Medicines Optimisation in COPD

Helen Marlow

Lead Primary Care Pharmacist, NICE Medicines and Prescribing Associate, and KSS Respiratory

Expert Advisory Group member

June 2016

What I will talk about

• How the treatment pathway for COPD is

changing

• What makes a difference to patient

outcomes

• Some medicines optimisation issues

2

Abbreviations

MDI = metered dose inhaler

DPI = dry powder inhaler

ICS = inhaled corticosteroid

LABA = long acting beta 2 agonist

SABA = short acting beta 2 agonist

LAMA = long acting muscarinic antagonist

BDP = beclametasone dipropionate

BUD = budesonide

FP = fluticasone priopionate

3

What do the guidelines say?

NICE and GOLD

4

NICE algorithm for inhaled therapy (2010)

5

Are we prescribing according to the

guidelines?

• An ICS is more cost –effective for those with severe

disease (FEV1 predicted <50%) and a history of

exacerbations. (1)

• One fifth of patients with COPD in the UK would need an

ICS, however estimates suggest that as many as 70% are

prescribed them. (2)

• An audit of primary care prescribing revealed that almost

25% of patients were prescribed an ICS inappropriately

and when this result was extrapolated to the population of

England, equated to an annual cost of £67 million. (3)

1. NICE Clinical Guideline 101 COPD 2010 2. Suissa & Barnes European Respiratory Journal. 2009;34(1):13-6. 3. White P et al. PLoS ONE. 2013;8(10):e75221.

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Are we prescribing according to the

guidelines – ICS in COPD?

White P, Thornton H, Pinnock H, Georgopoulou S, Booth HP (2013) Overtreatment of COPD with Inhaled Corticosteroids - Implications for Safety and Costs: Cross-Sectional Observational Study . PLoS ONE 8(10): e75221. doi:10.1371/journal.pone.0075221

Setting - 41 GP practices in SE London

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GOLD recommended inhaled

therapy for COPD (2016)

Patient

Characteristics

Spirometric

classification

Exacerb’ns

per year Group

Recommended first

choice

Low risk, Less symptoms

GOLD 1-2 0 - 1 no hosp’n A SABA or SAMA

Low risk, More symptoms

GOLD 1-2 0 - 1 no hosp’n B LAMA or LABA

High risk, Less symptoms

GOLD 3-4 ≥ 2 Or ≥ 1 with hosp’n C ICS + LABA or LAMA

High risk, More symptoms

GOLD 3-4 ≥ 2 Or ≥ 1 with hosp’n D ICS + LABA +/or LAMA

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What makes a difference to

patient outcomes?

9

What are we trying to achieve?

Maximise value

Porter ME; Lee TH NEJM 2010;363:2477-2481; 2481-2483

Telehealth £92000/

QALY

Triple Therapy £7000-

£187000/QALY

Long term Oxygen Therapy £11-16000/QALY

LABA

£5-8000/QALY

Tiotropium/LAMA

£7000/QALY

Pulmonary Rehabilitation

£2000-8000/QALY

Stop Smoking Support with pharmacotherapy £2000/QALY

Flu vaccination? £1000/QALY in “at risk” population

COPD Value Pyramid (from London RespiratoryTeam)

Cost per QALY*

*Quality Adjusted Life Year

Comparing Treatments for COPD

LABA LAMA ICS + LABA

(Cf LABA)

Quality of life

and symptom

improvement

Reduce

exacerbations

Reduces

deterioration

in lung

function

Side effects

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Comparing Treatments for COPD

LABA LAMA ICS + LABA

(Cf LABA)

Quality of life

and symptom

improvement

Yes Yes Yes

Reduce

exacerbations Yes

Yes Tiotropium appears better

than LABAs

Yes But is much more cost-

effective in frequent exacerbators and COPD

with FEV1 <50%

Reduces

deterioration

in lung

function

No Yes

Tiotropium ,but may not be clinically significant

No

Side effects

• Tremor • Palpitations • Hypokalaemia

• Dry mouth • Nasal congestion • Caution in cardiac

rhythm disorders, angle-closure glaucoma

Renal impairment – can use aclidinium and umcelidinium

• Fractures

• Pneumonia (NNH of ~50 for admission for pneumonia over 18 months)

• Increased risk of diabetes

(NNH of ~21 over 5 years)

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What about combination LABA and LAMA? (Karner C & Cates C. Cochrane Library 2012)

Tiotropium + LABA vs Tiotropium

• “Resulted, on average, in a slightly better quality of life and lung function for the patients ….

• but did not show a difference in hospital admissions or mortality.”

• Harms - not enough data to determine the risks and benefits of tiotropium + LABA vs LABA alone

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How is COPD pathway changing?

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Persistent exacerbations

Consider LABA + ICS + LAMA

Still symptomatic and more than 2 exacerbations per year

Continue LAMA + LABA, or consider switching to LABA + ICS

Still symptomatic

LAMA LABA

Still symptomatic – regular treatment

LAMA LABA

Initial PRN treatment

SABA SAMA or

or

and

Triple therapy

Medicines Optimisation in

COPD

ICS safety

Inhaler devices and technique

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What is the evidence for the side

effects of ICS?

