Outline. EPIC Project. February EPIC Project. Diagnosis: Spirometry. Differentiation between COPD & Asthma

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1 EPIC Project Enabling Patient health Improvements though COPD medicines optimisation Dr Toby Capstick Outline Background on COPD COPD Assessment Cost Effective Treatment Medication Practical Leeds Inhaler Guide Videos Exacerbations Lifestyle Patient Support EPIC Project New Leeds COPD Inhaler Algorithm and Preferred Formulary Support and E&T for primary care staff COPD algorithm (assessment & use of cost-effective treatment) Inhaler technique Virtual Clinics Targeted COPD patients (e.g. frequent exacerbations, medicines rationalisation) Future support Management of complex patients Additional advice & training Community Pharmacy enhanced service COPD review and assessment What is Chronic Obstructive Pulmonary Disease (COPD)? DEFINITION 1 : A common preventable and treatable disease characterised by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients. Encompasses several conditions affecting the airways e.g. emphysema and chronic bronchitis Characteristic symptoms: persistent breathlessness, cough and sputum production. Unlike asthma, COPD is usually progressive and not fully reversible, and there is often no noticeable change in condition over several months. 1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease Diagnosis: Spirometry Differentiation between COPD & Asthma Feature COPD Asthma Smoker or ex-smoker Nearly all Possibly Symptoms under age 35 Rare Often FEV 1 reduced (<80% predicted normal) FVC usually reduced, but to a lesser extent than FEV 1 FEV 1 /FVC ratio reduced (<0.7) Exhalation prolonged / slower Reversibility testing: Post bronchodilator response >400ml suggests presence of asthma. 1. GOLD. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease British Thoracic Society COPD Consortium. Spirometry in Practice 2 nd Ed Chronic productive cough Common Uncommon Breathlessness Night time waking with breathlessness and/or wheeze Significant diurnal or day-to-day variability of symptoms Persistent & progressive Uncommon Uncommon Variable Common Common Family history Uncommon? Common History of eczema or allergic rhinitis Uncommon Common 1

2 Differentiation between COPD & Asthma Feature COPD Asthma Smoker or ex-smoker Nearly all Possibly Symptoms under age 35 Rare Often Chronic productive cough Common Uncommon Breathlessness Night time waking with breathlessness and/or wheeze Significant diurnal or day-to-day variability of symptoms Persistent & progressive Uncommon Uncommon Variable Common Common Family history Uncommon? Common History of eczema or allergic rhinitis Uncommon Common Aetiology Exposure to particles Tobacco smoke Occupation (e.g. inorganic dusts, chemical agents & fumes) Indoor pollution (e.g. open fires, poorly functioning stoves) Genetic Alpha-1 antitrypsin Age & Gender Unclear Lung growth & development Correlation between birth weight & adult FEV1 Infection History of TB & childhood infections Socioeconomic status Lower status = higher risk Diet Fruit & veg associated with reduced risk Asthma ~20% of adults develop irreversible airways disease. Asthmatic smokers: 12-fold increased risk Why should we focus on COPD? Burden of Disease Prevalence UK: Estimated 3 million (2.2 million undiagnosed 1 ) Worldwide: 64 million 2 Mortality: UK: Approx. 25,000 deaths annually 1 Worldwide: >3m deaths annually & rising 2 Following admission for COPD Exacerbation: 3,4 Approx. 1 in 3 readmitted within 3 months Approx. 1 in 8 dead within 3 months 1 person dies in England & Wales every 20mins Projected to be the 3rd biggest killer by 2020 (behind IHD and CVA) NHS Burden: 1billion / year 1. DH (2011). An outcomes strategy for COPD and Asthma in England Roberts CM et al. Thorax 2002;57: Price LC et al. Thorax 2006;61: Leeds West CCG Position Population All Leeds Leeds West CCG Armley, Bramley, Pudsey Total Population 837, , ,824 COPD Population 16,190 6,013 2,648 COPD A&E attendances ( ) COPD Emergency Admissions ( ) 5,141 (33.7%) 2,028 (34.3%) 1,122 (42.4%) 1,733 (10.7%) 642 (10.7%) 334 (12.6%) Changing COPD Practice Significant expenditure on inhaled medicines in Leeds Approx. 7.2 million in 2013 for COPD Improvement in COPD patient outcomes is a priority 2

