DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) GUIDELINE ON COPD MANAGEMENT

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1 DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) GUIDELINE ON COPD MANAGEMENT o This is an updated guideline to include NICE COPD guideline CG101 June 2010 o o o o o o o Diagnosis of COPD should be considered in patients over the age of 35 who have a risk factor (generally smoking) presenting with exertional breathlessness, chronic cough, regular sputum production, frequent winter bronchitis or wheeze Stopping smoking remains the most important component of COPD management Care should be delivered by a multidisciplinary team Classification of severity informs treatment decisions Pulmonary rehabilitation can be considered for all patients with COPD (Usually MRC 3,4,5) and in those who consider themselves functionally disabled including those with recent hospitalisation for acute exacerbation, who are considered a priority to access pulmonary rehabilitation due to its impact on reducing readmission to hospital) Triple therapy (LABA/LAMA/ICS) use is restricted, subject to a diagnostic review and in the presence of severe disease with persistent exacerbations. If significant clinical benefit not seen within 2 months, STOP one of the drugs. Oral mucolytic therapy is an option for troublesome cough and sputum NOT on inhaled corticosteroids Page 1 of 21 First produced - May 2008 Updated - April 2011 Next review date - March 2013

2 C O N T E N T S Page Summary 3 Diagnosis COPD and differential diagnosis 3 &4 Assessment of severity 3 Reversibility testing 5 Ongoing treatment of stable COPD 5 Referral to specialist clinic 6 Treatment by disease stage 7 Inhaled corticosteroids 7 Mucolytic therapy 7 &16 Treatment of exacerbations 8 Factors that should be used to assess the need to treat patients in 8 hospital Appendix 1 spirometry 9 Appendix 2 pulmonary rehabilitation 10 Appendix 3 patient information and self management plans 12 Appendix 4 theophylline prescribing 13 Appendix 5 oxygen therapy 14 Appendix 6 mucolytic therapy in patients with diagnosed COPD & 16 troublesome cough and sputum Appendix 7 drug choice in COPD 17 & 18 Appendix 8 Management of stable COPD (multidisciplinary approach) 19 Appendix 9 cost of inhaled drugs 20 Goals of COPD management Early and accurate diagnosis Prevention of disease progression Relief of symptoms Improvement in exercise tolerance Improvement in self care through patient information Prevention and treatment of complications Prevention and treatment of exacerbations Reduction in mortality Minimisation of side effects from treatment Page 2 of 21 First produced - May 2008 Updated - April 2011 Next review date - March 2013

3 Derbyshire Health Community COPD Guidelines Summary Definition COPD (Chronic Obstructive Pulmonary Disease) is a chronic slowly progressive disorder, characterised by airflow obstruction, which does not change markedly over several months. The impairment in lung function is largely fixed, but may be partially reversible by bronchodilators or other therapy. Most cases are caused by tobacco smoking, though lifelong non-smokers may develop COPD probably related to occupation. COPD is now the preferred term for patients previously diagnosed as having chronic bronchitis and emphysema. Diagnosis History of chronic progressive symptoms (cough, wheeze, breathlessness). Cigarette smoking history (usually) of more than 20 pack years (20 cigs a day for one year = 1 pack year) Objective evidence of airflow obstruction that does not return to normal with treatment is vital. There is no simple diagnostic test for COPD. Making a diagnosis relies on clinical judgement based on a combination of history, physical examination and confirmation of the presence of airflow obstruction using spirometry. Lung function: must be measured with a spirometer (See Appendix 1). Assessment of severity may help to guide treatment decisions and relates to prognosis. TREATMENT All patients: smoking cessation, patient information and self management plan, exercise, nutrition, vaccination. Pulmonary rehabilitation should be considered for all. Treatment by disease stage: (stages based on post-bronchodilator FEV1) Gradation of severity of airflow obstruction Postbronchodilator FEV 1 /FVC FEV 1 % predicted NICE clinical guideline 12 (2004) ATS/ERS GOLD Severity of airflow obstruction NICE clinical guideline 101 (2010) Postbronchodilator Postbronchodilator Postbronchodilator < % Mild Stage 1 Mild Stage 1 Mild* < % Mild Moderate Stage 2 Moderate Stage 2 Moderate < % Moderate Severe Stage 3 Severe Stage 3 Severe < 0.7 < 30% Severe Very severe Stage 4 Very severe** Stage 4 Very severe** *Symptoms should be present to diagnose COPD in people with mild airflow obstruction (see recommendation ). **Or FEV 1 < 50% with respiratory failure. 1 Celli BR, MacNee W (2004) Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. European Respiratory Journal 23(6): Global Initiative for Chronic Obstructive Lung Disease (GOLD). (2008). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Page 3 of 21

