Review the need for ICS/LABA inhaler in COPD patients with an FEV1≥50%
Background
Prolonged treatment with inhaled corticosteroids (ICS) at high doses carries a risk of
systemic side effects such as adrenal suppression and a reduced bone mineral
density predisposing patients to osteoporosis. There have been reports of a small
risk of glaucoma and cataracts with prolonged high doses of inhaled corticosteroids,
together with an increased risk of developing diabetes. Hoarseness, dysphonia,
throat irritation, and candidiasis of the mouth or throat may occur. Paradoxical
bronchospasm has been reported very rarely. Anxiety, depression, sleep
disturbances, behavioural changes including hyperactivity, irritability, and aggression
have been reported; hyperglycaemia (usually only with high doses), cataracts, skin
thinning and bruising have also been reported.
Evidence statements in the NICE Clinical Guideline on COPD management say that
the use of combination inhalers of inhaled corticosteroid / long acting bronchodilator
agent (ICS/LABA) is not a cost-effective option for use in all COPD patients. So, the
the guidelines recommend that high dose ICS/LABA inhalers are only used in
patients with moderate and severe COPD (FEV1<50%).
The local COPD guidelines were produced to support the implementation of the
NICE COPD Clinical Guidelines. They recommend that a long acting muscarinic
agent (LAMA) is used when a short acting bronchodilator alone is not controlling
symptoms. After a 4 week trial of a LAMA, if this is ineffective, then it is stopped and
the patient changed to either a LABA (FEV1≥50%) or ICS/LABA (FEV1 <50%)
combination inhaler depending on the FEV1.
Aim
To optimise the use of ICS/LABA combination inhalers in COPD patients to ensure
that patients can use their device correctly and that they are being prescribed safely
and effectively.
Audit Objectives
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Patients with a repeat prescription for a high dose ICS / LABA combination
inhalers have a documented diagnosis of COPD.
Patients are able to use their inhaler correctly.
Patients with FEV1≥50% prescribed an ICS/LABA combination inhaler are
reviewed for suitability for a switch to a LAMA or LABA inhaler in line with the
COPD guidelines.
Written by: Sajida Khatri March 2010; Updated by: Darshna Gokal July 2010, Karen Homan, Sally-Jane Hamilton 2014, BCCG
MMT

Patients with recorded adverse effects to ICS/LABA are reviewed and
changed if clinically appropriate to a LAMA alone or LABA alone.
Patient Identification
Search for all patients on a repeat prescription for an ICS/LABA combination inhaler
and on the COPD register with an FEV1 ≥50% (see Appendix 1 for for SystmOne®
search procedure).
Data Collection
See Appendix 2 for data collection spread sheet.
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ICS/LABA combination inhaler prescribed.
Diagnosis recorded – COPD, COPD & Asthma
COPD review within the last 12 months – Yes or No
FEV1 value and date recorded.
Inhaler technique check documented in the last 12 months.
Steroid adverse effect recorded
Analysis
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Percentage of patients with a diagnosis recorded of COPD, COPD & Asthma.
Percentage of patients with a COPD review within the last 12 months.
Number of patients with an FEV1≥50% on an ICS/LABA combination inhaler.
Percentage of patients that have had their inhaler technique checked.
Patients with high dose steroid adverse effects recorded.
Possible Action Plan
For each patient, record what action is required. Some suggested actions include:
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If incorrect diagnosis recorded, then read code diagnosis.
If no COPD review within the last 12 months, review patient.
Review COPD patients with an FEV1≥50% on an ICS/LABA combination
inhaler, and consider changing to LAMA inhaler alone or LABA inhaler alone if
clinically appropriate.
 If inhaler technique has not been checked, review patient.
 If patient is experiencing side effects, review treatment.
References
 BNF May 2014 accessed on-line at www.medicinescomplete.com user
registration required.
 COPD guidelines. Updated 2013. Bedfordshire and Luton Joint Prescribing
Committiee and Bedfordshire Respiratory Implementation Group.
 NICE Clinical Guideline on the Management of COPD in Adults in Primary
and Secondary Care, issued June 2010.
