5/7/2020

Medication : Medication discontinuation, dose reduction, and switching in the PPD Promise™ hospice setting Quarterly In-Services Presented by: Corina Reyna, PharmD, BCGP Co-Founder/Head Clinical Hospice Pharmacist Origins Pharmacy Solutions® Eagle, Idaho

 Graduate of Idaho State University College of  Pharmacy benefits manager (PBM) for hospice agencies Pharmacy  Idaho based company providing services  15 years of hospice pharmacy experience nationwide ◦ Compounding  Advocate for hospice in the pharmacy setting  Minimizing medication costs ◦ Medication therapy reviews  Optimizing medication therapy through medication ◦ Speaker at state hospice conferences throughout reviews and streamlined reporting services the Northwest  PPD Promise™  Partner with hospice to meet hospice’s medication PPD  Board Certified Geriatric Pharmacist (BCGP) goal ®  Origins’ pricing model, reporting, service options, and  Co-founder of Origins Pharmacy Solutions hospice coaching combine to lower PPD by $3, on average  Built on premise of giving back to communities

Presenter Background

1) Upon completion of this session, participants will be able to describe the pitfalls of and why Target deprescribing is valuable in the hospice Audience population. •Nurses 2) Attendees will leave with the ability to list three barriers to depresribing and how to •Medical providers address them. •Administrators 3) Participants will leave the session able to describe key points important in conversations about deprescribing.

Objectives

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 Polypharmacy  One study estimates hospice patients come on ◦ Can be defined several ways: services on an average of 11.5 medications.  Oxford Dictionary: the simultaneous use of multiple to treat a single ailment or condition.  U.S. Pharmacist Journal: the use of several (usually five or more) medications on a daily basis, with the possibility that these may not all be clinically necessary.  Utilization Review Teams: the use of more medications than are clinically indicated.

Polypharmacy Polypharmacy US Pharm. 2017;42(6):13-14. https://www.express-scripts.com/art/pdf/kap37Medications.pdf McNeil, et.al. The burden of polypharmacy in patients near the end of life. J. Pain Symptom Manage. 2016 Feb;51(s):178-183.

 Polypharmacy increases risks:  According to www.deprescribing.org: ◦ Drug interactions ◦ “The planned and supervised process of dose ◦ Adverse effects reduction or stopping of medication that might be ◦ Pill burden causing harm, or no longer be of benefit.  Of particular concern if difficulty swallowing Deprescribing is part of good prescribing – backing  Higher rate of non-compliance off when doses are too high, or stopping  Hospice population more likely to medications that are no longer needed.” experience problems associated with  According to palliative care educator: polypharmacy ◦ “The process of identifying and discontinuing ◦ Hepatic and/or renal impairment medications with little or no benefit and potential harm, in order to improve quality of life.” ◦ Altered protein binding due to decreased nutritional status

Dangers of polypharmacy What is deprescribing?

Deprescribing.org. Retrieved from https://deprescribing.org/what-is-deprescribing. Accessed 3/4/2020 Thompson, J. Deprescribing in palliative care. Clinical Medicine. 2019;19(4):311-4

 Medication costs ◦ Why pay for medications that are no longer When used appropriately, providing benefit and/or putting patient at risk?  Patient’s goals of care might not align with deprescribing is ensuring medication therapy in place at admission the continuation of  Minimize risk of adverse effects ◦ Potentially increasing QoL compassionate comfort  Minimize drug interactions  Decrease pill burden care.  Allow for switch to more appropriate product or route of administration

Why consider deprescribing? What else is deprescribing?

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 Discontinuation of unnecessary or  Changes in goals of care inappropriate medications in the hospice  Anticipated decline in overall patient status setting  Impairment resulting from contributing  Decreases in dosing of medications to diagnoses compensate for declines in clearance and  Risk vs. benefit changes at end of life metabolism or to minimize risk of  Desire for maximal quality of life undesirable adverse effects  Satisfy CMS expectations  Switching medications in order to optimize symptom control and minimized ◦ Medications expected to help meet goals of care or enhance comfort, therefore palliative in nature. cost and adverse effects

What might deprescribing include? Why consider deprescribing?

