Transcript Practice Basics - American Society of Health

Chapter 16: Aseptic Technique, Sterile Compounding,
and IV Admixture Programs
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
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
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)
Parenteral Drug Administration
Parenteral – “not through digestive tract”
 Intravenous (IV)
 Intramuscular (IM)
 Intrathecal (IT)
 Epidural
 Intraarticular
 Intraarterial
 Intraocular
 Intraperitoneal
 Subcutaneous (SQ, SC, SubQ)
Risks of Intravenous Therapy
 Infection
 Air embolus
 Bleeding
 Allergic reaction
 Incompatibilities
 Extravasation
 Particulate Matter
 Pyrogens
 Phlebitis
Types of IV Administration
 Infusions
 Continuous
 Intermittent
IV Containers
 Large Volume Parenterals (LVPs)
 Small Volume Parenterals or “Piggyback” Systems
 Add-Vantage®
 Vial Spike Systems
 Flexible Plastic Bags
 Glass Containers
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
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
Non-coring Technique
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Aseptic Technique
 Manipulating sterile products without compromising
their sterility
 proper use of LAFW
 strict aseptic technique
 Conscientious work habits
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
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
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
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
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
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
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
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
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
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
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
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

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
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
Equipment & Supplies
 Syringes
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
Needles
 Note components
 Often color-coded=gauge
 Vented needles
 Filter needles
 Dead space
Vials
 Rubber stopper
 Powders or liquids
 70% isopropyl alcohol
 Avoid coring
 Normalize pressure
 Reconstitution
 SDV or MDV
 Preservative considerations
Ampules
 Move fluid to body of
ampule
 Swab neck with
alcohol pad
 Break at neck
 Tilt ampule, needle
bevel down
 Use filter needle
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
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
Closures & Seals
 Luer Tips for syringes when final product being
dispensed is not intended for injection
 oral
 topical
 IV port seals
 Tamperproof caps
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
Labeling of IV Preparations
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
1.
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
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
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
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
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
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
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
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
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
Total Parenteral Nutrition
 TPNs aka hyperalimentation
 Contain
 carbohydrates
 protein
 fats
 water
 electrolytes
 vitamins
 trace elements
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
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
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
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
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
1g
Magnesium sulfate
1g
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.
TPN Form
• Preprinted order forms
• Reduce error
• May be required in some
hospitals
•Each facility designs
components of
preprinted forms
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
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
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
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
Admixture Programs
 Policies & Procedures
 Space
 Training
 Equipment
 Standard & Non-Standard Preparations
 Labeling
 Handling
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
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