Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance
Tóm tắt
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.
Tài liệu tham khảo
Hendrick V. Psychiatric disorders in pregnancy and the postpartum: principles and treatment. Totowa: Humana Press; 2006.
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.
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.
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.
Pernia S, DeMaagd G. The new pregnancy and lactation labeling rule. Pharm Ther. 2016;41(11):713–5.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.