HUMAN FACTORS IN PHARMA IN 2016:

WHY PIPA SHOULD JOIN THE PARTY !

Colin Knight

Pharmaceutical Human Factors & Ergonomics Special Interest Group

Plenary Session Outline• What are Human Factors and Clinical Human Factors?

• Pharma and Human Factors back in 2011?

• Human Factors – the Challenges

• Human Factors – Organisations and Groups

• Current situation and future uncertainties

• What is Pharma HUF

• Working collaboratively

• Joining Pharma HUF

• Questions

WHAT ARE HUMAN FACTORS (HUF) AND SPECIFICALLY

CLINICAL HUMAN FACTORS?

Human Factors Definition:Definition from Chartered Institute of Ergonomics and Human Factors:

• “Ergonomics (or Human Factors) is the scientific discipline concerned with the understanding of 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”

Human Factors (HUF): So what does it mean for us?

• Thinking “Quality Management” and being concerned with:

– Wellbeing of the human in the system

– Stress

– Fatigue

– Distractions, etc.

Clinical Human Factors (CHF) definition:

• 'Enhancing clinical performance through an understanding of the effects of teamwork, tasks, equipment, workspace, culture, organisation on human behaviour and abilities, and application of that knowledge in clinical settings.”

Please examine this seminal website:http://chfg.org/

Clinical Human Factors (CHF): So what does it mean for us?

• Putting the human at the centre of all system design– This inevitably will result in patient centricity

• Our group (PHFE SIG) arose from the CHF Group (CHFG)

– PHFE SIG completely independent of CHFG

– However we are closely in contact with that group

Human Factors vs. Ergonomics?• Ergonomics can often be associated with work place

equipment only e.g. seating, posture, etc.

• This scientific discipline encompasses much more than that practical application including the impact of human factors within the work place:

– effective team working

– understanding human limits in process design

– optimal leadership in the work place

– anticipating unexpected issues

Relevance of Human Factors in the Pharmaceutical Industry:

• Do these factors really impact each of us in our different roles within our own Industry?

HOPEFULLY, AFTER THIS PRESENTATION, YOU WILL AGREE THAT THEY DO!!

PHARMA AND HUMAN FACTORS BACK IN 2011

Were you at the 2011 PIPA Conference?

Do you remember this slide?

• Dilbert’s reflections on Human Factors:

PIPA Conference 2011• At that meeting, Brian Edwards presented on

three key elements of Human Factors:

– Exploring issues around Human Factors and how these directly impact all of us

– Effectively managing those Human Factors

– Evolving Guiding Principles around implementing HUF in our (and any) industry

HUMAN FACTORSHOW HAVE WE MET THE

CHALLENGES IN THE PHARMACEUTICAL SYSTEM?

Human Factors Organisations:Human Factors Organisations /Common Interest Groups

Organisation Name Acronym Date of Implementation

Clinical Human Factors Group CHFG 2007

Pharmaceutical Industries and Ergonomics Alliance

PhErgAll 2012

NHS Concordat February 2014

Chartered Institute of Ergonomics and Human Factors

CIEHF January 2015. **

Health Safety Investigation Board HSIB April 2016

** Previously known as the Ergonomics Society and then the Institute of Ergonomics and Human Factors, the organisation received its Royal Charter in 2014.

The trigger for action NHS Concordat –February 2014

• Principles:– Raising awareness and promoting human principles and practices in healthcare– Understanding, identifying and addressing current capability, barriers to adoption, future

requirements and best practice in Human Factors in healthcare– Creating the appropriate conditions, through commissioning, quality assurance and

regulation, that support the NHS in embedding Human Factors at a local level

• Approach moving forward:– Requirement for every NHS organisation to commit to embedding an understanding of

human factors– Health Education England to support development of curricula and training frameworks

• NHS England will:– Communicate with commissioners and providers to increase awareness and understanding

of human factors– Scope current capacity and capability in Human Factors identifying what support and

development is required– Develop programmes of work based on the outcome of the scoping activity and roll this out

nationally, regionally and locally within the NHS

CIEHF - January 2015• Background:

– 1977 –Ergonomics Society (ES) formed

– 2009 ES was renamed the Institute of Ergonomics and Human Factors

• Organisational key dates:

– Royal Charter granted in 2014

– Established as the Chartered Institute in January 2015

• Remit:– To raise awareness of the discipline, to set and maintain professional standards; to

support its members, and promote networking and communication among those who have an interest in ergonomics, human factors and related fields

– Within its remit, it supports affiliated sub-groups of special interest –these include:

• Pharmaceutical Human Factors and Ergonomic group (PHFE) Special Interest Group (SIG) officially as of November 2015

OK. THEN:FURTHER REASONS INDICATING WHY

A GROUP SUCH AS PHFE SIGIS NECESSARY?

