PSL 3: Hazardous Sterile Compounding

What are the hazardous drug criteria?

• Carcinogenicity

• Teratogenicity or other developmental toxicity

• Reproductive toxicity

• Organtoxicity at low doses

• Genotoxicity

• Structure and toxicity profiles of new drugs mimic existing drugs determined hazardous by the above cities

NIOSH

National Institute for Occupational Safety and Health

Which are antineoplastic NIOSH>

Bleomycin

Carboplatin

Cisplatin

Cyclophosphamide 

Doxorubicin

Gemcitabin

Methotrexate

Mitomycin

Tamoxifen

What are non-antineoplastic NIOSH

Azathioprine

Carbamazepine

Ganciclovir

Rasagiline

Risperidone

Zidovudine

What are reproductive risk NIOSH?

Clonazepam

Finasteride

Misoprostol

Paroxetine

Telavacin (removed 4/12/2017)

Voriconazole

Warfarin

Zoledronic acid

What is misoprostol?

• A reproductive risk medication that is only available as a 100 mcg tablet and must be quartered to 25 mcg. 

• Exposed visitors to hazardous medications. 

• Prepared in a chemotherapy hood. 

• Packaged in unit dose packaging

What does USP 800 apply to?

• Hazardous sterile preparations

• Hazardous non-sterile preparations

What USP is hazardous drugs section at?

USP 800

• Practice for handling hazardous drugs to protect patients, workers, and environment

• Also include USP 797 (BUD) and 795

What are potential opportunities for HD exposure?

• Receipt: on the packaging of the containers

• Waste: 

• Spills: Occur during multiple steps

• Transport: Many are moving throughout the medical systems for examples form pharmacy to room.

• Compounding: 

• Administration: Performing administraiton activities

• Patient Care activities: Handling sweat, urine, feces, or vomit

Receipt

Unpack in a neutral or negative pressure area relative to the

surrounding areas

Handling

• Chemotherapy gloves must always be worn when handling HDs

• Receiving, distribution, stocking, inventorying, preparation for administration, and disposal

Storage for antineoplastic?

• Requiring manipulation 

• Must be stored separately from non-HDs

• Negative pressure, 12 ACPH,

Storage for non-antineoplastic, reproductive risk, and final dosage forms of antineoplastic HDs

• may be stored with other inventory if permitted

Sterile and non sterile HD storage?

• May be stored together 

What are requirements for personnel training?

◦ Overview of entity’s HDs list and their risks

◦ Review of entity’s Standard Operation Procedures (SOPs)

◦ Proper use of PPE

◦ Proper use of equipment

◦ Response to known or suspected HD exposure

◦ Spill management

◦ Proper disposal of HDs and trace-contaminated materials

How is competency assessed?

At baseline and at least every 12 months

What is the purpose of engineering controls?

Protect the patient, you and the environment

What are the engineering controls present in sterile compounding?

• Containment Primary Engineering Control

• Containment Secondary Engineering Control

• Supplementary Engineering Controls

C-PEC

Minimize environmental, personnel exposure to hazardous drugs

C-SEC

Room where the CPEC is placed

Supplementary Engineering Controls

Offer additional level of protection

What is consist of C-PEC?

• ISO Class 5 or better

  • Biological safety cabinet

    • Class I

    • Class II

  • Compounding Aseptic Containment Isolator

• Externally ventilated

BSC

Vertical flow by containing inward and downward flow of HEPA filter air.

Class 2 BSC

• Glass panel is present

Class 3 BSC

Maximum protection

For highly infectious 

What is Iso Class 7 Buffer Room with an Iso Class 7 Ante-Room

• Externally vented Externally vented

• Appropriate air exchange (ACPH) = 30

• Buffer Room: Negative pressure

between 0.01 and 0.03 inches of

water column relative to adjacent

areas

• Ante-Room: Positive pressure of at least 0.02 inches of water relative to all adjacent unclassified areas

• BUD: Per USP 797

Unclassified Containment C-SCA

• Externally vented

• Appropriate air exchange (ACPH) = 12

• Negative pressure between 0.01 and

0.03 inches of water column relative to adjacent areas

• BUD: Per USP 797 for CSPs prepared in a segregated compounding area

What is in the Buffer room?

• ISO Class 7

• Negative pressure

• Contains BSC or CACI

What is in the anteroom?

• ISO Class 7

• Positive pressure

Buffer for non-HD?

• ISO Class 7 

• Positive Pressure

• Contains LAFW or CAI

What is the order of airflow?

• Buffer for non-HD—> Ante—> Buffer for HD

What is in the C-SCA?

• C-SCA

• Negative pressur e

• Contained BSC or CACI

What is in the supplementary engineering controls?

Closed System Drug-Trasnfer Device

What is CSTDs not?

A substitute for a C-PEC when compounding

When should CSTDs be used?

Used when compounding HD when the dosage form allows

When must be CSTDs be used?

When administering antineoplastic HD

What are CSTDs?

ChemoClave System

TEVADAPTOR

The PhaSeal System

What is chemo dispensing pin?

Built-in 0.2 micron hydrophobic air venting

What are the PPE for compounding?

• 2 pairs of chemotherapy gloves

• Gowns

• Head/hair/shoe covers (second pair must be dawned)

What are the chemotherapy gloves like?

• American Society for testing and materials standard D6978

• Powder free (might possibly contaminate)

• Outer gloves must be sterile

• Change every 30 minutes

What are the gowns like?

• Disposable (resistant permeability to hazardous drugs)

• Close in the back

• Long sleeved

• Closed cuffs

How are HD reconstituted?

• With negative pressure

• Tilt the vial at a 30 degree angle to the work surface

• Pull air into the syringe by pulling the plunger

• Hold the barrel of the syringe firmly

• Do not go below the initial volume in the syringe

How should chemotherapy gloves be disposed?

Must be removed and discarded into appropriate waster container prior to exiting C-PEC

How should PPE be removed?

Discard PPE in proper waste contained before leaving the C-SEC

How must used PPE be discard?

Per local state and federal regulations

Usually in the yellow containers

How must administration of HD occur?

• Ready to administer preparation

• Closed needless system

• Appropriate PPE must be worn

Chemotherapy Robot 

Prepare HD and protect personnel form HD