Delay In Administration Research Articles

Evaluation of modified fixed dose four-factor prothrombin complex concentrate for warfarin reversal.

Non-activated four-factor prothrombin complex concentrate (4F-PCC) has emerged as the preferred reversal strategy for patients on warfarin with life-threatening bleeding. Current dosing recommendations for 4F-PCC require pre-treatment international normalized ratio (INR) and bodyweight values, resulting in ordering and administration delays. Studies have shown that alternative dosing regimens are safe and efficacious. This retrospective, single-center, pre- and post-protocol analysis was conducted to assess the efficacy of a pharmacist driven modified fixed-dose 4F-PCC regimen versus package insert weight- and INR-based dosing regimen for warfarin reversal. The primary outcome was achievement of INR less than two. Secondary outcomes included dose and cost of 4F-PCC, a time analysis, incidence of concomitant vitamin K administration, and incidence of thrombosis within seven days of 4F-PCC. There were 195 patients included in the analysis, with 74 in the pre-cohort and 121 in the post-cohort. Baseline characteristics were similar between cohorts with the most common indication for warfarin use being atrial fibrillation (48.6% versus 47.1%) and reversal being intracerebral hemorrhage (68.9% versus 43.0%). Achievement of the primary endpoint occurred in 92% versus 95% (p = 0.097) of patients. A statistically significant difference was seen between cohorts regarding median dose and cost of 4F-PCC administered (p < 0.001). Eleven thromboembolic events occurred with three events in the pre-cohort and eight events in the post-cohort (p = 0.453). A fixed-dose of 1500IU of 4F-PCC was effective in reversing INR to less than two in most patients regardless of reversal indication with minimal thrombotic risks.

Ranson Criteria – Old is Gold in Evaluating Acute Pancreatitis?

Abstract Acute pancreatitis (AP) is a communal gastrointestinal condition that can vary in severity and morbidity. The “Ranson Score,” which was created in 1974, was the 1st scoring scheme to predict the cruelty of AP. While the “Ranson Score” has remained popular for decades, it is to have some flaws, such as limited predictive power. It has also been chastised for requiring 48 h to compute the concluding score, which has been found to cause administration delays. Using the electronic databases Medline, PubMed, Embase, and Google, a literature search in English was carried out. The exploration terms were Ranson Criteria OR “Ranson Score” OR AP OR Diagnostic Criteria. Researchers concluded that the “Ranson Score” is comparable to other recent counting systems for classifying AP severity and predicting death, making it a valuable tool for prognosticating AP in contemporary clinical practice. The studies also demonstrated that there is no one best grading system for predicting mortality and severity in AP patients. There are advantages and disadvantages to using each measure, and variations in research outcomes may be attributed to changes in people’s characteristics, AP etiology, and clinical care heterogeneity. The “Ranson Score,” despite being the ancient scoring system known, has preserved its clinical validity over time. These features, combined with its comparative easiness of use and applicability in reserve/constrained situations, make the “Ranson Score” an important and useful instrument in present clinical practice.

Prior Authorization Leads to Administrative Burden and Delays in Treatment in Primary Total Joint Arthroplasty Patients

BackgroundThe prior authorization (PA) process is often criticized by physicians due to increased administrative burden and unnecessary delays in treatment. The effects of PA policies on total hip arthroplasty (THA) and total knee arthroplasty (TKA) have not been well described. The purpose of this study was to analyze the use of PA in a high-volume orthopaedic practice across 4 states. MethodsWe prospectively collected data on 28,725 primary THAs and TKAs performed at our institution between 2020 and 2023. Data collected included patient demographics, payer approval or denial, time to approval or denial, the number of initial denials, the number of peer-to-peer (P2P) or addenda, and the reasons for denial. ResultsSeven thousand five hundred twenty eight (56.4%) patients undergoing THA and 8,283 (54%) patients undergoing TKA required PA, with a mean time to approval of 26.3 ± 34.6 and 33.7 ± 41.5 days, respectively. Addenda were requested in 608 of 7,528 (4.6%) THA patients and 737 of 8,283 (8.9%) TKA patients. From a total of 312 (4.1%) THA patients who had an initial denial, a P2P was requested for 50 (0.7%) patients, and only 27 (0.4%) were upheld after the PA process. From a total of 509 (6.1%) TKA patients who had an initial denial, a P2P was requested for 55 (0.7%) patients, and only 26 (0.3%) were upheld after the PA process. The mean time to denial in the THA group was 64.7 ± 83.5, and the most common reasons for denial were poor clinical documentation (25.9%) and lack of coverage (25.9%). The mean time to denial in the TKA group was 63.4 ± 103.9 days, and the most common reason for denial was not specified by the payer (46.1%). ConclusionsThe use of PA to approve elective THA and TKA led to increased surgical waiting times and a high administrative burden for surgeons and healthcare staff.

