Pharma SIG Newsletter Jan2021 Final - ergonomics.org.uk

Pharmaceutical Sector Group

ContentsA message from the chairman - Brian Edwards

Arterial Lines Project - Angela Carrington

Sector group administration update - Gary Guan

Sector group training and education update - Colin Knight

A new way to connect and collaborate

Coping with complexity - Helen Vosper

NEWSLETTER

Issue 5January 2021

Guest Contribution: Arterial Lines Project

Sector group pharmacy update - Ravinder Bratch

The Pharmaceutical Sector Group has continued to make progress despite the unprecedented circumstances we found ourselves in this year. This edition of the newsletter will be an update on the different activities and projects of the sector group, and some of the plans we have for 2021.

As we move into 2021 it is timely to reflect on 2020 when the world has been turned upside down by COVID 19. It is a credit to the support that I and Helen have received as joint chairs that the Pharmaceutical Sector group continues to go from strength to strength with international outreach as well as local activities here in the UK. We have continued with our three topic themes based on systems and human factors approaches: Manufacturing; Product labelling and Pharmacy. We are still very keen to support training, education, and collaboration both nationally and internationally where it aligns with our own mission.

As we had announced previously, Dominic had handed over leadership of the manufacturing theme to Julie Avery although he continues to provide sterling support and help to organise meetings every two months to successfully engage with Biophorum members from pharma manufacturing https://www.biophorum.com/.We have a strategic plan to build a global human factors community as a group and tactical topics such as remote audits, alarm fatigue and electronic signatures. We have agreed a draft vision within the group focusing on human performance, ultimately for improvement of system outcomes. Although the initial scope of the group is globally within pharmaceutical manufacturing, conversations have started for it to extend the community throughout the wider healthcare product system. Following the success of last year’s meeting about a human factor approach to labelling, such as

SEIPS 2.0, the resulting actions are now focussed on several projects. The first is being led by our colleagues in Northern Ireland concerning the inappropriate use of glucose solutions in arterial blood lines causing falsely elevated blood glucose results followed by inappropriate insulin. Angela Carrington will explain more about this. Our interest in insulin is a natural follow on from the promotion of the research on intravenous insulin carried out at the University of Reading in Rosemary Lim’s group (in collaboration with Clare Crowley in Oxford). Rosemary’s PhD student, Mais Iflaifel, will presenting her research to the group.

We were contacted by NHS England/ NHS Improvement about whether we could provide human factors input into a short life working group looking into improving the packaging and labelling of specials. I am delighted that Ravinder Bratch is our representative on this group and will report back progress in due course. Of course, we wish to continue pursuing our liaison with the group examining syringe labelling group in the Association of Anaesthetists.

Our theme about pharmacy is led by Ravinder Bratch supported by Helen Vosper who is leading author in the CIEHF white paper about decision making for pharmacists. More about this follows! We are interested in supporting and collaborating with the workplace SIG lead by Kirsty Angerer and Ed Milnes especially with so many in the pharmaceutical sector working from home and with remote working practices in clinical research. We would welcome volunteers to look further into these topics.

A message from the chairman

CIEHF Pharmaceutical Sector Group Newsletter- Issue 5 (January 2021) Page 1 of 9

The SEIPS instructions and worksheet used are shown below as a demonstration with the images below.

One of our most loyal and a founding member of this group, Colin Knight leads the theme concerning training and local collaboration here in the UK. Our relationship with PIPA https://pipaonline.org/ has blossomed and we are delighted to have Anne Lloyd, who is a member of the PIPA Committee as one of our regular core members in our group. PIPA are happy to collaborate with the CIEHF into mutual areas of interest (such as labelling) and support any activities in which the group would like to be involved. Our conversations with ABPI are continuing in a positive manner with contributions to our different themes. As with regards to involvement with patients, I am glad to report that Helen Hughes of Patient Safety Learning continues to give us solid support and good advice. We would strongly recommend you follow ‘The Hub’ for up to date about Patient safety https://www.patientsafetylearning.org/the-hub .

Although we are primarily interested in the UK, we liaise internationally with the Medication Errors group of the International Society of Pharmacovigilance. https://isoponline.org/special-interest-groups/medication-errors/ Cecilia Landa-Avila, who is based in Loughborough, is our Latin American to the human factors network – RELAESA. https://www.facebook.com/groups/relaesa Finally, as I have stated previously, none of this would be possible without the continued solid support of our project manager Gary Guan ably supported by Dominic Furniss so my deepest thanks to both. So, if you are interested in participating in a vibrant Sector Group with ambitions to make a difference, please contact us. If you are a CIEHF member, you can join our online discussion forum.

