Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine
Identifieur interne : 000178 ( Pmc/Curation ); précédent : 000177; suivant : 000179Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine
Auteurs : Karin Fattinger [Suisse] ; Malgorzata Roos ; Patrice Vergères [Suisse] ; Clemens Holenstein [Suisse] ; Brigitt Kind [Suisse] ; Urspeter Masche [Suisse] ; David N. Stocker [Suisse] ; Suzanne Braunschweig [Suisse] ; Gerd A. Kullak-Ublick [Suisse] ; Renato L. Galeazzi [Suisse] ; Ferenc Follath [Suisse] ; Theo Gasser ; Peter J. Meier [Suisse]Source :
- British Journal of Clinical Pharmacology [ 0306-5251 ] ; 2000.
Abstract
To explore drug exposure, frequency of adverse drug reactions (ADRs), types of ADRs, predisposing risk factors and ADR-related excess hospital stay in medical inpatients.
Structured data regarding patient characteristics, ‘events’ (symptoms, laboratory results), diagnoses (ICD10) and drug therapy were collected using a computer-supported data entry system and an interface for data retrieval from electronic patient records. ADR data were collected by ‘event monitoring’ to minimize possible bias by the drug monitor. The causality of each event was assessed in relation to disease(s) and drug therapy.
The analysis included 4331 (100%) hospitalizations. The median observation period was 8 days. The median number of different drugs administered per patient and day was 6 and varied between 4 (Q1) and 9 (Q3) different drugs in 50% of all hospital days. In 41% of all hospitalizations at least one disease-unrelated event could be possibly attributed to drug therapy. Clinically relevant ADRs occurred in 11% of all hospitalizations. In 3.3% of all hospitalizations ADRs were the cause of hospital admission. The incidence of possibly ADR-related deaths was 1.4. Factors predisposing for clinically relevant ADRs were female gender and polypharmacy. ADR-related excess hospital stay accounted for 8.6% of hospital days.
These data demonstrate the feasibility of the developed ‘event monitoring’ system for quantitative analysis of ADRs in medical inpatients. With increasing numbers of recorded patients the pharmacoepidemiological database provides a valuable tool to study specific questions regarding drug efficacy and safety in hospitalized patients.
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DOI: 10.1046/j.1365-2125.2000.00132.x
PubMed: 10671911
PubMed Central: 2014906
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Stocker</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="au3"><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Braunschweig, Suzanne" sort="Braunschweig, Suzanne" uniqKey="Braunschweig S" first="Suzanne" last="Braunschweig">Suzanne Braunschweig</name><affiliation wicri:level="1"><nlm:aff id="au3"><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Kullak Ublick, Gerd A" sort="Kullak Ublick, Gerd A" uniqKey="Kullak Ublick G" first="Gerd A" last="Kullak-Ublick">Gerd A. Kullak-Ublick</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Galeazzi, Renato L" sort="Galeazzi, Renato L" uniqKey="Galeazzi R" first="Renato L" last="Galeazzi">Renato L. Galeazzi</name><affiliation wicri:level="1"><nlm:aff id="au4"><institution>Department of Internal Medicine, Kantonsspital</institution><addr-line>St Gallen, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>St Gallen</wicri:regionArea></affiliation></author><author><name sortKey="Follath, Ferenc" sort="Follath, Ferenc" uniqKey="Follath F" first="Ferenc" last="Follath">Ferenc Follath</name><affiliation wicri:level="1"><nlm:aff id="au5"><institution>Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Gasser, Theo" sort="Gasser, Theo" uniqKey="Gasser T" first="Theo" last="Gasser">Theo Gasser</name><affiliation><nlm:aff id="au2"><institution>Biostatistics, ISPM, University of Zurich</institution><addr-line>Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Meier, Peter J" sort="Meier, Peter J" uniqKey="Meier P" first="Peter J" last="Meier">Peter J. Meier</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">10671911</idno><idno type="pmc">2014906</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2014906</idno><idno type="RBID">PMC:2014906</idno><idno type="doi">10.1046/j.1365-2125.2000.00132.x</idno><date when="2000">2000</date><idno type="wicri:Area/Pmc/Corpus">000180</idno><idno type="wicri:Area/Pmc/Curation">000178</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine</title><author><name sortKey="Fattinger, Karin" sort="Fattinger, Karin" uniqKey="Fattinger K" first="Karin" last="Fattinger">Karin Fattinger</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Roos, Malgorzata" sort="Roos, Malgorzata" uniqKey="Roos M" first="Malgorzata" last="Roos">Malgorzata Roos</name><affiliation><nlm:aff id="au2"><institution>Biostatistics, ISPM, University of Zurich</institution><addr-line>Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Vergeres, Patrice" sort="Vergeres, Patrice" uniqKey="Vergeres P" first="Patrice" last="Vergères">Patrice Vergères</name><affiliation wicri:level="1"><nlm:aff id="au3"><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Holenstein, Clemens" sort="Holenstein, Clemens" uniqKey="Holenstein C" first="Clemens" last="Holenstein">Clemens