A Practical Guide to Implementing an Evidenced-Based Hands-On Naloxone Training

ABSTRACT Synthetic opioids contribute to the majority of opioid overdose-related deaths in the United States. Expansion of naloxone training to community laypersons is one strategy to mitigate opioid overdose-related deaths. A hands-on naloxone training demonstrated efficacy in improving opioid knowledge and overdose response in baccalaureate nursing students, Greek-affiliated students, and rural clinicians and staff post-training. The purpose of this practical guide is to provide detailed steps to implement an evidence-based hands-on naloxone training for laypersons in community settings. The hands-on naloxone training consisted of five components: evaluator training, a validated pre-post opioid knowledge questionnaire, an opioid lecture, a performance evaluation, and a satisfaction survey. Post-training, trainees demonstrated increased knowledge related to opioids and overdose response, and they felt comfortable administering naloxone to someone experiencing an opioid overdose. Researchers, educators, and community health nurses can adapt this evidence-based practical guide to train peers and acquaintances who are likely to witness an opioid overdose. Virtual training and multi-lingual protocols should be considered to successfully train diverse groups of community laypersons. An active hands-on naloxone training can improve confidence for community health nurses and other health care professionals, and it may reduce delays in response time and naloxone administration. Nurses can use this hands-on training to educate students, families, community members, and stakeholders how to respond to an opioid overdose event.

6-month Formulations of Androgen Deprivation Therapy for Advanced Prostate Cancer: Effectiveness and Rationale for Extended Dosing

Background: Luteinizing hormone-releasing hormone (LHRH) agonists and GnRH antagonists are the most widely used androgen deprivation therapy to achieve castration levels of serum testosterone (T). Adherence to dosing schedules is important to avoid treatment failure. A recent analysis found a high non-adherence rate of 84% for LHRH agonist injections based on dosing schedules used in pivotal trials. Method: Narrative review of LHRH therapy and evaluation of which offers optimal efficacy, safety, and practicality. Results: 6-month LHRH agonist formulations require fewer appointments for injections than shorter-acting formulations. Therefore, the frequency of late/missed doses and overall non-adherence may be reduced compared to options requiring frequent dosing (e.g., oral therapies and shorter-acting injections). This flexibility may be preferable for patients who live in multiple locations throughout the year, live long distances from clinics, and/or lack access to reliable transportation. 6-month formulations may also have cost benefits compared to shorter-acting doses. Despite similar levels of T suppression during the labeled dosing period, individual 6-month LHRH agonist formulations appear to have unique profiles, e.g., 6-month subcutaneous leuprolide acetate (LA) results in lower T escape rates compared to 6-month intramuscular LA, if dosing is late. Conclusion: The efficacy and practicality offered by 6-month LHRH formulations suggest these could reduce opportunities for late injections by requiring fewer office visits and provide greater confidence that efficacy will be maintained should there be extenuating circumstances leading to delays in therapy administration, as experienced during the recent pandemic.

A short decision time for transcatheter embolization can better associate mortality in patients with pelvic fracture: a retrospective study.

Early use of hemostasis strategies, transcatheter arterial embolization (TAE) is critical in cases of pelvic injury because of the risk of hemorrhagic shock and other fatal injuries. We investigated the influence of delays in TAE administration on mortality. Patients admitted to the Advanced Critical Care Center at Gifu University with pelvic injury between January 2008 and December 2019, and who underwent acute TAE, were retrospectively enrolled. The time from when the doctor decided to administer TAE to the start of TAE (needling time) was defined as "decision-TAE time." We included 158 patients, of whom 23 patients died. The median decision-TAE time was 59.5 min. Kaplan-Meier curves for overall survival were compared between patients with decision-TAE time above and below the median cutoff value; survival was significantly better for patients with values below the median cutoff value (p = 0.020). Multivariable Cox proportional hazards regression analysis revealed that the longer the decision-TAE time, the higher the risk of mortality (p = 0.031). TAE duration modified the association between decision-TAE time and overall survival (p = 0.109), as shorter TAE duration (procedure time) was associated with the best survival rate (p for interaction = 0.109). Decision-TAE time may play a key role in establishing resuscitation procedures in patients with pelvic fracture, and efforts to shorten this time should be pursued.

