Original Research Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union P. In  acio a,* , A. Cavaco b , E. Allan c , M. Airaksinen a a Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Finland b IMed.ULisboa Research Institute for Medicines and Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon, Portugal c Department of Pharmacy and Pharmacology, University of Bath, United Kingdom article info Article history: Received 10 July 2017 Received in revised form 20 September 2017 Accepted 26 November 2017 Keywords: Pharmacovigilance Spontaneous reporting Patient-reported adverse drug reactions Risk management European Union abstract Objectives: In the European Union (EU), legislation allows patients to directly report adverse drug reactions (ADRs) to competent authorities. Five years after its implementation, pa- tient reporting is not equal in all countries. This study aimed to explore key stakeholders' perceptions of patient reporting in four EU countries. Study design: Qualitative study design. Methods: Twelve representatives from national pharmacovigilance centres and/or author- ities as well as national pharmaceutical industry bodies in four EU countries participated in the study. Supranational organizations were also included. Data collection was via face- semi-structured interviews. Inductive content analysis was performed thereafter, applying principles of risk management as a theoretical framework. Results: Four themes (attitudes and beliefs, system maturation factors, regulatory im- provements, and cultural shifts) emerged, conceptually interconnected. Participants from countries introducing patient reporting recently expressed a negative attitude. Participants highlighted the need for additional resources, both human and financial, to address patient reporting and associated advantages. Conclusions: The findings identified perceived barriers and facilitators of patient reporting. The involvement of patients, use of information, and dissemination of patient reporting are far from optimal. A better integration of the work by EU regulatory authorities is recommended. © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved. * Corresponding author. Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, Viikinkaari 5E Viikinakaari 5E e 7 Huone (P.O. Box 56), 00014 University of Helsinki, Finland. E-mail address: pedro.inacio@helsinki.fi (P. In acio). Available online at www.sciencedirect.com Public Health journal homepage: www.elsevier.com/puhe public health 155 (2018) 119 e128 https://doi.org/10.1016/j.puhe.2017.11.023 0033-3506/© 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.