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Danni Zhao,1 Jonggyu Baek,1 Anne L Hume,2,3 Emily A McPhillips,1 Kate L Lapane1 1Department of Population and Quantitative Health Sciences, UMass Chan Medical School, Worcester, MA, USA; 2Department of Family Medicine, Alpert Medical School, Brown University, Memorial Hospital of Rhode Island, Providence, RI, USA; 3Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, RI, USACorrespondence: Kate L Lapane, Department of Population and Quantitative Health Sciences, UMass Chan Medical School, Worcester, MA, USA, Email kate.lapane@umassmed.eduBackground: Gabapentinoids have been prescribed off-label for almost all types of pain. The geographic variation in the use of gabapentinoids as analgesics remains unknown.Objective: To describe the geographic variation in gabapentinoids, opioids and concurrent use of both for pain by US state and metropolitan statistical area (MSA).Methods: We conducted a cross-sectional study on December 1, 2018, among commercially insured adults aged 18– 64 years without epilepsy or opioid use disorders using IBM® MarketScan® Research Databases. We described the geographic variation in the analgesic regimens (gabapentinoids, opioids and concurrent use of both) by state and MSA, and assessed factors associated with the geographic variation using multilevel logistic regression.Results: We included 9,314,197 beneficiaries; 1.4% had gabapentinoids, 1.5% had opioids and 0.3% had concurrent use of both. The majority of gabapentinoid use lacked an FDA-approved indication. Use of the analgesic regimens varied across states (gabapentinoids (median (interquartile range)): 1.4% (1.2– 1.7%); opioids: 1.5% (1.2– 1.9%); both: 0.3% (0.2– 0.4%)) and MSAs (gabapentinoids: 1.6% (1.3– 2.0%); opioids: 1.8% (1.3– 2.3%); both: 0.3% (0.2– 0.5%)). Demographics explained the largest proportion of the between-state and between-MSA variation. The pattern of the geographic variation in gabapentinoids was similar to that of opioids across states and MSAs.Conclusion: Gabapentinoids were as commonly used as opioids for pain in a commercially insured population (mostly off-label). The geographic variation in gabapentinoids was similar to that of opioids, which suggests that gabapentinoids may be widely used as alternatives or adjuvants to opioids across the US.Keywords: gabapentinoids, opioids, pain, geographic variation

Abstract Background Rab GTPases are regulators of intracellular membrane traffic. The Rab27 subfamily consists of Rab27a and Rab27b. Rab27a has been recently implicated in Griscelli Disease, a disease combining partial albinism with severe immunodeficiency. Rab27a plays a key role in the function of lysosomal-like organelles such as melanosomes in melanocytes and lytic granules in cytotoxic T lymphocytes. Little is known about Rab27b. Results The human RAB27B gene is organised in six exons, spanning about 69 kb in the chromosome 18q21.1 region. Exon 1 is non-coding and is separated from the others by 49 kb of DNA and exon 6 contains a long 3' untranslated sequence (6.4 kb). The mouse Rab27b cDNA shows 95% identity with the human cDNA at the protein level and maps to mouse chromosome 18. The mouse mRNA was detected in stomach, large intestine, spleen and eye by RT-PCR, and in heart, brain, spleen and kidney by Northern blot. Transient over-expression of EGF-Rab27b fusion protein in cultured melanocytes revealed that Rab27b is associated with melanosomes, as observed for EGF-Rab27a. Conclusions Our results indicate that the Rab27 subfamily of Ras-like GTPases is highly conserved in mammals. There is high degree of conservation in sequence and gene structure between RAB27A and RAB27B genes. Exogenous expression of Rab27b in melanocytes results in melanosomal association as observed for Rab27a, suggesting the two Rab27 proteins are functional homologues. As with RAB27A in Griscelli Disease, RAB27B may be also associated with human disease mapping to chromosome 18.

Objectives: Modifications to opioid regimens for persistent pain are typically made after an initial period of short-acting opioid (SAO) use. Regimen changes may include an escalation of the SAO dosage or an initiation of a long-acting opioid (LAO) as a switch or add-on therapy. This study evaluates the comparative effectiveness between these alternative regimens in nursing home residents., Design: A retrospective observational cohort analysis of US long-stay nursing home residents., Setting and Participants: Nursing home resident data were obtained from the national Minimum Dataset (MDS) version 3.0 and linked Medicare data, 2011-2016., Methods: Opioid regimen changes were identified using Part D dispensing claims to identify dosage escalation of SAOs, initiation of an LAO, or a switch to an LAO. Outcomes included indices of pain occurrence, frequency, and severity reported on the earliest MDS assessment within 3 months following the opioid regimen change. Resident attributes were described by opioid regimen cohort. Prevalence ratios of pain and depression indices were quantified using doubly robust inverse probability of treatment (IPT)-weighted log-binomial regression., Results: The study cohorts included 2072 SAO dose escalations, 575 LAO add-on initiations, and 247 LAO switch initiations. After IPT weighting, we observed comparable effects on pain and mood across the opioid regimen cohorts. A substantial number of residents continued to report frequent/constant pain (36% in SAO Escalation Cohort, 42% in LAO Add-on Cohort, 42% in the LAO Switch Cohort). The distribution of depressive symptoms was similar regardless of the opioid regimen change., Conclusions and Implications: Initiation of an LAO as an add-on to SAO or a switch from SAO had comparable effects on pain and mood to SAO dose escalation without initiation of an LAO. Although fewer residents reported any pain after the regimen change, persistent pain was reported by most residents., Competing Interests: Disclosure K.L.L. is a consultant for Exponent. A.P.N. is a consultant for Optum Epidemiology. The other authors declare no conflicts of interest., (Copyright © 2024. Published by Elsevier Inc.)

Background: Little to no data exist to guide treatment decision in patients with venous thromboembolism (VTE) and chronic liver disease., Objectives: To assess the effectiveness and safety of direct oral anticoagulants (DOACs)-individually and as a class-vs warfarin and between 2 DOACs in patients with acute VTE and chronic liver disease., Methods: We conducted a retrospective, US claims-based, propensity score-matched cohort study in adults with acute VTE and chronic liver disease who had newly initiated oral anticoagulants between 2011 and 2017. The primary outcome was a composite of hospitalization for recurrent VTE and hospitalization for major bleeding., Results: The cohorts included 2361 DOAC-warfarin, 895 apixaban-warfarin, 2161 rivaroxaban-warfarin, and 895 apixaban-rivaroxaban matched pairs. Lower risk of the primary outcome was seen with DOACs (hazard ratio [HR], 0.72; 95% CI, 0.61-0.85), apixaban (HR, 0.48; 95% CI, 0.35-0.66) or rivaroxaban (HR, 0.73; 95% CI, 0.61-0.88) vs warfarin but not apixaban-rivaroxaban (HR, 0.68; 95% CI, 0.43-1.08). The HRs of hospitalization for major bleeding were 0.69 (95% CI, 0.57-0.84) for DOAC-warfarin, 0.43 (95% CI, 0.30-0.63) for apixaban-warfarin, 0.72 (95% CI, 0.58-0.89) for rivaroxaban-warfarin, and 0.60 (95% CI, 0.35-1.06) for apixaban-rivaroxaban. Recurrent VTE risk was lower with apixaban (HR, 0.47; 95% CI, 0.26-0.86), but not DOACs (HR, 0.81; 95% CI, 0.59-1.12) or rivaroxaban vs warfarin (HR, 0.81; 95% CI, 0.57-1.14) or apixaban-rivaroxaban (HR, 0.92; 95% CI, 0.42-2.02)., Conclusion: While the magnitude of clinical benefit varied across individual DOACs, in adults with acute VTE and chronic liver disease, oral factor Xa inhibitors (as a class or individually) were associated with lower risk of recurrent VTE and major bleeding., (© 2023 The Authors.)

