Cannock Chase Clinical Commissioning Group South East Staffordshire and Seisdon Peninsula Clinical Commissioning Group Stafford and Surrounds Clinical Commissioning Group East Staffordshire Clinical Commissioning Group

South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Approved August 2017 Written by MMSESSP (2015), updated 2017 Review August 2018

South Staffordshire Area Prescribing Group

COPD Prescribing Guidelines

Inhaler choices in this guideline are different from previous versions produced by the APG.

It is not expected patients controlled on established therapy will be changed without clinical assessment.

All NEW patients should be initiated on inhaler therapy as per these guidelines.

South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page | 1

COPD Prescribing Guidelines This guideline is intended for use to aid diagnosis in patients with a suspected diagnosis of a COPD, and the management of patients with a confirmed diagnosis of COPD. It

is aimed primarily at cost-effective prescribing, and will be reviewed annually as evidence is rapidly emerging in this field

Diagnosis

COPD is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow obstruction that is due to airway and/or alveolar

abnormalities. The disease is predominately caused by smoking but other environmental exposures may contribute.2, 3

3. Interpreting Spirometry

Quality assessment Is it airflow

obstruction? Severity assessment Make sure it isn’t asthma

3 blows with FEV1 values within 100ml of one another

FEV1/ FVC <0.7 FEV1

> 80% Mild = GOLD stage 1 Check reversibility to salbutamol (>200ml consider asthma).

Consider any other clinical signs or

symptoms of asthma.

50 - 80% Moderate= GOLD 2

FVC obtained after blowing out ≥ 6 seconds

30 - 50% Severe -= GOLD 3

< 30% Very Severe= GOLD 4

1. Consider COPD if: Any of the following indicators are present in an individual over 35 years old.

Dyspnoea that is - Progressive - Characteristically worse with exercise - Persistent.

Recurrent wheeze Chronic cough – may be intermittent, and/or unproductive Chronic sputum production

- any pattern of chronic sputum production may indicate COPD History of exposure to risk factors and host factors

- tobacco smoke/smoke from cooking and heating fuels occupational dusts and chemicals - family history of COPD and/or childhood factors

Recurrent lower respiratory tract infections

AND do not have clinical features of Asthma: Chronic unproductive cough Significantly variable breathlessness Night-time wakening with breathlessness and/or wheeze Significant diurnal or day-to-day variability of symptoms

The presence of multiple key indicators increases the probability of diagnosis of COPD.

2. Required tests: FBC Chest X-ray Spirometry (note, hand-held

spirometers MUST NOT be used for diagnosis but can be used for monitoring or screening)1.

Diagnosis of COPD if post bronchodilator

spirometry demonstrates: FEV

1/FVC <70%

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COPD Prescribing Guidelines

Possible Alternative Diagnosis

Asthma Congestive Heart Failure

Bronchiectasis Tuberculosis

Lung Cancer (Chest X Ray- If ≥ 3 week history of cough and /or increasing breathlessness)

Management of Stable COPD Re-assess historic diagnosis of COPD and make sure it was confirmed by spirometry

A patient’s needs change over time according to the progression of COPD, hence regularly review disease severity and effectiveness of current

regimen and accordingly modify the treatment 2

Monitor disease progression at least annually: FEV1, symptoms (mMRC & CAT), document exacerbations ( frequency, severity, type, likely cause, sputum

volume & purulence) and smoking status1

Check inhaler technique and compliance to treatment regimen regularly.

Encourage all patients to stop smoking - beneficial at all ages.

Offer annual influenza vaccinations and one-off pneumococcal vaccination.

Pulmonary rehabilitation improves symptoms, quality of life, physical and emotional state. Refer to pulmonary rehabilitation when mMRC score is

≥2 (or for GOLD classification B-D).

Promote use of individualised self-management plan and rescue packs. Template of self-management plan can be found on net.Formulary.

Screen for common comorbidities e.g. lung cancer (2-4 times more common), IHD, heart failure, arrhythmias, hypertension, CVA, peripheral

vascular disease, depression, anxiety, diabetes/metabolic syndrome, bronchiectasis, sleep apnoea, anaemia, osteoporosis, malnutrition/obesity,

GORD.2

Consider referral to local services as appropriate e.g. community respiratory team/consultant led respiratory clinic, physiotherapists, dietician

(follow current malnutrition guidelines if BMI/MUST score is low or high respectively), occupational therapy, social services, and palliative care

teams.

