Investigation report: Management of chronic asthma in children aged 16 years and under

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The reference event relates to a Child who suffered a near-fatal asthma attack when he was five years old.

The Child was born prematurely and during his early years had a number of health issues, including a form of chronic lung disease. Secondary to this, he had a ‘wheeze’ (whistling sound made during breathing) and suffered from a ‘wet cough’ (producing mucus).

Due to his complex and varying health needs, the Child attended hospital frequently either as an outpatient, an inpatient or for emergency care. The Child was prescribed medication to treat his respiratory (airway-related) conditions, including corticosteroid taken using an inhaler. This is a medicine that reduces inflammation in the airways. However, medicines adherence was an issue – that is, he was not being given the corticosteroid medication in line with the prescriber’s instructions. In addition, a lack of capacity in the respiratory outpatient clinic meant he often waited much longer for an appointment to review his condition than was requested by the clinic consultant.

Safety risk

The Department of Health and Social Care shared with HSIB a report to Prevent Future Deaths (PFD) from HM Coroner relating to a child aged 10 years, who had died of asthma. HSIB was asked to consider whether it could identify further opportunities for learning. Prior to this, there had been two other PFD reports relating to the deaths of children between 2014 and 2017, and all three cases highlighted missed opportunities to recognise asthma as a chronic and life-threatening condition. There were issues around how the condition was managed across both primary and secondary care (for example, across GP practices and hospital-based clinics), and concerns that care did not meet national standards.

HSIB identified a reference event through a review of the Strategic Executive Information System (StEIS), a national database of serious patient safety incidents. Additional information was then gathered and the incident assessed against HSIB’s investigation criteria. Consequently, the Chief Investigator authorised a national investigation.

The national investigation focused on:

• the implications for children aged 16 years and under of having no formal diagnosis of asthma
• the current systems of oversight of care and review of their effectiveness
• the current mechanisms of sharing clinical information
• the factors which influence parental adherence to treatment plans for children aged 16 years and under.

The following work was carried out during the investigation:

• extensive reviews of research and other literature relevant to each of the lines of inquiry
• engagement with experts in the field of asthma, nationally and internationally
• exploration of the systems currently employed in primary care for managing the barriers to asthma care
• engagement with the BeatAsthma+ team and a consultant respiratory paediatrician (a specialist in the treatment of children with airway-related conditions) to discuss diagnostic hubs
• engagement with a representative from the Royal College of General Practitioners to review the Great North Care Record as an effective means of sharing clinical information
• interviews with parents of children with confirmed or suspected asthma to gain a wider perspective of the condition, including management, support, and treatment
• focus groups with children and young people to better understand asthma from the patient’s perspective
• engagement with a consultant paediatrician subject matter advisor (SMA)
• engagement with a human factors SMA
• engagement with a Professor of Behavioural Medicine from University College London, to better understand the factors which influence parental/child adherence to treatment.

The investigation identified opportunities and system-wide solutions to reduce the risk of acute asthma attacks in children and adolescents that result in significant harm. The investigation and the report focus primarily on chronic asthma in children aged 16 years and under in the context of safe management of the condition between different types of healthcare services. However, the findings, safety recommendations and safety observations may be helpful when considering adults with asthma and the management of other long-term conditions.

The investigation found that:

• For children under-five with wheeze (a whistling sound made during breathing) without a confirmed diagnosis of asthma, the use of an information and management plan to monitor symptoms and adjust treatment serves to educate parents/carers regarding symptoms, and empower them to self-manage their child’s condition.
• In the reference event, monitoring of the Child’s response to medicines was limited due to issues with the timeliness of follow-up paediatric respiratory outpatient appointments.
• The National Review of Asthma Deaths identified that a different, more effective and integrated approach to asthma care delivery was needed. The review made 19 recommendations, 12 of which were relevant to the reference event. Only one has been implemented nationally to date.
• The information used by NHS 111 to triage a breathless child over five years of age does not include a prompt for chest recession (an indrawn chest, which can indicate breathing difficulties) in the supporting information, as one of the indicators of a life-threatening breathing difficulty.
• There was limited communication and transfer of information regarding the Child’s suspected asthma diagnosis between primary care, secondary care, community services, the child’s school and the family.
• There are no nationally endorsed training packages for healthcare professionals caring for children with asthma.
• A combination of paper records and electronic systems, and the limited ability of different electronic systems to share information with one another, resulted in inconsistent and incomplete transfer of information about the Child’s condition and treatment.
• The interface between primary care and community pharmacy was limited in relation to asthma medicines management due to the pharmacy having only partial access to the Child’s Summary Care Record (an electronic record of patient information, created from GP medical records, which can be seen and used by staff in other parts of the health and care system).
• There was no correlation of ‘red flag’ markers such as the number of times a patient had sought emergency treatment, lack of improvement of symptoms and insufficient inhaled corticosteroid prescriptions. This meant it was not possible for primary care and community services to identify patients at increased risk of an asthma attack.
• Monitoring parental adherence to asthma medicines was limited in terms of effectively changing health-related behaviour, since the reason for nonadherence was not established.
• There was minimal parental education to enhance the Mother’s understanding of how to manage her son’s condition, prior to the near-fatal asthma attack.
• The involvement of a paediatric asthma nurse after the Child’s asthma attack enabled information and key messages to be communicated to the Child’s Mother in a way that she understood.
• There appears to be a general lack of understanding about the potential seriousness of asthma.
• There are no nationally endorsed educational resources for children and families on the management of asthma (confirmed or suspected).
• Children too young to consent were not eligible for advanced pharmacy services (Medicines Use Reviews and the New Medicines Service) that could assist their families in medicines management and adherence to treatment.

1.1.1 Asthma is a varied, long-term respiratory disease, associated with airway inflammation (swelling) and hyper-responsiveness, which makes the airways more sensitive and reactive to numerous types of stimuli (National Institute for Health and Care Excellence, 2018a).

1.1.2 Asthma is a clinical diagnosis, comprising wheeze (a whistling sound made during breathing), chest tightness, breathlessness and sometimes excessive cough (Pavord et al, 2018). The management of airway disease is based on the identification of ‘treatable traits’ in each patient (Agusti et al, 2016); namely, what is going on in the airway that is treatable.

1.1.3 In children, asthma is often an episodic disease, with few symptoms and near-normal lung function for long periods punctuated by periods of increased symptoms and exacerbations (asthma attacks) (Bisgaard et al, 2006). Symptoms can be triggered by factors including exercise, allergen exposure, certain medicines, air quality, changes in weather, and viral respiratory infections. Symptoms may resolve on their own or in response to treatment.

1.1.4 An acute asthma exacerbation (or asthma attack) is a term used to describe the onset of severe asthma symptoms, which can be fatal.

1.1.5 Recession is a clinical sign of respiratory distress (difficulty in breathing) which occurs as increasing pressure in the chest cavity causes indrawing of part of the chest. The different types of chest recession referred to in the report are outlined in figure 1.

1.1.6 There is no cure for asthma, so management focuses on reducing exposure to known triggers, relief of symptoms and reduction in airway inflammation by regular preventive treatment (National Institute for Health and Care Excellence, 2018b).

1.2.1 Asthma is the most common lung disease in the UK, with approximately 5.4 million people receiving treatment for asthma, equating to around 8% of the population. On average, three people die from an asthma attack in the UK every day. In children, asthma is the most common lung condition, affecting around 1 in 11 children in the UK (Asthma UK, 2021).

1.2.2 Analysis of data from the Office for National Statistics (Asthma UK, 2019) has identified that more than 1,400 adults and children died in 2018 from asthma attacks in England and Wales, an 8% increase compared to 2017.

1.2.3 The UK has one of the worst asthma death rates in Europe (National Institute for Health and Care Excellence, 2018b). Initial improvements in the number of asthma deaths have also stalled in recent years (Nuffield Trust, 2019). The UK performs less well than similar high-income countries particularly in relation to the support provided to young people to self-manage their condition. The Nuffield Trust (2019) states that

‘Adolescents and young adults in the UK are more likely to die from asthma … than their counterparts in the comparator countries’.

1.3.1 The basis of asthma prophylaxis (preventative measures) and treatment is inhaled therapy, most commonly by inhaler devices (see table 1).

Image courtesy of http://www.leedsformulary.nhs.uk/

1.3.2 In relation to the terminology used in this report:

• inhaled corticosteroids (ICS) relate to beclometasone and fluticasone inhalers
• short-acting beta agonist (SABA) relates to salbutamol.

1.3.3 Spacer devices (see figure 2) are recommended for everyone who uses an inhaler (National Institute for Health and Care Excellence, 2020a). These are issued with inhalers because of the difficulty in coordinating the device with breathing in at the same time.

1.4.1 The term adherence has been defined by the World Health Organization (2003) as ‘The extent to which a person’s behaviour … corresponds with agreed recommendations from a healthcare provider’. Medicines adherence focuses on the patient’s behaviour in taking their medicines.

1.5.1 School nursing. School nurses are specialist public health nurses. One aspect of their role, which is relevant to this investigation, is to lead and co-ordinate the delivery of the Healthy Child Programme (Department of Health, 2009). School nurses are registered nurses who have undertaken an additional qualification in public health nursing, which is recordable with the nursing profession’s regulatory body, the Nursing and Midwifery Council. Since April 2013, local authorities have been responsible for public health locally, including commissioning public health services for school age children.

1.5.2 School vaccination programme. Since the Health and Social Care Act 2012, NHS England is responsible for the routine commissioning of national immunisation programmes (NHS England and NHS Improvement, 2020). The commissioning model varies and, in the region where the patient safety incident described in this report occurred, a standalone vaccination team had been commissioned.

1.5.3 NHS 111 was introduced in 2013 and 2014 for patients with urgent medical concerns. NHS 111 is staffed by trained call advisors, supported by clinicians, who use the NHS Pathways triage system to direct patients to the most appropriate available service, both in and out of hours. NHS 111 services can be provided by ambulance services, private providers and other NHS trusts. Calls to the service are managed by non-clinical specially trained call handlers who refer the patient on to suitable services based on the patient’s health needs at the time of the call. These call handlers are supported by clinicians who are able to provide advice and guidance or who can take over the call if the situation requires it.

1.5.4 NHS Pathways provides the clinical decision support system used by NHS 111 and half of English ambulance services (NHS Digital, 2021). The NHS Pathways system is built around a clinical hierarchy, meaning that life-threatening problems assessed at the start of the call trigger ambulance responses, progressing through to less urgent conditions which require a less urgent response in other settings.

The investigation was completed between January 2020 and May 2021.

3.1.1 Investigative approach

HSIB adopts a no blame approach to all investigations and does not attribute blame or liability. The healthcare system is considered in its entirety to identify the factors that have contributed to the patient safety incident. This investigation has been guided by the AcciMap approach, explored in 3.1.6.