Background: The comparative safety of serotonin and norepinephrine reuptake inhibitors (SNRIs) as adjuvants to short-acting opioids in older adults is unknown even though SNRIs are commonly used. We compared the effects of SNRIs versus nonsteroidal anti-Inflammatory drugs (NSAIDs) on delirium among nursing home residents when SNRIs or NSAIDs were added to stable regimens of short-acting opioids., Methods: Using 2011-2016 national Minimum Data Set (MDS) 3.0 and Medicare claims data to implement a new-user design, we identified a cohort of nursing home residents receiving short-acting opioids who initiated either an SNRI or an NSAID. Delirium was defined from the Confusion Assessment Method in MDS 3.0 assessments and ICD9/10 codes using Medicare hospitalization claims. Propensity score matching balanced underlying differences for initiating treatments on 39 demographic and clinical characteristics (n SNRIs  = 5350; n NSAIDs  = 5350). Fine and Gray models provided hazard ratios (HRs) and 95% confidence intervals (CIs) adjusting for the competing risk of death., Results: Hydrocodone was the most commonly used short-acting opioid (48%). Residents received ~23 mg daily oral morphine equivalent at the time of SNRIs/NSAIDs initiation. The majority were women, non-Hispanic White, and aged ≥75 years. There were no differences in any of the confounders after propensity matching. Over 1 year, 10.8% of SNRIs initiators and 8.9% of NSAIDs initiators developed delirium. The rate of delirium onset was similar in SNRIs and NSAID initiators (HR(delirium in nursing home or hospitalization for delirium):1.10; 95% CI: 0.97-1.24; HR(hospitalization for delirium): 1.06; 95% CI: 0.89-1.25), and were similar regardless of baseline opioid daily dosage., Conclusions: Among nursing home residents, adding SNRIs to short-acting opioids does not appear to increase risk of delirium relative to initiating NSAIDs. Understanding the comparative safety of pain regimens is needed to inform clinical decisions in a medically complex population often excluded from clinical research., (© 2023 The American Geriatrics Society.)

Background and Objectives: Antiseizure medications (ASMs) are among the most commonly prescribed teratogenic drugs in women of childbearing age. Limited data exist on utilization patterns across different indications for therapy and for the newer-generation ASMs in this population. Thus, we assessed the pattern of ASM use in women of childbearing age with epilepsy and nonepilepsy indications (pain and psychiatric disorders)., Methods: We conducted a retrospective analysis of deidentified administrative data submitted to the Optum Clinformatics database. Eligible participants included women aged 12-50 years who filled ASMs between year 2011 and 2017. Participants were followed from date of index prescription filled to study end or insurance disenrollment, whichever came first. For the overall cohort and potential therapy indications, we assessed the type and frequency of ASMs filled; proportion of participants on monotherapy, polytherapy, or treatment switching; and duration of continuous use. Trends were characterized using annual percent change from study start to study end., Results: Our analysis included 465,131 participants who filled 603,916 distinct ASM prescriptions. At baseline, most of the participants had chronic pain (51.0%) and psychiatric disorders (32.7%), with epilepsy the least common (0.9%). The most frequently dispensed were diazepam (24.3%), lorazepam (20.1%), gabapentin (17.4%), clonazepam (12.7%), topiramate (11.3%), and lamotrigine (4.6%). Significant linear increase in trends were observed with gabapentin (annual percent change [95% CI]: 8.4 [7.3-9.4]; p < 0.001) and levetiracetam (3.4 [0.7-6.2]; p = 0.022) and decreasing trends for diazepam (-3.5 [-2.4 to 4.5]; p < 0.001) and clonazepam (-3.4 [-2.3 to 4.5]; p = 0.001). No significant change in trend was observed with valproate (-0.4 [-2.7 to 1.9]; p = 0.651), while nonlinear changes in trends were observed with lorazepam, topiramate, lamotrigine, and pregabalin., Discussion: Decreasing trends were observed with older ASMs in the overall cohort and across the potential indications for therapy. Conversely, increasing trends were seen with the newer ASMs. Considering the risk of teratogenicity associated with the newer medications largely unknown, counseling and education in addition to a careful consideration of the benefits vs potential risks should remain pivotal when prescribing ASMs for women of childbearing age., (© 2023 American Academy of Neurology.)

Background: The benefit-risk profile of direct oral anticoagulants (DOACs) compared with warfarin, and between DOACs in patients with atrial fibrillation (AF) and chronic liver disease is unclear., Methods: We conducted a new-user, retrospective cohort study of patients with AF and chronic liver disease who were enrolled in a large, US-based administrative database between January 1, 2011, and December 31, 2017. We assessed the effectiveness and safety of DOACs (as a class and individually) compared with warfarin, and between DOACs in patients with AF and chronic liver disease. The primary outcomes were hospitalization for ischemic stroke/systemic embolism and hospitalization for major bleeding. Inverse probability treatment weights were used to balance the treatment groups on measured confounders., Results: Overall, 10 209 participants were included, with 4421 (43.2%) on warfarin, 2721 (26.7%) apixaban, 2211 (21.7%) rivaroxaban, and 851 (8.3%) dabigatran. The incidence rates per 100 person-years for ischemic stroke/systemic embolism were 2.2, 1.4, 2.6, and 4.4 for DOACs as a class, apixaban, rivaroxaban, and warfarin, respectively. The incidence rates per 100 person-years for major bleeding were 7.9, 6.5, 9.1, and 15.0 for DOACs as a class, apixaban, rivaroxaban, and warfarin, respectively. After inverse probability treatment weights, the risk of hospitalization for ischemic stroke/systemic embolism was significantly lower between DOACs as a class (hazard ratio [HR], 0.64 [95% CI, 0.46-0.90]) or apixaban (HR, 0.40 [95% CI, 0.19-0.82]) compared with warfarin, but not significantly different between rivaroxaban versus warfarin (HR, 0.76 [95% CI, 0.47-1.21]) or rivaroxaban versus apixaban (HR, 1.73 [95% CI, 0.91-3.29]). Compared with warfarin, the risk of hospitalization for major bleeding was lower with DOACs as a class (HR, 0.69 [95% CI, 0.58-0.82]), apixaban (HR, 0.60 [95% CI, 0.46-0.78]), and rivaroxaban (HR, 0.79 [95% CI, 0.62-1.0]). However, the risk of hospitalization for major bleeding was higher for rivaroxaban versus apixaban (HR, 1.59 [95% CI, 1.18-2.14])., Conclusions: Among patients with AF and chronic liver disease, DOACs as a class were associated with lower risks of hospitalization for ischemic stroke/systemic embolism and major bleeding versus warfarin. However, the incidence of clinical outcomes among patients with AF and chronic liver disease varied between individual DOACs and warfarin, and in head-to-head DOAC comparisons.

Introduction: Vaccine hesitancy is a growing threat to public health. The objective of this research was to investigate the effect of incorporating a learning unit on addressing vaccine hesitancy into a doctor of pharmacy immunization delivery course., Methods: The learning unit, implemented fall 2019 at the University of Rhode Island, involved two interactive lectures and an at-home assignment. A family medicine physician spoke about her experiences with vaccine-hesitant families, and students viewed video scenarios depicting a pharmacist talking with vaccine-hesitant patients followed by an in-class discussion. Data was collected using pre- and post-surveys and a one-year follow-up survey., Results: Out of 125 students enrolled in the course, 121 completed the pre-survey, 113 the post-survey, and 120 the follow-up survey. For pre-/post-survey comparison questions, statistically significant improvements were seen in 9 of 13 items. The follow-up survey showed 83.4% of students had applied knowledge and 85.7% had applied skills gained from the learning unit., Conclusion: Incorporating a learning unit on addressing vaccine hesitancy into a pharmacy immunization class resulted in improvements in student self-reported knowledge and comfort in talking with patients who are vaccine hesitant. Long-term use of self-reported knowledge and skills gained was seen one-year post-implementation., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Abstract: Neuropathic pain is a common condition experienced by older adults. Prevalence estimates of neuropathic pain and descriptive data of pharmacologic management among nursing home residents are unavailable. We estimated the prevalence of neuropathic pain diagnoses and described the use of pain medications among nursing home residents with possible neuropathic pain. Using the Minimum Data Set 3.0 linked to Medicare claims for residents living in a nursing home on November 30, 2016, we included 473,815 residents. ICD-10 codes were used to identify neuropathic pain diagnoses. Identification of prescription analgesics/adjuvants was based on claims for the supply of medications that overlapped with the index date over a 3-month look-back period. The prevalence of neuropathic pain was 14.6%. Among those with neuropathic pain, 19.7% had diabetic neuropathy, 27.3% had back and neck pain with neuropathic involvement, and 25.1% had hereditary or idiopathic neuropathy. Among residents with neuropathic pain, 49.9% received anticonvulsants, 28.6% received antidepressants, 19.0% received opioids, and 28.2% had no claims for analgesics or adjuvants. Resident characteristics associated with lack of medications included advanced age, dependency in activities of daily living, cognitive impairment, and diagnoses of comorbid conditions. A diagnosis of neuropathic pain is common among nursing home residents, yet many lack pharmacologic treatment for their pain. Future epidemiologic studies can help develop a more standard approach to identifying and managing neuropathic pain among nursing home residents., (Copyright © 2021 International Association for the Study of Pain.)

