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2.
PLoS One ; 19(4): e0300629, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38557690

RESUMO

Taking the green financial ecosystem composed of innovators, green financial institutions and regulators as the object of research, it explores the issue of how to improve the level of efforts of the three types of subjects and the benefits of risk management in the green financial ecosystem. The optimal level of effort, optimal level of return, and optimal level of return on risk management of green financial ecosystems for innovators, green financial institutions, and regulators under the three modes of No-incentive Contract, Cost-sharing Contract, and Synergistic Cooperation Contract are investigated and analyzed respectively, and verified by numerical simulation analysis. The results show: (1) Compared to the No-incentive Contract, the Cost-sharing Contract and the Synergy Cooperation Contract generate more significant incentives, and returns increase over time in both models. (2) The effort level of the participating subjects under the Synergistic Cooperation Contract is the highest, which can realize the Pareto optimization of the participating subjects and the green financial ecosystem at the same time. The study's findings contribute to a deeper understanding of cooperation among innovators, green financial institutions and regulators in facilitating risk management in green financial ecosystems and provide a realistic reference for risk managers in green financial ecosystems.


Assuntos
Ecossistema , Motivação , Humanos , Gestão de Riscos , Simulação por Computador
3.
BMJ Health Care Inform ; 31(1)2024 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-38642920

RESUMO

OBJECTIVES: Incident reporting systems are widely used to identify risks and enable organisational learning. Free-text descriptions contain important information about factors associated with incidents. This study aimed to develop error scores by extracting information about the presence of error factors in incidents using an original decision-making model that partly relies on natural language processing techniques. METHODS: We retrospectively analysed free-text data from reports of incidents between January 2012 and December 2022 from Nagoya University Hospital, Japan. The sample data were randomly allocated to equal-sized training and validation datasets. We conducted morphological analysis on free text to segment terms from sentences in the training dataset. We calculated error scores for terms, individual reports and reports from staff groups according to report volume size and compared these with conventional classifications by patient safety experts. We also calculated accuracy, recall, precision and F-score values from the proposed 'report error score'. RESULTS: Overall, 114 013 reports were included. We calculated 36 131 'term error scores' from the 57 006 reports in the training dataset. There was a significant difference in error scores between reports of incidents categorised by experts as arising from errors (p<0.001, d=0.73 (large)) and other incidents. The accuracy, recall, precision and F-score values were 0.8, 0.82, 0.85 and 0.84, respectively. Group error scores were positively associated with expert ratings (correlation coefficient, 0.66; 95% CI 0.54 to 0.75, p<0.001) for all departments. CONCLUSION: Our error scoring system could provide insights to improve patient safety using aggregated incident report data.


Assuntos
Gestão de Riscos , Semântica , Humanos , Estudos Retrospectivos , Gestão de Riscos/métodos , Segurança do Paciente , Hospitais Universitários
4.
Med. clín (Ed. impr.) ; 162(8): e9-e14, abr.-2024. tab
Artigo em Inglês | IBECS | ID: ibc-ADZ-255

RESUMO

Introduction: The busiest times in the hospital are often met by the greatest challenges in complete and comprehensive documentation of the patient care event. The near complete transition to the Electronic Health Record (EHR) was to be the solution to a host of provider documentation concerns. It is clear the EHR provides reliability, reproducibility, integration, evidence based decision-making, multidisciplinary contribution across the entire healthcare spectrum.Methods: The use of a consensus of expert opinion supplemented by focused literature review allows a balanced evidence based presentation of data. Results: Documentation is not a perfect tool however, as issues with efficiency, reliability, use of shortcut maneuvers and potential for increased medico-legal risk have been raised. The solution is attention to documentation detail, and creation of systems that facilitate excellence. The focus on electronic documentation systems should include continual evaluation, ongoing improvement, involvement of a multidisciplinary patient care team and vendor receptiveness to in EHR development and operations. Conclusion: The most effective use of the EHR as a risk management tool requires documentation knowledge, targeted analysis, product improvement and co-development of clinical-commercial resource.(AU)


