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Professional Practice 2 > Week 6: USP 800 > Flashcards

Week 6: USP 800 Flashcards

(44 cards)

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1
Q

Hazardous Drug Exposure

A
  • can cause toxicity to those that handle them in any manner
  • healthcare workers face significant risk of being exposed to HDs
  • pharmacists and pharmacy technicians with high risk due to repeated exposures
  • studies have shown fertility impairment and increased risk of cancers due to occupational exposure to HDs
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2
Q

personnel at risk

A
  1. pharmacists
  2. pharmacy technicians
  3. nurses
  4. home health aides, nurses’ aides
  5. physicians, physician assistants
  6. veterinarians, veterinary technicians
  7. housekeeping, janitorial services, environmental services
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3
Q

NIOSH

A

national institute for occupational safety and health
1. OSHA (occupational safety and health act of 1970) established NIOSH as a research agency focused on the study of worker safety and health
2. part of the CDC
3. mission: to develop new knowledge in the field of occupational safety and health to transfer that knowledge into practice

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4
Q

NIOSH list

A

NIOSH maintains a list of antineoplastic and other HDs used in healthcare settings (first published in 2004)
1. table 1: antineoplastic drugs
2. table 2: non-antineoplastic drugs that neet one or more of the NIOSH criteria for a hazardous drug

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5
Q

NIOSH considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals:

A
  1. carcinogenicity (cancer causing)
  2. teratogenicity / developmental toxicity
  3. reproductive toxicity (infertility)
  4. organ toxicity at low doses
  5. genotoxicity (damages DNA, which can cause cancer)
  6. structure and toxicity profiles of new drugs that mimic existing hazardous drugs
  7. labeled by the manufacturer with special handling instructions
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6
Q

USP General Chapter 800 publication

A
  • published on february 1st, 2016
  • “official” on december 1st, 2019 (initially an informational chapter)
  • compendially applicable on november 1st, 2023 (enforced by state agencies and other regulators)
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7
Q

USP General Chapter 800 definition

A
  • provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and the environment (795 and 797 protects patients while 800 protects healthcare workers)
  • covers handling of sterile (797 and 800) and nonsterile (795 and 800) HDs
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8
Q

table of contents for USP 800

A
  • introduction and scope
  • list of hazardous drugs
  • types of exposure
  • responsibilities of personnel handling hazardous drugs
  • facilities and engineering controls
  • environmental quality and control
  • personal protective equipment
  • hazard communication program
  • personnel training
  • receiving
  • labeling, packaging, transport and disposal
  • dispensing final dosage forms
  • compounding
  • administering
  • deactivating, decontaminating, cleaning and disifecting
  • spill control
  • documentation and standard operating procedures
  • medical surveillance
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9
Q

list of hazardous drugs

A

NIOSH performs hazard idenitification for drug –> placed on NIOSH list
1. actual risk is determined by the toxicity of the drug, how the drug enters the body, how the drugs are handled
2. how they are manipulated/compounded, how often this happens, and what PPE, PEC is used

an entity must maintain a list of NIOSH drugs that they currently handle (list must be reviewed every 12 months whenever a new agent/dosage form is used)

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10
Q

assessment of risk

A
  • an entity must handle all NIOSH list drugs as hazardous or can perform an assessment of risk (avoid having to follow USP 800 for low risk HDs dispensed without manipulation)
  • only for low risk activities (counting, prepacking, not for compounding/manipulation)
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11
Q

assessment of risk must consider

A
  • type of HD
  • dosage form
  • risk of exposure
  • packaging
  • manipulation

if the assessment of risk is performed, entity must document alternative containment strategies for specific dosage forms

if assessment of risk is used, must. be reviewed and documented every 12 months

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12
Q

facilities and engineering controls

A
  • containment-primary engineering control (CPEC)
  • contaiment-secondary engineering control (CSEC)
  • containment-segregated compounding area (CSCA)
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13
Q

