Pharmaceutical Technologist - May 2008 - (Page 15)

Integrated safety evaluating the ADR in the light of the patient’s history. The ability to access a patient’s EMR would enable the pharmaceutical companies’ safety physicians to make the right decision early, as they would have the requisite information. This would improve both the quality of data captured and the time for assessment, and could positively impact the reporting rate, which has, historically, been very low, as less time and effort would be required. Adding patient health information The detection of patterns in drug reactions using signal detection algorithms run against an integrated data repository that combines internal and external data, allows drug safety scientists to perform analysis that was hitherto impossible. Scientists can carefully select and target treatment therapies based on patient data and can test hypothesis on potential signals. Large pharmaceutical companies and public heath consortiums are increasingly focusing on this area. Companies have already integrated internal clinical systems with external data sources, such as biomarker data, FDA AERS, clinical trial and postmarketing safety data. The next step in this evolution is to extend this infrastructure to include patient health information. The best approach for achieving this is to use a shared data content labelling standard, such as XML, to automatically transfer patient health information. Such a standard is universally acceptable, has a practical feasibility and is supported by enabling standards, such as ICH E2B, CDSIC and HL7. The creation of such an integrated infrastructure can be built using existing data warehousing and data mining technologies. Integrated safety platforms that have already been deployed for some companies can be extended to include EMR data sources. ● The staging layer to clean and process data from multiple sources, including FDA AERS, EMR and the Medicines and Healthcare Regulatory Agency. This component would receive and exchange data in an ICH-compliant XML format, and it would allow data stewards to perform data reviews and take remedial measures to improve data quality. data integration increases patient safety in multiple ways; from increasing the quality of signal detection to enabling faster capture of adverse event data. ● The blueprint An integrated safety platform (Figure 1) should consist of the following: ● The repository layer to store the integrated data. The data model for storage would follow CDISC ODM (or Janus) and SDTM structure to facilitate pooled analysis and regulatory submission. The distribution layer to present the data to different sets of users, such Figure 1 Integrated safety platform. Source layer Unstructured data sources Interactive voice response system documents Staging layer Repository layer Distribution layer Presentation layer Structured data sources Structured data sources SAS dataset for analysis Clinicians/ statisticians Clinical data Clinical data Archival database Post-marketing safety data Post-marketing Customized adapters E2B format Clinical data Staging area I (XML) E2B engine gateway Staging area II ETL EHR data CDISC format Signal detection algorithms FDA andWHO AERS data FDA & WHO AERS data Prescription data Prescription data Pharmacoepidemiologists Patient data DictionarIes and thesaurus Dictionaries & thesaurus Ad hoc reporting Reporting users (metrics, tracking, statistics ) EHR data www.ptemagazine.com 15 http://www.ptemagazine.com

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - May 2008

Pharmaceutical Technologist - May 2008 Contents Industry Highlights Morpheus Market Watch Pharma’s Need for Integrated Safety Is Pharma’s Future Mobile? Facing the CRO Behemoths Q&A

Pharmaceutical Technologist - May 2008

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