4 Algorithm 1: Diagnosing COPD Algorithm 1: Diagnosing COPD Definition of chronic obstructive pulmonary disease (COPD) COPD is characterised by airflow obstruction. The airflow obstruction is usually progressive, not fully reversible and does not change markedly over several months. The disease is predominantly caused by smoking. Think of the diagnosis of COPD for patients who are over 35 smokers or ex-smokers have any of these symptoms: - exertional breathlessness - chronic cough - regular sputum production -frequent winter bronchitis - wheeze and have no clinical features of asthma (See box Clinical features differentiated COPD and asthma below) Perform spirometry if COPD seems likely Airflow obstruction is defined as post-bronchodilator: FEV 1/FVC < 0.7 Spirometric reversibility testing is not usually necessary as part of the diagnostic process or to plan initial therapy If still doubt about diagnosis consider the following pointers Asthma may be present if: - there is a > 400 ml response to bronchodilators - serial peak flow measurements show significant diurnal or day-to-day variability - there is a > 400 ml response to 30 mg prednisolone daily for 2 weeks Clinically significant COPD is not present if FEV 1 and FEV 1/FVC ratio return to normal with drug therapy Refer for more detailed investigations if needed (see section 6.6 of the full guideline) If still in doubt, make a provisional diagnosis and start empirical treatment If in no doubt diagnose COPD and start treatment Reassess diagnosis in view of response to treatment Clinical features differentiating COPD and asthma COPD Asthma Smoker or ex-smoker Nearly all Possibly Symptoms under age 35 Rare Often Chronic productive cough Common Uncommon Breathlessness Persistent and progressive Variable Night- time waking with breathlessness and or wheeze Uncommon Common Significant diurnal or day-to-day variability of symptoms Uncommon Common Page 4 of 21

5 Reversibility testing In most patients, routine spirometric reversibility testing is not necessary as a part of the diagnostic process or to plan initial therapy with bronchodilators or corticosteroids. It may be unhelpful or misleading because: - repeated FEV 1 measurements can show small spontaneous fluctuations - the results of a reversibility test performed on different occasions can be inconsistent and not reproducible - over-reliance on a single reversibility test may be misleading unless the change in FEV 1 is greater than 400 ml - the definition of the magnitude of a significant change is purely arbitrary - response to long-term therapy is not predicted by acute reversibility testing To help resolve cases where diagnostic doubt remains, or both COPD and asthma are present, the following findings should be used to help identify asthma: - a large (greater than 400 ml) response to 400mcg salbutamol via a large volume spacer (FEV 1 15 minutes before and after) - a large (greater than 400 ml) response to 30 mg oral prednisolone daily for 2 weeks (although there is no evidence that a response to oral corticosteroids predicts long term benefit from inhaled corticosteroid in COPD) - serial peak flow measurements showing 20% or greater diurnal or day-to-day variability Clinically significant COPD is not present if the FEV 1 and FEV 1 /FVC ratio return to normal with drug therapy. Ongoing Treatment of stable COPD All patients should have the following general measures considered: 1. Smoking Cessation. All patients still smoking must be given advice on the benefits of stopping, together with the Derbyshire Helpline Number (for Fresh Start in Derby City the number is or ). Referral can be made online at Appropriate counselling must be offered alongside smoking cessation therapies. 2. Patient information and self management plan should be offered to assist patients in self care. 3. Advice and support re nutrition and weight management. 4. Advice and support re appropriate activity/exercise. 5. Flu vaccination yearly in the autumn. 6. Pneumococcal vaccination once. 7. Pulmonary Rehabilitation should be offered to appropriate patients. See Appendix 2 At all stages patients must be taught how and when to use their treatments, and it is vital to check and ensure inhaler technique is adequate. There should be a review of treatments being prescribed for other conditions. Avoid noncardioselective beta-blockers. Cardioselective beta-blockers may be tried in those who have a clear indication for a beta-blocker e.g. post myocardial infarction or left ventricular systolic dysfunction. NB beta-blocker containing eye drops may have systemic effects. Page 5 of 21

