Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Linda Härmark (), June Raine, Hubert Leufkens, I. Ralph Edwards, Ugo Moretti, Viola Macolic Sarinic and Agnes Kant
Additional contact information
Linda Härmark: Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Center for Pharmacovigilance in Education and Patient Reporting
June Raine: Medicines and Healthcare Products Regulatory Agency
Hubert Leufkens: Medicines Evaluation Board
I. Ralph Edwards: Uppsala Monitoring Centre
Ugo Moretti: University of Verona
Viola Macolic Sarinic: Halmed
Agnes Kant: Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Center for Pharmacovigilance in Education and Patient Reporting

Drug Safety, 2016, vol. 39, issue 10, No 1, 883-890

Abstract: 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.

Date: 2016
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Citations: View citations in EconPapers (6)

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DOI: 10.1007/s40264-016-0441-x

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