LABA as monotherapy for the treatment of asthma without ICS preventer treatment

Every 10 seconds someone in the UK is having a potentially life-threatening asthma attack. Shockingly asthma attacks kill three people each day and the UK has amongst the highest death rates from asthma in Europe. Most tragically many of these deaths could be prevented.

The National Review of Asthma Deaths (NRAD), published in 2014, was the first UK-wide investigation into asthma deaths, commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England and the Department of Health. It looked at deaths from asthma between 1st February 2012 and 31st January 2013.

The NRAD found wide-ranging and widespread issues with the quality of asthma care amongst those who died. In particular, people did not receive key elements of routine care and prescribing errors were widespread. One of the key recommendations from the NRAD for medical and professional care was ‘The use of combination inhalers should be encouraged. Where long-acting beta agonist (LABA) bronchodilators are prescribed for people with asthma, they should be prescribed with an inhaled corticosteroid in a single combination inhaler.’

This audit therefore aims to identify patients who have been prescribed a LABA who have not been prescribed or are not using an inhaled corticosteroid in a single combination inhaler, and to provide advice to these patients about the importance of regularly using an inhaled corticosteroid.

Formoterol and salmeterol are LABAs which are used as add-on therapy for patients whose asthma is not controlled using an inhaled short-acting β2 agonist and standard-dose inhaled corticosteroid. They are the first choice for add-on therapy; they improve lung function and symptoms, and decrease asthma attacks.

Patients who have asthma should not use an inhaled LABA, without also using a regular inhaled corticosteroid. When used alone, inhaled LABAs have been associated with a, sometimes severe, worsening of asthma in some patients. In clinical practice, it is generally considered that combination inhalers aid adherence and have the advantage of guaranteeing that the LABA is not taken without the inhaled corticosteroid.

Please note this audit is aimed specifically at patients with asthma, as patients with chronic obstructive pulmonary disease (COPD) can be prescribed an inhaled LABA as maintenance therapy without an inhaled corticosteroid if the Forced Expiratory Volume in 1 second (FEV₁) is 50% of predicted or more.

1. To collect a useful sample for this audit it is suggested that data is collected over approximately one month.
2. You can record details of each patient who presents a prescription for a LABA (either Formoterol (Foradil, Oxis) or Salmeterol (Serevent) on the audit questionnaire and work through the questions with them (Annex A).
3. The data from the audit questionnaires can then be collated on the audit data collection form (Annex B).
4. If you need to refer a patient to their GP, you could consider using the template referral letter (Annex C).
5. Once you have collated the data, you can then complete the audit summary (Annex D).

Standalone copies of the documents in Annex A-D can be downloaded below.

All patients who have a prescription for a LABA inhaler for the treatment of asthma, who are not also being prescribed a corticosteroid inhaler or who are being prescribed a corticosteroid inhaler, but who are not using it.

Standard 1

All patients prescribed a LABA inhaler for the treatment of asthma should also be using an inhaled corticosteroid on a regular basis.

Audit standard 100%

Action points before or after the audit may include speaking to your local GPs to explain the audit and what feedback or referral they would like. Pharmacists may also want to consider offering a targeted MUR to appropriate patients, to help develop their understanding of the management of their condition and the use of their medicines.

Standard 2

All patients presenting prescriptions for a LABA for the treatment of asthma are offered verbal advice about their medicine, including the importance of regular use of an inhaled corticosteroid.

Audit standard 100%

For this audit, the intention is to identify patients who are not offered verbal advice because someone else collects the medicine or it is delivered to them (including care homes), in order that the pharmacist can ensure that appropriate advice is provided to the patient by phone or by another method.

LABAs licensed for asthma

• Formoterol (Foradil, Oxis)
• Salmeterol (Serevent)

Corticosteroid inhalers

• Beclometasone dipropionate(Asmabec clickhaler, Clenil Modulite, Qvar)
• Budesonide(Budelin Novolizer, Pumicort)
• Ciclesonide (Alvesco)
• Fluticasone propionate(Flixotide)
• Mometasone furoate(Asmanex)

Community Pharmacy England Briefing 051/17: Clinical audit: LABA bronchodilator being used as monotherapy for the treatment of asthma without a corticosteroid inhaler (August 2017)

Audit questionnaire (e-form)

Audit questionnaire (PDF)

Audit data collection form (e-form)

Audit data collection form (PDF)

Audit data summary (e-form)

Audit data summary (PDF)

Community pharmacy referral form (e-form)

Community pharmacy referral form (PDF)

The Royal College of Physicians – National Review of Asthma Deaths

Community Pharmacy England – Community pharmacy and the management of people with asthma

Community Pharmacy England – Responding to the National Review of Asthma Deaths: The contribution that community pharmacies can make