Adverse Drug Reaction Reporting in the UK: A Retrospective Observational Comparison of Yellow Card Reports Submitted by Patients and Healthcare Professionals
Background: In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports. Objective: To compare patient charac...
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| creator | McLernon, David J. Bond, Christine M. Hannaford, Philip C. Watson, Margaret C. Lee, Amanda J. Hazell, Lorna Avery, Anthony |
| description | Background:
In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports.
Objective:
To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS.
Design and Setting:
Retrospective observational study in the UK.
Methods:
Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report.
Results:
In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range
IQR
] of 3 [
2
–
5
] vs 2 [
1
–
3
], respectively; p |
| doi_str_mv | 10.2165/11536510-000000000-00000 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_888097052</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A234936060</galeid><sourcerecordid>A234936060</sourcerecordid><originalsourceid>FETCH-LOGICAL-c465t-654094b71acd390a16553ef5ccd1ae8c51b2b7965b9ac4a9a0e341b666b398d13</originalsourceid><addsrcrecordid>eNqFkV1LHDEYhUOp1FX7F2RoEenF2Lz5msnl4kcrFQpFr0Mm884amc1skxmh_76R2VVaBJOLHJLnvJxwCCmAnjFQ8iuA5EoCLeluzeodWQBUugQt2HuyoACilBrUPjlI6SEDNVP1B7LPaEVBAF2QL8v2EWPC4iJOq-IXWjf6IWSxGeLow6rwoRjvsbj7cUT2Otsn_Lg9D8nd1eXt-ffy5ue36_PlTemEkmOppKBaNBVY13JNbY4rOXbSuRYs1k5Cw5pKK9lo64TVliIX0CilGq7rFvghOZ3nbuLwe8I0mrVPDvveBhymZOq6prqikmXy03_kwzDFkMOZSjAuKCiRoc8ztLI9Gh-6YYzWPY00y8xorqiimTp7hcq7xbV3Q8DO5_t_DPVscHFIKWJnNtGvbfxjgJqnjsyuI_Pc0ayy9Xgbe2rW2D4bd6Vk4GQL2ORs30UbnE8vHGfANJOZ0zOX8lNYYXz5_5sh_gJfxqQz</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>742340164</pqid></control><display><type>article</type><title>Adverse Drug Reaction Reporting in the UK: A Retrospective Observational Comparison of Yellow Card Reports Submitted by Patients and Healthcare Professionals</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>McLernon, David J. ; Bond, Christine M. ; Hannaford, Philip C. ; Watson, Margaret C. ; Lee, Amanda J. ; Hazell, Lorna ; Avery, Anthony</creator><creatorcontrib>McLernon, David J. ; Bond, Christine M. ; Hannaford, Philip C. ; Watson, Margaret C. ; Lee, Amanda J. ; Hazell, Lorna ; Avery, Anthony ; Yellow Card Collaboration</creatorcontrib><description>Background:
In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports.
Objective:
To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS.
Design and Setting:
Retrospective observational study in the UK.
Methods:
Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report.
Results:
In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range
IQR
] of 3 [
2
–
5
] vs 2 [
1
–
3
], respectively; p<0.001). A higher proportion of patient reports (16.1%) contained more than one suspect drug than healthcare professional reports (9%; p < 0.001). Healthcare professional reports had a higher proportion of ADRs that caused hospitalization (18.8% vs 12.9%), were life threatening (11.1% vs 6.2%) or caused death (2.6% vs 0.7%) than patient reports (all p<0.001). Patient reporters took a significantly longer time to report their reaction than healthcare professionals (median [IQR] of 104 [
27
–463] vs 28 [
13
–75] days respectively; p<0.001). Direct comparisons of the seriousness of the ADRs were not possible because of important differences between patient and healthcare professional versions of the Yellow Cards.
