Compounding: USP 800 Flashcards
What’s the hazardous drug list called?
NIOSH (duh)
What needs to be kept in every pharmacy?
NIOSH list
Purpose of the NIOSH list
Provides information to identify potential hazardous drugs
Each entity is responsible to do what with the NIOSH list?
Review specific information to determine drugs that are hazardous, including investigational drugs
What if there’s not enough information to determine whether or not a drug is hazardous?
Treat it as hazardous until more info is available
How can some hazardous drugs actually not post significant risk of direct occupational exposure?
If they’re intact capsules and tablets that are given without modifying the formulation
When can hazardous drugs pose a risk in preparation?
If you have to split tablets, open capsules, etc.
Basically anything that will cause dust to fly around- perform an assessment of risk!
Types of exposure to hazardous drugs
Dermal and mucosal absorption
Inhalation
Injection
Ingestion
Opportunities for hazardous drug exposure
Contacting HD residues on drug containers, individual dosage units, outer containers, work surfaces, floors
Counting or repackaging tablets/capsules
Crushing and splitting tablets, weighing and mixing components, reconstitution
Administration
Patient care activities
Spills, transporting, waste
Facilites and engineering controls for HDs: signage
Signs should designate the hazard and displayed before the entrance to the HD handling areas
Facilities and engineering controls for HDs: access to HD areas
Has to be restricted to authorized personnel to protect people not involved in HD handling
Facilites and engineering controls for HDs: where should HD handling areas be?
Away from break rooms and refreshment areas for personnel, patients, or visitors to reduce risk of exposure
Responsibilites of personnel handling HDs: who has to be there?
A designated person
Responsibilities of a designated person: USP 800
Ensure compliance with laws, regulations, and standards, environmental control of the store and compounding areas, setting up and implementing appropriate procedures
Goal is to prevent harm to patients, minimize exposure to personnel, and minimizing contamination of the work and patient care environment
Designated areas for HD handling
Receipt and unpacking
Storage of HDs
Nonsterile HD compounding, PRN
Sterile HD compounding, PRN
USP 800 compounding specifics: engineering controls (in regard to the PEC and SEC)
PEC has to be a containment PEC (C-PEC) at ISO 5 or better
SEC has to be a containment SEC (C-SEC)
USP 800 compounding specifics: sterile and nonsterile products must be compounded where?
Within a C-PEC that’s located in a C-SEC
Requirements of the C-SEC and C-PEC
Areas should be externally vented, physically separated, appropriate air exchange, and negative pressure, and have a sink available for hand washing along with an eyewash station and/or other emergency or safety procedures
C-PEC engineering controls for USP 800
ISO 5 air
Externally vented, or redundant HEPA filters
Examples of C-PECs used in HD compounding
CVE, Class I or II BSC, CACI
C-SEC requirements for USP 800: how is it vented, how many ACPH does it need, and what kind of pressure does it need?
Externally vented
12 ACPH
Negative pressure
Engineering controls for sterile HD compounding: C-PEC with an ISO 7 buffer room and an ISO 7 anteroom
Externally vented Class II BSC or CACI
Engineering controls for sterile HD compounding: C-SEC with an ISO 7 buffer room and an ISO 7 anteroom: how does it need to be vented, how many ACPH, and what kind of pressure
Externally vented
30 ACPH
Negative pressure
Engineering controls for sterile HD compounding: C-PEC in an unclassified C-SCA
Externally vented Class II BSC or CACI
Engineering controls for sterile HD compounding: C-SEC in an unclassified C-SCA: how is it vented, ACPH, and what kind of pressure?
Externally vented
12 ACPH
Negative pressure
USP 800: personnel training should occur initially when?
Before working with HDs (duh)
USP 800: how often should personnel be reassessed?
Every 12 months
USP 800: what should personnel training include?
Overview of HDs and their risk
Review of the SOPs related to the handling of HDs
Proper use of PPE, equipment, and devices
Response to known or suspected HD exposure
Spill management
Proper disposal of HDs and trace-contaminated materials
PPE used in USP 800 compounding
Gloves
Gowns
Head, hair, shoe, sleeve covers
Eye and face protection
Respiratory protection
Disposal of used PPE
Gowning and PPE: what’s required to wear for compounding sterile and nonsterile HDs?
gowns
head, hair, shoe covers
2 pairs of chemo gloves
When should you wear PPE with HDs?
Receipt, storage, cleaning, transport, compounding, administration, deactivation, spill control, waste disposal
Specifics on the type of gloves worn
Powder-free gloves
Specifics on the type of chemo gowns worn
Must be disposable and resist permeability by HDs
Must close in the back
Long-sleeves
Closed cuffs
How often should you change a gown when compounding HDs?
Every 2-3 hours or immediately after a spill/splash
2 pairs of what should be worn before compounding HDs?
Gloves and shoes
Eyewear for HD compounding
Face shields in combination with goggles
Respiratory protection for HD compounding
N95 respirator
Disposal of HD compounding waste: what goes in the black bin
Bulk waste that contains a clearly visible amount of HD and any supplies used to administer HDs or cleaning up HD spills
Disposal of HD compounding waste: what goes in the yellow bin
Trace HD waste: empty syringes, IV bags, used PPE like gowns, gloves, masks, and shoe covers
Disposal of HD waste: what goes in the red bin
Infectious waste like IV tubing and used culture dishes
How often should chemo gloves be replaced when compounding HD drugs?
Every 30 minutes or when torn, punctured, or contaminated
HD compounding procedures: where to unpack HDs
In an area that’s neutral/normal or negative pressure relative to surrounding areas
HD compounding procedures: where to NOT unpack them
From shipping containers in sterile compounding areas or in positive pressure areas
HD storage
Store them in a way that prevents spillage/breakage if the container falls, DON’T STORE ON THE FLOOR
How to store antineoplastic HDs requiring manipulation other than counting/repackaging
Store separately from non-HDs in a manner that prevents contamination and personnel exposure- store them in an externally ventilated negative-pressure room
Can you store sterile and nonsterile HDs together?
Yes, but HDs used for nonsterile compounding shouldn’t be stored in areas for HDs used for sterile compounding
How to store antineoplastic HDs that need to be in a fridge
The fridge has to be in a negative pressure area
Can you place 2 C-PECs, one used for nonsterile and the other used for sterile HD compounding, in the same room?
You technically should be placing them in separate rooms, but if you can find a way to have ISO 7 air and keep it there during nonsterile compounding, you can put them in the same room at least 1 meter apart
