Barriers and facilitators to implementing simulation into pharmacy programs globally.

BACKGROUND: MyDispense is a simulation software developed by Monash University that has been utilized by over 200 institutions worldwide to educate pharmacy students. However, little is known about the processes by which it is used to teach dispensing skills to students and how they use it to facilitate critical thinking in an authentic environment. This study aimed to understand and investigate how simulations are used to teach dispensing skills in pharmacy programs globally, and to determine the opinions, attitudes and experiences of pharmacy educators towards MyDispense and other simulation software within their pharmacy program. METHODS: Purposive sampling was used to identify pharmacy institutions for the study. A total of 57 educators were contacted, 18 responded to the study invitation, 12 were MyDispense users and 6 were non-users. Two investigators conducted an inductive thematic analysis to generate key themes and subthemes to provide insight into the opinions, attitudes and experiences towards MyDispense and other simulation software used specifically for dispensing within pharmacy programs. RESULTS: 26 pharmacy educators were interviewed, of which 14 were individual interviews and four were group interviews. Intercoder reliability was investigated and a Kappa coefficient of 0.72 indicated substantial agreement between both coders. Five main themes were identified: "dispensing and counseling", which encompassed discussions about how dispensing techniques were taught, the time allocated for students to practice their skills and the use of software other than MyDispense; "description of MyDispense use" includes discussions about the setup of the software, how dispensing skills were taught prior to using MyDispense as well as its use in student assessments; "barriers to MyDispense use", covers discussions about the obstacles users have faced; "facilitators to use MyDispense", includes discussion about the various motivators to using MyDispense and lastly "future use and suggested improvements" of MyDispense are covered by the interviewees. CONCLUSION: The initial outcomes of this project evaluated the awareness and utilization of MyDispense and other dispensing simulations by pharmacy programs globally. By addressing the barriers of use, promotion of the sharing of MyDispense cases can assist in creating more authentic assessments, as well as improving staff workload management. The outcomes of this research will also facilitate the development of a framework for MyDispense implementation, thus streamlining and improving the uptake of MyDispense by pharmacy institutions globally.

Drug-drug interaction between dexamethasone and direct-acting oral anticoagulants: a nested case-control study in the National COVID Cohort Collaborative (N3C).

OBJECTIVE: The goal of this work is to evaluate if there is an increase in the risk of thromboembolic events (TEEs) due to concomitant exposure to dexamethasone and apixaban or rivaroxaban. Direct oral anticoagulants (DOACs), as well as corticosteroid dexamethasone, are commonly used to treat individuals hospitalised with COVID-19. Dexamethasone induces cytochrome P450-3A4 enzyme that also metabolises DOACs apixaban and rivaroxaban. This raises a concern about possible interaction between dexamethasone and DOACs that may reduce the efficacy of the DOACs and result in an increased risk of TEE. DESIGN: We used nested case-control study design. SETTING: This study was conducted in the National COVID Cohort Collaborative (N3C), the largest electronic health records repository for COVID-19 in the USA. PARTICIPANTS: Study participants were adults over 18 years who were exposed to a DOAC for 10 or more consecutive days. Exposure to dexamethasone was at least 5 or more consecutive days. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary exposure variable was concomitant exposure to dexamethasone for 5 or more days after exposure to either rivaroxaban or apixaban for 5 or more consecutive days. We used McNemar's Χ2 test and adjusted logistic regression to evaluate association between concomitant use of dexamethasone with either apixaban or rivaroxaban. RESULTS: McNemar's Χ2 test did not find a discernible association of TEE in patients concomitantly exposed to dexamethasone and a DOAC (χ2=0.5, df=1, p=0.48). In addition, a conditional logistic regression model did not find an increase in the risk of TEE (adjusted OR 1.15, 95% CI 0.32 to 4.18). CONCLUSION: This nested case-control study did not find evidence of an association between concomitant exposure to dexamethasone and a DOAC with an increase in risk of TEE. Due to small sample size, an association cannot be completely ruled out.

Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia.

