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compounding exam 1 > intro > Flashcards

intro Flashcards

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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
water for non sterile products in compounding facilities
Purified water must be used when formulations indicate the inclusion of water and must also be used for rinsing equipment and utensils
26
____ for injection
sterile water and bacteriostatic
27
The equipment part deals essentially with
Weights and Balances, Prescription Balances, and Volumetric Apparatus
28
The equipment should be of _____ for compounding
appropriate design and size
29
The equipment should be ______ at appropriate intervals to ensure the accuracy and reliability of their performance
inspected, cleaned, maintained, and validated
30
The USP defines stability as
“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”
31
chemical stability
each active ingredient retains its chemical integrity and labeled potency within the specified limits
32
physical stability
appearance, palatability, uniformity, dissolution, and suspendibility are retained
33
microbio stability
sterility or resistance to microbio growth (antibmicrobio agents retain effectiveness)
34
therapeutic stability
unchanged therapeutic effect
35
toxicological stability
no increase in toxicity
36
The USP requires that compounded preparations should be packaged in
containers that meet USP standards
37
Primary packaging
The container is that which holds the compounded preparation and is or may be in direct contact with the compounded preparation
38
is the closure part of the container
yes
39
Four types of containers
light resistant container, well-closed container, tight container, hermetic container
40
Stability of Compounded Preparations
primary packaging sterility stability packaging guidelines for BUD for compounding preparations storage temps
41
freezer temps (C)
between -25 and -10
42
cold temps (C)
between 2 and 8
43
cool temps (C)
between 8 and 15
44
room temps (C)
temp in the working area
45
controlled room temps (C)
between 20 and 25
46
warm temps (C)
between 30 and 40
47
excessive heat temps (C)
above 40
48
protect from freezing temps (C)
store above 0
49
refrigerator temps (C)
between 2 and 8
50
freezer temps (F)
between -13 and -14
51
cold temps (F)
between 36 and 46
52
cool temps (F)
between 46 and 59
53
controlled room temps (F)
between 68 and 77
54
warm temps (F)
between 86 and 104
55
excessive heat temps (F)
above 104
56
protect from freezing temps (F)
store above 32
57
refrigerator temps (F)
between 36 and 46
58
The USP uses the term “beyond-use date” as the date after which
a compounded preparation should not be use (determined from the date the preparation is compounded)
59
BUD for nonaq formulations
not later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient or 6 months, whichever is earlier
60
Water-containing oral formulations BUD
not later than 14 days when stored at controlled cold temperatures
61
Water-containing topical/dermal and mucosal liquid and semisolid formulations BUD
no later than 30 days
62
Chapter 1075 of the USP classifies pharmaceutical compounding into ____categories
7 (to provide the compounding personnel an understanding when different forms of preparations are compounded)
63
Categories 1 and 2
non sterile compounding
64
Categories 3, 4, and 5
deal with compounding of sterile products and risk levels associated with them.
65
Categories 6 and 7
radio-pharmaceuticals and veterinary compounding
66
category 1
nonsterile simple mixing of 2+ commercial products
67
category 2
nonsterile- complex compounding with the bulk drug substances when calcs are required
68
category 3
sterile: Risk Level 1 low risk level
69
category 4
sterile risk level II medium levels
70
category 5
sterile risk level III high risk levels
71
category 6
radiopharmaceuticals
72
category 7
vet
73
Reference Resources for compounding
- U.S. Pharmacopeia/National Formulary - FDA Regulations of Hospital Compounding - State Regulations of Compounding - National Association of Boards of Pharmacy
74
nonsterile preparation components
- Preparation – Official substance – Active ingredient -Added substances – Compounded preparation
75
active ingredient
could be compounded prep
76
Compounded preparation
compounded dosage forms » compounded drugs » compounded formulations
77
abbreviations for sterile preparations
- for container specifications (LR, W, T) - for solubility parameters (VS, FS, Sol, etc) - for drugs (Table 1-10)
78
Many common abbreviations and notations may cause
errors or confusion
79
which one is correct: 0.25mg or .25mg
0.25mg
80
Terms used in prescription writing
Tables 1-12 and 1-13
81
as (left ear) may be misread as
os (left eye)
82
HS (bed time) may be misread as
half strength
83
q.d (every day) may be misread as
q.i.d (four times a day
84
MUg (microgram) may be misread as
mg (milligram)
85
OD
right eye and once daily
86
NC
no complaints and no code
87
QOD
every other day (read as “every once a day”
88
Abbreviated drug names that should not be used
6MP, 5 ASA, ddI, 5FU, PBZ, ARA A, ARA C, AZT, ASA, HCTZ, HCT, MS, MSO4 (shouldn't be abbreviated for safety)
89
All written prescription or medication orders must be
legible and abbreviation free
90
All prescriptions and medication orders should be written using the
metric system
91
Prescribers should provide
age and, when appropriate, the weight of the patient on the prescription order
92
The prescriptions or medication order should include
the name of the drug, metric weight or concentration, and dosage form
93
A leading zero should always precede a
decimal point in quantities less than one
94
Prescription and medication orders should include
notation of purpose of the medication
95
Prescribers should not use unclear or imprecise instructions such as
“Take as directed” or “Take as needed”

compounding exam 1 (5 decks)

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