CPEC for HDs

A
  • ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs
  • selection of type will depend on type of compounding (sterile or nonsterile) and type of secondary engineering control
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14
Q

types of CPEC

A
  • CVE: containment ventilated enclosure - powder containment hoods with HEPA-filtered air and negative air pressure (nonsterile compounding ONLY)
  • BSC: biological safety cabinet - vertical laminar airflow and negative air pressure for sterile compounding, must be class II or class III
  • CACI: compounding aseptic containment isolator - closed front CPECs that can be located in a buffer room or CSCA
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15
Q

CSECs for HDs

A
  • the room in which the CPEC is placed
  • must be externally ventilated, physically separated, have an appropriate air exchange (sterile versus nonsterile), have a negative pressure
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16
Q

nonsterile and sterile HD space

A

permissible to compound nonsterile and sterile HDs in the same place only if:
1. CPECs used for nonsterile compounding are sufficiently effective that the room can maintain ISO 7 air throughout nonsterile compounding activity
2. if there are separate sterile and nonsterile CPECs in the same CSEC, must be placed at least 1 meter apart
3. particle generating activity must not be performed when sterile compounding occurs
4. occasional nonsterile HD compounding can be completed in a sterile CPEC but must be decontaminated cleaned and disinfected before using to compound sterile HDs

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17
Q

air pressure

A

differential air pressure required between spaces to keep air enclosed OR permit air to enter (must have negative air pressure)

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18
Q

air changes per hour (acph)

Study These Flashcards
A
  • nonsterile HDs: 12 acph
  • sterile CSEC: 30 acph (same for sterile SEC for non HDs)
  • CSCA: 12 acph
19
Q

air quality

Study These Flashcards
A
  • air that has been contaminated with HDs must be externally exhausted
  • if cannot be externally exhausted, alternative for nonsterile HDs is to use redundant HEPA filtration (passed through two or more HEPA filters in a series)
20
Q

nonsterile HD compounding

Study These Flashcards
A
  • CPEC: externally vented (preferred) or redundant-HEPA filtered in series (CVE, Class I or II BSC, CACI)
  • C-SEC: externally vented with 12 acph and negative pressure
21
Q

sterile HD compounding

Study These Flashcards
A

ISO class 7 buffer room with an ISO class 7 anteroom

CPEC
1. externally vented
2. class II or II BSC or CACI

CSEC
1. externally vented
2. 30 acph
3. negative pressure

unclassified CSCA
1. CPEC same as above
2. CSEC same as above except 12 acph

22
Q

containment supplemental engineering controls

Study These Flashcards
A
  • closed system transfer devices
  • NIOSH: a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system (physical barrier or air cleaning technology)
23
Q

closed system transfer devices

Study These Flashcards
A
  • offer additional level of protection during compounding, administration
  • not a substitute for CPEC
  • should be used for compounding HDs when dosage form allowd
  • must be used when administering antineoplastic HDs when dosage form allows
  • caution: physical/chemical incompatibilitirs with specific HDs
  • examples: BD PhaSeal Optima, Bbraun OnGuard 2, ICUMedical, Equashield
23
Q

