Asthma / COPD advice for primary care pharmacists

1. Conducting Medication
Reviews in asthma & COPD
patients
Noshi Iqbal
Lead Pharmacist
Clinical Training & Development
October 2007

2. Learning Outcomes
By the end of this session, you will be able to:
• Differentiate between the conditions of asthma &
COPD (medication review perspective)
• Advise on the suitability of inhaler devices for
your patients (device considerations)
• Understand the pharmacokinetics of inhaled
drugs (inhaler selection in individuals)
• Discuss national guidelines for asthma & COPD
• Understand what information is needed in the
GMS 06/07 asthma & COPD templates

3. Background knowledge
• It is assumed that pharmacists are familiar with:
– Asthma & COPD as medical conditions
– General pharmacology of the conditions
– Broad knowledge of disease management
– Familiar with the BTS & SIGN guidelines for asthma
management
– Familiar with NICE guidelines for COPD management
• References for the above has been provided in
the module packs for the session.

4. Pharmacist interventions
During a medication review with an asthmatic or COPD patient, we
should look out for:
• Inappropriate use of medication
– Dosage regimen as patient takes it
– Patient’s knowledge of their medicine
– Compliance
• Side effects
– Oral thrush (steroids), tremors (�� agonists)
– Inappropriate formulation
– Drug interactions (theophylline & antibiotics)
• Other considerations
– OTC medicines (regular cough preps, sedatives suggesting
condition not under control)
– Spacer replacing (once every year) & cleaning
– Brand substitution (QVAR®, Clenil®, theophylline)
– Number of doses in inhalers (so enough supplied per issue)
• Advice
– Physical activity, reduction in body weight, healthy eating & smoking
cessation

5. Asthma

6. Overview of asthma management
• The aim of treatment of chronic asthma is to
achieve early control, to prevent exacerbations,
and to maintain control.
• Treat asthma using a stepwise approach. Start
treatment at level most appropriate to asthma
severity.
• Before recommending a new drug, check trigger
factors have been eliminated, check inhaler
technique and compliance
– if trials of add-on therapies are ineffective – advise to
stop
– if trials of increased steroids are ineffective - advise
to return to original dose
• Step down treatment levels when control is good
– review regularly whilst treatment is stepped down

7. Goals & outcome measures in asthma
BTS & SIGN guidelines for asthma:
• Minimal symptoms during day and night
• Minimal need for reliever medication
• No exacerbations
• No limitation of physical activity
• 'Normal' lung function, i.e. forced
expiratory volume in 1 second (FEV1) or
peak expiratory flow (PEF), or both,
greater than 80% predicted (or best)

8. BTS & SIGN guidelines on asthma
• Step 1 – As required reliever therapy: treat with a short-
acting � ��agonist in mild intermittent asthma.
• Step 2 – Regular preventer therapy: prevent asthma using
an inhaled corticosteroid (ICS) in both adults & children
• Step 3 – Add-on therapy: this consists of several treatment
options, such as a trial of long-acting � ��agonist, increasing
the dose of ICS, or adding one of a leukotriene receptor
antagonist (especially in children under 5 years), theophylline,
or an oral � ��agonist. Consider referral to respiratory
paediatrician for children under 2 years.
• Step 4 – Persistent poor control: increase to maximum
dose of ICS and consider a trial of two add-on drugs. Refer all
children under 5 years.
• Step 5 – Continuous or frequent use of oral
corticosteroids: add an oral corticosteroid to existing
treatment as single daily dose, and consider referral for
specialist advice (asthma clinic for adults, respiratory
paediatrician for children) if symptoms are not controlled.

