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542 sterile compounding > Final exam > Flashcards

Final exam Flashcards

1
Q

What should you never do when working with chemotherapy?

A

-take used materials directly out of the hood
-reuse anything

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2
Q

Who does USP 800 apply to?

A

Pharmacists, pharmacy technicians, nurses, physicians, physician
assistants, home healthcare workers, vets, and vet technicians

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3
Q

Who does USP 800 NOT apply too?

A

Manufacturers; Wholesale Personnel; Researchers; Family

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4
Q

List of hazardous drugs

A

-type of HD: antineoplastic, non-antineoplastic, reproductive risk
-Dosage form
-risk of exposure
-packaging
-manipulation

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5
Q

What designated areas MUST be available for HDs?

A

-receipt and unpacking
-storage
-non-sterile compounding
-sterile compounding

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6
Q

Where must HDs be unpacked?

A

with neutral/negative pressure

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7
Q

Where must HDs be stored?

A

-must be stored in a manner to prevent spillage/breakage
-HDs requiring manipulation
stored separately: externally vented, negative pressure

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8
Q

RABS

A

-must follow USP 795 and 797
-should use closed system drug transfer device (CSTD) for compounding

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9
Q

Hazardous C-SEC

A

-The room
-must be externally vented
-physically separated
-negative pressure
-eye wash station: within 10 seconds

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10
Q

What USP standard does non sterile hazardous compounding follow?

A

795

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11
Q

How often should environmental quality and control samples be done?

A

-routinely
-initially than every 6 months
-$400 per sample per drug

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12
Q

PPE for handling HDs

A

-receipt
-storage
-transport
-compounding
-administration
-deactivation/decontamination
-spill control
-waste disposal

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13
Q

HD gowns

A

-disposable
-polyethylene or laminate
-close in the back

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14
Q

HD gloves

A

2 pairs

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15
Q

HD shoe covers

A

-2 pairs
-remove outer when leaving
-anti skid

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16
Q

HD spill protection

A

-eye protection
-powered air purifying respirator

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17
Q

Hazard communication program

A

-OSHA required
-all containers must be labeled
-must have SDS for each chemical
-SDS must be available
-Personnel must be provided information and training before job
-women must confirm in writing that they understand the risks of handling HDs

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18
Q

HD Personnel training

A

-must be trained based on job functions
-must be assessed every 12 months
-must be trained on new HDs and equipment
-must document competencies

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19
Q

True or false: Antieoplastics may be placed in automated counting/packaging machines

A

False. MUST NOT
-ok for automated dispensing cabinets

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20
Q

best practices for HD compounding

A

-use a CSTD for sterile compounding
-use a chemo mat
-MUST dedicate equipment to HDs

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21
Q

Administration of HDs

A

-must use CSTDs or protective medical devices
-must pre prime IV tubing with non HD solution
-must wear PPE
-must avoid manipulation

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22
Q

spill control of HDs

A

-must have proper training
-spill kits available
-dispose materials as hazardous waste
-address size of spills

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23
Q

How often is the standard operating procedure reviewed?

A

every 12 months

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24
Q

What makes waste hazardous?

A

-ignitability, corrosivity, reactivity, and toxicity

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25
Q

carbohydrate

A

3.4 kcal/gm

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26
Q

protein

A

4 kcal/g
-maintenance: 1 g/kg/day
-more under stress

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27
Q

lipid emulsions

A

10 kcal/g

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28
Q

When should actual weight be used rather than IDW for TPN?

