Advertisement

International Journal of Clinical Pharmacy

, Volume 40, Issue 4, pp 783–786 | Cite as

Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance

  • Angela LupattelliEmail author
  • Olav Spigset
  • Hedvig Nordeng
Commentary

Abstract

The growing evidence on psychotropic drug safety in pregnancy has been possible thanks to the increasing availability of real-world data, i.e. data not collected in conventional randomised controlled trials. Use of these data is a key to establish psychotropic drug effects on foetal, child, and maternal health. Despite the inherent limitations and pitfalls of observational data, these can still be informative after a critical appraisal of the collective body of evidence has been done. By valuing real-world safety data, and making these a larger part of the regulatory decision-making process, we move toward a modern pregnancy pharmacovigilance. The recent uptake of real-world safety data by health authorities has set the basis for an important paradigm shift, which is integrating such data into drug labelling. The recent safety assessment of sodium valproate in pregnant and childbearing women is probably one of the first examples of modern pregnancy pharmacovigilance.

Keywords

Pharmacovigilance Pregnancy Psychotropic drugs Real-world data Safety 

Notes

Funding

AL’s postdoctoral research fellowship is funded through the HN’s ERC Starting Grant “DrugsInPregnancy”, ERC-STG-2014 under grant agreement No 639377.

Conflicts of interest

The authors declare that they have no conflict of interest.

References

  1. 1.
    Hendrick V. Psychiatric disorders in pregnancy and the postpartum: principles and treatment. Totowa: Humana Press; 2006.CrossRefGoogle Scholar
  2. 2.
    Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernandez-Diaz S. Medication use during pregnancy, with particular focus on prescription drugs: 1976–2008. Am J Obstet Gynecol. 2011;205(1):51.e1–8.  https://doi.org/10.1016/j.ajog.2011.02.029.CrossRefGoogle Scholar
  3. 3.
    Bakker MK, Kolling P, van den Berg PB, de Walle HE, de Jong van den Berg LT. Increase in use of selective serotonin reuptake inhibitors in pregnancy during the last decade, a population-based cohort study from the Netherlands. Br J Clin Pharmacol. 2008;65(4):600–6.  https://doi.org/10.1111/j.1365-2125.2007.03048.x.CrossRefPubMedGoogle Scholar
  4. 4.
    Miani C, Robin E, Horvath V, Manville C, Cave J, Chataway J. Health and healthcare: assessing the real world data policy landscape in Europe. Rand Health Q. 2014;4(2):15.PubMedPubMedCentralGoogle Scholar
  5. 5.
    Pernia S, DeMaagd G. The new pregnancy and lactation labeling rule. Pharm Ther. 2016;41(11):713–5.Google Scholar
  6. 6.
    Spigset O, Nordeng H. Safety of psychotropic drugs in pregnancy and breastfeeding. In: Spina E, Trifirò G, editors. Pharmacovigilance in psychiatry. Cham: Springer; 2016. p. 299–319.CrossRefGoogle Scholar
  7. 7.
    Dreyer NA, Blackburn SCF, Mt-Isa S, Richardson JL, Thomas S, Laursen M, et al. Direct-to-patient research: piloting a new approach to understanding drug safety during pregnancy. JMIR Public Health Surveill. 2015;1(2):e22.  https://doi.org/10.2196/publichealth.4939.CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Wood ME, Lapane KL, van Gelder M, Rai D, Nordeng HME. Making fair comparisons in pregnancy medication safety studies: an overview of advanced methods for confounding control. Pharmacoepidemiol Drug Saf. 2017.  https://doi.org/10.1002/pds.4336.PubMedCentralCrossRefPubMedGoogle Scholar
  9. 9.
    Toh S, Manson JE. An analytic framework for aligning observational and randomized trial data: application to postmenopausal hormone therapy and coronary heart disease. Stat Biosci. 2013;5(2):1.  https://doi.org/10.1007/s12561-012-9073-6.CrossRefGoogle Scholar
  10. 10.
    Kieler H, Artama M, Engeland A, Ericsson O, Furu K, Gissler M, et al. Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries. BMJ. 2012;344:d8012.  https://doi.org/10.1136/bmj.d8012.CrossRefPubMedGoogle Scholar
  11. 11.
    EUROmediCAT. Recommendations for European pharmacovigilance concerning safety of medication use in pregnancy. Pharmacoepidemiol Drug Saf. 2015;24(2):3–7.  https://doi.org/10.1002/pds.3866.CrossRefGoogle Scholar
  12. 12.
    Schaefer C, Hannemann D, Meister R. Post-marketing surveillance system for drugs in pregnancy–15 years experience of ENTIS. Reprod Toxicol. 2005;20(3):331–43.  https://doi.org/10.1016/j.reprotox.2005.03.012.CrossRefPubMedGoogle Scholar
  13. 13.
    Kurz X, Perez-Gutthann S. Strengthening standards, transparency, and collaboration to support medicine evaluation: ten years of the European network of centres for pharmacoepidemiology and pharmacovigilance (ENCePP). Pharmacoepidemiol Drug Saf. 2018.  https://doi.org/10.1002/pds.4381.PubMedCentralCrossRefPubMedGoogle Scholar
  14. 14.
    Pharmacovigilance Risk Assessment Committee (PRAC). Assessment report. Substances related to valproate 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Valproate_and_related_substances_31/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500177352.pdf. Accessed 18 Jan 2018.
  15. 15.
    Casassus B. France bans sodium valproate use in case of pregnancy. Lancet. 2017;390(10091):217.  https://doi.org/10.1016/s0140-6736(17)31866-4.CrossRefPubMedGoogle Scholar
  16. 16.
    Bromley R, Weston J, Adab N, Greenhalgh J, Sanniti A, McKay AJ, et al. Treatment for epilepsy in pregnancy: neurodevelopmental outcomes in the child. Cochrane Database Syst Rev. 2014;10:CD010236.  https://doi.org/10.1002/14651858.cd010236.pub2.CrossRefGoogle Scholar
  17. 17.
    Graham RK, Tavella G, Parker GB. Is there consensus across international evidence-based guidelines for the psychotropic drug management of bipolar disorder during the perinatal period? J Affect Disord. 2018;228:216–21.  https://doi.org/10.1016/j.jad.2017.12.022.CrossRefPubMedGoogle Scholar
  18. 18.
    FDA. U.S. Food and Drug Administration. Drugs. Development and approval process. Development resources. Labeling. Pregnancy and lactation labeling final rule. 2015. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm. Accessed 28 May 2018.
  19. 19.
    Risk assessment of medicinal products on human reproduction and lactation: from data to labelling: European Medicines Agency 2008. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000982.jsp&mid=. Accessed 20 Jan 2018.
  20. 20.
    European Medicines Agency (EMA). Summary of the EMA public hearing on valproate in pregnancy 2017. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/10/WC500236051.pdf. Accessed 20 Jan 2018.

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.PharmacoEpidemiology and Drug Safety Research Group, School of Pharmacy, and PharmaTox Strategic Research Initiative, Faculty of Mathematics and Natural SciencesUniversity of OsloOsloNorway
  2. 2.Department of Clinical PharmacologySt Olav’s University HospitalTrondheimNorway
  3. 3.Department of Clinical and Molecular MedicineNorwegian University of Science and TechnologyTrondheimNorway
  4. 4.Department of Child Health and DevelopmentNorwegian Institute of Public HealthOsloNorway

Personalised recommendations