Background and Objectives: This analysis evaluated insomnia severity and long-term impact on healthcare resource utilization (HCRU) and costs after treatment with Somryst® (previously called SHUTi), a digital therapeutic delivering cognitive behavioral therapy for insomnia (CBT-I). Methods: Change from baseline in insomnia severity index (ISI) score was assessed using last observed ISI score. A pre/post analysis of claims data was conducted, comparing HCRU in patients with self-identified sleep problems who successfully initiated the therapeutic (index date) between June 1, 2016 and December 31, 2018. Results: A total of 248 patients were analyzed (median age 56.5 years, 57.3% female, mean ISI score 19.13, 52.4% treated with sleep aid medications pre-index). After 9 weeks, mean ISI score declined by 37.2% from baseline (19.1 vs 12.0), 58.8% of patients achieved ISI responder status (ISI score improved by =>7; NNT: 1.7), and 26.6% of patients achieved insomnia remission (ISI score <8; NNT for remission: 3.8). After two-year follow-up, post-index events were reduced (compared to 2 years pre-index) for emergency department visits (-53%; IRR: 0.47; 95% CI 0.27, 0.82; P=0.008), hospiatizations (-21%; IRR: 0.79; 95% CI 0.46, 1.35; P=0.389) and hospital outpatient visits (-13%; IRR: 0.87; 95% CI 0.66, 1.14; P=0.315). Slightly increased rates were observed for ambulatory surgical center visits (2%; IRR: 1.02; 95% CI 0.73, 1.44; P=0.903) and office visits (2%; IRR: 1.02; 95% CI 0.92, 1.14; P=0.672). The number of patients treated with sleep aid medications dropped 18.5% (52.4% pre-index vs 42.7% post-index). Average number of prescriptions decreased from 3.98 pre-index to 3.73 post-index (P= 0.552). Total two-year cost reduction post-index vs pre-index was $510,678, or -$2059 per patient. Conclusion: In a real-world cohort of patients with chronic insomnia, treatment with a digital therapeutic delivering CBT-I was associated with reductions in insomnia severity, emergency department visits, and net costs.

Activity Measure for Post-Acute Care "6-Clicks" for the Prediction of Short-term Clinical Outcomes in Individuals Hospitalized With COVID-19: A Retrospective Cohort Study.

OBJECTIVE: To determine the ability of the Activity Measure for Post-Acute Care (AM-PAC) "6-Clicks" assessments of mobility and activity to predict key clinical outcomes in patients hospitalized with coronavirus disease 2019 (COVID-19). DESIGN: Retrospective cohort study. SETTING: An academic health system in the United States consisting of 5 inpatient hospitals. PARTICIPANTS: Adult patients (N=1486) urgently or emergently admitted who tested positive for COVID-19 and had at least 1 AM-PAC assessment. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Discharge destination, hospital length of stay, in-hospital mortality, and readmission. RESULTS: A total of 1486 admission records were included in the analysis. After controlling for covariates, initial and final mobility (odds ratio, 0.867 and 0.833, respectively) and activity scores (odds ratio, 0.892 and 0.862, respectively) were both independent predictors of discharge destination with a high accuracy of prediction (area under the curve [AUC]=0.819-0.847). Using a threshold score of 17.5, sensitivity ranged from 0.72-0.79, whereas specificity ranged from 0.74-0.83. Both initial AM-PAC mobility and activity scores were independent predictors of mortality (odds ratio, 0.885 and 0.877, respectively). Initial mobility, but not activity, scores were predictive of prolonged length of stay (odds ratio, 0.957 and 0.980, respectively). However, the accuracy of prediction for both outcomes was weak (AUC=0.659-0.679). AM-PAC scores did not predict rehospitalization. CONCLUSIONS: Functional status as measured by the AM-PAC "6-Clicks" mobility and activity scores are independent predictors of key clinical outcomes individual hospitalized with COVID-19.

"6-clicks" Predicts Discharge Destination for Patients Hospitalized with COVID-19

To investigate the ability of the initial Activity Measure for Post-Acute Care (AM-PAC) "6-clicks" mobility and activity scores to predict discharge disposition for patients hospitalized with COVID-19. Retrospective cohort using data from a COVID-19 registry. Five inpatient hospitals in a single academic Health System within the United States. Adults (> 17 years) who were urgently or emergently admitted to one of the five acute hospitals between March 1st and July 31st, 2020, tested positive for COVID-19 during their hospitalization, and had at least 1 AM-PAC "6-clicks" score in their medical record. N/A. Discharge destination, dichotomized as home vs. facility. Of the 2565 records in the registry, 1486 included AM-PAC "6-clicks" mobility scores and 1200 included activity scores. Median age was 64 years (IQR=26), COVID-19 was primary or admitting diagnosis for 47% (n = 700), and 61.6% (n = 915) were discharged home. Initial AM-PAC was assessed 1 (IQR=3) days after admission, and the median for both mobility and activity scores was 18 (IQR=14). Multivariate logistic regression analyses revealed that, after controlling for the influence of covariates, initial mobility and activity scores were both independent predictors of discharge destination. Each point decrease in initial AM-PAC score increased the odds of discharge to a faculty by 1.15 (95 CI% 1.12 - 1.19;p < 0.001) and 1.16 (95 CI% 1.11 - 1.22;p < 0.001) fold for mobility and activity scores, respectively. Receiver operating characteristic (ROC) curve analysis revealed that initial AM-PAC scores were strong predictors of discharge destination, with area under the curve (AUC) of 0.806 (95 CI% 0.781 - 0.831;p < 0.001) and 0.796 (95% CI 0.767 - 0.826;p < 0.001) for mobility and activity scores, respectively. A score of 17.5 predicted discharge with a sensitivity of.687 and specificity of 0.81 for mobility and 0.724 and 0.770 for activity. Initial AM-PAC "6-clicks" activity and mobility scores were both predictive of discharge destination in individuals hospitalized with COVID-19. Dr. Adler is a paid consultant for MedBridge Education.

