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Dosage II > Intro to Parenteral Products > Flashcards

Intro to Parenteral Products Flashcards

1
Q

Pharmacist role in health care

A

THE health care prof responsible for inspecting and approving, or rejecting all formulas, calculations, substances, containers, closures and in-process materials pertaining to compounded sterile preparations

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2
Q

3 levels of safety for patient

A

Physician
Nurse
Pharmacist

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3
Q

Steps 6-7 on flow of admixture orders

A

Components assembled
Admixture prepared

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4
Q

USP chapters with numbers >1000

A

Recommendations

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5
Q

USP chapters with numbers <1000

A

Enforceable (MUST FOLLOW)

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6
Q

Critical USP to parenteral product:

A

USP <797> -Pharm compounding -sterile prep

<USP> 800 - hazardous drugs - handling in healthcare settings, (official July 1, 2020)
</USP>

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7
Q

USP <797>

A

Law of compounding sterile mixtures
Anything that has to do with parenteral products: <797>

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8
Q

Parenteral meaning

A

Not by mouth (administered by injection)

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9
Q

Considerations about Parenteral Products

A

Admin of the therapeutic agent requires an injury to body
Admin bypasses the body’s natural defense
Admin makes the body vulnerable
Must meet some stringent requirements

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10
Q

Requirements of parenterals

A

Sterile
Particle free
Pyrogen free
(right potency, properly labeled)

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11
Q

Risk of harm to patient USP

A

Microbial contamination
Excessive bacterial endotoxins
Variability in the intended strength of correct ingredients
Unintended chemical and physical contaminants
Ingredients of inappropriate quality
(20% USP - meets MINIMUM requirements)

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12
Q

Sterilization

A

Steam (autoclave)
Filtration (bacteria retentive membrane)
Dry heat (oven)
Gas (ethylene oxide)
Irradiation (gamma rays)

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13
Q

Pyrogens definition

A

Bacterial endotoxins; contaminants that “produce fever.” they can also produce septic shock (pyro = fire; fever)

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14
Q

Where pyrogens come from

A

Remnants from microorganisms

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15
Q

Does sterilization eliminate pyrogens?

A

NO - kills them, but does not eliminate; leftover bodies

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16
Q

Septicemia vs Septic shock

A

Septicemia - infection of the blood (death in relation to the infection)
Septic shock - acute reaction to bacterial endotoxins (death due to reaction of body to pieces of bacteria in endotoxins)

17
Q

Particle free importance

A

Foreign particles can trigger immune response
Can produce damage to the lungs
Can produce damage to kidneys
can and have killed people

18
Q

Types of parenteral products

A

Solutions ready for injection
Dry, soluble preparations ready to be combined w/a solvent before use
Suspensions ready for injection
Dry, insoluble preps ready to be combined w/a vehicle before use
Emulsions
Liquid concentrates ready for dilution prior to admin

19
Q

Injection vs FOR injection

A

Injection- Liquid preps that are drug substances or solutions thereof
FOR injection - dry solids or liquid preparations that, upon the addition of suitable vehicles, yield solutions conforming in all respects to the requirements for injections (i.e. something has to be done to it before injected)

20
Q

Parenteral products variation as seen through Purduemycin

A

Purduemycin injection
- Drug in solution, may or may not be aqueous
for injection - sterile liquid or solid that needs to be reconstituted with a vehicle
-Injectable suspension
-Injectable emulsion

21
Q

LVP

A

Large volume parenteral - single dose injections packaged in a container containing more than 100mL

22
Q

Small volume parenterals

A

100mL or less

23
Q

LVP importance

A

If something goes wrong in a large quantity - big problem
LVP is typically used in hospitals

24
Q

Components of parenteral products: Vehicles

A

Solvents or mediums for the admin of therapeutic agents
Whatever the vehicle, it MUST meet USP standards for the pyrogen
“water” is the most common vehicle used in parenteral products
Water is the preferred vehicle

25
Q

Water for injection USP (WFI)

A

Pyrogen free, non sterile, single use sealed container

26
Q

Sterile water for injection USP (SWFI)

A

Pyrogen free, sterile, packed in sealed containers not larger than 1000mL

27
Q

Bacteriostatic Water for Injection USP (BWFI)

A

Pyrogen free, sterile with antimicrobial agent added

28
Q

SWFI is

A

Pharmacologically/biologically safe
Sterile
Particle free
Pyrogen free

29
Q

Remember with SWFI

A

NEVER inject plain water (SWFI) directly into blood stream - cells will swell like balloons

Dosage II (25 decks)

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