Medicines Management of Chronic Obstructive Pulmonary Disease (COPD)

Transcription

1 Medicines Management of Chronic Obstructive Pulmonary Disease (COPD) (Chronic & Acute) Guidelines for Primary Care Guideline Authors: Shaneez Dhanji (Wandsworth CCG) and Reena Rabheru-Dodhy (Merton CCG) Date Prepared: May 2010 Date Approved: August 2010 Update 1 & Approved: May 2012 Update 2 & Approved: November 2013 Date for Review: May 2015

2 Medicines Management of Chronic COPD All COPD patients still smoking, regardless of age, should be encouraged to stop, and offered help (including drug therapy) to do so, at every opportunity. Contact the Stop Smoking Service on Patients should have a diagnosis of COPD, confirmed by post-bronchodilator spirometry. The choice of drug should take into account the patient s response to a trial of the drug, side effects, patient preference,potential to reduce exacerbations and cost. Some patients may require unlicensed doses and devices and this should be decided on an individual basis, with specialist input. It is good practice to review all new treatment intitated and check inhaler technique regularly Breathlessness and/or Exercise limitation Assess symptoms, severity and disability and manage as below Short-acting beta agonist (SABA)- Salbutamol 100mcg; 2 puffs PRN ( 1.50) AND / OR Short-acting muscarinic antagonist (SAMA) Ipratropium 20mcg; 2 puffs PRN ( 5.05) If patient does not demonstrate satisfactory technique, add spacer device or change device Exacerbations or Persistent breathlessness FEV 1 > 50% FEV 1 < 50% OR Add Long Acting Beta Agonist (LABA) Formoterol 12mcg BD ( 24.80) Or Salmeterol 50mcg BD ( 29.26) Or Indacaterol 150mcg- 300mcg OD ( 29.26) Continue SABA or SAMA prn Add Long Acting Muscarinic Antagonist (LAMA) Continue SABA prn. Discontinue SAMA 1 st line: Tiotropium Handihaler 18mcg OD ( 34.87) ** 2 nd line: Gylcopyrronium Bromide ( 27.50) or Aclidinium Bromide ( 28.60) ** See Appx 1 for place in therapy If the patient does not demonstrate satisfactory technique with Tiotropium handihaler, consider Tiotropium Respimat 2.5mcg; 2 puffs OD. Use with caution in patients with known cardiac rhythm disorders MHRA advice (see Appx 1) Exacerbations or Persistent breathlessness LABA + Inhaled Corticosteroid (ICS) in a combination inhaler Budesonide/Formoterol (Symbicort ) Turbohaler: 200mcg/6mcg: 2 puffs BD or 400mcg/12mcg: 1 puff BD ( 38.00) OR Fluticasone/Salmeterol (Seretide ) 500mcg/50mcg Accuhaler: 1 puff BD ( 40.92) Note: If patient is already taking Indacaterol, this will need to be stopped when the patient is started on either Seretide or Symbicort preparations to avoid duplication of LABA component. ICS monotherapy is not licensed in COPD. If ICS declined or not tolerated, consider LABA + LAMA Be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with highdose inhaled corticosteroids. Continual exacerbations or persistent COPD symptoms, irrespective of FEV 1 Chronic cough / Sputum production: Consider a trial of carbocisteine capsules 750mg tds for 6-8 weeks then 750mg bd if there is an improvement in sputum production and reduction in viscosity. For futher information, see Appendix 2. Pneumococcal vaccination and annual influenza vaccination should be offered to all patients with COPD. LAMA + LABA + Inhaled Corticosteroid (ICS) in a combination inhaler

