Medicines Optimisation Prescribing Audit: Long acting muscarinic antagonist (LAMA ) review

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Susan Bond
5 years ago
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Medicines Optimisation Prescribing Audit: Long acting muscarinic antagonist (LAMA ) review Aim To identify all patients prescribed long acting muscarinic antagonists (LAMAs) and where clinically

with active ingredient umeclidinium bromide 65 microgram per 1 dose, Eklira Genuair with active ingredient aclidinium bromide. Tiotropium respimat with active ingredient tiotropium 2.

1 Medicines Optimisation Prescribing Audit: Long acting muscarinic antagonist (LAMA ) review Aim To identify all patients prescribed long acting muscarinic antagonists (LAMAs) and where clinically appropriate change them to the most cost effective formulary LAMA preparation and device which is suitable for the patient Seebri Breezehaler with active ingredient Glycopyronnium, Incruse Ellipta with active ingredient umeclidinium bromide 65 microgram per 1 dose, Eklira Genuair with active ingredient aclidinium bromide. Tiotropium respimat with active ingredient tiotropium 2.5 microgram per dose is the first line option. Braltus may be an option where patient wants to remain on a handihaler device. Rationale Prior to implementation the most commonly used LAMA in the area is Tiotropium handihaler and at a cost of for a refill pack, or for combination with inhaler 1. However, the price of the Tiotropium Respimat has now been dropped to and our COPD guidelines are now being reviewed to incorporate this as our first line choice. As the Tiotropium Respimat is now significantly cheaper than these other agents and requires less disruption as the switch involves the patient remaining on the same therapy and involves only changing the device to administer, this is now our preferred choice for LAMA therapy. The majority of this work will be done by letter and the counselling of the patients on the new device will utilise the pharmacy New Medicine Service (NMS). In asthma there is a RICAD locally, contained with the asthma guidelines 2 and if an asthma patient is on Tiotropium Handihaler they should be switched to the Tiotropium Respimat as this is the licensed preparation for asthma, unless the RICAD suggests this therapy to not be relevant and then this patient should be flagged up to the relevant nurse or GP for review. Previously there where some safety concerns with the Tiotropium Respimat device causing more deaths. However, the most recent drug safety update (2015) 3 concerning the medication refers to the Tiospir trial. This was a large trial which included 17,135 participants with COPD who were followed up for a mean of 2.3 years. The outcome of this trial was that there was no significant difference in all-cause mortality found between Tiotropium Respimat at the 5 micrograms or 2.5 micrograms dose compared with Tiotropium handihaler. In addition the incidence of cardiovascular death and major cardiovascular events was comparable across all three groups. Therefore the safety has been 1 P a g e

2 shown to be comparable the handihaler device. Renal function needs to be monitored closely with Tiotropium 4 : As plasma concentration increases with decreased renal function in patients with moderate to severe renal impairment (creatinine clearance 50 ml/min) tiotropium bromide should be used only if the expected benefit outweighs the potential risk. There is no long term experience in patients with severe renal impairment See exclusions for patients to be particularly cautious with regards to switch. Another option is Eklira Genuair which contains aclidinium bromide 375 microgram per 1 dose at a month, but please note as oppose to all previous preparations discussed which are once daily doses, this is a twice daily preparation so may not be appropriate for all patients 1. The Genuair device provides confirmation to the patient of successful inhalation. It also includes a dose indicator, a safety mechanism to prevent double dosing and an end-of-dose lockout mechanism to prevent use of the empty device. The Eklira may be a cost-effective option due to the 25% rebate making the cost a month. This inhaler may also be more suitable for patients with poor renal function as the SPC states No dose adjustments are required for patients with renal impairment. 5 The Seebri Breezehaler is a similar device to the Tiotropium handihaler at a monthly cost of (which includes device in each pack). 1 The Seebri Breezehaler is smaller than the Tiotropium handihaler, although does still require dexterity in terms of putting a capsule into the device 6.It contains Glycopyronnium which is an inhaled long-acting anticholinergic for once daily administration 6. Incruse Ellipta is another option costing which may be more suitable option for some patients as it is a self-contained device and there is no assembly required, with the active ingredient being umeclidinium bromide 65 microgram per 1 dose 4. If the patient prefers to stay on a similar device and same drug,another option may be to prescribe Braltus Tiotropium inhaler which is for 30 capsules and device.trial evidence summarised in Appendix 3 In summary there have been trials that have demonstrated similar efficacy for Glycopyronnium, umeclidinium and aclidinium and there is a cost saving associated with changing patients to these therapies and devices (Appendix 3). PLEASE NOTE THAT IF PATEINT IS ON TRIPLE THERAPY AND SO ON LAMA ALONGSIDE ICS/LABA IT IS PREFERABLE TO REVIEW AS PER COPD SOP FOR STEP DOWN OR IF NOT APPROPRIATE FOR REVIEW TO TRIPLE THERAPY COMBINATION INHALER. 2 P a g e

