Cost-effectiveness of full and partial opioid agonists for opioid use disorder in outpatient settings: United States healthcare sector perspective.

INTRODUCTION: Studies show that medications for opioid use disorder (MOUD) reduce illicit opioid use, emergency healthcare services, opioid-related overdose, and death. However, few studies have investigated the long-term cost-effectiveness of MOUD in office-based opioid treatment (OBOT) and opioid treatment program (OTP) settings. We aimed to estimate the cost, utility, quality-adjusted life years gained (QALYs), and incremental cost-effectiveness ratios (ICERs) of three MOUD compared to each other and counseling without medication from a US healthcare sector perspective. METHODS: Our study developed a Markov model to conduct a cost-effectiveness analysis of counseling and three MOUD in the OBOT and OTP settings: sublingual buprenorphine/naloxone (BUPNX), buprenorphine extended-release (XR-BUP) injection, and oral methadone. The model included five health states representing combinations of receiving or off treatment while either using or not actively using illicit opioids, and death. The cycle length was one month; the time-horizon was ten years. The study obtained model inputs from systematic reviews of published literature and public data. A 3 % annual discount rate was applied to cost and utility calculation. The primary outcomes included total costs, life-years (LYs), QALYs, and ICERs. We also conducted a scenario analysis using a hypothetical OBOT outpatient setting with methadone. RESULTS: In the base-case OBOT setting, the total costs and QALYs, respectively, were counseling $22,848, 5.60; BUPNX $29,875, 5.82; and XR-BUP $63,936, 5.87. ICERs were $32,345/QALY (BUPNX vs. counseling) and $625,858/QALY (XR-BUP vs BUPNX). In the OTP setting, the total costs of counseling, methadone, BUPNX, and XR-BUP were $20,124, $27,000, $33,500, and $75,272, respectively. QALYs of methadone were 5.86. QALYs of counseling, BUPNX, and XR-BUP remained the same as in the OBOT setting. Incremental ICERs were $26,714/QALY (methadone vs counseling) and $3,337,623/QALY (XR-BUP vs methadone). BUPNX was dominated by methadone. In the scenario analysis, BUPNX was also dominated by methadone. CONCLUSIONS: Outpatient MOUD resulted in important gains in quality of life and life expectancy. In both OBOT and OTP settings, XR-BUP was not cost-effective. BUPNX was cost-effective in the OBOT setting, while it was dominated by methadone in the OTP setting. The cost-effectiveness of BUPNX and XR-BUP could be enhanced if the costs of these medications were reduced.

Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

BACKGROUND: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.

Relative Risk of Adverse Events and Treatment Discontinuations Between Older and Non-Older Adults Treated with Antimuscarinics for Overactive Bladder: A Systematic Review and Meta-Analysis.

INTRODUCTION: Overactive bladder (OAB) affects adults of all ages. The risk for medication-related adverse events (AEs) may differ between age groups, given age-related changes in pharmacokinetics and pharmacodynamics. No previous study has differentiated the risk of AEs between older and non-older adults with OAB. OBJECTIVE: Our objective was to assess the risk of AEs and treatment discontinuations between older and non-older adults with OAB initiated on an antimuscarinic. METHODS: We searched MEDLINE (PubMed interface), Embase, SCOPUS, and Cochrane Central Register for Controlled Trials in a previous analysis in February 2015 and repeated the search in August 2018, with no additional studies identified. Studies that delineated AEs or treatment discontinuations between the older and non-older (age <65 years) subjects were included. RESULTS: Six studies that made nine comparisons between older and non-older subjects met the inclusion criteria. The AEs of dry mouth (46.7%), constipation (10.3%), and headache (7.7%) were most frequently reported. Older subjects were more likely to experience dry mouth (relative risk [RR] 1.09; 95% confidence interval [CI] 1.00-1.19), constipation (RR 1.92; 95% CI 1.52-2.43), dizziness (RR 2.37; 95% CI 1.21-4.62), and urinary retention (RR 4.17; 95% CI 1.76-9.89) than were non-older subjects. Headache was less likely to occur in older subjects (RR 0.58; 95% CI 0.40-0.86). Treatment discontinuations due to AEs were more likely to occur in the older subjects (RR 1.59; 95% CI 1.20-2.11). CONCLUSION: Treatment of OAB with antimuscarinics in the older population resulted in significantly higher rates of AEs, barring headache, when compared with non-older subjects.

