Respiratory Inhaler Check-up Service

Dr Toby Capstick Lead Respiratory Pharmacist Leeds Teaching Hospitals NHS Trust toby.capstick@nhs.net 8th May 2018

What is the Challenge?

1. British Lung Foundation. The Battle for breath. 2016

2. Asthma UK (2014) http://www.asthma.org.uk/asthma-facts-and-statistics

3. Asthma UK. The Asthma UK Data Portal. https://www.asthma.org.uk/get-involved/campaigns/data-portal/ (accessed 27/10/17)

4. DH (2011). An outcomes strategy for COPD and Asthma in England

5. Public Health England. Inhale - INteractive Health Atlas of Lung conditions in England. 2015/16 data. https://fingertips.phe.org.uk/profile/inhale/data

ASTHMA COPD

The Burden of Disease in the UK

Patients in Leeds:

• 50% have not had inhaler technique checked & recorded in the last 15 months.

• 1,400 receive ≥6 SABA inhalers in the past year & not on asthma/COPD register.

1.2 million people in the UK diagnosed with

COPD.1

• 2/3 of people with COPD thought to

remain undiagnosed.1

There were 140,000 UK Hospital

admissions each year.1

COPD was responsible for 25,000 –

30,000 deaths annually.1,4

8 million people in the UK diagnosed with

asthma.1

• 5.4 million asthmatics in UK1-2

• (1.1 million children)2

There were 65,623 UK Hospital

admissions in 2015/163

75% of admissions are avoidable2

Asthma was responsible for 1,468 deaths

in 2015.2

2/3 of deaths are preventable2

NHS Digital. Prescription Cost Analysis, England – 2017. Available at:

https://digital.nhs.uk/data-and-information/publications/statistical/prescription-cost-analysis/prescription-cost-analysis-england-2017

Publication date: 15th March 2018

Prescription Cost Analysis - England, 2017

Drug No. Items Supplied

Expenditure

1 Rivaroxaban 20mg tabs. 2,465,579 £127,150,612

2 Fostair 100/6 MDI 3,086,144 £106,563,396

3 Spiriva 18mcg refills 2,503,359 £99,989,225

4 Apixaban 5mg tabs. 1,900,432 £98,633,014

5 Sitagliptin 100mg tabs. 2,082,265 £77,692651

Overall, £987 million spent on inhalers in England in 2017

BUT, are we getting value for money?

Drug Expenditure

1 Tiotropium DPI £141,711,339

2 Fostair 100/6 MDI £106,563,396

3 Budesonide/formoterol 200/6 DPI

£94,356,310

4 Fluticasone propionate /salmeterol 250/25 MDI

£91,968,124

5 Budesonide/formoterol 400/12 DPI

£61,413,934

Asthma & COPD: Inhalers in 2010

Bronchodilators

SABAs

• Salbutamol (7+ devices)

• Terbutaline (1 device)

SAMAs

• Ipratropium (2 devices)

LABAs

• Formoterol (2 devices)

• Salmeterol (2 devices)

LAMAs

• Tiotropium (2 devices)

Corticosteroids

ICS

• Beclometasone (4 devices)

• Beclometasone extra-fine (3 devices)

• Budesonide (3 devices)

• Ciclesonide (1 device)

• Fluticasone propionate (2 devices)

• Mometasone (1 device)

ICS/LABA

• Fostair (beclometasone/formoterol)

(1 device)

• Seretide (fluticasone propionate/salmeterol)

(2 devices)

• Symbicort (budesonide/formoterol)

(1 device)

Asthma & COPD: Inhalers in 2018

†Not available as monotherapy

Corticosteroids ICS

• Beclometasone (2 devices)

• Beclometasone extra-fine (3 devices)

• Budesonide (3 devices)

• Ciclesonide (1 device)

• † Fluticasone furoate

• Fluticasone propionate (2 devices)

• Mometasone (1 device)

ICS/LABA

• Aerivio (fluticasone propionate/salmeterol) (1 device)

• AirFluSal (fluticasone propionate/salmeterol) (2 devices)

