Management of chronic asthma in children aged 16 years and under

Date Published:

Theme:

  • Long-term conditions,
  • Access to care

Considerations in light of coronavirus (COVID-19)

We have adapted some of our national investigations, reports and processes to reflect the impact that COVID-19 has had on our organisation as well as the healthcare system across England. For this report, the way we engaged with staff and families was revised.

A note of acknowledgement

We would like to thank the family of the child whose experience is documented in this report for their ongoing support and involvement. We would also like to thank the healthcare staff who engaged with the investigation for their openness and willingness to support improvements in this area of care.

About this report

This report is intended for healthcare organisations, policymakers and the public to help improve patient safety in relation to the management of chronic asthma in children aged 16 years and under.

Our investigations

Our investigators and analysts have diverse experience of healthcare and other safety-critical industries and are trained in human factors and safety science. We consult widely in England and internationally to ensure that our work is informed by appropriate clinical and other relevant expertise.

We undertake patient safety investigations through two programmes:

National investigations

Concerns about patient safety in any area of NHS-funded healthcare in England can be referred to us by any person, group or organisation. We review these concerns against our investigation criteria to decide whether to conduct a national investigation. National investigation reports are published on our website and include safety recommendations for specific organisations. These organisations are requested to respond to our safety recommendations within 90 days, and we publish their responses on our website.

Maternity investigations

We investigate all incidents in NHS maternity services that meet:

  • the criteria of the Royal College of Obstetricians and Gynaecologists’ Each Baby Counts programme, or
  • our HSIB defined criteria for maternal deaths.

Incidents are referred to us by the NHS trust where the incident took place, and, where an incident meets the criteria, our investigation replaces the trust’s own local investigation. Our investigation report is shared with the family and trust, and the trust is responsible for carrying out any safety recommendations made in the report. In addition, we identify and examine recurring themes that arise from trust-level investigations in order to make safety recommendations to local and national organisations for system-level improvements in maternity services.

For full information on our national and maternity investigations please visit our website.

Executive Summary

The purpose of this investigation is to help improve patient safety in relation to the management of chronic (longterm) asthma in children aged 16 years and under. It uses a real patient safety incident involving a child with asthma, referred to as ‘the reference event’, to examine this issue.

The reference event

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.

The national investigation

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.

Findings

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.

HSIB makes the following safety recommendations

Safety recommendation R/2021/124:

HSIB recommends that NHS England and NHS Improvement, as a commissioning body, supports local systems to implement evidence-based interventions, such as standardised information and wheeze management plans, for the parents/carers of pre-school children. This will be undertaken in conjunction with the British Paediatric Respiratory Society.

Safety recommendation R/2021/125:

HSIB recommends that NHS England and NHS Improvement reviews the recommendations arising from the National Review of Asthma Deaths to prioritise and ensure the implementation of recommendations that are outstanding.

Safety recommendation R/2021/126:

HSIB recommends that NHS Digital reviews the supporting information for triaging the breathless child up to 16 years of age, to determine whether there are features of life-threatening breathing difficulty.

Safety recommendation R/2021/127:

HSIB recommends that NHS England and NHS Improvement supports clinical experts to work with professional bodies to develop training competencies for healthcare professionals with responsibility for caring for children with suspected or confirmed asthma.

Safety recommendation R/2021/128:

HSIB recommends that NHS England and NHS Improvement and NHSX identify and integrate data items into information technology systems to develop a greater understanding of the risk factors present in the community.

Safety recommendation R/2021/129:

HSIB recommends that NHSX, supported by NHS England and NHS Improvement, implements a discovery programme into the roadmap for the digital personal child health record focused on developing support, self-reporting and alerting for asthma self-care.

Safety recommendation R/2021/130:

HSIB recommends that Public Health England develops resources for young people and their parents/carers to raise awareness and enable them to self-manage asthma more effectively.

HSIB makes the following safety observations

Safety observation O/2021/105:

It may be beneficial if suspected or possible asthma diagnosis is communicated by secondary care services to children, families, and other care sectors, when asthma is being considered as a possibility (but not formally diagnosed).

Safety observation O/2021/106:

It may be beneficial if children were coded as having suspected asthma if under five years of age and on inhalers without an asthma diagnosis, recognising that the lack of a formal diagnosis leads to suboptimal care.

Safety observation O/2021/107:

It may be beneficial if diagnostic hubs are introduced into all regions in England, modelling those already in existence, to provide specialist equipment and expertise to patients with asthma.

Safety observation O/2021/108:

It may be beneficial for a health intervention to be delivered to enhance the general public’s knowledge and understanding of asthma, emphasising the potential seriousness of the condition. This could be linked to the modernisation of the Healthy Child Programme, which is being led by Public Health England.

Safety observation O/2021/109:

It may be beneficial if every child with asthma (confirmed or suspected) has access to a healthcare professional who has been trained in accordance with a nationally recognised training programme and undertakes regular reviews and continuing educational support.

HSIB notes the following safety actions

Safety action A/2021/038:

There is now an alternative vaccine for those children whose parents refuse the nasal flu vaccine due to the porcine gelatine content. Children in a higher risk group are eligible to receive an injectable vaccine as an alternative to the nasal vaccine.

Safety action A/2021/039:

NHS England and NHS Improvement is amending the guidance for the directed enhanced service on Structured Medication Reviews and medicines optimisation to clarify and raise awareness that children, even those too young to give consent, are eligible to receive these services.

Safety action A/2021/040:

NHS England and NHS Improvement is amending the service specification for the New Medicines Service, so that it is available to patients of all ages, including younger children with parental/guardian consent, who may benefit from the service.

1 Background and context

1.1 Definition of asthma and explanation of the condition

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.

Annotated illustration of areas of chest muscle recession
Figure 1 Areas of chest muscle recession

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 Incidence of asthma, its impact, and outcomes of the disease

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 Asthma medicines

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

Table showing examples of different inhalers and medicines referring to in this report
Table 1 Examples of inhalers and medicines referred to in this report
Photo of spacer devices for children's inhaler
Figure 2 Spacer devices (image taken from a trust’s ‘Children’s inhaler and spacer device guide’)

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 Adherence

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 Details of certain services and systems alluded to in this report

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.

