exam 2

Question 1

How should USP chapter >1000 be treated?

Answer 1

Recommendation

Question 2

How should USP chapter <1000 be treated?

Answer 2

Enforceable- “minimum requirement”

Question 3

Which USP chapter involves pharmaceutical compounding- sterile preparations?

Answer 3

USP <797>

Question 4

Which USP chapter involves handling hazardous drugs in healthcare settings?

Answer 4

USP <800>

Question 5

Taken into the body or administered in a manner other than through the digestive tract, as by intravenous or intramuscular injection

Answer 5

parenteral

Question 6

What are parenteral requirements? (SPP)

Answer 6

Sterile, particle free, and pyrogen free

Question 7

Match with sterile/non-sterile and hazardous/non-hazardous
USP <797> , USP <800>

Answer 7

USP <797>: Sterile, hazardous and non-hazardous
USP <800>: Sterile and non-sterile, hazardous

Question 8

T/F: Sterilization eliminates pyrogens

Answer 8

False

Question 9

An acute reaction to bacterial endotoxins is (speticemia/septic shock) while infection of the blood is (speticemia/septic shock)

Answer 9

septic shock, speticemia

Question 10

What is the difference between [DRUG] injection vs [DRUG] for Injection

Answer 10

Injection- liquid preparation
FOR injection- not for use ‘as is’ needs reconstitution for prepared soln

Question 11

What size (mL) range small vs large volume parenteral?

Answer 11

Small- 100mL or less
Large- >100mL

Question 12

Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, non-sterile, single use sealed container

Answer 12

water for injection (WFI)

Question 13

Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, sterile, packed in sealed containers not larger than 1000 mL

Answer 13

Sterile water for injection USP (SWFI)

Question 14

Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, sterile with antimicrobial agent added

Answer 14

Bacteriostatic Water for Injection USP (BWFI)

Question 15

T/F: SWFI can be injected directly into the blood stream

Answer 15

False- would cause hemolysis

Question 16

Which criteria apply to USP <800>?
A. Informational
B. Mandatory
C. Injectable only
D. Injectable and non-injectable

Answer 16

B. Mandatory
D. Injectable and non-injectable

Question 17

A product used during preparation has an expiration date of 3/5/2026. Would this be used as the final products expiration date?

Answer 17

No! Would need a new beyond use date (BUD)

Question 18

What are the two “least forgiving” parenteral routes of administration?

Answer 18

IV and intraspinal

Question 19

T/F: Intra-spinal injections contain preservatives

Answer 19

FALSE

Question 20

Which solution is more desirable for parenteral administration?
Hypotonic or hypertonic?

Answer 20

Hypertonic. Hypotonic can cause hemolysis

Question 21

What are aqueous isotonic vehicles?
A. 5% Dextrose in normal saline
B. 5% Dextrose in water
C. 2.5% Dextrose in half normal saline
D. 2.5% in water
E. Sterile Water for Injection (SWFI)
F. Normal Saline
G. Bacteriostatic Sterile Water for Injection

Answer 21

B. 5% Dextrose in water
C. 2.5% Dextrose in half normal saline
F. Normal Saline

Question 22

Which are water miscible solvents (cosolvents)?
A. Ethyl alcohol
B. Benzyl alcohol
C. Ringer’s solution
D. Polyethylene glycol (PEG)
E. Propylene glycol (PG)

Answer 22

A. Ethyl alcohol
D. Polyethylene glycol (PEG)
E. Propylene glycol (PG)

Question 23

What is the benefits with PEG in IV concentrations?

Answer 23

Mild on cells: can be as high as 40% (v/v)

Question 24

Which type of oil solution is OK for IV injection?
Emulsion or Solution?

Answer 24

Emulsion
For IM injection, solutions are okay

Question 25

Antimicrobial preservatives are used for (single/multiple) dose preparations

Answer 25

multiple dose

Question 26

Which are antimicrobial preservatives? Which is the most common? A. Acetates B. Benzyl alcohol C. Cresol D. Citrates E. Parabens

Answer 26

B. Benzyl alcohol- Most common! C. Cresol E. Parabens

Question 27

T/F: Antimicrobials are NOT effective in non-aqueous (oil based) formulations

Answer 27

TRUE

Question 28

T/F: Single-use doses may contain preservatives

Answer 28

FALSE

Question 29

What is a clinical pearl for antimicrobial preservatives?

