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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.

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COPD Prescribing Guidelines

This guideline is intended for use to aid diagnosis in patients with a suspected diagnosis of a COPD, and in patients with a confirmed diagnosis of COPD. In the latter group it is intended to direct management including prescribing. It is aimed primarily at cost-effective prescribing, and will be reviewed annually as evidence is rapidly emerging in this field

COPD is characterised by airflow obstruction. The airflow obstruction is usually progressive, not fully reversible and does not change markedly over several months. The disease is predominately caused by smoking.

Diagnosis

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 A Check reversibility to salbutamol

>400ml = asthma 50 - 80% Moderate B

FVC obtained after blowing out

≥ 6 seconds 30 - 50% < 30% Severe Very Severe C D Check PEFR variation over 2/52 >20% = asthma

1. Suspect 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.

 Wheezing

 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

– tobacco smoke/ smoke from cooking and heating fuels/ occupational dusts and chemicals

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

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

2. Spirometry Test:

Spirometry is required to establish

a diagnosis of COPD.

Post bronchodilator spirometry

demonstrates:

FEV

1

/FVC <70%

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COPD Prescribing Guidelines

Possible Alternative Diagnosis

 Asthma

 Congestive Heart Failure  Bronchiectasis

 Tuberculosis

 Obliterative Bronchiolitis  Diffuse Panbronchiolitis

 Lung Cancer (Chest X Ray- If ≥ 3 week history of cough and /or increasing breathlessness)  Full blood count to identify anaemia or polycythaemia

Management of Stable COPD

Check inhaler technique

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

Offer annual pneumococcal and influenza vaccinations.

Refer to pulmonary rehabilitation when mMRC score is ≥2 (or for GOLD classification B-D as per GOLD guidelines)

Promote use of self-management plan and rescue packs. Template self-management plan can be found at:

[Link for Self-Management Plan]

Screen for common comorbidities e.g. IHD, HF, anxiety, and depression.

Consider referral to the rest of the multidisciplinary team 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 when O2 saturations are less than or equal to 92% breathing air.

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COPD Prescribing Guidelines

Assessment of COPD using GOLD Classification

GOLD Classification attempt 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).

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 Use spirometry to determine if patient is high risk (FEV1 <50%) or low risk (FEV1≥50%)

In some patients these three ways of assessing the risk of exacerbations will not lead to the same level of risk; in this case, the risk

should be determined by the method indicating high risk

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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

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

STEP 1: Symptom Assessment

CAT <10 CAT ≥10 mMRC 0-1 mMRC ≥2 ST EP 2: R is k Asse ss m en t Number of Exacerbations in previous 12 months Hospitalisation in previous 12 months FEV1 ≤ 1 zero Predicted ≥ 50%

Low risk – Gold A

Step 1: SABA or SAMA

(NB SABA can continue as reliever through all steps) Step 2: LABA

Moderate risk – Gold B

Step 1: LABA – (if LABA naïve) Or

Step 1: LAMA

Step 2: LABA/ LAMA combination – suitable where severe breathlessness

≥ 2 ≥1 Predicted < 50%

Severe risk – Gold C

Step 1: ICS/LABA – (if LAMA tried) Or

Step 1: LAMA – (if LAMA naïve) Step 2: LABA/ LAMA combination

Very Severe risk – Gold D

Triple therapy if patient has progressed from C or B.

OR

LABA/LAMA combination if treatment naïve Or

ICS/LABA & Theophylline Or

LAMA & Theophylline

Key:

1. Starting dose 150mcg, increased to 300mcg if needed. * Twice daily preparation therefore not suitable for all patients

LAMA caution use in patients with cardiac arrhythmias, recent

hospitalisation with cardiac background e.g. MI, HF, etc. These are class effects

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

LABA LAMA LABA/LAMA LABA/ICS

Easyhaler Formoterol Seebri Breezhaler Anoro Ellipta Fostair MDI

Onbrez Breezhaler1 Incruse Ellipta Duaklir Genuair* DuoResp Spiromax

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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

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COPD Prescribing Guidelines

ACUTE MANAGEMENT (at home)

Steroids

- Prednisolone 30mg daily for 7-14 days then stop

1st line antibiotic

- Amoxicillin 500mg three times a day for 5 days; OR

[Penicillin allergy]

