Analysis of evidence-based data and the information support of pharmaceutical care for preqnant women

N. M. Maksymovych

Abstract


The article presents the evidence-based data and the results of systematic analysis of the national and English publications, regulation documents, PubMed, Cochrane systematic reviews on the problem of the rational pharmacotherapy of nausea and vomiting of pregnant women (NVP). The range of drugs used for the evidence-based treatment of NVP has been analyzed. The economic costs of the drug regimen for ondansetron as the second-line drug treatment have been evaluated. The analysis of 32 official instructions on specific drugs in NVP has been carried out. It has been determined that the insufficient data or the lack of information about doses, duration of administration in NVP for such drugs as ondansetron, metoclopramide, promethazine, doxylamine complicate the correct dosing and the regimen in pregnancy. The necessity of addition and correction of official instructions concerning the dose, duration of administration in NVP has been substantiated. It has been shown that there is a need to extend the range of the registered drugs, in particular by the combination of doxylamine succinate and pyridoxine hydrochloride recommended by the FDA and commonly prescribed for pregnant women in many countries for the evidence-based effective treatment of NVP.


Keywords


evidence-based medicine; nausea and vomiting in pregnancy; economic costs of treatment of nausea and vomiting in pregnancy; ondansetron

References


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GOST Style Citations


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2. Maksymovych NM, Zalis’ka OM, Kosiachenko KL. Pharmaceutical review. 2014;1(29):128-32.

3. Melashchenko SG, Rud`VA. Zdorov’e zhenshhiny. 2015;10(106):45-50.

4. Pro zatverdzhennia ta vprovadzhennia medyko-tekhnolohichnykh dokumentiv zi standartyzatsii medychnoi dopomohy pry nudoti ta bliuvanni pid chas vahitnosti : proekt nakazu Ministerstva okhorony zdorovia Ukrainy [Internet]. Available from: http://www.moz.gov.ua/ua/portal/dn_20160517_0.html

5. Ukrainian Teratology Information System [Internet]. Available from: http://utis.in.ua/

6. American College of Obstetricians and Gynecologists: Practice bulletin no. 153: nausea and vomiting of pregnancy. Obstet Gynecol. 2015;126(3):12-24.

7. Danielsson B, Wikner BN, Källén B. Use of ondansetron during pregnancy and congenital malformations in the infant. Reprod Toxicol. 2014;50:134-37.

8. Ebrahimi N, Maltepe C, Einarson A. Optimal management of nausea and vomiting of pregnancy International Journal of Women’s Health. 2010;2:241-48.

9. Koren G, Clark S, Hankins GD, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of delayed–release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J.Obstel Gynecol. 2010;203:571.

10. Koren G, Hankins GD, Clark S, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of doxylamine–pyridoxine for morning sickness. Am J Obstet Gynecol. 2016;214(5):664-66.

11. Einarson TR, Piwko C, Koren G. Quantifying the global rates of nausea and vomiting of pregnancy: a meta analysis. J Popul Ther Clin Pharmacol. 2013;20:171-83.

12. FDA Drug Safety communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron). Available from: http://www. fda.gov/Drugs/ DrugSafety/ucm271913.htm.

13. Slaughter SR, Hearns–Stokes R, van der Vlugt T, Joffe HV. FDA approval of doxylamine–pyridoxine therapy for use in pregnancy. N Engl J Med. 2014;370(12):1081-83.

14. Fejzo MS, MacGibbon KW, Mullin PM. Ondansetron in pregnancy and risk of adverse fetal outcomes in the United States. Reprod Toxicol. 2016;62:87-91.

15. Boelig RC, Barton SJ, Saccone G, Kelly AJ,  Edwards SJ, Berghella V. Interventions for treating hyperemesis gravidarum. Cochrane Database Syst Rev. 2016;(5).

16. Jarvis S, Nelson–Piercy C. Management of nausea and vomiting in pregnancy. BMJ. 2011;17:342.

17. Koren G. Motherisk update. Is ondansetron safe for use during pregnancy? Can Fam Physician. 2012;58:1092-93.

18. Koren G, Maltepe C, Gow R. Therapeutic choices for nausea and vomiting of pregnancy: a critical review of a systematic review. Journal of Obstetrics and Gynaecology Canada. 2011;33(7):733-35.

19. RCOG release: Women suffering with nausea and vomiting and hyperemesis gravidarum in pregnancy ‘need more support’, new guidelines reveal. The Management of Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum. 2016;(69).

20. Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, Mattison DR, Matok I. Maternal safety of the delayed–release doxylamine and pyridoxine combination for nausea and vomiting ofpregnancy; a randomized placebo controlled tria. BMC Pregnancy Childbirth. 2015;18(15):59.

21. McCarthy FP, Lutomski JE, Greene RA. Hyperemesis gravidarum: current perspectives. Int J Womens Health. 2014;6:719-25.

22. Maksymovych N, Zalis’ka O, Horbachevska K. Analysis of Preeclampsia Prevention in Real Practice and the Need to Improve Information Support of Doctors in Ukraine. In: Abstracts 18th ISPOR Annual European Congress 7–11 November, Milan, Italy. Value in Health. 2015;18(7):735.

23. Anderka M, Mitchell AA, Louik C, Werler MM, Hernández–Diaz S, Rasmussen SA. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol. 2012;94(1):22-30.

24. Andersen JT, Jimenez–Solem E, Andersen NL, Poulsen JE. Ondansetron use in early pregnancy and the risk of congenital malformations. Presented at International Society of Pharmacoepidemiology. Montreal, Canada; 2013. Available from: http://www.abstracts2view.com/ispe/view.php?nu=ISPE13L1_576.

25. Oliveira LG, Capp SM, You WB, Riffenburgh RH, Carstairs SD. Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. Obstet Gynecol. 2014;124(4):735-42.

26. Abas MN, Tan PC. Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. Obstet Gynecol. 2014;123(6):1272-79.

27. Kashifard M, Basirat Z, Kashifard M, Golsorkhtabar–Amiri M, Moghaddamnia A. Ondansetrone or metoclopromide? Which is more effective in severe nausea and vomiting of pregnancy? Arandomized trial double–blind study. Clin Exp Obstet Gynecol. 2013;40(1):127-30.

28. Pasternak B, Svanstom H, Hviid A. Ondansetron in pregnancy and risk of adverse fetal outcomes. New England Journal of Medicine. 2013;368(9):814-23.

29. Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5 (2):78-84.

30. Piwko C, Koren G, Babashov V, Vicente C, Einarson TR. Economic burden of nausea and vomiting of pregnancy in the USA. J Popul Ther Clin Pharmacol. 2013;20(2):149-60.





DOI: https://doi.org/10.24959/sphhcj.16.52

Abbreviated key title: Soc. farm. ohor. zdor.

ISSN 2518-1564 (Online), ISSN 2413-6085 (Print)