Severe hypersensitivity reactions (anaphylaxis) may result from use of medication or exposure to other allgernes such as food, plant supplements, or insect poison. Symptoms are diverse but typically include dermal manifestations such as swelling or itching in combination with compromised circulation and/or breathing.
Anaphylaxis has also been described as a very rare complication of intravenously administered iron preparations. The European Authorisation Authority (EMA), after evaluation of the evidence, has found in principle that the benefits outweigh the risks. However EMA recommended further evaluation of the incidence of anaphylaxis related to iv iron.
For this purpose, a Post-Authorization Safety Study (PASS) is conducted in Large Databases from five European countries. The responsibility and funding of the study was imposed on manufacturers of iv iron represented in Europe, groupd in consortium of 17 companies. The study itself is coordinated by RTI-HS. The PASS is registered in THE European Register EUPAS. The study protocol is openly accessible. International Participants come from Aarhus (DK), Bordeaux (FR), the Pharmo Database Network (NL) and the Karolinska (S).
From Germany, BIPS (Bremen, GePaRD), DIMDI (Cologne, DaTraV) and the Board Of Trustees for Hemodialysis (KfH-QiN) take part in this Study, as these Institutes run potentially suitable databases for Investigating rare adverse events. In most databases, events are identified by using diagnosis codes. The validity of various codes and code combinations to identify anaphylaxis is unknwon. Therefore, we investigate the validity of outcome criteria as used in the PASS to describe anaphylaxis.
We cooperate with several departments within the Oldenburg Klinikum to determine the predictive value (PPV) of coding Based on hospital discharge diagnoses and related clinical Information. Results will facilitate interpretation of the safety information, in particular for German databases, as an essential part of the EMA Report.