2 The reference event

This investigation used the following patient safety incident, referred to as ‘the reference event’, to examine the management of chronic asthma in children aged 16 years and under.

Past medical history

2.1 The patient at the centre of the reference event (the Child) was born prematurely at 23 weeks and 6 days’ gestation, weighing 625g, in February 2014. He was an inpatient at Hospital 1 for six weeks before moving to Hospital 2 in April 2014. The Child required ventilation (support from a machine to help him breathe) for 21 days and assisted ventilation for 46 days, after which he was on oxygen. He was discharged home after four months in hospital on oxygen and was monitored by an outreach team from Hospital 2. He was on oxygen for his first year of life.

2.2 Because he was born prematurely, the Child had a number of health issues. He had been under paediatric respiratory medicine (the department specialising in conditions of the airway in children) at Hospital 2 since birth and was initially treated by paediatric Respiratory Consultants 1 and 2. The Child was diagnosed with bronchopulmonary dysplasia, a form of chronic lung disease. Secondary to this, he had a ‘wheeze’ (whistling sound made during breathing). He suffered from a ‘wet cough’ (producing mucus) and had investigations, including a bronchoscopy, during his early years to investigate the cause of this. He also experienced episodes of apnoea, (temporary pauses in breathing, especially during sleep).

2.3 In addition to the Child’s respiratory condition, he had the following health conditions:

  • reflux disease, treated with medication
  • hearing impairment/frequent ear infections, treated with grommet insertion and the removal of his tonsils and adenoids in 2018 (under the ear, nose and throat specialty and audiology at Hospital 2)
  • visual impairment (under ophthalmology at Hospital 2)
  • motor impairment (under physiotherapy, provided by community health services)
  • speech and language delay (under the speech and language therapy service, provided by community health services)
  • developmental follow up following premature birth (under community paediatrics, provided by community health services)
  • skin lesions, allergies and eczema (under dermatology at Hospital 2).

Background

2.4 The Child attended a number of outpatient appointments at Hospital 2 and a centre for child health for his varying health conditions and was predominately under consultant care. It was normal for the Child to be attending secondary care services (such as specialist hospital-based clinics) as an outpatient on a regular basis, to see a variety of clinicians for his complex health needs. He attended primary care (his GP) infrequently, and his contact with the health visiting service appeared to be minimal, based on evidence from the community services records. There was only one health visiting review documented in these records (five are mandated) (Public Health England, 2017).

2.5 The Child was prescribed various medicines on a regular basis, including inhalers from the age of one year, when the home oxygen was discontinued.

2.6 The Child started mainstream school in September 2018. He was taught in a speech and language group of 12 children, with close supervision/support due to his special educational needs. The Child had an Education, Health and Care Plan in place, which had been in progress since September 2017 and was shared with the school when he started there.

October 2018

2.7 The Child went to an outpatient clinic appointment at Hospital 2 and was seen by paediatric Respiratory Consultant 3. At the appointment, it became apparent that the Child’s Mother was not administering the corticosteroid ‘preventer’ inhaler (fluticasone) (see table 1), which had been prescribed by paediatric Respiratory Consultant 3 in August 2017, but only issued by the GP in early September 2018.

2.8 At this appointment, paediatric Respiratory Consultant 3 discussed adherence to treatment (see 1.4.1) with the Child’s Mother. The school nursing team was not advised of the concerns regarding medication at this point, or asked to follow up with the parent and check in with the school.

2.9 In the clinic letter (copied to the family), the consultant asked the GP to prescribe montelukast (medication used in the treatment of asthma) for six months. This was prescribed by the GP but the medication was not issued, as the request was not received from the Child’s Mother in accordance with the practice’s system.

2.10 A follow-up review after three months was requested by paediatric Respiratory Consultant 3, but this was not arranged until late July 2019, six months after the requested date. The Child’s Mother had not realised there was a delay, and therefore did not follow this up, as this was just one of a number of outpatient appointments attended by the Child during this time period. She also said it was not unusual for a slippage to occur in terms of the paediatric respiratory outpatient appointments, resulting in the timeframe being longer than the follow-up request made by the consultant.

From October 2018 until early July 2019

2.11 During his first year at school, the Child remained generally well and was discharged from ear, nose and throat, and audiology services at Hospital 2. However, there was an issue during this time regarding the flu vaccination, which was offered routinely to all children aged four and five years via the school vaccination scheme. The school offered a nasal flu vaccination, which was declined by the Child’s Mother, as it contained pork and the family do not eat pork for religious reasons. In previous winters the child had received the flu vaccination by injection at the GP practice.

2.12 In early November 2018, the Child attended the GP practice with his Mother for a flu vaccination. The nurse declined to give the injectable form of the vaccine because he was now in the school age cohort of children covered by the school vaccination scheme. There was a note in the GP practice summary records stating: ‘First intranasal seasonal influenza vaccination declined.’ The reason why the Child’s Mother had declined the school vaccine was not documented, and there was no further follow-up.

2.13 Once it became apparent that the Child was not going to receive the vaccine, his Mother went to a health food shop and bought herbal products (multi-vitamins) to build his immunity ahead of the winter period. Afterwards, the Child’s Mother recalled feeling relieved that he had “got through the winter”, with just the health food products and his inhalers, without becoming ill.

Events leading up to and following the near-fatal asthma attack

Day 1: Monday, July 2019

2.14 The Child’s Mother recalled that her son had a slightly raised temperature, which she treated with paracetamol before he went to school as normal. The day before, she recalls he had been playing at a nearby playground and seemed to be “absolutely fine”.

Day 2: Tuesday, July 2019

2.15 The Child again had a slightly raised temperature, so he was given some paracetamol. He went to school, although his Mother told the school he was still “a bit groggy”.

2.16 By 13:00 hours, the Child had a temperature of 39C and his Mother was asked to collect him from school. Once they arrived home, the Child was given further paracetamol and then spent the rest of the afternoon playing at home with his toys.

