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CNSC Exam 2021 > Chapter 15: PN Formulations > Flashcards

Chapter 15: PN Formulations Flashcards

1
Q

What is the amount of kcal/kg provided in dextrose? (Most commonly used carbohydrate in PN).

A

3.4 kcal/kg

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2
Q

What is the amount of kcal/kg provided by glycerol? What is glycerol?

A

4.3 kcal/kg

Sugar-alcohol; less frequently used CHO energy substrate.

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3
Q

What is the amount of kcal/kg of crystalline amino acids in PN formulations?

A

Yield 4.0 kcal/kg, when oxidized for energy.

AA products are generally assumed to be 16% N (6.25 g AA = 1 g N)

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4
Q

What are some differences between standard and concentrated AA formulations?

A

The acetate content is higher in the more concentrated products than in standard stock concentrations.

Chloride salts may be used to balance the chloride:acetate ratio in the final PN formulation to avoid iatrogenic acid-base disturbances.

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5
Q

What are the 3 ILE formulations used for PN?

A
  • 2 formulations are composed solely of LCTs; which are 100% soybean oil-based formulations
  • 50:50 blend of safflower oil and soybean oil (but has been out of stock due to safflower oil shortages)
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6
Q

What is Smoflipid? What is the composition, benefits?

A

“Smof” refers to the type of oils

  • S: oybean oil
  • M: CTs
  • O: live oil
  • F: ish oil

This ILE contains: 30% soybean oil, 30% MCTs, 25% olive oil, and 15% fish oil, and is available as a 20% solution.

Contraindicated in patients with a known hypersensitivity to soybean, fish, egg, or peanut protein

Essential acid concentration is lower than the traditional soybean oil-based ILEs

Benefit: Contains a vary of oils, while reducing the amounts and detrimetrial effects of w-6 FAs

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7
Q

What is the amount of kcal/kg for fat in PN formulations?

A

9 kcal/kg

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8
Q

**ASPEN/SCCM Recommendation**

What is the recommendation regarding w-6 FAs in critically ill patients receiving PN?

A

**ASPEN/SCCM Recommendation**

Suggests that clinicians either withhold soybean oil-based ILE or limit it to a maximum of 100 grams (often divided into 2 doses) during the first week following initiation of PN, if the patient is at risk for EFAD.

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9
Q

What are the preferred forms of calcium and magnesium for use in PN formulations? Why?

A
  • Calcium gluconate
  • Magnesium sulfate

Less likely to produce physiochemical incompatibilities compared to calcium chloride, calcium gluceptate, and magnesium chloride.

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10
Q

What are 5 commonly used trace elements in PN formulations?

A
  • Zinc
  • Copper
  • Chromium
  • Manganese
  • Selenium
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11
Q

**ASPEN Recommendation**

What types of trace elements products be used for PN formulations?

A

**ASPEN Recommendation**

When multiple-element products are inappropriate, single-element products should be used to meet individual patient needs.

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12
Q

**ASPEN Recommendation**

What are the specific recommendations ASPEN has made to commercially available multi-trace element products?

A

**ASPEN Recommendation**

Products need to undergo significant modifications:

  • Decreasing copper (to 0.3 from 0.5 mg/d)
  • Decreasing manganese (to 55 mcg/d)
  • Manufacturing a product without chromium (or a maximum of 1 mcg/d)
  • Including selenium in all products at a higher dose of 60 to 100 mcg/d)
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13
Q

What is the only iron approved for addition to PN?

A

Iron dextran; should only be considered for dextrose-AA formulations, because ILE formulations are disrupted by iron.

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14
Q

What are the benefits of glutamine?

A

AA found in the human body; has a role in intestinal integrity, immune function, and protein synthesis during stress states.

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15
Q

(TRUE/FALSE)

Glutamine can be added to PN formulations and is recommended for critically-ill patients.

A

FALSE.

No FDA-approved IV form of glutamine is commercially available in the US for admixture in PN formulations, because of poor solubility and stability and compatibility limitations.

Parenteral glutamine supplementation is no longer recommended for adult critically-ill patients because recent literature indicates either a lack of infectious or morality benefit.

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16
Q

What is carnitine?

A

A quaternary amine necessary for proper transport and metabolism of long-chain FAs into the matrix of the mitochrondria for beta-oxidation.

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17
Q

(TRUE/FALSE)

IV L-carnitine is commercially available to be added to PN formulations for the treatment of carnitine deficiency or those who are at risk for deficiency, such as neonates/infants.

A

TRUE.

Only IV L-carnitine can be added to PN, there are no other carnitine formulations available.

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18
Q

Define 2-in-1 PN formulation.

A

The traditional dextrose - AA formulation; along with the prescribed electrolytes, minerals, vitamins, and trace elements in either a single container for multiple containers each day.

