Dissemination Of Safety Information Research Articles

Concept analysis of safety climate in healthcare providers

To report an analysis of the concept of safety climate in healthcare providers. Compliance with safe work practices is essential to patient safety and care outcomes. Analysing the concept of safety climate from the perspective of healthcare providers could improve understanding of the correlations between safety climate and healthcare provider compliance with safe work practices, thus enhancing quality of patient care. Concept analysis. The electronic databases of CINAHL, MEDLINE, PubMed and Web of Science were searched for literature published between 1995-2015. Searches used the keywords 'safety climate' or 'safety culture' with 'hospital' or 'healthcare'. The concept analysis method of Walker and Avant analysed safety climate from the perspective of healthcare providers. Three attributes defined how healthcare providers define safety climate: (1) creation of safe working environment by senior management in healthcare organisations; (2) shared perception of healthcare providers about safety of their work environment; and (3) the effective dissemination of safety information. Antecedents included the characteristics of healthcare providers and healthcare organisations as a whole, and the types of work in which they are engaged. Consequences consisted of safety performance and safety outcomes. Most studies developed and assessed the survey tools of safety climate or safety culture, with a minority consisting of interventional measures for improving safety climate. More prospective studies are needed to create interventional measures for improving safety climate of healthcare providers. This study is provided as a reference for use in developing multidimensional safety climate assessment tools and interventional measures. The values healthcare teams emphasise with regard to safety can serve to improve safety performance. Having an understanding of the concept of and interventional measures for safety climate allows healthcare providers to ensure the safety of their operations and their patients.

A grey relational analytical approach to safety performance assessment in an aviation industry of a developing country

Safety in aviation impacts the overall success of the sector. It depends on the effectiveness and efficiency of safety management systems (SMSs), which contain diverse and complex elements. Thus, a quantitative methodology for aviation SMS in developing countries, capable of prioritising resources with incomplete information, is needed. Grey relational analysis (GRA) is the most appropriate tool for this situation. This study assessed an existing SMS and determined its critical elements in a developing country’s aviation industry. Questionnaires were framed from the SMS manual of the International Civil Aviation Organization and from previous literature. The robustness and the efficiency of the approach were tested with data obtained from airline operators in Nigeria. Assessment of SMSs was done among airline service providers ascertaining the important levels of SMS elements. GRA was then applied to this data to identify the most influential elements of an SMS. Several companies were examined. Company A needs for a focus on sharing safety information and sensitization techniques to enable SMSs to better permeate through all levels, making employees aware of their SMS roles and duties to pursue a better safety culture. Company B needs to focus on more in-depth safety information dissemination platforms and methods. Non-punitive reporting should be done and safety promotion, culture, training and education should be prioritised. Company A has a better safety record than B. Overall, from the grey model, 12 critical elements were found out of 22 revised SMS elements that affect SMS. The major critical component was the safety structure and regulation. This is needed to build long lasting and effective SMSs. The novelty of this work is its unique application of GRA for a developing country’s airline safety.

Application of satellite navigation system for emergency warning and alerting

One of the key responsibilities of any government is to communicate and disseminate safety information and warnings to the general public in case of an emergency. Traditionally, warnings are issued by the government through a broadcast approach using communication channels such as TV and radio. However this monopolistic approach is now challenged by new technologies and media capable of providing individualised warnings to personal mobile devices. Location-based emergency services and mobile alerts are becoming increasingly prevalent in the provision of emergency warnings. These new modes of emergency services have been adopted by several countries worldwide including Australia. One example is the Australian National Emergency Alert (EA) which is a telephone-based service enhanced with location-based capabilities. This paper introduces the concept of applying global satellite navigation systems such as the Japanese satellite system in the domain of emergency warning and alerting. The Japanese satellite warning system can be tailored to transmit real-time location-based emergency warnings to people's mobile devices while not being constrained by the limitations of ground-based communication technologies. A key advantage of satellite based communication is its high resilience to communication network overload and failure of ground systems and network infrastructure during a disaster. This enables people to obtain necessary information anywhere (outdoor) and anytime during times of disaster. A satellite-based warning system could also be integrated with existing warning services and be used as a complementary technology. This paper examines opportunities and challenges for using satellite navigation systems to deliver warnings and safety messages during emergencies and disasters.

