Advice on Drug Safety in Pregnancy

Widnes, Sofia Kristina Frost; Schjøtt, Jan

doi:10.2165/00002018-200831090-00008

Cited by 36 publications

(6 citation statements)

References 80 publications

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“…There is evidence of a lack of consistency between information on drug safety during pregnancy based on different information sources [23-25]. For example, according to the study by Frost Widnes and Schjøtt [24], the Norwegian Compendium on Product Monographs gives advice which is more restrictive than that given by drug information centers. Furthermore, patient information leaflets have been shown to include varying information concerning medicine use during pregnancy when different brand names of the same active substance are compared [23].…”

Section: Discussionmentioning

confidence: 99%

Multiple Information Sources and Consequences of Conflicting Information About Medicine Use During Pregnancy: A Multinational Internet-Based Survey

Hämeen‐Anttila¹,

Nordeng²,

Kokki³

et al. 2014

J Med Internet Res

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BackgroundA wide variety of information sources on medicines is available for pregnant women. When using multiple information sources, there is the risk that information will vary or even conflict.ObjectiveThe objective of this multinational study was to analyze the extent to which pregnant women use multiple information sources and the consequences of conflicting information, and to investigate which maternal sociodemographic, lifestyle, and medical factors were associated with these objectives.MethodsAn anonymous Internet-based questionnaire was made accessible during a period of 2 months, on 1 to 4 Internet websites used by pregnant women in 5 regions (Eastern Europe, Western Europe, Northern Europe, Americas, Australia). A total of 7092 responses were obtained (n=5090 pregnant women; n=2002 women with a child younger than 25 weeks). Descriptive statistics and logistic regression analysis were used.ResultsOf the respondents who stated that they needed information, 16.16% (655/4054) used one information source and 83.69% (3393/4054) used multiple information sources. Of respondents who used more than one information source, 22.62% (759/3355) stated that the information was conflicted. According to multivariate logistic regression analysis, factors significantly associated with experiencing conflict in medicine information included being a mother (OR 1.32, 95% CI 1.11-1.58), having university (OR 1.33, 95% CI 1.09-1.63) or other education (OR 1.49, 95% CI 1.09-2.03), residing in Eastern Europe (OR 1.52, 95% CI 1.22-1.89) or Australia (OR 2.28, 95% CI 1.42-3.67), use of 3 (OR 1.29, 95% CI 1.04-1.60) or >4 information sources (OR 1.82, 95% CI 1.49-2.23), and having ≥2 chronic diseases (OR 1.49, 95% CI 1.18-1.89). Because of conflicting information, 43.61% (331/759) decided not to use medication during pregnancy, 30.30% (230/759) sought a new information source, 32.67% (248/759) chose to rely on one source and ignore the conflicting one, 25.03% (190/759) became anxious, and 2.64% (20/759) did nothing. Factors significantly associated with not using medication as a consequence of conflicting information were being pregnant (OR 1.75, 95% CI 1.28-2.41) or experiencing 3-4 health disorders (OR 1.99, 95% CI 1.10-3.58). Women with no chronic diseases were more likely not to take medicines than women with ≥2 chronic diseases (OR 2.22, 95% CI 1.47-3.45). Factors significantly associated with becoming anxious were >4 information sources (OR 2.67, 95% CI 1.70-4.18) and residing in Eastern Europe (OR 0.57, 95% CI 0.36-0.90).ConclusionsAlmost all the pregnant women used multiple information sources when seeking information on taking medicines during pregnancy and one-fifth obtained conflicting information, leading to anxiety and the decision not to use the medication. Regional, educational, and chronic disease characteristics were associated with experiencing conflicting information and influenced the decision not to use medication or increased anxiety. Accurate and uniform teratology information should be made more available ...

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Section: Discussionmentioning

confidence: 99%

Multiple Information Sources and Consequences of Conflicting Information About Medicine Use During Pregnancy: A Multinational Internet-Based Survey

Hämeen‐Anttila¹,

Nordeng²,

Kokki³

et al. 2014

J Med Internet Res

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“…Moreover, lack of available relevant documentation can also increase the time spent handling a query, as extensive literature searches may have to be done to make sure no information is overlooked. Finally, queries regarding adverse events, which are the most common category of queries to RELIS, might require searches for case reports or case series in databases like Medline or Embase, and such searches might be time consuming, depending on the availability of suitable search terms [17]. This finding implies the importance of availability of high quality literature sources for DICs to be effective.…”

Section: Discussionmentioning

confidence: 99%

Which factors predict the time spent answering queries to a drug information centre?