ILE is administered separately as a piggyback infusion

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19
Q

Define 3-in-1 admixture, aka all-in-1 admixture; TNA.

A

Incorporates dextrose, AA, ILE and the prescribed micronutrients together in the same container for final administeration.

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20
Q

What is the CDC guideline for hang times of ILE?

A

Limits hang times of ILE given in the piggyback fashion to a maximum of 12 hours.

Faster infusion rates (4 to 6 hours) predispose susceptible patients to hypertriglyceridemia that could have been lessened by infusing ILE at a slower rate.

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21
Q

What is the CDC guideline for iLE incorporated into a TNA?

A

Can hang for up to 24 hours.

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22
Q

What is the USP?

A

A private, non-profit organization recognized by the federal gov. as the official group responsible for setting national standards for drug purity and safety and issues standards on the pharmaceutical compounding of sterile products.

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23
Q

What is Chapter {797}?

A

Established by USP, that discusses that standards that apply to all sterile dosage forms that are compounded, including PN.

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24
Q

What is a low-risk level for CSPs?

A

CSPs = Compounded Sterile Preparations

Low risk typically involves a simple, closed-system aseptic transfer

25
Q

What is a medium-risk for CSPs?

A

Involves reconstitution of several sterile commercial products for transfer into several small-volume minibags or a large-volume parenteral preparation, such as PN.

26
Q

What is a high-risk level for CSPs?

A

Involves the preparation from bulk, nonsterile ingredients or the preparation from sterile ingredients that are exposed to less than the International Org. for Standardization (ISO) Class 5 standards.

A low- or medium- risk product becomes high risk when any added component is high risk; thus a PN formulation with L-glutamine compounded from nonsterile powder becomes a high-risk product.

27
Q

What are ACDs?

A

Automated Compounding Devices; developed to streamline the manufacturing sequence for multiple-ingredient preparations, such as PN formulations, by automatically delivering individual components in a predetermined sequence under computerized control.

28
Q

What are some advantages of ACDs?

A
  • Enhanced accuracy
  • PN formulations can be more tailored to individual patient needs
  • More efficient process
  • Should reinforce proper compounding sequence
  • Reduce the likelihood of touch contamination
  • Reduces labor and supply costs for institutions that compound many PN formulations daily
29
Q

What are some double-checks that should still happen if an institution uses an ACDs for PN formulations?

A
  • Independent, double-check of the initial daily ACD set-up should be done using a printed checklist
  • PN formulations for: Adults, Peds, Neonates, should be done in separate location or time
  • Warning limits should be weight-based and determined by pharmacists’ review to ensure consistency with the needs of the specific patient population.
30
Q

What is gravimetric analysis?

A

Can be used as a quality control measure for manual or automated compounded systems, and is a method of quality assurance that can be applied independent of the ACD.

31
Q

What is refractometry?

A

Also used to determine whether PN formulations have been compounded properly. The refractive index of dextrose and AAs can be measured with a refractometer and compared to values established for known concentrations of dextrose and AAs in PN base formulations.

Cannot be used with ILE

32
Q

What are SCAPN products?

A

Standardized Commercially Available Parenteral Nutrition Formulations

These products have an internal membrane that separates the macronutrients into different chambers of the product and is broken so the components can be mixed just before administeration.

They require the addition of the MVI injection shortly before administeration because vitamins are essential components of PN that are not stable when added more than 24 hours in advance of use.

33
Q

What is ProcalAmine?

A
  • A SCAPN product
  • Glycerol-based products that can be used for short-term PPN administeration
  • Contains a final concentration of AA of 3%; glycerol 3% and electrolytes
  • Remember glycerol is a sugar-alcohol and can be premixed and steriled in a single bottle w/o undergoing the Mallard rxn
34
Q

What are some potential advantages of SCAPN products?

A
  • Reduction in costs
  • Decreased compounding time
  • Less risk for ordering and compounding errors
  • Fewer bloodstream infections
  • Shelf-stable and heat sterilized, allowing for more time before expiration than compounded PN.
35
Q

What does stability mean when referring to PN admixtures?

A

Stability of PN formulations refers to the degradation of nutritional components that changes their original characteristics

Example: Maillard reaction (that occurs between IV dextrose and certain AAs such as lysine, resulting in a brownish discoloration of the final formulation).

Also, photodegradation from light exposure, particulary fluorescent light, results in a loss of some vitamins.

36
Q

What does compatibility mean when referring to PN admixtures?

A

Compatibility issues with PN formulations generally involve the formation of precipitates.

May be solid (crystalline matter) or liquid (phase separation of oil and water in a TNA).

37
Q

(TRUE/FALSE)

The distinction between stability and compatibility with ILEs can be difficult to discern, because all emusions are inherently unstable systems that will return to their oil and water components over time.

A

TRUE.

ILEs clearly have compatibility issues. For example, the addition of trivalent cations such as iron dextran to an ILE results in phase separation of the ILE components.

