Dr Mark L Levy FRCGP General Practitioner & Respiratory Lead Harrow Clinical Lead National Review of Asthma Deaths Executive Board Member GINA marklevy@animalswild.com www.consultmarklevy.com @bigcatdoc www.animalswild.com

National Review of Asthma Deaths (NRAD) www.rcplondon.ac.uk/NRAD Why asthma still kills National Review of Asthma Deaths (NRAD) www.rcplondon.ac.uk/NRAD What are the lessons we’ve learnt? Rachael Andrews NRAD programme coordinator, Royal College of Physicians (RCP) Rhona Buckingham Operations director, Clinical Effectiveness and Evaluation Unit (CEEU), Royal College of Physicians (RCP) Hannah Evans Medical statistician, Royal College of Physicians (RCP) Caia Francis Senior lecturer in adult nursing, University of the West of England, and former chair, respiratory forum, Royal College of Nursing (RCN) Rosie Houston NRAD programme manager, Royal College of Physicians (RCP) (until February 2013) Derek Lowe Medical statistician, Royal College of Physicians (RCP) Dr Shuaib Nasser Consultant allergist and respiratory physician; British Society for Allergy and Clinical Immunology (BSACI); Eastern Region Confidential Enquiry of Asthma Deaths Dr James Y Paton Reader in paediatric respiratory medicine, Royal College of Paediatrics and Child Health (RCPCH) Navin Puri Programme manager for respiratory medicine Mark L Levy Clinical Lead, NRAD (2011-2014)

Case review 1 (from a number of cases - for annonymity) Female with late onset asthma Confirmation of diagnosis delayed - after many months on therapy with intermittent salbutamol (28% reversibility on spirometry) Low dose inhaled corticosteroids (beclometasone 100mcg prescribed She had a poor attendance record Asthma review with practice nurse: Waking at night; daytime symptoms and asthma limited her lifestyle Px last 12 months: 16 salbutamol inhalers; 1 beclometasone inhaler She was advised by the nurse to make an appointment to see the doctor without any advice or changes in the treatment ; no record of a PAAP The patient died 8 weeks later without ever making an appointment to be seen

Case history – from a few cases to preserve confidentiality male died age 6 - asthma diagnosed in 3rd year PICU - life threatening asthma attack 1X Follow up by paediatrician – failed 2X OPD - discharged from care (Trust policy) seen by his GP URTI: red and inflamed throat chest was clear with very little wheeze but cough ++ no record of any vital signs or SaO2 salbutamol 2 puffs up to 4 times daily prn; Amoxicillin125mg tds, and a volumatic Died 10 days later – pre-hospital cardiac arrest - status asthmaticus on Post Mortem

Case history – from a few cases to preserve confidentiality – 6yr old male At the time of death : not using asthma medication His last prescription - 3/12 before death Formoterol easyhaler Previous 12/12: Salbutamol – 12 inhalers; Seretide 50/25 – 1 inhaler; Formoterol – 2 inhalers; Qvar – 1 inhaler and Montelukast – 2 prescriptions (1 month supply each) Points: Neither hosp or GP taking the responsibility to follow this child up who had fallen between the hospital and the GP (?? Trust policy) ‘At-risk’ status not recognised Failure to take appropriate medication and attend follow-up appointments  asthma review / no personal asthma action plan / ? child protection issues

National Review of Asthma Deaths (NRAD) Key Messages Diagnosis (Asthma/COPD) Failure to call for or get help (45%) 77% no PAAP Failure to recognise danger signals Excess relievers/insufficient ICS Failure to follow up after attacks Failure to appreciate that asthma is a chronic illness – assess and optimise!