Where medication is initiated for persistent breathlessness, monitor and discontinue if no improvement.

Refer for oxygen assessment, following local pathways, when stable O2 saturations (not on exertion) are less than or equal to 92% breathing air.

A palliative care approach should be taken for end-of-life COPD patients. Main treatment goals should be symptom reduction and management of future risk of exacerbations. Referral to palliative care teams should be considered.

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COPD Prescribing Guidelines

Assessment of COPD using GOLD Classification

GOLD Classification attempts to class patients based on their risks of exacerbation.

STEP 1: Assess symptoms

COPD Assessment Test (CAT) [Link for CAT-test Online] is a patient-completed instrument that is a comprehensive measure of symptoms and complements existing approaches to assessing COPD. Determine whether patient has less symptoms (<10) or more symptoms (>10) if using CAT scale. Assess mMRC (modified Medical Research Council Questionnaire) providing an assessment of impact of dyspnoea. Determine if the patient is less breathlessness (0-1) or more breathlessness (≥ 2). [Link for mMRC score]

CAT and mMRC tools can be found in appendix 1.

STEP 2: Assess risk of exacerbations by the following method:

Assess the number of exacerbations the patient has had within the previous 12 months Determine whether the patient has had one or more hospitalisation in the previous year for a COPD exacerbation

Determine Gold Classification and treatment according to Table 1

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COPD Prescribing Guidelines

London respiratory team COPD value

The COPD value pyramid (developed by the London Respiratory Network with The London School of Economics and reproduced with permission from the

London Respiratory Team report 2013). This 'value' pyramid reflects what we currently know about the cost per QALY of some of the commonest

interventions in COPD. It was devised as a tool for health care organisations to use to promote audit and to ensure adequate commissioning of non-

pharmacological interventions. [QALY= quality-adjusted life year]

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COPD Prescribing Guidelines

Table 1: Gold Classification & Respective Drug Treatment –

Patients can start in any classification and can migrate between groups, therefore regular assessment is essential

Short-acting beta-agonist bronchodilators should continue as required for all patients.

(See Appendix 2 – for in list of inhaler brands, dosing, costs & images)

Symptom Assessment (Use highest result to guide classification)

Ris

k A

sse

ssm

en

t

Exacerbation history CAT <10 CAT ≥10

mMRC 0-1 mMRC ≥2

≥ 2 OR

≥1 leading to a hospital admission

Group C

LAMA

If further exacerbations: LAMA + LABA

(alternative option: LAMA + ICS)

Group D

LAMA + LABA

If further exacerbations: LAMA + LABA + ICS

(alternative 2nd line option: LABA + ICS)

If further exacerbations with LAMA/LABA/ICS seek specialist opinion.

0 OR 1 (not leading to

hospital admission)

Group A

Bronchodilator (SAMA or LAMA)

Evaluate effect: continue, stop or try alternative class of bronchodilator

Group B

A long-acting bronchodilator

(LABA or LAMA)

If persistent symptoms: LAMA + LABA

Inhaler choices for management of stable patients – try to maintain device consistency if possible

Inhaler type LABA LAMA LABA/LAMA LABA/ICS

MDI Formoterol Easyhaler 12mcg Fostair MDI 6/100mcg

Breezhaler Onbrez Breezhaler 150mcg Seebri Breezhaler 44mcg Ultibro Breezhaler 85/43mcg

Respimat Sprivia Respimat 2.5mcg Spiolto Respimat 2.5/2.5mcg

Ellipta Incruse Ellipta 55mcg Anoro Ellipta 22/55mcg Relvar Ellipta 22/92mcg

Genuair Eklira Genuair 322mcg Duaklir Genuair 12/340mcg

Other DPI Fostair NEXThaler 6/100mcg

DuoResp Spiromax 9/320mcg

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COPD Prescribing Guidelines

Treatment algorithms according to GOLD ABCD grade 2

Notes:

1. Trial of Roflumilast & Macrolide should only be initiated by respiratory specialist. Roflumilast is now recommended by NICE however locally

prescribing should remain within secondary care.

