COPD Prescribing Guidelines
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1 Cannock Chase Clinical Commissioning Group South East Staffordshire and Seisdon Peninsula Clinical Commissioning Group Stafford and Surrounds Clinical Commissioning Group East Staffordshire Clinical Commissioning Group South Staffordshire Area Prescribing Group COPD Prescribing Guidelines Inhaler choices in this guideline are different from previous versions produced by the APG. It is not expected patients controlled on established therapy will be changed without clinical assessment. All NEW patients should be initiated on inhaler therapy as per these guidelines. South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Approved August 2017 Written by MMSESSP (2015), updated 2017 Review August 2018
2 COPD Prescribing Guidelines This guideline is intended for use to aid diagnosis in patients with a suspected diagnosis of a COPD, and the management of patients with a confirmed diagnosis of COPD. It is aimed primarily at cost-effective prescribing, and will be reviewed annually as evidence is rapidly emerging in this field Diagnosis 1. Consider COPD if: Any of the following indicators are present in an individual over 35 years old. Dyspnoea that is - Progressive - Characteristically worse with exercise - Persistent. Recurrent wheeze Chronic cough may be intermittent, and/or unproductive Chronic sputum production - any pattern of chronic sputum production may indicate COPD History of exposure to risk factors and host factors - tobacco smoke/smoke from cooking and heating fuels occupational dusts and chemicals - family history of COPD and/or childhood factors Recurrent lower respiratory tract infections AND do not have clinical features of Asthma: Chronic unproductive cough Significantly variable breathlessness Night-time wakening with breathlessness and/or wheeze Significant diurnal or day-to-day variability of symptoms The presence of multiple key indicators increases the probability of diagnosis of COPD. 2. Required tests: FBC Chest X-ray Spirometry (note, hand-held spirometers MUST NOT be used for diagnosis but can be used for monitoring or screening) 1. Diagnosis of COPD if post bronchodilator spirometry demonstrates: FEV 1 /FVC <70% Quality assessment 3 blows with FEV 1 values within 100ml of one another FVC obtained after blowing out 6 seconds Is it airflow obstruction? FEV 1 / FVC <0.7 FEV 1 3. Interpreting Spirometry Severity assessment Make sure it isn t asthma > 80% Mild = GOLD stage 1 Check reversibility to salbutamol 50-80% 30-50% < 30% Moderate= GOLD 2 Severe -= GOLD 3 Very Severe= GOLD 4 (>200ml consider asthma). Consider any other clinical signs or symptoms of asthma. COPD is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow obstruction that is due to airway and/or alveolar abnormalities. The disease is predominately caused by smoking but other environmental exposures may contribute. 2, 3 South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 1
3 COPD Prescribing Guidelines Possible Alternative Diagnosis Asthma Congestive Heart Failure Bronchiectasis Tuberculosis Lung Cancer (Chest X Ray- If 3 week history of cough and /or increasing breathlessness) Management of Stable COPD Re-assess historic diagnosis of COPD and make sure it was confirmed by spirometry A patient s needs change over time according to the progression of COPD, hence regularly review disease severity and effectiveness of current regimen and accordingly modify the treatment 2 Monitor disease progression at least annually: FEV1, symptoms (mmrc & CAT), document exacerbations ( frequency, severity, type, likely cause, sputum volume & purulence) and smoking status1 Check inhaler technique and compliance to treatment regimen regularly. Encourage all patients to stop smoking - beneficial at all ages. Offer annual influenza vaccinations and one-off pneumococcal vaccination. Pulmonary rehabilitation improves symptoms, quality of life, physical and emotional state. Refer to pulmonary rehabilitation when mmrc score is 2 (or for GOLD classification B-D). Promote use