Intro to Parenteral Nutrition Flashcards

1
Q

Why are sterile products important for every pharmacist?

A

pharmacist is responsible for inspecting, approving or rejecting all formulas, calculations, a substances, containers, closures and in-process materials pertaining to compounded sterile preparations

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2
Q

Why are there concerns about PEN?

A
  1. Uncontrolled environments are still in use

2. Inadequate controls increase the incidence of medication errors

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3
Q

What is a tenfold medication error?

A

a decimal point error

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4
Q

Differentiate between USP chapters with numbers >1000 and those with numbers <1000

A
>1000 = chapter content is recommended. 
<1000 = chapter content is enforceable by law.
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5
Q

What two USP chapters are critical to parenteral products? What is their content?

A

USP <797> = pharmaceutical compounding for steriale preparations
USP <800> = handling hazardous drugs in HC settings.

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6
Q

Differentiate b/t the practical and etymological meaning of “parenteral.”

A
etymological = not oral
practical = all injectable products
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7
Q

What are three things to take into consideration when administering parenteral products?

A
  1. Administration of therapeutic agent requires an injury to the body.
  2. Administration bypasses the body’s natural defense barriers
  3. Administration makes the body vulnerable
    »> need stringent requirements
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8
Q

What are the requirements for compounding sterile preparations that are specific to parenterals

A
  1. Sterile
  2. Particle-free
  3. Pyrogen-free
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9
Q

What are the five topics that USP <797> covers?

A
  1. Microbial contamination
  2. Excessive bacterial endotoxins
  3. Variability in the intended strength of correct ingredients
  4. Unintended chemical and physical contaminants
  5. Ingredients of inappropriate quality.
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10
Q

What are methods of sterilization?

A
Steam (autoclave) 
filtration (bacteria retentive membrane) 
dry heat (oven) 
gas (ethylene oxide) 
irradiation (gamma rays)
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11
Q

What are pyrogens?

A

bacterial endotoxins that “produce fever” and can also produce septic shock.

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12
Q

Does sterilization eliminate pyrogens? Why or why not?

A

No; pyrogens are parts of bacteria, not actual bacterial. Sterilization may kill bacteria but it won’t get rid of the endotoxins still floating around.

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13
Q

Differentiate b/t septicemia and septic shock.

A

septicemia = infection of blood by live organisms

septic shock = acute reaction to bacterial endotoxins

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14
Q

Why do sterile preparations have to be particle-free?

A

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

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15
Q

Differentiate between _____ injection/emulsion/suspension and _______ for injection/emulsion/suspension.

A

The former means that the ____ is ready to be used for injection/emulsion/suspension as is - no prep required.
Addition of “for” into the phrase means that the product must go through an additional step before being used as an injection/emulsion/suspension.

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16
Q

Differentiate between large volume parenteral (LVP) and small volume parenteral.

A

LVP = Single dose injections packaged in a acontainer containing more than 100mL.
small volume parenteral = 100mL or less

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17
Q

What is the most common vehicle used in parenteral products? The preferred?

A

water (for both)

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18
Q

Types of water used in parenteral products and the preferred type.

A
  1. Water for injection (WFI) - pyrogen free, non-sterile, single use sealed container.
  2. Sterile Water for Inejction USP (SWFI) = pyrogen free, sterile, packed in sealed containers not larger than 1000mL&raquo_space; Preferred
  3. Bacteriostatic water for injection (BWFI) = pyrogen free, sterile with antimicrobial agent added.
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19
Q

Is it ok to inject SWFI directly into the blood stream?

A

No; it will cause hemolysis

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20
Q

What are some examples of aqueous isotonic vehicles?

A

NS, D5W, bacteriostatic sodium chloride injection (NS w/ microbial preservative), Ringer’s solution

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21
Q

What are some water miscible solvents used in parenterals?

A

alcohol, polyethylene glycol, propylene glycol

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22
Q

What are water miscible solvents used for in parenteral cases?

A

used to solubilize drugs

often used for intramuscular injection

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23
Q

Why is there a difference b/t the allowable concentrations of PEG and alcohol in IV?

A

alcohol - 10%
PEG - 40%
Their hemolytic potentials are different

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24
Q

What is the difference b/t oil and oil emulsions?