6 Refer to specialist clinic for diagnosis or investigation if: Reason Purpose Appropriate person There is diagnostic uncertainty Confirm diagnosis and optimise therapy Respiratory physician Suspected severe COPD Confirm diagnosis and optimise therapy Respiratory physician The patient requests a second Confirm diagnosis and optimise therapy Respiratory physician opinion Onset of cor pulmonale Confirm diagnosis and optimise therapy Respiratory physician Assessment for oxygen therapy Optimise therapy and measure blood gases Oxygen Assessment Service Assessment for long-term nebuliser therapy Optimise therapy and exclude inappropriate prescriptions Community Respiratory Team Assessment of oral maintenance Justify need for long-term treatment or Respiratory physician corticosteroid therapy supervise withdrawal Bullous lung disease Identify candidates for surgery Respiratory physician A rapid decline in FEV 1 Encourage early intervention Respiratory physician Assessment for pulmonary rehabilitation Identify candidates for pulmonary rehabilitation Community Respiratory Team or hospital Assessment for lung volume Identify candidates for surgery Respiratory physician reduction surgery Assessment for lung Identify candidates for surgery Respiratory physician transplantation Dysfunctional breathing Onset of symptoms under 40years or a family history of alpha-1 antitrypsin deficiency Confirm diagnosis, optimise pharmacotherapy and access other therapists Identify alpha-1 antitrypsin deficiency, consider therapy and screen family Respiratory physician Respiratory physician Uncertain diagnosis Make a diagnosis Respiratory physician Symptoms disproportionate to Look for other explanations Respiratory physician lung function deficit Frequent infections Exclude bronchiectasis Respiratory physician Haemoptysis Exclude carcinoma of the bronchus Respiratory physician Contact details for Community Respiratory Team: North Derbyshire Dena Ediker & Anil Ramineni, Clinical Specialist Physiotherapists: Simone Hodgson, Marion Gibson & Sarah Middleton, Respiratory Nurse Practitioners: Southern Derbyshire and Derby City Adult Respiratory Team (ART) comprises COPD Nurses and respiratory physiotherapists. Bases: Coleman Health Centre, Option 1. Royal Derby Hospital, Please NOTE ART team physiotherapy provision to Southern Derbyshire is for specialist advice only using the criteria below. Other patients should be referred to community physiotherapy. Criteria for Referral to Specialist Respiratory Physiotherapy Those with more than one respiratory diagnosis e.g. COPD, bronchiectasis, Interstitial Lung Disease (ILD) Page 6 of 21