of individualised self-management plan and rescue packs. Template of self-management plan can be found on net.formulary. Screen for common comorbidities e.g. lung cancer (2-4 times more common), IHD, heart failure, arrhythmias, hypertension, CVA, peripheral vascular disease, depression, anxiety, diabetes/metabolic syndrome, bronchiectasis, sleep apnoea, anaemia, osteoporosis, malnutrition/obesity, GORD. 2 Consider referral to local services as appropriate e.g. community respiratory team/consultant led respiratory clinic, physiotherapists, dietician (follow current malnutrition guidelines if BMI/MUST score is low or high respectively), occupational therapy, social services, and palliative care teams. Where medication is initiated for persistent breathlessness, monitor and discontinue if no improvement. Refer for oxygen assessment, following local pathways, when stable O2 saturations (not on exertion) are less than or equal to 92% breathing air. A palliative care approach should be taken for end-of-life COPD patients. Main treatment goals should be symptom reduction and management of future risk of exacerbations. Referral to palliative care teams should be considered. South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 2
4 Assessment of COPD using GOLD Classification COPD Prescribing Guidelines STEP 1: Assess symptoms COPD Assessment Test (CAT) [Link for CAT-test Online] is a patient-completed instrument that is a comprehensive measure of symptoms and complements existing approaches to assessing COPD. Determine whether patient has less symptoms (<10) or more symptoms (>10) if using CAT scale. Assess mmrc (modified Medical Research Council Questionnaire) providing an assessment of impact of dyspnoea. Determine if the patient is less breathlessness (0-1) or more breathlessness ( 2). [Link for mmrc score] CAT and mmrc tools can be found in appendix 1. STEP 2: Assess risk of exacerbations by the following method: Assess the number of exacerbations the patient has had within the previous 12 months Determine whether the patient has had one or more hospitalisation in the previous year for a COPD exacerbation Determine Gold Classification and treatment according to Table 1 GOLD Classification attempts to class patients based on their risks of exacerbation. South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 3
5 London respiratory team COPD value COPD Prescribing Guidelines The COPD value pyramid (developed by the London Respiratory Network with The London School of Economics and reproduced with permission from the London Respiratory Team report 2013). This 'value' pyramid reflects what we currently know about the cost per QALY of some of the commonest interventions in COPD. It was devised as a tool for health care organisations to use to promote audit and to ensure adequate commissioning of nonpharmacological interventions. [QALY= quality-adjusted life year] South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 4
6 Risk Assessment COPD Prescribing Guidelines Table 1: Gold Classification & Respective Drug Treatment Patients can start in any classification and can migrate between groups, therefore regular assessment is essential Short-acting beta-agonist bronchodilators should continue as required for all patients. (See Appendix 2 for in list of inhaler brands, dosing, costs & images) Symptom Assessment (Use highest result to guide classification) Exacerbation history CAT <10 mmrc 0-1 CAT 10 mmrc 2 Group C Group D 2 OR 1 leading to a hospital admission LAMA If further exacerbations: LAMA + LABA (alternative option: LAMA + ICS) LAMA + LABA If further exacerbations: LAMA + LABA + ICS (alternative 2 nd line option: LABA + ICS) If further exacerbations with LAMA/LABA/ICS seek specialist opinion. Group A Group B 0 OR 1 (not leading to hospital admission) Bronchodilator (SAMA or LAMA) Evaluate effect: continue, stop or try alternative class of bronchodilator A long-acting bronchodilator (LABA or LAMA) If persistent symptoms: LAMA + LABA Inhaler choices for management of stable patients try to maintain device consistency if possible Inhaler type LABA LAMA LABA/LAMA LABA/ICS MDI Formoterol Easyhaler 12mcg Fostair MDI 6/100mcg Breezhaler Onbrez Breezhaler 150mcg Seebri Breezhaler 44mcg Ultibro Breezhaler 85/43mcg Respimat Sprivia Respimat 2.5mcg Spiolto Respimat 2.5/2.5mcg Ellipta Incruse Ellipta 55mcg Anoro Ellipta 22/55mcg Relvar Ellipta 22/92mcg Genuair Eklira Genuair 322mcg Duaklir Genuair 12/340mcg Other DPI Fostair NEXThaler 6/100mcg DuoResp Spiromax 9/320mcg South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 5