2.17 On Tuesday evening, the Child started coughing, so he was given honey and lemon, and administered his inhalers “a bit more than normal, not much more”, as his Mother thought he had a cold. She recalled knowing (from personal experience) that the salbutamol inhaler relieved tension in the chest and so she gave her son the inhaler (with a spacer) to try and relieve the cough. She did not at any point consider that her son was suffering from asthma, instead relating his symptoms to the health conditions associated with his premature birth and underdeveloped lungs.

Day 3: Wednesday, July 2019

2.18 The Child did not attend school but stayed at home with his older (adult) Brother. The Child continued to have a cough and a high temperature. Ibuprofen (a non-steroidal anti-inflammatory medication) was given for the first time, and this was alternated with paracetamol, in an attempt to reduce his temperature. At night-time the coughing became a lot worse and the Child continued to have a very high temperature.

Day 4: Thursday, July 2019

2.19 In the morning, the Child’s Mother rang the GP practice for an emergency appointment, as her son had been coughing for two days by this time and still had a high temperature. She was initially offered an appointment at another practice in the GP hub system for the following day. The Mother explained her son’s medical history and she was advised to take her son to their local practice after 11:00 hours that same day.

2.20 The Mother went to work and the Child was taken to the surgery by his Brother. The GP told the Brother that the cause of the Child’s illness was viral, and said to keep an eye on him and to “continue with his asthma medication”. The GP sent a prescription for antibiotics to the pharmacy.

2.21 The Child’s Brother collected the prescription and gave it to his Mother, who was surprised to learn that the GP had prescribed antibiotics, given the viral illness diagnosis. The Child’s Mother decided to give the evening dose of the antibiotic and phone the GP the following morning to find out why he had been prescribed the medication. The GP recalled that: “I realised he was ill, but not how ill he was. I don’t often give kids antibiotics.” He was also mindful of the Child’s medical history when prescribing the antibiotics.

2.22 During the night, the Child was coughing constantly.

Day 5: Friday, July 2019

2.23 The Child continued to cough and he spent the day lying next to his Mother on the sofa. She recalled giving her son his inhalers more than normal. At this point, the Child’s Mother remembered a previous instruction she had been given, which was to give him “rescue breaths” if he was ever struggling to breathe. The rescue breaths were puffs of the salbutamol inhaler, given almost continuously, pausing after each two to evaluate for signs of improvement.

17:33 hours

2.24 The Child’s Mother was becoming increasingly concerned about her son’s condition as he continued to cough and was not improving, so she called NHS 111. She gave a brief history of her son’s illness to the call handler and explained that her son had a respiratory condition.

2.25 In relation to the present complaint, the Mother reported that her son’s breathing rate was fast and he was breathing heavily. She was concerned because she had given him rescue breaths of salbutamol, but she could not remember how much and did not want to overdose him. The Child’s Mother also said her son’s condition was not improving.

2.26 The call handler went through the assessment process, during which time the Child’s Mother mentioned his chest recession (see 1.1.5) and high temperature, in addition to the persistent cough, adding that he had been on the sofa all day, not playing. The Child’s cough was audible intermittently during the NHS 111 call, and this prompted the call handler to ask “whether he is struggling to breathe” or having to “fight for breath”. The response was negative, so the call handler obtained some advice and transferred the call to a clinician. The call lasted for just over 11 minutes.

17:44 hours

2.27 The clinician revisited the history of the current complaint. The Child’s Mother added that she was giving him his inhalers but that she was “struggling to get his breathing under control”. She also said she could see “recession in his chest” and that he was coughing continuously. The clinician asked the Mother about her son’s ongoing problems and she referred to her son’s respiratory condition, for which he was prescribed inhalers. When prompted, she said he had been born prematurely, adding that, in relation to the respiratory condition, “they’ve now kind of said is turning into an asthma type”.

2.28 The clinician then returned to the Child’s current complaint and asked a series of questions. The Child’s Mother reported her son was alert, but quieter than normal; that chest recession was visible below the ribcage, but also above the sternum (the front of his chest below his neck), and his respiratory rate had been 47 breaths per minute prior to the call.

2.29 The clinician’s impression was that the Child was suffering from an upper respiratory tract infection and advised that he needed to be seen face to face, at the nearby hospital. The clinician advised that the Mother should pack up her bags and get a taxi straight away. The clinician added that the Child’s condition was not life-threatening, so an ambulance was not required, but that if his condition worsened, his Mother should call 999. The call lasted for just under nine minutes.

2.30 The Child’s Mother managed to get a taxi promptly. During the journey from their home to the hospital, the Child’s Mother told the investigation that the taxi driver was so concerned, he went through red lights.

19:01 hours

2.31 The Child and his Mother arrived at the emergency department (ED) of their local hospital and joined a queue with other patients to go through ‘streaming’ so that they could be directed to the most appropriate care location. The presenting complaint noted in the ED records was shortness of breath.

19:05 hours

2.32 The Child was taken to a cubicle in the ‘paediatric waiting’ area, where he was promptly reviewed and triaged as a ‘Category 2’ (very urgent, seriously ill or injured but not in immediate danger) with the description being ‘shortness of breath in children, increased work of breathing’ (chest recession, nasal flaring and use of accessory respiratory muscles). It was documented in the ED records that he was in respiratory distress and coughing continuously, in addition to having intercostal subcostal recession (when the muscles between the ribs pull inward, see 1.1.5). The Child was moved to the ‘majors’ area of the ED, in accordance with the triage outcome.

19:15 hours

2.33 An ED specialist trainee (ST) 3 assessed the Child and recorded that his temperature was 38C; heart rate was 158 beats per minute; respiratory rate was 46 breaths per minute; and his oxygen saturations were 93%. It was noted that there was reduced air entry into his lungs, particularly on the right, and there was subcostal recession (see 1.1.5) and tracheal tug (the skin in the middle of the neck was pulled inward). A comprehensive history of the Child’s current condition, and his past medical history were recorded in the clinical notes, which included a note stating that he was ‘under respiratory team – now thought to have asthma’. In relation to medicines, it was recorded that he was being given salbutamol, beclometasone (brand 2) and montelukast (but there was no mention of fluticasone) (see 1.3.1, table 1).

