Pharmacy Technician Objectives. Pharmacist Objectives. The New Kids on the Block UPDATE IN PULMONARY MEDICINE: A HANDS ON APPROACH WITH NOVEL INHALERS

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1 Pharmacy Technician Objectives UPDATE IN PULMONARY MEDICINE: A HANDS ON APPROACH WITH NOVEL INHALERS List patient factors to aid in new inhaler selection Identify patient barriers to obtaining new inhaler devices Identify patient barriers to using new inhaler devices Pharmacist Objectives Summarize primary literature of new inhaler devices in asthma/copd and factors for patient selection Recommend strategies to help patients obtain inhalers at a lower cost Demonstrate how to use these new devices Counsel a patient on the appropriate use of these devices The New Kids on the Block Amber Lanae Smith, PharmD, MSc, BCPS Assistant Clinical Professor, Wayne State University Ambulatory Care Specialist, Henry Ford Health System Pharmacy Technician Objectives Pharmacist Objectives List patient factors to aid in new inhaler selection Identify patient barriers to obtaining new inhaler devices Identify patient barriers to using new inhaler devices Summarize primary literature of new inhaler devices in asthma/copd and factors for patient selection Recommend strategies to help patients obtain inhalers at a lower cost Demonstrate how to use these new devices Counsel a patient on the appropriate use of these devices 1

2 Inhalation Therapy Background: Inhaler Devices Preferred strategy for managing common lung diseases Delivery of medication directly to site of action Choices available for type of delivery device Incorrect use of all inhalational delivery systems is common, resulting in suboptimal outcomes Delivery to Airways Considerations in Designing an Inhaler Optimal Delivery of Aerosol Drug Molecule Characteristics Aerosol Properties Mass Median Aerodynamic Diameter (MMAD) Geometric standard deviation (GSD) Fine particle fraction (FPF) Air/Particle velocity Physicochemical Properties Solubility Hygroscopicity Particle Properties Volume diameter Bulk density Tap density Shape Charge Lung Properties Geometry of respiratory tree Influence of disease Breathing pattern Created from Ibrahim M et al. Med Devices: Evidence and Research 2015;8: Ibrahim M et al. Med Devices: Evidence and Research 2015;8: Effective Administration Inhalation Therapies: Devices Patient s age Physical and cognitive ability Delivery system Patient device interface Pressurized Meter Dose Inhaler (pmdi) Dry Powder Inhaler (DPI) Soft Mist Inhaler (SMI) Nebulized Medications Arzu A et al. Respir Care 2012; 57(4):

3 Key Components of a pmdi pmdi Formulations Canister Metering valve Actuator Mouthpiece Solutions or suspensions Can contain excipients such as ethanol or surfactants as solubilizers or to stabilize suspensions Propellants that are nontoxic, nonflammable, and compatible with drug formulation Propellant should maintain consistent vapor pressure for life of product Ibrahim M et al. Med Devices: Evidence and Research 2015;8: pmdi Technical Performance pmdis: 2nd Decade of 21st Century When not in use, an inner valve is open and allows metering chamber to fill with propellant drug mixture When actuated (pressed) by patient, outer valve opens, inner valve closes, and metered dose of medication is released Newer actuators include dose counter Significant advances in technology have occurred Dose counters becoming standard Auxillary devices (e.g., spacers, VHC): allow evaporation, deceleration, and filtering of large particles Spacers and VHC can modestly improve lung deposition and reduce risks VHCs may include features to facilitate teaching and improve technique Ibrahim M et al. Med Devices: Evidence and Research 2015;8: Dalby R et al. Advanced Drug Delivery Reviews 2003; 55: Dry Powder Inhalers Current DPI Classification Emerged as option during CFC transition Challenges include internal resistance (e.g., inspiratory force required to aerosolize powder) Risk of hygroscopicity Single unit dose Multi unit dose Multi dose reservoir 3