7 Treatment algorithms according to GOLD ABCD grade 2 COPD Prescribing Guidelines Notes: 1. Trial of Roflumilast & Macrolide should only be initiated by respiratory specialist. Roflumilast is now recommended by NICE however locally prescribing should remain within secondary care. 2. Theophylline may be considered to be used as an additional bronchodilator and it needs to monitored as per the BNF. South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 6
8 COPD Prescribing Guidelines Managing COPD Exacerbations Considerations: (circle as appropriate) Favours specialist treatment 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 LTOT currently received: Yes No Social circumstances: Living alone / not coping Good Acute confusion: Yes No Rapid rate of onset: Yes No Significant morbidity: Yes No SaO 2 <90%: Yes No Decide where to treat: Hospital Home Referral to community respiratory clinic/secondary care should be considered for: Diagnostic uncertainty Uncontrolled COPD Patient wants a second opinion Bullous lung disease Assessment for pulmonary rehabilitation or lung transplantation Dysfunctional breathing Onset of symptoms under 40 years or a family history of alpha 1- antitrypsin deficiency Assessment for oxygen therapy, long-term nebuliser therapy or oral corticosteroid therapy Onset of cor pulmonale Symptoms disproportionate to lung function deficit Frequent infections Haemoptysis (2 week wait) Rapid decline in FEV 1 South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 7
9 COPD Prescribing Guidelines ACUTE MANAGEMENT (at home) Optimise inhalation treatment - Increase SABA to 2-8 puffs up to 4 hourly (watch for side effects e.g. tremor) Steroids 1st line antibiotic - Prednisolone 40mg for 5 days then stop - Doxycycline 200mg day 1 then 100mg for further 4 days 2nd line antibiotic - Clarithromycin tablets 500mg every 12 hours for 5 days or amoxicillin 500mg every 8 hours for 5 days (If clarithromycin prescribed consider drug interactions concurrent statin to be stopped or dose reduced and halve theophylline if taking. If no improvement at one week or deterioration in symptoms, clinician to consider referral or advice from community COPD consultant / team. PREVENTION OF FUTURE EXACERBATIONS Refer to pulmonary rehabilitation Optimise inhaled therapy in line with GOLD standards (as above) Carbocisteine - If 2 or more exacerbations in the last 12 months, consider adding in carbocisteine 750mg three times a day (once symptoms improve maintenance dose of 750mg twice should be continued) especially if chronic productive cough - Review on-going need/ benefit and stop if ineffective after 4 6 weeks of treatment South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 8
10 COPD Prescribing Guidelines References: 1. Rytila P, Helin T, Kinnula V. The use of microspirometry in detecting lowered FEV1 values in current or former cigarette smokers. Primary Care Respiratory Journal (4): From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) Available from: <Accessed on > 3. NICE 2010 COPD guidelines 4. IMPRESS Guide to the relative value of COPD interventions July all drug files accessed 6. British National Formulary, BMA March <Accessed > 7. Chemist and Druggist March <Accessed > ACKNOWLEDGEMENTS TO ALICE TURNER AND PAN BIRMINGHAM APC South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 9