Side-effects of inhaled corticosteroids in COPD and type of evidence

Randomised controlled trial

Observational study

Systematic review

Pneumonia ✓ ✓ ✓

Tuberculosis ✓

Bone fracture (No effect on fracture risk)

✓ ✓

Skin thinning/ easy bruising

✓

Cataract ✓

Diabetes ✓

Oropharyngeal ✓ ✓ ✓

Price et al. Prim Care Respir J 2013; 22(1): 92-100 17

Inhaled Corticosteroid (ICS) patient

safety card

• MHRA 2006 “steroid treatment cards should be routinely provided for patients (or their parents/carers) who require prolonged treatment with high doses of inhaled steroids”

BUT Blue steroid card were not designed for use with inhaled corticosteroid therapy

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Endorsement

Approval pending from the British Lung Foundation and Asthma UK

Within one month of launch, orders for 40,000 cards were made from trusts and CCGs within London and the South of England

Inhaler devices

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22

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Inhaler technique

• >90% of patients cannot use an MDI effectively

• 91% of healthcare professionals who teach use of an MDI

cannot demonstrate it correctly*

• Even with effective technique, maximum lung deposition

from MDI is 15%

• Large volume spacer may be easier to use and increases

deposition to 30%

• If used incorrectly – most of the drug from MDI is wasted –

Seretide 500 is ~ £41/month

*Thorax 2010;65:A117

Do Health Care Professionals have sufficient knowledge of inhaler

techniques in order to educate their patients effectively in their use?

Inhalers are widely used in

the treatment of asthma

and chronic obstructive

pulmonary disease

(COPD). For patients to

gain maximum benefit

they need to be educated

by competent health care

professionals (HCPs)

whose own inhaler

technique meets accepted

standards. This study

looked at HCPs ability to

use the commonly

prescribed metered dose

inhaler (pMDI).

Introduction

If we [HCP’s] are going

to adequately educate

our patients with regard

to their inhaler usage

we need to be

competent in how each

device works. Incorrect

teaching and

assessment will

increase use of health

care resources, waste

medication, and mean

worsening symptoms

and poor control of

airways disease for our

patients.

Methods

Results

7% could demonstrate

all the recognised steps

in administration

including assessment

of inspiratory flow using

the in-check device1.

70% n=104

70% could not

demonstrate the

correct stages of

inhaler administration

or correct inspiratory

flow rate.

The main reason for

incorrect technique

was not breathing in at

the correct speed

(inspiratory flow rate).

Most breathed in much

too fast for an MDI.

150 Health care

professionals (74 Primary

Care Trust; 76 Acute

Trust) were asked to

demonstrate how they

would self administer an

pMDI placebo Inhaler. The

Group included hospital

doctors, hospital nurses,

general practitioners,

practice nurses, hospital

and community pharmacy

staff. They were also

asked to demonstrate the

correct inspiratory flow

rate using the In-check

dial device 1

Mark Baverstock, Nikki Woodhall & Vicki Maarman

&

Conclusion

Outcome

Health Care Professionals

need to be trained to a

high standard with regular

updates. As a result of this

audit, The Authors have

set up a train–the–trainer

scheme with regular

updates. In-Check dials

have been purchased as

training aids for use by

HCPs.

23% could demonstrate

the correct stages of

inhaler administration

but not the correct

inspiratory Flow

70%

N=104

23%

N=35

7%

N=11

Pharmaceutical Advisers

1 In-Check Dial - Clement Clarke International http://www.clementclarke.com/products/inspiratory_flow/index.html

Poster Prepared for the British Thoracic Society Winter Meeting December

2010

Inhalers: Responsible Respiratory Prescribing messages

Do the right things:

With the patient, decide the best device for them assess their ability to use, let them see, touch and feel the inhaler, then describe, show and provide written information

Do the right things right:

Ensure correct inhaler technique most patients don’t know how to use their inhaler and many health care professionals who teach the use of MDI cannot demonstrate it correctly

Use a spacer when using an MDI correctly a max of 15% of the drug enters the lung. With a spacer this can be increased up to 30%

Prescribe inhalers by brand, so patient receives correct inhaler device

Rationalise inhaler devices for an individual patient, avoid mixing too many different inhaler types

Re-check inhaler technique and retrain patients often, inhaler technique deteriorates over time, lots of patients think they are using their inhalers correctly when they are not

COPD: Responsible Respiratory Prescribing messages

Do the right things:

Smoking cessation is effective, it reduces exacerbations and slows

progression of COPD

Flu vaccination reduces the risk of COPD exacerbations

Pulmonary rehabilitation reduces admissions and health care resource use,

improves exercise capacity and health related quality of life

Aim to implement all of above before considering stepping up therapy

Prescribe according to guidelines

Provide individualised self management plan and exacerbation rescue pack,

to patients with COPD exacerbations

Do the right things right:

Undertake a ‘trial of treatment, for treatments aimed at reducing symptoms’, and don’t be afraid to discontinue if symptoms aren’t improved

Use an ICS patient safety card for patients on high dose ICS

Reserve ICS for more severe COPD and frequent exacerbations to minimise risk of harm and optimise benefit