Conclusions:
This is the first substantial, published study in the UK to compare Yellow Card reports from patients and healthcare professionals. Whilst patients report more suspected ADRs to more suspect drugs than healthcare professionals, healthcare professionals tend to report more serious reactions that result in hospitalization, are life threatening or cause death. Further research is required to investigate the extent to which the extra information from patient reporters contributes to signal identification when assessing drug safety.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.2165/11536510-000000000-00000</identifier><identifier>PMID: 20701410</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adult ; Adverse and side effects ; Adverse Drug Reaction Reporting Systems - statistics & numerical data ; Aged ; Biological and medical sciences ; Drug Safety and Pharmacovigilance ; Drug toxicity and drugs side effects treatment ; Drug-Related Side Effects and Adverse Reactions ; Drugs ; Female ; Health care industry ; Health Personnel - statistics & numerical data ; Humans ; Male ; Medical personnel ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Miscellaneous (drug allergy, mutagens, teratogens...) ; Original Research Article ; Patients - statistics & numerical data ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Practice ; Quality management ; Retrospective Studies ; Sex Factors ; Time Factors ; United Kingdom</subject><ispartof>Drug safety, 2010-09, Vol.33 (9), p.775-788</ispartof><rights>Adis Data Information BV 2010</rights><rights>2015 INIST-CNRS</rights><rights>COPYRIGHT 2010 Wolters Kluwer Health, Inc.</rights><rights>Copyright Wolters Kluwer Health Adis International Sep 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c465t-654094b71acd390a16553ef5ccd1ae8c51b2b7965b9ac4a9a0e341b666b398d13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.2165/11536510-000000000-00000$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.2165/11536510-000000000-00000$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23212925$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20701410$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>McLernon, David J.</creatorcontrib><creatorcontrib>Bond, Christine M.</creatorcontrib><creatorcontrib>Hannaford, Philip C.</creatorcontrib><creatorcontrib>Watson, Margaret C.</creatorcontrib><creatorcontrib>Lee, Amanda J.</creatorcontrib><creatorcontrib>Hazell, Lorna</creatorcontrib><creatorcontrib>Avery, Anthony</creatorcontrib><creatorcontrib>Yellow Card Collaboration</creatorcontrib><title>Adverse Drug Reaction Reporting in the UK: A Retrospective Observational Comparison of Yellow Card Reports Submitted by Patients and Healthcare Professionals</title><title>Drug safety</title><addtitle>Drug-Safety</addtitle><addtitle>Drug Saf</addtitle><description>Background:
In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports.
Objective:
To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS.
Design and Setting:
Retrospective observational study in the UK.
Methods:
Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report.
Results:
In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range
IQR
] of 3 [
2
–
5
] vs 2 [
1
–
3
], respectively; p<0.001). A higher proportion of patient reports (16.1%) contained more than one suspect drug than healthcare professional reports (9%; p < 0.001). Healthcare professional reports had a higher proportion of ADRs that caused hospitalization (18.8% vs 12.9%), were life threatening (11.1% vs 6.2%) or caused death (2.6% vs 0.7%) than patient reports (all p<0.001). Patient reporters took a significantly longer time to report their reaction than healthcare professionals (median [IQR] of 104 [
27
–463] vs 28 [
13
–75] days respectively; p<0.001). Direct comparisons of the seriousness of the ADRs were not possible because of important differences between patient and healthcare professional versions of the Yellow Cards.
Conclusions:
This is the first substantial, published study in the UK to compare Yellow Card reports from patients and healthcare professionals. Whilst patients report more suspected ADRs to more suspect drugs than healthcare professionals, healthcare professionals tend to report more serious reactions that result in hospitalization, are life threatening or cause death. Further research is required to investigate the extent to which the extra information from patient reporters contributes to signal identification when assessing drug safety.</description><subject>Adult</subject><subject>Adverse and side effects</subject><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>Drug-Related Side Effects and Adverse Reactions</subject><subject>Drugs</subject><subject>Female</subject><subject>Health care industry</subject><subject>Health Personnel - statistics & numerical data</subject><subject>Humans</subject><subject>Male</subject><subject>Medical personnel</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Miscellaneous (drug allergy, mutagens, teratogens...)</subject><subject>Original Research Article</subject><subject>Patients - statistics & numerical data</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Practice</subject><subject>Quality management</subject><subject>Retrospective Studies</subject><subject>Sex Factors</subject><subject>Time Factors</subject><subject>United Kingdom</subject><issn>0114-5916</issn><issn>1179-1942</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNqFkV1LHDEYhUOp1FX7F2RoEenF2Lz5msnl4kcrFQpFr0Mm884amc1skxmh_76R2VVaBJOLHJLnvJxwCCmAnjFQ8iuA5EoCLeluzeodWQBUugQt2HuyoACilBrUPjlI6SEDNVP1B7LPaEVBAF2QL8v2EWPC4iJOq-IXWjf6IWSxGeLow6rwoRjvsbj7cUT2Otsn_Lg9D8nd1eXt-ffy5ue36_PlTemEkmOppKBaNBVY13JNbY4rOXbSuRYs1k5Cw5pKK9lo64TVliIX0CilGq7rFvghOZ3nbuLwe8I0mrVPDvveBhymZOq6prqikmXy03_kwzDFkMOZSjAuKCiRoc8ztLI9Gh-6YYzWPY00y8xorqiimTp7hcq7xbV3Q8DO5_t_DPVscHFIKWJnNtGvbfxjgJqnjsyuI_Pc0ayy9Xgbe2rW2D4bd6Vk4GQL2ORs30UbnE8vHGfANJOZ0zOX8lNYYXz5_5sh_gJfxqQz</recordid><startdate>20100901</startdate><enddate>20100901</enddate><creator>McLernon, David J.