3 Medicines Management of Chronic Obstructive Pulmonary Disease (COPD) For the management of COPD, this fact sheet must be read in conjunction with NICE guidelines 1 and Wandsworth COPD Pathway 2. The main treatment goals are to reduce exacerbations, reduce hospital admissions and to improve patient s quality of life. All patients who smoke should be encouraged to stop smoking and offered help at every opportunity as smoking cessation is one of the most important components of their treatment 1. For further information regarding smoking cessation services, contact the local Stop Smoking Services. Patients who have a MRC score of 3 or more should be referred for Pulmonary Rehabilitation. Key Messages Inhaled short acting beta-2 agonists (SABA) or short acting muscarinic antagonists (SAMA) should be used as required for the relief of breathlessness in mild COPD. A combination of both can be used if the patient remains symptomatic on single therapy. Long acting beta-2 agonists (LABA) or long acting muscarinic antagonists (LAMA) should be used to control symptoms in patients with stable COPD who remain breathless or have exacerbations despite using short acting bronchodilators as necessary with an FEV 1 of 50% or greater.(once daily LAMA usage is recommended in preference to four-times-daily SAMA usage in patients with stable COPD. If using a LAMA, discontinue SAMA refer to LAMA guidelines Appendix 1 for further information 4. Inhaled corticosteroid (ICS) with LABA combination inhaler should be used to control symptoms in patients with stable COPD who remain breathless or have exacerbations, with an FEV 1 of < 50% despite therapy with a SABA, SAMA or LAMA. Remember A combination inhaler technique of an ICS + needs LABA to inhaler be checked and a LAMA regularly inhaler and is spacers recommended prescribed for patients with metered with continual dose inhalers exacerbations 2. or persistent COPD symptoms, irrespective of FEV 1. 1 Care must be taken regarding potential risk of developing side effects (including non-fatal pneumonia) in patients treated with high dose inhaled corticosteroids the risks should be discussed with the patient. Additional information: The choice of drug(s) should take into account the patient s response to a trial of the drug, the drug s side effects, patient preference and cost. Patients should have their inhaler technique reviewed by a competent healthcare professional to ensure they are using it correctly. 1 Other treatments: Prednisolone (oral corticosteroid) 30mg daily for 7-14 days 3 is recommended in the treatment of COPD exacerbations for all patients with significant increase in breathlessness and all hospital admitted patients, unless contraindicated 1. Maintenance use of oral corticosteroids is not normally recommended. In cases where maintenance therapy is appropriate, the lowest possible dose should be used. Patient response to oral corticosteroids cannot be used to predict response to inhaled corticosteroid therapy, and should not be used to identify patients suitable for inhaled corticosteroids. Osteoporosis prophylaxis should be considered for patients requiring frequent courses or a maintenance dose of oral corticosteroids. e.g. Adcal D3. Theophylline has a limited place in therapy and should only be used after a trial of SABA and LABA inhalers or in patients who are unable to use inhaled therapies. Theophylline levels need to be monitored every 6-12 months or more often if toxicity is suspected. Measure trough level immediately pre-dose. Levels should be between 10-20mg/litre. Common signs of toxicity include tachycardia, palpitations, nausea and headache. Particular caution should be taken in the elderly as the plasma theophylline concentration is increased in this group of patients. Caution in elderly patients and smokers due to pharmacokinetic differences. Prescribe by brand name only. Monitor drug interactions (check BNF). Mucolytics (e.g. carbocysteine) can be considered in patients with a chronic productive cough of sputum. Treatment should only be continued if there is symptomatic improvement (e.g. reduction in cough frequency or sputum). Mucolytics should not be routinely used as prevention of an exacerbation in patients with stable COPD. For further information see Appendix 2 5.

4 Pneumococcal vaccination and an annual influenza vaccination should be offered to all patients with COPD 1. Oral antibiotics are recommended for exacerbations causing purulent sputum. Prophylactic antibiotics is not recommended in the management of stable COPD 3. For further information refer to WCCG Primary Care antibiotic guidelines. Stand by antibiotics decision to prescribe should be at GP s discretion in appropriate patients. Roflumilast is recommended by NICE, only in the context of research as part of a clinical trial for adults with severe COPD (FEV 1 post-bronchodilator < 50% predicted) associated with chronic bronchitis with a history of frequent exacerbations as an add-on to bronchodilator treatment 6. Long-term, short-term and ambulatory oxygen therapy is also recommended for patients meeting necessary criteria 1 - Refer to the Community Respiratory Nurse Specialist.