7 Those patient's being worked up for Lung Volume Reduction Surgery (LVRS) /Lung transplant Patient's with a diagnosis of bronchiectasis on prophylactic antibiotics e.g. colomycin, azithromycin Patient's with a chronic respiratory diagnosis with Allergic Broncho Pulmonary Aspergillosis (ABPA) or asthma element Interstitial Lung Disease (ILD) patient's with rapidly declining oxygen sats despite being known to the home oxygen service Patient's with a known respiratory diagnosis (under resp consultant) with persistent chronic cough, despite chest physiotherapy Motor Neurone Disease (MND) patients for timely prophylactic management (MND pathway work under current development) Neuromuscular patients with respiratory compromise who are deteriorating despite receiving chest physiotherapy Patient's with a known respiratory diagnosis with a tracheostomy in situ who need help/advice with chest clearance Treatment by disease stage: If patients report a marked improvement in symptoms in response to inhaled therapy, the diagnosis of COPD should be reconsidered. To assess the effectiveness of COPD treatments, use improvements in symptoms, activities of daily living, exercise capacity and rapidity of symptom relief, in addition to lung function tests. These 5 simple questions have been recommended to assess the effectiveness of treatment (Thorax 2001, 56: 880-7): 1. Has your treatment made a difference to you? 2. Is your breathing easier in any way? 3. Can you do some things now that you couldn t do at all before, or do the same things but faster? 4. Can you do the same things as before but are now less breathless when you do them? 5. Has your sleep improved? Ask the patient to give examples. Inhaled Corticosteroids Oral corticosteroid reversibility tests do not predict response to inhaled corticosteroid therapy and should not be used to identify which patients should be prescribed inhaled corticosteroids. Be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with high dose (particularly at the 2000 microgram dose) inhaled corticosteroids and be prepared to discuss with patients. The doses of inhaled corticosteroids used in clinical trials are in the range micrograms of beclometasone CFC-containing equivalent per day. This is best delivered via a large volume spacer. Mucolytic Therapy see Appendix 6 Mucolytic drug therapy should be considered in patients with a chronic cough productive of sputum. Mucolytic therapy should be continued if there is symptomatic improvement (for example, reduction in frequency of cough and sputum production). Do not routinely use mucolytic drugs to prevent exacerbations in people with stable COPD but can be considered instead of inhaled corticosteroids. TREATMENT OF EXACERBATIONS An exacerbation is a sustained worsening of the patient s symptoms from their usual stable state, which is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication. Page 7 of 21

8 1. Increase bronchodilator therapy 2. Give short course of oral prednisolone 30mgs OD for 7-14 days if significant increase in breathlessness which interferes with daily activities. 3. Prescribe a 5-day course of doxycycline 200mg stat then 100mg daily (amoxicillin 500mg tds if a tetracycline not suitable). Treat exacerbations promptly with antibiotics if purulent sputum and increased shortness of breath and/or increased sputum volume. Patients with exacerbations without more purulent sputum do not need antibiotic therapy unless there is consolidation on a chest radiograph or clinical signs of pneumonia. Send sputum for culture if no response to empirical treatment. 4. Consider prescribing a rescue course of prednisolone for appropriate patients to keep at home for self initiation in conjunction with COPD Self Management Plan. Prednisolone 30mg (6x5mg plain tablets) once daily for one week, plus Doxycycline 200mg for 1st day then 100mg daily (total 5 day course) or Amoxicillin 500mg three times daily for 5 days are suggested regimes. Factors that should be used to assess the need to treat patients in hospital Factors to consider when deciding where to manage patient Factor Favours treatment in hospital Favours treatment at home Able to cope at home No Yes Breathlessness Severe Mild General condition Poor/deteriorating Good Level of activity Poor/confined to bed Good Cyanosis Yes No Worsening peripheral oedema Yes No Level of consciousness Impaired Normal Already receiving LTOT Yes No Social circumstances Living alone/not coping Good Acute confusion Yes No Rapid rate of onset Yes No Significant comorbidity Yes No (particularly cardiac disease and insulin-dependent diabetes) SaO 2 <90% Yes No Changes on the chest radiograph Present No Arterial ph level <7.35 >7.35 Arterial PaO 2 <7 kpa >7 kpa Page 8 of 21

