Principal investigator:


  • European Consortium of 17 Iron Manufacturers

Current status:

The study was completed in 2021. The results have been published.


External Validation of Severe Hypersensitiviy (Anaphylactic) Reaction Codes in German Hospital Departments (ANAVAL)


Severe hypersensitivity reactions (anaphylaxis) can occur to very different allergens. The most important groups concern foods, insect venoms and drugs.

For example, anaphylaxis is also described as a very rare complication of the administration of i.v. iron preparations. After reviewing the data, the European Medicines Agency (EMA) had concluded in principle that the benefits outweighed the risks, but made a recommendation to investigate the incidence of anaphylaxis in more detail. Responsibility and funding for the study were placed on the manufacturers represented in Europe. They are grouped in a consortium of 17 companies. The study was coordinated by RTI-HS, a spin-off of U.S.-based universities based in North Carolina and Barcelona. PASS is registered in the European registry EUPAS, and the study protocol is publicly available there. International participants are from Aarhus (DK), Bordeaux (FR), the Pharmo Database Network (NL), and Karolinska (S).

From Germany, the BIPS in Bremen (GePaRD), the DIMDI in Cologne (DaTraV), and the Kuratorium für Hämodialyse (KfH-QiN) participated in this study, as these institutes have potentially suitable databases to investigate rare adverse events. Here, anaphylaxis is recorded via coded discharge diagnoses. Our department was commissioned to validate the ICD-based algorithms.

The validation study was based on discharges from Oldenburg Hospital. It has now been completed.


  • de Sordi D, Kappen S, Otto-Sobotka F, Kulschewski A, Weyland A, Gutierrez L, Fortuny J, Reinold J, Schink T, Timmer A. Validity of Hospital ICD-10-GM Codes to Identify Anaphylaxis. Pharmacoepidemiology and Drug Saf. doi: 10.1002/pds.5348
(Changed: 19 Jan 2024)  | 
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