ASTH MA BOOK 2. September 2012 FP117/2 CENTRE FOR PHARMACY POSTGRADUATE EDUCATION

Transcription

1 A F O C A L P O I N T L E A R N I N G P R O G R A M M E ASTH MA S E C O N D E D I T I O N BOOK 2 September 2012 FP117/2 CENTRE FOR PHARMACY POSTGRADUATE EDUCATION

2 Content contributor Anna Murphy, consultant respiratory pharmacist, University Hospitals Leicester NHS Trust CPPE programme developer Christopher Cutts, director Reviewer (September 2012 edition) Toby Capstick, lead respiratory pharmacist, St James' University Hospital, Leeds NHS Trust Reviewers (November 2008 edition) Dr Helen Meynell, consultant pharmacist, Doncaster and Bassetlaw Hospitals NHS Foundation Trust Simon Selo and colleagues, Asthma UK The National Prescribing Centre CPPE focal point reference group (for details see: CPPE reviewers (September 2012 edition) Sue Carter, local tutor Karen Wragg, regional manager CPPE reviewers (November 2008 edition) Matthew Shaw, deputy director Paula Higginson, senior pharmacist - learning development Disclaimer We have developed this learning programme to support your practice in this topic area. We recommend that you use it in combination with other established reference sources. If you are using it significantly after the date of initial publication, then you should refer to current published evidence. CPPE does not accept responsibility for any errors or omissions. External websites CPPE is not responsible for the content of any non-cppe websites mentioned in this programme or for the accuracy of any information to be found there. Brand names and trademarks CPPE acknowledges the following brand names and registered trademarks mentioned throughout this programme: Clenil Modulite, Flixotide, Oxeze, Pulmicort, Qvar, Seretide, Symbicort, Symbicort SMART, Venturi First published in November 2008 (this edition published September 2012) by the Centre for Pharmacy Postgraduate Education, School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Oxford Road, Manchester M13 9PT Production Ambassador Litho Ltd 2 Printed on FSC certified paper stocks using vegetable based inks.

3 Contents Learning with CPPE 4 About your focal point event 5 Case study 6 Clinical vignettes 10 focal point Asthma Book 2 Directing change 12 Putting your learning into practice 13 Suggested answers 17 References 37 3

4 Learning with CPPE The Centre for Pharmacy Postgraduate Education (CPPE) is funded by the Department of Health and offers free continuing professional development opportunities for all practising pharmacists and registered practising pharmacy technicians providing NHS services in England. We are based in the University of Manchester s School of Pharmacy and Pharmaceutical Sciences. We recognise that people have different learning needs and not every CPPE programme is suitable for every pharmacist or pharmacy technician. We have created three categories of learning to cater for these differing needs: Core learning (limited expectation of prior knowledge) Application of knowledge (assumes prior learning) Supporting specialties (CPPE may not be the provider and will signpost you to other appropriate learning providers). This learning programme is a programme. Continuing professional development (CPD) - You can use this focal point unit to support your CPD. Consider what your learning needs are in this area. Use your CPD record sheets to plan and record your learning. Programme guardians - A programme guardian is a recognised expert in an area relevant to the content of a learning programme who will review the programme every six months to ensure quality is maintained. We will post any alterations or further supporting materials that are needed as an update on our website. We recommend that you refer to these updates if you are using a programme significantly after its initial publication date. Feedback - We hope you find this learning programme useful for your practice. Please help us to assess its value and effectiveness by visiting the my CPPE record page on our website. Otherwise, please us at: feedback@cppe.ac.uk 4

5 About your focal point event Before coming along to this event you will have already completed Book 1 to help you identify your own learning needs, read the key information and then related it to your own area of practice and professional development. This book uses a case study and clinical vignettes to help you apply what you have learnt so far and encourages you to measure the changes in your practice. We also include some suggested answers to the learning activities. focal point Asthma Book 2 At this event you will work through a more detailed case study and some brief clinical vignettes with your professional colleagues, and discuss your approach to the Directing change scenario that you chose from Book 1. You may be attending a CPPE tutor-led event or have arranged to meet with your own CPPE learning community. Just to remind you, in this unit we consider: how best to apply the evidence base for the treatment of patients with asthma how you can deliver an outcomes-focused service for patients with asthma how to ensure the safety and appropriate medicines management of patients with this long-term condition. This is to certify that attended the CPPE focal point event on asthma on Location CPPE tutor signature CPPE tutor name 5

6 Case study - Krystyna Time to prepare: 15 minutes to review and answer the questions. Time to discuss: 15 minutes to discuss the answers with your colleagues. Krystyna is a 49-year-old librarian. She was diagnosed with asthma as a child. As an adult her symptoms have generally been less troublesome, except in the weeks following an occasional cold. She would probably become wheezy following exercise but has led a sedentary lifestyle and so has not been troubled by her asthma. Krystyna has come in to your pharmacy for a medicines use review (MUR) because over the last few months her symptoms have gradually increased, becoming more of a problem. She experiences symptoms most days and is woken at least one night a week because of her asthma. She does not often use her peak flow meter but lately it has shown a measurement of between 250 and 300 litres/minute. Her best is recorded as 400 litres/minute. Krystyna is using her blue inhaler at least 14 times each day, especially when she has to walk her elderly mother s dog in the morning. Krystyna s current prescription is as follows: Salbutamol MDI 100 inhaler Beclometasone CFC-free (Clenil Modulite) MDI 200 inhaler Atenolol 25 mg Two puffs four times daily when required Two puffs twice daily Every morning (for hypertension) 6

