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PKPD II > Compounding Final > Flashcards

Compounding Final Flashcards

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1
Q

Define sterility and aseptic technique

A

complete absence of viable microorganisms

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2
Q

Identify points in CSP where contamination can occur

A

nonsterile ingredients, process water, packaging components, process equipment, compounding personnel

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3
Q

List routes of medication that require sterile preparation

A

IV, IA, IM, IT, epidural, ID, SC/SQ, ophthalmic, intranasal/inhalation, some ointments/otic/vaginal preps

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4
Q

Perform hand hygiene/garbing procedures in accordance with USP <797>

A

wash with soap and water up to forearms, no brushes/hand dryers/closed soap systems, alcohol-based (7-% IPA) sanitizing with sterile powder-free gloves

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5
Q

ISO Class distinctions?

A

ante-room = 8, buffer/cleanroom = 7, LAFW = 5

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6
Q

what are restricted-access barrier systems (RABS)

A

HEPA ISO Class 5 sealed hoods (glove manipulation)

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7
Q

immediate use CSPs cannot involve more than?

A

three different sterile products

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8
Q

Category 1 CSPs

A

ISO class 5 or better

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9
Q

Category 2 CSPs

A

prepared in a cleanroom suite

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10
Q

Category 3 CSPs

A

undergo sterility testing

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11
Q

Storage condition temperature ranges

A

controlled room temperature (20-25), refrigerator (2-8), freezer (-25 to -10)

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12
Q

BUD administration

A

cannot begin past BUD but if infusion is started BUD does not limit finishing it

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13
Q

core competencies for individuals working in sterile compounding

A

visual observation of hand hygiene and garbing, gloved fingertip and thumb sampling, media fill testing

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14
Q

Master formulary requirement situations

A

CSPs prepared from nonsterile ingredients, prepared for multiple patients

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15
Q

viable air sampling occurs

A

1/2 = 6mo, 3 = 1mo

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16
Q

surface sampling occurs

A

1/2 = 1mo, 3 = 1wk

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17
Q

chapters removed from 797

A

USP 800 = handling of hazardous drugs, 825 = radiopharmaceuticals

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18
Q

What does IV piggyback fall under?

A

IV intermittent

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19
Q

advantages of peripheral and central venous access devices

A

peripheral = convenient/easy to place, minimal adverse effects; central = fewer limitations on what can be infused, long-term

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20
Q

disadvantages of peripheral and central venous access devices

A

peripheral = limitations on what can be infused, short-term; central = requires trained personnel or sedation, can cause complications (infections)

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21
Q

vesicant example and steps to prevent extravasation

A

catecholamines, chemo agents, calcium salts; stop IV fluids/disconnect, aspirate residual drug from cannula, antidotes, elevation of limbs, local cooling/warming to site

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22
Q

examples of central venous catheters?

A

PICC, tCVC, mediport

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23
Q

what can cause phlebitis? (3)

A

catheter tip slipping out, passing through vein wall, medication leaks into surrounding tissue

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24
Q

physical incompatibility signs (4)

A

change in color, formation of turbidity, precipitation, evolution of a gas

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25
chemical incompatibility signs
>10% loss of intact drug within 24hrs
26
factors causing fluid incompatibilities?
pH (PRIMARY), salt form, formulation
27
Methods for provision of parenteral nutrition?
peripheral max 900mOsm, central higher dextrose concentrations
28
Calories from each macronutrient?
AA = 4, carbs = 3.4, fats = 9
29
Describe safe practices for ordering and processing of parenteral nutrition?
maximize decision support (infusion pump limits, dose range checking in software), time limits on ordering and standardized hang-time
30
units for %w/v?
grams per 100 mL
31
units for %w/v?
grams per 100 mL
32
most stable concentration for each component of TPN?
dextrose > 10%, AA >4%, lipid >2%
33
which type of emulsion is still stable and safe to administer?
creamed NOT CRACKED
34
what size filter for lipid emulsions?
>/= 1.2 micrometers
35
ILEs should always be provided over how many hours?
12-24 hrs
36
What factors affect calcium phosphate precipitation? (5)
concentration (dose), salt form, temp, pH, storage time
37
NIOSH list drugs table 1?
know carcinogens, antineoplastics
38
NIOSH list drugs table 2?
everything else, uncertain
39
role of USP <800>?
provides standards for safe handling of hazardous drugs - sterile and nonsterile (protects healthcare workers)
40
what is outside of the scope of <800>?
administration, dispensing
41
types of containment primary engineering controls? (3)
containment ventilated enclosures (CVE), biological safety cabinet (BSC), compounding aseptic containment isolator (CACI)
42
what is the containment secondary engineering control? What must it have?
the room that houses the C-PEC; negative pressure
43
how many air changes per hour for nonsterile in C-SEC? for sterile?
12, 30
44
for sterile hazardous drug compounding, what ISO class is necessary?
class 7
45
what is a closed system transfer device?
drug transfer device that mechanically prohibits transfer of contaminants into or out of the system
46
when should you wear PPE with HDs? Can you reuse any?
always; never
47
how many gloves should be worn with HDs? How often should you change them?
2 pairs, every 30 minutes or when damaged
48
how often should you change gowns?
every 2-3 hours or after spill/splash
49
deactivating definition
renders compound inert or inactive (peroxide, sodium hypochlorite)
50
decontamination definition
removes HD residue (water, alcohol, peroxide, sodium hypochlorite)
51
cleaning definition
removes organic and inorganic material (germicidal detergent)
52
disinfection definition
destroys microorganisms (EPA-registered disinfectant and/or sterile alcohol as appropriate
53
role of filters in sterile compounding
remove particles from solutions
54
which medications require filtration?
amphotericin B, infliximab
55
ROAs for meds that require sterile compounding (4)
intranasal, inhalation, meds used to irrigate, ophthalmic
56
ROAs for meds that require sterile compounding and no preservatives? (2)
epidural, intrathecal
57
explain procedure for garbing?
remove jewelry/accessories, shoes covers to cross line of demarcation, face mask head/hair covers, wash hands 30s, don gown, enter cleanroom, use alcohol on hands then place gloves and disinfect again with alcohol
58
how to clean the hood in a LAFW?
top, hanging pole (gripping motion), sides, bottom; new wipe for each
59
what are LVP solutions?
containers holding 100 mL or more
60
plastic LVP advantages? Disadvantages?
don't break, weigh less, easier to store/dispose; adsorption, leaching PVC, puncture easily
61
glass LVP advantages? Disadvantages?
easy to inspect contents; breakable, challenging to store/dispose
62
what is the difference between single and multidose vials?
single have no preservatives!
63
explain needle sizes (length and gauge meaning)?
length = how long; gauge = size (higher gauge = smaller)
64
purpose/examples of preservatives?
inhibit microbial growth; benzalkonium chloride, alcohol, chlorbutanol, thimerosal
65
purpose/examples of antioxidants?
prevent oxidation; ascorbic acid, sodium bisulfite, phosphoric acid
66
purpose/examples of buffers?
ensure/maintain drug solubility; sodium citrate, acetic acid, sdoium bicarbonate
67
purpose/examples of solubilizing agents?
increase drug solubility; non-aqueous solvents (polyethylene glycol, glycerin, ethyl alcohol
68
purpose/examples of chelating agents?
inactivates metals that catalyze drug degradation; EDTA
69
purpose/examples of inert gases?
enhance integrity of oxygen-sensitive meds by displacing air in solution; nitrogen, argon

PKPD II (2 decks)

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