Aseptic Technique, Sterile Compounding, and IV Admixture .... Aseptic...•Describe manual &...
Transcript of Aseptic Technique, Sterile Compounding, and IV Admixture .... Aseptic...•Describe manual &...
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Aseptic Technique, Sterile Compounding, and IV Admixture
Programs
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Learning Outcomes • Describe basics of intravenous drug therapy
• Describe key elements of working in laminar airflow workbenches
• List types of contamination in a laminar flow hood & describe how to minimize their risks
• Perform basic manipulations needed to prepare a sterile product by using aseptic technique
• Describe the risks of handling cytotoxic & hazardous drugs
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Learning Outcomes
• List steps in drug preparation & handling that are unique to cytotoxic & hazardous drugs
• List typical ingredients of total parenteral nutrition solutions
• Describe manual & automated means of preparing total parenteral nutrition solutions
• Describe benefits of having a formal intravenous admixture program
• Describe how USP 797 has impacted preparation of sterile products
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Key Terms
• Aseptic technique • Biological safety cabinet • Coring • Free –flow protection • HEPA filter • Laminar airflow workbench (LAFW) • Large volume parenteral (LVP) • Total parenteral nutrition (TPN) • Small volume parenteral (SVP)
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Parenteral Drug Administration
Parenteral – “not through digestive tract”
• Intravenous (IV)
• Intramuscular (IM)
• Intrathecal (IT)
• Epidural
• Intraarticular
• Intraarterial
• Intraocular
• Intraperitoneal
• Subcutaneous (SQ, SC, SubQ)
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Risks of Intravenous Therapy
• Infection • Air embolus • Bleeding • Allergic reaction • Incompatibilities • Extravasation • Particulate Matter • Pyrogens • Phlebitis
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Types of IV Administration
• Infusions
– Continuous
– Intermittent
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IV Containers
• Large Volume Parenterals (LVPs)
• Small Volume Parenterals or “Piggyback” Systems
• Add-Vantage®
• Vial Spike Systems
• Flexible Plastic Bags
• Glass Containers
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Basic Continuous IV Therapy
• Large volume parenteral (LVP)
– hung on an IV pole 36 inches above patient’s bed
– flow maintained by gravity
• Sterile tubing attached to LVP
– primary IV set
• Catheter in patient’s vein
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LVP
• Usually a simple solution of
– dilute dextrose
– sodium chloride
– or combination of both
• Additives
– swab rubber stopper with alcohol & let dry
– inject drug into fluid
– remove bottle vacuum
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Non-coring Technique
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Administration Systems • Continuous Infusions
– more effective & less toxic than when given intermittently
– basic fluid & electrolyte therapy
– blood products
– drugs that require tight administration control
• Intermittent Injections
– periodic administration increases efficacy
– reduces toxicity
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Pre-Mixed Admixtures
• Manufactured LVPs with additives
– stable in solution for longer periods of time
– available in many of sizes (250 mL, 500 mL, 1000 mL)
• Examples
– lidocaine
– potassium
– nitroglycerin
– dopamine
– aminophylline
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RTU Advantages
• Reduce handling by pharmacy
– Reduce potential for contamination
• Emergency situations-stocked in patient care area
• Standard concentrations of IV medications
– decrease potential medication errors in compounding & administration
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Pharmacy Prepared Admixtures
• Volumes (100 mL, 250 mL, 500 mL, or 1000 mL)
• Containers (glass, plastic, bag, bottle or syringe)
• Syringe Systems
– syringe pumps
– volume control chambers
– gravity feed
– intravenous push systems
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Syringe Systems
• Pharmacy fills syringes with drugs & labels
– stability in syringes related to drug concentration
• Syringe Pumps
– adjusted to administer volume over given period of time
– pumps are operated by battery or compressed spring
– may administer single dose or pre-programmed intervals
– doses must be sent from pharmacy in standard syringe sizes & concentrations
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Electronic Infusion Devices
• Electronic infusion devices
– increase precision & accuracy
– in fluid restricted patients
– when drug must be administered at precise rate
• “Smart pumps” alert user to problems
– infusion settings outside recommended range