9 Appendix 1 Spirometry Spirometry is essential for making a correct diagnosis and determining the severity of COPD in conjunction with a detailed history and examination and should never be used solely in determining diagnosis. Spirometry is a reliable and effective tool if used correctly. The spirometer should be accurate, reliable and produce a hard copy of the graph with a volume/time plot. It should also include the following readings: Slow vital capacity (VC), Forced vital capacity (FVC), Forced vital capacity in one second (FEV1) and FEV1/FVC ratio (FEV1%). This is mandatory to meet specifications within the COPD guidelines for the management of the disease. Other aspects which need to be taken into consideration are user friendliness and portability. You may also wish to consider a memory facility to store traces. Many electronic spirometers also display a flow volume curve. You do not need this information to calculate FEV 1 and FVC values. However as you become more experienced you may want to have this facility. Training Training is important for health professionals responsible for performing spirometry. At least one member of staff from each practice should attend an accredited course which includes professional tuition on the practical application of spirometry and the correct interpretation of the results. Health care professionals who perform spirometry should have completed an approved competency based training course in spirometry and will be expected to keep their skills up to date. Training courses available are as follows: Association for Respiratory Technology and Physiology [ARTP] - Two day certificate courses on COPD and Spirometry Education for Health - A range of one day workshops to identify learning needs and four to six month distance learning degree course. Spirometry workshop for HCAs. Respiratory Education UK - One day workshops and 2 day diploma courses The following organisations provide training in the use of spirometers. ARTP/BTS certificate in spirometry The ARTP/BTS Consortium, c/o Dr SL Hill, Honorary Chairman ARTP/BTS Liaison Committee, Lung investigation Unit, The Queen Elizabeth Hospital, Edgbaston, Birmingham B15 2TH. Telephone Fax Education for Health, The Athenaeum, 10 Church Street, Warwick CV34 4AB Tel: Fax: North Nottingham Respiratory Education Centre, The Kings Mill Centre, Mansfield Road, Sutton-in- Ashfield, Nottinghamshire NG17 4JL Tel: Fax: Respiratory Education UK, University Hospital Aintree, Lower Lane, Liverpool L9 7AL Tel: Fax: For further advice locally contact: North Derbyshire - Community Respiratory Team on Southern Derbyshire & Derby City - ART Team at Coleman Street of Option 1 or Royal Derby Hospital on Page 9 of 21

10 Appendix 2 Pulmonary Rehabilitation Pulmonary rehabilitation has been carefully evaluated in a large number of clinical trials, and there is now Grade A evidence to support its use (1,2). Pulmonary rehabilitation should be made available to all appropriate people with COPD (5) including those who have had a recent hospitalisation for an acute exacerbation (8). Patients with COPD at all stages of disease seem to benefit from exercise training programmes. Although most patients benefit from Pulmonary Rehabilitation, there remain some patients for whom effects are less substantial. There is a suggestion that responders to pulmonary rehabilitation would score 3 or 4 using the Medical Research Council (MRC) Dyspnoea score (6). (See MRC dyspnoea scale below). The introduction of rehabilitation becomes appropriate when patients become aware of their disability. Patients improve with respect to both exercise tolerance and symptoms of dyspnoea and fatigue (3). Data suggests that these benefits can be sustained even after a single pulmonary rehabilitation programme (4), and although benefit does wane after a rehabilitation programme ends if exercise training is maintained at home, the patient s health status remains above pre rehabilitation levels. Pulmonary rehabilitation has also been shown to be cost effective in reducing use of health services. It has been shown in several non randomised and observational studies that there is a trend towards a decrease in the total number of hospitalisation days as well as the total number of hospitalisations required for a patient with COPD in the years following the completion of a comprehensive pulmonary rehabilitation programme compared to the year preceding rehabilitation (5). An RCT published in May 2010 shows that pulmonary rehabilitation provided to patients post hospital discharge: Reduced proportion of patients who experienced an exacerbation which resulted in an unplanned hospital attendance (which was either an attendance at A&E or a readmission to hospital) over the subsequent 3 month period from 57% to 27% Reduced the proportion of patients readmitted to hospital within 3 months from 33% to 7% (8). Pulmonary rehabilitation programmes should include multi-component, multidisciplinary interventions, which are tailored to the individual patient s needs. The rehabilitation process should incorporate a programme of physical training, disease education, nutritional, psychological and behavioural intervention (5). A distinction should be drawn between encouragement to the individual to remain active and the deliberate supervised therapeutic process of restoring function through the process of formal rehabilitation. This distinction is important to ensure that proper emphasis is placed upon the restorative nature of the rehabilitation programme rather than the maintenance health benefits of regular exercise (7). References 1. British Thoracic Society (2001) Pulmonary Rehabilitation: Statement Thorax 56: Pauwels R.A., Buist S., Calverley P.M.A, Jenkins C.R., Hurd S.S. (2001) NHLBI/WHO Workshop Summary: Global strategy for the diagnosis, management and prevention of COPD (GOLD) Am J Respir Crit Care Med 163: Berry M.J., Rejeski W.J., Adair N.E., Zaccaro D., (1999) Exercise Rehabilitation and COPD stage Am J Respir Crit Care Med 160: Griffiths T.L., Burr M.L., Campbell I.A., (2000) Results at one year of outpatient multidisciplinary pulmonary rehabilitation: a randomised controlled trial Lancet 355: National Clinical Guideline Centre. (2010) Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care. London: National Clinical Guideline Centre. Available from: 6. Wedzicha J.A., Bestall J.C., Garrod R., Garnham R., Paul E.A., Jones P.W. (1998) Randomised controlled trial of pulmonary rehabilitation in severe chronic obstructive pulmonary disease patients, stratified with the MRC dyspnoea scale. European Respiratory Journal 12: IMPRESS February Seymour et al (2010). Outpatient pulmonary rehabilitation following acute exacerbation of COPD. Thorax 65: Page 10 of 21