7 1. How do the Royal College of Physicians three key questions used to assess patients with asthma relate to Krystyna s symptoms? Focus on clinical knowledge focal point Asthma Book 2 2. Consider the possible causes for the loss of control experienced by Krystyna. Focus on clinical knowledge Focus on therapeutics 3. Assuming that all the possible causes are addressed, what would your recommendation be to improve Krystyna s asthma? Relate your answer to the steps in the BTS/SIGN British guideline on the management of asthma. 1 7

8 Eight weeks later, Krystyna returns to your pharmacy. All your interventions have been implemented by her GP but, although she is significantly better, she is still feeling breathless on exertion and uses her salbutamol inhaler most days. She is unhappy about further increasing her dose of steroids, but feels she needs something extra. Her friend has mentioned that there is a tablet available for the management of asthma and Krystyna asks if it would be appropriate. You realise it is a leukotriene receptor antagonist. 4. What is the place for the use of leukotriene receptor antagonists in the management of asthma? Focus on safety Focus on evidence You decide to refer her back to her GP who adds in the local formulary choice, montelukast. After the adjustments in Krystyna s medicines her asthma control begins to improve: she no longer wakes at night, can exercise in comfort and needs far fewer reliever inhalations (she uses her inhaler only once or twice a week). Unfortunately, a few months into her new treatment she stops taking her steroid inhaler, both because her new tablets are so good and because she is struggling to pay for all her prescriptions. 5. What are your main concerns and how would you address these? 8

9 Krystyna s prescription is changed to: Symbicort 200/6 Turbohaler Montelukast 10 mg Salbutamol MDI inhaler 200 micrograms Amlodipine 5 mg Two puffs twice daily Every night When required Every morning focal point Asthma Book 2 Her asthma control improves drastically and she is very happy with her new medicines regimen. A few weeks later You have been invited to a learning event on respiratory medicine with other healthcare professionals. They are interested in your views on the new Symbicort SMART regimen. 6. What is the Symbicort SMART dosing approach? Would you recommend this treatment regimen for a patient like Krystyna? Focus on evidence 9

10 Clinical vignettes Time to prepare: 15 minutes to review and answer the questions in groups. Time to discuss: 15 minutes to discuss the answers with your colleagues. In this section of focal point, we look at brief clinical scenarios, focusing in particular on decision making and communication. Review each of the clinical vignettes and come up with a suitable response to manage the situation. Support your answer with suitable evidence. You may wish to practise these responses using role play. Clinical vignette 1 Leesa is a pharmacy technician working in a local GP practice. She used to work at the hospital and remembers that there was a large respiratory clinic with a diagnostics suite. She has been talking to the specialist asthma nurse, who visits the practice every month. Leesa wonders whether patients should take daily peak expiratory flow (PEF) readings even when they are well and symptom-free. Construct a response to Leesa. Clinical vignette 2 Hussain is planning an MUR with Mark, a patient who is on a long-term corticosteroid (prednisolone 5 mg) for control of asthma. Over the past ten years, Mark has been admitted several times to hospital with acute asthma despite using high doses of inhaled medicines. The local respiratory consultant started him on the prednisolone and he has been reviewed at the hospital. Mark is unable to step down his treatment. Hussain wants to ask him if he has been monitored for side-effects of the corticosteroids he has received but is unsure what to ask about. He knows about the risk of diabetes but decides to call the local medicines information service at the acute trust for further guidance. Construct a response to Hussain. 10

11 Clinical vignette 3 Devina, a mum of three, has come into your pharmacy and wants to talk about asthma. Her four-year-old son, Billy, was diagnosed with asthma two years ago. After previously using only a salbutamol inhaler with a spacer, he has now been started on a steroid inhaler. She is very worried about this because she has heard steroids can affect his height, cause him to get diabetes and damage his skin. Construct a response to Devina. focal point Asthma Book 2 11

12 Directing change Time to prepare: none you should have done this before the event. Time to discuss: 15 minutes to discuss your solution with your colleagues. Revisit the scenario you selected in Book 1. We suggested that you structure your thinking and ideas around several themes. Discuss the solutions and ideas you developed with your colleagues and make some notes in the space below to help you to put your ideas into action when you return to work. You have reached the end of the activities for this focal point event; the remainder of this book contains follow-up activities and the suggested answers. You may wish to spend some time after the event looking through these with colleagues. 12

13 After your focal point event: putting your learning into practice Now it is time to assess your learning, determine your readiness to change and put your new knowledge into practice. 13