– updates may be sent to pumps
– pump log data may be sent to information system
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Volume Control Chambers
• Buretrol or Volutrol
• Syringes used to administer drugs through volumetric chamber
– drug injected through port on top of chamber
– solution added from primary LVP
– minimal amounts of fluid can be given per dose
– beneficial in fluid-restricted or pediatric patients
– important that medication is followed by IV flush
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Gravity Feed • Syringes can use gravity to administer drugs
– vented set allows air to enter syringe
– inexpensive & requires no other special equipment
• Intravenous Push
– injected directly into IV tubing
– primary IV set is usually clamped off
• Drug delivered directly to patient
• Rapid onset of effects of drug
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Patient Controlled Analgesia
• Very effective in managing pain
• Patient administers dose as soon as pain felt
• Reduces nursing time
• Pump programmed
– Basal rate
– Bolus when patient pushes button
– Example: max 1 mg of morphine every 15 minutes
• If patient pushes button in 10 minutes, drug not released but attempt recorded so that pump tracks if pain not controlled
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Unique Infusion Devices
• Implanted pump
– drug reservoir for continuous low-dose chemotherapy administration
• Elastomeric infusion device (EID)
– acts as its own pump
– pressure of container forces drug through tubing
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Administration Sets
• Primary IV Set
– attached to the LVP
– can be one of several varieties
• Drip chamber-estimate administration rate by counting drops as they fall through chamber
• Drip chamber
– macrodrip or minidrip
– based on size of drop
– tubing is labeled according to number of drops it produces from 1 milliliter of solution
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Drip Sets
• Macro-drip sets deliver 10-20 drops per 1 mL
• Minidrip sets deliver sixty drops per 1 mL
• Rate controlled by roller clamp or electronic infusion device
• Drugs injected through ports
– either Y-sites or flashballs
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Venous Access Devices
• Peripheral insertion most common
• Peripheral catheters-limitations on what can be infused & at what rate
• Central catheter
– more complicated
– riskier to insert & maintain
– fewer restrictions
• concentration of drug
• rate of administration
• time venous access can remain in place
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Peripheral Catheters
• Plastic-flexible & most comfortable for patient
• Steel needle with short end of tubing
– scalp vein or butterfly
– may be left in the patient’s vein if flushed
• Central catheters
– temporary or permanent
– access vein with high blood flow
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Catheter Examples
• Permanent catheters
– Hickman®
– Broviac®
– Port-a-cath®
• Peripheral catheter
– “peripherally inserted central catheter” (PICC)
• PICC inserted peripherally
– flexible catheter threaded through venous system & its tip ends near heart
– high volume of blood flow
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IV Miscellaneous Information
• Heparin Lock
– maintain catheter access to vein
– resealable rubber diaphragm
– provide port for intermittent use
– concentration of heparin used in heparin locks is usually 10 units/mL or 100 units/mL
• Needleless Systems
– reduce risks of needle sticks
– required in some states & some healthcare systems
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IV Misc. Information Continued
• Final Filters
– located in the tubing
– used to remove particles in IV solution
– used with drugs that have a risk of particulate matter or crystals in final solution
– examples of drugs requiring filters
• phenytoin
• mannitol
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Aseptic Preparation
• Admixture preparation program includes:
1. Development & maintenance of good aseptic technique in personnel who prepare & administer sterile products
2. Development & maintenance of sterile compounding area, complete with sterilized equipment & supplies
3. Development & maintenance of skills needed to properly use laminar airflow workbench (LAFW) or laminar airflow hood
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Aseptic Technique
• Manipulating sterile products without compromising their sterility
– proper use of LAFW
– strict aseptic technique
• Conscientious work habits
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Sterile Compounding Area
• Compounded sterile products (CSPs) must be free of
– living microorganisms
– pyrogens
– visible particles
• Reduce number of particles in air
– no cardboard in clean room
• Clean work surfaces & floors daily
• Clean walls, ceilings, & shelving monthly
