Exchange Of Safety Information Research Articles

An innovative mobile app for the provision of medical information and collection of safety data on exposure to medicines during pregnancy or breastfeeding: An IHI ConcePTION contribution

AbstractObjectiveTo increase the volume, quality, and comprehensiveness of pregnancy and breastfeeding reports related to medication exposure.MethodsInnovative Health Initiative (IHI) ConcePTION, in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), has developed a mobile application designed for exchange of safety information for pregnancy and breastfeeding. The users will also be able to report medication exposure during pregnancy and breastfeeding, regardless of the outcome, by answering simple questions, tailored for their level of medical knowledge.ResultsThrough the first version of the app, the users will receive trusted safety information on their medication of interest, from the Health Authority (RSS feeds, tagged for ‘pregnancy’ and ‘breastfeeding’). By using the app, women and healthcare providers will also be able to help future mothers, by reporting the events they experienced following the utilization of medications during pregnancy and breastfeeding. These will be analyzed by MHRA to further characterize the safety profiles of the medications required to be used in these situations.ConclusionCollection of pregnancy outcomes after exposure to medications during pregnancy is limited by under‐reporting and focused on reporting of harms. By developing the app, ConcePTION brings reliable safety information closer to healthcare professionals and pregnant and breastfeeding women and proposes an easy‐to‐use, general data protection regulation‐compliant, secure tool tailored for safety in pregnancy and breastfeeding.

Cryptographic protocol for privacy-preserving integration of HAZOPs in modular process plants

Information which is contained in Hazard & Operability (HAZOP) studies is highly sensitive since it can reveal the vulnerabilities of a system and potential ways in which to bypass safeguards. Through the design of systems involving collaboration along a value chain, at some point this information is shared between several parties. In this paper, we propose a methodology for the secure exchange of safety information whilst preserving sensitive information for the application of modular Hazard & Operability (HAZOP) studies. We use homomorphic encryption in a workflow for the sharing of information between plant owners and operators as well as module vendors. We apply encryption to the risks from different modular HAZOPs (mHAZOPs), and combine and compare them without disclosing the risk level. Our contribution is a privacy-preserving protocol for mHAZOP comparison during the integration of modular process and equipment. We provide an exemplary implementation of the protocol and demonstrate the protocol’s privacy and correctness.

Confidence and Trust in the ‘Just Culture’ Construct

This paper reports on a series of studies examining pilot reporting behaviour, confidence in ‘just culture’, barriers that deter pilots from reporting safety information, and the origins of these barriers. Study 1 and 2 involved 270 Australian-based and 539 European-based pilots. The results reveal that 84% of the European and 57% of the Australian pilots trust their airline's just culture respectively. When comparing reporting behaviours, it was found that 54% of the Australian pilots and 30% of the European pilots failed to report safety information, with fear of reprisal from the airline being the leading reason to not report. Study 3 and 4 involved 27 Australian-based and 58 European-based pilots. The results revealed limited evidence of actual reprisal. However, pilots perceive the airline's actions in meeting its compliance and standards responsibilities as punitive in nature. These results highlight that there is a lack of understanding about the differences between punitive action and action to meet compliance and standards responsibility amongst flight crew. The studies reveal that important safety information could be lost due to an absence of trust and confidence in the principle of a just culture. The results also highlight that the principles underlying a just culture are largely misunderstood, which are likely to be affecting its successful implementation and the exchange of safety information.

QoS-Driven Spectrum Sharing for Reconfigurable Intelligent Surfaces (RISs) Aided Vehicular Networks