Overall aim of NRAD The aim of the NRAD was to understand the circumstances surrounding asthma deaths in the UK, in order to identify avoidable factors and make recommendations for changes to improve asthma care as well as patient self-management (This was not a prevalence study – did not aim to determine the number of asthma deaths in the UK)

Underlying cause of death On the basis of what is written on the Medical Certificate of the Cause of Death (MCCD), the Office for National Statistics (ONS), National Records of Scotland (NRS), Northern Ireland Statistics and Research Agency (NISRA) then determine the underlying cause of death. Based on the formula used world wide for this purpose - International Classification of Disease (ICD-10) So where an MCCD reads: The underlying cause of death (UCD) is determined to be Asthma The underlying cause of death (UCD) is also Asthma Ia Respiratory Failure Ib Asthma Ic Chest infection Ia Chest infection II Asthma, IBS, Liver failure, sepsis OR

NRAD Notification (Section 251 of the NHS Act 2006) Office for National Statistics (ONS); National Records of Scotland (NRS); Northern Ireland Statistics and Research Agency (NISRA). NRAD Website Clinicians Families / Friends Coroners Local co-ordinators (374 in 297 Hospitals) (ONS, NISRA and NRS) notified the project team of asthma deaths on a monthly basis, but some notifications also came directly from health professionals, coroners, families and others aware of the enquiry. This included 374 local coordinators who were appointed in 297 hospitals.

Asthma mentions MCCD* (3544) NRAD flow diagram - 1 Asthma mentions MCCD* (3544) Excluded – not underlying cause of death or >75 and asthma in part II (2644) Included (900) – 38 CYP * MCCD= Medical Certificate of Cause of Death

Clinical information requested for final 2 years (n=900) ALL CONSULTATIONS ALL CORRESPONDENCE ALL PRESCRIPTIONS (ACUTE & REPEAT) PM/CORONERS REPORT/AMBULANCE COPIES OF ANY LOCAL REVIEWS

Asthma mentions MCCD (3544) NRAD flow diagram - 2 Asthma mentions MCCD (3544) Excluded – not underlying cause of death or >75 and asthma in part II (2644) Included (900) Clinical Lead & Expert panel 276/900 included for panel discussion

Multidisciplinary confidential enquiry panels 37 panel meetings 174 volunteer assessors 6 -10 cases per panel Two assessors per case Panel assessment form Consensus agreement 195/276 died from asthma 1000 panel recommendations Major factors in 60% deaths potentially avoidable

12/28 (42%) of children/YP were thought to have mild/mod asthma Patients Duration of asthma (n=104) : 0-62 yrs (Median 11 yrs) Age at diagnosis (n=102) : 10 mths – 90 yrs (Median 37 yrs) Age at death (n=193) : 4 yrs – 97 yrs (Median 58 yrs) Severity of asthma (n=155): (classified by the Clinicians) Mild 14 (9%) Moderate 76 (49%) Severe 61 (39%) 12/28 (42%) of children/YP were thought to have mild/mod asthma

Definition of severity of asthma: ‘Amount of treatment required to gain control of the asthma’ 37 (19%) - had assessment of asthma control European respiratory Journal 2008;32(3):545-54

6th May 2014 www.ginasthma.org

GINA assessment of symptom control Symptoms Level of asthma symptom control In the past 4 weeks, has the patient had: Well-controlled Partly controlled Uncontrolled Daytime asthma symptoms more than twice/week? Yes  No  None of these 1-2 of these 3-4 of these Any night waking due to asthma? Yes  No  Reliever needed for symptoms* more than twice/week? Yes  No  Any activity limitation due to asthma? Yes  No  *Excludes reliever taken before exercise, because many people take this routinely GINA 2014, Box 2-2A

GINA 2014, Box 2-2

Giraud, European respiratory Journal. 2002;19(2):246-51 Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability AIS = Asthma Instability Score Giraud, European respiratory Journal. 2002;19(2):246-51

Results of the first (before training), and second and third Vitalograph Aerosol Inhalation Monitor (AIM) tests after training Levy et al, Prim Care Respir J 2013;22(4):406-411

pMDI technique using the Vitalograph Aerosol Inhalation Monitor (AIM) and GINA Control Levy et al, Prim Care Respir J 2013;22(4):406-411

pMDI with and without spacer and GINA Control Levy et al, Prim Care Respir J 2013;22(4):406-411

GINA control vs BDP pMDI (Clenil and QVAR) vs QVAR Easi-Breathe Levy et al, Prim Care Respir J 2013;22(4):406-411