• Aloflute (fluticasone propionate/salmeterol) (1 device)

• Combisal (fluticasone propionate/salmeterol) (1 device)

• DuoResp (budesonide/formoterol) (1 device)

• Flutiform (fluticasone propionate/formoterol) (1 device + 1 planned)

• Fobumix (budesonide/formoterol) (1 device)

• Fostair (beclometasone/formoterol) (2 devices)

• Relvar (fluticasone fuorate/vilanterol) (1 device)

• Sereflo (fluticasone propionate/salmeterol) (1 device)

• Seretide (fluticasone propionate/salmeterol) (2 devices)

• Sirdupla (fluticasone propionate/salmeterol) (1 device)

• Symbicort (budesonide/formoterol) (1 device)

ICS/LABA/LAMA

• Trelegy (fluticasone fuorate/vilanterol/umeclidinium) (1 device)

• Trimbow (beclometasone/formoterol/glycopyrronium) (1 device)

Bronchodilators SABAs

• Salbutamol (6 devices)

• Terbutaline (1 device)

SAMAs

• Ipratropium (1 devices)

LABAs

• Formoterol (4 devices)

• Salmeterol (2 devices)

• Indacaterol (1 device)

• Olodaterol (1 device)

• † Vilanterol

LAMAs

• Aclidinium (2 devices)

• Glycopyrronium (1 device)

• Tiotropium (3 devices)

• Umeclidinium (1 device)

LABA/LAMAs

• Anoro (vilanterol/umeclidinium (1 device)

• Duaklir (formoterol/aclidinium) (1 device)

• Spiolto (olodaterol/tiotropium) (1 device)

• Ultibro (indacaterol/glycopyrronium) (1 device)

Inhalers are not all the same Aerosol

MDI MDI + Spacer

Soft Mist Inhaler

Autohaler Easi-Breathe

Dry Powder Inhaler (DPI)

Single dose DPI - Blister Single dose DPI - Capsule

Accuhaler Ellipta Forspiro Aeroliser Breezhaler HandiHaler Zonda

Reservoir Multidose DPI

Easyhaler Genuair NEXThaler Novolizer Spiromax Turbohaler Twisthaler

Generic Prescribing • Budesonide/formoterol ● Beclometasone/formoterol

• Fluticasone/salmeterol

• Formoterol

Symbicort

Turbohaler

DuoResp

Spiromax

Atimos Modulite

pMDI

NEXThaler pMDI

Formoterol

Easyhaler

Foradil

Aeroliser

Oxis

Turbohaler

Seretide

Accuhaler AirFluSal

Forspiro

Fobumix

Easyhaler

Aerivio

Spiromax

BTS/SIGN 2016

Switching Inhaler Devices:

Effect of unconsented switch (Asthma)

Thomas et al. BMC Pulmonary Medicine 2009;9:1-10

Treatment Success OR: 0.29 [95% CI: 0.19, 0.44; p<0.001)

Why is Inhaler Technique Important?

• 50-75% of patients make errors using common inhaler

devices (Accuhaler, pMDI, Turbohaler).1

• Between 1:3 and 1:10 patients make ‘critical’ (serious)

errors using these inhalers.1

• % of healthcare professionals can use a pMDI

correctly.2

The Good Old days

1. Molimard M et al. Journal of Aerosol Medicine 2003;16:249-54

2. Baverstock M et al. Thorax 2010;65(Suppl 4): A117-A118

8

Inhaler Technique: Has it Improved Over 40 Years?

Systematic review. 144 studies, 54,354 patients

Sanchis et al. Chest 2016; 150(2):394-406

Association Between Inhaler Technique and COPD exacerbations

45

36

80

71

38

29

70 63

0

10

20

30

40

50

60

70

80

90

Hospital admissions Emergency deptvisits

Antibiotic courses Corticosteroidcourses

% o

f p

atie

nts

exa

cerb

atin

g

At least 1 Critical Error No Errors

OR 1.47; p=0.001 OR 1.62; p<0.001 OR 1.50; p<0.001 OR 1.54; p<0.001

Melani et al. Resp Med 2011;105:930-8

Misuse of Inhalers is Associated with Decreased Asthma Stability

Giraud V. Eur Respir J 2002;19:246-51.