Reconfigurable intelligent surfaces (RISs) have the capability of reconfiguring the wireless environment in a favorable way to improve the quality-of-service (QoS) of wireless communications. This makes RISs a promising candidate to enhance vehicle-to-everything (V2X) applications. This paper investigates the spectrum sharing problem in RIS-aided vehicular networks, in which multiple vehicle-to-vehicle (V2V) links reuse the spectrum already occupied by vehicle-to-infrastructure (V2I) links. To overcome the difficulty of acquiring instantaneous channel state information (CSI) due to the fast varying nature of some V2X channels, we rely upon large-scale (slowly varying) CSI in order to fulfill the QoS requirements of V2I and V2V communications. Particularly, we aim to maximize the sum capacity of V2I links that are used for high-rate content delivery and to guarantee the reliability of V2V links that are used for the exchange of safety information. The transmit power of vehicles, the multi-user detection (MUD) matrix, the spectrum reuse of V2V links, and the RIS reflection coefficients are jointly optimized, which results in a mixed-integer and non-convex optimization problem. To tackle this problem, the outage probability of each V2V link is first approximated by introducing an analytical expression to simplify the formulated problem. By leveraging the block coordinate descent (BCD) method, the considered optimization problem is decomposed into three sub-problems, whose optimal solutions are provided independently and updated alternately to obtain a near-optimal solution. Simulation results verify the theoretical analysis and the effectiveness of the proposed algorithm, as well as unveil the benefits of introducing RISs for enhancing the QoS performance of vehicular communications.

An evaluation of engineered nanomaterial safety data sheets for safety and health information post implementation of the revised hazard communication standard

In 2012, the Occupational Safety and Health Administration issued the revised Hazard Communication Standard to bring the US in closer alignment with the Globally Harmonized System of Classification and Labeling of Chemicals, and make the exchange of health and safety information more effective. To evaluate the impact of this change on the reliability and accuracy of safety data sheets, a sample of safety data sheets specific to engineered nanomaterials was obtained by using an internet search engine and subsequently evaluated. These safety data sheets were evaluated using a modified Kimlisch et al. (1997) criteria for ranking the quality of data into categories of reliability and the Eastlake et al. (2012) ranking scheme for scoring four categories. While 86 safety data sheets for nanomaterials were obtained during 2016-2017, 19 of these had no date of completion or revision and could not be evaluated since it was impossible to determine if they were pre or post 2012, when the revised OSHA Hazard Communication Standard was issued. The remaining 67 safety data sheets were ranked by the Kimlisch et al. criteria, and 28.4% (19) were found to be reliable without restrictions (excellent), 35.8% (24) were reliable with restrictions (good), and 35.8% (24) were determined to be unreliable. Evaluating the SDSs using the Eastlake et al. ranking scheme resulted in 3% (2) as satisfactory, 17.9% (12) as being in need of improvement, and 79% (53) in need of significant improvement. It is noteworthy that out of the 79% in need of significant improvement, 25.4% (17) did not have enough data to be evaluated. This evaluation of nanomaterial safety data sheets revealed that the quality of information on many still cannot be relied upon to offer adequate information on the inherent health and safety hazards, including handling and storage of engineered nanomaterials.

Citizen Journalism Through Mobile Communication An Approach for Crisis Communication

India is a multi-cultural country where different religions, signs, symbols and languages are practiced by the masses from varied demographic backgrounds. People communicate and exchange their thoughts which are based on their beliefs, attitudes and perceptions. Within this background the life moves on and communication takes place in an unsystematic and a diffused fashion. The information which is generated evolves and re-orients itself with each passing day. This procedure is full of barriers, communication gaps and prejudiced thinking patterns. The message is at times distorted and as it travels from media vehicles to opinion leaders and then to followers it gets a new meaning altogether. With the advent of new media technologies this message is exchanged at a much faster rate and it travels across national and international boundaries on a click of a button. This pattern of dissemination of news and information is also undefined and generally it flows from on community to another via group communication. As a society evolves it often faces situations of crisis and emergency. These situations can be dynamic, unexpected events that may involve a significant threat, on-going uncertainty, and can be a danger to life and property. India being a secular and the biggest democracy has also witnessed similar situations in the past. There have been riots, communal violence and situations of emergency declared by the government. Mobile being a common man's possession is the most powerful& easily accessible device to communicate at times of emergency and risk. Mobile phone is the appropriate tool to facilitate the exchange of risk-relevant and safety information during an emergency situation. Mobile phone can not only help in controlling the impact of message and false news it can also be useful to implement immediate and effective actions to lessen harm. It can also be useful for consensus-building, collaborative decision-making, and interactions with potentially affected communities. Depending on the intensity of the circumstances during a crisis, decision-making, risk perceptions, and information processing styles are often modified; thus, it is even more important than usual to not only get the information right, but also get the right information into concise, focused messages. Knowing how, when, and where to deliver the message may be the difference between keeping the public safe and to protect them form a crisis. This paper would attempt to discuss the participatory approach of communication through mobile phones which citizens can adopt at times of crisis. It will also try to integrate the concept of community communication through mobile phone in times of crisis. It will also look at normative concepts and will look at the points to be used by the stake holders, community leaders, opinion leaders and citizen journalists to control the crisis through participatory mobile communication.

