Abstract
The use of any medications during pregnancy is associated with a potential risk for deleterious effect on fetus and neonate. Many women take drugs during pregnancy however no studies were conducted to examine the extent of drug prescription to pregnant women in Russia. A retrospective study was conducted in six Russian cities among women regularly attending prenatal clinic with a late pregnancy (>35 gestational weeks). All prescribed drugs, including vitamins and minerals with brand name, dosage, date, duration and indication were monitored throughout the whole pregnancy from the first antenatal visit to gynecologist. Information was collected from original medical records in maternal obstetric history (supplemented with prescriptions during hospital stays, if available). Drugs were coded using the ATC classification (WHO, version 2004). Among 543 women enrolled, 100% received a prescription for at least one drug during pregnancy with a mean of 11.0±5.3 (range, 1 to 26) medications per women. Without vitamins, minerals, iron and iodide the average number was 6.7±3.8 (range, 1 to 19) but only 8 (1.5%) women had no other drug prescriptions. High rates of drug prescription were noted in the first trimester – 72.0% of women were administered at least one drug with a mean number 3.2±1.9 (range, 1 to 16) medications a prescription. The most frequently prescribed preparations were multivitamins (92.4% of women), iron (80.9%), spasmolytics (70.7%), gynecological antiinfectives/antiseptics (50.3%), folic acid (48.8%), minerals (48.6%), herbal urologicals (47.7%), antithrombotics, mainly dipyridamole (46.2%), herbal sedatives (43.8%), bile and liver drugs (40.1%). Commonly prescribed were vasoprotectives, mainly ascorutin (35.7%), tocolytics (27.1%), «actovegin» (26.2%), systemic antibiotics (21.5%). In accordance with the US Food and Drug Administration (FDA) risk classification system in pregnancy, most of the women were administered drugs with potentially dangerous effect on a fetus, as well as drugs with understudied safety during pregnancy. Based on the results of our study drug use during pregnancy in Russia should be continuously monitored and strictly related to an evidence based guidelines on efficacy and safety.
-
1.
Collaborative Group on Drug Use in Pregnancy (C.G.D.U.P.): Medication during pregnancy: an intercontinental cooperative study. Int J Gynecol Obstet 1992; 39:185-96.
-
2.
Lacroix I., Damase-Michel C., Lapeyre-Mestre M., Monastruc J.L. Prescription of drugs during pregnancy in France. Lancet 2000; 42:1735-6.
-
3.
Donati S., Baglio G., Spinelli A., Grandolfo M.E. Drug use in pregnancy among Italian women. Eur J Clin Pharmacol 2000; 56:323-8.
-
4.
Andrade S.E., Gurwitz J.H., Davis R.L., et al. Prescription drug use in pregnancy. Am J Obstet Gynecol 2004; 191:398-407.
-
5.
Headley J., Northstone K., Simmons H., Golding J. Medication use during pregnancy: data from the Avon longitudinal study of parents and children. Eur J Clin Pharmacol 2004; 60:355.
-
6.
Nordeng H., Eskild A., Nesheim B., Jacobson G. Drug use in pregnancy among parous Scandinavian women. Norw J Epidemiol 2001; 11:97-103.
-
7.
Schirm E., Willemijn M.M., Hilde T., de Jong-van den Berg L. Drug use by pregnant women and comparable non-pregnant women in the Netherlands with reference to the Australian classification system. Eur J Obstet Gynecol Reprod Biol 2004; 114:182-8.
-
8.
Olesen C., Sorensen H.T., de Jong-van den Berg L., et al. Prescribing during pregnancy and lactation with reference to the Swedish classification system. A populationbased study among Danish women. The Euromap Group. Acta Obstet Gynecol Scand 1999; 78:686-92.
-
9.
Czeizel A.E. Drug exposure in pregnant women. Lupus 2004 13:740-5.
-
10.
Egen V., Hasford J. Drug utilization in pregnancy – final report of the prospective study «PEGASUS». Pharmacoep Drug Saf 2002; 11:29.
-
11.
Rubin P.C., Rutherford J.M. Drug therapy in pregnant and breastfeeding women. - Clinical Pharmacology. New York: Melmon & Morellis; 2000. p.1117-41.
-
12.
