Drug use assessment and risk evaluation in pregnancy—the PEGASUS-project

Irl, Cornelia; Kipferler, Petra; Hasford, Joerg

doi:10.1002/(sici)1099-1557(199710)6:3+<s37::aid-pds274>3.3.co;2-r

Cited by 14 publications

(9 citation statements)

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“…This relatively higher extent of drug use may be due to the implementation of iron/fefol supplementation policy. This finding was similar to studies in Norway, Sweden (86%) and Germany (85%) [11, 12] and lower than a study in Hungary (92%) and Brazil (94.9%) [2, 13]. …”

Section: Discussionsupporting

confidence: 88%

Determinants of prescribed drug use among pregnant women in Bahir Dar city administration, Northwest Ethiopia: a cross sectional study

Admasie¹,

Wasie

Abeje

2014

BMC Pregnancy Childbirth

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BackgroundDrug use during pregnancy may be dangerous to the fetus. There is high consumption of prescribed drugs among pregnant women. This condition may be much higher in developing countries. There is no sufficient evidence on prescribed drug use among pregnant women in Bahir Dar town. The aim of this study was to assess the level of prescribed drug use and associated factors among pregnant women attending antenatal care (ANC) service at government health centers in Bahir Dar city administration.MethodsInstitution based cross sectional study was used. Data were collected from randomly selected 510 pregnant women. Data were analyzed using SPSS version 16.0. Back ward stepwise logistic regression model was used and p-values <0.05 were considered statistically significant.ResultA total of 510 pregnant women were included in the study of which 88.4% were prescribed at least one drug during pregnancy. Nearly 11% of the pregnant women were prescribed with drugs from category D or X of the US-FDA risk classification.Prescribed drug use among pregnant women was more likely when the pregnancy is wanted, (AOR = 2.4, 95% CI: 1.3 - 4.6), if the mother had maternal illness (AOR = 8.5, 95% CI: 5.4-13.4), when the educational level of ANC provider is diploma (AOR = 2.7, 95% CI: 1.5-4.7) and when number of pregnancies is more (AOR =2.1, 95% CI: 1.3-3.3).ConclusionPrescribed drug use including those with potential harm to the fetus during pregnancy was very high in Bahir Dar city administration. Prescribed drug use is more when the woman had illness, when the woman was multi gravida and when the educational level of ANC provider was low (diploma). It is important to upgrade providers’ educational level and institute prevention of diseases like malaria to reduce the level of prescribed drug use during pregnancy.

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Section: Discussionsupporting

confidence: 88%

Determinants of prescribed drug use among pregnant women in Bahir Dar city administration, Northwest Ethiopia: a cross sectional study

Admasie¹,

Wasie

Abeje

2014

BMC Pregnancy Childbirth

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“…4 This consumption rate is close to that reported by Irl et al in Germany. 5 Pharmacists gave better advice when they were asked about the right way to treat a symptom rather than when they had to avoid a medication: only 1 pharmacist advised an H2 receptor antagonist to treat dyspepsia (Question 6) whereas 7 said that it is possible to take cimetidine during the first trimester (Question 7a) and 17 during the third trimester (Question 7b). It seemed difficult for the pharmacist to refuse a drug to a patient who asked for it.…”

Section: Discussionmentioning

confidence: 99%

Drug counselling in pregnancy: an opinion survey of French community pharmacists

Damase‐Michel

Vié

Lacroix

et al. 2004

Pharmacoepidemiology and Drug

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“…use of medicines, maternal diabetes, alcohol abuse) [1]. Medicines usage during pregnancy is common with more than 80% of women reporting having used at least one medicine during their pregnancy [2,3]. Even with excluding common medicines such as folic acid, iron preparations and vitamins, 69% of pregnant women still use at least one medicine during their prenatal period [2].…”

Section: Introductionmentioning

confidence: 99%

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Arguello

Salgado

Fernández-Llimós

2015

Brit J Clinical Pharma

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AIMSTo assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). METHODSSmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing 'conclusive' or 'ambiguous' information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. RESULTSOf the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. CONCLUSIONSImportant information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Reliable information regarding the use of many medicines during pregnancy is critical for researchers and healthcare professionals who work in antenatal care, but this information has been found to differ across different sources.• The Summary of Product Characteristics (SmPCs) is the European official medicines information source for professionals and contains a specific section to include information on medicines use during pregnancy and lactation to guide decision making.• Future electronic versions of SmPCs to be included in clinical decision support systems will require intelligible and logical electronic information. WHAT THIS STUDY ADDS• Important information deficits on the use of medicines during pregnancy and lactation were found in European SmPCs, and the time elapsed since a SmPC's marketing authorization was not associated with an increase in information quality.• Post-authorization data on the exposure to medicinal products during pregnancy and lactation should be actively collected and included in official information sources to keep them updated and to assist decision making.

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Drug use assessment and risk evaluation in pregnancy—the PEGASUS-project

Cited by 14 publications

References 0 publications

Determinants of prescribed drug use among pregnant women in Bahir Dar city administration, Northwest Ethiopia: a cross sectional study

Determinants of prescribed drug use among pregnant women in Bahir Dar city administration, Northwest Ethiopia: a cross sectional study

Drug counselling in pregnancy: an opinion survey of French community pharmacists

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

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