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Flashcards in Key points Deck (35):
1

Goal of aspectic

practices utilized during sterile compounding to reduce risk of exposure to contaminants for personnel and patients

2

sources of contamination

human touch (most common)
packaging materials
equipment
supplies
environment

3

contaminants of concern

residues
particulates
pyrogens
microorganisms

4

major risks associated with IV therapy

infection
air embolus
allergic reaction
drug incompatibilities
particulate matter
pyrogens

5

USP >1000

considered general information

6

USP <1000

enforceable by FDA
May be adopted by state boards of pharmacy for the purpose of regulatory action

7

USP 797

standards affecting sterile compounding

8

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

9

For horizontal flow hood, arrangement of materials in a line ______ to and 6 inches from HEPA

parallel

10

For vertical flow hood, arrangement of materials in a line _______ to and 6 inches from HEPA

perpendicular

11

T/F

All hoods only serve to keep things clean. they will not clean or disinfect anything

False

12

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

13

contained area and design of air flow provides protection for product, personnel and environment

Biological safety cabinent

14

also provides product, personnel and environmental protection besides biological safety cabinet

compounding isolator (glove box)

15

must be strictly followed to assure the integrity and cleanliness of the sterile product compounding area

Standard operating procedures (SOPs)

16

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

17

T/F

the same syringe may be used for a limited number of additions of the exact same drug to admixtures

True

18

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

19

Risk level conditions are based upon the ______ for the introduction of microbial contamination

potential

20

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

21

Low risk

limited number of sterile ingredients , products, components, and devices
limited manipulations

22

medium risk

multiple small doses of sterile products pooled to prepare products that are given to multiple patients
more complex manipulation of longer duration

23

high risk

non-sterile ingredients
inferior air quality (no hood)

24

examples of compatibility resources

package insert
king guide to parenteral admixtures
trissel's handbook on injectable drugs

25

Critical elements in accurate and appropriate delivery of drug therapy to patients

drug stability and compatibility

26

What can be adversely affected by drug instability or incompatibility?

therapeutic efficacy
safety of treatment

27

types of compatibility/stability issues

precipitation
product instability
expiration
solubility
temperature impact
adsorption/absorption
drug delivery system
drug concentration

28

Peripheral venous access

typical hospital IV in hand or forearm
small veins with less blood flowing past needle/catheter

29

Peripheral venous access useful for

relatively small volumes of fluid and for IV push

30

central catheter, peripherally inserted

into body at elbow and tip threaded up into vein to heart
tip of catheter in superior vena cava

31

central catheter, peripherally inserted useful for

much higher volumes of solutions
irritating drugs

32

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

33

central catheter tunneled useful for

much higher volumes of solutions
irritating drugs

34

central catheters implanted ports

small titanium reservoir with rubber stopper attached to catheter entering vein below collarbone
port part implanted under skin

35

central catheters implanted ports useful for

advantages of central line
not as readily available
good for weekly meds
irritating meds can be delivered