2. Theophylline may be considered to be used as an additional bronchodilator and it needs to monitored as per the BNF.

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COPD Prescribing Guidelines

Managing COPD Exacerbations

Considerations: (circle as appropriate) Favours specialist treatment Favours treatment at home

Able to cope at home: No Yes

Breathlessness: Severe Mild

General condition: Poor / deteriorating Good

Level of activity: Poor / confined to bed Good

Cyanosis: Yes No

Worsening Peripheral Oedema: Yes No

Level of consciousness: Impaired Normal

LTOT currently received: Yes No

Social circumstances: Living alone / not coping Good

Acute confusion: Yes No

Rapid rate of onset: Yes No

Significant morbidity: Yes No

SaO2 <90%: Yes No

Decide where to treat: Hospital Home

Referral to community respiratory clinic/secondary care should be considered for:

Diagnostic uncertainty

Uncontrolled COPD

Patient wants a second opinion

Bullous lung disease

Assessment for pulmonary rehabilitation or lung transplantation

Dysfunctional breathing

Onset of symptoms under 40 years or a family history of alpha 1-

antitrypsin deficiency

Assessment for oxygen therapy, long-term nebuliser therapy or oral

corticosteroid therapy

Onset of cor pulmonale

Symptoms disproportionate to lung function deficit

Frequent infections

Haemoptysis (2 week wait)

Rapid decline in FEV1

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COPD Prescribing Guidelines

ACUTE MANAGEMENT (at home)

Optimise inhalation treatment - Increase SABA to 2 - 8 puffs up to 4 hourly (watch for side effects e.g. tremor)

Steroids - Prednisolone 40mg daily for 5 days then stop

1st line antibiotic - Doxycycline 200mg day 1 then 100mg daily for further 4 days

2nd line antibiotic - Clarithromycin tablets 500mg every 12 hours for 5 days or amoxicillin 500mg every 8 hours for 5 days

(If clarithromycin prescribed consider drug interactions – concurrent statin to be stopped or dose reduced and halve theophylline if taking.

PREVENTION OF FUTURE EXACERBATIONS

Refer to pulmonary rehabilitation

Optimise inhaled therapy in line with GOLD standards (as above)

Carbocisteine - If 2 or more exacerbations in the last 12 months, consider adding in carbocisteine 750mg three times a day (once symptoms

improve maintenance dose of 750mg twice daily should be continued) especially if chronic productive cough

- Review on-going need/ benefit and stop if ineffective after 4 – 6 weeks of treatment

If no improvement at one week or deterioration in symptoms, clinician to consider referral or advice from community COPD consultant / team.

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COPD Prescribing Guidelines

References:

1. Rytila P, Helin T, Kinnula V. The use of microspirometry in detecting lowered FEV1 values in current or former cigarette smokers. Primary Care Respiratory Journal

2008. 17(4): 232–7

2. From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. Available

from: http://www.goldcopd.org/ <Accessed on 19.03.2017>

3. NICE 2010 COPD guidelines

4. IMPRESS Guide to the relative value of COPD interventions July 2012

5. www.medicines.org.uk – all drug files accessed

6. British National Formulary, BMA March 2014 https://www.medicinescomplete.com/mc/bnf/current/ <Accessed 20.03.2017>

7. Chemist and Druggist March 2017 http://www.medicines.org.uk/emc/ <Accessed 20.03.2017>

ACKNOWLEDGEMENTS TO ALICE TURNER AND PAN BIRMINGHAM APC

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COPD Prescribing Guidelines

Appendices

Appendix 1 –

COPD Assessment Test (CAT) - Determine whether patient has less symptoms (<10) or more symptoms (>10) using CAT scale.

I never cough 1 2 3 4 5 I cough all the time

I have no phlegm (mucus) in my chest at all 1 2 3 4 5 My chest if full of phlegm (mucus)

My chest does not feel tight 1 2 3 4 5 My chest feels very tight

When I walk up a hill or one flight of stairs I am not breathless

1 2 3 4 5 When I walk up a hill or one flight of stairs I am

very breathless

I am not limited doing any activities at home 1 2 3 4 5 I am very limited doing activities at home

I am confident leaving my home despite my lunch condition

1 2 3 4 5 I am not at all confident leaving my home

because of my lung condition

I sleep soundly 1 2 3 4 5 I don’t sleep soundly because of my lunch

condition

I have lots of energy 1 2 3 4 5 I have no energy at all

mMRC – Modified Research Council Questionnaire - Determine if the patient is less breathlessness (0-1) or more breathlessness (≥ 2).

