Colchicine and/or Naltrexone for Hospitalized COVID-19 Patients Not Requiring High Levels of Ventilatory Support (COLTREXONE): A Prospective, Randomized, Open-Label Trial.

We assessed the efficacy and safety of colchicine and low-dose naltrexone (LDN), alone and in combination, in preventing progression to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In this prospective, randomized, open-label trial, colchicine and LDN were compared to standard of care (SOC) in patients hospitalized with SARS-CoV-2 not requiring high levels of ventilatory support. Patients were randomly assigned to colchicine alone, LDN alone, colchicine/LDN in combination, or SOC. The primary outcome was time to disease recovery. Secondary outcomes included total time hospitalized, study enrollment, level of care, oxygen support, and adverse events.  One-hundred and thirty-seven patients were randomized (Nc = 34, Nc+ldn = 33, Nldn = 35, Nsoc = 35). Eighty-four patients (61%) achieved disease recovery by day 5. There was no significant difference in the proportion of patients who experienced the primary efficacy outcome among those who received colchicine, LDN, or between the four study arms.Patients receiving colchicine had a shorter length of enrollment but not a significant reduction in the length of stay. Diarrhea was the most common adverse reaction. In adults hospitalized with SARS-CoV-2 not requiring high-level ventilatory support, colchicine and LDN, alone and in combination, were not associated with significant reductions in progression to severe disease.

Reducing Medication Therapy Problems in the Transition from Hospital to Home: A Pre- & Post-Discharge Pharmacist Collaboration.

BACKGROUND: With 30-day Medicare readmission rates reaching 20%, a heightened focus has been placed on improving the transition process from hospital to home. For many institutions, this charge has identified medication-use safety as an area where pharmacists are well-positioned to improve outcomes by reducing medication therapy problems (MTPs). METHODS: This system-wide (425 bed community hospital plus 18 primary care clinics) prospective study recruited inpatient and ambulatory pharmacists to provide comprehensive medication management before and after hospital discharge. The results analyzed were the success rate and timing of the inpatient to ambulatory pharmacist handoff, as well as the number, type, and severity of MTPs resolved in both settings. RESULTS: Of the 105 eligible patients who received a pharmacist evaluation before discharge, 61 (58%) received follow-up with an ambulatory pharmacist an average of 2.88 days after discharge (range 1-8 days). An average of 5 and 1.4 MTPs per patient were identified and resolved in the inpatient vs. ambulatory setting, respectively. Although average MTP severity ratings were higher in the inpatient setting, the highest severity rating was seen most frequently in the ambulatory setting. CONCLUSIONS: In the transition from hospital to home, pharmacist evaluation in both the inpatient and ambulatory settings are necessary to resolve medication therapy problems.

Supporting formative peer review of clinical teaching through a focus on process.

BACKGROUND: The professional need for development of clinical faculty is clear. Previous scholarship provides insight into the formative potential of peer review in both didactic and experiential settings. Less information exists on a comprehensive peer review process (PRP) designed to support faculty change. EDUCATIONAL ACTIVITY AND SETTING: A clinical faculty PRP was developed and implemented based on input from the literature, stakeholders, and field experts. The process included: 1) self-reflective pre-work, 2) a peer-observation component, 3) self-reflective post-work, and 4) creation of a specific action plan via meeting with an educational expert. The process was assessed by collecting evaluative data from peer reviewer and clinical faculty participants. FINDINGS: Eight of 26 faculty members participated in a pilot of the PRP and formed four clinical faculty-peer dyads. When surveyed, all participants unanimously reported that they would participate in the PRP again. Aspects perceived among most helpful to clinical teaching included peer observation, self-reflection, and meeting with an educational expert. Challenges related to the process included anxiety of peer observation, burden of pre-work, and logistics of scheduling meetings. DISCUSSION: While instruments are important in guiding and documenting the evaluation of clinical teaching during an observation period, this initiative focused on the process supporting the observation and evaluation, in order to optimize the formative feedback received by participating faculty and encourage professional development actions. SUMMARY: A PRP that incorporates preparation, reflective practice, and a meeting with an educational expert may support meaningful faculty development in the area of clinical teaching.