3 Prescription Cost Analysis - England, 2014 Drug Quantity Supplied Expenditure 1 Tiotropium 18mcg refills 3,799, ,637,730 2 Seretide 250 MDI 2,040, ,107,940 3 Symbicort 200/6 Turbohaler 2,043, ,310,430 4 Seretide 500 Accuhaler 2,041,100 98,247,900 5 Sitagliptan 100mg tablets 1,861,300 71,312,080 Inhaled medicines account for 6 of the top 7 drugs in terms of overall expenditure in primary care (includes Seretide 125 MDI & Symbicort 400/12 Turbohaler) accounting for 631 million in England BUT, are we getting value for money? Health & Social Centre Information Centre accessed 11 th October ,600,000 1,400,000 1,200,000 1,000, , , , ,000 0 LWCCG prescribing *Armley, Bramley & Pudsey Projected ICS ICS/LABA LABA LAMA LAMA/LABA The COPD value pyramid Assessment of COPD Assessment of COPD London Respiratory Network's Value Pyramid. Available at: Assessment of COPD: Education Assessment of COPD: Education Education Important to ensure patient knows & understands what COPD is. ACTION Use the BLF Living with COPD booklet as a guide. Ensure the patient understands what COPD is, and what they symptoms are. What is COPD? Chronic Inflammation: Parenchymal destruction Breakdown of alveolar attachments Loss of bronchiole elasticity Resulting Symptoms: Wheeze Breathlessness at rest & during activities Chronic irritation by tobacco smoke / noxious agents: Increased Narrowing no. of goblet cells of & airways enlarged submucosal glands Impaired mucociliary clearance Mucous plugging Chest tightness Cough Increased mucous & phlegm 3

4 Assessment of COPD Assessment of COPD: Spirometry GOLD (2016) Recommendations for the Management of COPD Assessment of COPD: Assess symptoms COPD Assessment Test (CAT) mmrc Dyspnoea Scale Assess degree of airflow limitation using spirometry Assess risk of exacerbations Combine these assessments for the purpose of improving management of COPD Spirometry Required to confirm diagnosis & assess severity of airflow limitation ACTION Have patients had their COPD diagnosis confirmed by spirometry (breathing tests)? Have patients had annual spirometry performed? If not, refer back to the GP. Assessment of COPD: Spirometry Assessment of COPD: Health Status Classification of Severity of Airflow Obstruction in COPD: Assess severity of airflow obstruction using reduction in FEV 1 Post-bronchodilator FEV 1 /FVC FEV 1 % predicted NICE clinical guideline 101 (2010) Post-bronchodilator < % Stage 1 (mild)* < % Stage 2 (moderate) < % Stage 3 (severe) < 0.7 < 30% Stage 4 (very severe)** * Symptoms should be present to diagnose COPD in people with mild airflow obstruction ** Or FEV 1 < 50% with respiratory failure Assessment of Health Status Two measures of health status are required: COPD Assessment Test (CAT) MRC Dyspnoea Scale ACTION Give the CAT questionnaire to the patient Complete immediately prior to each consultation Assess breathlessness using the MRC dyspnoea score Check MRC grade during each consultation. Assessment of COPD: Health Status Assessment of COPD: Health Status COPD Assessment Test (CAT) ( 8 Questions (max score 40) Score 5: normal healthy non-smokers <10: low impact of COPD on health status 10-20: medium impact >20: high impact >30: very high impact A change of 2 is clinically meaningful. MRC Dyspnoea Scale Ask patient to choose a phrase which best describes their condition; or Frame statements as a question MRC score 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 Walks slower than contemporaries on the level because of breathlessness, or has to stop for breath when walking at own pace Stops for breath after walking about 100m or after a few minutes on the level Too breathless to leave the house, or breathless when dressing or undressing Adapted from Fletcher CM. The clinical diagnosis of pulmonary emphysema an experimental study. Proc R Soc Med 1952;45:

5 Assessment of COPD: Exacerbations What does MRC mean? An MRC 3 separates people with more breathlessness from those with less breathlessness Action: Discuss Pulmonary Rehabilitation COPD Exacerbations (Flare ups) Definition: An acute event characterised by a worsening of the patient s respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication. A clinical diagnosis is made based on the presence of anacute change insymptoms (significantly increased breathlessness, cough and/or sputum production [volume/colour]). This change in symptom intensity is beyond a person s usual day-to-day variation. Causes: Infection (viral or bacterial) Air pollution Assessment of COPD: Exacerbations COPD Exacerbations Cost-effective Therapies ACTION: Ask each patients about their history of COPD exacerbations: 1 st Consultation: How many (requiring oral steroids and/or hospital admission) within past 12 months? 2 nd Consultation: How many since the 1 st consultation? Vaccination The COPD value pyramid Vaccination Influenza & Pneumococcal vaccination can reduce hospital admissions for both pneumonia and influenza, and reduce mortality risk. ACTION Ask about vaccination status Offer annual flu vaccination (up to end Feb 2016) From community pharmacy or GP Refer to GP for Pneumococcal (pneumonia) vaccination London Respiratory Network's Value Pyramid. Available at: 5

