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

Authors

  • N. M. Maksymovych Lviv National Medical University named after Danylo Halytsky, Ukraine

DOI:

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

Keywords:

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

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.

Author Biography

N. M. Maksymovych, Lviv National Medical University named after Danylo Halytsky

Assistent prof.

References

Клінічний випадок застосування Ксилату в комплексній терапії важкого раннього токсикозу вагітних / Ю. В. Давидова, А. Ю. Лиманська, В. Н. Тудай, А. Н. Мокрик // Здоровье женщины. – 2015. – № 1 (57). – С. 45-50.

Максимович, Н. М. Дослідження фармацевтичної складової лікування прееклампсії у вагітних / Н. М. Максимович, О. М. Заліська, К. Л. Косяченко // Фармацевтичний часопис. – 2014. – № 1 (29). – С. 128-132.

Мелащенко, С. Г. Амбулаторна допомога при блюванні та нудоті вагітних / С. Г. Мелащенко, В. О. Рудь // Здоровье женщины. – 2015. – № 10 (106). – С. 45-50.

Проект наказу Міністерства охорони здоров’я України «Про затвердження та впровадження медико-технологічних документів зі стандартизації медичної допомоги при нудоті та блюванні під час вагітності». – Режим доступу: http://www.moz.gov.ua/ua/portal/dn_20160517_0.html

Українська тератологічна інформаційна система. – Режим доступу: http://utis.in.ua/

American College of Obstetricians and Gynecologists: Practice bulletin no. 153: nausea and vomiting of pregnancy // Obstet Gynecol. – 2015. – Vol. 126, № 3. – Р. 12-24.

Danielsson, B. Use of ondansetron during pregnancy and congenital malformations in the infant // B. Danielsson, B. N. Wikner, B. Källén // Reprod Toxicol. – 2014. – Vol. 50. – P. 134-137.

Ebrahimi, N. Optimal management of nausea and vomiting of pregnancy / N. Ebrahimi, C. Maltepe, A. Einarson // International Journal of Women’s Health. – 2010. – Vol. 2. – P. 241-248.

Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial / G. Koren, S. Clark, G. D. Hankins [et al.] // Am. J. Obstet. Gynecol. – 2010. – Vol. 203. – P. 571.

Effectiveness of doxylamine – pyridoxine for morning sickness / G. Кoren, G. D. Hankins, S. Clark [et al.] // Am. J. Obstet. Gynecol. – 2016. – Vol. 214. – P. 664-666.

Einarson, T. R. Quantifying the global rates of nausea and vomiting of pregnancy: a meta analysis // T. R. Einarson, С. Piwko, G. Koren // J. Popul. Ther. Clin. Pharmacol. – 2013. – Vol. 20. – Р. 171-183.

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

FDA approval of doxylamine-pyridoxine therapy for use in pregnancy / S. R. Slaughter, R. Hearns-Stokes, T. van der Vlugt, H. V. Joffe// N. Engl. J. Med. – 2014. – Vol. 370, № 12.– Р. 1081-1083.

Fejzo, M. S. Ondansetron in pregnancy and risk of adverse fetal outcomes in the United States / M. S. Fejzo, K. W. Mac-Gibbon, P. M. Mullin // Reprod. Toxicol.– 2016. – Vol. 62. – P. 87-91.

Interventions for treating hyperemesis gravidarum / R. С. Boelig, S. J. Barton, G. Saccone [et al.] // Cochrane Database Syst Rev. – 2016. – Issue 5. – Режим доступу: http://www.cochrane.org/CD010607/PREG_interventions-treatingsevere-nausea-and-vomiting-duringpregnancy-hyperemesis-gravidarum

Jarvis, S. Management of nausea and vomiting in pregnancy / S. Jarvis, C. Nelson-Piercy // BMJ. – 2011. – Vol. 17. – Р. 342.

Koren, G. Motherisk update. Is ondansetron safe for use during pregnancy? / G. Koren // Can Fam Physician. – 2012. – Vol. 58. – P. 1092-1093.

Koren, G. Therapeutic choices for nausea and vomiting of pregnancy: a critical review of a systematic review / G. Koren, C. Maltepe, R. Gow // Journal of Obstetrics and Gynaecology Canada. – 2011. – Vol. 33, № 7. – Р. 733-735.

RCOG release: Women suffering with nausea and vomiting and hyperemesis gravidarum in pregnancy ‘need more support’, new guidelines reveal. – 2016. – № 69. – Режим доступу: https://www.rcog.org.uk/globalassets/documents/guidelines/green–topguidelines/gtg69–hyperemesis.pdf

Maternal safety of the delayed – release doxylamine and pyridoxine combination for nausea and vomiting ofpregnancy; a randomized placebo controlled trial / G. Koren, S. Clark, G. D. Hankins [et al.] // BMC Pregnancy Childbirth. – 2015. – Vol. 18, № 15. – Р. 59.

McCarthy, F. P. Hyperemesis gravidarum: current perspectives / F. P. McCarthy, J. E. Lutomski, R. A. Greene // Int. J. Womens Health. – 2014 – Vol. 6. – P. 719-725.

Maksymovych, N. Analysis of Preeclampsia Prevention in Real Practice and the Need to Improve Information Support of Doctors in Ukraine / N. Maksymovych, O. Zalis’ka, K. Horbachevska // Value in Health. – 2015. – Abstracts 18th ISPOR Annual European Congress 7–11 November, Milan, Italy. – 2015. – Vol. 18, № 7. – P. 735.

Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects / M. Anderka, A. A. Mitchell, C. Louik [et al.] // Birth Defects Res A Clin Mol Teratol. – 2012. – Vol. 94, № 1. – Р. 22-30.

Ondansetron use in early pregnancy and the risk of congenital malformations – A register based nationwide cohort study / J. T. Anderson, E. Jimenez-Solem, N. L. Andersen, J. E. Poulsen // International Society of Pharmaco-epidemiology. – Abstract

– Montreal, Canada. 2013. – Режим доступу: http://www.abstracts2view.com/ispe/view.php?nu=ISPE13L1_576.25. Ondansetron compared with doxylamine and pyridoxine for treatment of nausea inpregnancy: a randomized controlled trial / L. G. Oliveira, S. M. Capp, W. B. You [et al.] // Obstet. Gynecol. – 2014. – Vol. 124, № 4. – P. 735-742.

Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial / M. N. Abas, P. C. Tan / Obstet. Gynecol. – 2014. – Vol. 123. – P. 1272-1279.

Ondansetrone or metoclopromide? Which is more effective in severe nausea and vomiting of pregnancy? A randomized trial double-blind study / M. Kashifard, Z. Basirat, M. Kashifard [ et al.] // Clin. Exp. Obstet. Gynecol. – 2013. – Vol. 40, № 1. – P. 127-130.

Pasternak, B. Ondansetron in pregnancy and risk of adverse fetal outcomes / B. Pasternak, H. Svanstom, A. Hviid // New England Journal of Medicine. – 2013. – Vol. 368, № 9. – Р. 814-823.

Wegrzyniak, L. J. Treatment of hyperemesis gravidarum. / L. J. Wegrzyniak, J. T. Repke, S. H. Ural // Rev. Obstet. Gynecol. – 2012. – Vol. 5, № 2. – P. 78-84.

Еconomic burden of nausea and vomiting of pregnancy in the USA / C. Piwko, G. Koren, V. Babashov [et al.] // J. Popul. Ther. Clin. Pharmacol. – 2013. – Vol. 20, № 2. – Р. 149-160.

Published

2016-09-02

Issue

Section

Health organization