AIS = Asthma Instability Score

• 0: best asthma stability

• 9: worst asthma stability

Frequency distribution of

the number of errors in

inhalation technique

(left axis)

Asthma Instability Score

(right axis)

What do Guidelines Recommend?

BTS/SIGN Asthma Guidelines

2016

• Prescribe inhalers only after

patients have: • Received training in the use of the

device, and

• Have demonstrated satisfactory

technique

• Before initiating a new drug

therapy practitioners should

check: • Adherence with existing therapies

• Inhaler technique, and

• Eliminate trigger factors

NICE COPD Guidelines 2010

• Inhalers should be prescribed

only after patients have • received training in the use of the

device, and

• have demonstrated satisfactory

technique

• Patients should have their ability

to use an inhaler device regularly

assessed by a competent

healthcare professional and, if

necessary, should be re-taught

the correct technique

BTS/SIGN Asthma Guidelines 2016 NICE clinical guideline 101: Chronic

obstructive pulmonary disease. 2010

The Service

• Eligible Patients • Diagnosis of asthma / COPD, on inhaled therapy

• Registered with Leeds GP

• Speak & understand English (or translated by pharmacy team)

• Able to attend both consultations

• Service allowed once per patient

• Pharmacy requirements • Use consultation room

• Provided by Pharmacist or Registered Pharmacy Technician, • Must have completed CPPE Declaration of Competence for Improving Inhaler Technique.

• Must use In Check DIAL G16 with 1-way inspiratory mouthpieces, & placebos. • Initial supply provided.

• It is your responsibility to obtain more. • London Medicines Evaluation Network. Availability and supply of respiratory support devices to healthcare

professionals. http://www.medicinesresources.nhs.uk/upload/Availability%20of%20placebo%20inhalers%20FINAL_June13_LMEN.pdf

Service Outline

• Two appointments: baseline & 6-8 weeks later • Take telephone no. and/or email to use as a reminder

• Patient education:

1. Assessment of Asthma Control (ACT) or COPD health status (CAT)

2. Inhaler technique: • Measure inspiratory flow using In-Check DIAL G16

• Assess, teach and optimise inhaler technique

3. Medicines use

4. Adherence

5. Smoking cessation

6. Data recorded on Pharmoutcomes within 48 hours

7. GP referral: e.g. if alternative device needed

• NB. If patient has (1) good control (ACT≥20 or CAT<10), (2) good inhaler technique and (3) good inspiratory flow – DO NOT invite back for 2nd consultation.

• You can also carry out an MUR in addition to this inhaler service, if patient is eligible.

Consultation Format

Consultation 1 Consultation 2

• Patient education:

1. Assessment of Asthma Control (ACT) or COPD health status (CAT)

2. Inhaler technique:

• Measure inspiratory flow using In-Check DIAL G16

• Assess, teach and optimise inhaler technique

3. Medicines use

4. Adherence

5. Smoking cessation

6. Data recorded on Pharmoutcomes within 48 hours

7. GP referral: e.g. if alternative device needed

The Consultation

Resulting Symptoms: • Wheeze • Breathlessness at rest & during

activities

• Chest tightness • Cough • Increased mucous & phlegm

What is COPD?

Chronic Inflammation:

• Parenchymal

destruction

• Breakdown of

alveolar attachments

• Loss of bronchiole

elasticity

Narrowing

of airways

Chronic irritation by

tobacco smoke /

noxious agents:

• Increased no. of

goblet cells &

enlarged

submucosal glands

• Impaired mucociliary

clearance

• Mucous plugging

A common, preventable and treatable disease… characterised by persistent

respiratory symptoms and airflow limitation that is due to airway and/or alveolar

abnormalities usually caused by significant exposure to noxious particles or gases.

• Asthma is a chronic inflammatory disorder of the airways

• Involves a variety of cells and cellular mediators

• Airflow limitation is widespread, variable, and often reversible

• Chronic inflammation leads to an increase in airway hyperresponsiveness

with recurrent episodes of wheezing, coughing, and shortness of breath

What is Asthma?

