Reporting systems Practices

In addition to incident reporting systems, root cause analysis techniques can be used to evaluate the causes of serious incidents where resources are usually available for in-depth investigations. A practical example of root cause investigation methods is provided in Chapter 7. 

Jacobsen subsequently reported a practical and efficient method for promoting the highly enantioselective addition of TMSN3 to meso-epoxides (Scheme 7.3) [4]. The chiral (salen)Cl-Cl catalyst 2 is available commercially and is bench-stable. Other practical advantages of the system include the mild reaction conditions, tolerance of some Lewis basic functional groups, catalyst recyclability (up to 10 times at 1 mol% with no loss in activity or enantioselectivity), and amenability to use under solvent-free conditions. Song later demonstrated that the reaction could be performed in room temperature ionic liquids, such as l-butyl-3-methylimidazo-lium salts. Extraction of the product mixture with hexane allowed catalyst recycling and product isolation without recourse to distillation (Scheme 7.4) [5]. 

Four cis isomers of P-carotene (13,15-di-di-, 15-cis-, l3-cis-, and 9-cis-) and three of a-carotene (15-di-, 13-di-, and 9-cis-) were formed during heating of their respective dll-trans carotene crystals at 50,100, and 150°C. Isomerization catalyzed by heat was considered as a reversible first-order degradation reaction — a trans-to-cis conversion two- to three-fold slower than the backward (cis-to-trans) reaction (Table 4.2.6). The 9-cis- and 13-di- were the major P-carotene isomers formed and the 13 -cis- formed at a two- to three-fold faster rate than O-cw-P-carotene. In this system, a-carotene showed lower stability than P-carotene (Table 4.2.6). The activation energy (EJ was not reported since practically no degradation was observed... 

NDA requires manufacturers to submit product-labeling language, which describes the proper use, benefits, and risks of the product in question. FDA may also require, as a condition of approval of an NDA or BLA application, that postmarketing studies be conducted to monitor and confirm the safety and efficacy of a product as it is used more widely in clinical practice. In addition, all sponsors or manufacturers are required to monitor and report adverse effects, defined as health effects that may or may not be related to the drug in question. For vaccines, adverse events that occur after immunization must be reported to the Vaccine Adverse Event Reporting System. 

Hirota (13) has reported that the equilibration of a-methylstyrene with atmospheric water causes the absorption spectrum of this system practically to disappear. We find that although there is a marked decrease in the absorption spectrum under these conditions, it does not go to zero. In addition, the decay of the several transients is affected by oxygen and water in the manner discussed above. 

In this chapter we will rephrase, summarise and extend the set of practical aspects related to designing and implementing near miss reporting systems. First five general factors will be listed, followed by a more detailed discussion of two of these data collection, and acceptability. Also the overall important factor of training will be briefly outlined, Finally the relationship between an organisation s prevailing view of human error and its safety culture will be discussed. 

Given the perceived failure of spontaneous reporting systems and the paucity of ADR reports/ some institutions have instituted more active methods of ADR detection to supplement spontaneous reports. Medication order screening has become a common practice in U.S. hospitals. Manual chart reviews and audits and computer programs are used for retrospective/ concurrent/ and prospective medication utilization evaluation. Certain events often prompt an evaluation of a suspected adverse reaction. These include abrupt discontinuation of a medication/ abrupt dosage reduction/ orders for antidotes and emergency medications/ orders for special tests or serum drug concentration measurements/ and abnormal results from laboratory tests and medical procedures. 

Build a routine disease reporting system based on the Air Force prototype and adopt best practices from the commercial world. 

System and data security, data integrity and confidentiality through limited authorized system access. Procedures should be in place to limit the access to authorized users. Limited access must be ensured through physical and logical security mechanisms. Most companies already have similar procedures in place. Typically, users log onto a system with a user ID and password. Problems have been reported with practical implementation in analytical laboratories when computer controlled systems collect data over time. To prevent unauthorized access, a screen saver with password protection should be activated. 

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