exam 2 Flashcards

1
Q

How should USP chapter >1000 be treated?

A

Recommendation

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2
Q

How should USP chapter <1000 be treated?

A

Enforceable- “minimum requirement”

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3
Q

Which USP chapter involves pharmaceutical compounding- sterile preparations?

A

USP <797>

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4
Q

Which USP chapter involves handling hazardous drugs in healthcare settings?

A

USP <800>

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5
Q

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

A

parenteral

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6
Q

What are parenteral requirements? (SPP)

A

Sterile, particle free, and pyrogen free

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7
Q

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

A

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

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8
Q

T/F: Sterilization eliminates pyrogens

A

False

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9
Q

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

A

septic shock, speticemia

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10
Q

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

A

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

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11
Q

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

A

Small- 100mL or less
Large- >100mL

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12
Q

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

A

water for injection (WFI)

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13
Q

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

A

Sterile water for injection USP (SWFI)

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14
Q

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

A

Bacteriostatic Water for Injection USP (BWFI)

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15
Q

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

A

False- would cause hemolysis

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16
Q

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

A

B. Mandatory
D. Injectable and non-injectable

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17
Q

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

A

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

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18
Q

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

A

IV and intraspinal

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19
Q

T/F: Intra-spinal injections contain preservatives

A

FALSE

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20
Q

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

A

Hypertonic. Hypotonic can cause hemolysis

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21
Q

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

A

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

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22
Q

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

A

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

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23
Q

What is the benefits with PEG in IV concentrations?

A

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

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24
Q

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

A

Emulsion
For IM injection, solutions are okay

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25
Q

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

A

multiple dose

26
Q

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

A

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

27
Q

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

A

TRUE

28
Q

T/F: Single-use doses may contain preservatives

A

FALSE

29
Q

What is a clinical pearl for antimicrobial preservatives?

A

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

30
Q

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

A

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

31
Q

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

A

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

32
Q

What reduces oxidation from occurring in chelating agents?

A

The sequestering of trace metals

33
Q

What type of glass in parenteral products ‘minimize problems’?

A

Type I

34
Q

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

A

False: need sterile wipe

35
Q

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

A

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

36
Q

What are the names of the compounding syringes?

A

Luer Lok and Tip

37
Q

What is the volume?

A

1.5mL

38
Q

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

A

The higher the gauge the smaller the bore diameter

39
Q

What information is given in 18G3.5?

A

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

40
Q

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

A

True

41
Q

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

A

False- ex: totally unacceptable for IV

42
Q

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

A

rapid onset of action

43
Q

Inflammation from irritation of the tunica intima of the vein

A

Phlebitis

44
Q

Formation of a blood clot (thrombus) in the vein

A

Thrombosis

45
Q

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

A

Continuous

46
Q

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

A

Intermittent

47
Q

What vein is used for catheter IV infusion?

A

Subclavian vein

48
Q

Which has more pressure: arterial or venous blood flow?

A

Arterial

49
Q

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

A

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

50
Q

What is the maximum volume for SubQ?

A

1.5mL

51
Q

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

A

SubQ absorption tends to be slower than IM

52
Q

Term for infusion by subcutaneous

A

hypodermoclysis

53
Q

Match:
SubQ, IV and IM

A
  1. IV
  2. IM
  3. SubQ
54
Q

Intra-spinal route into the subarachnoid space and cerebrospinal fluid

A

Intrathecal

55
Q

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

A

Epidural

56
Q

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

A

Intrathecal- continuous NOT recommended
Epidural- continuous administration

57
Q

What is unique about the shape of an epidural needle?

A

Slightly curved

58
Q

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

A

Needs to be isotonic
Needs physiological pH
Cannot have preservatives

59
Q

Which routes have no absorption steps
IV, IM, SC

A

IM

60
Q

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

A

True