9. Notes
• In addition to drug treatment, offer self-management education,
including written asthma action plans, which should be tailored to
the needs and preferences of the individual. Give advice on
preventing exacerbations of asthma.
• People who have exercise-induced asthma, or occupational asthma,
or women who are pregnant, may require specific management,
solicit asthma nurse advice
Steroid therapy
• Inhaled steroids should be considered for patients with any of the
following: exacerbation in the last two years, using � �� agonists > 3
times a week or waking 1 night a week
• Once daily inhaled steroids at the same total daily dose can be
considered if good control is established in milder disease
• Higher doses of steroids may be needed in patients who are
smokers /ex-smokers
• Risk of systemic side effects with long-term or frequent oral steroid
therapy – monitor BP, check for signs of diabetes, hyperlipidaemia &
osteoporosis. In children also monitor growth, check if GP / asthma
nurse has mentioned signs of adrenal suppression & screening for
cataracts (in children).
• Dose reduction should be slow e.g. 20-50% every 3 months

10. GMS Quality Indicators for asthma
Records
• ASTHMA 1 - The practice can produce a register of patients
with asthma, excluding patients with asthma who have been
prescribed no asthma-related drugs in the previous twelve
months = 4 points.
Initial Management
• ASTHMA 8 - The percentage of patients aged eight and
over diagnosed as having asthma from 1 April 2006 with
measures of variability or reversibility = 15 points (40-80%
threshold).
Ongoing Management
• ASTHMA 3 - The percentage of patients with asthma
between the ages of 14 and 19 in whom there is a record of
smoking status in the previous 15 months = 6 points (40-
80% threshold).
• ASTHMA 6 - The percentage of patients with asthma who
have had an asthma review in the previous 15 months = 20
points (40-70% threshold).

11. Where we can help with QOF
Can help with
‘ongoing
management’
• ASTHMA 3 – during
a med review if we
check smoking
status
• ASTHMA 6 – if we
go through all
asthma medication
then can use XalfK
‘asthma medication
review’
• If check inhaler
technique can tick
appropriate box

12. Chronic Obstructive
Pulmonary Disease

13. Overview of COPD management
• A diagnosis of COPD should be
considered in patients over 35 years who
have a risk factor (usually smoking), and
one or more of:
– Exertional breathlessness
– Chronic cough
– Regular sputum production
– Frequent ‘winter bronchitis’
– Wheeze
• The degree of airflow obstruction cannot
be predicted from symptoms or signs.

14. Goals & outcome measures in COPD
NICE guidelines for COPD:
• Lung function should be assessed using spirometry
• Results indicate an abnormality if:
– FEV1 is < 80% predicted
– FVC is < 80% predicted
– Ratio FEV1 / FVC < 70%
• Classification % predicted FEV1
– Mild: 50-80%
– Moderate: 30-49%
– Severe: < 30%
• Can assess severity of COPD by MRC (dyspnoea)
scale, BMI
• Mild / moderate COPD – assess annually
• Severe COPD – assess twice a year
• All patients should have a chest x-ray & FBC [to exclude
lung cancer & blood disorders (anaemia, polycythaemia
etc)]

15. What else could it be?
The differential diagnosis of chronic obstructive pulmonary disease
(COPD) includes any condition that presents with persistent
breathlessness and/or cough. For example:
• Asthma — family history, atopy, non-smoker, younger age, nocturnal
symptoms.
• Bronchiectasis — copious sputum, frequent chest infections, history
of childhood pneumonia, coarse lung crackles.
• Congestive cardiac failure — breathlessness when lying flat, history
of ischaemic heart disease, fine lung crackles.
• Lung carcinoma — haemoptysis, weight loss, hoarseness.
• Interstitial lung disease (asbestosis, pneumoconiosis, fibrosing
alveolitis) — dry cough, fine crackles.
• Bronchopulmonary dysplasia — recurrent chest infections in young
adult.
• Anaemia.
• Obstructive sleep apnoea.
Note: some of these conditions may also coexist in a COPD patient.
If you suspect any of these other symptoms – let GP know

16. Differences between asthma & COPD
Clinical features COPD Asthma
Smoker or ex-smoker Nearly all Possibly
Age < 35 years Rare Often
Chronic productive Common Uncommon
cough
Breathlessness Persistent and Variable
productive
Night time waking with Uncommon Common
breathlessness or
wheeze
Significant diurnal or Uncommon Common
day-to-day variation in
symptoms

