Broadening the scope of pharmacovigilance

Abstract

Over the past years, the scope of pharmacovigilance widened, allowing for better adjusted information on adverse drug reactions (ADRs) to the needs of regulators, clinicians and patients. For treatment and managing the ADRs, not only is information on their clinical aspects important but also information characterising our attitude and behaviour towards ADRs. For healthcare professionals as well as patients, this information is vital for optimising treatment. Unfortunately, many of the methods used in pharmacovigilance are still focused on the detection of unknown serious and often rare events but not on extending our knowledge of the known, more common but often burdensome ADRs encountered by patients. To do this, pharmacovigilance should make a shift from the focus on finding new, previously unknown associations and elucidating the frequency of events to the analysis of the content and meaning of ADRs for both healthcare professionals and patients. This also implies a shift from population- and regulation-based pharmacovigilance to a patient-centred pharmacovigilance. The discrepancy between the way the rules and regulations are often being implemented and the needs of patients and healthcare professionals is a point of concern. In this article we describe the way the concepts of pharmacovigilance have developed over time, the current playground of pharmacovigilance, the influence of modern day’s rules and regulations and possible ways to overcome the existing gap between the need for information of ADRs taking different stakeholders’ perspectives into account and its availability and usefulness in daily practice.