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Studying drug safety during pregnancy based on routine data in Germany

Description

Examining the safety of drug use during pregnancy based on claims data in Germany

Pregnant women need drug treatment if an untreated illness were to endanger the mother or unborn child. However, the possible consequences of drug intake during pregnancy are quite uncertain. This is especially the case with newer active ingredients, but there are also many unanswered questions regarding the use of commonly used drugs. Often, there is a lack of studies assessing the risk of drug intake during pregnancy.
Based on insurance data, the project aims to examine the safety of drug therapy during pregnancy. Experts from clinical, epidemiological and statistical fields work closely together in a research group to pool their competences. Initially, the project develops suitable scientific methods to use insurance data for the respective research questions. For example, the start of pregnancy, the duration of drug intake and the existence of health problems in newborns need to be estimated as accurately as possible on the basis of the claims data. In pilot evaluations, the methodology is subsequently applied to specific, exemplary drug groups. It is checked for consistency and plausibility and, if necessary, optimized.
If successful, the results could help to prevent serious health risks in children. Furthermore, if assumed risks were not confirmed, the unnecessary discontinuation of essential medicines could be avoided. From a health economics perspective, minimizing risks for mother and child is also of great importance.

Funding period

Begin:   February 2017
End:   October 2020

Sponsor

  • The Federal Joint Committee (G-BA)

Contact

Prof. Dr. sc. hum. Ulrike Haug

Links

Poster: “Prescribing valproate to girls and women of childbearing age in Germany: Analysis of trends based on claims data” (2018 conference of the International Society for Pharmacoepidemiology (ISPE))

Poster: “Information on the expected delivery date in German claims data: Assessing its potential to estimate the beginning of pregnancy” (2018 conference of the International Society for Pharmacoepidemiology (ISPE))

Selected project-related publications

    Articles with peer-review

  • Haug U, Kollhorst B, Schink T, Thöne K, Dathe K, Schaefer C, Onken M. Investigating drug safety in pregnancy based on the German Pharmacoepidemiological Research Database (GePaRD): A proof-of-concept analysis on the association between valproate and spina bifida. Pharmacoepidemiology and Drug Safety. 2023;32(2):148-157.
    https://doi.org/10.1002/pds.5573
  • Wentzell N, Haug U. Characterization of pregnancies among women with epilepsy using valproate before or during pregnancy - A longitudinal claims data analysis from Germany. Epilepsy Research. 2022;179:106838.
    https://doi.org/10.1016/j.eplepsyres.2021.106838
  • Schäfer W, Wentzell N, Schink T, Haug U. Characterization of pregnancies exposed to St. John's wort and their outcomes: A claims data analysis. Reproductive Toxicology. 2021;102:90-97.
    https://doi.org/10.1016/j.reprotox.2021.04.005
  • Reutfors J, Cesta CE, Cohen JM, Bateman BT, Brauer R, Einarsdóttir K, Engeland A, Furu K, Gissler M, Havard A, Hernandez-Diaz S, Huybrechts KF, Karlstad Ø, Leinonen MK, Li J, Man KK, Pazzagli L, Schaffer A, Schink T, Wang Z, Yu Y, Zoega H, Bröms G. Antipsychotic drug use in pregnancy: A multinational study from ten countries. Schizophrenia Research. 2020;220:106-115.
    https://doi.org/10.1016/j.schres.2020.03.048
  • Schink T, Wentzell N, Dathe K, Onken M, Haug U. Estimating the beginning of pregnancy in German claims data: Development of an algorithm with a focus on the expected delivery date. Frontiers in Public Health. 2020;8:350.
    https://doi.org/10.3389/fpubh.2020.00350
  • Sill J, Steenbock B, Helmer S, Zeeb H, Pischke CR. Apps zur Förderung von körperlicher Aktivität - Nutzung und Einstellungen bei Erwachsenen im Alter von 50 Jahren und älter - Ergebnisse eines Online-Surveys. Prävention und Gesundheitsförderung. 2019;14(2):109-118.
    https://doi.org/10.1007/s11553-018-0674-x
  • Wentzell N, Haug U, Schink T, Engel S, Liebentraut J, Linder R, Onken M, Schaefer C, Dathe K. Valproatverordnungen bei Mädchen und Frauen im gebärfähigen Alter in Deutschland: Untersuchung zeitlicher Trends basierend auf Versichertendaten. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 2018;61(8):1022-1029.
    https://doi.org/10.1007/s00103-018-2768-1
  • Wentzell N, Schink T, Haug U, Ulrich S, Niemeyer M, Mikolajczyk R. Optimizing an algorithm for the identification and classification of pregnancy outcomes in German claims data. Pharmacoepidemiology and Drug Safety. 2018;27(9):1005-1010.
    https://doi.org/10.1002/pds.4588

    • Presentations at scientific meetings/conferences (invited)

  • Schink T. Use of insurance data to study drug utilization in children with congenital malformations. Health and Education Outcomes of Children Across Europe with Congenital Anomalies - EUROlinkCAT, 7-8 April 2022, online presentation.

    • Presentations at scientific meetings/conferences

  • Schink T, Wentzell N, Dathe K, Onken M, Haug U. Fetotoxicity of RAAS-inhibitors. 36th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 16-17 September 2020, online presentation. (Abstract published in: Pharmacoepidemiology & Drug Safety. 2020;29(S3):3705)
  • Schink T, Haug U. Estimation of the beginning of pregnancies ending in stillbirths. 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 24-28 August 2019, Philadelphia, USA. (Abstract published in: Pharmacoepidemiology & Drug Safety. 2019;28(S2):479)
  • Witzleb AJ, Schink T, Haug U. Investigating drug safety during pregnancy using German claims data: Proof-of-concept study on the association between valproate and spina bifida. Workshops der AG Pharmakoepidemiologie der Deutschen Gesellschaft für Epidemiologie (DGEpi) und der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), 23.-24. Mai 2019, Online-Vortrag.
  • Wentzell N, Haug U, Schink T, Engel S, Liebentraut J, Linder R, Onken M, Schaefer C, Dathe K. Valproatverordnungen bei Mädchen und Frauen im gebärfähigen Alter in Deutschland: Untersuchungen zeitlicher Trends basierend auf Versicherungsdaten. 13. Jahrestagung der Deutschen Gesellschaft für Epidemiologie (DGEpi), 26.-28. September 2018, Bremen.

    • Posters at scientific meetings/conferences

  • Princk C, Kollhorst B, Thöne K, Borst-Ohlraun J, Schaefer C, Onken M, Dathe K, Haug U. Treatment with tumor necrosis factor inhibitors during pregnancy and occurrence of severe infections among infants: A descripitve analysis based on German claims data. 38th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 24-28 August 2022, Copenhagen, Denmark. (Abstract published in: Pharmacoepidemiology and Drug Safety. 2022;31(Suppl.2):251)
  • Wentzell N, Schink T, Witzleb AJ, Haug U. Utilization patterns of valproate in women with epilepsy before and during pregnancy. 36th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 16-17 September 2020, online poster. (Abstract published in: Pharmacoepidemiology & Drug Safety. 2020;29(S3):3844)
  • Wentzell N, Haug U, Dathe K, Onken M, Schink T. Information on the expected delivery date in German claims data: Assessing its potential to estimate the beginning of pregnancy. 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 22-26 August 2018, Prague, Czech Republic.
  • Wentzell N, Haug U, Schink T, Engel S, Liebentraut J, Linder R, Onken M, Schaefer C, Dathe K. Prescribing valproate to girls and women of childbearing age in Germany: Analysis of trends based on claims data. 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 22-26 August 2018, Prague, Czech Republic.