2.34 The Child was prescribed a ‘full burst with 3x salbutamol’ [which were given at 19:20 hours, 19:35 hours and 19:50 hours] and 1x [Ipratropium bromide] [given at 19:35 hours]’. The ST3’s documented plan also contained an instruction to give a steroid medicine; ametop (local anaesthetic) in preparation for siting a needle in his vein; oxygen to maintain his oxygen levels in his blood at above 92%; to reassess after the nebuliser treatment; and to inform a more senior doctor in the ED.

21:30 hours

2.35 The Child was reviewed by an ED consultant, and the clinical notes reflect that he still had marked increased work of breathing following the treatment, in addition to which his chest sounded tight. A chest X-ray had been undertaken and this showed right-sided consolidation (lungs filled with substance other than air). The plan made by the consultant included giving intravenous hydrocortisone (corticosteroid), magnesium (bronchodilator) and antibiotics.

23:00 hours

2.35 A decision was made to admit the Child to a paediatric high dependency unit (HDU), with a plan to start ‘optiflow’ (high flow oxygen therapy), to provide respiratory support. The working diagnosis recorded in the clinical notes was ‘chest infection/wheeze’.

Day 6: Saturday, July 2019, 00:00 hours until 07:30 hours

2.36 The Child was maintained on optiflow at 3 litres/kilogram overnight. However, his condition deteriorated and he became exhausted, requiring additional support.

Day 6: Saturday, July 2019,

07:30 hours

2.37 The paediatric intensive care unit (PICU) night team reviewed the Child on the HDU, following which a decision was made to admit him to the PICU.

Day 6: Saturday, July 2019,

08:00 hours

2.38 The Child was admitted to the PICU from the HDU in respiratory failure. The medical records indicate ‘primary diagnosis: pneumonia secondary to Influenza A’; ‘secondary diagnosis: asthma’ and the ‘third diagnosis: pneumonia secondary to Mycoplasma’. It was noted that the Child suffered a ‘near fatal asthma exacerbation with bilateral infiltrated X-ray’ (lungs filled with fluid rather than air).

Day 6: Saturday, July 2019,

08:30 hours

2.39 The Child was intubated for ‘extreme work of breathing and quiet chest’, indicating that his lungs had tightened so much during the asthma attack that there was not enough air movement to produce wheezing. It was recorded in the clinical notes that there was very difficult ventilation after the intubation and there was a peri arrest episode.

Day 7: Sunday, July 2019

2.40 A consultant on the PICU explained to the Child’s Mother that her son was critically unwell and needed extracorporeal membrane oxygenation (ECMO), a technique to support his lungs and heart and ensure sufficient oxygen was getting into his bloodstream, as his heart would not be sustained if they did not do that. A decision was made regarding ECMO because it was apparent that the Child still was not responding to treatment and his condition was deteriorating despite various interventions.

Day 8: Monday, July 2019

2.41 The Child’s Mother recalls that the doctors explained to her that her son was in a critical condition. The doctors explained more about ECMO and said that the reason he was on this was because of a “massive asthma attack”. The Child’s Mother described being very shocked to be told about the asthma diagnosis, as she thought her son’s extreme prematurity and his chronic lung condition were the causes of his deterioration, not asthma.

Day 9, July 2019 onwards

2.42 From this point onwards, the Child’s condition started to improve. ECMO support was discontinued on day 15 and the Child was extubated (the tube in his airway was taken out) on day 17. Following this, it was noted that he had severe muscle weakness, poor interaction and severe sleep disorder. The Child made a gradual recovery and was discharged home five weeks later, with a plan for ongoing community therapy support.

3 Involvement of the Healthcare Safety Investigation Branch

3.1Method

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.

Table 2 Healthcare organisations in contact with the Child involved in the reference event
Healthcare setting Description
Secondary/tertiary care Specialist NHS children's hospital which is administratively part of an NHS foundation trust
Primary care Large, modern teaching group practice providing care with treatment from a healthcare team, including general practitioners (GPs)
Community services (paediatrics, speech and language therapy, physiotherapy, occupational therapy) Centre for child health services provided by the specialist NHS children's hospital
Health visiting The local authority commissioned the services from the NHS foundation trust
School nursing The local authority commissioned the services from the NHS foundation trust
School immunisation service Community healthcare NHS trust awarded the contract from NHS England in 2016 to help deliver the school age vaccinations programme
Community pharmacy Pharmacy was owned by a small, independent chain of pharmacies and provided an electronic prescription service

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).

Figure 3 The AcciMap Method (Svedung and Rasmussen, 2002)
Figure 3 The AcciMap Method (Svedung and Rasmussen, 2002)

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.

4 Analysis and findings from the reference event in relation to national and local policy

Introduction

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.

4.1 Suspected asthma

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

Figure 4 Overview of section 4
Figure 4 Overview of section 4
Table 3 Summary of the Child’s respiratory outpatient appointments, 2015 to 2018
Paediatric respiratory consultant Main symptoms Medication related information
October 2015 Consultant 1 Wheezy all the time, but worse on exertion and with a cold Increased beclometasone (brand 1) and prescribed montelukast for the first time
February 2016 Consultant 1 Wheezy, particularly with coughs and colds Montelukast stopped in January 2016 due to a rash. No other changes to medication
July 2016 Consultant 2 Intermittent wheeze and chesty cough Beclometasone (brand 2) and salbutamol inhalers, query montelukast
November 2016 Consultant 2 Chest the same, wheeze and wet cough Beclometasone (brand 2) and salbutamol inhalers, montelukast stopped (rash)
August 2017 Consultant 3 Wheezy, husky voice and breathless on exertion. Note to ‘Rx [treat] asthma over winter’ Fluticasone to replace beclometasone (brand 2) inhaler, montelukast restarted
February 2018 Consultant 3 Chronic wet cough Note to continue montelukast and beclometasone (brand 2) (but should have been fluticasone)
October 2018 Consultant 3 Chronic wet cough Fluticasone and salbutamol inhalers, montelukast 
Medicines adherence issues noted

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 reportLack 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.