Grade Description of Breathlessness

0 I only get breathless with strenuous exercise.

1 I get short of breath when hurrying on level ground or walking up a slight hill.

2 On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace.

3 I stop for breath after walking about 100 yards or after a few minutes on level ground.

4 I am too breathless to leave the house or I am breathless when dressing

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COPD Prescribing Guidelines Appendix 2 – Inhaler Profile

All inhalers should be prescribed by brand name

Drug Strength Brand Picture Type

of Device

Separate Spacer Dose &

Frequency Cost * (per

device)

SABA (Short Acting Beta2

Agonist)

Salbutamol

100mcg

Salamol

MDI Aerochamber

Plus/Volumatic Spacer

2 puffs when required

£1.46 (200 doses)

Ventolin

MDI Aerochamber

Plus/Volumatic Spacer

£1.50 (200 doses)

Airomir

MDI Aerochamber Plus £1.97

(200 doses)

Airomir Autohaler

DPI - £6.02

(200 doses)

Salamol Easi-Breathe

MDI - £6.30

(200 doses)

Salbutamol Easyhaler

DPI - £3.31

(200 doses)

Terbutaline 500mcg Bricanyl Turbohaler

DPI - 1 puff, up to four

times a day £6.92

(100 doses)

SAMA (Short Acting Anti-

Muscarinic) Ipratropium 20mcg Atrovent

MDI Aerochamber Plus 1 puff, up to

four times a day £5.56

(200 doses)

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COPD Prescribing Guidelines

LABA (Long Acting Beta2

Agonist)

Formoterol 12mcg Easyhaler

Formoterol

DPI - 1 puff Twice

daily

£23.75 (120 doses)

Note: device will last two

months

Indacaterol 150mcg Onbrez Breezhaler &

Caps

DPI - 1 puff Once daily £32.19

(30 doses)

LAMA (Long Acting Anti-

Muscarinic)

Note: inhaler strengths given.

Base drug strengths may be slightly different.

Glycopyrronium 44mcg Seebri Breezhaler &

Caps

DPI - 1 puff Once daily £27.50

(30 doses)

Tiotropium 2.5mcg Sprivia Respimat

DPI - 2 puffs Once

daily £23.00

(60 doses)

Umeclidinium 55mcg Incruse Ellipta

DPI - 1 puff Once daily £27.50

(30 doses)

Aclidinium 322mcg Eklira Genuair

DPI - 1 puff Twice

daily £28.60

(60 doses)

LABA/LAMA combination (Long Acting

Antimuscarinic & Long Acting Beta2

Agonist)

Note: inhaler strengths given.

Base drug strengths may be slightly different.

Vilanterol/ Umeclidinium

22mcg / 55mcg

Anoro Ellipta

DPI - 1 puff Once daily £32.50

(30 doses)

Indacaterol/ Glycopyrronium

85mcg/ 43mcg

Ultibro Breezhaler & Caps

DPI - 1 puff Once daily £32.50

(30 doses)

Olodaterol/ tiotropium

2.5mcg/ 2.5mcg

Spiolto Respimat

DPI - 2 puffs Once

daily £32.50

(60 doses)

Formoterol/ Aclidinium

12mcg/ 340mcg

Duaklir Genuair

DPI - 1 puff Twice

daily £32.50

(60 doses)

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COPD Prescribing Guidelines

Note:

- DPI = Dry-powder Inhaler - MDI = Metered Dose Inhaler

- Spacers - wash weekly, do NOT wipe dry. Replace every six to 12 months.

- * prices taken from March 2017 Drug Tariff and Chemist and Druggist

LABA/ICS combination

(Long Acting Beta2 Agonist & Inhaled

Corticosteroid)

Note: inhaler strengths given.

Base drug strengths may be slightly different.

Formoterol/ Beclometasone

6mcg/ 100mcg

Fostair MDI

MDI Aerochamber

Plus 2 puffs Twice

daily £29.32

(120 doses)

Formoterol/ Beclometasone

6mcg/ 100mcg

Fostair NEXThaler

DPI - 2 puffs Twice

daily £29.32

(120 doses)

Formoterol/ Budesonide

9mcg/ 320mcg

DuoResp Spiromax

DPI - 1 puff Twice

daily £29.97

(60 doses)

Vilanterol/ Fluticasone

22mcg/ 92mcg

Relvar Ellipta

DPI - 1 puff Once

daily £22.00

(30 doses)