Written by: Sajida Khatri March 2010; Updated by: Darshna Gokal July 2010, Karen Homan, Sally-Jane Hamilton 2014, BCCG
MMT
Appendix 1
Running the SystmOne® Search
1. In SystmOne enter Clinical Reporting
Clinical Reporting)
Searching for the high dose inhalers:
(in the top toolbar select Reporting 
2. Click ‘New’ to open a new search. Give the search a name.
3. From the left hand menu select Repeat Templates
4. Then select Exact drugs, and click on the brown bottle icon
5. The ‘Select Multiple Drugs or Appliances’ window opens. In the search box type
the drug name you are searching for and press Enter
6. Click on the drug you want to select to highlight it and click on the black arrow to
move it into the right hand pane
Written by: Sajida Khatri March 2010; Updated by: Darshna Gokal July 2010, Karen Homan, Sally-Jane Hamilton 2014, BCCG
MMT
7. Continue to select all the drugs and move them into the right hand pane. Make
sure you search both brand and generic:
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Beclometasone/Formoterol Inhaler 100/6
Fostair® 100/6 Inhaler
Budesonide/Formoterol Inhaler 400/12(60D)
Budesonide/Formoterol Inhaler 200/6(120D)
Symbicort® Turbohaler 400mcg/12mcg (60 D)
Symbicort® Turbohaler 200mcg/6mcg (120 D)
Fluticasone/Formoterol Inhaler 250/10mcg120D
Flutiform® Inhaler 250/10mcg (120 D)
Fluticasone/Salmeterol Inhaler 250/25mcg120D
Fluticasone/Salmeterol Inhaler 500/50mcg 60D
Fluticasone/Salmeterol Inhaler 250/50mcg 60D
Seretide® 250 Evohaler 250mcg/25mcg(120D)
Seretide® 500 Accuhaler 500mcg/50mcg(60D)
Seretide® 250 Accuhaler 250mcg/50mcg(60D)
Fluticasone /Vilanterol Inhaler 92µg/22µg
Relvar® Ellipta® 92µg/22µg
Fluticasone /Vilanterol Inhaler 184µg/22µg
Relvar® Ellipta® 184µg/22µg
8. When you have selected all the drugs click OK to close the Selection window
9. Click OK to complete & close the search
Searching for the FEV1:
10. Click ‘New’ to open a new search. Give the search a name
11. From the left hand pane select Numerics
12. Tick the box for ‘Numeric in Read Code Cluster’
Written by: Sajida Khatri March 2010; Updated by: Darshna Gokal July 2010, Karen Homan, Sally-Jane Hamilton 2014, BCCG
MMT
13. From the drop down menu select ‘FEV1 – Codes for FEV1’
14. In the boxes below choose >= and 50, to identify those with an FEV1 of more
than or equal to 50%
15. Tick the box ‘Only report on the most recent reading’
16. Click OK to complete & close the search
To join the searches:
17. Click ‘New’ to open a new search. Give the search a name
18. In the left hand pane select Report Joining  Join to more than two reports
19. Click on Select reports
20. The Select Reports window opens
21. Locate the two searches run above, and double click on them to move them into
the Selected Reports window at the bottom
22. Locate the COPD register (System Wide  QOF  COPD  COPD001
Register) and double click on it to select it
Written by: Sajida Khatri March 2010; Updated by: Darshna Gokal July 2010, Karen Homan, Sally-Jane Hamilton 2014, BCCG
MMT
23. Click OK
24. Back in the search window select the first join type:
(This will search for patients on the selected drugs
AND FEV1>50% AND on the COPD register)
25. Click OK to complete & close the search
26. Finally, click on the green triangle to run the search
, and the magnifying glass
to view the patients
Written by: Sajida Khatri March 2010; Updated by: Darshna Gokal July 2010, Karen Homan, Sally-Jane Hamilton 2014, BCCG
MMT
Appendix 2: Data Collection Template - Review the need for ICS / LABA inhaler in COPD patients with an FEV1≥50%
Practice ………………… Number of patients reviewed…………Audit carried out between …/…/2014 and …/…/2014 Audit lead ………………………
Patient
ID
Medication
details
ICS
/LABA
inhaler
Dose
Indication for ICS
/LABA inhaler in
patient notes?
COPD review
in the last 12
months
FEV1 % value and
date recorded.
Inhaler technique
check documented?
Yes or No
COPD
Yes
FEV1
%
Yes
COPD/
Asthma
No
Date
recorded
No
Any side effects reported (e.g.
symptoms of adrenal
suppression, low bone mineral
density, glaucoma, diabetes)
Action Plan
for individual
patient
Appendix 3
Example Patient Information Letter
Practice
Address
Tel:
Fax:
Date
~[Title/Initial/Surname]
~[Patient Address Block]
Dear ~[Title]~[Surname],
We would like to invite you to come for a COPD review as we are currently looking at
the medication we use to treat COPD where a high dose inhaled corticosteroid / long
acting reliever has been prescribed. National recommendations advise us to review
COPD patients regularly to check such things as how well the COPD is managed,
inhaler technique, how often inhalers are used, any side effects experienced, and
whether treatment needs to be changed.
Please book an appointment to see the asthma nurse at your earliest convenience.
Yours sincerely
Practice Nurse