Prescription opioid dispensing patterns among patients with schizophrenia or bipolar disorder.

BACKGROUND: Patients with schizophrenia (SZ) or bipolar disorder (BD) may have increased risk of complications from prescribed opioids, including opioid-induced respiratory depression. We compared prescription opioid pain medication dispensing for patients with SZ or BD versus controls over 5 years to assess dispensing trends. METHODS: This retrospective, observational study analysed US claims data from the IBM® MarketScan® Commercial and Multi-State Medicaid databases for individuals aged 18-64 years with prevalent SZ or BD for years 2015-2019 compared with age- and sex-matched controls. Baseline characteristics, comorbidities, and medication use were assessed. Proportions of individuals dispensed prescription opioids chronically (ie, ≥70 days over a 90-day period or ≥ 6 prescriptions annually) or nonchronically (≥1 prescription, chronic definition not met) were assessed. RESULTS: In 2019, the Commercial and Medicaid databases contained records for 4773 and 30,179 patients with SZ and 52,780 and 63,455 patients with BD, respectively. Patients with SZ or BD had a higher prevalence of comorbidities, including pain, versus controls in each analysis year. From 2015 to 2019, among commercially insured patients with SZ, chronic opioid-dispensing proportions decreased from 6.1% (controls: 2.7%) to 2.3% (controls: 1.2%) and, for patients with BD, from 11.4% (controls: 2.7%) to 6.4% (controls: 1.6%). Chronic opioid dispensing declined in Medicaid-covered patients with SZ from 15.0% (controls: 14.7%) to 6.7% (controls: 6.0%) and, for patients with BD, from 27.4% (controls: 12.0%) to 12.4% (controls: 4.7%). Among commercially insured patients with SZ, nonchronic opioid dispensing decreased from 15.5% (controls: 16.4%) to 10.7% (controls: 11.0%) and, for patients with BD, from 26.1% (controls: 17.5%) to 20.0% (controls: 12.2%). In Medicaid-covered patients with SZ, nonchronic opioid dispensing declined from 22.5% (controls: 24.4%) to 15.1% (controls: 12.7%) and, for patients with BD, from 32.3% (controls: 25.9%) to 24.6% (controls: 13.6%). CONCLUSIONS: The proportions of individuals dispensed chronic or nonchronic opioid medications each year were similar between commercially and Medicaid-insured patients with SZ versus controls and were higher for patients with BD versus controls. From 2015 to 2019, the proportions of individuals who were dispensed prescription opioids chronically or nonchronically decreased for patients with SZ or BD and controls.

Determinants of poor glycaemic control and proteinuria in patients with type 2 diabetes: a retrospective analysis of general practice records in Ireland.

BACKGROUND: Analysis of general practice records can address the information gap on the epidemiology of type 2 diabetes (T2DM) in Ireland, informing practice and the development of interventions in primary care. The aim of this study was to identify patients with poor glycaemic control, risk factors for complications and evidence of end organ damage in a large multi-practice study and to profile their characteristics. METHODS: Patients with T2DM were identified using disease coding in Health One practice management software in 41 general practices. Patients' demographics and clinical data were extracted. Rates of poor glycaemic control (glycated haemoglobin > 58 mmol/mol) and albumin creatinine ratio > 3 mg/mmol were calculated. A multilevel logistic regression analysis using both patient and practice variables was conducted. RESULTS: Data was collected from 3188 patients of whom 29% (95% CI 28 to 31%) had poor glycaemic control, which was associated with younger age, higher BMI and higher total cholesterol. Only 42% of patients (n = 1332) had albumin creatinine ratio measured with 42% (95% CI 40 to 45%) of these having values > 3 mg/mmol. Older age groups, men, those with hypertension, eGFR < 60 ml/min/1.73m2 and poor glycaemic control were most associated with higher values of albumin creatinine ratio. CONCLUSIONS: Analysing this large multi-practice dataset gives important information on the prevalence and characteristics of diabetic patients who are most at risk of poor outcomes. It highlights that recording of some data could be improved.

