Medicines Optimisation Team Standard Operating Procedure for Audit: High Dose Inhaled Corticosteroids

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 Team Standard Operating Procedure for Audit: High Dose Inhaled Corticosteroids Aim To identify all patients prescribed high dose inhaled corticosteroids for asthma and review them in line with national guidance, with a view to stepping down treatment to the lowest dose at which effective control is maintained. Rationale The British Thoracic Society (BTS) and Scottish Intercollegiate Guidelines Network (SIGN) joint National Guideline on the Management of Asthma, state that inhaled corticosteroids (ICS) are the recommended preventer drug for adults and children for achieving overall treatment goals in patients with asthma 1. High-dose inhaled corticosteroids are included at step 4 and above for review to BTS step 3. However, they are associated with a higher risk of local and systemic side effects, which can be particularly serious in children. As a result, treatment with ICS should be reviewed regularly and the dose titrated down to the lowest dose at which effective control of asthma is maintained. It is recommended that, for patients who are stable, reductions should be considered every three months, decreasing the dose by approximately 25-50% each time. The National Review of Asthma Deaths (NRAD) report was published in May 2014. One of the risk factors identified in the report was that patients that died where a LABA bronchodilator was prescribed as a single agent without steroid. It is required that a combination inhaler (ICS/LABA inhaler) should be prescribed to prevent the LABA being taken without the accompanying steroid component (patient adherence and patient safety). Therefore an additional search will be conducted to identify these patients to be seen as a priority. Audit criteria Inclusion criteria All patients currently prescribed a high dose combination inhaled corticosteroid (defined as >800mcg daily of beclomethasone dipropionate (BDP) or equivalent for adults. Prescribed as an acute or repeat prescription, unless they fall under any of the exclusion criteria defined below. Exclusion criteria A. Any patient receiving palliative care - refer to prescriber to determine appropriateness to change. B. 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. C. Any patient who is excluded by the prescriber. D. Any patient who has had an exacerbation of asthma in the last 12 weeks Page 1 of 10

E. If there is a contraindication/caution to the proposed replacement product e.g Relvar Ellipta is a formulary option especially where compliance is a problem but it is cautioned in those with severe cardiovascular disease - consult the relevant SPCs for each product (refer to formulary 2 ). F. 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. g. Patients with bronchiectasis Cautions Criteria Patients under secondary care review on case by case basis with the prescriber. B: 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 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 (eg patients who are deaf, illiterate etc) - refer to prescriber to determine appropriateness to change. F. Patients under secondary care clarify with prescriber appropriateness to review Method 1. A) Search the practice clinical system for all patients currently prescribed a high dose inhaled corticosteroid as an acute or repeat item all strengths. Following review of each patient s electronic medical record (refer to process section), record all relevant data using the data collection form (appendix 2) or similar, for each patient identified. Examples include Fluticasone/Salmeterol, Seretide Evohaler 250/25, Accuhaler 500/50, Fluticasone/Vilanterol, Relvar Ellipta 92/22 and 184/22, Budesonide/Formoterol 400/12 and 320/9, Duoresp Spiromax 320/9, Symbicort 400/12, Fluticasone/Formoterol 250/10, Flutiform 250/10, Beclometasone/Formoterol, Fostair 200/6. B) Search the practice clinical system for all patients currently prescribed a LABA inhaler and not a steroid. Examples include fomoterol fumarate (brands: Formoterol Easyhaler, Atimos modulate, Foradil, Oxis Turbohaler ), Indacterol (Onbrez breezehaler ), olodacterol (Striverdi respimat ). 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. Review the patients as per process documentation. 4. Invite patients, who appear suitable to be stepped down/have device changed, to a clinic (nurse/pharmacist/gp led) to be assessed for suitability using the patient letter in appendix 3. An asthma assessment is needed (see appendix 1) and the decision should be made in partnership with the patient explaining the benefits and risks around inhaled steroids. Use the standardised medicines management asthma template. For the patients on LABA only refer to prescriber for immediate action. 5. 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. 6. Carry out the dose change for all suitable patients by: - Adding the new dose. - Archiving the previous dosage into past drugs, if applicable. - Creating an entry in patient consultation/journal notes confirming the switch. Use the standardised emis template for the project. 7. Patients will need to be followed up either by the person conducting the audit or if the patient is happy details can be passed onto pharmacies participating in the NHS new medicine service. Page 2 of 10