Introduction: As dietary supplements are widely used in the United States, student pharmacists should be prepared to assess their appropriateness for self-care. The purpose of this project was to assess the impact of mock patient consults regarding common dietary supplements on second-year (P2) Doctor of Pharmacy (PharmD) students., Methods: This activity was part of a required course, Self-Care I. Twenty-four groups of 4 to 5 students were created, with each assigned a unique patient vignette. Students had 10 minutes to speak on the phone with their "patient" to obtain needed information in order to make an appropriate recommendation in the form of a 2 to 3-minute recorded oral response. Anonymous, voluntary pre- and post-project surveys assessing perceived dietary supplement knowledge, patient counseling skills, and attitudes about the activity were conducted during class through Google Forms. The Wilcoxon Signed-Rank Test was used to determine differences in mean 10-point Likert scale score between pre- and post-test for each survey question, with significance if p < 0.05., Results: Significant differences were found between pre- and post-survey Likert scale means. Reported confidence in using the QuEST/SCHOLAR-MAC approaches to self-care counseling increased by 45% from baseline. Perceived student knowledge on dietary supplements increased by 44%. Self-rated counseling abilities of students increased by 87% for glucosamine/chondroitin, 28% for melatonin, 39% for red yeast rice, 38% for fish oil, and 42% for cranberry regarding their use in particular cases., Conclusions: The activity provided students with realistic exposure to questions about dietary supplements that patients ask community pharmacists.

Background: About 29.2% of American adults ≥ 65 years of age have diabetes mellitus, but details regarding diabetes management especially among nursing home residents are dated., Objectives: Evaluate the prevalence of antihyperglycemic agents in residents with diabetes mellitus and describe resident characteristics using major drug classes., Design: cross-sectional study., Setting: virtually all United States nursing homes., Participants: 141,636 residents with diabetes mellitus., Measurements: Minimum Data Set (2016) and Medicare Part D claims determined use of metformin, sulfonylureas, meglitinide analogs, alpha-glucosidase inhibitors, TZDs, DPP4 inhibitors, SGLT2 inhibitors, GLP1 agonists, as monotherapy and with basal insulin., Results: Seventy-two percent received antihyperglycemic drugs [most common: basal insulins (53.9% total; 46.9% with other non-insulin agents), metformin (35.5% total; 14.2% monotherapy), sulfonylureas (19.6% total; 6.3% monotherapy), and DPP4 inhibitors (12.2% total; 2.2% monotherapy)]. Sixty-three percent of meglitinide monotherapy versus 34.1% of metformin monotherapy users; and 38.3% meglitinide-basal insulin versus 22.2% metformin-basal insulin users were ≥85 years. Obesity was greater among users of GLP1 agonists compared to those receiving other agents (monotherapy: 60.5% versus 33-42%; with basal insulin: 76.2% versus 50-58%). End-stage renal disease was least prevalent among metformin users (monotherapy: 6.6%; with basal insulin: 8.8%) and most common among meglitinide monotherapy (19.6%) and GLP1 agonists with basal insulin (22%) users., Conclusions: There is heterogeneity of diabetes treatment in nursing homes. Use of antihyperglycemic drugs with a higher risk of hypoglycemia, such as insulin with sulfonylureas or meglitinides, continue in nursing home residents., Competing Interests: Conflict of Interest: Drs. Hume, Osundolire, Mbrah, Nunes, and Lapane declare that they have no conflict of interest including financial, personal or potential and have nothing otherwise to disclose. Declaration of Interest: Anne Hume has no conflicts of interest to declare. Seun Osundolire has no conflicts of interest to declare. Attah K. Mbrah has no conflicts of interest to declare. Anthony Nunes has no conflicts of interest to declare. Kate Lapane has no conflicts of interest to declare.

Objective: To identify the dietary supplements most commonly promoted online for brain health and to compare their major ingredients over 18 months. Mild cognitive impairment and Alzheimer's disease are increasing globally with few effective treatments available. Dietary supplements are widely promoted in the media and online for brain health and memory improvement despite minimal evidence of an actual effect. Methods: Incognito mode on Google Chrome was used to conduct four separate searches using the terms: memory supplement, brain health supplement, Alzheimer's supplement, and dementia supplement. The four separate searches for products were conducted through CVS, Walgreens, Walmart, GNC, Amazon, Yahoo, and Google. For each website, the top 10 supplement products and their ingredients were documented in August 2017 and again in January 2019. Results: Of the four terms used, "memory supplement" and "brain health supplement" provided the most results. The most common products were Prevagen®, Procera®, and Neuro Health®. Amazon had the most repeated products in 2017 and 2019, while Google and CVS had the least. Focus Factor® appeared 11 times in 2019 compared with once in 2017. At both time points, the most commonly promoted products were proprietary blends of Ginkgo biloba, vitamins, particularly vitamin B12 and folic acid, huperzine-A, Bacopa monnieri, and phosphatidylserine. Conclusions: Though the 2017 and 2019 datasets showed diverse products, the primary ingredients were similar. These supplements have insufficient evidence of efficacy and are expensive. Health professionals must be knowledgeable about dietary supplements for brain health to appropriately counsel individuals.

Introduction: The United States has been battling an opioid epidemic for decades. As substance use disorders have grown, so too has investigation into treatment options, including integrative medicine approaches, for managing opioid withdrawal symptoms (OWS)., Objectives: This systematic review sought to assess the use of integrative medicine approaches for the alleviation of OWS in patients dependent on opioids and to summarize the available data., Methods: The authors searched using synonyms for opioids, substance use disorder, and integrative medicine and standardized searches in Embase, PubMed, and Cochrane Library. We also hand searched references for systematic reviews. This review did not include articles that could not be obtained as full-text publications via interlibrary loan. The review also excluded studies with interventions involving acupuncture because multiple systematic reviews on this approach already exist. In addition, we also excluded studies of therapy for opioid maintenance. We evaluated studies for inclusion based on the Jadad criteria. We compared opioid withdrawal outcomes of the studies to determine the efficacy of integrative medicine approaches., Results: The authors identified a total of 382 unique publications initially for possible inclusion through systematic searches. After applying inclusion and exclusion criteria, five studies met Jadad criteria. The authors identified an additional two studies for inclusion via hand searching. A total of seven studies included interventions consisting of passionflower, weinicom, fu-yuan pellet, jinniu capsules, tai-kang-ning, dynorphin, and l-tetrahydropalmatine. Analyzing the articles was difficult given the varied scoring methods they used to quantify opioid withdrawal symptoms and the small sample sizes in the trials. Most showed evidence that supported integrative medicine approaches for OWS, although the strength of evidence was limited because of sample sizes., Conclusions: This review found evidence of multiple integrative medicine approaches for opioid withdrawal symptoms. Well-designed randomized controlled trials should assess the efficacy of integrative medicine for improvement in OWS., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Little is known about trends in statin use in United States (US) nursing homes., Objectives: The aim of this study was to describe national trends in statin use in nursing homes and evaluate the impact of the introduction of generic statins, safety warnings, and guideline recommendations on statin use., Methods: This study employed a repeated cross-sectional prevalence design to evaluate monthly statin use in long-stay US nursing home residents enrolled in Medicare fee-for-service using the Minimum Data Set 3.0 and Medicare Part D claims between April 2011 and December 2016. Stratified by age (65-75 years, ≥ 76 years), analyses estimated trends and level changes with 95% confidence intervals (CI) following statin-related events (the availability of generic statins, American Heart Association/American College of Cardiology guideline updates, and US FDA safety warnings) through segmented regression models corrected for autocorrelation., Results: Statin use increased from April 2011 to December 2016 (65-75 years: 38.6-43.3%; ≥ 76 years: 26.5% to 30.0%), as did high-intensity statin use (65-75 years: 4.8-9.5%; ≥ 76 years: 2.3-4.5%). The introduction of generic statins yielded little impact on the prevalence of statins in nursing home residents. Positive trend changes in high-intensity statin use occurred following national guideline updates in December 2011 (65-75 years: β = 0.16, 95% CI 0.09-0.22; ≥ 76 years: β = 0.09, 95% CI 0.06-0.12) and November 2013 (65-75 years: β = 0.11, 95% CI 0.09-0.13; ≥ 76 years: β = 0.04, 95% CI 0.03-0.05). There were negative trend changes for any statin use concurrent with FDA statin safety warnings in March 2012 among both age groups (65-75 years: β trend change = - 0.06, 95% CI - 0.10 to - 0.02; ≥ 76 years: β trend change = - 0.05, 95% CI - 0.08 to - 0.01). The publication of the results of a statin deprescribing trial yielded a decrease in any statin use among the ≥ 76 years age group (β level change = - 0.25, 95% CI - 0.48 to - 0.09; β trend change = - 0.03, 95% CI - 0.04 to - 0.01), with both age groups observing a positive trend change with high-intensity statins (65-75 years: β = 0.11, 95% CI 0.02-0.21; ≥ 76 years: β = 0.05, 95% CI 0.01-0.09)., Conclusion: Overall, statin use in US nursing homes increased from 2011 to 2016. Guidelines and statin-related events appeared to impact use in the nursing home setting. As such, statin guidelines and messaging should provide special consideration for nursing home populations, who may have more risk than benefit from statin pharmacotherapy.