14 Putting your learning into practice There are four actions you should undertake to ensure that what you have learnt in this focal point unit influences your future practice. 1. Work through the practice activities listed below 2. Evaluate your learning by revisiting the Moving into focus questions 3. Complete the CPPE online e-assessment 4. Reflect on the Steps for change outlined on page Practice activities (45 minutes) You might wish to start to put some of your learning into practice by undertaking the following activities. Conduct two MUR sessions with asthma patients who use inhalers. Use the Royal College of Physicians questions to establish the effectiveness of their asthma management. Stepping down treatment is an important part of the British asthma guideline. Undertake a mini-audit of five asthma patients to see how stable their asthma management has been. Have they met the BTS/SIGN criteria for stepping down? Contact your local GP practice to find out if any local asthma clinics take place. Ask if you could attend one. You could also ask to shadow a pharmacist running clinics with respiratory patients. When will you undertake these? 2. Evaluate your learning (15 minutes) The second step is to revisit the Moving into focus questions that were presented at the start of Book Describe the five clear steps in the British asthma guideline. 2. List the Royal College of Physicians three questions to assess a patient s current asthma management. 3. Do anticholinergic drugs have a place in the management of both acute and chronic asthma? 14

15 4. What would you discuss with a GP colleague when debating the safety of inhaled long-acting beta 2 agonists (LABAs) with or without inhaled steroids? 5. Can long-term inhaled steroids be used safely in a three-year-old child with asthma? Can you answer these now? focal point Asthma Book 2 3. Access e-assessment (30 minutes) The next step in assessing your learning is to work through the online e-assessment on our website. Go to: Choose login and complete the login process. If you are a new user you will need to click on the Register with CPPE link, gain your password and follow the instructions to sign up. When you have logged in, go to assessment in the top menu bar, click on e-assessment portfolio, and then scroll down to find the e-assessment entitled focal point: Asthma. Click on the icon and follow the on-screen instructions. If you complete the e-assessment successfully you will be able to print your own certificate of achievement. When will you access the e-assessment? 15

16 4. Reflection steps for change (15 minutes) The final step is to think about the following statements and note down how you feel about them. This should help you determine any requirements for your further development. I have achieved the personal learning objectives that I set myself on page 9 in Book 1. Strongly disagree Disagree Agree Strongly agree I have identified additional learning I need to undertake to improve my knowledge of the therapeutic management of asthma. Strongly disagree Disagree Agree Strongly agree I would like to follow up a best practice idea expressed by a colleague at the focal point event/within my learning community. Strongly disagree Disagree Agree Strongly agree After reflecting on these statements, what steps will you now take to drive your development forward? 16

17 Suggested answers to: Moving into focus questions Practice points Talking points Case study Clinical vignettes 17

18 These are the authors suggested responses to the learning activities and they should be used as a guide during your focal point event. Where possible, use your own local guidelines and policies to inform the discussion and answers. We have provided short answers to the questions and case study and, where appropriate, these are followed by discussion points that provide a little more detail. Moving into focus 1. Describe the five clear steps in the British asthma guideline. The aims of chronic asthma treatment are to achieve early control, to prevent exacerbations, and to maintain control by stepping up treatment as necessary and stepping down when control is good. You will find details of the BTS/SIGN five steps in Book 1. Discussion points The British asthma guideline indicates that practitioners should: start treatment at the step most appropriate to the initial level of asthma severity tailor treatment plans to the needs and preferences of the individual check compliance issues before starting a new drug therapy or stepping up treatment. This includes establishing whether the patient understands their current treatment and if they are following existing advice correctly. Is their inhaler technique effective? Have other factors that may trigger asthma been eliminated, as far as possible? offer advice on self-management to all patients with asthma, including written asthma action plans focusing on individual needs. 2. List the Royal College of Physicians three questions to assess a patient s current asthma management. The Royal College of Physicians three questions are a useful symptom-monitoring tool, assessing the effect of asthma on the patient s life. 2 The questions detailed below provide a measurable baseline against which to assess whether treatments and services are being effective. In the last week/month: Have you had difficulty sleeping because of your asthma symptoms (including cough)? Continued on next page 18

19 Have you had your usual asthma symptoms during the day - cough, wheeze, chest tightness or breathlessness? (Asking about use of reliever medication may help to quantify this.) Has your asthma interfered with your usual activities, eg, housework, work, school, etc? The three questions can be applied to all asthma patients aged 16 and over, and should only be used after diagnosis has been established. focal point Asthma Book 2 3. Do anticholinergic drugs have a place in the management of both acute and chronic asthma? No. The most recent British asthma guideline does not include anticholinergics for the management of stable chronic asthma, but it does recommend the addition of short-acting anticholinergics, eg, ipratropium, in acute asthma if the patient has not responded to short-acting beta 2 agonists. Discussion points Anticholinergic agents act as bronchodilators. It is a widely held view that anticholinergics are less effective than beta 2 agonists in the symptomatic treatment of chronic asthma. When such drugs are prescribed in combination with more widely used bronchodilators, for example beta 2 agonists such as salbutamol, they have been shown not to add much benefit. However, it is possible there are some adults with chronic asthma who respond to treatment with anticholinergic drugs. Attempts to identify subgroups that respond better to anticholinergics have not been very successful. The possible differences in responsiveness to anticholinergics between different patient groups illustrate the diverse nature of asthma. At one end of the spectrum are patients whose airflow limitation shows marked spontaneous fluctuations and improves considerably with treatment. At the other are patients whose disease fluctuates to a very limited extent and is irreversible. This blurring of the boundaries becomes important when considering anticholinergics, since it is generally regarded that they may have a small but proportionately greater effect than beta 2 agonists in patients with chronic obstructive pulmonary disease (COPD). 3 19

