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Drug Safety

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01.06.2013 | Original Research Article

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

verfasst von: Sofia Frost Widnes, Jan Schjøtt, Geir Egil Eide, Anne Gerd Granas

Erschienen in: Drug Safety | Ausgabe 6/2013

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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.

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.PubMedCrossRef

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.PubMedCrossRef

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

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.CrossRef

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.PubMedCrossRef

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

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.PubMedCrossRef

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

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.

10.

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

11.

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

12.

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

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.PubMedCrossRef

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.PubMedCrossRef

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.

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

19.

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

20.

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

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.PubMedCrossRef

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

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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

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.PubMedCrossRef

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.

31.

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

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.PubMedCrossRef

33.

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

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.PubMedCrossRef

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.PubMedCrossRef

Titel: Teratogenic Risk Perception and Confidence in Use of Medicines in Pairs of Pregnant Women and General Practitioners Based on Patient Information Leaflets
verfasst von: Sofia Frost Widnes
Jan Schjøtt
Geir Egil Eide
Anne Gerd Granas
Publikationsdatum: 01.06.2013
Verlag: Springer International Publishing AG
Erschienen in: Drug Safety / Ausgabe 6/2013
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-013-0035-9

Die Highlights vom Kongress des American College of Cardiology 2024

Springer Medizin

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

Abstract

Objective

Methods

Results

Conclusions

Die Highlights vom Kongress des American College of Cardiology 2024

Springer Medizin

Abstract

Objective

Methods

Results

Conclusions

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