This supplement has been commissioned and funded by Glenmark Pharmaceuticals Europe Ltd and developed in partnership with Guidelines in Practice. Please see bottom of page for full disclaimer.
Darush Attar-Zadeh, Respiratory Lead Pharmacist in Barnet CCG and RPS London North West
- Identifying an alternative to Clenil Modulite
- Implementing the new formulary option
- After the stock issue was resolved
- Key points in asthma medicines optimisation
- Lessons learned
- Conflicts of interest
Early on during the novel coronavirus pandemic, it became apparent that coronavirus disease 2019 (COVID-19) has respiratory effects and that people with asthma or chronic obstructive pulmonary disease (COPD) are at risk of complications.1 This led to a rush on inhalers as patients began ordering them for a variety of reasons.2 People with asthma who may not have ordered preventer or reliever treatments for a while may have started to do so again. Others who did typically order inhalers may have ordered extra. Whatever the reasons, the result was that I and other pharmacists began receiving notification of supply issues—first with salbutamol and then later with beclometasone dipropionate 100 mcg pressurised metered-dose inhaler (pMDI) (Clenil® Modulite®) and a few other anti-inflammatory inhaler treatments. The Middlesex Group of Local Pharmaceutical Committees (LPC; www.middlesexlpcs.org.uk) kept the clinical commissioning groups (CCGs) up to speed with stock issues on the ground in community pharmacies.
None of the formularies in North Central London (NCL) and North West London (NWL) included a bioequivalent alternative to Clenil Modulite, so there was no obvious option to turn to in response to the supply issue; the other strengths of Clenil Modulite were also in short supply. In common with some other CCGs, choices of inhaled treatments in NCL and NWL had been narrowed down to keep options simple. Options in dry powder inhalers (DPIs) and pMDIs allowed tailoring to each patient’s inspiratory ability.
There has been an influx of new inhalers on the market and it can be hard to decipher which is the most appropriate choice. It is vital that clinicians and patients understand the different device types, as inhaler technique varies between them.
Identifying an alternative to Clenil Modulite
Barnet CCG and colleagues from other neighbouring CCGs needed a rapid response to identify suitable alternatives and communicate these to pharmacies and prescribers as soon as possible. A multidisciplinary team (MDT) involving colleagues in the CCG and the LPC worked together to identify a suitable alternative. The MDT also communicated with wholesalers and the manufacturers of less-used alternatives, who could have struggled to meet increased demand once the usual product with the largest share of prescribing was in short supply.
Efficacy, safety and patient preference are the primary considerations when choosing an appropriate inhaler, but other important factors also need to be taken into account (Box 1).
|Box 1: Considerations when choosing an inhaler|
Not all inhalers are licensed for children and adolescents. Good inhaler technique is a crucial aspect of successful treatment, and different types of inhaler require various inhalation techniques that may or may not be suited to an individual patient’s inspiratory ability. Some devices have dose counters, while others do not. Some pMDI inhalers are compatible and licensed with certain spacers, others are not. This needs to be factored in if changes are made.
Overdosing and underdosing are a risk when changing brands due to differences in strengths, displayed strength (metered dose and delivered dose), and particle size. For example, beclometasone dipropionate (the ingredient in Clenil Modulite and Soprobec®) is also available in a fine particle form in a pMDI (Qvar® and Kelhale®).3–6 Because of the difference in particle size, Qvar and Kelhale are twice the potency of Clenil Modulite and Soprobec and so not interchangeable in normal circumstances.7 The British Thoracic Society’s table showing equivalence of potencies is helpful in this regard.8
These differences all highlight the importance of prescribing inhalers by brand.7
In this case of short supply of Clenil Modulite, Soprobec was determined by the MDT to be the logical alternative, as it is equivalent to Clenil Modulite.9 The final decision took into account all the factors discussed above, and was aided by the RightBreathe resource, which enabled easy comparison of available inhalers.10
Implementing the new formulary option
Communicating the decision to healthcare professionals
Once the decision to recommend Soprobec was made, communication with primary care prescribers and community pharmacists was quickly needed to ensure all stakeholders were aware of the issue and the alternative recommendation. All respiratory contacts for the MDT, including national and local respiratory WhatsApp groups, were notified of the decision to use Soprobec as a recommended pMDI alternative if stocks were available. If a person was better suited to a DPI after a clinical review, then alternative beclometasone treatments were offered that were on formulary.
