PEBCs > Compounding - Low/Med Priority > Flashcards

Compounding - Low/Med Priority Flashcards

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1
Q

What is compounding?

A

the mixing or combining of >=2 ingredients (with >=1 being a drug or pharmacologically active component) to create a final product
-includes the preparation, mixing, assembling, packaging and labelling of safe and effective medicines for immediate use

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2
Q

When should compounding be done?

A

if there is a therapeutic need or lack of product availability

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3
Q

What kind of technique is required for sterile compounding?

A

aseptic

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4
Q

Who sets compounding model standards?

A

NAPRA
-non-sterile compounding
-non-hazardous sterile compounding
-hazardous sterile compounding

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5
Q

What do the NAPRA model standards for compounding include information on?

A

compounding facility
personnel
risk assessments
quality assurance
compliance
competencies

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6
Q

What is non-sterile compounding?

A

occurs when medications are prepared in a non-sterile environment whilst maintaining the products integrity

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7
Q

What is sterile compounding?

A

occurs when medications are prepared in an environment that prevents contamination

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8
Q

What are examples of sterile compounding?

A

topical creams
topical ointments
oral medications

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9
Q

What are examples of sterile compounds?

A

nasal inhalation solutions
respiratory therapy solutions
injections (e.g. IM, IV, intrathecal, intradermal, SC)
irrigation solutions for wounds and body cavities
ophthalmic drops and ointments
otic drops
parenteral nutrition
dialysis solutions
allergen extracts
topical preparations where sterility is required
radiopharmaceuticals

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10
Q

Which PPE is optional for non-sterile compounding?

A

face masks
-unless the substance is hazardous

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11
Q

Which PPE should be worn for most non-sterile compounding?

A

gloves and gown

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12
Q

Which PPE should be worn for non-sterile compounding when compounding hazardous preparations?

A

hair, beard, and shoe covers
face masks

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13
Q

When is eye protection required for non-sterile compounding?

A

if there is a risk of splashing or powder exposure

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14
Q

What is the use of oral liquid vehicles?

A

dilute drugs to a suitable volume for proper dosing, adherence, and stability

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15
Q

What kind of water is used for injections?

A

pyrogen-free distilled water

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16
Q

What are the four different compounding techniques in non-sterile compounding?

A

eutetic
levigation
trituration
geometric dilution

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17
Q

What is the eutetic technique?

A

solid + solid = liquid

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18
Q

What is the levigation technique?

A

powder + liquid = liquid or thin paste

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19
Q

What is the trituration technique?

A

grinding of powder(s) with a mortar and pestle

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20
Q

What is geometric dilution?

A

used when mixing a small amount of a drug with a large amount of another ingredient or diluent
-the drug present in a smaller quantity is placed in the mortar with an equal amount of the other ingredient then the two materials are triturated until they are well mixed

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21
Q

What are some important safety precautions to be taken in non-sterile compounding?

A

clean spillages right away to reduce harm
protect from dust, pollen, mould, bacteria, smoke, asbestos
use dust-resistant safety goggles
disposable gowns
proper safety gloves
proper safety shoes
filters must be certified
laminar air flow hoods

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22
Q

Describe the facility design for sterile compounding.

A

buffer zone –> anteroom –> sterile compounding room

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23
Q

What is the role of the primary engineering control?

A

ensures a safe air quality environment, providing unidirectional (laminar) air flow in the work area

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24
Q

What is the role of a HEPA filter?

A

removes nearly all bacteria from air and prevents entry of contaminated room air into hood

