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PURPOSE: Opportunities exist to meaningfully reduce suboptimal prescription opioid use among older adults. Deprescribing is one possible approach to reducing suboptimal use. Appropriate interventions should outline how to carefully taper opioids, closely monitor adverse events, substitute viable alternative and affordable nonopioid pain treatments, and initiate medications for opioid use disorder to properly manage use disorders, as needed. We sought to document and understand provider perceptions to begin developing effective and safe opioid deprescribing interventions. METHODS: We conducted 3 semistructured focus groups that covered topics such as participant perspectives on opioid deprescribing in older adults, how to design an ideal intervention, and how to identify potential barriers or facilitators in implementing an intervention. Focus group transcripts were double coded and qualitatively analyzed to identify overarching themes. RESULTS: Healthcare providers (n = 17), including physicians, pharmacists, nurses, social workers, and administrative staff, participated in 3 focus groups. We identified 4 key themes: (1) involve pharmacists in deprescribing and empower them as leaders of an opioid deprescribing service; (2) ensure tight integration and close collaboration throughout the deprescribing process from the inpatient to outpatient settings; (3) more expansive inclusion criteria than age alone; and (4) provision of access to alternative pharmacological and nonpharmacological pain management modalities to patients. CONCLUSION: Our findings, which highlight various healthcare provider beliefs about opioid deprescribing interventions, are expected to serve as a framework for other organizations to develop and implement interventions. Future studies should incorporate patients' and family caregivers' perspectives.

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PURPOSE: The high-value pharmacy enterprise (HVPE) framework and constituent best practice consensus statements are presented, and the methods used to develop the framework's 8 domains are described. SUMMARY: A panel of pharmacy leaders used an evidence- and expert opinion-based approach to define core and aspirational elements of practice that should be established within contemporary health-system pharmacy enterprises by calendar year 2025. Eight domains of an HVPE were identified: Patient Care Services; Business Services; Ambulatory and Specialty Pharmacy Services; Inpatient Operations; Safety and Quality; Pharmacy Workforce; Information Technology, Data, and Information Management; and Leadership. Phase 1 of the project consisted of the development of draft practice statements, performance elements, and supporting evidence for each domain by panelists, followed by a phase 2 in-person meeting for review and development of consensus for statements and performance elements in each domain. During phase 3, the project cochairs and panelists finalized the domain drafts and incorporated them into a full technical report and this summary report. CONCLUSION: The HVPE framework is a strategic roadmap to advance pharmacy practice by ensuring safe, effective, and patient-centered medication management and business practices throughout the health-system pharmacy enterprise. Grounded in evidence and expert recommendations, the statements and associated performance elements can be used to identify strategic priorities to improve patient outcomes and add value within health systems.

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BACKGROUND: How corticosteroid use affects treatment response to chemotherapy and immune-checkpoint inhibitors (CICPIs) remains unknown. We assessed how systemic corticosteroid exposure before CICPI modifies the effect of CICPI on outcomes among patients with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC). METHODS: We conducted a retrospective cohort study using electronic health records to examine patients with mNSCLC or ES-SCLC who received chemotherapy (CT) between 1st April 2015 and 31st January 2018 or CICPI between 1st February 2018 and 31st August 2019. We excluded those with an actionable driver mutation. Baseline corticosteroid use was defined as systemic corticosteroids within 28 days before the initiation of CT or CICPI, not including premedications. Coprimary outcomes included overall survival (OS), real-world progression (rwP), and real-world progression-free survival (rwPFS) in CICPI-treated corticosteroid users versus non-users. We used inverse probability of treatment weighting (IPW) to adjust for potential confounding. RESULTS: The cohort of 316 patients (median [interquartile range] age, 67 [61-73] years; 156 [49%] male) included 228 CT-treated and 88 CICPI-treated patients. After applying IPW, characteristics were well-balanced between the CT and CICPI groups, and steroid users and non-users. Using CT-treated steroid non-users as a common comparator, CICPI-treated steroid users were as likely as CICPI-treated steroid non-users to die (users IPW hazard ratio [HR] = 0.67, 95% CI = 0.35-1.28 versus non-users IPW-HR = 0.88, 95% C = I0.55-1.42; p = 0.49), have rwP (IPW-HR = 0.35, 95% C = I0.12-0.99 versus IPW-HR = 0.41, 95% C = I0.24-0.70; p = 0.77), or experience rwPFS (IPW-HR = 0.56, 95% C = I0.29-1.09 versus IPW-HR = 0.69, 95% CI0.46-1.03; p = 0.59). CONCLUSION: Corticosteroid use before CICPIs was not associated with worse outcomes, suggesting that corticosteroids should be used with CICPIs when indicated.

