Lecture 6: USP 800 Flashcards by Shiqi Zhang

Hazardous drug exposure

High risk due to repeated exposure
Studies show fertility impairment/ increased risk of cancers due to occupational exposure to HDs (chronic)
Acute AE = rashes

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National Institute for Occupational safety and health (NIOSH)

OSHA established this as a research agency focused on focused on the study of worker safety and health

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Mission of NIOSH

to develop new knowledge in the field of occupational safety and health to transfer the knowledge into practice

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NIOSH list

list of antineoplastics and other HD

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NIOSH considers drug to be hazardous if:

it exhibits 1 or more of the following characteristics in humans/animals:
- carinogenicity
- teratogenicity/developmental toxicity
- reproductive toxicity
- organ toxicity at low doses
- genotoxicity
- structure/toxicity profiles mimic existing HD

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NIOSH table 1

Meet NIOSH definition of HD + manufactures special handling info (MSHI) +/- classified “known to be human carcinogen”

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NIOSH table 2

Meet NIOSH definition of HD but DOES NOT HAVE MSHI AND NOT classified “known to be human carcinogen”

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Actual risk of HD is determined by

Toxicity of drug
how enter body
how handled

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USP 800 protects who?

healthcare workers

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USP 797 and 795 protects who?

patient

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Nonsterile HD covered by

USP 795 and 800

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Sterile HD covered by

USP 797 and 800

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USP 800 only applicable when

practitioner is engaged in compounding (as defined by 797/795)

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List of NIOSH drug

must be maintained by an entity

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NIOSH drug list must be reviewed

every 12 months
and when a new agent/dosage form is used

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An entity must handle all NIOSH list drugs as hazardous UNLESS

assessment of risk performed
- type of HD, dosage form, risk of exposure
- packaging, manipulation
Must document alternative containment strategy
= reviewed and documented every 12 months

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Containment PEC

ventilated device designed to minimize exposure

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Selection of type of Containment PEC depends on

Type of compounding (sterile/nonsterile)
Type of SEC

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Types of Containment PEC

Containment ventilated enclosure (CVE)
Biological safety cabinet (BSC)
Compounding aseptic containment isolator (CACI)

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What type of containment PEC do you use for sterile HDs?

Compounding aseptic containment isolator (CACI)

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What type of LAFW is used for HD?

Vertical airflow

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Containment SEC (the room) must be

Externally ventilated
physically separated
have appropriate air exchange
have negative pressure (0.01 – 0.03) inches of water column relative to all adjacent areas
(air flows from anteroom (lower pressure) into cleanroom)

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CPECs need to be placed in a separate room if compounding non-sterile and sterile HD UNLESS

Unless C-PECs used for nonsterile compounding are sufficiently effective that the room can maintain ISO 7 air throughout non-sterile compounding activity

If CEPCs are placed together in the same room, they must be:

placed at least 1 meter apart
particle-generating activity must not be performed when sterile compounding

Nonsterile HD compounding CPEC

externally vented (preferred) or reduntant HEPA filtered (CVE, Class 1 or 2 bSC, CACI)

Nonsterile HD compounding CSEC

Externaly vented 12 air changes per hour (ACPH) Negative pressure 0.01-0.03

Sterile HD compounding CPEC

iso class 7 buffer room + iso class 7 anteroom OR Unclassified C-SCA - Externally vented - Class 2 BSC - CACI

Sterile HD compounding CSEC

iso class 7 buffer room + iso class 7 anteroom - Externally vented 30 air changes per hour (ACPH) - negative pressure 0.01-0.03 -BUD described in 797 Unclassified C-SCA - Externally vented 12 ACPH - negative pressure 0.01-0.03 - BUD: 797 for category 1

Closed system transfer devices (CSTD)

Containment supplemental engineering controls -- drug transfer device that mechanically prohibits the transfer of contaminants into the system/escape

Example of Closed system transfer devices

Physical barrier or air cleaning technology

When MUST CSTDs be used?

when adminsitering antineoplastic HDs when dosage form allows

Can CSTDs be substitute for CPEC

NO, only offers an additonal level of protection

Caution use CSTDs

may have chemical or physical incompatibilities with specific HDs

Can you reuse HD PPE?

never

How many gloves when handling HDs?

2 pairs must meed ASTM standard 6978 Worn for any manipulation of HD

When sterile compounding HD, should wear ___ gloves

sterile gloves

When compounding chemo HD, should wear ___ gloves on the inside and _____ gloves on the outside

chemo specific gloves on inside Sterile gloves on outside

How often do you change gloves when handling HD?

every 30 minutes or when damaged

Gowns for HD compounding

disposable shown to resist permability to HDs Close in back

How often change gown?

every 2 to 3 hours immediately after spill/splash DO NOT WeAR to other areas

Head, hair, shoe, sleeve cover for HD

head/hair same as 797 Shoe cover = wear 2 pairs

When to wear shoe cover

second pair donned before enter CSEC doffed when leave CSEC

Adequate eye/face/resp protection against HD

eyeglasses/face shield alone not adequate Surgical mask do not provide adequate

Disposal of HD ppe

place in appropriate waste Dispose prior to exiting CSEC (room) Chemo gloves/sleeve covers discarded inside CPEC (hood) or placed in a sealed bag for discarding outside

Compounding HD requirements

Plastic backed prep mat should be palced on work surface of C-PEC Equipment should be for HD ONLY Powdered HDs should be handled in C-PEC

HD cleaning steps

1. deactivating 2. decontamination 3. cleaning 4. disinfection

Sodium hypochlorite (bleach)

Deactivates Decontaminates

Deactivation

makes compound inert - peroxide - bleach

Decontamination

removes HD residue - water - alcohol - bleach

Cleaning

removes organic and inorganic material - germicidal detergent

Disinfection

FOR STERILE COMPOUNDING destroys microorgansisms - EPA registered disinfectant

Spill control

Must be trained to do so (PPE + NIOSH respirator) Must have personnel and kits available Document circumstance/management of spill SOP developed

Environmental monitoring HD

Wipe sampling for HD surface residue routinely 1. interior of CPEC/equipment inside 2. pass through chambers 3. staging/work areas nearby 4. areas adjacent to CPEC 5. areas immediately outside buffer room/CSCA 6. patient administration areas

Are there specific guidelines for environemtal monitoring of HD?

NO, determine using facility specific baseline/action levels

Medical surveilllance

Enroll all workers that routinely handle HD Use to evaluate effectiveness of PPE/engineering controls ID exposure related health changes - prompt evaluation

Detailed recommendations on emplyee medical surveillance/follow up plans can be found in

USP 800

Role of RPH HD

protect (everyone) dispense (label, contain, dispose, dosage form) Niosh list vs risk