Abstract
Society has been increasingly intolerant of excuses for systems breakdown in many areas of public life. This is hardly surprising given that there is overwhelming evidence behind why processes fail and mistakes are made, and so, based on this evidence, processes should be designed to mitigate risk. The main root cause of many process failures can be attributed to the human factor, which encompasses all those factors that can influence people and heir behaviour. Based on experience from other safety-conscious industries, there is a major move to manage the human factor as part of delivery of safety culture in healthcare systems. Since pharmaceutical companies are healthcare companies, it makes sense that the principles underlying a pharmaceutical safety culture are aligned with those of the healthcare sector. A good place to start applying human factor management to a pharmaceutical safety process would be the complex process required to produce a good quality Periodic Safety Update Report (PSUR) on time and to an acceptable format. This can be achieved by a process aimed at building on an ongoing learning cycle through planning, observing if execution matches expectations and learning from mistakes and through the interdependent teamwork of PSUR contributors providing mutual support. Such a framework of teamwork and communication principles can be applied to the entire process for the preparation and submission of PSURs.
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Acknowledgements
No sources of funding were used to assist in the preparation of this article. Brian Edwards is an employee of NDA Regulatory Science Limited, who provide Periodic Safety Update Report (PSUR) services for the pharmaceutical sector. Giovanni Furlan used to be an employee of Bracco Imaging S.p.A and prepared PSURs for the company. Currently he is with PrimeVigilance who provide PSUR services for the pharmaceutical sector.
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Edwards, B.D., Furlan, G. How to Apply the Human Factor to Periodic Safety Update Reports. Drug-Safety 33, 811–820 (2010). https://doi.org/10.2165/11537620-000000000-00000
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DOI: https://doi.org/10.2165/11537620-000000000-00000