Compounding with Hazardous Drugs

5 alpha reductase inhibitors

dutasteride, finasteride

abortifacients

mifepristone, misoprostol

anticoagulants

warfarin

antivirals

cidofovir, ganciclovir, valganciclovir

antiseizure meds

carbamazepine

oxcarbazepine

fosphenytoin

phenytoin

topiramate

valproate

BZD

clonazepam, temazepam

dyslipidemia meds

lomitapide

heart failure meds

spironolactone

hepatitis meds

ribavirin

PAH meds

ambrisentan

bosentan

macitentan

riociguat

retinoic acid derivatives

tretinoin

SSRIs

paroxetine

thionamides

methimazole, propylthiouracil

transplant meds

cyclosporine

mycophenolate

tacrolimus

sirolimus

treatment for autoimmune conditions

acitretin

azathioprine

fingolimod

leflunomide

teriflunomide

hormonal agents

androgens

estrogens

oxytocin

progestins

SERD/SERM (fulvestrant, raloxifene, tamoxifen)

ulipristal

assessment of risk

allows staff to not have to follow USP 800 when doing low risk activities

C-PEC

C-SEC

C-SCA

containment-primary engineering control

containment-secondary engineering control

containment-segregated compounding area

examples of C-PEC appropriate for hazardous drug compounding

• class II biological safety cabinets (vertical laminar airflow)

• containment ventilated enclosures (CVE) - for nonsterile only

• compounding aseptic containment isolators (glovebox)

All hazardous drugs must be done in ___________ that is located in ______ or ________

ISO 5 C-PEC; C-SEC; C-SCA

Non-sterile and sterile compounding can be done in the same space if:

• C-SEC maintains ISO 7

• if there are separate sterile and non-sterile C-PECs in the same C-SEC, they must be kept at least 1 meter apart

What kind of air pressure must C-PECs, C-SECs, and C-SCAs have?

negative air pressure

air changes per hour (ACPH)

the number of times the air is replaced in the room

what is the ACPH for non sterile hazardous drugs?

12

what is the ACPH in a sterile C-SEC?

30

What is the ACPH in a C-SCA?

12

external exhaust

air cannot be recirculated

redundant HEPA filter

air is passed through two or more HEPA filters before returning. alternative to externnal exhaust

Storage for hazardous drugs

stored separately in a room with negative pressure and 12 ACPH

garbing is done in the _____

anteroom

approved respirators

fit tested NIOSH-certified N95

surgical N95 respirator

chemotherapy glove specifications

• must meet the American Society for Testing and Materials standard D6978

• powder-free

• must be changed every 30 minutes

• two pairs must be worn while compounding; one under cuff, other over cuff

  • can wear one pair while handling intact capsules or tablets or receiving and storage

chemotherapy gown specifications

• disposable

• impermeable

• close in the back, long sleeved, closed cuffs

• change every 2-3 hours or immediately after a spill or splash

shoe cover specifications

must wear two pairs

do you inject air into the vial before withdrawing liquid?

no

proper way to doff

outer layer of gloves yellow bin located inside C-PEC

gown and shoe covers off in the negative pressure area and into the yellow bin

what is the black container for?

bulk hazardous waste

steps for sanitization

deactivation, decontamination, cleaning, disinfection

bleach or peroxide can be used for

deactivation or decontamination

how often must wipe sampling must be performed

every 6 months

spill kit contents

• protective gown, gloves, N95 respirator and goggles

• HD waste bag, chemo pads

• HD spill report exposure form

eye exposure treatment

flush for 15 minutes