17. NICE guidelines on COPD
• In people with stable COPD who are symptomatic with
breathlessness &/or reduced exercise tolerance use
the following:
– Start with a short-acting bronchodilator (� ��agonist or
antimuscarinic) as required.
– If still symptomatic, either combine a short-acting � ��
agonist with a short-acting antimuscarinic, or add in a long-
acting bronchodilator (� ��agonist or antimuscarinic).
– If still symptomatic, in moderate-to-severe COPD consider
a trial of a combination of a long-acting � ��agonist and
inhaled corticosteroids.
– If still symptomatic, consider adding aminophylline or
theophylline.
• Review people 1-2 months after a treatment has been
started, and if there is no symptomatic improvement it
should be discontinued. Suggest a longer trial period
in people who have started an inhaled corticosteroid.

18. NICE guidelines on COPD
• In people with stable COPD who are having frequent
exacerbations:
– Optimise long-acting bronchodilator therapy with one or two
long-acting bronchodilators.
– Suggest to GP to add an inhaled corticosteroid — if the person
has moderate-to-severe COPD (FEV1 less than 50%) and two or
more exacerbations in a 12-month period.
– In people troubled by a chronic productive cough, consider a trial
of a mucolytic drug.
– In people with an exacerbation of COPD, firstly exclude the need
for admission to hospital, then increase the inhaled short-acting
bronchodilator therapy to maximum, and consider starting a
course of oral corticosteroids (if breathless), and an antibiotic if
they have purulent sputum and/or signs of infection (do with GP).
• People with frequent exacerbations should have an
action plan (as part of their self-management plan) on
how to recognise, and respond early (and appropriately)
to, an exacerbation. Check with nurse what info he / she
provides to patients.

19. NICE guidelines on COPD
• Referral to a specialist should help with an
uncertain diagnosis of COPD (or complications)
and for consideration of additional therapies:
– Oxygen therapy in anyone with moderate-to-severe
COPD, signs of cor pulmonale, or polycythaemia.
– Pulmonary rehabilitation in anyone who considered
themselves functionally disabled by their COPD
(usually MRC dyspnoea score > 3)
– Nutritional supplements (after a dietician referral) in
people with a BMI of less than 20 kg/m2.
• All patients and carers should be aware that
COPD can be a terminal disease and individuals
with end-stage COPD should receive palliative
care by a multi-disciplinary team.

20. Audit criteria in COPD
NICE recommends the following audit criteria to investigate COPD:
• Diagnosis of COPD
– Percentage of people over the age of 35 years who smoke consulting with
a chronic cough and/or breathlessness who have had spirometry
performed.
– Percentage of people with a diagnosis of COPD who have had spirometry
performed.
• Smoking cessation
– Percentage of people with COPD who are current smokers recorded in
the general practice records as having been offered smoking cessation
advice and or therapy.
• Effectiveness of inhaled therapy
– Percentage of people with FEV1 of equal to, or less than, 50% predicted
who have had two or more exacerbations in a 12-month period who are
prescribed inhaled corticosteroid therapy.
• Pulmonary rehabilitation
– Percentage of people with COPD who have undergone pulmonary
rehabilitation.
• Management of exacerbations
– Percentage of people with exacerbations receiving appropriate
corticosteroids and/ or antibiotics.

21. FAQs about COPD
1) When are oral corticosteroids recommended?
• Long-term (maintenance) oral corticosteroids are
generally not recommended for stable chronic
obstructive pulmonary disease (COPD).
• If the person finds it difficult to stop oral corticosteroids
(e.g. has immediate worsening of symptoms) after
repeated short courses prescribed for exacerbations
and/or has severe breathlessness, consider referring
for advice on maintenance oral corticosteroids
• People taking maintenance oral corticosteroids should
be:
– On the lowest dose possible to alleviate disabling symptoms
(e.g. prednisolone 5 mg/day).
– Advised not to stop taking corticosteroids suddenly, and to
carry a corticosteroid treatment card.
– Monitored for the development of osteoporosis if under 65
years of age or started on prophylaxis treatment (with
monitoring) if over 65 years of age.

