БЕЗОПАСНОЕ ИСПОЛЬЗОВАНИЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ ВО ВРЕМЯ БЕРЕМЕННОСТИ В ФОКУСЕ МЕЖДУНАРОДНОЙ ПРАКТИКИ ОРГАНИЗАЦИИ СИСТЕМЫ ФАРМАКОНАДЗОРА И ТЕРАТОЛОГИЧЕСКОЙ ИНФОРМАЦИОННОЙ СЛУЖБЫ
Аннотация
Безопасное использование лекарственных средств (ЛС) во время беременности является существенным для оптимизации здоровья самой женщины и ее будущего ребенка. Акушеры-гинекологи при этом часто сталкиваются с отсутствием основанной на доказательствах информации об использовании ЛС, предлагая женщине самостоятельно решать вопрос — превышает ли польза лечения для матери риски для нерожденного ребенка, основываясь на ограниченном количестве научных данных. Преконцепционное обсуждение реальных рисков и безопасного лечения уменьшает страхи пациенток и максимизирует фокус на безопасность терапии. Вместе с тем отсутствие адекватной информации в отношении безопасности большинства ЛС, используемых беременными женщинами, в совокупности с необходимостью принятия решений о соответствующем лечении и передачи информации о риске ЛС потенциально уязвимой популяции является наиболее проблематичным и критическим вопросом женского здоровья во время беременности.
Об авторах
К. А. Луцевич
Саратовский государственный медицинский университет им. В.И. Разумовского Минздрава Российской Федерации
Россия
Россия
доктор медицинских наук, профессор, заведующая кафедрой фармакологии ГБОУ ВПО «Саратовский государственный медицинский университет им. В.И. Разумовского» Минздравсоцразвития РФ
О. В. Решетько
Саратовский государственный медицинский университет им. В.И. Разумовского Минздрава Российской Федерации
Россия
Россия
И. И. Санина
Саратовский государственный медицинский университет им. В.И. Разумовского Минздрава Российской Федерации
Россия
Россия
Список литературы
1. Raal A., Fischer K., Irs A. Determination of drug information needs of health care professionals in Estonia. Medicina (Kaunas). 2006; 42: 1030–1034.
2. Webster W. S., Freeman J. A. Prescription drugs and pregnancy. Expert Opin Pharmacother. 2003; 4: 949–961.
3. Goodwin J., Rieder S., Rieder M. J., Matsui D. Counseling regarding pregnancy: related drug exposures by family physicians in Ontario. Can J Clin Pharmacol. 2007; 14: e58–e69.
4. Bondarianzadeh D., Yeatman H., Condon-Paoloni D. Listeria education in pregnancy: lost opportunity for health professionals. Aust N Z J Public Health. 2007; 31: 468–474.
5. Sinikovic D. S., Yeatman H. R., Cameron D., Meyer B. J. Women’s awareness of the importance of long-chain omega-3 polyunsaturated fatty acid consumption during pregnancy: knowledge of risks, benefits and information accessibility. Public Health Nutr. 2009; 12: 562–569.
6. Einarson A., Park A., Koren G. How physicians perceive and utilize information from a teratogen information service: the Motherisk Program. BMC Med Educ. 2004; 4: 6.
7. Archer N. P., Langlois P. H., Case A. P., Wolfe L. J. Linking teratogen information service and birth defects registry databases to improve knowledge of birth defect status. Birth Defects Res A Clin Mol Teratol. 2006; 76: 126–128.
8. Hancock R. L., Koren G., Einarson A. et al. The effectiveness of Teratology Information Services (TIS). Reprod Toxicol. 2007; 23: 125–132.
9. Chambers C. D., Polifka J. E., Friedman J. M. Drug safety in pregnant women and their babies: ignorance is not bliss. Clin Pharmacol Ther. 2008; 83: 181–183.
10. Schaefer C. Drug safety in pregnancy: Utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services. Congenital Anomalies. 2011; 51: 6–11.
11. Lyerly A. D., Little M. O., Faden R. The second wave: Toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008; 1: 5–22.
12. Della-Giustina K., Chow G. Medications in pregnancy and lactation. Emerg Med Clin North Am. 2003; 21: 585–613.
13. US Food and Drug Administration. Requirements on content and format of labeling for human prescription drug and biological products. Fed Regist. 2006; 71: 3921–3997.
