USP 800 - Block 4 Flashcards
Define hazardous drugs?
Drugs that can cause adverse health effects if health care workers are exposed to these products
USP 800 requires individual institutions to maintain ___?
List of HDs
What are the categories of NIOSH list?
- Antineoplastic HD
- Non-antineoplastic HD
- Reproductive Risks
How often are NIOSH lists reviewed?
Annually
A hospital must follow USP 800 containment strategies for:
- All hazardous drug APIs
- Antineoplastics that require further manipulation
AOR must document the following considerations (at a minimum)
- Type of HD
- Dosage forms
- Risk of exposure
- Packging
- Manipulation
How do you order HDs?
Establish with the suppliers that HD “should be recieved from the supplier in impervious palstic segregate them from other drugs to allow safety durign transfer”
How should hospitals recieve HDs?
- Must have a designated area for receipt and unpacking HD
- PPE
- API Removed in a neutral or negative pressure area
- HD removed from external shipping contain outside sterile compounding
- Inform police about damged packages
How do you stock HD?
- A sign designating the entrance to this hazardous drug handling area must be clearly visible
- This area must be away from a break room or area where food/drink are consumed
- Access to this designated receiving area must be restricted to authorized personnel
- Stored to prevent spilling or brekaing
Where should antineoplastics be stored?
- Separately from non-hazards
- Externally ventilated
- Negative pressure room with at least 12 air pressure changes per hr (ACPH) same goes for refrigerated
Hands must be washed with soap and water after ___?
Removing gloves
What is the purpose of PPE?
To provide employees protection from hazardous aerosols and drug residue during preparation of products
* GLoves and gowns
Glove guidelines?
- ASTM-tested chemo gloves
- Powder free
- No defects
- 2 pairs (inner worn under gown cuff and outer over)
- Changed every 30 min
- Discard inside C-PEC
Gown guidelines?
- Worn when handling HD
- Protection from spills and waste
- Disposable
- Polyethylene-coated polypropylene or other laminate materials
- Must close in back
- No seams or closure
- Cloth material or other absorbent materials are not appropriate wear to handle HDs
Respirtory protection fo HD?
- Unpacking HD that are not contained in plastic should wear an elastomeric half-mask whith a multigas cartridge and P100 filter
When shoudl PAPR be worn?
- HD spill
- Exposure underneath work surfce of a C-PEC
- Airborne exposure
What is a Closed System Transfer Devices (CSTDs)?
- Closed System Transfer Devices (CSTDs)
- prohibits the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside of the system
- Limit the potential for generating aersols during compounding
Work practices that must be followed when using CSTD?
- Provides supplemental control for compoudning shall be used inside a C-PEC
- Used when compounding HDs when dosage form allows
- Used when adminsitering HDs when the dosage form allows
What are the safety practices using negative pressure technique?
- Perform all manipulation of HDs in C-PEC
- Observe proper material handling practices before introducing any item into ISO Clss 5 C-PEC
- Swab the vital septum with sterile 70% IPA and allow to dry
- Perform manipulations in the direct compounding areas that is not obstructive of HEPA filter
- Use a syringe that is 25% larger than the total dose
- Carefully attach the needle and syringe being careful to avoid touch contamination of either critical site
- Draw up the amount of air that is equal to the total dose to be drawn up
- Insert the needle into the septum being mindful of the first air coming down from the top of the C-PEC
Cleanup procedure for HD?
- Use wet ipes with appropriate solution
- Don’t us spray bottles to avoid spreading HD
What is the purpose for deactivation?
Transform the HD int less HD agents using chemical, heat, UV light
What is the purpose of decontamination?
Removal of HD residue on exposed surfaces
What is the purpose of cleaning?
Removal of soil from surfaces/objects
What is the purpose for disinfection?
Inhibits or destroys microbes
What are is the cleaning process?
- Deactivation
- Decontamination
- Cleaning
- Disinfection
What is the disposal plan for trace HD waste?
- Containers/tubing with <3% by weight of HD remaining
- All disposable supplies involved in compounding or cleaning
- PPE used in compounding
What is the disposal plan for bulk HD waste?
- Containers/tubing w/ >3% by weight of HD remaining
- Significantly contaminated supplies and PPE used in compounding, cleaning, etc
- Materials used in cleaning up spills
What is unintended xposure?
Personnel who are potentially exposed to a HD or who have direct skin or eye contact require immediate evaluation
