Pharmaceutical Care in Asthma Omotola Morakinyo

FLOW OVERVIEW OF ASTHMA IMPROVING ASTHMA MANAGEMENT INHALER DEVICES SOAP CASE STUDY

Asthma is a two component disease Smooth muscle dysfunction Airway inflammation/ remodelling Inflammatory cell infiltration/ activation Mucosal oedema Cellular proliferation Epithelial damage Basement-membrane thickening ü ü Bronchoconstriction Bronchial hyper-reactivity Hyperplasia Inflammatory-mediator release ü ü Notes Asthma is a two-component disease with inflammation and bronchoconstriction at its core There is evidence that ICS/long-acting b2-agonist (LABA) combination therapy has complementary, additive, and synergistic inhibitory effects on pro-inflammatory signaling pathways, inflammatory mediator release, and recruitment and survival of inflammatory cells1 In patients with asthma, this is reflected in enhanced anti-inflammatory activity with combination therapy compared with LABAs or ICSs alone, or the potential for LABAs to provide a steroid-sparing effect1 In asthma, LABAs have shown to have long-last effects on airway smooth muscle and to attenuate components of acute inflammation1 Whereas ICSs inhibit many aspects of chronic inflammation and may resolve some of the processes of airway remodelling References Johnson M. Proc Am Thorac Soc 2004; 1: 200–206. ü ü ü ü ü ü ü Symptoms\exacerbations

Inflammation and bronchoconstriction: a two-part problem Damaged airway passage wall Inflammation Notes Inflammation is associated with a bronchoconstrictive response, as a result of recruitment of inflammatory cells into the airways1 The bronchoconstrictive response associated with acute inflammation is characterized by brief symptoms including wheezing, dyspnea, and shortness of breath which usually do not persist for more than a day or so1 Reference Bousquet J et al. Am J Resp Crit Care Med 2000; 161: 1720–1745. Airway inflammation and bronchoconstriction Normal airway

Aims of treatment People with asthma should: -Achieve and maintain control of symptoms -Prevent asthma exacerbations -Maintain normal activity levels, including exercise -Maintain pulmonary function as close to normal levels as possible

Asthma – a global healthcare issue Asthma is a worldwide problem Approximately 300 million individuals are affected1 Over the last 40 years there has been a sharp increase in the global prevalence, morbidity, mortality, and economic burden associated with asthma Asthma prevalence is expected to increase by 50% every decade Notes Asthma is a worldwide problem, affecting an estimated 300 million individuals1 The global prevalence of asthma ranges from 1% to 18% of the population in different countries1 The lack of a precise and universally accepted definition of asthma makes reliable comparison of reported prevalence from different parts of the world problematic1 Over the past 40 years, there has been a sharp increase in the prevalence, morbidity, mortality and economic burden associated with asthma, particularly in children2 The global prevalence of asthma is expected to increase by 50% every decade2 References 1. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007. 2. Braman SS. Chest 2006; 130: 4S–12S.

First, let’s define the terms ICS- Inhaled CorticoSteroid e.g Fluticasone propionate in Seretide LABA- Long Acting Beta-2 Agonist e.g Salmeterol in Seretide SABA- Short Acting Beta-2 Agonist e.g Salbutamol in Seretide Daily ICS + Daily LABA e.g Fluticasone propionate + Salmeterol (Seretide) Theophylline SR- e.g in Franol Oral corticosteroid e.g Prednisolone LTRA – LeukoTriene Receptor Antagonist e.g Montelukast in Singulair, Montiget. GINA – Global INitiative for Asthma

GINA stepwise management of asthma in adults and children >5 years Asthma control, rather than asthma severity1 3 Outcome: best possible results Outcome: Asthma Control When asthma is controlled, reduce therapy Monitor Controller: Daily ICS Plus Daily LABA Plus (if needed) Theophylline – SR Leukotriene LABA Oral corticosteroid Controller: Daily ICS Plus Daily LABA Controller: Daily ICS 2 Notes The recent update of the GINA guidelines places a strong emphasis on asthma control, rather than asthma severity, being the focus of treatment decisions1 GINA thus recommends a stepwise approach to treatment of asthma symptoms in adults and children >5 years. Each step represents treatment options that, although not of identical efficacy, are alternatives for controlling asthma2 Steps 1 to 5 provide options of increasing efficacy, except for Step 5 where issues of availability and safety influence the selection of treatment2 Step 2 is the initial treatment for most treatment-naive patients with persistent asthma symptoms. If symptoms at the initial consultation suggest that asthma is severely uncontrolled, treatment should be commenced at Step 32 GINA recommends that at each treatment step, a reliever medication should be provided for quick relief of symptoms. However, regular use of reliever medication is one of the elements defining uncontrolled asthma, and indicates that controller treatment should be increased. Thus, reducing or eliminating the need for reliever treatment is both an important goal and measure of success of treatment2 It is also recommended that treatment is stepped down once control is maintained, for example, controller treatment may be stopped if the patient’s asthma remains controlled on the lowest dose of controller and no recurrence of symptoms occurs for 1 year2 References 1. Bateman ED et al. Eur Respir J 2008; 31: 143–178. 2. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007. Controller: None Reliever: rapid-acting inhaled b2-agonist prn 1 STEP 1: STEP 2: STEP 3: STEP 4: Step Down Intermittent Mild Persistent Moderate Persistent Severe Persistent Step down

