1. Medicines optimisation in Asthma: stepping up and stepping down
Cathal Daly
Practice Prescribing Adviser for Elmham Clinical Services, Norfolk
Napp Pharmaceuticals Limited has funded this workshop including sourcing, briefing and paying an honorarium to the speaker
Date of preparation: June Job bag: UK/RES-16044

2. Literature review of key findings in asthma death confidential enquiries and studies
Underestimated attack severity
Poor adherence
Poor diagnosis
Underuse of steroids
Inadequate routine management
Inadequate past assessment
Unidentified risk status
Referral delayed or not considered
The National Review of Asthma Deaths (NRAD), was the first national investigation of asthma deaths in the UK and the largest study worldwide to date. Work on the NRAD was undertaken over a 3-year period and was one element of the Department of Health in England’s Respiratory Programme. The primary aim of the NRAD was to understand the circumstances surrounding asthma deaths in the UK in order to identify avoidable factors and make recommendations
to improve care and reduce the number of deaths.
Asthma deaths occurring between February 2012 and January 2013 were identified through the Office for National Statistics (ONS) for England and Wales, the Northern Ireland Statistics and Research Agency (NISRA) and the National Records of Scotland (NRS). Data were available for analysis on 195 people who were thought to have died from asthma during the review period
During the final attack of asthma, 87 (45%) of the 195 people were known to have died without seeking medical assistance or before emergency medical care could be provided.
The majority of people who died from asthma (112, 57%) were not recorded as being under specialist supervision during the 12 months prior to death. Only 83 (43%) were managed in secondary or tertiary care during this period.
Of 155 patients for whom severity could be estimated, 61 (39%) appeared to have severe asthma. Fourteen (9%) were being treated for mild asthma and 76 (49%) for moderate asthma. 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.
The expert panels identified factors that could have avoided death in relation to the health professional’s implementation of asthma guidelines in 89 (46%) of the 195 deaths, including lack of specific asthma expertise in 34 (17%) and lack of knowledge of the UK asthma guidelines in 48 (25%).
Royal college of Physicians. Why asthma still kills. Appendix 9 Literature review of key findings in asthma death confidential enquiries and studies. Available at: Accessed June 2016

3. What is the role of the pharmacist in medicines optimisation for people with asthma?
Including stepping up or stepping down with fixed dose inhalers?

4. We are all concerned about managing costs…

5. But cost review should adopt an appropriate lens through which to understand spend
ICS/LABA combination costs per device
MIMS Available at: Accessed June 2016

6. How is asthma currently being managed?

7. There are some common barriers to effective asthma management*…
GPs
Nurses
Pharmacists
Time available for consultation
94%
48%
62%
Patient adherence to therapy
60%
81%
69%
Patient understanding
43%
60%
62%
Patient inhaler technique
49%
60%
62%
*Slide content has been generated from a survey conducted with a range of healthcare professionals involved in the treatment and management of asthma patients (n=27). The survey was conducted on behalf of Napp Pharmaceuticals Ltd

8. Healthcare providers consider some key factors when moving people through the asthma treatment pathway*…
GPs
Nurses
Pharmacists
Patient response to therapy
80%
88%
77%
Patient familiarity with device
71%
69%
54%
Availability of different dosing strengths
69%
62%
70%
Continuity of active ingredient
63%
42%
70%
*Slide content has been generated from a survey conducted with a range of healthcare professionals involved in the treatment and management of asthma patients (n=26). The survey was conducted on behalf of Napp Pharmaceuticals Ltd

9. Multiple drug strengths, primary care and patient support materials and a dose counter are considered key product attributes*…
>90% - cite availability of multiple drug strengths
>80% - cite importance of primary care educational resources
>65% - cite importance of a dose counter [65% GPs, 80% nurses, 77% pharmacists]
>74% - cite importance of patient support materials [74% GPs, 92% nurses, 65% pharmacists]
*Slide content has been generated from a survey conducted with a range of healthcare professionals involved in the treatment and management of asthma patients (n=26). The survey was conducted on behalf of Napp Pharmaceuticals Ltd

10. Most respondents were confident or extremely confident about patient management but perceive the value of training*…
Most helpful training:
Management of complications
Management of severe asthma
*Slide content has been generated from a survey conducted with a range of healthcare professionals involved in the treatment and management of asthma patients (n=87). The survey was conducted on behalf of Napp Pharmaceuticals Ltd

11. Could I help improve clinical outcomes whilst managing cost pressures in my practice?

12. Some of the options which I have considered…
Taking a broader view of the service

13. Maintaining case review activities and identifying poor practice(s)
Regular clinical review (of patient management)
Use of spacers (to improve drug deposition)
Influence changes in prescribing

23. What are some of the clinical questions that you might be asking regarding this patient?
Discuss adherence
If the patient is using flutiform regularly, is beclomethasone an error? Should the patient be stepped up?
The patient does not appear to be using a spacer – should they be?

