LABA SOP v2

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
Medicines Optimisation Prescribing Audit:

Long acting beta agonist (LABA ) review
Aim
To identify all patients prescribed long acting beta agonist inhalers and where clinically appropriate
change them to the most cost effective formulary LABA preparation and device - formoterol
Easyhaler®.The second line option for patients who cannot be changed to formoterol is to review
patients to switch to Soltel , a brand of Salmeterol.
Rationale
Formoterol is a long acting beta2 agonist (LABA), which is pharmacologically different from salmeterol.
Both agents are selective agonists at the beta2 receptor; however formoterol is a full agonist whereas
salmeterol is a partial agonist. Clinically, formoterol has a rapid onset of action (3-5 minutes; similar to
salbutamol) and a wide dose range (6-72 mcg/day) 1. The second line option would be to review patients
to Soltel®, a brand of salmeterol. All preparations of salmeterol are non formulary as formoterol easyhaler
is preferred LABA but where patient needs to remain on salmeterol then Soltel® cfc 25 microgram’s/act
metered dose inhaler should be prescribed. Soltel® brand is £19.95 per month contains soya so is not
suitable for peanut or soya allergy and is not suitable for patients under 12 years.2
Formoterol is available as three devices, all of which have good lung deposition and are licensed for
COPD and asthma. Easyhaler® is currently the cheapest formoterol formulation (£23.75 for 120 doses in
the 12mcg device, equivalent to £11.88 per month) and based on this and the favourable characteristics
of the Easyhaler® dry powder device (ease of use and, particle size) this is the recommended formulation
in the Joint South Staffordshire formulary 3
Salmeterol (Serevent®) either as a 25mcg MDI is £29.26 (metered dose inhaler) or a 50mcg dry powder
inhaler has a monthly cost of £35.114and is not included in the Joint South Staffordshire formulary due to
this, its slower onset of action and unfavourable dose response curve.
Indaceterol (Onbrez Breezehaler®) at either the 150mg or 300mg dose has a monthly cost of £32.19 at
the lower 150mg dose. This is the second line formulary inhaler and may be a good option where
compliance is a problem. However, it is expected that these patients would have tried formoterol
Easyhaler® previously; otherwise a switch should be considered.
Olodaterol (Striverdi Respimat®) has a monthly cost of £26.35 and is considered ‘hospital only’ and
should not be prescribed in primary care. Patients prescribed this device in primary care should be
reviewed and referred to secondary care.
Although there is no direct equivalence, the normal dose of salmeterol is 50mcg twice daily, whereas
formoterol it is 12mcg twice daily. Therefore patient may need to change the number of doses and should
be advised accordingly.
BTS (British Thoracic Society) guidelines (2016) state LABAs should not be prescribed without a
corticosteroid for patients with asthma. Patients not currently prescribed a corticosteroid (as a separate or
combined inhaler) need referral to the GP/nurse as appropriate for review of treatment 4. Where separate
corticosteroid and LABA preparations are prescribed, the most cost effective combination preparation as
per South Staffordshire guidelines should be considered1.
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Version 2 developed april 18 by Irfan Saleji
To be revised:June 2020
MOG group approved: June 18
Audit criteria
Inclusion criteria
 All patients currently prescribed salmeterol MDI (Serevent MDI), salmeterol dry powder inhaler
(Serevent dry powder inhaler), formoterol dry powder inhaler capsules with device (Foradil),
formoterol dry powder inhaler (Oxis turbohaler), formoterol CFC free inhaler (Atmos Modulite),
indacterol dry powder inhaler (Onbrez Breezehaler®) or olodaterol (Striverdi Respimat®), as an
acute or repeat prescription, unless they fall under any of the exclusion criteria defined below.
Exclusion criteria
 A. If the previous dosage was “as directed” and there can be no indication as to the dose from the
records - refer to prescriber for clarification before changing.
 B. Any patient receiving palliative care - refer to prescriber to determine appropriateness to
change.
 C. Patients who do not appear to be taking the existing medication that is being proposed to
switch as prescribed (eg due to inconsistency in the pattern of ordering their repeat prescription) -
refer to prescriber to determine appropriateness to change or to archive and exclude.
 D. Patients on repeat dispensing – highlight for review before next batch issued OR discuss with
practice and decide what course of action is to be taken for such patients.
 E. Patients/carers for whom the method of communication outlined in the SOP may not be
appropriate (e.g. patients who are deaf, illiterate etc) - refer to prescriber to determine
appropriateness to change.
 G. Any patient that those involved in the switch feel is unsuitable for the mentioned change in
medication – refer to prescriber for clarification or exclude and highlight as appropriate. For
example, vulnerable patients might require a face-to-face or telephone discussion with the
prescriber. This reason must be documented on the data collection form.
 H. Any patient who is excluded by the prescriber.
 I. Any patient who has had an exacerbation of asthma or COPD in the last 12 weeks
 J. Asthmatic patients prescribed LABA only without a corticosteroid need referring to GP/nurse,
note asthmatic patients prescribed separate inhalers should be considered for switching to the
first line most cost effective combination inhaler.
 K. If there is a contraindication/caution to the proposed replacement product.
 L. Patients who have failed a previous switch of medication i.e. caused undue distress
 M. Any patient for whom it is not possible to assess inhaler technique for a change in device – eg
housebound patients where a home visit is not possible, unless the prescriber thinks it appropriate
to change without seeing, i.e community pharmacist can demonstrate or patient is very competent
and would manage from patient information leaflet.
 N. Patients initiated by hospital be more cautious, especially if still under respiratory clinician
Soltel cautions
 To exclude patients who have a peanut or soya allergy. These patients are not suitable for Soltel.
Soltel contains soya lecithin
 Soltel should not be used in children 12 or under due to lack of evidence to show its safety and
efficacy.
Method
1. Search the practice clinical system for all patients currently prescribed as an acute or repeat item
salmeterol MDI (Serevent MDI), salmeterol dry powder inhaler (Serevent dry powder inhaler,
formoterol dry powder inhaler capsules with device (Foradil), formoterol dry powder inhaler (Oxis
turbohaler), formoterol CFC free inhaler (Atmos Modulite) indacterol dry powder inhaler (Onbrez
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Breezehaler®) or olodaterol (Striverdi Respimat®) – all strengths. Following review of each

