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European Pharmaceutical Contractor

Bridging the Data Gap

 

Computable semantic interoperability (CSI) is the means to share information between disparate information systems in such a way that the information retains its significance (semantics), so that it can be used in meaningful ways. Often, information that is collected in one system is only really useful within that system; to communicate or share that information to another system in a meaningful way for machine processing (as opposed to human readability – that is to say document transfer) involves complex and expensive interfacing, with many mappings and transformation processes.

CSI:THE BENEFITS TO PHARMACOVIGILANCE

The science of pharmacovigilance involves collecting and analysing adverse event information collected from a range of sources – spontaneous reports from the global healthcare domain as well as more focused study reporting. Although individual reports can have value within themselves, the real benefit of this information lies in detecting trends or ‘signals’, and to do this effectively, all available data must be gathered together into standard structures for investigation, while clearly retaining its original meaning. It may also be useful to compare the adverse event information with other broader healthcare information to understand background event rates. This is reflected in the value chain of ‘data to information to knowledge to wisdom’.

Individual data elements need to be gathered together, while retaining their context and meaning, to produce information. This information can be analysed, processed and interpreted in a variety of ways, again still retaining its context and meaning, so as not to produce incorrect results, and this analysis and interpretation produces knowledge. This evidence-based knowledge, gained directly from the data and information, can then be blended with other sources that are applicable in the particular situation, to suggest an appropriate course of action in the situation.

This is easily illustrated in a clinical trials scenario: enormous amounts of data are gathered from the trial participants, including the adverse event data, and this needs to be meaningfully brought together to produce the information needed for the analyses that occur periodically through the trial period and in preparation for license submission. These analyses and interpretation provide ever increasing information about the safety of the investigational product, which should then be blended together with all the other available knowledge to enable wise decisions to be taken on further development, license application wording, specific population groups for further trialling or use, and so on.


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Julie James qualified as a pharmacist in the UK before moving into medical informatics, where she has worked for the last 15 years. In 2002, Julie became a partner in an independent health informatics consultancy, Blue Wave Informatics, which  specialises in ‘all things medicines’ – their descriptive terminology, their use in clinical applications, and in communication, such as adverse event and other safety reporting. Julie is a co-chair of the Pharmacy Special Interest Group of IHTDO, vocabulary facilitator for the Pharmacy Work Group in HL7, and an active member of the HL7 Patient Safety Work Group.

Email: julie_james@bluewaveinformatics.co.uk

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