Adverse Event Report
Analytical Software
Enhancing experience and safety
An effective medication can be successfully used by millions of patients across the world to treat their health conditions. However, in some rare cases medications might cause adverse events (AEs) negatively influencing patient health. The manufacturer of the medication is interested in learning from such adverse events to improve their offering. In addition, government regulators require pharma companies to report to these events, classified in accordance with an elaborate set of 70,000+ categories.
A large pharma company can receive annually tens of thousands of potential adverse reports submitted by patients, medical professionals, and insurance companies. These reports might come in different languages and formats. Manual processing and classification of adverse event reports is an extremely expensive and time consuming operation. Pharma companies can greatly benefit from an automated solution that detects and classifies events.
Minimize risk through Automated Classification of Patient Communications
Megaputer offers a solution for automated analysis and classification of potential AEs. The solution extracts relevant information from reports, detects all encountered adverse events, and performs classification of these events in accordance with the hierarchy of preferred terms in MedDRA ontology. The solution facilitates high recall and precision for extracting AEs. It can perform the analysis in many different languages.
How it works
The AE analysis solution can be deployed at either the customer location or at Megaputer. The solution parses AE reports received through multiple channels and in different formats, extracts important structured information, and then reads through the text of each report. It automatically detects all potential AEs, isolating them from indications for prescribing the medication and issues listed in the patient’s previous medical or family history. The solution can recognize AEs even when they are described in non-professional terms.
For each AE report, the system generates an output listing the name of the drug, the detected AEs, the corresponding MedDRA preferred terms, the seriousness of the event, and other identifiers of interest associated with the report.
A global pharmaceutical company needed a more efficient way of handling pharmacovigilance tasks. With the volume of adverse event reports rising every year, the company needed a solution that reduced the time and cost of validating, coding, categorizing, and reporting these issues to regulatory agencies.
Benefits