Faculty perception of team-based learning over multiple semesters.

INTRODUCTION: Perspectives from faculty regarding team-based learning (TBL) are not well understood. Previous studies describe faculty preference for TBL due to increased student interaction despite requiring increased time for design. The perception of changes in faculty workload over multiple semesters has not been measured. This research evaluates faculty workload and perceived student engagement after implementing TBL in a required non-prescription medication course over multiple semesters. METHODS: TBL was implemented in the non-prescription medication course and continued for three consecutive semesters. Faculty members' perception of TBL was captured using an anonymous survey. The survey was an 11 item questionnaire with five Likert-type response options to identify changes in workload, training, and student interaction using TBL. RESULTS: Twenty-eight total responses were collected from 10 faculty members who taught in at least one of the four semesters. Results were aggregated based on the number of semesters faculty continually taught in the course. More respondents agreed than disagreed that participation from and interactions with students increased with the TBL course compared to traditional lectures. However, more respondents believed the TBL course approach was more difficult and reported increased workload in the initial semester taught. Enjoyment of teaching increased for a majority of respondents. DISCUSSION AND CONCLUSIONS: This is the first study to explore the impact of TBL implementation over multiple semesters. These data can be used to help implement TBL in pharmacy school curricula.

Impact of co-investigators on pharmacy resident research publication.

OBJECTIVE: To explore influences of co-investigators on the successful publication of a pharmacy residency project. METHODS: We analyzed published and non-published research presented at a regional pharmacy conference. Abstracts were matched 1:1 based on state and abstract year. We assessed university affiliation, number, degree, and H-Index of co-investigators on the abstract. Descriptive and inferential analyses were used to identify variables associated with resident publication. RESULTS: University-affiliated programs (p=0.015), highest H-Index of a non-physician co-investigator (p=0.002), and positive H-Index (≥1) of a non-physician co-investigator (p=0.017) were significant predictors of resident publication on univariate analyses. There were no differences in the number of co-investigators (p=0.051), projects with physician co-investigators (p=1.000), or projects with Doctor of Philosophy (PhD) or Master of Science (MS) co-investigators (p=0.536) between published and non-published projects. Multivariate analysis found that the highest H-index of non-physician co-investigator remained significant as a predictor to resident publication (odds ratio (OR) 1.09, 95% Confidence Interval (CI) 1.01-1.17). CONCLUSIONS: The quality of co-investigators, as measured by an increasing H-Index, is associated with the successful publication of residency projects. More emphasis may need to be placed on resident research co-investigator selection and training to prepare pharmacy residents for research and scholarly activity.

Impact of co-investigators on pharmacy resident research publication

Objective: To explore influences of co-investigators on the successful publication of a pharmacy residency project. Methods: We analyzed published and non-published research presented at a regional pharmacy conference. Abstracts were matched 1:1 based on state and abstract year. We assessed university affiliation, number, degree, and H-Index of co-investigators on the abstract. Descriptive and inferential analyses were used to identify variables associated with resident publication. Results: University-affiliated programs (p=0.015), highest H-Index of a non-physician co-investigator (p=0.002), and positive H-Index (≥1) of a non-physician co-investigator (p=0.017) were significant predictors of resident publication on univariate analyses. There were no differences in the number of co-investigators (p=0.051), projects with physician co-investigators (p=1.000), or projects with Doctor of Philosophy (PhD) or Master of Science (MS) co-investigators (p=0.536) between published and non-published projects. Multivariate analysis found that the highest H-index of non-physician co-investigator remained significant as a predictor to resident publication (odds ratio (OR) 1.09, 95% Confidence Interval (CI) 1.01-1.17). Conclusions: The quality of co-investigators, as measured by an increasing H-Index, is associated with the successful publication of residency projects. More emphasis may need to be placed on resident research co-investigator selection and training to prepare pharmacy residents for research and scholarly activity (AU)

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Adverse events and treatment discontinuations of antimuscarinics for the treatment of overactive bladder in older adults: A systematic review and meta-analysis.