Considerations Questions to ask about each current medication  Provide relief from active symptoms of Indication Is it still indicated? disease Risk vs. benefit Does its benefit outweigh its associated risks?  Provide comfort Appropriateness Is use appropriate in light of age, co-morbidities, goals, etc.?  Not for the use of prolonging life Dosing Is dosing appropriate for age, co-morbidities, and indication? Adherence How is patient taking it? Is this as prescribed?  Not curative Duration of use Is the medication no longer beneficial?  CMS expects coverage under the hospice Life expectancy Is benefit unlikely to be realized given life expectancy? benefit of medications that are reasonable Adverse effects Is patient experiencing undesireable adverse effects? and necessary for the palliation of pain Patient's desires Does patient want to continue or stop it? and/or symptom management. Patient’s goals of care Does treatment goal align with patient’s goals of care?  Discontinuation of medications not helping Prescription cascade Is it treating adverse effects of another medication? patient/family meet goals of care or enhance comfort Considerations in presence of polypharmacy Palliative Medications

Update on Part D Payment Responsibility for Drugs for Beneficiaries Enrolled in Medicare Hospice, November 15, 2016

 Many barriers to deprescribing:  Abundance of guidelines on adding ◦ Psychologic connection to drug  Patient, family, and/or provider medications:  Fear of withdrawal effects or return of symptoms ◦ American Diabetic Association: diabetes ◦ Lack of patient/family understanding of prognosis guidelines ◦ Consumer advertising ◦ Lack of clear evidence in literature ◦ JNC 8 and ACC/AHA: STEMI guidelines ◦ Limited time with patient ◦ CHEST: VTE guidelines ◦ Lack of palliative care knowledge by prescriber ◦ AACE/ACE: osteoporosis guidelines ◦ Lack of clinician confidence  Low knowledge of palliative care ◦ GOLD: COPD guidelines  Fear of worsening patient’s symptoms ◦ APA: Depression guidelines  Fear of causing patient psychological distress  Fear of clinician’s liability Why can deprescribing be so Why can deprescribing be so difficult? difficult?

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What are the Hospice Deprescribing Guidelines?

 OncPal Deprescribing Guidelines: ◦ Helps identify potentially inappropriate medications in palliative cancer patients ◦ Results correspond strongly with analysis of expert panel ◦ Obstacles to use:  Desprescribing organization in Canada  Applied to palliative cancer patients only ◦ Various resources, including deprescribing  Still requires prescriber analysis of patient history algorithms for:  Does not take into consideration individual patient  PPIs goals of care  Cholinesterase inhibitors and memantine ◦ Provides good starting point for considerations  Antihyperglycemics in deprescribing

Deprescribing Guidelines Deprescribing Guidelines Lindsay, et.al. The development and evaluation of an oncological palliative care deprescribing guideline: the 'OncPal deprescribing guideline'. Support Care Cancer. July 2014. https://www.mascc.org/assets/Pain_Center/2014_July/july_2014- 2.pdf https://deprescribing.org/resources/deprescribing-guidelines-algorithms

 Lack short-term benefit (long time-to-benefit):  Some of the best evidence to support discontinuation for certain ◦ Statins patients in the hospice setting ◦ Antihypertensives  Kutner, et al. study can be directly applied to the hospice setting: ◦ Inclusion: ◦ Proton pump inhibitors (PPIs)  Adults with an estimated life expectancy of 1 month to 1 year ◦ Oral hypoglycemics (possibly)  Recent deterioration in functional status  Statin therapy for at least 3 months for primary or secondary prevention of  Otherwise preventative in nature cardiovascular disease ◦ Prophylactic antibiotics  No recent active cardiovascular disease ◦ Antithrombotics ◦ Intervention: Statin was withdrawn for patients randomized to the discontinuation group  No longer beneficial for certain populations ◦ Enrollment: 381 patients; mean age of 74.1 years; 22% were cognitively ◦ AChE inhibitors, i.e. donepezil (Aricept®), galantamine impaired; 48.8% had cancer (Razadyne®), rivastigmine (Exelon®), ◦ Results: ®  No significant difference in rate of death within 60 days between the ◦ Memantine (Namenda ) two groups  Vitamins/minerals/herbs  Overall quality of life (QoL) was found to be better for the discontinuation group ◦ Not likely to provide benefit unless treating confirmed low serum concentrations or patient history indicates significant improvement in QoL with use

