scholarly journals Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association

2018 ◽  
Vol 14 (3) ◽  
pp. e130-e136 ◽  
Author(s):  
Rebecca Fahrenbruch ◽  
Polly Kintzel ◽  
Anne Marie Bott ◽  
Steven Gilmore ◽  
Ryan Markham

Purpose: To present a position statement from the Hematology/Oncology Pharmacy Association (HOPA) that pertains to dose rounding of biologic and cytotoxic anticancer agents. Methods: The HOPA Standards Committee organized a work group of oncology pharmacist specialists to examine the safety and value of dose rounding of biologic and cytotoxic anticancer agents. Primary literature that describes methods for dose rounding, with clinical or economic data, were analyzed. Relevant pharmacokinetic characteristics and aspects of product formulation were considered. Issues for institutional application were addressed. Results: Rounding of biologic and cytotoxic agents within 10% of the ordered dose is designated as acceptable for routine clinical care. Dose changes ≤ 10% are not expected to reduce the safety or effectiveness of therapy. The rounding amount—10%—is rational in the context of standard dose adjustments for patient tolerance and tumor response (≥ 20%), clinical trial deficiency criteria (> 10%), and the influence of interpatient pharmacokinetic variability. HOPA supports the use of the same threshold for dose rounding of anticancer drugs as that used for palliative and curative therapy. Potential exceptions to dose rounding are discussed. Conclusion: Dose rounding reduces waste and health care costs. HOPA recommends that each institution develop its own dose-rounding policy that addresses biologic and cytotoxic agents. Institutional guidelines for dose rounding of anticancer agents, including criteria for automatic dose rounding, the allowable percentage, and institutional processes for operationalizing and documenting dose rounding, should be determined by collaborative stakeholder consensus. Exceptions to dose rounding should be determined a priori. Additional studies that evaluate the impact of dose rounding on patient outcome are warranted.

2012 ◽  
Vol 8 (2) ◽  
pp. 70-70
Author(s):  
Mithi Govil ◽  
Carla Wood ◽  
Thomas R. Barr

Purpose: The Centers for Medicare and Medicaid Services (CMS), through the Electronic Health Record (EHR) Incentive Program, are providing incentive payments to eligible professionals as they demonstrate meaningful use of certified EHR technology. Eligible professionals can receive up to $44,000 over a 5-year period for Medicare participation if they successfully demonstrate the ability to automatically generate, transmit, and meet thresholds for specific reporting elements from the EHR. Meeting the meaningful use requirement involves a reorganization of workflow within the clinical setting so that the data elements necessary to produce the relevant measurements are documented in the electronic medical record (EMR) as they are delivered. A by-product of this is operational efficiency improvement in three areas: coordination of data input throughout the care team to reduce or remove bottlenecks, assignment of responsibility for specific activity, and real-time objective monitoring of the work process. Methods: Using the reporting system functionality of a certified EMR deployed in a two-physician medical oncology practice at the New London Cancer Center, the objective measurement of the ability of each of the eligible providers in the clinic to improve their individual MU scores was tracked. Analysis of the progress of each provider revealed gaps. Process issues were identified by work group: secretaries, laboratory preparation and phlebotomy staff, nurses, and clinicians. The designated physician leader met with each group to discuss the sections relevant to that particular group. Results: By discovering and addressing work processes that were not utilizing the ability of the EHR to capture and document (ie, meaningful use of the EHR), rapid progress that affected all of the eligible providers and all patients cared for was made. Changes resulted in increased clarity of clinical and administrative responsibilities during patient processing and clinical care provision. Meaningful use attestation was completed in 14 weeks. Conclusion: Completion of the documentation necessary to meet the requirements of the EHR Incentive Program led to the discovery of systemic inefficiencies in administrative and clinical workflows. Addressing these bottlenecks, along with using the reporting capability of the EHR to measure the impact of workflow changes, enabled the administrative and care teams to make changes quickly and effectively. The certified EHR provided guidance and status-reporting capabilities that allowed the practice to achieve the meaningful use requirement.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14614-e14614
Author(s):  
Goro Nakayama ◽  
Naomi Hayashi ◽  
Chie Tanaka ◽  
Tsutomu Fujii ◽  
Yuichi Ando ◽  
...  