3.1.2 Investigation team

The HSIB investigation team was multidisciplinary:

• In relation to the skills and knowledge that the investigation team applied, it had expertise associated with clinical domains and human factors.

The team was supported by subject matter advisors, who specialised in general and specialist aspects of paediatric respiratory care, behavioural sciences and human factors.

3.1.3 Reference event investigation

A reference event was identified that resulted in a Child being admitted to hospital in respiratory failure, after being diagnosed with pneumonia following influenza A. Prior to this, he was being treated by secondary care as having ‘suspected asthma’, but this had not been formally communicated to the Child’s family or GP practice.

The reference event investigation required visits/meetings to where the patient’s care had occurred. This included the healthcare settings detailed in table 2 below.

Engagement (reference event)

The Child’s family was contacted and interviewed to establish their perspective on the reference event. The staff directly involved in the reference event were interviewed and included:

• paediatric respiratory consultants
• a consultant paediatrician
• a paediatric asthma clinical nurse specialist
• a service manager (booking system)
• a matron for respiratory services
• the managing partner at GP practice
• the Child’s GP
• community pharmacists.

The investigation also met with the health visiting team, the school nursing team and the school immunisation service.

3.1.4 National investigation

Following investigation of the reference event, HSIB evaluated the potential for national learning. The reference event highlighted some of the risks associated with the absence of a formal asthma diagnosis in children under the age of five years, particularly in cases where adherence to treatment is an issue. Such risks are exacerbated when patients move between primary, secondary and tertiary (highly specialised) care, where there is no system of oversight in place. In addition, the sharing of clinical information may be hindered by system interoperability issues (where different IT systems are not able to communicate and share information), impeding effective communication between services.

The missed opportunity to recognise asthma as a chronic and potentially life-threatening condition was identified as a safety risk. This led to a decision to broaden the investigation and identify healthcare settings to collect further data to understand the national context.

Engagement (national investigation)

Stakeholders across the healthcare system were contacted and interviewed to establish their perspective on the national context. In addition, there was engagement with:

• Three ‘Experts by Experience’, who are people with recent personal experience of using, or caring for someone who uses, health services. They are recruited, trained, and managed by a national organisation.
• One parent of a child with asthma and the Mother of the Child involved in the reference event.
• Children and young people, who took part in a facilitated focus group.
• Numerous contacts and experts across the UK.
• Primary and secondary care organisations in regions across England.

Limitations to engagement or access to information (national investigation)

Observation visits to hospitals necessarily ceased in 2020 when the COVID-19 pandemic significantly affected the UK. For this investigation, even though not all of the planned observations were completed, it was thought that the findings and safety recommendations were supported by the evidence gathered and analysed by the investigation.

3.1.5 Evidence gathering

Multiple sources of evidence were gathered and reviewed by the investigation, although evidence from primary care and the clinical commissioning group was limited. The evidence gathering process adopted an iterative approach; as further information was gained, additional data sources were identified.

The investigation gathered both interview and focus group data from the healthcare settings, ‘Experts by Experience’, other parents and young people with asthma:

• A semi-structured interview plan was developed to gather information on safety risks, and themes were explored by the investigation.
• A focus group with young people was recruited and facilitated externally, using interactive methods to gather the information, including cloud-based engagement and interaction software, whiteboard, and virtual polls.

Following a discussion with the human factors subject matter advisor and reference to the ‘Defining research table’ and ‘Decision tool’ (Health Research Authority, 2017; 2020), it was determined that the focus group study represented service evaluation and not research. Therefore, ethics approval was not required.

3.1.6 Analysis

The analysis process had the following aims:

• To generate findings, through group discussions after evidence gathering, analysis days, multidisciplinary team, reflections on what evidence was missing or inadequate.
• To develop visualisations of the system involved in the patient’s care pathway and a timeline of the events. This assisted in recognising communications, interactions and decision making.
• To develop a comprehensive understanding of the healthcare system so that recommendations could be identified, and their potential impact on the system could be considered.

These aims were achieved through the application of the following methods.

AcciMap model

The AcciMap model (Svedung and Rasmussen, 2002) was used to analyse the reference event information and support the direction of the national investigation. AcciMap is an incident analysis method that identifies factors within a system that influenced the occurrence of an incident. The analysis focuses on identifying relationships between the different levels of the system (see figure 3), which include government policy and budgeting; regulatory bodies and associations; local area management; physical processes and actor activities (what staff, people, organisations, systems did); and equipment and surroundings (Stanton et al, 2013).

Systems Engineering Initiative for Patient Safety

The investigation used a model called Systems Engineering for Patient Safety (SEIPS) (Holden et al, 2013) to inform the development of interview schedules and examine the safety factors influencing the management of chronic asthma in children. SEIPS provides a human factors framework for understanding the work system (that is, the external environment, organisation, internal environment, tools and technology, tasks, and persons), work processes (including physical, cognitive and social/ behavioural aspects) and outcomes in healthcare and the relationships between these.

3.1.7 Verification of findings

The findings were shared with the healthcare organisations involved in the reference event and with key stakeholders within the healthcare system.

• This enabled checking for factual accuracy and overall sense-checking.
• Stakeholder groups contributed to the verification and design of the improvement recommendations. This was achieved by NHS England and NHS Improvement, NHSX, Health Education England, British Paediatric Respiratory Society, British Thoracic Society and Scottish Intercollegiate Guidelines Network, NHS Digital, Academy of Medical Royal Colleges, Royal College of Nursing, and Public Health England.
• Further verification was achieved through consultation with Asthma UK and the British Lung Foundation.

This section explores the care and treatment of the Child involved in the reference event. Figure 4 provides an overview of the aspects considered, with signposting to the relevant sections.

Diagnosis of suspected asthma

4.1.1 The diagnosis and management of asthma, particularly in children and young people, can be complex, with the potential for significant harm or death as a result of complications. From infancy to teenage years there are age-specific challenges. These challenges include both underdiagnosis (where asthma is present but not diagnosed or treated) and overdiagnosis (where asthma is diagnosed but the patient does not have the condition).

4.1.2 Following discharge from the neonatal unit, the Child involved in the reference event was seen by a consultant neonatologist (a specialist in the care of newborn babies) in a respiratory clinic at Hospital 2. The Child was prescribed salbutamol and beclometasone inhalers (see 1.3.1, table 1) from the age of one year, when his home oxygen was discontinued. These medicines are used to try and increase the size of the breathing tubes by targeting any muscle spasm (with salbutamol) or inflammation (swelling) (with beclometasone). In this case, they were initially prescribed to try and ease the Child’s respiratory symptoms of intermittent wheeze and a cough.

4.1.3 At 20 months of age, the Child was transferred from the care of the consultant neonatologist to the paediatric respiratory team at Hospital 2 (the team specialising in the treatment of children with conditions affecting the airways). He was initially seen by Consultant 1, before Consultant 2 took over his care in July 2016 and Consultant 3 in August 2017 (see table 3).

Figure 4 Overview of section 4

Respiratory outpatients and follow-up

4.1.4 The three different paediatric respiratory consultants each oversaw the Child’s care in the respiratory outpatient clinic for relatively short periods of approximately 12 months. Following an appointment in November 2016, the Child was due to move over to Hospital 3 with paediatric Respiratory Consultant 2, for continuity of care. However, the Child’s Mother did not receive an appointment from Hospital 3, and her perception was that they got lost to follow-up in the administrative system. The Child’s Mother was not contacted by Hospital 2 or Hospital 3 until she made contact to find out whether her son’s care had been transferred. The outcome was that the Child did not attend the respiratory outpatient clinic from November 2016 until August 2017.

4.1.5 Paediatric Respiratory Consultant 3 took over the Child’s care in August 2017 at Hospital 2. The Child had three appointments with this consultant, prior to his asthma attack. The interval between these outpatient appointments should have been three months, but happened at intervals of six, eight and nine months respectively. The investigation was advised that:

“The significance is steroids take about six weeks to work and then you need another three weeks or six weeks to work it out, so clinically the best you can probably do is to see them in six weeks, and then you’ve got colds and coughs and things like that to be challenged, so on average the clinical guesstimate is: I’d like to see you in three months.”

4.1.6 The outpatient appointments were not scheduled for the three-monthly time intervals requested by the respiratory team, due to the demand for appointments within the asthma service exceeding capacity. This led to continual prioritisation of more urgent cases, resulting in appointments not being offered within the requested timeframe.

4.1.7 The investigation was unable to determine what impact an earlier follow-up appointment would have had in preventing the deterioration of the Child’s condition. However, a follow-up after the intended three months would have allowed the clinician to review the Child’s response to medicines (which was often seasonal), and then adjust the dosage and type of medicine, until improvements were seen. A timely follow-up would also have provided the opportunity for the clinician to regularly communicate the adherence messages.

4.1.8 In addition to the appointment issues, a number of discrepancies were identified by the investigation in respect of clinical information recorded following the Child’s outpatient appointments. The hospital letters contained different information from the electronic health record (EHR) on three occasions, resulting in the Mother, the GP practice, and others receiving different information than that recorded in the EHR:

• August 2017: the addition of ‘possible asthma’ was on the diagnosis list in the outpatient letter, but not in the outpatient consultation notes on the EHR (it had been in the EHR six months earlier).
• February 2018: in the outpatient letter it states that the Child continues on beclometasone, whereas the outpatient consultation notes states he was on fluticasone, which paediatric Respiratory Consultant 3 started in August 2017.
• February 2018: the same letter also states that one of the Child’s diagnoses was a chronic wet cough, which is also mentioned in the outpatient consultation notes. However, the content of the letter refers to a dry cough.

4.1.9 Staff told the investigation that the discrepancies may have occurred as a result of the outpatient clinic’s patient record system. An e-note would be updated/constructed ahead of each consultation with any presumed diagnosis and medications. Following the consultation, the letter would be dictated, which was the definitive document at that time point. The ‘present problem’ and the medication fields might not be updated until the following visit, from the content of the letter.

4.1.10 Paediatric Respiratory Consultant 3 told the investigation that the problem list in the letters reflected a continually changing view regarding an evolving condition and complex medical history, for a Child who was under ongoing investigation and treatment.

4.1.11 The lack of timeliness of follow-up appointments and harm caused to patients as a result is outlined in the HSIB national investigation report ‘Lack of timely monitoring of patients with glaucoma’ (Healthcare Safety Investigation Branch, 2020). In addition, a national investigation is in progress relating to the lack of reliability of outpatient booking processes: ‘Outpatient appointments intended but not booked after inpatient stays’ (Healthcare Safety Investigation Branch, 2021).

Community awareness of diagnosis

4.1.12 From the primary care perspective, the GP practice had not recorded the suspected asthma diagnosis on its system and only became aware of this after the asthma attack. The GP practice told the investigation that patients with asthma would be added to a register and invited to attend for an annual review. This group of patients would also have ‘flags’ on their records if there were any unplanned hospital attendances or a high number of inhalers requested. The investigation observed that while there was no flag for asthma on the GP’s IT system on the Child’s record, there was a pop-up when logging into the system stating, ‘please treat as priority’. This was because of his past medical history of prematurity and chronic lung disease.