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Sterile Compounding Area
• Segregate compounding area
– minimize traffic in sterile compounding area
– remove trash d frequently & regularly
• Filter incoming air
• Ultraviolet irradiation
• Air-lock entry portals
• Sticky mats
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Sterile Compounding Area
• Use anteroom for non-aseptic activities
– order processing
– gowning
– handling of stock
• ISO Class 5 environment
– no more than 100 particles per cubic foot that are 0.5 micron or larger in size
• LAFWs are used to achieve an ISO Class 5 environment
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Laminar Airflow Workbenches
• Principle of LAFWs
– twice-filtered laminar layers of aseptic air
– continuously sweep work area inside hood
– prevents entry of contaminated room air
• 2 common types of LAFWs
– horizontal flow
– vertical flow
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IV Hoods
Vertical Hoods used for preparing hazardous medications
Designed to protect preparer from exposure to hazardous medications
Horizontal Hoods most common for sterile preparation of IV solutions
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Horizontal LAFW
• Air moves from back to front
• Electrical blower draws room air through a prefilter
• Removes gross contaminants
• Should be cleaned or replaced on regular basis
• Prefiltered air moves through final filter
• Entire back portion of hood’s work area is HEPA
– high efficiency particulate air
• Removes 99.97% of particles that are 0.3 micron or larger
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Vertical LAFW
• Air emerges from the top and passes downward
• Exposure to airborne drug particulates minimized
• Used for preparation of antineoplastics
• Referred to as biological safety cabinets (BSCs)
• Space between the HEPA filter and the sterile object
– critical area.
• Must prevent downstream contamination
• Zone of turbulence
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LAFW Principles
• Position away from excess traffic, doors, air vents, etc.
• Must run for 15 -3o minutes if turned off & back on
• All interior working surfaces should be cleaned
– 70% isopropyl alcohol/other disinfecting agent
– clean, lint-free cloth
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Cleaning LAFWs
• Clean sides of hoods using up & down direction
– start at HEPA
– work toward outer edge of hood
• Order of cleaning
– walls 1st
– floor of hood 2nd
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Cleaning LAFWs
• Frequency
– beginning of each shift
– before each batch
– not longer than 30 minutes following previous surface disinfection when ongoing compounding activities are occurring
– after spills
– when surface contamination is known or suspected
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Cleaning LAFWs
• If materials not soluble in alcohol, initially use water
– follow with alcohol
• Do not use spray bottles of alcohol in hood
• Let alcohol air dry
• Clean Plexiglas sides -warm, soapy water
• Alcohol will dry out Plexiglas
– clouds & cracks
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Additional LAFW Instructions
• Nothing should come in contact with HEPA filter
• Nothing in hood that is not essential IV preparation
– no paper, pens, labels, or trays
• No jewelry on hands or wrists
• Talk & cough away from LAFW
• No smoking, eating, drinking in aseptic area
• Manipulations at least six inches within hood
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Additional LAFW Instructions
• Must test LAFWs at least every 6 months
– Also test if hood moved, or if filter damage suspected
– Specific tests
• airflow velocity
• HEPA filter integrity
• Strict aseptic technique must be used
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Aseptic Environment
• Personal Attire -Cover
– Shoes, head & facial hair, use face masks/eye shields
– cover scrub suits when leaving pharmacy
• Handwashing
– touch is most common source of contamination
– scrub hands, nails, wrists, forearms to elbows for at least 30 seconds with a brush, warm water, & appropriate bactericidal soap
• Gloving
– only sterile until they touch something unsterile
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Equipment & Supplies
• Syringes
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Syringes
• Volume of solution- 1/2 to 2/3 of syringe capacity
• Measuring-line up final edge to calibration mark on barrel
• Open syringe package in hood to maintain sterility
• Peel wrapper & discard out of hood
• Leave syringe tip protector in place until time to attach needle
• To attach needle to Luer-lock-type syringe ¼ turn is usually sufficient to secure needle to syringe
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Needles
• Note components
• Often color-coded=gauge
• Vented needles
• Filter needles
• Dead space