4.2 Ongoing care of a patient with complex health needs

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).

HSIB notes the following safety action

Safety action A/2021/038:

There is now an alternative vaccine for those children whose parents refuse the nasal flu vaccine due to the porcine gelatine content. Children in a higher risk group are eligible to receive an injectable vaccine as an alternative to the nasal vaccine.

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.

4.3 Parental knowledge and adherence to treatment

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.

5 Analysis and findings from the wider investigation

Introduction

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 The implications for children aged 16 years and under of having no formal diagnosis of asthma

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.

Figure 5 Overview of section 5
Figure 5 Overview of section 5

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

The investigation heard from parents that their child’s asthma often took a long time to diagnose. When the diagnosis was made, this sometimes occurred after a significant exacerbation:

“It wasn’t until she really hit the bottom and that’s when we got the diagnosis.”

Parents spoke of healthcare professionals suspecting asthma and suspecting it for a long time, but often the diagnosis was unclear.

“… we could just walk down our street and she’s still out of breath (demonstrating intake of breath) we can hear it inside her and no one’s still, today, told us that she needs a permanent, one of these pumps [inhalers] for asthma. They’ve suspected it; they have suspected it for a very, very long time, but they only give it her for very short periods of time.”

The lack of an asthma diagnosis had potential implications for later management and adherence to medicines too.

“I didn’t really think that he had a diagnosis of asthma. I didn’t necessarily then correlate these medications as serious if that makes sense …”

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.

HSIB makes the following safety observations

Safety observation O/2021/105:

It may be beneficial if suspected or possible asthma diagnosis is communicated by secondary care services to children, families, and other care sectors, when asthma is being considered as a possibility (but not formally diagnosed).

Safety observation O/2021/106:

It may be beneficial if children were coded as having suspected asthma if under five years of age and on inhalers without an asthma diagnosis, recognising that the lack of a formal diagnosis leads to suboptimal care.

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)

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

HSIB makes the following safety recommendation

Safety recommendation R/2021/124:

HSIB recommends that NHS England and NHS Improvement, as a commissioning body, supports local systems to implement evidence-based interventions, such as standardised information and wheeze management plans, for the parents/carers of pre-school children. This will be undertaken in conjunction with the British Paediatric Respiratory Society.

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).

colour, sporadic layout of word cloud reflecting young people's perceptions of asthma
Figure 8 Word cloud reflecting young people’s perceptions of asthma

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

Exploration of perceptions of asthma particularly related to the perceived severity of the condition. The severity of a child’s asthma was judged based on symptoms.

“He wasn’t actually admitted; he was in A&E [accident and emergency]. He didn’t need to be admitted because he responded to the prednisolone and the salbutamol nebulisers within quite a quick time … I just thought, it’s a one-off event … No, I didn’t follow it up because he is being managed at home and he has been stable apart from the incident with the aerosol.”

The above example might suggest a perception of milder asthma due to it being a “one-off event” and the child responding rapidly to treatment.

The investigation also heard that the absence of a diagnosis can influence the perception of severity. One parent described that their child was at serious risk because, as they did not have a diagnosis, they had not been given any medicines in case immediate treatment was needed. In contrast, a lack of diagnosis could also detract from perceptions of asthma as a potentially life-threatening condition.

“I think I did not understand at all the seriousness of asthma and how dangerous it can get for people. No, I didn’t have any understanding of it at all before [the child] got her diagnosis.”

Personal experience, including professional healthcare experience, played a role in highlighting the potential severity of asthma.

Other perceptions of asthma related to views about medicines. The investigation heard examples where parents were not familiar with the medicines their children were taking or the potential side-effects. However, they often knew that they worked and therefore were positive about them.

“I’m being honest, I don’t know what the side-effects are of it, to be honest, of either of the inhalers, but I feel like they’re just amazing to be honest. The second she takes them we see a massive difference and it’s just like they’re amazing, yes. I don’t have any issues.”

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.

Table 4 Key NRAD findings and recommendations relevant to reference event
Area of care Key findings Key recommendations
Use/organisation of NHS services There was a history of previous hospital admission for asthma in 47% of asthma deaths. Every NHS hospital and general practice should have a designated, named clinical lead for asthma services, responsible for formal training in the management of acute asthma.

Follow-up arrangements must be made after every attendance at an emergency department or out-of-hours service for an asthma attack. Secondary care follow-up should be arranged after every hospital admission for asthma, and for patients who have attended the emergency department two or more times with an asthma attack in the previous 12 months.

A standard national asthma template should be developed to facilitate a structured, thorough asthma review.

Electronic surveillance of prescribing in primary care should be introduced as a matter of urgency to alert clinicians to patients being prescribed excessive quantities of short-acting reliever inhalers, or too few preventer inhalers.
Medical and professional care Personal asthma action plans (PAAPs), acknowledged to improve asthma care, were known to be provided to only 23% of the people who died from asthma. All people with asthma should be provided with written guidance in the form of a personal asthma action plan (PAAP) that details their own triggers and current treatment, and specifies how to prevent relapse and when and how to seek help in an emergency.
Medical and professional care There was no evidence that an asthma review had taken place in general practice in the last year before death for 43% of the people who died. People with asthma should have a structured review by a healthcare professional with specialist training in asthma, at least annually.
Medical and professional care It is likely that many patients who were treated as having mild or moderate asthma had poorly controlled undertreated asthma, rather than truly mild or moderate disease. Factors that trigger or exacerbate asthma must be elicited routinely and documented in the medical records and PAAPs of all people with asthma.
Medical and professional care Health professionals must be aware of the factors that increase the risk of asthma attacks and death.
Prescribing and medicines use There was evidence of under-prescribing of preventer medication, with 80% of patients being issued with fewer than 12 preventer inhalers in the previous year. An assessment of inhaler technique to ensure effectiveness should be routinely undertaken and formally documented at annual review and also checked by the pharmacist when a new device is dispensed.
Prescribing and medicines use Nonadherence to preventer inhaled corticosteroids is associated with increased risk of poor asthma control and should be continually monitored.
Patient factors and perception of risk of poor control Poor recognition of risk of adverse outcome was found to be an important avoidable factor in 70% of children and 83% of young people in primary care. Patient self-management should be encouraged to reflect their known triggers.
Patient factors and perception of risk of poor control Parents and children, and those who care for or teach them, should be educated about managing asthma. This should include emphasis on ‘how’, ‘why’ and ‘when’ they should use their asthma medicines, recognising when asthma is not controlled and knowing when and how to seek emergency advice.