22. FAQs about COPD
2) When should antibiotics be prescribed?
• An antibiotic should be started if the person's sputum is more
purulent than usual and/or there are clinical signs of pneumonia.
• Consult local antibiotic prescribing guidelines. Empirical treatment
with:
– An aminopenicillin (e.g. amoxicillin) is usually first-line.
– A tetracycline (e.g. doxycycline), or a macrolide (e.g. erythromycin, or
clarithromycin), are suitable alternatives.
– If there is no clinical benefit after the first antibiotic, consider using an
alternative antibiotic from the first-line options, or co-amoxiclav.
• Note: use of an antibiotic is not recommended in the absence of
purulent sputum.
• Pneumonia in the elderly can be non-specific, but there should be
an increased suspicion of infection if there is a temperature and/or
clinical signs on examination (bronchial breathing, reduced air
entry), increased breathlessness or cough, increased volume of
sputum, reduced exercise capacity, or a recent hospitalisation.
Prophylactic antibiotics are not recommended for people with stable
chronic obstructive pulmonary disease, due to concerns about
antibiotic resistance and potential adverse effects

23. GMS Quality Indicators for COPD
Records
• COPD 1 - The practice can produce a register of patients
with COPD = 3 points
Initial diagnosis
• COPD 9 - The percentage of all patients with COPD in
whom diagnosis has been confirmed by spirometry including
reversibility testing = 10 points (40-80% threshold)
Ongoing management
• COPD 10 - The percentage of patients with COPD with a
record of forced expiratory volume in 1 second (FEV1) in the
previous 15 months = 7 points (40-70% threshold)
• COPD 11 - The percentage of patients with COPD receiving
inhaled treatment in whom there is a record that inhaler
technique has been checked in the previous 15 months = 7
points (40-90% threshold)
• COPD 8 - The percentage of patients with COPD who have
had influenza immunisation in the preceding 1 September to
31 March = 6 points (40-85% threshold)

24. Where we can help with QOF
Can help with
‘initial diagnosis’
• COPD 9 – can
check if patients
have had a
spirometry to
confirm diagnosis
Can help with
‘ongoing
management’
• COPD 11 – if we
check inhaler
technique can
select from drop
down menu

25. Biopharmaceutics
&
pharmacokinetics

26. Device considerations
1) What patients want from an inhaler device – i.e.
does it fit in with:
– Lifestyle (carry in handbag, pocket, work in damp
environments – DPIs clog)
– Ability (using Spiriva®, MDI vs. Easi-Breathe®, child)
– physical & sensory impairment (arthritis, blind, deaf)
– learning disabilities (MDI technique vs. accuhaler)
– Tracheostomies (difficult to administer – small volume
spacer which fits trachy device – can then use MDIs)
2) Cost effectiveness (60, 120 and 200 doses)
3) Range of devices – ease of use, patient
preference which will aid compliance & minimise
costs by less wastage due to inappropriate use.

27. Pharmacokinetics of inhaled drugs
• Drug molecules deposited in the mouth &
oropharynx are:
– swallowed
– absorbed from the gut
– taken into the portal circulation via the portal vein
– metabolised & deactivated in the liver (first pass)
• Systemic absorption also occurs in the lungs –
smaller particle size of some CFC-free inhaled
products can increased systemic drug
availability (Qvar® – used at half the dose)
• Some drugs are activated only when they reach
the target lung site (pro-drugs e.g. ciclesonide)

28. • The drug dose stated on • Drug particle size
the label is not always the has to be
dose that reaches lungs between 2-5
microns to be
• Some drugs are deposited in the
metabolised & upper & central
deactivated in the airways
liver more
effectively than
others (reduces
amount that • If size of drug
reaches systemic
circulation) – particles is less
fluticasone vs. than 2 microns
beclometasone drugs – passage to
circulation can
• High doses of inhaled
occur across the
corticosteroids may
alveolar-capillary
produce systemic effects
interface