38
Q

(TRUE/FALSE)

Medications should not be added to PN formulations unless there is clear evidence fro the literature or standard references to support stability, compatibility and maintenance of pharmacological and therapeutic efficacy that is specific to the nutrient composition in the PN to be dispensed.

A

TRUE.

39
Q

(TRUE/FALSE)

ILE consists of an interior oil phase dispersed in an external water phase.

A

TRUE.

40
Q

What are some factors that may alter the electrical charge on the fat droplet surface in ILEs?

A
  • Reductions in pH
  • Addition of electrolyte salts
41
Q

What is the most critical factor influencing the pH formulations?

A

The crystalline AA solution used for compounding

42
Q

(TRUE/FALSE)

The concentration or amounts of calcium and phosphate ions are directly related to the risk of precipitation.

A

TRUE.

43
Q

What are the two forms of calcium that are generally less dissociated salts forms of calcium than the chloride salts?

A
  • Calcium gluconate
  • Calcium gluceptate

Less impact on risk of precipitation

44
Q

Trace element contamination is found in most PN formulation components. What do these include? (6)

A
  • Arsenic
  • Aluminum
  • Chromium
  • Zinc
  • Manganese
  • Copper
45
Q

What is the primary route for aluminum elimination in the body to prevent toxicity?

A

Kidneys remove unbound aluminum from the blood

About 60% of infused aluminum is eliminated in patients with adequate renal function. The remaining is deposited in tissues, like the brain, bones, liver and lungs.

46
Q

Adult patients at risk for aluminum toxicity include? (3)

A
  1. Significant renal dysfunction
  2. High intake of PN
  3. Iron deficiency
47
Q

What size are large-pore filters? Purpose?

A

5 microm

Adequate for the removal of precipitates (ie: calcium phosphate) and particulate matter (ie: plastic fragments from the bag) from PN formulations.

48
Q

(TRUE/FALSE)

Filters are a good substitute for good compounding practices indended to prevent precipitate formation.

A

FALSE.

They are NOT

49
Q

What is the purpose of 1.2 microm filters, with ILE-containing PN formulations?

A

Avoid particle shearing and instability that may occur with filters of smaller size

Does not trap larger organisms including C. abicans

50
Q

With which PN type should 0.22 microm filter be used?

A

For dextrose-AA PN admixtures // 2-in-1

51
Q

If a 2-in-1 dextrose-AA admixture is administered with a separate infusion of ILE, what 2 filters would be required?

A
  1. 0.22 microm in-line filter for the 2-in-1
  2. 1.2 microm in-line filter for the ILE
52
Q

(TRUE/FALSE)

In-line filters should be changed with each new administration of PN?

A

TRUE

Q 24 hours with TNA and 2-in-1s

Q 10-12 hours for ILE

53
Q

(TRUE/FALSE)

In-line filters can increase the incidence of occlusion alarms during PN administration.

A

TRUE.

Should be recognized as a potential sign of a precipitate and should be investigated.

CDC does not endorse the use of in-line filters solely for the purpose of infection control.

54
Q

How much kcal/mL is provided in 20% ILE? (Think PPN)

A

2 kcal/mL

55
Q

How much kcal/mL is provided in 10% ILE? (Think PPN)

A

1.1 kcal/mL

56
Q

How much kcal/mL is provided in 30% ILE? (Think PPN)

A

2.9 - 3 kcal/mL

57
Q

ILE should not exceed what percentage of calories OR x g/kg/day?

A

Not exceed 60% of total energy OR

2.5 g/kg/kday

58
Q

What is the maximum rate of dextrose administration?

A

3 mg/kg/min

5 mg/kg/min is the maximum amount of dextrose the liver can oxidize

59
Q

CALCULATION:

A patient weighing 80 kg has estimated requirements of 30 kcal/kg/d and 1.5 g/kg/d. Between 20% and 30% of total energy will be provided as ILE. The volume should be restricted to 1.5 L/d.

  1. Calculate energy and protein needs.
  2. Calculate minimum and maximum of kcals from ILE.
  3. Calculate given stock solutions used by the pharmacy for compounding PN are AA 10%, dextrose 70%, and ILE 20%. PN formulations are manually compounded without an ACD as dextrose-AA formulations.
A

Page 317 in Textbook.

  1. Total energy = 2400 kcal/day; Protein = 120 g/d
  2. Minimum = 480 kcals/d; Maximum = 720 kcals/d.
  3. AA 10%: 400 kcal/d; 100 g; Dex 70%: 250 mL = 595 kcals; 175 g; 20% ILE 250 mL = 500 kcal/d

400 + 500 +595 = 1495 kcal/day in 1500 mL/day; cannot meet full estimated energy and protein needs given FR.

Other examples on page 316 - 317.

CNSC Exam 2021 (50 decks)

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