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.

HSIB makes the following safety recommendation

Safety recommendation R/2021/125:

HSIB recommends that NHS England and NHS Improvement reviews the recommendations arising from the National Review of Asthma Deaths to prioritise and ensure the implementation of recommendations that are outstanding.

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.

HSIB makes the following safety recommendation

Safety recommendation R/2021/126:

HSIB recommends that NHS Digital reviews the supporting information for triaging the breathless child up to 16 years of age, to determine whether there are features of life-threatening breathing difficulty.

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.

HSIB makes the following safety observation

Safety observation O/2021/107:

It may be beneficial if diagnostic hubs are introduced into all regions in England, modelling those already in existence, to provide specialist equipment and expertise to patients with asthma.

5.2 The current systems of oversight of asthma management and their relative effectiveness

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

There was evidence of gaps in communication between secondary care, specialist providers and primary care. This potentially influenced a perception that primary care was not fully understanding of a child’s condition.

“Obviously you’ve got your GP practice and you’ve got the hospital, and I feel like when we go to the hospital the treatment in there, because we’ve got specialists and people who know the ins and outs of it, I feel like the level of treatment that we get there is a lot better than we get at a GP, because they don’t fully … I don’t know whether the communication is not there, they don’t have the information, or whether it’s because they’re a GP and they see that many ... I don’t know, but I feel like the breakdown of what’s going on at the hospital to what’s going on at the GP practice, there’s something not there … So when we go to the GP, they don’t really know anything about …”

The investigation heard various accounts of how a child’s asthma was monitored and by whom. Parents reflected that annual reviews of their children were not undertaken, although one said that this now did occur.

“I know they are very busy at GP surgeries and I know they have got to ... nurse practitioners have to prioritise the patients but I feel that he should have had an annual review at least, an annual review at the GP surgery, and the information or the lack of information initially when he was diagnosed.”

There was a feeling that improved oversight was needed and more collaborative care.

“… it is no one’s fault but maybe had they been working together a bit more.”

The investigation also heard that some parents did not challenge the gaps in oversight that they encountered for various reasons.

“However, I didn’t question it. Well, you don’t. You have too many other things. For me, I had two disabled daughters and I was worried all the time. I didn’t want to question anything. I didn’t even take my girls; my husband would take them …”

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.

HSIB makes the following safety recommendation

Safety recommendation R/2021/127:

HSIB recommends that NHS England and NHS Improvement supports clinical experts to work with professional bodies to develop training competencies for healthcare professionals with responsibility for caring for children with suspected or confirmed asthma.

5.3 Exploration and evaluation of the current mechanisms for sharing clinical information

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.

HSIB makes the following safety recommendation

Safety recommendation R/2021/128:

HSIB recommends that NHS England and NHS Improvement and NHSX identify and integrate data items into information technology systems to develop a greater understanding of the risk factors present in the community.

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.

HSIB makes the following safety recommendation

Safety recommendation R/2021/129:

HSIB recommends that NHSX, supported by NHS England and Improvement, implement a discovery programme into the roadmap for the digital personal child health record focussed on developing support, self-reporting and alerting for asthma self-care.

5.4 The factors which influence patient/parental adherence to treatment for children aged 16 years and under

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.

Diagram of The Necessity Concerns Framework applied to SABA and ICS
Figure 11 The Necessity Concerns Framework applied to SABA and ICS

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

Factors affecting adherence to asthma medicines can be seen from parental and young peoples’ perspectives. For parents, interviews identified various factors that improved and reduced their children’s adherence to their asthma medicines. The investigation heard of parental perceptions of the effectiveness of inhalers in reducing symptoms significantly.

“… I feel like they’re just amazing to be honest. The second she takes them we see a massive difference and it’s just like they’re amazing, yes.”

However, parents also shared that it may be symptoms that drive compliance. Examples were given where inhalers were more likely to be used, for example during the summer:

“… in the summertime she probably uses it more … in a pattern like that, morning and night, but at the minute it’s not; I think it’s just as and when she feels the need for it. At the minute she’s managing really well.”

The investigation heard of other influencers for improved adherence, including the impact of acute episodes and life-threatening situations, and feeling shame when challenged by healthcare staff about levels of requested medicines.

The role of the diagnosis was also thought to have an influence. The investigation heard of parents not wishing their child to be on long-term medicines, particularly without a formal diagnosis. In fact, the lack of a diagnosis seemed to have significant negative effects on compliance.

“… I am going to say it is naivety, going back to thinking that he hasn’t got asthma didn’t make me commit to the medication regime then.”

Whether the child had a diagnosis or not, education around the role and significance of medicines was felt to be important. The investigation heard examples of limited understanding of the importance of medicines, but also where education had been effective, for example, from asthma nurses.

One young person commented on their mother’s support:

“If you make it fun for a child to take their medication, they are more likely to take it in a way prescribed. My Mum made a fake inhaler for herself and we used to take my medication together. That really helped me.”

The previous experience of a parent with asthma was also discussed. The investigation heard how parents’ history of their own asthma potentially influenced how they treated their child’s asthma. For example, when the parent was younger, they may not have taken their own inhalers as prescribed or may have had milder symptoms. Parental history also had a role in educating children, with one parent advising their child on how to take an inhaler.

Parents shared other factors that may affect adherence. For example, limited medicine reviews meant reduced clinical monitoring and review. There were also periods of time when a child may not have access to an inhaler, for example a school may not have a child’s inhalers.