Impact of the COVID-19 lockdown on the vitamin D status of people in the West of Ireland.

OBJECTIVE: Identify the impact of COVID-19 lockdown restrictions on the vitamin D status of individuals in the west of Ireland. DESIGN: Cross-sectional study. SETTING: Adults who had wintertime serum 25(OH)D analysis completed in Galway University Hospital. PARTICIPANTS: A total of 16,725 participants (2015-2020 (n = 13,449) and 2020-2021 (n = 3276)). Baseline demographics; sex, age, origin of the sample and the date of sample collection. RESULTS: Median serum vitamin D and serum vitamin D3 concentrations were higher in the 5-month period from October-February 2020-2021 (61 nmol/L (± 36-85 nmol/L) and 60 nmol/L (± 34-85 nmol/L)) respectively, than for the corresponding 5-month period (October-February) in 2015-2020 (53 nmol/L (± 32-78 nmol/L) and 51 nmol/L (± 30-77 nmol/L)) respectively. These changes coincided with a decline in the prevalence of deficiency. In the 5-month period October-February 2020-2021, 19.2% of the population were vitamin D deficient (< 30 nmol/L) compared to 22.5% in the corresponding 5-month period in 2015-2020, and 38.1% were vitamin D deficient (< 50 nmol/L) in the 5-month period October-February 2020-2021 compared to 46.6% in the corresponding 5-month period in 2015-2020. Males were more likely to be deficient at both thresholds (p < 0.001). For the total cohort, at the < 30 nmol/L threshold, inpatients (25.5%) and nursing home residents (34.1%) had higher prevalence of deficiency. CONCLUSIONS: Vitamin D levels were higher in the 5-month period of October-February 2020-2021, and this precipitated a decline in deficiency at both thresholds, indicating that lockdown coincided with enhanced vitamin D status. We postulate that it may be attributable to changes in diet and/or supplementation, or increased sun exposure, but further confirmatory studies are required.

Associations between Body Mass Index and Probable Sarcopenia in Community-Dwelling Older Adults.

(1) Background/Objectives: The relationship between body mass index (BMI) and probable sarcopenia, a precursor to sarcopenia diagnosis, is unclear. While low BMI has been associated with sarcopenia risk, some evidence suggests that obesity may confer protection. We aimed to investigate the association between probable sarcopenia and BMI and, furthermore, to explore associations with waist circumference (WC). (2) Methods: This cross-sectional study included 5783 community-dwelling adults (mean age 70.4 ± 7.5 years) from Wave 6 of the English Longitudinal Study of Ageing (ELSA). Probable sarcopenia was defined using the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria for low hand grip strength and/or slow chair rise. Associations between BMI and probable sarcopenia were examined using multivariable regression analysis and were similarly performed for WC. (3) Results: Our overall findings show that an underweight BMI was significantly associated with an increased likelihood of probable sarcopenia [OR (CI) 2.25 (1.17, 4.33), p = 0.015]. For higher BMI categories, the findings were conflicting. Overweight and obesity were associated with an increased likelihood of probable sarcopenia when defined by lower limb strength alone, [OR (CI), 2.32 (1.15, 4.70), p = 0.019; 1.23 (1.02, 1.49), p = 0.35, and 1.49 (1.21, 1.83), p < 0.001, respectively]. In contrast, overweight and obesity appeared protective when probable sarcopenia was assessed by low hand grip strength alone [OR (CI) 0.72 (0.60, 0.88), p = 0.001, and 0.64 (0.52, 0.79), p < 0.001, respectively]. WC was not significantly associated with probable sarcopenia on multivariable regression analysis. (4) Conclusion: This study supports the evidence that low BMI is associated with an increased likelihood of probable sarcopenia, highlighting an important at-risk group. The findings for overweight and obesity were inconsistent and may be measurement dependent. It seems prudent that all older adults at risk of probable sarcopenia, including those with overweight/obesity, are assessed to prevent underdetection of probable sarcopenia alone or with the double burden of obesity.

