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Dispensing II Lab > Ingredient Considerations in Compounding > Flashcards

Ingredient Considerations in Compounding Flashcards

1
Q

DEFINITION

pertains to the preparation of medications and is also included in the dispensing process

A

extemporaneous compounding

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2
Q

DEFINITION

practice of preparation of a therapeutic product by mixing and combining pharmaceutical agents for an individual patient in response to the identified need

A

extemporaneous compounding

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3
Q

What are the other cases in which extemporaneous compounding is needed?

A
  1. if px is allergic to a certain excipient
  2. if px has dysphagia (difficulty in swallowing)
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4
Q

What are the two types of extemporaneous compounding?

A
  1. simple
  2. complex
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5
Q

DEFINITION

extemporaneous compounding that requires 1 API

A

simple

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6
Q

DEFINITION

extemporaneous compounding that requires 2 or more APIs

A

complex

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7
Q

What is the potency to be considered acceptable for USP-NF?

A

API potency of 80% and above

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8
Q

FCC stands for?

A

Food Chemical Codex

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9
Q

What is the chemical grade with the highest purity?

A

analytical grade

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10
Q

T/F: reagent grade can be taken orally or parenterally

A

F - cannot be taken PO or parenterally

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11
Q

SOURCES OF INGREDIENTS

What are the recommended or standardized sources of ingredients for compounding all drug preparations?

A

USP, NF or FCC

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12
Q

SOURCES OF INGREDIENTS

Alternative high-quality source such as __________________________ or
certified _______________________ grade may be considered applying professional judgement

A

analytical reagent (AR) or certified American Chemical Society (ACS)

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13
Q

SOURCES OF INGREDIENTS

T/F: Only manufactured drug products from containers labeled with a batch control number and a future expiration date are acceptable as potential source of active ingredients

A

True

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14
Q

SOURCES OF INGREDIENTS

used when receiving raw materials to assure quality of material received for manufacture

A

certificate of analysis

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15
Q

SOURCES OF INGREDIENTS

when compounding with ______________________ products, all ingredients present in the drug product must be considered relative to the _______________________ of the compounded preparation

A

manufacture drug; intended use

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16
Q

What are the special considerations in compounding?

A

compounding with…
1. hydrates and solvates
2. inorganic salts
3. organic salts
4. esters
5. aliquots, dilutions, & concentrates
6. potency-designated ingredients
7. complex organic molecules
8. commercial products

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17
Q

Hours of stability of high-risk compounded products

A

24 hours

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18
Q

COMPOUNDING WITH HYDRATES AND SOLVATES

T/F: The more molecules of water present in the molecule, the less of the chemical should be weighed to obtain the actual active drug.

A

F - more of the chemical should be weighed

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19
Q

T/F: if water adds to the total weight, it is considered overdosage

A

F - underdosage

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20
Q

PACKAGING OF HYDRATES AND SOLVATES

Why must these products be packaged in tight containers?

A

to prevent the loss or gain of moisture

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21
Q

STORAGE OF HYDRATES AND SOLVATES

What is the importance of storing these products at the indicated temperatures?

A

to minimize exposure to high humidity levels

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22
Q

What is the required %humidity in the compounding area?

A

less than 60%

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23
Q

compounds that lose water in their molecules and may become powdery when exposed to air

A

efflorescent

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24
Q

compounds that gain water in their molecules or absorb water but remain solid

A

hygroscopic

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25
Q

compounds that absorb water and liquefies

A

deliquescent

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26
Q

COMPOUNDING WITH INORGANIC SALTS

What are the characteristics of inorganic salts that affect their physical and chemical properties?

A
  1. particle size
  2. tendency to absorb or give off water
  3. pH
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27
Q

COMPOUNDING WITH INORGANIC SALTS

_______________ properties of the compound should be considered

A

solubility

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28
Q

COMPOUNDING WITH INORGANIC SALTS

Acid salts corresponding to an insoluble salt will be _________________ than the original salt

A

more water soluble

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29
Q

COMPOUNDING WITH INORGANIC SALTS

__________________ are water-insoluble, except for their alkali metal salts

A

Sulfides

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30
Q

COMPOUNDING WITH INORGANIC SALTS

most products are combined with salts to increase _______________ and become readily _____________ by the body (e.g., Losartan mixed with Potassium)

A

solubility; absorbed

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31
Q

COMPOUNDING WITH INORGANIC SALTS

smaller particles have ___________ surface area

A

higher

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32
Q

examples of inorganic salts

A

NaCl, KCl, CaCO3

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33
Q

COMPOUNDING WITH ORGANIC SALTS

Many drugs are _______, and the dose may be based on the ______________ form or just the ________ form of the drug

A

salts; total salt form; base form

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34
Q

COMPOUNDING WITH ORGANIC SALTS

_______________________, USP, are based on the “albuterol” content (present as sulfate form)

A

Albuterol Sulfate Tablets

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35
Q

COMPOUNDING WITH ORGANIC SALTS

_________________________________, USP, are based on the total molecule

A

Diphenhydramine Hydrochloride Capsules

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36
Q

COMPOUNDING WITH ORGANIC SALTS

Drugs that are either weak acids or weak bases and have limited water solubility are often used as their “salts” form for what purpose?

