Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project.

Autor: Richardson JL; UK Teratology Information Service, The Regional Drug and Therapeutics Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, 16/17 Framlington Place, Newcastle upon Tyne, NE2 4AB, Tyne and Wear, UK. jonathan.richardson3@nhs.net.; Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. jonathan.richardson3@nhs.net., Moore A; Quantitative Safety and Epidemiology, Novartis Pharma AG, 4002, Basel, Switzerland., Bromley RL; Division of Neuroscience, University of Manchester, Manchester, UK.; Royal Manchester Children's Hospital, Oxford Road, Manchester, UK., Stellfeld M; Novo Nordisk A/S, Søborg, Denmark., Geissbühler Y; Evidence and Launch Excellence, Novartis Pharma AG, 4002, Basel, Switzerland., Bluett-Duncan M; Division of Neuroscience, University of Manchester, Manchester, UK., Winterfeld U; Swiss Teratology Information Service and Clinical Pharmacology Service, University Hospital, Lausanne, Switzerland., Favre G; Swiss Teratology Information Service and Clinical Pharmacology Service, University Hospital, Lausanne, Switzerland., Alexe A; QPPV and PRRC Office, Novartis Pharma AG, 4002, Basel, Switzerland., Oliver AM; UK Teratology Information Service, The Regional Drug and Therapeutics Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, 16/17 Framlington Place, Newcastle upon Tyne, NE2 4AB, Tyne and Wear, UK., van Rijt-Weetink YRJ; Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands., Hodson KK; UK Teratology Information Service, The Regional Drug and Therapeutics Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, 16/17 Framlington Place, Newcastle upon Tyne, NE2 4AB, Tyne and Wear, UK., Rezaallah B; Chief Medical Office and Patient Safety, Novartis Pharma AG, 4002, Basel, Switzerland., van Puijenbroek EP; Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.; PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands., Lewis DJ; Novartis Global Drug Development, Novartis Pharma GmbH, Oeflinger Strasse 44, 79664, Wehr, Germany.; School of Life and Medical Sciences, University of Hertfordshire, Hatfield, England., Yates LM; KRISP, University of KwaZulu-Natal, Durban, South Africa.; Institute of Genetic Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Jazyk: angličtina
Zdroj: Drug safety [Drug Saf] 2023 May; Vol. 46 (5), pp. 479-491. Date of Electronic Publication: 2023 Mar 28.
DOI: 10.1007/s40264-023-01291-7
Abstrakt: Introduction and Objective: The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated through pregnancy pharmacovigilance (PregPV) research can be heterogenous and difficult to interpret. The aim of this article is to describe the development of a reference framework of core data elements (CDEs) for collection in primary source PregPV studies that can be used to standardise data collection procedures and, thereby, improve data harmonisation and evidence synthesis capabilities.
Methods: This CDE reference framework was developed within the Innovative Medicines Initiative (IMI) ConcePTION project by experts in pharmacovigilance, pharmacoepidemiology, medical statistics, risk-benefit communication, clinical teratology, reproductive toxicology, genetics, obstetrics, paediatrics, and child psychology. The framework was produced through a scoping review of data collection systems used by established PregPV datasets, followed by extensive discussion and debate around the value, definition, and derivation of each data item identified from these systems.
Results: The finalised listing of CDEs comprises 98 individual data elements, arranged into 14 tables of related fields. These data elements are openly available on the European Network of Teratology Information Services (ENTIS) website ( http://www.entis-org.eu/cde ).
Discussion: With this set of recommendations, we aim to standardise PregPV primary source data collection processes to improve the speed at which high-quality evidence-based statements can be provided about the safety of medication use in pregnancy.
(© 2023. The Author(s).)
Databáze: MEDLINE
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