cf8de2a7b4d7f2bebede9fb455379110 pmc_34575164.pdf ab7381b6c4833a86ba7388b6ab68da58f6f438c9 pmc_34575164.pdf 947b6d8b61418356dcda967f1c455776bb0412fd3d6537f68f131faf358d6a18 pmc_34575164.pdf Title: Drug-Related Deaths in a Tertiary Hospital: Characteristics of Spontaneously Reported Cases and Comparison to Cases Detected from a Retrospective Study Subject: Drug-related deaths (DRDs) are a common cause of hospital death. Pharmacovigilance, either as spontaneous reporting or active surveillance, plays a key role in the detection and reporting of suspected adverse drug reactions (ADRs). We conducted a retrospective analysis of all DRDs spontaneously reported to a pharmacovigilance program of a tertiary hospital, by health care professionals. We compared these results to those of a previous retrospective study conducted in the same hospital from the hospital’s mortality registry. From 1460 spontaneous reported ADRs in a 10-year period, 73 (5%) were DRDs. The median age of DRD was 75 years (range 1 month–94) and 60.3% were men. The most frequent DRDs were hemorrhages (41.1%), followed by infections (17.8%). The most frequently involved drugs were anticoagulants and/or antithrombotic (30%), and antineoplastics (26.3%). When comparing both studies, spontaneous reporting detected more type B reactions (p < 0.001) and hospital-acquired DRD (p < 0.001); the number of concomitant drugs was higher (p = 0.0035); and the kind of ADR were different. The combination of several methods is mandatory to detect, assess, understand, and design strategies to prevent ADRs in a hospital setting, to ensure patient safety. Keywords: drug-related deaths; spontaneous reporting; active surveillance; pharmacovigilance; adverse drug reaction; hospital mortality Author: Ana Lucía Arellano, Pau Alcubilla, Magí Farré and Eva Montané Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Wed Sep 8 08:51:21 2021 CEST ModDate: Wed Sep 8 08:57:47 2021 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 15 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 293082 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- CVBEIY+URWPalladioL-Ital Type 1 Custom yes yes no 10 0 BUVVUF+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 NYUEPB+URWPalladioL-Roma Type 1 Custom yes yes no 19 0 YSPQJI+VnURWPalladioL-Bold Type 1 Custom yes yes no 23 0 HCBGQO+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 WABLSD+SFRM1000 Type 1 Custom yes yes no 81 0 WOWCNF+CMSY10 Type 1 Builtin yes yes no 92 0 MOSBKF+URWPalladioL-BoldItal Type 1 Custom yes yes no 99 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-10-02 03:39:22 CEST RepresentationInformation: pmc_34575164.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2023-03-31 12:05:46 CEST Size: 293082 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 284 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Children: Item: Title: Study Setting and Design Destination: subsection.2.1 Item: Title: Variables Destination: subsection.2.2 Item: Title: ADR Causality Assessment Destination: subsection.2.3 Item: Title: Preventability of ADR Destination: subsection.2.4 Item: Title: Comparison of Two Pharmacovigilance Studies Assessing DRD Cases Destination: subsection.2.5 Item: Title: Statistical Analysis Destination: subsection.2.6 Item: Title: Results Destination: section.3 Children: Item: Title: Characteristics of Fatal ADR Destination: subsection.3.1 Item: Title: Characteristics of Drug Related to ADR Destination: subsection.3.2 Item: Title: ADR Causality Assessment Destination: subsection.3.3 Item: Title: Preventability of ADR Destination: subsection.3.4 Item: Title: Comparison of DRD from Spontaneous Reporting vs. Retrospective Study on Diagnosis at Death Destination: subsection.3.5 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: section.5 Info: Title: Drug-Related Deaths in a Tertiary Hospital: Characteristics of Spontaneously Reported Cases and Comparison to Cases Detected from a Retrospective Study Author: Ana Lucía Arellano, Pau Alcubilla, Magí Farré and Eva Montané Subject: Drug-related deaths (DRDs) are a common cause of hospital death. Pharmacovigilance, either as spontaneous reporting or active surveillance, plays a key role in the detection and reporting of suspected adverse drug reactions (ADRs). We conducted a retrospective analysis of all DRDs spontaneously reported to a pharmacovigilance program of a tertiary hospital, by health care professionals. We compared these results to those of a previous retrospective study conducted in the same hospital from the hospital’s mortality registry. From 1460 spontaneous reported ADRs in a 10-year period, 73 (5%) were DRDs. The median age of DRD was 75 years (range 1 month 94) and 60.3% were men. The most frequent DRDs were hemorrhages (41.1%), followed by infections (17.8%). The most frequently involved drugs were anticoagulants and/or antithrombotic (30%), and antineoplastics (26.3%). When comparing both studies, spontaneous reporting detected more type B reactions (p < 0.001) and hospital-acquired DRD (p < 0.001); the number of concomitant drugs was higher (p = 0.0035); and the kind of ADR were different. The combination of several methods is mandatory to detect, assess, understand, and design strategies to prevent ADRs in a hospital setting, to ensure patient safety. 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