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Prolonged labor can lead to infection, fetal distress, asphyxia, and life-threatening harm to both the mother and the baby. Surfactant protein A (SP-A) was shown to contribute to the maintenance of pregnancy and timing of term labor. SP-A modulates the stoichiometric expression of the SP-R210L and SP-R210S isoforms of the SP-R210 receptor on alveolar macrophages (AMs). Lack of SP-R210L dysregulates macrophage inflammatory responses. We asked whether SP-A alters normal and inflammation-induced parturition through SP-R210 using SP-A- and SP-R210L-deficient mice. Labor and delivery of time-pregnant mice were monitored in real time using a time-lapse infrared camera. Intrauterine injection with either vehicle or Escherichia coli lipopolysaccharide (LPS) on embryonic (E) day 18.5 post coitus was used to assess the effect of gene disruption in chorioamnionitis-induced labor. We report that either lack of SP-A or disruption of SP-R210L delays parturition by 0.40 and 0.55 days compared with controls, respectively. LPS induced labor at 0.60, 1.01, 0.40, 1.00, and 1.31 days earlier than PBS controls in wild type (WT), SP-A-deficient, littermate controls, heterozygous, and homozygous SP-R210L-deficient mice, respectively. Lack of SP-A reduced litter size in PBS-treated mice, whereas the total number of pups delivered was similar in all LPS-treated mice. The number of live pups, however, was significantly reduced by 50%–70% in SP-A and SP-R210L-deficient mice compared with controls. Differences in gestational length were not associated with intrauterine growth restriction. The present findings support the novel concept that the SP-A/SP-R210 pathway modulates timely labor and delivery and supports fetal lung barrier integrity during fetal-to-neonatal transition in term pregnancy. NEW & NOTEWORTHY: To our knowledge, this study is the first to report that SP-A prevents delay of labor and inflammation-induced stillbirth through the receptor SP-R210L. [ABSTRACT FROM AUTHOR]

Purpose: To describe the development of a comprehensive framework of safeguarding strategies to address observed/anticipated errors with organizational high-alert medications. Methods: Observed/anticipated errors were identified for organizational high-alert medications and medication classes based on a review of external literature and alerts as well as internal voluntary error reporting. Anticipated or frequently reported errors were categorized into common cause error types. Error reduction strategies to address each common cause error were identified in collaboration with medication safety specialists and specialty practice pharmacists. Results: The review of externally and internally reported errors identified 101 observed/anticipated common cause errors across the 19 high-alert medication classes (median 5 error types per medication class, interquartile range 3-6). Safeguarding strategies specific to high-alert medications were identified in the following domains: separate or sequestered storage; restricted ordering; active alerts; dispensing in patient-specific dosing, unit of use, or unit-dose packaging; dispensing from pharmacy only; auxiliary labeling; level of care restriction; required monitoring; independent double checks; certification/privileging of staff; specific guidelines for use/monitoring; and other/miscellaneous. Identification of the observed/anticipated errors and the associated safeguarding strategies facilitated the development of a comprehensive tool and visual framework for addressing common cause errors associated with organizational high-alert medications. Conclusion: A comprehensive framework of safeguarding strategies to address anticipated errors with organizational high-alert medications is proposed. Although individual safeguards are institution-specific, the framework can be leveraged by all hospitals in order to take inventory of error-reduction strategies and prospectively identify gaps to address common cause errors. [ABSTRACT FROM AUTHOR]

