The manufacture of cytotoxic drugs and Systemic Anti Cancer Treatments (SACT) is a high risk process. Within the NHS, drugs are prepared in pharmacy aseptic units to rigorous and highly regulated quality standards, described below. Currently ensuring compliance with Good Manufacturing Practice (GMP) is predominately a manual process, thus subject to the risk human error and potential risk of significant harm to patients.

GMP is the quality system for ensuring that drug products are consistently produced. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product, and covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.

BD Cato is a software program developed by Becton Dickinson, which supports pharmacy manufacturing of SACT drugs whilst maintaining quality standards. It allows the removal of the risks associated with human error; it has been designed to reduce medication errors, waste reduction and automate some of the in-process QA (Quality Assurance) manual checks. It is proposed to pilot BD Cato at the pharmacy department Velindre Cancer Centre.

Interventions and Actions:

Preparing for Pilot:

• Pulling together project team including: (Velindre) IT, Pharmacy. (BD) Account Manager, Solutions Manager, Project Manager.
• Building Database, Drug File and liasing with pharmaceutical companies to get drug information.
• Validation of Data and Systems
• Working with Isolator manufacturer to get equipment ready for pilot

Change management, including:

• Risk analysis
• In depth workflow mapping to ensure safety and a smooth transition to the new ‘to be process’.
• In depth training of team to ensure smooth transition and positive uptake

Anticipated Benefits:

• Continued or improved compliance with GMP
• Provide a standardised aseptic process for NHS Wales
• Reduce the number and time of manual QA steps, potentially increasing the workload capacity of the aseptic unit
• Reduced drug wastage
• Reduction in dispensing errors

This Project Supports Prudent Healthcare:

Impact of people time: The manufacturing of an aseptic product has several Quality Assurance (QA)
in-process manual checks to ensure the final product is prepared to GMP;
It is estimated that these manual checks take 2 minutes per item. Totalling up the daily workload and staff time, the system frees up 2 hours daily across multiple staff groups which will support additional capacity within Velindre Cancer Centre across multiple staff groups, enabling additional workload without additional expenditure.

Error reduction: Analysis from UK NHS aseptic units’ shows that out of 210,000 aseptic items dispensed, these manual in-process QA checks found 1700 errors. Further analysis of these errors indicated that 64% of these errors could have been prevented using an automated software system.

Cost savings: When a drug vial is part used to prepare a dose of SACT for one patient and later the remainder is used to prepare a dose of SACT for another it is termed a Part Used Vial (PUV). If a PUV cannot be reused it must be discarded, an audit at Velindre estimated that £1,500.00 a week is wasted by discarding PUVs. BD Cato is able to schedule the workload to allow the manufacture of the same products consecutively, reducing the PUV wastage.

The aim of this project is to improve communication and dialogue between patients with palliative and terminal illness and their healthcare professionals about Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) decisions.

Four videos hosted on a website aim to describe some of the main areas to consider when discussing this important topic. Videos were co-directed by patients, in order for them to help explain relevant issues surrounding this sensitive subject. In addition, videos for healthcare professionals with guidance and tips on how to start these conversations sensitively and professionally are also available on the http://TalkCPR.wales website.

We also aimed to clarify some of the common misconceptions surrounding CPR, allowing natural death and DNACPR towards the end of life in a news article. This project is referenced in this Guardian article and can be found here www.gu.com/p/4g5pv/stw.

Anticipated Benefits:

Communicating the concept of DNACPR in a sensitive way requires skill and once it has been discussed it should be documented very clearly, for other healthcare team members to know what discussion has been held. There is a need to explain this procedure better within society, and also to create reproducible ways of giving clinicians opportunities to gain confidence in talking about this topic more.

Measures

• Use of the new All Wales DNACPR form, which came into effect during 2015. This form is used to document communications between healthcare professionals, patients and carers.
• Acceptability and readiness of patients and healthcare professionals to use communication videos on this topic, to help understand what CPR actually is.

Intervention

• Roll-out of the All Wales DNACPR Form across Wales, and its uptake and use as a communication tool between healthcare professionals, patients and carers.
• Roll-out of TalkCPR videos, four videos (all aimed at patients, carers and healthcare professionals) co-produced and co-directed by Dr Mark Taubert and stakeholders including patients and carers.