Smooth muscle

Mucus plug

Basement membrane

Epithelium

Mucous glands

Adapted from Jeffery PK. Am J Respir Crit Care Med. 2001;164:S28-S38.

4 4

Normal

airway

Asthmatic

airway

1. Assessment of Asthma Control (ACT) or COPD Health Status (CAT)

COPD Assessment Test (CAT) (http://catestonline.org). • 8 Questions (max score 40)

• Score ≤5: normal healthy

non-smokers

• <10: low impact of COPD on

health status

• 10-20: medium impact

• >20: high impact

• >30: very high impact

• A change of 2 is clinically meaningful.

• Influenza vaccination can reduce hospital admissions for both

pneumonia and influenza, and reduce mortality risk.

ACTION

• Ask whether patient had a flu vaccination during the most recent

winter

• If patient did not have their most recent vaccination when due

• Advise of the benefits and encourage to have it annually

• During ‘flu season’: offer annual flu vaccination

• From community pharmacy or GP

Vaccination

2. Inhaler Technique

How Should We Teach Inhaler Technique?

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pren=8

Postn=7

Pren=9

Postn=8

Pren=9

Postn=9

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Unsatisfactory

Satisfactory

Optimal

Verbal Augmented

Verbal

Augmented

Verbal + Physical Basheti IA et al. Respir

Care 2005;50:617-23.

• Assess Technique using Placebos • “Show and Tell” training method • Re-assess technique • Complete Inhaler Technique Labels • Repeat at frequent intervals

Impact of “Show and Tell” Inhaler Technique Counselling Service

Basheti IA et al. Patient Education and counseling 2008;72:26-33

Community Pharmacy Service: Teaching Inhaler Technique Improves Asthma Outcomes

Basheti IA et al. Patient Education and counseling 2008;72:26-33

Inhaler Technique

Asthma Severity

Inhaler Technique Assessment

Inhaler Technique

https://www.rightbreathe.com/

ACTION: Assess & improve inhaler technique • Step 1 - Check inspiratory flow

• Use In-Check DIAL G16 inspiratory flow meter to measure inspiratory flow through the

inhaler device(s).

• Step 2 - Check inhaler technique • Patient should demonstrate how they use their own inhaler (unless newly prescribed).

• Assess Inhaler technique as

• ‘Optimal’ (all steps completed correctly),

• ‘Satisfactory’ (some minor errors, but all critical steps completed correctly), or

• ‘Unsatisfactory’ (at least one critical error made).

• Step 3 - Teach correct inhaler technique • Pharmacist/Tech should demonstrate correct inhaler technique to the patient.

• Issue Aerochamber where appropriate

• Step 4 – Re-check inhaler technique and check understanding • After teaching correct technique, the patient should demonstrate how they would use it

again.

• This allows Pharmacist/Technician to check understanding & reinforce any difficulties.

Inhaler Technique Assessment

Aerosol

MDI MDI + Spacer

Soft Mist Inhaler

Autohaler Easi-Breathe

Dry Powder Inhaler (DPI)

Single dose DPI - Blister Single dose DPI - Capsule

Accuhaler Ellipta Forspiro Aeroliser Breezhaler HandiHaler Zonda

Reservoir Multidose DPI

Easyhaler Genuair NEXThaler Novolizer Spiromax Turbohaler Twisthaler

Categorising Inhaler Devices

Measuring Inspiratory Flow:

In-Check DIAL

Comparison of Inspiratory Resistance & Inspiratory Flow

Kruger P et al. on behalf of Almirall. ERS Poster 2014

1. Preparation • Check dose counter • Shake inhaler (where applicable)

2. Priming • Before first use (where applicable) • Open inhaler / remove cap

3. Exhaling • Fully and away from mouthpiece

4. Mouth • Place mouthpiece in mouth & close lips for tight seal

5. Inhalation • DPI: quick and deep inhalation (within 2–3 seconds) • pMDI/SMI: slow and steady inhalation (over 4–5 seconds)

6. Breath holding • Remove from mouth, hold breath for 5 seconds

7. Closing and repeating • Close inhaler / replace cap • Repeat as necessary For individual devices patients should refer to the Patient Information Leaflet that accompanies the inhaler

Inhaler Technique: 7 Steps to Success

Usmani, Capstick, Chowhan & Scullion. Choosing an appropriate inhaler device for the treatment

of adults with asthma or COPD. Guidelines.co.uk . In Press.