e14614 Background: We reported that relative dose intensity (RDI) of key cytotoxic agents, irinotecan (IRI) and oxaliplatin (OX), is a significant predictor of disease control in patients with metastatic colorectal cancer (mCRC). However, in concomitant therapy with bevacizumab (BEV), the influence of adding BEV on the relation between RDI of cytotoxic agents and outcomes are unclear. In this study, we evaluate the impact of BEV on RDI of IRI and OX-based chemotherapy on the outcome of mCRC. Methods: A retrospective analysis of mCRC patients entered into three prospective clinical trials, testing FOLFIRI (CCOG-0502), mFOLFOX6 (CCOG-0704), FOLFIRI plus BEV and mFOLFOX6 plus BEV (CCOG-0801), was performed. RDI was calculated as the delivered dose intensity divided by standard dose intensity calculated for each regimen and compared to response rate (RR), disease control rate (DCR) and progression-free survival (PFS). Results: In FOLFIRI therapy, higher RDI (IRI, >median: 80%) group achieved significant better RR, DCR and PFS than lower RDI (<median) group (RR: 65 vs. 6% [p=0.001], DCR: 100 vs. 41% [p=0.003] and PFS: 9.9 vs. 5.6 months [p=0.002]). The other hand, in FOLFIRI plus BEV therapy, there were no difference between higher and lower RDI (IRI, median: 76%) group in ORR, DCR and PFS (RR: 31 vs. 27% [p=0.779], DCR: 75 vs. 53% [p=0.208] and PFS: 6.2 vs. 7.3 months [p=0.903]). In mFOLFOX6 therapy, higher RDI (OX, >median: 79%) group achieved better disease control than lower RDI group (RR: 47 vs. 33% [p=0.456], DCR: 100 vs. 73% [p=0.032] and PFS: 8.5 vs. 6.2 months [p=0.064]). In addition of BEV, there were no difference between higher and lower RDI (OX, median: 76%) group in any outcomes (RR: 54 vs. 74% [p=0.159], DCR: 88 vs. 91% [p=0.672] and PFS: 11.6 vs. 11.7 months [p=0.797]). Conclusions: RDI of key cytotoxic agents is a significant predictor of disease control, especially in IRI-based regimen. Nevertheless, in concomitant therapy with BEV, there were no relations between RDI of cytotoxic agents and outcomes. These results suggest that BEV could have ‘covering effect’ to reduce the influence of dose modification of cytotoxic agents in mCRC patients.


GIS Business ◽  
2019 ◽  
Vol 14 (4) ◽  
pp. 85-98
Author(s):  
Idoko Peter

This research the impact of competitive quasi market on service delivery in Benue State University, Makurdi Nigeria. Both primary and secondary source of data and information were used for the study and questionnaire was used to extract information from the purposively selected respondents. The population for this study is one hundred and seventy three (173) administrative staff of Benue State University selected at random. The statistical tools employed was the classical ordinary least square (OLS) and the probability value of the estimates was used to tests hypotheses of the study. The result of the study indicates that a positive relationship exist between Competitive quasi marketing in Benue State University, Makurdi Nigeria (CQM) and Transparency in the service delivery (TRSP) and the relationship is statistically significant (p<0.05). Competitive quasi marketing (CQM) has a negative effect on Observe Competence in Benue State University, Makurdi Nigeria (OBCP) and the relationship is not statistically significant (p>0.05). Competitive quasi marketing (CQM) has a positive effect on Innovation in Benue State University, Makurdi Nigeria (INVO) and the relationship is statistically significant (p<0.05) and in line with a priori expectation. This means that a unit increases in Competitive quasi marketing (CQM) will result to a corresponding increase in innovation in Benue State University, Makurdi Nigeria (INVO) by a margin of 22.5%. It was concluded that government monopoly in the provision of certain types of services has greatly affected the quality of service experience in the institution. It was recommended among others that the stakeholders in the market has to be transparent so that the system will be productive to serve the society effectively


2019 ◽  
Vol 19 (10) ◽  
pp. 1285-1292 ◽  
Author(s):  
Kuldip D. Upadhyay ◽  
Anamik K. Shah