Identifying Core Content for Electrocardiogram Instruction in Doctor of Pharmacy Curricula.

Minimum competencies for diagnostic tools, such as the electrocardiogram, are not well-defined in current standards or publications. The electrocardiogram has significant pharmacotherapeutic implications that pharmacists should have an adequate understanding of. This commentary highlights the importance of pharmacists' understanding of key elements of the electrocardiogram and drafts a set of recommended minimum competencies for graduating pharmacy students.

A Five-Year Evaluation of Examination Structure in a Cardiovascular Pharmacotherapy Course.

Objective. To evaluate the composition and effectiveness as an assessment tool of a criterion-referenced examination comprised of clinical cases tied to practice decisions, to examine the effect of varying audience response system (ARS) questions on student examination preparation, and to articulate guidelines for structuring examinations to maximize evaluation of student learning. Design. Multiple-choice items developed over 5 years were evaluated using Bloom's Taxonomy classification, point biserial correlation, item difficulty, and grade distribution. In addition, examination items were classified into categories based on similarity to items used in ARS preparation. Assessment. As the number of items directly tied to clinical practice rose, Bloom's Taxonomy level and item difficulty also rose. In examination years where Bloom's levels were high but preparation was minimal, average grade distribution was lower compared with years in which student preparation was higher. Conclusion. Criterion-referenced examinations can benefit from systematic evaluation of their composition and effectiveness as assessment tools. Calculated design and delivery of classroom preparation is an asset in improving examination performance on rigorous, practice-relevant examinations.

Warfarin monitoring in antiphospholipid syndrome and lupus anticoagulant.

OBJECTIVE: To review the available literature on international normalized ratio (INR) and chromogenic factor X (CFX) monitoring in patients with antiphospholipid syndrome (APS), specifically lupus anticoagulant (LA), and furthermore, to identify benefits of one monitoring test compared with the other in the presence of LA. DATA SOURCES: A literature search was conducted through MEDLINE (1946-May 2014) utilizing the following MeSH terms chromogenic compounds, anticoagulants, and factor X. Further articles were identified from original literature citations. STUDY SELECTION: All English-language studies were included that involved INR and/or CFX monitoring in APS patients that focused on a therapeutic anticoagulation level with warfarin therapy. DATA SYNTHESIS: A total of 55 articles were identified, of which nine are referenced because of their relevance for this review: three articles focus on the efficacy of utilizing INR monitoring in patients with APS, five focus on CFX compared with INR for therapeutic warfarin dosing, and one compares different thromboplastins utilizing both INR and CFX monitoring. INR monitoring in patients with APS, specifically LA, was not found to be reliable because thromboplastin reagents are sensitive to LA. Furthermore, when INR was compared to CFX, patients with LA had supratherapeutic INRs despite having CFX within goal range. CONCLUSIONS: In a subgroup of APS patients, INR monitoring may not be safe for determining the dose of warfarin because their INR values can be falsely elevated. Although CFX monitoring is more accurate, it too comes with its own downsides. Managing warfarin therapy in the APS population needs to be individualized.

Pilot assessment of patient satisfaction and clinical impact of Medicare Part D in diabetic geriatric patients