29. Biopharmaceutics of inhalers
• Metered dose inhalers (MDIs) are pressurised,
hand-held devices that use propellants to deliver
doses of medication to the lungs of a patient.
• The propellant evaporates leaving the drug
particles to deposit in the lungs during an
actuation
• The Montreal Protocol on Substances That
Deplete the Ozone Layer is an international
treaty designed to protect the ozone layer by
phasing out the production of a number of
substances (including cfc-inhalers) believed to
be responsible for ozone depletion. The treaty
came into force on Jan 1st 1989 – it was agreed
that CFC-free inhalers would be in use by 1996.

30. CFC-free inhalers
• Hydrofluoroalkane 134a (HFAs) is the main type of CFC-
free inhaler
• All salbutamol MDIs in the UK are now CFC free
• Inhaled steroids are more difficult to reformulate with HFA
propellants, (especially beclometasone dipropionate) as the
drug particles behave differently
• QVAR® has a particle size of 2 microns to overcome this –
care with dose (to minimise systemic drug bioavailability)
• Modulite MDI use advanced technology where the orifice
size is finer which alters the cloud characteristics of the
drug particles enabling a slower moving inhaler cloud over
a longer time period – advantage - less dependency on
good coordination
• Modulite technology has enabled HFA formulations to be
developed with drugs that were previously difficult to
reformulate
• Clenil Modulite® & Respimat® utilise this new technology

31. Inhaler types
• There are two main types of inhalers
available:
• Pressurised MDIs (including breath
activated MDIs)
• Dry powder inhalers (DPIs)

32. Inhaler technique
• Generation of a drug aerosol for inhalation requires
energy
• The source of the energy varies depending on the
device used:
– In an MDI the aerosol is generated by the evaporation of
the propellant
– In a DPI the energy is generated from the flow of air
through the device by the inspiratory effort that the patient
produces
– In a nebuliser the energy is provided by the driving gas
• All inhaler devices require different amounts of
effort; each patient will be different so it is
important to determine from the inhaler
technique which type of inhaler will be most
suitable

33. Pressurised Metered Dose Inhalers
(pMDIs)
• The aerosol leaves the actuator of MDIs at high speed
• Patients need to co-ordinate inhalation and actuation of
the inhaler and needs to inhale at a low inspiratory flow
rate
• This serves to slow down the aerosol so that it doesn’t
impact at the back of the throat and in the large airways
• A common error with MDI technique is to inhale too fast
Drug deposition Inspiratory flow
Mouth Too slow
Throat Too fast
Lungs Correct

34. Dry Powder Inhalers (DPI)
• A DPI is designed such that the patient’s inhalation through
it will create sufficient turbulence to break the drug down
(deaggregate it) into the right sized particles for inhalation
(which form the dose)
• The drug in many DPIs is attached to a carrier molecule
(usually lactose)
• When the turbulent airstream causes deaggregation:
• Small drug particles are inhaled and deposited in the lungs
• Larger particles and the lactose carrier are deposited in the
mouth and swallowed
• The inspiratory flow rate needed to deaggregate the drug to
the appropriate fine particle mass varies from inhaler to
inhaler
• The amount of effort a patient needs to generate the
appropriate level of flow also varies from device to device
and depends on the internal design of the inhaler and
amount of internal resistance this creates

35. The correct inhalation technique
that generates the right inspiratory
flow rate through the internal
resistance of the inhaler needs to
be taught if the optimum dose of
drug is to reach the lungs
A breath hold at the end of
inhalation allows drug
particles to settle in the
small airways
(sedimentation) and
improve deposition of drug
in the lungs

36. Doing Medication Reviews with
Asthma / COPD patients
• Check patient understanding of treatment
• Check if treatment suitable for patients
• Provide advice to GPs & respiratory
nurses on management of conditions
• Help practices achieve GMS targets and
participate in audit (fill numbers in weekly
sheets)

37. References
• BTS guidelines for asthma 2007
• NICE guidelines for COPD Nov 05

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