A Driver Safety Information Broadcast Protocol for VANET

Due to the highly mobile nature of VANET, especially on highways, a reliable and fast penetration of emergency messages is required so that in-time decisions can be performed. A broadcast routing protocol can perform flooding in sparse network but it will suffer from high control overhead, higher delay and lower packet delivery ratio in dense environment. Since, a significant number of VANET messages including neighbour discovery, safety, destination discovery, location and service advertisements is broadcast therefore, the area of broadcast routing is important and needs careful design considerations. In this article, we propose ZoomOut Broadcast Routing Protocol for driver safety information dissemination in VANET. In ZBRP, 1-hop neighbour discovery messages are used in an intelligent way based on the speed and inter-vehicle distance of 1-hop neighbours to select a front and a behind vehicle. A neighbour from the front area is called front relative while the neighbour from behind area is called behind relative. During the processing of multi-hop safety messages, only a front or a behind relative rebroadcasts a safety message whereas nonrelatives drop it. ZBRP is compared with G-AODV, PGB and DV-CAST through ns-2 simulations. The results show that overall ZBRP performs better than the stated protocols. Keywords—Information dissemination; CAM; DENM; Intelligent beaconing; Intelligent transportation system; Broadcast suppression;

Information-centric dissemination protocol for safety information in vehicular ad-hoc networks

In vehicular networks, efficient safety information dissemination is a crucial issue. Unique characteristics of such an environment like highly mobility, fast topology changing, short-lived and intermittent connectivity pose challenges for safety information dissemination. Although IEEE 802.11p is standardized as an amendment to the IEEE 802.11 for connection-based wireless communication in vehicular environments (WAVE), it is still an open topic and a challenge to efficiently handle high mobility, intermittent connectivity, and spontaneous characteristics of vehicles on the roadway during wireless communication. This paper exploits information centric networking approach to design an efficient information dissemination protocol for such a challenging environment. The protocol is designed for both communication schemes in vehicular networks including vehicles-to-vehicles and vehicle-to-road. By focusing on information object itself, instead of end-to-end connection, the proposed mechanism supports fast and efficient data dissemination among multiple content consumers and multiple content providers, removing dependence on end-to-end connection between two nodes, thus improve the overall network performance. Through experimental results over different scenarios, we show that the proposed protocol achieves a significant improvement in term of the network performance compared to the conventional approach (WAVE).

Counting Geodesic Paths in 1D VANETs

In the IEEE 802.11p standard addressing vehicular communications, Basic Safety Messages (BSMs) can be bundled together and relayed as to increase the effective communication range of transmitting vehicles. This process forms a vehicular ad hoc network (VANET) for the dissemination of safety information. The number of "shortest multihop paths" (or geodesics) connecting two network nodes is an important statistic which can be used to enhance throughput, validate threat events, protect against collusion attacks, infer location information, and also limit redundant broadcasts thus reducing interference. To this end, we analytically calculate for the first time the mean and variance of the number of geodesics in 1D VANETs.

Analysis of Message Delivery Delay in Vehicular Networks

Improving the safety of roads and passengers is the main goal of intelligent transportation systems (ITS). However, reducing traffic and car accidents can only be achieved by disseminating safety information in a timely manner with high reliability. Although mathematical modeling of this process is extremely beneficial, analyzing the information dissemination is considerably complex due to the dynamics of vehicles and varying travel behavior. We present a mathematical model to study the delay–reliability features in a vehicular network. The proposed model not only captures both physical and medium access control (MAC) layers' characteristics of this network but addresses the partitioning problem, i.e., the tendency of cars to form disconnected islands, as well. To the best of the authors' knowledge, this is the first delay model that does all of these, and it can be used to understand the message propagation behavior in vehicular networks. The common assumption in the literature is that the intervehicle distances (IVDs) both inside the island and between islands have the same exponential distribution. We show that this assumption is flawed, and subsequently, a new and more accurate model is presented. Simulation studies validate the accuracy and effectiveness of the proposed model for both highway and urban scenarios.