6 COPD & smoking Smoking FEV1 (% of value at age 25) Disability Never smoked or not susceptible to smoke Smoked regularly and susceptible to its effects Stopped at 45 Death Age (in years) Stopped at 65 Smoking Smoking History Stopping smoking is the most important & costeffective intervention in COPD ACTION: Give very brief advice (30 seconds) Refer to local NHS stop smoking service: Leeds NHS Stop Smoking Service Tel: Text: SMOKEFREE to stopsmokingleeds@nhs.net Web: CPPE/NCSCT Training: Stop smoking MCSCT practitioners assessment: knowledge and skills Learning about stop smoking support Fletcher CM, Peto R. The natural history of chronic airflow obstruction. BMJ 1977; 1(6077): Smoking Very Brief Advice Smoking Very Brief Advice Do you or anyone else in your household smoke? Do you know that stopping smoking can improve breathlessness, reduce hospital admissions, help prevent disease progression and increase life expectancy? It s never too late to stop. Have you ever thought of stopping or tried to stop before? I can tell you where to get the best help. Smoking Very Brief Advice Medication MEDICATION The Local NHS Stop Smoking Service can offer you support and advice on quitting. You are up to 4 times more likely to stop with the support from the service The Stop Smoking Service can make this much easier for you. Shall I refer you? It really is the best thing you can do right now. It s a free advice service 6

7 Inhalers Today Know your medicines! Inhaled Corticosteroids (ICS) Long-Acting Beta-2 Agonists (LABA) Long-Acting Muscarinic Antagonist (LAMA) Medication The Good Old days Medication Association Between and COPD exacerbations 50-75% of patients make errors using common inhaler devices (Accuhaler, pmdi, Turbohaler). 1 Between 1:3 and 1:10 patients make critical (serious) errors using these inhalers. 1 8% of healthcare professionals can use a pmdi correctly Molimard M et al. Journal of Aerosol Medicine 2003;16: Baverstock M et al. Thorax 2010;65(Suppl 4): A117-A118 % of patients exacerbating OR 1.47; p=0.001 OR 1.62; p<0.001 OR 1.50; p<0.001 OR 1.54; p< Hospital admissions Emergency dept visits At least 1 Critical Error Melani et al. Resp Med 2011;105: Antibiotic courses No Errors Corticosteroid courses Medication Medication Currently/Commonly Used Devices Newer Devices Currently/Commonly Used Devices Newer Devices Less Commonly Used Devices Less Commonly Used Devices Discontinued Devices introducing Discontinued Devices introducing 7

8 Symbicort Turbohaler Medication Atimos Modulite pmdi Generic Prescribing Budesonide/formoterol Beclometasone/formoterol DuoResp Spiromax Fluticasone/salmeterol DPI Seretide Accuhaler Formoterol AirFluSal Forspiro Formoterol Easyhaler Salbutamol Breath-actuated Foradil Aeroliser pmdi NEXThaler Oxis Turbohaler Future Problems: Generic tiotropium Others Medication: adherence Medication Adherence ACTION: Complete the Questions about using your PREVENTER INHALER questionnaire EXPLORE and identify reasons for reported nonadherence (e.g. due to beliefs, device, medicine, or side-effects). ASK the patient how they feel about using their COPD inhalers. Do they have any concerns about using these medicines? DISCUSS and agree strategies and solutions to improve adherence with the patient. A patient-centred approach should be used at all times Accuhaler Easyhaler Easi-Breathe Clickhaler Autohaler Pulvinal Novolizer Medication: adherence Framework for discussions How are you getting on with this medicine / inhaler? An open question to get the patient talking about issues that are important to them When and how often do you use this medicine / inhaler? Are you having any problems with this medicine/ inhaler, or concerns about taking or using it? It may be important to assure the patient that it is normal to have concerns about taking any medicine Do you think this medicine / inhaler is working? (Prompt- is this different from what you were expecting?) Patients should understand their medicines & benefits in COPD Do you think you are getting any side effects or unexpected effects? Consider filling in a Yellow Card if severe or drugs Allows discussion about managing/preventing side effects Medication: adherence Consultation The Four Es supporting ExcEllEncE in medicines adherence ters/consult-p-02_taster.pdf Medication: adherence Consultation The Four Es supporting ExcEllEncE in medicines adherence Medication: adherence Possible Causes of Non-Adherence Beliefs Device Medicine Denial of condition Concern about quantity Misunderstand condition Misunderstand treatment Fear of side-effects Embarrassment Dexterity problems Incorrect technique Incorrect cleaning of spacer Frequency of dosing Several different medicines Actual side-effects Forgetfulness Cost of prescription ters/consult-p-02_taster.pdf 8

