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National Institutes of Health (NIH) NAEPP 2007 Asthma Guideline Expert Panel Report (EPR) ‐3 Susan K. Ross RN, AE‐C MDH Asthma Program 651‐201‐5629 [email protected] 1 National Institutes of Health National Asthma Education Prevention Program (NAEPP) 2007 Guidelines for the Diagnosis and Management of Asthma (EPR-3) http://www.nhlbi.nih.gov/guidelines/asthma/index.htm National Asthma Education and Prevention Program 2 What is Asthma? “Asthma is a common chronic disorder of the airways that involves a complex interaction of airflow obstruction, bronchial hyperresponsiveness and an underlying inflammation. This interaction can be highly variable among patients and within patients over time”. 3 EPR 3‐ EPR 3‐ Section 2, p 12. Characteristics of Asthma • Airway Inflammation • Airway Obstruction (reversible) • Hyperresponsiveness (irritability of airways) 4 Normal & Asthmatic Bronchiole 5 Why Do We Need Asthma Guidelines? 6 Asthma: – – In 2008, it was estimated that 23.3 million Americans currently have asthma Is one of the most common chronic disorders in childhood, affecting an approx. 7.1 million children under 18 years (9.6%) In 2007, 3,447 deaths were attributed to asthma, 152 deaths were children under the age of 15 Is the third leading cause of hospitalization among children under the age of 15 Is one of the leading causes of school absenteeism In 2008 asthma accounted for approx. 14.4 million lost school days The annual health care costs of asthma is approx. $20.7 billion dollars 1 – 2 – 6 – 3 4 – 5 From ALA website 11/2010 www.Lungusa.org 1 CDC: National Center for Health Statistics, National Health Interview Survey Raw Data, 2009 2 CDC. National Center for Health Statistics. Final Vital Statistics Report. Deaths: Final Data for 2007. April 17, 2009. Vol 58 No 19. 3 CDC. National Center for Chronic Disease Prevention and Health Promotion. Healthy Youth! Health Topics: Asthma. August 14, 2009 4 CDC: National Center for Health Statistics, National Health Interview Survey Raw Data, 2008. 5 NHLBI Chartbook, U.S. Department of Health and Human Services, National Institute of Health, 2009 6 CDC: National Center for Health Statistics, National Hospital Discharge Survey, 2006. 7 2007 ‐ Guidelines for the Diagnosis & Management of Asthma Expert Review Panel (EPR‐3) 8 Asthma Guidelines: History & Context Initial guidelines released in 1991 and updated in 1997 Updated again in 2002 (EPR‐2) with a focus on several key questions about medications, monitoring and prevention – – – – Long‐term management of asthma in children Combination therapy Antibiotic use Written asthma action plans (AAP) and peak flow meters (PFM) – Effects of early treatment on the progression of asthma 9 Old & New Asthma Guidelines: What has not changed Initial asthma therapy is determined by assessment of asthma severity – Ideally, before the patient is on a long‐term controller Stepping therapy up or down is based on how well asthma is controlled or not controlled Inhaled corticosteroids (ICS) are the preferred first‐line therapy for asthma Systemic steroids can still be used to treat asthma exacerbations Peak flows and written asthma action plans are recommended for asthma self management – Especially in moderate and severe persistent asthma, or for those with a history of severe exacerbations or poorly controlled asthma 10 Asthma Therapy Goals “The goal of asthma therapy is to control asthma so patients can live active, full lives while minimizing their risk of asthma exacerbations and other problems” Dr. William Busse, MD., chairman of the NAEPP EPR ‐3 11 2007 ‐ Guidelines for the Diagnosis & Management of Asthma (EPR‐3) – – – – – – (Almost) no new medications Restructuring into “severity” and “control” Domains of “impairment” and “risk” Six treatment steps (step‐up/step‐down) More careful thought into ongoing management issues Summarizes extensively‐validated scientific evidence that the guidelines, when followed, lead to a significant reduction in the frequency and severity of asthma symptoms and improve quality of life 12 New Strategies of the EPR‐3 Assessment Management Severity The intrinsic intensity of A clinical guide most useful the disease process for initiating controller therapy Control The degree to which symptoms are minimized & goals are met (After therapy is initiated) a clinical guide used to maintain or adjust therapy Responsiveness The ease of which prescribed therapy achieves asthma control (Variable) frequent followup to step-up and stepdown therapy to achieve the goal of control 13 Key Points: Definition, Pathophysiology & Pathogenesis – Asthma is a chronic inflammatory disorder of the airways – The immunohistopathologic features of asthma include inflammatory cell infiltration – Airway inflammation contributes to airway hyperresponsiveness, airflow limitation, respiratory symptoms, and disease chronicity – In some patients, persistent changes in airway structure occur, including sub‐basement fibrosis, mucus hypersecretion, injury to epithelial cells, smooth muscle hypertrophy, and angiogenesis (remodeling) 14 Key Points: cont.. – Gene‐by‐environment interactions are important to the expression of asthma – Atopy, the genetic predisposition for the development of an immunoglobulin E (IgE)‐mediated response to common aeroallergens, is the strongest identifiable predisposing factor for developing asthma – Viral respiratory infections are one of the most important causes of asthma exacerbation and may also contribute to the development of asthma EPR 3, Section 2: Page 11 15 Causes – We Don’t Know…Yet! – Asthma has dramatically risen worldwide over the past decades, particularly in developed countries, and experts are puzzled over the cause of this increase – Not all people with allergies have asthma, and not all cases of asthma can be explained by allergic response – Asthma is most likely caused by a convergence of factors that can include genes (probably several) and various environmental and biologic triggers – e.g., infections, dietary patterns, hormonal changes in women, and allergens 16 4 Components of Asthma Management Component 1: Measures of Asthma Assessment & Monitoring Component 2: Education for a Partnership in Asthma Care Component 3: Control of Environmental Factors & Comorbid Conditions that Affect Asthma Component 4: Medications 17 Component 1 Measures of Asthma Assessment & Monitoring 18 Key Points ‐ Overview: Measures of Asthma Assessment & Monitoring Assessment and monitoring are closely linked to the concepts of severity, control, and responsiveness to treatment: – Severity ‐ intensity of the disease process. Severity is measured most easily and directly in a patient not receiving long‐term‐control therapy. – Control ‐ degree to which asthma (symptoms, functional impairments, and risks of untoward events) are minimized and the goals of therapy are met. – Responsiveness ‐ the ease with which asthma control is achieved by therapy. 19 EPR ‐ EPR ‐3 , Pg. 36, Key Points – cont. Domains Assess Severity and Control based on: Impairment (Present): – Frequency and intensity of symptoms – Functional limitations (quality of life) Risk (Future): – Likelihood of asthma exacerbations or – Progressive loss of lung function (reduced lung growth) – Risk of adverse effects from medication EPR ‐ EPR ‐3, Pg. 38‐ 3, Pg. 38‐80, 277‐ 80, 277‐345 20 Key Points ‐ cont. Severity & Control Are used as follows for managing asthma: If the patient is not currently on a long‐term controller at the first visit: – Assess asthma severity to determine the appropriate medication & treatment plan Once therapy is initiated, the emphasis is changed to the assessment of asthma control – The level of asthma control will guide decisions either to maintain or adjust therapy 21 Assessing Impairment (Present) Domain Assess by taking a careful, directed history and lung function measurement Assess Quality of Life using standardized questionnaires – Asthma Control Test (ACT) – Childhood Asthma Control Test – Asthma Control Questionnaire – Asthma Therapy Assessment Questionnaire (ATAQ) control index Some patients may perceive the severity of airflow obstruction poorly 22 Assessing Risk (Future) Domain – Of adverse events in the future, especially of exacerbations and of progressive, irreversible loss of pulmonary function—is more problematic (airway remodeling) – The test most used for assessing the risk of future adverse events is spirometry 23 Measures of Assessment & Monitoring Diagnosis 24 Key Points – Diagnosis of Asthma To establish a diagnosis of asthma the clinician should determine that: – Episodic symptoms of airflow obstruction or airway hyperresponsiveness are present – Airflow obstruction is at least partially reversible – Alternative diagnoses are excluded 25 Key Points – Methods to Establish Diagnosis Recommended methods to establish the diagnosis are: – Detailed medical history – Physical exam focusing on the upper respiratory tract, chest, and skin – Spirometry to demonstrate obstruction and assess reversibility, including in children 5 years of age or older – Additional studies to exclude alternate diagnoses 26 Key Indicators: Diagnosis of Asthma Has/does the patient: – – – – – – had an attack or recurrent attacks of wheezing? have a troublesome cough at night? wheeze or cough after exercise? experience wheezing, chest tightness, or cough after exposure to airborne allergens or pollutants? colds ‘go to the chest’ or take more than 10 days to clear up? symptoms improved by appropriate asthma treatment? 27 Adapted from the GINA guidelines 2008 Characterization & Classification of Asthma Severity 28 Key Points ‐ Initial Assessment: Severity Once a diagnosis is established: – Identify precipitating factors (triggers) – Identify comorbidities that aggravate asthma – Assess the patient’s knowledge and skills for self‐ management – Classify severity using impairment and risk domains Pulmonary function testing (spirometry) to assess severity EPR ‐ EPR ‐3, Sec. 3, pg. 47 29 Assessment of Asthma Severity Previous Guidelines Frequency of daytime symptoms Frequency of nighttime symptoms Lung function 2007 Guidelines Impairment – Frequency of daytime /nighttime symptoms – Quality of life assessments – Frequency of SABA use – Interference with normal activity – Lung function (FEV1/FVC) Risk – Exacerbations (frequency and severity) 30 NOT Currently Taking Controllers C la ssifica tio n o f A sth m a S e v e rity (0 4 y e a rs o f a g e ) C o m p o n e n ts o f S e v e rity Im p a irm e n t R isk P e rs iste n t In te rm itte n t M ild M o d e ra te S e v e re S ym p to m s 2 d a ys/w e e k > 2 d a ys/w e e k b u t n o t d a ily D a ily T h ro u g h o u t th e d a y N ig h ttim e a w a ke n in g s 0 1 2 x /m o n th 3 4 x /m o n th > 1 x/w e e k S h o rt-a ctin g b e ta 2 -a g o n ist u se fo r sym p to m co n tro l (n o t p reven tio n o f E IB ) 2 d a ys/w e e k > 2 d a ys/w e e k b u t n o t d a ily D a ily S e ve ra l tim e s per day In te rference w ith n o rm a l a ctivity None M in o r lim ita tio n S o m e lim ita tio n E xtrem ely lim ited E xa ce rb a tio n s re q u irin g o ra l syste m ic co rtico ste ro ids 0 1 /ye a r 2 e xa ce rb a tio n s in 6 m o n th s re q u irin g o ra l syste m ic co rtico ste ro ids, o r 4 w h e e zin g e p iso d e s/1 y e a r la stin g > 1 d a y A N D risk fa cto rs for p e rsiste n t a sth m a C o n sid er se ve rity a n d in te rva l sin ce la st e xa ce rb a tio n . Fre q u e n cy a n d se v e rity m a y flu ctu a te o v e r tim e . E