5 Combination Therapy Corticosteroids Anticholinergic Beta2-agonists Table 1: Cost comparison of beta 2 agonists, corticosteroid, anticholinergic and combination inhalers Salbutamol 100mcg MDI Inhaler Salbutamol 200mcg Accuhaler Terbutaline 500mcg Turbohaler Formoterol Fumarate 12mcg Turbohaler Salmeterol 50mcg Accuhaler Salmeterol 25mcg MDI Inhaler Indacaterol 150mcg & 300mcg Inhaler Ipratropium 20mcg MDI Inhaler Gylcopyrronium bromide 50mcg Breezhaler Aclidinium Bromide 400mcg inhaler Tiotropium 18mcg Inhaled Capsules Fluticasone 100mcg Accuhaler Budesonide 200mcg Turbohaler Budesonide 400mcg Turbohaler Fluticasone 125mcg Evohaler Fluticasone 250mcg Accuhaler Fluticasone 250mcg Evohaler Fluticasone 500mcg Accuhaler Fluticasone and Salmeterol 100/50 Accuhaler Fluticasone and Salmeterol 250/50 Accuhaler Fluticasone and Salmeterol 125/25 Evohaler Budesonide and Formoterol Turbohaler 400/12 Budesonide and Formoterol Turbohaler 200/6 Fluticasone and Salmeterol 500/50 Accuhaler Fluticasone and Salmeterol 250/25 Evohaler Drug Tariff Nov 2013 (prices are subject to change) References: 1. National Institute for Health and Clinical Excellence. Management of Chronic Obstructive Pulmonary Disease in Adults in Primary and Secondary Care (partial update). Clinical Guideline No. 101 June Wandsworth CCG COPD pathway 3. WCCG Primary Care Antibiotic Guidelines Guidance on the use of LAMAs in patients with COPD. (Appendix 1) 5. Guidance on the use of Mucolytics in patients with COPD. (Appendix 2) 6. National Institute for Health and Clinical Excellence. Roflumilast for the management of severe chronic obstructive pulmonary disease. Technology Appraisal Guidance 244. January 2012

6 Appendix 1 Guidance on the use of Long Acting Muscarinic Antagonists (LAMAs) in patients with Chronic Obstructive Pulmonary Disease (COPD) TIOTROPIUM: Tiotropium is a long-acting muscarinic antagonist (LAMA), recommended as a treatment option in people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators 1. Licensed Indication 2,3 Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD) It is not to be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Co-administration of tiotropium with other anticholinergics, e.g. ipratropium has not been studied and is therefore not recommended. Place in therapy Tiotropium should be used 1st line. Those patients who are unable to take or tolerate tiotropium can be tried with an alternative LAMA. Prescribing of Tiotropium (Refer to algorithm of chronic COPD) Stop Ipratropium in patients who are commenced on tiotropium. There is no data on the co-administration of tiotropium with other anticholinergics and therefore it is not recommended 1. There is some evidence that suggests that inhaled anticholinergic drugs (e.g. tiotropium and ipratropium) increase the risk of cardiovascular (CV) events for patients with COPD compared with placebo or active comparators (inhaled ICS and β 2 -agonists). However the precise magnitude of this increase is uncertain. Bear this in mind when weighing up the benefits to risks of treatment 4. Data on the CV safety concerns about ipratropium (and to a lesser extent tiotropium) come from observational studies and retrospective pooled analyses of data. These have inherent limitations and only flag up potential safety issues, not confirm them. The UPLIFT trial and the report from the tiotropium trial database are reassuring about the safety of tiotropium. However, continued monitoring of both ipratropium and tiotropium is required 5. When decisions are made around which bronchodilator to use, NICE advises that choice in individual patients should take account of their response to a trial of the drug, the drug s side effects, patient preference and cost. This safety data, as well as the potential benefits from treatment, should also feature in these decisions. However, the individual choice will probably depend more on whether they can use the inhaler device, tolerate the drug and how effective the medication is for their symptoms 5. The MHRA advises that Spiriva Respimat should be used with caution in patients with known cardiac rhythm disorders 6. Refer to the SPC for further information. Report suspected adverse reactions on a Yellow Card at Choice of device This should be based on patient preference and ability to use the different devices. Handihaler -this device may be difficult for elderly and infirm patients to use. Respimat - this device could be used in patients who have poor manual dexterity, and who have difficulty using the Handihaler device. A gentler longer inhalation is required, which may be difficult to manage by some patients. Therefore inhaler technique should be assessed.

7 Dose 2,3 (check BNF for latest dose) Handihaler - Adults over 18 years: one capsule (18mcg) is inhaled once daily at the same time of day. Refills are also available to prescribe. Respimat - Adults over 18 years: 2 puffs (5mcg) to be inhaled once daily at the same time of day. Monitoring Response in terms of symptomatic relief and quality of life are important. Patient s response should be reviewed after commencing tiotropium. Check any improvement in symptomatic control, wheezing and shortness of breath on exertion Any reduction in the use of short acting bronchodilators Check dose compliance and ability to use the device Patients who have not demonstrated an improvement, consider discontinuing treatment. Adverse Effects 2,3 (See SPC for full list) Dry mouth most common Pharyngitis - uncommon Atrial fibrillation - uncommon Palpitations - uncommon Special precautions 2,3 Patients using the Handihaler or Respimat should be advised to avoid getting the medication into their eyes as it may precipitate or worsen narrow angled glaucoma. Cautions and Contraindications 2,3 (see SPC for full list) Tiotropium should be used with caution in patients with narrow angle glaucoma, prostatic hyperplasia or bladder neck obstruction. Tiotropium is contraindicated in patients with hypersensitivity to either tiotropium bromide, atropine or its derivatives e.g. ipratropium or to the exipients.