Background: Evidence to guide clinical decision making for pain management in nursing home residents is scant., Objective: Our objective was to explore the extent of consensus among expert stakeholders regarding what analgesic issues should be prioritized for comparative-effectiveness studies of beneficial and adverse effects of analgesic regimens in nursing home residents., Methods: Two stakeholder panels (nurses only and a mix of clinicians/researchers) were engaged (n = 83). During a three-round online modified Delphi process, participants rated and commented on the need for new evidence on nonopioid analgesic regimens and opioid regimens, short-term adverse effects, long-term adverse effects, comorbid conditions, and other factors in the nursing home setting (9-point scale; 1 = not essential to 9 = very essential to obtain new evidence). The quantitative data were analyzed to determine the existence of consensus using an approach from the RAND/UCLA Appropriateness Method User's Manual. The qualitative data, consisting of participant explanations of their numeric ratings, were thematically analyzed by an experienced qualitative researcher., Results: For nursing home residents, evidence generation was deemed essential for opioids, gabapentin (alone or with serotonin norepinephrine reuptake inhibitors [SNRIs]), and nonsteroid anti-inflammatory drugs with SNRIs. Experts prioritized the following outcomes as essential: long-term adverse effects, including delirium, cognitive decline, and decline in activities of daily living (ADLs). Kidney disease and depression were deemed essential conditions to consider in studies of pain medications. Coprescribing analgesic regimens with benzodiazepines, sedating medications, serotonergic medications, and non-SNRI antidepressants were considered essential areas of study. Experts noted that additional study was essential in residents with moderate/severe cognitive impairment and limitations in ADLs., Conclusions: Stakeholder priorities for more evidence reflect concerns related to treating medically complex residents with complex drug regimens and included long-term adverse effects, coprescribing, and sedating medications. Carefully conducted observational studies are needed to address the vast evidence gap for nursing home residents.

Background: Research comparing direct-acting oral anticoagulants (DOACs) to warfarin has excluded nursing home residents, a vulnerable and high-risk population., Objective: To compare the safety and effectiveness of DOACs versus warfarin., Design: New-user cohort study (2011-2016)., Patients: US nursing home residents aged > 65 years with non-valvular atrial fibrillation enrolled in fee-for-service Medicare for > 6 months., Exposures: Initiators of DOACs (2881 apixaban, 1289 dabigatran, 3735 rivaroxaban) were 1:1 propensity matched to warfarin initiators., Main Measures: Outcomes included ischemic stroke or transient ischemic attack (i.e., ischemic cerebrovascular event), bleeding (extracranial or intracranial), other vascular events, death, and a composite of all outcomes. Absolute rate differences (RD) and cause-specific hazard ratios (HR) with 95% confidence intervals (CI) were estimated. Subgroup analyses were performed by alignment of DOAC dosing with labeling., Key Results: Median age (84 years), CHA 2 DS 2 -Vasc (5), and ATRIA risk scores (3) were similar across medications. Clinical outcome rates were similar for dabigatran and rivaroxaban users versus warfarin users. However, ischemic cerebrovascular event rates were higher among dabigatran and rivaroxaban users that received reduced dosages without an indication. Overall, apixaban users had higher ischemic cerebrovascular event rates (HR 1.86; 95% CI 1.00-3.45) and lower bleeding rates (HR 0.66; 95% CI 0.49-0.88), but outcome rates varied by dosing alignment. Mortality rates (per 100 person-years) were lower for apixaban (RDs - 9.30; 95% CI - 13.18 to - 5.42), dabigatran (RDs - 10.79; 95% CI - 14.98 to - 6.60), and rivaroxaban (RDs - 8.92; 95% CI - 12.01 to - 5.83) versus warfarin; composite outcome findings were similar., Conclusions: Among US nursing home residents, the DOACs were each associated with lower mortality versus warfarin. Misaligned DOAC dosing was common in nursing homes and was associated with clinical and mortality outcomes. Overall, DOAC users had lower rates of adverse outcomes including mortality compared with warfarin users.

Objective: We estimated the use of prescribed analgesics and adjuvants among nursing home residents without cancer who reported pain at their admission assessment, in relation to resident-reported pain severity., Methods: Medicare Part D claims were used to define 3 classes of analgesics and 7 classes of potential adjuvants on the 21st day after nursing home admission (or the day of discharge for residents discharged before that date) among 180,780 residents with complete information admitted between January 1, 2011 and December 9, 2016, with no cancer diagnosis., Results: Of these residents, 27.9% reported mild pain, 46.6% moderate pain, and 25.6% reported severe pain. The prevalence of residents in pain without Part D claims for prescribed analgesic and/or adjuvant medications was 47.3% among those reporting mild pain, 35.7% among those with moderate pain, and 24.8% among those in severe pain. Among residents reporting severe pain, 33% of those ≥ 85 years of age and 35% of those moderately cognitively impaired received no prescription analgesics/adjuvants. Use of all classes of prescribed analgesics and adjuvants increased with resident-reported pain severity, and the concomitant use of medications from multiple classes was common., Conclusion: Among nursing home residents with recognized pain, opportunities to improve the pharmacologic management of pain, especially among older residents, and those living with cognitive impairments exist.

Importance: Prolonged opioid use after surgery may be associated with opioid dependency and increased health care use. However, published studies have reported varying estimates of the magnitude of prolonged opioid use and risk factors associated with the transition of patients to long-term opioid use., Objectives: To evaluate the rate and characteristics of patient-level risk factors associated with increased risk of prolonged use of opioids after surgery., Data Sources: For this systematic review and meta-analysis, a search of MEDLINE, Embase, and Google Scholar from inception to August 30, 2017, was performed, with an updated search performed on June 30, 2019. Key words may include opioid analgesics, general surgery, surgical procedures, persistent opioid use, and postoperative pain., Study Selection: Of 7534 articles reviewed, 33 studies were included. Studies were included if they involved participants 18 years or older, evaluated opioid use 3 or more months after surgery, and reported the rate and adjusted risk factors associated with prolonged opioid use after surgery., Data Extraction and Synthesis: The Meta-analysis of Observational Studies in Epidemiology (MOOSE) and Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines were followed. Two reviewers independently assessed and extracted the relevant data., Main Outcomes and Measures: The weighted pooled rate and odds ratios (ORs) of risk factors were calculated using the random-effects model., Results: The 33 studies included 1 922 743 individuals, with 1 854 006 (96.4%) from the US. In studies with available sex and age information, participants were mostly female (1 031 399; 82.7%) and had a mean (SD) age of 59.3 (12.8) years. The pooled rate of prolonged opioid use after surgery was 6.7% (95% CI, 4.5%-9.8%) but decreased to 1.2% (95% CI, 0.4%-3.9%) in restricted analyses involving only opioid-naive participants at baseline. The risk factors with the strongest associations with prolonged opioid use included preoperative use of opioids (OR, 5.32; 95% CI, 2.94-9.64) or illicit cocaine (OR, 4.34; 95% CI, 1.50-12.58) and a preoperative diagnosis of back pain (OR, 2.05; 95% CI, 1.63-2.58). No significant differences were observed with various study-level factors, including a comparison of major vs minor surgical procedures (pooled rate: 7.0%; 95% CI, 4.9%-9.9% vs 11.1%; 95% CI, 6.0%-19.4%; P = .20). Across all of our analyses, there was substantial variability because of heterogeneity instead of sampling error., Conclusions and Relevance: The findings suggest that prolonged opioid use after surgery may be a substantial burden to public health. It appears that strategies, such as proactively screening for at-risk individuals, should be prioritized.

