title: Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?
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.
authors.affiliation: Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Center for Pharmacovigilance in Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. l.harmark@lareb.nl.
authors.forename: Linda
authors.identifier: 0000-0002-9314-9298
authors.initials: L
authors.lastname: Härmark
authors.affiliation: Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London, SW1W 9SZ, UK.
authors.forename: June
authors.initials: J
authors.lastname: Raine
authors.affiliation: Medicines Evaluation Board, Postbus 8275, 3503 RG, Utrecht, The Netherlands.
authors.forename: Hubert
authors.initials: H
authors.lastname: Leufkens
authors.affiliation: Uppsala Monitoring Centre, Box 1051, 751 40, Uppsala, Sweden.
authors.forename: I Ralph
authors.initials: IR
authors.lastname: Edwards
authors.affiliation: Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
authors.forename: Ugo
authors.initials: U
authors.lastname: Moretti
authors.affiliation: Halmed, Ksaverska cesta 4, 10 000, Zagreb, Croatia.
authors.forename: Viola Macolic
authors.initials: VM
authors.lastname: Sarinic
authors.affiliation: Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Center for Pharmacovigilance in Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
authors.forename: Agnes
authors.initials: A
authors.lastname: Kant
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D000071066:Patient Reported Outcome Measures; D060735:Pharmacovigilance