8 GLYCOPYRRONIUM BROMIDE 7 : This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions on a Yellow Card at Licensed Indication Glycopyrronium bromide (Seebri) Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). It is not to be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. The co-administration of Seebri Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended Place in therapy Glycopyrronium Bromide (Seebri) could be used if the patient is unable to take or tolerate tiotropium. Dose (check BNF for latest dose) Adults over 18 years: The recommended dose is the inhalation of the content of one capsule once daily using the Seebri Breezhaler inhaler. Seebri Breezhaler is recommended to be administered, at the same time of the day each day. If a dose is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day. Monitoring Response in terms of symptomatic relief and quality of life are important. Patient s response should be reviewed after commencing Glycopyrronium Bromide (Seebri). Check any improvement in symptomatic control Any reduction in the use of short acting bronchodilators Check dose compliance and ability to use the device Patients who have not demonstrated an improvement, consider discontinuing treatment. Adverse Effects (See SPC for full list) Dry mouth, Nasopharyngitis, Insomnia, headache common Palpitations, Sinus congestion, Productive cough, Throat irritation - uncommon Caution Seebri Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention Contraindication Hypersensitivity to the active substance or to any of the excipients

9 ACLIDINIUM BROMIDE 8 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions on a Yellow Card at Licensed Indication Aclidinium bromide (Eklira Genuair) 322 micrograms inhalation powder is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). It is not to be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is not recommended Place in therapy Aclidinium bromide (Eklira Genuair) should be used if patient cannot use tiotropium handihaler or Seebri breezhaler. Dose (check BNF for latest dose) Adults over 18 years: The recommended dose is one inhalation of 322 µg aclidinium twice daily. If a dose is missed the next dose should be taken as soon as possible. However, if it is nearly time for the next dose, the missed dose should be skipped. Monitoring Response in terms of symptomatic relief and quality of life are important. Patient s response should be reviewed after commencing tiotropium. Check any improvement in symptomatic control Any reduction in the use of short acting bronchodilators Check dose compliance and ability to use the device Patients who have not demonstrated an improvement, consider discontinuing treatment. Adverse Effects (See SPC for full list) Nasopharyngitis, sinusitis, headache, cough, diarrhoea common Blurred vision, urinary retention - uncommon Special precautions Aclidinium bromide should be used with caution in patients with symptomatic prostatic hyperplasia or bladderneck obstruction or with narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely) Contraindications (see SPC for full list) Hypersensitivity to aclidinium bromide, atropine or its derivatives, including ipratropium, oxitropium or tiotropium, or to the excipients References

10 1. National Institute for Health and Clinical Excellence. Management of Chronic Obstructive Pulmonary Disease in Adults in Primary and Secondary Care (partial update). Clinical Guideline No. 101 June Spiriva 18mcg inhalation powder, hard capsules (tiotropium), SPC, updated 24/08/2010. [online] Accessed 06/02/ Spriva Respimat 2.5mcg solution of inhalation (tiotropium), SPC, updated 18/08/2010. [online] Accessed 06/02/ NPC MeReC Extra issue no.37. January Anticholinergics in COPD. [online] Accessed 02/08/10 5. NPC MeReC Rapid Review. Cardiovascular safety of anticholinergics in COPD, 25 March [online] Accessed 02/08/10 6. MHRA Drug Safety Update November 2011, Vol 4, Issue Glycopyrronium bromide (Seebri) Breezhaler, SPC, updated 02/11/12. Accessed online 10/10/ Aclidinium bromide (Eklira Genuair), SPC, Updated 23/07/13. Accessed online 11/10/13. Eklira Genuair 322 micrograms inhalation powder

