Putting the human at the centre of quality management - Brian Edwards' speaker abstract from the 5th European pharmacovigilance congress

Summary

Brian Edwards, Managing Director of Husoteria Ltd, shares his speaker abstract from the 5th European pharmacovigilance congress held 1-3 December 2021. To view all the speaker abstracts from the congress, published in the Therapeutics Advances in Drug Safety journal, download the attachment below.

Content

Human factors for the pharmaceutical and device sectors needs to be a more important topic. Human performance impacts how all forms of medical products are manufactured, how hospital and community services work effectively, and how patients use medicines and drug-device combination products. Human factors can be used to improve the quality of products, efficiencies in processes, reduce errors, understand critical incidents and promote the well-being of staff and patients. However, like other areas of healthcare, human factors is generally not well established. The good news is that there is growing interest in its application.

The UK Special Interest Group on Pharma Human Factors was launched in December 2015 and is based within the Chartered Institute of Ergonomics and Human Factors and its membership includes individuals with an interest in Human Factors and medical products across academia, the NHS, the Pharmaceutical Industry and Regulatory Authorities. It meets monthly via teleconference, and its Chair person is Brian Edwards, Adopting the principles and practices of human performance has led to valuable business and safety performance improvements in high-risk high-consequence industry sectors, such as energy and aviation.

Eager to realise similar levels of improvement, several companies in the pharmaceutical and biopharmaceutical manufacturing sector have begun the adoption of human performance within their operations. However, the unique industry context and regulatory environment of this sector has proven the adoption of human performance principles and practices to be more challenging and complex than simply copying from the successes of other industries.

Human performance is believed by many companies in our industry to be a focus on human error reduction, where work outcomes will improve by adding more requirements and coercing people to try harder to be infallible. This archaic approach is not sustainable today and is not human performance.

In the United Kingdom, there is a unique pharmaceutical human factors group whose aim is to accelerate the pharmaceutical and device system maturity by building a greater understanding of what is  desired what we mean by optimizing human performance, examining the evidence and explaining how to get there. We propose international harmonization of the systems for both pharmaceuticals and devices through guiding principles and we invite others to join our international community of practice.

References

1. https://www.biophorum.com/download/human performance-blue-sky-thinking-in-human performanceand-how-to-get-there/

2. https://www.ergonomics.org.uk/Public/Resources/ Publications/Learning_from_Adverse_Events/ Learning_from_Adverse_Events.aspx 3 3. Pharmaceutical Human Factors Sector Group, https://www.ergonomics.org.uk/Public/ Get_Involved/Group_Details/Pharma_Human_ Factors.aspx

Attachments