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Pharmaceutics FINAL > Chapter 15 - Parenterals part 3 > Flashcards

Chapter 15 - Parenterals part 3 Flashcards

1
Q

name 4 USP official tests for parenterals

A

Sterility test
Pyrogen Test
Clarity Test
Leaker test

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2
Q

explain the USP Clarity Test

A

tests for the size and number of particles undissolved in solution

uses a “Coulter counter” to test

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3
Q

what is the leaker test done on?

A

ampuls

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4
Q

what USP General Chapter addresses compounding, preparation, and labeling of STERILE DRUG PREPARATIONS?

when was it published?

A

USP General Chapter <797>

published in fall 2003 and went into effect january 1, 2024

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5
Q

what does CSP stand for in Chapter <797>

A

compounded sterile preparations

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6
Q

chapter <797> applies to all organizations that…….

A

compound sterile preparations. this includes health care institutions, home infusion pharmacies, and other facilities

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7
Q

USP General Chapter <797> addresses _____, _____, and _______ of sterile drug preparations

A

compounding, preparation, and labeling

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8
Q

give the title of USP General Chapter <797>

A

“Pharmaceutical Compounding - Sterile Preparations”

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9
Q

name 5 requirements of compounding sterile preparations

A

-cleaner facilities
-personnel must be trained and tested in principles and practices of ASEPTIC manipulations
-air quality evaluation and maintenance (in the compounding area)
-sound knowledge of sterilization
-know and apply the principles and practices of solution stability

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10
Q

name 4 factors that affect compounding sterile preparations

A

-the status of the components used in the preparation

-the process used in preparing the preparation

-the performance of the personnel performing the preparation

-the environmental conditions in which the process was performed

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11
Q

there are ___ and ____ engineering controls

A

primary and secondary

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12
Q

primary engineering controls include…….

A

horizontal flow clean benches
vertical flow clean benches
biological safety cabinets
barrier isolaters (plexiglass)

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13
Q

secondary engineering controls are….

A

they provide a “buffer zone” or a buffer room as a core for the location of the workbenches or isolators

have the cleanest work surfaces
(horizontal/vertical workbenches, biological safety cabinets or isolators)

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14
Q

at least _______ quality of air must be provided to sterile ingredients and components

what does this mean?

A

ISO class 5

means the number of particles having a particle size 0.5 micrometers and larger in the environment DOES NOT EXCEED 3520 PARTICLES PER CUBIC METER

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15
Q

USP requires compounding personnel to be proficient in performing which 5 duties?

A

-performing antiseptic hand cleansing and disinfection of non-sterile compounding surfaces

-select and appropriately wear protective gloves, goggles, gowns, masks, and hair and shoe covers (PPE)

-use laminar flow clean-air hoods, barrier isolaters, and other contamination control devices

-identify, weigh, and measure ingredients

-manipulate sterile products aseptically and label and quality inpect compounded sterile preparations

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16
Q

name 5 sources of contamination

A

solid and liquid matter from the compounding personnel and objects (no jewelry, no earrings)

non-sterile components used and incorporated

inappropriate conditions within the compounding area

prolonged pre-sterilization procedures with aquepus preparations

non-sterile dosage forms used in compounding

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17
Q

name the rapid acting insulins

A

insulin lispro
insulin aspart
insulin glulisine

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18
Q

insulin glulisine brand name

A

APIDRA

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19
Q

regular insulin is ___ acting

A

short acting

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20
Q

name the intermediate acting insulins

A

Isophane (NPH) insulin
Insulin-zinc (Lente)

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21
Q

lente is insulin-_____ and it is ___ acting

A

insulin-zinc
intermediate acting

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22
Q

name the long-acting insulins

A

insulin-zinc extended (Ultralente)
insulin glargine

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23
Q

name the insulin mixtures

A

Isophane/regular insulin

NPL/lispro mix

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24
Q

which type of insulin has the shortest onset time?
what is the onset time

A

shortest onset - rapid-acting
0.25 hours (15 minutes)

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25
Q

which insulin has the shortest duration and what is the duration

A

rapid-acting
3 hour duration

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26
Q

insulin is a ____volume parenteral

A

SMALL VOLUME

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27
Q

name the insulin devices

A

insulin pens
insulin infusion pump

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28
Q

duration of the long-acting insulins

A

insulin-zinc extended (Ultralente) 24-28 hours

insulin glargine >24 hours

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29
Q

which insulin has no peak time?