20 4. What would you discuss with a GP colleague when debating the safety of inhaled long-acting beta 2 agonists (LABAs) with or without inhaled steroids? The British asthma guideline and Medicines and Healthcare products Regulatory Agency guidance emphasise the need for adequate anti-inflammatory therapy before starting any add-on treatment. Inhaled LABAs should only be used in combination with inhaled corticosteroids in patients not adequately controlled on low-dose inhaled corticosteroids alone. When used in combination with inhaled corticosteroids, prospective studies have demonstrated improvements in both asthma control and exacerbation rate. Although the majority of asthmatic patients appear to benefit from the use of LABAs, a small subclass may be prone to harmful effects. 4 Discussion points The results of the Salmeterol Multi-Centre Asthma Research Trial (SMART) caused many to question the safety of LABAs for the management of asthma. The SMART study was a large randomised controlled trial (n = 26,355) that investigated the effect of salmeterol with or without an inhaled corticosteroid in older children and adults. The trial was stopped prematurely after it was found that there was a higher incidence of asthma-related adverse effects (such as severe asthma exacerbations and asthma-related deaths) in people who had used salmeterol without an inhaled corticosteroid. 4,5 A meta-analysis pooled the results from 19 trials (n = 33,826 including the SMART study) and similarly concluded that LABA therapy without corticosteroid therapy increases severe and life-threatening asthma exacerbations, and the risk of asthma-related death. 6 Following on from SMART, the MHRA recommended that: people taking LABAs, eg, salmeterol or formoterol, should always be prescribed an inhaled corticosteroid and should not discontinue this treatment while taking a LABA people with acutely deteriorating asthma should not be started on LABA therapy. In addition, LABAs should never be used to treat the sudden onset of asthma, or acute asthma attacks people should be monitored closely, especially during the first three months of treatment, and LABAs should be continued only if they have shown benefit. 5 20

21 5. Can long-term inhaled steroids be used safely in a three-year-old child with asthma? Yes, inhaled steroids can be safely prescribed but at low doses, ie, less than 400 micrograms/day beclometasone (CFC-containing) or equivalent. Discussion points Inhaled steroids are the most effective preventer drug for adults and children for achieving overall treatment goals. focal point Asthma Book 2 In children, a reasonable starting dose will usually be 200 micrograms/day. However, in children under five years, higher doses may be required if there are problems in obtaining consistent drug delivery. Administration of inhaled steroids at or above 400 micrograms/day of beclometasone (CFC-containing) or equivalent may be associated with systemic side-effects. These may include growth failure and adrenal suppression. The British asthma guideline recommends that the height of children on high doses of inhaled steroids is monitored on a regular basis and that the lowest dose of inhaled steroids compatible with maintaining disease control should be used. 1 Clinical adrenal insufficiency has been identified in a small number of children who have become acutely unwell at the time of intercurrent illness. Most of these children had been treated with high doses of inhaled corticosteroids, at or above 400 micrograms/day beclometasone (CFC-containing) or equivalent. 21

22 Practice and talking points Practice point 1 What are the clinical similarities and differences between a patient with asthma and one with COPD? Both asthma and COPD are major chronic obstructive diseases that involve underlying airway inflammation. However, COPD is characterised by airflow limitation that is not fully reversible and is usually progressive. It is also associated with an abnormal inflammatory response of the lungs to noxious particles or gases. In contrast, episodes of asthma are usually associated with widespread but variable airflow obstruction, which is often reversible. Practice point 2 What is the best way to deliver short-acting beta 2 agonists in the management of an acute exacerbation of asthma? In mild-to-moderate acute asthma, short-acting beta 2 agonists can be given by nebulisation or from an inhaler with a spacer device or holding chamber. In acute asthma, inhaled short-acting beta 2 agonists are often administered to relieve bronchospasm by wet nebulisation, but metered-dose inhalers with a holding chamber (spacer) can be equally effective in mild-to-moderate cases (four to ten puffs for adults, or four to six puffs for children, although up to ten puffs may be required for more severe asthma) 1,7 Discussion points A meta-analysis of trials in adults with asthma or COPD suggested that metereddose inhalers with a spacer are as effective as nebulisers. 8 Nebulisers require a power source, need regular maintenance and are more expensive. Indeed, current guidelines have moved towards the use of spacers with a metered-dose inhaler for managing mild-to-moderate acute asthma. However, in potentially life-threatening cases of acute asthma, the nebulised route driven by oxygen is the preferred method of administration. Intravenous beta 2 agonists should be reserved for those patients who cannot be treated reliably using inhaled therapy. 22

23 Talking point A Should patients with asthma be advised to use their short-acting beta 2 agonist regularly throughout the day eg, four times daily or when required for shortness of breath? Randomised controlled trials have found that regular use of inhaled short-acting beta 2 agonists provides no additional clinical benefits compared with use when required, and may worsen control of asthma. 1,9 In summary, the advice is that shortacting beta 2 agonists should be prescribed and inhaled on a when-required basis. focal point Asthma Book 2 Discussion points Two case-controlled studies found an association between increased asthma mortality and the overuse of inhaled short-acting beta 2 agonists, although the evidence does not establish causality. Overusing beta 2 agonists to treat frequent symptoms may simply indicate severe uncontrolled asthma in high-risk individuals. 9 However, inhaling a short-acting beta 2 agonist on a when-required basis is a useful indicator of disease control and allows the patient to judge how often they require rescue medication and how effective it is when administered. Patients who rely heavily on inhaled short-acting beta 2 agonists should have their asthma management reviewed. Using two or more canisters of short-acting beta 2 agonists per month or more than 10 to 12 puffs per day are markers of poorly controlled asthma. Remember, short-acting beta 2 agonists can mask symptoms but do not change the underlying disease process. Patients using high doses of beta 2 agonists are also more likely to experience adverse effects, such as tremors, cramps, palpitations and headaches. 23