Outcomes

• DNACPR forms obtained from notes in late 2015 and early 2016 contained more information on communication between healthcare professionals, patients and carers than previous DNACPR forms.
• There was a significant increase in DNACPR forms that were demonstrably discussed with patients and/or proxy compared to previous years.
• TalkCPR videos were acceptable to both patients/proxy, nurses, and doctors and pre-and post-video surveys as well as focus-group results showed a high level of readiness to engage in DNACPR discussions, readiness to show information videos to patients and carers and a better level of understanding about what CPR actually means.

This Project Supports Prudent Healthcare:

• Public and professionals are equal partners through co-production: DNACPR discussions are some of the most sensitive and delicate in healthcare today. Many palliative care workers have experienced that patients want to be involved in these decisions and are not usually offended by their healthcare professional bringing this The TalkCPR videos and website encourage this dialogue, try to inform about the challenges of CPR and encourage open communication. They were made, produced and reviewed by patients and carers in Wales, and are all the more powerful for it.
• Care for those with the greatest health needs first: The videos are aimed at patients with palliative and life-limiting illness, as well as their carers and their healthcare There are tips on how to frame these conversations within the wider care that will be provided.
• Do only what is needed and do no harm: More should be done to prevent modern medicine from automatically defaulting to cardiopulmonary resuscitation in palliative care patients. Admission to hospitals and ITU in situations where a prior, honest and candid discussion with a seriously ill patient may have elicited that they would rather remain at home, are a missed opportunity. DNACPR forms do not preclude patients from very active treatment and the treatment ladder approach in the Top Tips video makes sure that only those procedures are considered that patients would feel appropriate, no more, no We checked carefully with our user groups that these videos were not insensitive or harmful, and in fact some responses felt that they could have been more explicit and blunt. But overall view was that we got the balance right.
• Reduce inappropriate variation through evidence- based approaches: Videos are being rolled out via the DNACPR implementation group to each Health Board and Trust in Wales and are also available on Howis. Two English Trusts have approached Public Health Wales and asked whether they could use the videos in their own setting, and Pulse magazine have written a feature for GPs in the UK, on this novel video and website approach to get patients and carers to take a lead on DNACPR. Videos are available in English and welsh and provisions have also been made for blind, partially sighted and deaf patients.

Conclusion:

These short films have been made available in each health board and trust in Wales. Three English Trusts have asked permission to use the videos in their own setting, and Pulse magazine have written a feature for GPs in the UK, on this novel video and website approach. A media campaign has made the TalkCPR project very prominent in the public domain, with Benedict Cumberbatch reading out a letter at Hay Festival mentioning this NHS Wales project and a Guardian article on CPR which went viral. Both NICE and the GMC have published the TalkCPR website resource.

It is hoped that the use of video and website information for patients around difficult areas such as CPR wishes can inform part of a more sharing approach, allowing patients and their proxy to be involved in key decisions and providing good quality information.

The project is to validate an automated method of extraction of cell free DNA from blood, to introduce into service for the Institute of Medical Genetics. The project is being carried out in collaboration with Qiagen, transferring from the current manual method using the QIAVac, to the automated system using the QIAsymphony.

Project Plan:

February: Procure Consumables from Qiagen

March – September: Sample Collection: Samples would be collected from 2 areas:

1. Prenatal: The Institute of Medical Genetics was awarded £92,000 for validation of Non- Invasive Prenatal From March, 100 blood samples were to be collected from Antenatal Screening Wales.
2. Cancer: The Institute of Medical Genetics are collaborating with Cardiff University on two research projects for the application of cell free DNA in lung patients and colorectal patients. The collection of 20-40 samples from these patients will begin in March

June-October: Training and extraction of samples.

September-October: Completion of validation paperwork, SOPs

October: Introduce service into lab

Starting Conditions:

Recent developments in technology has shown that cell free DNA is a useful resource with vast potential for cancer patients (circulating tumour DNA) and in prenatal testing (free fetal DNA). As a laboratory we are expanding our services to offer genetic analysis to these categories of patients.