patient’s electronic medical record, record all relevant data using the data collection form
(appendix 1) or similar, for each patient identified.
2. Exclude patients according to the specific exclusion criteria. Any patient excluded from the switch
should have a relevant read code and explanation added to their electronic medical record for
audit purposes and any future work.
3. Refer patients requiring clarification or individual authorisation at this stage, to the relevant
prescriber.
4. Invite patients, who appear suitable to be changed to more cost effective device, to a clinic
(nurse/pharmacist/GP led) to be assessed for suitability using the patient letter in appendix 2.
5. If the patient is asthmatic this may be an opportunity to conduct an assessment and to link in with
the high dose inhaled corticosteroid review if appropriate. The decision should be made in
partnership with the patient explaining the benefits and risks around inhaled steroids.
6. For patients with COPD, review against current COPD guidelines. Where patients are also
prescribed a LABA, it would be more cost effective to rationalise to Anoro Ellipta 5.
7. Change all patients who are suitable. If the change is made on a different day to the data
collection due to referral of queries to the prescriber etc., ensure that there has been no clinically
significant change to a patient’s circumstances and/or medication immediately prior to undertaking
the change (i.e. all information recorded on the data collection form is still accurate). Add a
relevant code to the additional information/pharmacy box to record that this has been carried out.
8. Carry out the preparation/device change :
- Adding the new preparation/device.
- Archiving the previous dosage into past drugs, if applicable.
- Creating an entry in patient consultation/journal notes confirming the switch. Use wording
‘LABA review in line with CCG policy’.
9. Provide details of the total number of patients changed to their community pharmacy, as
applicable.
Notes for Practice Pharmacist/ nurse/GP:

COPD: Ensure prescribing is in line with COPD formulary. Conduct COPD review where possible with
CAT score and assessment of number of exacerbations and hospitalisations in previous 12 months and
MRC and latest FEV1. Where a patient has not had spirometry in last 12 months, refer for spirometry or
conduct if able. Refer to prescriber or change in line with local formulary if current prescription does not
represent optimal therapy. If patient is also prescribed a LAMA, it is more cost effective to rationalise to
the LABA/LAMA combination preparation as per south Staffordshire formulary.
Asthma: If a patient is prescribed a high dose corticosteroid, refer to separate high dose inhaled
corticosteroid SOP. Rationalise these patients to most cost effective combination device. If prescribed
LABA alone therapy. This needs reviewing in line with BTS guidelines (2016), to the most appropriate
step of BTS guidelines 4.
References:
1. Orion Pharma (2018). Summary of Product Characteristics Easyhaler Formoterol. Orion Pharma.
Available at: https://www.medicines.org.uk.
2. Rightbreath(2018) Soltel inhaler. Available at https://www.rightbreathe.com/medicines/soltel-

25microgramsdose-inhaler-cfc-free-kent-pharmaceuticals-ltd-120-dose/
3. South Staffordshire Area Prescribing Guidelines. Asthma prescribing guidelines. Adults and
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children over 12 year. June 2015. Available at:

http://www.southstaffordshirejointformulary.nhs.uk/docs/apg/Respiratory-
System/Asthma%20Guidelines%20FINAL.pdf
4. NHS Business Services Authority. NHS Electronic Drug Tariff. April 2018. Available at
http://www.drugtariff.nhsbsa.nhs.uk/.
5. British Thoracic Society, Scottish Intercollegiate Guideline Network. British Guideline on the
Management of Asthma. Edinburgh: SIGN; September 2016 (SIGN Guideline No. 153). Available
at: https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-
guideline-2016/
6. South Staffordshire Area Prescribing Guidelines. COPD prescribing guidelines. 2015. Available at:
http://www.southstaffordshirejointformulary.nhs.uk/docs/apg/Respiratory-
System/COPD%20Guidelines%20FINAL.pdf
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Appendix 1 – data collection form