Introducción: Los momentos de mayor actividad en el hospital a menudo se enfrentan con los mayores desafíos en cuanto a la documentación completa y exhaustiva del evento de atención al paciente. La transición casi completa a la historia clínica electrónica (HCE) iba a ser la solución a una serie de preocupaciones sobre la documentación de los proveedores. Está claro que la HCE proporciona confiabilidad, reproducibilidad, integración, toma de decisiones basada en la evidencia y contribución multidisciplinaria en todo el espectro de la atención médica.Métodos: El uso de un consenso de opinión de expertos complementado con una revisión de la literatura enfocada permite una presentación equilibrada de los datos basada en la evidencia.Resultados: La documentación no es una herramienta perfecta, ya que se han planteado problemas de eficiencia, confiabilidad, uso de maniobras abreviadas y la posibilidad de un mayor riesgo medicolegal. La solución es la atención al detalle de la documentación y la creación de sistemas que faciliten la excelencia. El enfoque en los sistemas de documentación electrónica debe incluir evaluación continua, mejora continua, participación de un equipo multidisciplinario de atención al paciente y receptividad de los proveedores en el desarrollo y las operaciones de la HCE. Conclusión: El uso más eficaz de la HCE como herramienta de gestión de riesgos requiere conocimiento de la documentación, análisis específicos, mejora del producto y desarrollo conjunto de recursos clínico-comerciales.(AU)


Assuntos
Humanos , Masculino , Feminino , Registros Médicos , Registros Eletrônicos de Saúde , Assistência ao Paciente , Prova Pericial , Imperícia , Gestão de Riscos
5.
Int J Med Inform ; 186: 105442, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38564960

RESUMO

BACKGROUND: The nature of activities practiced in healthcare organizations makes risk management the most crucial issue for decision-makers, especially in developing countries. New technologies provide effective solutions to support engineers in managing risks. PURPOSE: This study aims to develop a Decision Support System (DSS) adapted to the healthcare constraints of developing countries that enables the provision of decisions about risk tolerance classes and prioritizations of risk treatment. METHODS: Failure Modes and Effects Analysis (FMEA) is a popular method for risk assessment and quality improvement. Fuzzy logic theory is combined with this method to provide a robust tool for risk evaluation. The fuzzy FMEA provides fuzzy Risk Priority Number (RPN) values. The artificial neural network is a powerful algorithm used in this study to classify identified risk tolerances. The risk treatment process is taken into consideration in this study by improving FMEA. A new factor is added to evaluate the feasibility of correcting the intolerable risks, named the control factor, to prioritize these risks and start with the easiest. The new factor is combined with the fuzzy RPN to obtain intolerable risk prioritization. This prioritization is classified using the support vector machine. FINDINGS: Results prove that our DSS is effective according to these reasons: (1) The fuzzy-FMEA surmounts classical FMEA drawbacks. (2) The accuracy of the risk tolerance classification is higher than 98%. (3) The second fuzzy inference system developed (the control factor for intolerable risks with the fuzzy RPN) is useful because of the imprecise situation. (4) The accuracy of the fuzzy-priority results is 74% (mean of testing and training data). CONCLUSIONS: Despite the advantages, our DSS also has limitations: There is a need to generalize this support to other healthcare departments rather than one case study (the sterilization unit) in order to confirm its applicability and efficiency in developing countries.


Assuntos
Gestão de Riscos , Máquina de Vetores de Suporte , Humanos , Medição de Risco , Redes Neurais de Computação , Atenção à Saúde , Lógica Fuzzy
6.
Medicine (Baltimore) ; 103(16): e37807, 2024 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-38640335

RESUMO

OBJECTIVES: This paper analyzed the research on risk management in the doctor-patient relationship (DPR) based on a systematic quantitative literature review approach using bibliometric software. It aims to uncover potential information about current research and predict future research hotspots and trends. METHODS: We conducted a comprehensive search for relevant publications in the Scopus database and the Web of Science Core Collection database from January 1, 2000 to December 31, 2023. We analyzed the data using CiteSpace 6.2.R2 and VOSviewer 1.6.19 software to examine the annual number of publications, countries/regions, journals, citations, authors, and keywords in the field. RESULTS: A total of 553 articles and reviews that met the criteria were included in this study. There is an overall upward trend in the number of publications issued; in terms of countries/regions, the United States and the United Kingdom are the largest contributors; Patient Education and Counseling is the most productive journal (17); Physician communication and patient adherence to treatment: a meta-analysis is the most cited article (1637); the field has not yet to form a stable and obvious core team; the analysis of high-frequency keywords revealed four main research directions: the causes of DPR risks, coping strategies, measurement tools, and research related to people prone to doctor-patient risk characteristics; the causes of DPR risks, coping strategies, measurement tools, and research related to people prone to doctor-patient risk characteristics; the keyword burst analysis revealed several shifts in the research hotspots for risk management in the DPR, suggesting that chronic disease management, is a future research direction for the continued development of risk management in the DPR. CONCLUSIONS: The visualization analysis of risk management literature in the DPR using CiteSpace and VOSviewer software provides insights into the current research status and highlights future research directions.