Background: Quinoline analogues exhibited diversified biological activities depending on the structure type. A number of natural products with pyrano[3,2-c]quinolone structural motifs and patented chromenes were reported as promising cytotoxic agents. Objective: The present study is aimed to evaluate a new series of pyrano[3,2-c]quinoline scaffolds derived from the fusion of bioactive quinolone pharmacophore with structurally diverse aryl substituted chromene for its cytotoxicity. Methods: A library of pyrano[3,2-c]quinoline analogues was prepared from one-pot multi component synthesis using various aromatic aldehydes, malononitrile and 2,4-dihydroxy-1-methylquinoline. The new synthetics were primarily screened for its cytotoxicity (IC50) against different human cancer cell lines in vitro. The promising synthetics were further evaluated in vitro for their potency against different kinase activity. The promising compounds were finally tested for their in vivo efficacy in SCID type mice HCT-116 tumor model. Results: The screening results revealed that compounds 4c, 4f, 4i and 4j showed promising activity in in vitro study. However, compound 4c was found to be the most potent candidate with 23% tumor growth inhibition in HCT-116 tumor mice model. Conclusion: The structure activity relationship suggested that 3-substitution on the aryl ring at C4 position of the pyrano[3,2 c]quinolone moiety seems to have an important position for cytotoxicity activity. However, 3- chloro substitution at C4 aryl ring showed a significant alteration of the bioactive conformer of the parent scaffold and outcome with compound 4c as the most potent candidate of the series.


2020 ◽  
pp. flgastro-2020-101563
Author(s):  
Stephanie Shields ◽  
Allan Dunlop ◽  
John Paul Seenan ◽  
Jonathan Macdonald

COVID-19 has dominated life in 2020 with, at the time of writing, over 4.9M global cases and >320 000 deaths. The impact has been most intensely felt in acute and critical care environments. However, with most UK elective work postponed, laboratory testing of faecal calprotectin halted due to potential risk of viral transmission and non-emergency endoscopies and surgeries cancelled, the secondary impact on chronic illnesses such as inflammatory bowel disease (IBD) is becoming apparent. Data from the Scottish Biologic Therapeutic Drug Monitoring (TDM) service shows a dramatic drop in TDM testing since the pandemic onset. April 2020 saw a 75.6% reduction in adalimumab testing and a 36.2% reduction in infliximab testing when compared with February 2020 data, a reduction coinciding with the widespread cancellation of outpatient and elective activity. It is feared that disruption to normal patterns of care and disease monitoring of biologic patients could increase the risk of disease flare and adverse clinical outcomes. Urgent changes in clinical practice have been instigated to mitigate the effects of the pandemic on routine clinical care. Further transformations are needed to maintain safe, effective, patient-centred IBD care in the future.


2003 ◽  
Vol 27 (08) ◽  
pp. 301-304
Author(s):  
Gavin Reid ◽  
Mark Hughson

Aims and Method We conducted a postal questionnaire survey of the practice of rapid tranquillisation among 215 consultant psychiatrists in the West of Scotland, before and after the withdrawal of droperidol by the manufacturer. Results One hundred and eighty questionnaires (84% of those sent) were returned. Droperidol had been used extensively, often combined with lorazepam, for rapid tranquillisation. The main replacement suggested for droperidol was haloperidol. About half of the respondents to our survey chose to comment on the withdrawal of droperidol. More than half of the comments were unfavourable, including lack of an adequate replacement and lack of consultation with the psychiatric profession. Clinical Implications The abrupt withdrawal of droperidol, partly for commercial reasons, was regrettable. There was no time for an adequate evaluation of possible replacement medications and a lack of consultation with the profession regarding the impact on clinical care.


2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S439-S439
Author(s):  
Eric Ellorin ◽  
Jill Blumenthal ◽  
Sonia Jain ◽  
Xiaoying Sun ◽  
Katya Corado ◽  
...  

Abstract Background “PrEP whore” has been used both as a pejorative by PrEP opponents in the gay community and, reactively, by PrEP advocates as a method to reclaim the label from stigmatization and “slut-shaming.” The actual prevalence and impact of such PrEP-directed stigma on adherence have been insufficiently studied. Methods CCTG 595 was a randomized controlled PrEP demonstration project in 398 HIV-uninfected MSM and transwomen. Intracellular tenofovir-diphosphate (TFV-DP) levels at weeks 12 and 48 were used as a continuous measure of adherence. At study visits, participants were asked to describe how they perceived others’ reactions to them being on PrEP. These perceptions were categorized a priori as either “positively framed,” “negatively framed,” or both. We used Wilcoxon rank-sum to determine the association between positive and negative framing and TFV-DP levels at weeks 12 and 48. Results By week 4, 29% of participants reported perceiving positive reactions from members of their social groups, 5% negative, and 6% both. Reporting decreased over 48 weeks, but positive reactions were consistently reported more than negative. At week 12, no differences in mean TFV-DP levels were observed in participants with positively-framed reactions compared with those reporting no outcome or only negatively-framed (1338 [IQR, 1036-1609] vs. 1281 [946-1489] fmol/punch, P = 0.17). Additionally, no differences were observed in those with negative reactions vs. those without (1209 [977–1427] vs. 1303 [964–1545], P = 0.58). At week 48, mean TFV-DP levels trended toward being higher among those that report any reaction, regardless if positive (1335 [909–1665] vs. 1179 [841–1455], P = 0.09) or negative (1377 [1054–1603] vs. 1192 [838–1486], P = 0.10) than those reporting no reaction. At week 48, 46% of participants reported experiencing some form of PrEP-directed judgment, 23% reported being called “PrEP whore,” and 21% avoiding disclosing PrEP use. Conclusion Over 48 weeks, nearly half of participants reported some form of judgment or stigmatization as a consequence of PrEP use. However, individuals more frequently perceived positively framed reactions to being on PrEP than negative. Importantly, long-term PrEP adherence does not appear to suffer as a result of negative PrEP framing. Disclosures All authors: No reported disclosures.