Assessing Sarcopenia, Frailty, and Malnutrition in Community-Dwelling Dependant Older Adults-An Exploratory Home-Based Study of an Underserved Group in Research.

BACKGROUND: Adults of advanced age, with functional dependency, socioeconomic disadvantage, or a need for home care, are expected to be at high risk of sarcopenia, frailty and malnutrition, yet are likely to be underrepresented in research. We aimed to explore the assessment of sarcopenia, frailty, and malnutrition in-home, and to describe the practicality of performing these assessments. METHODS: Home-based health assessments and post-study feedback surveys were conducted among community-dwelling older adults ≥65 years in receipt of state-funded home care (n = 31). Assessments included probable sarcopenia [hand-grip strength (HGS), chair rise-test, and SARC-F case-finding tool], the Mini Nutritional Assessment (MNA), and the Clinical Frailty Scale (CFS). RESULTS: The study group was of mean age 83.2 ± 8.2 years, 74% were female and 23% lived in socioeconomically disadvantaged areas. Almost all met the criteria for probable sarcopenia (94%, n = 29/31), were frail or vulnerable by the CFS (97%, n = 30/31), and over a quarter were at risk of malnutrition (26%, n = 8). Participants had low physical activity (71.0%, n = 22/31), with a mean daytime average of 11.4 ± 1.6 h spent sitting. It was possible to assess probable sarcopenia (by HGS and SARC-F, but not the chair rise test), malnutrition (MNA), and frailty (CFS). Home-based research was a complex environment, and unearthed significant unmet need, prompting referrals to health services (36%, n = 11), in addition to technology assistance. The majority of participants (93%) reported a willingness to partake in future research. CONCLUSIONS: Most community-dwelling older people in receipt of home support, assessed in this exploratory study, were at risk of probable sarcopenia, frailty, and low physical activity, with over a quarter were at risk of malnutrition. Our initial findings provide practical data for large scale studies and may inform the development of intervention studies aiming to support ageing in place.

Residential Area Socioeconomic Deprivation is Associated with Physical Dependency and Polypharmacy in Community-Dwelling Older Adults: An Analysis of Health Administrative Data in Ireland.

Introduction: Socioeconomic disadvantage is associated with multiple adverse health outcomes in ageing. Whether this negative impact persists in populations of more advanced age and dependency is less clear. We aimed to determine the association between residential area deprivation and pre-specified health characteristics among community-dwelling dependent older adults. Methods: We conducted a cross-sectional analysis of data from 1591 community-dwelling adults aged 65 years and older of mean age 83.9 ± 7.1 years and in receipt of state home support in Ireland. The HP Pobal Deprivation Index was used to categorize residential areas by socioeconomic deprivation. Health variables analysed included physical dependency (Barthel Index), polypharmacy (≥5 medications), previous acute hospital admission, cognitive impairment, and mental health diagnoses. Associations between residential area deprivation and prespecified health outcomes were explored in multivariable logistic regression analysis. Results: In socioeconomically disadvantaged areas, high physical dependency was twice that observed in affluent areas (16.2% vs 6.9%, p = 0.009). Similarly, acute hospitalization, as the trigger for increased dependency, was more common in deprived settings (41.6% v 29.1%, p < 0.001). Polypharmacy was common in this population (67.6%), but significantly higher in deprived vs affluent settings (74.7% v 64.5%, p = 0.030). The findings persisted in multivariable analyses when adjusted for age and gender. While all participants were accessing home support, those in deprived areas were on average 6.5 years younger than in affluent areas. Associations between residential deprivation and mental health conditions or cognitive impairment, however, were not observed in this study. Conclusion: Community-dwelling older adults living in socioeconomically disadvantaged areas experienced greater polypharmacy, high physical dependency, hospitalization-associated dependency, and a 6.5-year earlier need for state home support than in affluent settings. The findings suggest that health inequality persists in populations of more advanced age and dependency and highlight a need for further research as well as community-based health and social care initiatives.