Appendix 1 - Process Step 1 Patient identification Patients at Step 4 as below for review to step 3 where possible. BTS STEP 4 ICS dose > 800mcg of non-fine particle beclometasone (BDP)/24 hrs (equivalence) ICS/LABA Inhaler Strength Dose Non-Extra Fine Beclometasone Equivalence/24hrs Inhaler cost PM Fostair (Beclomet Diprop/Formoterol 120D) 100/6 2 inh 1000 mcg 29.32 Seretide 125 evohaler (Fluticasone/Salmeterol 120D) 125/25 2 inh 1000 mcg 35.00 Seretide Accuhaler (Fluticasone/Salmeterol Inh 60D) 250/50 1000 mcg 35.00 DuoResp Spiromax (Budesonide/Formoterol 60D) 320/9 2 inh 1600 mcg 29.97 Symbicort Turbohaler (Budesonide/Formoterol 60D) 400/12 2 inh 1600 mcg 38.00 Fostair (Beclomet Diprop/Formoterol 120D) 200/6 2 inh 2000 mcg 29.32 Flutiform (Fluticasone/Formoterol 120 D), 250/10 2 inh 2000mcg 45.56 Seretide Evohaler (Fluticasone/Salmeterol 120D) 250/25 2 inh 2000mcg 59.48 Seretide Accuhaler (Fluticasone/Salmeterol 60D) 500/50 2000mcg 40.92 Relvar Ellipta (Fluticasone/Vilanterol30D) 184/22 od 2000 mcg* 29.50 Preferred choice of inhaler noted in green (i.e. newer cost effective inhaler devices). Please note Symbicort and Duoresp are equivalent in dosage as one is described as the actuated dose and the other is the delivered dose. Consider Fostair for SWITCH patients to only NOT for review, both strengths of Fostair are licensed for Asthma (note high strengths not licensed for COPD). Note flutiform 250/25 is soon to be made non-formulary as fostair 200/6 is a more cost effective mdi at an equivalent steroid potency. BTS STEP 3-4 ICS dose equivalence intermediate step for Relvar Ellipta Relvalr Ellipta (Fluticasone/Vilanterol30D) 92/22 od 1000mcg * 22.00 BTS STEP 3 ICS dose 800mcg of non-fine particle beclometasone (BDP)/24 hrs (equivalence) Strength ICS/LABA Inhaler 160/4.5 DuoResp Spiromax (Budesonide/Formoterol) 120 D Symbicort turbohaler (Budesonide/formoterol) 120 d 200/6 Flutiform (Fluticasone/Formoterol) 120 D 50/5 Dose 2 inh Non-Extra Fine Beclometasone Equivalence/24hrs Inhaler cost PM 400 mcg 14.98 400 mcg 38.00 400 mcg 14.40 Fostair (Beclomet Diprop/Formoterol) 120D 100/6 500 mcg 14.66 DuoResp Spiromax (Budesonide/Formoterol) 120D DuoResp Spiromax 9mcg/320mcg 60D Relvalr Ellipta (Fluticasone/Vilanterol30D) 160/4.5 320/4.5 92/22 2 inh od 800mcg 29.97 800mcg 14.98 1000mcg* 22.00 Page 3 of 10

