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NAPLEx > compounding I: basics > Flashcards

compounding I: basics Flashcards

1
Q

U.S Pharmacopeia

A

sets the standard for compounding preperations.

795 for non-sterile
797 for sterile

+800 if it is hazard..

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2
Q

non-sterile compounding

A
  • prepare a dose or formulation taht is not commercially available: such as
    —> Changing a solid tab to liquid
    —> compounding an ointment 10% when only 5% and 15% available
  • avoid an excipient (ex. dye, gluten)
  • add a flavor to med

non-sterile prep admin include: by mouth, via tube, rectally, vaginally, topically, nasally or in the ear

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3
Q

USP 795 divides non-sterile compounding into three categories based on complexity

A
  • simple: following instructions (kits, w/ step by step)
  • moderate: specialized calculations or procedures, or making a preparation that no established stability data. (ex. mixing two topical creams when stability data for mixture is not available)
  • complex: requires specialized training, equipment, facilities or procedures (ex. transdermal dosage forms)
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4
Q

specifically designated for non-sterile compounding

A
  • separate location
  • performed in ambient air (room air)
  • separated from the dispensing part of pharm
  • all components, equipment should be stored off the floor

two types of water:
- portable (drinkable)
- purified (distilled) for water-containing formulations and for rinsingequipment..

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5
Q

sterile compounding used to prep:

A
  • IV
  • IM and subq
  • radio pharm
  • eye drops
  • irrigation
  • pulmonary inhalation (not include nasal inhalation)
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6
Q

CSPs

A

compounding sterile products

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7
Q

SVP

A

small volume parenteral
<100ml

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8
Q

LVP

A

large volume parenteral
>100ml

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9
Q

PPI

A

personal protective equipment
“don”- put on
“doff”- take off

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10
Q

PEC

A

primary engineering control

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11
Q

LAFW

A

Laminar Airflow Workbench

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12
Q

C-PEC

A

containment Primary engineering control

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13
Q

BSC

A

biologic safety cabinet

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14
Q

SEC

A

secondary engineering control

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15
Q

C-SEC

A

containment secondary engineering control

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16
Q

SCA

A

segregated compounding area

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17
Q

C-SCA

A

containment segregated compounding area

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18
Q

CAI

A

compounding aseptic isolator

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19
Q

CACI

A

compounding aseptic containment isolator

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20
Q

RABS

A

restricted access barrier system

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21
Q

CSTD

A

closed system transfer device

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22
Q

CVE

A

containment ventilated enclosure

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23
Q

air quality

A

particles per volume of air, lower particle= cleaner air

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24
Q

critical areas, closet to exposed sterile drugs

A

ISO 5
particles in the count 0.5 microns or larger

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25
Q

buffer area
anteroom (garbing)

A

buffer ISO 7- the SEC contains PEC
anteroom- at least ISO 8 if it opens into positive-pressure room, but at least ISO7 if negative pressure room

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26
Q

ISO 5
ISO 6
ISO 7
ISO 8

A

3,520
35,200
352,000
3,520,000

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27
Q

high efficiency article air filters

A

HEPA are >99.97% efficient at removing particle as small as 0.3
must be recertified every 6 month

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28
Q

vertical flow

A

HEPA filter at at the top of the sterile hood

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29
Q

laminar flow

A

HEPA filter at the back- horizontal flow

30
Q

direct compounding and first air

A
  • PEC provides ISO 5 air quality for sterile compounds. air coming directly out of HEPA is first air
  • do not obstruct first air
  • do not block airflow

to prevent contamination, injection port of the villa and syringe needle must be kept in the first air

31
Q

Prevent contamination of air in PEC

A
  • wipe off outsides of all material w/ 70% isopropyl alcohol before bring into PEC
  • open packages along designed tear lines
  • compound 6” inside the sterile hood
  • move waste outside shortly after it is created
32
Q

non-hazardous compounding

A

pressure inside PEC and SEC is positive

33
Q

hazardous

A

PEC (C-PEC) and SEC (C-SEC) is negative pressure

34
Q

types of sterile compounding area

A
  • cleanroom suite: one or more ISO-5 PECs (sterile hoods) inside an ISO 7 buffer room that is entered through an adjacent anteroom
  • segregated sterile compounding area (SCA) w/ ISO 5-PEC: sterile hood often an isolated (glovebox) w/ closed front. -unclassified air
35
Q

