8e33f4fcf130e75e34ef51a7f5a226ab 271832.pdf e97c45e840ad778d9b2f5b343830204c66cec0c8 271832.pdf 5baad6b84ce7640e575d60522fdbd92112b42e9b75e6c5eb7fe63fbff524926c 271832.pdf Title: Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre Subject: (1) Background: Antimicrobial resistance (AMR) requires urgent multidisciplinary solutions, and pharmacovigilance has the potential to strengthen current antimicrobial stewardship strategies. This study aimed to characterize AMR-relevant adverse drug reaction (ADR) reports submitted to The Netherlands Pharmacovigilance Centre; (2) Methods: We carried out a descriptive analysis of ADR reports submitted to Lareb, coded with AMR-relevant MedDRA Preferred Terms (PTs); (3) Results: Between 1998 and January 2019, 252 AMR-relevant ADR reports were submitted to Lareb. The most frequent antibiotics were tobramycin (n = 89; 35%), colistin (n = 30; 11.9%), cipro-floxacin (n = 16; 6.3%), doxycycline (n = 14; 5.5%), and aztreonam (n = 12; 4.8%). The PTs used included off label use (n = 91; 36.1%), drug ineffective (n = 71; 28.2%), product use in unapproved indication (n = 28; 11.1%), pathogen resistance (n = 14; 5.6%), and drug resistance (n = 13; 5.2%). 54% of the reports were on Watch antibiotics and 19% were involved in the Reserve group. In the Watch group, “off label use” and “product use in unapproved indication” were the most frequent PTs and the majority of reports on Reserve antibiotics were coded as “Off label”. A sharp increase in the number of reports was observed in the three consecutive years with 21 in 2013, 54 in 2014, and 83 in 2015; (4) Conclusions: In addition to existing AMR monitoring strategies, pharmacovigilance databases can serve as a source of data on suspected resistance and inappropriate use. Future research should explore how these AMR-relevant MedDRA Terms are used in resource-limited settings with less capacity to generate laboratory-confirmed resistance data. Keywords: antibiotics; antimicrobial resistance; antimicrobial stewardship; AWaRe; pharmacovigilance; Lareb; adverse drug reactions Author: Jean Marie Vianney Habarugira, Linda Härmark and Albert Figueras Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Thu Dec 9 11:29:24 2021 CET ModDate: Thu Dec 9 11:34:09 2021 CET Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 9 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 462670 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- LWJOET+VnURWPalladioL Type 1 Custom yes yes no 10 0 DNIVZX+URWPalladioL-Ital Type 1 Custom yes yes no 15 0 MCNKNK+URWPalladioL-Bold Type 1 Custom yes yes no 20 0 YSWVCH+URWPalladioL-Roma Type 1 Custom yes yes no 24 0 AOPHAZ+CMSY10 Type 1 Builtin yes yes no 28 0 YYFPCJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 37 0 MCBCCI+SourceSansRoman-Regular Type 1C Custom yes yes no 59 0 MCBCCM+SourceSansRoman.613wght Type 1C Custom yes yes no 63 0 MCBCCO+SourceSansRoman-Bold Type 1C Custom yes yes no 67 0 NGHDHH+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 94 0 NGHDHJ+PalatinoLinotype TrueType WinAnsi yes yes no 97 0 NGHDHL+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 100 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2023-07-07 02:41:40 CEST RepresentationInformation: 271832.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2023-07-06 13:31:05 CEST Size: 462670 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 229 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@44c8afef Children: Item: Title: Antimicrobial Resistance (AMR) and Antimicrobial Stewardship Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7b69c6ba Item: Title: The Access, Watch and Reserve (AWaRe) Classification for Availability and Appropriate Use Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@46daef40 Item: Title: Pharmacovigilance and Antimicrobial Resistance Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@12f41634 Item: Title: Pharmacovigilance in The Netherlands Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@13c27452 Item: Title: Study Objective Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@262b2c86 Item: Title: Material and Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@371a67ec Item: Title: Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@5ed828d Children: Item: Title: ADR Reports with AMR-Relevant Codes Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@50d0686 Item: Title: Most Frequently Used PTs in Cases of Suspected Resistance or Use-Related Issues Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7a3d45bd Item: Title: Applying the AWaRe Classification to the Reports Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1e7c7811 Item: Title: The 2015 Peak in Numbers of AMR-Relevant ADR Reports to Lareb Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77ec78b9 Item: Title: Discussion and Conclusions Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1a3869f4 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@a38d7a3 Info: Title: Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre Author: Jean Marie Vianney Habarugira, Linda Härmark and Albert Figueras Subject: (1) Background: Antimicrobial resistance (AMR) requires urgent multidisciplinary solutions, and pharmacovigilance has the potential to strengthen current antimicrobial stewardship strategies. This study aimed to characterize AMR-relevant adverse drug reaction (ADR) reports submitted to The Netherlands Pharmacovigilance Centre; (2) Methods: We carried out a descriptive analysis of ADR reports submitted to Lareb, coded with AMR-relevant MedDRA Preferred Terms (PTs); (3) Results: Between 1998 and January 2019, 252 AMR-relevant ADR reports were submitted to Lareb. The most frequent antibiotics were tobramycin (n = 89; 35%), colistin (n = 30; 11.9%), cipro-floxacin (n = 16; 6.3%), doxycycline (n = 14; 5.5%), and aztreonam (n = 12; 4.8%). The PTs used included off label use (n = 91; 36.1%), drug ineffective (n = 71; 28.2%), product use in unapproved indication (n = 28; 11.1%), pathogen resistance (n = 14; 5.6%), and drug resistance (n = 13; 5.2%). 54% of the reports were on Watch antibiotics and 19% were involved in the Reserve group. In the Watch group, “off label use” and “product use in unapproved indication” were the most frequent PTs and the majority of reports on Reserve antibiotics were coded as “Off label”. A sharp increase in the number of reports was observed in the three consecutive years with 21 in 2013, 54 in 2014, and 83 in 2015; (4) Conclusions: In addition to existing AMR monitoring strategies, pharmacovigilance databases can serve as a source of data on suspected resistance and inappropriate use. Future research should explore how these AMR-relevant MedDRA Terms are used in resource-limited settings with less capacity to generate laboratory-confirmed resistance data. Keywords: antibiotics; antimicrobial resistance; antimicrobial stewardship; AWaRe; pharmacovigilance; Lareb; adverse drug reactions Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Thu Dec 09 11:29:24 CET 2021 ModDate: Thu Dec 09 11:34:09 CET 2021 ID: 0x1750efa76cddddccf781b794f48e17ff, 0x1750efa76cddddccf781b794f48e17ff Filters: FilterPipeline: FlateDecode Fonts: Type1: Font: BaseFont: MCNKNK+URWPalladioL-Bold FontSubset: true FirstChar: 3 LastChar: 228 FontDescriptor: FontName: MCNKNK+URWPalladioL-Bold Flags: Symbolic FontBBox: -152, -301, 1000, 935 FontFile: true EncodingDictionary: Differences: true Font: BaseFont: YSWVCH+URWPalladioL-Roma FontSubset: true FirstChar: 2 LastChar: 235 FontDescriptor: FontName: YSWVCH+URWPalladioL-Roma Flags: Symbolic FontBBox: -166, -283, 1021, 943 FontFile: true EncodingDictionary: Differences: true Font: BaseFont: LWJOET+VnURWPalladioL FontSubset: true FirstChar: 177 LastChar: 226 FontDescriptor: FontName: LWJOET+VnURWPalladioL 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