A

insulin glargine

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30
Q

what is the onset time for short acting insulin

A

0.5 hours (30 mins)

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31
Q

what is the onset time for intermediate-acting insulin

A

1-2 hours

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32
Q

what is the onset time for the long-acting insulins

A

insulin-zinc extended (Ultralente) – 4-6 hours

Insuline Glargine – 2 hours

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33
Q

what is the onset time for NPL/lispro mix
what is the % of each

A

5 minutes

75% NPL 25% lispro
75/25

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34
Q

what is unique about NPH insulin

A

it is a suspension

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35
Q

name 4 uses for large volume parenterals

A

maintenance therapy (normalwater, dextrose, sodium, potassium, etc)

replacement therapy (when pt lost a heavy volume of water/electrolytes due to severe diarrhea and vomiting)

parenteral hyperalimentation (infusion of basic nutrients to achieve active tissue synthesis and growth)

enteral nutrition (like feeding tube(

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36
Q

replacement therapy via large volume infusion involves satisfying ____, ____, and ____ requirements

A

water, electrolyte, and caloric requirements

37
Q

what is the daily water requirement for humans

A

25-40mL/kg

38
Q

go into detail about the electrolyte requirements for humans

A

cations needed: sodium potassium, calcium, and magnesium

anions needed: chloride, phosphate, and acetate

39
Q

TCPN

A

total central parenteral nutrition

40
Q

PCTN

A

patient central parenteral nutrition

41
Q

TPPN

A

total peripheral parenteral nutrition

42
Q

PPPN

A

partial peripheral parenteral nutrition

43
Q

what is the difference between total and partial parenteral nutriton

A

total – given when you can’t digest things at all

partial –supplement other kinds of feeding

44
Q

what is the difference between central and peripheral parenteral nutrition

A

central – delivered through a central vein

peripheral – through a smaller peripheral vein

45
Q

large volume parenterals are given via_____ infusion devices

A

intravenous

46
Q

give 7 SPECIFIC examples of large volume parenterals

A

Amino Acid
Dextrose Injection, USP
Dextrose and Sodium Chloride Injection, USP
Mannitol Injection, USP
Ringer’s Injection, USP
Lactated Ringer’s Injection, USP
Sodium Chloride Injection, USP

47
Q

what is the purpose of Amino Acid Injection

A

Fluid and nutrient replenisher

48
Q

what is the purpose of Dextrose Injection, USP

A

fluid and nutrient replenisher

49
Q

what is the purpose of Dextrose and Sodium Chloride Injection, USP

A

Fluid, nutrient, and electrolyte replenisher

50
Q

What is the purpose of Mannitol Injection, USP

A

diagnostic aid in renal function
diuretic
fluid and nutrient replenisher

51
Q

what is the purpose of Ringer’s Injection, USP

A

Fluid and electrolyte replenisher

52
Q

what is the purpose of Sodium Chloride Injection, USP

A

fluid and electrolyte replenisher; isotonic vehicle

53
Q

name 5 special considerations associated with parenteral therapy

A

-standardization of IV concentration – reduce error
-look-alike products
-adsorption of drug
-absorption (sorption) of drugs
-handling and disposal of chemotherapeutic agents for cancer

54
Q

explain why “adsorption of drug” is a special consideration associated with parenteral therapy

A

studies have shown that some drugs are adsorbed to the inner lining of IV containers/tubing/administration sets. these most often include peptides and proteins

55
Q

explain of “absorption (sorption) of drugs” is a special consideration with parenteral therapy

A

plastic material can absorb some drugs

56
Q

___ and ___ are sterile products manufactured by the same standards used to process intravenous preparations

A

IRRIGATION AND DIALYSIS SOLUTIONS

57
Q

True or false

irrigation and dialysis solutions are intended for infusion into the venous system

A

FALSE

58
Q

Name the 2 ways in which irrigation solutions are administered and what they’re for

A

topical administration and infusion

topical administration – packaged in pour bottles to be poured directly on the area

used for irrigating wounds, moistening dressings, and cleansing surgical instruments

infusion – used for surgical patients
perfuse tissues (bring color/ fluidto them)
maintain integrity of the surgical field
remove blood
provide clear field of view

59
Q

what is often put in irrigating solutions that are infused in order to decrease the risk of infection?

A

an antibiotic preparation (1 mL of Neosporin G.U. Irrigant)

60
Q

dialysis solutions are used in patients with….