Assessment of Delay in Door-to-antibiotic Administration Time after Arrival to the Hospital among Post-chemotherapy Febrile Neutropenia Patients: A Cohort Study

ntroduction: Febrile Neutropenia (FN), a common side effect of chemotherapy, is regarded as an oncologic emergency necessitating prompt treatment. A delay in door-to-antibiotic administration time is associated with poor patient outcomes. Aim: To assess the time lag in the administration of antibiotics after arrival at the hospital in patients with solid/haematological malignancy presenting with post-chemotherapy FN. Materials and Methods: This was a cohort study conducted in the Department of Medical Oncology at Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India, over a period of one year from December 2019 to November 2020 among 80 patients with solid or haematological malignancy who presented with fever and Absolute Neutrophil Count (ANC) &lt;1000/mm3 to the Outpatient Department (OPD) or the Emergency Department and were diagnosed with FN post-chemotherapy. Upon obtaining consent, these patients were enrolled, and the timing of antibiotic administration was noted for the study participants. The participants were further followed-up for the assessment of morbidity {in terms of Intensive Care Unit (ICU) admission)}, duration of hospital stay, delay in the further chemotherapy schedule, and survival status. Data was entered into MS Excel and analysed using Statistical Packages for Social Sciences (SPSS) version 16.0. Associations were established using Chi-square tests. Results: Out of a total of 80 study participants, the mean±SD age was 45.6±18.3 years, and the number of males was 43 (53.8%). Total 57 (71.25%) patients were on chemotherapy for solid organ malignancies. The median delay in door-to-antibiotic time was 120 minutes (ranging from 30 to 260 minutes). The median day of presentation with FN after chemotherapy was day 7. Delay in antibiotic administration was found to have a significant impact on the further chemotherapy schedule and doses (p=0.004). However, ICU admission rates (p=0.133), length of hospital stay (p=0.662), and mortality (p=0.201) were not significantly associated with the delay in antibiotic administration. Conclusion: The adoption of standardised algorithms and protocols for the management of FN and ensuring timely healthseeking by the patients shall help reduce the delay in Time-toantibiotic Administration (TTA).

Vaccination coverage and delay in vaccination of infants born in 2017 and 2018 in municipalities in the Southern region of Brazil: National Vaccination Coverage Survey 2020.

To evaluate vaccination coverage and delay in vaccine dose administration in infants in six municipalities in the Southern region of Brazil. National Vaccination Coverage Survey 2020, with infants born alive in 2017 and 2018, carried out from September 2020 to March 2022. Coverage of doses administered, doses administered on time and delay in dose administration were evaluated. For 4681 infants analyzed, coverage for vaccines recommended up to 24 months was 68.0% (95%CI 63.9;71.8%) for doses administered and 3.9% (95%CI 2.7%;5.7%) for doses administered on time. Delay time for the majority of late vaccinations was ≤ 3 months. For some boosters, 25% of vaccine administration was delayed by ≥ 6 months. In addition to tracking vaccine defaulters, strategies are needed to encourage compliance with the vaccination schedule at the recommended ages. Vaccination coverage for the set of vaccines recommended up to 24 months was 68.0% and 3.9% for on-time doses. Delay time for some doses exceeded six months in up to 25% of infants with delayed vaccination. Monitoring vaccine administration at the recommended ages is necessary, with the adoption of strategies that reinforce routine vaccination to prevent vaccination delays and abandonment. Primary care in surveillance and care for infants needs to reinforce actions to ensure timely vaccination. Studies to deepen knowledge of vaccination delay, determinants and strategies for their reduction are necessary.

Stakeholders’ perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

ObjectivesThe Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS,...

Parkinson’s disease medications in hospital: A retrospective audit of prescribing and administration errors

Background: Managing Parkinson’s disease (PD) medications in the acute hospital setting is complex. Mismanagement of PD medications such as inaccurate medication administration time and prescribing errors is common which can lead to the worsening of PD symptoms. Aim and Objectives: The aim of the study was to identify the extent of PD medication prescribing and administration errors in adult inpatients and pharmacists’ impact across a Victorian metropolitan hospital. Materials and Methods: A retrospective review analyzed a sample of 30 patients admitted between January and April 2022. PD medication orders (PDMO) and medication administration records (MAR) were reviewed; charting errors were identified based on reconciliation of PDMO with the pharmacist-led best-possible medication history (p-BPMH). Administration errors were identified through a review of MAR and PDMO charted time or p-BPMH documented administration time for each PD medication. Results: A total of 60 PDMO and 469 administration instances were reviewed. About 83.3% (50) of PDMOs had at least one instance of delay or omission in administration. 45.0% (27) of PDMO charting errors led to delays or omissions in administration. The timing of administration was the most common charting error accounting for 18.3% (11) of PDMOs. Documentation of p-BPMH within 24 h of admission led to a reduction of charting errors (52.9% vs. 76.9%, respectively). PD medications that were administered on time compared to p-BPMH documented time and PDMO charted time were 48.6% (228/469) and 53.7% (252/469), respectively. Conclusion: This study identified a high degree of PDMO charting and administration errors for patients with PD. Strategies to improve PD medication management are warranted.

