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9/28/2020
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USP 800 Pearls:Technicians Are The Key To Compliance
Presented by: Joellyn Schefke B.A., CPhT, CSPT Pharmacy Quality Assurance Technician
Loyola University Medical CenterMaywood, IL
Preceptor: Alexa Anthaney, PharmD, BCPSClinical PharmacistMacNeal Hospital
Berwyn, IL
Conflict of Interest Declaration
• Joellyn Schefke: I or my spouse/partner have no actual or potential conflict of interest in relation to this activity.
• Alexa Anthaney: I or my spouse/partner have no actual or potential conflict of interest in relation to this activity.
Learning Objectives
Explain the rationale of why these guidelines are being put in place
Describe your facility’s readiness for USP 800
Identify areas where you can improve compliance
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What is USP 800?
“USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.”1
1 USP General Chapter Hazardous Drugs-Handling in Healthcare Settings. USP. https://www.usp.org/compounding/general-chapter-hazardous-
drugs-handling-healthcare.
Why USP 800?
• Over 200 hazardous drugs commonly used in healthcare setting
Public health need
USP 797 does not go beyond compounding
NIOSH provides very little guidance in handling*
Healthcare-Occupational Risks
• Largest array of agents that are hazardous to humans
• Estimated 8 million people exposed
• Range from acute symptoms to reproductive toxicity and cancer
Highlighting the Risk of Occupational Exposure to Hazardous Drugs in the Health Care Setting. Pharmacy Times. https://www.pharmacytimes.com/resource-centers/usp-800/highlighting-the-risk-of-occupational-exposure-to-hazardous-drugs-in-the-health-care-setting-.
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NIOSH List of Hazardous Drugs In Healthcare Settings
• National Institute for Occupational Safety and Health
• Concerns about occupational exposure began in the 1970’s
• First list published in 2004
NIOSH [2020]. Managing Hazardous Drug Exposures: Information for Healthcare Settings. By Hodson L, Ovesen J, Couch J, Hirst D, Lawson C, Lentz TJ, MacKenzie B, and Mead K. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 2020–XXX.
NIOSH Criteria
CarcinogenicityTeratogenicity or
other developmental toxicity
Reproductive Toxicity
Organ toxicity at low doses
Genotoxicity
Structure and toxicity profiles of new drugs that mimic existing
hazardous drugs
NIOSH List Categories
Table 1
• Meet NIOSH definition of hazardous drug
• Contain MHSI in the package insert
• Classified as “carcinogenic” or “probably carcinogenic”
Table 2
• Meet one or more of NIOSH definitions of hazardous drugs
• NOT classified as “carcinogenic” or “probably carcinogenic”
• Reproductive Hazards
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NIOSH Managing Hazardous Drug Exposures: Information for Healthcare Settings
Additional document drafted in 2020 to accompany drug list
Purpose is to help facilities perform risk assessments and create strategies to ensure staff safety
Includes “Table of Control” which lists manipulation scenarios and control approaches that need to be taken for each
Test Your Knowledge
What is the primary reason USP 800 was created?
a. To better maintain the sterility of hazardous drugs
b. To protect healthcare workers and patients from exposure to hazardous drugs
c. To better explain how hazardous drugs work
Facility List of HD’s
Every facility must maintain a list of every drug on the NIOSH list that the facility handles
List must be reviewed and updated at least every 12 months
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Designated Person
Every facility must have one
Qualified and trainedImplement procedures
and oversee complianceMaintain reports and
recordsCan be for USP 797 &
800
Pressures
Negative -0.01 to -0.03 inches of
water column
Neutral
No Pressurization
PositiveAt least 0.02 inches of water column relative to adjacent
areas
Buffer Room AnteRoom
Dwyer Instruments - Primer On How Our Products Work: Dwyer Instruments. (n.d.). Retrieved from https://www.dwyer-inst.com/Products/ManometerIntroduction.cfm. Reprinted with permission.