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Vials
• Rubber stopper
• Powders or liquids
• 70% isopropyl alcohol
• Avoid coring
• Normalize pressure
• Reconstitution
• SDV or MDV
• Preservative considerations
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Ampules
• Move fluid to body of ampule
• Swab neck with alcohol pad
• Break at neck
• Tilt ampule, needle bevel down
• Use filter needle
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Prefilled Syringes
• Manufactured ready-to-inject syringes
• Commonly given IM, IV, or subcutaneously
• Convenient for administration
– emergency situations
• Most likely to be kept in patient care areas
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Preparation of IV Admixtures
• Pharmacist inputs order into computer system
• Assemble all materials & visually inspect
• Clean hood-only needed products in hood
• Disinfect all injection surfaces
• Withdraw & measure drug fluid
• Remove air bubbles from syringe
• Discard syringes & uncapped needles
• Recapping needles is generally unsafe practice
– use one-handed scoop method if recap needed
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Closures & Seals
• Luer Tips for syringes when final product being dispensed is not intended for injection
– oral
– topical
• IV port seals
• Tamperproof caps
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Automated Compounding
• Sterile product preparation is technically complex
• Verification challenging
• Automation can eliminate preparation errors
• Enclosed IV preparation environments & robotics
– used in high volume situations
– or may prepare patient specific doses
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Labeling of IV Preparations 1. Patient name, identification #, room #
2. Bottle or bag sequence number
3. Name & amount of drug(s) added
4. Name & volume of admixture solution
5. Final total volume of admixture
6. Prescribed flow rate (in milliliters per hour)
7. Date & time of scheduled administration
8. Date & time of preparation
9. Expiration date
10. Initials of person who prepared/checked IV admixture
11. Auxiliary labeling
12. Bar coding
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Beyond Use Date (Exp Date)
• Label & final sterile product- validated by registered pharmacist
• Label with beyond use date (BUD)
– stability
– sterility
• Policies & procedures
– substantiated by
• references
• published literature
• reasonable professional judgment
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Cytotoxic & Hazardous Drugs
• Hazardous agents
– special procedures for labeling, storage, transport
– special clothing
– Biological Safety Cabinets (BSCs)
– special handling of spills & waste
• Additional information is available from ASHP
• Technical Assistance Bulletin on Handling of Cytotoxic and Hazardous Drugs
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Protective Apparel
• Disposable coveralls 0r or solid front gown
• Low-permeability, lint-free fabric
• Long sleeves & tight-fitting elastic or knit cuffs
• Wash hands before putting on the gloves & after removing them
• One or two pairs of gloves may be required
• Tuck one pair under cuffs of gown & place second pair over cuffs
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First Aid
• Eyewash fountain in work area with hazardous drugs
• Appropriate first aid equipment
• Follow established first aid procedures
• Obtain medical attention without delay & document injury
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Biological Safety Cabinet (BSC)
• Type of vertical LAFW
• Designed to protect workers
• BSCs must meet standards set by National Sanitation Foundation (NSF Standard 49)
• Do not use horizontal LAFWs to prepare hazardous drugs
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BSC
• Front air barrier-protects handler from contact with hazardous drug dusts & aerosols
• Types of Class II BSCs
– Type A
– Type B
• BSCs must be operated continuously, 24/7
• Inspected & certified every 6 months
• Clean work surface, back, side walls with water or cleaner recommended by cabinet manufacturer
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BSC
• Disinfect work surface with 70% isopropyl alcohol
• Do not to use excessive amounts of alcohol
• Treat cleaning supplies as hazardous waste
• Decontaminate on weekly basis/immediately after spill
• Refer to facility’s procedure on hood maintenance for specific cleaning procedures & schedules
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Preparing Hazardous Drugs
• Same as regular drugs EXCEPT
– attach & prime IV sets before adding hazardous drug
– maintain slight negative pressure inside vial or use chemotherapy dispensing pin
– use syringes & IV sets with locking fittings
– use oversize syringe for reconstitution
– apply warnings on IV bag (Hazardous)
– place IV in sealable bag to contain any leakage
