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International Journal of Clinical Pharmacy

, Volume 34, Issue 5, pp 719–727 | Cite as

Drug use before and during pregnancy in Serbia

  • Marina Odalovic
  • Sandra Vezmar Kovacevic
  • Katarina Ilic
  • Ana Sabo
  • Ljiljana Tasic
Research Article

Abstract

Background Observation of drug use patterns during pregnancy is necessary for the recognition of potential bad practices and improvement of safe drug use in pregnancy. Objective To investigate prescription and over the counter drug use among Serbian women in the 6 months before pregnancy and in the first 6 months of pregnancy, and to evaluate the drugs used according to the risk to a fetus. Setting Six maternity care units and five community pharmacies Method A multi-center study was performed in Serbia during the period from March 2009–March 2010. A self-reporting questionnaire was used as a data source. Food and Drug Administration (FDA) risk classification system was used to determine the risk of used drugs for the fetus. Differences between subgroups were assessed using McNemar’s test on paired proportions. Main outcome measure Proportion of women exposed to drugs or class of drugs. Results The overall drug exposure was higher in pregnancy (34.7 %) than before pregnancy (29.9 %), p > 0.05, in the cohort of 311 pregnant women. A significantly greater prescription drug use, 19.0 versus 27.3 % of women, p < 0.05, and less selfmedication with over the counter drugs in pregnancy, 15.1 versus 8.7 %, p < 0.05, were observed. Commonly used drugs were musculoskeletal drugs, analgesics/antipyretics and respiratory system drugs before pregnancy (13.8, 12.5, and 6.4 % of women, respectively), and progestogens, analgesics/antipyretics, and antibiotics for the systemic use in pregnancy (9.0, 7.7, and 7.4 %, respectively). A greater exposure to drugs belonging to the FDA risk category A (3.9 vs. 60.8 %, p < 0.05), B (18.0 vs. 19.6 %, p > 0.05), C (10.0 vs. 10.3 %, p > 0.05) and D (2.9 vs. 10.9 %, p < 0.05), as well as less exposure to drugs belonging to category X (0.3 vs. 0 %, p > 0.05) were observed in pregnancy. Folic acid was used by 60.8 % of women in pregnancy, and by only 3.9 % before pregnancy. Conclusion Besides higher overall drug use in pregnancy than before pregnancy, particularly the use of progestogens, and, subsequently, D category drugs, less selfmedication with over the counter drugs was observed in pregnancy. Insufficient use of folic acid before pregnancy requires public health service activities.

Keywords

Drug use FDA pregnancy risk classification OTC medication Pregnancy Serbia 

Notes

Acknowledgments

We are very grateful to the Associate Professor Natasa Bogavac Stanojevic, the University of Belgrade-Faculty of Pharmacy for her useful comments in the statistical analysis, to the Associate Professor Hedvig Nordeng, School of Pharmacy, the University of Oslo, for her comments and to Mr. David Jones and Mrs. Zorica Bogdanovic for editing of the English. We are grateful to all the mothers, nurses and pharmacists who participated and cooperated in this study.

Funding

This work is supported by the Ministry of Education and Science, Republic of Serbia, Project No. 41012, and Project No. 175064, 2011-2014.

Conflicts of interest

The authors declare no conflict of interest.