What medication classes most Deprescribing Considerations: likely need addressed? Statins

Kutner, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA. 2015 May;175(5):691-700 https://www.ncbi.nlm.nih.gov/pubmed/25798575

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 Consider discontinuation of statins when:  Reason for discontinuation: ◦ No recent cardiovascular disease events ◦ Hypertension is oftentimes asymptomatic ◦ Tight blood pressure control provides only long-term benefit ◦ Risks associated with continuation  Consider discontinuation when:  Pill burden when patient has difficulty swallowing ◦ When used for primary prevention  Drug interactions ◦ When time to benefit exceeds estimated life expectancy ◦ Likely benefits of discontinuation ◦ When treating mild to moderate hypertension  Increase in QoL ◦ When blood pressure monitoring causes distress or discomfort  Risks associated with continuation:  Consider extrapolating study results to ◦ Hypotension due to natural drop in blood pressure near end of life include other lipid-lowering agents  Increased risk for falls ◦ Niacin  Benefit of discontinuation: ◦ Fibrates ◦ Decreases pill burden ◦ Eliminate risk of drug-induced hypotension (which can lead to ◦ Ezetimibe dizziness, syncope, and falls) ◦ Eliminates need for frequent monitoring

Deprescribing Considerations: Deprescribing Considerations: Statins Antihypertensive Medications

  Consider discontinuation when: Instances when antihypertensives may be ◦ No recent history of GI bleeding, peptic ulcer, gastritis, or GERD providing palliation of symptoms: ◦ No concomitant NSAIDs, steroids, or blood thinner  Discontinuation of GI protectants can be overlooked when GI irritants are ◦ Heart failure: ACE-I, diuretics, beta-blockers discontinued ◦ No longer indicated ◦ Atherosclerotic heart disease: ACE-I, beta- ◦ Typically indicated for 6-8 weeks unless treating chronic condition blockers  Risks associated with continuation of proton pump inhibitor ◦ Coronary artery disease: Calcium channel (PPI): ◦ Higher risk of fractures, C. difficile, community-acquired blockers pneumonia, vitamin B12 deficiency, hypomagnesemia, kidney ◦ Symptomatic hypertension disease1  Benefit of discontinuation: ◦ Very high blood pressure ◦ Decreases pill burden ◦ Use for other comfort-related indications ◦ Decreases risk of adverse effects

 i.e. clonidine for treatment of chronic pain

Deprescribing Considerations: Deprescribing Considerations: Antihypertensive Medications Proton Pump Inhibitors

1. Xie, et al. Proton pump inhibitors and risk of incident CKD and progression to ESRD. J Am Soc Nephrol. 2016 Oct;27(10):3153-3163 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5042677

 Reason for discontinuation:  Education points for patient/family: ◦ Long time to benefit of tight glucose control (5-10 years) ◦ Risk outweighs benefit ◦ Early tight control of blood glucose is what  Consider discontinuation when: provides patients the greatest benefits as they ◦ High risk of hypoglycemia  Advanced age near end-of-life  Tight glycemic control  Multiple comorbidities  Already effective in preventing/delaying  History of hypoglycemia neuropathy, retinopathy, and nephropathy ◦ Experiencing adverse effects or at high risk of adverse effects ◦ Beta-blocker is necessary as it can mask symptoms of hypoglycemia ◦ Frail geriatric patients are at higher risk of  Risks associated with continuation of antihyperglycemic ◦ Hypoglycemia hypoglycemia  Impaired cognition  Impaired physical function ◦ Geriatric patients may not demonstrate  Falls and fractures symptoms with hypoglycemia (i.e. sweating,  Benefit of discontinuation: ◦ Decreases pill burden tachycardia, tremor) ◦ Decreases risk of adverse effects  If discontinued, monitor for hyperglycemic symptoms (thirst, dehydration, urinary frequency, fatigue)