Objectives: To evaluate the prevalence and factors associated with statin pharmacotherapy in long-stay nursing home residents with life-limiting illness., Design: Cross-sectional., Setting: US Medicare- and Medicaid-certified nursing home facilities., Participants: Long-stay nursing home resident Medicare fee-for-service beneficiaries aged 65 years or older with life-limiting illness (n = 424 212)., Measurements: Prevalent statin use was estimated as any low-moderate intensity (daily dose low-density lipoprotein-cholesterol [LDL-C] reduction <30%-50%) and high-intensity (daily dose LDL-C reduction >50%) use via Medicare Part D claims for a prescription supply on September 30, 2016, with a 90-day look-back period. Life-limiting illness was operationally defined to capture those near the end of life using evidence-based criteria to identify progressive terminal conditions or limited prognoses (<6 mo). Poisson models provided estimates of adjusted prevalence ratios and 95% confidence intervals for resident factors., Results: A total of 34% of residents with life-limiting illness were prescribed statins (65-75 y = 44.0%, high intensity = 11.1%; >75 y = 31.1%, high intensity = 5.4%). Prevalence of statins varied by life-limiting illness definition. Of those with a prognosis of less than 6 months, 23% of the 65 to 75 and 12% of the older than 75 age groups were on statins. Factors positively associated with statin use included minority race or ethnicity, use of more than five concurrent medications, and atherosclerotic cardiovascular disease or risk factors., Conclusion: Despite having a life-limiting illness, more than one-third of clinically compromised long-stay nursing home residents remain on statins. Although recent national guidelines have expanded indications for statins, the benefit of continued therapy in an advanced age population near the end of life is questionable. Efforts to deprescribe statins in the nursing home setting may be warranted. J Am Geriatr Soc 68:708-716, 2020., (© 2020 The American Geriatrics Society.)

Background: Antiepileptic drugs (AEDs) are commonly used by nursing home residents, both on- and off-label. The landscape of AED use has changed over the past two decades; however, despite this, contemporaneous research on AED use in US nursing home residents is scant., Objective: The aim of this study was to estimate the prevalence of AED use, describe prescribing patterns, identify factors associated with AED use, and assess whether these factors differ among AEDs with expanded indications in older adults (i.e. gabapentin, pregabalin, topiramate, and lamotrigine)., Methods: We conducted a cross-sectional study among 549,240 long-stay older residents who enrolled in fee-for-service Medicare and lived in 15,111 US nursing homes on 1 September 2016. Demographics and conditions associated with AED indications, epilepsy comorbidities, and safety data came from the Minimum Data Set Version 3.0 (MDS 3.0). Medicare Part D claims were used to identify AED use. Robust Poisson models and multinomial logistic models for clustered data estimated adjusted prevalence ratios (aPR), adjusted odds ratios (aOR), and 95% confidence intervals (CIs)., Results: Overall, 24.0% used AEDs (gabapentin [13.3%], levetiracetam [4.7%], phenytoin [1.9%], pregabalin [1.8%], and lamotrigine [1.2%]). AED use was associated with epilepsy (aPR 3.73, 95% CI 3.69-3.77), bipolar disorder (aPR 1.20, 95% CI 1.18-1.22), pain (aPR moderate/severe vs. no pain 1.42, 95% CI 1.40-1.44), diabetes (aPR 1.27, 95% CI 1.26-1.28), anxiety (aPR 1.12, 95% CI 1.11-1.13), depression (aPR 1.17, 95% CI 1.15-1.18), or stroke (aPR 1.08, 95% CI 1.06-1.09). Residents with advancing age (aPR 85+ vs. 65-74 years 0.73, 95% CI 0.73-0.74), Alzheimer's disease/dementia (aPR 0.87, 95% CI 0.86-0.88), or cognitive impairment (aPR severe vs. no impairment 0.62, 95% CI 0.61-0.63) had decreased AED use. Gabapentinoid use was highly associated with pain (aOR moderate/severe vs. no pain 2.07, 95% CI 2.01-2.12) and diabetes (aOR 1.79, 95% CI 1.76-1.82), but not with an epilepsy indication., Conclusions: AED use was common in nursing homes, with gabapentin most commonly used (presumably for pain). That multiple comorbidities were associated with AED use underscores the need for future studies to investigate the safety and effectiveness of AED use in nursing home residents.

Objectives: Our objective was to describe the prevalence of adjuvants to opioid therapy and changes in these agents for pharmacologic management in nursing home residents with cancer., Methods: We included Medicare beneficiaries with cancer and documented opioid use at nursing home admission in 2011-2013 (N = 3268). The Minimum Data Set 3.0 provided information on sociodemographic and clinical characteristics. Part D claims provided information on opioid and adjuvant use during the 7 days after admission and 90 days later. Proportions of changes in these agents were estimated. Separate logistic models estimated associations between resident characteristics and (1) use of adjuvants at admission and (2) intensification of pharmacologic management at 90 days., Results: Nearly 20% of patients received adjuvants to opioids at admission, with gabapentin the most common adjuvant (34.4%). After 90 days, approximately 25% had maintained or intensified pharmacologic management. While advanced age (≥ 85 vs. 65-74 years, adjusted odds ratio [aOR] 0.80; 95% confidence interval [CI] 0.63-1.02) and comorbidities, including dementia (aOR 0.65; 95% CI 0.53-0.82) and depression (aOR 1.55; 95% CI 1.29-1.87), were associated with adjuvant use at admission, worse cognitive impairment (severe vs. no/mild, aOR 0.80; 95% CI 0.64-0.99) and presence of more severe pain (moderate/severe vs. no pain, aOR 1.60; 95% CI 1.26-2.03) were associated with intensification of drug regimen., Conclusion: Given aging-related changes and the presence of comorbid conditions in older adults, safety studies of these practices are warranted.

Background Nursing home residents with atrial fibrillation are at high risk for ischemic stroke and bleeding events. The most recent national estimate (2004) indicated less than one third of this high-risk population was anticoagulated. Whether direct-acting oral anticoagulant ( DOAC ) use has disseminated into nursing homes and increased anticoagulant use is unknown. Methods and Results A repeated cross-sectional design was used to estimate the point prevalence of oral anticoagulant use on July 1 and December 31 of calendar years 2011 to 2016 among Medicare fee-for-service beneficiaries with atrial fibrillation residing in long-stay nursing homes. Nursing home residence was determined using Minimum Data Set 3.0 records. Medicare Part D claims for apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin were identified and point prevalence was estimated by determining if the supply from the most recent dispensing covered each point prevalence date. A Cochran-Armitage test was performed for linear trend in prevalence. On December 31, 2011, 42.3% of 33 959 residents (median age: 85; Q1 79, Q3 90) were treated with an oral anticoagulant, of whom 8.6% used DOAC s. The proportion receiving treatment increased to 47.8% of 37 787 residents as of December 31, 2016 ( P<0.01); 48.2% of 18 054 treated residents received DOAC s. Demographic and clinical characteristics of residents using DOAC s and warfarin were similar in 2016. Half of the 8734 DOAC users received standard dosages and most were treated with apixaban (54.4%) or rivaroxaban (35.8%) in 2016. Conclusions Increases in anticoagulant use among US nursing home residents with atrial fibrillation coincided with declining warfarin use and increasing DOAC use.

Context: Despite many nursing home residents experiencing pain, research about the multidimensional nature of nonmalignant pain in these residents is scant., Objectives: To identify and describe pain symptom subgroups and to evaluate whether subgroups differed by sex., Methods: Using Minimum Data Set 3.0 data (2011-2012), we identified newly admitted nursing home residents reporting pain (n = 119,379). A latent class analysis included 13 indicators: markers for pain (i.e., severity, frequency, impacts sleep, and function) and depressive symptoms. Sex was evaluated as a grouping variable. Multinomial logistic models identified the association between latent class membership and covariates, including age and cognitive impairment., Results: Four latent subgroups were identified: severe (15.2%), moderate frequent (26.4%), moderate occasional with depressive symptoms (26.4%), and moderate occasional without depressive symptoms (32.0%). Measurement invariance by sex was ruled out. Depressed mood, sleep disturbances, and fatigue distinguished subgroups. Age ≥75 years was inversely associated with belonging to the severe, moderate frequent, or moderate occasional with depressive symptoms subgroups. Residents with severe cognitive impairment had reduced odds of membership in the severe pain subgroup (adjusted odds ratio [aOR]: 0.84; 95% confidence interval [CI]: 0.78-0.90) and moderate frequent pain subgroup (aOR: 0.60; 95% CI: 0.56-0.64) but increased odds in the moderate occasional pain with depressive symptoms subgroup (aOR: 1.12; 95% CI: 1.06-1.18)., Conclusion: Identifying subgroups of residents with different patterns of pain and depressive symptoms highlights the need to consider physical and psychological components of pain. Expanding knowledge about pain symptom subgroups may provide a promising avenue to improve pain management in nursing home residents., (Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Depression, anxiety, and pain are commonly experienced by older adults living in nursing homes., Objectives: To describe the prevalence of depression, anxiety disorders, and pain among newly admitted nursing home residents in the United States and to describe the treatment of these disorders., Design: Cross-sectional study of newly admitted residents., Setting: Residents able to complete a pain assessment (n=783,826) living in Medicare- and Medicaid-certified nursing homes in the United States in 2011-2012., Measures: Measures of sociodemographic, mood and behavior, pain, diagnoses, and functioning items from the Minimum Data Set (MDS) version 3.0., Results: Approximately 36% of residents had a diagnosis of depression (other than bipolar disorder) and/or an anxiety disorder (n = 272,311). Of these residents, 25.2% had both depression and an anxiety disorder (95% CI = 25.0-25.4%), 54.3% (95% CI = 54.1-54.5%) had depression without an anxiety disorder, and 20.5% had an anxiety disorder without depression (95% CI = 20.3-20.6%). Fifteen percent had the triad of depression, anxiety, and pain at admission (95% CI = 9.3-23.3%). Depressive symptoms were more commonly reported by residents with pain than by those without pain. Receipt of psychological therapy (range: 0.9%-2.0%) or any psychiatric medication was lacking (range: 35.3%-48.5%), regardless of pain status. Participants reporting pain received a combination of scheduled, pro re nata ( PRN)/as-needed, and non-medication pain interventions (range: 59.8% depression without anxiety to 62.9% depression and anxiety disorder)., Conclusion: Residents often suffer from combinations of depression, anxiety and pain at admission to nursing home. While treatment of pain is more common than treatment of psychiatric treatments, both psychiatric treatment and pain management may be suboptimal in nursing homes.