ISO 27500: British & International Standard on the Human-Centred Organisation -Launched 1st September 2016

• Background:• Historically Other related ISO standards have been introduced

– ISO9241 – IT issues

– ISO1999 –Design process standards

– ISO 31000 – Risk management – this was the “light bulb” moment and where the need for a “human-centred” standard for organisations was defined

• Key timelines:• BSI Applied Ergonomics Committee tasked with developing this standard, which

was finalised in late-Spring 2016 and launched September 2016

ISO 27500:A “Human-centred” approach will need to meet the criteria for seven top level principles defined by the BSI committee:• 1) Capitalise on differences between employees and see diversity as a corporate

strength

• 2) Diversity and performance go together

• 3) Usability and accessibility need to be strategic business objectives

• 4) Adopting a total systems approach

• 5) Ensure health, safety and well-being of employees

• 6) Value employees and create meaningful work environments

• 7) Be open and trustworthy and act in socially responsible ways

ISO 27500:Companies committed to a “Human-centred” organisational approach will also:

• Appoint a person at board level who will “champion” the human centred approach

• Establish an “organisational wide” Ergonomics programme

• Make those principles described earlier “Business as Usual”

• Develop further internal standards as required to complement the “human centred” approach

ISO 27500:• How to implement:

• Conduct a Gap Analysis of the organisation, thinking about:– What does “good” really look like in the organisation?

– Is there, for example, high staff turnover resulting in additional training requirements and support?

– What are the organisation’s risks?

– What is put on the organisation’s website?

– Can these claims be substantiated?

– How do you measure success?

• Prepare an “Action plan” for implementation –this needs “buy-in” from all key stakeholders

• Size of organisation may be a consideration for successful implementation

Multiple pharmaceutical stakeholders in UK -How do we work together ?

Patient

RegulatorsProfessional:. GPC, GMC, GDC, HCPC,

NMCIndustrial: MHRA, ABPI, (FDA), ISO,

CIOMS

BuyersOTC*/Trial

NHS/NICE

Insurance

Trial (funders)

Dispensing

Industry(Pharmaceutical &

Biotech)Manufacturing (industry and hospital-level)

SafetyInformationPromotion

R&D

Audience Participation:Ask the Audience Poll

Expertise in Human Factors Within our Industry: Ask the Audience.

• 1) Do you feel there is sufficient human factors expertise inputting into the medicines industry as of today? Y /N

• 2) Are we aware of elements of it being evident right now? Y/N

• 3) Is this an area we need to explore? Y/N

WHAT IS THE PHFE SIG ANDWHO ARE WE?

Membership of PHFE SIG • Membership crosses boundaries between academia,

regulatory and healthcare industries

• Current Membership includes:– Professors of Ergonomics & Human Factors

– Experienced Pharmaceutical Industry individuals

– Experienced Healthcare Providers from the NHS

– Individuals from Regulatory Authorities

– Experienced Professionals from the Medical Device Industry

– Representatives from industry trade associations e.g. ABPI and regulatory agencies e.g. MHRA

– AND OPEN TO MANY MORE DISCIPLINES AS WELL!!

OBJECTIVES OF PHFE SIG • Stimulate dialogue across the healthcare sector

• Provide a non-judgemental forum for pharmaceutical professionals to explore how the culture, the beliefs, incentives, motivation of individuals, teams and organisations can impact both system and healthcare product safety.

• Facilitate how this understanding can be applied to optimise the current system

• Strengthen trust in patient safety leading to risk –based compliance

• Demonstrate how a better understanding of human factors can significantly impact on safety, quality and productivity in the healthcare product sector

OUR APPROACH AT PHFE SIG• Our vision is of a healthcare product system that

places an understanding of human and other organisational factors at the heart of improving clinical, managerial and organisational pharmaceutical practice leading to significant improvements in safety and efficiency across the lifecycle of a pharmaceutical product (this includes the active medicine, excipients and all associated labelling).