Enhancing Existing Formal Home Care to Improve and Maintain Functional Status in Older Adults: Results of a Feasibility Study on the Implementation of Care to Move (CTM) in an Irish Healthcare Setting.

Background: Care to Move (CTM) provides a series of consistent 'movement prompts' to embed into existing movements of daily living. We explored the feasibility of incorporating CTM approaches in home care settings. Methods: Feasibility study of the CTM approach in older adults receiving home care. Recruitment, retention and attrition (three time points), adherence, costs to deliver and data loss analyzed and differentiated pre and post the COVID-19 pandemic. Secondary outcomes, including functional status, physical activity, balance confidence, quality of life, cost to implement CTM. Results: Fifty-five home care clients (69.6% of eligible sample) participated. Twenty were unable to start due to COVID-19 disruptions and health issues, leaving 35 clients recruited, mostly women (85.7%), mean age 82.8 years. COVID-19 disruption impacted on the study, there was 60% retention to T2 assessments (8-weeks) and 13 of 35 (37.1%) completed T3 assessments (6-months). There were improvements with small to medium effect sizes in quality of life, physical function, balance confidence and self-efficacy. Managers were supportive of the roll-out of CTM. The implementation cost was estimated at EUR 280 per carer and annual running costs at EUR 75 per carer. Conclusion: Embedding CTM within home support services is acceptable and feasible. Data gathered can power a definitive trial.

A Response to Paolo Euron's "Uncanny Beauty: Aesthetics of Companionship, Love, and Sex Robots".

The emergence of sex robots raises important issues about what it means to be human and the commodification of love, companionship, and sex. This commentary discusses the following question: If some members of society relate to robots as "humans," what does this mean for society's conceptualisation of personhood and intimate relationships? How love is expressed between individuals is normally considered a very private expression of companionship that should remain in the private sphere. This article examines whether sex robots should be subject to public regulation given the broader societal impacts of their ability to emotionally connect and elicit empathy from humans.

A Qualitative Study of Older Adults' Experiences of Embedding Physical Activity Within Their Home Care Services in Ireland.

Purpose: Physical activity has been shown to improve older adults' functional capacity, independence, and quality of life. In a feasibility study, we embedded a movement approach within older adults existing home care services through "Care to Move" (CTM). The aim of this qualitative study is to explore older adults' experiences of CTM within their home care support services and to identify the strengths and barriers of engaging in CTM from the perspective of the older recipient. Materials and Methods: We conducted semi-structured telephone interviews with 13 older adults and one informal carer. Topics covered included participants' overall experiences of CTM, changes to their overall activity and participation, aspects of CTM that they found valuable and issues that were challenging. Interview transcripts were coded and analyzed thematically to capture barriers and facilitators to the approach delivery. Results: Four themes were developed: i) "I have good days and bad days", ii) "safety and security is the name of the game", iii) "we're a team as it stands', iv) "it's [COVID-19] depressing for everybody at the moment". Older adults identified benefits of CTM engagement including improvements in physical and psychological wellbeing. However, subjective frailty and self-reported multimorbidity influenced overall engagement. Participants expressed concerns around the logistics of delivering CTM and competing care staff interests. The broader role of care staff in supporting CTM was highlighted, as well as the emotional support that staff provided to older adults. Care staff continuity was identified as a barrier to ongoing engagement. The impact of COVID-19 on older adults physical and mental health negatively impacted the delivery of the approach. Conclusion: Our findings suggest that embedding CTM within home care services is feasible and that older adults enjoyed engaging in CTM. Addressing care staff continuity and adopting individual approaches to CTM delivery may enhance the implementation of services.

Embedding Physical Activity Within Community Home Support Services for Older Adults in Ireland - A Qualitative Study of Barriers and Enablers.

