Conducting MedicationReviews in asthma & COPD patients Noshi Iqbal Lead Pharmacist Clinical Training & Development October 2007
Learning OutcomesBy the end of this session, you will be able to:• Differentiate between the conditions of asthma & COPD (medication review perspective)• Advise on the suitability of inhaler devices for your patients (device considerations)• Understand the pharmacokinetics of inhaled drugs (inhaler selection in individuals)• Discuss national guidelines for asthma & COPD• Understand what information is needed in the GMS 06/07 asthma & COPD templates
Background knowledge• It is assumed that pharmacists are familiar with: – Asthma & COPD as medical conditions – General pharmacology of the conditions – Broad knowledge of disease management – Familiar with the BTS & SIGN guidelines for asthma management – Familiar with NICE guidelines for COPD management• References for the above has been provided in the module packs for the session.
Pharmacist interventionsDuring a medication review with an asthmatic or COPD patient, we should look out for:• Inappropriate use of medication – Dosage regimen as patient takes it – Patient’s knowledge of their medicine – Compliance• Side effects – Oral thrush (steroids), tremors (�� agonists) – Inappropriate formulation – Drug interactions (theophylline & antibiotics)• Other considerations – OTC medicines (regular cough preps, sedatives suggesting condition not under control) – Spacer replacing (once every year) & cleaning – Brand substitution (QVAR®, Clenil®, theophylline) – Number of doses in inhalers (so enough supplied per issue)• Advice – Physical activity, reduction in body weight, healthy eating & smoking cessation
Overview of asthma management• The aim of treatment of chronic asthma is to achieve early control, to prevent exacerbations, and to maintain control.• Treat asthma using a stepwise approach. Start treatment at level most appropriate to asthma severity.• Before recommending a new drug, check trigger factors have been eliminated, check inhaler technique and compliance – if trials of add-on therapies are ineffective – advise to stop – if trials of increased steroids are ineffective - advise to return to original dose• Step down treatment levels when control is good – review regularly whilst treatment is stepped down
Goals & outcome measures in asthmaBTS & SIGN guidelines for asthma:• Minimal symptoms during day and night• Minimal need for reliever medication• No exacerbations• No limitation of physical activity• Normal lung function, i.e. forced expiratory volume in 1 second (FEV1) or peak expiratory flow (PEF), or both, greater than 80% predicted (or best)
BTS & SIGN guidelines on asthma• Step 1 – As required reliever therapy: treat with a short- acting � ��agonist in mild intermittent asthma.• Step 2 – Regular preventer therapy: prevent asthma using an inhaled corticosteroid (ICS) in both adults & children• Step 3 – Add-on therapy: this consists of several treatment options, such as a trial of long-acting � ��agonist, increasing the dose of ICS, or adding one of a leukotriene receptor antagonist (especially in children under 5 years), theophylline, or an oral � ��agonist. Consider referral to respiratory paediatrician for children under 2 years.• Step 4 – Persistent poor control: increase to maximum dose of ICS and consider a trial of two add-on drugs. Refer all children under 5 years.• Step 5 – Continuous or frequent use of oral corticosteroids: add an oral corticosteroid to existing treatment as single daily dose, and consider referral for specialist advice (asthma clinic for adults, respiratory paediatrician for children) if symptoms are not controlled.
Notes• In addition to drug treatment, offer self-management education, including written asthma action plans, which should be tailored to the needs and preferences of the individual. Give advice on preventing exacerbations of asthma.• People who have exercise-induced asthma, or occupational asthma, or women who are pregnant, may require specific management, solicit asthma nurse adviceSteroid therapy• Inhaled steroids should be considered for patients with any of the following: exacerbation in the last two years, using � �� agonists > 3 times a week or waking 1 night a week• Once daily inhaled steroids at the same total daily dose can be considered if good control is established in milder disease• Higher doses of steroids may be needed in patients who are smokers /ex-smokers• Risk of systemic side effects with long-term or frequent oral steroid therapy – monitor BP, check for signs of diabetes, hyperlipidaemia & osteoporosis. In children also monitor growth, check if GP / asthma nurse has mentioned signs of adrenal suppression & screening for cataracts (in children).• Dose reduction should be slow e.g. 20-50% every 3 months
GMS Quality Indicators for asthmaRecords• ASTHMA 1 - The practice can produce a register of patients with asthma, excluding patients with asthma who have been prescribed no asthma-related drugs in the previous twelve months = 4 points.Initial Management• ASTHMA 8 - The percentage of patients aged eight and over diagnosed as having asthma from 1 April 2006 with measures of variability or reversibility = 15 points (40-80% threshold).Ongoing Management• ASTHMA 3 - The percentage of patients with asthma between the ages of 14 and 19 in whom there is a record of smoking status in the previous 15 months = 6 points (40- 80% threshold).• ASTHMA 6 - The percentage of patients with asthma who have had an asthma review in the previous 15 months = 20 points (40-70% threshold).
