Search results for: vigilance

Authors: Osman Turkoglu, Alvin Estilo, Ritu Gupta, Liliam Pineda-Salgado, Rajesh Pandey

Abstract:

Background: Hepatotoxicity can be linked to a variety of clinical symptoms and histopathological signs, posing a great challenge in the surveillance of suspected drug-induced liver injury (DILI) cases in the safety database. Additionally, the majority of such cases are rare, idiosyncratic, highly unpredictable, and tend to demonstrate unique individual susceptibility; these qualities, in turn, lend to a pharmacovigilance monitoring process that is often tedious and time-consuming. Objective: Develop a multifactorial algorithm to assist pharmacovigilance physicians in identifying high-risk hepatotoxicity cases associated with DILI from the sponsor’s safety database (Argus). Methods: Multifactorial selection criteria were established using Structured Query Language (SQL) and the TIBCO Spotfire® visualization tool, via a combination of word fragments, wildcard strings, and mathematical constructs, based on Hy’s law criteria and pattern of injury (R-value). These criteria excluded non-eligible cases from monthly line listings mined from the Argus safety database. The capabilities and limitations of these criteria were verified by comparing a manual review of all monthly cases with system-generated monthly listings over six months. Results: On an average, over a period of six months, the algorithm accurately identified 92% of DILI cases meeting established criteria. The automated process easily compared liver enzyme elevations with baseline values, reducing the screening time to under 15 minutes as opposed to multiple hours exhausted using a cognitively laborious, manual process. Limitations of the algorithm include its inability to identify cases associated with non-standard laboratory tests, naming conventions, and/or incomplete/incorrectly entered laboratory values. Conclusions: The newly developed multifactorial algorithm proved to be extremely useful in detecting potential DILI cases, while heightening the vigilance of the drug safety department. Additionally, the application of this algorithm may be useful in identifying a potential signal for DILI in drugs not yet known to cause liver injury (e.g., drugs in the initial phases of development). This algorithm also carries the potential for universal application, due to its product-agnostic data and keyword mining features. Plans for the tool include improving it into a fully automated application, thereby completely eliminating a manual screening process.

Keywords: automation, drug-induced liver injury, pharmacovigilance, post-marketing

Procedia PDF Downloads 151

Authors: Jot Prakash Kaur

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The paper aims to showcase that with the introduction of anti-graft instruments and willingness of the governments towards their implementation, a significant change can be witnessed in the anti-corruption landscape of any country. Since the past decade anti-graft instruments have been introduced by several international non-governmental organizations with the vision of curbing corruption. Transparency International’s ‘Integrity Pact’ has been one such initiative. Integrity Pact has been described as a tool for preventing corruption in public contracting. Integrity Pact has found its relevance in a developing country like India where public procurement constitutes 25-30 percent of Gross Domestic Product. Corruption in public procurement has been a cause of concern even though India has in place a whole architecture of rules and regulations governing public procurement. Integrity Pact was first adopted by a leading Oil and Gas government company in 2006. Till May 2015, over ninety organizations had adopted Integrity Pact, of which majority of them are central government units. The methodology undertaken to understand impact of Integrity Pact on Public procurement is through analyzing information received from important stakeholders of the instrument. Government, information was sought through Right to Information Act 2005 about the details of adoption of this instrument by various government organizations and departments. Contractor, Company websites and annual reports were used to find out the steps taken towards implementation of Integrity Pact. Civil Society, Transparency International India’s resource materials which include publications and reports on Integrity Pact were also used to understand the impact of Integrity Pact. Some of the findings of the study include organizations adopting Integrity pacts in all kinds of contracts such that 90% of their procurements fall under Integrity Pact. Indian State governments have found merit in Integrity Pact and have adopted it in their procurement contracts. Integrity Pact has been instrumental in creating a brand image of companies. External Monitors, an essential feature of Integrity Pact have emerged as arbitrators for the bidders and are the first line of procurement auditors for the organizations. India has cancelled two defense contracts finding it conflicting with the provisions of Integrity Pact. Some of the clauses of Integrity Pact have been included in the proposed Public Procurement legislation. Integrity Pact has slowly but steadily grown to become an integral part of big ticket procurement in India. Government’s commitment to implement Integrity Pact has changed the way in which public procurement is conducted in India. Public Procurement was a segment infested with corruption but with the adoption of Integrity Pact a number of clean up acts have been performed to make procurement transparent. The paper is divided in five sections. First section elaborates on Integrity Pact. Second section talks about stakeholders of the instrument and the role it plays in its implementation. Third section talks about the efforts taken by the government to implement Integrity Pact in India. Fourth section talks about the role of External Monitor as Arbitrator. The final section puts forth suggestions to strengthen the existing form of Integrity Pact and increase its reach.