INTRODUCTION: Antimuscarinics should be used with caution in older adults with overactive bladder (OAB) due to anticholinergic adverse events (AEs). Systematic reviews and meta-analyses (SRMAs) have analyzed safety-related outcomes but have not specified risk in the elderly, the population at highest risk for AEs. The aim of this review is to explore and evaluate AEs and treatment discontinuations in adults 65 or older taking antimuscarinics for OAB. METHODS: Keywords were searched in MEDLINE, EMBASE, SCOPUS, and Cochrane Central Register for Controlled Trials. Randomized controlled trials (RCTs) along with sub-analyses and pooled analyses that compared antimuscarinics to placebo or another antimuscarinic were performed in February 2015. Studies assessing AEs or treatment discontinuations in a population of adults 65 or older were included. The Jadad Criteria and McHarm Tool were used to assess the quality of the trials. RESULTS: A total of 16 studies met the inclusion criteria. Eighty AEs and 27 reasons for treatment discontinuation were described in the included studies and further explored. Anticholinergic AEs were more common in antimuscarinics compared to placebo. Incidence of dizziness, dyspepsia, and urinary retention with fesoterodine, headache with darifenacin, and urinary tract infections with solifenacin were significantly higher compared to placebo. Treatment discontinuation due to AEs and dry mouth were higher in the antimuscarinics when compared to placebo in older adults. CONCLUSIONS: Treatment for overactive bladder using antimuscarinics in adults aged 65 or older resulted in significant increases in risk for several AEs compared to placebo including anticholinergic and non-anticholinergic AEs.

The Importance of Research and Scholarly Activity in Pharmacy Training.

Regardless of practice setting, it is imperative that pharmacists be able to either participate in generating new knowledge or use the ever-expanding body of literature to guide patient care. However, competing priorities in Pharm.D. curricula and residency training programs have resulted in limited emphasis on acquiring research and scholarly skills. Factors likely contributing to this reduced focus include the lack of curricular and postgraduate training standards emphasizing the development of research skills, time to commit to scholarly activity, and accessibility to experienced mentors. Strategies for increasing scholarly activity for pharmacy students and residents should therefore continue to be a focus of professional degree and residency training programs. Several resources are available for academic planners, program directors, and institutions to augment scholarly experience for pharmacy trainees and clinicians. This commentary highlights the importance of providing research opportunities for students and residents, describes the potential barriers to these activities, and provides recommendations on how to increase the instruction and mentoring of trainees to generate and use research.

Impact of resident research publication on early-career publication success.

PURPOSE: The impact of resident research publication on early-career publication success is evaluated. METHODS: This study included a retrospective cohort of pharmacy residents' abstracts presented at the Great Lakes Pharmacy Resident Conference (GLPRC). Published residency research projects at GLPRC (n = 76) were matched 1:1 to unpublished projects. Residents were followed forward for five years to identify early-career publications (postresidency publication positive) versus no publications (postresidency publication negative). The following characteristics of postresidency publication-positive and publication-negative residents were compared: publication of residency project, university-affiliated residencies, median number and interquartile range of coinvestigators, presence of a physician coinvestigator, highest nonphysician H-index of coinvestigators, and nonphysician H-index of ≥1 for any coinvestigator (indicating that a coinvestigator has previously published and been cited). RESULTS: A total of 152 abstracts were reviewed (76 published and 76 unpublished projects). Using a predefined systematic search strategy, 55 former residents had a postresidency publication within five years after presenting their project at the GLPRC. Of the former residents who published their residency project, 38 (50%) were postresidency publication positive, while 17 former residents (22.4%) who did not publish resident research projects were postresidency publication positive. Univariate and multivariate analyses revealed that publication of the pharmacy resident research project and a university-affiliated residency program was positively associated with postresidency publication success. CONCLUSION: Pharmacy residents who published their residency research project after its presentation at the GLPRC were twice as likely to have publication success within five years compared with residents who did not publish their residency research project. A university-affiliated residency was associated with postresidency publication success within five years after project presentation.