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BACKGROUND: Although landmark trials in the metastatic (CLEOPATRA) and neo-adjuvant (NeoSphere; TRYPHAENA) settings identified all-grade diarrhea as a pertuzumab-associated adverse event, it was not classified as dose-limiting. In actual practice, diarrhea is often a reason for treatment modifications. OBJECTIVES: To compare the risk of pertuzumab-associated diarrhea in actual practice to the risks in randomized controlled trials. METHODS: We conducted a retrospective cohort study of HER2/neu-positive breast cancer patients who received a pertuzumab-containing regimen between January 2012 and August 2015. We calculated the risk of diarrhea with 95% confidence limits (CLs), and then used two-sample t-tests to compare the risk between trials and actual practice. RESULTS: A total of 27 patients in the study cohort received a pertuzumab-containing treatment regimen for HER2/neu-positive breast cancer. The overall risk of all-grade and severe diarrhea in actual practice was 70% (95% CLs 55-90%) and 37% (95% CLs 20-66%), respectively. No severe diarrhea was observed in the metastatic setting, and the risk of all-grade diarrhea (44%, 95% CLs 21-92%) was similar to the CLEOPATRA study (67%). The risk of all-grade diarrhea in the neo-adjuvant setting was 83% (95% CLs 68-100%), compared to 46% in the NeoSphere trial (p = 0.03). The risk of severe diarrhea (Grade 3-4) in the neo-adjuvant setting was 47% (95% CLs 27-80%) versus 6% in the NeoSphere (p < 0.0001) and 12% in the TRYPHAENA (p < 0.01) trials. CONCLUSIONS: The risk of all-grade and severe diarrhea associated with neoadjuvant pertuzumab use for HER2/neu-positive breast cancer was greater in actual practice than in trials.

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This study was designed to explore the relationship between participation (measured by percentage of time spoken) in team-based learning (TBL) exercises and final examination in a 4-week medical microbiology course for college students from backgrounds underrepresented in medicine (URM). A significant correlation was found between participation and examination scores in lower performing students. Although male participation was higher, a significant correlation between participation and examination scores was found only in females. These data suggest that female participation is based on knowledge of the subject under discussion and that affirmation in TBL positively reinforces self-confidence, increasing student's efficiency during peer teaching.

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INTRODUCTION: Guidelines recommend pegfilgrastim for primary prophylaxis of febrile neutropenia after highly myelosuppressive chemotherapy. While deviations from guidelines could result in overuse and increased costs, underuse is also a concern and could compromise quality of care. Our objectives were to evaluate guideline adherence and quantify the extent to which physician heterogeneity may influence pegfilgrastim use. METHODS: We randomly sampled 550 patients from a retrospective cohort of those who received infusions at an academic cancer center between 1 September 2013 and 1 September 2014. Electronic medical and drug dispensing records provided information on patient characteristics, chemotherapy characteristics, prescribing physician, and pegfilgrastim administration. RESULTS: We included 154 patients treated by 25 physicians. About half of patients were male and mean age was 61.3 years. Forty (26.1%) patients had no febrile neutropenia risk factors, 62 (40.5%) had one, and 51 (33.3%) had two or more. Thirty patients (19.5%) received pegfilgrastim, of which 12 (40%) received palliative chemotherapy. Nine (60%) of 15 patients on a regimen with a febrile neutropenia risk ≥ 20% received pegfilgrastim. Pegfilgrastim use significantly varied by cancer type (p < 0.01), chemotherapy regimen (p < 0.001), and regimen febrile neutropenia risk (p < 0.001). Multivariable analysis reaffirmed the association between chemotherapy regimen febrile neutropenia risk ≥ 20% and pegfilgrastim use (odds ratio (OR) = 10.1, 95% confidence interval (CI): 1.6-62.7) and suggested that 31% (95% CI: 8%-71%) of the variation in use was attributable to physician characteristics. CONCLUSION: Pegfilgrastim was potentially overused for palliative chemotherapy and underused for chemotherapy regimens with febrile neutropenia risk ≥ 20%. Successful interventions to modify prescribing practices likely require an understanding of the relationship between specific physician characteristics and pegfilgrastim use.