9 Medication: adherence Adherence Interventions Information and education about COPD & medicines to address beliefs & concerns Set realistic expectations (e.g. ICS do not have an immediate effect on symptoms) Advice on use and care of inhaler devices & spacers Addressing forgetfulness: reminders, location etc Managing and avoiding ADRs Education on COPD Medicines Drug Role in Treatment Common side effects Short-acting beta 2 -agonist (SABA) Salbutamol, terbutaline Long-acting muscarinic antagonists (LAMA) Eklira, Incruse, Seebri, Spiriva Long-acting beta 2 -agonist (LABA) Onbrez, Oxis, Serevent, Striverdi PRN use for fast-acting relief of breathlessness and wheezing. Onset within 5 mins; duration: 4-6 hours. All COPD patients should have a SABA inhaler. Regular OD or BD use (aclidinium/eklira only). More effective than short-acting relievers, Larger improvements in lung function, breathlessness and quality of life, and reductions in hospitalisations. Recommended for patients with more significant COPD symptoms (CAT score 10; MRC 3). Regular OD (Onbrez and Striverdi ) or BD use. More effective than short-acting relievers, Larger improvements in lung function, breathlessness and quality of life, and reductions in hospitalisations. Recommended for patients with more significant COPD symptoms (CAT score 10; MRC 3). Tremor, palpitations, headache. Tend to occur with high use, or larger doses given as a nebuliser. Dry mouth is the most common side effect. This may be managed by rinsing mouth after use, or may require switch to an alternative within this class. Tremor, palpitations, headache, muscle cramps. May occur more commonly with high use of SABA. Education on COPD Medicines Drug Role in Treatment Common side effects Combination longacting bronchodilator Regular OD or BD (Duaklir only) use. Combining two classes of long-acting bronchodilator produces Side effects are likely to be similar to those observed with each single agent, i.e. dry mouth, tremor, palpitations, (LAMA/LABA) Anoro, Duaklir, Spiolto, Ultibro Greater increases in lung function, breathlessness and headache, muscle cramps. quality of life than using only one LA-bronchodilator. Significant increase in exercise endurance may be seen. In Leeds, they are recommended as a first-line option for patients with more significant COPD symptoms (CAT score 10; MRC 3), ahead of using single-agent long-acting bronchodilator. Combination corticosteroid & long-acting beta 2 - agonist (ICS/LABA) AirFluSal, DuoResp, Fostair, Relvar, Seretide, Sirdupla, Symbicort Regular OD (Relvar only) or BD use. ICS decrease the number & activity of inflammatory cells that are present in the lungs of people with severe COPD (FEV 1 <50%) who experience frequent exacerbations. NO role in mild-moderate airway obstruction as these inflammatory cells are not present in sig. numbers. NB. Inhaled corticosteroid inhalers are only licensed for use in COPD when used as a combination ICS/LABA inhaler. Local ICS ADRs: oral thrush and dysphonia. Management: rinse mouth after use, spacer with MDI, or switching to an alternative drug/device. Other ADRs include skin thinning and bruising, osteoporosis. Some ICS increase risk of pneumonia, which may require discontinuation. High dose ICS/LABA: issue High Dose Inhaled Steroid Warning Card. Evidence for the Side Effects of ICS Price et al. Prim Care Respir J 2013; 22(1): Risks of High Dose Inhaled Corticosteroids MHRA May 2006: Prolonged use of high doses of ICS carries a risk of systemic side effects... Corticosteroid treatment cards should be routinely provided for high doses of ICS. MHRA, September 2010: Inhaled (and intranasal) corticosteroids... High Dose Inhaled Corticosteroid Warning Cards, 2014 For all patients Rxed high doses of ICS ( 1000mcg BDP/day). Consider for medium doses of ICS (e.g. 800mcg BDP/day) + Intranasal steroids Further information: MHRA. Current Problems in Pharmacovigilance 2006 MHRA. Drug Safety Update

