D8.8 IDMP ICSR-Clinical Systems Connectivity

UNICOM Task 8.4 aims to improve a core international pharmacovigilance activity: processing and analysis of individual case safety reports (ICSR) that describe one or more suspected adverse drug reactions (ADRs) that occur in a single patient. One possible intervention to improve spontaneous ADR reporting is to integrate ADR reporting functionalities in clinical systems, e.g. hospital information systems, general practitioner systems or pharmacy systems. This deliverable explores the use of ADR reporting features in clinical system software, with emphasis on identifying reusable initiatives and characterising their use of medication description for suspect and concomitant medication. To this end, a survey amongst UK and EU National Competent Authorities and a tailored literature review were conducted. Using the ICSR-IDMP coding guidance developed earlier in Deliverable 8.7, and taking into consideration the guidance for use of Identification of Medicinal Products (IDMP) in Medicinal Product Dictionaries (MPD) (Deliverable 9.2), general recommendations are made for transformation of MPD descriptions in clinical systems to IDMP descriptions for ADR reporting in the ICSR format. Furthermore, this deliverable provides general recommendations for development and implementation of spontaneous ADR reporting functionalities in clinical systems.

Keywords: Pharmacovigilance, ADR, ISO IDMP, ICSR, ICH E2B(R3), EU ICSR Implementation Guide, case processing, MPD, EHR, clinical systems