2010

Self Cite

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Objective To develop a model based upon factors able to predict the time spent answering drug-related queries to Norwegian drug information centres (DICs). Setting and method Drug-related queries received at 5 DICs in Norway from March to May 2007 were randomly assigned to 20 employees until each of them had answered a minimum of five queries. The employees reported the number of drugs involved, the type of literature search performed, and whether the queries were considered judgmental or not, using a specifically developed scoring system. Main outcome measures The scores of these three factors were added together to define a workload score for each query. Workload and its individual factors were subsequently related to the measured time spent answering the queries by simple or multiple linear regression analyses. Results Ninety-six query/answer pairs were analyzed. Workload significantly predicted the time spent answering the queries (adjusted R2 = 0.22, P < 0.001). Literature search was the individual factor best predicting the time spent answering the queries (adjusted R2 = 0.17, P < 0.001), and this variable also contributed the most in the multiple regression analyses. Conclusion The most important workload factor predicting the time spent handling the queries in this study was the type of literature search that had to be performed. The categorisation of queries as judgmental or not, also affected the time spent answering the queries. The number of drugs involved did not significantly influence the time spent answering drug information queries.

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“…To evaluate discrepancies related to the medicine use during pregnancy and lactation, the investigators collected the data for all the COVID-19 medications. They were then divided into six following categories, namely 'can be used,' 'individual benefit-risk assessment,' 'should not be used, 'trimester-specific information' (related to pregnancy), 'not classifiable,' 'no available information as derived by Frost Widnes and Jan Schott [ 41 ]. The research team also provided descriptions of each category for the proper classifications of the recommendations.…”

Section: Methodsmentioning

confidence: 99%

Assessment of the scope, completeness, and consistency of various drug information resources related to COVID-19 medications in pregnancy and lactation

Shareef

Sridhar

Bhupathyraaj

et al. 2023

BMC Pregnancy Childbirth

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Background Drug use in pregnancy and lactation is challenging. It becomes more challenging in pregnant and lactating women with certain critical clinical conditions such as COVID-19, because of inconsistent drug safety data. Therefore, we aimed to evaluate the various drug information resources for the scope, completeness, and consistency of the information related to COVID-19 medications in pregnancy and lactation. Methods Data related to COVID-19 medications from various drug information resources such as text references, subscription databases, and free online tools were used for the comparison. The congregated data were analyzed for scope, completeness, and consistency. Results Scope scores were highest for Portable Electronic Physician Information Database (PEPID), Up-to-date, and drugs.com compared to other resources. The overall completeness scores were higher for Micromedex and drugs.com (p < 0.05 compared to all other resources). The inter-reliability analysis for overall components by Fleiss kappa among all the resources was found to be 'slight' (k < 0.20, p < 0.0001). The information related to the older drugs in most of the resources, provides in-depth details on various components such as pregnancy safety, clinical data related to lactation, the effect of the drug distribution into breast milk, reproductive potential/infertility risk and the pregnancy category/recommendations. However, the information related to these components for newer drugs was superficial and incomplete, with insufficient data and inconclusive evidence, which is a statistically significant observation. The strength of observer agreement for the various COVID-19 medications ranged from poor to fair and moderate for the various recommendation categories studied. Conclusion This study reports discrepancies in the information related to pregnancy, lactation, drug level, reproductive risk, and pregnancy recommendations among the resources directing to refer to more than one resource for information about the safe and quality use of medications in this special population.The present study also emphasizes the need for development of comprehensive, evidence-based, and precise information guide that can promote safe and effective drug use in this special population.

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Advice on Drug Safety in Pregnancy

Cited by 36 publications

References 80 publications

Multiple Information Sources and Consequences of Conflicting Information About Medicine Use During Pregnancy: A Multinational Internet-Based Survey

Multiple Information Sources and Consequences of Conflicting Information About Medicine Use During Pregnancy: A Multinational Internet-Based Survey

Which factors predict the time spent answering queries to a drug information centre?

Assessment of the scope, completeness, and consistency of various drug information resources related to COVID-19 medications in pregnancy and lactation

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