(adapted from Anna Murphy (simplestepseducation) Seven Step approach)

Aerosol Inhalers

MDI

SMI Respimat

BA-MDI Autohaler/Easi-Breathe

Range of Drugs

• Wide range of drugs/classes

• Compatibility with Spacer (needed for many)

• Long-acting bronchodilators

• ICS and SABA only

Dose Delivery

• Low IFR needed • Many inhale too fast

• Low IFR needed • Efficient dose delivery

• Low IFR needed

Ease of Use • Moderate dexterity • Coordination required • Many use incorrectly • Haleraid available

• High dexterity • Complex

loading/priming • Locks when empty

• Low dexterity

Dose Counter

• Dose counter: ICS/LABA (not SABA or ICS)

• Dose indicator

• None

Feedback • Taste / sound • Taste / click • Taste / click

Single Dose DPI - Blisters

Accuhaler

Ellipta Forspiro

Range of Drugs

• SABA • LABA • ICS; ICS/LABA

• ICS/LABA • LAMA • LAMA/LABA

• FP/Salm only (1 strength)

Dose Delivery

• Medium-low airflow resistance

• Relatively consistent across IFR 30-90L/min

• Do not invert

• Medium-low airflow resistance

• Consistent across IFR 43-130L/min

• Do not invert

• Medium-low airflow resistance

• Relatively consistent across IFR 30-90L/min

• Do not invert

Ease of Use • Low-moderate dexterity • Gritty if not used

correctly

• Low dexterity • Simple device

• Moderate-high dexterity

Dose Counter

• Small dose counter • Large dose counter

• Dose counter

Feedback • Taste • Taste • Taste • Visual: loading of doses

& used blisters

Single Dose DPI - Capsule

Breezhaler

HandiHaler Zonda

Range of Drugs

• LABA • LAMA • LAMA/LABA

• LAMA • LAMA

Dose Delivery

• Low airflow resistance • Relatively consistent

across IFR 50-100L/min • Do not invert • Risk of inhaling capsule

fragments

• High airflow resistance • Relatively consistent

across IFR 28-60L/min • Do not invert • Risk of inhaling capsule

fragments

• High airflow resistance • No data on drug

delivery? • Do not invert • ? Risk of inhaling

capsule fragments ?

Ease of Use • High dexterity • Significant manipulation • Redesigned blisters

easier to open

• High dexterity • Significant manipulation • Blisters difficult to open

• High dexterity • Significant manipulation • Capsules in bottle

Dose Counter

• Capsule count (in blister)

• Capsule count (in blister)

• Capsule count (in blister)

Feedback • Taste • Whirring/vibration • Visual: transparent caps

• Taste • Whirring/vibration • Visual: open caps

• Taste • Whirring/vibration • Visual: transparent caps

Single Dose DPI - Capsule

Breezhaler

HandiHaler Zonda

Range of Drugs

• LABA • LAMA • LAMA/LABA

• LAMA • LAMA

Dose Delivery

• Low airflow resistance • Relatively consistent

across IFR 50-100L/min • Do not invert • Risk of inhaling capsule

fragments

• High airflow resistance • Relatively consistent

across IFR 28-60L/min • Do not invert • Risk of inhaling capsule

fragments

• High airflow resistance • No data on drug

delivery? • Do not invert • ? Risk of inhaling

capsule fragments ?