The control-based asthma management cycle NEW! GINA 2014, Box 3-2

Excess use of beta-agonists (SABA)

Asthma consultation = opportunity to reduce risk Sheriff Kelly said that Emma's death might have been avoided if the consultant paediatrician at Yorkhill Hospital in Glasgow and her GP or pharmacist had acted differently. Review dose inhaled steroids in children

Prescribing NRAD Recommendation: Electronic surveillance of prescribing in primary care to alert clinicians and pharmacists -excessive Short Acting Beta-Agonist Bronchodilators (SABAs) or too few preventers

Practices (denominator = 138 except where mentioned otherwise) Median 4 Doctors/practice (n=131); median 9000 patients Quality Outcomes Framework (QOF) data (n=89) Full points 74/89 (83%) Asthma reviews - performed by: 78/136 (57%) GPs 3 (2%) GP with Special Interest 82 (60%) Nurses with diploma 62 (46%) nurses without asthma diplomas * These practices had a median of 4 doctors IQR (3,5) n=131 returns, and cared for a median 9500, IQR (6250,12000) patients, n= 134 returns. Thirteen (10%) of 131 of the practices had only one full time doctor, 9 of whom employed between one and six part time doctors. Thirty eight (28%) of 135 practices said they had a doctor with a special interest in respiratory diseases. One hundred (81%) of 124 practices who returned data 100 (81%) employed at least one nurse known to have an asthma diploma. Fifty seven (41%) of 138 practices provided student teaching and GP postgraduate training, and 15 (11%) of 138 were research practices.   for 89/138 (64%) of the 195 people who died from asthma; full points (i.e. 45 points) were attained by 74 (83%) of the 89 practices, with a median of 45, IQR (45,45 points) for these 89 practices. Asthma reviews were said to be performed by GPs in 78 (57%) of 136 practices, by GPs with an interest in respiratory diseases in 3 (2%), by nurses with an asthma diploma in 82 (60%) and by ‘general’ practice nurses in 62 (46%),

Main conclusions for the 276 cases considered by panels People who died from asthma 195 (71) People who had asthma but did not die from it 36 (13) People who did not have asthma 27 (10) Insufficient information:   - To decide whether the person had asthma 14 (5) - To decide whether the person died of asthma 4 (1)

Diagnosis of asthma, COPD and asthma-COPD overlap syndrome (ACOS) A joint project of GINA and GOLD

© Global Initiative for Asthma GINA 2014 GINA 2014, Box 5-4 © Global Initiative for Asthma

Quality of Care – Panel Conclusions All ages (195) 0-19 (28) Chronic Management - Adequate 56 (29%) 2 (7%) Previous Attack Management 69 (35%) 8 (29%) Final Attack Management 66 (34%) 13 (46%) Overall Standard of Asthma Care - Good practice 31 (16%) 1 (4%) Adequate – level of care panel members would accept for themselves or their families National audit Standard national asthma template

Major factors identified by panels (i. e Major factors identified by panels (i.e. contributed significantly to the deaths, where different management would reasonably be expected to have affected the outcome ) n Did not recognise high-risk status 21 Lack of specific asthma expertise 17 Did not perform adequate asthma review 16 Did not refer to another appropriate team member Failure to take appropriate medication in month before death 15 Failure to take appropriate medication in year before death 13  Over prescribed short acting beta agonist bronchodilator 13 Poor or inadequate implementation of policy/pathway/protocol Lack of knowledge of guidelines 12 Did not adhere to medical advice 10

Potential avoidable factors identified by panels in recognition of risk status Primary Care Secondary Care < 10 yrs N=10 n(%) 10-19 yrs N=18 N=7 N=9 One or more avoidable factors 7(70) 15(83) 2(29) 3(33) Delay in recognising Risk status 5(50) 9(50) 0(0) 2(22) Quality of assessment 6(60) 14(78) 2 (29) 1 (11) Did not diagnose or recognise high risk status 5 (50) 13 (72)