4.1.13 There were also alerts on the system for the clinical staff denoting the Child’s allergies to bananas and eggs. After the asthma attack in July 2019 an additional alert was added, which contained the contact details for the Paediatric Asthma Clinical Nurse Specialist at Hospital 2.

4.1.14 The investigation reviewed the Child’s community electronic patient record and identified that five emergency department (ED) attendances were recorded by the health visiting team in just under two years, four of which related to respiratory symptoms. Additionally, in May 2016, it is documented that the Child’s Mother reported him ‘to be wheezing a lot more’ and in July 2016, ‘persistent wet cough reported by mum’. There appeared to be no connection made between these events in terms of the frequently reported respiratory symptoms. There were also no referrals to other healthcare professionals or follow-up, and no evidence of a risk assessment. There was no mention of asthma in the community records until after the asthma attack in July 2019.

4.1.15 The Child started school in September 2018. The investigation found no evidence of a formal handover between the health visiting and school nursing teams. The Child had a complex medical history (including chronic lung disease), which did not appear to have been communicated to the school nursing team. The Child was also prescribed inhalers, but there was no specific action plan for inhaler use, including the provision of an emergency inhaler at school.

4.1.16 The investigation was advised that there would have been a verbal handover from the health visitors to the school nurses when the Child started at the school. This process has now been replaced by written communication, and a form has been devised for this purpose.

Overall responsibility for a child’s care

4.2.1 The effectiveness of asthma management is particularly challenging in those patients whose care falls between hospital and general practice, where responsibility for monitoring the condition is not clearly defined.

4.2.2 The Child was mainly seen as an outpatient at Hospital 2. The different specialties involved in his care copied their correspondence to each other, the GP and the Child’s Mother, to provide a shared understanding of the Child’s progress. The investigation identified multiple sources of information regarding the Child’s care with no mechanism to correlate concerns or care issues from the various sources. This resulted in limited alerting to a relevant specialty of a concern that warranted attention.

4.2.3 From an overview of the Child’s medical records across the different specialties, the investigation found a generally improving clinical picture in relation to his various conditions, the exception being his respiratory issues. The ongoing concerns regarding the Child’s respiratory symptoms were potentially lost among the various other information. Without a mechanism for alerting and correlation of findings, these concerns were difficult to identify.

4.2.4 The investigation also found that the Child attended the ED nine times between June 2014 and July 2019. Three of these visits resulted in him being admitted as an inpatient. A review of the reasons for the attendances showed that eight of the nine episodes were associated with respiratory symptoms (including respiratory distress, acute wheeze). The investigation found no evidence from the community records of follow-up by primary or community care after the Child’s emergency attendances. The Quality Statement for Asthma states that patients should be reviewed in primary care within two working days of treatment in hospital for an asthma attack (National Institute for Health and Care Excellence, 2018b). Follow-up provides an opportunity for the correlation of emergency attendances with ongoing planned care.

4.2.5 A patient’s named, accountable GP is generally the clinician with overall responsibility for a patient’s care, as explored further in section 5.2. In the case of the reference event, the Child had a named GP, but continuity was variable from early 2017 due to a period of absence and the subsequent retirement of this GP.

4.2.6 The Child attended the hospital on a regular basis and the GP practice infrequently. There were no face-to-face contacts/appointments recorded on the GP’s consultation record between November 2018 and early July 2019. There was routine hospital outpatient activity to action by the practice and repeat prescriptions to issue, which were tasks carried out by a variety of GPs, dependent on who was the duty doctor.

4.2.7 The investigation found that information was available, but that it was retained in certain areas of the system without mechanisms to ensure it was consistently shared. ‘Distributed situation awareness’ was evident in that information on the Child and his care was held by various people and in various places (Stanton et al, 2015), requiring complex interactions to ensure communication of important aspects pertaining to his care.

4.2.8 In the case of the reference event, it appears that there was no single person in control of the Child’s clinical care and varying perceptions of who was in control, including a perception that the Child’s Mother was responsible. The human factors subject matter advisor (SMA) described the ‘critical nature of a single mind where one member of a team has overall control and, in safety research, with whom ultimate responsibility lies’. The SMA highlighted that ‘where all the parts of a system are designed without knowledge or respect of the overall outcome, or where a system is designed by many different organisations without much knowledge of what the other parties are hoping to achieve’, mechanisms for sharing information and supporting the ‘controlling mind’ will be limited. In the reference event the various elements of the system treating/caring for the Child acted independently and with limited reference to others.

4.2.9 It is evident that care co-ordination would have been beneficial in this complex case to organise the care of a child with a chronic health condition. A care co-ordinator could have supported the family, helping to manage the number of conditions and healthcare interactions (The King’s Fund, 2013).

Sharing clinical information and system interoperability

4.2.10 The communication pathways and interfaces that share clinical information between secondary care and primary care were inconsistent. The GP practice had solely electronic systems in place whereas Hospital 2 had a combination of electronic and paper-based systems.

4.2.11 Outpatient clinic letters were sent electronically from Hospital 2 to the GP practice and transferred into its system. They would be coded by administrative staff to be reviewed by the duty doctor, if there were actions that needed to be carried out. An exception to this was when a patient/family were given an ‘Outpatient medication referral’ form by the hospital, usually for a new medication. If this occurred, the paper form would be handed to the patient/family member and they would be asked to take it into the surgery. Following this, the form would be scanned into the GP’s electronic system and the new medications would be added to the list of repeat medicines, ready for the patient/family member to request.

4.2.12 If there were instructions from the hospital about an existing medication, the information would be contained in the outpatient clinic letter, which was acted upon once received by the GP practice. However, sometimes a new prescription was contained with the clinic letter, rather than the patient being given a form, resulting in dual, overlapping processes. From the perspective of the GP practice, there did not appear to be a consistent process between the hospital and GP practice in relation to prescribing responsibilities.

4.2.13 In relation to communication pathways between primary care and community-based services, local commissioning arrangements and the differing electronic systems in use led to a fragmented system. This resulted in information being held in isolation with suboptimal information transfer between community services (health visiting, school nursing, community pharmacy and the school immunisation programme); the GP practice; and the family (see appendix B).

4.2.14 The transfer of information about the Child was limited by incompatible record systems. This resulted in pockets of information being held in disparate systems with no single system reflecting the complete picture. The investigation was told that community services used a different electronic system to the GP practice, with no interoperability between them (that is, they could not communicate and share information). However, it was ascertained by the investigation that the GP practice should have been able to view the community electronic patient record via the Local Care Record, although the level of awareness of and uptake of this was said to be variable.

4.2.15 Since the evidence relating to information sharing across systems was limited to the reference event scenario, it was not possible for the investigation to issue a safety recommendation. However, the investigation observed that if community and primary care providers review how they access Local Care Records (where systems exist), this may enable a more cohesive approach and informed decision making for their patients.

4.2.16 Additionally, the investigation considers that a review by commissioning organisations of how information is shared between local care providers, may highlight areas for improvement in the facilitation of information transfer, ensuring parents have access to their child’s records/information.

Seasonal flu vaccination

4.2.17 The issue of sharing of clinical information also contributed to the Child not receiving a flu vaccine in the autumn prior to his asthma attack. This was in addition to issues regarding eligibility for an alternative form of the vaccine, as outlined below.

4.2.18 Children of school age are normally given the nasal flu vaccine as part of the national immunisation programme (Public Health England, 2020). When starting school in autumn 2018, the nasal flu vaccine was offered to the Child but declined by the Mother as it contained pork gelatine, which the family do not eat for religious reasons. The only option at this time was for the Child to have the injectable form of the vaccine.

4.2.19 The school nursing service was not commissioned to deliver vaccinations. The contract for this had been awarded to the school immunisation programme in 2015; this was a service provided by a community healthcare trust. Standalone immunisation teams are not connected to school nursing services and do not routinely advise the school nurse on the vaccine uptake.

4.2.20 The immunisation team advised the investigation that GPs receive all the flu vaccine data for children it has vaccinated, but not for those who decline. If parents decline the nasal vaccine, an entry is made on the immunisation team’s IT system. However, this system is not interoperable with the GP’s IT system and therefore the information will not be transferred.

4.2.21 From a review of guidance for the parents of any child at risk from flu because of an underlying medical condition (Public Health England, 2019a), it was apparent that: ‘GP practices should invite these children for vaccination, making it clear to their parents that they have the option to have their child vaccinated in general practice.’

4.2.22 In the reference event, the GP practice first became aware of the Child not receiving the vaccine when his Mother attended the practice in November 2018 requesting a non-porcine (pork-free) gelatine alternative. The GP practice declined to give the injectable form of the vaccine at this point, as the Child was in the school cohort for immunisation. The Child’s Mother was then referred to the school nursing team.

4.2.23 The named nurse for the school spoke to the Child’s Mother and explained that the school vaccination service was provided by a separate community organisation. Following a telephone call between the school nursing team and the immunisation service, the Child’s Mother was advised that the immunisation team did not give the flu vaccination by injection, only by nasal spray. She was provided with the immunisation team’s number to get further information if required and advised to speak to her GP. Since the Child’s Mother had already attended the GP practice for her son to be vaccinated, she did not attend again.

4.2.24 The GP practice carried out a significant event analysis once they were made aware of the hospital admission and the influenza A strain the Child had contracted. One of the learning points from this was that children in a higher risk group were eligible to receive an injectable vaccine as an alternative to the nasal vaccine (Public Health England, 2019a).

4.2.25 Additionally, from November 2020, ‘children whose parents refuse live attenuated influenza vaccine (LAIV) due to the porcine gelatine content may now be offered an inactivated influenza vaccine, subject to availability’ (Public Health England, 2020).

Communication systems in community-based services

4.2.26 The investigation was informed that each GP practice in the region where the reference event occurred had a named health visitor. Regular meetings took place between the GPs and health visitors to discuss the children registered at the practice, particularly where there were specific requirements. The investigation discussed this with the health visiting team but was unable to find evidence from the Child’s community electronic patient record that such a meeting took place.

4.2.27 The investigation was advised that there was a health visitor referral process for children with complex health needs who were attending mainstream schools. If ‘clinically necessary’, a referral could be made to the school nursing service and this would be sent to the ‘Electronic School Nurse Access Point’ for triage and allocation to the nurse attached to the identified school. This did not occur in the reference event.

4.2.28 The investigation was advised that for children with complex health needs, there used to be a verbal handover from the health visitor to the school nursing team as part of school readiness and transition. Integral to this communication with the school nurse would have been a discussion about identified health needs and possible support required from the service. A referral form for transition of a child’s care from the health visitor to the school nurse has since been developed by the school nursing team in an attempt to make the system more robust.