Assuntos
Relações Médico-Paciente , Médicos , Humanos , Bibliometria , Comunicação , Gestão de Riscos
7.
Sci Rep ; 14(1): 8091, 2024 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-38582954

RESUMO

Safety incidents have always been a crucial risk in work spaces, especially industrial sites. In the last few decades, significant efforts have been dedicated to incident control measures to reduce the rate of safety incidents. Despite all these efforts, the rate of decline in serious injuries and fatalities (SIFs) has been considerably lower than the rate of decline for non-critical incidents. This observation has led to a change of risk reduction paradigm for safety incidents. Under the new paradigm, more focus has been allocated to reducing the rate of critical/SIF incidents, as opposed to reducing the count of all incidents. One of the challenges in reducing the number of SIF incidents is the proper identification of the risk prior to materialization. One of the reasons for risk identification being a challenge is that companies usually only focus on incidents where SIF did occur reactively, and incidents that did not cause SIF but had the potential to do so go unnoticed. Identifying these potentially significant incidents, referred to as potential serious injuries and fatalities (PSIF), would enable companies to work on identifying critical risk and taking steps to prevent them preemptively. However, flagging PSIF incidents requires all incident reports to be analyzed individually by experts and hence significant investment, which is often not affordable, especially for small and medium sized companies. This study is aimed at addressing this problem through machine learning powered automation. We propose a novel approach based on binary classification for the identification of such incidents involving PSIF (potential serious injuries and fatalities). This is the first work towards automatic risk identification from incident reports. Our approach combines a pre-trained transformer model with XGBoost. We utilize advanced natural language processing techniques to encode an incident record comprising heterogeneous fields into a vector representation fed to XGBoost for classification. Moreover, given the scarcity of manually labeled incident records available for training, we leverage weak labeling to augment the label coverage of the training data. We utilize the F2 metric for hyperparameter tuning using Tree-structured Parzen Estimator to prioritize the detection of PSIF records over the avoidance of non-PSIF records being mis-classified as PSIF. The proposed methods outperform several baselines from other studies on a significantly large test dataset.


Assuntos
Gestão de Riscos , Local de Trabalho , Meio Ambiente , Aprendizado de Máquina , Processamento de Linguagem Natural
8.
Psychoanal Q ; 93(1): 77-103, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38578266

RESUMO

Questions concerning analysts' publication of material from the analyses of their patients have troubled the field of psychoanalysis since its inception. Disguise inevitably distorts the clinical material and is often insufficient to protect the patient from recognition. Asking the patient's consent for publication intrudes upon and alters the analytic process. While analysts have largely reached a consensus about the need for anonymity in published material, there is still considerable debate about the necessity for obtaining patients' consent when using their material for publication. In this paper, I will trace the evolving meanings of disguise, and particularly of consent, in the analytic literature. I will place a particular emphasis upon the differing theoretical belief systems that underlie the analyst's decision to ask consent from her patient or not to do so, and I will argue that, although decisions on asking consent remain a complex matter, such coherent belief systems should play an important part in analysts' decisions regarding consent. I will illustrate my thought processes and some clinical situations with brief examples, and I will conclude with some practical recommendations, with the hope that these will stimulate further discussion in the analytic community.


Assuntos
Psicanálise , Terapia Psicanalítica , Humanos , Feminino , Confidencialidade , Redação , Gestão de Riscos , Processos Mentais
9.
Br J Nurs ; 33(7): S3, 2024 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-38578943
10.
PLoS One ; 19(3): e0299956, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38457447

RESUMO

Extreme precipitation usually cause grievous losses&casualties, which varies greatly under different scenarios. This paper took Henan province as an example, it innovatively constructed three different extreme precipitation scenarios and built indicators system of social vulnerability from exposure, sensitivity and resilience based on MOVE framework. Social Vulnerability Indexs(SoVI) were then calculated by mathematical models under three different reoccurrence intervals. The results show that SoVI was low in the west and high in the north. High SoVI areas expanded to the middle and south as recurrence intervals increased. SoVI in each area of Henan province increased along with the recurrence intervals at different growth rates. The larger the recurrence interval was, the faster the SoVI increased. The results indicate SoVI is greatly affected by disaster levels, which need to be incorporated into social vulnerability. This study provides not only a new thought for social vulnerability assessment, but also a reference for the policymakers to formulate related risk management policies.