11 MRC dyspnoea scale Grade Degree of breathlessness related to activity 1 Not troubled by breathlessness except on strenuous exercise 2 Short of breath when hurrying or walking up a slight hill 3 Walks slower that contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace 4 Stops for breath after walking about 100 m or after a few minutes on level ground 5 Too breathless to leave the house, or breathless when dressing or undressing Adapted from Fletcher C.M., Elmes P.C., Fairbairn M.B. et al (1959). The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population British Medical Journal 2: Page 11 of 21

12 Appendix 3 - Patient Information Living with COPD Patient Information and Self Care Diary The Living with COPD Patient Information and Self Care Diary is for people affected by COPD. It aims to help and support people in self monitoring, behaviour change and lifestyle modification. The information covers a range of topics from a description of the condition and how it is diagnosed along with what medication may be prescribed and the benefits. Along side this there are also sections which include lifestyle information such as diet, exercise and smoking, clinical information which is to be completed by the health care professionals involved in the patients care along with a respiratory action plan. The respiratory action plan aims to help people to monitor and manage their condition by dividing their symptoms into green, amber and red management zones. Under each coloured zone it details the general symptoms and action to take and then there is space for this to be personalised by the health care professional for the patient. COPD Self Care Diaries are available to order through Derwent Shared Services Logistics Department. Order forms for the Self Care Diaries are available from the Community Specialist Respiratory Teams in North Derbyshire and Southern Derbyshire. COPD Information Prescription The COPD Information Prescription is a free directory which includes details of useful sources of information on COPD and practical lifestyle management. The directories work like a yellow pages in that they signpost people to resources, leaflets, websites, telephone numbers, support groups and organisations that may be able to provide support. They offer patients and carers with a choice of information at a time that is right for them, at the point of diagnosis and beyond. The Information Prescription is divided into five key sections which includes information about: Prevention e.g. risk factors of COPD Diagnosis e.g. tests to help diagnose COPD Treatment and follow up care such e.g. pulmonary rehabilitation Living with a long term condition e.g. support groups and travel Practical information such as carers and financial support Information prescriptions are available at: NHS Derbyshire County - or for patients to request copies via PALS on NHS Derby City - or to request copies or assistance PALS on National Information Prescriptions are also available at NHS Choices - Page 12 of 21

13 Appendix 4 Theophylline Prescribing and Monitoring Start with mg of a modified release preparation. Titrate dose to the minimum that achieves desired therapeutic response. Discontinue if little benefit is seen or side effects limit dose increases. Monitoring Theophylline levels: There are no national guidelines - be guided by side effects and clinical response. Only 50% of patients will tolerate the quoted therapeutic range of 10-20mg/l, however many patients will benefit below this range. Consider an annual plasma level and check more frequently when starting regular medication that has the potential to interact and in disease states that alter theophylline clearance (see below). Blood samples should be taken at least 48 hours after initiating therapy or changing dose. Disease States Affecting Theophylline Clearance: Smokers - may require higher doses. Chronic alcoholism variable effect Start with half the usual dose in the following: Congestive heart failure Acute pulmonary oedema Severe COPD Hepatic cirrhosis Common Drug Interactions: Any changes in plasma levels are likely to occur between 48 hours and 5 days after initiating the interacting drug. Ciprofloxacin and Quinolones: Avoid concurrent use with theophylline if possible, as these drugs double the serum level of theophylline. There have been isolated reports of seizures and deaths through this drug interaction therefore avoid in epileptics. If a quinolone is essential the maintenance theophylline dose should be halved during and 48 hours post quinolone treatment. Erythromycin and Macrolides: Erythromycin is a poor choice of antibiotic for exacerbations of COPD use amoxicillin or a tetracycline. If concurrent treatment is essential halve the theophylline dose during and 48 hours after treatment. Similar interactions have been reported with other macroides. Cimetidine Halve the theophylline dose when using cimetidine and measure theophylline level after 5 days. Page 13 of 21

