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ABSTRACT
Background: Inconsistencies in information on safety of medicine use during pregnancy and lactation can result in sub-optimal treatment for pregnant and lactating women, risks to the fetus or child and unnecessary weaning off breastfeeding. The objective of this study was to analyze information discrepancies regarding medicine use during pregnancy and lactation between on-line sources for patients and health care professionals (HCPs) in four European languages.
Research design and methods: The medicines analyzed were ibuprofen, ondansetron, olanzapine, fingolimod, methylphenidate and adalimumab. Recommendations were classified into different data source categories, for patients and for HCPs, and compared between the data source categories for each medicine and language.
Results: For patients, 11/24 (46%) and 4/24 (17%) comparisons of the pregnancy and lactation recommendations, respectively, were consistent between all sources. The corresponding figures for HCP-sources were 13/24 (54%) and 5/24 (21%). Regulatory sources had generally more restrictive recommendations. Teratology Information Services (TIS) centers’ recommendations for medicine use during pregnancy and lactation were consistent in 25/27 (93%) and 15/22 (68%) of cases respectively.
Conclusion: Discrepancies between online information sources regarding medicine use during pregnancy and lactation are common, especially for lactation. TIS centers recommendations were more aligned. Additional work is needed to harmonize information within and between countries to avoid conflicting messages.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Previous presentations
The results concerning information in patient data sources in this study have previously been presented as a poster at the ICPE all access conference: Sep 16-17, 2020 in Berlin, Germany and as an abstract at the 31st ENTIS conference (published in Reprod.Toxicol. 2020;97:11). The data regarding information in data sources for health care professionals have not been presented before nor simultaneously submitted to any other journal.
Author contributions
Ulrika Nörby, Ludivine Douarin, Benedikte-Noël Cuppers, Sashka Hristoskova, Monali Desai, Linda Härmark and Michael Steel planned and designed the study. Ulrika Nörby, Benedikte-Noël Cuppers, Ludivine Douarin, Sashka Hristoskova, Chantal El-Haddad and Monali Desai, collected and analyzed the data. Ulrika Nörby and Chantal El-Haddad drafted the initial manuscript. All authors critically reviewed, and revised the manuscript and approved the final version as submitted. All authors agree to be accountable for all aspects of this work.
Declaration of interest
S Hristoskova is an employee and shareholder in Novartis Pharma AG and shareholder in Alcon. M Steel is an employee and shareholder in Novartis Pharma AG. C El-Haddad is an employee of Excelya working as a contractor for Sanofi. L Douarin is an employee and shareholder in Sanofi. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2021.1935865.