A

-pt is under weight or ideal weight

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29
Q

TPNs for severely underweight pts

A

-actual weigh initially
-gradually increase in nutrition doesn’t increase
-upper limit of 35 kcal/kg/day

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30
Q

TPNs for overweight patients

A

-adjusted body weight
-25 kcal/kg may overestimate requirments

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31
Q

Adjusted body weight

A

(actual weight-ideal weight)/2 + ideal

-ideal weight calculated using Hamwi equation

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32
Q

Hamwi Equation: Men

A

48.1 kg (first 152.4 cm) + 2.72 kg (in)

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33
Q

Hamwi Equation: women

A

45.4 kg (first 152.4 cm) + 2.27 kg (in)

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34
Q

Peripheral Parenteral Nutrition (PPN)

A

-Fluid restriction NOT possible
-avoids central catheter related complications
-high amount of kcal/protein in short amount of time

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35
Q

Total Parenteral Nutrition (TPN)

A

-long term
-fluid restriction
-large amounts of nutrients can be supplied

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36
Q

flow rate for dextrose solutions

A

no higher than 0.36 g/kg/hr

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37
Q

micronutrients in TPN

A

-water and fat soluble
-vitamin K should be given: Coagulopathy

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38
Q

adult fluid needs TPN

A

35 ml/kg/day
-not all in TPN

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39
Q

4 ethical principles relevant to artificial nutrition and hydration

A

-Autonomy
-Beneficence
-Non-maleficence
-Justice

“All badger must jump”

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40
Q

3 prerequisites of artificial nutrition

A

1)indication of medical treatment: beneficence
2) the definition of a therapeutic goal to be achieved AND: nonmalefiecence
3) the will of the patient and his/her informed consent: Autonomy

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41
Q

distributive justice

A

Resources have to be distributed
fairly without any discrimination

42
Q

procedural justice

A

In regard to limited resources, there has to be proper use of ethically appropriate
and transparent criteria

43
Q

Discuss how the three prerequisites of artificial nutrition and hydration are related to the
discontinuation of this therapy

A

TPN should be discontinued when the 3 prerequisites are no longer met

44
Q

Medical Intervention and what ethical principle applies

A

-have to use a device
-trained personnel

-BENEFICENCE

45
Q

Medical Indications

A

-beneficial
-prolong life
-short term critical care
-GI disease
-Do NOT use PN solely on medical diagnosis of disease state

-BENEFICENCE

46
Q

Harm may outweigh benefits

A

-end stage dementia
-palliative care for cancer

47
Q

Beneficence and nonmaleicence as a healthcare provider

A

-if the harm outweighs the good, you are obligated to not provide therapy (TPN)

48
Q

Family perspective around food

A

-psychological benefit
-give comfort, dignity, quality of life

49
Q

Therapeutic goals

A

-realistic goal
-prolong or preserve life
-enhance quality of life
-some believe patient comfort is NOT an appropriate goal

50
Q

Informed consent

A

-informed about the nature, significance and scope of the
measure, including potential complications and risks
-patient has the right to refuse treatment

51
Q

Informed consent elements

A

-competence
-disclosure
-understanding
-voluntariness
-consent

52
Q

Will of the patient

A

-Autonomy does not mean that a patient has the
right to obtain every treatment he or she wishes or
requests
-decision needs to be respected

53
Q

how to distribute scarce resources

A

-triage committees
-protocols
-management of limited resources

54
Q

Biodegradable polymers

A

-lactic acids
-glycolic acids
-caprolactone

-all have ester back bones

55
Q

First order release systems

A

-peak release
-slow

hydrogel,microneedle

56
Q

zero order kinertics

A

-levels out over time
-ex) vaginal ring

57
Q

contraceptive implant

A

-lasts years with zero order kinetics
-non biodegradable
-has to be removed

58
Q

surface degradation

A

-drug release rate is proportional to surface area
-Hydrophobic molecule in backbone
-zero order drug release
-ex) Gliadel wafer contains chemo

59
Q

bulk degradation

A

-poly glycolic acid
-2 different chiral centers with different release kinetics
-water breaks ester bonds

60
Q

poly glycolic acid (PGA) properties

A

-achiral
-highly crystallized
-degrades over 2-3 months

61
Q

poly lactic acid (PLA) L and D form

A

-crystallize
-hydrophobic
-degrades over 2 years
-used in drug delivery systems

62
Q

peptide

A

-short chain of amino acids
-linked by amide bonds
-2-50 amino acids
-poor oral and plasma availability
-peptidase mediated hydrolysis

63
Q

Risperidone inj. (consta) release time

A

-microparticles
-0.5 months

64
Q

Lupron Depot release time

A

-microparticles
-1, 3, 4 month formulations

65
Q

Why is it easier to formulate peptide than proteins?