14 Appendix 5 Oxygen therapy In general oxygen therapy should only be given to patients who have proven hypoxaemia (SaO2 <92%, PaO2 <7.3 kpa). Record oxygen saturation on all patients with moderate to severe COPD. Oxygen saturation should be recorded after 10 minutes of rest and not during or after exertion unless assessing for ambulatory oxygen. FEV1 < 50% of predicted record oxygen saturation annually FEV1 < 30% of predicted, record oxygen saturation every 6 months Oxygen saturation 93-94% check every 3 months Oxygen saturation < 92% check after 2 weeks Patients with COPD (and other at-risk conditions) who have had an episode of hypercapnic respiratory failure should be issued with an oxygen alert card and with a 24% or 28% Venturi mask. They should be instructed to show the card to the ambulance crew and emergency department staff in the event of an exacerbation Long Term Oxygen Therapy (LTOT) If oxygen saturation <92% on 2 occasions (2-3 weeks apart), refer to Oxygen assessment service for LTOT assessment Before referral for home oxygen assessment ensure that the patient is on maximal therapy as per the Derbyshire COPD guideline, is compliant with treatment, and ideally has stopped smoking (attempts must have be made). LTOT assessment consists of arterial blood gas analysis on air on 2 separate occasions at least 3 weeks apart. All assessments must be performed when patient is in a stable condition i.e. not less than 1 month after an exacerbation, unless exacerbating too frequently to allow stable assessment. Indications for referral for oxygen assessment Oxygen saturation <92% breathing air at rest, or Raised JVP or peripheral oedema due to right heart failure, or Polycythaemia thought to be secondary to hypoxia, or Cor pulmonale on echocardiogram or ECG Short Burst Oxygen There is no evidence that short burst oxygen improves quality of life in COPD patients or that it reduces use of health care resources. It should therefore only be considered for palliative use in patients nearing end of life. Before considering short burst oxygen, optimise drug therapy and implement other methods of relieving dyspnoea i.e. positioning, use of a fan, and breathing control techniques. In addition evaluate if tricyclic antidepressant, benzodiazepines and opiate therapy are appropriate Page 14 of 21

15 Ambulatory oxygen therapy In some circumstances a few patients may benefit from ambulatory oxygen therapy. If the patient has oxygen saturation of >93% at rest but there is a fall in oxygen saturation of >4% to a value of less than 90% on exertion, refer to secondary care for ambulatory oxygen assessment. Oxygen Assessment Services can be contacted North Derbyshire - Steven Collis Fax Southern Derbyshire - Sue Smith The British Thoracic Oxygen Alert Card can be found on the BTS website Example of the card. Page 15 of 21

16 Appendix 6 Mucolytic therapy in patients with diagnosed COPD and troublesome cough and sputum NOT on Inhaled corticosteroids Adult, with diagnosed COPD and persistent troublesome cough and sputum Initial assessment: Exclude differential diagnoses Establish chronic, stable cough and thick, tenacious sputum Patient perceives problem, and is willing to try drug treatment Seasonal symptoms, infrequent exacerbations Seasonal symptoms, frequent exacerbations Year-round symptoms + frequent exacerbations Trial of mucolytic at initial fixed dose Trial of mucolytic at initial fixed dose Trial of mucolytic at initial fixed dose 1-month review 1-month review 1-month review Improvement in symptoms, no unacceptable side effects and patient willing to continue? Yes Continue at fixed dose for duration of troublesome period No unacceptable side effects and patient willing to continue + improvement in symptoms? No Stop treatment No Improvement in symptoms, no unacceptable side effects and patient willing to continue? Yes Continue long-term at minimum dose required for symptom control Repeat annually as acceptable to patient Annual review Taken from: Rudolf M et al. Mucolytic therapy in patients with diagnosed COPD Page 16 of 21