Preferred choice of inhaler noted in green (i.e. newer cost effective inhaler devices). Symbicort and Duoresp are equivalent in dosage as one is described as the actuated dose and the other is the delivered dose. Consider Fostair for SWITCH only NOT for review, both strengths of Fostair & are licensed for Asthma (note high strengths not licensed for COPD) *Ellipta is unique in that the steroid equivalence is only approximate as it depends whether you look at side effects or efficacy, in terms of efficacy it is most similar to the equivalences shown but with less side effects. Step 2 Review of medical records For all patients identified in step 1, have they had an asthma review in the previous 12 months? If not these patients need to be prioritised For all patients identified in step 1, is their asthma stable? To determine this, check whether their asthma was stable at their last review i.e RCP score and also what the inhaler technique was like, whether they have had their ICS dose stepped down within the previous 3 months already and whether they have had an exacerbation of asthma within the previous 6 months. Also look at their reliever inhaler usage (short acting beta agonist inhaler) usage over 12 months. Action required: If stable, send proposed action for prior agreement to prescriber so intervention can be actioned in consultation if patient is found to be stable on review. If not stable but may benefit from change to formulary preparation also assess suitability of this action and gain prior approval for this from the prescriber. Invite all identified patients in for an asthma review using standard letter (appendix 3). Step 3 Consultation Check their peak flow is above 80% predicted/ patients personal best and that they are scoring 0 on their 3 RCP questions (see appendix 1 for more information). Consider stepping down the dose by 50%, in line with national and local guidance. Action required: Assess suitability for step down and if on non-formulary inhaler, step down to the most appropriate formulary inhaler. If not stable and on non-formulary inhaler consider whether they may benefit from rationalisation to a formulary inhaler, as long as they have not had an exacerbation in last 6 months or if they have had one it is related to poor inhaler technique. Ensure patient has an asthma action plan (appendix 4 ) Step 4 Follow up Once stepped down patient will need to be followed up in 4 weeks time. They can either be asked if they are happy for their details to be passed to the community pharmacy for review through the new medicines service if this is appropriate and offered by the pharmacy, otherwise a follow up call by the individual conducting the audit should be conducted. Notes for Practice Pharmacist/GP/Nurse: For each patient, conduct asthma review with the following aspects as a minimum (see appendix 1): Ask the 3 Royal College of Physician questions to assess control Conduct peak flow (best of 3 ) Ask how often patient has been needing rescue inhaler to assess suitability for stepping down Provide asthma action plan and peak flow meter for home use where needed.(appendix 4) You should also observe the patients inhaler technique to see if they would benefit from a device change. Any healthcare professionals undertaking this audit should ensure they have supplies of all the available devices as placebos for demonstration purpose and are able to demonstrate these effectively to patients. Preferred preparations to switch to are Relvalr Ellipta 92/2, and both strengths of Duoresp Spiromax and Fostair. Page 4 of 10

References: 1. British Thoracic Society, Scottish Intercollegiate Guideline Network. British Guideline on the Management of Asthma. Edinburgh: SIGN; October 2014. (SIGN Guideline No. 141). Available at: https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthmaguideline-2014/ 2. British National Formulary, Version 68,BMA 2014 South Staffordshire Area Prescribing Guidelines. Asthma prescribing guidelines. Adults and children over 12 year. June 2015. Available at: http://www.southstaffordshirejointformulary.nhs.uk/docs/apg/respiratory- System/Asthma Guidelines FINAL.pdf Page 5 of 10

