human factors and medicine safety

Human FactorsOptimising the usability of processes and technology in Pharma R&D

Andrew Alexander ParsonsMSc, PhDwww.reciprocalminds.com

5th Annual Pharmacovigilance Forum

2 March 2017Berlin

A dilemmaAffordability vs Availability?

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 Environme

nt

Cost effective use of

Medicine Societal

Value

Innovative New

DrugsR&D

Adequate cash Flow

Sales

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!

• 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

Considerations

• Increasing usability and productivity

• Reducing errors

• Human Centred Organisations

• Safety

Human Factors – what are they?

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

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

The Process & Environment: Where conditions matter…

ChemistryReagent 1 + Reagent 2 Product 1 + Product 2

Innovation

People + Technology Product + Value

Catalyst

Process Conditions

Socio-Techno Process(e.g. Safety, Quality, Usability)

Investment

Buying

Delivering

Doing

“What’s the benefit?”

“How will we provide that benefit?”

“What will we produce?”

3 Levels of Customer Value

System Control Points

Quality

Safe and Effective Medicines

Organisation focus

Product or Medicine focus

ValueCost

Individual focus

Team focus

Safety

Buying

Delivering

Doing

High Level System Control Points

Clinical Safety

Clinical Effective

ness

Management and Process

use-ability

Health and

Safety

Distribution

/ supply of Product

Manufacture

Product Use-

ability

Commercial Value

Payer Value

HCP Value

Product or Medicine focus

Individual focus

Patient Value

Societal Value

Management and Process Effectiveness

Compensation and reward

ProcessExtrinsic Motivatio

n

Intrinsic Motivatio

nAbilities

Autonomy

Political factors

Environmental

factors

Financial factors

Societal factors

Management 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 / Heuristi

cs

Organisation focus

Safe and Effective Medicines

Illustrative Example: Weighting of decisions in each phase

clinical safetyclinical effectivenesspayer valuemanufacture

product userbaiitycommercial value

patient value

HCP valuesocietal value

Distribution/Product supplyHealth and SafetyMangement and Process usebabilitypolitical factorsfinancial factorsmanagemnt and process effectiveness

compensation and reward processenvironmental factors

societal factors

intrinsic motivation

extrinsic motivationperception

abilitiesautonomybias/heuristics

0

5

preclinical



patient value




societal factors




0

2

4

phase 1

phase 1



patient value




societal factors




0

5

phase 2phase 2



patient value




societal factors




0

5

phase 3phase 3



patient value




societal factors




0

5

phase 4phase 4

Steering CtteParty A Party B

Program TeamDevelopmen

t Project Team

Define and DecideWhere, What, HowWho DecidesTransparency of RisksCommunicateAlignment of Purpose Meaning rather than perceptions

Governance and Commissioning

• Tracking lag measures – reactive and ‘out of control’. • Focus on the process (Lead) measures• Ensure Congruence of lag and lead measures

Performance Measures

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

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

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….

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

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

• 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

In Life

Adaptability is Key

Andrew A Parsons [email protected]+44 7854 029 268

Drag picture to placeholder or click icon to addThank You

Thanks to Colleagues in Pharmaceutical Human Factor SIG

mailto:[email protected]

human factors and medicine safety

Health & Medicine