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compounding > Lecture 6: USP 800 > Flashcards

Lecture 6: USP 800 Flashcards

1
Q

Hazardous drug exposure

A

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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2
Q

National Institute for Occupational safety and health (NIOSH)

A

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

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3
Q

Mission of NIOSH

A

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

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4
Q

NIOSH list

A

list of antineoplastics and other HD

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5
Q

NIOSH considers drug to be hazardous if:

A

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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6
Q

NIOSH table 1

A

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

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7
Q

NIOSH table 2

A

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

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8
Q

Actual risk of HD is determined by

A

Toxicity of drug
how enter body
how handled

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9
Q

USP 800 protects who?

A

healthcare workers

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10
Q

USP 797 and 795 protects who?

A

patient

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11
Q

Nonsterile HD covered by

A

USP 795 and 800

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12
Q

Sterile HD covered by

A

USP 797 and 800

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13
Q

USP 800 only applicable when

A

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

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14
Q

List of NIOSH drug

A

must be maintained by an entity

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15
Q

NIOSH drug list must be reviewed

A

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

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16
Q

An entity must handle all NIOSH list drugs as hazardous UNLESS

A

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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17
Q

Containment PEC

A

ventilated device designed to minimize exposure

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18
Q

Selection of type of Containment PEC depends on

A

Type of compounding (sterile/nonsterile)
Type of SEC

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19
Q

Types of Containment PEC

A

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

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20
Q

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

A

Compounding aseptic containment isolator (CACI)

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21
Q

What type of LAFW is used for HD?

A

Vertical airflow

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22
Q

Containment SEC (the room) must be

A

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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23
Q

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

A

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

24
Q

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

A

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

25
Q

Nonsterile HD compounding CPEC

A

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

26
Q

Nonsterile HD compounding CSEC

A

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

27
Q

Sterile HD compounding CPEC

A

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

28
Q

Sterile HD compounding CSEC

A

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

29
Q

Closed system transfer devices (CSTD)

A

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

30
Q

Example of Closed system transfer devices

A

Physical barrier or air cleaning technology

31
Q

When MUST CSTDs be used?

A

when adminsitering antineoplastic HDs when dosage form allows

32
Q

Can CSTDs be substitute for CPEC

A

NO, only offers an additonal level of protection

33
Q

Caution use CSTDs

A

may have chemical or physical incompatibilities with specific HDs

34
Q

Can you reuse HD PPE?

A

never

35
Q

How many gloves when handling HDs?

A

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

36
Q

When sterile compounding HD, should wear ___ gloves

A

sterile gloves

37
Q

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

A

chemo specific gloves on inside
Sterile gloves on outside

38
Q

How often do you change gloves when handling HD?

A

every 30 minutes or when damaged

39
Q

Gowns for HD compounding

A

disposable
shown to resist permability to HDs
Close in back

40
Q

How often change gown?

A

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

41
Q

Head, hair, shoe, sleeve cover for HD

A

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

42
Q

When to wear shoe cover

A

second pair donned before enter CSEC
doffed when leave CSEC

43
Q

Adequate eye/face/resp protection against HD

A

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

44
Q

Disposal of HD ppe

A

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

45
Q

Compounding HD requirements

A

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

46
Q

HD cleaning steps

A
  1. deactivating
  2. decontamination
  3. cleaning
  4. disinfection
47
Q

Sodium hypochlorite (bleach)

A

Deactivates
Decontaminates

48
Q

Deactivation

A

makes compound inert
- peroxide
- bleach

49
Q

Decontamination

A

removes HD residue
- water
- alcohol
- bleach

50
Q

Cleaning

A

removes organic and inorganic material
- germicidal detergent

51
Q

Disinfection

A

FOR STERILE COMPOUNDING destroys microorgansisms
- EPA registered disinfectant

52
Q

Spill control

A

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

53
Q

Environmental monitoring HD

A

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

54
Q

Are there specific guidelines for environemtal monitoring of HD?

A

NO, determine using facility specific baseline/action levels

55
Q

Medical surveilllance

A

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

56
Q

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

A

USP 800

57
Q

Role of RPH HD

A

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

compounding (12 decks)

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