Pharmacy resident publication success: factors of success based on abstracts from a regional meeting.

OBJECTIVE: To determine the publication rate among pharmacy resident research projects in a region of the United States and to compare characteristics of published and unpublished projects. METHODS: Research project abstracts from the Great Lakes Pharmacy Residency Conference in 2003, 2005, and 2007 were reviewed. Two independent investigators collected all study data. Data on residency year, state, institution, study design, and whether results were reported were extracted from available abstracts. Publication rate was determined systematically using a search algorithm within the following databases: Scopus, International Pharmaceutical Abstracts (IPA), and MEDLINE (PubMed). Kappa-statistic was used to determine inter-rater variability. Descriptive statistics were used to analyze nominal and continuous data. Univariate and multivariate regression analyses were used to determine characteristics of publication success. Sensitivity analysis was performed on projects that were successfully published. RESULTS: Information was extracted from 655 abstracts in which 76 abstracts were published (11.4%). Publication rate trended down over the three years analyzed (2003=12.9%, 2005=12.2%, 2007=9.9%; p=0.57). Study design (interventional, observational, cross-sectional, or service development, p=0.115), direction of inquiry (prospective or retrospective; p=0.146), intervention of interest (drug, human, or other; p=0.096), results in abstract (p=0.096), and institution type (university-affiliated, veterans affairs, community-hospital, or retail; p=0.001) were entered into the multivariate model. Cross-sectional design (odds ratio (OR) 3.6), human (OR 1.9) and other (OR 2.1) interventions, as well as university-affiliated residency (OR 2.6) remained significant for publication success. The mean time to publication from abstract to presentation was 24.5 months, and 83% of projects were published within pharmacy journals. CONCLUSION: Publication rate of pharmacy resident research projects presented at the Great Lakes Pharmacy Residency Conference is low, but it is consistent with other regions of the United States. Study design and study outcomes may influence chance of project publication as well as institution-type, which may have unique research resources, training, and mentorship.

The Importance of Research during Pharmacy Residency Training.

Practice-related projects and pharmacy practice research are requirements to complete postgraduate pharmacy residency programs. Many residents will complete residencies without fully developing the skills needed to perform research required for new clinical and academic positions. Many studies have quantified successes and identified characteristics that may be associated with successful resident publication. There are many benefits to gaining research and publication skills during residency training for the resident, preceptor/mentors, and the residency program. Published works have also suggested approaches than can be taken to improve research within a residency program. The aims of this article are to discuss the publication rates of resident research projects, suggest ways to improve residency research, review benefits of residency research, and briefly review research training alternatives.

A multidisciplinary intervention for reducing readmissions among older adults in a patient-centered medical home.

