USP 800 and Hazardous Drugs: Safety Standards and Protocols (II)

All HDs must be unpacked in neutral/normal or ___________________ relative to surrounding areas and must not be unpacked in sterile compounding areas or in positive pressure

negative pressure

HDs must be stored in manner that prevents _________________ if container falls

spillage or breakage

Do NOT store HDs on the

floor

HDs that require ______________ of final dosage form must be stored separately from non-HDs

manipulation

Sterile and nonsterile HDs may be stored together, but HDs used for ______________ compounding should not be stored in sterile compounding area to minimize foot traffic

nonsterile

Engineering controls required to protect preparation from cross-contamination and microbial contamination

1. Containment primary engineering control (C-PEC)

2. Containment secondary engineering control (C-SEC)

3. Supplemental engineering controls

characteristics that C-SEC must have

1. externally vented

2. physically separated (different room from other prep areas)

3. appropriate air exchange

4. negative pressure

the C-PEC must

Operate continuously

Sink for hand washing and eyewash station must be readily available and water sources must be located at least ____________ from the C-PEC

1 meter

Thoroughly wash hands, nails, and arms up to the elbow with antiseptic cleaning agent and water for _______________. Dry hands with a non-shedding towel.

30 seconds

when compounding nonsterile HDs

1. Follow USP 795 standards

2. C-PEC not required if only handling final dosage forms

3. C-PEC for manipulation must be externally vented or have HEPA filters

4. Does not require unidirectional

airflow

5. C-SEC must have negative pressure

when compounding sterile HDs

1. Follow USP 797 standards

2. C-PEC must be externally vented

3. Compounding must be performed in C-PEC with ISO Class 5 or better air quality

4. C-PEC must be located in C-SEC, which should be ISO Class 7 buffer room with an ISO Class 7 ante-room

5. C-SEC must have negative pressure

___________________________ provide adjunct controls to offer additional level of protection during compounding or administration. No published universal performance standard and Must NOT be used as a substitute for C-PEC when compounding

Supplemental engineering controls

Check for HD surface residue at baseline and every ______________ with Environmental Wipe Sampling

6 months

Provide worker protection to reduce exposure to HD

PPE

________________ PPE must NOT be re-used

Disposable

Required equipment for compounding sterile and nonsterile HDs

1. Gowns

2. Head/hair covers

3. Shoe covers

4. Two pairs of chemotherapy gloves

Requirements for Gloves

1. Test to meet American Society for Testing and Materials (ASTM)

standard D6978

2. Powder free

3. Inspected for physical defects before use

4. must be changed every 30 minutes and when torn, punctured, contaminated

Requirements for disposable gowns

1. Must be long sleeved, close in back, and closed cuffs

2. No seams that could allow HDs to pass through

3. May not wear in other areas

4. must be changed every 2-3 hours or immediately after spills

Requirements for Head, Hair, Eyes, Shoes, and Respirators

1. Must wear head, hair, beard, and shoe covers

2. a second pair of shoe covers MUST be put on before

entering C-SEC and taken off when leaving C-SEC

3. Goggles needed for manipulations that may cause aerosolization or

spills

4. If respirator required, must be fit tested and NIOSH certified

when donning what are donned

1. Hair cover, face mask, and two

pairs of shoe covers before

entering cleanroom

2. Wash hands in anteroom

3. Two pairs of chemo gloves

when doffing what are doffed

1. Remove outer chemo gloves

prior to handling or labeling

products

2. Remove chemo gown and outer

shoe covers before leaving C-

PEC

3. Remove all garb when leaving

the anteroom

Collection and disposal of hazardous waste and trace contaminated waste is a potential opportunity for exposure

HD waste

____________________ agency regulates hazardous waste through the Resource Conservation and Recovery Act

Environmental protection

Trace waste, including PPE are what colored bin

yellow bin

If >3% of drug left in vial during compounding HD deemed appropriate for ____________ (i.e. arsenic)

black bin

when labeling HDs must be clearly labeled at all times and do not introduce _____________________ into non-HD handling areas while labeling

contamination

when packaging HDs must protect HD from _____________________

damage, leakage, contamination, and degradation

when transporting HDs must minimize risk of breakage or leakage and may NOT use __________________

pneumatic tube system

when disposing HDs all ________________ must be trained in appropriate procedures. Must comply with federal, state, and local regulations

custodial personnel

Render compound inactive. Oxidizers (i.e. peroxide formulations, sodium hypochlorite)

deactivation

Remove HD residue. Alcohol, water, peroxide, or sodium hypochlorite

decontamination

Remove organic and inorganic material. Germicidal detergent

cleaning

Destroy microorganisms. Disinfectant and Sterile alcohol

Disinfection (sterile compounding)

how do you deal with spill control

1. All personnel must receive proper training in spill management

2. contained and cleaned immediately by qualified personnel with appropriate PPE

3. Spill kits must be readily available

4. Personnel potentially exposed require immediate evaluation

Part of a comprehensive exposure control program where the purpose is to minimize __________________________ in personnel potentially exposed to HDs. This includes assessment and documentation of symptom complaints,

physical findings, and laboratory values (such as blood count)

adverse health effects