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PEDIATRIC INFUSION THERAPY
Pediatric Infusion Therapy
List common intravenous therapies seen in a pediatric outpatient infusion center
Describe challenges to starting a pediatric infusion center
Provide updates to USP 797 regulations
Medications
• IV fluids• Antibiotics• Steroids• Blood
ACUTE
• Immune globulin• Chemotherapy• Biologics• Blood factor products
CHRONIC
RheumatologyRemicade
Solu-Medrol
Rituxan
Allergy/Immunology Xolair
IVIG
Gastroenterology Remicade
NeurologyIVIG
Soliris
Lumizyme
OBSTACLES
Medication administration
Financial
Communication
Emergency Preparedness
Medication Administration
IV access
Nursing experience
Chemoport
Anxiety
Oral medications
FINANCIAL
Inventory
Pharmacy vs Medical benefit
Prior authorizations
Reconciliation
Communication
Physician
Parent/caregiver
Patient
Emergency Preparedness
PALS
Crash cart
AED
Broselow tape
Documentation
PHARMACEUTICAL COMPOUNDING
“Compounding” – the act of combining or altering ingredients to create medicines to meet the unique medical needs of individual patients
“Sterile compounding” – combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication
United States PharmacopeialConvention(USP)
USP <795> Pharmaceutical Compounding – Nonsterile Preparations
USP <797> Pharmaceutical Compounding – Sterile Preparations
USP <800> Hazardous Drugs –Handling in Healthcare Settings
USP <825> Radiopharmaceuticals –Preparation, Compounding, Dispensing, and Repackaging
USP <797> UPDATES
RISK LEVELS
Eliminated low-, medium-, and high-risk
Category 1 vs Category 2 Category 1 – CSPs prepared in a segregated
compounding area
Category 2 – CSPs prepared in a clean room suite
Immediate Use
Category 2 Compounded Sterile Products (CSPs)
CSPs prepared in a clean room suite
Ante room and buffer room containing a laminar airflow system (hood) or restricted-access barrier system (glovebox)
4 days at room temp, 10 days refrigerated, 45 days frozen
Regulations for garbing, cleaning, air pressure/filtration/exchanges, surface and air sampling
Category 1 Compounded Sterile Products
CSPs prepared in a segregated compounding area. Contains a hood, glove box or isolator. Must have visible perimeter, away from windows, doors to outside, or high-traffic areas.
12 hours at room temp and 24 hours refrigerated
Cleaning, sampling, garbing requirements still apply
Immediate use CSPs
Prepared outside of a sterile environment
No more than 3 different sterile products
Intended for direct administration to a specific patient within 4 hours
USP <797> UPDATES
BUD for single-dose vial is now 12 hours when punctured in ISO 5 environment
Master formulation record
Compounding record
Provisions for administration and preparation per approved labeling
USP <797> UPDATES
Surface sampling has been changed from “periodically” to “monthly”
Addition of a sporicidal agent to cleaning and disinfecting regimens required monthly
Same garbing requirements regardless of Category 1 or 2 CSP
Allergenic extracts
USP <797>: Allergenic Extracts
PERSONNEL QUALIFICATIONS
Designated person to train, evaluate, supervise
Prior to compounding
Complete training about principles and skills for sterile compounding
Complete gloved fingertip sampling
Competency testing (including written/electronic)
Annual evaluation – gloved fingertip, media fill test
PERSONNEL HYGIENE AND GARBING
Hand hygiene and garbing procedures according to facility SOPs
Low linting garment enclosed at neck and tight at wrists
Face mask
Hair covers
Sterile powder-free gloves
Must use sterile 70% IPA throughout the compounding process
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 disinfecting
Restrictions 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 not exceed 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
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