Resilience and ongoing quality care for cancer clinical trials during COVID-19: Experience from a tertiary hospital in Australia.

BACKGROUND: The COVID-19 pandemic has forced rapid system-wide changes to be implemented within cancer care at an alarming pace. Clinical trials are a key element of comprehensive cancer care. Ensuring the continuing safe conduct of cancer clinical trials in the context of a pandemic is challenging. METHODS: We aimed to describe the COVID-19 pandemic response of a Cancer Care Clinical Research Unit (CRU) of a tertiary hospital in Queensland, Australia. We used a mixed methods approach for this case study. Emailed directives from CRU managers to all CRU staff sharing were qualitatively analysed and mapped against our unit activities over longitudinal time points. Data from patient recruitment and protocol deviations were analysed using descriptive statistics. RESULTS: Mapping activity from 11 March to 30 September 2020 revealed rapid change during the first 2 weeks. Four key strategies to accommodate change were identified: supporting patients and families, introduction of telehealth, accessing investigational product, and social distancing. Early in the pandemic we recognised that our core key stakeholders were integral to our response. When compared to the previous 12 months, our recruitment numbers dropped markedly in early phases of the response but recovered over time, as we accommodated internal and external impacts. CONCLUSION: Our experience of agility as a necessity, adapting to support patients, and managing both clinical research activity and sponsors during the height of the pandemic response is presented here in order to inform future disaster response planning by clinical trial organisations.

Comparative incidence of acute kidney injury in patients on vancomycin therapy in combination with cefepime, piperacillin-tazobactam or meropenem.

Recent studies have shown that the incidence of nephrotoxicity increases when vancomycin is combined with a beta-lactam antibiotic. The objective of this study was to compare the incidence of acute kidney injury (AKI) in adult patients who received vancomycin with either piperacillin-tazobactam (VPT), cefepime (VC), or meropenem (VM). This was a single center retrospective chart review. Patients were included if they were 18 years or older, received 48 hours of combination therapy and antibiotics were started within 24 hours of each other. Exclusion criteria were receiving more than one combination of antibiotics, serum creatinine > 1.2 mg/dL, AKI at the time of inclusion, or any form of renal replacement therapy. Two hundred patients met inclusion criteria. A total of 27 (13%) patients experienced AKI. The incidence of AKI was 21.6%, 9%, and 7.4% in the VPT, VC and VM groups, respectively. A patient who received VPT was 5 times more likely to develop AKI when compared to a patient who received VC (adjusted OR 5.09 95% CI (1.51-17.08), p = 0.008) and 7 times more likely to develop AKI when compared to VM (adjusted OR 7.03 95% CI (1.97-28.08), p = 0.002). This study found a statistically significant difference in the incidence of AKI in patient receiving VPT when compared to VC or VM. This finding supports the need for careful monitoring of renal function in patients receiving VPT therapy and routine evaluation for de-escalation of antimicrobial therapy.

The risks and benefits of early venous thromboembolism prophylaxis after elective spinal surgery: A single-centre experience.

BACKGROUND: There is a wide ranging incidence of venous thromboembolism after surgery and it continues to be a major cause of morbidity after spinal procedures.This study's aim was to investigate the relationship between timing and administration of venous thromboembolism (VTE) pharmacologic chemoprophylaxis after spinal surgery and the resulting VTE and bleeding complications by reviewing current practices and outcomes at a high-volume single institution to better define opportunities for perioperative intervention to prevent VTE without increasing bleeding complications. METHODS: All patients who underwent elective one or two-stage lumbar spinal fusion procedures were identified. A logistic regression was used to evaluate (1) risk of symptomatic VTE within 30 days of surgery and (2) bleeding-related complications. The odds of developing a VTE as well as bleeding-related complications were compared among the three treatment groups: no chemoprophylaxis, chemoprophylaxis < 24h of surgery and chemoprophylaxis given > 24h post-surgery. RESULTS: When adjusted for doses administered, the odds of developing a postoperative VTE within 30 days were 0.189 (95% confidence interval (0.044, 0.808)) in patients who received anticoagulation < 24h postoperatively, compared to those who received no anticoagulation (p = 0.025). There was no difference in bleeding rates. CONCLUSION: Patients undergoing elective spinal surgery who received anticoagulation within 24h of the conclusion of their procedure had an 81% reduction in the odds of developing a deep vein thrombosis within 30 days with no significant difference in bleeding complications.

Changes to summative skills-based assessments within the Big Ten Academic Alliance Performance-Based Assessment Collaborative (BTAA-PBAC) due to COVID-19.

Background: In Spring 2020 many academic institutions transitioned to remote learning in response to the developing COVID-19 pandemic. These changes affected skills-based training, as schools of pharmacy were forced to transition traditionally in-person assessments to a remote setting. The purpose of this article is to describe the experience of pharmacy skills lab coordinators when transitioning summative skills-based assessments (SSBA). Methods: A web-based survey instrument administered through QualtricsXM was sent to all institutions in the Big Ten Academic Alliance-Performance Based Assessment Collaborative. Only one member from each institution completed the survey on behalf of the institution. The survey consisted of four sections: changes made to skills evaluated; changes made to the delivery of those evaluations; challenges to and strategies used by the skills lab program when switching to remote learning; and recommendations for incorporating remote learning within future SSBAs. Survey respondents were invited to participate in an optional unstructured interview regarding survey answers. Results: Nine of ten invited institutions responded to the survey. Of the nine respondents, three participated in the post-survey interview. Overall, 79.5% (93/117) of skills planned to be assessed were assessed with or without modification, with 8.5% (10/117) of skills canceled and 10.3% (12/117) of skills assessments postponed. The most common challenges mentioned were the lack of preparation time, inability to assess certain skills virtually, and student barriers. The most common recommendations made were to prioritize lab components and incorporate flexibility in planning and scheduling. Discussion: The results indicate that most skills were still assessed during the Spring 2020 semester. Though the transition to remote learning was challenging and unique for each institution, common strategies and recommendations identified here provide opportunities for academics to analyze and prioritize learning objectives and to rethink how to develop and deliver SSBAs as remote assessments.