Introduction: Prioritization and acuity tools have been leveraged to facilitate targeted and efficient clinical pharmacist interventions. However, there is a lack of established pharmacy-specific acuity factors in the ambulatory hematology/oncology setting. Therefore, National Comprehensive Cancer Network's Pharmacy Directors Forum conducted a survey to establish consensus on acuity factors associated with hematology/oncology patients that are high priority for ambulatory clinical pharmacist review. Methods: A three-round electronic Delphi survey was conducted. During the first round, respondents were asked an open-ended question to suggest acuity factors based on their expert opinion. Respondents were then asked in the second round to agree or disagree with the compiled acuity factors, in which those with ≥75% agreement were included in the third round. The final consensus was defined as a mean score ≥3.33 on a modified 4-point Likert scale (4 = strongly agree, 1 = strongly disagree) during the third round. Results: A total of 124 hematology/oncology clinical pharmacists completed the first round of the Delphi survey (invitation response rate, 36.7%), of which 103 completed the second round (response rate, 83.1%) and 84 the third round (response rate, 67.7%). A final consensus was achieved for 18 acuity factors. Acuity factors were identified in the following themes: antineoplastic regimen characteristics, drug interactions, organ dysfunction, pharmacogenomics, recent discharge, laboratory parameters, and treatment-related toxicities. Conclusions: This Delphi panel of 124 clinical pharmacists achieved consensus on 18 acuity factors that would identify a hematology/oncology patient as a high priority for ambulatory clinical pharmacist review. The research team envisions incorporating these acuity factors into a pharmacy-specific electronic scoring tool. [ABSTRACT FROM AUTHOR]

Introduction: Due to the abbreviated approval pathway and extrapolation to non-studied indications, an increased importance is placed on post-marketing surveillance of biosimilars to supplement existing evidence and enhance patient and provider confidence. Bevacizumab-awwb (ABP 215, Mvasi) was the first biosimilar approved to bevacizumab (Avastin), a recombinant humanized monoclonal IgG1 antibody that inhibits the vascular endothelial growth factor (VEGF). Purpose: To evaluate utilization, safety, and financial outcomes of bevacizumab-awwb compared to bevacizumab at a national cancer institute (NCI)-designated cancer center. Methods: A single center, retrospective, 1:1 indication-matched cohort study of adult patients who received bevacizumab or bevacizumab-awwb between October 1, 2019 and October 1, 2020 was performed. Thirty-four patients received bevacizumab-awwb during the study period and were matched by indication to 34 randomly selected patients who received bevacizumab. Indications for both groups included: colorectal cancer (n = 19), gynecologic cancer (n = 10), glioblastoma (n = 3), hepatocellular carcinoma (n = 1), and lung cancer (n = 1). Results: Baseline and medication utilization characteristics were similar for this indication-matched cohort of 68 patients receiving bevacizumab-awwb or bevacizumab. Patients in the bevacizumab group had a higher proportion of public payer coverage (64.7% vs 38.2%, P =.029). A higher proportion of patients in the bevacizumab-awwb group remained on active treatment at the end of the study period (52.9%) as compared to the bevacizumab group (35.3%); however, differences in final treatment status and reasons for discontinuation were not statistically significant (P =.218). Rates of worsened hypertension (44.1% vs 44.1%) and worsened proteinuria (38.2% vs 23.5%, P =.077) were common in both groups. Grade 3 adverse drug events in the bevacizumab group included: gastrointestinal perforation (n = 1), gastrointestinal bleed (n = 1), hypertension (n = 2), and venous thromboembolism (n = 2). Grade 3 adverse drug events in the bevacizumab-awwb group included: epistaxis (n = 1), gastrointestinal bleed (n = 1), hypertension (n = 1), intracerebral hemorrhage (n = 1), venous thromboembolism (n = 3), and arterial thromboembolism (n = 1). One patient in the bevacizumab-awwb group experienced grade 4 hypertension. Median drug cost per dose and per milligram for bevacizumab-awwb was less than bevacizumab, representing a 15.8% and 12.1% discount, respectively. Conclusion: Utilization and safety outcomes were similar for this indication-matched cohort of 68 patients receiving bevacizumab or bevacizumab-awwb across a wide range of disease states. [ABSTRACT FROM AUTHOR]