14. Fiebus K. B. FDA’s proposed rule for pregnancy and lactation labelling: improving maternal child health through well-informed medicine use. J Med Toxicol. 2008; 4: 284–288.
15. Koren G., Sakaguchi S., Klieger C. et al. Toward improved pregnancy labeling. J Popul Ther Clin Pharmacol. 2010; 17: e349–e357.
16. Scialli A. R., Buelke-Sam J. L., Chambers C. D. et al. Communicating risks during pregnancy: A workshop on the use of data from animal developmental toxicity studies in pregnancy labels for drugs. Birth Defects Res A Clin Mol Teratol. 2004; 70: 7–12.
17. Kweder S. L. Drugs and biologics in pregnancy and breastfeeding: FDA in the 21 (st) century. Birth Defects Res A Clin Mol Teratol. 2008; 82: 605–609.
18. Widnes S. K. F., Schjott J. Advice on drug safety in pregnancy: Are there differences between commonly used sources of information? Drug Saf. 2008; 31: 799–806.
19. Lo W. Y., Friedman J. M. Teratogenicity of recently introduced medications in human pregnancy. Obstet Gynecol. 2002; 100: 465–473.
20. Adam M. P., Polifka J. E., Friedman J. M. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet. 2011; 157: 175–182.
21. Herring C., McManus A., Weeks A. Off-label prescribing during pregnancy in the UK: an analysis of 18,000 prescriptions in Liverpool Women's Hospital. Int J Pharm Pract. 2010; 18: 226–229.
22. Schwarz E. B., Maselli J., Norton M., Gonzales R. Prescription of teratogenic medications in United States ambulatory practices. Am J Med. 2005; 118: 1240–1249.
23. Malm H., Martikainen J., Klaukka T., Neuvonen P. J. Prescription of hazardous drugs during pregnancy. Drug Saf. 2004; 27: 899–908.
24. Koren G., Nickel C. Perpetuating fears: bias against the null hypothesis in fetal safety of drugs as expressed in scientific citations. J Popul Ther Clin Pharmacol. 2011; 18: e28–e32.
25. Pole M., Einarson A., Pairaudeau N. et al. Drug labeling and risk perceptions of teratogenicity: a survey of pregnant Canadian women and their health professionals. J Clin Pharmacol. 2000; 40: 573–577.
26. Bjerrum L., Foged A. Patient information leaflets: helpful guidance or a source of confusion? SPCs and product monographs for the same drug. Pharmacoepidemiol Drug Saf. 2003; 12: 55–59.
27. Fusier I., Tollier C., Husson M. C. Infovigilance: reporting errors in official drug information sources. Pharm World Sci. 2005; 27: 166–169.
28. Morgan M. A., Cragan J. D., Goldenberg R. L. et al. Obstetriciangynaecologist knowledge of and access to information about the risks of medication use during pregnancy. J Matern Fetal Neonatal Med. 2010; 23: 1143–1150.
29. Van der Pal-de Bruin K. M., le Cessie S., Elsinga J. et al. Pre-conception counselling in primary care: prevalence of risk factors among couples contemplating pregnancy. Paediatr Perinat Epidemiol. 2008; 22: 280–287.
30. Han J. Y., Nava-Ocampo A. A., Koren G. Unintended pregnancies and exposure to potential human teratogens. Birth Defects Res A Clin Mol Teratol. 2005; 73: 245–248.
31. Andrade S. E., Gurwitz J. H., Davis R. L. et al. Prescription drug use in pregnancy. Am J Obstet Gynecol. 2004; 191: 398–407.
32. Lee E., Maneno M. K., Smith L. et al. National patterns of medication use during pregnancy. Pharmacoepidemiol Drug Saf. 2006; 15: 537–545.
33. Sanz E., Gomez-Lopez T., Martinez-Quintas M. J. Perception of teratogenic risk of common medicines. Eur J Obstet Gynecol Reprod Biol. 2001; 95: 127–131.
34. Schwarz E. B., Postlethwaite D. A., Hung Y.-Y., Armstrong M. A. Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive-age women. Ann Intern Med. 2007; 147: 370–376.