Background: Despite the growing importance of skilled nursing facility care for Medicare patients hospitalized with heart failure, no risk prediction models for these patients exist., Objectives: To develop and validate separate predictive models for 30-day all-cause mortality and 30-day all-cause re-hospitalization., Design: Retrospective cohort study using a nationwide Medicare claims data cross-linked with Minimum Data Set 3.0., Setting: 11,529 skilled nursing facilities in the United States (2011-2013)., Participants: 77,670 hospitalized heart failure patients discharged to skilled nursing facilities (randomly split into development (2/3) and validation (1/3) cohorts)., Measurements: Using data on patient sociodemographic and clinical characteristics, health service use, functional status, and facility-level factors, we developed separate prediction models for 30-day mortality and 30-day re-hospitalization using logistic regression models in the development cohort., Results: Within 30 days, 6.8% died and 24.2% were re-hospitalized. Thirteen patient-level factors remained in the final model for 30-day mortality and 10 patient-level factors for re-hospitalization with good calibration. The area under receiver operating characteristic curves were 0.71 for 30-day mortality and 0.63 for re-hospitalization in the validation cohort., Conclusions: Among Medicare patients with heart failure discharged to skilled nursing facilities, predicting 30-day mortality and re-hospitalization using administrative data is challenging. Further work identifying factors for re-hospitalization remains needed.

Purpose: To estimate the proportion of residents newly initiating long-acting opioids in comparison to residents initiating short-acting opioids and examine variation in long-acting opioid initiation by region and resident characteristics., Methods: This cross-sectional study included 182 735 long-stay nursing home residents in 13 881 US nursing homes who were Medicare beneficiaries during 2011 to 2013 and initiated a short-acting or long-acting opioid (excluding residents <50 years old, those with cancer, or receiving hospice care). Medicare Part D prescription claims were used to identify residents as newly initiating short-acting or long-acting opioids, defined as having a prescription claim for an opioid with no prior opioid prescriptions in the preceding 60 days. We estimated the overall proportion of initiators prescribed long-acting opioids. Regional variation was examined by mapping results by state and hospital referral regions. Logistic models were used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs)., Results: Two percent of opioid initiators were prescribed long-acting opioids. State variation in long-acting opioid initiation ranged from 0.6% to 7.5% (5th-95th percentiles: 0.6-6.4%). Resident characteristics associated with increased long-acting opioid initiation included severe physical limitations (vs none/mild limitations; aOR: 2.13, 95% CI: 1.92-2.37) and pain (staff-assessed vs no pain; aOR: 1.59 95% CI: 1.40-1.80), whereas being non-White was inversely associated (non-Hispanic black vs non-Hispanic white; aOR: 0.70, 95% CI: 0.62-0.79)., Conclusion: United States nursing home residents predominantly initiate short-acting opioids in accordance with Center for Disease Control and Prevention guidelines. Documented variation by geographic and resident characteristics suggests that improvements are possible., (© 2018 John Wiley & Sons, Ltd.)

Background: Thromboembolic and bleeding risk are elevated in older patients with atrial fibrillation and prior stroke. We compared dabigatran with rivaroxaban for secondary prevention in a national population after skilled nursing facility (SNF) discharge., Methods: Medicare fee-for-service beneficiaries aged ≥ 65 years with atrial fibrillation hospitalized for ischemic stroke (November 2011-October 2013) and subsequently admitted to an SNF were studied. Dabigatran (n = 332) and rivaroxaban users (n = 378) were compared in a retrospective, active comparator, new-user cohort. The index medication claim occurred within 120 days after hospital discharge and exposure continued until a 14-day treatment gap ('as treated'). The primary net clinical benefit outcome was the time to recurrent stroke, transient ischemic attack, intracranial hemorrhage, extracranial bleed, myocardial infarction, venous thromboembolism, or death. All-cause mortality was evaluated separately as a secondary outcome. Multivariable adjusted Cox models stratified by dosage estimated hazard ratios (aHR)., Results: Among those receiving low dosages, the crude composite event rate was 40.4/100 person-years among dabigatran users and 33.7/100 person-years among rivaroxaban users. The composite outcome [aHR 1.48; 95% confidence interval (CI) 0.87-2.51] and all-cause mortality (aHR 1.67; 95% CI 0.84-3.31) rates were higher among low-dose dabigatran users. For those receiving standard doses, the crude composite event rates were 19.5/100 person-years for dabigatran users and 37.1/100 person-years for rivaroxaban users. Although no difference in mortality was observed, the composite outcome rate was lower among standard-dose dabigatran users (aHR 0.65; 95% CI 0.36-1.15)., Conclusions: In older adults treated with direct-acting oral anticoagulants after ischemic stroke, outcome rates varied considerably by drug and dosage.

Context: The aim of palliative care is to improve quality of life for patients with serious illnesses by treating their symptoms and adverse effects. Hospice care also aims for this for patients with a life expectancy of six months or less. When conventional therapies do not provide adequate symptom management or produce their own adverse effects, patients, families, and caregivers may prefer complementary or alternative approaches in their care., Objectives: The objectives of this study were to evaluate the available evidence on the use of complementary or alternative medicine (CAM) in hospice and palliative care and to summarize their potential benefits., Methods: A defined search strategy was used in reviewing literature from major databases. Searches were conducted using base terms and the symptom in question. Symptoms included anxiety, pain, dyspnea, cough, fatigue, insomnia, nausea, and vomiting. Studies were selected for further evaluation based on relevancy and study type. References of systematic reviews were also assessed. After evaluation using quality assessment tools, findings were summarized and the review was structured based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines., Results: Out of 4682 studies, 17 were identified for further evaluation. Therapies included acupressure, acupuncture, aromatherapy massage, breathing, hypnotherapy, massage, meditation, music therapy, reflexology, and reiki. Many studies demonstrated a short-term benefit in symptom improvement from baseline with CAM, although a significant benefit was not found between groups., Conclusion: CAM may provide a limited short-term benefit in patients with symptom burden. Additional studies are needed to clarify the potential value of CAM in the hospice or palliative setting., (Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Objectives: To examine and quantify geographic variation in the initiation of commonly used opioids and prescribed dosage strength among older US nursing home residents., Methods: We merged 2011 Minimum Data Set 3.0 to Medicare claims and facility characteristics data to conduct a cross-sectional study among long-stay nursing home residents who initiated short-acting opioids commonly used in nursing homes (oxycodone, hydrocodone, or tramadol). We examined geographic variation in specific opioids initiated and potentially inappropriate doses (≥50 mg oral morphine equivalent/d) across hospital referral regions (HRRs). Multilevel logistic models quantified the proportional change in between-HRR variation and associations between commonly initiated opioids and inappropriate doses after adjusting for resident characteristics, facility characteristics, and state., Results: Oxycodone (9.4%) was initiated less frequently than hydrocodone (56.2%) or tramadol (34.5%) but varied dramatically between HRRs (range, 0%-74.5%). In total, resident/facility characteristics and state of residence, respectively explained 84.1%, 58.2%, 59.1%, and 46.6% of the between-HRR variation for initiating oxycodone, hydrocodone, tramadol, and inappropriate doses. In all cases, state explained the largest proportion of between-HRR variation. Relative to hydrocodone, residents initiating oxycodone were more likely (adjusted odds ratio, 5.00; 95% confidence interval, 4.57-5.47) and those initiating tramadol were less likely (adjusted odds ratio, 0.28; 95% confidence interval, 0.25-0.31) to be prescribed potentially inappropriately high doses., Conclusions: We documented extensive geographic variation in the opioid and dose initiated for nursing home residents, with state explaining the largest proportion of the observed variation. Further work is needed to understand potential drivers of opioid prescribing patterns at the state level.