4.2.29 There was no action plan in place for inhaler use prior to the Child’s asthma attack, including the provision of an emergency inhaler at school. An asthma care plan was completed by the hospital’s asthma nurse specialist following the asthma attack, and shared with the school by the Child’s Mother. The school then shared a copy with the school nursing team, which subsequently uploaded it to its electronic records.

Interface with community pharmacy and medicines management

4.2.30 The GP practice was linked electronically to the family’s choice of community pharmacy. This was a local pharmacy, owned by a small independent company. The community pharmacist advised the investigation that he knew the Child and his Mother, but was not aware of his complex medical history or the reasons for the inhalers being prescribed. The community pharmacist recognised he could have played an important role in supporting the Child/his Mother in relation to his suspected asthma condition and medicines.

4.2.31 Pharmacy staff have professional responsibilities under the General Pharmaceutical Council. The Pharmaceutical Services Negotiating Committee (2004) outlines the aims and intended service outcomes, stating there is a requirement for pharmacy staff to provide ‘information and advice to the patient on the safe use of their medicine’ and ‘when appropriate broader advice to the patient on the medicine’.

4.2.32 Hospital 2 told the investigation that it was rare for medicines to be issued by the hospital for patients attending as outpatients, which was in accordance with its regional prescribing policy. This policy stated:

‘When the patient does not require an immediate supply, the patient should be informed that their treatment is not urgent. The clinician must fill out all relevant sections (including diagnosis, allergies, prescribing information and contact details of prescriber) of the Out-Patient Referral form and tick the ‘Non-Urgent’ box ... All relevant information enabling the GP to prescribe, should reach the practice as soon as possible but no longer than 10 working days.’

4.2.33 All of the Child’s ‘repeat’ medicines and new medicines were prescribed by the GP practice. The system relied on the parent taking the hospital prescription to their GP, or the hospital notifying the GP of medication changes in the outpatient letter.

4.2.34 Once requested by the Mother, the prescription would be sent electronically to the community pharmacy, where the medicine would be dispensed and collected. The GP practice said that it did not have an alert system in place to highlight medication not requested, so it was reliant on the patient/family requesting the medication.

4.2.35 The investigation was advised that hospitals can prescribe on ‘FP10 prescription forms’ (which go to a community pharmacy) or via internal prescription forms (which go to a hospital pharmacy). These processes negate the need for GP intervention in respect of prescribing new medicines initiated by secondary care, and are more straightforward for patients/families. In the case of the reference event, if the new medicines been prescribed within the paediatric respiratory outpatient clinic at the Trust, this would have ensured the montelukast was issued.

4.2.36 A GP subject matter advisor told the investigation that there are also no contractual requirements for GP practices to monitor patient adherence with treatment, which includes prescribed medicines. There is however a professional regulatory expectation that prescribers have a duty to ensure that patients with long-term conditions are offered regular reviews, during which their prescribed treatment is discussed. According to ‘Good practice in prescribing and managing medicines and devices’ (General Medical Council, 2013), ‘At each review, you [doctors] should confirm that the patient is taking their medicines as directed, and … should also consider whether requests for repeat prescriptions received earlier or later than expected may indicate poor adherence, leading to inadequate therapy or adverse effects’.

4.2.37 In the reference event, the community pharmacy reported having limited access to the Summary Care Record, which meant it could not see the outcome of hospital changes to prescribing or review patients’ medical histories. The investigation heard that if information uploaded from secondary care to the ‘NHS Spine’ was simultaneously viewable by primary care and community pharmacies, this would improve communication flows between the sectors.

4.2.38 The community pharmacy was not monitoring adherence to medicines administration, as indicated by prescriptions collected. This was because it was not aware of the context due to minimal information being available to it. The investigation heard that if community pharmacists could edit the Summary Care Record, they could upload information such as uncollected prescribed medicines. This is supported by the Royal Pharmaceutical Society (2014), which has a longstanding policy aim of full read/write access to the patient health record in the interest of high-quality, safe and effective, patient care.

Parental education and support

4.3.1 The Child’s Mother was unaware of the suspected asthma diagnosis and was not provided with a personalised asthma action plan (PAAP) until after the asthma attack. Therefore, information about the management of symptoms and treatment to be given was not clearly documented for the Child’s Mother to refer to.

4.3.2 Parental education is provided by various members of the multidisciplinary team, including paediatric asthma clinical nurse specialists (CNSs). However, cover in the outpatient clinic at Hospital 2 was limited at the time of the event, due to capacity and the requirement to cover the inpatient wards and the ED. A fixed commitment to clinic cover was achieved when a second CNS started in post in February 2019.

4.3.3 Following the asthma attack, the Child’s Mother recalls being spoken to about her son’s condition by a paediatric asthma CNS in hospital. A PAAP was also provided. She found this engagement to be helpful and supportive, commenting that the CNS spoke to her in terms that she understood and remembered. One example was being told that if 24 hours of ‘preventer’ inhaler doses were missed, then it could result in the Child’s lungs being unprotected for six weeks. This would subsequently increase the risk of a life-threatening asthma attack.

4.3.4 A Paediatric Respiratory Consultant involved in the Child’s care told the investigation:

“I am pretty sure when I met [the Child’s] mum I said we wouldn’t normally send every single asthmatic through to the asthma nurse even if they were asthmas [had confirmed asthma]. If they knew what they were doing, if they had already got a plan and if it was ‘Please just take the medicines’, then I would not send them through to the asthma nurse.”

4.3.5 Paediatric Respiratory Consultant 3 documented in outpatient correspondence following an appointment in October 2018: ‘Compliance with [ICS inhaler] is not good and I have advised mother to take two puffs twice a day every day.’ This was recorded on the GP system as: ‘Problem: Asthma treatment compliance unsatisfactory’, despite there being no mention of asthma in the outpatient letter. The Mother was invited to attend a GP appointment, but there is no evidence of further exploration of the Child’s suspected asthma following this.

4.3.6 Paediatric Respiratory Consultant 3 reflected on a general perception that inhalers are often not considered to be a medicine, saying:

“People just don’t take it seriously … Because inhalers aren’t medicines really.”

The investigation heard that this perception exacerbates adherence issues since asthma inhalers are not considered to be an essential asthma treatment.

4.3.7 Prior to the asthma attack, the last prescription issued by the GP practice for the Child’s steroid inhaler and salbutamol was in September 2018. The Child’s condition appeared to be stable from a respiratory perspective, with the transition to school being unremarkable, apart from the flu vaccine issue. The Child’s Mother appeared not to appreciate how the medication influenced health as a prophylactic agent (a preventative treatment), which is a wider issue than the reference event (see section 5).

Monitoring parental adherence to asthma medicines

4.3.8 Throughout the Child’s first five years of life, different treatment regimens were tried by the paediatric respiratory consultants who saw the Child in the hospital outpatient clinic (see table 3).

4.3.9 The GP prescribed the asthma medicines initiated by Hospital 2, following which they would be added to the list of ‘repeat’ medicines, ready for the Child’s Mother to request. If no request was received, the medicines would not be issued. The investigation heard from the Child’s Mother that she did not regularly request the asthma medicines, as she was unaware of the suspected asthma diagnosis and the importance of regularly giving her son the preventative treatment every day as prescribed. The investigation found that there was also no mechanism to highlight to the GP when the Child’s medicines were not being requested.

4.3.10 The variable adherence to administering the corticosteroids resulted in no therapeutic change and meant that an asthma diagnosis could not be made or excluded. Paediatric Respiratory Consultant 3 attempted to mitigate this risk by prescribing a medicine to be taken by mouth (montelukast granules/tablets) in an attempt to improve medicines adherence and emphasised to the Child’s Mother the importance of giving it.

4.3.11 Paediatric Respiratory Consultant 3 told the investigation that prescribing data became available to Hospital 2 via the electronic health record (EHR) in late 2018 or early 2019. The system enabled the hospital clinician to view which medicines had been issued, in addition to past medication, repeat medication and medication not yet issued. This provided an indirect way of monitoring adherence to treatment plans, particularly in respect of those patients/families who were finding this a challenge.

4.3.12 Paediatric Respiratory Consultant 3 considered that this provided a more robust way of monitoring medicines adherence as he would not have received similar information from the hospital pharmacy at Hospital 2. He said:

“So one of the massive enhancements in my practice here is round about 30 to 40% of GP practices I can see the GP prescribing, and I can see, like this morning, someone who, instead of picking up their inhaled steroids every two months, was picking it up every four months and they then admitted they were only taking it once a day.”

4.3.13 From a primary care perspective, detailed medication histories could be obtained from the GP practice’s electronic patient record system and compliance data used to monitor adherence to treatment. One example shared with the investigation was for fluticasone. In September 2018, ‘current usage was recorded as 23% and average usage as 29%’. These figures were calculated automatically by a formula within the electronic patient record system and include an average usage over the last six issues of the medication. A low percentage would indicate suboptimal adherence to treatment. When asked, none of the clinicians seemed aware of the figures or were able to explain how they were derived. It is not known if, or how, this information was used in the Child’s case.

4.3.14 There are no contractual requirements for GP practices to actively monitor their patients’ adherence with prescribed medicines, only to ‘order’ it, thus ‘making available such treatment’ (British Medical Association and NHS England, 2020). Additionally, even with a system of monitoring in place, the final responsibility/choice lies with the patient.

This section explores at a national level the factors relating to formally diagnosing asthma, systems of oversight, mechanisms of sharing clinical information and adherence to treatment. Figure 5 provides an overview of areas explored as part of the national investigation, with signposting to relevant sections.

5.1.1 Analysis of the reference event has highlighted some of the risks associated with the absence of a formal asthma diagnosis in children under the age of five years. In accordance with British Thoracic Society and Scottish Intercollegiate Guidelines Network (2019), the inclusion of the term ‘suspected or possible asthma’ should be used when asthma is being considered as a possible diagnosis, but no formal diagnosis has been made. The Child’s Mother could not recall being informed of the suspected diagnosis during the Child’s respiratory outpatient appointments. Additionally, the investigation only found one reference to ‘possible asthma’ in an outpatient clinic letter sent to the GP in 2017, and copied to the family.

5.1.2 On the ‘Diagnosis/problem list’ of the Child’s hospital records, there was the inclusion of ‘possible asthma’ in 2017. Additionally, on the ‘Outpatient Consultation record’ completed following an appointment in February 2018, ‘Asthma’ was recorded at the top of the ‘Diagnosis’ section, with the diagnosis date unspecified. However, there was no further mention of asthma in the hospital records until the Child’s asthma attack in July 2019.