Introduction: In Ireland, over 55,000 older adults are supported in their community by formal home support, amounting to an estimated 23 million care hours annually. There is a growing need to move beyond care, to more proactive approaches to maintain physical function. In a feasibility study, we delivered the "Care to Move" (CTM) program through existing home support services. This qualitative study aimed to explore the experience and perceptions of Health Care Assistants (HCAs), who were trained in and delivered the CTM program. Methods: We conducted semi-structured telephone interviews with 22 HCAs [mean age 49.0 ± 10.7 years and female 21/22] involved in the delivery of the program with older adults [n = 35, mean age 82.8 (7.8) years]. Interview transcripts were coded and analyzed thematically to capture barriers and enablers to program delivery. Results: Barriers and enablers were identified under three themes i) the CTM approach ii) the home support setting, iii) older adults and physical activity, with iv) delivering care in a crisis and v) future directions further identified. Overall, there was a positive perception of the program's focus on "movement prompts and motivators", the "fit" within home support services, and the training provided. Practical challenges of limited time and the task-orientated nature of home support were reported as recurring barriers for CTM. Many HCAs commented on the value and perceived positive benefits of the program for their clients. Though negative perceptions of older adults' motivation or ability to engage with physical activity were noted. Risk, such as injury or pain, was identified but was not a dominant theme. Conclusion: Our findings suggest that embedding physical activity initiatives within home support services could be feasible. Restructuring of services, engaging HCAs, and moving beyond traditional "task-oriented" care models to more personalised proactive approaches may facilitate this initiative and support aging in place.

Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended-release naltrexone in a residential setting.

BACKGROUND AND OBJECTIVES: Treatment for individuals receiving medication for opioid use disorder (MOUD) should follow an informed patient-centered approach. To better support patient autonomy in the decision-making process, clinicians should be aware of patient preferences and be prepared to educate and assist patients in transitioning from one MOUD to another, when clinically indicated. This posthoc analysis describes the characteristics of clinical trial participants (NCT02696434) with a history of opioid use disorder (OUD) seeking to transition from buprenorphine (BUP) to extended-release naltrexone (XR-NTX). METHODS: The posthoc analysis included adults with OUD currently receiving BUP (≤8 mg/day) and seeking transition to XR-NTX (N = 101) in a residential setting. Baseline participant characteristics and OUD treatment history were reviewed. All patients completed a screening questionnaire that asked about their reasons for seeking transition to XR-NTX and for choosing BUP. RESULTS: The most common reasons for initiating a transition to XR-NTX were "Seeking to be opioid-free" (63.4%) and "Tired of daily pill taking" (25.7%). Positive predictors of transition included a more extensive BUP treatment history and a history of prescription opioid abuse. Most participants stated they were not aware of XR-NTX as a treatment option when initiating BUP (78.2%). DISCUSSIONS AND CONCLUSIONS: Patients' reasons for seeking XR-NTX transition, more extensive BUP treatment history, and a history of prescription opioid abuse, may positively predict outcomes. SCIENTIFIC SIGNIFICANCE: These findings may assist clinicians in optimizing outcomes of the BUP to XR-NTX transition and supporting patients to make better informed MOUD decisions.

Patient characteristics associated with initiation of XR-naltrexone for opioid use disorder in clinical trials.