Where we can help with QOF Can help with ‘ongoing management’ • ASTHMA 3 – during a med review if we check smoking status • ASTHMA 6 – if we go through all asthma medication then can use XalfK ‘asthma medication review’ • If check inhaler technique can tick appropriate box
Overview of COPD management• A diagnosis of COPD should be considered in patients over 35 years who have a risk factor (usually smoking), and one or more of: – Exertional breathlessness – Chronic cough – Regular sputum production – Frequent ‘winter bronchitis’ – Wheeze• The degree of airflow obstruction cannot be predicted from symptoms or signs.
Goals & outcome measures in COPDNICE guidelines for COPD:• Lung function should be assessed using spirometry• Results indicate an abnormality if: – FEV1 is < 80% predicted – FVC is < 80% predicted – Ratio FEV1 / FVC < 70%• Classification % predicted FEV1 – Mild: 50-80% – Moderate: 30-49% – Severe: < 30%• Can assess severity of COPD by MRC (dyspnoea) scale, BMI• Mild / moderate COPD – assess annually• Severe COPD – assess twice a year• All patients should have a chest x-ray & FBC [to exclude lung cancer & blood disorders (anaemia, polycythaemia etc)]
What else could it be?The differential diagnosis of chronic obstructive pulmonary disease (COPD) includes any condition that presents with persistent breathlessness and/or cough. For example:• Asthma — family history, atopy, non-smoker, younger age, nocturnal symptoms.• Bronchiectasis — copious sputum, frequent chest infections, history of childhood pneumonia, coarse lung crackles.• Congestive cardiac failure — breathlessness when lying flat, history of ischaemic heart disease, fine lung crackles.• Lung carcinoma — haemoptysis, weight loss, hoarseness.• Interstitial lung disease (asbestosis, pneumoconiosis, fibrosing alveolitis) — dry cough, fine crackles.• Bronchopulmonary dysplasia — recurrent chest infections in young adult.• Anaemia.• Obstructive sleep apnoea. Note: some of these conditions may also coexist in a COPD patient. If you suspect any of these other symptoms – let GP know
Differences between asthma & COPDClinical features COPD AsthmaSmoker or ex-smoker Nearly all PossiblyAge < 35 years Rare OftenChronic productive Common UncommoncoughBreathlessness Persistent and Variable productiveNight time waking with Uncommon Commonbreathlessness orwheezeSignificant diurnal or Uncommon Commonday-to-day variation insymptoms
NICE guidelines on COPD• In people with stable COPD who are symptomatic with breathlessness &/or reduced exercise tolerance use the following: – Start with a short-acting bronchodilator (� ��agonist or antimuscarinic) as required. – If still symptomatic, either combine a short-acting � �� agonist with a short-acting antimuscarinic, or add in a long- acting bronchodilator (� ��agonist or antimuscarinic). – If still symptomatic, in moderate-to-severe COPD consider a trial of a combination of a long-acting � ��agonist and inhaled corticosteroids. – If still symptomatic, consider adding aminophylline or theophylline.• Review people 1-2 months after a treatment has been started, and if there is no symptomatic improvement it should be discontinued. Suggest a longer trial period in people who have started an inhaled corticosteroid.
NICE guidelines on COPD• In people with stable COPD who are having frequent exacerbations: – Optimise long-acting bronchodilator therapy with one or two long-acting bronchodilators. – Suggest to GP to add an inhaled corticosteroid — if the person has moderate-to-severe COPD (FEV1 less than 50%) and two or more exacerbations in a 12-month period. – In people troubled by a chronic productive cough, consider a trial of a mucolytic drug. – In people with an exacerbation of COPD, firstly exclude the need for admission to hospital, then increase the inhaled short-acting bronchodilator therapy to maximum, and consider starting a course of oral corticosteroids (if breathless), and an antibiotic if they have purulent sputum and/or signs of infection (do with GP).• People with frequent exacerbations should have an action plan (as part of their self-management plan) on how to recognise, and respond early (and appropriately) to, an exacerbation. Check with nurse what info he / she provides to patients.