Appendix 1 Assessment of control for consideration of step down Each patient should be assessed as to their adherence with, and ability to correctly take, current treatment as well as their corresponding asthma control. 1. 3 RCP questions Table.UK Royal College of Physicians 3 Questions screening tool In the last month: Yes No In the past four weeks -Have you had difficulty sleeping because of your asthma symptoms (including cough)? In the past four weeks -Have you had your usual asthma symptoms during the day (cough, wheeze, chest tightness or breathlessness)? In the past four weeks -Has your asthma interfered with your usual activities (e.g. housework, work/school etc)? Interpretation: No to all three questions indicates good control (score of 0) and these are the cohort of patients who should be considered for step down. Yes to 2 or 3 questions (score of 2 or 3) indicates poor control and the if the inhaler technique is the cause this would be an ideal opportunity to assess for suitability for change to a more appropriate inhaler, where needed refer to prescriber. Yes to 1 question (score of 1) indicates that more detailed questioning is needed to assess level of asthma control (using another validated questionnaire or by asking about frequency of daytime symptoms, reliever requirement, and limitation of activities and symptoms at night or on waking during the previous month). Note: This test provides a quick and easy way of confirming someone s asthma control is good, or identifying those who need more assessments. 2. Peak Flow test: This should be above 80% of the patient s personal best to be defined as suitable for step down. 3. Exacerbations: In last 6 months check from consultation and medication history, i.e steroid or antibiotic for chest infection, if none would be suitable for step down, if not suitable may for step down may still be suitable for rationalisation to formulary device unless exacerbation in last 3 months and is using the device appropriately. If there was an exacerbation but the patient has poor device technique this should be changed so as to prevent further reoccurrences. 4. Reliever Inhaler usage: Uses reliever less than or equal to 2 days a week is defined as well controlled and suitable for step down. Page 6 of 10

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 Appendix 2 data collection form Practice support data collection form: Practice Name Patient identifier Responsible GP Pharmacy (if applicable) Original product details Exclusion code (core SOP) Exacerbation in past 6 months?(steroid OR ANTIBIOTIC) Date last asthma review of Last RCP score SABA usage in last 12 months Replacement product details Action taken Summary Total number of patients identified Total number of patients switched Work completed by: <insert name and job title> Date completed: <insert date> Page 7 of 10

Appendix 3 patient letter : clinic invite Date as Postmark Title Initial Last Name Home Full Address (stacked) Dear Calling Name IMPORTANT INFORMATION MEDICATION REVIEW REQUIRED As a practice 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> Page 8 of 10

Appendix 4 Asthma action plan information Notes from asthma action plan taken from BTS &SIGN (2014) Asthma action plans can e found at https://www.asthma.org.uk/globalassets/health-advice/adultasthma-action-plan.pdf PEF < 80% of best: increase inhaled steroids. Those on low doses e.g. 200mcg of inhaled steroid daily should be advised to increase the dose substantially e.g. to 1200mcg beclometasone daily at the onset of a deterioration. Increasing inhaled steroids is ineffective if patients are already taking moderate or high doses (>400mcg daily) and these patients should move straight to the oral steroid step. PEF < 60% of best: commence oral Steroids or see nurse/gp if don t keep rescue pack PEF <40% of best: seek urgent medical advise. Asthma is getting worse if the reliever inhaler is required more than once/day. Asthma attack: Asthma is more severe if the reliever inhaler is required every four hours or more, and the patient is experiencing constant symptoms. Comparison of high dose potency steroids for review *Note this is equivalence in efficacy but cortisol suppression is much lower then compared to same dose of other steroids Adults and children over 12yrs Beclometasone dipropionate- standard potency >800 micrograms daily Beclometasone dipropionate - increased potency >400 micrograms daily (eg Qvar, Fostair) Budesonide >800 micrograms daily Fluticasone propionate Fluticasone furoate >400 micrograms daily 92 micrograms daily* Mometasone furoate >400 micrograms daily Head of Medicine Optimisation Cannock Chase, South East Staffordshire and Seisdon Peninsula and Stafford and Surrounds Clinical Commissioning Group GP Prescribing Lead Stafford and Surrounds Clinical Commissioning Group Samantha Buckingham Dr Paddy Hannigan Date 10 th March 2017 Date 10 th March 2017 Document Change History Version 2 Date of review: February 2017 Page 9 of 10

Author: Bronchietasis added as an exclusion Cautions separated out from contraindications Prices of inhalers updated Flutiform higher strengths removed from BTS 3 as non formulary Relvar Ellipta added as a intermediate step between 3 and 4 and as preferred products Cautions from Relvalr Ellipta now removed also as more evidence around usage Updated 2017 by Mary Johnson Senior medicines optimisation pharmacist in SES &SP Approved by: Date of approval: 1 st March 2017 Medicines Optimisation Group March 2017. Chaired by Dr Paddy Hannigan Page 10 of 10