Objectives: The aim of this study was to estimate the comparative safety of initiating commonly used opioids among older, long-stay United States nursing home residents with fracture hospitalizations., Methods: We conducted a new-user retrospective cohort study of nursing home residents initiating short-acting oxycodone, hydrocodone, or tramadol by merging the 2011-2013 Minimum Data Set 3.0 to Medicare hospitalization and pharmacy claims. Residents (≥ 65 years, no cancer or hospice use) contributed treatment episodes (> 120 days with no prior opioid claims) and were followed for 180 days until incident fracture hospitalization (hip, femur, humerus, pelvis, radius/ulna), death (competing risk), treatment changes (e.g., discontinuation), or administrative censoring. Competing risks models with inverse probability of treatment weighting were used to estimate subdistribution hazard ratios (HR SD ) and 95% confidence intervals (CI)., Results: Overall, 110,862 residents contributed 134,432 treatment episodes: 14,373 oxycodone; 69,182 hydrocodone; and 50,877 tramadol initiators. The incidences of fracture hospitalizations per 100 person-years were 9.4 (95% CI 7.5-11.7) for oxycodone, 7.9 (95% CI 7.1-8.8) for hydrocodone, and 5.0 (95% CI 4.3-5.7) for tramadol initiators. In weighted models, oxycodone initiators had a similar rate of fractures to hydrocodone initiators (HR SD 1.08, 95% CI 0.79-1.48). Tramadol initiators had lower fracture rates than hydrocodone initiators (HR SD 0.67, 95% CI 0.56-0.80)., Conclusions: The lower rate of fractures that we documented among tramadol initiators compared with hydrocodone initiators is consistent, albeit attenuated compared with prior studies among community-dwelling older adults. However, overall fracture rates were lower than in community settings, potentially due to the limited risk of falling in this population with limited mobility.

Objective. To address the gap in evidence-based knowledge among pharmacy students and practicing pharmacists regarding complementary and integrative health approaches due to insufficient education and a lack of standardized training. Methods. The National Center for Integrative Primary Healthcare (NCIPH) developed 22 pharmacy competencies linked to a set of 10 interprofessional "metacompetencies" in integrative health care. Results. The NCIPH pharmacy competencies are well-aligned with the current educational standards and Center for the Advancement of Pharmacy Education (CAPE) outcomes for pharmacy programs. Therefore, the NCIPH competencies may provide a foundation for the incorporation of interprofessional integrative health care education into pharmacy curricula. Conclusion. The NCIPH pharmacy competencies in integrative health care, linked to the interprofessional "metacompetencies," are aligned with educational standards and outcomes, and may serve as a basis for pharmacy curriculum.

Background/objectives: Overall and long-term opioid use among older adults have increased since 1999. Less is known about opioid use in older adults in nursing homes (NHs)., Design: Cross-sectional., Setting: U.S. NHs (N = 13,522)., Participants: Long-stay NH resident Medicare beneficiaries with a Minimum Data Set 3.0 (MDS) assessment between April 1, 2012, and June 30, 2012, and 120 days of follow-up (N = 315,949)., Measurements: We used Medicare Part D claims to measure length of opioid use in the 120 days from the index assessment (short-term: ≤30 days, medium-term: >30-89 days, long-term: ≥90 days), adjuvants (e.g., anticonvulsants), and other pain medications (e.g., corticosteroids). MDS assessments in the follow-up period were used to measure nonpharmacological pain management use. Modified Poisson models were used to estimate adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for age, gender, race and ethnicity, cognitive and physical impairment, and long-term opioid use., Results: Of all long-stay residents, 32.4% were prescribed any opioid, and 15.5% were prescribed opioids long-term. Opioid users (versus nonusers) were more commonly prescribed pain adjuvants (32.9% vs 14.9%), other pain medications (25.5% vs 11.0%), and nonpharmacological pain management (24.5% vs 9.3%). Long-term opioid use was higher in women (aPR = 1.21, 95% CI = 1.18-1.23) and lower in racial and ethnic minorities (non-Hispanic blacks vs whites: APR = 0.93, 95% CI = 0.90-0.94) and those with severe cognitive impairment (vs no or mild impairment, aPR = 0.82, 95% CI = 0.79-0.83)., Conclusion: One in seven NH residents was prescribed opioids long-term. Recent guidelines on opioid prescribing for pain recommend reducing long-term opioid use, but this is challenging in NHs because residents may not benefit from nonpharmacological and nonopioid interventions. Studies to address concerns about opioid safety and effectiveness (e.g., on pain and functional status) in NHs are needed., (© 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.)

The American College of Clinical Pharmacy (ACCP) published an initial white paper on herbal products in 2000. Since then, the global market for natural products has continued to expand, with tens of millions of consumers using such products on an annual basis in the United States alone. However, despite this expansion, natural products remain largely unregulated compared with prescription medications, have moderate- to low-level clinical evidence for efficacy, and continue to have safety concerns, including adulteration and misbranding. As comprehensive medication management experts, clinical pharmacists are uniquely qualified to navigate these concerns and advise patients appropriately. To develop and recommend a suitable care plan involving natural products, clinical pharmacists must establish a strong pharmacist-patient relationship, assess the appropriateness of therapy, educate the patient regarding key issues, and continuously monitor and follow up on the effectiveness of the care plan. This process should not only occur in an individual community or hospital setting, but also whenever a patient transitions from one care setting to another in cooperation with other clinicians., (© 2016 Pharmacotherapy Publications, Inc.)

Objectives: To estimate the prevalence of new initiation of long-acting opioids since introduction of national efforts to increase prescriber and public awareness on safe use of transdermal fentanyl patches., Design: Cross-sectional., Setting: U.S. nursing homes (NHs)., Participants: Medicare-enrolled long-stay NH residents (N = 22,253)., Measurements: Minimum Data Set 3.0 was linked with Medicare enrollment, hospital claims, and prescription drug transaction data (January-December 2011) and used to determine the prevalence of new initiation of a long-acting opioid prescribed to residents in NHs., Results: Of NH residents prescribed a long-acting opioid within 30 days of NH admission (n = 12,278), 9.4% (95% confidence interval = 8.9-9.9%) lacked a prescription drug claim for a short-acting opioid in the previous 60 days. The most common initial prescriptions of long-acting opioids were fentanyl patch (51.9% of opioid-naïve NH residents), morphine sulfate (28.1%), and oxycodone (17.2%)., Conclusion: New initiation of long-acting opioids-especially fentanyl patches, which have been the subject of safety communications-persists in NHs., (© 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.)

Introduction: The availability of comprehensive and accurate medication history information in electronic medical records and through electronic prescribing provides the opportunity to create tailored interventions based on individuals' particular medication information needs. To meet the challenges of providing medication information to low-literate English and Spanish speaking older adults, we sought to create individualized, culturally and linguistically inclusive medication education materials for older adults from diverse backgrounds., Methods: We used a mixed-method design including a systematic review, analysis of existing data, a telephone survey (n=326), and exploratory focus groups stratified by race/ethnicity and language spoken (11 focus groups; n=106) to identify what information about medications older adults need, want to learn, and in what format. We evaluated reactions to three DVDs at low-income senior community centers (2 focus groups; n=16)., Results: Exploratory focus groups provided insights on areas for improvement in patient-provider communication, and suggested use of vignettes and testimonials. Upon viewing, participants could relate to the testimonials in which actors portrayed people who have problems with their medications and were interested in the medication advice presented, especially when it was presented by a healthcare professional., Discussion: Tailored medication education materials in English and Spanish DVD and print material format are suitable for low-literate audiences, acceptable to older adults, and feasible to implement using health IT. Virtually all households in the United States have a television, with most having a DVD player. DVD segments can be used in Internet links, physician office-based television, and consumer health IT applications., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