A

to increase aqueous solubility

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37
Q

COMPOUNDING WITH ORGANIC SALTS

What are the other uses of salt forms?

A
  1. to enhance stability
  2. to change other attributes of the drug to aid handling during compounding
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38
Q

COMPOUNDING WITH ORGANIC SALTS

acids mixed with bases would yield water and salts that would cause ___________

A

precipitation

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39
Q

COMPOUNDING WITH ESTERS

__________ prepared for solubility and stability purposes, to enhance resistance to degradation after administration and for use as prodrugs

A

esters

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40
Q

COMPOUNDING WITH ESTERS

Drugs that form a precipitate upon injection may cause what?

A

pain at the site of injection and damage to the surrounding tissue

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41
Q

COMPOUNDING WITH ESTERS

pain at the site of injection caused by drug precipitate formation may be overcome by?

A

preparing a drug with increased solubility

42
Q

COMPOUNDING WITH ESTERS

example of an ester drug preparation

A

Chloramphenicol succinate

43
Q

COMPOUNDING WITH ESTERS

T/F: Since some drugs may occur in salt forms, ester forms, and/or salt-ester forms, it is important to document what form is used and whether it is a salt, ester, or combination

44
Q

COMPOUNDING WITH ESTERS

examples of salts

A

Erythromycin estolate & Erythromycin stearate

45
Q

COMPOUNDING WITH ESTERS

example of an ester

A

Erythromycin ethylsuccinate

46
Q

Reasons for preparing aliquots, dilutions and concentrates:

A

summarized answer:

  1. quantities required are too small for accurate weighing
  2. some are explosive and must be diluted
  3. many substances are commercially available in percentage strengths that vary from one acid to another
47
Q

What is a possible incompatibility when acids and bases are mixed?

A

precipitation

48
Q

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS

Some antibiotics, endocrine products, biotechnology-derived products, and biologics, have potencies that are based on “__________” and are expressed in terms of “________________”

A

activity; units of activity

49
Q

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS

T/F: There is a relationship between the units of potency of one drug with another different drug

A

F - no relationship

50
Q

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS

What is the basis of potency determination?

A

dried or anhydrous basis

51
Q

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS

Antibiotics potency is expressed as _________________________

A

mcg of activity per mg of substance

52
Q

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS

in drugs like heparin and insulin, the actual dose may be expressed in ________, instead of mg

53
Q

LABELLING OF POTENCY-DESIGNATED INGREDIENTS

Each container must be labeled with the _________________, and this information is to be used in calculations involving dosing prior to compounding

A

actual potency

54
Q

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES

identified as the most complex molecules and biotechnology products

55
Q

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES

proteins are inherently _________________ molecules and require special handling, and their ________________ profiles can be quite complex

A

unstable; degradation

56
Q

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES

pharmacists should be knowledgable on the protein’s ________________, _________________, and _______________ to the site of action

A

stabilization, formulation, and delivery

57
Q

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES

Protein drugs are ________________ and are used in quite _____________________________

A

very potent; low concentrations

58
Q

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES

T/F: The bulk of compounded protein preparations may be the excipients, including the vehicle, buffers and stabilizers

59
Q

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES

In TPN’s containing Calcium and Phosphate salts can form precipitate with proteins ________________

A

less than 6%

60
Q

What are the factors to be considered when compounding with complex organic molecules?

A
  1. pH
  2. chelating agents
  3. antioxidants
  4. preservatives
  5. stabilizers and tonicity-adjusting agents
61
Q

What is the key to formulating a stable preparation?

62
Q

What are used to obtain optimal pH range?

A

physiologic buffers

63
Q

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES

T/F: An increase in buffer concentration indicates decrease in pain on injection

A

F - increase in pain

64
Q

Purpose of adding chelating agents in preparations

A
  1. to bind trace metals, like copper, iron, calcium and manganese
  2. to minimize rates of degradation
65
Q

Example of chelating agent

A

EDTA (0.01-0.05%)

66
Q

incorporated to prevent protein degradation due to oxidation

A

antioxidants

67
Q

Examples of antioxidants

A

ascorbic acid, sodium disulfide, a-tocopherol (0.05-0.1%)

68
Q

T/F: Preservatives may be required, especially if multiple dose vials are prepared.