Parents shared their perceptions of what affected their child’s adherence. The young people’s focus group also gave insights. Adherence appears to relate in part to the age and behaviours of the child. The investigation heard of young people who were assuming more responsibility as they grew older and those who were more proactive, through reminding their parents of the need for their medicines and by searching out information on websites.

Parents again suggested that the severity of a child’s symptoms affected the use of their inhalers. For example:

“… she knows that before a PE lesson she has to take her inhalers before she even does exercise because she knows she can’t manage it, it’ll not work, so no, there’s never been any time where it’s been missed.”

However, the opposite was also seen in respect of having a pattern for taking an inhaler.

“No, not now. We did used to do that. Yes, we did have that pattern, but now, because we feel like it’s really well managed …”

Embarrassment in using inhalers in front of friends was described, particularly if a spacer device had to be used. The investigation heard that an older young person did not use his spacer because:

“… it had got teddy bears on it and he felt he had grown out of it.”

The investigation also heard of factors that affected the young people’s compliance with treatment. These included having to try to remember to take their inhalers, losing them and mixing them up with other people’s. One young person described how public media often showed inhalers being taken incorrectly.

The associated diagram produced by the young people (see figure 13) gave insights into their perceptions of their inhalers with the phrase ‘boring medical text goes here’ on a diagram of an inhaler.

Figure 13 Young people’s perception of what asthma meant to them
Figure 13 Young people’s perception of what asthma meant to them

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.

HSIB makes the following safety observation

Safety observation O/2021/108:

It may be beneficial for a health intervention to be delivered to enhance the general public’s knowledge and understanding of asthma, emphasising the potential seriousness of the condition. This could be linked to the modernisation of the Healthy Child Programme, which is being led by Public Health England.

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

Discussion around communication and training considered the current knowledge of parents and young people; information sources used for education; and potential future opportunities. The investigation heard that some children, but not all, had personalised asthma plans.

With regards to current levels of knowledge around asthma, there was evidence of gaps in parental knowledge around diagnosis, severity and medicines. Parents spoke of limited information from GPs and appeared to be accepting of what they were told.

“I suppose because of naivety but also you just take the doctor’s word for it, that this is what she needs; you don’t realise … was worried about, so I kind of just accepted the antibiotics, thinking that was going to make her better, that will be all right.”

Parents reported that asthma nurses and the internet were sources of education and wider information about asthma. Personal experience, whether as a healthcare professional or from the parent having asthma themselves, also played a role. Parents spoke of limited written information available at the time of diagnosis. Some recalled that information was provided, particularly following an asthma attack.

“… she gave me a leaflet, I remember it being a leaflet at the time, just giving me some knowledge and things like that of what it was all about; where it was going next, what would happen next, which was a referral to children’s outpatients to see a specialist asthma doctor. So, yes, I did get that. I didn’t get any website at that point but I did get some information to take away ...”

Parents and young people had a number of thoughts about improvements in the education around asthma. These included:

  • more written information about the condition
  • regular updates regarding education and access to help and resources
  • public health messages, similar to the banning smoking campaign; media presentation of good inhaler technique; and adverts acting as “wake up calls” on the potential severity of the condition
  • internet resources
  • annual review provision and feedback on progress
  • age-appropriate education materials.

Young people also described wanting their parents and teachers to have a better understanding of their condition.

Parents described the fear of their children being unwell and just wanting the best for them. They described a need for reassurance that they were doing the right things:

“At initial diagnosis, to be given more information and for frequent reviews, and to be reassured as a parent/for a parent with a non-medical background to be reassured that you have got the information to be able to manage such a disease if you have such a disease.”

Parents also wanted more choice and involvement in the diagnosis and management of their child’s asthma. This included being given the opportunity to ask questions, clarify concerns and challenge where needed.

Parents described the impact of their child’s asthma on themselves and how education had a positive impact on their wellbeing.

“I felt for a long, long time that that asthma controlled us and that was in control. We were doing everything we could but then once we were educated it made me feel like, actually, we can manage this. We can actually do it.”

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

The investigation heard that school could create situations where a child’s asthma might be exacerbated, for example in physical education classes. Parents described the role of the school nurse, some of whom had access to asthma plans and held an inhaler for the child.

“There is a school nurse and she has … it’s like a pastoral lead or something, and she knows her by name, so she can go to [her] …”

The school nurse was often aware of the medical conditions of the child and was a reassurance to parents. The investigation also heard how school would monitor the expiry date of the inhaler it held and request a new one from the parent when required. If a school did not have a nurse, a child’s inhalers would be kept in the office.

The perspectives of young people were also provided, who felt more education was needed for schools.

“… better awareness, especially with teachers because when ur asthma gets bad they say ur being dramatic and they don’t understand.”

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.

HSIB makes the following safety recommendation

Safety recommendation R/2021/130:

HSIB recommends that Public Health England develops resources for young people and their parents/carers to raise awareness and enable them to self-manage asthma more effectively.

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

Parents spoke positively of the asthma nurse where there was one available; they had a role in accessing advice and support when it was required. They were also seen as fundamental in helping parents and children to understand asthma.

“I definitely feel like that is excellent support and really good advice for parents to understand, and children … I carried a burden for a long time, a lot of stress and worry because personally I didn’t understand it until I had that [asthma nurse explanation], and then once ... It was as if somebody had just released that burden. So, yes, I feel that any child being newly diagnosed, I think that kind of explanation, that detailed explanation, is just huge; it’s a big thing.”

The asthma nurse was considered to have a different role to doctors and to be more accessible, with less hierarchy, more appropriate language and more time. Parents also cited the asthma nurses’ role in ongoing training regarding the use of inhalers.

“… so, when I got educated by the asthma nurse I just felt as if a weight had been lifted. I just felt a little bit more, “You know what, I know what these inhalers are for. I know what the blue one’s for. I know why they’re giving her the purple inhaler”. It just all made sense, so I knew what they were put in place for.”

The asthma nurse also appeared to deliver education in a preferred way for the parent and young person.