Currently the extraction team at the All Wales Medical Genetics Service are undertaking manual extraction of these samples in a time consuming, difficult process that is open to error. In order to meet anticipated demands for this growing technology an automated extraction method is required. The implementation of automated cell free DNA extraction from blood would mean that more samples can be processed in a shorter time period, with less room for error.

Analysis & Approach:

A legal issue regarding the tendering process meant that there were delays to the initiation of the NIPT validation project. This in turn impacted on this automation project, by the fact that there were no samples to extract.

This was added to by the lack of samples collected by the cancer teams, due to a mixture of consent, eligible patients and volume of sample received.

To date approximately 15 samples have been received that may be used for the automated extraction. This will increase in the next month to allow training to begin.

Goals & Targets:

Improved Healthcare Outcomes:

Laboratory able to provide automated cell free DNA extraction service throughout Wales.

Improved Patient Experience/Safety Outcomes:

More patients will be able to reliably access non-invasive services for either personalised medicine (avoiding the need for tumour biopsy) or pre-natal diagnosis (avoiding the need for amniocentesis). This will allow our laboratory to expand our downstream testing repertoire, resulting in further benefits from cancer patients and allowing our Non-Invasive Prenatal Testing service to thrive.

We can evaluate the output DNA using our standard quantification methods (Nanodrop and Qubit), and through downstream processing. This project would benefit two groups of patients; cancer patients with poor health who cannot undergo surgery can be genetically tested to elucidate effective treatments.

It also reduces risk of miscarriage in pregnancies, by avoiding the commonly used amniocentesis test.

Resource Efficiency:

Reduction in hands-on time.

Accuracy:

We expect the accuracy of the extraction to be improved, processing a large number of samples would be impossible in the same time period, and with the same level of consistency.

Future State:

At the current time, the project has not moved forward. Samples are currently being collected, to initiate the project. This has resulted in a huge delay to the project, but the team is confident that an automated service is still possible and achievable. The project is vitally important to being able to offer patients the best healthcare, while ensuring the laboratory is the most efficient it can be!

This Project Supports Prudent Healthcare:

Principle 1: This validation will ultimately providing a better Health Service for antenatal and oncology patients, allowing the Laboratory to provide a robust non-invasive genetic testing service, as a cost effective and low-risk alternative to surgery, and therefore improving the patient experience.

Principle 2: Automating our extraction service will allow the Laboratory to increase the number of extractions we can currently perform from 24 in 6 hours to 96 in 6 hours. The amount of hands on time will be reduced significantly.

Principle 3: If the validation is successful, there will be ultimately a reduction in the number of invasive pre-natal testing and also the number of biopsies taken, as we are able to provide a non- invasive genetic testing service.

Principle 4: The Qiasymphony eliminates manual pipetting errors, ensures standardisation and avoids contamination with the use of tip guards and built-in UV lamps. The system has a barcode reading system to allow full sample tracking throughout the process. Publications from Qiagen have shown the automated system compared to manual produces a higher concentration better quality DNA, and this particular machine is being used in other Laboratories, Great Ormond Street Hospital and Dundee Genetic Laboratories for cell free DNA extraction.

This Project Supports Prudent Healthcare:

1.     Achieve health and well-being:

• The primary outcome of this health technology is to improve patient health and well-being.
• The use of NGS is beneficial to patient health as it increases the sensitivity of mutation detection compared to the currently utilised technology. This means that low level mutations in tumour samples can be identified, providing more patients the opportunity to benefit from available stratified medicine treatments.

2.     Effective use of resources:

• This health technology identifies cancer patients that are most likely to benefit from the administration of specific anti-cancer drugs, so these drugs can be targeted to those patients with the greatest need.
• The use of NGS has distinctive benefits over the current technology in terms of effectively utilising skills and The same NGS pipeline will be used for the analysis of all lung and colorectal solid tumour samples received by the laboratory thereby removing the need to perform multiple different analyses for each tumour sample. This streamlined workflow will allow significant savings to be realised in terms of staff time.

3.     Do no harm:

• As already mentioned, the aim of the genetic analysis of tumour samples within the laboratory is to identify patients most likely to benefit from anti-cancer drugs. Conversely, the genetic analysis performed allows the identification of patients for whom treatment should be avoided as, given the patient’s tumour genotype, such drugs are unlikely to hold any benefit and could in fact simply cause adverse side-effects.
• The GeneRead NGS panel requires significantly less DNA compared to the currently utilised pyrosequencing technology therefore ensuring that precious tumour sample DNA is preserved, as well as allowing more patients the opportunity to have their tumours genotyped and potentially benefit from available stratified medicine treatments.