The panels identified potential avoidable factors related to the assessment of the final attack Primary Care (n=38) n(%) Secondary Care (n=59) < 10 yrs Sec Care (n=2) 10-19 yrs Sec Care (n=5) ≥ 1 factors 13(34) 20(34) 1(50) 1(20) NRAD Recommendation: Every NHS hospital and general practice - clinical lead for asthma services responsible for formal training in acute asthma care Poor in prim and sec care Extract from Table 6.3.5 Abpout a third inadequate Rx

The panels identified potential avoidable factors related to the management of the final attack Primary Care (n=38) n(%) Secondary Care (n=59) < 10 sec care (n=2) 10-19 prim care (n=1) 10-19 sec care (n=5) ≥ 1 factors 12(32) 20(34) 1(50) 1(100) 2(40) Delay or failure : to initiate treatment / to follow guidelines Use of NIV in acute severe asthma Failure to recognise risk features (High normal pCO2 levels) NRAD Recommendation: Every NHS hospital and general practice - clinical lead for asthma services responsible for formal training in acute asthma care The use of patient-held ‘rescue’ medications should be considered for all patients who have had a life-threatening asthma attack or a near fatal episode Poor in prim and sec care Extract from Table 6.3.5 Abpout a third inadequate Rx

The panels identified potential avoidable factors related to follow-up after attacks 19/195 (10%) died within 28 days of hospital discharge for asthma attack In 13/19 (68%) potentially avoidable factors discharge into the community follow-up arrangements At least 40 (21%) attended an emergency department (ED) with an asthma attack in the previous year (23 ≥ 2 occasions)   NRAD Recommendations – follow-up and referral: Follow-up after every attendance for an asthma attack Secondary care follow-up - after every hospital admission for asthma, and after two or more ED visits with an asthma attack in 12 mths Patients with > 2 courses systemic corticosteroids or on BTS step 4/5 must be referred to a specialist asthma service Nineteen (10%) of those who died did so within 28 days of being treated in hospital for an asthma attack. In 13 (68%) of these patients the panels identified potentially avoidable factors in relation to both their discharge into the community and follow-up arrangements. At least 40 (21%) of those who died had attended an emergency department (ED) with an asthma attack in the previous year and of these 23 had attended on at least two occasions.   According to national standards people admitted to hospital with an acute exacerbation of asthma should have a structured review by a member of a specialist respiratory team before discharge.1, 2, 43-47

Asthma Deaths – What now? Use of Informatics New Models of Care Specialist involvement PAAP National Audit Levy & Winter. Thorax, 3 Feb 2015

Whqt cqn we do? Change system (? More specialist involvement) Review Diagnoses (Asthma, COPD & ACOS) Identification and reduction of risk Current control AND future risk Admissions & ED attendances Prescriptions (Salbutamol & ICS) Educate colleagues and patients Implement guidelines (& change them) PAAPs Improve quality of death certification Levy ML, Winter R. Asthma deaths: what now? Thorax Feb 2015 Levy ML, The National Review of Asthma Deaths – what did we learn and what needs to change? Breathe, March 2015

Post attack review

Key recommendations 1: Organisation of NHS services Every NHS hospital and general practice - clinical lead for asthma services Patients with > 2 courses systemic corticosteroids or on BTS step 4/5 must be referred to a specialist asthma service Follow-up arrangements : after every attendance for an asthma attack Secondary care follow-up - after every hospital admission for asthma, and after two or more times ED visits with an asthma attack in 12 mths A standard national asthma template Electronic surveillance of prescribing in primary care to alert clinicians (excessive SABAs or too few preventers A national ongoing audit of asthma 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. Patients with asthma must be referred to a specialist asthma service if they have required more than two courses of systemic corticosteroids, oral or injected, in the previous 12 months or require management using British Thoracic Society (BTS) stepwise treatment 4 or 5 to achieve control.1 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. This should improve the documentation of reviews in medical records and form the basis of local audit of asthma care. 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. A national ongoing audit of asthma should be established which would help clinicians, commissioners and patient organisations work together to improve asthma care.