Keywords: corruption, integrity pact, procurement, vigilance

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Authors: Anastasios Zopiatis, Antonis L. Theocharous

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In the midst of a fierce war for talent, the hospitality industry is seeking new and innovative ways to enrich its image as an employer of choice and not a necessity. Historically, the industry’s professions are portrayed as ‘unattractive’ due to their repetitious nature, long and unsocial working schedules, below average remunerations, and the mental and physical demands of the job. Aligning with the industry, hospitality and tourism scholars embarked on a journey to investigate pertinent topics with the aim of enhancing our conceptual understanding of the elements that influence employees at the hospitality world of work. Topics such as job involvement, commitment, job and career satisfaction, and turnover intentions became the focal points in a multitude of relevant empirical and conceptual investigations. Nevertheless, gaps or inconsistencies in existing theories, as a result of both the volatile complexity of the relationships governing human behavior in the hospitality workplace, and the academic community’s unopposed acceptance of theoretical frameworks mainly propounded in the United States and United Kingdom years ago, necessitate our continuous vigilance. Thus, in an effort to enhance and enrich the discourse, we set out to investigate the relationship between intrinsic and extrinsic job satisfaction traits and the individual’s career satisfaction, and subsequent intention to remain in the hospitality industry. Reflecting on existing literature, a quantitative survey was developed and administered, face-to-face, to 650 individuals working as full-time employees in 4- and 5- star hotel establishments in Cyprus, whereas a multivariate statistical analysis method, namely Structural Equation Modeling (SEM), was utilized to determine whether relationships existed between constructs as a means to either accept or reject the hypothesized theory. Findings, of interest to both industry stakeholders and academic scholars, suggest that the individual’s future intention to remain within the industry is primarily associated with extrinsic job traits. Our findings revealed that positive associations exist between extrinsic job traits, and both career satisfaction and future intention. In contrast, when investigating the relationship of intrinsic traits, a positive association was revealed only with career satisfaction. Apparently, the local industry’s environmental factors of seasonality, excessive turnover, overdependence on seasonal, and part-time migrant workers, prohibit industry stakeholders in effectively investing the time and resources in the development and professional growth of their employees. Consequently intrinsic job satisfaction factors such as advancement, growth, and achievement, take backstage to the more materialistic extrinsic factors. Findings from the subsequent mediation analysis support the notion that intrinsic traits can positively influence future intentions indirectly only through career satisfaction, whereas extrinsic traits can positively impact both career satisfaction and future intention both directly and indirectly.