OBJECTIVES: To evaluate the effectiveness of a multidisciplinary practice model consisting of medical providers, clinical pharmacists, and social workers on reducing 30-day all-cause readmissions. STUDY DESIGN: Retrospective cohort study. METHODS: This study included adults 60 years or older discharged from a large academic medical center. Patients were grouped as either receiving the primary care-based transitional care program (intervention group) or usual care (control group) after an index hospitalization. Only 1 index hospitalization was included per patient. All-cause 30-day readmission rates between propensity score matched study groups were analyzed by intention-to-treat, per protocol, and as-treated methods. Secondary outcomes included time to readmission, subgroup analysis, process measures, and cost avoidance influence of covariates on chance of readmission measured by logistic regression. RESULTS: Over 27 months, 19,169 unique patients had 18,668 index hospitalizations and 572 interventions scheduled after discharge. Among matched subjects, 30-day readmission rates were not significantly different between those scheduled for the intervention and those never scheduled (21% vs 17.3%, respectively; P = .133). However, when those completing the intervention (n = 217) were examined, readmission rates were significantly reduced (11.7% vs 17.3%, respectively; P < .001). Likewise, time to readmission was significantly longer among those receiving the intervention (18 ± 9 days compared with 12 ± 9 days with usual care; P = .015) and potential cost avoidance was observed only when the intervention was completed. CONCLUSIONS: A community-based multidisciplinary transitional care program may reduce hospital readmissions among older adults.

Treatment of hypertension with chronotherapy: is it time of drug administration?

OBJECTIVE: To review evidence for dosing antihypertensives at bedtime and possible cardiovascular risk reduction. DATA SOURCES: A PubMed, EMBASE, and Cochrane Controlled Trials database literature search (1990-September 2014) limited to human subjects was performed using the search terms hypertension, chronotherapy, ambulatory blood pressure, morning administration, evening administration, and antihypertensives. Additional references were identified from literature citations. STUDY SELECTION: All prospective studies assessing cardiovascular outcomes or comparing morning to evening administration of antihypertensives were selected. DATA SYNTHESIS: Compared with morning administration, dosing one or more antihypertensive medications at bedtime helps induce a normal circadian blood pressure pattern and reduces the risk of cardiovascular disease morbidity and mortality in individuals with hypertension. Similar results have been reported in high-risk individuals with diabetes, chronic kidney disease, and resistant hypertension. A lack of diversity among studied populations and reliance on subgroup analyses are among the limitations of these data. All antihypertensive medications have not been studied in chronotherapy and do not uniformly achieve desired results. The most substantial evidence exists for medications affecting the renin-angiotensin-aldosterone system. CONCLUSIONS: Despite growing evidence and promise as a cost-effective strategy for reducing cardiovascular risk, chronotherapy is not uniformly recommended in the treatment of hypertension. Careful selection of patients and antihypertensives for chronotherapy is required. Further investigation is needed to evaluate the definitive impact of chronotherapy on cardiovascular outcomes.

Cost-effectiveness analysis evaluating fidaxomicin versus oral vancomycin for the treatment of Clostridium difficile infection in the United States.

OBJECTIVES: Fidaxomicin is a novel treatment for Clostridium difficile infections (CDIs). This new treatment, however, is associated with a higher acquisition cost compared with alternatives. The objective of this study was to evaluate the cost-effectiveness of fidaxomicin or oral vancomycin for the treatment of CDIs. METHODS: We performed a cost-utility analysis comparing fidaxomicin with oral vancomycin for the treatment of CDIs in the United States by creating a decision analytic model from the third-party payer perspective. RESULTS: The incremental cost-effectiveness ratio with fidaxomicin compared with oral vancomycin was $67,576/quality-adjusted life-year. A probabilistic Monte Carlo sensitivity analysis showed that fidaxomicin had an 80.2% chance of being cost-effective at a willingness-to-pay threshold of $100,000/quality-adjusted life-year. Fidaxomicin remained cost-effective under all fluctuations of both fidaxomicin and oral vancomycin costs. The decision analytic model was sensitive to variations in clinical cure and recurrence rates. Secondary analyses revealed that fidaxomicin was cost-effective in patients receiving concominant antimicrobials, in patients with mild to moderate CDIs, and when compared with oral metronidazole in patients with mild to moderate disease. Fidaxomicin was dominated by oral vancomycin if CDI was caused by the NAP1/Bl/027 Clostridium difficile strain and was dominant in institutions that did not compound oral vancomycin. CONCLUSION: Results of our model showed that fidaxomicin may be a more cost-effective option for the treatment of CDIs when compared with oral vancomycin under most scenarios tested.