Key recommendations 2: Medical and Professional Care All people with asthma -personal asthma action plan (PAAP) Structured review by a healthcare professional with specialist training in asthma, at least annually Factors that trigger or make asthma worse must be elicited routinely and documented in the medical records and personal asthma action plans (PAAPs) Assess asthma control at every asthma review. Where loss of control is identified, immediate action is required including escalation of responsibility, treatment change and arrangements for follow-up Aware of the features that increase the risk of asthma attacks and death, including the significance of concurrent psychological and mental health issues All people with asthma should be provided with written guidance in the form of a personal asthma action plan (PAAP) which details their own triggers and current treatment, and specifies how to prevent relapse and when to seek help in an emergency. People with asthma should have a structured review by a healthcare professional with specialist training in asthma, at least annually. People at high risk of severe asthma attacks should be more closely monitored, ensuring their personal asthma action plans (PAAPs) are reviewed and updated at each review. Factors that trigger or make asthma worse must be elicited routinely and documented in the medical records and personal asthma action plans (PAAPs) of all people with asthma, so that measures can be taken to reduce their impact. An assessment of recent asthma control should be undertaken at every asthma review. Where loss of control is identified, immediate action is required including escalation of responsibility, treatment change and arrangements for follow-up. Health professionals must be aware of the features that increase the risk of asthma attacks and death, including the significance of concurrent psychological and mental health issues.

Key recommendations 3: Prescribing and medicines use Patients prescribed > 12 SABAs in 12 mths - for urgent review of their asthma control An assessment of inhaler technique - routinely undertaken and also checked by the pharmacist Monitor non-adherence with preventers Where long-acting beta agonist bronchodilators are prescribed for people with asthma - should be in a single combination inhaler All asthma patients who have been prescribed more than 12 short-acting reliever inhalers in the previous 12 months should be invited for urgent review of their asthma control, with the aim of improving their asthma through education and change of treatment if required. 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. Non-adherence with preventer inhaled corticosteroids is associated with increased risk of poor asthma control and should be continually monitored. The use of combination inhalers should be encouraged. Where long-acting beta agonist bronchodilators are prescribed for people with asthma, they should be prescribed with an inhaled corticosteroid in a single combination inhaler.

Key recommendations 4: Patient factors and perception of risk Patient self-management should be encouraged to reflect their known triggers (increase Rx before the start of the hay fever season, avoiding NSAIDs, early use of oral corticosteroids with viral or allergic-induced exacerbations) Smoking and/or exposure to second-hand smoke -documented & offer referral 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 medications, recognising when asthma is not controlled and knowing when and how to seek emergency advice Efforts to minimise exposure to allergens and second-hand smoke should be emphasised especially in young people with asthma Patient self-management should be encouraged to reflect their known triggers eg increasing medication before the start of the hay fever season, avoiding non-steroidal anti-inflammatory drugs or by the early use of oral corticosteroids with viral or allergic-induced exacerbations. A history of smoking and/or exposure to second-hand smoke should be documented in the medical records of all people with asthma. Current smokers should be offered referral to a smoking-cessation service. 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 medications, recognising when asthma is not controlled and knowing when and how to seek emergency advice. Efforts to minimise exposure to allergens and second-hand smoke should be emphasised especially in young people with asthma.

Eastern Region Confidential Enquiry of Asthma Deaths Supporting partners Eastern Region Confidential Enquiry of Asthma Deaths

Acknowledgements Colleagues on the NRAD Core team Rachael Andrews Programme coordinator Hannah Evans Medical statistician Jenny Gingles Northern Ireland Debora Miller Northern Ireland Rosie Houston Programme manager (until February2013) Navin Puri Programme manager (from February 2013) Laura Searle Program Administrator (until October 2013) Strategic Advisory Group (Robert Winter) ; RCP Rhona Buckingham & Kevin Stewart (CEEU) Steering Group (Derek Lowe) ; Expert Advisors ; Panel members ; Hospital co-ordinators ; HQIP (Jenny Mooney) ; Hannah Bristow (RCP Press Team) Craig Bell (Scotland), Jenny Gingles (NI) and Karen Gully (Wales) Writers group – Caia Francis, Shuaib Nasser, Jimmy Paton and Mike Thomas Those who died from asthma & the clinicians who returned data