4.     Consistency:

• All lung and colorectal solid tumour samples will be analysed using the same NGS technology and utilising the same analysis pipeline; therefore ensuring consistency within the solid tumour service and uniform analysis for cancer patients throughout Wales.

Ectodermal dysplasia (ED) is not a single condition but a group of closely related genetic disorders affecting the development or function of the ectodermal structures – hair, teeth, nails, sweat glands, cranial-facial structure, parts of the eye and ear, digits, nerves and parts of some organs. Physical features vary greatly between affected individuals even for the same type of ED, and abnormalities range from mild to severe.

Cardiff is considered to be a centre of clinical excellence for the genetic aspects of ED. Currently, Laboratory Genetics provides a worldwide service for this disorder.

The current laboratory service is offered using an expensive, low-throughput sequencing technology that requires analysis of individual genes leading to high costs (£500-1,000 per gene).

The laboratory requires the validation of clinical exome sequencing to replace single gene for the ED service; the required technology is Illumina’s TruSight One panel and HiSeq 2500 sequencing system. This will allow all clinically-relevant ED genes to be analysed at the same time, instead of individually as present.

Results:

Peripheral blood extracted DNA samples were collected from 32 patients with ED and 32 patient control samples. This cohort contained 69 unique variants identified using Sanger sequencing which were targeted for next-generation sequencing using the Illumina TruSight One clinical exome.

Assay sensitivity was 100.00% (94.79% to 100.00% 95CI). The panel can detect single- nucleotide and small insertion-deletion (<~40bp) variants.

This Project Supports Prudent Healthcare:

Positive patient outcomes increased:

• Improve public health – Increased diagnostic yield.
• Improve patient care – deliver a genetic diagnosis that matter to families.
• The opportunity to recognise interactions between genetic variants at functionally-related loci

Health system efficiency increased:

As a great exemplar of Prudent Healthcare, clinical exome analysis for patients with ED if undertaken early enough, could potentially:

• Avoid needless clinical appointments in specialist clinics. Avoid additional investigations.
• Patients often have to travel long distances to attend these clinics, sometimes out of Wales.
• Prevent unnecessary investigations or treatments. By achieving a molecular diagnosis in a timely fashion, family-based testing can allow those at-risk but who are shown NOT to carry the family’s mutation to be removed from the additional recommended health monitoring and surveillance.
• Avoid significant delays in patients receiving a diagnosis.
• Provide timely genetic counselling for family members, in time for critical family planning decision-making.
• It is cheaper than the current service due to the clinical uncertainty around the most likely gene responsible.
• The precise gene and mutation involved will be therapeutically important in the future.

Impact of validating the clinical exome sequencing workflow for the laboratory:

• Replace the current expensive Sanger sequencing for other rare genetic disease services.
• Repatriation of rare genetic disease services currently sent to external laboratories.
• Remain competitive in the field of genetic testing to deliver up to date patient services.
• Improve the ability to attract and retain staff.

The need to deliver 7-day stroke rehabilitation through an integrated multidisciplinary workforce was identified in staff engagement workshops.

This project aimed to provide patient-centred, focused rehabilitation and enhanced ward activity, over 7 days, by trialling the role of Rehab Assistant (RA).

Method:

The RA role was trialled with a group of 15 patients (yellow team) over 8 weeks. RAs received training from each of the therapy disciplines to enhance their knowledge and skills in the delivery of rehabilitation programs. 6 RAs working a 7 day job plan provided rehab input and activities every day. 16 student volunteers were also recruited to assist in running activities.

Results:

This project tested the principles of Appreciative Inquiry (AI) at the front line of healthcare.

This was a short intervention, at the ward level, using the leadership of a clinical psychologist that explored how AI could be used to develop nurses’ understanding of what enhances compassionate care. AI holds at its core the principle that something works well in every system. Using the 7Cs of caring conversations (Dewar, 2013) as the model, the things that worked ie good practice was observed and reflected on with nursing staff.

What makes this approach different?

