PEDIATRIC INFUSION THERAPY - Msadvancedmedicine

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PEDIATRICINFUSION THERAPY

Pediatric Infusion Therapy List common intravenous therapies seen in a pediatricoutpatient infusion center Describe challenges to starting a pediatric infusion center Provide updates to USP 797 regulations

ACUTEMedications IV fluids Antibiotics Steroids BloodCHRONIC Immune globulin Chemotherapy Biologics Blood factor products

VIGSolirisLumizyme

OBSTACLESMedication administrationFinancialCommunicationEmergency Preparedness

MedicationAdministration IV access Nursing experience Chemoport AnxietyOral medications

FINANCIAL Inventory Pharmacy vs Medical benefit Prior authorizations Reconciliation

Communication Physician Parent/caregiver Patient

EmergencyPreparedness PALS Crash cart AED Broselow tape Documentation

PHARMACEUTICAL COMPOUNDING“Compounding” – the act of combining or altering ingredients tocreate medicines to meet the unique medical needs of individualpatients“Sterile compounding” – combining, admixing, diluting, pooling,reconstituting, repackaging, or otherwise altering a drug or bulkdrug substance to create a sterile medication

United StatesPharmacopeialConvention(USP)USP 795 PharmaceuticalCompounding – Nonsterile Preparations USP 797 PharmaceuticalCompounding – Sterile Preparations USP 800 Hazardous Drugs –Handling in Healthcare Settings USP 825 Radiopharmaceuticals –Preparation, Compounding, Dispensing,and Repackaging

RISK LEVELSUSP 797 UPDATES Eliminated low-, medium-, and high-risk Category 1 vs Category 2 Category 1 – CSPs prepared in a segregatedcompounding area Category 2 – CSPs prepared in a clean room suiteImmediate Use

Category 2 Compounded SterileProducts (CSPs) CSPs prepared in a clean room suite Ante room and buffer room containing a laminarairflow system (hood) or restricted-accessbarrier system (glovebox) 4 days at room temp, 10 days refrigerated, 45days frozen Regulations for garbing, cleaning, airpressure/filtration/exchanges, surface and airsampling

Category 1 CompoundedSterile Products CSPs prepared in asegregated compoundingarea. Contains a hood,glove box or isolator. Musthave visible perimeter,away from windows, doorsto outside, or high-trafficareas. 12 hours at room temp and24 hours refrigerated Cleaning, sampling, garbingrequirements still apply

Immediate useCSPs Prepared outside of asterile environment No more than 3different sterileproducts Intended for directadministration to aspecific patient within4 hours

USP 797 UPDATES BUD for single-dose vial is now 12hours when punctured in ISO 5environment Master formulation record Compounding record Provisions for administration andpreparation per approved labeling

USP 797 UPDATES Surface sampling has been changedfrom “periodically” to “monthly” Addition of a sporicidal agent tocleaning and disinfecting regimensrequired monthly Same garbing requirementsregardless of Category 1 or 2 CSP Allergenic extracts

USP 797 : Allergenic Extracts PERSONNEL QUALIFICATIONS Designated person to train,evaluate, supervise Prior to compounding PERSONNEL HYGIENE AND GARBING Hand hygiene and garbingprocedures according to facilitySOPs Complete training about principlesand skills for sterile compounding Low linting garment enclosed atneck and tight at wrists Complete gloved fingertip sampling Face mask Competency testing (includingwritten/electronic) Hair covers Sterile powder-free gloves Must use sterile 70% IPA throughoutthe compounding processAnnual evaluation – glovedfingertip, media fill test

USP 797 : Allergenic Extracts Facilities ISO Class 5 primary engineering control (PEC) Dedicated allergenic extracts compounding area (AECA) walls, floors, fixtures, shelving, counters, cabinets must be cleanable Compounding surface must allow for easy cleaning and disinfectingRestrictions on location (away from traffic, windows, food, restrooms, etc)Cleaning and disinfecting Daily cleaning with sterile 70% IPA Monthly cleaning – walls, doors, ceilings Vial stoppers

USP 797 : Allergenic Extracts BUD – no later than expiration date on each extract or diluent, and must notexceed 1 year from the date the prescription set is mixed or diluted Labeling Documentation SOPs Personnel training records, competency assessments, qualification records,corrective actions Certification of PECs if used Temperature logs for refrigerators Compounding records

Pediatric Infusion Therapy List common intravenous therapies seen in a pediatric outpatient infusion center De

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