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PPEPPE must be worn during:
Receipt Storage Transport Compounding
Administration Cleaning Spill ControlWaste
Disposal
Garbing
GlovesWaterless Hand ScrubGownHand
HygieneMaskHair
Cover2 Shoe Covers
Gloves
Chemo Tested
Powder Free
Sterile
TWO Pairs
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Gowns
Disposable
HD Resistant
Long Sleeve
Back Closure
Doffing
Prior to Exit
• Outer gloves (inside PEC)
• Outer shoe cover
• HD Gown
• NO REUSE
Anteroom
• Mask
• Hair Cover
• Under Gown (If worn)
• Inner shoe cover
Receipt
YES
Neutral Pressure Area
Negative Pressure Area
NO
Positive Pressure area
Sterile compounding
area
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Receipt (continued)
Always wear gloves
Remove from tote
Wipe down outside
Transfer via Pass Through
Storage
Negative Pressure
Externally Vented
Anti-neoplastics separated
Test Your KnowledgeA pharmacy with limited space places both hazardous and non-hazardous medications in the same refrigerator in a negative pressure space. They then designate all drugs from that fridge as potentially contaminated and use all precautions. Is this acceptable?
a. Yes, as long as the hazardous drugs are separated from the non-hazardous inside the refrigerator.
b. No, hazardous drugs must be kept in a separate refrigerator.
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DeactivateRender a drug inert or inactive; no single agent deactivates all
HDs
DecontaminateMove a hazardous substance
(active or inactive) from a permanent surface to the surface
of a wipe for disposal
CleanRemove organic or inorganic
materials with a germicidal or sporicidal agent
DisinfectDestroy microorganisms with
disinfectant cleaner
Cleaning
Cleaning
Deactivate Disinfect
Happy PEC!
Decontaminate Clean
CompoundingAll USP 797 standards apply
CSTDs recommended
Preparation mat recommended
Work surface decontaminated between different HDs
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Administration
CSTDs Required
TWO Pairs of Gloves
Chemo Gown
Test Your KnowledgeA chemotherapy pharmacy practice has one pharmacist and one technician. The pharmacist is in the buffer room checking a preparation, and goes out to the anteroom to answer the phone. Do they need to remove all PPE is they come right back?
a. Yes, HD contaminated PPE must be removed prior to exiting the
buffer room
b. No, as long as they do not leave the anteroom
c. They only need to remove their HD gown
Preparation Checklist
Reprinted with permission from the International Journal of Pharmaceutical Compounding, Remington: The Science and Practice of Pharmacy
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CriteriaCurrent
StatusPlan Assigned To
Preliminary Work
Assemble a Hazardous Drug Library consisting of at least:
Source 1 - USP Chapter <800> Hazardous Drugs - Handling in healthcare Settings -
available most economically via purchase of USP's Compounding Compendium for $150
per year. http://www.usp.org/store/products/usp-compounding-compendium.
Source 2 - NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare
Settings, 2016
www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf
Source 3 - Controlling Occupational Exposure to Hazardous Drugs -
https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html
Source 4 - ASHP (American Society of Health-System Pharmacists) [2006]. Guidelines on
handling hazardous drugs. Am J of Health Syst Pharm 63:1172-1193.
https://www.ashp.org/doclibrary/bestpractices/prepgdlhazdrugs.aspx
Program Management - USP <800> Section 4
Concerning the Designated Person (DP) required to manage all aspects of hazardous drug
(HD) handling:
Create a job description for the DP including at least the following elements:
Creating and implementing procedures (typically in the form of SOPs) concerning HDs
Performing a documented annual review of these SOPs (as per Section 17 of USP
<800>)
Monitoring compliance with these SOPs and relevant rules and regulations
Ensuring worker competency (which reasonably also entails coordinating worker
training)
Ensuring "environmental control" of areas where HDs are found and handled, e.g.
through environmental wipe sampling
Overseeing facility monitoring, managing related documents, and acting on results,
including incident reports concerning HDs (as may be inferred from Section 10 of USP
<800>
Identify an individual to become DP.
Ensure that the DP has or obtains sufficient training, time and resources to fulfill his/her
duties.
Ensure that all workers understand the importance of the DP role, and are ready to support
it.
Developing and Maintaining a List of Hazardous Drugs - USP <800> Section 2
Create a hazardous drug and substance list by:
Identifying all drugs stocked or likely to be stocked that appear on the NIOSH List 2016
(Source 2 above)
Add additional hazardous or dangerous substances, e.g. strong acids or bases, toxic
cleaning agents, etc., as desired.
Make this list available to all workers with potential exposure to HDs
USP <800> Preparation Checklist
This checklist is a successor to the USP <800> Gap Analysis posted on the Compounding Today website approximately one year ago. It includes new information and recommendations as
to how best to comply with USP <800> by July 1, 2018.
It should be seen as an accessory to the Hazardous Drug Consensus Statement, which will be available free of charge on the Compounding Today website in the near future. This document
will provide in depth interpretations of USP <800> as well as best practice recommendations provided by a group of seasoned and diverse experts.