24 Practice point 3 Inhaled corticosteroids differ in potency and bioavailability, although relatively few studies have been able to confirm the clinical relevance of these differences. Complete the gaps in the table below with the approximate equipotent doses of the different inhaled corticosteroids. Which agents are listed in your local formulary? Ratio compared Equivalent dosage Is this a local to beclometasone to 200 micrograms/ formulary choice (CFC-containing) day beclometasone in your area? (CFC-containing) Hydrofluoroalkane 134a 1 : (HFA) containing beclometasone (Qvar) HFA containing 1 : beclometasone (Clenil Modulite) Budesonide 1 : Fluticasone 1 : Mometasone 1 : Ciclesonide 1 : Comparisons are based on efficacy data. Discussion point The most important determinant of appropriate dosing is the clinician s judgment of the patient s response to therapy. The clinician must monitor the patient s response in terms of clinical control and adjust the dose accordingly. Once control of asthma is achieved, the dose of medication should be carefully adjusted to the minimum dose required to maintain control, thereby reducing the potential for adverse effects. 24

25 Talking point B What are the major risks associated with inhaled corticosteroids? Oral candidiasis, sore mouth, hoarseness and dysphonia. Systemic side-effects can occur with prolonged high-dose treatment. Understanding the safety of inhaled corticosteroids is of crucial importance and a balance between the benefits and risks for each individual needs to be assessed. Take account of the use of other systemic or topical corticosteroid therapy when assessing risk. focal point Asthma Book 2 Discussion points The main adverse effects are: oral candidiasis and sore mouth, which are commonly recognised problems associated with inhaled corticosteroid used in high doses. They can be minimised by using a large-volume spacer device, which reduces oropharyngeal deposition by filtering out larger particles. Additionally, rinsing the mouth with water after inhaled corticosteroid use can minimise such problems. If there is a major problem for a patient, an alternative strategy is to use ciclesonide, which may cause oral candidiasis less frequently than other inhaled corticosteroids 13 hoarseness and dysphonia, which are experienced by many people taking inhaled corticosteroids. Use of a spacer device does not appear to alleviate this systemic side-effects, eg, adrenal suppression or crisis, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and skin thinning. These can occur in patients who require prolonged high-dose inhaled steroids. These patients should be issued with a steroid treatment card a 2010 Drug Safety Update from the MHRA advises that psychological and behavioural side-effects may occur in association with use of inhaled and intranasal formulations of corticosteroids

26 Case study - Krystyna Time to prepare: 15 minutes to review and answer the questions. Time to discuss: 15 minutes to discuss the answers with your colleagues. Krystyna is a 49-year-old librarian. She was diagnosed with asthma as a child. As an adult her symptoms have generally been less troublesome, except in the weeks following an occasional cold. She would probably become wheezy following exercise but has led a sedentary lifestyle and so has not been troubled by her asthma. Krystyna has come in to your pharmacy for a medicines use review (MUR) because over the last few months her symptoms have gradually increased, becoming more of a problem. She experiences symptoms most days and is woken at least one night a week because of her asthma. She does not often use her peak flow meter but lately it has shown a measurement of between 250 and 300 litres/minute. Her best is recorded as 400 litres/minute. Krystyna is using her blue inhaler at least 14 times each day, especially when she has to walk her elderly mother s dog in the morning. Krystyna s current prescription is as follows: Salbutamol MDI 100 inhaler Beclometasone CFC-free (Clenil Modulite) MDI 200 inhaler Atenolol 25 mg Two puffs four times daily when required Two puffs twice daily Every morning (for hypertension) 26

27 1. How do the Royal College of Physicians three key questions used to assess patients with asthma relate to Krystyna s symptoms? Focus on clinical knowledge Krystyna s asthma is not controlled. This can be identified by using the Royal College of Physicians questions and relating these to her markers of control. Krystyna s description of her symptoms fulfil all three criteria for poor asthma control as identified using the Royal College of Physicians three questions. focal point Asthma Book 2 Discussion Points In Krystyna s case, the Royal College of Physicians questions operate as follows: Have you had difficulty sleeping because of your asthma symptoms (including cough)? Yes - she is woken at least one night a week by her asthma. Have you had your usual asthma symptoms during the day - cough, wheeze, chest tightness or breathlessness? Yes she experiences asthma symptoms on most days. She requires her salbutamol inhaler at least 14 times on a daily basis and her peak flow recording is reduced to between 62 percent and 75 percent of her best. Has your asthma interfered with your usual activities, eg, housework, work, school, etc? Yes she is experiencing problems when walking the dog. Further questioning regarding her day-to-day activities may be useful. Answering yes to all three questions is indicative of poor asthma control. Good control should mean that a person with asthma can lead a normal life. They should be able to do what they wish and participate in any sports or activities without being restricted by their asthma. This should be possible for all but the small percentage of people whose asthma is more severe. 27

