exam 2 Flashcards
How should USP chapter >1000 be treated?
Recommendation
How should USP chapter <1000 be treated?
Enforceable- “minimum requirement”
Which USP chapter involves pharmaceutical compounding- sterile preparations?
USP <797>
Which USP chapter involves handling hazardous drugs in healthcare settings?
USP <800>
Taken into the body or administered in a manner other than through the digestive tract, as by intravenous or intramuscular injection
parenteral
What are parenteral requirements? (SPP)
Sterile, particle free, and pyrogen free
Match with sterile/non-sterile and hazardous/non-hazardous
USP <797> , USP <800>
USP <797>: Sterile, hazardous and non-hazardous
USP <800>: Sterile and non-sterile, hazardous
T/F: Sterilization eliminates pyrogens
False
An acute reaction to bacterial endotoxins is (speticemia/septic shock) while infection of the blood is (speticemia/septic shock)
septic shock, speticemia
What is the difference between [DRUG] injection vs [DRUG] for Injection
Injection- liquid preparation
FOR injection- not for use ‘as is’ needs reconstitution for prepared soln
What size (mL) range small vs large volume parenteral?
Small- 100mL or less
Large- >100mL
Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, non-sterile, single use sealed container
water for injection (WFI)
Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, sterile, packed in sealed containers not larger than 1000 mL
Sterile water for injection USP (SWFI)
Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, sterile with antimicrobial agent added
Bacteriostatic Water for Injection USP (BWFI)
T/F: SWFI can be injected directly into the blood stream
False- would cause hemolysis
Which criteria apply to USP <800>?
A. Informational
B. Mandatory
C. Injectable only
D. Injectable and non-injectable
B. Mandatory
D. Injectable and non-injectable
A product used during preparation has an expiration date of 3/5/2026. Would this be used as the final products expiration date?
No! Would need a new beyond use date (BUD)
What are the two “least forgiving” parenteral routes of administration?
IV and intraspinal
T/F: Intra-spinal injections contain preservatives
FALSE
Which solution is more desirable for parenteral administration?
Hypotonic or hypertonic?
Hypertonic. Hypotonic can cause hemolysis
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
B. 5% Dextrose in water
C. 2.5% Dextrose in half normal saline
F. Normal Saline
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. Ethyl alcohol
D. Polyethylene glycol (PEG)
E. Propylene glycol (PG)
What is the benefits with PEG in IV concentrations?
Mild on cells: can be as high as 40% (v/v)
Which type of oil solution is OK for IV injection?
Emulsion or Solution?
Emulsion
For IM injection, solutions are okay
Antimicrobial preservatives are used for (single/multiple) dose preparations
multiple dose
Which are antimicrobial preservatives?
Which is the most common?
A. Acetates
B. Benzyl alcohol
C. Cresol
D. Citrates
E. Parabens
B. Benzyl alcohol- Most common!
C. Cresol
E. Parabens
T/F: Antimicrobials are NOT effective in non-aqueous (oil based) formulations
TRUE
T/F: Single-use doses may contain preservatives
FALSE
What is a clinical pearl for antimicrobial preservatives?
*Do NOT use in neonates (children) especially Benzyl alcohol
*Intra-spinal must be free of antimicrobial preservatives
Which are commonly used buffers?
Clinical pearls?
A. Acetates
B. Benzyl alcohol
C. Cresol
D. Citrates
E. Phosphates
A. Acetates
D. Citrates-safe by IV, irritating by IM or SC
E. Phosphates- Caution, potentially fatal
Which are antioxidants? Chelating agents?
A. Ascorbic acid
B. Normal saline
C. EDTA
D. D5W
A. Ascorbic acid- Antioxidants
C. EDTA- chelating agent
What reduces oxidation from occurring in chelating agents?
The sequestering of trace metals
What type of glass in parenteral products ‘minimize problems’?
Type I
T/F: If there is a metal cover protecting the rubber stopper, it is properly sterilized
False: need sterile wipe
Which part of the ampule is broken? How is the solution used?
Ampules are broken at the neck and a filtered needle is needed to keep out microparticles of glass
What are the names of the compounding syringes?
Luer Lok and Tip
What is the volume?
1.5mL
The higher the gauge the (smaller/larger) the bore diameter
The higher the gauge the smaller the bore diameter
What information is given in 18G3.5?
18G- 18” diameter gauge
3.5- needle shaft length
T/F: If an excipient is acceptable for IV injection, it is acceptable for other parenteral routes of admin
True
T/F: If an excipient is acceptable for IM injection, it is acceptable for other parenteral routes of admin
False- ex: totally unacceptable for IV
The IV route is characterized by ___ ____ __ ____ because there is no absorption step
rapid onset of action
Inflammation from irritation of the tunica intima of the vein
Phlebitis
Formation of a blood clot (thrombus) in the vein
Thrombosis
What type of IV infusion is administered?
(Continuous or Intermittent)
Continuous
What type of IV infusion is administered?
(Continuous or Intermittent)
Intermittent
What vein is used for catheter IV infusion?
Subclavian vein
Which has more pressure: arterial or venous blood flow?
Arterial
What are the maximum IM volumes of administration in…
Deltoid muscle, Thigh and Gluteal muscle
Deltoid- 2mL
Thigh- 5mL
Gluteal muscle- 5mL
What is the maximum volume for SubQ?
1.5mL
SubQ absorption tends to be (faster/slower) than IM
SubQ absorption tends to be slower than IM
Term for infusion by subcutaneous
hypodermoclysis
Match:
SubQ, IV and IM
- IV
- IM
- SubQ
Intra-spinal route into the subarachnoid space and cerebrospinal fluid
Intrathecal
Intra-spinal route into the space at the thoracic or lumbar level between the dura mater and the vertebral canal
Epidural
For the intrathecal and epidural routes, which have continuous administration?
Intrathecal- continuous NOT recommended
Epidural- continuous administration
What is unique about the shape of an epidural needle?
Slightly curved
What are the 3 special care requirements for intra-spinal admin? (IPP)
Needs to be isotonic
Needs physiological pH
Cannot have preservatives
Which routes have no absorption steps
IV, IM, SC
IM
T/F: All parenteral routes of administration bypass hepatic first-pass metabolism
True