17 Appendix 7 Page 17 of 21

18 Measurements / basic data FEV 1 absolute & % predicted Usual loss 40ml / year BMI <20 increased mortality nutritional advice >35 Consider also sleep apnoea O 2 saturation <92% refer O 2 assessment Exacerbation Frequency Frequent exacerbators need a treatment and diagnostic review. MRC dysnoea score Score of 3,4,5 refer to pulmonary rehabilitation Smoking? Advice to stop and active referral to smoking cessation services Frequent exacerbators Check for co morbidities Cardiac failure / IHD Consider beta blockers in this case as they reduce death rates by 30% in COPD Consider unusual organism: Check for Acid-Fast Bacillius (AFB), Pseudomonas Consider wrong diagnosis? FEV 1 / FVC <70% Bronchiectasis Cardiac failure Consider adherence to therapy Check inhaler technique Is the treatment working? 1. Has your treatment made a difference to you? 2. Is your breathing easier? If there is no benefit from a new treatment it should be stopped. If the treatment is not working Review the diagnosis FEV 1 / FVC ratio: <70% obstructive >80% restrictive Prescribing notes NICE guidance 2010 and Cochrane database 2010 Long acting beta agonists (LABA) e.g. formoterol or salmeterol, compared with long acting muscarinic antagonist (LAMA) e.g.tiotropium NICE proposes no significant difference between these classes with regard to exacerbations or hospitalisations. However JAPC reflected on this guidance and trial data and concluded that LAMAs are the preferred option in exacerbations and LABAs for symptom control. MHRA November 2010 advises that Spiriva Respimat should be used with caution in patients with known cardiac rhythm disorders. Triple therapy (LABA +LAMA + ICS) Triple therapy for exceptional use only Undertake diagnostic review before commencing triple therapy It remains unclear whether there is benefit from using triple combination of two long acting bronchodilators and corticosteroid. Use only in severe disease in the presence of persistent exacerbations despite other treatment. (NICE 2010) If no clinical benefit after 2 months STOP one of the drugs. Side effects Be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with high dose (particularly at the 2000 microgram beclomethasone or equivalent dose) inhaled corticosteroids and be prepared to discuss with patients Mucolytics Mucolytic drug therapy should be considered in patients with a chronic cough productive of sputum Mucolytic therapy should be continued if there is symptomatic improvement (for example, reduction in frequency of cough and sputum production) Do not routinely use mucolytics to prevent exacerbations in people with stable COPD but they can be considered instead of inhaled corticosteroids Theophylline Offer only after inhaler therapy has been optimised Rationale for fostair dosage Page 18 of 21 Usual doses: Symbicort 400/12 one puff twice daily (licensed) therefor First produced equivalent - May 2008 Fostair Updated 100/6 two July puffs 2011 twice Next daily review (unlicensed date June 2013 use)

19 Appendix 8 Appendix 8 Management of stable COPD Page 19 of 21

20 Appendix 9 Cost of inhaled drugs in COPD for 12 months (July 2010) Fostair 200/12 bd 351 Seretide 50/500 bd 490 Symbicort 12/400 bd 456 Salmeterol 50 mcg bd 350 Formoterol 12mcg bd - Easyhaler Atimos Modulite Turbohaler 298 Tiotropium - HandiHaler 18mcg od Respimat 5mcg od 435 Beclometasone 1500mcg od (Clenil) 178 Budesonide 400mcg bd - Easyhaler Turbohaler 202 Fluticasone 500mcg bd 435 Combinations of inhalers Tiotropium HH + Clenil Modulite 561 Tiotropium HH + Budesonide Easyhaler 513 Tiotropium HH + Fluticasone 818

21 Formoterol + Budesonide Easyhalers 275 Triple therapy Tiotropium HH + Seretide 873 Tiotropium HH + Symbicort 839 Tiotropium HH + Formoterol Easyhaler + Budesonide Easyhaler 658