Bojungikgi-tang for Chemotherapy-induced Leukopenia: A Systematic Review and Meta-Analysis.

Chemotherapy-induced leukopenia is a common side effect of cytotoxic anticancer drugs. It can deprive patients of treatment opportunities, resulting in the delay, reduction, or discontinuation of chemotherapy or other anticancer drug administration. Two researchers searched English, Chinese, Japanese, and Korean electronic databases, without limiting the time period and language, using search terms such as "Bojungikgi," "WBC," "leuko," and "neutrop." Among the human randomized controlled studies in which Bojungikgi-tang was administered to patients who underwent chemotherapy, studies reporting leukopenia-related outcomes were selected, and data extraction, bias risk assessment, and meta-analysis were performed on the selected papers. Ten studies were selected, and a systematic review with meta-analysis was conducted. Nine papers were published in China and the total number of participants was 715. As a result of administering Bojungikgi-tang to these patients, the number of patients with chemotherapy-induced leukopenia significantly decreased (OR: 0.41, 95% CI: 0.27-0.61, P = .0001, I2 = 35%). Further, white blood cell counts were compared with that of the control group, and it showed an effect on prevention (MD: 0.64, 95% CI: 0.46-0.83, P < .00001, I2 = 90%). A pronounced effect was observed, especially when administered after a diagnosis based on the pattern identification, such as Qi deficiency. (OR: 0.32, 95% CI: 0.18-0.58, P = .0002, I2 = 0%). However, all studies had a high risk of bias due to non-blinding, and most studies had a high or uncertain risk of bias in creating random assignment orders and concealing them. Bojungikgi-tang has an effect on the prevention and treatment of chemotherapy-induced leukopenia. The effect rate can be increased when administered after proper diagnosis, and the possibility of adverse reactions and side effects is lower than that of Granulocyte-Colony Stimulating Factor (G-CSF) injection. Bojungikgi-tang appears to be useful in the treatment and prevention of leukopenia caused by cytotoxic anticancer drugs. However, it is necessary to conduct high-quality clinical studies in the future, considering the possibility of local and language bias, heterogeneity of carcinoma and intervention, and the risk of bias.Registration: PROSPERO CRD4202341054.

Pralidoxime Is no Longer Fit for Purpose as an Antidote to Organophosphate Poisoning in the United Kingdom.

Pralidoxime is the only oxime antidote to organophosphate poisoning stocked in the United Kingdom, produced by rational drug design in the 1950s. Typically, it is used alongside atropine, to reverse the effects of acetylcholinesterase inhibition. However, its efficacy has been questioned by recent meta-analyses of use treating attempted suicides in less economically developed countries, where organophosphate poisoning is more common. This policy analysis assesses the likely efficacy of pralidoxime in the United Kingdom, in scenarios largely different from those evaluated in meta-analyses. In all scenarios, the UK delay in antidote administration poses a major problem, as pralidoxime acts in a time-critical reactivation mechanism before "ageing" of acetylcholinesterase occurs. Additionally, changes in the organophosphates used today versus those pralidoxime was rationally designed to reverse, have reduced efficacy since the 1950s. Finally, the current dosage regimen may be insufficient. Therefore, one must re-evaluate our preparedness and approach to organophosphate poisoning in the United Kingdom.