xa ce rb a tio n s o f a n y se ve rity m a y o ccu r in p a tie n ts in a n y se v e rity ca te g o ry. R e c o m m e n d e d S te p fo r In itia tin g T h e ra p y (S e e fig u re 4 1 a fo r tre a tm e n t s te p s .) S te p 1 S te p 2 S te p 3 a n d co n sid e r sh o rt co u rse o f o ra l syste m ic co rtico ste ro id s In 2 6 w e e ks, d e p e n d in g o n se ve rity, e va lu a te le v e l o f a sth m a co n tro l th a t is a ch ie ve d . If n o cle a r b e n e fit is o b se rve d in 4 6 w e eks, co n sid e r a d ju stin g th e ra p y o r a lte rn a tiv e d ia g n o se s. Level of severity is determined by both impairment and risk. Assess impairment by caregivers recall of previous 2‐4 weeks. NOT Currently Taking Controllers Classification of Asthm a Severity (511 years of age) Com ponents of Severity Persistent Interm ittent M ild M oderate Severe 2 days/week >2 days/week but not daily Daily Throughout the day Nighttim e awakenings 2x/month 34x/month >1x/week but not nightly Often 7x/week Short-acting beta 2 -agonist use for sym ptom control (not prevention of EIB) 2 days/week >2 days/week but not daily Daily Several times per day Interference with norm al activity None Minor limitation Some limitation Extremely limited Sym ptom s Im pairm ent • Normal FEV 1 between exacerbations Lung function Risk Exacerbations requiring oral systemic corticosteroids Recom m ended Step for Initiating Therapy (See figure 41b for treatm ent steps.) • FEV 1 >80% predicted • FEV 1 = >80% predicted • FEV 1 = 6080% predicted • FEV 1 <60% predicted • FEV 1 /FVC >85% • FEV 1 /FVC >80% • FEV 1 /FVC = 7580% • FEV 1 /FVC <75% 01/year (see note) 2/year (see note) Consider severity and interval since last exacerbation. Frequency and severity may fluctuate over time for patients in any severity category. Relative annual risk of exacerbations may be related to FEV 1 . Step 1 Step 2 Step 3, mediumdose ICS option Step 3, medium-dose ICS option, or step 4 and consider short course of oral systemic corticosteroids In 26 weeks, evaluate level of asthma control that is achieved, and adjust therapy accordingly. NOT Currently Taking Controllers Classification of Asthm a Severity 12 years of age Com ponents of Severity Interm ittent M ild M oderate 2 days/w eek > 2 days/w eek but not daily Daily Throughout the day Nighttim e aw akenings 2x/m onth 34x/m onth > 1x/w eek but not nightly Often 7x/w eek Short-acting beta 2 -agonist use for sym ptom control (not prevention of EIB) 2 days/w eek Daily Several tim es per day Interference w ith norm al activity None Sym ptom s Im pairm ent N orm al FEV 1 /FVC : 819 yr 85% 20 39 yr 80% 40 59 yr 75% 60 80 yr 70% >2 days/w eek but not daily, and not m ore than 1x on any day M inor lim itation Som e lim itation Severe Extrem ely lim ited • Norm al FEV 1 betw een exacerbations Lung function R isk Persistent Exacerbations requiring oral system ic corticosteroids • FEV 1 > 80% predicted • FEV 1 > 80% predicted • FEV 1 > 60% but < 80% predicted • FEV 1 < 60% predicted • FEV 1 /FVC norm al • FEV 1 /FVC norm al • FEV 1 /FVC reduced 5% • FEV 1 /FVC reduced > 5% 01/year (see note) 2/year (see note) Consider severity and interval since last exacerbation. Frequency and severity m ay fluctuate over tim e for patients in any severity category. Relative annual risk of exacerbations m ay be related to FEV 1 . R ecom m ended Step for Initiating Treatm ent (See figure 45 for treatm ent steps.) Step 3 Step 1 Step 2 Step 4 or 5 and consider short course of oral system ic corticosteroids In 26 w eeks, evaluate level of asthm a control that is achieved and adjust therapy accordingly. Classifying Severity AFTER Control is Achieved – All Ages Classification of Asthma Severity Lowest level of treatment required to maintain control Intermittent Step 1 Persistent Mild Moderate Severe Step 2 Step 3 or 4 Step 5 or 6 (already on controller) Periodic Assessment & Monitoring Asthma Control 35 Key Points – Asthma Control (Goals of Therapy) Reducing impairment – Prevent chronic & troublesome symptoms – Prevent frequent use (< 2 days /wk) of inhaled SABA for symptoms – Maintain (near) “normal” pulmonary function – Maintain normal activity levels (including exercise and other physical activity and attendance at work or school) – Meet patients’ and families’ expectations of and satisfaction with asthma care 36 EPR‐ EPR‐ 3, p. 50 Key Points – cont. Reducing Risk – Prevent recurrent exacerbations of asthma and minimize the need for ER visits and hospitalizations – Prevent progressive loss of lung function ‐ for children, prevent reduced lung growth – Provide optimal pharmacotherapy with minimal or no adverse effects Periodic assessments at 1‐6 month intervals Patient self‐assessment (w/clinician) Spirometry testing EP‐ EP‐3 , sec. 3, p. 53 37 Key Points cont. ‐ Written AAP’s & PFM Provide to all patients a written AAP based on signs and symptoms and/or PEF – Written AAPs are particularly recommended for patients who have moderate or severe persistent asthma, a history of severe exacerbations or poorly controlled asthma. Whether PF monitoring, symptom monitoring (available data show similar benefits for each), or a combo of approaches is used, self‐ monitoring is important to the effective self‐ management of asthma. EPR ‐ EPR ‐3 Sec. 3, P.53 38 Peak Flow Monitoring Long‐term daily PF monitoring can be helpful to: – Detect early changes in asthma control that require adjustments in treatment: – Evaluate responses to changes in treatment – Provide a quantitative measure of impairment EPR‐ EPR‐3 , Sec. 3, P.54 39 Asthma Control = Asthma Goals Definition of asthma control is the same as asthma goals reducing impairment and risk Monitoring quality of life, any: – work or school missed because of asthma? – reduction in usual activities? – disturbances in sleep due to asthma? – Change in caregivers activities due to a child's asthma? 