Objectives: To assess patients’ 1) satisfaction with their decision to enroll or not enroll in the Medicare Part D program, and 2) clinical status of diabetes before and after decision to enroll in Medicare Part D. Methods: Patients 65 years or older were enrolled in the study from November 2006 through February 2007. Patients were screened by a clinical pharmacist at their clinician visit and administered a Medicare Part D satisfaction survey. Upon completion of the survey, a retrospective chart review was completed in diabetic patients who were enrolled in Medicare Part D to assess goal attainment of glycosylated hemoglobin (HbA1c), low-density lipoprotein (LDL) and blood pressure. Pre-enrollment values were obtained in the 6 months prior to the start of Medicare Part D enrollment (July 1- December 31, 2005). Post-enrollment values were obtained after enrollment was complete for the 2006 year (May 1- October 31, 2006). Results: Results show that 74% (60/81) of patients surveyed were enrolled into the Medicare Part D program, including patients who have dual eligibility. Of the 60 patients who were enrolled in Medicare Part D, 48 patients (80.0%) responded that they were satisfied with their decision to enroll. Clinical outcomes were unchanged from the pre-enrollment to the post-enrollment periods. Mean HbA1c was 7.47% in the pre-enrollment period and 7.25% post-enrollment (difference pre-post = 0.23; 95%CI = -0.28 to 0.73). There was no change in LDL in the two time periods (pre = 79.4 mg/dL; post = 79.7; difference pre-post = -0.25; 95%CI = -13.6 to 13.1). Similarly, there were no significant differences observed for blood pressure. Mean systolic blood pressure was 129.5 in the pre-enrollment period and 131.6 in the post-enrollment period (difference pre-post = -2.1; 95%CI = -7.0 to 2.7). Mean diastolic blood pressure was 70.3 for the pre-enrollment period and 70.7 for the post-enrollment period (difference pre-post = -0.4; 95%CI = -4.2 to 3.4). Conclusion: Patients were generally satisfied with their decision to enroll in Medicare Part D. Clinical outcomes were not affected by participation in a Medicare Part D plan. More longitudinal studies are necessary to determine long term impact of Medicare Part D on diabetes management (AU)

Objetivos: Evaluar 1) la satisfacción de los pacientes con la decisión de incluirlos o no en el programa de Medicare Part D, y 2) el estado clínico de la diabetes antes y después de incluirlos en el Medicare Part D. Métodos: Se incluyeron en el estudio pacientes de 65 o más años desde noviembre 2006 a febrero 2007. Los pacientes fueron cribados por un farmacéutico clínico en su visita clínica y se les administró una encuesta de satisfacción sobre Medicare Part D. Después de completar la encuesta, se realizó una revisión del historial en los pacientes diabéticos incluidos en Medicare Part D, para evaluar la consecución de objetivos de hemoglobina glicosilada (HbA1c), lipoproteínas de baja densidad (LDL) y presión sanguínea. Los valores pre-inclusión se obtuvieron en los 6 meses anteriores a comenzar la inclusión en Medicare Part D (1-jul a 31-dic). Los valores post-inclusión se obtuvieron en el año 2006 (1-may a 31-oct). Resultados: El 74% de los pacientes se incluyeron en el programa Medicare Part D, incluyendo los pacientes que tenían doble elegibilidad. De los 60 pacientes incluidos en Medicare Part D, 48 (80,0%) respondieron que estaban satisfechos con la decisión de incluirse. Los resultados clínicos no variaron del periodo pre- al periodo post-inclusión. La HbA1c media fue de 7,47% en el periodo pre- y de 7,25% en el post-inclusión (diferencia pre-post=0,23; IC95%=-0,28 a 0,73). No hubo cambios en las LDL en los dos periodos (pre=79,4 mg/dL; post=79,7; diferencia pre-post= -0,25; IC95%=-13,6 a 13,1). Igualmente, no hubo diferencias en la presión arterial. La media de la presión sistólica fue de 129,5 en el periodo pre- y 131,6 en el periodo post-inclusión (diferencia pre-post=-2,1; IC95%= -7,0 a 2,7). La media de la presión diastólica fue de 70,3 para el periodo pre- y de 70,7 para el periodo post-inclusión (diferencia pre-post= -0,4; IC95%= -4,2 a 3,4). Conclusión: Los pacientes estaban generalmente satisfechos con la decisión de incluirse en el Madicare Part D. Los resultados clínicos no se afectaron por su participación en el plan Medicare Part D. Son necesarios más estudios para determinar el impacto a largo plazo de Medicare Part D en la diabetes (AU)

Model for medication therapy management in a university clinic.