11 Appendix 2 Guidance on the use of Mucolytics in Chronic Obstructive Pulmonary Disorder (COPD) Introduction Consider mucolytic therapy for patients with a chronic cough productive of sputum, including COPD 1.Mucolytics can help increase the ability to expectorate sputum by reducing its viscosity. Treatment with mucolytic agents has shown a small but significant reduction in acute exacerbations and total number of days disability. It has been suggested if patients take mucolytics regularly through the winter months, it could result in a 20% reduction in exacerbations, which in turn may prevent hospitalisations. They are safe and well tolerated 2. Licensed Indications Mucolytics are used for adjunctive therapy for respiratory tract disorders characterised by excessive, viscous mucus to help increase the ability to expectorate sputum by reducing its viscosity. Treatment should be continued if there is symptomatic improvement i.e. a reduction in frequency of cough and sputum production. Place in Therapy Patients should have a confirmed diagnosis of COPD with a chronic cough and sputum production Patients should have a cough and sputum on most days for 3 months in 2 consecutive years Patients should be in a chronic, stable, but symptomatic state Exclude differential diagnosis such as bronchiectasis, rhinitis, post nasal drip, lung cancer Dose 3 Carbocisteine is available in capsule and liquid preparations Initially 2250mg daily in divided doses (375mg capsules x 2 tds or 15mls liquid tds) and reducing to 1500mg daily in divided doses (375mg capsules x 1 qds or 10mls liquid tds) Monitoring Patients should be reviewed after one month of commencing treatment. Only continue with carbocisteine if there is a reported reduction in frequency of cough and sputum production and that the patient perceives a benefit in the mucolytic treatment 1. Do not routinely use for the prevention of exacerbations in stable COPD 1. References 1. National Institute for Health and Clinical Excellence. Management of Chronic Obstructive Pulmonary Disease in Adults in Primary and Secondary Care (partial update). Clinical Guideline No. 101 June The Cochrane Library 2006 Issue 3. Poole P and Black P. Mucolytic agents for chronic bronchitis or chronic obstructive pulmonary disease (review). The Cochrane Library Issue ; Article No. CD DOI: / CD pub2. 3. Mucodyne capsules (carbocisteine), SPC, updated 20/04/2009. [online] Accessed 02/08/10.

12 Medicines Management of Acute COPD 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 Acute Exacerbation Increase short-acting bronchodilators Oral Corticosteroids Oral Antibiotics Initial management: 1. Short Acting Bronchodilators: Increase frequency of short-acting bronchodilator use. Consider using a spacer or using a nebuliser, if appropriate Nebulised doses: 2.5mg/2.5ml QDS and increase up to 6 times per day, if necessary 2. Oral Corticosteroids: Prednisolone 30mg daily for 7-14 days For all patients with significant increase in breathlessness, sputum or cough and all patients admitted to hospital, unless contraindicated. Patients should be made aware of the adverse effects of prolonged steroid therapy Osteoporosis prophylaxis should be considered for patients requiring frequent courses of oral corticosteroids Routine use of oral steroids in stable COPD is NOT recommended 3. Oral Antibiotics: if increased dyspnoea and purulent sputum 1 st line: Amoxicillin 500mgs, 3 times a day for 7 days OR Doxycycline 200mgs STAT then 100mgs daily for 6 days Clarithromycin 500mg twice daily for 5-7 days [if penicillin allergic and doxcycline contraindicated] 2 nd line: (If treatment failure, send sputum sample first) Co-amoxiclav 625mgs, 3 times a day for 7 days In acute exacerbations of COPD 30% are viral, 30-50% are bacterial, the remainder are undetermined. Exacerbations without purulent sputum do not need an antibiotic unless consolidation on chest x-ray or clinical signs of pneumonia If sputum is sent for culture, antibiotic treatment should be based on sensitivity results

13 Original 2012 Acknowledgements Dr Charlotte Levitt - GP, St Paul s Cottage Surgery & PBC rep NHSW Samantha Prigmore - Respiratory Nurse Consultant, St George s Hospital Ioulia Mariaki - Respiratory Clinical Nurse Specialist, NHSW Nikki Davies - Respiratory Clinical Nurse Specialist, NHSW Wendy Kong - Respiratory Clinical Nurse Specialist, NHSW Vanessa Flagg - Long Term Conditions Development Manager, NHSW David Tambyrajah - Community Pharmacy Lead, NHSW Nick Beavon - Chief Pharmacist, NHSW Louise Paterson - Physiotherapist, Brysson Whyte Rehab Lisa Ronson - Physio, St George s Hospital Pamela Nyatanga - Respiratory Pharmacist, St George s Hospital Helen Parnell - Respiratory Specialist Nurse, St Helier Hospital Dr Veronica Varney - Respiratory Consultant, St Helier Hospital Anne Lowson - Formulary Pharmacist, St Helier Hospital Dr Simon Elliott - GP, Robin Hood Health Centre & GP Medicines Management Lead, NHSSM Fiona White - Nurse Consultant in Primary Care, NHSSM Sedina Agama - Pharmaceutical Advisor, NHSSM Jan Walker - Specialist Respiratory Nurse, NHSSM Julia Russell - Specialist Respiratory Nurse, NHSSM