5.1.3 In children under the age of five years, a diagnosis of asthma is based on symptoms and the response to treatment, because of the difficulties in carrying out testing for asthma in this age group. In cases where there is insufficient evidence to formally diagnose asthma, a monitored initiation of treatment (such as inhaled corticosteroids (ICS)) is prescribed for six to eight weeks. Following this, if there is evidence of clinical improvement in terms of symptom control, the treatment plan will be continued and a formal diagnosis of asthma given. The aim of treatment is to control day-to-day symptoms so that the child’s sleep and play is not affected and also to prevent asthma attacks.

5.1.4 The investigation was advised that in the reference event, the Child’s diagnosis of asthma could not be formalised in accordance with the 2016 guidance. This was due to the limited number of symptoms; the inability to perform lung function tests (due to his age); and the previous history of chronic lung disease.

5.1.5 Paediatric Respiratory Consultant 3, who saw the Child in the paediatric respiratory outpatient clinic at Hospital 2, decided to opt for the monitored initiation of treatment approach. However, it was difficult to assess the Child’s response to treatment because of adherence to medicine issues (see 4.3) and outpatient appointments not being booked in accordance with the intended plan (see 4.1.4 to 4.1.7).

5.1.6 There are no reliable, evidence-based biomarkers (indicators) for the accurate diagnosis of asthma in children or for monitoring the response to treatment (Lenney et al, 2018). Management of the condition ‘focuses on reducing exposure to known triggers if possible, relief of symptoms if there is airway narrowing, and reduction in airway inflammation by regular preventive treatment’ (National Institute for Health and Care Excellence, 2020a).

5.1.7 There are age-specific challenges in diagnosing asthma in children aged 16 years and under, including underdiagnosis and overdiagnosis (Lenney et al, 2018). Accurately diagnosing asthma may be a complex, gradual process over time, particularly in the under-five age group. This is supported by evidence from the Experts by Experience (EbEs) (see figure 6).

5.1.8 Children may show signs of the first symptoms of asthma during the pre-school age period, during which time they may be given a diagnosis of ‘suspected’ asthma. According to the National Institute for Health and Care Excellence (2020a),

‘Suspected asthma describes a potential diagnosis of asthma based on symptoms and response to treatment that has not yet been confirmed with objective tests’.

Figure 6 ‘Experts by Experience’ findings: difficulty in diagnosing asthma

5.1.9 In the case of the reference event, it was evident there needed to be awareness of the Child’s suspected asthma diagnosis, from the parent’s perspective and other care sectors, to facilitate implementation of the Child’s treatment plan.

5.1.10 According to Charlton et al (1991), ‘while labelling a child as ‘asthmatic’ cannot reduce morbidity’, assigning the diagnosis leads to improved care. This is in relation to attention being given to inhaler technique; proactive follow-up by the nurse or doctor; the development of self-management skills; and better explanation to parents.

5.1.11 For children under five with suspected asthma, it is recommended to ‘treat symptoms based on observation and clinical judgement, and review the child on a regular basis. If they still have symptoms when they reach 5 years, carry out objective tests’ (cited in National Institute for Health and Care Excellence, 2020a).

5.1.12 Evidence from the literature, EbEs, a subject matter advisor and clinical staff throughout the investigation, has demonstrated the negative implications of not having a suspected diagnosis of asthma communicated, recorded or coded.

Pre-school wheeze action plan

5.1.13 The investigation was advised that many children have at least one episode of wheezing associated with a viral infection before the age of five years. Some will grow out of this tendency, but for a smaller number of children, it is their first presentation of what will go on to be asthma. The management of the individual episodes is very similar to an acute asthma attack, and frequent episodes may be treated with ICS. A doctor with a specialist interest in asthma told the investigation that ‘children with recurrent episodes of wheezing should be referred to a paediatric respiratory consultant to consider asthma and other diagnoses’.

5.1.14 The investigation was advised that in the case of pre-school wheeze, the clinician will want to determine whether the child has the sort of inflammation (eosinophilic) that responds to ICS. This type of objective evidence is needed to support a diagnosis and is more meaningful than trying to determine whether it is asthma or not.

5.1.15 O’Leary et al (2016) recommend the provision of an asthma action plan (see figure 7) to children with a pre-school wheeze, acknowledging that the majority will not develop chronic asthma. The study outlines how the asthma action plan was integrated into the patient’s electronic health record, with a paper copy given to the family for use at home and to share with the GP and school. This correlates with the Global Initiative for Asthma (2020) which advocates good communication and partnership with the patient/family.

Figure 7a Pre-school action plan (developed by Queensland Government and cited by O’Leary et al (2016)

5.1.16 Similarly, the paediatric SMA told the investigation that an information and management plan should be given to the parents/carers of pre-school children with a wheeze. This would include those children who have viral-induced wheeze, whose diagnosis cannot be ascertained by objective testing. This would enable the patient/parents to be involved and educated about symptoms to be aware of and actions to take, including the administration of ‘rescue’ treatment.

5.1.17 In the paediatric SMA’s experience, the use of a pre-school action plan has been hugely welcomed by families, who really appreciate some guidance on how to manage the episodes. When the SMA has undertaken training sessions with GPs, they also welcome the action plan as a concept and are in agreement about using it. Generally, offering a tool that GPs can give to patients to empower them to manage their condition themselves is well received.

5.1.18 Returning to the reference event, the Child’s Mother could not recall how much of the salbutamol inhaler to give her son when “rescue breaths” were required and was worried about giving him an overdose. An action plan would have assisted her at this point by providing guidance on treatment and the action required.

5.1.19 Evidence from the reference event, SMA and literature suggest that action plans are beneficial for parents and carers of pre-school children with a wheeze but no formal diagnosis of asthma.

Diagnosis of asthma in children

5.1.20 In children aged five and over, who are able to undertake objective testing, this provides a more reliable means of diagnosing asthma more effectively. However, there is currently no single test available to diagnose asthma (National Institute for Health and Care Excellence, 2020a). Diagnosis is based on a comprehensive history taken by a clinician and the patient’s response to treatment trials. Results of tests are not based on the patient’s symptoms, but on measurements of their lung function or evidence of inflammation.

5.1.21 The investigation heard that asthma meant different things to the young people who were involved in the focus group – they used multiple different words to sum up what it meant to them (see figure 8).

5.1.22 In all age groups, the National Review of Asthma Deaths (NRAD) (Royal College of Physicians, 2014) identified issues in primary and secondary care. These included the diagnosis of asthma; the identification of risk factors; and the failure to provide care to a satisfactory standard (Levy and Winter, 2015).

5.1.23 In relation to the identification of risk, the investigation heard that severity of asthma is defined by the amount of medication required to achieve symptom control. The NRAD review reported that 42% of children and young people who died were classified as having mild or moderate asthma, but were in fact suffering from poorly controlled, undertreated asthma. This highlights the challenges of attempting to grade risk in a highly variable condition (Levy and Winter, 2015). This was supported by evidence from the EbEs who spoke to the investigation (see figure 9).

Figure 9 ‘Experts by Experience’ findings: perceptions of asthma and seriousness of the condition

5.1.24 While NRAD focused on asthma deaths, its findings indicated that a different, more effective and integrated approach to asthma care delivery was needed. There were 19 recommendations made following the review, which attempted to address the issues identified. However, only one has been nationally implemented, which relates to the establishment of the National Asthma and COPD (chronic obstructive pulmonary disease) Audit Programme (Royal College of Physicians, 2018.

5.1.25 The investigation has reviewed in detail the key findings from NRAD; the following findings in table 4 are relevant to the reference event.

5.1.26 The NHS Long Term Plan outlined a clear aim to ‘improve asthma diagnosis and has … set up a database to understand the causes of harm to young people’ (British Medical Association, 2019). Arising from the ambitions outlined in the plan, NHS England and NHS Improvement has established a programme of work. The purpose is to improve the accuracy of diagnosis for children and young people with asthma, supporting the healthcare system to better manage their asthma. The programme aims to help children and families to control and reduce the risk of asthma attacks to prevent avoidable deaths.

5.1.27 NHS England and NHS Improvement has been working with key stakeholders across the system, including young people and their families, to develop improvements for each of the following components:

• environmental impacts
• early and accurate diagnosis
• effective preventative medication
• management of asthma attacks
• severe asthma.

5.1.28 One of the programme’s workstreams will be reviewing the outstanding NRAD recommendations, with a view to prioritising and implementing them. Evidence from the HSIB investigation correlates with the national programme of work.

NHS 111 and respiratory failure in a child

5.1.29 In the reference event, when the Child’s Mother telephoned NHS 111, the ‘NHS Pathway’ selected by the call handler was ‘Breathing Problems, Breathlessness or Wheeze’. A series of questions was asked by the call handler and responded to by the Child’s Mother. ‘Breathing harder or faster when doing nothing was described’ and a previous, similar episode requiring hospital admission was noted, although the symptoms were not said to have been as severe as those previously, requiring hospital admission. Finally, it was noted that the ‘The breathing had worsened in the previous hour’ and then the assessment ended, because transfer to a clinician was required.

5.1.30 In relation to prompts for chest recession (see 1.1.5), the supporting information in the NHS Pathway for children aged one to five years included, ‘The chest and upper tummy will look like they are being sucked in with every breath’ and ‘The head may bob up and down with the effort’ (see appendix A). These prompts were not part of the supporting information for the over five age group, so were not used for the Child in the reference event.

5.1.31 During the clinician’s assessment, it was noted that the Child’s respiratory rate was 47 breaths per minute. The investigation was unable to determine what information was available to support the clinician’s decision making. However, when an audit of the clinician’s call was carried out, it was evident that the ‘Traffic light system for identifying the risk of serious illness’ (National Institute for Health and Care Excellence, 2019) was used. This refers to a respiratory rate of more than 40 breaths per minute as an ‘amber’ risk for children over 12 months of age.

5.1.32 The British Thoracic Society and the Scottish Intercollegiate Guidelines Network advised the investigation that the view of their expert was that a respiratory rate of 47 breaths per minute in a child aged five years was a significant warning sign that they had a severe acute respiratory illness meriting urgent assessment.

5.1.33 The NHS 111 clinician’s documentation also indicated ‘increase WOB [work of breathing] – mum describes subcostal and suprasternal recession [indrawing in the chest and neck region – see 1.1.5]’. The investigation was advised by a consultant in paediatrics that recession is more easily identified in young children, and progressively more respiratory effort is required in older children to create the same amount of recession. This view was supported by the paediatric subject matter advisor (SMA). Therefore, if identified, recession in older children reflects a much greater respiratory effort than if seen in younger children. So, while recession is unusual in older age groups, the investigation was told that its presence was more significant than in younger age groups and should be considered during assessment and categorisation.

5.1.34 The paediatric SMA also advised the investigation that assessing for the presence of recession and the reporting of this symptom is included in the book ‘Advanced Paediatric Life Support’ (Advanced Life Support Group, 2016). Specifically, this publication refers to chest recession in older children being an indication of severe respiratory distress.