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AIMS: To assess whether nursing home (NH) residents with type 2 diabetes mellitus (T2D) preferentially received "T2D-friendly" (vs "T2D-unfriendly") ß-blockers after acute myocardial infarction (AMI), and to evaluate the comparative effects of the two groups of ß-blockers. MATERIALS AND METHODS: This new-user retrospective cohort study of NH residents with AMI from May 2007 to March 2010 used national data from the Minimum Data Set and Medicare system. T2D-friendly ß-blockers were those hypothesized to increase peripheral glucose uptake through vasodilation: carvedilol, nebivolol and labetalol. Primary outcomes were hospitalizations for hypoglycaemia and hyperglycaemia in the 90 days after AMI. Secondary outcomes were functional decline, death, all-cause re-hospitalization and fracture hospitalization. We compared outcomes using binomial and multinomial logistic regression models after propensity score matching. RESULTS: Of 2855 NH residents with T2D, 29% initiated a T2D-friendly ß-blocker vs 24% of 6098 without T2D (P < 0.001). For primary outcomes among residents with T2D, T2D-friendly vs T2D-unfriendly ß-blockers were associated with a reduction in hospitalized hyperglycaemia (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.21-0.97), but unassociated with hypoglycaemia (OR 2.05, 95% CI 0.82-5.10). For secondary outcomes, T2D-friendly ß-blockers were associated with a greater rate of re-hospitalization (OR 1.26, 95% CI 1.01-1.57), but not death (OR 1.06, 95% CI 0.85-1.32), functional decline (OR 0.91, 95% CI 0.70-1.19), or fracture (OR 1.69, 95% CI 0.40-7.08). CONCLUSIONS: In older NH residents with T2D, T2D-friendly ß-blocker use was associated with a lower rate of hospitalization for hyperglycaemia, but a higher rate of all-cause re-hospitalization.

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Background: A multidisciplinary approach is recommended for the management of type 2 diabetes mellitus (DM). Aim: To evaluate the impact of a pharmacist intervention on haemoglobin A1c (HbA1c), systolic blood pressure (SBP), diastolic blood pressure (DBP), and diabetes-related hospitalisations in an underserved cohort with unmanaged type 2 DM. Methods: This analysis was a retrospective cohort study. Criteria for inclusion were persons with unmanaged type 2 DM defined as HbA1c values ≥8% at time of enrolment, ≥18 years old, and enrolment in a pharmacist-managed clinic for ≥12 months. Pre- and post-intervention differences in HbA1c, SBP and DBP values were assessed using repeated measures analysis of variance (ANOVA). The risk of diabetes-related hospitalisations was estimated during the 12 months prior and during the 12 months post-intervention, and the relative risk (RR) was calculated. Results: Mean HbA1c values at 3, 6 and 12 months post-intervention were lower than baseline values (p < 0.05). There was no significant difference in mean HbA1c values at 6 or 12 months compared to 3 months post intervention. Mean SBP values at 3, 6 and 12 months were lower than baseline (p < 0.05). Likewise, mean DBP values at 6 and 12 months were lower than baseline (p < 0.05). The estimated RR of diabetes-related hospitalisations was 0.40 (95% CI: 0.20-0.83; p = 0.013). Conclusion: Enrolment in a pharmacist-managed diabetes program was associated with a significant reduction in HbA1c, SBP and DBP and reduction in risk of diabetes-related hospitalisations in an underserved cohort of patients with diabetes over a 12-month period.

