Publications

Authors:

Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I. Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

Title:

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Year:

2016

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Referee:

Sì

Name of journal:

Drug Safety

ISSN of journal:

0114-5916

N° Volume:

9

Number or Folder:

10

:

ADIS

Page numbers:

883-890

Keyword:

EU pharmacovigilance legislation

Short description of contents:

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.

Product ID:

92460

Handle IRIS:

11562/945738

Last Modified:

November 26, 2022

Bibliographic citation:

Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I. Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes, Patient-Reported Safety Information: A Renaissance of Pharmacovigilance? «Drug Safety» , vol. 9 , n. 10 , 2016 , pp. 883-890

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