미국 의회의 입법적 거부권에 관한 연구

For more than half a century in the United States, congressional or legislative vetoes have been adopted and used as a means of balancing power between the administration, especially the president and the federal parliament. Since the 1930s, when the Federal Assembly was unable to effectively exercise legislative power, it has gradually delegated legislative power to the President and the Administrative Committee, and the Federal Assembly adopted the veto as a preliminary legislative procedure to monitor the exercise of such delegated power. In general, legislative veto power refers to the delegation of legislative power to the president or administrative agency somewhat broadly, but the Congress has a veto on the exercise after the fact. In other words, this can be seen as a legislative mandate conditional on the rejection of Congress. Legislative veto power has its origins in the laying system, a precedent for the British Parliament. The return system is a system in which laws and regulations enacted by the administration are returned to the council to deliberate upon the delegation of the council, but are not recognized for effect if approval is not obtained. In the United States, legislative veto power was introduced by the Federal Assembly after the Great Depression in the 1930s to strengthen control over the administration's regulatory policies. In the 1970s, legislative veto power expanded rapidly. In the mid-1970s, Congress granted legislative vetoes to more than 100 laws. These legislative vetoes have contributed to strengthening Congress' control over the administration's regulatory policies. However, the legislative veto has caused a number of problems. First, the legislative veto system further delays the establishment of rules that are being delayed. Second, if Congress actually considers legislative veto power, the administrative committee and the parliament's competent standing committee will be sharply opposed, resulting in delays in administration. Third, criticism has been raised that the legislative veto increases the workload of Congress. Fourth, criticism has been raised that the legislative veto weakens and confuses judicial control over the administrative committee. The legislative veto, which has functioned as a strong means of control of legislative power delegation, was ruled unconstitutional in the 1983 Chadha ruling. This case is a case in which deportation of foreigners is a problem, and the background is as follows. Chadha, an East Indian, was on the verge of being deported from the country after his student visa period had elapsed. However, in 1974, Chadha requested an order to suspend deportation from the Minister of Justice based on the provisions of the Immigration and Nationality Act due to the difficulties of living following deportation abroad, and finally obtained the permission. However, the law gave the Senate or the House of Representatives the power to reject the Minister of Justice's decision by a simple resolution, and the House of Representatives passed a resolution rejecting the Minister's order to suspend deportation order. Eventually, in 1976, Chadha was finally ordered deported. In 1983, the Supreme Court ruled by 7:2 that the legislative veto under the Immigration and Nationality Act violates the Constitution in that it violates the transfer clause (Article 1, Paragraph 7, No. 3) and the bicameral clause (Article 1, Paragraphs 1 and 7 of the U.S. Constitution). In the Chadha case, it is evaluated that any form of legislative veto is unconstitutional. The ruling has shocked Congress and is expected to further affect the political process in the United States. Immediately after the Chadha ruling, the Congress came up with its own alternative. The most extreme opinion was to recognize the legislative veto as a prestigious through the revision of the current law or to deprive the Administrative Committee of its authority to enact rules at all, but it did not gain much sup

Custom order entry for Parkinson's medications in the hospital improves timely administration: an analysis of over 31,000 medication doses.

Patients with Parkinson's disease (PD) are at increased risk for hospital acquired complications. Deviations from home medication schedules and delays in administration are major contributing factors. We had previously developed a protocol to ensure adherence to home medication schedules using "custom" ordering. In this study we are assessing the impact this order type may have on reducing delays in PD medication administration in the hospital. We reviewed 31,404 orders placed for PD medications from January 2, 2016 to April 30 2021. We evaluated the orders to determine if they were placed in a Custom format or using a default non-custom order entry. We further evaluated all orders to determine if there was a relationship with the order type and timely administration of medications. We compared medications that were administered within 1 min, 15 min, 30 min and 60 min of due times across custom orders vs. non-custom default orders. We also evaluated the relationship between ordering providers and type of orders placed as well as hospital unit and type of orders placed. 14,204 (45.23%) orders were placed using a custom schedule and 17,200 (54.77%) orders were placed using non-custom defaults. The custom group showed a significantly lower median delay of 3.06 minutes compared to the non-custom group (p<.001). Custom orders had a significantly more recent median date than non-custom default orders (2019-10-07 vs. 2018-01-06, p<0.001). In additional analyses, medication administration delays were significantly improved for custom orders compared to non-custom orders, with likelihoods 1.64 times higher within 1 minute, 1.40 times higher within 15 minutes, and 1.33 times higher within 30 minutes of the due time (p<0.001 for all comparisons). This is the largest study to date examining the effects of order entry type on timely administration of PD medications in the hospital. Orders placed using a custom schedule may help reduce delays in administration of PD medications.

Effect of delayed cell infusion in patients with large B-cell lymphoma treated with chimeric antigen receptor T-cell therapy.

Complications occurring after lymphodepleting chemotherapy (LDC) may delay chimeric antigen receptor (CAR) T-cell infusion. The effect of these delays on clinical outcomes is unclear. We performed a retrospective analysis of 240 patients with relapsed/refractory large B-cell lymphoma treated with standard-of-care axicabtagene ciloleucel (axi-cel) and identified 40 patients (16.7%) who had delay in axi-cel infusion. Of these, 85% had delay due to infection. At time of LDC initiation, patients with delayed infusion had lower absolute neutrophil count (P=0.006), lower platelets (P=0.004), lower hemoglobin (P<0.001) and higher C-reactive protein (P=0.001) than those with on-time infusion. Patients with delayed infusion had lower day 30 overall response rates (59.0% vs. 79.4%; P=0.008) and shorter median progression-free survival (PFS) (3.5 vs. 8.2 months; P=0.002) and overall survival (7.8 vs. 26.4 months; P=0.046) than those with on-time infusion. The association with PFS was maintained on multivariate analysis. There was also an association between extent of delay and survival, with shorter median PFS in patients who had delays of 2-5 days (1.8 vs. 8.2 months; P=0.001) and >5 days (4.6 vs. 8.2 months; P=0.036), but not 1 day (5.7 vs. 8.2 months; P=0.238). Following propensity score matching, patients with delayed infusion continued to have shorter median PFS (3.5 vs. 6.0 months; P=0.015). Levels of pro-inflammatory cytokines on day of infusion were significantly higher in patients with delayed infusion. Together, these findings suggest that delays in CAR T-cell administration after initiation of LDC are associated with inferior outcomes. Further studies are needed to guide strategies to improve efficacy in such patients.