By Brian Edwards


Manufacturing Theme Lead - Julie Avery

Themes

CIEHF Pharmaceutical Sector Group Chair - Brian Edwards Co-chair - Helen Vosper

Pharmacy Theme Lead - Ravinder Bratch

Clinical Research Theme Lead - Hema Mistry

Marketed LabellingTheme Lead - Cristina Parau

System Investigation Theme Lead - Maria Bantouna

Automation and AI SIG Lead - Mark Sujan

Training Theme Lead - Colin Knight

International Collaboration Lead - Brian Edwards

Since taking on the role of project administrator at the start of the year, it has given me a great opportunity to see some of the great work which the group does across its multiple themes. Although 2020 was an unprecedented year, the group made great progress throughout all the themes.

At the start of the year the group moved away from sub-groups to themes instead, which aimed to reflect the life cycle of medicines and we transitioned smoothly. Julie Avery has now taken over the pharmaceutical manufacturing theme and has outlined a vision around optimising human performance which has gained a lot of interest from industry. The marketed labelling theme continues to develop with new projects, the latest being around incorrect fluids used for arterial lines flushes co-ordinated by Angela over in Northern Ireland.

The group’s relationship with professional bodies continue to develop. Anne Lloyd who is the group’s liaison with PIPA has continued to build the relationship between the committee, and they have agreed a list of topics which they are willing to collaborate with the group on. As well as providing us with the opportunity for an institute representative at the symposium next year. Brian was invited by Steve Hoare from ABPI to chair a workshop as part of the Medical Innovation Summit back in October. While the manufacturing theme is working with Steve on a survey around how human factors is current used in industry.

The monthly calls have continued to grow in the number of attendees, and it is great to see new people regularly joining the calls as they can offer another perspective on discussions based on their knowledge and experience. The group has had a smooth transition from Powwownow to Zoom, as the Institute has switched the platform based on feedback from users.

The group also had a really good virtual annual event due to COVID. The webinar was titled “A day in the life of a Pharmacovigilance Officer: how can understanding human factors help?” The webinar was based on the guest contribution from Anne Lloyd and her colleges, who were also the speakers for the webinar. The event had a good attendance with some fruitful discussions at the end.

Although 2020 has been a turbulent year in many ways, the group has continued to make fantastic progress in all aspects. We are now working closely with the Institute to plan events and work towards publications for an even better 2021. However, none of this would be possible without our outstanding group of volunteers being passionate about our work. I will continue to try my best as project administrator, but please do not hesitate to contact me if you have any suggestions on the administration of the group.

By Gary Guan

Pharmaceutical Sector Group administration

As you may know the Pharmaceutical Sector Group has slowly started to adopt the CIEHF Communities discussion forum. It is a great secure platform for us to share ideas and have general discussions within the group. The platform is also a centralised area where you will be able to access all the documents relating to the group. Access to this Communities area is usually restricted to CIEHF members, however we are now able to provide some non-members with access to this space. If you are interested in this opportunity, please send an email to [email protected].

A new way to connect and collaborate

CIEHF Pharmaceutical Sector Group Newsletter- Issue 5 (January 2021) Page 3 of 9Designed by Freepik

Arterial Lines Project

Patient safety incidents have been report reported where patients have died or have experienced serious harm because of neuroglycopenic brain injury as a consequence of arterial line blood sampling when glucose infusion is being used an arterial flush. The use of glucose infusions to unintentionally flush arterial lines, results in falsely elevated blood glucose readings when blood samples are drawn from the arterial line. This erroneously elevated blood glucose level may lead to unnecessary insulin administration which dangerously reduces a normal blood glucose level. This series of errors continues to happen despite it being a nationally recognised patient safety risk; the subject of a former National Patient Safety Alert and MHRA guidance, professional guidance by the Association of Anaesthetists of Great Britain and Ireland, published research informed by surveys and simulated exercises.

A recent tragic case reported in the media also highlighted the need for more to be done to prevent this type of incident from re-occurring.

https://www.bmj.com/content/370/bmj.m3507/rr-0

The author of this article concluded that ‘it is now time for patient representatives, clinicians, regulators and industry to work together to achieve widespread implementation of an engineered solution’.