</creator><creator>Bond, Christine M.</creator><creator>Hannaford, Philip C.</creator><creator>Watson, Margaret C.</creator><creator>Lee, Amanda J.</creator><creator>Hazell, Lorna</creator><creator>Avery, Anthony</creator><general>Springer International Publishing</general><general>Adis International</general><general>Wolters Kluwer Health, Inc</general><general>Springer Nature B.V</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7RV</scope><scope>7T2</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7U2</scope></search><sort><creationdate>20100901</creationdate><title>Adverse Drug Reaction Reporting in the UK</title><author>McLernon, David J. ; Bond, Christine M. ; Hannaford, Philip C. ; Watson, Margaret C. ; Lee, Amanda J. ; Hazell, Lorna ; Avery, Anthony</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c465t-654094b71acd390a16553ef5ccd1ae8c51b2b7965b9ac4a9a0e341b666b398d13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Adverse and side effects</topic><topic>Adverse Drug Reaction Reporting Systems - statistics & numerical data</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Drug toxicity and drugs side effects treatment</topic><topic>Drug-Related Side Effects and Adverse Reactions</topic><topic>Drugs</topic><topic>Female</topic><topic>Health care industry</topic><topic>Health Personnel - statistics & numerical data</topic><topic>Humans</topic><topic>Male</topic><topic>Medical personnel</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Miscellaneous (drug allergy, mutagens, teratogens...)</topic><topic>Original Research Article</topic><topic>Patients - statistics & numerical data</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Practice</topic><topic>Quality management</topic><topic>Retrospective Studies</topic><topic>Sex Factors</topic><topic>Time Factors</topic><topic>United Kingdom</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>McLernon, David J.</creatorcontrib><creatorcontrib>Bond, Christine M.</creatorcontrib><creatorcontrib>Hannaford, Philip C.</creatorcontrib><creatorcontrib>Watson, Margaret C.</creatorcontrib><creatorcontrib>Lee, Amanda J.</creatorcontrib><creatorcontrib>Hazell, Lorna</creatorcontrib><creatorcontrib>Avery, Anthony</creatorcontrib><creatorcontrib>Yellow Card Collaboration</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Safety Science and Risk</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>McLernon, David J.</au><au>Bond, Christine M.</au><au>Hannaford, Philip C.</au><au>Watson, Margaret C.</au><au>Lee, Amanda J.</au><au>Hazell, Lorna</au><au>Avery, Anthony</au><aucorp>Yellow Card Collaboration</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adverse Drug Reaction Reporting in the UK: A Retrospective Observational Comparison of Yellow Card Reports Submitted by Patients and Healthcare Professionals</atitle><jtitle>Drug safety</jtitle><stitle>Drug-Safety</stitle><addtitle>Drug Saf</addtitle><date>2010-09-01</date><risdate>2010</risdate><volume>33</volume><issue>9</issue><spage>775</spage><epage>788</epage><pages>775-788</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>Background:
In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports.
Objective:
To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS.
Design and Setting:
Retrospective observational study in the UK.
Methods:
Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report.
Results:
In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range
IQR
] of 3 [
2
–
5
] vs 2 [
1
–
3
], respectively; p<0.001). A higher proportion of patient reports (16.1%) contained more than one suspect drug than healthcare professional reports (9%; p < 0.001). Healthcare professional reports had a higher proportion of ADRs that caused hospitalization (18.8% vs 12.9%), were life threatening (11.1% vs 6.2%) or caused death (2.6% vs 0.7%) than patient reports (all p<0.001). Patient reporters took a significantly longer time to report their reaction than healthcare professionals (median [IQR] of 104 [
27
–463] vs 28 [
13
–75] days respectively; p<0.001). Direct comparisons of the seriousness of the ADRs were not possible because of important differences between patient and healthcare professional versions of the Yellow Cards.
Conclusions:
This is the first substantial, published study in the UK to compare Yellow Card reports from patients and healthcare professionals. Whilst patients report more suspected ADRs to more suspect drugs than healthcare professionals, healthcare professionals tend to report more serious reactions that result in hospitalization, are life threatening or cause death. Further research is required to investigate the extent to which the extra information from patient reporters contributes to signal identification when assessing drug safety.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>20701410</pmid><doi>10.2165/11536510-000000000-00000</doi><tpages>14</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0114-5916 |
| ispartof | Drug safety, 2010-09, Vol.33 (9), p.775-788 |
| issn | 0114-5916 1179-1942 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_888097052 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Adverse and side effects Adverse Drug Reaction Reporting Systems - statistics & numerical data Aged Biological and medical sciences Drug Safety and Pharmacovigilance Drug toxicity and drugs side effects treatment Drug-Related Side Effects and Adverse Reactions Drugs Female Health care industry Health Personnel - statistics & numerical data Humans Male Medical personnel Medical sciences Medicine Medicine & Public Health Middle Aged Miscellaneous (drug allergy, mutagens, teratogens...) Original Research Article Patients - statistics & numerical data Pharmacology. Drug treatments Pharmacology/Toxicology Practice Quality management Retrospective Studies Sex Factors Time Factors United Kingdom |
| title | Adverse Drug Reaction Reporting in the UK: A Retrospective Observational Comparison of Yellow Card Reports Submitted by Patients and Healthcare Professionals |
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