Ease of Use • High dexterity • Significant manipulation • Redesigned blisters

easier to open

• High dexterity • Significant manipulation • Blisters difficult to open

• High dexterity • Significant manipulation • Capsules in bottle

Dose Counter

• Capsule count (in blister)

• Capsule count (in blister)

• Capsule count (in blister)

Feedback • Taste • Whirring/vibration • Visual: transparent caps

• Taste • Whirring/vibration • Visual: open caps

• Taste • Whirring/vibration • Visual: transparent caps

Reservoir Multidose DPI (1)

Easyhaler

Spiromax Turbohaler

Range of Drugs

• SABA • LABA • ICS • ICS/LABA (due 2017)

• ICS/LABA • SABA • LABA • ICS • ICS/LABA

Dose Delivery

• High airflow resistance • Consistent across IFR 30-

60L/min • Do not invert

• Medium airflow resistance

• Higher dose delivery at faster IFRs (90 vs 40 L/min)

• Do not invert

• Medium-high airflow resistance

• Higher dose delivery at faster IFRs (90 vs 40 L/min)

• Do not invert

Ease of Use • Low dexterity • Prime in vertical position

• Low dexterity • Simple device • Prime in vertical-

horizontal position

• Moderate dexterity • Prime in vertical position • Turn aid available

Dose Counter

• Dose counter (steps of 10)

• Dose counter (steps of 2)

• Dose counter (Symbicort –

steps of 20) or indicator

Feedback • Taste • Window shows unused

doses

• Taste • Generally no taste

Reservoir Multidose DPI (2)

Genuair

NEXThaler

Range of Drugs

• LAMA • LAMA/LABA

• ICS/LABA

Dose Delivery

• Medium airflow resistance

• Consistent • No delivery <35L/min • Do not invert

• Medium-high airflow resistance

• Relatively consistent across IFR 30-90L/min

• No delivery <30L/min

Ease of Use • Low dexterity • Prime in vertical

position • Locks when empty

• Low dexterity • Simple device • Prime in vertical

position

Dose Counter

• Dose counter (steps of 10)

• Dose counter (steps of 1)

Feedback • Taste • Click • Window Green -> Red

• Taste • Click

3. Education on Medicines

Education on COPD Medicines Drug Role in Treatment Common side effects Short-acting

beta2-agonist

(SABA)

Salbutamol,

terbutaline

PRN use for fast-acting relief of breathlessness and

wheezing.

Onset within 5 mins; duration: 4-6 hours.

All Asthma & COPD patients should have a SABA inhaler.

Tremor, palpitations, headache.

Tend to occur with high use, or larger

doses given as a nebuliser.

Long-acting

muscarinic

antagonists

(LAMA)

Braltus®, Eklira®,

Incruse®,

Seebri®, Spiriva®

Regular OD or BD use (aclidinium/Eklira® only).

More effective than short-acting relievers,

• Larger improvements in lung function, breathlessness

and quality of life, and reductions in hospitalisations.

COPD: Recommended for patients with more significant

COPD symptoms (CAT score ≥10; MRC ≥3).

Asthma: Spiriva Respimat recommended as add on

therapy to ICS/LABA to improve lung function & prevent

exacerbations

Dry mouth is the most common side

effect.

This may be managed by rinsing

mouth after use, or may require

switch to an alternative within this

class.

Long-acting

beta2-agonist

(LABA)

e.g. Onbrez®,

Oxis®, Serevent®,

Striverdi®

Regular OD (Onbrez® and Striverdi®) or BD use.

More effective than short-acting relievers,

• Larger improvements in lung function, breathlessness

and quality of life, and reductions in hospitalisations.

COPD: Recommended for patients with more significant

COPD symptoms (CAT score ≥10; MRC ≥3).

Asthma: Not recommended as single inhaler. Must be

taken with ICS (ideally as combination inhaler)

Tremor, palpitations, headache,

muscle cramps.

May occur more commonly with high

use of SABA.

Education on COPD Medicines

Drug Role in Treatment Common side effects Combination long-

acting

bronchodilator

(LAMA/LABA)

Anoro®, Duaklir®,

Spiolto®, Ultibro®

Regular OD or BD (Duaklir® only) use. Combining two classes of long-acting bronchodilator produces • Greater increases in lung function, breathlessness and

quality of life than using only one LA-bronchodilator. • Significant increase in exercise endurance may be seen. Licensed for COPD only. In Leeds, they are recommended as a first-line option for patients with more significant COPD symptoms (CAT score ≥10; MRC ≥3), ahead of using single-agent long-acting bronchodilator.

