Long-Term Care: Providing Monoclonal Antibody Therapy Safely
Long-Term Care:Providing MonoclonalAntibody Therapy SafelyJune 16, 2021
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Meet your Speakers:Rick Mancini, RPH,Pharmacy Director,PharMericaLinda Walker, BSN, RN,Chief Nursing Officer,Trauma CoordinatorJesse Kinsey, BS, RN,Pharmacy NurseConsultantRick has 27 years ofexperience in long-termcare pharmacy, includingconsulting pharmacy andmanagement positions.Linda is currently workingat Three Rivers Health inBasin, Wyoming, as thechief nursing officer andtrauma coordinator.Jesse serves as a long-termcare pharmacy nurseconsultant for customersthroughout Montana andWyoming for PharMerica.3
Monoclonal Antibodies (mAbs) There are currently four mAbs given FDA authorization foremergency use in early stage, high risk COVID-19patients bamlanivimab and etesevimab (Eli Lilly)casirivimab and imdevimab (Regeneron) mAbs are laboratory produced antibodies that are specificfor a designated antigen Monoclonal Antibodies can aid in the bodies immune response tofight the COVID-19 virus Authorized use: The treatment of mild to moderate coronavirus disease 2019(COVID-19) in adults and pediatric patients (12 years of age andolder weighing at least 40 kg) with Positive results of direct SARS-CoV-2 viral testing, and Who are at high risk for progressing to severe COVID-19and/or hospitalizationLimitation of AuthorizedUseNot to be used in patients who Are hospitalized due toCOVID-19, OR Require oxygen therapydue to COVID-19, OR Require an increase inbaseline oxygen flow ratedue to COVID-19 in thoseon chronic oxygen therapydue to underlying nonCOVID-19 relatedcomorbidity.Source: mAbs Evolving Evidence (DUKE)4
Monoclonal Antibodies (mAbs)The FDA’s definition of high-risk is based on age and meeting 1 of thefollowing defined criteria:5
Monoclonal Antibodies (mAbs) continuedMarch 24th Update on Variants Avoid the use of bamlanivimab monotherapy and to instead consider using thealternative monoclonal antibody therapies (bamlanivimab/etesevimab,casirivimab/imdevimab), which are expected to maintain activity against circulatingCOVID-19 variants.This will lower the risk of treatment failure if patients become infected with a SARS-CoV2 viral variant resistant to bamlanivimab alone.BAMmonotherapyno longereffectiveSource: HHS March 24Advisory6
Monoclonal Antibodies (mAbs) Emerging safety and efficacy dataBLAZE-1 demonstrated that bamlanivimab and etesevimab in combination reducedthe need for hospitalization or death by approximately 70%BLAZE-3, studying bamlanivimab for post-exposure prophylaxis for nursing homeresidents and workers, has 2 significant topline findings; A significant reduction of symptomatic COVID-19 infection 8 weeks post mAb treatmentAn 80% reduction in risk of contracting COVID-19 vs placeboPer a Regeneron interim analysis: casirivimab and imdevimab given prophylacticallyafter exposure to a COVID-19 patient in the household demonstrated: A complete reduction in symptomatic infections (8 cases in placebo and 0 in treatment)A 50% reduction in asymptomatic infections (23 cases in placebo and 8 in treatment)Viral load was cut by 100-foldThis data helps to support use of mAbs in early stage, high-riskpatients before serious symptoms occurSource: mAbs Evolving Evidence (DUKE)7
Monoclonal Antibodies (mAbs) Number Needed to Treat (NNT) Bamlanivimab NNT 10 to 25 residents4-10% absolute risk reduction For some context Warfarin for Atrial Fibrillation Statins In patients without a prior history of stroke, the NNT to prevent one case of stroke with warfarinis 25In patients without known heart disease receiving daily statin therapy over 5 years, the NNT forheart attack prevention is 104. Additionally, the NNT for stroke prevention is 154Antihypertensives for Cardiovascular Disease In patients receiving antihypertensive therapy for 5 years, the NNT to prevent 1 death is 125The NNT to prevent heart attack is 100, and to prevent stroke, 678
Monoclonal Antibodies (mAbs) Challenges of administration in Long-Term Care Facilities (LTCFs) Vascular Access Timing Within 10 days of diagnosis 4-7 hours window at room temperature once compounded24-36 hours stored at refrigerated temperatures once compoundedNeed to account for infusion time as well bamlanivimab and etesevimab (Eli Lilly) Combination therapy – Options for 21 to 70 minute infusions depending onvolumecasirivimab and imdevimab (Regeneron) 1 hour infusion time Short beyond-use-dating Infusion time Post Administration Monitoring – 1 hour9
LESSONS FROM THE BATTLEGROUNDBonnie Bluejacket Memorial Nursing Home Bonnie Bluejacket Memorial NursingHome is located in beautiful Big HornCounty in Basin, Wyoming. The facility has 37 beds for long-termcare and offers skilled nursing care. The Care Center is affiliated with ThreeRivers Health/South Horn CountyHospital District and is on the samecampus as the Hospital and MidwayClinic.
