Key points

Question 1

Goal of aspectic

Answer 1

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

Question 2

sources of contamination

Answer 2

human touch (most common)
packaging materials
equipment
supplies
environment

Question 3

contaminants of concern

Answer 3

residues
particulates
pyrogens
microorganisms

Question 4

major risks associated with IV therapy

Answer 4

infection
air embolus
allergic reaction
drug incompatibilities
particulate matter
pyrogens

Question 5

USP >1000

Answer 5

considered general information

Question 6

USP <1000

Answer 6

enforceable by FDA

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

Question 7

USP 797

Answer 7

standards affecting sterile compounding

Question 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 _________

Answer 8

first; hand; turbulence

Question 9

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

Answer 9

parallel

Question 10

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

Answer 10

perpendicular

Question 11

T/F

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

Answer 11

False

Question 12

this provides product protection only since air is blown through the HEPA filter from back wall of cabinet to front opening of hood

Answer 12

horizontal flow hood

Question 13

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

Answer 13

Biological safety cabinent

Question 14

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

Answer 14

compounding isolator (glove box)

Question 15

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

Answer 15

Standard operating procedures (SOPs)

Question 16

examples of specific functions that must be completed on the institution’s standardized time schedule

Answer 16

• mopping of floors in clean room and buffer area

- cleaning of walls and ceilings of entire sterile compounding area

Question 17

T/F

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

Answer 17

True

Question 18

T/F for different types of drugs, the same syringe may be used

Answer 18

False

a new syringe must be used for each different drug to avoid compatibility issues

Question 19

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

Answer 19

potential

Question 20

Risk results from

Answer 20

• use of non-sterile components
• novel, complex or prolonged aseptic processes
• open exposure of drug product or product containment devices to the atmosphere

Question 21

Low risk

Answer 21

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

Question 22

medium risk

Answer 22

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

Question 23

high risk

Answer 23

non-sterile ingredients

inferior air quality (no hood)

Question 24

examples of compatibility resources

Answer 24

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

Question 25

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

Answer 25

drug stability and compatibility

Question 26

What can be adversely affected by drug instability or incompatibility?

Answer 26

therapeutic efficacy | safety of treatment

Question 27

types of compatibility/stability issues

Answer 27

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

Question 28

Peripheral venous access

Answer 28

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

Question 29

Peripheral venous access useful for

Answer 29

relatively small volumes of fluid and for IV push

Question 30

central catheter, peripherally inserted

Answer 30

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

Question 31

central catheter, peripherally inserted useful for

Answer 31

much higher volumes of solutions | irritating drugs

Question 32

central catheter tunneled

Answer 32

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

Question 33

central catheter tunneled useful for

Answer 33

much higher volumes of solutions | irritating drugs

Question 34

central catheters implanted ports

Answer 34

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

Question 35

central catheters implanted ports useful for

Answer 35

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