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NYS MPJE 2024 > Compounding: USP 800 > Flashcards

Compounding: USP 800 Flashcards

1
Q

What’s the hazardous drug list called?

A

NIOSH (duh)

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2
Q

What needs to be kept in every pharmacy?

A

NIOSH list

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3
Q

Purpose of the NIOSH list

A

Provides information to identify potential hazardous drugs

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4
Q

Each entity is responsible to do what with the NIOSH list?

A

Review specific information to determine drugs that are hazardous, including investigational drugs

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5
Q

What if there’s not enough information to determine whether or not a drug is hazardous?

A

Treat it as hazardous until more info is available

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6
Q

How can some hazardous drugs actually not post significant risk of direct occupational exposure?

A

If they’re intact capsules and tablets that are given without modifying the formulation

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7
Q

When can hazardous drugs pose a risk in preparation?

A

If you have to split tablets, open capsules, etc.

Basically anything that will cause dust to fly around- perform an assessment of risk!

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8
Q

Types of exposure to hazardous drugs

A

Dermal and mucosal absorption
Inhalation
Injection
Ingestion

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9
Q

Opportunities for hazardous drug exposure

A

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

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10
Q

Facilites and engineering controls for HDs: signage

A

Signs should designate the hazard and displayed before the entrance to the HD handling areas

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11
Q

Facilities and engineering controls for HDs: access to HD areas

A

Has to be restricted to authorized personnel to protect people not involved in HD handling

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12
Q

Facilites and engineering controls for HDs: where should HD handling areas be?

A

Away from break rooms and refreshment areas for personnel, patients, or visitors to reduce risk of exposure

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13
Q

Responsibilites of personnel handling HDs: who has to be there?

A

A designated person

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14
Q

Responsibilities of a designated person: USP 800

A

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

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15
Q

Designated areas for HD handling

A

Receipt and unpacking
Storage of HDs
Nonsterile HD compounding, PRN
Sterile HD compounding, PRN

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16
Q

USP 800 compounding specifics: engineering controls (in regard to the PEC and SEC)

A

PEC has to be a containment PEC (C-PEC) at ISO 5 or better
SEC has to be a containment SEC (C-SEC)

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17
Q

USP 800 compounding specifics: sterile and nonsterile products must be compounded where?

A

Within a C-PEC that’s located in a C-SEC

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18
Q

Requirements of the C-SEC and C-PEC

A

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

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19
Q

C-PEC engineering controls for USP 800

A

ISO 5 air
Externally vented, or redundant HEPA filters

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20
Q

Examples of C-PECs used in HD compounding

A

CVE, Class I or II BSC, CACI

21
Q

C-SEC requirements for USP 800: how is it vented, how many ACPH does it need, and what kind of pressure does it need?

A

Externally vented
12 ACPH
Negative pressure

22
Q

Engineering controls for sterile HD compounding: C-PEC with an ISO 7 buffer room and an ISO 7 anteroom

A

Externally vented Class II BSC or CACI

23
Q

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

A

Externally vented
30 ACPH
Negative pressure

24
Q

Engineering controls for sterile HD compounding: C-PEC in an unclassified C-SCA

A

Externally vented Class II BSC or CACI

25
Q

Engineering controls for sterile HD compounding: C-SEC in an unclassified C-SCA: how is it vented, ACPH, and what kind of pressure?

A

Externally vented
12 ACPH
Negative pressure

26
Q

USP 800: personnel training should occur initially when?

A

Before working with HDs (duh)

27
Q

USP 800: how often should personnel be reassessed?

A

Every 12 months

28
Q

USP 800: what should personnel training include?

A

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

29
Q

PPE used in USP 800 compounding

A

Gloves
Gowns
Head, hair, shoe, sleeve covers
Eye and face protection
Respiratory protection
Disposal of used PPE

30
Q

Gowning and PPE: what’s required to wear for compounding sterile and nonsterile HDs?

A

gowns
head, hair, shoe covers
2 pairs of chemo gloves

31
Q

When should you wear PPE with HDs?

A

Receipt, storage, cleaning, transport, compounding, administration, deactivation, spill control, waste disposal

32
Q

Specifics on the type of gloves worn

A

Powder-free gloves

33
Q

Specifics on the type of chemo gowns worn

A

Must be disposable and resist permeability by HDs
Must close in the back
Long-sleeves
Closed cuffs

34
Q

How often should you change a gown when compounding HDs?

A

Every 2-3 hours or immediately after a spill/splash

35
Q

2 pairs of what should be worn before compounding HDs?

A

Gloves and shoes

36
Q

Eyewear for HD compounding

A

Face shields in combination with goggles

37
Q

Respiratory protection for HD compounding

A

N95 respirator

38
Q

Disposal of HD compounding waste: what goes in the black bin

A

Bulk waste that contains a clearly visible amount of HD and any supplies used to administer HDs or cleaning up HD spills

39
Q

Disposal of HD compounding waste: what goes in the yellow bin

A

Trace HD waste: empty syringes, IV bags, used PPE like gowns, gloves, masks, and shoe covers

40
Q

Disposal of HD waste: what goes in the red bin

A

Infectious waste like IV tubing and used culture dishes

41
Q

How often should chemo gloves be replaced when compounding HD drugs?

A

Every 30 minutes or when torn, punctured, or contaminated

42
Q

HD compounding procedures: where to unpack HDs

A

In an area that’s neutral/normal or negative pressure relative to surrounding areas

43
Q

HD compounding procedures: where to NOT unpack them

A

From shipping containers in sterile compounding areas or in positive pressure areas

44
Q

HD storage

A

Store them in a way that prevents spillage/breakage if the container falls, DON’T STORE ON THE FLOOR

45
Q

How to store antineoplastic HDs requiring manipulation other than counting/repackaging

A

Store separately from non-HDs in a manner that prevents contamination and personnel exposure- store them in an externally ventilated negative-pressure room

46
Q

Can you store sterile and nonsterile HDs together?

A

Yes, but HDs used for nonsterile compounding shouldn’t be stored in areas for HDs used for sterile compounding

47
Q

How to store antineoplastic HDs that need to be in a fridge

A

The fridge has to be in a negative pressure area

48
Q

Can you place 2 C-PECs, one used for nonsterile and the other used for sterile HD compounding, in the same room?

A

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

NYS MPJE 2024 (27 decks)

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