The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case–control study

Hunsel, Florence van; Talsma, Attje; Puijenbroek, Eugène van; Berg, Lolkje de Jong-van den; Grootheest, Kees van

doi:10.1002/pds.2092

Cited by 52 publications

(48 citation statements)

References 19 publications

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“…Nevertheless, similar proportions of reports contain at least one reaction term that is classified as 'serious', demonstrating that most patients report clinically significant problems [9]. Studies from the UK and the Netherlands have found that patient reports have strengthened rather than hampered signal detection [5,6]. Patient reports add weight to HCP reports by creating new and important potential signals.…”

Section: Patient Reporting Adds Value To Pharmacovigilance Signal Detmentioning

confidence: 93%

“…Hence, both previously unknown associations and new aspects about an already known association are considered to be signals. Patient reports of suspected adverse reactions have contributed enormously to pharmacovigilance signal detection in a number of ways [5,6]. Patient reports gave detailed descriptions of suspected ADRs, attributed reactions to specific medicines and provided information useful for assessing causality.…”

Section: Patient Reporting Adds Value To Pharmacovigilance Signal Detmentioning

confidence: 99%

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Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Härmark

Raine²,

Leufkens

et al. 2016

Drug Saf

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The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

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Section: Patient Reporting Adds Value To Pharmacovigilance Signal Detmentioning

confidence: 93%

Section: Patient Reporting Adds Value To Pharmacovigilance Signal Detmentioning

confidence: 99%

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Härmark

Raine²,

Leufkens

et al. 2016

Drug Saf

View full text Add to dashboard Cite

show abstract

“…So far, the quality of patient reports appears to be similar to that of healthcare professional (HCP) reports [7]. Studies have also shown the possible benefits of patient reporting for signal detection [8,9].…”

Section: Introductionmentioning

confidence: 90%

Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting

Matos

Hunsel

Joaquim

2015

Eur J Clin Pharmacol

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“…Pharmaceutical companies are also interested in the direct reporting of ADRs by consumers in a timely manner during post-marketing drug surveillance due to the severe legal and monetary implications [2]. Since reporting of ADRs by patients is in line with the striving for quality in the healthcare system, a growing number of countries allow patients to report suspicious ADRs directly to a pharmacovigilance system [3]. Study has shown that consumer reporting of ADRs contributes significantly to a reliable pharmacovigilance [4].…”

Section: Introductionmentioning

confidence: 98%