Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis.

INTRODUCTION: Involving patients in decision making adds value in the context of pharmacovigilance (PV). This added value goes beyond participation in spontaneous reporting systems for adverse drug reactions. However, there is a gap between allowing patients to report and actual patient involvement. Views regarding best practices from regulators, patient organizations and pharmaceutical companies could help increase and improve patient involvement in PV. OBJECTIVE: The aim of this study was to investigate the factors contributing to best practices for patient involvement in PV and to develop a definition of patient involvement based on a qualitative multistakeholder study across Europe. METHODS: A literature review was conducted to map the field of study and obtain insights for the elaboration of an interview guide. Subsequently, patient representatives, members of the pharmaceutical industry and regulators were invited to participate in interviews. These interviews were analyzed using NVIVO® software and employing reflective thematic analysis. RESULTS: A total of 20 interviews were conducted with representatives at both the national and European levels. The best practices identified were engagement from the start, face-to-face communication, a full circle of feedback, same-level partners, structured involvement and guidelines, establishing common goals, patient education and empowerment, and developing trust and balance. These activities can be implemented via deep collaboration among stakeholders. A definition of patient involvement was constructed in accordance with the input of all stakeholder groups, which reflects the involvement of all types of patients at all levels of the decision-making process. CONCLUSION: In this study, we developed a definition for patient involvement based on qualitative interviews. The factors contributing to best practices for patient involvement were mentioned across stakeholder groups and aimed to stimulate patient involvement in PV. Patients are eager to become equal partners and to engage effortlessly in the same manner as other stakeholders.

Patient Organizations' Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation.

INTRODUCTION: European drug regulations aim for a patient-centered approach, including involving patients in the pharmacovigilance (PV) systems. However many patient organizations have little experience on how they can participate in PV activities. AIM: The aim of this study was to understand patient organizations' perceptions of PV, the barriers they face when implementing PV activities, and their interaction with other stakeholders and suggest methods for the stimulation of patient organizations as promoters of PV. METHODS: A sequential qualitative method study was conducted and integrated with the quantitative study performed by Matos, Weits, and van Hunsel to complete a mixed method study. RESULTS: The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organization participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organizations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities. CONCLUSION: Both study phases show congruent results regarding patients' involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.