Current trends in pharmacovigilance: value and gaps of patient reporting

Excerpt

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. …