P528 Reducing intravenous monoclonal antibody observation times without compromising patient safety; a single-centre observational study

Abstract Background Monoclonal antibodies (MAbs) are integral to manage Inflammatory Bowel Disease (IBD). At Brighton & Sussex University Hospitals, intravenous MAbs, infliximab and vedolizumab, are administered in an outpatient setting. Licensing specifies post-infusion observation times of 1 to 2 hours. This affects waiting lists and capacity, particularly pertinent during the COVID-19 pandemic. Methods A single-centre observation study was conducted. Part 1 Retrospective data was collected for all infliximab and vedolizumab infusions from April to July 2019. Patients seen twice, were included once. For established infusion patients, historical reactions were recorded. Reaction incidence was established by observations, patient questioning and patient record review. To standardise the reactions, we used the cancer Common Terminology Criteria for Adverse Events; grade 3 is ‘severe’. Part 2 Observation time was removed from infusion 4 in April 2020. Prospective data was collected for all infliximab and vedolizumab infusions from April to December 2020. Multiple attendances were included. Results Part 1 130 infliximab patients (2607 infusions) and 69 vedolizumab patients (557 infusions) were reviewed. No severe reactions were recorded. All reactions occurred during induction dosing period. Analysis showed high levels of ‘no reactions observed’ after the first 4 infliximab infusions 97.7% (+1.6%, -4.7%), and the first 3 vedolizumab infusions 96.9% (+2.3%, -8.8%). 121 hours could be saved for infliximab and 64 hours for vedolizumab. Extrapolated this equates to 740 hours per year. Part 2 679 infliximab infusions were administered (including 12 new starters). 418 vedolizumab infusions were administered (16 new starters). No reactions were reported. Table key: Pt – patients, Inf – infusions, MAb – monoclonal antibody, Induct – Induction, Maint – maintenance, IV – intravenous, PO – oral, NC – not collected Conclusion All MAb infusion reactions occurred within 3 infusions, were non-severe and managed in clinic. By removing observation periods from infusion 4, capacity increased in concordance with COVID-19 social distancing, without affecting waiting times or patient safety. Patient experience was anecdotally improved. Further data from other centres are required to prove significance.

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PMO-9 Reducing intravenous monoclonal antibody observation times without compromising patient safety; a single-centre observational study.

10.1136/gutjnl-2021-bsg.148 ◽

2021 ◽

Author(s):

Fiona Rees ◽

Angela Packham ◽

Archna Parmar ◽

Emma Hills ◽

Melissa Smith ◽

...

Keyword(s):

Monoclonal Antibody ◽

Patient Safety ◽

Observational Study ◽

Single Centre ◽

Observation Times

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P604 Can we reduce intravenous monoclonal antibody observation times without compromising patient safety? A single centre retrospective observational study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.732 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S504-S505

Author(s):

F REES ◽

A Packham ◽

C Blake ◽

E Hills ◽

G Scutt ◽

...

Keyword(s):

Patient Safety ◽

Observational Study ◽

Small Sample Size ◽

Waiting Times ◽

Small Sample ◽

University Hospital ◽

Single Centre ◽

Maintenance Infusion ◽

Survival Plot ◽

Observation Times

Abstract Background Monoclonal antibodies (MAbs) are integral to inflammatory bowel disease (IBD) management. The administration of intravenous (IV) MAbs, infliximab and vedolizumab, for Brighton and Sussex University Hospital patients is via an outpatient clinic. Licensing specifies lengthy observation times; infliximab for induction (infusion 1 to 3) and maintenance (infusion 4 onwards) requires 1 to 2 h observation. Vedolizumab for induction (infusion 1 to 2) requires 2 h observation and maintenance (infusion 3 onwards) 1-h observation. This can affect waiting times; 33% UK patients waited longer than two weeks for infliximab. A reduction in observation times could improve capacity but needs to be done without compromising patient safety. Methods A single centre observational study was conducted. Retrospective data were collected on all current patients receiving infliximab or vedolizumab at BSUH. Data were collected over 12 weeks (April to July 2019); patients seen twice in this period were included once. The presence of reaction from current and previous infusions was determined by patient questioning and patient records review. Reaction occurrence, nature and management were recorded. There is not a grading system for IBD infusion-related reactions. To standardise we used the cancer Common Terminology Criteria for Adverse Events; grade 3 and above is designated severe (grade 5 being death). Results For infliximab 130 patients were reviewed with 2607 infusions administered in total. For vedolizumab 69 patients were reviewed with 557 infusions administered in total. Due to the small sample size significance could not be reached. The survival plot indicates high levels of ‘no reactions’ observed in the first 4 infusions of infliximab 97.7% (+1.6%, -4.7%), and first 3 infusions of vedolizumab 96.9% (+2.3%, −8.8%). Considering capacity over 12 weeks, for infliximab a minimum of 121 could be recouped and 64 h for vedolizumab. Extrapolated this could equate to 740 h per year. Conclusion All reactions occurred within three infusions, were non-severe and managed within the infusion clinic. By removing the observation period from infusion 4 onwards, infusion clinic capacity could be increased but further data from multiple centres are required to prove significance.