Unlike the typical approach of ‘finding the problem and fixing it’, AI offers an alternative where the focus is placed on the things that work well. By creating a better balance, can we improve care?

Our project has shown that this is possible, but also that a lot more work is needed. We see this as the start of a journey, one that includes better balance in feedback that recognises and celebrates the things that we do well and encourages more of the same.

Early Outcomes:

By being involved in this project, staff have developed increased:

• Awareness of how the small things that they see as part of their normal work make a big and positive difference to patient experience.
• Opportunity to reflect upon what they can do to enhance and build compassionate behaviour. Understanding in how challenging it can be for qualified staff to reflect and celebrate compassionate care.

Examples of findings using the 7Cs model:

Being courageous: courage to ask questions and try things out

• Going out of your way to change someone’s meal because they’d ‘lost their appetite’ following their operation.
• Asking ‘are you ok’ and stopping their task to listen to the response.

Connecting emotionally: noticing how we are feeling

• Noticing a lady with dementia was reassured through affectionate touch and making sure that they spent time tucking in her blanket.
• Stopping and asking other staff how they feel at the start of a shift.

Being curious: suspending certainty and looking for the sense of what is said

• Finding out more about a patient and what they used to do when they were working.
• Admiring a patient’s book selection and sharing their interest.

Collaborating: talking together, looking for the good in others

• Asking others for help and expertise in understanding a situation.
• Checking with each other and helping each other out when we can.

Considering other perspectives: creating space to hear differences

• Engaging in banter and humour with patients.
• Reflecting that beliefs may be different from patients.

Compromising: working hard to suspend judgement and talking together

• Delay washing patients until the afternoon after patient asked.
• Supporting patients to eat their lunch.
• Celebrating – making a point of noticing what works well.
• Sharing appreciation to the morning shift for their hard work.
• Praising others and calling them a ‘superstar’.
• Giving each other a hug.

This Project Supports Prudent Healthcare:

By improving

• Dignity and respect for patients as equal partners in care.
• The expectation of a positive experience of care.
• The memory of what happens in hospital.
• Staff awareness of the impact of how we do what we do, improve the connectivity between tasks and outcome, and consistency for the patient experience.

Betsi Cadwaladr University Health Board (BCUHB) is geographically the largest health organisation in Wales and provides a full range of primary, community, mental health and acute hospital services for a population of over 670,000 people across the six counties of North Wales (Anglesey, Gwynedd, Conwy, Denbighshire, Flintshire and Wrexham) as well as some parts of mid Wales, Cheshire and Shropshire. 44% of the Health Board’s population speak Welsh, well above the national average of 19% (2011 Census)

• BCUHB sent over 600,000 appointment reminder text messages (SMS) during the last financial year; the need to send bilingually doubles the output to over 1,200,000 text messages (and doubles the cost!).
• Over 43,000 appointment reminders were delivered via an agent telephone call; these calls are always made initially in English, with the patient given an option of receiving a follow-up call in Welsh
• The Welsh Language Standards state that BCUHB should be actively asking patients for their preferred language of communication, recording the choice and then using this information to inform future communications.
• As a result of the above, this project aims to improve the patient experience by allowing patients to choose the language in which communications are received; this in turn will make significant cost and efficiency savings for the health board.

The project will enable patients to state their language of choice for appointment reminders (Welsh, English or Bilingual) – this could be:

• when at a GP reception desk.
• during a telephone call with a hospital booking clerk.
• by responding to a text message specifically asking for language choice.
• when visiting the health board’s internet site.

In the long term, the recorded language choice could be used to manage resources, inform patient booking/clinic management and impact on all patient communications.

In 2015-16, over 600,000 text message appointment reminders were sent.

• If just 10% of patients chose to receive appointment reminders in one language, thousands of pounds would be saved by the health board.
• If all patients asked to have their reminders in one language, the cost would be reduced by 50%.

With the future scope to send text reminders for the majority of BCUHB’s 1.1 million outpatient appointments and for nearly 80,000 planned admissions, the potential savings could be massive.

There were also over 43,000 agent telephone calls made in 2015-16. Distressed and concerned patients immediately feel more at ease when contacted in their first or preferred language. The project will allow the appropriate agent to call patients initially without needing a second phone call, improving the quality of the experience for the patient.

