The Future of Pharmacovigilance: Proposals for More Efficient and Effective Systems-Based Approaches
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LEADING ARTICLE
The Future of Pharmacovigilance: Proposals for More Efficient and Effective Systems-Based Approaches Giovanni Furlan1 • Brian Edwards2 • Antonio Mastroianni3 • Greg Koski4
Ó Springer International Publishing Switzerland 2016
Abstract Clinical research is at a cross-roads of sustainability due to the current cost of development, amount of regulation, and irrational use of medicine. There are also too many silos in clinical research and development, postmarketing safety, as well as a lack of standards, and effective communication. This paper covers the future of pharmacovigilance and argues that it needs to re-focus and not be a silo in the last phase of clinical research. In fact, the integration of pharmacovigilance is an integral part of much needed change in clinical research and development based on the application of systems thinking. Clinical research and development must improve as a whole system through the synergy of all parts.
Key Points The need for bringing pharmacovigilance back to its original focus. The need for a comprehensive systems approach. Having a unified drug safety-clinical database for improved data capture. Need for regulatory harmonisation. & Greg Koski [email protected]; [email protected] 1
EU QPPV Helsinn Birex Pharmaceuticals, Dublin, Ireland
2
NDA Regulatory Science Ltd, Surrey, UK
3
Aros Performance Management, Uppsala, Sweden
4
Alliance for Clinical Research Excellence and Safety (ACRES), One Broadway, 14th Floor, Cambridge, MA 02142, USA
1 The Need for Bringing Pharmacovigilance Back to its Original Focus The human relationship with medicines is as dynamic as it is complex and our understanding of effective use is continually developing. The traditional view was that licensed medicines were consistently beneficial and completely safe. However, as medical advancements were made and non-communicable diseases, along with their corresponding treatments increased, it became clear that there are not just risks associated with medicines themselves but also in the systematic context in which they are taken. These include not only side effects but also interactions between medicines (both licensed and unlicensed) and other products (devices, food and environmental chemicals), individual variation in responses (both genetic and comorbidity of underlying disease) as well as the ubiquitous potential for medication errors. All these forms of adverse events (AEs) carry varying and detrimental individual, societal and economic impact, so that life-cycle safety surveillance of a medicine—commonly referred to as pharmacovigilance—needs to be better appreciated as a critical part of our holistic understanding of not only the medicine but also the systematic influences on how a medicine is used, rather than just a regulatory requirement where compliance is all that matters. The aim of pharmacovigilance is that of identifying drug-induced adverse reactions as soon as possible in a medicine’s lifecycle so as to take appropriate measures to minimise their impact on pati
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