Compounding with Hazardous Drugs

Question 1

What are the key hazardous (teratogenic) drugs according to NIOSH?

Answer 1

1. 5-alpha reductase inhibitors (finasteride)
2. Abortifacients (mifepristone)
3. Warfarin
4. Antivirals (cidofovir, ganciclovir, valganciclovir)
5. Antiseizure medications (carbamazepine, oxcarbazepine, topiramate, valproate, (fos)phenytoin)
6. Benzos (clonazepam, temzepam)
7. Dyslipidemia (lomitapide)
8. Spirinolactone
9. Ribavirin (HCV)
10. Ambrisentan, bosentan, macitrenan, riociguat (PAH)
11. Tretinoin
12. Paroxetine
13. Methimazole, Propylthiouracil
14. Transplant (cyclosporine, mycophenolate, tacrolimus, sirolimus)
15. Azathioprine, Acitretin, Fingolimod, Leflunomide, Teriflunomide (Autoimmune)
16. Hormonal agents (androgens, estrogens, oxytocin, progestins, SERD/SERMs, Ulipristal)
17. ALL CHEMOTHERAPY

Question 2

How many air changes per hour are required in spaces where nonsterile HDs are compounded?

Answer 2

12/h

Question 3

How many air changes per hour are required in the C-SEC where sterile HDs are compounded?

Answer 3

30/h (same as nonhazardous)

Question 4

How many air changes per hour are required in the SCA where sterile HDs are compounded?

Answer 4

12/h

Question 5

Where must hazardous bulk drugs be stored?

Answer 5

A separate negative-pressure room with 12 air changes per hour

Question 6

How is equipment used for hazardous compounding disposed of?

Answer 6

Black bin: unused/partially used IV bags, syringes, and vials
Yellow bin: Trace HD (gloves used for compounding, other PPE, empty syringes/IV bags)
Red: HD infectious waste (used syringes, IV tubing, culture dishes)

Question 7

What are the steps for cleaning HD equipment?

Answer 7

1. Deactivation (peroxide/hypochlorite)
2. Decontamination (alcohol, water, peroxide, hypochlorite)
3. Cleaning (germicidal detergent)
4. Disinfection 70% IPA (sterile compounding only)

Question 8

How often must gloves/gown be changed while compounding HDs?

Answer 8

Gloves: change every 30 min or if contaminated/torn
Gown: change every 2-3h or immediately after a spill

Question 9

What quality of air is required for compounding HD?

Answer 9

PEC: ISO 5
SEC: ISO 7
Anteroom: ISO 7