COPD Prescribing Guidelines

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. Written by MMSESSP Review December 2016

COPD Prescribing Guidelines This guideline is intended for use to aid diagnosis in patients with a suspected diagnosis of a COPD, and in patients with a confirmed diagnosis of COPD. In the latter group it is intended to direct management including prescribing. It is aimed primarily at cost-effective prescribing, and will be reviewed annually as evidence is rapidly emerging in this field 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 predominately caused by smoking. Diagnosis 1. Suspect 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. Wheezing 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 tobacco smoke/ smoke from cooking and heating fuels/ occupational dusts and chemicals 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 2. Spirometry Test: Spirometry is required to establish a diagnosis of COPD. Post bronchodilator spirometry demonstrates: FEV 1 /FVC <70% NB. The presence of multiple key indicators increases the probability of diagnosis of COPD. 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 3. Interpreting Spirometry Severity assessment Make sure it isn t asthma* FEV 1 > 80% Mild A Check reversibility to salbutamol 50-80% Moderate B >400ml = asthma 30-50% Severe C Check PEFR variation over 2/52 < 30% Very Severe D >20% = asthma

COPD Prescribing Guidelines Possible Alternative Diagnosis Asthma Congestive Heart Failure Bronchiectasis Tuberculosis Obliterative Bronchiolitis Diffuse Panbronchiolitis Lung Cancer (Chest X Ray- If 3 week history of cough and /or increasing breathlessness) Full blood count to identify anaemia or polycythaemia Check inhaler technique Encourage all patients to stop smoking, beneficial at all ages. Offer annual pneumococcal and influenza vaccinations. Management of Stable COPD Refer to pulmonary rehabilitation when mmrc score is 2 (or for GOLD classification B-D as per GOLD guidelines) Promote use of self-management plan and rescue packs. Template self-management plan can be found at: [Link for Self-Management Plan] Screen for common comorbidities e.g. IHD, HF, anxiety, and depression. Consider referral to the rest of the multidisciplinary team 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 when O2 saturations are less than or equal to 92% breathing air.

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). 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 Use spirometry to determine if patient is high risk (FEV 1 <50%) or low risk (FEV 1 50%) In some patients these three ways of assessing the risk of exacerbations will not lead to the same level of risk; in this case, the risk should be determined by the method indicating high risk Determine Gold Classification and treatment according to Table 1 GOLD Classification attempt to class patients based on their risks of exacerbation.

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 (See Appendix 2 for in list of inhaler brands, dosing, costs & images) CAT <10 STEP 1: Symptom Assessment CAT 10 Number of Exacerbations in previous 12 months Hospitalisation in previous 12 months FEV 1 mmrc 0-1 Low risk Gold A mmrc 2 Moderate risk Gold B STEP 2: Risk Assessment 1 2 zero 1 50% Predicted < 50% Predicted Step 1: SABA or SAMA (NB SABA can continue as reliever through all steps) Step 2: LABA Severe risk Gold C Step 1: ICS/LABA (if LAMA tried) Or Step 1: LAMA (if LAMA naïve) Step 2: LABA/ LAMA combination Step 1: LABA (if LABA naïve) Or Step 1: LAMA Step 2: LABA/ LAMA combination suitable where severe breathlessness Very Severe risk Gold D Triple therapy if patient has progressed from C or B. OR LABA/LAMA combination if treatment naïve Or ICS/LABA & Theophylline Or LAMA & Theophylline Inhaler choices for management of Stable patients try to maintain device consistency if possible LABA LAMA LABA/LAMA LABA/ICS Easyhaler Formoterol Seebri Breezhaler Anoro Ellipta Fostair MDI Onbrez Breezhaler 1 Incruse Ellipta Duaklir Genuair * DuoResp Spiromax Eklira Genuair* Ultibro Breezehaler Relvar Ellipta Key: 1. Starting dose 150mcg, increased to 300mcg if needed. * Twice daily preparation therefore not suitable for all patients LAMA caution use in patients with cardiac arrhythmias, recent hospitalisation with cardiac background e.g. MI, HF, etc. These are class effects

Managing COPD Exacerbations COPD Prescribing Guidelines 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

