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