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- Title
Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?
- Authors
Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I.; Moretti, Ugo; Sarinic, Viola; Kant, Agnes; Härmark, Linda; Edwards, I Ralph; Sarinic, Viola Macolic
- Abstract
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.
- Subjects
PHARMACOLOGY; DRUG side effects; PUBLIC health; MEDICATION errors; METHODOLOGY; DRUG side effects laws; DATABASES; EUROPEAN Union
- Publication
Drug Safety, 2016, Vol 39, Issue 10, p883
- ISSN
0114-5916
- Publication type
journal article
- DOI
10.1007/s40264-016-0441-x