4 DPIs: Where We Are Today Soft mist Inhalers Significant advances in technology and ease of use Each device has specific instructions Efforts to simply use by open inhale close instructions Products include dose counter or indicator Aerosolizes a propellant free drug solution as a soft mist Tension spring forces metered volume of drug through a capillary tube into a micropump When dose release button is pressed, the dose enters a uniblock (e.g., a combination of filters and nozzles made of silicon and glass) Two converging jets of solution collide to produce an aerosol Dalby RN et al. Medical Devices: Evidence and Research 2011;4: Problems with Inhalation Devices Inhaler Use: Problems Hand lung coordination with pmdi Poor inspiratory force with DPI Inefficient dose delivery with nebulizer Suboptimal technique with all devices Lack of knowledge and instruction among clinicians with all devices 40 Years of Inhaler Technique What a Patient Wants Meta analysis conducted from Articles reporting direct observation of inhaler technique by trained personnel 144 articles; 54,354 subjects Overall prevalence of correct technique: 31% No significant difference between first and second 20 year periods No need for external power Convenient and unobtrusive to carry Quiet and unobtrusive to use in public Robust enough to survive routine transport, use, and cleaning No extraordinary respiratory maneuvers required for correct use Dose counter Sanchis J, et al CHEST 2016; 150: Dalby R et al. Advanced Drug Delivery Reviews 2003; 55:

5 What a Clinician Wants Intuitive and easy to use Technique that can be easily taught Mastery of technique can be visually confirmed Familiar instructions for use New Inhaler Devices: Comparisons Dalby R et al. Advanced Drug Delivery Reviews 2003; 55: Clinical Outcomes and Patient Preference Systematic Review conducted in August 2014 Evaluated randomized control trials (RCT) in asthma and COPD Inhaler Device Number of RCTs for COPD Number of RCTs for Asthma Respimat 5 0 Ellipta 3 5 Respimat vs Handihaler 5 RCTs for COPD patients with tiotropium Parameters were similar, except for device and dose of tiotropium Studies: dose finding study, non inferiority studies, and safety studies Dose finding study: lower dose of tiotropium required for the Respimat Non inferiority demonstrated in 2/2 studies Safety profile and exacerbation efficacy found to be similar (17,000 patients over 2.3 years) Ninane V, et al. Respiratory Medicine 2015(109): Ninane V, et al. Respiratory Medicine 2015(109): Ellipta vs Diskus Device Comparison: Summary Five RCTs for patients with persistent asthma uncontrolled by inhaled corticosteroid Parameters: device, active substance, and inhalation frequency differed Studies: equivalent efficacy Combination therapy was well tolerated and resulted in greater improvements in lung function (compared to monotherapy) Three RCTs for patients with COPD Parameters: device, active substance, and inhalation frequency differed Studies: equivalent efficacy Pooled analysis had favorable lung function improvement (limited by differences in individual study outcomes) Patient preference was once daily Ellipta device Limited data exists Improved outcomes? Studies hard to compare based on study population and concomitant drug therapy Patient preference for Ellipta device Additional abstract data demonstrate patient preference for Ellipta, PressAir, and SMI devices Ninane V, et al. Respiratory Medicine 2015(109):

6 Key Takeaways Inhalation delivery systems have undergone significant technological advances during the last 50 years The device used to deliver the dose is as important as the medication itself Patient s ability to use inhalation device is an important and modifiable limitation Inhaler technique has not improved significantly over 40 years Limited literature supporting outcomes and patient preferences for new devices Right Drug, Wrong Price Amber Lanae Smith, PharmD, MSc, BCPS Assistant Clinical Professor, Wayne State University Ambulatory Care Specialist, Henry Ford Health System Inhaler Cost Considerations Patients pay ~$6000 more in medical costs annually Majority of inhalers are not generically available Cash Price: $200 $400 per inhaler Insurance often put inhalers on Tier 3 4 Average out of pocket cost: $30 60 per inhaler Medicare patients pay 45% of cash price once in the coverage gap Inhalers: Factors to Consider Acceptability Financial Burden Technique Sadowski CA, et al. Ann Pharmacother. 2015; 49(5): Meet WR WR Clinical Pharmacy Visit 74 YO AAM with severe COPD, T2DM, and HTN Patient has had multiple admissions for COPD exacerbation over the last six months Inpatient notes refer to WR as poorly controlled and non compliant Current Medications: Albuterol HFA Atrovent HFA Advair Diskus Lantus Aspart Insulin Carvedilol Losartan Montelukast Patient very knowledgeable about his medications, can provide all details without prompting Patient demonstrates proper inhaler technique Also provides a notebook in which he logs his daily BP, glucose, and weight Does this patient seem to be non compliant based on this information alone? 6