If a patient’s asthma is controlled, they should not experience asthma symptoms or exacerbations Exacerbations of asthma are episodes of progressive increase in shortness of breath, cough, wheezing, or chest tightness Severe exacerbations are potentially life-threatening and treatment requires close supervision GINA defines clinical control of asthma as involving no exacerbations Notes Exacerbations of asthma may be defined as increased intensity or frequency of symptoms and/or worsened lung function that force the patient to either change prescribed treatment and/or to seek medical attention1 Clinical control of asthma, as defined by the GINA guidelines, involves no exacerbations2 References 1. Fabbri L et al. Thorax 1998; 53: 803–808. 2. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007. 1. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007.

The goal of asthma management: guideline-defined control The Global Initiative for Asthma (GINA) defines clinical control of asthma as:1 No (twice or less/week) daytime symptoms No limitations of daily activities, including exercise No nocturnal symptoms or awakening because of asthma No (twice or less/week) need for reliever treatment Normal or near-normal lung function No exacerbations Notes Improved asthma control is reflected by fewer symptoms, less need for reliever medications, and fewer exacerbations1 It is recommended that treatment be aimed at controlling the clinical features of disease, including lung function abnormalities1 Overuse of rescue medication is an indication of poor asthma control. GINA defines >2/week use of rescue medication or 2 rescue medication prescriptions per year as suggestive of poor control1 Studies have shown that as few as 5% of patients meet all of the criteria for guideline-defined control2 In the AIRLA study, only 2.4% of asthma patients surveyed in South America achieved guideline-defined levels of control3 References 1. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007. 2. Rabe KF et al. Eur Resp J 2000; 16: 802–807. 3. Neffen H et al. Pan American Journal of Public Health 2005; 17: 191–197. 1. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007.

Any symptoms of asthma are a sign of inflammation Inflammation in asthma patients can be present during symptom-free periods:1 Symptoms resolve quickly. Inflammation, however, as measured by airway hyperresponsiveness, takes far longer1 As chronic inflammation causes an increase in airway hyperresponsiveness, if the inflammation is not controlled, symptoms are likely to reoccur. Notes Inflammation in asthma patients can be present during symptom-free periods Symptoms resolve quickly. Inflammation, however, as measured by airway hyperresponsiveness, takes far longer1 Any asthma symptoms are a sign of ongoing inflammation. As chronic inflammation causes an increase in airway hyperresponsiveness, if the inflammation is not controlled, symptoms are likely to reoccur Reference 1. Woolcock AJ. Clin Exp Allergy Rev 2001; 1: 62–64. 1. Woolcock AJ. Clin Exp Allergy Rev 2001; 1: 62–64.

The inhaler “buffet” The large number of inhalers marketed itself creates problems for healthcare professionals and patients !!

Inhaler Techniques

Idealhaler The ideal inhaler Patient friendly Easy to use 100% lung deposition Dose indicator Small Attractive Competely safe Inspiratory flow independent Easy to use Friendly to environment Discrete Inexpensive Moisture proof Multi-dose system etc.. Idealhaler, den ideala inhalatorn, finns inte i sinnevärlden. Alla inhalatorer utgör en kompromiss. Inte desto mindre bör vi ha dess egenskaper för ögonen när vi tar fram det mest lämpliga till våra patienter. Borgström L. Medicinskt Forum 1997; 4: 4-10

Patient compliance with asthma medication Concern about side effects Patient’s perceived need Past experience Poor Compliance Views of others Notes Compliance may be influenced by:1 Concern about side effects Patient’s negative attitude towards medicines in general Past experience Views of others Cultural influences Practical difficulties Patient’s perceived need Reference 1. Horne R. Chest 2006; 130; 65–72 Practical difficulties Cultural influences Patient’s negative attitude towards medicines in general 1. Horne R. Chest 2006; 130; 65–72