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Limiting infusion and observation times for infliximab and vedolizumab in the COVID-19 pandemic: a UK multicentre audit of practice and safety

Gastrointestinal Nursing ◽

10.12968/gasn.2020.18.8.30 ◽

2020 ◽

Vol 18 (8) ◽

pp. 30-36

Author(s):

Pearl Avery ◽

Lisa Younge ◽

Anya St Clair-Jones ◽

Rachel Campbell ◽

Deirdre Braim ◽

...

Keyword(s):

Current Practice ◽

Observation Time ◽

Supporting Evidence ◽

Safety Signal ◽

Time Burden ◽

Post Infusion ◽

Infusion Reactions ◽

Inflammatory Bowel ◽

The Uk ◽

Observation Times

Background: Infusions units in the UK are under increasing pressure, and this has been increased by the SARS-COV-2 pandemic. People with inflammatory bowel disease (IBD) are considered vulnerable, requiring enhanced social distancing or shielding, as defined in the UKz government's recommendations for COVID-19. Evidence that post-infusion observation time is unnecessary for infliximab (IFX) and vedolizumab (VDZ) exists in the literature, but the summary of product characteristics for both agents states that anywhere from 0.5 hours to 2 hours of observation post-infusion is required. Methods: A call was put out using the Royal College of Nursing's Facebook page, and IBD nurses from eight trusts in the UK took part. Data were gathered on trusts' current practice, infusion times for IFX and VDZ and reported infusion reactions. Results: Two (25%) trusts reported already having reduced post-infusion observation periods for people receiving IFX infusions 1–3; this increased to three units (37.5%) for infusions 4–9 and six (75%) for infusions >10. No infusion reactions were seen after the first 20 minutes of infusion time in 3934 IFX and 1265 VDZ infusions. Conclusions: The audit results suggested that there is no safety signal reduced post-infusion observation time, supporting evidence already present in the literature, and this can support increased capacity in infusion units. The time burden for people with Crohn's disease (CD) or ulcerative colitis (UC) is reduced, which is increasingly important during the pandemic. The reduced length of time that people need to spend at hospital offers trusts an option to help shield those who need to be protected from COVID-19.

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Practical considerations for creating a strategic and proactive clinical safety and pharmacovigilance organization for the future

International Journal of Risk & Safety in Medicine ◽

10.3233/jrs-200082 ◽

2021 ◽

pp. 1-16

Author(s):

Magnus Nord ◽

Magnus Ysander ◽

Tim Sullivan ◽

Mayur Patel

Keyword(s):

Decision Making ◽

Patient Safety ◽

Observation Time ◽

Operating Model ◽

Clinical Safety ◽

Patent Expiry ◽

Multiple Challenges ◽

Set Up ◽

Main Components ◽

Future Business

OBJECTIVE: In 2012, Patient Safety (PS) in AstraZeneca was facing a situation with multiple challenges, scientifically and structurally. To meet these and support AstraZeneca’s ambition to return to growth after years of patent expiry, we undertook a project to fundamentally revisit ways of working to create an organisation set up to provide strategic safety in support of drug project decision-making. METHOD: In this paper, we describe the challenges we faced, the project to deliver changes to respond to them, and the methodology used. The project had two main components: creating a new operating model and simplifying the procedural framework. RESULTS: It was delivered in a focused effort by internal PS resources with cross-functional input. The framework simplification resulted in a 71% reduction in procedural documents and a survey of PS staff revealed an increase in satisfaction of 10%–20% across all scores. CONCLUSIONS: With >3 years of observation time, this project has provided AstraZeneca with a PS organisation able to provide strategic safety, supporting successful portfolio delivery, while ensuring patient safety and maintaining compliance with global pharmacovigilance regulations. It has driven efficiency and set the foundation for continued organisational evolution to meet future business needs in an everchanging environment.