LESSONS FROM THE BATTLEGROUNDBackground/Timeline December 17, 2020 COVID-19 Breakout at Bonnie Bluejacket Over Half of the Residents Tested Positive for COVID-19 December 18, 2020 6 Residents Received Monoclonal Antibody Therapy
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LESSONS FROM THE BATTLEGROUNDAdult Bamlanivimab Referral Pack/Resident ConsentsAdult Monoclonal Antibody Referral Packet Engage Patients or DPOA in SharedDecision Making Explaining the Meaning of EUA Status Educate on Potential Risks and Benefits Discuss Alternative Treatment Options Provide Fact Sheet for Patients, Parentsand Caregivers Obtain Informed Consent for Treatment
LESSONS FROM THE BATTLEGROUNDChecklistsCriteria Met Under EUA for MonoclonalAntibody Therapy Administration as DefinedBelow:Patients must meet at leaseone of the following criteria: Body Mass Index 35 Chronic Kidney Disease Have Immunosuppressive Disease,Specify Currently Receiving ImmunosuppressiveTreatment, Specify Are 65 years of Age Are 55 years of Age AND have Cardiovascular Disease, or ChronicObstructive Pulmonary Disease/OtherChronic Respiratory DiseaseDocumentation of shared Decision MakingRegarding EUA Status and ConsentThe following have been discussed and understood by the patient orcaregiver Monoclonal Antibody Therapy is anunapproved drug by the FDA that is authorizedfor use under Emergency Use Authorization Alternatives to receiving authorized MonoclonalAntibody Therapy Provided “Fact Sheet for Patients, Parents andCaregivers” and all questions answered to theirsatisfaction Signed “Informed Consent to Treatment withEUA, Bamlanivimab for Mild to Moderate COVID19”
LESSONS FROM THE BATTLEGROUNDVital Signs Vital Signs Including Pulse Oximetryupon initiation of Monoclonal Therapyinfusion: Pre-infusion, every 15 min x1hour; then every 30 min x2 after infusionhas been completed Notify Provider of Vital SignsChanges in vital signs ( /-10%) during andimmediately following Monoclonal Therapyinfusion, T 100.5 Notify Provider and Stop InfusionObserve for infusion reaction which mayinclude fever, chills, nausea, headache,bronchospasms, hypotension, angioedema,throat irritation, rash include urticaria,pruritis, myalgia, dizziness during andimmediately following infusion
LESSONS FROM THE BATTLEGROUNDMedication Standing OrdersPremedicationsIf ordered must be administered at least 30 min prior to starting Infusion Diphenhydramine 25mg, PO X1; Indication: Allergy Prophylaxis Diphenhydramine 50mg, PO X1; Indication: Allergy Prophylaxis Acetaminophen 650 mg, PO X1; Indication: Allergy Prophylaxis Ondansetron 4mg, ODT X1; Indication: Nausea Prophylaxis Ondansetron 4mg, IV Push x1: Nausea ProphylaxisEmergency Allergic Reaction MedicationsIf patient develops any signs of hypersensitivity reaction, STOP infusion,contact provider Methyprednisolone (SOLU-Medrol) 40mg, IV Push, X1 PRN; Max Dose125mg Diphenhydramine (Benadryl) 50mg, IV Push, X1 Epinephrine 1mg/mL solution, 0.3mg IM, X1 PRNInfusion Bamlanivimab 700mg/20mL, IV x1Use 0.2-micron filter, infuse at 270mL/hr
LESSONS FROM THE BATTLEGROUNDEquipmentAppropriate PPEIV SuppliesIV PumpVital Signs MonitorEmergency Kit Contains Standard AnaphylaxisTherapy Prepared by Pharmacist Comfortable Seating for Resident Support/Staff Registered Nurse 3:1 Ratio CNA Assist with VS Monitoring Social Worker Consents Phone Calls to Family Members
LESSONS FROM THE BATTLEGROUNDBarriers Supply of Monoclonal Antibody Limited Due to State Allocation Specialized 0.2-micron filter Time and Resources Total of 5 hours Resident Education/Consents Prep IV Starts Infusion Time Post Infusion Monitoring Availability of Staffing Short Staffing Due To COVID EmployeesSuccesses 6 Residents Received theMonoclonal Antibody All Infusions Were CompletedSuccessfully None of These Residents WereHospitalized Related to COVID19 Built Teamwork and Confidencein Nursing
COVID-19 ( ) cases versusVaccination Rates19
