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compounding exam 1 > intro > Flashcards

intro Flashcards

1
Q

community form dosage forms (non parenterals)

A

solid, liquid, semi solid

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2
Q

solid dosage form (community)

A

powders and capsules

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3
Q

liquid dosage form (community)

A

solutions and suspensions

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4
Q

semi solid dosage form (community)

A

ointments and suppositories

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5
Q

hospital pharm dosage forms

A

parenterals, non parenterals

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6
Q

hospital parenteral dosage forms

A

IV admixture, mEQ, TPN, radiopharmaceuticals

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7
Q

pt consulting tips

A

listen carefully, don’t assume, ask open ended q’s, don’t use fancy language, don’t state risk vs benefit comparisons, don’t guarantee anything and don’t blame anyone

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8
Q

history of compounding

A

More than 5000 years old
– “One-man” show

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9
Q

Compounding versus manufacturing

A

Specific physician-patient-pharmacist relationship
– The quantity prepared is very small
– Condition of sale is different in both situations

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10
Q

condition of compounding

A

limited to specific rx order

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11
Q

condition of manufacturing

A

intended for public at large

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12
Q

Is compounding legal?

A

yes but there are restrictions imposed on extemporaneous compounding

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13
Q

what can’t one compound

A

commercial products and drugs for the physician’s office

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14
Q

rx for compounding must be

A

UNSOLICITED

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15
Q

One can compound a product prior to receiving prescription, but only in

A

limited quantity (based upon history of rx’s)

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16
Q

Can a pharmacy advertise their compounding services?

A

YES, but only the service and not the products

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17
Q

Authorized prescribers

A

Physicians, midwives, optometrists, veterinarians, dentists, nurse practitioners, podiatrists

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18
Q

historical background of compounding

A
  • Patient counseling
  • Assistance by unlicensed personnel
  • identification of pharmacists
  • Pharmacy
  • Licensing examinations
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19
Q

Compounding environment components

A

facilities and equipment

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20
Q

Stability of compounding preparations components

A

primary packaging, sterility, stability criteria and beyond use dating

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21
Q

space in compounding facilities

A

should have adequate space for orderly placement of equipment and materials to prevent mix-ups between ingredients, containers, labels, in-process materials, and finished preparations

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22
Q

cross contamination in compounding facilities

A

should be designed, arranged, used, and maintained to prevent adventitious cross-contamination

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23
Q

sterile preparations in compounding facilities

A

should be separate and distinct from the compounding area for non-sterile preparations

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24
Q

water for hand and equipment washing in compounding facilities

A

For washing hands and equipment, use potable water which meets the standards prescribed in Environmental Protection Agency’s National Primary Drinking Water Regulations (40 CFR Part 14)

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25
Q

water for non sterile products in compounding facilities

A

Purified water must be used when formulations indicate the inclusion of water and must also be used for rinsing equipment and utensils

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26
Q

____ for injection

A

sterile water and bacteriostatic

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27
Q

The equipment part deals essentially with

A

Weights and Balances, Prescription Balances, and Volumetric Apparatus

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28
Q

The equipment should be of _____ for compounding

A

appropriate design and size

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29
Q

The equipment should be ______ at appropriate intervals to ensure the accuracy and reliability of their performance

A

inspected, cleaned, maintained, and validated

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30
Q

The USP defines stability as

A

“the extent to which a preparation retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding”

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31
Q

chemical stability

A

each active ingredient retains its chemical integrity and labeled potency within the specified limits

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32
Q

physical stability

A

appearance, palatability, uniformity, dissolution, and suspendibility are retained

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33
Q

microbio stability

A

sterility or resistance to microbio growth (antibmicrobio agents retain effectiveness)

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34
Q

therapeutic stability

A

unchanged therapeutic effect

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35
Q

toxicological stability

A

no increase in toxicity

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36
Q

The USP requires that compounded preparations should be packaged in

A

containers that meet USP standards

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37
Q

Primary packaging

A

The container is that which holds the compounded preparation and is or may be in direct contact with the compounded preparation

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38
Q

is the closure part of the container

A

yes

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39
Q

Four types of containers

A

light resistant container, well-closed container, tight container, hermetic container

40
Q

Stability of Compounded Preparations

A

primary packaging
sterility
stability packaging
guidelines for BUD for compounding preparations
storage temps

41
Q

freezer temps (C)

A

between -25 and -10

42
Q

cold temps (C)

A

between 2 and 8

43
Q

cool temps (C)