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Nurses’ Experiences of Transitional Care in Multiple Chronic Conditions

Home Health Care Management & Practice ◽

10.1177/10848223211002166 ◽

2021 ◽

pp. 108482232110021

Author(s):

Alireza Nikbakht Nasrabadi ◽

Leila Mardanian Dehkordi ◽

Fariba Taleghani

Keyword(s):

Patient Safety ◽

Data Collection ◽

Continuity Of Care ◽

Chronic Conditions ◽

Transitional Care ◽

Major Elements ◽

Study Data ◽

Multiple Chronic Conditions ◽

University Hospitals ◽

Levels Of Care

Transitional care is a designed plan to ensure the continuity of care received by patients as they transfer between different locations or levels of care. The aim of this paper is to explore nurses’ experiences of transitional care in multiple chronic conditions. A qualitative method with a conventional content analysis approach was utilized. The study was conducted at university hospitals in 2 big cities (Isfahan and Tehran) of Iran. This study is performed from November 2018 to December 2019 using deep, semi-structured, and face-to-face interviews which are focused on nurses’ experiences of transitional care. Data collection continued until saturation was reached. Finally, 15 nurses take part in this study. Data collection and data analysis were conducted concurrently. Data were analyzed using Graneheim and Lundman’s techniques. Two main themes providing a descriptive summary of the major elements of transitional care identified: “threat to patient safety” and “Care breakdown”. Findings showed an exclusive image of unsafe transitional care which was done unplanned without appropriate delegating care to family and threat patient safety. There is still a gap in the transition from hospital to home. Nursing managers can address this issue by creating a culture of teamwork, training competent nurses by continuum education, and more supervision of nursing care. Policymakers can ensure continuity of care by developing policies and programs about transitional care.

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Safety of vitamin E-infused highwall liners for routine use in primary total hip arthroplasty: single centre, short-term follow-up of 1221 cases

Hip International ◽

10.1177/1120700020969644 ◽

2020 ◽

pp. 112070002096964

Author(s):

Kirill Gromov ◽

Nanna H Sillesen ◽

Thomas Kallemose ◽

Henrik Husted ◽

Henrik Malchau ◽

...

Keyword(s):

Patient Safety ◽

Vitamin E ◽

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Single Centre ◽

Short Term ◽

Total Hip ◽

Arthroplasty Registry ◽

Primary Total Hip Arthroplasty

Background: Introduction of new implants should be monitored closely to capture any signs of compromising patient safety. Vitamin E infused highly-crosslinked polyethylene liners (VEPE) offer the potential for reduced wear. Highwall liners have been hypothesised to result in increased wear and potential liner fractures. The aim of this study was to determine the 3–7-year follow-up of highwall VEPE for primary total hip arthroplasty (THA), focusing on liner-related complications. Methods: We included 1221 consecutive THA operations from July 2010 to May 2014 with minimum follow-up of 3 (3.1–6.8) years Data collected included demographics, implant data, complications, reoperations, and deaths. Data were cross-referenced with the Danish Hip Arthroplasty Registry in order to ensure validity and completeness. Acetabular shell position was measured using Martell Hip Analysis Suite in a subgroup of 931 THAs. Results: Cumulative stem revision and shell revision at 3-year follow-up was 3.4% and 0.4% respectively. There were no revisions due to liner failure. Reason for revision included 11 dislocations, 15 soft-tissue revisions for infection, 44 stem revisions of which 34 were periprosthetic fractures and 13 shell revisions of which 6 were combined shell and stem revisions. Conclusion: Early follow-up of VEPE liners for primary THA have not shown any revisions associated with liner failure. Continued monitoring of new materials are necessary to capture any signs of compromised patient safety.

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513. Use of Antimicrobial Stewardship Program in Operationalizing Monoclonal Antibody Therapy in SARS-CoV-2 Infection

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.712 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S358-S358

Author(s):

Jessica Abrantes-Figueiredo ◽

Stephanie Nalewyko ◽

Dora E Wiskirchen

Keyword(s):

