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, patient 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 authorities 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 improvements, 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.
journal_name
Public Healthjournal_title
Public healthauthors
Inácio P,Cavaco A,Allan E,Airaksinen Mdoi
10.1016/j.puhe.2017.11.023subject
Has Abstractpub_date
2018-02-01 00:00:00pages
119-128eissn
0033-3506issn
1476-5616pii
S0033-3506(17)30398-0journal_volume
155pub_type
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