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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

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Task / E

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Route

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Severity

Score

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Tota

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Mitigations

Total

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Inh

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De

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exp

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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

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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.