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Waste Disposal & Spill Cleanup
• Spills-use spill kit – cleanup should follow established procedures
– kits contain
• protective gear,
• eye protection
• respirator
• utility & latex gloves
• disposable gown or coveralls
• shoe covers
• scoop, plastic container for glass fragments, absorbent spill pads, gauze & disposable toweling, absorbent powder, & sealable, thick plastic waste disposal bags
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Total Parenteral Nutrition
• TPNs aka hyperalimentation
• Contain
– carbohydrates
– protein
– fats
– water
– electrolytes
– vitamins
– trace elements
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TPN Therapy
• Meets nutritional needs for patients
– who can’t eat
– who will not eat
– who should not eat
– who cannot eat enough to sustain their needs due to increased nutritional requirements from their medical condition
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Components of TPNs
• Base components
– dextrose (carbohydrates)
– amino acids (protein)
– may also include fat & water
• Additives
– electrolytes
– vitamins
– trace elements (micronutrients)
– drugs such as heparin, insulin, H2 antagonists
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Components
• Dextrose -usually a 50% or 70%
– final dextrose concentration ~25% if via central vein
– maximum of 10–12.5% for peripheral administration
• Protein –usually 8.5%, 10%, or 15%
– special formulations for pediatric patients, kidney disease, liver disease, high stress situation (ICU pts)
• Fats (or lipids)-10% or 20% fat emulsions
– emulsions separately through peripheral IV line
– or may be added to TPN solution: 3-in-1 solution
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Components
• Water
• Electrolytes –to meet daily metabolic needs
– sodium, potassium, chloride, acetate, phosphate, magnesium, calcium
– administered as a specific salt of product
– can cause precipitation: wrong sequence or concentrations of electrolytes are added to bag
• Vitamins- “MVI” for multiple-vitamin infusion
• Vitamin K (phytonadione)
• Trace elements for proper enzymatic reactions
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Example of TPN Order
• Dextrose 250 g
• Amino acids 42.5 g
• Sodium chloride 60 mEq
• Potassium chloride 40 mEq
• Potassium phosphate 20 mEq
• Calcium gluconate 1 g
• Magnesium sulfate 1 g
• Trace elements 2 mL
• MVI 10 mL
• Total volume 1000 mL
• Infuse at 100 mL per hour. Also give: Vitamin K 10 mg intramuscularly (IM) every week,
• 10% fat emulsion 500 mL intravenously three times per week.
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TPN Form
• Preprinted order forms
• Reduce error
• May be required in some hospitals
•Each facility designs components of preprinted forms
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Preparation of TPN Solutions
• Automated compounder
– 2 primary versions of TPN compounders
• 1st-provides a separate compounder for base solutions and electrolytes
• 2nd -uses one compounder to infuse all compounded ingredients
• Gravity fill preparation
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Administration
• Central line
– immediate dilution of administered solution by blood
– allows use of very concentrated solution
• Peripheral parenteral nutrition (PPN)
– same components as TPN
– not as concentrated
– may not meet all the patient’s nutritional needs
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Pediatric IV Drug Administration • Doses individualized
– calculated based on patients’ body weight
• Intermittent doses via syringe through volume control chamber or by using syringepump
– maximize accuracy
– Minimize amount of fluid
• Calculations should be checked & double-checked
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Epidural Administration
• Special catheter into epidural space of spine
• Drug injected at nerve ending-dose greatly reduced
• All solutions must be free of preservatives
• Epidural patient controlled analgesia
• Continuous infusions
• Bolus injections
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Admixture Programs
• Policies & Procedures
• Space
• Training
• Equipment
• Standard & Non-Standard Preparations
• Labeling
• Handling
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Quality Assurance Program
• ASHP’s Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products – preparation
– expiration dating
– labeling
– facilities
– equipment
– personnel education
– training
– evaluation
– end-product testing
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USP Chapter 797
• Refer to USP Chapter 797, “Pharmaceutical Compounding—Sterile Preparations” recommendations & regulations regarding IV admixture programs
– different levels of risk for products
– fourth class, immediate-use CSPs
– training
– policies & procedures
– garb, aseptic technique, process validation, end-product evaluation