Publication

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database: A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database

Rolfes, L., van Hunsel, F., Caster, O., Taavola, H., Taxis, K. & van Puijenbroek, E., Jul-2018, In : British Journal of Clinical Pharmacology. 84, 7, p. 1514-1524 11 p.

Research output: Contribution to journalArticleAcademicpeer-review

APA

Rolfes, L., van Hunsel, F., Caster, O., Taavola, H., Taxis, K., & van Puijenbroek, E. (2018). Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database: A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database. British Journal of Clinical Pharmacology, 84(7), 1514-1524. https://doi.org/10.1111/bcp.13576

Author

Rolfes, Leàn ; van Hunsel, Florence ; Caster, Ola ; Taavola, Henric ; Taxis, Katja ; van Puijenbroek, Eugène. / Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database : A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database. In: British Journal of Clinical Pharmacology. 2018 ; Vol. 84, No. 7. pp. 1514-1524.

Harvard

Rolfes, L, van Hunsel, F, Caster, O, Taavola, H, Taxis, K & van Puijenbroek, E 2018, 'Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database: A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database', British Journal of Clinical Pharmacology, vol. 84, no. 7, pp. 1514-1524. https://doi.org/10.1111/bcp.13576

Standard

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database : A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database. / Rolfes, Leàn; van Hunsel, Florence; Caster, Ola; Taavola, Henric; Taxis, Katja; van Puijenbroek, Eugène.

In: British Journal of Clinical Pharmacology, Vol. 84, No. 7, 07.2018, p. 1514-1524.

Research output: Contribution to journalArticleAcademicpeer-review

Vancouver

Rolfes L, van Hunsel F, Caster O, Taavola H, Taxis K, van Puijenbroek E. Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database: A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database. British Journal of Clinical Pharmacology. 2018 Jul;84(7):1514-1524. https://doi.org/10.1111/bcp.13576


BibTeX

@article{a6f206d87b934a43a289528830f515d4,
title = "Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database: A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database",
abstract = "OBJECTIVE: To explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug-adverse drug reaction (ADR) associations which led to drug safety signals.DESIGN: This was a retrospective comparison of time to reporting selected drug-ADR associations which led to drug safety signals between patients and healthcare professionals.SETTING: ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug-ADR associations of actual drug safety signals.MAIN OUTCOME MEASURES: Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann-Whitney U test.RESULTS: In total 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs 8.3 years (p <0.001).CONCLUSIONS: Patients contributed a large proportion of reports on drug-ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection, and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future.",
keywords = "adverse drug reaction, drug safety, patient reporting, pharmacovigilance, signal detection, IMMUNIZATION, NETHERLANDS, INFORMATION, EXPERIENCE",
author = "Le{\`a}n Rolfes and {van Hunsel}, Florence and Ola Caster and Henric Taavola and Katja Taxis and {van Puijenbroek}, Eug{\`e}ne",
note = "This article is protected by copyright. All rights reserved.",
year = "2018",
month = jul,
doi = "10.1111/bcp.13576",
language = "English",
volume = "84",
pages = "1514--1524",
journal = "British Journal of Clinical Pharmacology",
issn = "0306-5251",
publisher = "Wiley",
number = "7",

}

RIS

TY - JOUR

T1 - Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

T2 - A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database

AU - Rolfes, Leàn

AU - van Hunsel, Florence

AU - Caster, Ola

AU - Taavola, Henric

AU - Taxis, Katja

AU - van Puijenbroek, Eugène

N1 - This article is protected by copyright. All rights reserved.

PY - 2018/7

Y1 - 2018/7

N2 - OBJECTIVE: To explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug-adverse drug reaction (ADR) associations which led to drug safety signals.DESIGN: This was a retrospective comparison of time to reporting selected drug-ADR associations which led to drug safety signals between patients and healthcare professionals.SETTING: ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug-ADR associations of actual drug safety signals.MAIN OUTCOME MEASURES: Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann-Whitney U test.RESULTS: In total 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs 8.3 years (p <0.001).CONCLUSIONS: Patients contributed a large proportion of reports on drug-ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection, and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future.

AB - OBJECTIVE: To explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug-adverse drug reaction (ADR) associations which led to drug safety signals.DESIGN: This was a retrospective comparison of time to reporting selected drug-ADR associations which led to drug safety signals between patients and healthcare professionals.SETTING: ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug-ADR associations of actual drug safety signals.MAIN OUTCOME MEASURES: Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann-Whitney U test.RESULTS: In total 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs 8.3 years (p <0.001).CONCLUSIONS: Patients contributed a large proportion of reports on drug-ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection, and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future.

KW - adverse drug reaction

KW - drug safety

KW - patient reporting

KW - pharmacovigilance

KW - signal detection

KW - IMMUNIZATION

KW - NETHERLANDS

KW - INFORMATION

KW - EXPERIENCE

U2 - 10.1111/bcp.13576

DO - 10.1111/bcp.13576

M3 - Article

C2 - 29522255

VL - 84

SP - 1514

EP - 1524

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

SN - 0306-5251

IS - 7

ER -

ID: 55385410