28 2. Consider the possible causes for the loss of control experienced by Krystyna. Focus on clinical knowledge There are a number of reasons why Krystyna s asthma may be uncontrolled or getting worse. You should consider: her drug history a differential diagnosis factors associated with her inhaled medicines trigger factors. Fortunately, most of these are surprisingly easy to remedy and should be addressed before there are any changes in her medicines regimen. Discussion points Check her drug history Have any other medicines exacerbated her asthma symptoms? Krystyna has been prescribed a beta-blocker (atenolol); have symptoms deteriorated since this was added? Consider a differential diagnosis Are there signs of menorrhagia, anaemia, heart failure, or COPD? Has she any risk factors for developing COPD, for example, a history of smoking? You could ask Krystyna to chart her peak flows to provide an objective assessment of her symptoms and allow diurnal variation to be assessed. Consider factors associated with her inhaled medicines Does she use her inhaler correctly? Inhaler techniques should be regularly reviewed. Check the expiry date on the devices Has Krystyna an old or dirty spacer device? If the spacer is not kept clean the medicine will adhere to the inside surface instead of being inhaled. Spacers should be washed in detergent and allowed to air-dry every month, and replaced at least every 12 months. Does Krystyna use her steroid inhaler on a daily basis? 28 Consider trigger factors Is her mother s dog dander triggering Krystyna s asthma? Is the exercise associated with walking her mother s dog triggering her asthma? Are there any other potential trigger factors at work or home?

29 3. Assuming that all the possible causes are addressed, what would your recommendation be to improve Krystyna s asthma? Relate your answer to the steps in the British asthma guideline. Focus on therapeutics The most appropriate recommendation is to add a LABA. This is one option at Step 3 of the British asthma guideline. Krystyna is currently taking 800 micrograms/day of beclometasone. Increasing the dose of inhaled corticosteroid above this dose is not recommended because this increases the risk of adverse effects and there is little increase in benefit. A trial of other treatments should be initiated before the dose of inhaled corticosteroid is increased above 800 micrograms/day in adults. focal point Asthma Book 2 Discussion points Patients whose asthma is not well controlled by inhaled corticosteroids alone may benefit from the addition of a LABA, such as salmeterol or formoterol. A LABA is the first choice recommended by the British asthma guideline at this point, Step 3. There have now been many high-quality studies showing that the control of moderate or severe asthma can be improved by adding a LABA to therapy with inhaled corticosteroids. Furthermore, a meta-analysis (called MIASMA) of nine parallel group trials made a comparison between increasing the dose of inhaled corticosteroids and the addition of salmeterol to inhaled corticosteroids in patients with symptomatic asthma. 15 Results showed that when trying to gain control of asthma which is not well controlled, a LABA is superior to doubling the dose of inhaled corticosteroids, or increasing the steroid even further. The use of a LABA in this situation has demonstrated a range of outcomes, including reductions in asthma symptoms; nocturnal awakenings; use of shortacting beta 2 agonists and asthma exacerbations, and improvements in healthrelated quality of life; spirometry measurements and peak expiratory flows. 29

30 Eight weeks later, Krystyna returns to the pharmacy. All your interventions have been implemented by her GP but, although she is significantly better, she is still feeling breathless on exertion and uses her salbutamol inhaler most days. She is unhappy about further increasing her dose of steroids, but feels she needs something extra. Her friend has mentioned that there is a tablet available for the management of asthma and Krystyna asks if it would be appropriate. You realise it is a leukotriene receptor antagonist. 4. What is the place for the use of leukotriene receptor antagonist drugs in the management of asthma? Focus on evidence The current British asthma guideline recommends that leukotriene receptor antagonists should be considered as one option at Step 4 in adults. The guideline states that leukotriene receptor antagonists should be prescribed only if control of the patient s asthma remains suboptimal, despite a trial of LABAs, when-required short-acting beta 2 agonists and a high dose of inhaled corticosteroid, eg, 800 micrograms/day beclometasone or equivalent in adults. In very young children, leukotriene receptor antagonists can be considered at Step 3. Discussion points The leukotrienes are inflammatory mediators released by inflammatory cells, particularly mast cells, neutrophils, eosinophils and macrophages. Leukotriene-mediated effects in asthma include airway oedema, microvascular leakage, smooth muscle contraction, mucus secretion and recruitment of eosinophils into the airway. Leukotriene receptor antagonists also have mild anti-inflammatory effects and may reduce the eosinophilic inflammation provoked by the leukotrienes. Leukotriene receptor antagonists provide additional benefit in terms of symptom control and lung function in adults and children (older than two years of age) when used with inhaled corticosteroids in poorly controlled asthma, compared with placebo. Their effect on reducing exacerbation rates is less certain. Leukotriene receptor antagonists appear to provide no additional benefit over increasing the inhaled corticosteroid dose in the management of chronic asthma. Leukotriene receptor antagonists alone are less effective than inhaled corticosteroids alone or inhaled corticosteroids plus LABAs in the management of asthma