Side effects are likely to be similar to those observed with each single agent, i.e. dry mouth, tremor, palpitations, headache, muscle cramps.

Combination

corticosteroid &

long-acting beta2-

agonist (ICS/LABA) Aerivio®, AirFluSal®,

Aloflute®, Combisal®,

DuoResp®, Flutiform®,

Fobumix®, Fostair®,

Fusacomb®, Relvar®,

Sereflo®, Seretide®,

Sirdupla®, Symbicort®

Regular OD (Relvar® only) or BD use.

ICS decrease the number & activity of inflammatory cells

that are present in the lungs of people with severe COPD

(FEV1 <50%) who experience frequent exacerbations.

NO role in mild-moderate airway obstruction as these

inflammatory cells are not present in sig. numbers.

NB. Inhaled corticosteroid inhalers are only licensed for

use in COPD when used as a combination ICS/LABA

inhaler.

Local ICS ADRs: oral thrush and

dysphonia. Management: rinse mouth

after use, spacer with MDI, or switching

to an alternative drug/device.

Other ADRs include skin thinning and

bruising, osteoporosis.

Some ICS increase risk of pneumonia,

which may require discontinuation.

High dose ICS/LABA: issue High Dose

Inhaled Steroid Warning Card.

NB. Fusacomb Easyhaler is licensed for use in UK, but has not been launched yet

Education on COPD Medicines

Drug Role in Treatment Common side effects Combination

corticosteroid +

long-acting beta2-

agonist + long-

acting muscarinic

antagonist

(ICS/LABA/LAMA)

Trelegy®, Trimbow®

Regular OD (Trelegy®) or BD (Trimbow®) use. Combining an inhaled corticosteroid with two classes of long-acting bronchodilator produces • Greater increases in lung function, breathlessness and

quality of life than using either dual LA-bronchodilator, or an ICS/LABA

• Significant reduction in COPD exacerbations may be seen.

Licensed for COPD only. In Leeds, they are proposed first-line option for patients with more significant COPD symptoms (CAT score ≥10; MRC ≥3) and frequent (≥2 per year) exacerbations despite LABA/LAMA.

Local ICS ADRs: oral thrush and

dysphonia. Management: rinse mouth

after use, spacer with MDI, or switching

to an alternative drug/device.

Other ADRs include skin thinning and

bruising, osteoporosis.

Some ICS increase risk of pneumonia,

which may require discontinuation.

Bronchodilator side effects are likely to be similar to those observed with each single agent, i.e. dry mouth, tremor, palpitations, headache, muscle cramps.

NB. Fusacomb Easyhaler is licensed for use in UK, but has not been launched yet

Evidence for the Side Effects of ICS

Price et al. Prim Care Respir J 2013; 22(1): 92‐100

• MHRA May 2006: • Prolonged use of high doses of ICS…carries a risk of systemic side effects... • Corticosteroid treatment cards should be routinely provided for…high doses of ICS.

• MHRA, September 2010: • Inhaled (and intranasal) corticosteroids...

• High Dose Inhaled Corticosteroid Warning Cards, 2014 • For all patients Rxed high doses of ICS (≥1000mcg BDP/day). • Consider for medium doses of ICS (e.g. 800mcg BDP/day) + Intranasal steroids

• Further information: • https://www.networks.nhs.uk/nhs-networks/london-lungs/documents/inhaled-

corticosteroids-in-adults/view

• https://www.networks.nhs.uk/nhs-networks/london-lungs/documents/high-dose-inhaled-corticosteroid-alert-card-order-form

Risks of High Dose Inhaled Corticosteroids

MHRA. Current Problems in Pharmacovigilance 2006

MHRA. Drug Safety Update 2010.

4. Adherence

ACTION:

• EXPLORE and identify reasons for reported non-

adherence

• (e.g. due to beliefs, device, medicine, or side-effects).