Teratology Society. Teratology Primer. Available from www.teratology.org.
-
13.
Powrie R.O., Kuri R. Prescribing drugs to pregnant women. Women’s Health in Primary Care 1999; 2:547- 54.
-
14.
Bánhidy F., Lowry R.B., Czeizel A.E. Risk and Benefit of Drug use during pregnancy. Int J Med Sci 2005; 2:100-6.
-
15.
McElhatton P.R. General principles of drug use in pregnancy. The Pharmaceut J 2003; 270:232-4.
-
16.
Reviewer Guidance Evaluating the Risks of Drug Exposure in Human Pregnancies; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). 2005: 28 p.
-
17.
Lagoy C.T., Joshi N., Cragan J.D., Rasmussen S. Medication use during pregnancy and lactation: An urgent call for public health action. J of Women’s Health 2005; 14:104-9.
-
18.
Lo W.Y., Friedman J.M. Teratogenicity of recently introduced medications in human pregnancy. Obstet Gynecol 2002; 100:465.
-
19.
Acs N., Bánhidy F., Puho E., Czeizel A.E. Populationbased case-control study of influenza during pregnancy for congenital abnormalities. Birth Defects Research (Part A). Submitted.
-
20.
Acs N., Bánhidy F., Puho E., Czeizel A.E. Populationbased case-control study of acute infectious diseases of respiratory system for congenital abnormalities. Obstet Gynec. Submitted.
-
21.
Лекарственные средства, применяемые в акушерстве и гинекологии. Под ред. Кулакова В.И., Серова В.Н., Барашнева Ю.И. М.: ГЭОТАР-МЕД; 2004. 320 c.
-
22.
Руководство по безопасному материнству // Под ред. Кулакова В.И., Серова В.Н. Москва: Триада Х; 1998. 596 с.
-
23.
Серов В.Н., Стрижаков А.Н., Маркин С.А. Руководство по практическому акушерству. М.: Медицинское информационное агенство; 1997. 424 с.
-
24.
Сидельникова В.М. Актуальные проблемы невынашивания беременности. М., 1999. 140 с.
-
25.
Страчунский Л.С., Белоусов Ю.Б., Козлов С.Н. Практическое руководство по антиинфекционной химиотерапии. М.: Боргес; 2002. 384 с.
-
26.
Антибактериальная терапия инфекций мочевыводящих путей у беременных. Пособие для врачей. Клин микробиол и антимикроб химиотер 2004; 6:218-23.
-
27.
Клинико-организационное руководство для лечения женщин с гипертензией, вызванной беременностью. Комитет по здравоохранению РоссийскоАмериканской Межправительственной комиссии по экономическому и технологическому сотрудничеству. 2001. 29 с.
-
28.
Шехтман М.М. Руководство по экстрагенитальной патологии у беременных. М.: Медицина; 2003. 815 с.
-
29.
Prevention and control of deficiency anaemia in women and children. Report of the UNICEF/WHO regional consultation 1999. 119 p.
-
30.
World Health Organization (1997) Standards for maternal and antenatal care. Department for making pregnancy safer. WHO Reproductive Health Center. 2006. Available from URL: http://www.who.int/making_pregnancy_safer/publications/standards/en/index.html.
-
31.
American College of Obstetricians and Gynecologists (ACOG). Intrauterine growth restriction // ACOG prac. bulletin № 12. - Washington (DC): ACOG, 2000. 12 p.
-
32.
American College of Obstetricians and Gynecologists: Antimicrobal therapy for obstetrics patients. ACOG educ. bulletin № 245. Washington (DC): ACOG, 1998.
-
33.
American College of Obstetricians and Gynecologists: Hypertension in pregnancy. ACOG techn. bulletin № 219. Washington (DC): ACOG, 1996.
-
34.
American College of Obstetricians and Gynecologists: Management of preterm labor. ACOG prac. bulletin № 43. Washington (DC): ACOG, 2003. 9 p.
-
35.
American College of Obstetricians and Gynecologists: Nausea and vomiting of pregnancy. ACOG prac. bulletin № 52. Washington (DC): ACOG, 2004.
-
36.
Centers for disease control and prevention. Sexually transmitted diseases treatment guidelines 2006. MMWR. 2006; 55: № RR-11. 94 p.
