Development, Validation, and Reliability of a P1 Objective Structured Clinical Examination Assessing the National EPAs.

OBJECTIVE: To document the performance of first-year pharmacy students on a revised objective structured clinical examination (OSCE) based on national entrustable professional activities, identify risk factors for poor performance, and assess its validity and reliability. METHODS: A working group developed the OSCE to verify students' progress toward readiness for advanced pharmacy practice experiences at the L1 level of entrustment (ready for thoughtful observation) on the national entrustable professional activities, with stations cross-mapped to the Accreditation Council for Pharmacy Education educational outcomes. Baseline characteristics and academic performance were used to investigate risk factors for poor performance and validity, respectively, by comparing students who were successful on the first attempt with those who were not. Reliability was evaluated using re-grading by a blinded, independent grader, and analyzed using Cohen's kappa. RESULTS: A total of 65 students completed the OSCE. Of these, 33 (50.8%) successfully completed all stations on first attempt, and 32 (49.2%) had to re-attempt at least 1 station. Successful students had higher Health Sciences Reasoning Test scores (mean difference 5, 95% CI 2-9). First professional year grade point average was higher for students who passed all stations on first attempt (mean difference 0.4 on a 4-point scale, 95% CI 0.1-0.7). When evaluated in a multiple logistic regression, no differences were statistically significant between groups. Most kappa values were above 0.4 (range 0.404-0.708), suggesting moderate to substantial reliability. CONCLUSION: Though predictors of poor performance were not identified when accounting for covariates, the OSCE was found to have good validity and reliability.

The Report of the 2021-2022 AACP Research and Graduate Affairs Committee.

EXECUTIVE SUMMARY. The work of the 2021-2022 AACP Research and Graduate Affairs Committee (RGAC) focused on barriers to graduate education and research-related careers in pharmacy education. AACP President Stuart Haines charged the RGAC with identifying the critical barriers that hinder current PharmD students/recent graduates as well as under-represented groups (e.g., Black and Latino) from pursuing advanced degrees and research-related career paths in the pharmaceutical, social & behavioral, and clinical sciences and recommending changes that might address these barriers - this may include recommendations to change the fundamental structure of graduate education.The committee began its work with a literature review to survey current perspectives on these barriers and assess the supporting evidence for effective solutions and programs, including their relevance to pharmacy education. Based on the review, the committee was able to identify numerous obstacles to entry into and progression through research training, for both underrepresented learners and student pharmacists. Obstacles are individual, e.g., lack of exposure to and self-efficacy in research, financial constraints, structural, e.g., lengthy training time, programmatic rigidity, and institutional, e.g., implicit and explicit bias. The committee found evidence of effective approaches and programs to address these barriers that could be applied in pharmacy schools. These approaches include improvements to existing practices in recruitment, admissions and hiring practices as well as creation of new programs and structural changes to existing programs to increase accessibility to learners. The committee also recognized a need for more research and development of additional approaches to address these barriers.The committee makes a series of recommendations that AACP develop resource guides and programs to address key issues in the recruitment and retention of underrepresented students and student pharmacists into graduate education and research careers, including as faculty. The committee also proposes new AACP policies to support innovative graduate programs and early, longitudinal engagement of learners from elementary school onward to increase access to graduate education and to support environments and cultures of commitment to accessibility, diversity, equity, inclusiveness, antiracism in pharmacy education.

A descriptive analysis of concomitant opioid and benzodiazepine medication use and associated adverse drug events in United States adults between 2009 and 2018.