References

  1. 1.
    Smithells RW, Newman CGH. Recognition of thalidomide defects. J Med Genet. 1992;29(10):716–23.PubMedCrossRefGoogle Scholar
  2. 2.
    Leck IM, Millar EL. Incidence of malformations since the introduction of thalidomide. BMJ. 1962;2(5296):16–20.PubMedCrossRefGoogle Scholar
  3. 3.
    Adam MP, Polifka JE, Friedman JM. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet. 2011;157C(3):175–82.Google Scholar
  4. 4.
    Singh S, Sedgh G, Hussain R. Unintended pregnancy: worldwide levels, trends, and outcomes. Stud Fam Plann. 2010;41(4):241–50.PubMedCrossRefGoogle Scholar
  5. 5.
    Finnell RH. Teratology: general considerations and principles. J Allergy Clin Immunol. 1999;103(2):S337–42.PubMedCrossRefGoogle Scholar
  6. 6.
    World Health Organization. Body mass index classification. Available at: http://apps.who.int/bmi/index.jsp?introPage=intro_3.html. Accessed on 09 June 2012.
  7. 7.
    World Health Organization. ATC/DDD index 2012. Available at: http://www.whocc.no/atc_ddd_index/. Accessed on 10 June 2012.
  8. 8.
    Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation: A reference guide to fetal and neonatal risk. 8th ed. Philadelphia: Lippincott Wiliams & Wilkins; 2008. ISBN: 978-0-7817-7876-3.Google Scholar
  9. 9.
    Sipetic T. National formulary. Belgrade: Medicines and Medical Devices Agency of Serbia; 2010.Google Scholar
  10. 10.
    De Vigan C, De Walle HEK, Cordier S, Goujard J, Knill-Jones R, Ayme S, et al. Therapeutic drug use during pregnancy: a comparison in four European countries. J Clin Epidemiol. 1999;52(10):977–82.PubMedCrossRefGoogle Scholar
  11. 11.
    Kebede B, Gedif T, Getachew A. Assessment of drug use among pregnant women in Addis Ababa. Ethiopia. Pharmacoepidemiol Drug Saf. 2009;18(6):462–8.CrossRefGoogle Scholar
  12. 12.
    Rohra DK, Das N, Azam SI, Solangi NA, Memon Z, Shaikh AM, et al. Drug-prescribing patterns during pregnancy in the tertiary care hospitals of Pakistan: a cross sectional study. BMC Pregnancy Childbirth. 2008;8:24–8.PubMedCrossRefGoogle Scholar
  13. 13.
    Bakker MK, Jentink J, Vroom F, Van Den Berg PB, De Walle HEK, De Jong-Van Den Berg LTW. Drug prescription patterns before, during and after pregnancy for chronic, occasional and pregnancy-related drugs in the Netherlands. BJOG. 2006;113(5):559–68.PubMedCrossRefGoogle Scholar
  14. 14.
    Andrade SE, Gurwitz JH, Davis RL, Chan KA, Finkelstein JA, Fortman K, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol. 2004;191(2):398–407.PubMedCrossRefGoogle Scholar
  15. 15.
    Egen-Lappe V, Hasford J. Drug prescription in pregnancy: analysis of a large statutory sickness fund population. Eur J Clin Pharmacol. 2004;60(9):659–66.PubMedCrossRefGoogle Scholar
  16. 16.
    Stephansson O, Granath F, Svensson T, Haglund B, Ekbom A, Kieler H. Drug use during pregnancy in Sweden—assessed by the prescribed drug register and the medical birth register. Clin Epidemiol. 2011;3(1):43–50.PubMedGoogle Scholar
  17. 17.
    Engeland A, Bramness JG, Daltveit AK, Rønning M, Skurtveit S, Furu K. 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(5):653–60.PubMedCrossRefGoogle Scholar
  18. 18.
    Nordeng H, Eskild A, Nesheim BI, Jacobsen G. Drug use in pregnancy among parous Scandinavian women. Norsk Epidemiologi. 2001;11:97–103.Google Scholar
  19. 19.
    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(5):355–61.PubMedCrossRefGoogle Scholar
  20. 20.
    Olesen C, Steffensen FH, Nielsen GL, de Jong-van den Berg L, Olsen J, Sørensen HT, et al. Drug use in first pregnancy and lactation: a population-based survey among Danish women. Eur J Clin Pharmacol. 1999;55(2):139–44.PubMedCrossRefGoogle Scholar
