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Review
. 2023 Apr 1;45(2):159-172.
doi: 10.1097/FTD.0000000000001039. Epub 2023 Jan 19.

Optimizing Therapeutic Drug Monitoring in Pregnant Women: A Critical Literature Review

Fernanda de Lima Moreira  1 , Jhohann Richard de Lima Benzi  1 , Leonardo Pinto  1 , Matheus de Lucca Thomaz  1 , Geraldo Duarte  2 , Vera Lucia Lanchote  1
Affiliations
Review

Optimizing Therapeutic Drug Monitoring in Pregnant Women: A Critical Literature Review

Fernanda de Lima Moreira et al. Ther Drug Monit. .

Abstract

Background: More than 90% of pregnant women take at least one drug during pregnancy. Drug dose adjustments during pregnancy are sometimes necessary due to various pregnancy-induced physiological alterations frequently associated with lower plasma concentrations. However, the clinical relevance or benefits of therapeutic drug monitoring (TDM) in pregnant women have not been specifically studied. Clinical pharmacokinetic studies in pregnant women are incredibly challenging for many reasons. Despite this, regulatory agencies have made efforts to encourage the inclusion of this population in clinical trials to achieve more information on the pharmacotherapy of pregnant women. This review aims to provide support for TDM recommendations and dose adjustments in pregnant women.

Methods: The search was conducted after a predetermined strategy on PubMed and Scopus databases using the MeSH term "pregnancy" alongside other terms such as "Pregnancy and dose adjustment," "Pregnancy and therapeutic drug monitoring," "Pregnancy and PBPK," "Pregnancy and pharmacokinetics," and "Pregnancy and physiological changes."

Results: The main information on TDM in pregnant women is available for antiepileptics, antipsychotics, antidepressants, antibiotics, antimalarials, and oncologic and immunosuppressive drugs.

Conclusions: More data are needed to support informed benefit-risk decision making for the administration of drugs to pregnant women. TDM and/or pharmacokinetic studies could ensure that pregnant women receive an adequate dosage of an active drug. Mechanistic modeling approaches potentially could increase our knowledge about the pharmacotherapy of this special population, and they could be used to better design dosage regimens.

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Conflict of interest statement

The authors declare no conflict of interest.

References

    1. 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;205:51.e1–51.e8. e.58.
    1. Colbers A, Mirochnick M, Schalkwijk S, et al. Importance of prospective studies in pregnant and breastfeeding women living with human immunodeficiency virus. Clin Infect Dis. 2019;69:1254–1258.
    1. Harden CL, Pennell PB, Koppel BS, et al. Practice parameter update: management issues for women with epilepsy–focus on pregnancy (an evidence-based review): vitamin K, folic acid, blood levels, and breastfeeding: report of the quality standards subcommittee and therapeutics and technology assessment subcommittee of the American Academy of Neurology and American Epilepsy Society. Neurology. 2009;73:142–149.
    1. U.S. Food and Drug Administration (FDA). Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; 2018. Available at: https://www.fda.gov/media/112195/download . Accessed December 2, 2021.
    1. U.S. Food and Drug Administration (FDA). Postapproval Pregnancy Safety Studies Guidance for Industry; 2019. Available at: https://www.fda.gov/media/124746/download . Accessed December 3, 2021.

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