7 Brief Group Discussion What factors presented within the case should be taken into account when deciding a course of action for managing WR s COPD? Possible Pharmacy Interventions Discuss adherence with patient Identify adherence barriers Don t forget to ask about affordability of medications Educate patient Disease state Inhaler Technique Adherence Deliver discharge medications to bedside WR Visit Cont. WR: Factors to Consider Patient reports that he lives on a fixed income Receives a monthly social security check (total $ 1100 per month) Reports that he has a hard time filling his medications due to cost (often risk manages to fill meds) Patient has Medicare A/B and no prescription drug coverage Financial Burden Fixed income, no insurance Medication burden: 8 prescriptions, 4 of which are brand only Acceptability Patient risk manages due to costs only; otherwise accepts his regimen Technique Patient has good technique Adherence Acceptability Financial Burden Adherence Technique Sadowski CA, et al. Ann Pharmacother. 2015; 49(5): Assess Patient's Insurance Helping Patients Obtain their Medications Private Insurance Governmental No Insurance Patient eligible for drug coupons through manufacturer Medicaid Most formularies are restrictive, complete prior authorization if necessary or switch to preferred agent Part A/B Medicare Nebulized solutions will be covered 20/80 or 30/70 Part D See next algorithm Patient may be eligible for assistance through drug companies Patient may need to apply for coverage 7

8 Private Insurance Drug Manufacturer Coupons Manufacture websites have co pay discount coupons Patient or Provider can request Coupon will reduce the out of pocket co pay Some provide 1 month free Uninsured Patients Difficult patient population May be eligible for assistance through drug companies Some companies will have coupons for one time fill for free Discount drug programs Insurance through pharmacies Need to be encouraged to apply for coverage Pharmaceutical Assistance Programs for Newer Inhalers for COPD Inhaler Device Company Comments Anoro Ellipta GSK First prescription free (1) no registration required, (2) not be on Medicare or (umeclindium 62.5 mcg/vilanterol Medicaid, or private insurance (3) not seeking reimbursement for True Out of 25 mcg) Pocket or similar programs. Incruse Ellipta (umeclindium 62.5 mcg) Breo Ellipta Discount Card One year free (1) registration is required, (2) not be on Medicare or Medicaid, or private insurance, (3) cannot be Medicare eligible. Maximum monthly value $295. (fluticasone 100 mcg/vilanterol 25 mcg) Striverdi Respimat Boehringer Discount card Patients must register on website. Cash paying individuals or those on (olodateol) Ingelheim governmental assistance may receive three free 30 day supplies over a 12 month period. Savings even available for those with private insurance. Spiriva Respimat Discount card Patients must register on website. Patients pay no more than (tiotropium) $10/month with a maximum savings of $50/monthly prescription. Card is valid for 1 year. Only for cash paying patients and those with private insurance. Stiolto Respimat (tiotropium 2.5mcg/olodaterol 2.5 Discount card Patients must register on website. Patients pay no more than $0/month with a maximum savings of $350/monthly prescription. Card is valid for 1 mcg) year. Only for cash paying patients and those with private insurance. Tudorza Pressair AstraZeneca Discount card Patients must register on website. Cash paying patients program (aclindinium) covers up to $100 per 30 day supply. Private insured patients pay no more than $25/month. Card is valid for 1 year. No governmental insurance patients. RespiClick (albuterol) Teva Discount card Patients must obtain from provider. No governmental insurance patients. Discount Drug Programs ellipta/price?drug name=anoro+ellipta. Accessed Sept 23, Discount Drug Programs Other Programs NeedyRx 4Rx Card America s Drug Card Easy Drug Card Free RX Plus True RX Savings Many others Discount Drug Programs Advantages Free Personal information not required for enrolling Some programs allow for comparison shopping Coupons or discount cards are available for many drugs Disadvantages Not all websites allow for true comparison shopping Determining an exact price will not happen until the prescription is actually processed Discounts likely will be minimal for brand name medications 8