Assuntos
Desastres , Vulnerabilidade Social , China , Medição de Risco , Gestão de Riscos
11.
PLoS One ; 19(3): e0289857, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38457469

RESUMO

BACKGROUND: Globally, increased occurrences of patient safety incidents have become a public concern. The implementation of Patient safety incidents reporting and learning guidelines is fundamental to reducing preventable patient harm. To improve the implementation of these guidelines in specialised care units in KwaZulu-Natal, the views of healthcare professionals were unearthed. AIM: This study explores the healthcare professionals' views toward the implementation of Patient safety incident reporting and learning guidelines in specialised care units. METHODS: A descriptive, explorative qualitative approach was used to collect qualitative data from healthcare professionals working in specialised care units. The study was conducted in specialised care units of three purposely selected public hospitals in two districts of KwaZulu-Natal. Group discussions and semi-structured interviews were conducted from August to October 2021. Content data analysis was performed using Tesch's method of analysis process. RESULTS: The main themes that emerged during data analysis were; ineffective reporting system affecting the communication of Patient safety incident guidelines, inadequate institutional and management support for the healthcare professionals, insufficient education and training of healthcare professionals, and poor human resources affecting the implementation of Patient Safety Incident guidelines. The findings highlighted that there were more major barriers to the implementation of the Patient safety incident reporting and learning guidelines. CONCLUSION: This study confirmed that the Patient safety incident reporting and learning guidelines are still not successfully implemented in the specialised care units and the barriers to implementation were highlighted. For rigorous implementation in South Africa, the study recommends revised Patient safety incident reporting and learning guidelines, designed in consultation with the frontline healthcare professionals. These must consist of standardised, simple- user-friendly reporting process as well as a better implementation strategy to guide the healthcare professionals. Continuous professional development programmes may play an important role in the facilitation of the implementation process.


Assuntos
Segurança do Paciente , Gestão de Riscos , Humanos , África do Sul , Pesquisa Qualitativa , Pessoal de Saúde
12.
Sci Rep ; 14(1): 6005, 2024 03 12.
Artigo em Inglês | MEDLINE | ID: mdl-38472452

RESUMO

Extensive research into dementia has more recently honed in on several key areas. These areas include the advancement of techniques such as the accumulation of amyloid-ß and tau proteins, the monitoring of cerebral hypometabolism rates etc. The primary objective of this study is to explore the intricate interplay between Alzheimer's disease (AD)-other dementias (D) and various chronic illnesses in terms of time, intensity, and connectivity. In this context, we retrospectively examined data of 149,786 individuals aged 65 and above who received diagnoses of AD and D in the year 2020. At first, logistic regression (LR) analysis has been made with "sex", "age" and "foreigner" (citizenship status) independent variables for AD and D. The LR models shows that while "sex" and "age" variables have a small rate on the risk of developing AD/D, it is detected that being a foreigner increase the risk of AD and D as 69.8% and 88.5% respectively. Besides, the LR models have middle-level success prediction rate for both of the two dependent variables. Additionally, we used the parallel coordinates graphs method within the R Studio to visualize their relationships and connections. The findings of this investigation strongly suggest that AD/D don't stand as isolated conditions, but rather stem from intricate interactions and progressive processes involving diverse chronic diseases over time. Notably, ailments including hypertension, coronary artery disease, diabetes, hyperlipidemia, and psychological disorders, contribute substantially to the emergence of both AD and D. This study highlights that the fight against AD/D can only be possible with next-generation prophylactic interventions that can predict and manage risks. Such an approach holds the potential to potentially lower AD and dementia to levels that are amenable to treatment.