3 Audit criteria Inclusion criteria All patients currently prescribed Tiotropium (Handihaler ) monotherapy (combination should be reviewed as per copd sop) 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 (e.g. 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 COPD in the last 12 weeks should be changed with caution J. Any patient for whom it is not possible to assess inhaler technique for a change in device e.g. housebound patients where a home visit is not possible. Asthmatic patients ensured this prescribing is in line with RiCAD in the asthma guidelines and refer to prescriber if not 2. Patient is also prescribed a separate LABA inhaler. In this instance it would be more cost effective to switch patient to a formulary LABA/LAMA device- discuss this with the GP Patient is also on an ICS/LABA review as per COPD sop either for step down or for combination triple inhaler. Cautions A.Caution with patients who have a recent MI in the last 6 months, have unstable or life threatening cardiac arrhythmia or a change in drugs in for heart failure or have had to be hospitalised due to heart failure in the last year. These patients were excluded from the Tiospir trial, and also all previous Tiotropium trials. These patients should be highlighted to the GP for review on an individual case by case basis. B Caution with patients with narrow angle glaucoma, prostatic hyperplasia or bladder neck obstruction- notes these cautions are consistent with all Tiotropium devices. 3 P a g e

4 Method 1. Search the practice clinical system for all patients currently prescribed as an acute or repeat item Tiotropium Handihaler. 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 or if the practice is happy change the patients by letter sending them a leaflet on how to use the inhaler (Appendix 4). 5. For patients with COPD, review against current COPD guidelines (see COPD inhaled steroid and triple therapy review for more information on process of review and consultation). Where patients are also prescribed a LABA, it would be more cost effective to rationalise to a combination LABA/LAMA e.g. Anoro Ellipta 6. 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. 7. 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 LAMA review in line with CCG policy. 8. Patients can be referred to use the new medicines service at participating community pharmacies. Notes for Practice Pharmacist/ nurse/gp: COPD: Ensure prescribing is in line with COPD formulary. 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 LABA, it is more cost effective to rationalise to the LABA/LAMA combination preparation e.g Anoro Ellipta as per COPD guidelines 6. 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. Alternatively it may be more appropriate to change these patients by letter (Appendix 4) if the practice is happy as they will have a COPD review by the nurse anyway and participating pharmacies are capable of demonstrating the device through a new medicines review a leaflet can be provided to patients on this service. 4 P a g e

5 References: 1. MIMS (2018). MIMS online. Available at: 2. South Staffordshire Area Prescribing Guidelines. Asthma prescribing guidelines. Adults and children over 12 year. June Available at: System/FINAL%20asthma%20guidelines%20v2.0%20(2017).pdf 3. Drug safety updates (2015). Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial.2015, Issue 7, Feb 15:1. Available at < 4. Novartis Pharmaceuticals UK Ltd (2018).Summary of Product Characteristics Tiotropium respimat. Novartis Pharmaceuticals UK Ltd Available at: 5. Novartis Pharmaceuticals UK Ltd (2018).Summary of Product Characteristics Eklira Genuair 322 micrograms inhalation powder. Novartis Pharmaceuticals UK Ltd Available at: 6. Novartis Pharmaceuticals UK Ltd (2018).Summary of Product Characteristics Seebri Breezehaler. Novartis Pharmaceuticals UK Ltd Available at: 7. South Staffordshire Area Prescribing Guidelines. COPD prescribing guidelines Available at: System/FINAL%20COPD%20guidelines%20v2.0%20(2017).pdf 8. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press < [Accessed on 05/07/2018] Drug safety updates (2015). Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial.2015, Issue 7, Feb 15:1. Available at < 9. South Staffordshire Area Prescribing Guidelines. Asthma prescribing guidelines. Adults and children over 12 year. June Available at: System/FINAL%20asthma%20guidelines%20v2.0%20(2017).pdf 10. Kerwin E et al (2012). Eur Respir J; 40: CHAPMAN K et al (2014). BMC Pulmonary Medicine; 14: Trivedi R et al. Eur Respir J 2014; 43: Donohue JF et al. Respir Med 2013; 107: Kerwin EM et al. COPD 2012; 9: Jones PW et al. Eur Respir J 2012, accepted article; DOI: 5 P a g e