BACKGROUND: Extended-release injectable naltrexone (XR-naltrexone) is effective for treatment of patients with opioid use disorder (OUD), but initiation remains a barrier due to the challenge of tolerating opioid withdrawal prior to administration. Understanding factors associated with successful initiation of XR-naltrexone could facilitate its implementation through patient-treatment matching. METHODS: We combined data from five consecutive studies that sought to initiate patients with active opioid use onto XR-naltrexone using a rapid procedure consisting of minimal buprenorphine, non-opioid medications for treating opioid withdrawal, and ascending low doses of oral naltrexone. Associations between patient characteristics and initiating naltrexone were estimated with logistic regression models. To evaluate whether associations differed between inpatient and outpatient settings, patient characteristic-by-setting interactions were also estimated. RESULTS: 409 patients were included in the analyses and 228 (56%) received the first injection. A significantly greater percent of inpatients (62%) vs outpatients (48%) initiated XR-naltrexone. Initiation success was significantly more likely on an inpatient basis for heroin (60.9% inpatient vs 36.2% outpatient), intravenous (56.3% inpatient vs 22.5% outpatient), and speedball users (68.1% inpatient vs 32.3% outpatient). Prescription opioid users showed similar, higher initiation rates across settings (68.9% inpatient; 73.7% outpatient). CONCLUSIONS: An inpatient setting may be the preferred strategy for rapid initiation of XR-naltrexone for opioid users with greater severity, including heroin or speedball injection users or those who use opioids intravenously. Initiation on an outpatient basis may be more likely to succeed for prescription opioid users.

Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone.

BACKGROUND: Pharmacologic treatment is recommended for many individuals with opioid use disorder (OUD). For patients who select opioid antagonist treatment, effective management of opioid withdrawal symptoms during transition to antagonist treatment requires consideration of the patient experience. OBJECTIVES: To compare patterns of opioid withdrawal between those withdrawing from untreated opioid use and those withdrawing from buprenorphine. METHODS: We performed a post hoc, cross-study comparison of the temporal pattern of opioid withdrawal during 1-week induction onto extended-release naltrexone by similar protocols enrolling two participant populations: participants with OUD entering a study with untreated opioid use (N = 378, NCT02537574) or on stable buprenorphine (BUP) treatment (N = 101, NCT02696434). RESULTS: The temporal pattern of withdrawal from induction day 1 through day 7 differed between the two participant populations for Clinical Opiate Withdrawal Score (COWS) and Subjective Opiate Withdrawal Score (SOWS): participants with untreated OUD prior to study entry were more likely to experience an earlier relative peak in opioid withdrawal followed by a gradual decline, whereas participants on stable BUP treatment prior to study entry were more likely to experience a relatively later, though still mild, peak opioid withdrawal. The peak COWS was reached at a mean (standard deviation) of 1.9 (1.5) days for participants with untreated OUD and 5.0 (1.5) days for participants on stable BUP. Daily peak cravings were generally higher for participants with untreated OUD than participants on stable BUP. CONCLUSION: Awareness of population-specific variations in the patient experience of opioid withdrawal may help clinicians anticipate the expected course of withdrawal.

Socioeconomic Inequality and Risk of Sarcopenia in Community-Dwelling Older Adults.

INTRODUCTION: Maintaining skeletal muscle function throughout life is a crucial component of successful aging. Disadvantaged socioeconomic position (SEP) is associated with adverse health outcomes, but has not been extensively studied for the muscle disease sarcopenia. We aimed to determine the prevalence of probable sarcopenia, a precursor to sarcopenia diagnosis, based on the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) guidelines overall, and according to SEP. METHODS: This cross-sectional study comprised 3342 community-dwelling older adults [mean age (SD) 68.9 ± 6.3 years] from Wave 1 of the Irish Longitudinal Study on Ageing. Probable sarcopenia was identified using gender-specific cut-off values for handgrip strength as recommended by EWGSOP2. SEP was defined by educational attainment. Multivariate regression analysis was employed to determine associations between probable sarcopenia and pre-defined risk factors. RESULTS: Overall, 23.4% of the population had probable sarcopenia and was significantly higher in the subset with low compared with high SEP (28.9% vs 18.1%, p<0.001). Consistent with this, multivariate logistic regression analysis showed that disadvantaged SEP was a significant determinant of probable sarcopenia [OR, CI 1.48 (1.17, 1.87) p<0.001]. Other known risk factors, namely, increased age, low physical activity, comorbidity, and osteoarthritis were significantly associated with an increased likelihood of probable sarcopenia, while overweight/obesity appeared to be protective. CONCLUSION: Disadvantaged SEP was an independent determinant of probable sarcopenia in community-dwelling older adults. These findings highlight that SEP and health inequality should be considered in prevention and treatment policy for sarcopenia in the community.

