Adverse events classification

The two items belonging to the remote patient monitoring classification are telemedicine and telehealth. Finally, the pattern identification (to learn from errors and systems influences on adverse events) classification includes items such as electronic medical records and workload and staffing data systems. Additional information on technology commonly used by the nursing profession is available in Ref. [4]. 

Increasing the concentration increases the penetration, but not to the same degree. Solubility of the corticosteroid in the vehicle is an other determinant of absorption and efficacy. So different formulations of the same corticosteroid can end up in a different efficacy classification. Efficacy can be further augmented by using the corticosteroid under occlusion. Occlusion with plastic enhances penetration and also absorption. However, with increased absorption also the risk of systemic side-effects increases. Systemic absorption will suppress the pituitary-adrenal axis and may cause Cushing s syndrome and a plethora of other adverse events (see Chapter 24, Section Il.b). Even small amounts absorbed may already cause growth retardation in children. 

To attempt to deal with the incompleteness of data in these case-based reports, the WHO developed a classification system for these adverse events (Table 35-1). This involves identifying a temporal association with the use of the drug and the OADR, a dose-response relationship, both positive dechallenge and positive rechallenge corroboration for the effect, and a plausible scientific explanation of the effect, including similar responses being noted with other drugs in the same class. Rarely is... 

With improved adverse-events listing and classification,... 

Furthermore, the recognition of variations across the different scales of spatial and temporal dimensions would enable the identification of shifting therapeutic targets to address both of the individual and the time variances in personalized medicine (see Fig. 1). Accurate and robust biomarkers can also be useful for the stratification of diseases and classification of patient subgroups for more effective prevention and therapy. The prediction of drug responses would in turn help avoid adverse events for better clinical outcomes. In addition, the construction of dynamic disease predictive networks derived from the analyses of omics data would allow for the transition from reactive treatments to holistic and proactive care. With the transformation from disease-centered to human-based care, the systems and dynamical models would provide patient-centric information to enhance the participation of individuals, the goal of participatory medicine. 

VC th this kind of classification in mind, how can a sponsor (or anyone else interested) assess whether an adverse event is associated with a particular medicine Broadly, there are two approaches - global introspection and use of algorithms. Both rely on the application of logic to the set of circumstances presented. Global introspection is most frequently used and involves one or more experts considering the factors associated with the medicine and institution. The main factors to consider are ... 

One cannot expect classification systems for events as complicated, varied, and idiosyncratic as the possible collective of adverse events to be ideal, but some methods can enhance the quality of these data. For certain events, diaries provide a systematic approach to collection. For example, in trials of vaccines, the participant fills out a daily diary card identifying events they experience in the immediate days after immunization from a list of expected adverse events that often occur at such times. 

Patient safety indicators have almost always been considered quantitative by nature (e.g. EUNetPas 2010 33 Kristensen et al. 2007 7). However, qualitative indicators can also provide important information on patient safety. For example, personnel s expressions of worry about patient safety issues in the organisation or quality audits that provide a written summary evaluation provide important information about patient safety - often more important than the quantitative indicators do. The problem of the quantification of, for example, adverse events and near misses is the loss of context, i.e. the loss of the story behind the incidents (Dekker 2011 Reiman and Rollenhagen 2011). Instead of data analysis it is merely a classification of data (Dekker 2011 143). Too often this classification is taken as a sufficient basis for managerial decisionmaking in situations that should require more in-depth analysis of the individual... 

To sum up, the issue of risk is a wide topic covered by a range of definitions, classifications and associated terms. Clearly, risk leads to various losses. Hence, risk needs to be effectively managed. To that end, it is necessary - first - to identify the external and internal sources of risk (threats) to the supply chain, and then take actions to minimise the risk of potential adverse events. 

Service life the period of time that a respirator, filter or sorbent, or other respiratory equipment provides adequate protection to the wearer Service robots machines that extend human capabilities Severity consequences of a failure as a result of a particular failure mode Severity classification a classification assigned to provide a qualitative measure of the worst potential consequences resulting from design error or item failure Sharp end point of vulnerability in care delivery where failure is visible, where expertise is applied, and adverse events are experienced Sharps objects that can penetrate the skin, such as needles, scalpels, and lancets Shielding material between a radiation source and a potentially exposed person that reduces exposure... 

Drug-related problems can be defined as Any undesirable event experienced by the patient that involves or is suspected to involve drug therapy and that actually or potentially interferes with a desired patient outcome (Strand et al. 1990). This is a vital component of Pharmaceutical Care and Clinical Pharmacy and will be described more in detail in another chapter. It should however be noted that there are several definitions and classification systems for DRPs. A literature review (van Mil et al. 2004) identified fourteen classifications and their critical elements. In the presented definition a potential problem is a DRP but this is not the case in all definitions and classifications. This is also the case for unavoidable adverse drug reactions (e.g. with cytotoxic agents). 

Many of the included trials were small and short term, resulting in few adverse cardiovascular events or deaths. Accordingly, since the results of the analysis were based on a relatively small number of events, the odds ratio could be affected by small changes in the classification of events. ... 

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