There is a solution to daunting compliance issues, says Dr Brian Edwards, and it is a very human one at that…
The pharmaceutical system is struggling with ever-changing regulations, under-resourcing, increased costs and serious criticism concerning transparency resulting in mistrust. If that was not enough, for a company who wishes to be truly global, they are faced with a changing pharmaceutical environment with greater patient involvement, more and more digital technology, the adoption of personalised medicine, incorporation of real world evidence sources, concerns about product quality and complicated supply chains.
All these changes are occurring under close media scrutiny and are moving at different speeds. Regulations cannot possibly keep up to date. For those aiming just to comply, they will struggle to succeed especially as such an approach is no guarantee of safety. 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. What a company needs is a future system which needs to be flexible and adaptable to change using robust scientific methodologies. But surely we are doing all we can do aren’t we? The reality is that we have systematically ignored organisational science where there is now a mass of evidence about how to improve systems.
We now accept the importance of a quality management system supporting the lifecycle of a medicine. However, this requires an understanding of the psychological, social and organisational factors that influence quality from a systems perspective and how the evidence about ‘human factors’ can be applied.
The challenges of the pharmaceutical system can only be fully understood with a thorough understanding of how people act within and shape system performance. Ergonomics – or human factors – is the scientific discipline concerned with understanding the interactions among humans and other elements of a system, and the profession that applies theory, principles, data, and methods to design in order to optimise human well-being and overall system performance. The key human factors concern decision-making, situational awareness, leadership, communication, error management, personality and behaviour.
The term ‘human factors’ itself can be…