Holenstein</name><affiliation wicri:level="1"><nlm:aff id="au3"><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Kind, Brigitt" sort="Kind, Brigitt" uniqKey="Kind B" first="Brigitt" last="Kind">Brigitt Kind</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="au3"><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Masche, Urspeter" sort="Masche, Urspeter" uniqKey="Masche U" first="Urspeter" last="Masche">Urspeter Masche</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="au3"><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Stocker, David N" sort="Stocker, David N" uniqKey="Stocker D" first="David N" last="Stocker">David N. Stocker</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="au3"><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Braunschweig, Suzanne" sort="Braunschweig, Suzanne" uniqKey="Braunschweig S" first="Suzanne" last="Braunschweig">Suzanne Braunschweig</name><affiliation wicri:level="1"><nlm:aff id="au3"><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Kullak Ublick, Gerd A" sort="Kullak Ublick, Gerd A" uniqKey="Kullak Ublick G" first="Gerd A" last="Kullak-Ublick">Gerd A. Kullak-Ublick</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Galeazzi, Renato L" sort="Galeazzi, Renato L" uniqKey="Galeazzi R" first="Renato L" last="Galeazzi">Renato L. Galeazzi</name><affiliation wicri:level="1"><nlm:aff id="au4"><institution>Department of Internal Medicine, Kantonsspital</institution><addr-line>St Gallen, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>St Gallen</wicri:regionArea></affiliation></author><author><name sortKey="Follath, Ferenc" sort="Follath, Ferenc" uniqKey="Follath F" first="Ferenc" last="Follath">Ferenc Follath</name><affiliation wicri:level="1"><nlm:aff id="au5"><institution>Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Gasser, Theo" sort="Gasser, Theo" uniqKey="Gasser T" first="Theo" last="Gasser">Theo Gasser</name><affiliation><nlm:aff id="au2"><institution>Biostatistics, ISPM, University of Zurich</institution><addr-line>Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Meier, Peter J" sort="Meier, Peter J" uniqKey="Meier P" first="Peter J" last="Meier">Peter J. Meier</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Zurich</wicri:regionArea></affiliation></author></analytic><series><title level="j">British Journal of Clinical Pharmacology</title><idno type="ISSN">0306-5251</idno><idno type="eISSN">1365-2125</idno><imprint><date when="2000">2000</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Aims</title><p>To explore drug exposure, frequency of adverse drug reactions (ADRs), types of ADRs, predisposing risk factors and ADR-related excess hospital stay in medical inpatients.</p></sec><sec sec-type="methods"><title>Methods</title><p>Structured data regarding patient characteristics, ‘events’ (symptoms, laboratory results), diagnoses (ICD10) and drug therapy were collected using a computer-supported data entry system and an interface for data retrieval from electronic patient records. ADR data were collected by ‘event monitoring’ to minimize possible bias by the drug monitor. The causality of each event was assessed in relation to disease(s) and drug therapy.</p></sec><sec><title>Results</title><p>The analysis included 4331 (100%) hospitalizations. The median observation period was 8 days. The median number of different drugs administered per patient and day was 6 and varied between 4 (Q<sub>1</sub>) and 9 (Q<sub>3</sub>) different drugs in 50% of all hospital days. In 41% of all hospitalizations at least one disease-unrelated event could be possibly attributed to drug therapy. Clinically relevant ADRs occurred in 11% of all hospitalizations. In 3.3% of all hospitalizations ADRs were the cause of hospital admission. The incidence of possibly ADR-related deaths was 1.4. Factors predisposing for clinically relevant ADRs were female gender and polypharmacy. ADR-related excess hospital stay accounted for 8.6% of hospital days.</p></sec><sec><title>Conclusions</title><p>These data demonstrate the feasibility of the developed ‘event monitoring’ system for quantitative analysis of ADRs in medical inpatients. With increasing numbers of recorded patients the pharmacoepidemiological database provides a valuable tool to study specific questions regarding drug efficacy and safety in hospitalized patients.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Br J Clin Pharmacol</journal-id><journal-id journal-id-type="publisher-id">bcp</journal-id><journal-title>British Journal of Clinical Pharmacology</journal-title><issn pub-type="ppub">0306-5251</issn><issn pub-type="epub">1365-2125</issn><publisher><publisher-name>Blackwell Science Inc</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">10671911</article-id><article-id pub-id-type="pmc">2014906</article-id><article-id pub-id-type="doi">10.1046/j.1365-2125.2000.00132.x</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Articles</subject></subj-group></article-categories><title-group><article-title>Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Fattinger</surname><given-names>Karin</given-names></name><xref ref-type="aff" rid="au1">1</xref></contrib><contrib contrib-type="author"><name><surname>Roos</surname><given-names>Malgorzata</given-names></name><xref