35. Elsinga J., de Jong-Potjer L. C., van der Pal-de Bruin K. M. et al. The effect of preconception counselling on lifestyle and other behaviour before and during pregnancy. Womens Health Issues. 2008; 18 (6 Suppl.): S117–125.
36. Winterbottom J. B., Smyth R. M., Jacoby A., Baker G. A. Preconception counselling for women with epilepsy to reduce adverse pregnancy outcome. Cochrane Database Syst Rev. 2008; 3: CD006645.
37. Griffiths F., Lowe P., Boardman F. et al. Becoming pregnant: exploring the perspectives of women living with diabetes. Br J Gen Pract. 2008; 58: 184–190.
38. Schwarz E. B., Santucci A., Borrero S. et al. Perspectives of primary care clinicians on teratogenic risk counseling. Birth Defects Res A Clin Mol Teratol. 2009; 85: 858–863.
39. Santucci A. K., Gold M. A., Akers A. Y. et al. Women’s perspectives on counseling about medication-induced birth defects. Birth Defects Res A Clin Mol Teratol. 2010; 88: 64–69.
40. Nordeng H., Koren G., Einarson A. Pregnant women’s beliefs about medications — A study among 866 Norwegian women. Ann Pharmacother. 2010; 44: 1478–1484.
41. Damase-Michel C., Pichereau J., Pathak A. et al. Perception of teratogenic and foetotoxic risk by health professionals: a survey in Midi-Pyrenees area. Pharmacy Practice. 2008; 6: 15–19.
42. Nordeng H., Ystrom E., Einarson A. Perception of risk regarding the use of medications and other exposures during pregnancy. Eur J Clin Pharmacol. 2010; 66: 207–214.
43. Gendron M. P., Martin B., Oraichi D., Berard A. Health care providers’ requests to Teratogen Information Services on medication use during pregnancy and lactation. Eur J Clin Pharmacol. 2009; 65: 523–531.
44. Koren G. The way women perceive teratogenic risk. Can J Clin Pharmacol. 2007; 14: e10–e16.
45. Bonari L., Koren G., Einarson T. R. et al. Use of antidepressants by pregnant women: evaluation of perception of risk, efficacy of evidence based counseling and determinants of decision making. Arch Womens Ment Health. 2005; 8: 214–220.
46. Cohen-Kerem R., Nulman I., Abramow-Newerly M. et al. Diagnostic radiation in pregnancy: perception versus true risks. J Obstet Gynaecol Can. 2006; 28: 43–48.
47. Jasper J. D., Goel R., Einarson A. et al. Effects of framing on teratogenic risk perception in pregnant women. Lancet. 2001; 358: 1237–1238.
48. Erdeljic V., Francetic I., Makar-Ausperger K. et al. Clinical pharmacology consultation: a better answer to safety issues of drug therapy during pregnancy? Eur J Clin Pharmacol. 2010; 66: 1037–1046.
49. Schirm E., Pedersen L., Tobi H. et al. Drug use among fathers around time of conception: two register based surveys from Denmark and The Netherlands. Pharmacoepidemiol Drug Saf. 2004; 13: 609–613.
50. Engeland A., Bramness J. G., Daltveit A. K. et al. Prescription drug use among fathers and mothers before and during pregnancy. A population-based cohort study of 106,000 pregnancies in Norway 2004–2006. Br J Clin Pharmacol. 2008; 65: 653–660.
51. Trasler J. M., Doerksen T. Teratogen update: paternal exposu resreproductive risks. Teratology. 1999; 60: 161–172.
52. Rajapakse R. O., Korelitz B. I., Zlatanic J. et al. Outcome of pregnancies when fathers are treated with 6-mercaptopurine for inflammatory bowel disease. Am J Gastroenterol. 2000; 95: 684–688.
53. Martinez-Frias M. L. Postmarketing analysis of medicines. Methodology and value of the Spanish case-control study and surveillance system in preventing birth defects. Drug Saf. 2007; 30: 307–316.
54. Yoon P., Rasmussen S. A., Lynberg M. et al. The National Birth Defects Prevention Study. Public Health Rep. 2001; 116 (Suppl. 1): 32–40.
55. Chambers C. D., Braddock S. R., Briggs G. G. et al. Postmarketing surveillance for human teratogenicity: a model approach. Teratology. 2001; 64: 252–261.