Why does this matter to the Chartered Institute of Ergonomics and Human Factors Pharma Group?The CHIEF Pharma Group held a meeting with various stakeholders in Birmingham 2019 to discuss approaches based on a systems and human factors approach to regulated user information such as labelling, and packaging of

medicinal products, might mitigate medication errors.

The Birmingham workshop led to a concept developed by the CIEHF Pharma Group which is referred to as a ‘User Support Program (USP)’. This involves defining ideal personas: nurse, pharmacist, junior doctor, consultant, and then collatating all regulated information whose aim is to instruct how the end user should be using the medical products of interest (SPC, PIL, NPSA alerts, MHRA alerts; information from a Trust). This would then be compared with the information in this information package with reality of use based on the SEIPS2 Framework.

The labelling and packaging of intravenous fluid solutions has been cited by national bodies and in the published literature as a major contributory factor in the miss-selection of glucose containing fluids for arterial lines flushes, due to their similarities in appearance.

As a lead for Medication Safety in Northern Ireland, I was aware of reported incidents and ‘near misses’ with arterial lines flushes and the existing ‘latent’ hazards that have the potential for these incidents to re-occur. So through my Associate Membership of CIEHF, I proposed to our Chair, Brian Edwards for this area to be considered as a ‘test’ for the USP at a macro-ergonomics level. There are multiple benefits for healthcare to involve the CIEHF Pharma Sector Group; namely Human Factors expertise and focus on systems based thinking, the credibility of the organisation and its ability to raise awareness of the Human Factors implications in the design of intravenous fluids and help identify suitable solutions.


Source: RadiometerMedical, 2017


The CIEHF Pharma Sector Group held an introductory virtual meeting with a group of subject experts and interested stakeholders, to propose the application of the USP to this known risk problem. To support this meeting, a background briefing document was produced to summarise the current evidence concerning the risk of glucose being used to flush an arterial line.

Whilst it is also known that the sampling technique used in arterial line transducer sets has also been acknowledged as an area for improvement the group agreed that the focus of this work should centre on intravenous fluids and that glucose should never be administered to adult patients via an arterial line.

The CIEHF plan to hold a series of virtual workshops in the New Year using the USP and System Engineering Initiative for Patient Safety (SEIPS) model to consider the reality of the work system from the perspectives of the types of people who are routinely involved and from the current regulatory information and evidence available. This will involve multi-disciplinary and a cross-sector panel consisting of:• Patients • Anaesthetists / ICU doctors • Nurses • ICU / medicines safety Pharmacists • Pharmaceutical Industry

As this is an ambitious project especially as it will be undertaken virtually, effective planning is essential. A stakeholders meeting was held in mid-December to confirm suitable panel representatives; and to look at the creation of personas; and the scope of products involved and the pre-reading for panel members; that includes confirmation of the regulatory information and an introductory guidance on the SEIPS 2 framework.

In addition to this, I am at the start of my academic Human Factors journey; currently undertaking Staffordshire University Human Factors and Patient Safety Course, led by Sue Whalley-Lloyd and Paul Bowie. The arterial line flushes project is a great personal opportunity for me to put my learning into practice and connect and learn with other Human Factors specialists.

By Angela Carrington

A diagram depicting flushing an arterial line with a glucose infusion which isn’t to happen

Source: Brennan and Turnbull, 2010


Coping with Complexity

As you are no doubt aware, the CIEHF Covid-19 workstream has engaged with a range a different high-impact projects. What most of these have had in common is that they were developed by short-term working groups, delivering an initial output sometimes in a matter of days. When this project for newly qualified pharmacist’s decision making was assigned to us, we assumed this would be the same. The reality was quite different! Most new healthcare professionals experience some anxiety when moving from education to the practice environment, but it is recognised as being particularly challenging for pharmacists, largely as a result of their limited clinical exposure on most undergraduate courses. The first major clinical experience in most pharmacists’ careers is during their pre-registration year, which is assessed through a national pre-registration examination. Successful completion of the pre-registration year allows pharmacists to enter the national register.

One area known to provoke anxiety in newly-qualified pharmacists is clinical decision making, and in recent years, this has been exacerbated by the changing role of the pharmacist. When the primary pharmacist role was dispensing, decision making often centred around an initial consideration of whether a patient needed to be referred to a doctor. Arriving at such a decision was supported by the availability of local protocols to direct questioning. If the decision was made not to refer the patient, the likely next stage would be a recommendation from the limited number of medications available without a prescription. New, enhanced clinical roles now see pharmacists often as independent prescribers, taking responsibility for patient outcomes and frequently having to make difficult therapeutic decisions in the face of uncertainty and incomplete data.