A

Oil = straight oil. Cannot be injected directly into the bloodstream b/c it is an embolus
Oil emulsion = little droplets of oil (smaller than RBCs) distributed in aqueous phase. No risk of embolism => can use for IV injection. Oil =/= oil emulsion.

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25
Q

Common antimicrobial preservatives used in parenterals.

A

Benzyl alcohol 0.9%

Parabens: methyl paraben 0.18% + propyl paraben 0.02% mix

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26
Q

Antimicrobials are not very effective in ____ solutions.

A

oil-based

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27
Q

Compatibility issues with antimicrobial preservatives

A

Some excipients sequester antimicrobial preservatives

E.g. polysorbate (through micelles) and PVP complex-like formation

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28
Q

Any sterile product intended for multiple dose use must contain __________.

A

antimicrobial preservative

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29
Q

Contraindications for antimicrobial preservatives in parenterals.

A
  1. Neonates - don’t use microbial preservatives, especially benzyl alcohol b/c it can cause gasping syndrome.
  2. Intra-spinal preparations cannot have antimicrobial preservatives
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30
Q

Examples of pH buffers in parenterals

A

citrates
acetates
phosphates

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31
Q

Citrate: appropriate routes

A

IV is ok

IM or subcutaneous is irritating

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32
Q

Phosphate: contraindications

A

Adding calcium (can precipitate)

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33
Q

Why do you want to make buffers as dilute as possible?

A

So the physiological pH takes over quickly

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34
Q

Antioxidants and the pHs they should be used at

A

Ascorbic acid
metabisulfate salts - low pH
bisulfite - intermediate pH
sulfite - high pH

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35
Q

Chelating agents - function and example

A

most common = EDTA

Enhance antioxidant’s effect and sequester trace metals

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36
Q

What glass type should e used for parenterals?

A

type 1

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37
Q

Are containers considered ingredients of the product?

A

Yes, because they are in direct contact with the product

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38
Q

Ampules are for how many uses?

A

one

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39
Q

Piggyback containers should be ____ than the large volume container.

A

Higher

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40
Q

What syringe is required for hazardous drugs?

A

Luer Lok

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41
Q

How is needle size described?

A

Two numbers, gauge and length

  1. gauge = diameter of the bore; higher gauge&raquo_space; smaller bore diameter
  2. length = length of needle shaft. 3/8” to 3.5”
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42
Q

Are excipients for IV and non-IV formulations interchangeable?

A

No. Ok for IV&raquo_space; generally ok for others. But ok for others =/= ok for IV.

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43
Q

IV route is characterized by rapid onstep because…?

A

no absorption phase

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44
Q

What are common venous complications?

A

Phlebitis = inflammation of a vein
Thrombosis = blood clot
Both can cause great pain, may take days or weeks to subside, and limit the number of veins available for future therapy.

45
Q

Why should you look at both infusion rates and volume for IV?

A

Small injections can give very high injection rates, but they’re not dangerous b/c it’s a small volume.
Large volumes can give very “reasonable-looking” infusion rates that are in fact dangerous

46
Q

Setup for continuous vs intermittent IV infusion

A

Continuous: has one bag only
Intermittent: has two bags, one of which is the medication being given intermittently.

47
Q

Why are substances infused into arteries rather than veins?

A

arteries have higher pressure than veins and are also more sensitive than veins

48
Q

Sites of administration and typical maximum volumes of IM administration

A

deltoid = about 2mL
thigh = about 5mL
gluteal muscle = about 5mL

49
Q

Maximum volume for subcutaneous route

A

1.5mL

50
Q

Absorption rate of IM vs SC route of administration

A

SC absorption slower b/c skin has less vascularization than muscle

51
Q

Types of intraspinal administration

A
intrathecal = into the subarachnoid space
epidural = b/t dura mater and the vertebral canal
52
Q

Special considerations for intra-spinal

A

must be isotonic
must have physiological pH
must NOT have preservatives
gauge may matter

53
Q

How much fluid can the body void?

A

3000mL/day => 100 - 150mL/hr

54
Q

What is aseptic technique?

A

manipulation of materials in such a way as to avoid accidental intro of microorganisms

55
Q

3 ways to dilute something?

A

inject small volumes
inject slowly
inject into a central vein

56
Q

What is the main source of contamination during sterile compounding?