5.1.35 The Child’s Mother shared with the investigation the personalised asthma action plan (PAAP) that she had been given by Hospital 2, subsequent to the near-fatal asthma attack. Within this plan were the Mother’s handwritten notes outlining the information she should give to the call handler if phoning NHS 111 or 999 in the future, to ensure that her son received a higher-level response. This included the near-fatal asthma attack, his previous admission to the paediatric intensive care unit and the extracorporeal membrane oxygenation (ECMO) treatment.

5.1.36 Based on the evidence, the investigation found that when triaging the breathless child aged 16 years and under, the supporting information needed to be reviewed to support identification of children with life-threatening breathing difficulties. As a result, and following discussions with NHS Digital, it was identified that the supporting information for triaging the breathless child up to 16 years of age, needed to be reviewed.

Guidance to support asthma diagnosis and management

5.1.37 Levy and Winter (2015) highlighted that ‘Despite the development and publication of evidence-based asthma guidelines nearly three decades ago, potentially preventable factors are repeatedly identified in studies of the care provided for patients who die from asthma’.

5.1.38 There are two national asthma guidelines currently in place in the UK, produced by the National Institute for Health and Care Excellence (2020a) and British Thoracic Society and Scottish Intercollegiate Guidelines Network (2019). The investigation was advised that the existence of two national guidelines can cause confusion in clinical practice, since they differ in their approach to diagnosis and management. However, it is anticipated that these issues will be alleviated by a new ‘Joint guideline for the diagnosis, monitoring and management of chronic asthma’ (National Institute for Health and Care Excellence, British Thoracic Society and Scottish Intercollegiate Guidelines Network, 2021).

5.1.39 It has been acknowledged that new thinking is needed to enable substantial improvements in asthma diagnosis and management (Lenney et al, 2018). Szefler et al (2020) suggested that guidelines ‘need supplementing by government support, changes in policy, access to diagnosis and effective therapy for all children, with research to improve implementation’. The authors commented that community involvement was considered to be crucial, along with the development of asthma champions and educational tools.

5.1.40 An example of a successful co-development process is the London Children and Young People Asthma Standards. This initiative involved local government, health organisations, professional societies and non-governmental organisations, following which the standards were adapted and integrated into a comprehensive plan at a local level.

5.1.41 The paediatric SMA advised the investigation of an example of an initiative arising from guidelines published by the National Institute for Health and Care Excellence (NICE), (2017). These guidelines focus on the diagnosis and management of patients with mild to moderate asthma, and are targeted more towards primary care. However, primary care practitioners were unable to follow the recommendations in full as NICE was advocating the use of objective tests such as ‘spirometry’, which requires specialist equipment and training to enable staff to safely use the equipment and interpret the results.

5.1.42 The paediatric SMA told the investigation that the concept of diagnostic hubs arose from this identified limitation in resource. The intention was that each primary care network would have a small number of trained healthcare professionals and the equipment required to serve all the patients in the primary care network.

5.1.43 A Consultant Respiratory Paediatrician in northwest England told the investigation that his region was planning to set up a diagnostic hub. He described the requirement for integrated models of care, to prevent children from falling into a void between hospital and general practice. The investigation heard that the interface between the two care sectors provided an opportunity to optimise care.

5.1.44 A further example of an integrated model of care was provided by a trust in northeast England, which had collaborated with the local Academic Health Science Network to set up a pilot in primary care called ‘BeatAsthma+’. The investigation met with members of the project team and heard how a triage tool is used to identify those children more at risk of poor outcomes. This then automatically streams them into a pathway for assessment, testing and follow-up. The pathway begins with a visit to a diagnostic hub where a trained nurse ensures the correct diagnosis using a digital template and objective testing, if required. Following this, the child will have subsequent appointments at their local surgery with a practice nurse trained to provide paediatric asthma care.

5.1.45 The evidence provided in the literature, by regional contacts and by advisors to the investigation demonstrates the potential benefit of diagnostic asthma hubs.

5.2.1 All registered patients have a named accountable GP, whose role is predominately oversight. It reassures patients they have one GP who is responsible for their care. The British Medical Association (2020) outlines one of the responsibilities of named GPs:

‘The named GP works with relevant health and social care professionals to deliver a multi-disciplinary care package that meets the needs of the patient.’

5.2.2 The investigation was advised that while patients have a named GP on their records, reviews of long-term conditions are often undertaken by other members of the multidisciplinary team (MDT). In terms of appointments, patients can choose who they see, often not choosing their named GP, but other GPs or members of the allied healthcare team within the practice.

5.2.3 Care for children with asthma in primary care is often limited to the tasks set out in the Quality and Outcomes Framework (QOF) (NHS England, 2019a) to provide data to qualify for payments. The QOF requires information to be collected on the percentage of patients with asthma on the GP register who have had an asthma review in the preceding 12 months.

5.2.4 Evidence suggests the challenges in terms of asthma management in children include the lack of capacity, accessibility and paediatric expertise of GPs (Nuffield Trust, 2017). Consequently, there is significant variation across the UK in almost every facet of asthma care delivery (Public Health England, 2019b). There are also potential inadequacies in the level of care and support children and young people are receiving outside the emergency hospital setting (Nuffield Trust, 2017). One example is that follow-up after emergency care is still being missed. This is significant since one in six people who have emergency treatment for their asthma have another asthma attack within the following two weeks (Asthma UK, 2018).

5.2.5 The Quality Statement for Asthma (National Institute for Health and Care Excellence, 2018b) states that patients should be reviewed in primary care within two working days of treatment in hospital for an asthma attack. The post-attack review is intended to determine (i) whether the attack has resolved; (ii) the reasons for the attack; and (iii) to optimise therapy including correcting inhaler technique or providing a different type of inhaler, and the modification or provision of a personalised asthma action plan (PAAP). The post-attack review also provides an opportunity to explain the rationale for ICS treatment and the risks of over-reliance on short-acting beta agonists (SABAs).

5.2.6 A further example of suboptimal asthma management relates to the monitoring of SABA usage. Disparity has been identified in the definition of acceptable SABA use, ranging from 0.5 to 12 SABA inhalers per year, and complacency in the perception that over-use did not represent a marker for risk of asthma death (McKibben et al, 2018). Patients with well-controlled asthma should not need reliever therapy (SABA) more than twice weekly (Global Initiative for Asthma, 2020), and the use of three or more SABA inhalers per year is an indicator of a dose-dependent trend (Nwaru et al, 2020).

5.2.7 However, this is challenging to monitor as there is limited availability of population-based data on use, risk factors and the impact of long-term SABA use on asthma attacks and death. The deficiency of data is a global issue and prompted the initiation of the SABINA (SABA use IN Asthma) programme (Nwaru et al, 2020) which aims to describe asthma medication prescription patterns, the extent of SABA over-prescription and its impact on healthcare resource utilisation. This is being undertaken via a series of observational studies in more than 25 countries.

5.2.8 In terms of UK-based initiatives, the investigation was told about an electronic paediatric emergency asthma assessment tool, which automatically identifies all children presenting to an emergency department (ED) who are at increased risk of adverse asthma outcomes. This tool identifies children by a single positive response to one of 4 key questions in the previous 12 months – that is, whether they have had:

• two or more courses of oral steroids
• an inpatient stay
• two or more asthma attendances at ED
• six or more salbutamol inhalers.

In addition to the 48-hour review by a GP, children are offered a follow-up at a nurse led clinic, for a review and education. Annual data has shown a 71% reduction in emergency admissions of children with asthma.

5.2.9 The investigation met with a group of GPs from a health group in the northeast of England consisting of a number of surgeries. The GPs had undertaken training on various aspects of asthma, including techniques and devices, but they reflected that there were gaps. The GPs highlighted that the education of patients/families takes more time than the standard 12-minute consultation allows, reflecting that nurses and pharmacists were perhaps in a better position to provide more in-depth education to patients. This interaction with the GPs identified a need for consultation aids, to communicate asthma and asthma treatment in a way that both motivates the patient/carer and enables optimal self-management.

5.2.10 The EbEs told the investigation about their experiences regarding communication between the care sectors and the oversight of their child (see figure 10).

5.2.11 It has been suggested that new models of care need to be developed to meet the needs of children with asthma. This includes the development of asthma outreach services staffed by specialist MDTs in the community (Levy and Winter, 2015). Child health GP hubs have also been proposed, involving paediatric consultants and other child health experts, in addition to training programmes for GPs (Nuffield Trust, 2017).

5.2.12 A review of these new care models highlighted common principles, which include:

• understanding the general and specific needs of children, young people and their families, and organising care to meet these needs
• strengthening early and easy access to appropriate expert paediatric/child health assessment in the community
• linking up information, data, communication, and care
• improving the health literacy [1] and education of families as well as professionals.

5.2.13 In Finland, a 10-year asthma programme instituted a national network of asthma-responsible professionals, resulting in a dramatic reduction in illness and deaths from asthma (Haahtela et al, 2006). The Finnish Lung Health Association rolled out education campaigns, focusing particularly on primary care. It trained nurses, GPs and pharmacists to act as local asthma champions and to help compile data on the condition. A network of specialists was set up, linking respiratory physicians with primary care and pharmacies.

5.2.14 The investigation was advised that the ever-increasing number of chronic diseases that primary care is tasked with targeting often means that paediatric asthma is not prioritised. In addition, the previous overdiagnosis of paediatric asthma has led to uncertainty regarding the condition. This is compounded by a lack of resources and training for the healthcare professionals tasked with caring for children with asthma.

Figure 10 ‘Experts by Experience’ findings: communication pathways and oversight of care

5.2.15 As cited by Szefler et al (2020), collaborative care includes training and support for primary care clinicians/nurses from hospital paediatric specialists, including joint consultations, case discussions, and tailored education. A Paediatric Asthma Clinical Nurse specialist at the reference event Trust told the investigation that part of her role was to educate families and community-based teams in relation to asthma management.

5.2.16 The paediatric SMA advised the investigation that standardising resources and the approach to asthma management across the country would contribute to patients receiving high-quality care that meets all national recommendations, wherever they go to get it. An example is Beat Asthma (2020) which is a set of online resources aimed separately at primary care, secondary care, schools, families and young people. Its overarching aim is centred on ‘working together to change the lives of children and young people with asthma’. The intention of this resource is for children to receive the same high-quality treatment wherever they receive the care (ED, walk-in centre, GP, hospital or school), so empowering children/families to take control of their asthma.

5.2.17 Another regional example of such a model is London’s ambitions for asthma care for children and young people (Healthy London Partnership, 2016), which has developed standards to validate, challenge and quality assure services. The aim is for each organisation (primary, community, acute care, pharmacy, schools) to have a named lead to be responsible and accountable for asthma and the delivery of proactive, accessible and co-ordinated care.

5.2.18 The investigation has identified from evidence gathered from the literature, EbEs and other advisors that training provision for community-based healthcare professionals caring for children with asthma needs to be strengthened.

