{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,5,26]],"date-time":"2022-05-26T11:41:53Z","timestamp":1653565313229},"reference-count":0,"publisher":"IOS Press","license":[{"start":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T00:00:00Z","timestamp":1653436800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,5,25]]},"abstract":"<jats:p>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\u2019 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.<\/jats:p>","DOI":"10.3233\/shti220499","type":"book-chapter","created":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T12:14:42Z","timestamp":1653480882000},"source":"Crossref","is-referenced-by-count":0,"title":["An Adverse Drug Reaction Database for Clinical Use \u2013 Potential of and Difficulties with the Summary of Product Characteristics"],"prefix":"10.3233","author":[{"given":"Birgit","family":"Eiermann","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden"},{"name":"Inera AB, Swedish Association of Local Authorities and Regions, Stockholm, Sweden"}]},{"given":"Daniel","family":"Rodrigues","sequence":"additional","affiliation":[{"name":"Swedish Institute for Drug Informatics (SIDI), c\/o Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden"}]},{"given":"Paul","family":"Cohen","sequence":"additional","affiliation":[{"name":"Swedish Institute for Drug Informatics (SIDI), c\/o Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden"}]},{"given":"Lars L.","family":"Gustafsson","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden"},{"name":"Swedish Institute for Drug Informatics (SIDI), c\/o Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","Challenges of Trustable AI and Added-Value on Health"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI220499","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T12:14:43Z","timestamp":1653480883000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI220499"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,25]]},"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti220499","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"value":"0926-9630","type":"print"},{"value":"1879-8365","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,25]]}}}