9 Governmental: Medicaid or Medicare Medicaid: often requires a formulary switch or prior authorization Medicare: Medicare A/B Only covers nebulized solutions/nebulizer at 20/80 or 30/70 split Medicare Part D Patient cannot afford co pays Social security office to apply for low income subsidies (dual enrollment) Patient Access Network Patient in GAP: Assess patient's financial status, if below 150% of federal poverty line patient may qualify for Patient Assistance programs through drug companies Experience with Resolving Costs Cross sectional retrospective study of patients seen in the outpatient pulmonary clinic at Henry Ford Hospital from January 2015 to December 2015 Primary endpoint: patient s out of pocket cost savings following pharmacist intervention Included all patients seen in clinic by the pharmacist Results: Pharmacist Intervention Results: Out of Pocket Savings Results: Collaboration Educated inpatient pharmacists and providers about the role of the hospital based ambulatory care pharmacist Developed a referral process to ensure access to medications following discharge Conclusions Pharmacists are a potential resource for reducing patient out of pocket costs and improving medication adherence 9

10 Key Takeaways Pharmacists can help patients reduce costs Collaborate with other team members who can help make medications as affordable as possible Remind patients they may have to shop around for the best deals Stay current with assistance programs UPDATE IN PULMONARY MEDICINE: A HANDS ON APPROACH WITH NOVEL INHALERS Pharmacist Objectives Step by Step: Hands on Approach to Patient Education 1. Identify barriers to using these new devices. 2. Demonstrate how to use these new devices. 3. Counsel a patient on how to use these new devices. Nancy C. MacDonald, PharmD, BCPS Transition of Care Coordinator Henry Ford Hospital Detroit, Michigan Technician Objectives Audience Poll 1. Identify barriers to using these new devices. 2. List patient factors to aid in new inhaler selection. Has anyone observed someone using an inhaler improperly? How many of your health systems have inhaler counseling as part of the practice model? 10

11 Inhaler Type Any Inhaler MDI (with or without spacer) Errors with Inhalers Common Errors Not holding breath long enough Forgetting to exhale before or exhaling into device Not using maintenance inhaler when asymptomatic Using a device with zero on the counter Not shaking Wrong inhalation technique Inhaling foreign object from uncapped device Dirty/damaged spacer valves limiting amount of drug General Counseling Points Preparing to use the Device Controller versus rescue Assembly, including timing of assembly Documenting expiration date Priming and if needed, re-priming Activation Dry Powder, Breath Activated Dry Powder, Loading or Capsule Piercing Required Failure to load device or holding device wrong after loading Failure to draw drug out of device Forgetting to pierce capsule or remove old capsule Failing to take 2 nd breath to receive full dose Swallowing capsule Putting capsule in mouthpiece instead of holding chamber ISMP Medication Safety Alert July 14, 2016 General Counseling Points General Counseling Points Administration Best inhalation technique Number of inhalations Re-activate before subsequent dose Audio or visual aids Maintaining the Device Closure Reading the counter Calling for refill Storage Ellipta Device Ellipta Pressair Respimat RespiClick Cover Medication Devices: Tray opened Discard 11

