Reporting systems Database Report

Although this section does not present historical information regarding TRI chemical releases over time, note that, in general, toxic chemical releases have been declining.13 Although onsite releases have decreased, the total amount of reported toxic waste has not declined because the amount of toxic chemicals transferred offsite has increased. Better management practices have led to increases in offsite transfers of toxic chemicals for recycling. More detailed information can be obtained from U.S. EPA s annual Toxics Release Inventory Public Data Release book, or directly from the Toxic Release Inventory System database. 

Database, Rugby, Institution of Chemical Engineers MARS(Major Accident Reporting System) Database... 

Moore N, Kreft-Jais C, Haramburu F, Noblet C, Andrejak M, Ollagnier M, Begaud B. Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs a case/non-case study in the French pharma-covigilance system database. Br J Clin Pharmacol 1997 44(5) 513-8. 

Abbokinase problems. of investigation of nonconformances (NCM) multiple failed lots "expected" and no statistical analysis of failures computer system database defects not reported to users through identified since 1997. July inspection resulted in warning letter... 

NTP. 1990. Chemical status report produced from NTP chemtrack system (database). Department of Health and Human Services, National Toxicology Program, Division of Toxicology Research and Testing, Research Triangle Park, NC. January 10, 1990. 

Upgrades due to developments, inclnding the installation of bug Axes (patches), must be tightly controlled by the personnel responsible for LIMS. Following the production of the Validation Report, LIMS is deemed to be in a validated state (snbject to any issues raised in that report). Changes at the operating system, database system, and application levels must be assessed for impacts on the validated status of LIMS. 

In an analysis of cases of torsade de pointes associated with fluoroquinolones on the FDA Adverse Events Reporting System database, two cases of torsade de pointes were noted in patients taking a fluoroquinolone with sotalol (there were 37 cases identified, and 19 occurred in patients also taking other drugs known to prolong the QT interval). Sotalol has class III antiarrhythmic effects and prolongs the QT interval, and this could be additive with the effects of quinolones that prolong the QT interval (e.g. gat-ifloxacin, moxifloxacin, sparfloxacin, see Table 9.2 , (p.257)). The... 

In addition to 3 of the cases in Table 31.1 , (p.ll27), a review of the FDA s Adverse Event Reporting System database in January 2003 found... 

Liver The FDA adverse events reporting system database have been used to identify... 

Environmental education of and information for employees Environmental information system/database Information collection for internal environmental care Environmental information collection on emissions Regular check of environmental impact Information collection for internal environmental evaluation Regular internal environmental reporting... 

Body temperature In an analysis performed using the US Food and Drug Administration s Adverse Events Reporting System database, hypothermia was associated with concomitant administration of topiramate and valproic acid in patients who tolerated either drug alone (see also Topiramate ) [326 ]. 

However, there is also evidence that adverse reactions may be more common when this combination is used. During a pharmacokinetic study in healthy volunteers a 68-year-old woman developed severe thrombocytopenia after taking the combination, and no other drug therapy, for 2 weeks [266 j. Her platelet count fell from 200 to 15 X 10 /1. The two drugs were discontinued and her platelet count returned to normal within 1 week. In a review of the FDA s Adverse Event Reporting System database there were 93 cases of reduced platelet counts associated with oseltamivir and 24 associated with probenecid. Signal detection analyses were significant for oseltamivir but not probenecid. 

From July 2006 to September 2008, 10 cases of acute phosphate nephropathy, associated with sodium phosphate tablets for bowel cleansing, were reported to the FDA s Adverse Event Reporting System database [85 ]. Renal biopsy in these patients showed nephrocalcinosis (calcium phosphate crystal deposition in the distal tubules and collecting ducts). All these patients had at least one underlying susceptibility factor for acute renal insufficiency, such as pre-existing renal impairment, hypertension, diabetes mellitus, advanced age, underlying electrolyte imbalance, and... 

Gandhi PK, Gentry WM, Bottorff MB. Cardiovascular thromboembolic events associated with febuxostat investigation of cases from the FDA adverse event reporting system database. Semin Arthritis Rheum June 2013 42(6) 562-6. 

Cardiovascular A retrospective data mining analysis of the United States Food and Drug Administration (FDA) adverse event report system database identified 10 cases (2 male, mean age 37.4 years) of thrombotic events associated with administration of one Cl esterase inhibitor product (Cinryze ). The authors identified an elevated IC025 (the lower limit of the 95% two-sided Cl of the information component) of 2.91 suggesting a higher than expected likelihood of causation between product administration and thrombotic-related preferred terms used in the analysis [36 ]. 

In a search for novel adverse events to bevacizumab, the FDA Adverse Event Reporting System database was used to identify all such events over the period between 2004 and 2009. The highest number of reports concerned... 

Shamloo BK, Chhabra P, Freedman AN, Potosky A, Mabn J, Smith SW. Novel adverse events of bevacizumab in the US FDA adverse event reporting system database. A disproportionality analysis. Drug Saf 2012 35(6) 507-18. 

Historical DataBase Subsystem We have discussed the use of on-hne databases. An historical database is built similar to an on-line database. Unlike their on-line counterparts, the information stored in a historical database is not normally accessed directly by other subsystems for process control and monitoring. Periodic reports and longterm trends are generated based on the archived data. The reports are often used for long-term planning and system performance evaluations such as statistical process (quality) control. The trends may be used to detect process drifts or to compare process variations at different times. 

Primarily recordkeeping system for individual facilities. Includes information on chemicals and manufacturers and records of accidents and training. Chris Plus adds capability of storing and printing MSDS information and assists with the preparation of Tier I and Tier II reports and right-to-know requests. Doth systems contain database of 600 toxic substances and synonyms. 

Database management system for MSDS information. Modules include SARA, for assistance in creating reports for Title III, and SAFETY for accident and incident recordkeeping. 

OLS is the Online Librar System for the Librar Network of the United States Environmental Protection Agency. It consists of several related databases that can be used to locate books, reports, and audiovisual materials on a variety of top ics. 

The main function of an incident reporting system (IRS) is to identify recurring trends from large numbers of incidents with relatively minor outcomes, or from near misses. One of the important characteristics of an IRS is that the time and resources required to evaluate an incident and incorporate it into the database must be minimized. This means that the designers of an IRS have to carefully evaluate the benefits and costs of requiring more comprehensive information from each incident that is to be reported. A requirement for too much information will bring the system into disrepute, and too little information will mean that the results are too general to be of any real value. 

These reports were in addition to the internal reporting for OSHA PSM and various local or state requirements. While Quality Chemical had long ago consolidated a number of these programs, there were still four different accident/incident reporting systems—one for external reporting of releases, one for external reporting of injuries and other nonrelease events, one for a corporate-wide database and one for each site itself. 

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