Practice support data collection form:
Practice Name
Patient Responsible Pharmacy Original Replacement Exclusion Housekeeping Referral Date Additional Action
identifier GP (if product product code details details (if letter information inc taken
applicable) details and details (core SOP) (if applicable) applicable) sent other inhalers
indication for prescribed
treatment
Summary
Total number of patients identified
Total number of patients switched
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Work completed by: <insert name and job title> Date completed: <insert date>
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Appendix 2 – Example patient letter

Date as Postmark
Title Initial Last Name

Home Full Address (stacked)
Dear Calling Name
IMPORTANT INFORMATION
MEDICATION REVIEW REQUIRED
Across Staffordshire the local NHS team we are currently reviewing our prescribing of
certain inhaler devices. We are committed to ensuring that all of our patients are receiving
the best possible care based on current national guidelines and also local NHS
recommendations.
As an ongoing service improvement process and to enhance patient care at the practice, we
are running a series of medication review clinics related to asthma and COPD. The purpose
of this clinic is to ensure you are receiving the most appropriate treatment and monitoring for
your condition.
The clinics will be run by our practice pharmacist/GP/practice nurse/respiratory nurse, (insert
NAME), (who is part of our clinical team). *Delete as appropriate.
After an initial review of your medication in practice, we are inviting you to attend an
appointment which has been booked for you on:
Date: (INSERT)
Time: (INSERT)
Venue: (INSERT)
With: (INSERT)
Please bring all stocks you have of your regular medication to the appointment, including
any inhalers, eye drops or creams etc. Please also make a note of any other medicines you
take.
If you are unable to attend this appointment, please contact the practice as soon as possible,
to arrange an alternative time/date.
Yours sincerely,
On behalf of
<Insert details>
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Appendix 2 – Patient letter

Date as Postmark
Title Initial Last Name

Home Full Address (stacked)
Dear Calling Name

IMPORTANT INFORMATION
Across Staffordshire the local NHS team are currently reviewing our prescribing of certain inhaler
devices. We are committed to ensuring that all of our patients are receiving the best possible care
based on current national guidelines and also local NHS recommendations.
I am writing to tell you that following a review of your respiratory condition your prescription for
[insert name of product] has been changed to [insert name of product].This product is in the
same class of drugs as your original medication. [insert name of product] has been shown to be
better value for the NHS and has been shown to be just as effective in treating COPD/asthma. This
choice is supported by the [insert CCG] Clinical Commissioning Group. This will help us to utilise
NHS funds more effectively. Please note the number of puffs of your inhaler may have changed, but
this is equivalent in effectiveness.
Old Prescription New Prescription

Drug: Drug:
Strength: Strength:
Dose: Dose: …
Frequency: … Frequency: …
Please continue to use your old inhaler until you are ready for your next repeat (Do not take both at
the same time).
A prescription for your new inhaler has been added to your repeat medication file and so the change
will be activated when you request your next repeat prescription from the practice.
We enclose a leaflet on how to use your new device.
When you collect your next prescription from the pharmacy, ask about the New Medicines Service.
This free pharmacy service will enable you to go through with the pharmacist how to use it and how
much to use. Please note
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Yours sincerely,
On behalf of
<Insert details
Document Change History
Version Date Editor Details of significant

changes
1.0 NBov 15 Gemma Dowell and Mary Initial SOP approved
Johnson
2.0 April 2018 Irfan Saleji Added letter –appendix 2
Added new information
regarding Soltel
Head of Medicine Optimisation Sam Buckingham Date 27/06/18

Cannock Chase, South East Staffordshire
and Seisdon Peninsula, Stafford and
Surrounds and East Stafford Clinical
Commissioning Group
GP Prescribing Lead Claire Pilkington Date 27/06/18
SESSP Clinical Commissioning Group
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LABA SOP v2

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Cannock Chase Clinical Commissioning Group

South East Staffordshire and Seisdon Peninsula Clinical Commissioning Group

Medicines Optimisation Prescribing Audit:

Breezehaler®) or olodaterol (Striverdi Respimat®) – all strengths. Following review of each

Notes for Practice Pharmacist/ nurse/GP:

2. Rightbreath(2018) Soltel inhaler. Available at https://www.rightbreathe.com/medicines/soltel-

children over 12 year. June 2015. Available at:

Appendix 1 – data collection form

Appendix 2 – Example patient letter

Title Initial Last Name

Dear Calling Name

Appendix 2 – Patient letter

Title Initial Last Name

Dear Calling Name

Old Prescription New Prescription

We enclose a leaflet on how to use your new device.

Document Change History

Version Date Editor Details of significant

Head of Medicine Optimisation Sam Buckingham Date 27/06/18

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