“I think everybody has their own learning style. Some people are very visual, some people are listeners, et cetera, but I feel like it was brilliant for me and [the child]. We both sat through it and she had all the different scientific – the lungs and all the bits and pieces – and she just sat and explained in detail everything, and she said, “When you’re struggling to breathe, this pipe here expands”, and she was just showing her and explaining, and she said, “And then when you take the puff of the blue inhaler”, and she did it on the dummy … She just explained absolutely everything in perfect detail to the point where you’re visualising it, you’re seeing it, you’re understanding.”

Asthma nurses were felt to have an important role in supporting adherence with medicines too.

“… so, when we went to see the asthma nurse she did explain to [the child], “Sometimes you’re going to feel that there is no issue and you’re going to feel, ‘Ah, I feel fine. I don’t need this anymore’, but absolutely not; you still need to continue because you need to get back on to a level where you’re feeling you can manage it and you’re in control”, so she did actually explain the importance of her to carry on with the inhalers …”

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.

HSIB makes the following safety observation

Safety observation O/2021/109:

It may be beneficial if every child with asthma (confirmed or suspected) has access to a healthcare professional who has been trained in accordance with a nationally recognised training programme and undertakes regular reviews and continuing educational support.

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

Discussions with parents about their community pharmacy suggested there was a lack of public understanding of the role of a pharmacist.

“I think the role that I see is them just prescribing the medication to [my child]. They don’t have any sort of ... There’s no other role. I don’t see them being in any other role in [my child’s] asthma other than providing her with the inhalers.”

Wider conversations around prescribing highlighted that communication issues between secondary and primary care could lead to the interruption of medicines. The investigation heard that one parent sometimes had to collect prescriptions from the GP pharmacy and sometimes from the hospital pharmacy.

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.

HSIB notes the following safety action

Safety action A/2021/039:

NHS England and NHS Improvement is amending the guidance for the directed enhanced service on Structured Medication Reviews and medicines optimisation to clarify and raise awareness that children, even those too young to give consent, are eligible to receive these services.

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’.

HSIB notes the following safety action

Safety action A/2021/040:

NHS England and NHS Improvement is amending the service specification for the New Medicines Service, so that it is available to patients of all ages, including younger children with parental/guardian consent, who may benefit from the service.

6 Summary of findings, safety recommendations, safety observations and safety actions

6.1 Findings

  • 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.

HSIB makes the following safety recommendations

Safety recommendation R/2021/124:

HSIB recommends that NHS England and NHS Improvement, as a commissioning body, supports local systems to implement evidence-based interventions, such as standardised information and wheeze management plans, for the parents/carers of pre-school children. This will be undertaken in conjunction with the British Paediatric Respiratory Society.

Safety recommendation R/2021/125:

HSIB recommends that NHS England and NHS Improvement reviews the recommendations arising from the National Review of Asthma Deaths to prioritise and ensure the implementation of recommendations that are outstanding.

Safety recommendation R/2021/126:

HSIB recommends that NHS Digital reviews the supporting information for triaging the breathless child up to 16 years of age, to determine whether there are features of life-threatening breathing difficulty.

Safety recommendation R/2021/127:

HSIB recommends that NHS England and NHS Improvement supports clinical experts to work with professional bodies to develop training competencies for healthcare professionals with responsibility for caring for children with suspected or confirmed asthma.

Safety recommendation R/2021/128:

HSIB recommends that NHS England and NHS Improvement and NHSX identify and integrate data items into information technology systems to develop a greater understanding of the risk factors present in the community.

Safety recommendation R/2021/129:

HSIB recommends that NHSX, supported by NHS England and NHS Improvement, implements a discovery programme into the roadmap for the digital personal child health record focused on developing support, self-reporting and alerting for asthma self-care.

Safety recommendation R/2021/130:

HSIB recommends that Public Health England develops resources for young people and their parents/carers to raise awareness and enable them to self-manage asthma more effectively.

HSIB makes the following safety observations

Safety observation O/2021/105:

It may be beneficial if suspected or possible asthma diagnosis is communicated by secondary care services to children, families, and other care sectors, when asthma is being considered as a possibility (but not formally diagnosed).

Safety observation O/2021/106:

It may be beneficial if children were coded as having suspected asthma if under five years of age and on inhalers without an asthma diagnosis, recognising that the lack of a formal diagnosis leads to suboptimal care.

Safety observation O/2021/107:

It may be beneficial if diagnostic hubs are introduced into all regions in England, modelling those already in existence, to provide specialist equipment and expertise to patients with asthma.

Safety observation O/2021/108:

It may be beneficial for a health intervention to be delivered to enhance the general public’s knowledge and understanding of asthma, emphasising the potential seriousness of the condition. This could be linked to the modernisation of the Healthy Child Programme, which is being led by Public Health England.

Safety observation O/2021/109:

It may be beneficial if every child with asthma (confirmed or suspected) has access to a healthcare professional who has been trained in accordance with a nationally recognised training programme and undertakes regular reviews and continuing educational support.

HSIB notes the following safety actions

Safety action A/2021/038:

There is now an alternative vaccine for those children whose parents refuse the nasal flu vaccine due to the porcine gelatine content. Children in a higher risk group are eligible to receive an injectable vaccine as an alternative to the nasal vaccine.

Safety action A/2021/039:

NHS England and NHS Improvement is amending the guidance for the directed enhanced service on Structured Medication Reviews and medicines optimisation to clarify and raise awareness that children, even those too young to give consent, are eligible to receive these services.

Safety action A/2021/040:

NHS England and NHS Improvement is amending the service specification for the New Medicines Service, so that it is available to patients of all ages, including younger children with parental/guardian consent, who may benefit from the service.

7 Endnotes

[1] The World Health Organization (2020) defines health literacy as:

“The personal characteristics and social resources needed for individuals and communities to access, understand, appraise and use information and services to make decisions about health.”

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9 Appendix

Appendix A: NHS Pathway information

Supporting information for children aged 5 to 16 years
Supporting information for children aged 5 to 16 years
Supporting information for children aged 5 to 16 years
Supporting information for children aged 5 to 16 years

Image courtesy of NHS Digital.

Appendix B: Relationships between services
Appendix B: Relationships between services

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