Communicating the change to patients
Prescribers were advised to have virtual consultations with patients about the enforced substitution, which was intended to be temporary, as patients needed to agree to the change. Inhaled corticosteroid potency charts from the British Thoracic Society (BTS) and RightBreathe were used to support these informed discussions.8,10
Any differences between the usual product and the alternative needed to be flagged up to the patient. In this case, for example, there is a colour difference between the Soprobec inhaler and the Clenil Modulite device. Patients’ personal asthma action plans (PAAPs) needed to be updated with the new product. Prescribers were advised to change the duration of each prescription on EMIS/SystmOne to ensure that only 1 month of replacement treatment was prescribed rather than 2 months, so asthma control could be checked after a month to ensure the switch had not had any negative effect.
After the stock issue was resolved
Once Clenil Modulite was back in stock, prescribers discussed with each patient whether they were happy to continue with Soprobec or wanted to revert back to Clenil Modulite. Once the patient and clinician had decided as part of a shared decision-making process, the chosen treatment was prescribed by brand to ensure the patient received the right treatment every month.
Key points in asthma medicines optimisation
This stock shortage situation offered an opportunity to review patients’ asthma control and management, as discussions with patients were needed to explain the reason for the change and to reassure them. Box 2 provides a reminder of the key points in asthma control and medicines optimisation, including some additional considerations for the COVID-19 pandemic.
Virtual consultations to discuss the patient’s current level of asthma control should be held during the COVID-19 pandemic. Telemedicine apps, such as AccuRx, should be utilised so that the prescriber can see the patient and assess their inhaler technique. If this is not possible, the patient could upload a video of them using their inhaler. Many patients may actually be happier to have remote consultations and this may be a good way to run asthma reviews in the future.
Reviewing the patient’s repeat prescription history can help to determine whether they are not ordering enough preventer inhalers or are over-reliant on rescue inhalers. Community pharmacy patient medication records are also useful to identify if a patient is at risk of poorly controlled asthma. Discuss with patients who have not ordered repeat prescriptions for months until the COVID-19 pandemic whether they are usually symptom free and have good control (to establish if they genuinely need the inhaler).
Inhaler choice should be based on the drug but more importantly the patient’s ability to optimise technique to ensure that the prescribed drug reaches the patient’s lungs. It is essential not only to check whether patients can correctly use their current device but also whether the current treatment is still appropriate, including the level of treatment and the use of spacers, and to step down or up as required.
Given the myriad of available inhaler devices, the RightBreathe resource10 and the Guidelines device choice algorithm11 can be helpful guides for prescribers. Switching between device types—for example, from metered-dose inhalers to dry powder inhalers, or vice versa—should be avoided, even (or perhaps especially) for a temporary switch, as the different types require different techniques that may not suit the patient. As inhalers for respiratory diseases are not interchangeable, prescribing by brand is always essential to minimise errors and optimise efficacy and safety.
Switching devices may be tempting since advice was issued by NICE and the GP contract was updated to encourage use of low-carbon footprint inhalers to gain QOF points,12–14 but all inhalers, not just pressurised aerosols, have a level of environmental impact through their manufacture and transportation. The temptation to enact a blanket switch should be resisted, as it is most important for each patient to have the right device for their inspiratory ability.
Differences between devices should be highlighted so patients know what to expect, including differences in inhaler colour, whether or not there is a dose counter (and how to tell if the inhaler is running out if there is not), different mouthpieces, different spacers, and different presentations of the same doses. The PAAP should be updated every time a treatment is changed, even if it is only a temporary switch, and should be updated again if the patient returns to the original product.
|Box 2: Key points|
Supply issues are not isolated to the setting of the COVID-19 pandemic and are also reported for other inhalers, but this example highlights the potential problem of having no alternative on the local formulary for fast-moving medicines like salbutamol and beclometasone dipropionate, in both a DPI and pMDI option. In case of supply and other issues in the future, it therefore is important to have alternative drugs on formulary. A script-switch message for the formulary alternative can be added to guide the prescriber when there are stock issues.
When a switch is needed when problems arise, even when temporary, prescribers should take the opportunity to review the patient, check their inhaler technique and asthma control, and update their PAAP with any updated information that the patient understands and has co-created with the clinician.