Serum potassium changes due to concomitant ACEI/ARB and spironolactone therapy: A systematic review and meta-analysis.

PURPOSE: To provide evidence of serum potassium changes in individuals taking angiotensin-converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) concomitantly with spironolactone compared to ACEI/ARB therapy alone. METHODS: PubMed, Embase, Scopus, and Web of Science were searched for studies including exposure to both spironolactone and ACEI/ARB therapy compared to ACEI/ARB therapy alone. The primary outcome was serum potassium change over time. Main effects were calculated to estimate average treatment effect using random effects models. Heterogeneity was assessed using Cochran's Q and I2. Risk of bias was assessed using the revised Cochrane risk of bias tool. RESULTS: From the total of 1,225 articles identified, 20 randomized controlled studies were included in the meta-analysis. The spironolactone plus ACEI/ARB group included 570 patients, while the ACEI/ARB group included 547 patients. Treatment with spironolactone and ACEI/ARB combination therapy compared to ACEI/ARB therapy alone increased the mean serum potassium concentration by 0.19 mEq/L (95% CI, 0.12-0.26 mEq/L), with intermediate heterogeneity across studies (Q statistic = 46.5, P = 0.004; I2 = 59). Sensitivity analyses showed that the direction and magnitude of this outcome did not change with the exclusion of individual studies, indicating a high level of reliability. Reporting risk of bias was low for 16 studies (80%), unclear for 3 studies (15%) and high for 1 study (5%). CONCLUSION: Treatment with spironolactone in combination with ACEI/ARB therapy increases the mean serum potassium concentration by less than 0.20 mEq/L compared to ACEI/ARB therapy alone. However, serum potassium and renal function must be monitored in patients starting combination therapy to avoid changes in serum potassium that could lead to hyperkalemia.

Evaluation of the cost-utility of a prescription digital therapeutic for the treatment of opioid use disorder.

Background: The opioid epidemic continues to generate a significant mental and physical health burden on patients, and claims the life of almost 150 Americans daily. Making matters worse, an increase in relapses and/or opioid-related deaths has been reported in more than 40 U.S. states since the start of the COVID-19 pandemic. Opioid use disorder (OUD) is one of the single most expensive disorders in the United States, generating average medical costs of $60B from just 2 million Americans diagnosed with the disorder. In commercial use since 2019, reSET-O is a non-drug, prescription digital therapeutic (PDT) that delivers evidence-based neurobehavioral treatment for OUD and helps overcome the barriers associated with access to care, stigma, and social distancing. Although shown to be cost effective and efficacious in clinical trials and real-world evidence studies, respectively, information on its value for money from a health utilities and cost per quality-adjusted life-year is needed to inform policy discussions.Objectives: To evaluate the impact of reSET-O on health utilities and assess its overall cost per quality-adjusted life year (QALY) gained vs. treatment-as-usual (TAU).Methods: Decision analytic model comparing reSET-O plus TAU to TAU alone (i.e. buprenorphine, face-to-face counseling, and contingency management) over 12 weeks. Clinical effectiveness data (abstinence and health utility) were obtained from a clinical trial, and resource utilization and cost data were adapted from a recent claims data analysis to reflect less frequent face-to-face counseling with the therapeutic.Results: The addition of reSET-O to TAU decreases total health care costs by -$131 and resulted in post-treatment utility values within population norms, with a corresponding gain of 0.003 QALYs. reSET-O when used adjunctively to TAU was economically dominant (less costly, more effective) vs. TAU alone.Conclusion: reSET-O is an economically-dominant adjunctive treatment for OUD and is associated with an overall reduction in total incremental cost vs TAU.