An infrastructure-aided cooperative spectrum sensing scheme for vehicular ad hoc networks

The Wireless Access in Vehicular Environments (WAVE) protocol stack has been recently defined to enable vehicular communication on the Dedicated Short Range Communication (DSRC) frequencies. Recent studies have demonstrated that the Control Channel (CCH) of the DSRC protocol on which all vehicular safety messages are sent might not provide sufficient spectrum for reliable exchange of safety information over congested urban scenarios. In this paper, we develop a scheme that calls for collecting spectrum sensing measurements by cars and then aggregating these measurements by Road Side Units (RSUs) to assess the state of the spectrum on road segments. We propose to opportunistically use the white spaces in the spectrum as an extension of the crowded Control Channel (CCH) for the next passing cars. A blind detector is applied and tested on the cars level, which takes advantage of their mobility to span a large area of the roads and deliver more accurate decisions in dynamic vehicular environments. To ensure homogeneity in the sensing samples among cars, we make the sensing rate of the cars dependent on their traveling speed. A fusion and decision algorithm is employed by Road Side Units (RSUs) to aggregate the individual sensing data and decide on the vacancy of the sensed frequency bands. The performance of the sensing and decision algorithms are evaluated and tested in various vehicular scenarios using the network simulator ns2. The obtained results prove the effectiveness of the system in detecting available ISM channels.

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: Part 2 – The pilot version

The screening and careful selection of excipients is a critical step in paediatric formulation development as certain excipients acceptable in adult formulations, may not be appropriate for paediatric use. While there is extensive toxicity data that could help in better understanding and highlighting the gaps in toxicity studies, the data are often scattered around the information sources and saddled with incompatible data types and formats. This paper is the second in a series that presents the update on the Safety and Toxicity of Excipients for Paediatrics ("STEP") database being developed by Eu-US PFIs, and describes the architecture data fields and functions of the database. The STEP database is a user designed resource that compiles the safety and toxicity data of excipients that is scattered over various sources and presents it in one freely accessible source. Currently, in the pilot database data from over 2000 references/10 excipients presenting preclinical, clinical, regulatory information and toxicological reviews, with references and source links. The STEP database allows searching "FOR" excipients and "BY" excipients. This dual nature of the STEP database, in which toxicity and safety information can be searched in both directions, makes it unique from existing sources. If the pilot is successful, the aim is to increase the number of excipients in the existing database so that a database large enough to be of practical research use will be available. It is anticipated that this source will prove to be a useful platform for data management and data exchange of excipient safety information.

Improving vehicular safety message delivery through the implementation of a cognitive vehicular network

The Wireless Access in Vehicular Environments (WAVE) protocol stack has been recently defined to enable vehicular communication on the Dedicated Short Range Communication (DSRC) frequencies. Some recent studies have demonstrated that the WAVE technology might not provide sufficient spectrum for reliable exchange of safety information over congested urban scenarios. In this paper, we address this issue, and present a novel cognitive network architecture in order to dynamically extend the Control Channel (CCH) used by vehicles to transmit safety-related information. To this aim, we propose a cooperative spectrum sensing scheme, through which vehicles can detect available spectrum resources on the 5.8GHz ISM band along their path, and forward the data to a fixed infrastructure known as Road Side Units (RSUs). We design a novel Fuzzy-Logic based spectrum allocation algorithm, through which the RSUs infer the actual CCH contention conditions, and dynamically extend the CCH bandwidth in network congestion scenarios, by using the vacant frequencies detected by the sensing module. The simulation results reveal the effectiveness of our architecture in providing dynamic and scalable allocation of spectrum resources, and in increasing the performance of safety-related applications.