Deprescribing Considerations: Deprescribing Considerations: Oral Hypoglycemics Oral Hypoglycemics Farrell B, Black C, Thompson W, McCarthy L, Rojas-Fernandez C, Lochnan H, et al. Deprescribing antihyperglycemic agents in older persons. Evidence-based clinical practice guideline. Can Fam Physician 2017;63:832-43

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 Discontinuation often missed prior to admission to hospice  If patient/family hesitant about ◦ Clopidogrel (Plavix®) discontinuation, consider switch in  Recommended duration of therapy: 12 months post ACS/PCI ◦ Aspirin therapy, instead  The 2019 ACC/AHA guidelines for primary prevention of CVD no longer recommend use of low-dose aspirin unless patient is high  If continued, ensure renal dosing is risk  Bleeding risk generally outweighs benefit in geriatric hospice considered for directly acting oral patient population ◦ Anticoagulants anticoagulants (DOACs)  Duration of therapy depends on indication for use ◦ Rivaroxaban (Xarelto®) ◦ VTE: CHEST guidelines – 3 months ◦ Cancer-associated VTE: commonly recommended for 3-6 months ◦ Apixaban (Eliquis®) ◦ A. fib. and mechanical valves - indefinite ◦ Dabigatran (Pradaxa®)

Deprescribing Considerations: Deprescribing Considerations: Antithrombotics Antithrombotics

 Cholinesterase Inhibitors: donepezil (Aricept®),  Memantine (Namenda®) galantamine (Razadyne®), rivastigmine (Exelon®) ◦ Consider discontinuation when: ◦ Consider discontinuation when:  When cognitive function has declined to near total or total  When cognitive function has declined to total or near total dependence for ADLs (severe dementia) dependence for ADLs (severe dementia)  If no benefit was seen when originally added  If no benefit was seen when originally added ◦ Consider dosage decrease when: ◦ Risks associated with continuation of cholinesterase inhibitors  If eGFR<30 mL/minute: maximum dose of 5 mg twice daily  Pill burden  Adverse effects ◦ Risks associated with continuation of memantine ◦ GI-related: nausea, vomiting, diarrhea, loss of appetite, weight loss  Pill burden ◦ CNS-related: dizziness, drowsiness  Adverse effects ◦ If discontinued, monitor for labile mood, hallucinations, ◦ CNS: Drowsiness, dizziness, confusion delusions, and agitation ◦ GI: Nausea, vomiting, constipation ◦ If discontinued, monitor for cognitive decline and behavior changes

Deprescribing Considerations: Deprescribing Considerations: Cognitive Enhancers Cognitive Enhancers

 Calcium and vitamin D for bone mineral  Eye drops for treatment of glaucoma density ◦ Discontinuation is typically appropriate ◦ Time to benefit exceeds life expectancy  If symptoms return (eye pain, blurry vision,  Contribute to pill burden redness), restart drops  Herbs may interact with other medications ◦ Ginkgo ◦ Ginseng ◦ St. John’s wort ◦ SAMe ◦ Saw palmetto

Deprescribing Considerations: Deprescribing Considerations: Vitamins/minerals/herbs/other Eye Drops

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 Docusate  Commonly prescribed inappropriately at hospice admission ◦ Poor evidence of efficacy as a stool softener ◦ Dry powder inhalers ◦ Study of hospice patients: ◦ Duplicate therapies ◦ Inappropriate directions  No significant difference found in frequency, stool  PRN use of long-acting beta-agonists and anticholinergics volume, or consistency in patients on docusate vs.  Higher than recommended dosing placebo  Non-compliance of patients  Consider continuing if patient history indicates ◦ Ask how patient is actually taking each product clear benefit from docusate use  High cost associated with many respiratory products ◦ Can lead to waste of fiscal resources when using costly medications inappropriately such that they are not providing benefit

Deprescribing Considerations: Deprescribing Considerations:

