Human Factors and Medicine Safety
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This document discusses optimizing usability in pharmaceutical R&D processes and technology through a human factors approach. It describes how the traditional linear drug development model is changing, with more parallel pathways and stakeholders involved. Applying human factors principles can help manage risks around usability, errors, safety, and productivity. These principles include considering the human/technical system interaction, conducting task and error analyses, and ensuring processes adapt to human capabilities and limitations. Taking a human-centered approach treats employees and external stakeholders holistically and aims to create meaningful and socially responsible organizations.
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Human Factors and Medicine Safety
- 1. Human Factors Optimising the usability of processes and technology in Pharma R&D Andrew Alexander Parsons MSc, PhD www.reciprocalminds.com 5th Annual Pharmacovigilanc e Forum 2 March 2017 Berlin
- 2. A dilemma Affordability vs Availability?
- 3. Medicines Life Cycle – Traditional View Discovery Preclinical Phase 1 Phase 2 Phase 3 Phase 4 • Described as a linear process • High attrition • High costs in Operation • Sales drive further innovation • (high cost due to attrition) • Long cycle times - 10-20 years • Many Risks and uncertainties Favourable Scientific and Regulatory Environment Cost effective use of Medicine Societ al Value Innovat ive New Drugs R&D Adequ ate cash Flow Sales
- 4. Changing Times and New Directions • Stem cell therapies • Gene therapies • Epi-genetic modulation • Focus on Orphan Disease • Limited Patient Numbers • Parallel development (e.g. cancer) • Disaggregation of the industry • Small R&D companies supported by CRO and CMOs • Several Stakeholders in managing supply and operations A linear model no longer describes the system!
- 5. • Andrew A Parsons • Allison Morgan • Simon Whiteley • Crystal Ruff • Ralph Hibbard Education and Training Human Centred Organisations • Brian Edwards • Fiona Day • Julia Mironova Pharma HuF has several Teams Systems Mapping Sub Team Pharma Huf
- 6. Considerations • Increasing usability and productivity • Reducing errors • Human Centred Organisations • Safety Human Factors – what are they?
- 7. What are Human Factors? • Capability depends on combination of interacting elements • Operation of equipment and systems in circumstances of fatigue, hunger, stress and even fear • Usability in demanding circumstances will determine success • Named roles in Human Factor integration in product life cycle Learning from Ministry of Defence UK
- 8. Human Factors • Is a risk management process – particularly around usability engineering • Proactively manages all elements of the process • Application description • Requirements specifications • System design • Implementation
- 9. The Process & Environment: Where conditions matter… Chemistry Reagent 1 + Reagent 2 Product 1 + Product 2 Innovation People + Technology Product + Value Catalyst Process Conditions Socio-Techno Process (e.g. Safety, Quality, Usability) Investment
- 10. Buying Delivering Doing “What’s the benefit?” “How will we provide that benefit?” “What will we produce?” 3 Levels of Customer Value
- 11. System Control Points Quality Safe and Effective Medicines Organisatio n focus Product or Medicine focus ValueCost Individual focus Team focus Safety Buying Delivering Doing
- 12. High Level System Control Points Clinical Safety Clinical Effectiven ess Manageme nt and Process use-ability Health and Safety Distribution / supply of Product Manufactur e Product Use- ability Commerci al Value Payer Value HCP Value Product or Medicine focus Individual focus Patient Value Societal Value Management and Process Effectiveness Compensation and reward Process Extrinsic Motivation Intrinsic Motivation Abilities Autonom y Political factors Environmen tal factors Financial factors Societal factors Manageme nt and Process use-ability Health and Safety Team focus Management and Process Effectiveness Compensation and reward Process Political factors Environmental factors Financial factors Societal factors Perception Bias / Heuristic s Organisation focus Safe and Effective Medicines
- 13. Illustrative Example: Weighting of decisions in each phase 0 1 2 3 4 5 clinical safety clinical… payer value manufacture product… commercial… patient value HCP value societal value Distribution/P… Health and… Mangement… political factors financial factors managemnt… compensatio… environmenta… societal factors intrinsic… extrinsic… perception abilities autonomy bias/heuristics preclinical 0 1 2 3 4 clinical safety clinical… payer value manufacture product userbaiity commercial value patient value HCP value societal value Distribution/Pro… Health and Safety Mangement… political factors financial factors managemnt… compensation… environmental… societal factors intrinsic… extrinsic… perception abilities autonomy bias/heuristics phase 1 phase 1 0 1 2 3 4 5 clinical safety clinical… payer value manufacture product… commercial… patient value HCP value societal value Distribution/P… Health and… Mangement… political factors financial factors managemnt… compensatio… environmenta… societal factors intrinsic… extrinsic… perception abilities autonomy bias/heuristics phase 2 phase 2 0 1 2 3 4 5 clinical safety clinical… payer value manufacture product userbaiity commercial value patient value HCP value societal value Distribution/Pro… Health and Safety Mangement… political factors financial factors managemnt… compensation… environmental… societal factors intrinsic… extrinsic… perception abilities autonomy bias/heuristics phase 3 phase 3 0 1 2 3 4 5 clinical safety clinical… payer value manufacture product… commercial value patient value HCP value societal value Distribution/Pro… Health and… Mangement… political factors financial factors managemnt… compensation… environmental… societal factors intrinsic… extrinsic… perception abilities autonomy bias/heuristics phase 4 phase 4
- 14. Steering Ctte Party A Party B Program Team Development Project Team Define and Decide Where, What, How Who Decides Transparency of Risks Communicate Alignment of Purpose Meaning rather than perceptions Governance and Commissioning
- 15. • Tracking lag measures – reactive and ‘out of control’. • Focus on the process (Lead) measures • Ensure Congruence of lag and lead measures Performance Measures
- 16. Use failure and effects analysis • Lots of different risk management plans for when stuff does not work • Focus of human safety analysis is SAFETY • Process of assessment is • 1 – task analysis • 2 – PCA analysis (Perception, cognitive and action) • 3- use error analysis • Protocol evaluation
- 17. Managing usability risks • Task analysis - to each user error and how it is linked to PCA Risk mitigation is • Design – changes made to the design • Protection – protective barrier put in place • Information – changes to the instructions for use (training) – seen as weakest HF focus: how to ensure the system can adapt to the human error
- 18. Being Human Centred Recognition that organisations have impact on customers and employees, their families and the wider community It is an approach to integrate a social-technical methodologies and manage the complex risks of business today e.g. • Wasted effort, poor efficiency, effectiveness and satisfaction • Errors and system failures, product recalls… • Absenteeism, presenteeism, poor recruitment and retention • Litigation, reputational damage • Etc….
- 19. Putting Human Factors First – Principles • Capitalise on individual differences as an organisational strength • Make usability and accessibility strategic business objectives • Adopt a total systems approach • Ensure health, safety and wellbeing are business priorities • Value employees and create meaningful work environments • Be open and trustworthy and act in socially responsible ways ISO 275000 Human Centred Organisations
- 20. Can you help? • Led by safety and HF Professionals Lee Allford and Shama Didla • Aim to create “best practice” stories for the industry • Can you share? • Would you like to learn more? Pharma Huf ISO27500 Workstream
- 21. • Use design thinking • Think systems and human factors • Describe the solution state • Remember you get what you measure • Lead and Lag measures • What we do • How we do it Clear strategy, tactics and operations How to change effectively
- 23. Andrew A Parsons PhD aaparsons@reciprocalminds.com +44 7854 029 268 Thank You Thanks to Colleagues in Pharmaceutical Human Factor SIG