Occupational driver safety: Conceptualising a leadership-based intervention to improve safe driving performance

Occupational driving crashes are the most common cause of death and injury in the workplace. The physical and psychological outcomes following injury are also very costly to organizations. Thus, safe driving poses a managerial challenge. Some research has attempted to address this issue through modifying discrete and often simple target behaviours (e.g., driver training programs). However, current intervention approaches in the occupational driving field generally consider the role of organizational factors in workplace safety. This study adopts the A–B–C framework to identify the contingencies associated with an effective exchange of safety information within the occupational driving context. Utilizing a sample of occupational drivers and their supervisors, this multi-level study examines the contingencies associated with the exchange of safety information within the supervisor–driver relationship. Safety values are identified as an antecedent of the safety information exchange, and the quality of the leader–member exchange relationship and safe driving performance is identified as the behavioural consequences. We also examine the function of role overload as a factor influencing the relationship between safety values and the safety information exchange. Hierarchical linear modelling found that role overload moderated the relationship between supervisors’ perceptions of the value given to safety and the safety information exchange. A significant relationship was also found between the safety information exchange and the subsequent quality of the leader–member exchange relationship. Finally, the quality of the leader–member exchange relationship was found to be significantly associated with safe driving performance. Theoretical and practical implications of these results are discussed.

Extraction and translation of safety knowledge in organizations using incident reports

The Incident Report-Based Safety Knowledge Transfer (IRSKT) model found in this paper identifies the elements necessary for social systems in workplaces to extract, disseminate and use new safety knowledge emanating from incident reports. The purpose of this paper is twofold: to understand how recent developments in systems thinking and materiality of knowledge can influence understanding of safety knowledge transfer (SKT); and to propose a new systems-based safety knowledge transfer model founded on incident reports. The paper is a review of the literature on safety knowledge transfer, materiality of knowledge and systems thinking; leading to the proposal of a new SKT paradigm. This paper shows that the IRSKT model is well suited to analyzing safety knowledge transfer in both complex and small-scale systems. Empirical studies in various systems (of complexity) environments will help affirm and enrich the model. The paper sees that in organizations where safety of employees is important, the ability to extract knowledge from incidents reports – which is an accessible and ready estimate of safety situations in organizations - is vital for establishing safe workplaces. The capacity for effective exchange and utilization of safety information inherent in incident reports by employees, equipment manufacturers, professional bodies and government agencies as reflected in IRSKT will inform the decisions to build in safety in machinery, better safety rules, effective safety campaigns and enhance safety conscious behaviours in organizations. The paper offers a new safety knowledge transfer paradigm that views safety knowledge as a systemic, emergent, embedded and materially entangled representation of reality. The proposed knowledge transfer model is different from earlier attempts, concentrating movement of safety information in incident reports and the significance stakeholders must attach to them to minimize both human and machine error. Key words: Incident reports, accidents, knowledge transfer, safety knowledge, systems analysis.

Establishment of the Global International Fatigue Risk Management Forum

For many years, fatigue-related risk has been recognized as a significant issue for aircraft operators. The International Civil Aviation Organization (ICAO) states that a basic building block underlying the process of managing safety is “sharing safety lessons learned and best practices through the active exchange of safety information.” An example of this organized active exchange is the global Fatigue Risk Management System (FRMS) Forum which was launched in 2009 and includes 65 organizations (2011) (regulators, airline operators, and academic institutions). The Forum is apolitical and facilitates better communication between these bodies. New information from the ICAO and European Aviation Safety Agency (EASA) cites the fact that operators can no longer interpret binary compliance with prescriptive flight time limitations as ensuring “legality” or safety. This paper describes how the FRMS Forum can help.