31 You decide to refer her back to her GP who adds in the local formulary choice, montelukast. After the adjustments in Krystyna s medicines her asthma control begins to improve: she no longer wakes at night, can exercise in comfort and needs far less reliever inhalations (using her inhaler only once or twice a week). Unfortunately, a few months into her new treatment she stops taking her steroid inhaler because her new tablets are so good and also she is struggling to pay for all her prescriptions. focal point Asthma Book 2 5. What are your main concerns and how would you address these? Krystyna is not receiving an inhaled corticosteroid. She is taking a LABA alone without the inhaled steroid, potentially increasing her risk of asthma-related death. Focus on safety One way to address your concerns is recommend a combination inhaler, combining both the LABA and the inhaled corticosteroid. Benefits of one inhaler include: lower costs for patients who pay prescription charges patients cannot stop the steroid alone if both medicines are given in a single inhaler. This addresses the concern that patients using two inhalers would be tempted to use just the LABA, as it produces a symptomatic improvement faster than steroids can. Discussion points Current maintenance therapy for asthma is directed primarily at airway inflammation. The application of topical inhaled steroids on the air passages is a very effective way of managing the chronic symptoms of asthma. Inhaled corticosteroids target the inflamed airways directly, reducing inflammation and airway hyper-responsiveness. LABAs such as salmeterol should always be used in conjunction with inhaled corticosteroids for patients with asthma. The results from the SMART trial, conducted in the United States, showed that patients who did not use inhaled corticosteroids with salmeterol had a higher incidence of asthma-related adverse events than patients who used inhaled corticosteroids with salmeterol (particularly African-American patients). As a result the MHRA has produced guidance for the prescribing of LABAs. 5 31

32 Krystyna s prescription is changed to: Symbicort 200/6 Turbohaler Montelukast 10 mg Salbutamol MDI inhaler 200 micrograms Amlodipine 5 mg Two puffs twice daily Every night When required Every morning Her asthma control improves drastically and she is very happy with her new medicines regimen. A few weeks later You have been invited to a learning event on respiratory medicine with other healthcare professionals. They are interested in your views on the new Symbicort SMART regimen. 6. What is the Symbicort SMART dosing approach? Would you recommend this treatment regimen for a patient like Krystyna? Focus on evidence The SMART (Symbicort Maintenance And Reliever Therapy) dosing approach allows patients to take a maintenance dose of Symbicort every day in line with normal practice, to keep control of their asthma, and to take additional inhalations when required if symptoms occur - to provide both rapid symptom relief and increased asthma control. Symbicort SMART is suitable for adult asthma patients for whom treatment with a combination of inhaled corticosteroids and LABAs is appropriate. Using Symbicort in this way for Krystyna may improve her adherence to her treatment as only one inhaler is required. Discussion points With Symbicort SMART, the underlying inflammation is treated with every inhalation of both maintenance and reliever therapy, making it a more effective way to manage asthma, compared to traditional therapy involving a shortacting bronchodilator. Symbicort SMART improves daily symptom control and reduces asthma attacks. Additionally, patients only need one inhaler - a separate short-acting bronchodilator is no longer needed. 32 Continued on next page

33 It has been tested in a wide clinical trial involving over 16,000 patients with mild to severe persistent asthma although this was limited to companysponsored clinical trials. The results of all studies indicate that Symbicort SMART improves overall asthma control and reduces the risk of patients developing potentially life-threatening asthma attacks. It does so significantly better than either implementing fixed dosing with higher-dose inhaled corticosteroids alone, or with combination therapy, plus a short-acting bronchodilator. From a patient's perspective, one appeal of Symbicort SMART is that some sufferers may be reluctant to contact doctors as their symptoms worsen, preferring to 'wait it out', only for the situation to get progressively worse. Symbicort SMART allows them to readily adjust their therapy early, whenever they identify an increase in symptoms. Additionally, as Symbicort is used as both maintenance therapy and symptom relief, this overcomes the need for a separate reliever inhaler. As complex treatment regimens are detrimental to adherence among patients, the Symbicort SMART approach, which requires fewer inhalers, may improve results because it is simpler for patients to use. Further research on Symbicort SMART dosing is particularly needed for two groups of patients. The first are those who overuse reliever therapy, who could potentially be using high doses of inhaled corticosteroids. The second are those who are unable or fail to recognise worsening asthma symptoms. focal point Asthma Book 2 33

34 Clinical vignettes Clinical vignette 1 Leesa is a pharmacy technician working in a local GP practice. She used to work at the hospital and remembers that there was a large respiratory clinic with a diagnostics suite. She has been talking to the specialist asthma nurse, who visits the practice every month. Leesa wonders whether patients should take daily peak expiratory flow (PEF) readings even when they are well and symptom-free. The bottom line: Yes, patients with asthma should measure peak expiratory flows even when they are well. Why? Home charting can be a useful way of monitoring a wide variety of aspects of the condition. Such measurements can be useful for patients who are not adept at assessing their symptoms, eg, children. Supporting the statements Peak expiratory flow home charting is useful at diagnosis and initial assessment; when assessing response to changes in treatment; when monitoring response during exacerbations and as part of a personalised written asthma action plan (self-management plan). Peak-flow based asthma action plans are designed for patients who wish to be closely involved in their asthma management; those with regular symptoms; or those who are at risk of attacks. Many patients can manage their asthma by monitoring their symptoms. A Cochrane systematic review concluded that written action plans based on peak expiratory flow are no more effective than action plans based on symptoms. 17 However, in practice, some individuals are poor at judging the severity of their condition. In these cases, regularly measuring PEF can help practitioners determine if a change in treatment or an admission to hospital is required. 34

