using an 80% sample of fee-for-service Medicare beneficiaries with Part D, we conducted a retrospective cohort study of nursing facility residents with ADRD, bipolar disorder, psychosis, Parkinson's disease, and residents exempt from the policy due to diagnoses of schizophrenia, Tourette syndrome, and/or Huntington's disease. We used interrupted time-series analyses to compare changes in diagnoses, antipsychotic use, and PM utilization before (January 1, 2011-June 30, 2012) and after (July 1, 2012-September 30, 2015) ARI implementation. RESULTS: We identified 874,487 long-stay nursing facility residents with a diagnosis of ADRD (n = 358,518), exempt (n = 92,859), bipolar (n = 128,298), psychosis (n = 93,402), and Parkinson's disease (n = 80,211). In all cohorts, antipsychotic use declined prior to the ARI; upon policy implementation, antipsychotic use reductions were sustained throughout the study period, including statistically significant ARI-associated accelerated declines in all cohorts. PM changes varied by cohort, with ARI-associated increases in non-benzodiazepine sedatives and/or muscle relaxants noted in ADRD, psychosis, and Parkinson's cohorts. Although anticonvulsant use increased throughout the study period in all groups, with the exception of the bipolar cohort, these increases were not associated with ARI implementation. Findings are minimally explained by increased post-ARI membership in the psychosis and Parkinson's cohorts. CONCLUSIONS: Our study documents antipsychotic use significantly declined in non-ADRD clinical and exempt cohorts, where such reductions may not be clinically warranted. Furthermore, ARI-associated compensatory increases in PMs do not offset these reductions. Changes in PM utilization and diagnostic make-up of residents using PMs require further investigation to assess the potential for adverse clinical and economic outcomes.