- Clarithromycin 500mg twice daily for 5 days

[Significant drug Interaction] - Theophylline halve dose and

- Simvastatin stop/reduce dose

- Consider other interactions

2nd line antibiotic - Doxycycline 200mg immediately then 100mg daily for a further 4 days

If resistant

- Co-Amoxiclav 625mg three times a day for 5 days (consider C.Diff risk)

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

PREVENTION OF FUTURE EXACERBATIONS

Refer to pulmonary rehabilitation

Optimise inhaled therapy in line with GOLD standards above

Carbocisteine

- Two or more exacerbations in the next 12 month, consider adding in Carbocisteine 750mg twice daily (maintenance dose) especially if chronic

productive cough

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

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COPD Prescribing Guidelines

References:

1. From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Available from: http://www.goldcopd.org/. accessed on 8th April 2015

2. NICE 2010 COPD guidelines

3. IMPRESS Guide to the relative value of COPD interventions July 2012 4. www.medicines.org.uk – all drug files accessed

5. British National Formulary, version 68, BMA 2014 6. Mims Online accessed May 2015

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COPD Prescribing Guidelines

Appendices

Appendix 1 - mMRC – Modified Research Council Questionnaire

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

Prescribe all inhalers by Brand Name

Drug Strength Brand Picture Type of

Device Separate Spacer

Dose &

Frequency Cost

** £

SABA (Short Acting Beta2

Agonist) Salbutamol 100 mcg

Salamol MDI Plus/Volumatic Aerochamber Spacer 2 puffs when required 1.46¥ (200 doses) Ventolin

MDI Plus/Volumatic Aerochamber Spacer

1.50¥

(200 doses)

Airomir MDI Aerochamber Plus (200 doses) 1.97¥

Airomir Autohaler DPI - (200 doses) 6.02¥

Salamol Easi-Breathe MDI - 6.30 ¥ (200 doses) Salbutamol Easyhaler DPI - 3.31 ¥ (200 doses)

Terbutaline 500 mcg Bricanyl Turbohaler DPI - 1 puff, up to four times a day (100 doses) 6.92¥

SAMA (Short Acting

Anti-Muscarinic) Ipratropium 20 mcg Atrovent MDI Aerochamber Plus

1 puff, up to

four times a day 5.56

¥

(200 doses) LABA

(Long Acting Beta2

Agonist) Formoterol 12 mcg

Easyhaler

Formoterol DPI - 1 puff Twice daily

23.75 Device will last

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COPD Prescribing Guidelines

Note:

- DPI = Dry-powder Inhaler - *Fostair NEXThaler for asthma only

- MDI = Metered Dose Inhaler - ¥ Cost per device

- Spacers - wash weekly, do NOT wipe dry. Replace every six to 12 months. - ** prices taken from Mims online accessed May 2015

Indacaterol 150 mcg Onbrez Breezhaler & Caps DPI - 1 puff Once daily (30 doses) 29.26

LAMA (Long Acting

Anti-Muscarinic)

Glycopyrronium 50 mcg Seebri Breezhaler & Caps DPI - 1 puff Once daily (30 doses) 27.50

Umeclidinium 55 mcg Incruse Ellipta DPI - 1 puff Once daily (30 doses) 27.50

Aclidinium 322 mcg Eklira Genuair DPI - 1 puff Twice daily (60 doses) 28.60

LABA/ LAMA combination (Long Acting Antimuscarinic & Long Acting Beta2

Agonist)

Vilanterol/

Umeclidinium 22 mcg / 55 mcg Anoro Ellipta DPI - 1 puff Once daily (30 doses) 32.50 Indacaterol/

Glycopyrronium 110 mcg / 50 mcg Ultibro Breezhaler & Caps DPI - 1 puff Once daily (30 doses) 36.88 Formoterol/

Aclidinium 12 mcg / 340 mcg Duaklir Genuair DPI - 1 puff Twice daily (60 doses) 32.50

LABA/ICS combination (Long Acting Beta2

Agonist & Inhaled Corticosteroid)

Formoterol/

Beclometasone 100 mcg 6 mcg / Fostair* MDI Aerochamber Plus 2 puffs Twice daily (120 doses) 29.32

Formoterol/

Budesonide 320 mcg 9 mcg / DuoResp Spiromax DPI - 1 puff Twice daily (60 doses) 29.97 Vilanterol/

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COPD Prescribing Guidelines

Appendix 3: COPD intervention Value Pyramid

References

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