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

Abstract

Objective: 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. Methods: 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.Results: 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.Conclusions: 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.

Patients' Associations as Co-Creators of Knowledge: Tools and Insights into Stakeholders’ Engagement Process. The Experience of the ProSafe Project for Advancing Treatment Safety in Proximity Medicine

“…The ProSafe study arises from a research partnership between the University of Verona and an advisory board made by presidents and members of the Boards of Directors of four National Patient Associations (PAs) named the Patient Safety Council (PSC) (12). PAs of the PSC represent patients affected by diseases with a signi cant impact on healthcare system provision and a notable burden on quality of life; these include chronic in ammatory bowel disease (AMICI), congenital coagulation disorders (FedEmo-Federation of Hemophilia Associations), and cancer (WALCE-Women Against Lung Cancer in Europe and "La Lampada di Aladino").…”

“…The PSC was initially established with the support of the pharmaceutical company Roche, which promoted the project. At its establishment in 2020, the PSC was tasked with promoting knowledge and awareness in pharmacovigilance (PV) activities (12). After effectively carrying out the rst project on this topic, a brainstorming session was conducted to identify the next steps, revealing the need to explore new therapeutic safety challenges related to the development of proximity medicine.…”

Pharmacists’ Knowledge and Attitudes About Adrs Reporting and Pharmacovigilance Practice in Egyptian Hospitals”

“…As a result, ADR reporting is the foundation of any PV system, and early detection and reporting of ADRs to regional or national drug-regulatory agencies is critical. 4 The World Health Organization defines an adverse drug reaction (ADR) as "an unpleasant and unexpected reaction to a treatment that occurs at doses typically used in man for the prevention, diagnosis, or therapy of disease, or for the adjustment of physiological function." 5 Adverse drug reactions (ADRs) are a major public health concern connected to prolonged hospital stays and greater therapy expenditures.…”