Skip to main content
Log in

Teratogenic Risk Perception and Confidence in Use of Medicines in Pairs of Pregnant Women and General Practitioners Based on Patient Information Leaflets

  • Original Research Article
  • Published:
Drug Safety Aims and scope Submit manuscript

Abstract

Objective

The aim of this study was to examine teratogenic risk perceptions and confidence in the use of medicines in pairs of pregnant women and general practitioners (GPs) through assessments of medicines information texts from patient information leaflets (PILs).

Methods

A questionnaire was handed out to women attending regular ultrasound examination in week 17–19 of pregnancy. The women stated name and address of their GP and questionnaires were sent to the GPs’ clinic. The questionnaires contained texts regarding pregnancy from PILs for pivmecillinam, metoclopramide, paracetamol, escitalopram, Valeriana officinalis and dexchlorpheniramine. For each PIL, teratogenic risk (scale from 0: never teratogenic to 10: always teratogenic), confidence in use of medicines (yes or no) and clarity of the text (scale from 0: exceptionally clear to 3: exceptionally unclear) were assessed.

Results

In total, 171 pregnant women and 74 GPs participated, of which 98 pairs were identified. Pregnant women had significantly higher perceptions of teratogenic risks and lower confidence in use of medicines compared to GPs. Differences in teratogenic risk perceptions and confidence in use were highest for escitalopram and lowest for dexchlorpheniramine, representing texts with different phrasing and length. Neither pregnant women nor GPs were confident in using Valeriana officinalis.

Conclusions

Perceptions of teratogenic risks and confidence in use of medicines during pregnancy differ within pairs of pregnant women and their GP when they assess PILs. Phrasing of medicines information texts can influence teratogenic risk perceptions and thereby prescribing of medicines and adherence.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Olesen C, Steffensen FH, Nielsen GL, et al. Drug use in first pregnancy and lactation: a population-based survey among Danish women. The EUROMAP group. Eur J Clin Pharmacol. 1999;55(2):139–44.

    Article  PubMed  CAS  Google Scholar 

  2. Engeland A, Bramness JG, Daltveit AK, 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(5):653–60.

    Article  PubMed  Google Scholar 

  3. Stephansson O, Granath F, Svensson T, et al. Drug use during pregnancy in Sweden - assessed by the Prescribed Drug Register and the Medical Birth Register. Clin Epidemiol. 2011;3:43–50.

    PubMed  Google Scholar 

  4. Irvine L, Flynn RW, Libby G, et al. Drugs dispensed in primary care during pregnancy: a record-linkage analysis in Tayside. Scotland. Drug Saf. 2010;33(7):593–604.

    Article  Google Scholar 

  5. Nordeng H, Ystrom E, Einarson A. Perception of risk regarding the use of medications and other exposures during pregnancy. Eur J Clin Pharmacol. 2009;66(2):207–14.

    Article  PubMed  Google Scholar 

  6. Santucci AK, Gold MA, Akers AY, et al. Women’s perspectives on counseling about risks for medication-induced birth defects. Birth Defects Res A Clin Mol Teratol. 2010;88(1):64–9.

    PubMed  CAS  Google Scholar 

  7. Gustafsson J, Kalvemark S, Nilsson G, et al. Patient information leaflets–patients’ comprehension of information about interactions and contraindications. Pharm World Sci. 2005;27(1):35–40.

    Article  PubMed  Google Scholar 

  8. Koren G, Sakaguchi S, Klieger C, et al. Toward improved pregnancy labelling. J Popul Ther Clin Pharmacol. 2010;17(3):e349–57.

    PubMed  Google Scholar 

  9. Raynor DK, Blenkinsopp A, Knapp P, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007;11(5):iii1–160.

    Google Scholar 

  10. Fuchs J, Hippius M, Schaefer M. Analysis of German package inserts. Int J Clin Pharmacol Ther. 2006;44(1):8–13.

    PubMed  CAS  Google Scholar 

  11. Fisher B, Rose NC, Carey JC. Principles and practice of teratology for the obstetrician. Clin Obstet Gynecol. 2008;51(1):106–18.

    Article  PubMed  Google Scholar 

  12. Bianca S. Drug use during pregnancy: are risk classifications more dangerous than the drugs? Lancet. 2003;362(9380):329.

    Article  PubMed  Google Scholar 

  13. 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(6):573–7.

    Article  PubMed  CAS  Google Scholar 

  14. Sanz E, Gomez-Lopez T, Martinez-Quintas MJ. Perception of teratogenic risk of common medicines. Eur J Obstet Gynecol Reprod Biol. 2001;95(1):127–31.

    Article  PubMed  CAS  Google Scholar 

  15. Damase-Michel C, Pichereau J, Pathak A, et al. Perception of teratogenic and foetotoxic risk by health professionals: a survey in Midi-Pyrenees area. Pharm Pract. 2008;6(1):15–9.

    Google Scholar 

  16. Koren G, Bologa M, Long D, et al. Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester. Am J Obstet Gynecol. 1989;160(5 Pt 1):1190–4.

    Article  PubMed  CAS  Google Scholar 

  17. Koren G, Pastuszak A. Prevention of unnecessary pregnancy terminations by counselling women on drug, chemical, and radiation exposure during the first trimester. Teratology. 1990;41(6):657–61.