Answer 29

*Do NOT use in neonates (children) especially Benzyl alcohol *Intra-spinal must be free of antimicrobial preservatives

Question 30

Which are commonly used buffers? Clinical pearls? A. Acetates B. Benzyl alcohol C. Cresol D. Citrates E. Phosphates

Answer 30

A. Acetates D. Citrates-safe by IV, irritating by IM or SC E. Phosphates- Caution, potentially fatal

Question 31

Which are antioxidants? Chelating agents? A. Ascorbic acid B. Normal saline C. EDTA D. D5W

Answer 31

A. Ascorbic acid- Antioxidants C. EDTA- chelating agent

Question 32

What reduces oxidation from occurring in chelating agents?

Answer 32

The sequestering of trace metals

Question 33

What type of glass in parenteral products 'minimize problems'?

Answer 33

Type I

Question 34

T/F: If there is a metal cover protecting the rubber stopper, it is properly sterilized

Answer 34

False: need sterile wipe

Question 35

Which part of the ampule is broken? How is the solution used?

Answer 35

Ampules are broken at the neck and a filtered needle is needed to keep out microparticles of glass

Question 36

What are the names of the compounding syringes?

Answer 36

Luer Lok and Tip

Question 37

What is the volume?

Answer 37

1.5mL

Question 38

The higher the gauge the (smaller/larger) the bore diameter

Answer 38

The higher the gauge the smaller the bore diameter

Question 39

What information is given in 18G3.5?

Answer 39

18G- 18" diameter gauge 3.5- needle shaft length

Question 40

T/F: If an excipient is acceptable for IV injection, it is acceptable for other parenteral routes of admin

Answer 40

True

Question 41

T/F: If an excipient is acceptable for IM injection, it is acceptable for other parenteral routes of admin

Answer 41

False- ex: totally unacceptable for IV

Question 42

The IV route is characterized by ___ ____ __ ____ because there is no absorption step

Answer 42

rapid onset of action

Question 43

Inflammation from irritation of the tunica intima of the vein

Answer 43

Phlebitis

Question 44

Formation of a blood clot (thrombus) in the vein

Answer 44

Thrombosis

Question 45

What type of IV infusion is administered? (Continuous or Intermittent)

Answer 45

Continuous

Question 46

What type of IV infusion is administered? (Continuous or Intermittent)

Answer 46

Intermittent

Question 47

What vein is used for catheter IV infusion?

Answer 47

Subclavian vein

Question 48

Which has more pressure: arterial or venous blood flow?

Answer 48

Arterial

Question 49

What are the maximum IM volumes of administration in... Deltoid muscle, Thigh and Gluteal muscle

Answer 49

Deltoid- 2mL Thigh- 5mL Gluteal muscle- 5mL

Question 50

What is the maximum volume for SubQ?

Answer 50

1.5mL

Question 51

SubQ absorption tends to be (faster/slower) than IM

Answer 51

SubQ absorption tends to be slower than IM

Question 52

Term for infusion by subcutaneous

Answer 52

hypodermoclysis

Question 53

Match: SubQ, IV and IM

Answer 53

1. IV 2. IM 3. SubQ

Question 54

Intra-spinal route into the subarachnoid space and cerebrospinal fluid

Answer 54

Intrathecal

Question 55

Intra-spinal route into the space at the thoracic or lumbar level between the dura mater and the vertebral canal

Answer 55

Epidural

Question 56

For the intrathecal and epidural routes, which have continuous administration?

Answer 56

Intrathecal- continuous NOT recommended Epidural- continuous administration

Question 57

What is unique about the shape of an epidural needle?

Answer 57

Slightly curved

Question 58

What are the 3 special care requirements for intra-spinal admin? (IPP)

Answer 58

Needs to be isotonic Needs physiological pH Cannot have preservatives

Question 59

Which routes have no absorption steps IV, IM, SC

Answer 59

IM

Question 60

T/F: All parenteral routes of administration bypass hepatic first-pass metabolism

Answer 60

True