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Streptococcus pneumoniae is a causative agent of community-acquired pneumonias. The recommendations of the 2012 Advisory Committee on Immunization Practices include vaccination with Prevnar®13 (protein-polysaccharide conjugate vaccine; PCV), followed by Pneumovax®23 (polysaccharide-based vaccine; PSV) in adults 65+ or the immunocompromised. In this experiment, a group of 4 healthy volunteers were vaccinated with PCV followed by PSV 60 days later. ELISAs were optimized to study kinetics of IgA, IgM, total IgG and its four subclasses against 14 polysaccharides of the pneumococcal capsule. Although this is a small sample, results from volunteers consistently showed that rapid induction of monomeric IgA followed by rapid decline is typical for both vaccines. IgA was not detected after PSV vaccination in those serotypes present in PCV, suggesting the population of B cells secreting IgA is not renewed within 60 days of activation by PCV. In contrast to mice, human neutrophils expressed a functional receptor for the constant region of monomeric IgA. Thus, the role of IgA early in the human immune response should be further investigated.

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BACKGROUND: Activated partial thromboplastin time (aPTT) and antifactor Xa (anti-Xa) monitoring methods for unfractionated heparin (UFH) often disagree. The extent of discordance for those with elevated bilirubin remains unclear. Our objective was to evaluate concordance between activated aPTT and anti-Xa methods for hyperbilirubinemic patients on UFH. METHODS: This was a retrospective cohort study of 26 patients hospitalized at Rhode Island Hospital between August 2014 and September 2014. Patients had at least one bilirubin measurement >5 mg/dL. After categorizing lab values, percent agreement and kappa were used to examine concordance between aPTT and anti-Xa. RESULTS: Overall percent agreement between aPTT and anti-Xa was 50%. A nontherapeutic aPTT and therapeutic anti-Xa accounted for 98% of all disagreement. Specifically, 76.7% of disagreement was due to a subtherapeutic aPTT and a therapeutic anti-Xa. Unweighted kappa was 0.141 (95%CI: 0.048-0.235). CONCLUSION: Concordance between aPTT and anti-Xa values was poor in hyperbilirubinemic patients.

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Chemotherapy drugs are characterized by low therapeutic indices and significant toxicities at clinically prescribed doses, raising serious issues of drug safety. The safety of the chemotherapy medication use process is further challenged by regimen complexity and need to tailor treatment to patient status. Errors that occur during chemotherapy prescribing are associated with serious and life-threatening outcomes. Computerized provider order entry (CPOE) systems were shown to reduce overall medication errors in ambulatory and inpatient settings. The adoption of chemotherapy CPOE is lagging due to financial cost and cultural and technological challenges. Institutions that adopted infusional or oral chemotherapy electronic prescribing modified existing CPOE systems to allow chemotherapy prescribing, implemented chemotherapy-specific CPOE systems, or developed home-grown chemotherapy electronic prescribing programs. Implementation of chemotherapy electronic prescribing was associated with a significant reduction in the risk of prescribing errors, most significantly dose calculation and adjustment errors. In certain cases, implementation of chemotherapy CPOE was shown to improve the chemotherapy use process. The implementation of chemotherapy CPOE may increase the risk of new types of errors, especially if processes are not redesigned and adapted to CPOE. Organizations aiming to implement chemotherapy CPOE should pursue a multidisciplinary approach engaging all stakeholders to guide system selection and implementation. Following implementation, organizations should develop and use a risk assessment process to identify and evaluate unanticipated consequences and CPOE-generated errors. The results of these analyses should serve to further enhance the chemotherapy electronic prescribing process and improve the quality and safety of cancer care.