Defining the Epidemiology of Safety Risks in Neonatal Intensive Care Unit Patients Requiring Surgery.

OBJECTIVE: The aim of the study was to determine the incidence, type, severity, preventability, and contributing factors of nonroutine events (NREs)-events perceived by care providers or skilled observers as a deviations from optimal care based on the clinical situation-in the perioperative (i.e., preoperative, operative, and postoperative) care of surgical neonates in the neonatal intensive care unit and operating room. METHODS: A prospective observational study of noncardiac surgical neonates, who received preoperative and postoperative neonatal intensive care unit care, was conducted at an urban academic children's hospital between November 1, 2016, and March 31, 2018. One hundred twenty-nine surgical cases in 109 neonates were observed. The incidence and description of NREs were collected via structured researcher-administered survey tool of involved clinicians. Primary measurements included clinicians' ratings of NRE severity and contributory factors and trained research assistants' ratings of preventability. RESULTS: One or more NREs were reported in 101 (78%) of 129 observed cases for 247 total NREs. Clinicians reported 2 (2) (median, interquartile range) NREs per NRE case with a maximum severity of 3 (1) (possible range = 1-5). Trained research assistants rated 47% of NREs as preventable and 11% as severe and preventable. The relative risks for National Surgical Quality Improvement Program - pediatric major morbidity and 30-day mortality were 1.17 (95% confidence interval = 0.92-1.48) and 1.04 (95% confidence interval = 1.00-1.08) in NRE cases versus non-NRE cases. CONCLUSIONS: The incidence of NREs in neonatal perioperative care at an academic children's hospital was high and of variable severity with a myriad of contributory factors.

Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018.

INTRODUCTION: After treatment with naltrexone extended-release injectable suspension (XR-NTX), a µ-opioid receptor antagonist, opioid tolerance is reduced from pretreatment baseline. Patients may be vulnerable to opioid overdose if they attempt to override the blockade during treatment, at the end of a dosing interval, after missing a dose, or after discontinuing treatment. OBJECTIVE: We analyzed postmarketing data to characterize reporting rates of opioid overdose during treatment with and after discontinuation of XR-NTX. METHODS: Postmarketing adverse event reports within the XR-NTX safety database, received 2006-2018, for patients treated with XR-NTX for any indication were reviewed for opioid overdose cases. Assessable cases were categorized by timing of the event from the last dose of XR-NTX (latency): ≤28 days (on treatment), 29-56 days, and >56 days from last dose of XR-NTX. Within each latency group, cases were further classified as serious and, of those, cases that had a fatal outcome. RESULTS: During the 12-year period, an estimated 495,602 patients received XR-NTX. Opioid overdose was reported in 161 cases; of these, 66 contained sufficient information to determine latency. Reporting rates of opioid overdose per 10,000 patients treated were similar among latency groups: 0.54 for ≤28 days (0.24 fatal), 0.34 for 29-56 days (0.16 fatal), and 0.44 for >56 days (0.40 fatal) from the last dose of XR-NTX. CONCLUSIONS: Over the 12-year period, the reporting rates of opioid overdose were similar during treatment with or after discontinuation of XR-NTX and <10/10,000 patients exposed. Our findings are limited by the nature of spontaneously reported safety data.

A High Prevalence of Vitamin D Deficiency Observed in an Irish South East Asian Population: A Cross-Sectional Observation Study.