Assuntos
Doença de Alzheimer , Humanos , Doença de Alzheimer/metabolismo , Estudos Retrospectivos , Turquia , Peptídeos beta-Amiloides/metabolismo , Proteínas tau , Gestão de Riscos , Biomarcadores
13.
PLoS One ; 19(3): e0299207, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38466755

RESUMO

This study employs a bivariate EGARCH model to examine the Taiwan Futures Exchange's regular and after-hours trading, focusing on the critical aspects of spillover and expiration effects, as well as volatility clustering and asymmetry. The objective of this study is to observe the impact on the trading sessions in Taiwan by the influences of the European and American markets, focusing on the essential roles of the price discovery function and risk disclosure effectiveness of the regular hours trading. This research is imperative considering the increasing interconnectedness of global financial markets and the need for comprehensive risk assessment for investment strategies. It also examines the hedging behavior of after-hours traders, thereby aiming to contribute to pre-investment analysis by future investors. This examination is vital for understanding the dynamics of after-hours trading and its influence on market stability. Results indicate price continuity between both trading sessions, with regular trading often determining after-hours price ranges. Consequently, after-hours price changes can inform regular trading decisions. This finding highlights the importance of after-hours trading for shaping market expectations. Significant profit potential exists in after-hours trading open interest, which serves speculative and hedging purposes. While regular trading volatility influences after-hours trading, the reverse is not true. This suggests Taiwan market information poses a higher risk impact than European and American market data, emphasizing the unique position of the Taiwan market in the global financial ecosystem. After-hours trading volatility reflects the absorption of international market information and plays a crucial role in advance revelation of risks. This underscores the importance of after-hours trading in global risk management and strategy formulation.


Assuntos
Ecossistema , Investimentos em Saúde , Previsões , Gestão de Riscos , Taiwan
14.
J Patient Saf ; 20(3): 202-208, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38525975

RESUMO

OBJECTIVE: Electronic medication management (EMM) systems have been shown to introduce new patient safety risks that were not possible, or unlikely to occur, with the use of paper charts. Our aim was to examine the factors that contribute to EMM-related incidents and how these incidents change over time with ongoing EMM use. METHODS: Incidents reported at 3 hospitals between January 1, 2010, and December 31, 2019, were extracted using a keyword search and then screened to identify EMM-related reports. Data contained in EMM-related incident reports were then classified as unsafe acts made by users and the latent conditions contributing to each incident. RESULTS: In our sample, 444 incident reports were determined to be EMM related. Commission errors were the most frequent unsafe act reported by users (n = 298), whereas workarounds were reported in only 13 reports. User latent conditions (n = 207) were described in the highest number of incident reports, followed by conditions related to the organization (n = 200) and EMM design (n = 184). Over time, user unfamiliarity with the system remained a key contributor to reported incidents. Although fewer articles to electronic transfer errors were reported over time, incident reports related to the transfer of information between different computerized systems increased as hospitals adopted more clinical information systems. CONCLUSIONS: Electronic medication management-related incidents continue to occur years after EMM implementation and are driven by design, user, and organizational conditions. Although factors contribute to reported incidents in varying degrees over time, some factors are persistent and highlight the importance of continuously improving the EMM system and its use.


Assuntos
Erros de Medicação , Gestão de Riscos , Humanos , Erros de Medicação/prevenção & controle , Segurança do Paciente , Hospitais , Eletrônica
16.
Water Sci Technol ; 89(5): 1264-1281, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38483497

RESUMO

Water treatment public-private partnership (PPP) projects are pivotal for sustainable water management but are often challenged by complex risk factors. Efficient risk management in these projects is crucial, yet traditional methodologies often fall short of addressing the dynamic and intricate nature of these risks. Addressing this gap, this comprehensive study introduces an advanced risk classification prediction model tailored for water treatment PPP projects, aimed at enhancing risk management capabilities. The proposed model encompasses an intricate evaluation of crucial risk areas: the natural and ecological environments, socio-economic factors, and engineering entities. It delves into the complex relationships between these risk elements and the overall risk profile of projects. Grounded in a sophisticated ensemble learning framework employing stacking, our model is further refined through a weighted voting mechanism, significantly elevating its predictive accuracy. Rigorous validation using data from the Jiujiang City water environment system project Phase I confirms the model's superiority over standard machine learning models. The development of this model marks a significant stride in risk classification for water treatment PPP projects, offering a powerful tool for enhancing risk management practices. Beyond accurately predicting project risks, this model also aids in developing effective government risk management strategies.


Assuntos
Meio Ambiente , Gestão de Riscos , Medição de Risco
17.
AMA J Ethics ; 26(3): E248-256, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38446730

RESUMO

Inpatient psychiatric units should be therapeutic environments that support dignity and recovery. When adverse outcomes (eg, self-harm, violence) happen in these settings, clinicians and administrators can face litigation and other pressures to prioritize risk management over supporting patients' access to personal belongings, exercise equipment, and private spaces. This article describes these downward pressures toward sparser, controlling environments in inpatient psychiatric settings as a safety funnel and suggests strategies for balancing safety, humanity, and recovery in these contexts.


