Ch. 17 Compounding with Hazardous Drugs

Stabinsky

hazardous drugs

can cause toxicity to the healthcare workers who handle them in any manner

HDs require workspaces, equipment, devices, and procedures that are designed to reduce exposure

USP 800

the national institute for occupational safety and health (NIOSH)

determines which drugs are hazardous

has a NIOSH list of antineoplastic and other hazardous drugs in healthcare settings

ex of drugs considered hazardous --> carcinogenic, teratogenic, genotoxic, toxic to organs

select hazardous key drugs on the NIOSH list

antineoplastic drugs (chemotherapeutics)

5-alpha reductase inhibitors --> finasteride, dutasteride

abortifacients --> mifepristone, misoprostol

anticoagulants --> warfarin

antivirals --> cidofovir, ganciclovir, valganciclovir

antiseizure meds --> carbamazepine, oxcarbazepine, fosphenytoin, phenytoin, topiramate, valproate

benzos --> clonazepam, temazepam

lomitapide

spirinolactone

ribavirin

PAH meds --> ambrisentan, bosentan, macitentan, riociguat

tretinoin

paroxetine

thionamides --> PTU, methimazole

transplant meds --> cyclosporine, tacrolimus, sirolimus, mycophenolate

treatment for autoimmune conditions --> acitretin, azathiopurine, fingolimod, leflunomide, teriflunomide

hormonal agents --> androgens, estrogens, oxytocin, progestins, SERD/SERMs, ulipristal

safety data sheets (SDS)

series of safety documents required by OSHA to be accessible to all employees who are working with hazardous materials

hazard communication program

each facility must have a designated person who is responsible for creating standard operating procedures (SOPs)

this hazard communication program includes a written plan with all procedures and training

both men and women with reproductive ability must confirm in writing that they understand the risks

assessing risk

lower risk activities include counting and packaging tablets

a pharmacy can conduct an assessment of risk (AoR) to avoid having to follow all USP 800 requirements

as part of the AoR, SOPs must be developed, which include actions to limit staff exposure, such as wearing chemotherapy gloves

if any manipulation of the low-risk HD is required, USP 800 requirements must be followed

if no AoR is conducted, the pharmacy must follow the full USP 800 requirements

physical space basics

hoods and buffer rooms used for compounding HDs include the work containment

containment is required to keep HDs, particles, and vapors contained within the space

all spaces should have negative air pressure

C-PECs for hazardous drug compounding

both sterile and nonsterile hazardous compounds must be prepared in an ISO 5 C-PEC that is located in a C-SEC or C-SCA

types of C-PECs

biological safety cabinets (BSCs) --> have vertical laminar airflow, for sterile HD compounding, the BSC must be Class II

containment ventilated enclosures (CVEs) --> used for nonsterile compounding only

compounding aseptic containment isolators (CACIs) --> are vented externally and have negative air pressure

nonsterile and sterile HD compounding in the same space

can only occur if these exceptions are met:

- the C-SEC maintains ISO 7 air

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

air handling

C-PECs, C-SECs, and C-SCAs must have negative air pressure

the air in the anteroom must be maintained at ISO 7

the air changes per hour (ACPH) is the number of times (per hour) that the air is replaced in the room

air that has been contaminated with HDs must be externally exhausted and cannot be recirculated

an alternative option to an external exhaust (for nonsterile HD ONLY) is to use redundant HEPA filters

number of ACPHs required

nonsterile HD --> at least 12 ACPH

sterile --> at least 30 ACPH

C-SCA --> at least 12 ACPH

hazardous drug storage

HDs must be stored separately from non-HDs

should be stored in a room with external ventilation and negative pressure, with at least 12 ACPH

garb for hazardous drugs

appropriate personal protective equipment (PPE) must be worn

garb for compounding is donned in the anteroom from dirtiest to cleanest

items included in garbing

respirator --> a fit tested NIOSH-certified N95 or surgical N95 respirator (provides some face protection)

face mask --> required for sterile compounding

head and hair covers

eye/face protection --> must be worn when there is a risk for HD spills or splashes when working OUTSIDE of a C-PEC

chemo gown --> must be disposable, impermeable, and long sleeves with closed cuffs that closes in the back; change every 2-3 hours or immediately after a spill or splash

shoe covers --> two pairs are required when compounding HDs

chemo gloves --> must meet the american society for testing and materials (ASTM) standard D6978, must be powder free and changed every 30 minutes; 2 pairs must be worn while compounding (one under the cuff and one over the cuff of the gown)

garb for administration

appropriate PPE must be worn when administering HDs

two pairs of chemo gloves are required when administering antineoplastic HDs and performing any manipulation of HDs

a single pair of gloves can be used for handling intact tablets or capsules

a chemo gown is required when administering injectable HDs

garb for receiving, storage, and transport

a single pair of chemo gloves can be used for receiving and storage

pneumatic tube systems cannot be used to transport any liquid HDs or any antineoplastics

hazardous drug equipment and preparation

equipment should be dedicated for HD preparation and sanitized after use, or they should be disposable

pharmacy and nursing staff should avoid manipulating oral HDs

air should not be injected into a vial --> instead, the negative pressure technique or a closed-system transfer device (CSTD) should be used

CSTDs

have a built in valve that equalizes air pressure

should be used to transfer HDs whenever possible as they keep the HDs contained within the device

reduce spills when reconstituting

are recommended when compounding HDs and required for administering antineoplastics

label requirements

all hazardous preparations must have a label that portrays special handling

hazardous drug disposal

the outer chemo gloves worn during compounding are discarded in a yellow trace chemo waste bin located inside the C-PEC

the rest of the garb (chemo gown, shoe covers) must be taken off before exiting the negative pressure area and thrown away in the yellow trace chemo waste bin

all trace hazardous waste is thrown away in a yellow container

bulk hazardous waste are thrown away in a black container

sanitization

all areas and equipment must be sanitized, which includes deactivating, decontaminating, and cleaning, at LEAST once a day

sterile compounding areas must be disinfected

wetted wipes should be used for sanitizing instead of a spray bottle

some cleaning agents combine deactivation and decontamination --> bleach or peroxide can be used for both steps

all workers performing these activities must wear appropriate PPE

deactivation

make compound inert/inactive

peroxide or sodium hypochlorite (2% bleach)

decontamination

remove HD residue

alcohol, water, peroxide, or 2% bleach

cleaning

remove dirt and microbial contamination

germicidal detergent

disinfection

for sterile compounding only

destroy microorganisms

EPA-registered disinfectant or 70% IPA

surface sampling

should perform wipe sampling of all compounding surfaces initially and at least every 6 months to ensure that hazardous residue is contained

hazardous drug spills

the SDS should be consulted for guidance on spill clean-up procedures

establish WHO, WHAT, and WHEN

managing the spill --> spill kits must be kept in the area, post warning signs

spill kit contents

gown

gloves

N95 respirator

goggles

HD waste bag

chemo pads

HD spill report exposure form

procedure for cleaning up a spill

put ASTM D6978 (chemo)-rated gloves on

this is bulk hazardous waste, which is discarded in the black waste bin

drug exposure

get the drug or chemical off the person ASAP

- remove the garb that has the drug on it

- immediately cleanse any affected skin

- for eye exposure, flood the affected eye for at least 15 minutes

- obtain medical attention if needed