• ASK the patient how they feel about using their COPD

inhalers.

• Do they have any concerns about using these medicines?

• DISCUSS and agree strategies and solutions to

improve adherence with the patient.

• A patient-centred approach should be used at all times

Medication Adherence

Possible Causes of Non-Adherence

Beliefs Device Medicine

• Denial of condition • Concern about quantity • Misunderstand

condition • Misunderstand

treatment • Fear of side-effects • Embarrassment

• Dexterity problems • Incorrect technique • Incorrect cleaning of

spacer

• Frequency of dosing • Several different

medicines • Actual side-effects • Forgetfulness • Cost of prescription

• How are you getting on with this medicine / inhaler?

• An open question to get the patient talking about issues that are important

to them

• When and how often do you use this medicine / inhaler?

• Are you having any problems with this medicine/ inhaler, or concerns

about taking or using it?

• It may be important to assure the patient that it is normal to have concerns

about taking any medicine

• Do you think this medicine / inhaler is working?

(Prompt- is this different from what you were expecting?)

• Patients should understand their medicines & benefits in COPD

• Do you think you are getting any side effects or unexpected effects?

• Consider filling in a Yellow Card if severe or ▼ drugs

• Allows discussion about managing/preventing side effects

Framework for discussions

• Information and education about COPD & medicines to address

beliefs & concerns

• Set realistic expectations (e.g. ICS do not have an immediate effect

on symptoms)

• Advice on use and care of inhaler devices & spacers

• Addressing forgetfulness: reminders, location etc.

• Managing and avoiding ADRs

Adherence Interventions

5. Smoking Cessation

FEV1 (% of value at age 25)

COPD & smoking

Fletcher CM, Peto R. The natural history of chronic airflow obstruction. BMJ 1977; 1(6077):1645-1648

100

75

50

25

0 25 50 75

Never smoked or not susceptible to smoke

Smoked regularly and susceptible to its effects

Stopped at 45

Stopped at 65

Disability

Death

Age (in years)

• Stopping smoking is the most important & cost-effective

intervention in COPD

ACTION:

• Give very brief advice (30 seconds)

• Ask / Advise / Act

• Refer to local NHS stop smoking service:

• Web: https://oneyouleeds.co.uk/be-smoke-free/

• CPPE/NCSCT Training:

• Stop smoking NCSCT practitioners

assessment: knowledge and skills

• Learning about stop smoking support

Smoking History

Very Brief Advice

‘Do you or anyone else in your

household smoke?’

www.ncsct.co.uk

Very Brief Advice

‘Do you know that stopping smoking

can improve breathlessness, reduce

hospital admissions, help prevent

disease progression and increase life

expectancy?’

‘It’s never too late to stop.’

‘Have you ever thought of stopping or

tried to stop before? I can tell you

where to get the best help.’ www.ncsct.co.uk

Very Brief Advice

‘The Local NHS Stop Smoking Service

can offer you support and advice on

quitting. You are up to 4 times more

likely to stop with the support from the

service’

‘The Stop Smoking Service can make

this much easier for you.’

‘Shall I refer you? It really is the best

thing you can do right now.’

‘It’s a free advice service’

www.ncsct.co.uk

• Signpost patients to patient resources on the internet, e.g.

• British Lung Foundation (https://www.blf.org.uk/)

• Asthma UK (https://www.blf.org.uk/)

• Inhaler technique videos e.g. • Right Breathe (https://www.rightbreathe.com/)

• BLF Breathe Easy support groups (https://www.blf.org.uk/support-

for-you/breathe-easy)

• Groups in Beeston, Bramley, Gipton, Hunslet, Middleton,

Guiseley/Yeadon, Bradford, Dewsbury

Further support for patients

• Summarise key points:

• Smoking cessation, inhaler technique & adherence,

vaccination, healthy lifestyle

• Confirm issues being referred to their GP

• And send it to the GP!

• Ask if they have any final questions.

• Arrange follow-up appointment.

• Record consultation on PharmOutcomes – within 48hrs

End of Consultation