6 appendix 1 data collection form Practice support data collection form: Practice Name Patient identifier Responsible GP Pharmacy (if applicable) Original product details and indication for treatment Calculated CrCl (ml/min) Replacement product details Exclusion code (core SOP) Housekeeping details (if applicable) Referral details (if applicable) Date letter sent Additional information inc other inhalers prescribed 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> 6 P a g e

7 Appendix 2 Patient letter (clinic) 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 COPD. The purpose of this clinic is to ensure you are receiving the most appropriate treatment and monitoring for your condition. The new inhalers are shown to be more effective in treatment of COPD. 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> 7 P a g e

8 Appendix 3 Trial data summarised A series of studies have demonstrated the efficacy of glycopyronium: two of which are summarised below: GLOW 2 : 52 week efficacy randomized double blind controlled study (n=1066) with randomization to Glycopyrronium (n=529), tiotropium or placebo. SGRQ score at week 52 was significantly improved in patients receiving glycopyrronium, with a treatment difference vs. placebo of -3.32, p<0.001; this was comparable to the improvements demonstrated by tiotropium. Over 52 weeks, glycopyrronium reduced the risk of moderate or severe exacerbations by 34% compared to those receiving placebo (p=0.001) 10. GLOW 5: 12-week study demonstrate that in patients with moderate-to-severe COPD, glycopyrronium 50mcg once daily provided similar efficacy and safety to tiotropium 18mcg once daily, with glycopyrronium providing faster onset of action on Day 1 compared with tiotropium 10. The efficacy of once-daily umeclidinium (administered via the Ellipta inhaler) was evaluated in two double-blind, placebo-controlled phase III trials involving 904 adults with COPD: a 12-week study and a 24-week study. In both studies, statistically significant and clinically meaningful improvements in lung function, defined by change from baseline trough FEV1, reduction in rescue medication 12,13. In addition at week 24, the probability of experiencing a COPD exacerbation was 8.9% in patients treated with umeclidinium compared with 13.7% in those receiving placebo (HR 0.6, p=0.035) 13. The efficacy and safety of aclidinium bromide in the maintenance treatment of COPD was investigated in two randomised, placebo-controlled, double-blind phase III studies of similar design: the ACCORD COPD I study (n=561) assessed patients over 12 weeks and the ATTAIN study (n=828) evaluated patients over 24 weeks 14,15. In both studies, patients with moderate to severe COPD were randomised (1:1:1) to receive twicedaily doses of aclidinium bromide 200 microgram, 400 microgram or placebo, all administered using a proprietary dry powder inhaler (Genuair) 14,15. In a pooled analysis of the two trials, the 400 microgram twice-daily dose significantly reduced the rate of moderate to severe exacerbations (i.e., those requiring hospitalisation or treatment with antibiotics or corticosteroids) compared with placebo (0.31 vs 0.44 per patient per year; p=0.0149) P a g e

9 Appendix 4 Patient letter (no clinic) 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. 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 more effective in treating COPD. This choice is supported by the [insert CCG] has Clinical Commissioning Group. This will help us to utilise NHS funds more effectively. Drug: Old Prescription Drug: New Prescription 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 (delete where appropriate). If you would like to discuss the change with your usual GP/the practice nurse/practice pharmacist, then please call the practice for an appointment. You may also direct any queries to your community pharmacist who will be able to demonstrate your new device and answer any queries you may have, please see the leaflet on the new medicine service that you are able to have at your local pharmacy. Yours sincerely, On behalf of <Insert details 9 P a g e

10 Document Change History Version Date Editor Details of significant changes 1.0 Nov 15 Gemma Dowell and Mary Initial SOP approved Johnson 2.0 July 2018 Irfan Saleji Added letter amalgamated the respimat and lama sops, added new info on tiotropium in renal. Letter wording adapted.also information on ekliira and rebate. Head of Medicine Optimisation Cannock Chase, South East Staffordshire and Seisdon Peninsula, Stafford and Surrounds and East Stafford Clinical Commissioning Group GP Prescribing Lead SESSP Clinical Commissioning Group Sam Buckingham Date 19/07/18 Claire Pilkington Date 19/07/18 10 P a g e

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

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