  21. 21.
    Malm H, Martikainen J, Klaukka T, Neuvonen PJ. Prescription drugs during pregnancy and lactation—a Finnish register-based study. Eur J Clin Pharmacol. 2003;59(2):127–33.PubMedGoogle Scholar
  22. 22.
    Thach TS. Progestogen for preventing miscarriage: RHL commentary. World Health Organization; 2009. Available at: http://apps.who.int/rhl/pregnancy_childbirth/antenatal_care/miscarriage/cd003511_thacht/en/index.html. Assessed on 09 June 2012.
  23. 23.
    Haas DM, Ramsey PS. Progestogen for preventing miscarriage. Cochrane Database Sys Rev. 2008;2:CD003511.Google Scholar
  24. 24.
    Donati S, Baglio G, Spinelli A, Grandolfo ME. Drug use in pregnancy among Italian women. Eur J Clin Pharmacol. 2000;56(4):323–8.PubMedCrossRefGoogle Scholar
  25. 25.
    De-Regil LM, Fernández-Gaxiola AC, Dowswell T, Peńa-Rosas JP. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010;10:007950.Google Scholar
  26. 26.
    European surveillance of congenital anomalies special report: prevention on neural tube defect by periconceptual folic acid supplementation in Europe. Available at: http://www.eurocat-network.eu/content/Special-Report-NTD-3rdEd-Part-I.pdf. Accessed on 10 June 2012.
  27. 27.
    Law R, Bozzo P, Koren G, Einarson A. FDA pregnancy risk categories and the CPS: do they help or are they a hindrance? Can Fam Physician. 2010;56(3):239–41.PubMedGoogle Scholar
  28. 28.
    Hardy JR, Leaderer BP, Holford TR, Hall GC, Bracken MB. Safety of medications prescribed before and during early pregnancy in a cohort of 81 975 mothers from the UK general practice research database. Pharmacoepidemiol Drug Saf. 2006;15(8):555–64.PubMedCrossRefGoogle Scholar
  29. 29.
    Yang T, Walker MC, Krewski D, Yang Q, Nimrod C, Garner P, et al. Maternal characteristics associated with pregnancy exposure to FDA category C, D, and X drugs in a Canadian population. Pharmacoepidemiol Drug Saf. 2008;17(3):270–7.PubMedCrossRefGoogle Scholar
  30. 30.
    Andrade SE, Raebel MA, Morse AN, Davis RL, Chan KA, Finkelstein JA, et al. Use of prescription medications with a potential for fetal harm among pregnant women. Pharmacoepidemiol Drug Saf. 2006;15(8):546–54.PubMedCrossRefGoogle Scholar
  31. 31.
    Daw JR, Hanley GE, Greyson DL, Morgan SG. Prescription drug use during pregnancy in developed countries: a systematic review. Pharmacoepidemiol Drug Saf. 2010;20(9):895–902.Google Scholar
  32. 32.
    Olesen C, Søndergaard C, Thrane N, Nielsen GL, de Jong-van den Berg L, Olsen J, EuroMAP Group. Do pregnant women report use of dispensed medications? Epidemiology. 2001;12(5):497–501.PubMedCrossRefGoogle Scholar
  33. 33.
    Ministry of health republic of Serbia. National health survey. Key findings. 2006. Available at: http://www.batut.org.rs/index.php?content=59. Accessed on 10 June 2012.

Copyright information

© Springer Science+Business Media B.V. 2012

Authors and Affiliations

  • Marina Odalovic
    • 1
  • Sandra Vezmar Kovacevic
    • 2
  • Katarina Ilic
    • 3
  • Ana Sabo
    • 4
  • Ljiljana Tasic
    • 1
  1. 1.Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of PharmacyThe University of BelgradeBelgradeSerbia
  2. 2.Department of Pharmacokinetics and Clinical Pharmacy, Faculty of PharmacyThe University of BelgradeBelgradeSerbia
  3. 3.Department of Pharmacology, Faculty of PharmacyThe University of BelgradeBelgradeSerbia
  4. 4.Department of Pharmacology, Toxicology and Clinical Pharmacology, Medical FacultyThe University of Novi SadNovi SadSerbia

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