A

between 8 and 15

44
Q

room temps (C)

A

temp in the working area

45
Q

controlled room temps (C)

A

between 20 and 25

46
Q

warm temps (C)

A

between 30 and 40

47
Q

excessive heat temps (C)

A

above 40

48
Q

protect from freezing temps (C)

A

store above 0

49
Q

refrigerator temps (C)

A

between 2 and 8

50
Q

freezer temps (F)

A

between -13 and -14

51
Q

cold temps (F)

A

between 36 and 46

52
Q

cool temps (F)

A

between 46 and 59

53
Q

controlled room temps (F)

A

between 68 and 77

54
Q

warm temps (F)

A

between 86 and 104

55
Q

excessive heat temps (F)

A

above 104

56
Q

protect from freezing temps (F)

A

store above 32

57
Q

refrigerator temps (F)

A

between 36 and 46

58
Q

The USP uses the term “beyond-use date” as the date after which

A

a compounded preparation should not be use (determined from the date the preparation is compounded)

59
Q

BUD for nonaq formulations

A

not later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient or 6 months, whichever is earlier

60
Q

Water-containing oral formulations BUD

A

not later than 14 days when stored at controlled cold temperatures

61
Q

Water-containing topical/dermal and mucosal liquid and semisolid formulations BUD

A

no later than 30 days

62
Q

Chapter 1075 of the USP classifies pharmaceutical compounding into ____categories

A

7 (to provide the compounding personnel an understanding when different forms of preparations are compounded)

63
Q

Categories 1 and 2

A

non sterile compounding

64
Q

Categories 3, 4, and 5

A

deal with compounding of sterile products and risk levels associated with them.

65
Q

Categories 6 and 7

A

radio-pharmaceuticals and veterinary compounding

66
Q

category 1

A

nonsterile simple
mixing of 2+ commercial products

67
Q

category 2

A

nonsterile- complex
compounding with the bulk drug substances when calcs are required

68
Q

category 3

A

sterile: Risk Level 1
low risk level

69
Q

category 4

A

sterile risk level II
medium levels

70
Q

category 5

A

sterile risk level III
high risk levels

71
Q

category 6

A

radiopharmaceuticals

72
Q

category 7

A

vet

73
Q

Reference Resources for compounding

A
  • U.S. Pharmacopeia/National Formulary
  • FDA Regulations of Hospital Compounding
  • State Regulations of Compounding
  • National Association of Boards of Pharmacy
74
Q

nonsterile preparation components

A
  • Preparation
    – Official substance
    – Active ingredient
    -Added substances
    – Compounded preparation
75
Q

active ingredient

A

could be compounded prep

76
Q

Compounded preparation

A

compounded dosage forms
» compounded drugs
» compounded formulations

77
Q

abbreviations for sterile preparations

A
  • for container specifications (LR, W, T)
  • for solubility parameters (VS, FS, Sol, etc)
  • for drugs (Table 1-10)
78
Q

Many common abbreviations and notations may cause

A

errors or confusion

79
Q

which one is correct: 0.25mg or .25mg

A

0.25mg

80
Q

Terms used in prescription writing

A

Tables 1-12 and 1-13

81
Q

as (left ear) may be misread as

A

os (left eye)

82
Q

HS (bed time) may be misread as

A

half strength

83
Q

q.d (every day) may be misread as

A

q.i.d (four times a day

84
Q

MUg (microgram) may be misread as

A

mg (milligram)

85
Q

OD

A

right eye and once daily

86
Q

NC

A

no complaints and no code

87
Q

QOD

A

every other day (read as “every once a day”

88
Q

Abbreviated drug names that should not be used

A

6MP, 5 ASA, ddI, 5FU, PBZ, ARA A, ARA C, AZT, ASA, HCTZ, HCT, MS, MSO4 (shouldn’t be abbreviated for safety)

89
Q

All written prescription or medication orders must be

A

legible and abbreviation free

90
Q

All prescriptions and medication orders should be written using the

A

metric system

91
Q

Prescribers should provide

A

age and, when appropriate, the weight of the patient on the prescription order

92
Q

The prescriptions or medication order should include

A

the name of the drug, metric weight or concentration, and dosage form

93
Q

A leading zero should always precede a

A

decimal point in quantities less than one

94
Q

Prescription and medication orders should include

A

notation of purpose of the medication

95
Q

Prescribers should not use unclear or imprecise instructions such as

A

“Take as directed” or “Take as needed”

compounding exam 1 (5 decks)

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