At northern latitudes, non-ethnic population groups can be at an increased risk of vitamin D deficiency (defined as a 25-hydroxyvitamin D [25(OH)D] status ≤30 nmol/L). The vitamin D status of ethnic minority groups has been examined both in UK and European populations, but not in the Irish context. The aim of this study is to assess the vitamin D status from a selection of the Dublin population of South East Asian descent. A search was conducted, using the laboratory information system of St James's Hospital, Dublin, for vitamin D requests by General practitioners. From 2013 to 2016, 186 participants were identified and 25(OH)D analysis was quantified using liquid chromatography-tandem mass spectrometry (LC-MS-MS). Overall, the median age was 32 years, 51% were male, and the 25(OH)D concentration ranged from 10 to 154 nmol/L. In total, 66.7% of the total sample were vitamin D deficient and 6.7% had a 25(OH)D status greater than 50 nmol/L (the 25(OH)D concentration defined by the EU as 'sufficient'). Females had a significantly higher 25(OH)D concentration than males (25.0 vs. 18.0 nmol/L; p = 0.001) but both groups had a significant proportion with deficient status (56% and 76.8%, respectively). Seasonal variation of 25(OH)D was not evident while high rates of deficiency were also observed in those aged <18 years and >50 years. Given the importance of vitamin D for health, this sub-population could be at a significantly increased risk of rickets, impaired bone metabolism, and osteoporosis. In addition, vitamin D deficiency has been associated with several non-bone related conditions, including cardiovascular disease and diabetes. Currently, there is no unique vitamin D intake or vitamin D status maintenance guidelines recommended for adults of non-Irish descent; this needs to be considered by the relevant public health bodies in Ireland.

Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.

BACKGROUND: Opioid use disorder (OUD) is associated with cognitive dysfunction. Understanding how pharmacotherapy may affect cognition is an important treatment consideration. METHODS: This was a hybrid residential-outpatient, randomized trial assessing transition regimens (naltrexone/buprenorphine [NTX/BUP] vs placebo-NTX/buprenorphine [PBO-N]/BUP) to extended-release naltrexone (XR-NTX) in patients with OUD seeking BUP discontinuation. Cognition was assessed at baseline, Day 22 (XR-NTX Day 14), and Day 36 (XR-NTX Day 28) using a range of measures (Brief Assessment of Cognition Symbol Coding test, Controlled Oral Word Association Task, Wechsler Memory Scale-III Spatial Span test, Continuous Performance Test, and Test of Attentional Performance). Pre-specified exploratory analyses compared treatment groups. Post hoc analyses were treatment-arm-independent analyses overall and by baseline BUP dose (<8 mg/day [low-dose] or 8 mg/day [higher-dose]). RESULTS: Baseline cognitive measures were similar between NTX/BUP and PBO-N/BUP groups and between BUP low-dose and higher-dose groups. There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed. Participants entering the study on low-dose BUP showed improvements at Day 36 relative to baseline in 5 of 7 cognitive outcomes; participants entering the study on higher-dose BUP generally did not show improvements in cognitive outcomes. CONCLUSIONS: Improvements in most cognitive domains were associated with the transition from BUP to XR-NTX, particularly in participants entering the study on low-dose (<8 mg/day) BUP. These improvements may be due to the discontinuation of BUP, the treatment with XR-NTX, or both.

Enhancing existing formal home care to improve and maintain functional status in older adults: Protocol for a feasibility study on the implementation of the Care to Move (CTM) programme in an Irish healthcare setting.

An increasing ageing population leads to greater demand for care services to help maintain people in their own homes. Physical activity programmes have been shown to improve older adults' functional capacity, enabling the older adult to live independently and maintain functional status. There has been a lack of quality research conducted around physical activity within the landscape of home care services. We describe a feasibility study of implementing the Care to Move (CTM) programme in older adults receiving low-level home care. A Phase 1 mixed-methods feasibility study design will explore the recruitment, attrition, retention, costs to deliver and data loss. It will also explore the acceptability and impact of the CTM programme on older adults and thematic analysis of data collected from older people, home care workers and relevant stakeholders through use of semi-structured interviews and focus groups. We will measure functional status and fall outcomes in older adults receiving low levels of home care, facilitating this population to continue living independently at home and providing data currently not known around this group.