Outcomes:

• The language choice intelligence for appointment reminders has been developed by our industry partner Healthcare Communications within their Envoy patient communications This will be available for BCUHB in late January 2017. Furthermore, Healthcare Communications have created a language choice selection feature for online letters accessed via their patient portal (not currently used by BCUHB).
• Within secondary care, language choice can be recorded in the main patient administration systems used within the health board; work with the NHS Wales Informatics Service (NWIS) continues in order to allow the recording of ‘Bilingual – Welsh/English’ as a conscious choice on the national systems. In the meantime, a work around solution will prevent delays in ‘going-live’.
• Adapting the e-referrals process to bring though preferred language from primary care has been deemed too resource heavy, with too many external dependencies, at this point in time. This still remains an integral part of the long term vision (as recording information at the start of the patient journey will be key for long term success) but is out-of-scope for the immediate future.

• It is expected that language choice for appointment reminders will be implemented across the health board in early 2017.

This Project Supports Prudent Healthcare:

The project supports prudent healthcare by encouraging collaboration and co-production within secondary care, primary care, local and national informatics teams and with an industry partner. This is a prudent innovation project, making effective and best use of existing resources, offering both financial and quality benefits: the health board can do this and should do this.

Rationale for Service Re-design:

In 2012 CAMHS was affected by long waiting times for

routine assessment in excess of 12 months. This was having a negative impact on the quality of service user experience and affecting morale of the clinicians.

There was an acceptance and willingness for change across the teams to alter our methods of service delivery. The CAPA model was proposed as a basis for a re-design of the service.

At that stage there was partially implemented job planning and limited knowledge of skill mix and a lack of clarity about service capacity. We needed a language with which we could describe the amount of work it was possible for the teams to deliver whilst being able to communicate to our organisation what was needed in order to reduce waiting times.

The complex processes involved in our CAMHS needed a framework to examine, streamline and refine systems.

What is CAPA?

CAPA is an evidence based framework for the delivery of modern CAMHS which places emphasis on collaboration and shared decision making with service users (York and Kingsbury, 2013). This model has been adopted by more than 500 services across the UK and the world but has not been widely adopted in Wales.

The CAPA model involves several key components and is most effective when all components are in place. It is underpinned by principles of empowerment of children and families to take an active role in improvement of their mental health. It combines demand and capacity theory, evidence based practice, clinical leadership and staff development.

• “Choice” appointments put the service user at the centre of The clinician acts as a “facilitator with expertise” rather than an “expert with power”.
• Work carried out by the team is categorised as “Core” and “Specific” Partnership work – identifying the team skills required to meet the needs of the service users.
• Job planning allows calculation of the availability capacity of a particular skill set.
• Peer group meetings- discussion of the service user goals, any obstacles can be identified or This allows us to learn from each other and facilitates “letting go” of families.

What did we do?

This BCUHB pharmacovigilance / quality improvement project is about finding out more about just one fraction of medication-related harm; that of drug-associated bleeds (DaBs). It seeks to improve local / national data capture of DaBs, in order to learn lessons and reduce future occurrences.

Project Scope:

Stakeholders include the local Endoscopy Steering Group and the Welsh Medical Imaging Sub-Committee of the Welsh Scientific Advisory Committee, local / national Clinical Coding departments, external Gastro-intestinal (GI) Reporting tool commercial software companies, NHS Wales Informatics Service (NWIS), the Medicines and Healthcare Products Regulatory Agency (MHRA) and its associates, BCUHB’s Drug and Therapeutics Group, finance department and cross-sector healthcare professionals.

The project, in time will be a Wales-wide project impacting on the wider UK and beyond.

Initially, the Bevan Exemplar is working with stakeholders to refine the processes involved in identification of and capturing clinical coding of DaBs.

Another aspect is the collection of pharmacovigilance data regarding DaBs in the form of yellow MHRA cards. All drugs, whether new or long established therapies, have an inherent risk of Adverse Drug Reactions (ADRs). Identifying and reporting ADRs to the MHRA is an important part of drug surveillance. With time, root cause analysis of individual DaB cases should highlight avoidable DaBs and reveal potentially rectifiable contributory factors.