Biology ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 463
Author(s):  
Narjiss Sallahi ◽  
Heesoo Park ◽  
Fedwa El Mellouhi ◽  
Mustapha Rachdi ◽  
Idir Ouassou ◽  
...  

Epidemiological Modeling supports the evaluation of various disease management activities. The value of epidemiological models lies in their ability to study various scenarios and to provide governments with a priori knowledge of the consequence of disease incursions and the impact of preventive strategies. A prevalent method of modeling the spread of pandemics is to categorize individuals in the population as belonging to one of several distinct compartments, which represents their health status with regard to the pandemic. In this work, a modified SIR epidemic model is proposed and analyzed with respect to the identification of its parameters and initial values based on stated or recorded case data from public health sources to estimate the unreported cases and the effectiveness of public health policies such as social distancing in slowing the spread of the epidemic. The analysis aims to highlight the importance of unreported cases for correcting the underestimated basic reproduction number. In many epidemic outbreaks, the number of reported infections is likely much lower than the actual number of infections which can be calculated from the model’s parameters derived from reported case data. The analysis is applied to the COVID-19 pandemic for several countries in the Gulf region and Europe.


Author(s):  
Fatma Boukid ◽  
Elena Curti ◽  
Agoura Diantom ◽  
Eleonora Carini ◽  
Elena Vittadini

AbstractIndustrial processing of tomato includes its cutting and mincing, thermal treatments, and the addition of ingredients, which might induce changes in physicochemical properties of the final products. In this frame, the impact of texturing/thickening [xanthan gum (X) or potato fiber (F)] on the macroscopic, mesoscopic and molecular properties of tomato double concentrate (TDC) was investigated to determine if F can efficiently substitute X, in association with small solutes (sugar and salt) and thermal treatment (cold and hot). At a macroscopic level, multivariate statistics (MANOVA) underlined that color change (ΔE) was increased by X and F addition contrary to heating and the addition of salt and sugar. MANOVA revealed that texture was greatly enhanced through the use of F over X. 1H NMR molecular mobility changes were more controlled by texturing agents (F and X) than thermal treatment and small solutes. Particularly F increased the more rigid population indicating stronger interaction with water molecules resulting in shear-thinning flow. However, adding X contributed into the increase of the dynamic and mobile populations. Therefore, F can be a valid “clean label” substitute of X in modulating tomato products properties.


2021 ◽  
pp. 1-10
Author(s):  
Lindsay E. Wyatt ◽  
Anne Sophie Champod ◽  
Gabrielle M. Haidar ◽  
Gail A. Eskes

BACKGROUND: While prism adaptation (PA) has been recognized as a promising tool for treating spatial neglect, implementation as a standard treatment in clinical care has been lagging. Limited evidence for the generalization of after-effects to everyday activities has been a barrier towards implementation. OBJECTIVES: This study examined whether a home-friendly standardized PA protocol (Peg-the-Mole, PTM) induces after-effects that can transfer to wheelchair maneuvering. We also examined the impact of using constant (1 starting hand position) or variable (3 starting hand positions) training conditions on the transfer of after-effects to wheelchair maneuvering. METHODS: Sixty participants were randomly assigned to one of four PTM conditions: 1) prisms/constant training; 2) prisms/variable training; 3) sham goggles/constant training; 4) sham goggles/variable training. RESULTS: The use of PTM with rightward shifting prisms induced after-effects on proprioceptive and visual pointing outcome tasks. Groups using PTM with prism goggles showed a leftward shift in their position within a wheelchair course and a reduction in the number of right-sided collisions. The training condition did not have an impact on the transfer of after-effects to wheelchair driving. CONCLUSION: PTM is a clinically appealing PA protocol that induces after-effects that can transfer to an everyday activity relevant to patients with neglect.


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