Other Respiratory Products Tarumi, et.al. Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. J Pain Symptom Manage. 2013 Jan;45(1):2-13. MacMillan, et.al. Missed opportunity to deprescribe: docusate for constipation in medical inpatients. Am J Med. 2016 Sep;129(9):1001

 Example:  Reason for discontinuation: ◦ Low likelihood of appropriate delivery in end-stage COPD ◦ Patient with primary hospice diagnosis of COPD patients comes on services on: ◦ High cost relative to more readily-delivered products  Spiriva® HandiHaler®: Contents of one capsule inhaled  Consider discontinuation when: (with two inhalations) once daily ◦ Poor breath strength ◦ Tiotropium = Long-acting anticholinergic ◦ Poor coordination ® ® ◦ Proved inability to appropriately administer  Serevent Diskus : Contents of one capsule inhaled ◦ Recent significant decline while on current long-term twice daily therapies ◦ Salmeterol = Long-acting beta-agonist  Benefit of discontinuation:  ProAir® HFA: 1 inhalation every 4 hours as needed ◦ Switch to product with greater delivery (i.e. nebulized solution or MDI with spacer) ◦ High costs due to being brand name only: ◦ More appropriate use of financial resources  Spiriva® HandiHaler®: ~$450 per month  Serevent® Diskus®: ~$410 per month Deprescribing Considerations: Deprescribing Considerations: Dry Powder Inhalers Dry Powder Inhalers

 Consider whether patient is a candidate  Commonly encountered medications for a switch to: requiring renal dosing ◦ Iptratropium-albuterol nebulizer solution ◦ Gabapentin (Neurontin®)  Contains short-acting anticholinergic and short- ◦ Pregabalin (Lyrica®) acting beta-agonist ◦ Venlafaxine (Effexor®)  Recommended dosing would be: Administer one ◦ Duloxetine (Cymbalta®) vial via nebulizer four times daily ◦ H2 blockers: ranitidine (Zantac®), cimetidine  Low cost: ~$30 per month (Tagamet®), and nizatidine (Axid®)  Typical results of switch: ◦ Fluoroquinolones: Ciprofloxacin (Cipro®) and ◦ Patient has increased QoL due to decreased SOB levofloxacin (Levaquin®) ◦ Hospice saves ~$830 per month in medication costs ◦ Trimethoprim-Sulfamethoxazole (Bactrim®, Septra®)

Deprescribing Considerations: Deprescribing Considerations: Dry Powder Inhalers Decreasing Dose

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 Commonly encountered medications requiring lower dosing or avoidance in geriatric patients  Antihypertensives ◦ Zolpidem (Ambien®) ◦ Beta-Blockers: TAPER  Avoid use  If necessary, use max dose of 5 mg nightly  Do NOT stop high doses abruptly ◦ Cetirizine (Zyrtec®) ◦ Risk for rebound symptoms  Max dose of 5 mg once daily in geriatric patients  Taper gradually over at least 1-2 weeks ◦ Citalopram (Celexa®)  Max dose of 20 mg/day in patients >60 years of age due to risk ◦ Clonidine: TAPER of QT prolongation  Abrupt discontinuation may result in BP elevation ◦ Rivaroxaban (Xarelto®)and dabigatran (Pradaxa®)  Use with caution for atrial fibrillation or venous and sympathetic overload thromboembolism treatment in adults 75 years and older due to an increased risk of GI bleeding compared with warfarin and ◦ ACE-I/ARBs: Typically safe to discontinue w/o other direct oral anticoagulants taper ◦ Aspirin for primary prevention of CVD  Use with caution in adults 70 years and older due to no significant difference in prevention of CVD compared to placebo Deprescribing Considerations: Decreasing Dose To Taper or Not to Taper…

American Geriatrics Society 2019 Updated AGS Beers Criteria®

 Proton Pump Inhibitors (PPIs): TAPER  Cholinesterase Inhibitors: TAPER ◦ Tapering approaches ◦ Decrease dosing by 25-50% every 1-2 weeks  Cut daily dose by 50% or dose every other day ◦ Monitor for worsening symptoms  Stop and use as needed  Labile mood, hallucinations/delusions, agitation ®  Rebound reflux symptoms may occur with abrupt  Memantine (Namenda ): TAPER cessation ◦ Immediate release tablet: decrease by 5 mg weekly ◦ Extended release tablet: decrease by 7 mg weekly ◦ Monitor for worsening symptoms  Behavioral changes