Resolving a Double Standard for Risk Management of Thalidomide

Thalidomide, once withdrawn because of its teratogenicity, has now been re-launched worldwide. In Japan, thalidomide has been imported by individual doctors since around the year 2000. In October 2008, it was approved for the treatment of multiple myeloma (MM) by the Ministry of Health, Labour and Welfare (MHLW) on the condition that the manufacturer implemented a risk management programme termed the Thalidomide Education and Risk Management System (TERMS). It is likely that the imports of thalidomide will be used off-label to treat diseases other than MM. Thus, the MHLW is also planning to introduce a web-based registration system, referred to as the Safety Management System for Unapproved Drugs (SMUD), for thalidomide imported by individual doctors. To evaluate the difference between TERMS and SMUD and establish a way to resolve the 'double standard' for risk management of thalidomide treatment in Japan. The fraction of patients with disorders other than MM was estimated by the volume of annual imports obtained from the MHLW and records of the imports for patients with MM, other oncological diseases (ODs) and non-ODs in 2007 through a major supplier covering 63% of the total imported thalidomide. The information for TERMS was obtained from web pages of the manufacturer and the MHLW. The components of TERMS were compared with those in SMUD. Provided that the distribution of the indication for thalidomide (MM) in 2007, estimated from the records of imports through the major supplier, is representative of the entire nation, it is estimated that on average 866 patients, including 851 (98.3%) with MM, are using thalidomide on any one day. However, if the major supplier's imports, which account for 63% of the total imports, are not representative of the nation as a whole, possibly only half of the patients treated with thalidomide in Japan have MM. This would be the case in a scenario where the remaining 37% of imports are exclusively used to treat disorders other than MM. TERMS consists of tools for education and registration of patients, and has the potential for real-time intervention. SMUD is a system for registration of patients and exchange of safety information between health professionals, but has some mandatory components that encourage patient registration. TERMS and SMUD are different in nature, and they impose different criteria that doctors and patients should satisfy in order to use thalidomide. To eliminate this double standard, implementation of a single system would be desirable. However, improvement of SMUD may be the second best option by developing tools for patient education, enhancing the potential for real-time intervention and monitoring thalidomide usage by each patient. On average, a total of about 1000 patients are estimated to be using thalidomide on any one day in Japan. It is likely that those patients are placed under one of two different risk management programmes. SMUD should be improved so that all patients are monitored in a way that results in a similar level of risk management.

International Nuclear Safety Center database on thermophysical properties of reactor materials

The International Nuclear Safety Center (INSC) database has been established at Argonne National Laboratory to provide easily accessible data and information necessary to perform nuclear safety analyses and to promote international collaboration through the exchange of nuclear safety information. The INSC database, located on the World Wide Web at http://www.insc.anl.gov, contains critically assessed recommendations for reactor material properties for normal operating conditions, transients, and severe accidents. The initial focus of the database is on thermodynamic and transport properties of materials for water reactors. Materials that are being included in the database are fuel, absorbers, cladding, structural materials, coolant, and liquid mixtures of combinations of UO{sub 2}, ZrO{sub 2}, Zr, stainless steel, absorber materials, and concrete. For each property, the database includes: (1) a summary of recommended equations with uncertainties; (2) a detailed data assessment giving the basis for the recommendations, comparisons with experimental data and previous recommendations, and uncertainties; (3) graphs showing recommendations, uncertainties, and comparisons with data and other equations; and (4) property values tabulated as a function of temperature.

Scope and functions of the U.S. nuclear safety analysis center

The Nuclear Safety Analysis Center (NSAC) was set up at EPRI t in April 1979, soon after the Three Mile Island accident, at the request of the nation's electric power utility industry. NSAC was conceived as one of the nuclear utility industry's responses to the TMI accident. Industry leaders perceived a need for the industry's own impartial and objective investigation and analysis of the TMI accident. NSAC was instructed to carry out this investigation and analysis, and to draw lessons applicable to the industry generally. It was to indicate areas where safety-related improvements were desirable, and to set up mechanisms for better exchange of safety information among the nuclear utilities. Administratively, NSAC operates as a division of EPRI and is served by similar administrative and facility support, and advisory committee structure as is EPRI. NSAC is supported by special funding assessments which are separate from those which support EPRI or the Institute for Nuclear Power Operations. Both public and private companies of the utility industry participate, including APPA (American Public Power Association); NRECA (National Rural Electric Cooperatives) and the investor owned companies of EEI (Edison Electric Institute). NSAC's output is information data analysis and advice on matters of nuclear plant safety. To be valid, such information and advice must be independent, objective, and technically sound. These important requirements are generally recognized and respected by the utilities which support NSAC. The work of NSAC is organized in four departments. These include (l) Plant Engineering Department (Significant Events Program); (2) Instrumentation and Control Department (Safety Display Panel, Human Factors, Safety Instrumentation and Control); (3) Operations Analysis Department (Degraded Core studies, environment and health