Keywords: career satisfaction, Cyprus, hotel employees, structural equation modeling, SEM

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Authors: Lauren Dhugga, Meena Parameswaran, David Blundell, Abbas Khushnood

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Context: A multidisciplinary weekly safety briefing was implemented at the Paediatric Cardiothoracic Unit at the Freeman Hospital in Newcastle-upon-Tyne. It is a tertiary referral centre with a quarternary cardiac paediatric intensive care unit and provides complexed care including heart and lung transplants, mechanical support and advanced heart failure assessment. Aim: The aim of this briefing is to provide a structured platform of communication, in an effort to improve efficiency, safety, and patient care. Problem: The paediatric cardiothoracic unit is made up of a vast multidisciplinary team including doctors, intensivists, anaesthetists, surgeons, specialist nurses, echocardiogram technicians, physiotherapists, psychologists, dentists, and dietitians. It provides care for children with congenital and acquired cardiac disease and is one of only two units in the UK to offer paediatric heart transplant. The complexity of cases means that there can be many teams involved in providing care to each patient, and frequent movement of children between ward, high dependency, and intensive care areas. Currently, there is no structured forum for communicating important information across the department, for example, staffing shortages, prescribing errors and significant events. Strategy: An initial survey questioning the need for better communication found 90% of respondents agreed that they could think of an incident that had occurred due to ineffective communication, and 85% felt that incident could have been avoided had there been a better form of communication. Lastly, 80% of respondents felt that a weekly 60 second safety briefing would be beneficial to improve communication within our multidisciplinary team. Based on those promising results, a weekly 60 second safety briefing was implemented to be conducted on a Monday morning. The safety briefing covered four key areas (SAFE): staffing, awareness, fix and events. This was to highlight any staffing gaps, any incident reports to be learned from, any issues that required fixing and any events including teachings for the week ahead. The teams were encouraged to email suggestions or issues to be raised for the week or to approach in person with information to add. The safety briefing was implemented using change theory. Effect: The safety briefing has been trialled over 6 weeks and has received a good buy in from staff across specialties. The aim is to embed this safety briefing into a weekly meeting using the PDSA cycle. There will be a second survey in one month to assess the efficacy of the safety briefing and to continue to improve the delivery of information. The project will be presented at the next clinical governance briefing to attract wider feedback and input from across the trust. Lessons: The briefing displays promise as a tool to improve vigilance and communication in a busy multi-disciplinary unit. We have learned about how to implement quality improvement and about the culture of our hospital - how hierarchy influences change. We demonstrate how to implement change through a grassroots process, using a junior led briefing to improve the efficiency, safety, and communication in the workplace.

Keywords: briefing, communication, safety, team

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Authors: Huseyin Sinan Gunesli

Abstract:

Process Safety Management is a disciplined framework for managing the integrity of systems and processes that handle hazardous substances. It relies on good design principles, well-implemented automation systems, and operating and maintenance practices. Alarm Management Systems play a critically important role in the safe and efficient operation of modern industrial plants. In that respect, Alarm Management is one of the critical factors feeding the safe operations of the plants in the manner of applying effective process safety principles. Trans Anatolian Natural Gas Pipeline (TANAP) is part of the Southern Gas Corridor, which extends from the Caspian Sea to Italy. TANAP transports Natural Gas from the Shah Deniz gas field of Azerbaijan, and possibly from other neighboring countries, to Turkey and through Trans Adriatic Pipeline (TAP) Pipeline to Europe. TANAP plays a crucial role in maintaining Energy Security for the region and Europe. In that respect, the application of Process Safety principles is vital to deliver safe, reliable and efficient Natural Gas delivery to Shippers both in the region and Europe. Effective Alarm Management is one of those Process Safety principles which feeds safe operations of the TANAP pipeline. Alarm Philosophy was designed and implemented in TANAP Pipeline according to the relevant standards. However, it is essential to manage the alarms received in the control room effectively to maintain safe operations. In that respect, TANAP has commenced Alarm Management & Rationalization program as of February 2022 after transferring to Plateau Regime, reaching the design parameters. While Alarm Rationalization started, there were more than circa 2300 alarms received per hour from one of the compressor stations. After applying alarm management principles such as reviewing and removal of bad actors, standing, stale, chattering, fleeting alarms, comprehensive review and revision of alarm set points through a change management principle, conducting alarm audits/design verification and etc., it has been achieved to reduce down to circa 40 alarms per hour. After the successful implementation of alarm management principles as specified above, the number of alarms has been reduced to industry standards. That significantly improved operator vigilance to focus on mainly important and critical alarms to avoid any excursion beyond safe operating limits leading to any potential process safety events. Following the ‟What Gets Measured, Gets Managed” principle, TANAP has identified key Performance Indicators (KPIs) to manage Process Safety principles effectively, where Alarm Management has formed one of the key parameters of those KPIs. However, review and analysis of the alarms were performed manually. Without utilizing Alarm Management Software, achieving full compliance with international standards is almost infeasible. In that respect, TANAP has started using one of the industry-wide known Alarm Management Applications to maintain full review and analysis of alarms and define actions as required. That actually significantly empowered TANAP’s process safety principles in terms of Alarm Management.