69
Q

phenol, chlorobutanol and benzyl alcohol are examples of

A

preservatives

70
Q

Example of stabilizer

A

polyols at 1-10%

71
Q

Example of tonicity-adjusting agents

A

sodium chloride and dextrose

72
Q

COMPOUNDING WITH COMMERCIAL PRODUCTS

commonly used to prepare oral liquids (solutions and suspensions) for pediatric use

A

oral tablets and capsules

73
Q

COMPOUNDING WITH COMMERCIAL PRODUCTS

used to prepare intravenous admixtures

A

injectable drugs

74
Q

T/F: Use of commercial products as source of API usually result in lower prescription cost

A

F - higher prescription cost

75
Q

Uncertainties in compounding involve the presence of __________________ and ____________________

A

excipients and actual assay potency

76
Q

presence of ____________ in the commercial drug product may influence and dictate the _____ of the final compounded preparation

A

buffers; pH

77
Q

This type of dosage form should not be used in compounding unless it has been indicated or documented that they can be used

A

modified-release dosage forms (e.g., extended-release, delayed-release, repeat-action and targeted release)

78
Q

Important things to note when using commercial products in compounding

A

list the…
1. manufacturer
2. lot number
3. expiration date
and,
4. assign the BUD based on the product stability and insert

79
Q

What are the basis of the most appropriate method for medication disposal?

A
  1. government regulations
  2. environmental impact
  3. type, volume, and toxicity of medication
  4. setting and risk of diversion
80
Q

What is the optimal method of medication disposal?

A

incineration

81
Q

What are the types of pharmaceutical waste?

A
  1. hazardous waste
  2. regulated medical waste
  3. universal waste
  4. controlled substance waste
  5. non-hazardous medical waste
82
Q

Types of hazardous wastes

A
  1. ignitable
  2. corrosive
  3. reactive
  4. toxic
83
Q

DETERMINE WHAT TYPE OF WASTE

aqueous drug formulations containing >24% alcohol by volume

A

hazardous - ignitable waste

84
Q

DETERMINE WHAT TYPE OF WASTE

oxidizers or materials that readily supply oxygen to a reaction in the absence of air (e.g. AgNO3 applicators)

A

hazardous - ignitable waste

85
Q

DETERMINE WHAT TYPE OF WASTE

flammable aerosol propellants

A

hazardous - ignitable waste

86
Q

DETERMINE WHAT TYPE OF WASTE

agents with pH <2 or >12.5

A

hazardous - corrosive waste

87
Q

DETERMINE WHAT TYPE OF WASTE

glacial acetic acid, NaOH

A

hazardous - corrosive waste

88
Q

DETERMINE WHAT TYPE OF WASTE

heavy metals like barium, selenium and thimerosal

A

hazardous - toxic waste

89
Q

DETERMINE WHAT TYPE OF WASTE

biohazardous waste or infectious medical waste

A

regulated medical waste

90
Q

DETERMINE WHAT TYPE OF WASTE

waste contaminated by blood, body fluids, or other potentially infectious material, including sharps

A

regulated medical waste

91
Q

DETERMINE WHAT TYPE OF WASTE

commonly generated hazardous waste (e.g., batteries, pesticides, mercury-containing products and bulbs/lamps)

A

universal waste

92
Q

DISPOSAL OF MEDICATION WASTE

ASHP recommends that healthcare facilities have a ____________________ waste management team

A

multidisciplinary

93
Q

DISPOSAL OF MEDICATION WASTE

_________________ must be incinerated at an EPA-approved facility

A

Hazardous waste

94
Q

What does EPA stand for?

A

Environmental Protection Agency

95
Q

DISPOSAL OF MEDICATION WASTE

________________________________ should be disposed of in a medical waste or municipal incinerator

A

nonhazardous pharmaceutical waste

96
Q

T/F: Do not flush medications unless otherwise stated

97
Q

T/F: When disposal programs are not available, do not throw away unwanted medications in the trash.

A

F - throw away unwanted medications in the trash using appropriate safeguards

98
Q

Topical patches should be folded in _____, _______________, and should remain intact

A

half, adhesive in

99
Q

Mix the medications with ___________________, like used coffee grounds, sawdust, or kitty litter to make them less appealing to children and animals

A

undesirable substance

100
Q

T/F: Throw away medication container in household trash

Dispensing II Lab (1 decks)

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