To support this increase in both public and professional expectations of pharmacists, there

has been significant development of the framework for pharmacist education and development. One of the most recent updates has been the Royal Pharmaceutical Society Foundation Pharmacist Programme, which was published with the intention to use it as the starting point for the development of a national syllabus to ensure that all new registrants can access the necessary training and development for achieving the necessary capabilities to practise ‘confidently and competently’ across different clinical settings. Interestingly, Covid-19 has accelerated this ambition. Graduates of the class of 2019 have seen their pre-registration training significantly disturbed with their pre-registration exam deferred until March 2021. However, they have already been provisionally registered and are still facing the pressures of clinical practice. In order to address this need, Health Education England has responded with the Interim Foundation Pharmacist Programme (IFPP), described as “a supportive, formative, trainee-led vocational training programme. The learning is predominantly based in the workplace reflecting on ‘lived experiences’ in your day-to-day practice. This will help you to identify areas of good practice and where you need to focus your learning and development, setting an excellent path for your career in pharmacy.” All provisionally registered pharmacists are eligible to take part (about 2500 in total) and each will be allocated an educational supervisor. The IFPP has involved the development of educational resources and this is where the CIEHF came into the picture. Our COVID-19 response Gold Team was approached by David Gibson, Associate Dean Foundation Pharmacy at HEE. He was looking for some help with resources to support decision making in newly-qualified pharmacists. This project was handed over to the Pharma Sector Group, and Dominic Furniss and I worked with David to develop the resources which were launched at the webinar on the 2nd of December.

A resource to support pre-registration and early career pharmacists in clinical decision-making


The resources capture the full story but, briefly, our first finding from a systematic consideration of the literature was that clinical decision making is an advanced skill, requiring time and practice over prolonged periods. Furthermore, very little is known about how advanced practitioners make decisions, and even less is known about complex decision making specific to pharmacy. In terms of what is known, pattern recognition is central. Furthermore, expert decision makers accept that their decisions will not always be correct, and consequently identify cues that will allow early detection of errors. They will also have considered ‘recovery strategies’ to mitigate the risk. In situations where clinical decisions are necessary, experts are constantly gathering and assessing information and using this to build a model of their ‘problem.’ While there are no easy answers, it was also apparent that decision making skill development can be accelerated, and there are three key elements when it comes to achieving this:

• Inexperienced practitioners can ‘borrow’ experience from peers• Using a structured framework for peer discussion helps us understand how others make decisions – it starts to uncover implicit practice• Reflection is key for organising knowledge so that inexperienced practitioners can start to recognise patterns.

Other sectors (such as Aviation) have existing frameworks that support all of these aspects. The resource we developed essentially recreates this for a pharmacy-specific context. Using the tools,

information can be gathered, shared, discussed and reflected upon, helping the users to understand more about their practice, and support future decision making. To improve usability and accessibility of the tools, we also sought to bring them alive by developing several personas that reflected a range of pharmacy contexts, and a range of decision making expertise. Our personas were evidence based as much as possible using real-life practitioners as an example. At the webinar launch, we included a short video of a discussion between two of these practitioners: Hannah Beba (an expert diabetes pharmacist) and Emma Pearson (a more recently qualified pharmacist, currently on secondment to HEE as a Clinical Leadership Fellow). The discussion used the resource as a framework for discussing a complex Type 2 diabetes case, and the video received a hugely enthusiastic response, because it showed just how the resource can be used in a supportive way to underpin skill development.

This is envisaged as just the start. We are now entering an evaluation phase, and we will also be presenting our experience at both EHF2021, and the UK Clinical Pharmacy Association Conference in March. Watch this space – there will be further opportunities for Sector Group members to get involved. On that note, I’d like to thank group members Ravinder Bratch and Angela Carrington for their role on the review team for the resource.

By Helen Vosper

Coping with complexity infographic

Pharmaceutical Sector Training and Education Theme

In my report for our previous newsletter I alluded to the reorganisation of our Sector Group into themes earlier this year. Since then we have been involved in several activities even though these have been constrained by the current pandemic.You may recall that in our summer edition of the newsletter I reported about our very successful webinar held in June, which was kindly hosted by our contacts at the ABPI.