- Without an alternative present on the CCG formulary, a suitable alternative had to be identifed rapidly when Clenil Modulite became unavailable during the COVID-19 pandemic
- Having more than one option for fast-moving lines (such as salbutamol, and beclometasone dipropionate, in a pressurised metered-dose inhaler and dry powder inhaler) is important to ensure continuity of treatment
- The alternative products should ideally be bioequivalent and with near-identical device technique
- Inhalers should be prescribed by brand to ensure the patient receives the same familiar device and medication each time
- Any changes to the device prescribed must be clearly communicated with the patient to ensure they understand any differences to their usual device.
|Box 3: Useful resources|
The author would like to thank Gerald Alexander and LPC colleagues for supporting the CCG with information on stock shortages and relaying information to the community pharmacists, and Suzanne Lever for setting up the script switch messages and supporting suggestions for temporary formulary alternatives.
Conflicts of interest
Darush Attar-Zadeh works closely with most pharmaceutical companies that produce inhaled and smoking cessation treatments to benefit patients and clinicians, and received an honorarium from Glenmark Pharmaceuticals for this supplement.
- NHS. Advice for people at higher risk. Available at: www.nhs.uk/conditions/coronavirus-covid-19/people-at-higher-risk (Accessed 5 July 2020).
- MIMS. Inhaler prescribing guidance issued as spike in demand causes shortages.www.mims.co.uk/article/1679208 (Accessed 5 July 2020)
- Chiesi Limited. Clenil Modulite 100 micrograms inhaler (with Dose Indicator)—summary of product characteristics. December 2018. www.medicines.org.uk/emc/product/6975 (Accessed 5 July 2020)
- Glenmark Pharmaceuticals Europe Ltd. Soprobec 100 micrograms per actuation pressurised inhalation solution—summary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9816 (Accessed 5 July 2020)
- Teva UK Limited. Qvar MDI 50 micrograms—summary of product characteristics. November 2019. www.medicines.org.uk/emc/product/604 (Accessed 5 July 2020)
- Cipla EU Ltd. Kelhale 50 micrograms per actuation pressurised inhalation solution—summary of product characteristics. March 2020. www.medicines.org.uk/emc/product/10117 (Accessed 5 July 2020)
- British National Formulary. Beclometasone dipropionate.https://bnf.nice.org.uk/drug/beclometasone-dipropionate.html (Accessed 5 July 2020)
- British Thoracic Society. BTS information: respiratory inhalers. Available at: www.brit-thoracic.org.uk/document-library/quality-improvement/covid-19/bts-information-respiratory-inhalers (Accessed 28 June 2020).
- MHRA. April 2019 Public Assessment Report: Soprobec 50, 100, 200, 250 mcg, UK/H/6818/001-004/DC https://mhraproductsprod.blob.core.windows.net/docs-20200302/3bc836d25349185931b189bf3ba25c395c23447b
- RightBreathe online tool. Available at: www.rightbreathe.com (Accessed 5 July 2020).
- MGP Ltd. Choosing an appropriate inhaler device for the treatment of adults with asthma or COPD. MGP, 2020. Available at: www.guidelines.co.uk/inhalerchoice
- NICE. NICE encourages use of greener asthma inhalers.www.nice.org.uk/news/article/nice-encourages-use-of-greener-asthma-inhalers (Accessed 5 July 2020).
- NICE. Patient decision aid: inhalers for asthma. London: NICE, 2019. Available at: www.nice.org.uk/guidance/ng80/resources/inhalers-for-asthma-patient-decision-aid-pdf-6727144573 (accessed 21 June 2020).
- General Pharmaceutical Council. Update to the GP contract agreeement 2020/21 – 2023/24. London: GPC, 2020.
This supplement has been commissioned and funded by Glenmark Pharmaceuticals Europe Ltd and developed in partnership with Guidelines in Practice. Glenmark Pharmaceuticals Europe Ltd suggested the topic and author, and carried out full medical approval on all materials to ensure compliance with regulations. The sponsorship fee included an honorarium for the author. The views and opinions of the author are not necessarily those of Glenmark Pharmaceuticals Europe Ltd, or or Guidelines in Practice, its publisher, advisers, or advertisers. No part of this publication may be reproduced in any form without the permission of the publisher.
Date of preparation: November 2020