LAUSR

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any drug-related problems [1]. Broadly speaking, this definition relates to a system used for adverse drug reaction (ADR) reporting and, having detected a potential problem, minimize its impact in the population. This is done using the spontaneous reporting system (SRS), in which a healthcare professional (HCP) or patient sends an unsolicited communication to competent authorities or pharmaceutical companies describing one or more ADRs [2]. However, pharmacovigilance is much more than just spontaneous reporting (SR) [2]. Its scope has grown considerably in the past few decades, encompassing not only ADR reporting but as well medication errors (ME), counterfeit or substandard medicines, lack of efficacy or drug–drug interactions [1]. Currently, pharmacovigilance covers the life-cycle of a medicinal product with concerns to its safety and quality. As such, it needs the active involvement of responsible stakeholders, such as HCPs, patients, regulatory authorities and industry. Since the creation of the SRS that reporting was mostly restricted to HCPs [1]. Patient reporting (PR) was accepted in some countries, but its value to produce quality information on ADRs was questioned [3]. The accumulation of evidence on PR has allowed to dissipate the fears that patient reports might not be useful [4]. In the European Union (EU), the new pharmacovigilance legislation introduced several changes such as the formal implementation of PR, updated the definition of ADR (now including MEs, misuse and abuse, off-label use and overdose), additional monitoring measures such as the introduction of the black triangle, or a higher level of transparency [5]. Many other countries have followed with the implementation of a PR system [6]. The introduction of PR is part of a wider trend towards an active involvement of patients in decision-making in pharmacovigilance. As defined by Peter Arlett, excellence in pharmacovigilance is based on a patient-focused, proactive, proportionate, multidisciplinary benefit-risk balancing, transparent and science-based approach [7].