Hepatitis B Reactivation without Hepatitis Is a Common Event in Adolescent/Adult Patients of Acute Lymphoblastic Leukemia with Occult Hepatitis B (OHBI) Treated on Pediatric Protocols and Warrants Prophylactic Antivirals: A Prospective Cohort Study

Introduction: Patients with occult Hepatitis B infection(OHBI) (HBsAg negative but HBcIgG &amp;/or anti-HBs positive in the absence of immunization) are at an increased risk of Hepatitis B(HBV) reactivation while on and after chemotherapy. It can present over a spectrum ranging from asymptomatic or mild transaminitis to fatal hepatitis, affect the dose intensity of chemotherapy and compromise outcomes. The reported risk of reactivation is variable (1-24%, Yeo, 2009), and depends on the type of therapy and the method used to detect reactivation. Antiviral prophylaxis is recommended in patients with OHBI who are treated with antiCD20 monoclonal antibodies and those who undergo allogeneic stem-cell transplant, however this has not been evaluated in patients treated on pediatric-inspired ALL protocols comprising of several immunosuppressive drugs.. Methods: This was a prospective longitudinal cohort study conducted at a single tertiary care center in India between October 2017 to July 2021 (CTRI/2017/01/007747). The primary objective was to study the incidence of HBV reactivation in patients with OHBI on ALL protocol, and secondary objectives were to study the incidence of OHBI, HBV related hepatitis and its impact on chemotherapy intensity. Newly diagnosed patients with ALL/LBL, aged ≥15 years were screened for the presence of OHBI. Patients with OHBI were considered for enrollment into the prospective part of the study if they were treated on intense protocol (modified BFM-90 ALL protocol), had normal liver function tests, and no co-infection with HCV, HIV or history of HBV vaccination. Liver functions were monitored twice weekly during the induction/reinduction phase, prior to the early and delayed intensification and once every 2-3 months during the maintenance phase. HBV DNA copies by quantitative PCR (threshold for detection 20 units/ml), were measured at baseline, week 4, week 8, week 20, 32, week 48, completion of maintenance and every 3-6 months for 1 year. If a patient developed hepatitis, serum was collected for HBV DNA levels, HBsAg, HB core IgM antibody, IgM HAV antibody, IgM HEV, HCV and CMV DNA levels. HBV reactivation was defined as- either increase in serum HBV DNA level to more than 1 log higher than that of baseline or any copy numbers if it was negative at baseline. Seventy five patients with OHBI were to be studied to detect a true incidence of &amp;gt;10% HBV reactivation at a one-sided significance level of 5% and 90% power (Fleming's design) Results: A total of 566 patients were screened for the study, and 172(30.4% (95% C.I. (26.6-34.4)) patients were diagnosed with OHBI. 74 patients were enrolled in the prospective part of the study (Fig 1). The baseline characteristics of the study population are summarized in Table 1. HBV DNA was detectable at baseline in only 2(2.3%) patients. 51 patients (68.9%) completed all phases of treatment. The median follow-up was 21.6 months (range 0.03-53.5 months). A total of 402 HBV DNA tests were done in this cohort with an average of 5 tests per patient. HBV reactivation occurred in 5 patients ((6.7% 95% C.I.(1.03-12.47)), none of these patients developed hepatitis during HBV reactivation. In all the patients, reactivation occurred during the maintenance phase. All of these patients were started on antivirals (Entecavir). Overall 15(20.3%) patients developed hepatitis during the study period and CMV viremia was the cause for hepatitis in 4(26.7%) patients and HCV infection was the cause in 1 (6.6%) patient. Median AST, ALT during the episodes of hepatitis were 363 and 459 respectively (range AST 150-3490, range ALT 218-1950). Two(2.7%) patients had a delay in administration of chemotherapy due to hepatitis and median duration of delay was 21 days (range 18-24). Conclusion: We conclude that the risk of HBV reactivation is significant in adolescent/adult ALL patients with OHBI treated on pediatric inspired ALL protocols. HBV related hepatitis is a late event, and monitoring with liver function tests alone is not sufficient. The use of prophylactic antivirals is justified in patients with ALL.