Monoclonal Antibody ◽

Antimicrobial Stewardship ◽

Multidisciplinary Approach ◽

Antibody Therapy ◽

Dual Therapy ◽

Monoclonal Antibody Therapy ◽

Hospital Leadership ◽

Stewardship Program ◽

Frequent Monitoring ◽

Post Infusion

Abstract Background Antimicrobial stewardship programs (ASP) have been essential during the coronavirus disease 2019 (COVID-19) pandemic response. Use of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has proven difficult to operationalize, despite being available through emergency use authorization (EUA). Utilizing existing ASP and multidisciplinary approach to lead the effort, we aim to describe our experience in operationalizing monoclonal antibody therapy. Methods Retrospective study of SARS-CoV-2 infected adults receiving monoclonal antibody therapy under EUA (December 2020-April 2021). An algorithm developed by the ASP provided education and an interactive online tool allowing referring physicians and patients to assess eligibility prior to hospital arrival. Patients were screened and approved by existing ASP which included; Infectious Disease (ID) physicians, pharmacist, and ID Nurse. A multidisciplinary approach with ER staff and development of pharmacy workflow with order set were utilized as eligible patients received infusion in dedicated ER location. Data such as demographics, co-morbid condition, infusion related complications, hospitalization, and death were reviewed and collected regularly by the ASP team with frequent monitoring and regulatory reporting. Primary patient outcome was preventing hospitalization. Results 107 patients received monoclonal antibody therapy. 47% patients were male, 50% White, and 79% non-Hispanic. 87% received monotherapy (bamlanivimab) and 13% received dual therapy (bamlanivimab/etesevimab). 17 patients required hospitalization post infusion. 1 death occurred. COVID-19 related hospitalization within 30-days was avoided in 84% of treated patients. No adverse event directly related to infusion were seen. Conclusion Use of monoclonal antibody therapy under EUA for patients for SARS-CoV-2 infection led to decrease in hospitalization in this cohort. An existing ASP using an algorithmic approval process, frequent monitoring, and multidisciplinary approach successfully operationalized the use of monoclonal antibody therapy. ASP’s provide benefit and versatility beyond monitoring of antimicrobials alone and should continue to receive support by hospital leadership. Disclosures All Authors: No reported disclosures

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Fatores facilitadores na implantação das estratégias de segurança dopaciente: estudo descritivo-exploratório

Online Brazilian Journal of Nursing ◽

10.17665/1676-4285.20175515 ◽

2017 ◽

Vol 16 (2) ◽

pp. 108

Author(s):

João Lucas Campos de Oliveira ◽

Gislene Aparecida Xavier dos Reis ◽

Verusca Soares de Souza ◽

Maria Antonia Ramos Costa ◽

Ingrid Mayara Almeida Valera ◽

...

Keyword(s):

Human Capital ◽

Patient Safety ◽

Content Analysis ◽

Nurse Managers ◽

Implementation Process ◽

Individual Interview ◽

University Hospitals ◽

Management Tools ◽

Educational Processes ◽

Safety Strategies

Aim: the aim of this paper is to investigate, from the perspective of nurse managers, the means/factors that facilitate the implementation process of patient safety strategies. Method: seventy-two nurse managers from four university hospitals of the state of Paraná participated, through an individual interview, which was recorded and guided by the question "Tell me about aspects that facilitate the implementation of safety strategies in this hospital." The statements were transcribed in full and were submitted for content analysis in the thematic modality. Results: two categories emerged from the speeches: "Management tools as facilitators in the implementation of patient safety strategies" and "Educational processes: means that facilitate the implementation of patient safety strategies". Conclusion: it was found that the support of the top management contributed greatly to the implementation of security strategies, as well as the militant leadership for this benefit and the improvement of human capital, which was strictly conveyed to the institutional teaching characteristic.

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Measuring Patient Safety Climate in Acute Stroke Therapy

Frontiers in Neurology ◽

10.3389/fneur.2021.686649 ◽

2021 ◽

Vol 12 ◽

Author(s):

Ferdinand O. Bohmann ◽

Joachim Guenther ◽

Katharina Gruber ◽

Tanja Manser ◽

Helmuth Steinmetz ◽

...

Keyword(s):

Patient Safety ◽

Acute Stroke ◽

Safety Climate ◽

Stroke Care ◽

University Hospitals ◽

Acute Stroke Care ◽

Safety Attitudes ◽

Patient Safety Climate ◽

Stroke Team ◽

First Time

Background: Treatment of acute stroke is highly time-dependent and performed by a multiprofessional, interdisciplinary team. Interface problems are expectable and issues relevant to patient safety are omnipresent. The Safety Attitudes Questionnaire (SAQ) is a validated and widely used instrument to measure patient safety climate. The objective of this study was to evaluate the SAQ for the first time in the context of acute stroke care.Methods: A survey was carried out during the STREAM trial (NCT 032282) at seven university hospitals in Germany from October 2017 to October 2018. The anonymous survey included 33 questions (5-point Likert scale, 1 = disagree to 5 = agree) and addressed the entire multiprofessional stroke team. Statistical analyses were used to examine psychometric properties as well as descriptive findings.Results: 164 questionnaires were completed yielding a response rate of 66.4%. 67.7% of respondents were physicians and 25.0% were nurses. Confirmatory Factor Analysis revealed that the original 6-factor structure fits the data adequately. The SAQ for acute stroke care showed strong internal consistency (α = 0.88). Exploratory analysis revealed differences in scores on the SAQ dimensions when comparing physicians to nurses and when comparing physicians according to their duration of professional experience.Conclusion: The SAQ is a helpful and well-applicable tool to measure patient safety in acute stroke care. In comparison to other high-risk fields in medicine, patient safety climate in acute stroke care seems to be on a similar level with the potential for further improvements.Trial registration:www.ClinicalTrials.gov Identifier: NCT032282.

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