Differences between pharmacists’ perception of counseling and practice in the era of prescription drug misuse

Objective: This study was conducted to assess pharmacists\u27 practices when counseling patients on their prescription medications, and their preferences for training. Methods: Five focus group discussions of community pharmacists (n=45, with seven to eleven participants in each group) were conducted in a major metropolitan city in the southern United States. Participants were recruited via email using a list of community pharmacists provided by the Texas State Board of Pharmacy. All focus group discussions were structured using a moderator guide consisting of both discrete and open-ended questions. Qualitative analysis software was used to analyze the data with a thematic analysis approach. Results: The participants in this study had a high self-efficacy regarding their ability to counsel on both new and opioid prescriptions. Many pharmacists experienced the same barriers to counseling and agreed on the components of counseling. However, the themes that emerged showed that the participants exhibited only a partial understanding of the components of counseling. The themes that emerged in the thematic analysis were perceived confidence and discordant counseling practices, inadequate infrastructure, lack of comprehensive counseling, inconsistent use of the Prescription Drug Monitoring Program (PDMP), and pharmacists\u27 desired training/assistance. Conclusions: Community pharmacists are in a unique position to help combat the opioid crisis; however, there has been very little research on the pharmacist-patient interaction in this context. With policy changes, such as the PDMP mandate, going into effect across the country, it is important to capitalize on the potential community pharmacists have in ameliorating the opioid crisis in the United States

Efficacy and Safety of Ciltacabtagene Autoleucel and Idecabtagene Vicleucel in Multiple Myeloma Patients

Background: Ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel) are chimeric antigen receptor (CAR) T-cell therapies used to treat adult patients with relapsed or refractory multiple myeloma (rrMM) after at least four lines of therapy. However, no head-to-head clinical trials to compare them have been conducted. Objective: To compare between CARTITUDE-1 and KarMMa clinical trials in terms of efficacy, safety, and patient characteristics. Method: Overall response rate (ORR) and safety signals were compared using reporting odds ratios (RORs) with 95% confidence intervals (CIs) at p \u3c 0.05. Overall survival (OS) and progression-free survival (PFS) were compared using the Kaplan–Meier method with a log-rank test. Patient characteristics were compared using the chi-square test. Statistical analyses were conducted using Microsoft Excel and R version 4.0.5. Results: Statistically significant differences were observed between cilta-cel and ide-cel in terms of ORR, complete response (CR), OS, and PFS (p \u3c 0.05). Partial response (PR) showed no statistically significant difference (p \u3e 0.05). Ide-cel was significantly associated with higher incidences of any Grade ≥ 3 adverse events than cilta-cel. Cilta-cel on the other hand, was significantly associated with higher incidences of leukopenia, lymphopenia, and CRS Grade 1 & 2 than ide-cel (RORs \u3e 1, p \u3c 0.05). Penta-drug refractory showed a statistically significant difference between cilta-cel and ide-cel clinical trials. Conclusion: This study found that cilta-cel is a superior treatment over ide-cel with better efficacy and less incidence of serious adverse events

Disentangling the Cost of Orphan Drugs Marketed in the United States

The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983. This study evaluated the factors associated to the differences in the treatment cost of new orphan and non-orphan drugs approved by the FDA from 2017 to 2021. A generalized linear model (GLM) with the Gamma log-link analysis was used to ascertain the association of drug characteristics with the treatment costs of orphan and non-orphan drugs. The results of the study showed that the median and interquartile range (IQR) drug cost was USD 218,872 (IQR = USD 23,105) for orphan drugs and USD 12,798 (IQR = USD 57,940) for non-orphan drugs (p \u3c 0.001). Higher market entry prices were associated with biologics (108%; p \u3c 0.001), orphan status (177%; p \u3c 0.001), US sponsor companies (48%; p = 0.035), chronic use (1083%; p \u3c 0.001), treatment intent (163%; p = 0.004), and indications for oncology (624%; p \u3c 0.001) or genetic disorders (624%; p \u3c 0.001). Higher market entry treatment cost for newly approved drugs were associated with biologics, orphan status, US sponsor companies, chronic use, therapeutic intent, and indications for oncology or genetic disorders