10 COPD Treatment: Combined Assessment Background information on Leeds COPD Formulary Risk (GOLD Classification of Airflow Limitation)) Good QoL & ET Poor lung function or (C) Many Exacerbations Good QoL & ET Good lung function Few Exacerbations (A) Poor QoL & ET Poor lung function Many Exacerbations (D) Poor QoL & ET Good lung function Few Exacerbations (B) 2 or > 1 leading to hospital admission 1 (not leading to hospital admission) 0 Risk (Exacerbation history) Manage Stable COPD: The Leeds Preferred Formulary Approach CAT < 10 Symptoms CAT > 10 MRC 1-2 MRC > 3 Breathlessness Adapted from Global Initiative for Chronic Obstructive Lung Disease 2015 Adapted from: Global Initiative for Chronic Obstructive Lung Disease 2015 How Should We Teach? How should we teach correct inhaler technique? Turbohaler Technique Score 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Pre n=8 Post n=7 Pre n=9 Post n=8 Pre n=9 Post n=9 Unsatisfactory Satisfactory Optimal Verbal Augmented Verbal Augmented Verbal + Physical Basheti IA et al. Respir Care 2005;50: Impact of Show and Tell Counselling Service Assess Technique using Placebos Show and Tell training method Re-assess technique Complete Labels Repeat at frequent intervals Impact of Show and Tell Counselling Service Basheti IA et al. Patient Education and counseling 2008;72:26-33 Basheti IA et al. Patient Education and counseling 2008;72:

11 Impact of Show and Tell Counselling Service Assessment Basheti IA et al. Patient Education and counseling 2008;72:26-33 Assessment ACTION: Assess & improve inhaler technique Step 1 - Check inhaler technique Patient should demonstrate how they use their own inhaler (unless newly prescribed). Assess Inhaler technique as Optimal (all steps completed correctly), Satisfactory (some minor errors, but all critical steps completed correctly), or Unsatisfactory (at least one critical error made). Step 2 - Teach correct inhaler technique Pharmacist/Technician should demonstrate correct inhaler technique to the patient. Issue Aerochamber where appropriate Step 3 - Check inspiratory flow - (when uncertain/definitely wrong) If necessary, use In-Check DIAL inspiratory flow meter to measure inspiratory flow through the inhaler device(s). Step 4 Re-check inhaler technique and check understanding After teaching correct technique, the patient should demonstrate how they would use it again. This allows Pharmacist/Technician to check understanding & reinforce any difficulties. Assess Inhaler technique as Optimal, Satisfactory, or Unsatisfactory. 1. Turn the DIAL to select the inhaler resistance Using In-Check Dial Currently validated for few common devices Device Setting Resistance Approximately Suitable for Setting pmdi Low pmdi Autohaler Low Autohaler EasiBreathe Low EasiBreathe, Breezhaler Accuhaler Medium-Low Accuhaler, Ellipta Turbohaler ( S Symbicort) Medium Turbohaler ( S Symbicort), Clickhaler, Spiromax, Genuair Turbohaler (old style) Medium-High Turbohaler (old style), NEXThaler, Twisthaler. Consider use for Easyhaler, HandiHaler (caution: this setting will overestimate actual inspiratory flow through these devices. Inspiratory flow rates <35L/min may suggest these devices are not suitable) 11

12 Exacerbations Exacerbations Exacerbations (flare ups) Exacerbations: Plan of Action Symptoms Well. Patient should understand: What is normal E.g. ADLs, SOB at rest & activity, phlegm Mild Flare Reduced energy Loss of appetite No fever & no change in phlegm Moderate Flare. Major symptoms More SOB & wheeze, &after SABA Increased phlegm (Vol. & colour) Plan of Action Continue Rx Healthy living Increase SABA Relax & get plenty of rest Take more time over ADLs Small meals, drink plenty As mild flare Start Rescue Pack & contact GP within 2 days BLF Action plan. Available at: Severe Flare. Danger signs Very SOB at rest Severe chest pain Drowsiness or confusion Blue appearance Urgent GP appointment or 999 Lifestyle All patients will benefit from brief lifestyle advice Refer to BLF Living with COPD booklet (p9, 16-19). Exercise At mild breathlessness pace for 30 minutes on 5 days a week Pulmonary rehabilitation Healthy balanced diet Fruit & veg, starchy foods for energy, protein foods, and dairy products Fluids Aids sputum clearance. 6-8 cups per day Managing Breathlessness Tips in BLF booklet p Specialist advice available through PR. Anxiety & Depression Signpost to BLF booklet p19. Emotional support from family & peers. Further support for patients 12

13 End of Consultation Summarise key points: Smoking cessation, inhaler technique & adherence, vaccination, healthy lifestyle Confirm issues being referred to their GP And send it to the GP! Ask if they have any final questions. Patient to complete feedback questions On the consultation form Arrange follow-up appointment. Record consultation on PharmOutcomes within 48hrs 13