A

people

57
Q

How do you control the three sources of contamination?

A
  1. people - train, garb, make sure skill is developed, periodically test them
  2. environment - control it
  3. equipment - sterilize, sanitize (disinfect)
58
Q

What is a laminar flow? How is it important in aseptic technique?

A

laminar flow = streamline flow of a fluid in which the fluid moves in layers without turbulence. Occurs at low air velocities (100ft/min)
Used in laminar flow hoolds = critical are for aseptic technique

59
Q

What kind of air is required for aseptic technique?

A

ISO class 5: no more than 100 particles > 0.5 micron per cubic foot

60
Q

Which type of laminar flow hoods is preferred?

A

vertical (must be used for cytotoxic and vesicant products)

vesicant = causes blistering

61
Q

Critical site = ?

A

= any point where microorganisms or other contamination could enter a parenteral product during compounding

62
Q

critical area = ?

A

space b/t HEPA filter and the critical site

Must keep First Air laminar air flow in this area

63
Q

Direct compounding area = ?

A

area within the LAFW where critical sites are exposed to HEPA filtered air.

64
Q

Is laminar flow hood a sterile environment?

A

No; it’s very clean (so clean that it allows one to maintain sterility throughout compounding) but not sterile. Things will not be cleaned just because you place it in a laminar flow hood.

65
Q

First air = ?

A

the air exiting the HEPA filter in a unidirectional air stream that is essentially particle free
Critical sites must be bathed at all times (so arrange materials for compounding accordingly)

66
Q

What are four separate categories of points to remember whenever we are preparing a CSP

A

garbing points, hand/glove points, hood points, conduct points

67
Q

Rules for personnel cleansing and garbing

A
  1. no outdoor garments in clean room; dedicated shoes, shoe covers, head, and facial head covers
  2. no jewelry, no makeup, no artificial nails, no perfume, no iPods
  3. low-shed gown
  4. free from skin/respiratory ailments or excessive perspiration
68
Q

What is isotonicity ?

A

Maintaining and possessing a uniform tension or tone in the semipermeable membrane between two solutions that have the same concentration of particles.

69
Q

What kinds of stresses are RBC membranes resistant against? Sensitive to?

A

resistant to curvature, sensitive to expansion

70
Q

What happens if the solution is not isotonic to the RBC?

A

solution hypertonic = RBC shrivel

solution hypotonic = RBC bursts

71
Q

How can we measure the risk of non-isotonicity of any given preparation?

A

By knowing osmolarity or osmolality of the preparation. Can use osmometer to measure property

72
Q

What are colligative properties?

A

Properties of solutions that depend on the quantity of particles (moleculettes) in solution, rather than the chemical nature of dissolved materials.
Any solute dissolved can have the same effect as something else as long as the concentrations of dissolved particles is the same.

73
Q

Differentiate b/t osmolarity and osmolality.

A
osmolarity = [# Osmoles of solute/(volume of solute + solvent)]
osmolality = # of Osmoles of solute/wt (kg) of only the solvent
74
Q

Differentiate b/t osmolarity and molarity.

A
molarity = (# of moles of solute/L of sol'n) 
osmolarity = (# of Osmoles of solute/L of sol'n)
75
Q

formula for osmolarity

A

[(# moles of solute/L of sol’n) x (# Osmoles/1 mol)]

76
Q

Iso-osmotic vs isotonic

A
osmolarity = # measured by an instrument
tonicity = effect on the living cell
77
Q

Can you use osmolarity and osmolality interchangeably?

A

At low concentrations, yes

At high concentrations, NO

78
Q

Are NS and D5W interchangeable?

A

NOT ALWAYS

79
Q

Isotonic solution + large amount of drug = what tonicity?

A

hypertonic solution

80
Q

range of isotonicity?

A

serum osmolarity = 280 - 300 mOsmol/L

81
Q

Types of vascular access devices

A
  1. peripheral - needle, over-the-needle catheter

2. central - PICC, surgically implanted

82
Q

Macrodrip vs microdrip

A

Macrodrip: delivers large quantities, faster rates. 10,15, or 20gtt/mL
Microdrip: delivers small amounts. 60gtt/mL. Used in pediatrics and patients who need small/closely-regulated amounts of IV solution

83
Q

Poiseuille’s Law

A

rate = driving force/resistance

84
Q

Components of resistance to flow

A
  1. Tubing (macrobore vs microbore)
  2. in-line filter
  3. viscosity of IV fluid
  4. Length of tubing
  5. Venous backpressure
85
Q

Actual number of drops/mL depends on…?