An information dissemination model of product quality and safety based on scale-free networks

In the small-world model, information nodes' positions are relatively ordered. However, information dissemination between nodes is unordered on the Internet. In this study, a product quality and safety information dissemination model on the Internet is proposed in terms of the characteristics of the scale-free model in the complex network. Using the simulation tests, we found that the information diffusion rate will speed up and the time needed for the system to reach the equilibrium will shorten when the spontaneous dissemination coefficient increases. Additionally, the scope of information coverage also increases as the system's size increases. However, the time of information diffusion needed to cover the maximum area does not change with the system's size. The media's influence has also been found to have an effect on the information dissemination.

Managers’ Perceptions of Organizational Safety: Implication for the Development of Safety Culture

A key feature of a company’s safety culture is shared perceptions between managers and employees concerning the importance of safety. The purpose of the study was to assess senior managers’ perceptions of the current safety culture in Estonian SMEs from different branches of industry, based on a sample of 463 senior managers. The relationships of different aspects of safety culture and safety management systems, senior managers’ and employees’ perceptions and attitudes to safety were explored through the deployment of different research measures and methods. In addition, a qualitative approach to assessing safety culture is presented. Studies of eight SMEs included observation, analysis of documentation and semistructured interviews with senior managers and focus group interviews with employees. This paper reports on the empirical examination of the relationship between a safety climate and a safety culture through a knowledge management dimension with a special focus on management of safety knowledge. The results of this study indicate that safety climate has impact on the three dimensions of safety culture, namely, psychological, behavioral and organizational aspects of safety culture. Several specific features of safety and knowledge management, such as management commitment to safety, safety information dissemination, communication and workers’ involvement in safety were found to influence the relationship between a safety climate and a safety culture. It is concluded that the development of ‘communities of practice’ is an effective way for employees to exchange explicit and tacit safety knowledge.

Multi-Hop Broadcasting in VANET for Safety Applications

Intelligent Transportation Systems (ITS), which rely on vehicular ad hoc communication networks (VANETs), have the potential to alleviate road accidents and to save lives. Several use cases to VANETs safety applications have been proposed. Most of these applications use multi-hop broadcasting communications to disseminate safety information as far as needed in zones of relevance. A wide variety of multi-hop broadcasting approaches have been proposed in recent years. In this paper the authors review, characterize and categorize multi-hop broadcast protocols. A set of classification criteria is proposed to highlight the design principles and performance of broadcasting protocols.

Strengthening the Pharmacovigilance Programme in Nepal

The aims of pharmacovigilance are early recognition of previously unknown adverse drug reactions (ADRs), recognition of changes in frequency of known ADRs, identification of risk factors and mechanism of ADRs, quantitative analysis of benefit/risk ratio and dissemination of safety information for rational drug prescribing and regulation. The pharmacovigilance programme in Nepal is a recent development. The Department of Drug Administration (DDA) took the initiative to set up a pharmacovigilance program in 2002; however, it was initiated systematically only after two years. DDA acts as the National Pharmacovigilance Centre (NPC). It collects ADR case reports from the Regional Pharmacovigilance Centre (RPC). Currently there are six RPCs operating in the country. The current reporting trends suggest high under-reporting of suspected ADRs. This paper is a review of those studies which are focused on pharmacovigilance and healthcare professionals’ perspectives on ADR reporting in Nepal. It also recommends the possible ways to improve the ADR reporting based on the context of Nepal.DOI: http://dx.doi.org/10.3126/nje.v3i1.8286 Nepal Journal of Epidemiology 2013;3 (1): 230-235