Background: In 2016, the Centers for Disease Control and Prevention (CDC) published guidelines for prescribing opioids for chronic pain in response to the opioid epidemic and recommended avoiding concomitant use of opioid and benzodiazepine medications whenever possible. However, based on a recent report, 16% of overdose deaths involving opioids also involved benzodiazepines. Objective: The objectives of this study were to examine 1) trends in concomitant opioid and benzodiazepine usage and factors associated with utilization 2) and related adverse event reporting before and after the publication of CDC chronic pain prescribing guidelines. Methods: This study employed a retrospective data analysis of the National Health and Nutrition Examination Survey (NHANES) and FDA Adverse Event Reporting System (FAERS) databases between 2009 and 2018. Descriptive statistics and logistic regression were used to examine characteristics and temporal trends in people taking or reporting adverse events with opioid, benzodiazepine, and both medications. Results: Among those taking an opioid medication, 19.7% were also taking a benzodiazepine within the same 30 days. Characteristics for those who reported taking both medications together include being female, non-Hispanic White, being middle aged, and having a lower household income. Concomitant medication use rose between 2009 and 2016 and declined in 2017-2018. Among FAERS reports examined with an opioid suspect medication, 17.9% also included a benzodiazepine suspect medication. Over time, there was an increase in identified FAERS reports involving concomitant opioid and benzodiazepine medications. Conclusions: Concomitant opioid and benzodiazepine use was detected in a small but notable proportion of NHANES survey participants and FAERS reports between 2009 and 2018. Further research examining causal associations between opioids, benzodiazepines, and identified social risk factors are needed to inform prescribing and to best tailor public health interventions to address physical and mental illness safely and effectively across the population.

The pharmacist's active role in combating COVID-19 medication misinformation.

Pharmacists listen to and dispel medication misinformation daily. Because of their accessibility, pharmacists have the opportunity during pharmacist-patient interactions to begin a dialogue with their patients and provide critical education to improve patient safety and public health. Current examples of pharmacists intervening with medication misinformation include addressing the antivaccination community, educating on the safety of generic drugs, and using evidence-based medicine for antimicrobial stewardship. However, combating medication misinformation in pharmacy practice with patients takes on many forms and can pose a number of challenges. Most recently during the coronavirus disease 2019 (COVID-19) pandemic, a concurrent infodemic has led to claims of pharmacotherapeutic superiority and efficacy unsubstantiated by scientific evidence. Misinformation and partisan politics have also created a distrust in COVID-19 vaccine development. In addition, rogue Internet pharmacies and companies have marketed new and unverified COVID-19 treatments and tests. Pharmacists must actively combat these instances of medication misinformation and educate their patients on how not to fall victim to convincing marketing and misinformation schemes. Pharmacists can help patients recognize misinformation by vetting sources of information and communicating how negative emotional information circulates. In addition, pharmacists combat misinformation with patients by providing accurate alternative explanations in patient-friendly language. Although it is easier to stay silent and let misinformation circulate, pharmacists must work with their health care team members to actively reject misinformation pertaining to medications, COVID-19 pharmacotherapy and vaccinations, and in any future public health crisis.

Investigating multiple sources of data for smart infusion pump and electronic health record interoperability.

PURPOSE: Infusion pump data, which describe compliance to dose-error reduction software among other metrics, are retrievable from infusion pump vendor software, electronic health record (EHR) systems, and regional and national data repositories such as the Regenstrief National Center for Medical Device Informatics (REMEDI). Smart infusion pump and EHR interoperability has added to the granularity and complexity of data collected, and clinicians are challenged with efficiently comprehending and interpreting the data and reports available. SUMMARY: Collaborative partnerships between the Indianapolis Coalition for Patient Safety and the Regenstrief Center for Healthcare Engineering allowed for clinicians, informaticists, researchers, and engineers to compare the information gained and strengths of using smart infusion pumps, EHR, and REMEDI to assess hospital medication safety in a setting of interoperability. Seven reporting capabilities were used to compare available reports, and 2 hypothetical scenarios were developed to highlight these processes. Infusion pump vendor-provided software and reports were found to provide the most usable information for detailed infusion reporting, while the EHR was strongly usable for interoperability compliance and REMEDI excelled in benchmarking capabilities. CONCLUSION: While infusion analytics needs may differ across health systems, a better understanding of the strengths of infusion pump data and EHR data may help provide structure and direction in the infusion analytics process. Infusion data repositories such as REMEDI are useful tools to obtain information in a way not delivered by smart pump data.

An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System.

