Patient Associations as key players in pharmacovigilance: results of an Italian survey from the Patient Safety Council


Despite an increasing role in selecting and evaluating treatments, Patient Associations (PAs) do not yet play a significant role in pharmacovigilance (PV). The Patient Safety Council (PSC) is an initiative that brings together five PAs (AISM, AMICI Onlus, Fedemo, La Lampada di Aladino, Walce). The aim of PSC is to encourage PAs to play an active role in patient education, reporting Adverse Drug Reactions (ADRs) and assessing the safety of treatments.
To this aim, PSC carried out a survey to assesse the level of information on PV among the members of the five associations and their interest in getting more information on PV.
A questionnaire was administered to patients recruited by the five PAs. The questions were grouped into three clusters exploring: 1) Level of knowledge of patients about PV, 2) Sources of information and their behavior regarding reporting ADRs 3) Interest in receiving more information on PV.
The survey received 1,368 replies. In the first cluster, more than 80% of the participants stated that they had little or no knowledge of PV. In the second cluster, 35% of the patients never reported any ADR they had experienced. Among those who reported ADRs, they mainly contacted their specialist (46%) or general practitioner (35%). Most of the patients were not aware they could report ADRs directly to the Competent Authority. Finally, more than 80% of the patients stated they would like to receive more information on PV. There is an unmet need in the field of information and education of patients regarding PV. There is also a great deal of interest among the patients to be informed on PV. PAs could play a significant role in patient education and reporting of ADRs to the Competent Authorities.

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