Assessing Donor and Platelet Transfusion Characteristics on Intracranial Hemorrhage Outcomes

Introduction: Intracranial hemorrhage (ICH) patients require rapid treatment to reverse coagulopathy, which can help establish hemorrhage control and improve outcomes. While acute platelet transfusions are given in ICH to reverse platelet dysfunction, delays in administration of hemorrhage control therapies and platelet unit characteristics themselves may impact the efficacy and clinical outcomes in different patient populations. Thus, we sought to evaluate the relationship of platelet transfusion timing and platelet unit characteristics with ICH mortality. Methods: Available data for incident hospitalizations of adult ICH patients between 2019-2022 from 3 of the 5 participating sites within the multicenter REDS-IV-P network were assessed. ICH patients were included if they received ≥ 1 acute platelet transfusion within 48 hours of admission and presented with one of the following ICH etiologies: trauma (tICH), spontaneous intracerebral hemorrhage (sICH), and aneurysmal subarachnoid hemorrhage (aSAH). Patients with early withdrawal of care and death within the first 48 hours were excluded. Separate logistic regression models (each adjusting for age, sex, race/ethnicity, comorbidities, and number of platelet transfusions) assessed the relationship of 30 day ICH mortality outcome with the following: a) time to initial platelet transfusion in hour quartiles: &amp;lt;2.7 hours [reference] vs 2.7-5.6 hours vs 5.7-14.5 hours vs 14.6-48 hours, b) any major ABO incompatible platelet transfusion versus identical or minor mismatch, and c) any donor-recipient sex mismatched platelet transfusion. Separate subgroup analyses were performed by ICH etiologic subgroups. Results: Amongst 619 ICH patients receiving an acute platelet transfusion, 52% were from tICH, 36% from sICH, and 12% from aSAH. Mortality was seen in 17% of the overall cohort. Longer times to platelet transfusion (longest quartile: 14.6-48 hours) were associated with mortality in the overall ICH cohort (adjusted OR 2.12; 95%CI: 1.10-4.12). In sICH, effect size estimates were notably greater with the longest quartile time to platelet transfusion also being associated with mortality (adjusted OR 4.66; 95%CI: 1.58-14.8). Longer times to platelet transfusion were not associated with mortality in tICH (adjusted OR 1.19; 95%CI: 0.45-3.15). Amongst 543 ICH patients with available donor-recipient ABO data, 32% received a major ABO incompatible platelet transfusion. While there was not an association of major ABO incompatible platelet transfusion with mortality in the overall cohort (adjusted OR 1.41; 95%CI 0.82-2.40), there again was a significant association of this exposure with mortality in the sICH subgroup (adjusted OR 3.06; 95%CI: 1.22-7.90). No associations of major ABO incompatible platelet transfusions were identified in tICH subgroup (adjusted OR 1.02; 95%CI: 0.49-2.10). We did not identify a relationship of sex mismatched platelet units with mortality in the overall ICH cohort or in any ICH subgroups. Conclusions: In our analyses of data available from the REDS-IV-P network, we identified a suggestive relationship between longer times to platelet transfusion and mortality, but not of ABO mismatch in our overall ICH cohort. However, sICH may be a specific ICH subgroup more vulnerable to platelet transfusion characteristics and practices, particularly time to platelet transfusion and major ABO incompatible platelet unit exposures. Further work is necessary to assess the generalizability of our data and to clarify whether certain adult ICH patients require specially tailored platelet transfusion approaches.

Door-to-Needle Time for Administration of Antibiotic in Children with Cancer Within the Golden Hour- an Audit from a Tertiary Cancer Hospital in a Low-Middle Income Country

Abstract Background Fever neutropenia (FN) is the commonest complication during treatment in children with cancer. Most guidelines recommend administration of intravenous antibiotics within 60 minutes of presentation to the Emergency Room (ER) to minimize life threatening complications of FN(1). We performed a 3-month audit at our ER to see if this target was being met(2). The departmental FN management policy was revised and implemented from February 2021 based on the prevailing hospital antibiogram. All children undergoing treatment in the Paediatric Oncology Department are provided with written FN Alerts/Advice (Fig. 1). All patient prescriptions include instructions on antibiotic choice and dosage. Annual educational sessions are held with the ER staff and Paediatric Oncology Residents. A stock of essential antibiotics is maintained in the ER. Methods All children on chemotherapy or radiotherapy presenting to ER with fever (≥38°C) either at home or documented at ER had blood counts and blood cultures sent both from a peripheral vein and the indwelling central venous device (if present). The first dose of antibiotics as prescribed was administered without waiting for the blood count report or assessment by the Clinician. Time of patient’s arrival at ER and time of administration of the first antibiotic dose were obtained from ER nursing records and patient drug cards. Data was entered prospectively within 24 hours and tabulated for analysis on Microsoft Excel. Fig.1: Fever Neutropenia Sticker on Patient File Results Eighty-four children presented with 129 episodes of fever during the audit period (1st April 2022-30th June 2022). Median age was 6.4 years (IQR 3.1,12). Median time interval from last chemotherapy was 6 days (IQR 2,10). All children reporting to ER were seen by a Clinician, with 106 (82%) episodes seen within 30 minutes of reporting (median 15 minutes, IQR 5,21). All children received initial intravenous antibiotics after blood sampling. Median door-to-needle time was 45 minutes (IQR 35,60 minutes) There were 2 deaths in this cohort, one due to cancer progression and the other due to an unidentified infection of the central nervous system. Conclusions Over 80% children received the first dose of antibiotics within the target of &amp;lt;60 minutes. There were no deaths attributable to sepsis. Though the outcome was excellent in this cohort, we need to analyse the reasons for delay in administration of the first antibiotic dose and take remedial measures to improve compliance.

