The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis

Rolfes, Leàn; Hunsel, Florence van; Linden, Laura van der; Taxis, Katja; Puijenbroek, Eugène van

doi:10.1007/s40264-017-0530-5

Cited by 57 publications

(33 citation statements)

References 24 publications

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“…Signal detection is not about obtaining the exhaustive or full number of cases in a population but about obtaining sufficiently documented cases in real time to detect a signal as early as possible. Research has shown that in the Netherlands the information type and quality of patient reports is similar to HCP reports . A previous study found that HCPs more often reported objective information compared with patients.…”

Section: Discussionmentioning

confidence: 89%

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The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

Hunsel

Waal

Härmark

2017

Pharmacoepidemiology and Drug

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Section: Discussionmentioning

confidence: 89%

“…A recent study compared differences in clinical documentation on ADRs that were reported in duplicate, so‐called paired reports of patient and HCPs. Differences in the clinical documentation of these ADRs were small …”

Section: Discussionmentioning

confidence: 95%

The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

Hunsel

Waal

Härmark

2017

Pharmacoepidemiology and Drug

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“…There are also studies that demonstrated no difference in seriousness between both groups 6, 7, 13, 14. Although there have been concerns about the quality of patient reports in the past, it has recently been shown that the clinical quality of information reported by patients is comparable to that of healthcare professionals 15. Concerning the detection of new drug safety signals, it was demonstrated that reports by patient are taken into account 16, 17, 18, 19.…”

Section: Introductionmentioning

confidence: 99%

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

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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.

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“…This has advantages because the ADEs were selfreported by the individual experiencing the event, but also drawbacks as the ADEs were not medically confirmed. However, although comparative studies of ADE reporting between people with disease and healthcare professionals found results conflicted [26], recent studies have suggested that the level of relevant clinical information was similar [27]. Additionally, since people with disease do not have a healthcare professional view of what to expect to report, they can add information and provide other perspectives on ADEs, which might increase the chance of finding new events [28].…”

Section: Discussionmentioning

confidence: 99%

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

Torre

Guerreiro²,

Longo³

et al. 2019

Diabet. Med.

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Aims To determine the frequency and the time‐course profile of adverse drug events associated with new glucose‐lowering drugs in daily practice and to explore factors potentially associated to these events. Methods An inception cohort study was implemented. Adults with type 2 diabetes mellitus initiating a dipeptidyl peptidase‐4 inhibitor, a glucagon‐like peptide‐1 receptor agonist or a sodium‐glucose co‐transporter‐2 inhibitor were eligible for inclusion. Data were collected through baseline and follow‐up telephone questionnaires, administered at 2 weeks, 3 months and 6 months. Kaplan–Meier curves and log‐rank were computed to compare the time to adverse drug event onset. Cox models were used to explore potential factors associated with adverse drug events. Results A total of 1328 participants were recruited to the study. In all, 1118 adverse drug events were reported (of which 36% were not listed in the summary of product characteristics) by 41% of participants. The median latency time of adverse drug events reported in ≥1% of participants ranged from 0 to 2 days. Glucagon‐like peptide‐1 receptor agonist and sodium‐glucose co‐transporter‐2 inhibitor subgroups were associated with an increased likelihood of adverse drug event reporting when compared with the dipeptidyl peptidase‐4 inhibitor subgroup. A total of 328 glucose‐lowering drugs were withdrawn, more than half as a result of an adverse drug event. Conclusions More than two‐fifths of participants reported an adverse drug event; dipeptidyl peptidase‐4 inhibitors led to the highest proportion of unlabelled adverse drug events. Adverse drug event latency time data show that counselling and adverse drug event management should be proactively addressed from treatment initiation. There should be greater focus on prevalent new users of glucose‐lowering drugs, who were more complex participants in this study in terms of type 2 diabetes disease, as they were more likely to report an adverse drug event than the incident new users.

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The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis

Cited by 57 publications

References 24 publications

The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

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

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

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