58b946e633bb7b6731908cb83d84b966 pmc_34362076.pdf 239992b83cba77f76072d13c9b41469f6e1f0775 pmc_34362076.pdf a66ba88bc1b7acf80798740e0fffeb3d7eb7d97aae952f8d8de6391f4a923699 pmc_34362076.pdf Title: Spontaneously Reported Adverse Drug Reactions and Their Description in Hospital Discharge Reports: A Retrospective Study Subject: The inclusion of spontaneously reported adverse drug reactions (ADRs) in hospital discharge reports was examined, in addition to the factors associated with their inclusion, the resulting therapeutic decisions, and any recommendations made upon patient discharge regarding the suspected offending drugs. ADRs that were spontaneously reported during 2017 and 2018 to the pharmacovigilance program were retrospectively analyzed. Information regarding patient characteristics, drug treatments, and ADRs was collected from the ADR notifications and from patient electronic medical records. The dependent variable was the mentioning of ADRs in the discharge reports, while characteristics of the ADRs, pharmacovigilance causality algorithms, and some of the suspected drugs themselves were the independent variables during bivariant analysis. A total of 286 reports of suspected ADRs from 271 patients (50.2% female; 77% adults) were included. Information regarding the ADRs was present in the discharge reports for 238 reports (83.2%); the ADR seriousness and the lack of potential alternative causes were the only associated factors. Withdrawal or withdrawal and substitution by an alternative drug were the most common therapeutic decisions, although often no recommendation was made. Overall, there is still room for improvement in terms of including information related to ADRs in hospital discharge reports. Keywords: pharmacovigilance; spontaneously reported; adverse drug reaction; hospital discharge report; bivariant analysis Author: Cristina Aguilera, Antònia Agustí, Eulàlia Pérez, Rosa M. Gracia, Eduard Diogène and Immaculada Danés Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Mon Jul 26 13:11:24 2021 CEST ModDate: Mon Jul 26 13:14:10 2021 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 10 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 259665 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- VTKZJD+URWPalladioL-Ital Type 1 Custom yes yes no 10 0 LGIPYL+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 NWIVFO+URWPalladioL-Roma Type 1 Custom yes yes no 19 0 WBIKFD+VnURWPalladioL-Bold Type 1 Custom yes yes no 23 0 GFKJOY+VnURWPalladioL Type 1 Custom yes yes no 28 0 XPUSBJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 36 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 39 0 MCBCCI+SourceSansRoman-Regular Type 1C Custom yes yes no 61 0 MCBCCM+SourceSansRoman.613wght Type 1C Custom yes yes no 65 0 MCBCCO+SourceSansRoman-Bold Type 1C Custom yes yes no 69 0 IVTQIQ+CMSY10 Type 1 Builtin yes yes no 81 0 WBVKDJ+URWPalladioL-BoldItal Type 1 Custom yes yes no 94 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-10-02 03:08:07 CEST RepresentationInformation: pmc_34362076.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2023-03-31 12:14:46 CEST Size: 259665 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 207 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Item: Title: Results Destination: section.3 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: section.5 Info: Title: Spontaneously Reported Adverse Drug Reactions and Their Description in Hospital Discharge Reports: A Retrospective Study Author: Cristina Aguilera, Antònia Agustí, Eulàlia Pérez, Rosa M. Gracia, Eduard Diogène and Immaculada Danés Subject: The inclusion of spontaneously reported adverse drug reactions (ADRs) in hospital discharge reports was examined, in addition to the factors associated with their inclusion, the resulting therapeutic decisions, and any recommendations made upon patient discharge regarding the suspected offending drugs. ADRs that were spontaneously reported during 2017 and 2018 to the pharmacovigilance program were retrospectively analyzed. Information regarding patient characteristics, drug treatments, and ADRs was collected from the ADR notifications and from patient electronic medical records. The dependent variable was the mentioning of ADRs in the discharge reports, while characteristics of the ADRs, pharmacovigilance causality algorithms, and some of the suspected drugs themselves were the independent variables during bivariant analysis. A total of 286 reports of suspected ADRs from 271 patients (50.2% female; 77% adults) were included. Information regarding the ADRs was present in the discharge reports for 238 reports (83.2%); the ADR seriousness and the lack of potential alternative causes were the only associated factors. Withdrawal or withdrawal and substitution by an alternative drug were the most common therapeutic decisions, although often no recommendation was made. Overall, there is still room for improvement in terms of including information related to ADRs in hospital discharge reports. 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