Monoclonal Antibodies Are Not New Nearly 100 mAbs are FDA approved totreat health conditions including cancersand autoimmune diseases.In April, nearly a million doses ofmonoclonal antibody had been purchasedby the government and made availableacross the country.SPEED (Special Projects and Equitableand Efficient Distribution)20
Underused Unfamiliar Narrow window Underestimated/unknown Hesitancy related to environment21
Build Your KnowledgeImportance of understanding your partnersand resources: IV nursing support servicesInfusion therapy education and competencyAssessment confidenceOrder forms and templatesPolicy and procedure guidance22
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Q&AThank you for attending today’s session!For questions, please contactLinda Walker linda.walker@trhealth.com orJill Hult jhult@mpqhf.org.Developed by Mountain-Pacific Quality Health, the Medicare Quality Innovation Network-Quality Improvement Organization (QIN-QIO)for Montana, Wyoming, Alaska, Hawaii and the U.S. Pacific Territories of Guam and American Samoa and the Commonwealth of theNorthern Mariana Islands, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Departmentof Health and Human Services. Contents presented do not necessarily reflect CMS policy. 12SOW-MPQHF-AS-NH-21-7224
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Jun 16, 2021 · Vital Signs Vital Signs Including Pulse Oximetry upon initiation of Monoclonal Therapy infusion: Pre-infusion, every 15 min x1 hour; then every 30 min x2 after infusion has been completed Notify Provider of Vital Signs Changes in vital signs ( /-10%) during and immed
MRC reagents catalogue for monoclonal antibodies Category Reference Number . J.Exp.Med. 162:117 86100903 Monoclonal Antibody A857/0065 anti-CD25 (IL-2R alpha) monoclonal antibody OX39 CD25 cell surface
Select Long-Term Care Occupations, Pooled 2003-2013. 27. UCSF Health Workforce Research Center on Long-Term Care Research Report 6 Entry and Exit of Workers in Long-Term Care Executive Summary In the past decade, the health care industry, and long-term care (LTC) in particular, saw substantial job growth. In anticipation of growing demand .
insurance called Qualified Long-Term Care Insurance. This regulation is intended to provide requirements for all long-term care insurance contracts, including qualified long-term care insurance contracts, as defined in the NAIC Long-Term Care Insurance Model Act and by Section 7702B(b) of the Internal Revenue Code of 1986, as amended.
Long Term Care and Personal Care Homes FINANCIAL SUBSIDY APPLICATION FOR: PERSONAL CARE HOME LONG TERM CARE . Financial Assessment Officer - Eastern Health Long Term Care 760 Topsail Road - Business Side, Mount Pearl, NL A1N 3J5 Tel: (709) 752-4361 Fax: (709) 752-4740 .
into long-term health care benefit plans. Conversely, Medicaid expenses on long-term health care services for residents may be offset by similar amounts (as aforementioned) annually. This is about 5.07-5.78 percent of the Medicaid long-term care appropriations for Nursing Home Careor 2.99-3.40 percent of the total Medicaid Long Term
Decisional Balance Worksheet Good things Not so good things Current Behavior Short Term Long Term Short Term Long Term Change Short Term Long Term Short Term Long Term . Thinking About Drinking Here is an example of someone exploring their ambivalence about alcohol use. Everyone’s decisional balance will look a little different.
Mental Health in Long-Term Care 9 It is important to be aware of problems or changes in your mood, thinking and behaviour while in long-term care. These could be signs that something is wrong. If there is a problem, staff at the home can help you and your family. To take care of the mental health of all residents, long-term care homes should:
bachelor’s degree in Mechanical Engineering from Cooper Union School of Engineering in New York. He is the author of more than 100 books in engineering and related fields. CIVIL ENGINEERING FORMULAS Tyler G. Hicks, P.E. International Engineering Associates Member: American Society of Mechanical Engineers United States Naval Institute Second Edition New York Chicago San Francisco Lisbon .
