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Safety Information (safety + information)
Selected AbstractsFood Scares and Trust: A European StudyJOURNAL OF AGRICULTURAL ECONOMICS, Issue 1 2008Mario Mazzocchi Abstract The complex interactions between the determinants of food purchase under risk are explored using the SPARTA model, based on the theory of planned behaviour, and estimated through a combination of multivariate statistical techniques. The application investigates chicken consumption choices in two scenarios: (a) a ,standard' purchasing situation; and (b) following a hypothetical Salmonella scare. The data are from a nationally representative survey of 2,725 respondents from five European countries: France, Germany, Italy, the Netherlands and the United Kingdom. Results show that the effects and interactions of behavioural determinants vary significantly within Europe. Only in the case of a food scare do risk perceptions and trust come into play. The policy priority should be on building and maintaining trust in food and health authorities and research institutions, while food chain actors could mitigate the consequences of a food scare through public trust. No relationship is found between socio-demographic variables and consumer trust in food safety information. [source] Management of metadata and automation for mail-in measurements with the APS 11-BM high-throughput, high-resolution synchrotron powder diffractometerJOURNAL OF APPLIED CRYSTALLOGRAPHY, Issue 6 2009Brian H. Toby A high-resolution and high-throughput synchrotron powder diffractometer has been automated for use with samples that are mailed in by Advanced Photon Source users. Implementation of a relational database with web interfaces for both outside users and beamline staff, which is integrated into the facility-wide proposal and safety system, allows all aspects of beamline management to be integrated. This system permits users to request kits for mounting samples, to provide sample safety information, to obtain their collected data and to provide usage information upon project completion in a quick and simple manner. Beamline staff use a separate interface to note receipt of samples, schedule and collect diffraction data, post-process and quality-check data, and dispose of samples. The design of the software and database are discussed in detail. [source] Developing tools for the safety specification in risk management plans: lessons learned from a pilot project,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2008Andrew J. P. Cooper BSc Abstract Purpose Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience and identifying limitations in safety information are now required for marketing authorisation applications (MAA). A collaborative research project was conducted to gain experience with tools for presenting and evaluating data in the safety specification. This paper presents those tools found to be useful and the lessons learned from their use. Methods Archive data from a successful MAA were utilised. Methods were assessed for demonstrating the extent of clinical safety experience, evaluating the sensitivity of the clinical trial data to detect treatment differences and identifying safety signals from adverse event and laboratory data to define the extent of safety knowledge with the drug. Results The extent of clinical safety experience was demonstrated by plots of patient exposure over time. Adverse event data were presented using dot plots, which display the percentages of patients with the events of interest, the odds ratio, and 95% confidence interval. Power and confidence interval plots were utilised for evaluating the sensitivity of the clinical database to detect treatment differences. Box and whisker plots were used to display laboratory data. Conclusions This project enabled us to identify new evidence-based methods for presenting and evaluating clinical safety data. These methods represent an advance in the way safety data from clinical trials can be analysed and presented. This project emphasises the importance of early and comprehensive planning of the safety package, including evaluation of the use of epidemiology data. Copyright © 2008 John Wiley & Sons, Ltd. [source] An oven explosion: Lessons learned on PSM applicationsPROCESS SAFETY PROGRESS, Issue 1 2010Michael D. Cazabon Abstract An explosion occurred at one of our customer's locations in late 1998 involving unburned and partially burned natural gas while the unit was in high fire mode. Investigation of the incident led to many contributing causes, most of which can be categorized broadly as lack of process safety information, failure of a fuel combustion control system, contractor control and lack of management of change. Combustion systems are found throughout all industries and homes. Code-based safeguards are thoroughly and adequately described in NFPA. But is the spirit and intent of the