-
37.
National Heart Lung and Blood Institute. National High Blood Pressure Education Program: Working Group Report on High Blood Pressure in Pregnancy. Bethesda (MD): National Heart, Lung and Blood Institute (NHLBI). 2000. 38 p.
-
38.
The investigation and management of the small-for-gestational-age fetus. Royal College of Obstetricians and Gynecologists. Guideline № 31. 2002. 16 p.
-
39.
Addis A., Magrini N., Mastroiacovo P. Drug use during pregnancy. Lancet 2001; 357:800.
-
40.
Haramburu F., Miremont G., Moore N. Good and bad drug prescribing in pregnancy. Lancet 2000; 356:1704.
-
41.
Physicians’ Desk Referens, 2003. Montvale, N.J.: Medical Economics Co Inc, 2003.
-
42.
Alejandro A, Koren G. Multivitamin supplements for pregnant women. Motherisk Update. 2004. available at http://www.motherisk.org.
-
43.
Czeizel, A. E., Dudas, I. and Metneki, J. Pregnancy outcomes in a randomized-controlled trial of periconceptional multivitamin supplementation. Arch Gynec Obst 1994; 255:131-9.
-
44.
Коденцова В.М., Вржесинская О.А. Витамины в питании беременных. Гинекология 2002; 4(1):7-12.
-
45.
World Health Organization (1997) Management of lowand high-risk pregnancies. WHO Regional Office for Europe.
-
46.
Taruscio D. Folic acid: from research to public health practice. Report of WHO Regional Office for Europe and the Instituto Superiore di Sanita. November 11-12, 2002 Rome.
-
47.
Арбатская Н.Ю. Йод–дефицитные заболевания и беременность: профилактика, диагностика и лечение. Русский медицинский журнал 2004; 12(13):14-6.
-
48.
Шехтман М.М. Железодефицитная анемия и беременность. Гинекология 2004; 4(6):204-10.
-
49.
Beard J.L. Effectiveness and strategies of iron supplementation during pregnancy. Am J Clin Nutr 2000; 71:1288-94.
-
50.
Cuervo L.G., Mahomed K. Treatments for iron deficiency anaemia in pregnancy (Cochrane Review). In: The Cochrane Library, Issue 4, 2004. - Chichester, UK: John Wiley & Sons, Ltd.
-
51.
Taylor-Robinson D. Ureaplasma urealyticum, Mycoplasma hominis and Mycoplasma genitalium. In: Mandell GL, Bennett J.E., Dolin R. (Eds). Principles and Practice of Infectious Diseases. 5th Ed. Philadelphia: Churchill Livingstone; 2000. 2027-32.
-
52.
Horowitz J. et al. Ureaplasma urealyticum cervical colonization as a marker for pregnancy complications. Int J Gynaecol Obstet 1995; 48: 15-9.
-
53.
Abele-Horn M., Scholz M., Wolff C., Kolben M. Highdensity vaginal Ureaplasma urealyticum colonization as a risk factor for chorioamnionitis and preterm delivery. Acta Obstet Gynecol Scand 2000; 79: 973-8.
-
54.
Donders G.C., Van Bulck B., Caudron J. et al. Relationship of bacterial vaginosis and mycoplasmas to the risk of spontaneous abortion. Am J Obstet Gynecol 2000; 183: 431-7.
-
55.
Paul V.K., Gupta U., Singh M. et al. Association of genital mycoplasma colonization with low birth weight. Int J Gynaecol Obstet 1998; 63: 109-14.
-
56.
Povlsen K., Thorsen P., Lind I. Relationship of Ureaplasma urealyticum biovars to the presence or absence of bacterial vaginosis in pregnant women and to the time of delivery. Eur J Clin Microbiol Infect Dis 2001; 20:65-7.
-
57.
Gibbs R.S., Eschenbach D.A. Use of antibiotics to prevent preterm birth. Am J Obstet Gynecol 1997; 177: 375- 80.
-
58.
Briggs G.G., Freeman R.K., Yaffe S.J. Drugs in Pregnancy and Lactation. Philadelphia: Lippincott Williams & Wilkins; 2005.
-
59.
Rubin P.C. Drug treatment during pregnancy. BMJ 1998; 317:1503-6.