A Motivational Interviewing Intervention to Improve Adherence to ACEIs/ARBs among Nonadherent Older Adults with Comorbid Hypertension and Diabetes

Background Hypertension and diabetes mellitus are independent risk factors for cardiovascular diseases. Due to the cardioprotective nature of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), they are recommended for patients with comorbid hypertension and diabetes. However, poor adherence to ACEIs/ARBs among older adults is a major public health concern. This study aimed to assess the effectiveness of a telephonic motivational interviewing (MI) intervention conducted by pharmacy students among a nonadherent older population (≥ 65 years old) with diabetes and hypertension. Methods Patients continuously enrolled in a Medicare Advantage Plan who received an ACEI/ARB prescription between July 2017 and December 2017 were identified. Group-based trajectory modeling (GBTM) was used to identify distinct patterns of ACEI/ARB adherence during the 1-year baseline period: adherent, gaps in adherence, gradual decline, and rapid decline in adherence. Patients from the three nonadherent trajectories were randomized into MI intervention or control group. The intervention consisted of an initial call and five follow-up calls administered by MI-trained pharmacy students and tailored to the baseline ACEI/ARB adherence trajectories. The primary outcome was adherence to ACEI/ARB during the 6- and 12-month periods post-MI implementation. The secondary outcome was discontinuation, defined as no refills for ACEI/ARB during the 6- and 12-month periods post-MI implementation. Multivariable regression analyses examined the impact of MI intervention on ACEI/ARB adherence and discontinuation while adjusting for baseline covariates. Results A total of 240 patients in the intervention group and 480 patients as randomly selected controls were included in this study. At 6 months, patients receiving the MI intervention had significantly better adherence (β = 0.06; p = 0.03) compared with the controls. Linear and logistic regression models also showed patients in the intervention group were more likely to be adherent than controls within 12 months of intervention implementation (β = 0.06; p = 0.02 and OR: 1.46; 95% CI 1.05–2.04, respectively). MI intervention did not have any significant impact on the ACEI/ARB discontinuation. Conclusion Patients who received the MI intervention were more likely to be adherent at 6 and 12 months following the intervention initiation, despite gaps in the follow-up calls due to COVID-19. Pharmacist-led MI intervention is an effective behavioral strategy to improve medication adherence among older adults and tailoring the intervention to past adherence patterns may enhance the intervention effectiveness

Patient-Reported Barriers to Adherence Among ACEI/ARB Users from a Motivational Interviewing Telephonic Intervention

Purpose: Hypertension is a common comorbidity among type 2 diabetes mellitus (T2DM) patients, which increases the risk of cardiovascular diseases. Despite the proven benefit of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in this population, poor medication adherence is prevalent, resulting in higher complications and mortality rate. Motivational interviewing (MoI) has demonstrated effectiveness in improving medication adherence and identifying barriers. This study aimed to assess and identify patient-reported barriers to adherence to ACEI/ARB from an MoI telephonic intervention conducted by student pharmacist interns. Patients and Methods: This retrospective study was conducted within an MoI intervention customized by past ACEI/ARB adherence trajectories for nonadherent patients with T2DM and hypertension enrolled in a Medicare Advantage Plan. Adherence barriers were extracted from the interviewers’ notes by two independent researchers. Descriptive analysis was performed to summarize the overall frequency of barriers as well as across trajectory groups, identified from the initial and follow-up calls. Results: In total, 247 patients received the initial MoI call from which 41% did not communicate any barrier for ACEI/ARB use despite having low adherence. About 59% of the patients reported at least one barrier during the initial call. The most common barriers included forgetfulness, discontinuation by physicians, side effects, multiple comorbidities, polypharmacy, lack of knowledge about disease/medication, and cost issues. The follow-up calls helped with uncovering at least one new barrier for 28 patients who previously communicated a different issue with their medication during the first call. Additionally, 18 patients with initial denial for having any barrier to adherence reported at least one barrier throughout the follow-up calls. Conclusion: This study summarized patient-reported barriers to ACEI/ARB adherence from an MoI telephonic intervention performed among nonadherent patients. Identifying specific barriers for patients may help to further design tailored interventions that address the barriers and improve adherence