NIOSH general categories of hazardous meds

A
  • carcinogenic
  • teratogenic
  • genotoxic
  • toxic to organs at low doses
  • labeled by the manufacturer w/ special handling instructions
36
Q

Key hazardous drugs on NIOSH list
abortifacient

A

Mifepristone, misoprostol

37
Q

Key hazardous drugs on NIOSH list
antiretrovirals
antiviral

A

abacivr, entecavir, zidovudine

cidofovir, ganciclovir, valganciclovir

38
Q

Key hazardous drugs on NIOSH list
antibiotics
antifungal
anticoagulants

A

chloramphenicol

fluconazole, voriconazole

warfarin

39
Q

Key hazardous drugs on NIOSH list
acne
arrhythmias

A

isotretinoin

dronedarone

40
Q

Key hazardous drugs on NIOSH list
autoimmune condition

A

acitretin, azathioprine, leflunomide
fingolimod, teriflunomide

41
Q

Key hazardous drugs on NIOSH list
benign prostatic hyperplasia (BPH)
biphosphate

A

dutasteride, finasteride

pamidronate, zoledronic acid

42
Q

Key hazardous drugs on NIOSH list
chemoprotectant (cardiac)
depression
diabetes

A

dexrazoxane

paroxetine

exenatide, liraglutide

43
Q

Key hazardous drugs on NIOSH list
dyslipidemia
seizure/epilepsy

A

lomitapide

clobazam, clonazepam
carbamazepine, oxcarbamazepine, eslicarbazepine, divalproex, fosphenytoin, phenytoin, topiramate, vigabatrin, zonisamide

44
Q

Key hazardous drugs on NIOSH list
gout
HF
Hepatitis

A

colchicine

ivabradine, spironolactone

ribavarin

45
Q

Key hazardous drugs on NIOSH list
hormonal agents

A

androgens
estrogens
oxytocin, dinoprostone
progesterones
SERD/SERMs
ulipristal

46
Q

Key hazardous drugs on NIOSH list
hyperthyroid
insomnia

A

methimazole, propylthiouracil

temazepam, triazolam

47
Q

Key hazardous drugs on NIOSH list
iron overload
migraine
Parkinson

A

deferiprone

dihydroergotamine

apomorphine, rasagiline

48
Q

Key hazardous drugs on NIOSH list
pulmonary arterial hypertension
schizophrenia
transplant

A

ambrisentan, bosentan, macitentan, riociguat

ziprasidone

cyclosporine, mycophenolate, tacrolimus, sirolimus

49
Q

as part of assessment of risk (AoR), standard operating procedures (SOPs) must be developed:

A
  • putting HDs in distinctive shelf bins to alert staff
  • wearing ASTM D6978 rated gloves when counting or packaging drugs
  • dedicating a counting tray and spatial for HDs and decontaminating both after use
  • placing prepared HD containers into a sealable plastic bag

AoR doc reviewed every 12 months or whenever a new drug or dosage form is stocked or used

50
Q

HD hoods and buffer room include word containment

A

C-PEC
C-SEC
C-SCA
CACI

C-PEC is located inside C-SEC or C-SCA

51
Q

type of C-PEC for HD
BSCs

A

biological safety cabinets have vertical laminar airflow and negative air pressure

for sterile hazardous drugs

52
Q

type of C-PEC for HD
CVEs

A

containment ventilated enclosures are powder containment hood w/ HEPA filter air and negative air pressure
used for non-sterile compounding only

53
Q

type of C-PEC for HD
CACIs

A

are closed-front C-PECs (gloveboxes) located in buffer room (SEC) but are often located in C-SCA

external vent, negative air pressure

54
Q

it is perferred that non-sterile and sterile compounding space separate, an exception can be made to prepare a non-sterile hazardous drug in a C-PEC inside a C-SEC if these requirements are met

