Skip to main content

Advertisement

SpringerLink
Log in

Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims Data

  • Original Research
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

Purpose

Evaluation of drug safety during pregnancy is dependent on the number of exposed women during routine clinical practice with data available for analysis. We examined medication fills in pregnant and nonpregnant women within select disease cohorts: general population, migraine, diabetes, and hyperlipidemia to explore the potential use of claims data to assess medication use and safety during pregnancy.

Methods

This cohort study, using IBM MarketScan® Research Databases claims data, included women 10–54 years of age with pregnancy resulting in a liveborn infant between January 2010 and September 2015 and matched nonpregnant women. Medication use (antidepressants, antihypertensives, sedatives, glucose-lowering medications, antiepileptics, antipsychotics, lipid-lowering medications) was abstracted from pharmacy claims 180 days before last menstrual period through 180 days postdelivery.

Results

Among 753,760 women in the general pregnancy population (including 73,268 migraine, 50,155 hyperlipidemia, and 8361 diabetes; non-exclusive cohorts), antidepressants, antihypertensives, and sedatives were the most commonly used medications during pregnancy. Medications of interest were less commonly used in the pregnancy cohort than in the matched nonpregnant cohort within each time period (e.g., 3.7% vs 13.1% antidepressant use in 1st trimester). Most prescription fills were less common during pregnancy then pre-pregnancy. Post-pregnancy, prescription fills increased to or exceeded pre-pregnancy levels, except antihypertensive and glucose-lowering medications, which increased during pregnancy.

Conclusions

Medication use among pregnant women was low and different from that among matched nonpregnant women. The underlying size of large commercial claims databases offer opportunities for efficient evaluation of potential safety concerns, particularly for rare drug exposures, compared to traditional pregnancy registries.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Figure 1
Figure 2

Similar content being viewed by others

References

  1. Cragan JD, Friedman JM, Holmes LB, Uhl K, Green NS, Riley L. Ensuring the safe and effective use of medications during pregnancy: planning and prevention through preconception care. Matern Child Health J. 2006;10(5 Suppl):S129-135.

    Article  PubMed  Google Scholar 

  2. Mitchell AA, Gilboa SM, Werler MM, et al. Medication use during pregnancy, with particular focus on prescription drugs: 1976–2008. Am J Obstet Gynecol. 2011;205(1):51.

    Article  PubMed Central  Google Scholar 

  3. Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Womens Health Issues. 2013;23(1):e39-45.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Shields KE, Lyerly AD. Exclusion of pregnant women from industry-sponsored clinical trials. Obstet Gynecol. 2013;122(5):1077–81.

    Article  PubMed  Google Scholar 

  5. Kennedy DL, Uhl K, Kweder SL. Pregnancy exposure registries. Drug Saf. 2004;27(4):215–28.

    Article  PubMed  Google Scholar 

  6. Reiff-Eldridge R, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynecol. 2000;182(1 Pt 1):159–63.

    Article  CAS  PubMed  Google Scholar 

  7. Wyszynski DF. Pregnancy exposure registries: academic opportunities and industry responsibility. Birth Defects Res A. 2009;85(1):93–101.

    Article  CAS  Google Scholar 

  8. U.S. Department of Health and Human Services Food and Drug Administration. Postapproval Pregnancy Safety Studies Guidance for Industry. 2019; https://www.fda.gov/media/124746/download. Accessed December 03, 2021.

  9. European Medicines Agency. Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data. EMEA/CHMP/313666/2005. 2005; http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/11/WC500011303.pdf. Accessed December 03, 2021.

  10. Gliklich R, Dreyer N, Leavy M. Pregnancy Registries. In: Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. . Rockville: Agency for Healthcare Research and Quality (US); 2014.

  11. Sutton EF, Cain LE, Vallo PM, Redman LM. Strategies for successful recruitment of pregnant patients into clinical trials. Obstet Gynecol. 2017;129(3):554–9.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Bird ST, Gelperin K, Taylor L, et al. Enrollment and retention in 34 United States Pregnancy Registries contrasted with the manufacturer’s capture of spontaneous reports for exposed pregnancies. Drug Saf. 2018;41(1):87–94.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Huybrechts KF, Bateman BT, Hernandez-Diaz S. Use of real-world evidence from healthcare utilization data to evaluate drug safety during pregnancy. Pharmacoepidemiol Drug Saf. 2019;28(7):906–22.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Andrade SE, Toh S, Houstoun M, et al. Surveillance of medication use during pregnancy in the mini-sentinel program. Matern Child Health J. 2016;20(4):895–903.