During the past decade, patient safety issues during care transitions have gained greater attention at both the local and national level. Readmission rates to U.S. hospitals are high, often because of poor care transitions. Serious adverse drug events (ADEs) caused by an incomplete understanding of changes in complex drug regimens can be an important factor contributing to readmission rates. This paper describes the roles and responsibilities of pharmacists in ensuring optimal outcomes from drug therapy during care transitions. Barriers to effective care transitions, including inadequate communication, poor care coordination, and the lack of one clinician ultimately responsible for these transitions, are discussed. This paper also identifies specific patient populations at high risk of ADEs during care transitions. Several national initiatives and newer care transition models are discussed, including multi- and interdisciplinary programs with pharmacists as key members. Among their potential roles, pharmacists should participate on medical rounds where available, perform medication reconciliation and admission drug histories, apply their knowledge of drug therapy to anticipate and resolve problems during transitions, communicate changes in drug regimens between providers and care settings, assess the appropriateness and patient understanding of drug regimens, promote adherence, and assess health literacy. In addition, this paper identifies barriers and ongoing challenges limiting greater involvement of pharmacists from different practice settings during care transitions. Professional degree programs and residency training programs should increase their emphasis on pharmacists' roles, especially as part of interdisciplinary teams, in improving patient safety during care transitions in diverse practice settings. This paper also recommends that Accreditation Council for Pharmacy Education (ACPE) standards include specific language regarding the exposure of students to issues regarding care transitions and that students have several opportunities to practice the skills needed for effective care transitions. Moreover, reimbursement mechanisms that permit greater pharmacist involvement in providing medication assistance to patients going through care transitions should be explored. Although health information technology offers the potential for safer care transitions, pharmacists' use of information technology must be integrated into the national initiatives for pharmacists to be effectively involved in care transitions. This paper concludes with a discussion about the importance of recognizing and addressing health literacy issues to promote patient empowerment during and after care transitions., (© 2012 Pharmacotherapy Publications, Inc.)

Objective: To describe the development of evidence-based electronic prescribing (e-prescribing) triggers and treatment algorithms for potentially inappropriate medications (PIMs) for older adults., Design: Literature review, expert panel and focus group., Setting: Primary care with access to e-prescribing systems., Participants: Primary care physicians using e-prescribing systems receiving medication history., Interventions: Standardised treatment algorithms for clinicians attempting to prescribe PIMs for older patients., Main Outcome Measure: Development of 15 treatment algorithms suggesting alternative therapies., Results: Evidence-based treatment algorithms were well received by primary care physicians. Providing alternatives to PIMs would make it easier for physicians to change decisions at the point of prescribing., Conclusion: Prospectively identifying older persons receiving PIMs or with adherence issues and providing feasible interventions may prevent adverse drug events.

Put your patient on aspirin? Take him off? Here's what you need to know to get it right.

Objective: To describe the development, implementation, and assessment of a geriatric pharmacotherapy elective course emphasizing a patient-centered approach and active, self-directed learning strategies., Design: The course content included fundamental concepts in aging, geriatric syndromes, activities involving assessment of medically complex older adults, presentation of controversies in clinical geriatrics, book and film clubs, an Adopt-a-Patient project, and scientific and reflective writing. Students participated in site visits to interview and interact with older adults., Assessment: Student evaluation of the course was assessed with the teaching evaluation tool, an end-of-semester survey, a follow-up P4 survey, and reflective writings. Students strongly agreed that course goals were achieved. Learning how to communicate with older adults and assess complex medication regimens were the areas of highest importance to students. P4 students strongly agreed that skills learned in the course were important to their success in advanced pharmacy practice experiences (APPEs)., Conclusion: A pharmacotherapy course emphasizing active and self-directed learning in geriatrics through innovative teaching was adaptable to doctor of pharmacy (PharmD) students at various stages of their training and improved students' perceptions of aging.

American adults take many types of vitamin supplements, despite limited evidence of their efficacy, especially in preventing chronic diseases such as cardiovascular disease and cancer. Supplements contain significant amounts of vitamins when consumed from multiple sources. Excess consumption of some vitamins may have detrimental health effects. Use of MMVM products appears to be safe; however, clinical outcomes have not been established. Although vitamin D and preconception folic acid may be appropriate for self care, a health care provider should monitor other vitamin supplements for disease prevention, such as niacin. Beyond supplementation as treatment for vitamin deficiencies, evidence is lacking.

Background: The observation that angiotensin II is a potent angiogenic and growth factor raises the possibility that blocking its effects could reduce the incidence of cancer. We evaluated associations between use of angiotensin-converting enzyme (ACE) inhibitors and of angiotensin receptor blockers (ARBs) and keratinocyte cancer incidence in a population at high risk of the disease., Methods: A cohort study design was conducted using data on 1051 participants in the randomized Department of Veterans Affairs Topical Tretinoin Chemoprevention (VATTC) Trial, all of whom were at increased risk of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). We followed participants from enrollment (November 1998 through January 2003) until first BCC or SCC. Study participants were examined every 6 months by a study dermatologist; biopsies were taken on all suspicious lesions and centrally reviewed. Use of ACE inhibitors and ARBs was ascertained from VA pharmacy records. Cox proportional hazards models were used to estimate adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) of BCC and SCC with use of ACE inhibitors or ARBs., Results: During a median follow-up of 3.4 years, 472 incident BCCs, 309 SCCs, and 200 deaths from any cause were observed. Compared with nonusers, users of ACE inhibitors or ARBs had statistically significantly reduced risks of BCC (IRR(BCC) = 0.61, 95% CI = 0.50 to 0.76) and SCC (IRR(SCC) = 0.67, 95% CI = 0.52 to 0.87). The combined absolute incidence rates of BCC and SCC were 237 per 1000 person-years among users of ACE inhibitors or ARBs and 374 per 1000 person-years among nonusers. The greatest reduction in keratinocyte cancer was seen among people who initiated use of ACE inhibitors or ARBs during the study period (IRR(BCC) = 0.45 [95% CI = 0.34 to 0.59]; IRR(SCC) = 0.48 [95% CI = 0.35 to 0.67])., Conclusion: Among a high-risk group of veterans, users of ACE inhibitors or ARBs had a lower incidence of keratinocyte cancers than nonusers. The more pronounced reduction among those who initiated use during the study may indicate an immediate effect.

Objective: To review approaches and tools that pharmacists may use in communicating evidence of risk to older patients and their caregivers., Data Sources: Relevant publications related to tools to communicate evidence to patients were identified through a systematic MEDLINE and Internet search engines using key words: evidence-based medicine/practice, patient, and risk communication. Additional articles were identified through use of the PubMed "related articles" feature and a review of citations of previously identified articles., Study Selection and Data Extraction: Relevant English language publications were reviewed, with particular focus on articles about older adults., Data Synthesis: Communicating evidence from clinical trials to patients remains a challenge because of patient- and clinician-related barriers. Communicating with older adults faces additional challenges: perceptions of patient involvement in care and uncertainty of drug benefit-to-risk ratio because of the potential increase in adverse events. This is especially true in this population because of their multiple medical conditions. To actively involve patients in health care decisions, an ordered approach to teaching risks and benefits can be valuable. Evidence presented as a general risk estimate should be reinforced with specific numbers to depict patient-specific risk. Understanding may be strengthened with visual aids such as risk ladders or perspective scales. Each step in the process serves as a framework and should consider patients' individual values and beliefs., Conclusions: For patients to fully understand medications' risks and benefits, clinicians must use a systematic approach to present data from clinical trials and reinforce patients' comprehension using visual aids. Ultimately, these approaches and tools aim to support patient involvement in health care decisions.

Purpose: The results of a survey conducted to characterize participating practice sites, patient populations, and collaborative physician-pharmacist services provided through an emerging practice-based research network (PBRN) in the primary care setting are presented., Methods: A targeted sample of faculty pharmacist investigators practicing in primary care settings were selected for participation in this PBRN based on several factors, including past research activities, their interest in soliciting additional clinics within their state to participate in a research network, the potential for regional collaboration, geographic location, and the patient population served. A baseline survey to characterize the PBRN was distributed to members of the PBRN in June 2006. Data were analyzed using descriptive statistics., Results: A total of 81 pharmacists in 48 practice sites were recruited to join the PBRN. Most practice sites were located within family medicine residency programs, and the majority were affiliated with a community hospital or health system. Half of participating practices had 300-599 ambulatory care visits per week. Pharmacists in the PBRN spent their time performing direct patient management and had collaborative practice agreements with physicians. Patient revenue was used to cover pharmacist salaries in about one fifth of the practice sites. Pharmacists in the PBRN reported participation in diverse educational activities, such as point-of-care resident education and curbside consultation in the clinic hallways or their office., Conclusion: Eighty-one pharmacists from 48 primary care practice sites in 11 states were recruited to join a PBRN. These pharmacists provided descriptive data regarding their practice site, characteristics of patients served, and clinical services provided as a first step in collaborative research efforts.