Adverse drug reaction reporting in the UK

David J McLernon, Christine M Bond, Philip C Hannaford, Margaret C Watson, Amanda J Lee, Lorna Hazell, Anthony Avery, Yellow Card Study Collaboration

Research output: Contribution to journalArticle

62 Citations (Scopus)

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.
LanguageEnglish
Pages775-788
Number of pages14
JournalDrug Safety
Volume33
Issue number9
DOIs
Publication statusPublished - 1 Sep 2010

Fingerprint

Drug-Related Side Effects and Adverse Reactions
Delivery of Health Care
Pharmaceutical Preparations
Hospitalization
Observational Studies
Cause of Death
Retrospective Studies

Keywords

  • adult
  • adverse drug reaction reporting systems
  • aged
  • drug-related side effects and adverse reactions
  • female
  • Great Britain
  • health personnel
  • humans
  • male
  • middle aged
  • patients
  • retrospective studies
  • sex factors
  • time factors

Cite this

Yellow Card Study Collaboration. / Adverse drug reaction reporting in the UK. 2010 ; Vol. 33, No. 9. pp. 775-788.
@article{5fdca352e11d433c99437a998b4f3fb8,
title = "Adverse drug reaction reporting in the UK",
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.",
keywords = "adult, adverse drug reaction reporting systems, aged, drug-related side effects and adverse reactions, female, Great Britain, health personnel, humans, male, middle aged, patients, retrospective studies, sex factors, time factors",
author = "McLernon, {David J} and Bond, {Christine M} and Hannaford, {Philip C} and Watson, {Margaret C} and Lee, {Amanda J} and Lorna Hazell and Anthony Avery and {Yellow Card Study Collaboration}",
year = "2010",
month = "9",
day = "1",
doi = "10.2165/11536510-000000000-00000",
language = "English",
volume = "33",
pages = "775--788",
number = "9",

}

Yellow Card Study Collaboration 2010, 'Adverse drug reaction reporting in the UK' vol. 33, no. 9, pp. 775-788. https://doi.org/10.2165/11536510-000000000-00000

Adverse drug reaction reporting in the UK. / Yellow Card Study Collaboration.

Vol. 33, No. 9, 01.09.2010, p. 775-788.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Adverse drug reaction reporting in the UK

AU - McLernon, David J

AU - Bond, Christine M

AU - Hannaford, Philip C

AU - Watson, Margaret C

AU - Lee, Amanda J

AU - Hazell, Lorna

AU - Avery, Anthony

AU - Yellow Card Study Collaboration

PY - 2010/9/1

Y1 - 2010/9/1

N2 - 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.

AB - 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.

KW - adult

KW - adverse drug reaction reporting systems

KW - aged

KW - drug-related side effects and adverse reactions

KW - female

KW - Great Britain

KW - health personnel

KW - humans

KW - male

KW - middle aged

KW - patients

KW - retrospective studies

KW - sex factors

KW - time factors

U2 - 10.2165/11536510-000000000-00000

DO - 10.2165/11536510-000000000-00000

M3 - Article

VL - 33

SP - 775

EP - 788

IS - 9

ER -

Yellow Card Study Collaboration. Adverse drug reaction reporting in the UK. 2010 Sep 1;33(9):775-788. https://doi.org/10.2165/11536510-000000000-00000