code always applied and interpreted safely? Instrumentation application and installation are similarly well described in manufacturer's literature and the ISA standards. But are these systems installed and arranged properly? Is it important to manage change in something as mundane as fuel fired equipment? Is explosion venting on industrial ovens a sound way to limit damage? Is it even possible in all instances? Are there alternatives? This article highlights the investigation activities, answers these questions, presents conclusions and suggests remedies while showing the applicability of PSM concepts to industries other than the CPI. This article will describe, in general terms: the process, critical changes in design, key components involved, applicable codes, discoveries during the investigation and solutions deployed during the rebuild to address these issues. © 2009 American Institute of Chemical Engineers Process Saf Prog 2010 [source] The Majority of Men with Lifelong Premature Ejaculation Prefer Daily Drug Treatment: An Observation Study in a Consecutive Group of Dutch MenTHE JOURNAL OF SEXUAL MEDICINE, Issue 4i 2007Marcel D. Waldinger MD ABSTRACT Introduction., Whether men with lifelong premature ejaculation (PE) prefer on-demand drug treatment to delay ejaculation time to daily drug treatment, has never been studied as a separate study question. Aim., To study how men with lifelong PE feel about the use of serotonergic antidepressants, and which option they would prefer for themselves: either a daily drug, a drug to be used on demand, or a topical anesthetic cream to be applied on demand. Main Outcome Measures., Treatment preference was determined by questionnaire. Methods., An observational questionnaire survey in a clinical sample. Preferences of different treatment strategies were queried before and after standard efficacy and safety information. Results., A consecutive group of 88 men with lifelong PE who decided for themselves to be seen for rapid ejaculation was studied. The age was 37 ± 11 years (mean ± SD), range 18,64 years. None of these men was ever treated for PE and 21% used medication that did not affect sexual performance. Of them, 71 (81%) preferred a drug for daily use, 14 (16%) a drug on demand, while three men preferred topical anesthetic cream. Those men who initially preferred daily treatment did not change their view after standard information about efficacy and side effects, while 9 of 17 men who initially preferred on-demand drug treatment had switched their preferences to daily oral drug usage. Around 60% of men did not care about the nature of the drug, i.e., an antidepressant. The most frequently reported argument to prefer daily drug treatment was that this strategy would have the least effects toward the spontaneity of having sex. Conclusion., As opposed to agents that must be taken 4,6 hours prior to coitus and with the methods used here, this group of Dutch men with lifelong PE favor uninterrupted daily drug treatment to delay ejaculation mainly because daily treatment guarantees no interference with the spontaneity of having sex. Waldinger MD, Zwinderman AH, Olivier B, and Schweitzer DH. The majority of men with lifelong premature ejaculation prefer daily drug treatment: An observation study in a consecutive group of Dutch men. J Sex Med 2007;4:1028,1037. [source] ThiaZolidineDiones and the Influence of Media Adverse Reporting on Prescribing Attitudes in PraCTice (TZD-IMPACT) StudyCARDIOVASCULAR THERAPEUTICS, Issue 2 2009Jacob George Prescribing behavior may be linked to media influence rather than to scientific evidence. Recently, the oral diabetic drug class of thiazolidinedione has been under the spotlight because of concerns over their cardiovascular safety. We have therefore conducted an electronic questionnaire survey among prescribing physicians in Tayside, Scotland to evaluate the prescribing attitudes and knowledge of the available evidence regarding the cardiovascular safety of thiazolidinedione use. Nationally representative prescribing data thoughout Scotland and Tayside from the IMS Health RSA dataset were also examined. Prescriptions for rosiglitazone alone or in combination with metformin have steadily decreased since the publication of a meta-analysis suggesting harm from rosiglitazone. This was mirrored by a gradual increase in prescriptions of pioglitazone. However, when questioned, the majority of doctors rate the level of information received regarding drug safety information on thiazolidinediones to be low with 68% of respondents scoring 5 or less (scale 1,10) on the level of information received. The source of information regarding drug safety warning was highly varied ranging from journals (21%), scientific meetings (19%) and the news media (15%). The findings of this study clearly show a need to disseminate reliable drug safety information more effectively to prescribers. [source] | |||||||||||||