12 Ellipta Device Ellipta Device Priming Not needed Expiration When zero appears in counter or 6 weeks after tray is opened. Counter Air Vent Call for refill Cleaning Storage When you have less than 10 doses left (RED appears in dose counter window). Not necessary Close mouthpiece. Room temperature. Keep in a dry place away from heat and sunlight. EO-ELLIPTA-PI-MG.PDF. Accessed 10/4/16. Ellipta Device Interactive Scenario Activation Use of Device Slide cover down until you hear a click. Slide cover down until you hear a click. Breathe out. Place mouth around mouthpiece and take one long, steady, deep breath in through mouth. Remove from mouth. Hold breath 3-4 seconds. Breathe out slowly/gently. Rinse mouth if needed with medication in device. Pick a partner and counsel them on how to prepare, use and store the device. When you are done, reverse roles. Do NOT place the device in your mouth during the demonstration. REO-ELLIPTA-PI-MG.PDF. Accessed 10/4/16. Pressair Device Pressair Device Pouch opened: Use by: Dose Counter Control Window 12

13 Pressair Device Pressair Device Priming/Re-priming Expiration Not needed. When zero in RED appears or 45 days once removed from foil. Call for refill When RED ban appears in the dose indicator window (10 remaining doses). Cleaning Storage Not necessary Can clean outside of mouthpiece with dry cloth. Place cap back on. Room temp away from heat/light. Keep in foil until ready to open. Activation Use of Device Push green button down and release. Remove cap and hold with green button up. Push green button/check control window to ensure it turned green. Place in mouth & inhale quickly with deep breath. Listen for the click and confirm the control window turned RED. Remove from mouth and breathe out through nose. Press, release, inhale. Accessed 10/4/16. Accessed 10/4/16. Interactive Scenario Respimat Device Pick a partner and counsel them on how to prepare, use and store the device. When you are done, reverse roles. ONE person can consider placing their mouth on the device to demonstrate how the proper inhalation of the demo inhaler will make the control window change color. Discard By: Clear Base Cartridge Respimat Device Respimat Device Air Vent Turn clear base in direction of the arrows. Priming/Re-priming Expiration Call for refill Cleaning Storage Priming: Once spray is visible, perform T.O.P three more times. Re-Priming: If not used for >3 days: release 1 puff. If not used for more than 21 days, full priming is required. 3 months from the date the cartridge is inserted into inhaler. When the dose indicator is at 30 (RED zone). Mouthpiece, including metal part inside mouthpiece with damp cloth at least 1 time a week. Outside can be cleaned with damp cloth. Room temperature Accessed 10/4/16. 13

14 Respimat Device Interactive Scenario Activation Use of Device Hold upright & turn base until it clicks. Flip cap until open. Breathe out slowly & fully. Place device in mouth, pointing device to the back of throat. While taking slow, deep breath in, press the dose release button. Breathe in as long as you can. Hold breath for 10 seconds. Take device out of mouth and breathe out. Turn Open Press Pick a partner and counsel them on how to prepare, use and store the device. When you are done, reverse roles. Do NOT place your mouth on the device during demonstration. Accessed 10/4/16. RespiClick Device RespiClick Device Cap Priming/Re-priming Expiration Call for refill Cleaning Storage Not needed. When zero appears in counter or 13 months after removing from foil pack. When the counter is at 20 and turns red. If mouthpiece needs cleaning, use a dry cloth or tissue. Room temperature with cap closed. Accessed 10/8/16. Accessed 10/4/16. RespiClick Device Interactive Scenario Activation Use of Device Hold upright and fully open the red cap and there will be a click sound Breathe out through mouth. Put mouthpiece in mouth and close lips around it. Breathe in deeply through mouth, until lungs are full of air. Hold breath for about 10 sec. Check to ensure the counter decreases by one. Close the cap when done. Pick a partner and counsel them on how to prepare, use and store the device. When you are done, reverse roles. Do NOT place your mouth on the device during demonstration. Accessed 10/4/16. 14

15 Key Takeaways Improper use of inhaler devices may result in omitted doses, overdoses, uncontrolled disease or other problems. Patients should be taught how to prepare, administer and maintain their inhaler device. The inhalation technique for each novel inhalation device is unique. Reflection Questions: Active Learning What patients might benefit from using each device? How might a technician help identify patients having difficulty using each device? 15