An Adverse Drug Reaction Database for Clinical Use - Potential of and Difficulties with the Summary of Product Characteristics

التفاصيل البيبلوغرافية
العنوان: An Adverse Drug Reaction Database for Clinical Use - Potential of and Difficulties with the Summary of Product Characteristics
المؤلفون: Birgit, Eiermann, Daniel, Rodrigues, Paul, Cohen, Lars L, Gustafsson
المصدر: Studies in health technology and informatics. 294
سنة النشر: 2022
مصطلحات موضوعية: Europe, Databases, Factual, Drug-Related Side Effects and Adverse Reactions, Adverse Drug Reaction Reporting Systems, Humans
الوصف: Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved Summary of Product Characteristics (SmPC). An overview of all ADRs of the patients' drug list can support healthcare staff to link patient symptoms to possible ADRs. We review the possibilities and challenges to extract ADR information from SmPCs and present the development of our semi-automated procedure for extraction of ADRs from the tabulated section of the SmPCs to create a database, named Bikt, which is regularly updated and used at point of care in Sweden. The existence of five major table formats for ADRs used in the SmPCs required the development of different parsing scripts. Manual checks for correctness for all content has to be performed. The quality of extraction was investigated for all SmPCs by measuring precision, recall and F1 scores (i.e. the weighted harmonic mean of precision and recall) and compared with other methods published. We conclude that it is possible to semi-automatically extract ADR information from SmPCs. However, clear technical and content guidelines and standards for ADR tables and terms from drug registration authorities would lead to improved extraction and usability of ADR information at point of care.
تدمد: 1879-8365
URL الوصول: https://explore.openaire.eu/search/publication?articleId=pmid________::e7c95800c6540150b29092704a954069
https://pubmed.ncbi.nlm.nih.gov/35612120
رقم الانضمام: edsair.pmid..........e7c95800c6540150b29092704a954069
قاعدة البيانات: OpenAIRE