(215) Use of intravenous iron between 2004 and 2019 in Germany overall and in pregnant women

Background: Intravenous iron is a long-established treatment for iron deficiency anemia. However, due to concerns related to the occurrence of anaphylaxis, there was a direct healthcare provider communication in 2013 regarding the required risk-benefit assessment. This applies particularly to patients with allergies and immune or inflammatory conditions as well as to pregnant women, who should not be treated with intravenous iron during first trimester.

Objectives: The aim of this study was to investigate trends in outpatient prescription of intravenous iron between 2004 and 2019 and to assess exposure to intravenous iron during pregnancy, with a special focus on first trimester exposure.

Methods: Based on 2004–2019 data from the GePaRD database (claims data from ~20% of the German population), two different study designs were used: (A) To assess trends in the prescription of intravenous iron, year-wise cross-sectional analyses stratified by age and sex were conducted. We calculated annual prescription rates defined as the number of prescriptions of intravenous iron in the respective year (numerator) divided by all persons with at least one day of health insurance in the same year (denominator) (B) To describe the use of intravenous iron during pregnancy, we identified pregnancies in women aged 13-49 years with ≥1 prescription and assessed the trimester at prescription. We used established algorithms developed for GePaRD to identify pregnancies and estimate their beginning. We included pregnancies beginning between 2005 and 2018. The study was financed by the German Federal Institute for Drugs and Medical Devices (BfArM).

Results: In women, prescription rates increased in all age groups except in children aged 0-9 years (e.g. age group 40-49 years: from 5.2 per 1,000 in 2004 to 10.2 per 1,000 in 2019). In men, there was an increase in age groups 60 years and older (e.g., age groups 60-69, 70-79 and 80-89 years: from 6.3, 13.0 and 19.8 per 1,000 in 2004 to 9.5, 17.3 and 27.1 per 1,000 in 2019, respectively). Overall, we identified 12,279 pregnancies with a prescription of intravenous iron during pregnancy (2005: N=368; 2018: N=1,450). Of those, 10.4% had a prescription during the first trimester.

Conclusions: The use of intravenous iron in Germany increased between 2004 and 2019, particularly in women and older men. One tenth of pregnant women with a prescription of intravenous iron received it during the first trimester.