Potential impacts of climate and environmental change on the stored water of Lake Victoria Basin and economic implications

The changing climatic patterns and increasing human population within the Lake Victoria Basin (LVB), together with overexploitation of water for economic activities call for assessment of water management for the entire basin. This study focused on the analysis of a combination of available in situ climate data, Gravity Recovery and Climate Experiment (GRACE), Tropical Rainfall Measuring Mission (TRMM) observations, and high resolution Regional Climate simulations during recent decade(s) to assess the water storage changes within LVB that may be linked to recent climatic variability/changes and anomalies. We employed trend analysis, principal component analysis (PCA), and temporal/spatial correlations to explore the associations and covariability among LVB stored water, rainfall variability, and large-scale forcings associated with El-Niño/Southern Oscillation (ENSO) and Indian Ocean Dipole (IOD). Potential economic impacts of human and climate-induced changes in LVB stored water are also explored.Overall, observed in situ rainfall from lake-shore stations showed a modest increasing trend during the recent decades. The dominant patterns of rainfall data from the TRMM satellite estimates suggest that the spatial and temporal distribution of precipitation have not changed much during the period of 1998–2012 over the basin consistent with in situ observations. However, GRACE-derived water storage changes over LVB indicate an average decline of 38.2 mm/yr for 2003–2006, likely due to the extension of the Owen Fall/Nalubale dam, and an increase of 4.5 mm/yr over 2007–2013, likely due to two massive rainfalls in 2006–2007 and 2010–2011. The temporal correlations between rainfall and ENSO/IOD indices during the study period, based on TRMM and model simulations, suggest significant influence of large-scale forcing on LVB rainfall, and thus stored water. The contributions of ENSO and IOD on the amplitude of TRMM-rainfall and GRACE-derived water storage changes, for the period of 2003–2013, are estimated to be ~2.5 cm and ~1.5 cm, respectively

The Ninth Data Release of the Sloan Digital Sky Survey: First Spectroscopic Data from the SDSS-III Baryon Oscillation Spectroscopic Survey

The Sloan Digital Sky Survey III (SDSS-III) presents the first spectroscopic data from the Baryon Oscillation Spectroscopic Survey (BOSS). This ninth data release (DR9) of the SDSS project includes 535,995 new galaxy spectra (median z=0.52), 102,100 new quasar spectra (median z=2.32), and 90,897 new stellar spectra, along with the data presented in previous data releases. These spectra were obtained with the new BOSS spectrograph and were taken between 2009 December and 2011 July. In addition, the stellar parameters pipeline, which determines radial velocities, surface temperatures, surface gravities, and metallicities of stars, has been updated and refined with improvements in temperature estimates for stars with T_eff<5000 K and in metallicity estimates for stars with [Fe/H]>-0.5. DR9 includes new stellar parameters for all stars presented in DR8, including stars from SDSS-I and II, as well as those observed as part of the SDSS-III Sloan Extension for Galactic Understanding and Exploration-2 (SEGUE-2). The astrometry error introduced in the DR8 imaging catalogs has been corrected in the DR9 data products. The next data release for SDSS-III will be in Summer 2013, which will present the first data from the Apache Point Observatory Galactic Evolution Experiment (APOGEE) along with another year of data from BOSS, followed by the final SDSS-III data release in December 2014.Comment: 9 figures; 2 tables. Submitted to ApJS. DR9 is available at http://www.sdss3.org/dr

The Fourteenth Data Release of the Sloan Digital Sky Survey: First Spectroscopic Data from the extended Baryon Oscillation Spectroscopic Survey and from the second phase of the Apache Point Observatory Galactic Evolution Experiment

