Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals

Egberts, Toine C. G.; Smulders, Maartje; Koning, Fred H. P. De; Meyboom, R.H.B.; Leufkens, Hubert G. M.

doi:10.1136/bmj.313.7056.530

Cited by 98 publications

(56 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It has been suggested that patient reports might enable earlier signal detection 20, 21. In 1996, Egberts et al .…”

Section: Discussionmentioning

confidence: 99%

“…In 1996, Egberts et al . 21 compared information obtained from patients and healthcare professionals on the, at the time, new antidepressant paroxetine. At that time in the Netherlands, patients were not yet able to report directly to the pharmacovigilance centre but could consult a telephone medicines information service maintained by pharmacists.…”

Section: Discussionmentioning

confidence: 99%

“…It has been suggested that reporting by patients contributes to an earlier detection of drug safety signals 20, 21. Indeed, a certain number of reports is necessary to generate new drug safety signals and reports by patients provide an additional source of information.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Rolfes

Hunsel

Caster

et al. 2018

Brit J Clinical Pharma

View full text Add to dashboard Cite

AimsTo explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug–adverse drug reaction (ADR) associations that led to drug safety signals.MethodsThis was a retrospective comparison of time to reporting selected drug–ADR associations which led to drug safety signals between patients and HCPs. 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. 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.ResultsIn 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).ConclusionsPatients 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.

show abstract

“…It has been suggested that patient reports might enable earlier signal detection 20, 21. In 1996, Egberts et al .…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

Rolfes

Hunsel

Caster

et al. 2018

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…However, regarding to age, the comparison with the general Portuguese population shows us that there is a greater representation of [45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64] classes, which results in an underrepresentation of the elderly class of 65+ years.…”

Section: Respondents' Characteristicsmentioning

confidence: 99%

“…Patients reporting has already led to important contributions in valuable information on drug safety. (31) Patients may contribute to the detection of known and unknown ADRs, symptoms or signs earlier than HCPs, (49,50) and they may identify some different ADRs from those reported by HCPs or those which not feature in existing product information, contributing to a better knowledge of the nature and incidence of ADRs.…”

Section: Possible Benefits Of Patient Reportingmentioning

confidence: 99%

Are patients ready to take part in the Pharmacovigilance system? a portuguese preliminary study concerning adr reporting

Matos

Hunsel

Joaquim

2015

Clinical Therapeutics

View full text Add to dashboard Cite

New Statins Also Produce Fatigue: Spontaneous Reporting as a Complementary System to Increase Safety Knowledge—Reply

Golomb¹,

Koperski²

2013

JAMA Intern Med

View full text Add to dashboard Cite

Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals

Cited by 98 publications

References 5 publications

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

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

Are patients ready to take part in the Pharmacovigilance system? a portuguese preliminary study concerning adr reporting

New Statins Also Produce Fatigue: Spontaneous Reporting as a Complementary System to Increase Safety Knowledge—Reply

Contact Info

Product

Resources

About