To Taper or Not to Taper… To Taper or Not to Taper…

 Setup–Plan discussion. Connect with patient.  Perception–Before you tell, ask. Deprescribing is a trial:  Invitation–How would you like changes addressed? Medications can be  Knowledge–Provide information on medications.  Emotion–Respond to patient’s feelings. restarted!  Summarize/Strategize–Provide plan.

What do patients need to understand about the deprescribing process? Conversation Points

Baile, et al. SPIKES-A Six-Step Protocol for Delivering Bad News: Application to Patient with Cancer. The Oncologist. 2000 August;5(4):302-311 https://theoncologist.onlinelibrary.wiley.com/doi/full/10.1634/theoncologist.5-4-302

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 Clarify that hospices have to follow Medicare’s rules ◦ One rule is that all hospice-related medications be paid for by hospice  “Our hospice has a formulary which is a list of medications that have been shown to meet hospice patient’s needs.” ◦ “If some current medications are not on the formulary, other medications that may be even more effective will be recommended.” Discussion Example ◦ “These changes will help hospice make sure you are both comfortable and safe. Hospice wouldn’t make any medication changes if we though it would make symptoms worse or cause harm.” Discussing Formulary with

Modified from materials initially presented by Dr. Mary Lynn McPherson and Dr. Shaida Talebreza Patients Turning Points: Mastering Transitions in Care Virtual Conference July 18-19, 2018

 Prior to discussion of a particular Hospice Team Member Patient medication change, consider… ◦ What is our goal with this change?  I want to make sure  I just want to make ◦ What barriers might there be? that we are giving sure that I don’t feel ◦ How do we discuss with patient? you the best care like I am suffocating. ◦ How do we present to a resistant prescriber? possible. At this And I want to spend point, what about as much time as your care matters to possible with my you most? family.

Discussion Considerations

Hospice Team Member Patient Hospice Team Member Patient

 Those are important goals  That sounds like a good  Do you mind if I ask  Well, I’m thankful for that we need to know about. One of our goals is idea. how you feel about medications and all, but to make sure that we keep taking all of these it is so hard keeping you safe. Because of this, medications? track of them all. it is important that we review your medications to see if there are changes that should be made. Is it alright with you if go ahead  Are there any  I know I forget to take and review your medications that you some of them. But I medications with you and aren’t taking or want to don’t think it would be your family? stop? right to stop them!

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Hospice Team Member Patient Hospice Team Member Patient

 Yes, I’m sure it may  Yes. For sure! My  Would it help you if  I think it would. be a little scary to doctor has had me on we discussed how change medications. most of these your medications fit medications for in with your goals years. and with our goal to keep you safe?

Hospice Team Member Patient Hospice Team Member Patient

 Quite often medications  But my doctor told me  It sounds like you are worried that  Yes. That really scares me. that we needed at one that I need to never, ever stopping some of your medications means you are going to die sooner. time are not helpful stop these medications Is that right? anymore, and sometimes because I might die if I they start to actually stop them!  We certainly wouldn’t want to stop  I didn’t know that was the case cause harm. From what I a medication if doing so would about any of my medications. know about your health shorten your life. Medications that history, my concern is help you reach your goals and that that you are on will keep you safe are important. Many of the medications I am medications that are not talking about have done their job helpful to you anymore. to help you already so that you will see the benefits from them even after you stop them.

Hospice Team Member Patient

 Is it OK if I make a  Well, yes, I guess so. recommendation that will Keep discussions help you? patient centered  I recommend that we stop  That sounds like ______because it is no something worth trying. with the goal of longer helpful. We will monitor you closely and continuation of will restart , change, or add medications if you compassionate comfort don’t feel better without that medication. care.

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QUESTIONS? Email Corina at: [email protected]

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