A
  • C-SEC must maintain ISO 7
  • separate sterile and non-sterile C-PEC in same C-SEC y at least 1 meter apart
  • particle-generating activity (powders) can not be performed at the same time
  • occasional non-sterile HD compounding can be completed C-PEC but it must be properly decontaminated, cleaned, and disinfected before using again with sterile HDs
55
Q

negative pressure

A

C-PECs, C-SECs, and C-SCAs

56
Q

air changes

A

non-sterile HD (C-SEC) 12ACPH
sterile C-SEC 30 ACPH
C-SCA 12 ACPH

ACPH- air changes per hour

57
Q

hazardous drug storage

A

stored separately from non-hazardous drugs, negative pressure 12 ACPH

58
Q

temp monitoring

A

SEC buffer room- once daily, kept at 20 C or 68F or cooler

refrigerator and freezer monitor daily unless they contain vax which is twice daily monitoring
refrigerator: 2 to 8C
freezer: -25 to -10C- w/vax -50 to-15 per CDC

59
Q

air sampling

A

every 6 months

60
Q

Keep PEC running

A

running at all times,

if there is a power outage, all compounding must stop, and PEC cleaned w/ germicidal detergent and then disinfected w/ sterile 70% isopropyl alcohol

must be on for least 30min before compounding

61
Q

deactivation and decontamination

A

2%bleach (sodium hypochlorite) or peroxide

62
Q

cleaning

A

germicadal detergetn such as
Quat, ammonium, phenolics (removes dirt and microbial contamination)

63
Q

Disinfection

A

sterile 70% isopropyl alcohol (PA)
inhibits or destroys microorganism; required in sterile compounding

64
Q

black waste bin

A

black is for bulk HD waste: any containers (drug vials, IV bags) that contain a clearly visible amount of HD and any supplies that were used to admin HDs or to clean HD spills

65
Q

Yellow waste bin

A

trace HD waste: empty syringes, IV bags, used PPE, including gowns, gloves, masks, and shoes

red sharps contain is only for non-hazardous sharps

66
Q

disposal hazard

A
  • outer chemotherapy gloves worn during compounding is discarded in yellow waste bin inside C-PEC. or put in a sealable bag if discarding outside
  • chemo gown and outer shoe covering ist take off before exiting the negative-pressure area and thrown in yellow bin
67
Q

garb for HD

general
Nonsterile HD

A
  • double ASTM D6978 (chemotherapy) rated golves when compounding or cleaning up spills
  • single gloves can be used for HD receiving and storage
  • double gloves, gown, a mask and
  • disposable pad to protect the work surface
68
Q

garb for HD

sterile HD

A
  • head covers, face mask, and beard covers if applicable
  • two pairs of shoe covers
  • gown impermeable to liquid
  • two pairs of ASTM D6978 gloves
  • full-facepiece respirator or a face shield w/ googles
69
Q

garbing for sterile

A

-remove coat, rings, watches, etc. no make up
- don head and facial coverings, facemask and then shoe covers (2nd pair are needed for HD)
- perform hand hygiene w/ sopa and warm water
–> clean under fingernails, fingertips to elbow, circular motion for 30 seconds
–> Dry hands
-don nonshedding gown and disposable gown
- enter buffer area (SEC)
–> apply an alcohol-based surgical hand scrub
–> don sterile, powder-free gloves, two pairs of chemo for HD
–> stanize gloves w/ 70% IPA

70
Q

garbing for HD

A
  • N95
  • fae shield w/googles or respirator
  • gloves must be changed every 30min or when torn, punctured or contaminated
  • gloves powder free
  • for non-sterile HD, glove one pair is ok
  • glove two pairs must be to admin drug
  • gown changed every 2-3 hrs or immediately after spill
  • two pairs of shoe covering
71
Q

Admin HD

A
  • two pairs of chemo drugs
  • ## gown required when IV HD
72
Q

test to ensure pharmacists and techs are performing sterile compounds safely good and properly

A
  • gloved fingerprint test
  • media-fill test (tryptic soy broth)

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