QLTI-10. STANDARD WORK FOR ORAL CHEMOTHERAPY IMPROVES SAFETY WITHOUT INCREASING DELAYS

Abstract Purpose Oral chemotherapy in the outpatient setting does not have the same level of oversight as chemotherapies delivered in an infusion treatment area. This project aimed to create a standardized process to prescribe outpatient oral chemotherapy to improve patient safety. The primary process-measure was laboratory data review prior to ordering therapy, with primary outcome-measure being number of days between approval to administer therapy and actual administration. A secondary process-measure was documentation quality, and counterbalance-measure was delay in ordering due to lab review. METHODS A Failure Mode Effects Analysis was performed. Standard work was developed for each step of prescribing and roles and responsibilities were assigned for each step in the process. A checklist was developed within the medical record to review and document essential steps in the process allowing for greater visibility. Fifty-three patient encounters were reviewed prior to intervention and 39 post-intervention. RESULTS FMEA identified 7 high-risk points. For the primary process measure, prior to intervention, 34/53 (64%) encounters had laboratory data review prior to chemotherapy order. After intervention, 38/39 (97%). The change did not delay ordering; we observed a mean 2-day delay between laboratory data review and chemotherapy order (significant difference from zero [p = 0.001]) pre-intervention. After intervention, there was no statistically significant delay (mean -0.74 days, p = 0.376). Documentation improved after intervention; 23/53 (43%) chemotherapy encounters contained complete data pre-intervention, and 36/39 encounters (92%) post-intervention. CONCLUSIONS As part of our standardized process, we developed a new chemotherapy checklist and flowsheet in the medical record. While the fraction of patients with zero delay in chemotherapy administration after approval did not change, patient safety improved with more patients having laboratory review prior to chemotherapy order. This review did not increase delays in ordering therapy. Documentation quality also improved. Having a standard process increases patient safety while prescribing outpatient oral chemotherapy.

Improving Parkinson's Medicine Administration in Hospitals: The Impact of an Out-of-Hours Drug Box.

Background Parkinson'sdisease (PD) is a progressive neurodegenerative condition characterised by the loss of dopaminergic neurons and the presence of Lewy bodies. PD medications, notably Levodopa, are critical in controlling patients' symptoms and improving their quality of life. These medications are time-critical, and a delay in administration can have a negative impact on a patient's mobility, quality of life and symptoms. Objective The objective of this quality improvement project (QIP) was to (1) determine the occurrence and underlying factors contributing to delays in PD medication administration at Huddersfield Royal Infirmary and (2) evaluate the impact of subsequent interventions in improving the administration of time-critical PD medications. Methods A total of 20 patients were recruited from Ward 5, a care of the elderly ward, at Huddersfield Royal Infirmary for the entire duration of this QIP; 10 in the pre-intervention phase and 10 for the post-intervention phase one month following the implementation of three interventions: 'Parkinson's Drug Box', ward-based teaching and a hospital-wide screensaver reminder. Datawascollected from the electronic patient record (EPR) to determine and compare the following measures before and after the interventions: the percentage of PD medications administered within the 30-minuterecommendedwindow, the admission-to-medication reconciliation time, scheduled-to-actual dose administration time, and factors causing delays. Results Following the implementation of three interventions, the percentage of patients receiving PD medications within the recommended 30-minute window doubled, increasing from 10% to 20%. Moreover, the average delay in patients receiving their initial PD medication dose decreased from 7.8 hours to 3.7 hours. The percentage of patients experiencing medication delays due to stock shortages also dropped from 50% to 10%. Conclusions Earlier medicines reconciliation and the availability of time-critical drugs out of hours are both key factors in helping to ensure PD medication is administered on time in hospitals. Staff education and a 'Parkinson's Drug Box' are two relatively simple measures that have resulted in improved outcomes for Parkinson's inpatients.