Information on adverse drug reactions—Proof of principle for a structured database that allows customization of drug information

ADR databases for on‐site clinical use: Potentials of summary of products characteristics

“…Additionally, the French SmPC documents contained many SmPCs with ADR information as unstructured text (64%) compared to almost none in Sweden. Recently, Kusch et al described the extraction of ADRs from a limited number of Swiss SmPC documents (10) in XML (=Extensible Markup Language) format with an F1 score of 0.96 13 . Swiss documents had to be used since SmPCs in Germany like in Sweden are not available in XML format.…”

“…The improved use of standards for both table format and terminology within the SmPC guidelines for the ADR tables, and an increased control of the adherence to the standards by the medical product agencies would lead to improvement for both human and machine reading purposes. This is an established truth but poorly implemented 8,13,19,26 . Some studies also have pinpointed the need for a revised structure of the SmPC with improved wording, layout and formatting and a more tabular structure for ADRs 5,27 …”

“…Providing SmPCs in a more formally structured format like XML (Extensible Markup Language), which is, for example available in Switzerland, would facilitate the extraction of ADRs if the XML format supports a good representation of ADR Tables 13 . Additionally, stricter mapping of ADR terms to Snomed and/or MedDRA terms would improve possibilities for following up ADRs by the MPA or within the EHRs.…”

“…For this purpose, MedDRA terms need to be translated into various European languages. Further improvement for the use of the database in a patient setting could be achieved by mapping ADR terms to terms relevant for laypeople as described 13 . Standardization of table types and ADR terms would improve the usefulness of the information and increase human and machine readability.…”

“…To our knowledge, no ADR database, based on extraction of officially approved information and updated regularly, is available in clinical practice. Some databases exist based on ADR data of the SPLs in the United States 9‐11 and some based on SmPC information in Europe 8,12,13 . However, none of these databases are complete regarding all approved drugs and none are regularly updated with new information and distributed for use at point of care in EHR systems.…”