40 Responsiveness ‐ Questions for Assessing Asthma Control Ask the patient: – – – – – Has your asthma awakened you at night or early morning? Have you needed more quick‐relief medication (SABA) than usual? Have you needed any urgent medical care for your asthma, such as unscheduled visits to your provider, an UC clinic, or the ER? Are you participating in your usual and desired activities? If you are measuring your peak flow, has it been below your personal best? 41 Adapted from Global Initiative for Asthma: Pocket Guide for Asthma Management & Prevention.” 1995 Responsiveness ‐ Actions Actions to consider: – – – – Assess whether the medications are being taken as prescribed Assess whether the medications are being inhaled with correct technique Assess lung function with spirometry and compare to previous measurement Adjust medications, as needed; either step up if control is inadequate or step down if control is maximized, to achieve the best control with the lowest dose of medication 42 Adapted from Global Initiative for Asthma: Pocket Guide for Asthma Management & Prevention.” 1995 Assessing Asthma Control in Children 0 ‐ 4 Years of Age C o m p o n e n ts o f C o n tro l I m p a irm e n t C la s s ific a tio n o f A s th m a C o n tro l (C h ild re n 0 4 y e a rs o f a g e ) W e ll C o n tro lle d N o t W e ll C o n tro lle d V e ry P o o rly C o n tro lle d S ym p to m s 2 d a ys/w ee k > 2 d a ys/w ee k T hro ug ho ut the d a y N ig h ttim e aw ake n ing s 1 x /m o nth > 1 x/m o n th > 1 x/w ee k In te rfe re n ce w ith n o rm al activity None S o m e lim ita tio n E xtrem e ly lim ite d S h o rt-a ctin g b e ta 2 -a g o n ist u se fo r sym p to m co ntro l (n o t p re ve n tio n o f E IB ) 2 d a ys/w ee k > 2 d a ys/w ee k S e ve ra l tim e s p e r d a y E xa ce rb a tio n s re q u iring o ra l system ic co rtico stero id s 0 1/ye ar 2 3/ye ar > 3 /ye a r R is k T re a tm e nt-re la ted a d ve rse e ffe cts M e d ica tio n sid e e ffe cts ca n va ry in in te n sity fro m n o n e to ve ry tro u b le so m e a n d w o rriso m e . T h e le ve l o f in te n sity d o e s no t co rre la te to sp e cific le ve ls o f co n tro l b ut sho u ld b e co n sid ere d in th e o ve ra ll a sse ssm e n t o f risk. Assessing Asthma Control in Children 5 ‐ 11 Years of Age C la s s ific a t io n o f A s t h m a C o n t r o l ( C h ild r e n 5 1 1 y e a r s o f a g e ) C o m p o n e n ts o f C o n tr o l I m p a ir m e n t W e ll C o n t r o lle d N o t W e ll C o n t r o lle d V e r y P o o r ly C o n t r o lle d S y m p to m s 2 d a y s /w e e k b u t n o t m o re th a n once on each day > 2 d a y s /w e e k o r m u ltip le tim e s o n 2 d a y s /w e e k T h ro u g h o u t th e d a y N ig h ttim e a w a k e n in g s 1 x /m o n th 2 x /m o n th 2 x /w e e k In te rfe re n c e w ith n o rm a l a c tiv ity None S o m e lim ita tio n E x tre m e ly lim ite d S h o rt-a c tin g b e ta 2 -a g o n is t u s e fo r s y m p to m c o n tro l (n o t p re v e n tio n o f E IB ) 2 d a y s /w e e k > 2 d a y s /w e e k S e v e ra l tim e s p e r d a y L u n g fu n c tio n F E V 1 o r p e a k flo w > 8 0 % p re d ic te d / p e rso n a l b e s t 6 0 8 0 % p re d ic te d / p e rso n a l b e s t < 6 0 % p re d ic te d / p e rso n a l b e s t F E V 1 /F V C > 80% 7580% < 75% E x a c e rb a tio n s re q u irin g o ra l s y s te m ic c o rtic o s te ro id s R is k R e d u c tio n in lu n g g ro w th T re a tm e n t-re la te d a d v e rs e e ffe c ts 0 1 /y e a r 2 / y e a r (s e e n o te ) C o n s id e r s e v e rity a n d in te rv a l s in c e la s t e x a c e rb a tio n E v a lu a tio n re q u ire s lo n g -te rm fo llo w u p . M e d ic a tio n s id e e ffe c ts c a n v a ry in in te n s ity fro m n o n e to v e ry tro u b le s o m e a n d w o rris o m e . T h e le v e l o f in te n s ity d o e s n o t c o rre la te to s p e c ific le v e ls o f c o n tro l b u t s h o u ld b e c o n s id e re d in th e o v e ra ll a s s e s s m e n t o f ris k . Assessing Asthma Control in Youths 12 Years of Age & Adults C o m p o n e n ts o f C o n tr o l S y m p to m s N ig h ttim e a w a k e n in g In te rfe re n ce w ith n o rm a l a ctiv ity I m p a irm e n t S h o rt-a ctin g b e ta 2 -a g o n is t u s e fo r s y m p to m co n tro l (n o t p re v e n tio n o f E IB ) F E V 1 o r p e a k flo w C la s s ific a tio n o f A s th m a C o n tr o l (Y o u th s 1 2 y e a rs o f a g e a n d a d u lts ) W e ll-C o n tro lle d Not W e ll-C o n tro lle d V e ry P o o rly C o n tro lle d 2 d a y s /w e e k > 2 d a y s /w e e k T h ro u g h o u t th e d a y 2 x /m o n th 1 3 x /w e e k 4 x /w e e k None S o m e lim ita tio n E x tre m e ly lim ite d 2 d a y s /w e e k > 2 d a y s /w e e k S e v e ra l tim e s p e r d a y > 8 0 % p re d icte d / p e rs o n a l b e s t 6 0 8 0 % p re d icte d / p e rs o n a l b e s t < 6 0 % p re d icte d / p e rs o n a l b e s t 0 0 .7 5 * 20 1–2 1 .5 1619 3–4 N /A 15 V a lid a te d Q u e s tio n n a ire s ATAQ ACQ ACT E x a ce rb a tio n s R is k 0 1 /y e a r 2 /y e a r (s e e n o te ) C o n s id e r s e v e rity a n d in te rv a l s in ce la s t e x a c e rb a tio n P ro g re s s iv e lo s s o f lu n g fu n ctio n E v a lu a tio n re q u ire s lo n g -te rm fo llo w u p ca re T re a tm e n t-re la te d a d v e rs e e ffe cts M e d ica tio n sid e e ffe cts ca n v a ry in in te n s ity fro m n o n e to v e ry tro u b le s o m e a n d w o rris o m e . T h e le v e l o f in te n s ity d o e s n o t co rre la te to s p e cific le v e ls o f co n tro l b u t s h o u ld b e co n s id e re d in th e o v e ra ll a s s e s s m e n t o f ris k . Component 2 Education for a Partnership in Asthma Care 46 Key Points ‐ Education Self management education is essential and should be integrated into all aspects of care; requires repetition and reinforcement Provide all patients with a written asthma action plan that includes 2 aspects: – Daily management – How to recognize & handle worsening asthma symptoms Regular review of the status of patients asthma control – Teach and reinforce at every opportunity Develop an active partnership with the patient and family EPR – EPR – 3, Section 3, Pg. 93 47 Key Points – Education cont. Encourage adherence by: Choosing a tx regimen that achieves outcomes and addresses preferences important to the patient – Review the success of tx plan and make changes as needed Tailor the plan to needs of each patient Encourage community based interventions Asthma education provided by trained health professionals should be reimbursed and considered an integral part of effective asthma care ! (AE‐C) – 48 Key Educational Messages – – – – – – – – – Significance of diagnosis Inflammation as the underlying cause Controllers vs. quick‐relievers How to use medication delivery devices Triggers, including 2nd hand smoke Home monitoring/ self‐management How/when to contact the provider Need for continuous, on‐going interaction w/the clinician to step up/down therapy Annual influenza vaccine 49 Other Educational Points of Care ER Department and hospital based Medication therapy management (Pharmacist) Community based Home based for caregivers including home based allergen/ environmental assessment Computer based technology Case management for high‐risk patients 50 Maintaining the Partnership Promote open communication w/patient and family by addressing at each visit: – – – – – – Ask what concerns they have and what they want addressed during the visit Review short – term goals agreed to at the initial visit Review written AAP and steps to take – adjust as needed Encourage parents to take a copy of AAP to the school or childcare setting or send a copy to the school nurse Teach and reinforce key educational messages Provide simple, brief, written materials that reinforce the actions and skills taught 51 Component 3 Control of Environmental Factors & Comorbid Conditions that Affect Asthma 52 Key Points – Environmental Factors All patients with asthma should: – – – – – – Reduce, if possible, exposure to allergens & irritants they are sensitive too Understand effective allergen avoidance is multifaceted and individual steps alone are ineffective Avoid exertion outdoors when levels of air pollution are high Avoid use of nonselective beta‐blockers Avoid sulfite‐containing and other foods they are sensitive to Avoid use of humidifiers (generally) 53 Key Points – Environmental Cont. Clinicians should: – – – – Evaluate a patient for other chronic co‐morbid conditions when asthma cannot be well controlled Encourage their asthma patients to receive a yearly influenza vaccination (inactivated) Consider allergen immunotherapy when appropriate Ask about possible occupational exposures, particularly those who have new‐onset disease (work related asthma) 54 Component 4 Medications 55 Key Points ‐ Medications 2 general classes: – Long‐term control medications – Quick‐Relief medications Controller medications: – Corticosteroids – Long Acting Beta Agonists (LABA’s) – Leukotriene modifiers (LTRA) – Cromolyn & Nedocromil – Methylxanthines: (Sustained‐release theophylline) 56 Key Points – Medications cont. Quick‐ relief medications – Short acting bronchodilators (SABA’s) – Systemic corticosteroids – Anticholinergics 57 Key Points: Safety of ICS’s – ICS’s are the most effective long‐term therapy available, are well tolerated & safe at recommended doses – The potential but small risk of adverse events from the use of ICS treatment is well balanced by their efficacy – The dose‐response curve for ICS treatment begins to flatten at low to medium doses – Most benefit is achieved with relatively low doses, whereas the risk of adverse effects increases with dose 58 Key Points: Reducing Potential Adverse Effects Spacers or valved holding chambers (VHCs) used with non‐breath‐ activated MDIs reduce local side effects – There is little or no data on use of spacers with hydrofluoroalkane (HFA) MDIs Patients should rinse their mouths (rinse and spit) after (ICS) inhalation Use the lowest dose of ICS that maintains asthma control: – Evaluate patient adherence and inhaler technique as well as environmental factors before increasing the dose of ICS To achieve or maintain control of asthma, add a LABA to a low or medium dose of ICS rather than using a higher dose of ICS Monitor linear growth in children 59 Key Points: Safety of Long‐Acting Beta2‐Agonists (LABA’s) – Adding a LABA to the tx of patients whose asthma is not well controlled on low‐ or medium‐dose ICS improves lung function, decreases symptoms, and reduces exacerbations and use of SABA for quick relief in most patients – The FDA determined that a Black Box warning was warranted on all preparations containing a LABA – For patients who have asthma not sufficiently controlled with ICS alone, the option to increase the ICS dose should be given equal weight to the option of the addition of a LABA to ICS – It is not currently recommended that LABA be used for treatment of acute symptoms or exacerbations – LABAs are not to be used as monotherapy for long‐term control 60 FDA Recommendations for LABA’s February 2010 – – – Are contraindicated without the use of an asthma controller medication such as an ICS Single‐ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone Should only be used long‐term in patients whose asthma cannot be adequately controlled on asthma controller medications 61 FDA Recommendations for LABA’s Cont. – – – Should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved Patients should then be maintained on an asthma controller medication Pediatric and adolescent patients who require the addition of a LABA to an ICS should use a combination product containing both an ICS and a LABA, to ensure compliance with both medications 62 Key Points: Safety of Short ‐Acting Beta2‐Agonists (SABA’s) – – – SABAs are the most effective medication for relieving acute bronchospasm Increasing use of SABA treatment or using SABA >2 days a week for symptom relief (not prevention of EIB) indicates inadequate control of asthma Regularly scheduled, daily, chronic use of SABA is not recommended 63 Section 4 Managing Asthma Long Term “The Stepwise Approach” 64 Key Points: Managing Asthma Long Term The goal of therapy is to control asthma by: – Reducing impairment – Reducing risk A stepwise approach to medication therapy is recommended to gain and maintain asthma control Monitoring and follow‐up is essential 65 Treatment: Principles of “Stepwise” Therapy “The goal of asthma therapy is to maintain long‐ term control of asthma with the least amount of medication and hence minimal risk for adverse effects”. EPR ‐ EPR ‐3, Section 4, P. 284 66 Principles of Step Therapy to Maintain Control Step up medication dose if symptoms are not controlled If very poorly controlled, consider an increase by 2 steps, add oral corticosteroids, or both Before increasing medication therapy, evaluate: – Exposure to environmental triggers – Adherence to therapy – For proper device technique – Co‐morbidities 67 Follow‐up Appointments Visits every 2‐6 weeks until asthma control is achieved When control is achieved, follow‐up every 3‐6 months Step‐down in therapy: – When asthma is well‐controlled for at least 3 months Patients may relapse with total discontinuation or reduction of inhaled corticosteroids 68 Assessing Control & Adjusting Therapy Children 0‐4 Years of Age C la ssifica tio n o f A sth m a C o n tro l (0 4 y e a rs o f a g e ) C o m p o n e n ts o f C o n tro l Im p a irm e n t R isk W e ll C o n tro lle d N o t W e ll C o n tro lle d V ery P o o rly C o n tro lle d S ym ptom s 2 d ays/w e e k > 2 d ays/w e e k T h ro u gh o u t th e day N igh ttim e aw ak en in gs 1 x/m on th > 1 x/m on th > 1 x/w eek In te rfe re n ce w ith n orm al activity N on e S om e lim itation E xtre m e ly lim ite d S h ort-actin g b e ta 2 -agon ist u se for sym ptom con trol (n ot preve ntion of E IB ) 2 d ays/w e e k > 2 d ays/w e e k S e ve ral tim e s pe r day Ex ace rb atio n s re qu irin g oral syste m ic corticoste roids 0 1 /ye ar 2 3 /ye ar > 3 /ye ar T re atm e n t-re la te d adve rse e ffe cts R e c o m m e n d e d A ctio n fo r T re a tm e n t (S e e fig u re 4 1 a fo r tre a tm e n t ste p s.) M e dication side e ffe cts can vary in in te n sity from n on e to ve ry tro u ble som e an d w orrisom e . T h e le ve l of in te n sity doe s n ot corre la te to spe cific le v e ls of con trol bu t sh ou ld be co n side re d in th e ove rall asse ssm e n t o f risk. • M ain tain cu rre n t tre atm e n t. • R e gu la r follow u p e ve ry 1 6 m on th s. • C on side r ste p dow n if w e ll con trolle d fo r at le ast 3 m on th s. • S te p u p (1 ste p ) an d • R e e valu ate in 2 6 w e e ks. • If n o cle ar be n e fit in 4 6 w e e ks, con side r alte rn a tive diag n ose s or adju stin g th e rapy. • For side e ffe cts, con side r alte rn a tive tre atm e n t o p tio n s. • C on side r sh ort cou rse of oral syste m ic corticoste roids, • S te p u p (1 2 ste ps), a n d • R e e valu ate in 2 w e e ks. • If n o cle ar be n e fit in 4 6 w e e ks, con side r alte rn ative diagn ose s or adju stin g th e rapy . • For side e ffe cts, co n sid e r alte rn a tive tre atm e n t option s. Stepwise Approach for Managing Asthma in Children 0-4 Years of Age Intermittent Asthma Persistent Asthma: Daily Medication Consult asthma specialist if step 3 care or higher is required. Consider consultation at step 2 Step 6 Step up if needed Preferred (first check adherence, environment al control) Step 5 Step 2 Preferred Step 1 Preferred SABA PRN Low dose ICS Alternative Montelukast or Cromolyn Step 4 Preferred Step 3 Preferred High Dose ICS Preferred Medium Dose ICS Medium Dose ICS AND AND Either: Montelukast Either: High Dose ICS AND Either: Montelukast or LABA or LABA Montelukast or LABA AND Oral corticosteroid Patient Education and Environmental Control at Each Step Quick-relief medication for ALL patients -SABA as needed for symptoms. With VURI: SABA every 4-6 hours up to 24 hours. Consider short course of corticosteroids with (or hx of) severe exacerbation Assess control Step down if possible (and asthma is well controlled at least 3 months) Assessing Control & Adjusting Therapy Children 5‐11 Years of Age C la ssifica tio n o f A sth m a C o n tro l (5 1 1 y e a rs o f a g e ) C o m p o n e n ts o f C on tro l W ell C o n tro lled N o t W ell C o n tro lled V ery P o o rly C o n tro lled Sym ptom s 2 days/w eek but not m ore than once on each day > 2 days/w eek or m ultiple tim es on 2 days/w eek T hroughout the day N ighttim e aw akenings 1x/m onth 2x/m onth 2x/w eek Interference w ith norm al activity N one Som e lim itation Extrem ely lim ited Short-acting beta 2 -agonist use for sym ptom control (not prevention of EIB) 2 days/w eek > 2 days/w eek Several tim es per day Im p a irm en t Lung function • FEV 1 or peak flow > 80% predicted/ personal best 6080% predicted/ personal best < 60% predicted/ personal best • FEV 1 /FV C > 80% 7580% < 75% R isk R eduction in lung grow th T reatm ent-related adverse effects R eco m m en d ed A ctio n fo r T rea tm en t (S ee fig u re 4 1 b fo r trea tm en t step s.) 2/year (see note) 01/year Exacerbations requiring oral system ic corticosteroids Consider severity and interval since last exacerbation Evaluation requires long-term follow up. M edication side effects can vary in intensity from none to very troublesom e and w orrisom e. T he level of intensity does not correlate to specific levels of control but should be considered in the overall assessm ent of risk. • • • M aintain current step. R egular follow up every 16 m onths. Consider step dow n if w ell controlled for at least 3 m onths. • • • Step up at least 1 step and R eevaluate in 26 w eeks. For side effects: consider alternative treatm ent options. • • • • Consider short course of oral system ic corticosteroids, Step up 12 steps, and R eevaluate in 2 w eeks. For side effects, consider alternative treatm ent options. Stepwise Approach for managing asthma in children 5-11 years of age Intermittent Asthma Persistent Asthma: Daily Medication Consult asthma specialist if step 4 care or higher is required. Consider consultation at step 3 Step 5 Step 2 Preferred Step 1 Low dose ICS Preferred Alternative SABA PRN LTRA, Cromolyn Nedocromil or Theophylline Step 4 Preferred Step 3 Preferred Preferred Medium Dose ICS + LABA High Dose ICS + LABA Either Low Dose ICS + LABA, LTRA, or Theophylline OR Medium Dose ICS Alternative Medium dose ICS + either LTRA, or Theophylline Step 6 Preferred High Dose ICS + LABA + oral corticosteroid Alternative Alternative High dose ICS + either LTRA, or Theophylline High dose ICS + either LTRA, or Theophylline + oral corticosteroid Patient Education and Environmental Control at Each Step Quick-relief medication for ALL patients SABA as needed for symptoms. Short course of oral corticosteroids maybe needed. Step up if needed (first check adherence, environmen tal control, and comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months) Assessing Control & Adjusting Therapy in Youths > 12 Years of Age & Adults C la ssifica tio n o f A sth m a C o n tro l ( 1 2 y e a rs o f a g e ) C o m p o n e n ts o f C o n tro l W ell C o n tro lled Im p a irm en t Not W ell C o n tro lled V ery P o o rly C o n tro lled Sym ptom s 2 days/w eek > 2 days/w eek T hroughout the day N ighttim e aw akenings 2x/m onth 13x/w eek 4x/w eek Interference w ith norm al activity N one Som e lim itation Extrem ely lim ited Short-acting beta 2 -agonist use for sym ptom control (not prevention of E IB) 2 days/w eek > 2 days/w eek Several tim es per day FEV 1 or peak flow > 80% predicted/ personal best 6080% predicted/ personal best < 60% predicted/ personal best 0 0.75* 20 1–2 1.5 1619 3–4 N /A 15 V alidated questionnaires ATAQ ACQ ACT Exacerbations requiring oral system ic corticosteroids R isk 2/year (see note) 01/year Consider severity and interval since last exacerbation Progressive loss of lung function Evaluation requires long-term follow up care T reatm ent-related adverse effects M edication side effects can vary in intensity from none to very troublesom e and w orrisom e. T he level of intensity does not correlate to specific levels of control but should be considered in the overall assessm ent of risk. R eco m m en d ed A ctio n fo r T rea tm en t (see fig u re 4 5 fo r treatm en t step s) • M aintain current step. • R egular follow ups every 16 m onths to m aintain control. • Consider step dow n if w ell controlled for at least 3 m onths. • Step up 1 step and • R eevaluate in 26 w eeks. • For side effects, consider alternative treatm ent options. • Consider short course of oral system ic corticosteroids, • Step up 12 steps, and • R eevaluate in 2 w eeks. • For side effects, consider alternative treatm ent options. Stepwise Approach for Managing Asthma in Youths >12 Years of Age & Adults Intermittent Asthma Persistent Asthma: Daily Medication Consult asthma specialist if step 4 care or higher is required. Consider consultation at step 3 Step 6 Step 5 Step 4 Step 3 Preferred: Low dose ICS Low-dose ICS + LABA OR – Medium dose ICS Alternative: Cromolyn, LTRA, Nedocromil or Theophylline Alternative: Low-dose ICS + either LTRA, Theophylline, or Zileuton Step 2 Preferred: Step 1 Preferred: SABA PRN Preferred: Medium Dose ICS + LABA Alternative: Medium-dose ICS + either LTRA, Theophylline, or Zileuton Preferred High Dose ICS + LABA AND Consider Omalizumab for patients who have allergies Preferred High dose ICS + LABA + oral corticosteroid AND Consider Omalizumab for patients who have allergies Each Step: Patient Education and Environmental Control and management of comorbidities Steps 2 – 4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma Step up if needed (first check adherence, environmental control & comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months) •Quick-relief medication for ALL patients -SABA as needed for symptoms: up to 3 tx @ 20 minute intervals prn. Short course of o systemic corticosteroids may be needed. • Use of SABA >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control & the need to step up treatment. Section 5 Managing Exacerbations of Asthma 75 Key Points – Managing Exacerbations Early treatment of asthma exacerbations is the best strategy for management: Patient education includes a written asthma action plan (AAP) to guide patient self‐management of exacerbations – especially for patients who have moderate or severe persistent asthma and any patient who has a history of severe exacerbations A peak‐flow‐based plan for patients who have difficulty perceiving airflow obstruction and worsening asthma is recommended EPR ‐ EPR ‐3 Pg. 373 76 Key Points – cont. – – – – Recognition of early signs of worsening asthma & taking prompt action Appropriate intensification of therapy, often including a short course of oral corticosteroids Removal or avoidance of the environmental factors contributing to the exacerbation Prompt communication between patient and clinician about any serious deterioration in symptoms or peak flow, decreased responsiveness to SABAs, or decreased duration of effect 77 Exacerbations Defined ‐ RISK Are acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness? — or some combination of these symptoms Are characterized by decreases in expiratory airflow that can be documented and quantified by spirometry or peak expiratory flow – These objective measures more reliably indicate the severity of an exacerbation than does the severity of symptoms 78 Classifying Severity of Asthma Exacerbations in the UC or ER Setting Severity Mild Symptoms & Signs Dyspnea only with activity (assess tachypnea in young children) Initial PEF (or FEV1) PEF 70 percent predicted or personal best Usually cared for at home Prompt relief with inhaled SABA Possible short course of oral systemic corticosteroids PEF 4069 percent predicted or personal best Usually requires office or ED visit Relief from freq. inhaled SABA Oral systemic corticosteroids; some symptoms last 1–2 days after treatment is begun PEF <40 percent predicted or personal best Usually requires ED visit and likely hospitalization Partial relief from frequent inhaled SABA PO systemic corticosteroids; some symptoms last >3 days after treatment is begun Adjunctive therapies are helpful Moderate Severe Dyspnea interferes with or limits usual activity Dyspnea at rest; interferes with conversation Clinical Course Subset: Life threatening Too dyspneic to speak; perspiring PEF <25 percent predicted or personal best Requires ED/hospitalization; possible ICU Minimal or no relief w/ frequent inhaled SABA Intravenous corticosteroids Adjunctive therapies are helpful Managing Asthma Exacerbations at Home A s s e s s S e v e rity P a t ie n t s a t h ig h r is k f o r a fa ta l a t t a c k (s e e fig u r e 5 – 2 a ) r e q u ir e im m e d ia t e m e d ic a l a t te n t io n a f t e r in it ia l t r e a t m e n t. S y m p t o m s a n d s i g n s s u g g e s t iv e o f a m o r e s e r i o u s e x a c e r b a t i o n s u c h a s m a r k e d b r e a t h le s s n e s s , i n a b i l it y t o s p e a k m o r e t h a n s h o r t p h r a s e s , u s e o f a c c e s s o r y m u s c le s , o r d r o w s i n e s s ( s e e f i g u r e 5 – 3 ) s h o u l d r e s u l t in in i t ia l t r e a t m e n t w h i le im m e d i a t e l y c o n s u l t i n g w i t h a c l in ic i a n . L e s s s e v e r e s i g n s a n d s y m p t o m s c a n b e t r e a t e d i n i t i a ll y w i t h a s s e s s m e n t o f r e s p o n s e t o t h e r a p y a n d f u r t h e r s t e p s a s l is t e d b e l o w . I f a v a i la b le , m e a s u r e P E F — v a l u e s o f 5 0 – 7 9 % p r e d i c t e d o r p e r s o n a l b e s t in d ic a t e t h e n e e d f o r q u ic k - r e l i e f m e d ia t i o n . D e p e n d i n g o n t h e r e s p o n s e t o t r e a t m e n t , c o n t a c t w i t h a c l in i c i a n m a y a l s o b e in d ic a t e d . V a l u e s b e lo w 5 0 % i n d i c a t e t h e n e e d f o r i m m e d i a t e m e d i c a l c a r e . In itia l T r e a tm e n t In h a le d S A B A : u p to tw o tr e a tm e n ts 2 0 m in u te s a p a r t o f 2 – 6 p u ffs b y m e t e r e d - d o s e i n h a le r ( M D I ) o r n e b u li z e r t r e a t m e n t s . N o t e : M e d i c a t i o n d e l i v e r y i s h ig h l y v a r i a b l e . C h il d r e n a n d i n d i v id u a l s w h o h a v e e x a c e r b a t i o n s o f l e s s e r s e v e r i t y m a y n e e d fe w e r p u ffs th a n s u g g e s te d a b o v e . G ood Response In c o m p le te R e s p o n s e Poor Response N o w h e e z in g o r d y s p n e a ( a s s e s s ta c h y p n e a in y o u n g c h il d r e n ) . P e r s is t e n t w h e e z i n g a n d d y s p n e a (ta c h y p n e a ). M a r k e d w h e e z in g a n d d y s p n e a . P E F 8 0 % p r e d ic t e d o r p e rs o n a l b e s t. C o n ta c t c lin ic ia n fo r f o l lo w u p i n s t r u c t i o n s a n d fu rth e r m a n a g e m e n t. M a y c o n t in u e i n h a l e d S A B A e v e ry 3 – 4 h o u rs fo r 2 4 – 4 8 h o u rs . C o n s id e r s h o r t c o u r s e o f o r a l s y s t e m ic c o r t ic o s t e r o i d s . P E F 5 0 – 7 9 % p r e d ic te d o r p e rs o n a l b e s t. A d d o ra l s y s te m ic c o r t ic o s t e r o i d . C o n tin u e in h a le d S A B A . C o n ta c t c lin ic ia n u r g e n tly ( th is d a y ) fo r fu r th e r in s tru c tio n . P E F < 5 0 % p r e d ic t e d o r p e rs o n a l b e s t. A d d o ra l s y s te m ic c o r t ic o s t e r o i d . R e p e a t i n h a le d S A B A i m m e d ia t e l y . I f d is t r e s s i s s e v e r e a n d n o n r e s p o n s i v e t o i n it i a l tr e a tm e n t: — C a ll y o u r d o c to r A N D — PROCEED TO ED; — C o n s id e r c a ll i n g 9 – 1 – 1 ( a m b u la n c e tr a n s p o r t) . To ED. What the EPR ‐3 Does NOT Recommend – Drinking large volumes of liquids or breathing warm, moist air (e.g., the mist from a hot shower) – Using over‐the‐counter products such as antihistamines or cold remedies – Although pursed‐lip and other forms of controlled breathing may help to maintain calm during respiratory distress, these methods do not bring about improvement in lung function EPR ‐ EPR ‐3 , P.384 81 Many Thanks To ‐ Colleagues who shared their power point presentations and/or provided feedback on the foundation for this presentation: – – – – – Dr. Gail M Brottman MD, Director, Pediatric Pulmonary Medicine, HCMC Dr. Don Uden, Pharm. D., Professor, University of Minnesota, College of Pharmacy Dr. Barbara P. Yawn, MD, MSc, Director of Research, Olmsted Medical Clinic Dr. Mamta Reddy, MD, Chief Allergy/ Immunology, Bronx Lebanon Hospital Center, NY Mary Bielski, RN, LSN, CNS, Nursing Service Manager, Minneapolis Public Schools 82 Minnesota Department of Health Asthma Program www.health.state.mn.us/asthma 83