Reprinted with permission from the International Journal of
Pharmaceutical Compounding, Remington: The Science and Practice of Pharmacy
Engin
eerin
g
Contro
ls
Handlin
g
PP
E
Deactiv
atio
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/ Cle
anin
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Oth
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Task / E
xposure
Route
#
Severity
Score
Cum
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tive %
Tota
l Severity
Mitigations
Total
1 2 3 4 5
6 7 8 9 10
11 12 13 14 15
16 17 18 19 20
21 22 23 24 25
26 27 28 29 30
31 32 33 34 35
36 37 38 39 40
41 42 43 44 45
Inje
ction
Eye e
xpo
sure
Inge
stion
Inh
alation
De
rmal
exp
osu
re
Assessment Matrix
Exposure Route
Labeling and
Packaging
Ta
sk
Receipt
Compounding
Transport /
Dispensing
Administering
Deactivating and
Cleaning
Disposal
Spill Handling
Other:
Reprinted with permission from the International Journal of Pharmaceutical Compounding, Remington: The Science and Practice of Pharmacy
#Assigned
To
Target
Date
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Action Item Details
Gloves GownsSleeve
covers
Head /
Hair
Cover
Shoe
covers
Eye /
Face 12
Respiratory
Protection
Receipt & Storage
General 1 pair 2
Not in plastic 1 pair 2 BPR N95
Suspected breakage 1 pair 2 BPR N95 - BPR
Compounding 8
Nonsterile 2 pair 2 Yes 7 Optional 4 Yes 5 2 pair 11
Sterile 2 pair 2, 3 Yes 7 Optional 4 Yes 5 2 pair 11
Administration 2 pair 2, 6 13 Yes 1
Deactivation / Decontamination /
Cleaning / Disinfection
General 2 pair 2 Yes 7 BPR BPR 1, 9 FFR - BPR 12
Underneath C-PEC work surface2 pair 2 Yes 7 BPR BPR 1, 9 FFR - BPR 12
Above eye level 2 pair 2 Yes 7 BPR BPR Yes 1 FFR - BPR 12
Spills
General BPR BPR BPR Yes 1 N95
Spill too large for kit BPR BPR BPR Yes 1 FFR
Other suspected exposure to
powder, vaporBPR BPR BPR Yes 1 N95
Disposal BPR BPR
BPR-not mentioned in USP 800, but a reasonable best practice suggestion
N95 - fit-tested NIOSH-certified N95
FFR - full-face piece, fit-tested chemical cartridge-type respirator
Footnotes:
1 - can be provided by a full-face respirator (FFR); otherwise, must be goggles
3 - outer pair must be sterile for sterile compounding
4- impermeable material; disposable; must be sterile if used for sterile compounding
5 - including facial hair coverage as needed
6 - standard actually specifies antineoplastic administration
8-disposable items must not leave the area(s) involved in HD handling
9- if splashes likely
10-"if warranted"
11-outer pair put on / taken off when entering / exiting C-SEC
12-in general whenever splashes likely
13 - required only for antineoplastics; BPR otherwise
2 - American Society for Testing and Materials (ASTM) standard D6978 "chemo" gloves; unpowdered;
change at least every 30 minutes; inner glove under gown cuff, outer glove over gown cuff; remove
outer layer for labeling, other handling of final product; wash hands when removed
7-impermeable; disposable; back-closing; closed cuffs; change as per manufacturer recommendations
or every 2-3 hrs and after spill / splash
Reprinted with permission from the International Journal of Pharmaceutical Compounding, Remington: The Science and Practice of Pharmacy
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Sources• USP 800: USP General Chapter Hazardous Drugs - Handling in Healthcare Settings
https://www.usp.org/usp-chapter-800-download
• The Chapter 800 Answer Book: Kienle PC. The Chapter <800> Answer Book. Bethesda, MD: American Society of Health-System Pharmacists; 2017.
• NIOSH [2020]. NIOSH list of hazardous drugs in healthcare settings 2020. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP, Ovesen JL, Whittaker C. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2020-xxx (Supersedes 2016-161)
• NIOSH [2020]. Managing Hazardous Drug Exposures: Information for Healthcare Settings. By Hodson L, Ovesen J, Couch J, Hirst D, Lawson C, Lentz TJ, MacKenzie B, and Mead K. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 2020–XXX.