11 Appendices COPD Prescribing Guidelines Appendix 1 COPD Assessment Test (CAT) - Determine whether patient has less symptoms (<10) or more symptoms (>10) using CAT scale. I never cough I cough all the time I have no phlegm (mucus) in my chest at all My chest if full of phlegm (mucus) My chest does not feel tight My chest feels very tight When I walk up a hill or one flight of stairs I am When I walk up a hill or one flight of stairs I am not breathless very breathless I am not limited doing any activities at home I am very limited doing activities at home I am confident leaving my home despite my lunch I am not at all confident leaving my home condition because of my lung condition I sleep soundly I don t sleep soundly because of my lunch condition I have lots of energy I have no energy at all mmrc Modified Research Council Questionnaire - Determine if the patient is less breathlessness (0-1) or more breathlessness ( 2). Grade Description of Breathlessness 0 I only get breathless with strenuous exercise. 1 I get short of breath when hurrying on level ground or walking up a slight hill. 2 On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace. 3 I stop for breath after walking about 100 yards or after a few minutes on level ground. 4 I am too breathless to leave the house or I am breathless when dressing South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 10
12 Appendix 2 Inhaler Profile COPD Prescribing Guidelines All inhalers should be prescribed by brand name Drug Strength Brand Picture Type of Device Separate Spacer Dose & Frequency Cost * (per device) Salamol MDI Aerochamber Plus/Volumatic Spacer 1.46 (200 doses) Ventolin MDI Aerochamber Plus/Volumatic Spacer 1.50 (200 doses) SABA (Short Acting Beta2 Agonist) Salbutamol 100mcg Airomir MDI Aerochamber Plus Airomir Autohaler DPI - 2 puffs when required 1.97 (200 doses) 6.02 (200 doses) Salamol Easi- Breathe MDI (200 doses) Salbutamol Easyhaler DPI (200 doses) Terbutaline 500mcg Bricanyl Turbohaler DPI - 1 puff, up to four times a day 6.92 (100 doses) SAMA (Short Acting Anti- Muscarinic) Ipratropium 20mcg Atrovent MDI Aerochamber Plus 1 puff, up to four times a day 5.56 (200 doses) South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 11
13 COPD Prescribing Guidelines LABA (Long Acting Beta2 Agonist) Formoterol Indacaterol 12mcg 150mcg Easyhaler Formoterol Onbrez Breezhaler & Caps DPI - 1 puff Twice DPI - 1 puff Once (120 doses) Note: device will last two months (30 doses) LAMA (Long Acting Anti- Muscarinic) Note: inhaler strengths given. Base drug strengths may be slightly different. Glycopyrronium 44mcg Seebri Breezhaler & Caps Tiotropium 2.5mcg Sprivia Respimat DPI - DPI - 1 puff Once 2 puffs Once Umeclidinium 55mcg Incruse Ellipta DPI - 1 puff Once Aclidinium 322mcg Eklira Genuair DPI - 1 puff Twice (30 doses) (60 doses) (30 doses) (60 doses) LABA/LAMA combination (Long Acting Antimuscarinic & Long Acting Beta2 Agonist) Vilanterol/ Umeclidinium Indacaterol/ Glycopyrronium 22mcg / 55mcg 85mcg/ 43mcg Anoro Ellipta DPI - 1 puff Once Ultibro Breezhaler & Caps DPI - 1 puff Once (30 doses) (30 doses) Note: inhaler strengths given. Base drug strengths may be slightly different. Olodaterol/ tiotropium Formoterol/ Aclidinium 2.5mcg/ 2.5mcg 12mcg/ 340mcg Spiolto Respimat DPI - Duaklir Genuair DPI - 2 puffs Once 1 puff Twice (60 doses) (60 doses) South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 12
14 COPD Prescribing Guidelines LABA/ICS combination (Long Acting Beta2 Agonist & Inhaled Corticosteroid) Formoterol/ Beclometasone Formoterol/ Beclometasone 6mcg/ 100mcg 6mcg/ 100mcg Fostair MDI MDI Aerochamber Plus Fostair NEXThaler DPI - 2 puffs Twice 2 puffs Twice (120 doses) (120 doses) Note: inhaler strengths given. Base drug strengths may be slightly different. Formoterol/ Budesonide Vilanterol/ Fluticasone 9mcg/ 320mcg 22mcg/ 92mcg DuoResp Spiromax DPI - Relvar Ellipta DPI - 1 puff Twice 1 puff Once (60 doses) (30 doses) Note: - DPI = Dry-powder Inhaler - MDI = Metered Dose Inhaler - Spacers - wash weekly, do NOT wipe dry. Replace every six to 12 months. - * prices taken from March 2017 Drug Tariff and Chemist and Druggist South Staffordshire Area Prescribing Group COPD prescribing Pathway v2.0 Review date August 2018 Page 13
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