COPD Prescribing Guidelines ACUTE MANAGEMENT (at home) Steroids - Prednisolone 30mg daily for 7-14 days then stop 1st line antibiotic - Amoxicillin 500mg three times a day for 5 days; OR [Penicillin allergy] - Clarithromycin 500mg twice daily for 5 days [Significant drug Interaction] - Theophylline halve dose and - Simvastatin stop/reduce dose - Consider other interactions 2nd line antibiotic If resistant - Doxycycline 200mg immediately then 100mg daily for a further 4 days - Co-Amoxiclav 625mg three times a day for 5 days (consider C.Diff risk) Optimise treatment - Increase SABA to 2-8 puffs up to 4 hourly (watch for side effects e.g. tremor) 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 above Carbocisteine - Two or more exacerbations in the next 12 month, consider adding in Carbocisteine 750mg twice daily (maintenance dose) especially if chronic productive cough - Review on-going need/ benefit and stop if ineffective after 4 6 weeks of treatment

COPD Prescribing Guidelines References: 1. From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Available from: http://www.goldcopd.org/. accessed on 8 th April 2015 2. NICE 2010 COPD guidelines 3. IMPRESS Guide to the relative value of COPD interventions July 2012 4. www.medicines.org.uk all drug files accessed 5. British National Formulary, version 68, BMA 2014 6. Mims Online accessed May 2015 ACKNOWLEDGEMENTS TO ALICE TURNER AND PAN BIRMINGHAM APC

Appendices COPD Prescribing Guidelines Appendix 1 - mmrc Modified Research Council Questionnaire 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 CAT Test Online - http://catestonline.org/english/indexen.htm or Direct link to CAT-test online: [Link]

Appendix 2 Inhaler Profile COPD Prescribing Guidelines Prescribe all inhalers by Brand Name Drug Strength Brand Picture Type of Device Separate Spacer Dose & Frequency Cost ** Salamol MDI Aerochamber Plus/Volumatic Spacer 1.46 Ventolin MDI Aerochamber Plus/Volumatic Spacer 1.50 SABA (Short Acting Beta2 Agonist) Salbutamol 100 mcg Airomir MDI Aerochamber Plus Airomir Autohaler DPI - 2 puffs when required 1.97 6.02 Salamol Easi- Breathe MDI - 6.30 Salbutamol Easyhaler DPI - 3.31 Terbutaline 500 mcg Bricanyl Turbohaler DPI - 1 puff, up to four times a day 6.92 (100 doses) SAMA (Short Acting Anti- Muscarinic) Ipratropium 20 mcg Atrovent MDI Aerochamber Plus 1 puff, up to four times a day 5.56 LABA (Long Acting Beta2 Agonist) Formoterol 12 mcg Easyhaler Formoterol DPI - 1 puff Twice daily 23.75 Device will last two months (120 doses)

COPD Prescribing Guidelines Indacaterol 150 mcg Onbrez Breezhaler & Caps DPI - 1 puff Once daily 29.26 (30 doses) LAMA (Long Acting Anti- Muscarinic) Glycopyrronium 50 mcg Seebri Breezhaler & Caps DPI - 1 puff Once daily Umeclidinium 55 mcg Incruse Ellipta DPI - 1 puff Once daily 27.50 (30 doses) 27.50 (30 doses) Aclidinium 322 mcg Eklira Genuair DPI - 1 puff Twice daily 28.60 (60 doses) LABA/ LAMA combination (Long Acting Antimuscarinic & Long Acting Beta2 Agonist) Vilanterol/ Umeclidinium Indacaterol/ Glycopyrronium Formoterol/ Aclidinium 22 mcg / 55 mcg 110 mcg / 50 mcg 12 mcg / 340 mcg Anoro Ellipta DPI - 1 puff Once daily Ultibro Breezhaler & Caps Duaklir Genuair DPI - DPI - 1 puff Once daily 1 puff Twice daily 32.50 (30 doses) 36.88 (30 doses) 32.50 (60 doses) LABA/ICS combination (Long Acting Beta2 Agonist & Inhaled Corticosteroid) Formoterol/ Beclometasone Formoterol/ Budesonide Vilanterol/ Fluticasone 6 mcg / 100 mcg 9 mcg / 320 mcg 22 mcg / 92 mcg Fostair* MDI Aerochamber Plus DuoResp Spiromax DPI - Relvar Ellipta DPI - 2 puffs Twice daily 1 puff Twice daily 1 puff Once daily 29.32 (120 doses) 29.97 (60 doses) 27.80 (30 doses) Note: - DPI = Dry-powder Inhaler - *Fostair NEXThaler for asthma only - MDI = Metered Dose Inhaler - Cost per device - Spacers - wash weekly, do NOT wipe dry. Replace every six to 12 months. - ** prices taken from Mims online accessed May 2015

Appendix 3: COPD intervention Value Pyramid COPD Prescribing Guidelines