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PURPOSE: The impact of a quality-improvement (QI) initiative to decrease the risk of bleeding in renally impaired patients receiving enoxaparin prophylaxis for venous thromboembolism (VTE) was evaluated. METHODS: A retrospective cohort with a before-and-after study design was employed. Inclusion criteria included age over 40 years, hospitalization exceeding six days, treatment with enoxaparin or unfractionated heparin (UFH), and acute or chronic renal insufficiency. Major bleeding included fatal bleeding, symptomatic bleeding requiring hemodynamic support or causing a decrease of 2 g/dL or more in hemoglobin concentration, or bleeding leading to the transfusion of at least 2 units of packed red blood cells. The QI intervention restricted enoxaparin use in patients with a creatinine clearance (CL(cr)) concentration of <30 mL/min and recommended UFH instead. RESULTS: The rate of major bleeding in the preintervention group was 13.5% with enoxaparin compared with 4.1% with UFH (p = 0.005). The relative risk (RR) of bleeding with enoxaparin compared with UFH was 3.21 (95% confidence interval [CI], 1.40-7.34). In patients with a CL(cr) concentration of <30 mL/min, the RR of bleeding with enoxaparin compared with UFH was 4.68 (95% CI, 1.06-20.59). The rate of major bleeding in the postintervention period was 9.5% with enoxaparin or 4.5% with UFH (p = 0.15). The RR of bleeding in the postintervention period was 0.64 (95% CI, 0.37-1.12). CONCLUSION: A QI initiative that eliminated the use of enoxaparin for prophylaxis of VTE in patients with renal impairment resulted in lower rates of major bleeding associated with pharmacologic prophylaxis. No differences in the rate of in hospital VTE as a result of the intervention were observed.

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OBJECTIVE: To reduce the probability of failure in the oral chemotherapy order, review and administration process and to reduce oral chemotherapy-related prescribing errors intercepted by clinical pharmacists prior to reaching the patient. DESIGN: A before-and-after cohort study. SETTING: A 719-bed multidisciplinary tertiary care institution with a pediatric division and an outpatient cancer center. PARTICIPANTS: A multidisciplinary team characterized key elements of the oral chemotherapy process using healthcare failure modes and effects analysis (HFMEA). INTERVENTION(S): Oral chemotherapy computerized provider order entry (CPOE) was developed and implemented. MAIN OUTCOME MEASURE(S): Pharmacist-intercepted oral chemotherapy prescribing errors over a 24-month period (before) and over a 6-month period (after) were analyzed according to the error type (errors in clinical decision making, errors in transcription or errors related to prescribing policy). The incidence of prescribing errors prior to and following CPOE implementation was compared by calculating the odds ratio (OR) and the 95% confidence interval (CI). RESULTS: HFMEA hazard analysis revealed seven potential failure modes, with the highest hazard scores in the prescribing and administration components of the process. CPOE implementation significantly (P= 0.023) reduced prescribing error risk by 69% [OR (95% CI) = 0.31 (0.11-0.86)] and eliminated certain types of errors that can lead to significant patient harm. CONCLUSIONS: Prescribing oral chemotherapy is a failure mode with significant risk of inducing patient harm. CPOE is effective in reducing prescribing errors of oral chemotherapy and should be considered part of a fail-safe process to improve safety.

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PURPOSE: The implementation of vendor-based integrated clinical information technology was studied, and its effect on medication errors throughout the medication-use process in a health care system was evaluated. METHODS: The integrated systems selected for implementation included computerized physician order entry, pharmacy and laboratory information systems, clinical decision-support systems (CDSSs), electronic drug dispensing systems (EDDSs), and a bar-code point-of-care medication administration system. The primary endpoint was the reduction in related medication errors. Secondary endpoints included the reductions in medication order turnaround time and EDDS override transactions. RESULTS: Integrated clinical information system technology was implemented in a multihospital health care system with a phased-in approach. A positive effect of this integration on medication errors throughout the medication-use process was demonstrated. Most prescribing errors decreased significantly in the selected categories monitored, specifically drug allergy detection, excessive dosing, and incomplete or unclear orders. Pharmacists were also twice as likely to identify dosages requiring adjustment for renal insufficiency when the integrated technology was in place and more than six times as likely for drug levels outside of the therapeutic range. A positive effect on medication administration safety was also demonstrated: 73 administration-related errors were intercepted through electronic bar-code scanning for every 100,000 doses charted. CONCLUSION: Integration of clinical information system technology decreased selected types of medication errors throughout the medication-use process in a health care system and improved therapeutic drug monitoring in patients with renal insufficiency and in patients receiving drugs with narrow therapeutic ranges through the use of CDSS alerts.

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