NICE guidelines on COPD• Referral to a specialist should help with an uncertain diagnosis of COPD (or complications) and for consideration of additional therapies: – Oxygen therapy in anyone with moderate-to-severe COPD, signs of cor pulmonale, or polycythaemia. – Pulmonary rehabilitation in anyone who considered themselves functionally disabled by their COPD (usually MRC dyspnoea score > 3) – Nutritional supplements (after a dietician referral) in people with a BMI of less than 20 kg/m2.• All patients and carers should be aware that COPD can be a terminal disease and individuals with end-stage COPD should receive palliative care by a multi-disciplinary team.
Audit criteria in COPDNICE recommends the following audit criteria to investigate COPD:• Diagnosis of COPD – Percentage of people over the age of 35 years who smoke consulting with a chronic cough and/or breathlessness who have had spirometry performed. – Percentage of people with a diagnosis of COPD who have had spirometry performed.• Smoking cessation – Percentage of people with COPD who are current smokers recorded in the general practice records as having been offered smoking cessation advice and or therapy.• Effectiveness of inhaled therapy – Percentage of people with FEV1 of equal to, or less than, 50% predicted who have had two or more exacerbations in a 12-month period who are prescribed inhaled corticosteroid therapy.• Pulmonary rehabilitation – Percentage of people with COPD who have undergone pulmonary rehabilitation.• Management of exacerbations – Percentage of people with exacerbations receiving appropriate corticosteroids and/ or antibiotics.
FAQs about COPD1) When are oral corticosteroids recommended?• Long-term (maintenance) oral corticosteroids are generally not recommended for stable chronic obstructive pulmonary disease (COPD).• If the person finds it difficult to stop oral corticosteroids (e.g. has immediate worsening of symptoms) after repeated short courses prescribed for exacerbations and/or has severe breathlessness, consider referring for advice on maintenance oral corticosteroids• People taking maintenance oral corticosteroids should be: – On the lowest dose possible to alleviate disabling symptoms (e.g. prednisolone 5 mg/day). – Advised not to stop taking corticosteroids suddenly, and to carry a corticosteroid treatment card. – Monitored for the development of osteoporosis if under 65 years of age or started on prophylaxis treatment (with monitoring) if over 65 years of age.
FAQs about COPD2) When should antibiotics be prescribed?• An antibiotic should be started if the persons sputum is more purulent than usual and/or there are clinical signs of pneumonia.• Consult local antibiotic prescribing guidelines. Empirical treatment with: – An aminopenicillin (e.g. amoxicillin) is usually first-line. – A tetracycline (e.g. doxycycline), or a macrolide (e.g. erythromycin, or clarithromycin), are suitable alternatives. – If there is no clinical benefit after the first antibiotic, consider using an alternative antibiotic from the first-line options, or co-amoxiclav.• Note: use of an antibiotic is not recommended in the absence of purulent sputum.• Pneumonia in the elderly can be non-specific, but there should be an increased suspicion of infection if there is a temperature and/or clinical signs on examination (bronchial breathing, reduced air entry), increased breathlessness or cough, increased volume of sputum, reduced exercise capacity, or a recent hospitalisation. Prophylactic antibiotics are not recommended for people with stable chronic obstructive pulmonary disease, due to concerns about antibiotic resistance and potential adverse effects
GMS Quality Indicators for COPDRecords• COPD 1 - The practice can produce a register of patients with COPD = 3 pointsInitial diagnosis• COPD 9 - The percentage of all patients with COPD in whom diagnosis has been confirmed by spirometry including reversibility testing = 10 points (40-80% threshold)Ongoing management• COPD 10 - The percentage of patients with COPD with a record of forced expiratory volume in 1 second (FEV1) in the previous 15 months = 7 points (40-70% threshold)• COPD 11 - The percentage of patients with COPD receiving inhaled treatment in whom there is a record that inhaler technique has been checked in the previous 15 months = 7 points (40-90% threshold)• COPD 8 - The percentage of patients with COPD who have had influenza immunisation in the preceding 1 September to 31 March = 6 points (40-85% threshold)
Where we can help with QOF Can help with ‘initial diagnosis’ • COPD 9 – can check if patients have had a spirometry to confirm diagnosis Can help with ‘ongoing management’ • COPD 11 – if we check inhaler technique can select from drop down menu
Device considerations1) What patients want from an inhaler device – i.e. does it fit in with: – Lifestyle (carry in handbag, pocket, work in damp environments – DPIs clog) – Ability (using Spiriva®, MDI vs. Easi-Breathe®, child) – physical & sensory impairment (arthritis, blind, deaf) – learning disabilities (MDI technique vs. accuhaler) – Tracheostomies (difficult to administer – small volume spacer which fits trachy device – can then use MDIs)2) Cost effectiveness (60, 120 and 200 doses)3) Range of devices – ease of use, patient preference which will aid compliance & minimise costs by less wastage due to inappropriate use.