Pharmacovigilance in the Middle East

The importance of countries to support their own national pharmacovigilance cannot be understated. While adverse drug reaction (ADR) data from other countries is helpful in making medication safety decisions, information may not be relevant or applicable to domestic populations. The aim of this study was to inventory national pharmacovigilance systems in place in the Middle East region. The Uppsala Monitoring Centre Assessment of Country Pharmacovigilance Situation questionnaire (February 2008) was adapted and translated into Arabic and administered to the head of the identified centres responsible for medication safety in 13 Arabic-speaking Middle Eastern countries. This survey contains domains pertaining to general programme information; overview of technology and personnel support; suspected ADR reporting and subsequent data use; and pharmacovigilance activity and advocacy. Data for 11 countries were obtained: representatives from two countries did not participate (Lebanon, Syria). Six described formal national pharmacovigilance programmes (Egypt, Iraq, Jordan, Oman, Kingdom of Saudi Arabia and the United Arab Emirates), while five (Bahrain, Kuwait, Palestine, Qatar and Yemen) reported no active programme or designated centre. The majority are government funded, but staff resources are constrained, ranging from two to ten people. Sixty-seven percent of programmes facilitated submission of spontaneous ADRs to the centre by email, but none directly through a web-based platform. All used the information for drug regulatory purposes and five reported dissemination of safety information to the public. This is the first survey to inventory the status of pharmacovigilance in the Middle East. While a number of countries participate in suspected ADR reporting activities, an estimated population of 30-50 million is without formal domestic programmes. Current emphasis of drug safety in the region is on detection and prevention of counterfeit products reaching the consumer. Existing mechanisms for regional collaboration should be advanced so experience from model programmes can be shared. Technology must be exploited to enhance ease of spontaneous reporting and subsequent data management.

Pharmacovigilance in the Middle East

Background: The importance of countries to support their own national pharmacovigilance cannot be understated: citizens may have unique ethnicities, traditions, and diets influencing reaction to medication; alternate brands of therapy may be imported or manufactured and differ in ingredients or production processes; ADRs and toxicities associated with traditional and herbal remedies also need to be monitored. The objective of this study is to inventory national pharmacovigilance systems in place in the Middle East region. Methods: The Uppsala Monitoring Center Assessment of Country Pharmacovigilance Situation (February 2008) was adapted and translated into Arabic. Survey domains pertain to general program overview; information technology support; suspected ADR reporting and subsequent data use; pharmacovigilance activity and advocacy. A comprehensive search was conducted to determine the existence of a governing body responsible for medication safety in 13 Arabic speaking Middle Eastern countries. Surveys were emailed to the head of the identified centres, with follow-up messages and telephone calls subsequently made as necessary. Results: Data for 10 countries was obtained: representatives from two countries did not respond (Lebanon, Syria). Six described formal national pharmacovigilance programs (Egypt, Iraq, Jordan, Oman, Saudi Arabia, and the UAE), while five (Bahrain, Kuwait, Palestine, Qatar, Yemen) reported no active program or designated center. All active programs were recently formed (< 5 years). The majority (83%) are government funded and two (33%) receive suspected ADR reports and offer drug information services. Most (83%) welcomed reports from a wide variety of health professionals, as well as from the public. Sixty-seven percent facilitated submission to the centre by email, but none directly through a web-based platform. All used the information for drug regulatory purposes but only 2 (33%) reported dissemination of safety information to the public. Conclusion: This is the first comprehensive review of the status of pharmacovigilance in the Middle East. While a number of countries participate in suspected ADR reporting activities, an estimated population of 30–50 million is without formal domestic programs. Technology must be exploited to ease spontaneous reporting and subsequent data management. Existing mechanisms for regional collaboration should be advanced so experience from model programs can be shared.

If you build it, will they come? Using a mobile safety centre to disseminate safety information and products to low-income urban families

Objective:To examine the utilisation-related outcomes associated with visiting the Johns Hopkins CareS (Children are Safe) Mobile Safety Center (MSC), a 40-foot vehicle designed to deliver effective injury prevention interventions and...