hazardous drug storage

Study These Flashcards
A
  • stored separately
  • externally vented, negative pressure room
  • 12 acph
24
PPE for HDs
gowns, head, hair, shoe covers and two pairs of gloves are required for compounding sterile and nonsterile HDs
25
when handling HDs, proper PPE must be worn during
compounding, receipt, storage, transport, administration, cleaning, waste disposal proper use: donning/doffing should be defined in facility SOP
26
PPE for administering HDs
* antineoplastics HDs - two pair of chemo gloves * injectable antineoplastic HDs - also need chemo gown * all other HD administration - per hospital policy
27
HD PPE: Gloves
* two pairs * must meet american society for testing materials standard d6978 * worn for handling all HDs * sterile outer gloves when sterile compounding * changed every 30 minutes or when damaged * hands washed with soap and water after removing gloves
28
HD PPE: gowns
* disposable * shown to resist permeability by HDs * close in the back * changed every 2-3 hours, or immediately after spill/splash * gowns worn in HD areas must not be worn in other areas
29
HD PPE: eye and face
* risk for spills/splashes, cleaning a spill * goggles in combo with face shield optimal
29
HD PPE: head, hair, shoe, sleeve covers
* second pair of shoe covers donned before entering CSEC and doffed when exiting the CSEC * disposable sleeve covers may be used to protect areas of the arm that may come into contact with HDs
30
HD PPE: respiratory
* surgical masks do not provide adequate protection * n95 sufficient for most HD compounding
31
additional respiratory protection is needed if direct HD exposure examples
1. cleaning under the work surface of the CPEC; cleaning up large spills, known airborne exposure to HD powders or vapors 2. respirator mask with has canisters (gas mask) 3. powered air purifying respirator (PAPR)
32
disposal of PPE
* yellow container used for all trace antineoplastic waste (empty vials, empty syringes, empty containers, used PPE, chemo pads) - destroyed by incineration * black containers used for all bulk antineoplastic waste (unused or partially used HD IV bags, syringes and vials) - destroyed by incineration * remover outer glove before handling/labeling the CNSP/CSP * chemo gown and outer show covers discarded before leaving CSEC * Remainder of grab removed when leaving the ante room or C-SCA once compounding is complete
33
hazard communication program
written plan that details implementation of HD safety procedures, proper personnel training, competency assessment, and maintaining a list of all required HD documentation 1. desginated person is responsible 2. pharmacies must keep a list of all HDs stocked; list reviewed every 12 months or when new drug added 3. anyone with reproductive capability must confirm in writing that they understand the risks
34
compounding
* must be compliant with 795 or 797 * when compounding in CPEC a plastic backed prep mat should be on work surface (chemo pad) * equipment used should be dedicated for use with HDs * powdered HDs should be handled in a CPEC, especially during particle generating activities * HD tablets/capsules cannot be put into automated counting or packaging machines
35
transporting HDs
* transported in containers that minimize the risk of breakage or leakage * pneumatic tubes must not be used for any liquid HDs or table 1 antineoplastics * conduct assessment of risk and develop SOPs
36
HD sanitizing steps
1. deactivation: renders compound inert or inactive (peroxide formulation, sodium hypochlorite) 2. decontamination: removes HD residue (may include water, alcohol, peroxide, or sodium hypochlorite) 3. cleaning: removes organic and inorganic material (germicidal detergent) 4. disinfection (for sterile compounding): destroys microorganisms (EPA-registered disinfectant and/or sterile alcool as appropriate)
37
spills: personnel
* all personnel must be trained in spill management and the use of PPE and NIOSH certified respirators * SOPs developed to prevent spills and direct the cleanup * SDS provide drug specific safety info
38
what materials contained in spill kits need to be readily available for HD spills in all areas that HDs are routinely handled?
1. protective gown 2. latex gloves 3. n95 4. goggles with side shields 5. HD waste bag, scoop and scraper, chemo pads 6. HD spill report exposure form
39
order of how to clean spills
1. open the spill kit and don PPE 2. clean up large amounts of spilled drug and broken glass 3. cover liquid with absorbent spill pad 4. decontaminate the surfaces where the HD spilled 5. put trash in a hazardous waste bag and seal 6. doff PPE and perform hand hygiene 7. decontaminate respirator if needed 8. replace the spill kit
40
environmental quality and control
environmental wipe sampling for HD surface residue should be performed every 6 months to ensure hazardous residue is contained should include: 1. interior of CPEC and equipment within 2. pass through chambers 3. surfaces in staging or work areas near CPEC 4. areas adjacent to CPECs 5. areas immediately outside the HD buffer room or the CSCA 6. patient administration areas
41
medical surveillance
* healthcare workers who routinely handle HDs should be enrolled in a medical surveillance program * purpose: minimize adverse effects in personnel potentially exposed to HDs * can be used to evaluate effectiveness of PPE and engineering controls * identification of exposure-related health changes should prompt evaluation of PPE anf preventative measures
42
role of the pharmacist
* responsibility to protext ourselves, our colleagues, and other healthcare workers * appropriate labeling, containment, disposal * how does dosage form factor into decision making * NIOSH list v. assessment of risk

Professional Practice 2 (3 decks)

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