Use of electronic systems to improve patient safety

5.3.1 Coroners’ Prevention of Future Deaths reports covering different care sectors highlighted recurring issues across the healthcare system, including a lack of co-ordination of records and care across primary and secondary care. As an example, a child aged 13 had a fatal asthma attack in 2014 (Senior Coroner, Gateshead and South Tyneside, 2015). She was seen by medical professionals 47 times in the last four years of her life. Linking these records could have allowed her doctors to better understand her medical history, to treat her differently and perhaps prevent her death.

5.3.2 Asthma UK (2018) highlighted issues with data sharing and data linkage between primary and secondary care, which it states are key in preventing asthma attacks and keeping people with asthma out of hospital. This is supported by Levy et al (2018) who state that linking electronic hospital discharge, ED attendances, and out-of-hours data with the primary care patient record would support a seamless transfer of patient care from secondary to primary care.

5.3.3 NHSX set a target for all 42 local systems/integrated care systems (healthcare systems) to have shared records in place by September 2021, in accordance with the ‘Core information standard’ (Professional Record Standards Body, 2020). The aim is to ensure patient data can flow between care settings. This will be enabled through the Local Health and Care Record Exemplar, which is a regional collaboration across health, care, and local authorities to develop shared health and care records.

5.3.4 One of the objectives of the Digital Child Health Programme (NHS Digital, 2020) relates to improvements for services delivering the Healthy Child Programme (Department of Health, 2009). The plan is to ‘improve the efficiency of information exchange between health visiting, primary care and school nursing, leading to more timely and comprehensive information on a child’s health available to professionals, potentially leading to better decision support and improved outcomes for children’.

5.3.5 The investigation engaged with a clinical informatician and former GP to discuss the Great North Care Record (n.d.) as an example of an effective way of sharing patient information with health and care teams. The Great North Care Record is a patient record initiative covering 3.6 million people living in Cumbria and northeast England. It allows information such as diagnoses, hospital admissions and treatments to be shared with the different healthcare services involved in a patient’s care.

5.3.6 A previous HSIB report, ‘Electronic prescribing and medicines administration systems and safe discharge’ (Healthcare Safety Investigation Branch, 2019), discusses interoperability of patient record systems in greater detail.

Identification of patients at risk

5.3.7 According to Levy and Winter (2015), one of the measures that could make a significant difference if introduced across the UK is the use of ‘informatics’. They suggest that software providers should be commissioned to provide high-risk alerts for patients prescribed excessive SABAs; insufficient ICS; and with other factors known to increase the likelihood of future asthma attacks, such as an emergency admission to hospital. The article refers to risk algorithms linked to decision support software for identifying patients with these risk factors to prevent adverse outcomes. The rationale for this is outlined by Levy et al (2018), who state that ‘An asthma attack or exacerbation signals treatment failure. Most attacks are preventable and failure to recognise risks of asthma attacks are well recognised as risk factors for future attacks and even death’.

5.3.8 Asthma UK (2016) supported the use of automatic alerts being sent to GPs if their patient had been admitted to the ED following an attack, so they were notified and a follow-up appointment booked within 48 hours. However, the annual survey undertaken by Asthma UK (Asthma UK, 2020a) identified that issues with data-sharing across the NHS means that this is not happening.

5.3.9 An audit by Levy et al (2018) identified that clinicians should focus learning on patients who have had asthma attacks and utilise these events as a catalyst for active reflection, in particular on modifiable risk factors. This audit found that the identification of such patients at risk could be improved using technology. One of the recommendations by the National Review of Asthma Deaths was to encourage general practice software companies to develop systems for identifying patients at risk, particularly regarding prescribing issues. However, this has not been implemented.

5.3.10 The National Institute for Health and Care Excellence (2017) introduces risk stratification (assigning a risk status) as a means of categorising people with asthma by their relative likelihood of experiencing negative clinical outcomes (for example, severe attacks or hospitalisations). Factors including nonadherence to asthma medicines, psychosocial problems and repeated episodes of unscheduled care can be used to guide the assigning of risk. Once the population is risk assessed, the delivery of care can be targeted to improve the care of those with the highest risk factors.

5.3.11 A risk assessment based approach is centred on the availability of data to highlight to healthcare professionals that a patient’s asthma needs to be reviewed (Asthma UK, 2020b). Some local health economies are developing data-sharing agreements across their local systems/integrated care systems to develop condition-specific dashboards that collate all data held locally in one place.

5.3.12 The North West London Local System developed a risk stratification platform in 2017, called the Asthma Radar. This presents asthma risk factors in a single dashboard with data integrated from primary, community, secondary and social care sectors.

5.3.13 The Asthma Radar dashboard ranks all asthma patients according to their aggregate score of all asthma risk factors. These risk factors include the number of hospital attendances, asthma attacks and prescriptions, asthma care and the patients’ overall long-term asthma control. The dashboard works on a numbering and traffic light system. It enables clinicians to sort patients by a number of parameters, including the number of red flags, number of risk factors, number of asthma attacks and patient age, to assess overall risk and prioritise care.

5.3.14 There is a requirement to better understand risk factors present in the community, by identifying the data that needs to be integrated into unified information technology systems, for example, number of hospital attendances, asthma attacks and prescriptions. To progress this initiative, a prioritised list is required of the data flows that need to be enabled.

5.3.15 The Digital Child Health Programme (NHS Digital, 2020) aims to provide interoperability for digital personal child health records to supplement or replace paper ‘redbooks’, making it easier for families to hold online records for their children and access them via smartphones, laptops, and tablets.

5.3.16 The investigation was told that while the revised operational roadmap for this work is not yet fully matured, it is evident that the current work is seen as the first part of a record that will be in existence throughout a person’s life. Asthma is a condition that will need specialised platforms/products to support children and young people to achieve optimal control. In order to develop supporting digital systems, there needs to be prioritisation in place and appropriate commissioning. Therefore, once the initial discovery work has been undertaken to capture the scope; this will inform the prioritisation and commissioning work to deliver it.

Understanding adherence to medicines issues

5.4.1 The National Institute for Health and Care Excellence (2018b) states that ‘Adherence to regular treatment reduces the risk of significant asthma attacks in most people with asthma’. At the time of the reference event, the regular treatment prescribed for many patients comprised daily maintenance with anti-inflammatory inhaled corticosteroid (ICS). This would often be coupled with a SABA prescribed on an ‘as needed’ basis for the relief of symptoms.

5.4.2 For patients over the age of 12 years, the new recommendations outlined in the Global Initiative for Asthma (2020) guidelines represent a paradigm shift in asthma treatment for patients. These recommendations are founded on an understanding of asthma as an inflammatory disease and the need to ensure that ICS treatments take ‘centre stage’ for the prevention and control of asthma symptoms/attacks (Nwaru et al, 2020).

5.4.3 Changes to asthma treatment are required to address nonadherence to ICS, which remains a significant and prevalent barrier to effective control in children (and adults). A commonly observed pattern is the use of medication only when symptoms occur, and avoidance of treatment when it is perceived to be unnecessary (O’Byrne et al, 2017). This is supported by Burgess et al (2008) who state that often, parents or children have great difficulty adhering to twice-daily treatment during long asymptomatic periods, and either use ICS sparingly or interrupt treatment altogether.

5.4.4 Several studies confirm that when symptoms worsen, most patients increase SABA use to quickly relieve asthma symptoms (O’Byrne et al, 2017). This symptomatic treatment is important for managing asthma attacks in the short term. However, continued use of SABA as ‘rescue’ treatment when symptoms do not ease, or the over-reliance on SABA, can result in the patient not receiving appropriate anti-inflammatory treatment (Nwaru et al, 2020).

5.4.5 More frequent SABA inhaler use is also associated with a higher risk of future asthma attacks, hospital admission and increased levels of airway inflammation. A correlation has also been found between increased SABA use and asthma deaths because these inhalers are used preferentially by patients rather than regular ICS (Martin and Harrison, 2019).

5.4.6 Chapman et al (2017) state that nonadherence to daily maintenance ICS is for many patients an understandable, ‘common-sense’ response based on their beliefs about asthma and asthma treatment. Daily treatment may seem unnecessary with the absence of symptoms and concerns about steroids are common and often unfounded (Fitzgerald et al, 2017). Likewise, the rapid symptom relief that can be experienced with SABA convinces may patients that this is the most important aspect of their treatment and that continued use is necessary even when asthma symptoms are not relieved. Moreover, patient concerns about SABA seem to be less prevalent than concerns about ICS (Bloom et al, 2020).

5.4.7 It is evident that the reasons for nonadherence to ICS are complex and vary between patients. They can be best understood by applying the ‘Perceptions and Practicalities Approach’ (Horne et al, 2019), adopted in the NICE medicines adherence guidelines (National Institute for Health and Care Excellence, 2009). This approach recognises that adherence is variable behaviour and adherence rates vary not just between people, but within the same individual over time and across treatments. Nonadherence can be understood in terms of the interaction between the person and the particular disease/treatment. It is determined by the perceptions and practicalities influencing patients’ (and parental) motivation, and the ability to adhere to the recommendations (Horne et al, 2019).

5.4.8 Although practical issues such as difficulties with inhaler techniques are an important barrier to adherence, research suggests that patients’ perceptions of asthma and its treatment are the key factors (Bidad et al, 2018).

Nonadherence: an understandable response to common beliefs about asthma and asthma treatment

5.4.9 Research across long-term conditions including asthma suggests that how a person evaluates and subsequently uses medicines is influenced by ‘how they judge their personal need for the treatment (necessity beliefs) relative to their concerns about the potential negative consequences of taking it’ (Horne et al, 2013). The ‘Necessity Concerns Framework’ (Horne et al, 2013) (see figure 11) can aid understanding of patients’ and parents’ perspectives of asthma treatment and how beliefs influence adherence.

5.4.10 Patients’ treatment necessity beliefs and concerns are influenced by their perceptions of asthma (Bidad et al, 2018) and by social and cultural factors (De Simoni et al, 2017). How the illness and treatment are communicated by healthcare professionals is influential. Emphasis on ‘rescue treatment with SABA’ without an appreciation of the need to manage underlying inflammation may be particularly problematic.

5.4.11 The investigation heard from an expert in behavioural medicine that there is a need to ‘rebrand’ asthma and asthma treatment, for example by applying an asthma model as an explanatory framework (Katzer et al, 2018). This is necessary to counter scepticism about the change in emphasis from SABA to ICS. Daines et al (2020) similarly refer to supporting patients to break unhelpful habits, identifying the overuse of SABA and suggesting an alternative strategy (regular use of ICS).

5.4.12 The EbEs and the young people in the focus group shared their views on adherence to asthma treatment with the investigation (see figure 12).