Tailoring treatment to patient needs: range of devices available for children with asthma Different age groups require different inhalers for effective therapy: Choice of inhaler must be individualised1 Children using a pressurised, metered-dose inhaler (MDI) without a spacer perform worst2 SFC is available as DPI and MDI formulations GINA Guidelines Age Preferred device <4 years Pressurised MDI + spacer with face mask Notes In addition to low patient expectations, insufficient monitoring by health professionals, and the underutilisation of ICSs, it has also been suggested that persistent symptoms of asthma in children may be a result of the prescribing of inappropriate inhalers and/or inadequate inhaler technique1 It is well recognised that the selection of an appropriate inhaler device is as important as choosing the right medication2 Guidelines recommend that different age groups require different inhalers for effective therapy, so the choice of inhaler must be individualised3 A study of inhalation techniques in the Netherlands has shown that of 76% of children who inhale their medication incorrectly, children using a pressurised, metered-dose inhaler (MDI) without a spacer perform worst4 GINA guidelines also suggest a MDI with spacer is preferable to nebulized therapy due to its greater convenience, more effective lung deposition, lower risk of side effects, and lower cost in children aged 4–6 years3 Spacer devices with face masks are available for younger children and are recommended by guidelines for use in children less than 4 years3 In children ≥6 years, dry powder inhaler, or breath-actuated pressurized MDI, or pressurized metered-dose inhaler with spacer and mouthpiece are recommended3 References Child F et al. Arch Dis Child 2002; 86: 176–179. Gilles J. Pediatr Pulmonol 1997; 15: 55–58. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007. Hagmolen of ten Have W et al. J Asthma 2008; 45: 67–71. 4–6 years Pressurised MDI + spacer ≥4 years Dry powder inhaler or breath-actuated pressurised MDI, or pressurised MDI with spacer + mouthpiece 1. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007. 2. Hagmolen of ten Have W et al. J Asthma 2008; 45: 67–71.

Special situations

Occupational asthma Remove precipitating factor Treat as normal

Developing Pharmaceutical Care plan Step 1. Gathering Information Step 2. Identifying Problems Stop 3. Assessing Problems Step 4. Developing the Plan Step 5. Evaluating the Achievement of Outcomes

Gathering information The pharmacist should gather both OBJECTIVE and SUBJECTIVE DATA - an accurate medication history, including both prescription and nonprescription medications and the reasons the medications were prescribed or taken. Vital signs The pharmacist may have to obtain some information from the physician, such as laboratory test results and hospitalizations. If so, the pharmacist should get written permission from the patient before soliciting this information. Once this information is compiled, the preparation of a PCP can begin.

Identifying drug therapy problems From the patient's medication profile, only one problem is evident: diagnosis of asthma. If applicable, other problem should also be listed. Subjective and objective findings correlated to the problem are listed. Subjective findings are those that the patient describes (e.g., 'I feel tired all the time, “I feel bloated,” or "I woke up coughing Objective findings are those that can be observed or measured by the pharmacist (e.g., patient appears tired, blood pressure is 180/105, pitting edema in ankles). The pharmacist would have the patient use a peak expiratory flow meter and record the results.

Assessing DTP The pharmacist analyzes and integrates the information gathered, draws conclusions in preparation for developing a patient-specific PCP. The pharmacist may first investigate the etiology of the factors that exacerbated the asthma. The pharmacist should attempt to determine if drugs (eg., aspirin, nonsteroidal anti-inflammatory agents, or beta-blockers) caused or exacerbated the asthma in the patient. Thus, the importance of an accurate and complete drug history becomes evident. Next, the pharmacist assesses the severity of the asthma. This could be accomplished by determining the PEFR, examining the patient's daily symptom and peak flow diary, or determining if the patient had been hospitalized and placed on steroids or nebulized.

Developing plan The pharmacist establishes goals linked to each of the patient's problems and specifies a course of action aimed at meeting each goal. Each goal (i.e., desired improvement) should be stated in terms of measurable outcomes that indicate the extent to which the particular problem has been resolved. Often, the patient has several problems, and the plan must be comprehensive enough to have a positive effect on the overall health of the patient.

Evaluating the Achievement of Outcomes Outcomes must be meaningful, measurable, and manageable. Outcomes are specific, measurable indicators for the goals of treatment. Thus, they should be identified in the planning process. The outcomes for asthma include, lower frequency and severity of acute exacerbations, fewer physician office visits, elimination of side effects, PEFRs that never fall below 80% of previous personal-best predicted rates, fewer emergency department visits, and maintenance of activities that enhance the patient's quality of life.

Documentation should include these components 1. Patient data such as name, medical record number, location, date of hospital admission (if applicable). age, sex, height, weight, known medication or other allergies, and medication history. 2. Name of pharmacist(s) responsible for developing and implementing the PCP. 3. Patient problem(s) listed Individually in order of potential pharmacotherapeutic impact (highest to lowest priority). Subjective and objective data that lead to identification of a specific problem and potential drug-related problems should also be included. 4. Date on which a patient problem is identified. Many diseases remain chronic throughout the patient's life. Problems such as urinary tract infection or upper respiratory tract infection usually resolve in 10 to 14 days.

Asthma Control Test (1) This slide and the next show the 5 questions that were found to be highly predictive of the specialist’s global assessment of asthma control and prebronchodilator FEV1 (% predicted) and were included in the ACT. Asthma prevents patient getting as much done at work/home. Shortness of breath. Waking with asthma symptoms at night. Use of rescue medication. Patient rating of asthma control.

Asthma Control Test (2) Each question could be answered on a 5-point scale, so the total score could range from 5 to 25.

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