Pharmacokinetics of inhaled drugs• Drug molecules deposited in the mouth & oropharynx are: – swallowed – absorbed from the gut – taken into the portal circulation via the portal vein – metabolised & deactivated in the liver (first pass)• Systemic absorption also occurs in the lungs – smaller particle size of some CFC-free inhaled products can increased systemic drug availability (Qvar® – used at half the dose)• Some drugs are activated only when they reach the target lung site (pro-drugs e.g. ciclesonide)
• The drug dose stated on • Drug particle size the label is not always the has to be dose that reaches lungs between 2-5 microns to be• Some drugs are deposited in the metabolised & upper & central deactivated in the airways liver more effectively than others (reduces amount that • If size of drug reaches systemic circulation) – particles is less fluticasone vs. than 2 microns beclometasone drugs – passage to circulation can • High doses of inhaled occur across the corticosteroids may alveolar-capillary produce systemic effects interface
Biopharmaceutics of inhalers• Metered dose inhalers (MDIs) are pressurised, hand-held devices that use propellants to deliver doses of medication to the lungs of a patient.• The propellant evaporates leaving the drug particles to deposit in the lungs during an actuation• The Montreal Protocol on Substances That Deplete the Ozone Layer is an international treaty designed to protect the ozone layer by phasing out the production of a number of substances (including cfc-inhalers) believed to be responsible for ozone depletion. The treaty came into force on Jan 1st 1989 – it was agreed that CFC-free inhalers would be in use by 1996.
CFC-free inhalers• Hydrofluoroalkane 134a (HFAs) is the main type of CFC- free inhaler• All salbutamol MDIs in the UK are now CFC free• Inhaled steroids are more difficult to reformulate with HFA propellants, (especially beclometasone dipropionate) as the drug particles behave differently• QVAR® has a particle size of 2 microns to overcome this – care with dose (to minimise systemic drug bioavailability)• Modulite MDI use advanced technology where the orifice size is finer which alters the cloud characteristics of the drug particles enabling a slower moving inhaler cloud over a longer time period – advantage - less dependency on good coordination• Modulite technology has enabled HFA formulations to be developed with drugs that were previously difficult to reformulate• Clenil Modulite® & Respimat® utilise this new technology
Inhaler types• There are two main types of inhalers available:• Pressurised MDIs (including breath activated MDIs)• Dry powder inhalers (DPIs)
Inhaler technique• Generation of a drug aerosol for inhalation requires energy• The source of the energy varies depending on the device used: – In an MDI the aerosol is generated by the evaporation of the propellant – In a DPI the energy is generated from the flow of air through the device by the inspiratory effort that the patient produces – In a nebuliser the energy is provided by the driving gas• All inhaler devices require different amounts of effort; each patient will be different so it is important to determine from the inhaler technique which type of inhaler will be most suitable
Pressurised Metered Dose Inhalers (pMDIs)• The aerosol leaves the actuator of MDIs at high speed• Patients need to co-ordinate inhalation and actuation of the inhaler and needs to inhale at a low inspiratory flow rate• This serves to slow down the aerosol so that it doesn’t impact at the back of the throat and in the large airways• A common error with MDI technique is to inhale too fast Drug deposition Inspiratory flow Mouth Too slow Throat Too fast Lungs Correct
Dry Powder Inhalers (DPI)• A DPI is designed such that the patient’s inhalation through it will create sufficient turbulence to break the drug down (deaggregate it) into the right sized particles for inhalation (which form the dose)• The drug in many DPIs is attached to a carrier molecule (usually lactose)• When the turbulent airstream causes deaggregation:• Small drug particles are inhaled and deposited in the lungs• Larger particles and the lactose carrier are deposited in the mouth and swallowed• The inspiratory flow rate needed to deaggregate the drug to the appropriate fine particle mass varies from inhaler to inhaler• The amount of effort a patient needs to generate the appropriate level of flow also varies from device to device and depends on the internal design of the inhaler and amount of internal resistance this creates
The correct inhalation technique that generates the right inspiratory flow rate through the internal resistance of the inhaler needs to be taught if the optimum dose of drug is to reach the lungsA breath hold at the end of inhalation allows drug particles to settle in the small airways (sedimentation) andimprove deposition of drug in the lungs
Doing Medication Reviews with Asthma / COPD patients• Check patient understanding of treatment• Check if treatment suitable for patients• Provide advice to GPs & respiratory nurses on management of conditions• Help practices achieve GMS targets and participate in audit (fill numbers in weekly sheets)
References• BTS guidelines for asthma 2007• NICE guidelines for COPD Nov 05
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