With improved clinical coding and identification, more accurate DaBs data should reflect a truer picture of both patient harm and NHS resource consumption.

Ultimately, national standards for the software companies engaged in GI reporting tools are strived for with parallel development of Bronchoscopy reporting tools for collecting drug- associated harm to lungs.

This project seeks to make a positive difference to reducing DaB harm and costs.

Why this Project?

• The NHS can’t fix what it doesn’t know is wrong.
• All NHS Professionals have a duty of care to learn and feedback regarding avoidable harm.
• Landmark research published in 2004 highlighted that 6.5% of all admissions are related to medicines, of which 72% are avoidable (1). It involved 18,000 patients in two Merseyside hospitals.
• Gastro-intestinal (GI) bleeding was cited as the cause for 54% of deaths in this landmark study (1).
• GI bleeding caused by drugs needs preventing.
• However, bleeding as a mode of drug harm takes various forms, whether intracranial haemorrhage, haematoma or GI bleeding or from other body sites, so harm capture needs to count bleeds wherever they happen.
• Capturing information regarding drug-associated bleeds should be routine for healthcare professionals across the specialties.
• Pirmohamed et al (1) reported drugs causing bleeding were aspirin, non steroidal anti-inflammatory drugs, warfarin, and antidepressants. However there are new drugs which weren’t available in 2004. These include a novel class of oral anticoagulants widely prescribed within the NHS called NOACs. There is a known risk of GI bleeding with these and this risk is greater for those over 75years of age (2).
• NWIS data is available for emergency admissions involving DaBs, as coded by NHS Wales’ clinical coding departments but clinical coders rely on clear documentation in medical notes/ reports.
• Analysing DaB harm adds a new focus to a suspected medication-related admissions Wrexham project led by the Bevan Exemplar since April 2006.
• Here is the Bevan Commission’s opportunity to use Welsh intelligence to lead the rest of the UK.

Anticipated Benefits:

Within BCUHB & ultimately across Wales:

Make it safer:

• Help NHS Wales provide a safer, more efficient service.
• Drive pharmacovigilance forward.

Make it sound:

• More accurately count and clinically code DaBs.

Make it happen:

• Elucidate which, when, where, how and why DaBs occur & identify solutions.

Make it sustainable:

• Ultimately reduce DaB patient harm (and associated measures of this: deaths, inpatient bed days, gastroenterology scoping DaB costs, litigation, primary/secondary care consultations).
• Work to reduce NHS pressure and hospital escalation status frequency.
• Count DaBs’ financial cost to enable wider engagement.
• Continuing motivation of applicant and front- line colleagues.
• Continuing Professional Development of all through learning and feedback.

Within the UK

• Develop a national standard, endorsed by the MHRA for all GI reporting tool commercial software companies.
• Incorporate into the GI reporting tool which drugs are known to be associated with bleeds but include a free-text option to enable new harm from existing/new drugs to be recorded.
• Similarly trigger development of a national standard for a Bronchoscopy reporting tool.

This Project Supports Prudent Healthcare:

• Through co-production with Gastroenterology / MHRA /software company/ healthcare professionals: Better capture DaB clinical coding data. Introduce national standards for GI reporting tools and explore similar for eg Bronchoscopy. Ultimately achieve fewer DaBs.
• Utilising skills: Benefiting from Pharmacists’ root cause analysis/ drug safety skills.
• Harm & resource usage limitation: Reduce patient harm in terms of deaths, haemorrhages, bed days consumed, DAB episodes, gastroenterology scoping resource usage.
• Helping the needy: DaBs (which includes haemorrhagic strokes) affect quality of life and can be fatal. The elderly are frequently affected.
• Reduce inappropriate variation: Drive pharmacovigilance forward across BCUHB / Wales /UK for new and existing drug therapies.

References:

1. Pirmohamed M, James S, Meakin S et al Adve rse drug reactions as cause of admission to hospital: prospective analysis o f 18,820 patients. British Medical Journal 2004; 329 (7456):15-9. http://www.bmj.com/content/329/7456/15.long  (access d 31 August 2016)

2. Abraham NS, Sin h S, Alexander GC et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study British Medical Journal 2015; 350:h1857 http:/ /www.bmj.com/content/350/ bmj.h1857 (accessed 31 August 2016)