35 Clinical vignette 2 Hussain is planning an MUR with Mark, a patient who is on a long-term corticosteroid (prednisolone 5 mg) for control of asthma. Over the past ten years, Mark has been admitted several times to hospital with acute asthma despite using high doses of inhaled medicines. The local respiratory consultant started him on the prednisolone and he has been reviewed at the hospital. Mark is unable to step down his treatment. Hussain wants to ask him if he has been monitored for side-effects of the corticosteroids he has received but is unsure what to ask. He knows about the risk of diabetes but decides to call the local medicines information service at the acute trust for further guidance. focal point Asthma Book 2 The bottom line: There are a wide number of side-effects associated with the long-term use of corticosteroids of which pharmacists and patients should be aware. Like what? Metabolic, cardiovascular, gastrointestinal, ocular, musculoskeletal, dermal and growth problems should all be monitored. It is important to speak to the patient about their chickenpox history and warn them of associated risks. Hussain should be aware that the risk of suffering adverse effects from oral corticosteroid use increases in line with both dose and duration. Supporting the statements Patients using corticosteroids as part of their long-term treatment for asthma should be monitored for: metabolic disturbances screen regularly for diabetes mellitus and treat as necessary, be aware of the risks of weight gain and hypokalaemia the development of cardiovascular problems monitor blood pressure, watch for signs of oedema, be aware of any exacerbation of cardiac failure gastrointestinal tract problems in particular, peptic ulceration adverse ocular developments including glaucoma. Community optometric services should be prompted to screen child patients periodically for cataracts musculoskeletal problems including myopathy and decreasing muscle mass. A falls risk assessment or dexascan should be considered for vulnerable patients. growth suppression in children. dermal thinning and easy bruising. 35

36 Clinical vignette 3 Devina, a mum of three, has come into your pharmacy and wants to talk about asthma. Her four-year-old son, Billy, was diagnosed with asthma two years ago. After previously using only a salbutamol inhaler with a spacer, he has now been started on a steroid inhaler. She is very worried about this because she has heard steroids can affect his height, cause him to get diabetes and damage his skin. The bottom line: Devina needs to know that there are risks associated with inhaled corticosteroid use but also that they are low. Why? Pharmacists talking with a worried parent like Devina should stress the reduced incidence of side-effects experienced by patients taking inhaled corticosteroids compared to those taking oral corticosteroids. However, they should nonetheless acknowledge that problems can occur. They should ask Devina to be vigilant for non-specific symptoms and to report them promptly. Supporting the statements The Committee on Safety of Medicines (now the Commission on Human Medicines) has strongly advised that the paediatric licensed dose of all inhaled corticosteroids should not be exceeded. Use the lowest dose that will maintain disease control. 11 Inhaled corticosteroids have considerably fewer systemic side-effects than oral corticosteroids, but adverse effects have been reported. Administration of inhaled steroids at or above 400 micrograms/day of beclometasone (CFC-containing) or equivalent may be associated with systemic side-effects. These may include short-term growth suppression and adrenal suppression. Parents of child patients using high doses of inhaled corticosteroids (400 micrograms or more per day of beclometasone (CFC-containing) or equivalent) should be advised to immediately report signs of anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased consciousness, hypoglycaemia and seizures. All of these could indicate clinical adrenal insufficiency. 36 Some initial slowing of growth may occur in children who have used inhaled corticosteroids, but final adult height does not appear to be affected. However, it is recommended that the height of children receiving prolonged treatment is monitored; if growth is slowed, referral to a paediatrician should be considered.

37 References All URLs were checked on 30 July The Scottish Intercollegiate Guidelines Network and the British Thoracic Society. Clinical Guideline 101: British guideline on the management of asthma. May 2008 (revised January 2012) Pearson MG, Bucknall CE (eds.) Measuring clinical outcome in asthma - A patientfocused approach. London: Royal College of Physicians; focal point Asthma Book 2 3. Westby M, Benson M, Gibson P. Anticholinergic agents for chronic asthma in adults. Cochrane Database of Systematic Reviews 2004;3: Art. No.: CD frame.html. 4. Nelson HS et al. The salmeterol multicenter asthma research trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 129(1): Medicines and Healthcare products Regulatory Agency. Reminder: Salmeterol (Serevent) and formoterol (Oxis, Foradil) in asthma management. Safetywarningsandmessagesformedicines/CON Salpeter SR et al. Meta-analysis: effect of long-acting beta 2 agonists on severe asthma exacerbations and asthma-related deaths. Annals of Internal Medicine 2006;144(12): Turner MO et al. Bronchodilator delivery in acute airflow obstruction. Archives of Internal Medicine 1997;157(15): Cates CJ, Crilly JA, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database of Systematic Reviews 2006;2: Art. No.: CD Walters EH et al. Inhaled short acting beta2-agonist use in chronic asthma: regular versus as needed treatment. Cochrane Database of Systematic Reviews 2003;1: Art. No.: CD frame.html. 37