24. What might you do next?
Request a full medicines review with the patient
Cancel beclometasone
Reduce salbutamol to 1 inhaler per prescription
Leave patient on current therapy
Answer: a

25. BTS guidelines

26. BTS guidelines are the key recommendations for asthma management
PHARMACOLOGICAL MANAGEMENT
The aim of asthma management is control of the disease. Complete control is defined as:
no daytime symptoms
no night time awakening due to asthma
no need for rescue medication
no asthma attacks
no exacerbations
no limitations on activity including exercise
normal lung function (in practical terms FEV1 and/or PEF >80% predicted or best)
minimal side effects from medication
THE STEPWISE APPROACH
Start treatment at the step most appropriate to initial severity
Achieve early control
Maintain control by:
↑ stepping up treatment as necessary
↓ stepping down when control is good
Before initiating a new drug therapy practitioners should check adherence with existing therapies, inhaler technique and eliminate trigger factors.
British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. SIGN 141. BTS/SIGN, Available at: Accessed June 2016

27. Adult management advocates a stepwise approach to disease control
British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. SIGN 141. BTS/SIGN, Available at: Accessed June 2016

28. However relatively little information is given about how and when dose reduction should be done upon reaching sustained asthma control
STEPPING DOWN
Regular review of patients as treatment is stepped down is important. When deciding which drug to step down first and at what rate, the severity of asthma, the side effects of the treatment time on current dose, the beneficial effect achieved, and the patients preference should be taken into account.
Patients should be maintained at the lowest possible dose of inhaled corticosteroid. Reduction in inhaled corticosteroid dose should be slow as patients deteriorate at different rates. Reductions should be considered every three months, decreasing the dose by approximately 25-50% each time.
Rate of stepping down
Time-period considered sufficient for stability
Stepping down with combination doses
British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. SIGN 141. BTS/SIGN, Available at: Accessed June 2016

29. British Thoracic Society, Scottish Intercollegiate Guidelines Network
British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. SIGN 141. BTS/SIGN, Available at: Accessed June 2016

30. Round table discussion Spring 2016

31. A multi-disciplinary group worked together to provide practical guidance on stepping up and stepping down in practice
The discussion group was commissioned by Napp Pharmaceuticals Limited
Chair: Dr James Chalmers (Chair, Consultant Respiratory Physician and Senior Clinical Lecturer)
Cathal Daly (CCG Prescribing Lead)
Dr Steve Holmes (GP, Park Medical Practice, Shepton Mallet)
Deirdre Siddaway (Respiratory Nurse Specialist, Ixworth Surgery, Suffolk)

32. Key recommendations for choosing patients for step down and selecting the most appropriate treatment
Step down is appropriate if symptoms are well controlled with appropriate medication (for at least 3 months), and minimal use of SABA therapy1
The step down process should be a shared decision between clinician and patient (using PAAP)
For patients on ICS/LABA combination products, step down to the next available strength, reducing the ICS dose by 25–50% each time
Availability of lower doses should be considered when stepping up, stepping down, and changing treatment
Review inhaler technique and consider which device is most appropriate for each individual patient
SABA=short-acting β2-agonist; PAAP=personalised asthma action plan; LABA=long-acting β2-agonist
Guidelines in Practice. Practical Considerations when stepping down treatment in asthma: a round-table discussion. Available at: Accessed June 2016

33. Common errors and areas of confusion were identified in discussion
Steady and simple step down
Keep the step down simple and steady and ensure that the process is relevant to the needs of each individual
Avoid changing more than one factor (e.g. inhaler device, ICS, or LABA) at a time
For people using combination ICS/LABA therapies, step down to the next available dose of the same product
Avoid multiple changes
Step down to the next dose in the same product
Ensure each patient has a PAAP
ICS=inhaled corticosteroid; LABA=long-acting β2-agonist; PAAP=personalised asthma action plan

34. Measuring the success of step-down initiatives should be considered
Comparing the percentage of patients pre and post step down on the top dose of each drug
Use data alongside measures of control (e.g. SABA use, hospital admissions, GP visits)
Review data to identify people on high dose treatment as candidates for step down discussion