PURPOSE: Experience with a referral-based medication therapy management (MTM) clinic in a university medical center is described. SUMMARY: The MTM clinic's mission is to assist patients who take multiple medications due to multiple chronic conditions with the management of their drug therapy to improve or maintain their health and prevent or minimize drug-related problems. The clinical services provided at the clinic have evolved into a comprehensive program providing five distinct service areas: access, adherence, coordination of care, medication therapy review, and education. During initial visits, patient information is collected, patients are interviewed, medications are reconciled, and the pharmacist identifies and attempts to solve any immediate drug-related problems and concerns. Routine visits are scheduled monthly to coincide with a patient's medication refills. On a typical day, a minimum of two MTM pharmacists and one pharmacy technician staff the clinic. On two days of the week, three MTM pharmacists are available in the clinic. The clinic averages 9-13 scheduled patient visits per day. The MTM clinic functions as a subset of the outpatient pharmacy and is merged financially in the general operational budget of the ambulatory care pharmacy. This model of MTM patient care is intensive and comprehensive and is significantly different from the majority of MTM models currently provided by Medicare Part D plans. CONCLUSION: A referral-based MTM clinic managed by pharmacists at a university medical center outpatient pharmacy provides care to patients with the goal of improving medication access, medication adherence, continuity of care, medication therapy management, and patient education.

Pilot assessment of patient satisfaction and clinical impact of Medicare Part D in diabetic geriatric patients.

OBJECTIVES: To assess patients' 1) satisfaction with their decision to enroll or not enroll in the Medicare Part D program, and 2) clinical status of diabetes before and after decision to enroll in Medicare Part D. METHODS: Patients 65 years or older were enrolled in the study from November 2006 through February 2007. Patients were screened by a clinical pharmacist at their clinician visit and administered a Medicare Part D satisfaction survey. Upon completion of the survey, a retrospective chart review was completed in diabetic patients who were enrolled in Medicare Part D to assess goal attainment of glycosylated hemoglobin (HbA1c), low-density lipoprotein (LDL) and blood pressure. Pre-enrollment values were obtained in the 6 months prior to the start of Medicare Part D enrollment (July 1- December 31, 2005). Post- enrollment values were obtained after enrollment was complete for the 2006 year (May 1- October 31, 2006). RESULTS: Results show that 74% (60/81) of patients surveyed were enrolled into the Medicare Part D program, including patients who have dual eligibility. Of the 60 patients who were enrolled in Medicare Part D, 48 patients (80.0%) responded that they were satisfied with their decision to enroll. Clinical outcomes were unchanged from the pre-enrollment to the post-enrollment periods. Mean HbA1c was 7.47% in the pre-enrollment period and 7.25% post- enrollment (differencepre-post = 0.23; 95%CI = -0.28 to 0.73). There was no change in LDL in the two time periods (pre = 79.4 mg/dL; post = 79.7; differencepre-post = -0.25; 95%CI = -13.6 to 13.1). Similarly, there were no significant differences observed for blood pressure. Mean systolic blood pressure was 129.5 in the pre-enrollment period and 131.6 in the post-enrollment period (differencepre-post = -2.1; 95%CI = -7.0 to 2.7). Mean diastolic blood pressure was 70.3 for the pre- enrollment period and 70.7 for the post-enrollment period (differencepre-post = -0.4; 95%CI = -4.2 to 3.4). CONCLUSION: Patients were generally satisfied with their decision to enroll in Medicare Part D. Clinical outcomes were not affected by participation in a Medicare Part D plan. More longitudinal studies are necessary to determine long term impact of Medicare Part D on diabetes management.

Information resources used in antimicrobial prescribing.

To describe resources clinicians use when they prescribe antimicrobials, the authors surveyed prescribers by telephone within hours (median 2.9) after they ordered one or more antimicrobials for a patient. Among 157 prescribers, 87 (55%) used one or more external resources to aid in decisions about their order. The other 70 (45%) used only their own knowledge and experience. Fifty-nine (38%) consulted another person. Fifty-four (34%) used a print, computer, or Internet resource. In multivariate analysis, use of an external resource was associated with the clinician being on the medical service (odds ratio [OR] 2.99, 95% confidence interval [CI] 1.41-6.3) or being an intern (OR 13.65, 95% CI 1.44-128). Eighty percent of providers said information about antimicrobial prescribing at the point of electronic order entry would be helpful. It was concluded that decision support at the point of electronic order entry is likely to be used and might improve antimicrobial prescribing.