ref-type="aff" rid="au2">2</xref></contrib><contrib contrib-type="author"><name><surname>Vergères</surname><given-names>Patrice</given-names></name><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Holenstein</surname><given-names>Clemens</given-names></name><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Kind</surname><given-names>Brigitt</given-names></name><xref ref-type="aff" rid="au1">1</xref><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Masche</surname><given-names>Urspeter</given-names></name><xref ref-type="aff" rid="au1">1</xref><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Stocker</surname><given-names>David N</given-names></name><xref ref-type="aff" rid="au1">1</xref><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Braunschweig</surname><given-names>Suzanne</given-names></name><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Kullak-Ublick</surname><given-names>Gerd A</given-names></name><xref ref-type="aff" rid="au1">1</xref></contrib><contrib contrib-type="author"><name><surname>Galeazzi</surname><given-names>Renato L</given-names></name><xref ref-type="aff" rid="au4">4</xref></contrib><contrib contrib-type="author"><name><surname>Follath</surname><given-names>Ferenc</given-names></name><xref ref-type="aff" rid="au5">5</xref></contrib><contrib contrib-type="author"><name><surname>Gasser</surname><given-names>Theo</given-names></name><xref ref-type="aff" rid="au2">2</xref></contrib><contrib contrib-type="author"><name><surname>Meier</surname><given-names>Peter J</given-names></name><xref ref-type="aff" rid="au1">1</xref></contrib><aff id="au1"><label>1</label><institution>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></aff><aff id="au2"><label>2</label><institution>Biostatistics, ISPM, University of Zurich</institution><addr-line>Switzerland</addr-line></aff><aff id="au3"><label>3</label><institution>Foundation for Drug Safety and Comprehensive Hospital Drug Monitoring, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></aff><aff id="au4"><label>4</label><institution>Department of Internal Medicine, Kantonsspital</institution><addr-line>St Gallen, Switzerland</addr-line></aff><aff id="au5"><label>5</label><institution>Department of Internal Medicine, University Hospital</institution><addr-line>Zurich, Switzerland</addr-line></aff></contrib-group><author-notes><corresp id="cor1">Correspondence: Dr Karin Fattinger, Division of Clinical Pharmacology and Toxicology, Department of Medicine, University Hospital, Rämistrasse 100, 8091 Zürich, Switzerland. Tel.: 41-1-255 20 67, Fax: 41-1-255 44 11, E-mail: <email>fattinge@kpt.unizh.ch.</email></corresp></author-notes><pub-date pub-type="ppub"><month>2</month><year>2000</year></pub-date><volume>49</volume><issue>2</issue><fpage>158</fpage><lpage>167</lpage><history><date date-type="received"><day>07</day><month>9</month><year>1998</year></date><date date-type="accepted"><day>05</day><month>11</month><year>1999</year></date></history><copyright-statement>© 2000 Blackwell Science Ltd</copyright-statement><copyright-year>2000</copyright-year><abstract><sec><title>Aims</title><p>To explore drug exposure, frequency of adverse drug reactions (ADRs), types of ADRs, predisposing risk factors and ADR-related excess hospital stay in medical inpatients.</p></sec><sec sec-type="methods"><title>Methods</title><p>Structured data regarding patient characteristics, ‘events’ (symptoms, laboratory results), diagnoses (ICD10) and drug therapy were collected using a computer-supported data entry system and an interface for data retrieval from electronic patient records. ADR data were collected by ‘event monitoring’ to minimize possible bias by the drug monitor. The causality of each event was assessed in relation to disease(s) and drug therapy.</p></sec><sec><title>Results</title><p>The analysis included 4331 (100%) hospitalizations. The median observation period was 8 days. The median number of different drugs administered per patient and day was 6 and varied between 4 (Q<sub>1</sub>) and 9 (Q<sub>3</sub>) different drugs in 50% of all hospital days. In 41% of all hospitalizations at least one disease-unrelated event could be possibly attributed to drug therapy. Clinically relevant ADRs occurred in 11% of all hospitalizations. In 3.3% of all hospitalizations ADRs were the cause of hospital admission. The incidence of possibly ADR-related deaths was 1.4. Factors predisposing for clinically relevant ADRs were female gender and polypharmacy. ADR-related excess hospital stay accounted for 8.6% of hospital days.</p></sec><sec><title>Conclusions</title><p>These data demonstrate the feasibility of the developed ‘event monitoring’ system for quantitative analysis of ADRs in medical inpatients. With increasing numbers of recorded patients the pharmacoepidemiological database provides a valuable tool to study specific questions regarding drug efficacy and safety in hospitalized patients.</p></sec></abstract><kwd-group><kwd>adverse drug reactions</kwd><kwd>event monitoring</kwd><kwd>hospital pharmacoepidemiology</kwd><kwd>inpatients</kwd><kwd>medication usage</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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