Using Electronic Health Record Technology to Teach Inpatient Medication Order Verification to Pharmacy Students.

Objective. To measure Doctor of Pharmacy (PharmD) students' confidence and assess their performance when processing inpatient medication orders, and to determine students' opinions regarding electronic health record (EHR) technology. Methods. Using an EHR platform, students processed inpatient medication orders during two laboratory sessions and one assessment. Each student was assigned one unique patient per session and was given three inpatient orders to process. Medication errors were randomly imbedded in the medication orders. Students needed to determine if the order was acceptable or required flagging because of an identified error. Pre- and post-activity surveys were administered to assess students' level of confidence and perceptions regarding the simulated EHR activities. Aggregate performance scores were compared between a cohort of PharmD students that used an EHR for the activity versus those who completed the activity the previous year using a paper-based medication form. Results. One hundred eight of 158 students (68%) in the course had pre- and post-activity survey data that could be paired. Less than one quarter (24%) of students had prior work experience in a hospital setting. For the medication verification questions, the confidence levels of students who used the EHR doubled and in some cases tripled pre- and post-EHR implementation. In each of the areas surveyed, results for all medication order processing statements were significant. Student performance improved significantly compared with that of those who completed the activity the previous year using a paper-based medication form. Post-EHR implementation, a significantly lower number of students felt that learning to use EHR technology would prepare them for advanced pharmacy practice experiences. Conclusion. Exposure to EHR technology improved PharmD students' confidence and performance scores related to processing inpatient medication orders. These findings support the continued use of an EHR platform in skills-based activities.

Implementation of systematic progression of community pharmacy-based prescription verification into the skills-based laboratory curriculum.

BACKGROUND AND PURPOSE: To describe the design, implementation, and evaluation of systematic progressive community pharmacy-based prescription verification activities across a skills-based laboratory course series. EDUCATIONAL ACTIVITY AND SETTING: Community pharmacy-based prescription verification activities were implemented into three laboratory courses, Abilities Lab (ABL) 1, 2, and 4. During each activity, students practiced prescription verification using a handout with two components. First, a checklist outlining an eight-step verification process serves as a student resource. In the second handout component, students are required to identify which step contains a prescription error(s), the appropriate pharmacist action, and the recommendation needed in order to correct the error(s). After verifying and completing the handout, the students participate in a facilitator-led discussion on the recommendations necessary to dispense the prescription. As students progressed through ABL 1, 2, and 4, both the error type and scope of the verification process expanded. Class verification exercises culminated in a final practical assessment at the end of each semester. FINDINGS: In ABL 1 students scored an average of 99.5% (n = 161, standard deviation (SD) = 1.92) on the final practical assessment. In ABL 2, students scored an average of 97.6% (n = 166, SD = 3.07). In ABL 4, students scored an average of 90.3% (n = 159, SD = 11.2). SUMMARY: This manuscript adds value to the current literature by describing the implementation of progressive community pharmacy-based prescription verification activities across a skills-based laboratory course series.

Perioperative Intravenous Lidocaine Infusion Adverse Reaction: A Case Report.

Intravenous lidocaine is increasingly being utilized as an opioid-sparing analgesic. A 55-year-old man with well-controlled human immunodeficiency virus on highly active antiretroviral therapy was prescribed a lidocaine infusion at 1 mg/kg/h for postoperative pain. On postoperative day 2, the patient experienced 4 unresponsive episodes with tachycardia, hypertension, and oxygen desaturation. Serum lidocaine level was available 2 days later (high 6.3 µg/mL, therapeutic range 2.5-3.5 µg/mL). There is significant pharmacokinetic interaction between lidocaine and this patient's human immunodeficiency virus medications. This case highlights the need for a readily accessible list of medications that caution against lidocaine. We propose in-house serum lidocaine levels to monitor patients at an increased risk for toxicity.

Engaging Postgraduate Year-2 Pharmacy Residents in Formal Co-evaluation of Platform Presentations at a Regional Residency Conference.

Objective. To implement and assess the perceived impact of a program designed to engage postgraduate year-2 (PGY2) pharmacy residents in formal co-evaluation of platform presentations at a regional residency conference. Design. A PGY2 formal co-evaluator program was designed and conducted over two years. Postgraduate year-2 residents were paired with a preceptor for modeling, coaching, and facilitating. To assess the perceived usefulness of this program, a 2-question presurvey and an 11-question postsurvey were distributed to participating residents. Assessment. Eighty-two residents completed the program and pre/postsurveys (response rate=94.3%). The percentage of residents who rated themselves as skilled in critically evaluating a platform presentation increased from 56.1% to 100%, while the percentage of residents who rated themselves as skilled in providing constructive feedback increased from 67.1% to 98.8%. Conclusion. This novel program, which was designed to engage PGY2 pharmacy residents in formal platform presentation co-evaluation, was well received and improved resident self-reported skills.