New Patient Safety Organizations Can Help Health Providers Learn From and Reduce Patient Safety Events

After the passage of the Patient Safety and Quality Improvement Act of 2005, the Federal Government has published a final rule that aims to encourage health providers to report, learn from, and, ultimately, reduce the incidence of patient safety events. The final rule is broad in scope: it describes the roles and activities of new patient safety organizations (PSOs) and establishes a process to report, protect, and disseminate safety information. In the interim, guidelines that describe how organizations can become PSOs were released in October by the U.S. Department of Health and Human Services (HHS). 1 These guidelines will be in effect until 60 days after the date of publication of the final rule in November. Under these guidelines, HHS’ Agency for Healthcare Research and Quality (AHRQ) was authorized to receive applications from qualified entities that seek to become PSOs. Ten organizations were officially listed as PSOs on November 5, 2008, and 5 more were listed on November 19. Qualified organizations can continue to submit applications through the interim period. There is no limit to the number of organizations that may apply to become PSOs. THE ROLE AND RATIONALE Private voluntary entities, PSOs were called for by the Institute of Medicine and established by Congress in the 2005 law. 2 They are intended to address a major stumbling block to sustained quality improvement: a lack of uniform Federal standards for privilege and confidentiality of information about patient safety events. Existing state-based legal protections for quality improvement activities, known as peer review protections, do not exist in all states and cover only review of hospital-based care, not services provided in other health care settings. The result has been a pervasive fear of legal liability and sanctions among physicians, other health care providers, and health care organizations. A second related barrier to quality improvement that the final rule seeks to address is the inability of health care providers to collect and share data about patient safety events with other facilities locally, within, and across states. This limitation makes it harder for providers and organizations to identify and adopt patterns of practice that reduce the risk of medical errors.

Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw

More than half of all serious adverse reactions are identified 7 or more years after a drug receives approval from the US Food and Drug Administration (FDA). In 2002, 9 months after the intravenous bisphosphonate zoledronic acid received regulatory approval for marketing, the FDA received reports of nine patients with cancer, who were treated with zoledronic acid, who unexpectedly developed osteonecrosis of the jaw. During the next 2 years, three oral surgeons described 104 patients with cancer with osteonecrosis of the jaw in the medical literature and identified intravenous bisphosphonate therapy as being common to the care of these patients. In subspecialty medical, radiology, and dental journals, case reports and case series described clinical features of osteonecrosis of the jaw in patients with cancer who were treated with bisphosphonates. Manufacturer-sponsored epidemiological studies reported the first estimates of the incidence of this toxic effect, ranging from 0.1% to 1.8%. By contrast, independent epidemiological efforts from clinicians and the International Myeloma Foundation reported incidence estimates between 5% and 10%. Between 2003 and 2005, warnings about the risks of bisphosphonate-associated osteonecrosis were disseminated by national regulatory agencies, the manufacturers of bisphosphonates, and the International Myeloma Foundation. From 2006, independent clinical recommendations for diagnosis, prevention, and treatment of this toxic effect have been disseminated by manufacturers, national regulatory authorities, the International Myeloma Foundation, and medical specialty organisations. Furthermore, independent efforts by pharmaceutical manufacturers, dental and medical professionals, a non-profit organisation (the International Myeloma Foundation), patients, and regulatory authorities has led to the rapid identification and dissemination of safety information for this serious adverse reaction. Better coordination of safety-related pharmacovigilance initiatives is now needed.

Training and selection of paraprofessional home visitors for injury prevention in low-income neighbourhoods

Responding to the lack of information on the selection and training of home visitors in the injury prevention sector, this article evaluates a training curriculum provides paraprofessionals with the requisite knowledge and skills to deliver childhood injury prevention home visiting services in four low income neighborhoods in South Africa. Pre and post training measures were used to determine the effectiveness of the training. Measures of demographic and personality characteristics were used to examine the relationship between trainee characteristics and: 1) training outcomes; and 2)commitment to the home visiting project. Trainees' performance improved significantly for safety information dissemination and closure of the home visit, but there were no improvements for introduction of the home visits and gathering of injury risk information. Training outcomes were related to education level and qualities such as warmth and enthusiasm. commitment was related to qualities such as trust and preference for teamwork. Our professional home visits, may have potential for child injury reduction provided staff recruitment, training and support are adequately addressed.