56. US Food and Drug Administration. Guidance for industry establishing pregnancy exposure registries. Rockville (MD): US Department of Health and Human Services. 2002.
57. Charlton R. A., Cunnington M. C., de Vries C. S., Weil J. G. Data resources for investigating drug exposure during pregnancy and associated outcomes: the general practice research database (GPRD) as an alternative to pregnancy registries. Drug Saf. 2008; 31: 39–51.
58. Reefhuis J., Zandwijken G. R. J., deWalle H. E.K., Cornel M. C. Birth defect and risk factor surveillance in the Northern and Southwestern Netherlands. Community Genet. 1999; 2: 97–108.
59. Czeizel A. E., Rockenbauer M., Siffel C., Varga E. Description and mission evaluation of the Hungarian case-control surveillance of congenital abnormalities, 1980–1996. Teratology. 2001; 63: 176–185.
60. Dolk H. EUROCAT: 25 years of European surveillance of congenital anomalies. Arch Dis Child Fetal Neonatal. Ed. 2005; 90: F355–358.
61. Botto L. D., Robert-Gnansia E., Siffel C. et al. Fostering International Collaboration in Birth Defects Research and Prevention: A Perspective From the International Clearinghouse for Birth Defects Surveillance and Research. Am J Public Health. 2006; 96: 774–780.
62. Meijer W. M., Cornel M. C., Dolk H. et al. The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance. Pharmacoepidemiol Drug Saf. 2006; 15: 675–682.
63. Ehrenstein V., Sorensen H. T., Bakketeig L. S., Pedersen L. Medical databases in studies of drug teratogenicity: methodological issues. Clin Epidemiol. 2010; 2: 37–43.
64. Wurst K. E., Ephross S. A., Loehr J. et al. The utility of the general practice research database to examine selected congenital heart defects: a validation study. Pharmacoepidemiol Drug Saf. 2007; 16: 867–877.
65. Островская А. В., Шефер К., Штаккельберг Л. Европейская тератологическая информационная служба: опыт работы, проблемы и перспективы. Педиатрическая фармакология. 2007; 4 (5): 32–36.
66. Felix R. J., Jones K. L., Johnson K. A. et al. Postmarketing surveillance for drug safety in pregnancy: The Organization of Teratology Information Services Project. Birth Defects Res A Clin Mol Teratol. 2004; 70: 944–947.
67. Einarson A., Lockett D. Do we have a knowledge transfer and translation plan at Teratogen Information Services? Reprod Toxicol. 2006; 22: 542–545.
68. Viguera A. C. C.L., Bouffard S., Whitfield T. H., Baldessarini R. J. Reproductive decisions by women with bipolar disorder after prepregnancy psychiatric consultation. Am J Psych. 2002; 159: 2102–2104.
69. Robertson J., Polifka J. E., Avner M. et al. A survey of pregnant women using isotretinoin. Birth Defects Res A Clin Mol Teratol. 2005; 73: 881–887.
70. Garcia-Bournissen F., Tsur L., Goldstein L. H. et al. Fetal exposure to isotretinoin — an international problem. Reprod Toxicol. 2008; 25: 124–128.
Рецензия
Для цитирования:
Луцевич К.А., Решетько О.В., Санина И.И. БЕЗОПАСНОЕ ИСПОЛЬЗОВАНИЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ ВО ВРЕМЯ БЕРЕМЕННОСТИ В ФОКУСЕ МЕЖДУНАРОДНОЙ ПРАКТИКИ ОРГАНИЗАЦИИ СИСТЕМЫ ФАРМАКОНАДЗОРА И ТЕРАТОЛОГИЧЕСКОЙ ИНФОРМАЦИОННОЙ СЛУЖБЫ. Педиатрическая фармакология. 2012;9(6):40-47. https://doi.org/10.15690/pf.v9i6.517
For citation:
Lutsevich K.A., Reshetko O.V., Sanina I.I. SAFE USE OF DRUGS DURING PREGNANCY IN FOCUS OF INTERNATIONAL PRACTICE OF PHARMACOVIGILANCE SYSTEM AND TERATOLOGICAL INFORMATION SERVICE ORGANIZATION. Pediatric pharmacology. 2012;9(6):40-47. (In Russ.) https://doi.org/10.15690/pf.v9i6.517
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