PRIMARY GOAL OF PHFE SIG

• The Primary Goal

• To optimise human performance within the pharmaceutical sector for patient safety and efficiency by systematically applying evidence from organisational and human factors science

What’s happened so far?• Regular team meetings have been held: PHFE SIG has representatives

from:– Pharmaceutical Industry

– Academia

– Pharmacologists

– NHS

– ABPI

– MHRA

– Human factors and system experts

• Membership of MHRA Human Factors Study working Group

• Regular meetings at ABPI to map out system for medicines in UK

• Need to demonstrate control structures in clinical research and marketed medicine

• IT & Technology group is underway

• Ongoing discussions on how to develop an “implementation group”

PHFE SIG SUB-TEAMS

Current PHFE SIG Sub-TeamsSub-Team Team Lead

Clinical Research Andy Parsons

Human Factors studies Dr Philip LanceMedical Device Usability Ltd

Insulin case studies John Solomon

I.T. & Technology Steve Mott

Manufacturing & Supply Chain Professor Peter Buckle

Media & Publicity Brian Edwards

Other systems case studies Brian Edwards/Simon Whiteley

Training & Development Colin Knight

Training & Development Sub-Team:

• Cross section of members in this team including CIEHF Training Lead.– Developing system mapping and building a key stakeholder platform

– Specifically, mapping pharmacy and drug safety curricula for human factors input

– Planning to develop “white paper” to address major outcome drivers and system improvements

– Looking to identify opportunities for postgraduate work involving Human Factors science from both the academic and Industry groups

– In current discussions with the MSc Pharmacovigilance (PV) team at Hatfield to consider building in human factors into the MSc PV course

Overview of Sub team activities :• Clinical Research:

– Team established, with key representation from academia and industry -meetings have been held with contacts at ABPI

• Human factors studies:– Discussions ongoing with regulatory and device team members to

determine appropriate studies to develop

• Insulin case study:– Case studies being planned to look at “Never Events” such as

preventable hypoglycaemia after insulin administration

• Other systems case studies:– Ongoing work with academia in Cambridge with system mapping using

methotrexate “Never Events”

WORKING COLLABORATIVELY WITH OTHER GROUPS AND INDIVIDUALS

Collaborations and PHFE SIG development

• Pharma HUF SIG arisen as a collaboration of Pharma HUF and PH Erg All Groups

• Pharma HUF SIG Training Sub team in active discussions with the University of Hertfordshire around the MSc PV programme and providing human factors expertise input into that programme

• Direct collaboration with medicines optimisation unit at UCL School of Pharmacy

PHFE SIG and PIPA working collaboratively together –next steps

• Please complete the feedback form on this session

• We would like to know if this is of particular interest to you as a PIPA member

• Potential to develop a role within the PIPA Committee for an interested individual to link up with PHFE SIG

• That individual would assume responsibility for facilitating collaborative working, and this could include:

– Linking PIPA to those healthcare professionals with specific HF expertise as required

– Provide training /courses to PIPA members using the PHFE SIG network of expertise

– Provide feedback on Pharma HUF developments

JOINING PHFE SIG

Membership of PHFE SIG

• Open to all members of our industry• PHFE SIG recognises the diverse expertise

amongst PIPA members who would be very welcome

• New CIEHF members always very welcome• Annual CIEHF membership fee preferred• To learn more, please contact one of the

following:• Brian Edwards; Ralph Hibberd; Colin Knight; Steve Mott

DO COME AND JOIN US

Pharma HUF – Linked In group is free

• Pharma HUF is a Linked In Group that is independent of CIEHF and has around 1700 global members

• Set up by S Mott and C Seal (chair UK Air Safety group May 2014) following the issuance of the NHS Concordat in February 2014

Useful Pharma HUF e- mail address contacts

• Brian Edwards: Brian.Edwards@ndareg.com

• Ralph Hibberd: ralph.hibberd@googlemail.com

• Colin Knight: crichardknight@btinternet.com

• Steve Mott: steve@keepmeinformed.org.uk

Useful web links:

• NHS Concordat: https://www.england.nhs.uk/index.php?s=concordat

• CHFG: http://chfg.org/

• CIEHF: http://www.ergonomics.org.uk/

• HSIB: https://www.gov.uk/government/groups/independent-patient-safety-investigation-service-ipsis-expert-advisory-group

ANY QUESTIONS?

THANK YOU FOR YOUR ATTENTION