Assuntos
Pacientes Internados , Comportamento Autodestrutivo , Humanos , Ciências Humanas , Pessoal Administrativo , Gestão de Riscos
18.
Harefuah ; 163(3): 170-173, 2024 Mar.
Artigo em Hebraico | MEDLINE | ID: mdl-38506359

RESUMO

INTRODUCTION: An adverse event is defined as an unwanted and unexpected occurrence in a medical process that may end in harm to the patient. In the USA the number of deaths due to failures reaches 253,000 per year. In Israel, over 10,000 deaths occur per year due to errors in the medical treatment of hospitalized patients, the third most common cause of death after heart disease and cancer. The main cause of failures in medical diagnosis and treatment is the complexity of the medical profession. A large number of caregivers in different medical disciplines are needed to treat one patient, therefore there are many errors, especially regarding communication between therapists. The Israeli health system has been operating with a budget deficit for many years and an addition of at least NIS 20 billion is needed to bring it to optimal functioning. The number of doctors, nurses, and hospital beds per 1000 inhabitants is significantly less than the average of the OECD countries. When there was a 30% increase in the population of Israel it was necessary to enhance the existing situation, with the addition of 7700 hospital beds, but only 1400 were added. This caused a decrease from 2.1 beds per 1000 residents to 1.8 beds per 1000 residents. There is an urgent need to change the elements of treatment safety in the Ministry of Health's strategic plan. An administration for quality, treatment safety, risk management in medicine, and accreditation should be established which, in addition to the care quality division, will include a safety division with investigation and monitoring units and will prepare strategic improvement plans, and a university-level research institute with researchers, computing, statistics, and information gathering units. The institute will receive all reports of adverse events, results of investigations, inspection committees, control and quality committees, relevant verdicts, and updated literature reviews, for research and systemic learning. Strategic plans will be prepared to prevent failures in diagnosis and medical treatment, leading to a decrease in mortality due to adverse events and the significant expenses involved.


Assuntos
Segurança do Paciente , Gestão de Riscos , Humanos , Israel , Qualidade da Assistência à Saúde
19.
AAPS J ; 26(2): 34, 2024 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-38485849

RESUMO

ICH Q12 asserts that science- and risk-based approaches are applicable to stability studies supporting Chemistry, Manufacturing and Controls (CMC) post-approval changes (PAC) to enable more timely implementation; however, no guidance or specific examples are provided to demonstrate how prior knowledge of the product can inform the risk assessment for the proposed change(s). Ten diverse case studies are presented in this manuscript to demonstrate how science- and risk-based stability strategies were used to support drug substance and product CMC PAC and lifecycle management activities. The accumulated stability knowledge held by original manufacturers of marketed products is substantial, and different elements of this knowledge base were used to assess the risks and impact of the proposed changes for confident change management. This paper provides ways to leverage science- and risk-based stability strategies as part of the post-approval change-management risk-mitigation strategy, which may enable a reduced stability data commitment and/or a reduced reporting category for change implementation.


Assuntos
Gestão de Riscos , Medição de Risco
20.
J Bus Contin Emer Plan ; 17(3): 220-234, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38424588

RESUMO

From 2017 to 2023, British Columbians experienced four record-breaking wildfire seasons, resulting in reduced air quality, mass evacuations and the destruction of homes, properties and livelihoods. Wildfire risk reduction is vital to breaking the sequence of disaster that has befallen such communities as Kelowna, BC in 2003, Ft. McMurray, AB in 2016, and Lytton, BC in 2021. As the City of Penticton ('the City') is located in a wildfire-prone environment, its Fire Department, FireSmart Team and Emergency Program have worked closely together to facilitate a proactive and comprehensive approach towards reducing the impacts of wildfire on Penticton's neighbourhoods, businesses and residents through a variety of wildfire mitigation initiatives. This paper discusses the City's efforts to achieve a holistic wildfire risk management plan through alignment with the seven disciplines of FireSmart and the four pillars of emergency management, namely: the use of education; land use planning and development considerations; vegetation management; emergency planning; and cross training and interagency cooperation. The paper describes the challenges the City has faced, as well its successes, and provides recommendations to help other local authorities reduce the risk of wildfire in their communities.


Assuntos
Planejamento em Desastres , Incêndios Florestais , Conservação dos Recursos Naturais , Comportamento de Redução do Risco , Gestão de Riscos
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