hazardous drug compounding

A drug is considered hazardous if it is:

• Carcinogenic

• Teratogenic

• Toxic to reproduction

• Genotoxic

• Toxic to organs at low doses

Meds on the NIOSH list

Category	Key Drugs
Antineoplastics	All chemo
5-α Reductase Inhibitors	Dutasteride, Finasteride
Abortifacients	Mifepristone, Misoprostol
Anticoagulant	Warfarin
Antivirals	Cidofovir, Ganciclovir, Valganciclovir
Antiseizure	Carbamazepine, Oxcarbazepine, Fosphenytoin, Phenytoin, Topiramate, Valproate
Benzodiazepines	Clonazepam, Temazepam
Diabetes	Exenatide
Dyslipidemia	Lomitapide
Heart Failure	Spironolactone
Hepatitis	Ribavirin
PAH	Ambrisentan, Bosentan, Macitentan, Riociguat
Retinoic Acid	Tretinoin
SSRI	Paroxetine
Thionamides	Methimazole, Propylthiouracil
Transplant	Cyclosporine, Mycophenolate, Tacrolimus, Sirolimus
Autoimmune	Acitretin, Azathioprine, Fingolimod, Leflunomide, Teriflunomide
Hormonal Agents	Androgens, Estrogens, Oxytocin, Progestins, SERMs/SERDs (tamoxifen, raloxifene, fulvestrant), Ulipristal

Prior to handling Hazardous drugs, both males and females with reproductive capacity must

confirm in writing that they understand risks

What is an Assessment of Risk?

Allows pharmacies to skip strict USP 800 containment rules for hazardous drugs that are dispensed without any manipulation (like counting regular pills).

• The pharmacy must write official Standard Operating Procedures (SOPs) to explain how they handle those drugs safely.

When AoR is NOT allowed: If you have to manipulate the drug—such as working with bulk powders, crushing tablets, or compounding liquids—you cannot use an AoR. You must follow full USP 800 rules.

The default rule: If a pharmacy chooses not to do an AoR, they must follow all full USP 800 requirements.

What pressure is needed for hazardous compounding?

negative pressure; in sterile non-hazardous its + pressure

What are containment Primary Engineering Control(C-PEC)?

aka “contained hood”

Types:

• Biological safety cabinets: have unidirectional air flow(vertical)

  • for sterile HD compounding, BSC must be at least Class II or III

• Contained Ventilation Enclosures: used for non sterile compounding only

• Compounding Asepetic Containment Isolators: close fronted CPECs

How to handle sterile & non sterile hazardous compounds?

it is preferred to keep sterile and non-sterile separate

However you can keep them together if:

• CSEC provides ISO 7 air

• Separate CPEC and CSEC by 1 meter

• particle generating activity can’t be performed in the same time in the same CSEC

• can compound non sterile in sterile CPEC, but it must be cleaned before compounding new sterile products

CSEC

area that contains CPEC

• 12ACPH for non sterile

• 30 ACPH for sterile compounding

What is unique for hazardous compounding?

External ventilation is needed

Anteroom in hazardous compounding

provides ISO 7

Garb requirements for Hazardous drugs

Mask: 

• N95: Good enough for almost everything routine (compounding, receiving, administering).

• PAPR / Full-Face Mask: Only needed for large spills or hazardous vapors/gases.

Gloves: 

• Two pairs are needed when administering antineoplastics and performing any manipulation 

• Single pair can be used for: 

  • Handling intact capsules or tablets 

  • Receiving and storing HDs

Gown: must be worn when doing injections

T/F: Pneumatic tubes can not be used for transporting liquid HDs

True

When reconstituting/compounding HDs:

air should not be injected into the vial; Instead the negative pressure technique or closed system transfer device should be used

What are closed system transfer devices used for?

• used to transfer HDs

• reconstituting dried powders into solutions

• Recommended for compounding HDs and required for administration

What goes in yellow trace

empty/used syringes, IV bags, used PPE(gowns, masks, and shoe covers)

What goes in black container

Black is for Bulk Waste

What goes in red container?

• Items contaminated with blood, body fluids, or infectious agents (gloves, gauze, IV tubing, standard sharps).

• What does NOT go in: Chemotherapy agents or hazardous chemical drugs.

Hazardous compounding steps after finishing compounded product

1. Deactivating: make inert/inactive

• peroxide or 2% bleach

2. Decontamination

• alcohol, peroxide, 2% bleach

3. Cleaning

4. Disinfection: EPA disinfectant or 70% IPA

Done at least once daily

How often should wipe sampling be done?

every 6 months

if a spill occurs who to consult?

SDS

• establishes who, what and where of spills