Methodology for the analysis and representation of the medical information about drugs in the Summary of Product Characteristics (SPC).

We present a methodology for the representation of the medical knowledge in the drug SPCs. It includes four steps, the two first of which are automated. All instances of a particular SPC text are gathered into a single file. Lexical analysis of the content of this file is performed and a lexicon with the occurrence of words and groups of words is built. Semantic analysis is carried out considering the concepts underlying each word of the lexicon and the most important concepts are kept. This semantic analysis results in a list of attributes which are then included in an object-oriented model. We have used this method to structure drug indications. This application clearly illustrates the advantages of this method over purely manual analysis. This method could be generalized for all categories of medical information about drugs.