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PKPD II > Compounding Final > Flashcards

Compounding Final Flashcards

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
Q

chemical incompatibility signs

A

> 10% loss of intact drug within 24hrs

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26
Q

factors causing fluid incompatibilities?

A

pH (PRIMARY), salt form, formulation

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27
Q

Methods for provision of parenteral nutrition?

A

peripheral max 900mOsm, central higher dextrose concentrations

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28
Q

Calories from each macronutrient?

A

AA = 4, carbs = 3.4, fats = 9

29
Q

Describe safe practices for ordering and processing of parenteral nutrition?

A

maximize decision support (infusion pump limits, dose range checking in software), time limits on ordering and standardized hang-time

30
Q

units for %w/v?

A

grams per 100 mL

31
Q

units for %w/v?

A

grams per 100 mL

32
Q

most stable concentration for each component of TPN?

A

dextrose > 10%, AA >4%, lipid >2%

33
Q

which type of emulsion is still stable and safe to administer?

A

creamed NOT CRACKED

34
Q

what size filter for lipid emulsions?

A

> /= 1.2 micrometers

35
Q

ILEs should always be provided over how many hours?

A

12-24 hrs

36
Q

What factors affect calcium phosphate precipitation? (5)

A

concentration (dose), salt form, temp, pH, storage time

37
Q

NIOSH list drugs table 1?

A

know carcinogens, antineoplastics

38
Q

NIOSH list drugs table 2?

A

everything else, uncertain

39
Q

role of USP <800>?

A

provides standards for safe handling of hazardous drugs - sterile and nonsterile (protects healthcare workers)

40
Q

what is outside of the scope of <800>?

A

administration, dispensing

41
Q

types of containment primary engineering controls? (3)

A

containment ventilated enclosures (CVE), biological safety cabinet (BSC), compounding aseptic containment isolator (CACI)

42
Q

what is the containment secondary engineering control? What must it have?

A

the room that houses the C-PEC; negative pressure

43
Q

how many air changes per hour for nonsterile in C-SEC? for sterile?

A

12, 30

44
Q

for sterile hazardous drug compounding, what ISO class is necessary?

A

class 7

45
Q

what is a closed system transfer device?

A

drug transfer device that mechanically prohibits transfer of contaminants into or out of the system

46
Q

when should you wear PPE with HDs? Can you reuse any?

A

always; never

47
Q

how many gloves should be worn with HDs? How often should you change them?

A

2 pairs, every 30 minutes or when damaged

48
Q

how often should you change gowns?

A

every 2-3 hours or after spill/splash

49
Q

deactivating definition

A

renders compound inert or inactive (peroxide, sodium hypochlorite)

50
Q

decontamination definition

A

removes HD residue (water, alcohol, peroxide, sodium hypochlorite)

51
Q

cleaning definition

A

removes organic and inorganic material (germicidal detergent)

52
Q

disinfection definition

A

destroys microorganisms (EPA-registered disinfectant and/or sterile alcohol as appropriate

53
Q

role of filters in sterile compounding

A

remove particles from solutions

54
Q

which medications require filtration?

A

amphotericin B, infliximab

55
Q

ROAs for meds that require sterile compounding (4)

A

intranasal, inhalation, meds used to irrigate, ophthalmic

56
Q

ROAs for meds that require sterile compounding and no preservatives? (2)

A

epidural, intrathecal

57
Q

explain procedure for garbing?

A

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
Q

how to clean the hood in a LAFW?

A

top, hanging pole (gripping motion), sides, bottom; new wipe for each

59
Q

what are LVP solutions?

A

containers holding 100 mL or more

60
Q

plastic LVP advantages? Disadvantages?

A

don’t break, weigh less, easier to store/dispose; adsorption, leaching PVC, puncture easily

61
Q

glass LVP advantages? Disadvantages?

A

easy to inspect contents; breakable, challenging to store/dispose

62
Q

what is the difference between single and multidose vials?

A

single have no preservatives!

63
Q

explain needle sizes (length and gauge meaning)?

A

length = how long; gauge = size (higher gauge = smaller)

64
Q

purpose/examples of preservatives?

A

inhibit microbial growth; benzalkonium chloride, alcohol, chlorbutanol, thimerosal

65
Q

purpose/examples of antioxidants?

A

prevent oxidation; ascorbic acid, sodium bisulfite, phosphoric acid

66
Q

purpose/examples of buffers?

A

ensure/maintain drug solubility; sodium citrate, acetic acid, sdoium bicarbonate

67
Q

purpose/examples of solubilizing agents?

A

increase drug solubility; non-aqueous solvents (polyethylene glycol, glycerin, ethyl alcohol

68
Q

purpose/examples of chelating agents?

A

inactivates metals that catalyze drug degradation; EDTA

69
Q

purpose/examples of inert gases?

A

enhance integrity of oxygen-sensitive meds by displacing air in solution; nitrogen, argon

PKPD II (2 decks)

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