A
  1. viscosity of the CSP
  2. surface tension
  3. density
86
Q

How does metered burette work?

A

reconstituted drug injected in burette; diluent from the primary IV bag used to dilute dosage to proper volume

87
Q

How does a partial-fill container work?

A

reconstitued drug added to plastic bag containing diluent

88
Q

How does partial-fill premix work?

A

drug and diluent are premixed in plastic IV bag. Less stable drugs, delivered frozen, must be thawed.

89
Q

How does ADD-vantage work?

A

vial containing drug attached to partial-fill bag. Internal seal separating the drug from diluent is removed and the two components are mixed

90
Q

How does a syringe-pump infusion work?

A

reconstituted drug is withdrawn into syringe; delivery is by positive pressure exerted on syring plunger.

91
Q

How does vented syringe infusion work?

A

reconstituted drug is withdrawn into syringe. Speical IV set vents syringe to drug may be delivered by gravity.

92
Q

How does drug manufacturer’s piggyback/Faspak work?

A

Diluent added to container prefilled with single dose of drug

93
Q

Characteristics of central venous therapy

A
  1. Infusion of large volume of fluid
  2. Multiple infusions
  3. Long-term infusion therapy
  4. Infusion or irritating medications like
    potassium
  5. Infusion of fluids of high osmolarity
94
Q

Common names for central lines

A

Hickman and Broviac

95
Q

Characteristics of Hickman Catheter

A

Dacron cuff prevents excess motion

Requires surgical insertion

96
Q

Advantages of central venous therapy

A
  1. Access to central veins
  2. Rapid infusion of large amounts of fluid
  3. A way to draw blood and measure CV pressure
  4. Reduced need for repeated venipunctures
  5. Reduced risk of vein irritation from infusing
    irritating substances
97
Q

Risks of Central Venous Therapy

A
  1. Sepsis
  2. Thrombus formation
  3. Perforation of vessel and adjacent organs
  4. Air embolism
98
Q

Disadvantages of central venous therapy

A
  1. Cost
  2. Requires more skill to insert than peripheral
    therapy
99
Q

Risks associated with infusion

A

Complications from damage to the inner lining of
the vein (intima):
– Stenosis (narrowing)
– Thrombus (clot)
– Venous occlusion
– Chemical inflammation (phlebitis) and pain

100
Q

Instrumental flow control: controllers vs pumps

A

controllers - Use gravity as driving force

pumps - powered devices

101
Q

Infusion pumps: provided pressure

A

Pumps provide pressures in the range of 2 - 12 psi
(100 – 600 mm Hg). The high end of this pressure
range is used for intra-arterial infusions.

102
Q

Infusion pumps: caution

A

The use of excessive infusion pressures can
be a hazard with respect to infiltration at the site of
injection.
*Infiltration = leakage of IV fluid/medications into surrounding tissue

103
Q

Features of infusion pump

A
  1. Volumetric delivery independent of vascular backpressure,
    position of patient, composition of infusion
    solution, or tubing resistance
  2. Safety features (alarms)
  3. Becoming increasingly smart
104
Q

What an infusion pump might react with an alarm to

A
  1. Occlusion of line
  2. Infusion complete
  3. Air in line
  4. Empty container
  5. Flow rate error
105
Q

Syringe pump: advantage

A
  1. Use commercial syringes
  2. Smart machines
  3. Especially useful for giving
    intermittent IV medications
  4. Provide the best control for
    small volume infusions
  5. Useful for pediatric patients
106
Q

Other parenteral pumps

A

patient-controlled analgesia, ambulatory pumps, implantable pumps

107
Q

Adv of patient-controlled analgesia

A

Pain relief is generally obtained at a lower total dose of drug

108
Q

Special characteristic about ambulatory pumps

A

Easy to carry

Able to operate without an external power source

109
Q

Implantable pumps: reservoir size, ROA it’s used for, and low range of delivery rate

A

reservoir = about 50mL
Used for IV, intrathecal, and intra-arterial routes
Can deliver as low as 1
microliter per hour.