A

-peptides are smaller and don’t fold
-proteins need to fold in order t function

66
Q

in situ forming depot

A

-drug is in a polymeric get
-injected into skin
-liquid dissipates leaving depot

67
Q

PLGA

A

-amorphous
-degrades 1-6 months
-sutures, microspheres, implants

68
Q

short acting insulin

A

-onset in 30 min-1 hour

69
Q

rapid onset insulin

A

-insulin lispro
-15 minutes

70
Q

intermediate acting insulin

A

-NPH
-1-1.5 hours

71
Q

regular insulin

A

-beef, pork, or human
-hexameric, complexed with zinc: needs to break up before its absorbed
-neutral pH more stable than original acidic form

72
Q

Isophane insulin suspension (NPH)

A

-NEUTRAL PROTAMINE HAGEDORN
sodium phos buffer
-zinc-insulin crystals modified from addition of pprotamine
-30 um length
-intermediate acting

73
Q

Mixed insulin

A

-two forms: 70/30 and 50/50
-50/50 has faster absorption

74
Q

Insulin glargine

A

-long acting
-acidic
-precipitates: hexamers…

75
Q

Lipohypertrophy

A

-buildup of fibrous tissue after continual injection in the same spot
-tissue is spongy and avascular
-rotate sites!

76
Q

SC absorption of insulin

A

-fastest from abdomen>arms>legs>butt

77
Q

primary structure

A

amino acid sequence

78
Q

secondary structure

A

-alpha helix
-b pleated sheets

79
Q

tertiart structure

A

-folding into native conformation

80
Q

quanternary

A

1 or more teriary structures
-active structure

81
Q

Biologics

A

-supplement natural proteins
-refrigerate
-large, complex

82
Q

Consequences of immunogenicity

A

-Neutralizations: block binding of drug
-Accelerated clearance
-Adverse reactions: shaking bed syndrome, delayed hypersensitivity, anaphylaxis

83
Q

biologics stability factors

A

-pH
-ionic strength
-temp
-O2

84
Q

amino acid associated with deamidation?

A

Asn
Gin

85
Q

amino acid associated with cleavage?

A

Asp-X

86
Q

amino acid associated with oxidation

A

Met
cys
His
Trp
Tyr

87
Q

amino acid associated with thiol disulfide exchange

A

Cys

88
Q

Physical stability of biologics

A

-conformational change
-aggregation
-adsorption

89
Q

racemization

A

L to D form as we age

90
Q

cleavage

A

-with water at amide

91
Q

thiol disulfide exchange

A

-free thiol
-chain reaction
-aggregation

92
Q

denaturation

A

protein unfolding
-heating, pH, detergent, solvent
-partial, or complete
-can be reversible or irreversible

93
Q

true or false: hydrophobic interactions drive protein folding

A

true

-acids will unfold proteins

94
Q

aggregation

A

-formation of abnormal soluble aggregates of peptides
-chemical and/or physical
-high conc
-loss of activity
-precipitation

95
Q

protein adsorption

A

-air/water, solid/water interfaces
-often irreversible
-reduce with LIKE CHARGES
-add surfactants to prevent

96
Q

antibodies ranked by immunogenicity(highest)

A

human>humanized>chimeric>murine

97
Q

cloning and protein expression

A

-target DNA
-cloning into DNA vector
-transfer into host cell

98
Q

biologics preparation

A

-reconstitution can denature proteins
-diluent is critical
-proteins may adsorb onto plastic and glass
-dosing based on units of activity

99
Q

expiration date for biologics after reconstitution(2-8C)

A

up to 30 days

-except activase (8 hours)

100
Q

types of proteins removed by kidneys?

A

small
-large proteins removed by liver

101
Q

biosimilar

A

-biologic generic
-similiar to reference product

542 sterile compounding (3 decks)

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