Key points Flashcards
Goal of aspectic
practices utilized during sterile compounding to reduce risk of exposure to contaminants for personnel and patients
sources of contamination
human touch (most common) packaging materials equipment supplies environment
contaminants of concern
residues
particulates
pyrogens
microorganisms
major risks associated with IV therapy
infection air embolus allergic reaction drug incompatibilities particulate matter pyrogens
USP >1000
considered general information
USP <1000
enforceable by FDA
May be adopted by state boards of pharmacy for the purpose of regulatory action
USP 797
standards affecting sterile compounding
Drug and other compounding materials must be arranged on the hood work surface in a manner which maximizes their exposure to ______ air and minimizes ____ interference and zones of _________
first; hand; turbulence
For horizontal flow hood, arrangement of materials in a line ______ to and 6 inches from HEPA
parallel
For vertical flow hood, arrangement of materials in a line _______ to and 6 inches from HEPA
perpendicular
T/F
All hoods only serve to keep things clean. they will not clean or disinfect anything
False
this provides product protection only since air is blown through the HEPA filter from back wall of cabinet to front opening of hood
horizontal flow hood
contained area and design of air flow provides protection for product, personnel and environment
Biological safety cabinent
also provides product, personnel and environmental protection besides biological safety cabinet
compounding isolator (glove box)
must be strictly followed to assure the integrity and cleanliness of the sterile product compounding area
Standard operating procedures (SOPs)
examples of specific functions that must be completed on the institution’s standardized time schedule
- mopping of floors in clean room and buffer area
- cleaning of walls and ceilings of entire sterile compounding area
T/F
the same syringe may be used for a limited number of additions of the exact same drug to admixtures
True
T/F for different types of drugs, the same syringe may be used
False
a new syringe must be used for each different drug to avoid compatibility issues
Risk level conditions are based upon the ______ for the introduction of microbial contamination
potential
Risk results from
- use of non-sterile components
- novel, complex or prolonged aseptic processes
- open exposure of drug product or product containment devices to the atmosphere
Low risk
limited number of sterile ingredients , products, components, and devices
limited manipulations
medium risk
multiple small doses of sterile products pooled to prepare products that are given to multiple patients
more complex manipulation of longer duration
high risk
non-sterile ingredients
inferior air quality (no hood)
examples of compatibility resources
package insert
king guide to parenteral admixtures
trissel’s handbook on injectable drugs
Critical elements in accurate and appropriate delivery of drug therapy to patients
drug stability and compatibility
What can be adversely affected by drug instability or incompatibility?
therapeutic efficacy
safety of treatment
types of compatibility/stability issues
precipitation product instability expiration solubility temperature impact adsorption/absorption drug delivery system drug concentration
Peripheral venous access
typical hospital IV in hand or forearm
small veins with less blood flowing past needle/catheter
Peripheral venous access useful for
relatively small volumes of fluid and for IV push
central catheter, peripherally inserted
into body at elbow and tip threaded up into vein to heart
tip of catheter in superior vena cava
central catheter, peripherally inserted useful for
much higher volumes of solutions
irritating drugs
central catheter tunneled
tip in superior vena cava
other end tunneled 6 inches away under skin on chest
Dacron cuff on catheter inside skin tunnels which seals around to prevent bacteria from migrating along outside of catheter and into bloodstream
central catheter tunneled useful for
much higher volumes of solutions
irritating drugs
central catheters implanted ports
small titanium reservoir with rubber stopper attached to catheter entering vein below collarbone
port part implanted under skin
central catheters implanted ports useful for
advantages of central line
not as readily available
good for weekly meds
irritating meds can be delivered