Since then we have organised another webinar, which was kindly hosted by the CIEHF. The webinar, entitled “Ensuring Medication Safety was held in September” This was a follow-up to the excellent article that Anne Lloyd’s colleagues, Shania and Salomi authored for our previous newsletter on the subject of “A day in the life of a Pharmacovigilance Officer”. The webinar presentation was a summary of that article that was shared with the wider CIEHF network. Our thanks go to Saloni and Shaina who assembled the article, which Shaina presented. Our thanks also to Anne for her support with webinar questions and to Cristina Parau for Cristina’s input into the webinar.

Our links continue to develop with the Drug Safety Research Unit (DSRU) in Southampton. Currently, they are very involved with establishing and coordinating a number of planned observational studies to assess the long term safety of COVID 19 vaccines. Given the approval of the first COVID 19 vaccine just earlier this month, their activities in this area will now be crucial in establishing the post marketing safety versus what safety issues have been identified during the clinical development phase. We look forward with great interest in receiving updated feedback from the DSRU on this.

Our theme maintains our close contacts with the University of Hertfordshire (UOH). In our next

newsletter, which is due in Summer 2021, our colleagues at the UOH have kindly agreed to write an article on the MSc Pharmacovigilance course that they have been running for 25 years. One of our key contributions to that course over time has been the opportunity we have had to offer a range of appropriate HUF factors for their MSc Pharmacovigilance students where applicable. In addition to our contacts at the UOH, we maintain excellent links with Professor Sue Hignett and her HUF colleagues at Loughborough University.

Finally, I would like to say thank you to all those who have contributed to the activities of our theme in the last six months which have been for all of us a very challenging period. Let’s look forward to 2021 where we can continue to train and educate others, and champion the essential contribution that HUF makes in both the Pharmaceutical and Scientific world.

Colin Knight- Sub-team Lead – e mail: [email protected]

Our team would welcome comments from any members of our Pharmaceutical Sector Group – if you would like to get involved with any of the activities of our theme, then please get in contact with Colin, who leads the activities of this theme.

By Colin Knight

Contributors to the activities of the theme

Colin Knight (Theme Lead)Gary GuanDominic Furniss Sue HignettRosemary LimHelen Vosper

Cristina ParauBrian Edwards Alda HummelinckAngela CarringtonAnne LloydNatasa MihajlovicAllison Morgan


Photo by: Daniel Schludi

Pharmaceutical Sector Pharmacy Theme

The Pharma Group had creative and varied journey this year and I have found it a joy to be involved as Pharmacy Lead. The group creates a platform where like-minded individuals can apply human factors understanding to medicines management. Each monthly meeting allows conversations and exchange of ideas from different perspectives that help us push work streams along.

Joined up thinking has been key to the work this year and sub-groups have been created to shine the spotlight on iatrogenic events caused by medication related incidents. Differing specialities and complex systems within healthcare means that ‘one size’ does not always fit all. Setting up bespoke sub-groups helps us to collectively understand specific medication related problems that our front-line colleagues often face and discuss any potential solutions.

During 2020, close collaboration, with our front-line colleagues had helped us to understand ‘work-as-done’ and provided important insights for our work streams. We have been working with a number of stakeholders with issues relating to labelling, mis-selection of medicines and inadvertent administration of insulin. Liaising with the Association of Anaesthetists regarding syringe labelling was one such project. Anaesthesia is a complex speciality within which high risk medicines are administered.

We have been invited to help with national work around improving packaging and labelling of “specials” medication. Mis-selection of medicines is a well-documented error type within healthcare, and can lead to catastrophic consequences for patients. Other work includes inadvertent insulin administration leading to severe patient harm. This work stream explores how to mitigate the risk of inadvertent administration of insulin following the

use of glucoses flushes in arterial lines.Due to work commitments during COVID19, the TeamSTEPPS work-stream may have to wait till the Spring. COVID19 has presented numerous challenges that I can't even begin to quantify, through these challenges and hardships brings renewed understanding that allows us to understand the individual with excellent technical skills is not enough. To withstand the pressures of the front-line we also require teams with excellent non-technical skills.

Team-working amongst hospital pharmacists is essential for building workforce resilience - so that the unpredictability of the everyday patient-facing work can be dealt with safely. The importance of communication, strong leadership, mutual support and situation monitoring has become a necessity for pharmacists at the 'sharp end' - to ensure we keep both our patients and ourselves safe. When we work within ever-changing environments and face the 'messy reality' of everyday work, good teamwork and a little mutual support can go a long way.

By Ravinder Bratch


Photo by: Pexelbay

Pharma SIG Newsletter Jan2021 Final - ergonomics.org.uk

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