Bisphosphonate use and osteonecrosis of the jaw: Pharmacovigilance and reporting of this serious adverse event from the Research on Adverse Drug Events and Reports (RADAR) project

6519 Background: Two years after zoledronate, received FDA approval, four dental professionals treated 107 cases of osteonecrosis of the jaw (ONJ). We review the timeline and source for initial recognition of ONJ and the comprehensiveness of dissemination of information on this adverse drug event. Methods: Data sources included primary case series from dental professionals; published case reports, clinical trials, and cases reported to the manufacturers or the FDA. Exposure adjusted incidence rates estimates were derived from manufacturer sponsored and investigator initiated review of claims data from large cancer centers. Safety notifications were disseminated by the manufacturers, regulatory authorities, and academic investigators. Results: Between 2001 and 2003, 107 patients with ONJ received care from dental professionals. In late 2003, and 2004 peer-reviewed case series were published. By 2006, safety databases maintained by the FDA, the manufacturer, and the RADAR project included information on 2,270, 1,178, and 368 cases of ONJ, respectively. In 2004 and 2005, incidence estimates of 0.8 and 22 ONJ cases per 1,000 person-years of intravenous bisphosphonate therapy were reported by the manufacturer and academic investigators. From 2003 to 2006, safety information from manufacturers, national regulatory authorities, case series, and clinical guidelines were disseminated. Conclusions: Recognition and reporting of ONJ occurred two years after FDA approval of zoledronate, dissemination of safety information occurred in the third year, and publications were disseminated from year three to year five. The life-cycle for identification and information dissemination for this serious adverse drug reaction was short and comprehensive. [Table: see text] [Table: see text]

Confidentiality Laws And Secrecy In Medical Research: Improving Public Access To Data On Drug Safety

Pharmaceutical manufacturers have long considered results collected from drugs' clinical trials to be confidential information or trade secrets, even after submission to the Food and Drug Administration (FDA). We describe FDA policies regarding disclosure of clinical trial data and evaluate how courts have interpreted the Freedom of Information Act in cases seeking access to unreleased information. Recent examples of approved drugs later found to have dangerous side effects show the importance of complete dissemination of safety information. We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs.

From the FDA

DRUG labeling is of vital importance in guiding the safe and effective use of approved drugs. Drug labels represent the most visible expression of months or years of scientific review by physicians and scientists at the U.S. Food and Drug Administration (FDA), and they are also fundamental to the purpose and mission of the FDA. Creation of the FDA dates to the 1906 passage of the Food and Drugs Act, which prohibited the manufacture and interstate shipment of adulterated and misbranded foods and drugs.† A 1937 disaster, in which more than 100 people died after ingestion of Elixir Sulfanilamide, precipitated the Federal Food, Drug, and Cosmetic Act of 1938, which, for the first time in U.S. history, required demonstration of safety before marketing new drugs. Elixir Sulfanilamide contained diethylene glycol and had never been tested for safety. In 1960, a marketing application for the drug thalidomide was submitted to the FDA. Withstanding enormous pressure from the applicant, FDA reviewers, including Frances Kelsey, M.D., Ph.D., a medical officer at the Center for Drug Evaluation and Research at the FDA (Washington D.C.),‡ determined that inadequate data were available to support the safety of the drug product despite its already widespread use throughout the rest of the world. The application was not approved. After thousands of children in 46 countries were born with deformities as a consequence of thalidomide use, leaving the United States relatively unscathed, a political movement for tighter drug controls in the United States gained popular support. The Drug Amendments of 1962 were the first to require demonstration of effectiveness before marketing, recognizing that the assessment of safety must also consider benefit. Since 1962, more than a thousand prescription drugs have had their labeling changed or have been taken off the market to reflect the scientific evidence (or lack thereof) documenting their safety and/or effectiveness.§ Section 505 of the Federal Food, Drug, and Cosmetic Act (21 USC 355) currently specifies that approved drugs must be safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Current regulations stipulate the following labeling requirements: