End Stage COPD Guidance Document

End Stage COPD Guidance Document Suggested Guidelines for the Determination of Hospice Eligibility A patient with severe chronic pulmonary disease that meets the following criteria may be eligible for hospice services: The patient has all of the following: Disabling dyspnea at rest or with minimal exertion Little or no response to bronchodilators Decreased functional capacity (e.g. bed to chair existence, fatigue and cough) AND Progression of disease as evidenced by a recent history of increasing physician office or emergency visits and/or hospitalizations for pulmonary infection and/or respiratory failure. Documentation within the past 3 months of one or more of the following: Hypoxemia at rest on room air (p02 55 mmhg by ABG) or oxygen saturation 88% or Hypercapnia evidenced by pco2 50 mmhg Note: A serial decrease of FEVI > 40 ml/yr is objective evidence for disease progression but is not required Supporting documentation includes: Cor pulmonale and right heart failure secondary to pulmonary disease (e.g. not secondary to the left heart disease or valvulopathy) Unintentional progressive weight loss > 10% of body weight over the preceding six months Resting tachycardia > 100 bpm In the absence of one or more of the above criteria, rapid decline or co morbidities may also support the physician s determination of a life expectancy of less than 6 months and eligibility for hospice care. Palliative Dyspnea Management Low doses of short acting opioids are the mainstays of palliative dyspnea management in end stage COPD. In addition, because of the extreme anxiety that can accompany the sensation of dyspnea, low dose benzodiazepines may also be useful. The goal is not to lower the respiratory rate, but to reduce the patient s sensation of breathlessness and any associated anxiety. The following initial doses are recommended for opioid naïve patients: Morphine 2.5mg PO/SL every 2 hours as needed for dyspnea Lorazepam 0.25mg PO/SL every 4 hours as needed for dyspnea associated anxiety Non Pharmacological Management Providing an over the bed table will help patients who are bedbound position themselves with their head up; this allows support from their elbows and arms to lengthen and expand the chest cavity (tripoding). Cool air, avoid closed in spaces, minimize odors, and provide visual signs of air movement such as ribbons tied to fans to help reduce the patient s sense of suffocation. Psychosocial, emotional and spiritual support is extremely helpful in reducing fear, anxiety, and depression. Oxygen therapy should be considered for any patient with hypoxemia and during periods of exacerbation. Clinical Pearls In general, patients with end stage COPD no longer have the ability to use inhalers correctly due to lack of breath control. Administering medications using a nebulizer does not require additional breathing effort from the patient. Also, nebulized medications do not require patients to coordinate activation of device and inspiratory breath, or to hold breath while waiting for the inhaled medication to deposit in the lungs. This makes for a more effective and efficient route of administration. Oral corticosteroids, such as prednisone or dexamethasone, may be more effective than inhaled corticosteroids. Oral corticosteroids can also palliate associated symptoms by increasing appetite and helping with fatigue. Low, non sedating doses of benzodiazepines, such as lorazepam, scheduled around the clock (ATC) and on an as needed (PRN) basis will help reduce the anxiety component which can exacerbate the sensation of dyspnea. Normal saline via nebulizer, offered as frequently as the patient would like, provides moisture to the airways and gives the individual the feeling that they are doing something to help with breathing. Patients who have end stage pulmonary disease should receive the seasonal influenza vaccine. Evaluate patient ability to use inhalers, both metered dose (MDI) and dry powder (DPI), for both lung capacity, cognitive and physical ability to coordinate inhalation with inhaler activation (see chart next page). Convert patients not able to demonstrate proper technique on a routine basis to nebulized treatments for improved medication delivery. 2013, HospiScript Services druginformation@hospiscript.com tel: 800-227-0848 fax: 800-616-2479

End Stage COPD Guidance Document Appropriate medication use at end of life: As the patient s medication profile is reviewed, the hospice clinician can assist the patient and family in decision making about which medications are providing benefit and contributing to quality of life. The clinician must also be alert to medications that may be contributing to problematic symptoms, causing adverse effects, or simply no longer have a beneficial role at end of life. The interdisciplinary team (IDT) can serve as a resource for the clinician who is not experienced or confident in discussing medication appropriateness. The team meeting is one opportunity for learning from team members including nurses, pharmacists and physicians. Clinicians who do not attend team meetings, such as admissions or on call staff, must be intentional in seeking the input and expertise of these co workers. Knowledge sharing about appropriate medication use happens between clinicians, hospice team members, and patient or family. This process facilitates informed decisions about medication use that is driven by the patient s goals of care and evidenced based medicine. The BUILD Model: In hospice, BUILDing the plan of care with the patient, family, and the IDT is the key to success. The BUILD model provides a framework for members of the hospice IDT to facilitate discussions of medication appropriateness. Talking points are incorporated into the BUILD model to spark conversations with the patient or family regarding the appropriate use of medications. B=Build a foundation of trust and respect GOAL: Affirm the patient and caregiver; listen more than you talk. Validate their efforts and concerns. This is an opportunity to gain insights into cultural norms, spiritual practices and family dynamics. U=Understand what the patient knows about the medication GOAL: By asking open ended questions, facilitate the patient and caregiver in drawing their own conclusions that the medicine may no longer be effective OR at some point will no longer be effective. Understanding what the patient knows about a medication, or what he/she expects from it, will allow the hospice clinician to provide individualized, evidence based information regarding the medication and how it impacts the disease process. Address worry as it will be a barrier in decision making. I=Inform the patient of evidenced based information regarding the medication GOAL: Provide evidence based information in a neutral manner by bridging medical terminology and reasoning to the patient level. L=Listen to the patient s goals and expectations GOAL: Learn what is important to the patient/family. It is important to take information the patient has shared about why he/she takes the medication and relate that to his/her goals and expectations. If the patient is struggling with making a change it may be helpful to share experiences. Many patients feel they are losing control. Re assuring patients about the importance of their participation in decision making can go a long way in keeping conversations open. For those situations where the patient is unable to participate in the discussion or decision making, the patient s wishes should still be the focus, and not the wishes of the decisionmaker, which may be different than the patient s. D=Develop a plan of care in collaboration with the patient, family and interdisciplinary team GOAL: Being part of the process empowers the patient and caregiver and increases compliance with the plan. The patient and caregiver must realize they DO have choices. Work as a team for the benefit of the patient. Goals need to be patient centered and measurable. Focus on patient comfort and what enhances quality of life. Include acknowledgement that the patient s physician continues to provide input about these decisions. Once the plan has been developed, ask the patient for feedback regarding the plan and make adjustments if needed. This demonstrates your interest in meeting them where they are in this process and that their input has value. Revisiting the topic on an ongoing basis is often necessary; let the patient know changes are part of this process. Assessing the Patient s Ability to Use Inhalers Dry Powder Inhaler (DPI) Metered Dose Inhaler (MDI) For efficient use, patient must be able to: For efficient use, patient must be able to: 1. Follow instructions to prepare specific DPI device for use (e.g., Diskus, Flexhaler, Twisthaler ) 1. Follow instructions to prepare specific MDI device for use (e.g., traditional MDI, Respimat ) 2. Turn head away from device to exhale completely 2. Shake inhaler, if appropriate, and hold properly 3. Close mouth around mouthpiece 3. Position for open airway inhalation 4. Inhale forcefully, steadily, and deeply to propel medicated 4. Exhale completely powder into lungs 5. Close mouth around device mouthpiece 5. Hold breath for 10 seconds 6. Activate inhaler device timed to start of inspiration 6. Remove DPI from mouth and exhale slowly 7. Slowly and deeply inhale medication over 5 7 seconds 7. Repeat steps 1 6 if more than 1 inhalation is prescribed 8. Hold breath for 10 seconds 9. Wait 1 minute and repeat steps 2 8 if more than 1 inhalation is ordered See Complete COPD Toolkit for reference list 2013, HospiScript Services druginformation@hospiscript.com tel: 800-227-0848 fax: 800-616-2479

COPD and Asthma Medications Generic Brand Dosage Forms Available FDA Approved Indication 1 Generic Available? Average AWP/Month ANTICHOLINERGICS (Short Acting, SAMA) provide bronchodilation by inhibiting acetylcholine at parasympathetic sites in bronchial smooth muscle Ipratropium Atrovent Nebulizer, Aerosol inhaler COPD Yes (neb) $240 HFA / $48 Neb ANTICHOLINERGICS (Long Acting, LAMA) provide bronchodilation by inhibiting acetylcholine at type 3 muscarinic (M 3 ) receptors Aclidinium Tudorza Pressair Powder inhaler COPD No $261 DPI Tiotropium Spiriva Powder capsule inhaler COPD No $312 DPI BETA 2 AGONISTS (Short Acting, SABA) relax airway smooth muscle (bronchodilation) by stimulating beta 2 receptors Albuterol AccuNeb, Ventolin, Proair Nebulizer, Aerosol inhaler Asthma/ COPD Yes $45 HFA / $20 Neb Levalbuterol Xopenex Nebulizer, Aerosol inhaler Asthma Yes (neb) $105 HFA / $458 Neb Metaproterenol Alupent Tablets, Syrup Asthma/ COPD Yes $140 tabs Pirbuterol Maxair Autohaler Aerosol inhaler Asthma No $490 MDI Terbutaline Terbutaline Tablets Asthma Yes $63 tabs BETA 2 AGONISTS (Long Acting, LABA) relax airway smooth muscle (bronchodilation) by stimulating beta 2 receptors Arformoterol Brovana Nebulizer COPD No $517 Neb Formoterol Foradil Aerolizer, Perforomist Nebulizer, Powder inhaler Asthma/COPD No $510 Neb / $215 DPI Indacaterol Arcapta Powder inhaler COPD No $210 DPI (capsules) Salmeterol Serevent Powder inhaler Asthma/COPD No $222 MDI INHALED CORTICOSTEROIDS (ICS) control inflammation with slightly varying specific mechanisms most work by decreasing leukocyte migration and capillary permeability while increasing cellular lysosomal stabilization Beclomethasone 2 QVAR Aerosol inhaler Asthma No $170 MDI Budesonide Pulmicort Nebulizer, Powder inhaler Asthma Yes (neb) $500 Neb / $183 DPI Ciclesonide Alvesco Aerosol inhaler Asthma No $209 MDI Flunisolide 2 Aerospan (formerly AeroBid) Aerosol inhaler Asthma No Available Fall 2013 Fluticasone 2 Flovent Aerosol inhaler, Powder inh. Asthma No $301 HFA / $150 DPI Mometasone Asmanex Aerosol inhaler Asthma No $180 MDI LEUKOTRIENE MODIFIERS help control inflammation, inhibit bronchoconstriction, and decrease airway edema by inhibiting leukotriene receptors Montelukast Singulair Tablets, granules Asthma Yes $170 tabs/ $340 gran Zafirlukast Accolate Tablets Asthma Yes $107 tabs MAST CELL STABILIZERS decrease inflammation by preventing activation of many inflammatory mediators including mast cell release of histamine and leukotrienes Cromolyn 2 Cromolyn Nebulizer Asthma Yes $120 Neb 2013, HospiScript Services druginformation@hospiscript.com tel: 800 227 0848 fax: 800 616 2479

COPD and Asthma Medications Generic Name Brand Name Dosage Forms Available FDA Approved Indication 1 Generic Available? COMBINATION combine two medications with different mechanisms of action (found above) Budesonide/ Formoterol Fluticasone/ Salmeterol Fluticasone/ Vilanterol Ipratropium/ Albuterol Mometasone/ Formoterol Symbicort Aerosol inhaler Asthma/ COPD No $280 MDI Average AWP/Month Advair HFA, Advair Diskus Aerosol inhaler, Powder inhaler Asthma/COPD No $375 HFA / $305 DPI Breo Ellipta Powder inhaler COPD No Available Fall 2013 Combivent Respimat, DuoNeb Nebulizer, Aerosol inhaler Asthma/COPD Yes (neb) $288 MDI / $90 Neb Dulera Aerosol inhaler Asthma No $235 MDI OTHER result in bronchodilation believed to be the result of inhibiting phosphodiesterase III and IV Roflumilast Daliresp Tablets COPD No $210 tabs Theophylline Theo Dur Tablets, Elixir Asthma/COPD Yes $40 tabs / $111 elixir 1 The FDA approved indications are listed but some of the medications are additionally used off label for either COPD or Asthma 2 These medications also available in intranasal forms indicated for allergic rhinitis: beclomethasone (Beconase AQ ), fluticasone (Flonase ), cromolyn (NasalCrom OTC) DPI = dry powder inhaler MDI = metered dose inhaler HFA = hydrofluoroalkane propellant (chlorofluorocarbon/cfc replacement) AWP= average wholesale price In compliance with a rule about ozone depleting substances, the FDA has announced that 7 available asthma and chronic obstructive pulmonary disease (COPD) metered dose inhalers that use CFCs as propellants are being removed from the marketplace. The affected products and their phase out dates are as follows: nedocromil (Tilade Inhaler, King Pharmaceuticals), June 14, 2010 metaproterenol (Alupent Inhalation Aerosol, Boehringer Ingelheim), June 14, 2010 triamcinolone (Azmacort Inhalation Aerosol, Abbott Laboratories), December 31, 2010 cromolyn (Intal Inhaler, King Pharmaceuticals), December 31, 2010 flunisolide (Aerobid Inhaler System, Forest Laboratories), June 30, 2011; to be replaced with Aerospan Fall 2013 ipratropium and albuterol in combination (Combivent Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals), December 31, 2013; to be replaced with Combivent Respimat mid 2013. pirbuterol (Maxair Autohaler, Graceway Pharmaceuticals), December 31, 2013 References: Lexi Comp Online [Internet database]. Lexi Drugs Online, Hudson, Ohio: Lexi Comp, Inc. Accessed August 20, 2013 Micromedex Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Reuters (Healthcare) Inc. Accessed 2/18/2013 Hitt E. FDA announces phase out of CFC based asthma and COPD inhalers. Medscape Medical News, April 16, 2010. Available at: http://www.medscape.com/viewarticle/720397 2013, HospiScript Services druginformation@hospiscript.com tel: 800 227 0848 fax: 800 616 2479

COPD Inhaler Decision Algorithm Patient PPS 40% AND/OR Poor Inhaler Technique Assess & document patient s function and ability to use inhalers: 1. On admission to hospice 2. With any exacerbation of condition 3. With a decline in status 4. At every recertification 5. Prior to ordering inhaler refills 6. With every change in location (transfer to/from ECF, IPU, etc) Patient Function PPS 40% AND/OR Patient unable to use inhalers correctly** STEP 1: Assess for adverse effects (AE) Review medication profile and address AE resulting from exposure to polypharmacy and/or incorrect use.** Common AE from incorrect use of inhalers: Beta-agonists: anxiety, tachycardia, tremor ICS: oral thrush, pharyngitis Anticholinergics: dry mouth, urinary retention NO Acute Symptom Management Needed? YES STEP 2: Eliminate duplications Review medication profile and eliminate duplications of therapy. Removing duplications also reduces AE exposure risk. See Inhaler Component Matrix for guidance. Common duplications include: Multiple beta-agonists: scheduled short and long-acting inhalers Multiple corticosteroids: oral and ICS Multiple anticholinergics: oral and inhaled anticholinergics GOAL: Discontinue ineffective inhalers while maintaining symptom control. Prioritize approach based on patient assessment and goals.** Optimize therapy to minimize risk of COPD exacerbations. Assess therapy to determine medication problems and set priorities for change. Ideal therapy for most patients with ES COPD will include nebulized albuterol +/- ipratropium and an oral corticosteroid. Provide benzodiazepine and opioid as needed for dyspnea symptom management. 1. Manage symptoms per Dyspnea GEMS** 2. Re-assess patient function to optimize therapy 3. Develop proactive plan of care to avoid recurrence TARGET ASSESS PLAN Optimize therapy: Treat adverse effects Discontinue inhalers Initiate nebulizers Eliminate duplications OPTION Patient or HCP resistant to medication changes? Continue therapy. Monitor patient for symptom control and AE. Assess & document patient s function and treatment plan. Consult BUILD Model for discussion points** ** additional information provided in supporting text Abbreviations: AE = adverse effects, GEMS = guidelines for effective management of symptoms, HCP = health care provider, ICS = inhaled corticosteroid, LABA = long acting beta agonist, LAMA = long acting muscarinic antagonist, SABA = short acting beta agonist, SAMA = short acting muscarinic antagonist 2013, HospiScript Services

Inhaler Component Matrix: Determining Therapy Duplications Therapeutic Class aclidinium (Tudorza) albuterol (Proair, Ventolin, Proventil) beclomethasone (QVAR) budesonide (Pulmicort) ciclesonide (Alvesco) flunisolide (Aerospan) Medication (Brand): Inhalers fluticasone (Flovent) formorterol budesonide (Symbicort) formoterol (Foradil) formoterol mometasone (Dulera) indacaterol (Arcapta) ipratropium (Atrovent) ipratropium albuterol (Combivent) levalbuterol (Xopenex) pirbuterol (Maxair) mometasone (Asmanex) salmeterol (Serevent) Beta Agonist, Short Acting (SABA) X X X X Beta Agonist, Long Acting (LABA) X* X X X X X* X* X* X X Anticholinergic, Short Acting (SAMA) X* X* (LAMA) X X Corticosteroid X X X X X X X X X Anticholinergic, Long Acting Inhalers X = indicates inhaler or nebulizer component X* = when scheduled, short acting agents (SABA & SAMA) are therapeutic duplications with long acting agents (LABA or LAMA) salmeterol fluticasone (Advair) tiotropium (Spiriva) Therapeutic Class Beta Agonist, Short Acting albuterol (Accuneb) arformoterol (Brovana) budesonide (Pulmicort) formoterol (Perforomist) Medication (Brand): Nebulizers & Orals ipratropium (Atrovent) ipratropium albuterol (Duoneb) levalbuterol (Xopenex) dexamethasone (Decadron) methylprednisolone (Medrol) montelukast (Singulair) roflumilast (Daliresp) prednisone (Deltasone) (SABA) X X X* O Beta Agonist, Long Acting theophylline (Theo 24) zafirlukast (Xolair) Therapeutic Targets: Ideal therapy for most patients with ES COPD will include nebulized albuterol +/ ipratropium and an oral corticosteroid. Provide benzodiazepine and opioid as needed for dyspnea symptom management. Control symptoms (LABA) X* X X X* X* O Avoid adverse events Anticholinergic, Short Acting (SAMA) X X Reduce polypharmacy Corticosteroid X X O O X O O Nebulizers Oral X = indicates inhaler or nebulizer component X* = when scheduled, short acting agents (SABA) are therapeutic duplications with long acting agents (LABA) O = indicates oral medication with same or similar therapeutic action to inhaler or nebulizer component Note: there are currently no LAMA agents with a nebulizer dosage form on the market in the US = indicates ideal therapy for most patients (nebulized beta agonist +/ anticholinergic and oral corticosteroid) (c) 2013, HospiScript Services druginformation@hospiscript.com tel: 800 227 0848 fax: 800 616 2479