Introduction: To describe pharmacist interventions as a result of an independent double check during cognitive order verification of outpatient parenteral anti-cancer therapy. Methods: A single-center, retrospective analysis of all individual orders for outpatient, parenteral anti-cancer agents within a hematology/oncology infusion center during a 30 day period was conducted. The primary endpoint was error identification rates during first and second verification. Secondary endpoints included the type, frequency, and severity of errors identified during second verification using a modified National Coordinating Council for Medication Error Reporting and Prevention Index. Results: A total of 1970 anti-cancer parenteral orders were screened, from which 1645 received an independent double check and were included. The number of errors identified during first and second verification were 30 (1.8%) and 10 (0.6%) respectively; second verification resulted in a 33.3% increase in corrected errors. The 10 errors identified during second verification included: four rate transcriptions to optimize pump interoperability, three rate and/or volume modifications, two dosage adjustments, and one treatment deferral due to toxicity. The severity was classified as Category A for four (40%), Category C for three (30%), and Category D for three (30%) errors. This correlated to a low capacity for harm for seven (70%) and a serious capacity for three (30%) errors. Conclusions: Second verification of outpatient, parenteral anti-cancer medication orders resulted in a 33.3% increase in corrected errors. Three errors detected during second verification were determined to have a serious capacity for harm, supporting the value of independent double checks during pharmacist cognitive order verification. [ABSTRACT FROM AUTHOR]

Purpose: As costs continue to rise in oncology, a strategy that has been implemented to limit these costs is use of alternative sites of care. However, there are differences in regulatory standards between common sites of care such as freestanding infusion clinics and hospital outpatient departments. The costs associated with United States Pharmacopeia compliance were evaluated in order to better understand the cost of universally compliant hospital outpatient departments. Methods: Annual operational costs associated with United States Pharmacopeia compliance were estimated for a 30-chair infusion clinic with United States Pharmacopeia <797> and <800> pharmacy cleanrooms for non-hazardous and hazardous drugs, respectively. Annual United States Pharmacopeia compliance costs included: competency assessments, personal protective equipment, closed system transfer devices, labels, cleaning supplies, and environmental monitoring. One-time costs included initial cleanroom construction and renovations. Published information and benchmarks provided baseline assumptions for patient volume, staffing, and unit costs. If no published data was available, prices were estimated based on a similarly sized clinic. Results: Recurring annual costs for a 30-chair fully compliant infusion clinic were calculated to be $785,207. One-time costs associated with initial construction and renovations were estimated to be $1,365,207–$1,535,207 and $965,207–$1,005,207, respectively. Conclusions: Costs associated with increased operational oversight and regulatory standards are a major contributing factor to the facility fee of hospital outpatient departments. Ultimately, all sites of care share in the goal to provide optimal patient care while considering all aspects of patient care, including cost. Therefore, a move towards consistent regulatory standards across all settings would aid in preventing discrepancies in care. [ABSTRACT FROM AUTHOR]

This study investigated the association of nine biopsychosocial variables and athletic performance among 40 elite collegiate baseball players. High scores on confidence and perceived timess and low scores on repressive denial, strength of religious faith, and sensitivity to glare were reliably associated with ratings of superior athletic performance by four coaches. Preliminary results suggest that the biopsychosocial model may prove useful in predicting athletic performance.

The article presents author's views regarding his experiences as the archivist of the Cricket Society and talks about the Society Archive.

Purpose: A review of existing measurement instruments was conducted to examine their suitability to measure disability prevalence and assess quality of life, protection of disability rights and community participation by people with disabilities, specifically within the context of development programs in low and middle-income countries. Methods: From a search of PubMed and the grey literature, potentially relevant measurement instruments were identified and examined for their content and psychometric properties, where possible. Criteria for inclusion were: based on the WHO's International Classification of Functioning Disability and Health (ICF), used quantitative methods, suitable for population-based studies of disability inclusive development in English and published after 1990. Characteristics of existing instruments were analysed according to components of the ICF and quality of life domains. Results: Ten instruments were identified and reviewed according to the criteria listed above. Each version of instruments was analysed separately. Only three instruments included a component on quality of life. Domains from the ICF that were addressed by some but not all instruments included the environment, technology and communication. Conclusion: The measurement instruments reviewed covered the range of elements required to measure disability-inclusion within development contexts. However no single measurement instrument has the capacity to measure both disability prevalence and changes in quality of life according to contemporary disability paradigms. The review of measurement instruments supports the need for developing an instrument specifically intended to measure disability inclusive practice within development programs. [ABSTRACT FROM AUTHOR]