The time to apply organisational science to systematically manage the risks of medicines is overdue

Brian Edwards. NDA Regulatory Science Ltd, Surrey, UK.

The pharmaceutical safety system across all sectors is struggling with changing regulations, under-resourcing, increased costs and serious criticism concerning transparency resulting in mistrust. Part of the problems is failure to define the complexity of the system and design processes which are evidenced based, adaptable and flexible for those who work in them. The lack of training about working and coping in complex systems is notable.

The need for a global safety system is best reflected in the quality management requirements for EU pharmacovigilance systems as described in the Good Vigilance Practice module introduced in July 2012. Unfortunately, this does not include healthcare. This approach includes viewing safety of a medicinal products more holistically – in the context of benefit as well as risk. However, this requires an understanding of the psychological, social and organizational factors that influence quality and risk management from a systems perspective and how the evidence can be applied. This evidence is notably missing from all guidelines and regulations. Key to successful implementation of a safety system at a European, institutional or team level is an understanding of how ‘human factors’ impact safety. Human factors explain most (but not all) breakdowns in safety and yet there are no standardised approaches to designing processes centred on humans. The vast body of systems science evidence needs to be extrapolated to pharmaceutical safety and quality management. The key human factors concern decision-making, situational awareness, leadership, communication, error management, personality and behaviour. The challenges of the pharmaceutical safety system can only be fully understood with a thorough understanding of how people act within and shape system performance. Human Factors engineering includes examination of competence, team-working, information processing, compliance with procedures and coping with stress and time pressure. In addition, safety engineering is concerned about prospective system design based on the principles that safety is about control and risk management. A model called STAMP developed by The Massachusetts Institute of Technology defines appropriate safety constraints within a risk management system. The aim is to build on what we already know about the evidence underpinning pharmacological and regulatory science in pharmaceutical safety blending this with system science.