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28. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

11.11. - 12.11.2021, digital

Prescription of potentially teratogenic drugs in women of childbearing age and during first trimester of pregnancy in a large cohort of statutory health insured women

Meeting Abstract

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  • author presenting/speaker Veronika Lappe - PMV Forschungsgruppe, Universität zu Köln, Medizinische Fakultät und Uniklinik Köln, Köln, Germany
  • corresponding author Ingrid Schubert - PMV Forschungsgruppe, Universität zu Köln, Medizinische Fakultät und Uniklinik Köln, Köln, Germany
  • author Daniel Grandt - Klinik für Innere Medizin I, Klinikum Saarbrücken, Saarbrücken, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 28. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. sine loco [digital], 11.-12.11.2021. Düsseldorf: German Medical Science GMS Publishing House; 2021. Doc21gaa07

doi: 10.3205/21gaa07, urn:nbn:de:0183-21gaa077

Veröffentlicht: 10. November 2021

© 2021 Lappe et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Background: Certain drugs have a teratogenic potential if taken during the vulnerable phase in pregnancy. Especially in the first weeks after implantation of the embryo, the risk for severe malformations is high. At this time not all women are aware of their pregnancy. Since women of childbearing age are at risk of unintended pregnancy, a safe medication or contraception method should be chosen. The analysis of the claims data aimed to quantify the number of women of childbearing age and pregnancy who were prescribed teratogenic drugs.

Materials and Methods: Two populations insured with a large German statutory health insurance were analyzed: a) women of childbearing age (13–49) in 2018 and b) women with childbirth in 2018, who completed at least the 13th week of pregnancy. Inpatient deliveries (about 98% of all births in Germany) were identified through hospitalisation with the following DRG codes: O01A-O01H, O02A-O02B and O06A-O06D. Date of birth was defined as the first date with an obstetrical OPS code (5-72 – 5-75, 9-26) coded during the hospitalization or, if missing, the date of hospital admission. The length of pregnancy was derived from the ICD code O09 coded in hospital. The most important teratogens according to the publication of Dathe and Schaefer [1] and drugs with risk management plan because of their teratogenic risk (according to Medicinal Products Act (Arzneimittelgesetz – AMG) sect. 28, para. 3a, 3b) were considered.

Results: In 2018, 7.8% of the 1,976,584 women in childbearing age received a prescription for a potentially teratogenic drug. According to the teratogenic potential, 6.8% received a weak teratogen (malformation risk 1:100 to 1:1000), 0.8 an assured teratogen (risk 1:10), and 0.6% a strong teratogen (risk 3:10). Most often glucocorticoids (4.6% of women) and trimethoprim with/without sulfamethoxazole (2.0%) – both weak teratogens – were prescribed. The most common strong teratogens were valproic acid (214:100,000 women) and retinoids for systemic use (177:100,000). During the first trimester of pregnancy teratogens were prescribed to 1.0% of the 66,549 women with delivery in 2018: 92:10,000 received weak teratogens, 5:10,000 assured teratogens, and 3:10,000 strong teratogens. The most often prescribed strong teratogen was valproic acid (2:10,000 women). Nearly all women with strong teratogens had already received a prescription for these drugs in the three quarters before pregnancy.

Conclusion: A relevant number of prescriptions for potential teratogenic drugs for women of childbearing age and especially during first trimester of pregnancy was observed. In particular, the prescription of strong teratogens should be treated as “never event”, i.e. an event with serious consequences that can be avoided. In order to improve drug safety in childbearing age and to avoid the use of teratogens in the vulnerable phase of pregnancy, women should be entitled to receive the national medication plan regardless of the number of drugs taken. There, the potential teratogenic risk of the drugs when taken in the first trimester should be documented to make it visible to women and all treating physicians.

Acknowledgement: The study is part of the „BARMER Drug Report 2021 („Arzneimittelreport 2021“) and was financed by BARMER.


References

1.
Dathe K, Schaefer C. The Use of Medication in Pregnancy. Dtsch Arztebl Int. 2019;116 (46): 783–90. DOI: 10.3238/arztebl.2019.0783. Externer Link