    Article  PubMed  Google Scholar 

  15. Li Q, Andrade SE, Cooper WO, et al. Validation of an algorithm to estimate gestational age in electronic health plan databases. Pharmacoepidemiol Drug Saf. 2013;22(5):524–32.

    Article  PubMed  PubMed Central  Google Scholar 

  16. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index 2017. https://www.whocc.no/atc_ddd_index/. Accessed November 14, 2022.

  17. Berard A, Sheehy O. The Quebec Pregnancy Cohort–prevalence of medication use during gestation and pregnancy outcomes. PLoS ONE. 2014;9(4): e93870.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Stephansson O, Granath F, Svensson T, Haglund B, Ekbom A, Kieler H. Drug use during pregnancy in Sweden-assessed by the Prescribed Drug Register and the Medical Birth Register. Clin Epidemiol. 2011;3:43–50.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Tepper D. Pregnancy and lactation–migraine management. Headache. 2015;55(4):607–8.

    Article  PubMed  Google Scholar 

  20. Practice Bulletin No. 137: Gestational diabetes mellitus. Obstet Gynecol. 2013;122(2 Pt 1):406–16.

    Google Scholar 

  21. Practice Bulletin No. 201: Pregestational diabetes mellitus. Obstet Gynecol. 2018;132(6):e228–48.

    Article  Google Scholar 

  22. Jacobson TA, Ito MK, Maki KC, et al. National lipid association recommendations for patient-centered management of dyslipidemia: part 1–full report. J Clin Lipidol. 2015;9(2):129–69.

    Article  PubMed  Google Scholar 

  23. Wierzbicki AS, Humphries SE, Minhas R, Guideline DG. Familial hypercholesterolaemia: summary of NICE guidance. BMJ. 2008;337: a1095.

    Article  PubMed  Google Scholar 

  24. Ventura SJ, Curtin SC, Abma JC, Henshaw SK. Estimated pregnancy rates and rates of pregnancy outcomes for the United States, 1990–2008. Natl Vital Stat Rep. 2012;60(7):1–21.

    PubMed  Google Scholar 

  25. Bertoia ML, Phiri K, Clifford CR, et al. Identification of pregnancies and infants within a US commercial healthcare administrative claims database. Pharmacoepidemiol Drug Saf. 2022;31(8):863–74.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Funding

This study was funded by Amgen Inc. The authors wish to acknowledge Jon Nilsen, PhD (Amgen Inc.) for medical writing assistance, and Michael Gruber (Amgen Inc.) and Tracy Thomas (Amgen Inc.) for their assistance with study analysis.

Author information

Authors and Affiliations

  1. Center for Observational Research, Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA, 91320, USA

    Rohini K. Hernandez, Brian D. Bradbury & Victoria Chia

  2. Graticule, Inc., Newton, USA

    Sonja S. Nakasian

  3. Global Patient Safety, Amgen Inc., Thousand Oaks, USA

    Lisa Bollinger & Eric Ng

  4. Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Boston, USA

    Susan S. Jick

  5. Department of Epidemiology, University of Alabama at Birmingham School of Public Health, Birmingham, USA

    Paul Muntner

Authors
  1. Rohini K. Hernandez
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Sonja S. Nakasian
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Lisa Bollinger
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Brian D. Bradbury
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Susan S. Jick
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Paul Muntner
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Eric Ng
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Victoria Chia
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work: All authors. Drafting the work or revising it critically for important intellectual content: All authors. Final approval of the version to be published: All authors. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: RH.

Corresponding author

Correspondence to Rohini K. Hernandez.

Ethics declarations

Conflict of interest

Rohini K Hernandez, Lisa Bollinger, Brian D Bradbury, Eric Ng, and Victoria Chia are or were employees and stockholders of Amgen Inc. at the time of the study. Susan Jick reports consulting fees from Amgen Inc. Sonja S Nakasian reports no conflicts of interest in this work. Paul Muntner receives research support and consulting fees from Amgen, Inc.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 27 KB)

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hernandez, R.K., Nakasian, S.S., Bollinger, L. et al. Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims Data. Ther Innov Regul Sci 57, 570–579 (2023). https://doi.org/10.1007/s43441-022-00489-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s43441-022-00489-8

Keywords

Search

Navigation