Figure 12 ‘Experts by Experience’ and focus group findings: adherence to asthma medicines

To help improve adherence, it was suggested that:

• more age appropriate education was needed for young people
• there should be reminders to take inhalers, particularly the preventer
• training around medicines was needed, with evidence of effective education which included clear descriptions, updates, observed practice, clear information about the role of the medicine, and the role of the spacer
• explanations should be given to parents/young people around the role, importance, and technique for use of the medicines.

5.4.13 The Children and Young Persons Transformation Team at NHS England and NHS Improvement is involved in a programme of care looking at the portrayal of asthma medicines in the media. The aim is to increase the use of images that show the correct inhaler technique, including more accurately representing the use of the preventer rather than reliever inhaler and the use of a spacer for all children and young people.

5.4.14 It is evident that there is a need for culturally sensitive interventions tailored to explain asthma and asthma treatment in ways that communicate a common-sense rationale for the necessity for appropriate treatment and address specific concerns. The importance of healthcare professionals using behavioural change techniques to support patients has been demonstrated by McCleary et al (2018).

5.4.15 Evidence from the EbEs and the young people in the focus group, the Mother of the Child in the reference event, a professor in behavioural medicine and the research literature identify a need to enhance understanding of asthma and its potential seriousness.

Patient/parent education and self-management

5.4.16 The National Institute for Health and Care Excellence (2018b) reports that:

‘The focus of asthma management in recent years has been on supporting people with asthma and their healthcare professional to devise a personalised treatment plan that is effective and relatively easy to implement.’

Further to this, the advice is to: ‘Consider an asthma self-management programme, comprising a written personalised action plan and education, for the families or carers of children under 5 with suspected or confirmed asthma’ (National Institute for Health and Care Excellence, 2018b). However, the views of parents and young people do not always correlate with the strategic intentions (see figure 14).

Figure 14 ‘Experts by Experience’ and focus group findings: communication and training to enhance understanding of asthma

5.4.17 Lenney et al (2018) highlighted the need to strengthen health education through school-centred asthma programmes, and also within the community to engage with families. Deeny et al (2018) support the focus on education stating that it helps to empower young people and their families to self-manage their condition, a factor which is known to lead to improved outcomes. The British Lung Foundation asthma management programme similarly demonstrated significant improvement in asthma control after educational intervention (Carroll et al, 2017).

5.4.18 Young people often wish to take control of their own health; some may stop medication due to stigma or embarrassment. Barriers to asthma management are more common in teenage boys, but teenage girls do less well in terms of overall asthma control (Lenney et al, 2018).

5.4.19 In young people, a lack of self-management skills and insufficient health literacy contribute to poorer outcomes and worse adherence. Young people with asthma are at risk of being overlooked due to a complex interplay of issues as they transition from childhood to adolescence. This is also a period when patients do not regularly attend appointments. The investigation was advised of the importance of this age group linking into school nursing services for support and guidance (see figure 15).

Figure 15 ‘Experts by Experience’ and focus group findings: involvement of the school nursing team

5.4.20 The literature provides evidence that public-facing educational packages are required to support self-management. This is echoed by the experiences of the EbEs. More effective methods for explaining asthma are required, communicating the necessity of anti-inflammatory treatment, addressing any concerns about ICS treatment, and cautioning against over-reliance on SABA.

5.4.21 In addition to the improvements identified from education, it is evident that ‘coordinated practice systems combining several interventions afford the greatest benefits’ (Szefler et al, 2020). This included structured approaches to patient education. Gray et al (2018) similarly proposed a multi-faceted approach as they found that adherence was improved by providing additional asthma education, guidance, and feedback on the appropriate use of inhalers, and supportive behavioural management techniques. Outside of the clinic setting, the involvement of clinical staff with families was also associated with higher adherence (see figure 16).

Figure 16 ‘Experts by Experience’ findings: role of the asthma nurse

5.4.22 The investigation heard that paediatric asthma nurse specialists are fundamental in delivering education and providing support. The investigation undertook a survey of the Association of Chief Children’s Nurses to determine the extent of asthma nurse provision across the UK. The responses covered the majority of regions across England and related to service provision by acute hospital services. In relation to paediatric asthma nurse posts, these ranged from zero to five whole time equivalents per region, with some regions having no provision at all, and others having more than the average. Where provided, the number of paediatric asthma patients for a service ranged from 150 to 800 and routine appointments with the nurse ranged from three monthly up to once yearly.

5.4.23 The paediatric SMA has advised this variable provision has implications for whether centres are able to comply with guidance, including the checking of inhaler technique and providing education to parents. It also has implications in respect of outcomes for children with asthma since reviews by an asthma nurse have been shown to have such a positive impact.

5.4.24 The evidence demonstrates the value of children with diagnosed or suspected asthma being supported by healthcare professionals with appropriate training in the condition and its management.

Community pharmacists’ role in supporting adherence

5.4.25 The National Institute for Health and Care Excellence (2020b) suggests there are services and expertise available from community pharmacy teams, who ‘are well placed to offer health and wellbeing advice and education to everyone in the local community’.

5.4.26 This concept is developed further in the NHS Long Term Plan (NHS England and Improvement, 2019b), which states that pharmacists in primary care networks will be essential to support patients with respiratory diseases to receive and use the right medication. They will undertake a range of medicine reviews, including educating patients/families on the seriousness of chronic asthma and the correct use of inhalers and contributing to multidisciplinary working. As part of this work, they will support patients, through assessments of inhaler techniques (or when a new device is dispensed) to ensure effectiveness and documenting this as part of an annual review of the patient’s condition.

5.4.27 The quality standard for community pharmacies (National Institute for Health and Care Excellence, 2020b) includes a statement on integrating services: ‘Community pharmacies and commissioners work together to integrate community pharmacy services into care and referral pathways.’ Community pharmacy teams are skilled, knowledgeable, and easily accessible professionals, but currently appear to be an underutilised resource.

Figure 17 ‘Experts by Experience’ findings: interface with community pharmacy and medicines management

5.4.28 Resources that supported safe medicines management in the community at the time of the reference event included Medicines Use Reviews (MURs) (Pharmaceutical Services Negotiating Committee, 2021) and a New Medicines Service (NHS, 2019).

5.4.29 The MUR service was an ‘Advanced Service within the NHS Community Pharmacy Contractual Framework’ (Pharmaceutical Services Negotiating Committee, 2021). It was a structured review that was undertaken by a pharmacist and intended for those patients who were receiving medicines for long-term conditions (including asthma). The aim of the MUR was to improve patients’ adherence and experience of using their medication(s), maximise the benefits of medication and reduce waste due to unused medicines (Pharmaceutical Services Negotiating Committee, 2021).

5.4.30 There were national target groups for MURs which stipulated that 70% must relate to patients taking high-risk medicines, or those recently discharged from hospital who have had changes made to their medicines. A MUR could have been undertaken with a child, but only if they had the capacity to give informed consent and were able to engage in the discussion with the pharmacist. Under the regulatory framework, a MUR could not be carried out with the parent of a child who was unable to give informed consent.

5.4.31 The Child involved in the reference event did not meet the criteria in terms of the national target groups for MURs and was not old enough to provide informed consent, so it was not considered. The community pharmacist told the investigation that had the Child been eligible for a MUR, the irregularities in collecting medicines may well have been identified, with appropriate feedback provided to the prescriber.

5.4.32 The investigation was advised that MURs were decommissioned in April 2021, to be replaced by structured medication reviews (SMRs), undertaken by pharmacists within GP practices/primary care networks.

5.4.33 SMRs are designed to be a comprehensive and clinical review of a patient’s medicines and detailed aspects of their health. They are delivered by facilitating shared decision-making conversations with patients aimed at ensuring that their medication is working well for them. The guidance includes various questions that should be asked, including ‘can the patient demonstrate how they will use the medicines (formulation, device, regimen)?’.

5.4.34 Following our investigation findings, NHS England and NHS Improvement plans to make clarifications that children should be considered eligible for SMRs (and the NMS), even if too young to consent themselves.

5.4.35 The New Medicines Service (NMS) is undertaken by community pharmacists and affords additional medicines-related help and advice to treat a long-term condition. Asthma is an eligible condition for a NMS in community pharmacy. However, the service could not be provided to a child who was not competent to give consent, nor to the child’s parents, so would not have been available to the family involved in the reference event.

5.4.36 The NMS service specification is being revised to include the expanded eligibility for the service. The accompanying guidance/toolkit will also be updated to reinforce that ‘the service can be offered to younger children involving their guardians as well as to older patients involving their carers where appropriate’.

• For children under five with wheeze (a whistling sound made during breathing) without a confirmed diagnosis of asthma, the use of an information and management plan to monitor symptoms and adjust treatment serves to educate parents/carers regarding symptoms, and empower them to self-manage their child’s condition.
• In the reference event, monitoring of the Child’s response to medicines was limited due to issues with the timeliness of follow-up paediatric respiratory outpatient appointments.
• The National Review of Asthma Deaths identified that a different, more effective and integrated approach to asthma care delivery was needed. The review made 19 recommendations, 12 of which were relevant to the reference event. Only one has been implemented nationally to date.
• The information used by NHS 111 to triage a breathless child over five years of age does not include a prompt for chest recession (an indrawn chest, which can indicate breathing difficulties) in the supporting information, as one of the indicators of a life-threatening breathing difficulty.
• There was limited communication and transfer of information regarding the Child’s suspected asthma diagnosis between primary care, secondary care, community services, the child’s school and the family.
• There are no nationally endorsed training packages for healthcare professionals caring for children with asthma.
• A combination of paper records and electronic systems, and the limited ability of different electronic systems to share information with one another, resulted in inconsistent and incomplete transfer of information about the Child’s condition and treatment.
• The interface between primary care and community pharmacy was limited in relation to asthma medicines management due to the pharmacy having only partial access to the Child’s Summary Care Record (an electronic record of patient information, created from GP medical records, which can be seen and used by staff in other parts of the health and care system).
• There was no correlation of ‘red flag’ markers such as the number of times a patient had sought emergency treatment, lack of improvement of symptoms and insufficient inhaled corticosteroid prescriptions. This meant it was not possible for primary care and community services to identify patients at increased risk of an asthma attack.
• Monitoring parental adherence to asthma medicines was limited in terms of effectively changing health-related behaviour, since the reason for nonadherence was not established.
• There was minimal parental education to enhance the Mother’s understanding of how to manage her son’s condition, prior to the near-fatal asthma attack.
• The involvement of a paediatric asthma nurse after the Child’s asthma attack enabled information and key messages to be communicated to the Child’s Mother in a way that she understood.
• There appears to be a general lack of understanding about the potential seriousness of asthma.
• There are no nationally endorsed educational resources for children and families on the management of asthma (confirmed or suspected).
• Children too young to consent were not eligible for advanced pharmacy services (Medicines Use Reviews and the New Medicines Service) that could assist their families in medicines management and adherence to treatment.

Image courtesy of NHS Digital.