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25
Describe horizontal air flow.
air circulates from back to front used for most sterile IV preparations order of cleaning: walls and floors should be back to front place objects next to each other
26
Describe vertical air flow.
air circulates from top down used for chemotherapy and hazardous agents since air flows away from the person order of cleaning: walls should be top down, floor should right to left on surface
27
What is used to clean sterile rooms?
70% IPA
28
What is the PPE required for sterile compounding?
pair of shoe covers or dedicated shoes hair cover beard cover surgical mask non-shedding gowns enclosed at the neck with sleeves that fit snuggly around the wrists pair of non-powdered sterile gloves which cover the cuffs of gown
29
What should be done prior to entering the anteroom?
remove all personal outer garments remove jewelry and personal electronic devices remove all cosmetics tie up long hair remove nail polish and other nail applications ensure skin of hands and forearms is undamaged change into low-shedding apparel wear pants that fully cover the legs, closed shoes, and socks wash hands
30
Describe proper conduct while in the controlled areas.
food items, drinks, chewing gum, candy, and cigarettes are prohibited all access doors must be kept closed access to controlled areas is restricted to certain personnel only essential conversations are allowed
31
Describe the garbing procedure while in the anteroom.
while on "dirty" side of demarcation line: -don hair net, then beard cover, then face mask whilst stepping over the demarcation line to "clean" side: -don shoe covers under warm running water, use nail pick to remove debris under fingernails, wash hands, and forearms -dry with disposable, lint-free towel apply alcohol-based hand rub don a gown (closed at the neck and elastic cuffs) don sterile gloves shoe covers or dedicated shoes required at all times in clean area of anteroom and clean room
32
How often must dedicated shoes be cleaned and disinfected?
once a week
33
How many pairs of gloves are required for hazardous products?
two pairs
34
What should be done after cleaning and disinfecting in the sterile room?
document in the maintenance log
35
How is hood cleaned in the sterile room?
lint-free sterile wipes and 70% IPA
36
How long should the hood be allowed to run before use in the sterile room?
30 minutes
37
How far should materials be placed into the hood?
at least 6 inches
38
Describe doffing PPE in the anteroom after leaving the sterile room.
while on dirty side of demarcation line: -remove gloves (avoid touching outer part) -remove gown (pull away from body and roll in ball) -remove mask -remove shoe covers -hand hygiene
39
When are drugs considered to be hazardous?
when they possess >=1 of the following characteristics: -carcinogenicity -teratogenicity or other developmental toxicity -reproductive toxicity -serious organ toxicity at low doses -genotoxicity
40
What are the two main classifications of hazardous drugs?
cytotoxic hazardous drugs non-cytotoxic hazardous drugs
41
Describe cytotoxic hazardous drugs.
detrimental/destructive to cells in the body such agents are commonly used for cancer treatments associated with the highest risk of harm in the event of occupational exposure
42
Describe non-cytotoxic hazardous drugs.
medications (other than cytotoxic) that adversely affect the reproductive system, endocrine system, immune system, respiratory system, or can transmit infection associated with possible risk of harm in the event of occupational exposure
43
What are examples of cytotoxic drugs?
azathioprine bleomycin cisplatin cyclophosphamide docetaxel doxorubicin fluorouracil gemcitabine hydroxyirea idarubicin methotrexate mercaptopurine
44
What are examples of drugs with reproductive risk?
anastrozole dutasteride finasteride divalproex/VPA isotretinoin/tretinoin misoprostol testosterone warfarin topiramate
45
What are examples of standard hazardous risk drugs?
carbamazepine/oxcarbazepine cyclosporine estrogen/progesterone leflunomide letrozole levonorgestrel phenytoin mycophenolate methimazole & PTU tacrolimus thalidomide & lenalidomide spironolactone
46
What is pharmaceutical waste?
pharmaceutical products that are expired or otherwise no longer usable
47
Describe proper hazardous waste management.
medications and sharp or pointed instruments are to be disposed of safety medications that will be destroyed must be stored in a location separate from other medications a procedure must be implemented for destruction of pharmaceutical waste
48
How must hazardous waste containers be identified?
with a self-adhesive label marked "Hazardous waste - cytotoxic"
49
How much can hazardous waste containers be filled?
only to 3/4 of their capacity and then sealed
50
Where should PPE be discarded?
hazardous waste container
51
How should commercial products used for preparations be stored?
stored immediately upon receipt in a manner that prevents cross-contamination and incompatibilities -product storage specified by the manufacturer must be strictly observed, regardless of where products are stored
52
What should be done with compounded products before use?
inspected for evidence of deterioration
53
What colour of bottles should be used for compounded products?
amber -protect from light
54
What must be presented on the compounded product?
storage conditions expiry date
55
What is shelf life?
determines how long a product can be on the shelves in the dispensary -medications have different physical, chemical, and bacterial properties which affect deterioration rates
56
What is the BUD?
refers to the date after which a non-sterile preparation should not be used -dependent on literature and documentation on the specific stability of the active ingredient
57
What is the BUD of non-sterile preparations?
non-aqueous: -does not surpass earliest expiry date of ingredients or 6 months (whichever is earlier) water-containing oral formulation: -cannot exceed more than 14 days water-containing dermal/topical: -BUD cannot exceed more than 30 days
58
What is the BUD of a single-dose vial?
if the vial is punctured, the BUD is 6 hrs if removed from hood, discard immediately *affix a label to the vial indicating time of puncture*
59
What is the BUD of an open ampoule?
no storage is permitted, therefore, no BUD applies
60
What is the BUD of a multiple-dose container?
28 days unless otherwise specified -usually contains a preservative
61
Describe the different contamination risk levels for sterile preparations.
low: -drug prepared for one pt, simple aseptic transfer technique, final product compounded using up to 3 sterile units medium: -batch preparations, complex manipulations, prolonged preparation time, final product compounded using >= 4 sterile units high: -non-sterile ingredients used before terminal sterilization, improper garbing by personnel
62
What is a sterile unit?
a vial, ampoule or bag of drug, or diluent
63
What is the BUD of sterile preparations without sterility testing?
low risk of contamination: -at controlled room temp: 48 hrs -with storage in fridge: 14 days -with storage in freezer: 45 days medium risk of contamination:; -at controlled room temp: 30 hrs -with storage in fridge: 9 days -with storage in freezer: 45 days high risk of contamination: -at controlled room temp: 24 hrs -with storage in fridge: 3 days -with storage in freezer: 45 days
64
What are the labelling requirements for compounded products?
pharmacy identification drug identification (API, [ ], form, route of admin, amount) overfill volume (sterile) special precautions and storage (AUX labels) date when sterile prep was compounded BUD preparation batch number all info required by P/T
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