The Effect Object Paradigm - a Means to Support Medication Safety with Clinical Decision Support

Background: In many countries, officially approved drug information known as summary of product characteristics (SPC) is mostly available in text form, which cannot be used for Clinical Decision Support Systems (CDSS). It may be essential however to substantiate CDSS advice with such legally binding text snippets. In an attempt to link various drug data sources including SPC towards a CDSS to support medication safety in psychiatric patients we arrived at the notion of an effect object. Methods: A requirements analysis revealed data items and data structure which are needed from the patient and from the drug information source for the CDSS functionality. Published drug data modelling approaches were analyzed and found unsuitable. A conceptional database modeling approach using top down and bottom up modeling was performed. Results: The schema based data model implemented within the django framework centered on SPC "effect objects" which comprise all SPC data required for the respective CDSS function such as search for contraindications in the proposed medication. Today six effect objects have been defined for contraindications and warnings, missing indications, adverse effects, drug-drug interactions, dosing and pharmacokinetics. Conclusion: The transformation of SPC data to a database-driven "effect objects" structure permits decoupling between the CDSS functions and different underlying data sources and supports the design of reusable, stable and verified CDSS functions.