    Article  PubMed  CAS  Google Scholar 

  18. Mazzotta P, Magee LA, Maltepe C, et al. The perception of teratogenic risk by women with nausea and vomiting of pregnancy. Reprod Toxicol. 1999;13(4):313–9.

    Article  PubMed  CAS  Google Scholar 

  19. Davies C. Statistical methods for the analysis of repeated measurements. New York: Springer; 2003. p. 444.

    Google Scholar 

  20. Kleinbaum D, Klein M. Logistic regression. a self-learning text. 3rd ed. New York: Springer; 2010.

    Book  Google Scholar 

  21. McDonald K, Amir LH, Davey MA. Maternal bodies and medicines: a commentary on risk and decision-making of pregnant and breastfeeding women and health professionals. BMC Public Health. 2011;11(Suppl 5):S5.

    Article  PubMed  Google Scholar 

  22. Walfisch A, Sermer C, Matok I, et al. Perception of teratogenic risk and the rated likelihood of pregnancy termination: association with maternal depression. Can J Psychiatry. 2011;56(12):761–7.

    PubMed  Google Scholar 

  23. Koren G, Levichek Z. The teratogenicity of drugs for nausea and vomiting of pregnancy: perceived versus true risk. Am J Obstet Gynecol. 2002;186(5 Suppl understanding):S248–52.

    Article  PubMed  CAS  Google Scholar 

  24. Polifka JE, Faustman EM, Neil N. Weighing the risks and the benefits: a call for the empirical assessment of perceived teratogenic risk. Reprod Toxicol. 1997;11(4):633–40.

    Article  PubMed  CAS  Google Scholar 

  25. Einarson A, Schachtschneider AK, Halil R, et al. SSRI’S and other antidepressant use during pregnancy and potential neonatal adverse effects: impact of a public health advisory and subsequent reports in the news media. BMC Pregnancy Childbirth. 2005;5:11.

    Article  PubMed  CAS  Google Scholar 

  26. Widnes SF, Schjott J, Granas AG. Risk perception and medicines information needs in pregnant women with epilepsy—a qualitative study. Seizure. 2012;21(8):597–602.

    Article  PubMed  Google Scholar 

  27. Chambers CD, Polifka JE, Friedman JM. Drug safety in pregnant women and their babies: ignorance not bliss. Clin Pharmacol Ther. 2008;83(1):181–3.

    Article  PubMed  CAS  Google Scholar 

  28. Carolan MC. Towards understanding the concept of risk for pregnant women: some nursing and midwifery implications. J Clin Nurs. 2009;18(5):652–8.

    PubMed  Google Scholar 

  29. Stichele RH, De Potter B, Vyncke P, et al. Attitude of physicians toward patient package inserts for medication information in Belgium. Patient Educ Couns. 1996;28(1):5–13.

    Article  PubMed  CAS  Google Scholar 

  30. Holst L, Wright D, Haavik S, et al. Safety and efficacy of herbal remedies in obstetrics-review and clinical implications. Midwifery. 2011;27(1):80–6.

    Google Scholar 

  31. Oyebode F, Rastogi A, Berrisford G, et al. Psychotropics in pregnancy: safety and other considerations. Pharmacol Ther. 2012;135(1):71–7.

    Article  PubMed  CAS  Google Scholar 

  32. Bonari L, Koren G, Einarson TR, 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(4):214–20.

    Article  PubMed  CAS  Google Scholar 

  33. Cox AR, Butt TF. Adverse drug reactions: when the risk becomes a reality for patients. Drug Saf. 2012;35(11):977–81.

    PubMed  Google Scholar 

  34. Statistics Norway. Births. Table 4 average age of parent at child’s birth. 1946–2011 Statistics Norway; Available from: http://www.ssb.no/english/.

  35. Linden-Bostrom M, Persson C. A selective follow-up study on a public health survey. Eur J Public Health. 2012;23(1):152–7.

    Article  PubMed  Google Scholar 

  36. Farrar JT, Young JP Jr, LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–58.

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgments

We express gratitude to the reception staff at the ultrasound laboratory, the Department of Gynecology and Obstetrics at Haukeland University Hospital, for invaluable help with recruiting pregnant women. We also thank the participating pregnant women and the general practitioners.

Authors’ individual contribution to the manuscript:

SFW, JS and AGG conceived and planned the work that led to the manuscript. All authors played an important role in the acquisition, analysis and interpretation of the data. GEE and SFW performed the statistical analyses. SFW wrote the paper and all three co-authors made substantial suggestions for revisions. All authors approved the final submitted version.

Conflicts of interest:

The authors have no conflicts of interest to declare.

Sources of funding:

The Norwegian regional medicines information and Pharmacovigilance Centres, and the University of Bergen. The work was performed independently of the funders.

Persons contributing other than authors:

None.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Sofia Frost Widnes.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Widnes, S.F., Schjøtt, J., Eide, G.E. et al. Teratogenic Risk Perception and Confidence in Use of Medicines in Pairs of Pregnant Women and General Practitioners Based on Patient Information Leaflets. Drug Saf 36, 481–489 (2013). https://doi.org/10.1007/s40264-013-0035-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40264-013-0035-9

Keywords

Navigation