35. Regular training is crucial to supporting efficient patient management
Training carried out at least annually
Appoint asthma lead for each practice
Step down discussion included in primary care education
Training needs to be carried out at least annually
An asthma lead should be appointed at each practice, this person is responsible for keeping abreast of developments and sharing their knowledge with colleagues
Discussion and training in step down should be included in primary care education in asthma, particularly given the absence of practical steps in the current guidelines

36. Algorithm for stepping up / stepping down*
Include link for algorithm when available
Algorithm for stepping up / stepping down*
*This management algorithm was developed by a multidisciplinary expert group: Chalmers J et al, and was
commissioned by Napp Pharmaceuticals Limited

37. Working group proposed algorithm
ACT, asthma control test; A&E, accident & emergency; bd, twice daily; BDP, beclometasone propionate dose equivalent; BTS, British Thoracic Society; DPI, dry powder inhaler; FEV1, forced expiratory volume in 1 second; GINA, Global Initiative for Asthma; GP, general practitioner; ICS, inhaled corticosteroid; ICU, intensive care unit; LABA, long-acting beta-agonist; MDI, metered-dose inhaler; od, once daily; PEF, peak expiratory flow; RCP: Royal College of Physicians; SABA, short-acting beta-agonist; SIGN, Scottish Intercollegiate Guidelines Network
Fostair=beclometasone dipropionate/formoterol fumarate dihydrate; Flutiform=fluticasone propionate/formoterol fumarate dihydrate; Relvar=fluticasone furoate/vilanterol trifenatate; Seretide=fluticasone propionate/salmeterol xinafoate; Symbicort=budesonide/formoterol fumarate dehydrate ®flutiform is a registered trade mark of Jagotec AG and is used under licence; ®Fostair is a registered trade mark of Chiesi Farmaceutici S.p.A; ®SERETIDE and EVOHALER are registered trademarks of the GlaxoSmithKline Group of Companies; ®Symbicort is a registered trade mark of AstraZeneca AB; ®Relvar is a registered trademark of the GlaxoSmithKline Group of Companies; ®Sirdupla is a registered trademark of Generics
(UK) Limited; ®DuoResp Spiromax is a registered trademark of IVAX International B.V.

38. Working group proposed algorithm
ACT, asthma control test; A&E, accident & emergency; bd, twice daily; BDP, beclometasone propionate dose equivalent; BTS, British Thoracic Society; DPI, dry powder inhaler; FEV1, forced expiratory volume in 1 second; GINA, Global Initiative for Asthma; GP, general practitioner; ICS, inhaled corticosteroid; ICU, intensive care unit; LABA, long-acting beta-agonist; MDI, metered-dose inhaler; od, once daily; PEF, peak expiratory flow; RCP: Royal College of Physicians; SABA, short-acting beta-agonist; SIGN, Scottish Intercollegiate Guidelines Network
Fostair=beclometasone dipropionate/formoterol fumarate dihydrate; Flutiform=fluticasone propionate/formoterol fumarate dihydrate; Relvar=fluticasone furoate/vilanterol trifenatate; Seretide=fluticasone propionate/salmeterol xinafoate; Symbicort=budesonide/formoterol fumarate dehydrate ®flutiform is a registered trade mark of Jagotec AG and is used under licence; ®Fostair is a registered trade mark of Chiesi Farmaceutici S.p.A; ®SERETIDE and EVOHALER are registered trademarks of the GlaxoSmithKline Group of Companies; ®Symbicort is a registered trade mark of AstraZeneca AB; ®Relvar is a registered trademark of the GlaxoSmithKline Group of Companies; ®Sirdupla is a registered trademark of Generics
(UK) Limited; ®DuoResp Spiromax is a registered trademark of IVAX International B.V.

39. IN SUMMARY We cannot review all of our patients overnight…
We can educate ourselves on when to step-up and step-down
We can support our clinical colleagues to do the same
We still need to address the wider facets of asthma care:
Inhaler technique
Use of spacers
Patient engagement
Managing costs

41. Case studies

49. What might you do next? Check spacer use
Review with the intention of stepping patient up
Review with the intention of stepping patient down
Leave patient on current therapy
ANSWER: a and d

57. What might you do next? Reduce salbutamol prescription to 1 inhaler
Call patient in for medicine review
Discuss internal training opportunity relating to asthma review
Leave the patient on current therapy
ANSWER: a, b and c

62. What might you do next? Review with the intention of stepping down
Check for a spacer
Leave the patient on current therapy
Call patient in for medicine review
ANSWER: b and c

67. What might you do next? Review with the intention of stepping up
Check for a spacer
Discuss internal training opportunity relating to asthma review
Leave the patient on current therapy
ANSWER: b and c

68. REMEMBER: review patients who are on 12 inhalers or more a year without a preventer

69. Thank you for participation