A

disorders like renal failure, poisoning, and electrolyte disturbances.

it removes waste materials, serum electrolytes, and toxic products from the body

61
Q

name the types of dialysis

A

hemodialysis, peritoneal dialysis

62
Q

in PERITONEAL DIALYSIS, a _______ dialysate is infused ________ via a _____

A

a HYPERTONIC dialysate is infused DIRECTLY INTO THE PERITONEAL CAVITY via a SURGICALLY IMPLANTED CATHETER

63
Q

in peritoneal dialysis, what is infused?

A

dextrose and electrolytes

64
Q

how does the dialysate remove harmful substances?

A

by OSMOSIS and DIFFUSION

65
Q

what may be added to the dialysate in peritoneal dialysis?

A

antibiotics and heparin

66
Q

explain hemodialysis

A

the patient’s blood is transfused through a dialyzing membrane unit that removes the harmful substances from the patient’s vascular system

after passing through this dialyzer, the blood reenters the body via a vein

67
Q

low risk/medium risk/high risk compounding

A

didnt do

68
Q

According to the practice problems, what is the onset time of NHP (Isophane)

A

1.5-4 hours

69
Q

NPH/isophane is given through which route of administration

A

subcutaneous NOT IV

70
Q

brand name NPH

A

humilin

71
Q

steam sterilization sterilizes by mechanisms involving….

A

COAGULATION ONLY

72
Q

Define sterilization

A

freeing an object from life of ANY kind

73
Q

true or false

drugs given by intravenous route avoid first pass effects, are suitable when the oral route is not feasible, and has predictable drug release and absorption

A

FALSE — has predictable release but does not undergo absorption

74
Q

name the 4 different types of parenteral hyperalimentation

A

TCPN (total central parenteral nutrition)
PCTN (partial central parenteral nutrition)
TPPN (total peripheral parenteral nutrition)
PPPN (partial peripheral parenteral nutrition)

75
Q

explain what low risk compounding is

A

compounded with aseptic manipulation entirely within ISO class 5 or better quality environment

only the transfer, measuring, and mixing manipulations with CLOSED or SEALED packaging systems that are performed promptly and attentively

76
Q

in low risk compounding, manipulations are limited to what?

A

aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products

77
Q

explain medium risk compounding

A

multiple individual or small doses are pooled to prepare a COMPOUNDED sterile preparation that will be administered to either MULTIPLE PATIENTS or to one patient on MULTIPLE OCCASSIONS

NOT a single volume transfer (like low risk) — more complex. usually long duration (ie: achieve complete dissolution or homogenous mixing

78
Q

in medium risk compounding, do the compounded sterile preparations contain a broad spectrum bacteriostatic substance?
how are the preparations administered? give specific examples

A

do NOT contain a broad spectrum antiseptic
administered over several days (example – internally worn or implanted infusion device)

79
Q

explain high risk compounding

A

the sterile ingredients, components, and devices and mixtures are exposed to air quality inferior to ISO class 5 – includes storage in an environment inferior to ISO class 5 of opened or partially used of manufactured sterile products that lack preservatives

80
Q

in high risk compounding, non-sterile preparations are exposed for at least _____ before being sterilized

A

6 hours

81
Q

state whether it is low, medium, or high risk:

“filling of reservoirs of injection and infusion devices with multiple sterile drug products and evacuation of air from those reservoirs before the filled device is dispensed”

A

medium risk

82
Q

state whether it is low, medium, or high risk compounding:

“manually mixing and measuring no more than 3 manufactured products to compound drug admixtures and nutritional solutions”

A

low risk

83
Q

“single transfers” is a key word for which compounding

A

low risk

84
Q

state whether it is low, medium, or high risk compounding:

“transfer of vials from mutliple ampuls or vials into a single, final sterile container or product”

A

medium risk

85
Q

state whether it is low, medium, or high risk compounding:

“measuring and/or mixing sterile ingredients in non-sterile devices before sterilization is performed”

A

high risk

86
Q

state whether it is low, medium, or high risk:

“assuming, without appropriate evidence or direct determination, that packages of bulk ingredients contain at least 95% of their active chemical moeity and have not been contaminated or adulterated between uses”

A

high risk

87
Q

inferior to ISO class 5 air quality = ___ compounding

A

high risk

88
Q
A

Pharmaceutics FINAL (8 decks)

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