INTRODUCTION: Adverse reactions with an outcome of death are inherently important for pharmacovigilance organizations to evaluate. Prior efforts to systematically evaluate individual case safety reports (ICSRs) with an outcome of death have been limited to high-level summaries. OBJECTIVE: The aim of this study was to characterize ICSRs with an outcome of death contained in the US FDA Adverse Event Reporting System (FAERS) database. METHODS: All ICSRs received through 31 December 2017 reporting an outcome of death were characterized by patient demographics, suspect product(s), adverse events, and reporter type. Using the ICSR's narrative and reporter information, we classified ICSRs by source to include those from industry-sponsored programs, poison control centers, specialty pharmacies, and litigation. Additionally, a random sample of ICSRs was evaluated for completeness of structured data fields and manually reviewed for the availability of key information in the narrative (i.e. cause of death, medical history, and causality assessment). RESULTS: Overall, 1,053,716 ICSRs with a death outcome were received in the study period. Ten medications treating conditions for malignancies, pain, and kidney disease accounted for nearly 20% of all fatal ICSRs. ICSRs originating from industry-sponsored programs, poison control centers, litigation, and specialty pharmacies accounted for 14%, 6.5%, 5.0%, and 3.3% of all fatal ICSRs, respectively. ICSRs in which the only adverse event coded was 'death' were more likely to be missing structured data and less likely to include key information in the narrative. CONCLUSION: Understanding the origins and characteristics of ICSRs with an outcome of death supports meaningful evaluations and interpretations of FAERS data. A wide variability in ICSR quality exists, even in those reports with the most serious outcome.

High-alert medication administration and intravenous smart pumps: A descriptive analysis of clinical practice.

BACKGROUND: The Institute for Safe Medication Practices (ISMP) describes high alert medications (HAM) as medications that represent a heightened risk of patient harm when used in error. IV smart pumps with dose error reduction systems (DERS) were created to help address medication administration errors. Compliance with DERS provides a measure of how accurately a hospital uses smart pump technology to reduce IV medication error. OBJECTIVE: The primary purpose of this research was to use the REMEDI dataset, an aggregate, multi-hospital database inclusive of smart pump analytics, to improve the current understanding of clinical practices for IV HAM administration. METHODS: Descriptive analyses and analysis of variance (ANOVA) were used to test for differences in the mean DERS alert override rate, and mean DERS alert override to reprogram ratio between non-HAM and HAM overall, by hospital system, and by pump type. RESULTS: High mean override rates for non-HAM (73.8%) and HAM (75.8%) and high override to reprogram ratios for both non-HAM (7.30) and HAM (9.92) were seen. No significant differences were found in override rates (p = 0.23) and override to reprogram ratios (p = 0.06) between non-HAM and HAM. By hospital system, significant variability in override rates and override to reprogram ratios were seen. By pump type, there were no significant differences in the mean override rates (Baxter: p = 0.09; BD p = 0.34; ICU Medical p = 0.18) and the mean override to reprogram ratios (Baxter p = 0.84; BD p = 0.03; ICU Medical p = 0.63) between non-HAM and HAM. CONCLUSIONS: These findings indicate that the majority of alerts generated are bypassed by clinicians at the point of care, a symptom of alert fatigue. Given the potential for significant patient harm with HAM and the high DERS alert override rates that routinely occur during IV medication administration, this study provides further support for clinician-driven IV smart pump innovation to improve alert fatigue.

One Chance for Your Best First Impression: Tips for New Pharmacists.

Background: New practitioner pharmacists enter the workplace with an array of knowledge and skills ready to engage in patient care. However, obtaining a first postgraduate position or earning a desired promotion poses a challenge when the candidate pool is filled with many similarly skilled professionals. Objective: Educate new practitioner pharmacists on ways to pitch their new skills and make a memorable first impression among their competition. Methods: This article aims to (1) enhance their career prospects by practicing their soft skills, (2) develop strategies to build credibility and creating a personal brand and (3) describe efforts to showcase their professional identity. Conclusions: Preceptors and mentors can help by providing effective feedback to new pharmacists in efforts to improve performance and enhance soft skills.