The fourth generation of the Sloan Digital Sky Survey (SDSS-IV) has been in operation since July 2014. This paper describes the second data release from this phase, and the fourteenth from SDSS overall (making this, Data Release Fourteen or DR14). This release makes public data taken by SDSS-IV in its first two years of operation (July 2014-2016). Like all previous SDSS releases, DR14 is cumulative, including the most recent reductions and calibrations of all data taken by SDSS since the first phase began operations in 2000. New in DR14 is the first public release of data from the extended Baryon Oscillation Spectroscopic Survey (eBOSS); the first data from the second phase of the Apache Point Observatory (APO) Galactic Evolution Experiment (APOGEE-2), including stellar parameter estimates from an innovative data driven machine learning algorithm known as "The Cannon"; and almost twice as many data cubes from the Mapping Nearby Galaxies at APO (MaNGA) survey as were in the previous release (N = 2812 in total). This paper describes the location and format of the publicly available data from SDSS-IV surveys. We provide references to the important technical papers describing how these data have been taken (both targeting and observation details) and processed for scientific use. The SDSS website (www.sdss.org) has been updated for this release, and provides links to data downloads, as well as tutorials and examples of data use. SDSS-IV is planning to continue to collect astronomical data until 2020, and will be followed by SDSS-V.Comment: SDSS-IV collaboration alphabetical author data release paper. DR14 happened on 31st July 2017. 19 pages, 5 figures. Accepted by ApJS on 28th Nov 2017 (this is the "post-print" and "post-proofs" version; minor corrections only from v1, and most of errors found in proofs corrected

The Long-Baseline Neutrino Experiment: Exploring Fundamental Symmetries of the Universe

The preponderance of matter over antimatter in the early Universe, the dynamics of the supernova bursts that produced the heavy elements necessary for life and whether protons eventually decay --- these mysteries at the forefront of particle physics and astrophysics are key to understanding the early evolution of our Universe, its current state and its eventual fate. The Long-Baseline Neutrino Experiment (LBNE) represents an extensively developed plan for a world-class experiment dedicated to addressing these questions. LBNE is conceived around three central components: (1) a new, high-intensity neutrino source generated from a megawatt-class proton accelerator at Fermi National Accelerator Laboratory, (2) a near neutrino detector just downstream of the source, and (3) a massive liquid argon time-projection chamber deployed as a far detector deep underground at the Sanford Underground Research Facility. This facility, located at the site of the former Homestake Mine in Lead, South Dakota, is approximately 1,300 km from the neutrino source at Fermilab -- a distance (baseline) that delivers optimal sensitivity to neutrino charge-parity symmetry violation and mass ordering effects. This ambitious yet cost-effective design incorporates scalability and flexibility and can accommodate a variety of upgrades and contributions. With its exceptional combination of experimental configuration, technical capabilities, and potential for transformative discoveries, LBNE promises to be a vital facility for the field of particle physics worldwide, providing physicists from around the globe with opportunities to collaborate in a twenty to thirty year program of exciting science. In this document we provide a comprehensive overview of LBNE's scientific objectives, its place in the landscape of neutrino physics worldwide, the technologies it will incorporate and the capabilities it will possess.Comment: Major update of previous version. This is the reference document for LBNE science program and current status. Chapters 1, 3, and 9 provide a comprehensive overview of LBNE's scientific objectives, its place in the landscape of neutrino physics worldwide, the technologies it will incorporate and the capabilities it will possess. 288 pages, 116 figure

Wdr74 Is Required for Blastocyst Formation in the Mouse

Preimplantation is a dynamic developmental period during which a combination of maternal and zygotic factors program the early embryo resulting in lineage specification and implantation. A reverse genetic RNAi screen in mouse embryos identified the WD Repeat Domain 74 gene (Wdr74) as being required for these critical first steps of mammalian development. Knockdown of Wdr74 results in embryos that develop normally until the morula stage but fail to form blastocysts or properly specify the inner cell mass and trophectoderm. In Wdr74-deficient embryos, we find activated Trp53-dependent apoptosis as well as a global reduction of RNA polymerase I, II and III transcripts. In Wdr74-deficient embryos blocking Trp53 function rescues blastocyst formation and lineage differentiation. These results indicate that Wdr74 is required for RNA transcription, processing and/or stability during preimplantation development and is an essential gene in the mouse