Keywords: process safety principles, energy security, natural gas pipeline operations, alarm rationalization, alarm management, alarm management application

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Authors: N. Reza Pour, S. Chuah, T. Vo

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Background: Vertebral artery dissection (VAD) is a rare complication of pregnancy. It can occur spontaneously or following a traumatic event. The pathogenesis is unclear. Predisposing factors include chronic hypertension, Marfan’s syndrome, fibromuscular dysplasia, vasculitis and cystic medial necrosis. Physiological changes of pregnancy have also been proposed as potential mechanisms of injury to the vessel wall. The clinical presentation varies and it can present as a headache, neck pain, diplopia, transient ischaemic attack, or an ischemic stroke. Isolated cases of VAD in pregnancy and puerperium have been reported in the literature. One case was found to have posterior circulation stroke as a result of bilateral VAD and labour was induced at 37 weeks gestation for preeclampsia. Another patient at 38 weeks with severe neck pain that persisted after induction for elevated blood pressure and arteriography showed right VAD postpartum. A single case of lethal VAD in pregnancy with subsequent massive subarachnoid haemorrhage has been reported which was confirmed by the autopsy. Case Presentation: We report two cases of vertebral artery dissection in pregnancy. The first patient was a 32-year-old primigravida presented at the 38th week of pregnancy with the onset of early labour and blood pressure (BP) of 130/70 on arrival. After 2 hours, the patient developed a severe headache with blurry vision and BP was 238/120. Despite treatment with an intravenous antihypertensive, she had eclamptic fit. Magnesium solfate was started and Emergency Caesarean Section was performed under the general anaesthesia. On the second day after the operation, she developed left-sided neck pain. Magnetic Resonance Imaging (MRI) angiography confirmed a short segment left vertebral artery dissection at the level of C3. The patient was treated with aspirin and remained stable without any neurological deficit. The second patient was a 33-year-old primigavida who was admitted to the hospital at 36 weeks gestation with BP of 155/105, constant headache and visual disturbances. She was medicated with an oral antihypertensive agent. On day 4, she complained of right-sided neck pain. MRI angiogram revealed a short segment dissection of the right vertebral artery at the C2-3 level. Pregnancy was terminated on the same day with emergency Caesarean Section and anticoagulation was started subsequently. Post-operative recovery was complicated by rectus sheath haematoma requiring evacuation. She was discharged home on Aspirin without any neurological sequelae. Conclusion: Because of collateral circulation, unilateral vertebral artery dissections may go unrecognized and may be more common than suspected. The outcome for most patients is benign, reflecting the adequacy of the collateral circulation in young patients. Spontaneous VAD is usually treated with anticoagulation or antiplatelet therapy for a minimum of 3-6 months to prevent future ischaemic events, allowing the dissection to heal on its own. We had two cases of VAD in the context of hypertensive disorders of pregnancy with an acceptable outcome. A high level of vigilance is required particularly with preeclamptic patients presenting with head/neck pain to allow an early diagnosis. This is as we hypothesize, early and aggressive management of vertebral artery dissection may potentially prevent further complications.

Keywords: eclampsia, preeclampsia, pregnancy, Vertebral Artery Dissection

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