USP <797> and <800> Update

USP <797> and <800> Update USP <797> and <800> Update - Start

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Patricia C. Kienle, RPh, MPA, FASHP. Disclosure. Patricia Kienle is a member of the USP Compounding Expert Committee but this talk is not affiliated with nor endorsed by USP. Objectives - Pharmacists. ID: 741025 Download Presentation

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USP <797> and <800> Update




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Presentations text content in USP <797> and <800> Update

Slide1

USP <797> and <800> Update

Patricia C. Kienle, RPh, MPA, FASHP

Slide2

Disclosure

Patricia Kienle is a member of the USP Compounding Expert Committee but this talk is not affiliated with nor endorsed by USP

Slide3

Objectives - Pharmacists

Cite the status of the USP compounding chapters

Explain the types of facilities required for sterile compounding and for hazardous drug compounding

Define the types of environmental monitoring required for sterile and hazardous compounding

State the document that must be used to develop your hazardous drug list

List three alternative containment strategies and/or work practices that can be used to mitigate risks of hazardous drugs that are not

antineoplastics

Slide4

Objectives - Technicians

Differentiate the USP compounding chapters that are official now, and those that will be official

wthin

the next year

State the two types of IV rooms where compounded sterile preparations can be mixed

List the two required environmental monitoring tests required by USP <797>

State the organization that maintains the list of drugs that are hazardous to healthcare personnel

State the three types of engineering controls required by USP <800>

Slide5

Is your pharmacy compliant with USP <797> and <800>?

Yes, compliant with both

Compliant with <797> and working on <800>

Partially compliant with <797> and working on <800>

We’ve got a ways to go

Slide6

Status of USP Chapters

Chapter

Current

Future

<795>

2014

Probably

published for revision during 2015-2020 USP Committee cycle

<797>

2008

Proposed revised published for public comments in September 2015

Second

public comment proposed revision will be published

<800>

2016

Will be official on

December

1, 2019

Slide7

Legal Status of USP Chapters

Standards in USP-NF for compounded preparations may be enforced by

States (as pharmacy practice/compounding is traditionally regulated by state boards of pharmacy)

FDA (as compounded preparations remain subject to the adulteration and misbranding provisions of the FD&C Act which require conformance to certain USP-NF standards

Slide8

Major Changes in Proposed <797>

Removal of hazardous drug section

Intent to Revise will direct you to <800>

Change from three ingredient-based risk levels to two categories based on facility

Segregated Compounding Area

Cleanroom suite

Limited BUD for Category 1 for any PEC

Increased frequency of monitoring

Slide9

Dedicated Compounding Room

Massachusetts DCR

Only allowed in institutions

Only for non-hazardous, low-risk CSPs

C-SCA with classified air

Must be at least ISO 8

Slide10

Monitoring for Current <797>

Personnel

Media fill

Gloved fingertip tests

Environmental

Electronic air sampling

Surface sampling

Slide11

Purpose of USP <800

Approximately 8 million workers are potentially exposed to hazardous drugs (HDs) each year

<800> was developed to promote patient safety, worker safety, and environmental protection

Defines practice and quality standards for handling HDs

Builds on existing science, guidelines, and expertise

Slide12

Hazardous Drug Guidance

December 1, 2019

Slide13

Scope of <800>

Slide14

What is a Hazardous Drug?

Any drug identified by at least one of the following criteria

Carcinogenicity

Teratogenicity or other developmental toxicity

Reproductive toxicity

Organ toxicity at low doses

Genotoxicity

Structure and toxicity profile of new drug that mimics existing HD

Slide15

Scope of <800>

Slide16

Official Date of USP <800>

Official on

December 1, 2019

This is a recent change

Enforceable

Federal agencies

State agencies

Accreditation organizations

Slide17

Genesis of <800>

Slide18

Elements of <800>

Slide19

NIOSH Approach

USP <800> establishes the containment strategies and work practices best known to control hazardous drug contamination

Engineering controls

Protective equipment

Work practices

https://www.cdc.gov/niosh/topics/hierarchy/

Slide20

Key Elements of <800>

Slide21

NIOSH List of Hazardous Drugs

Hazardous to healthcare personnel

Different from EPA hazardous materials which are hazardous to the environment

Use of the list is required

Tables 1, 2, and 3

Use of Table 5 Personal Protective Equipment (PPE) is not required, but provides a comprehensive list for policy development

www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf

Slide22

What’s the status of your Assessment of Risk?

Completed

Identified list and working on Assessment

Need to get working on this

No need to do this since we don’t handle hazardous drugs

Slide23

Your HD List

Must contain all the HDs on the NIOSH list that you handle

Must be specific to the dosage form level

Slide24

Acknowledgement of Risk

OSHA

Hazard Communication Standard (HCS) is based on the concept that employees have both a need and a right to know the hazards and identifies the chemicals they are exposed to when working

<800>

Personnel of reproductive capability must confirm in writing that they understand the risks of handling HDs

https://www.pppmag.com/documents/V8N10/CC/PDFs/HazDrugRisk_Acknowledg.pdf

Slide25

NIOSH List of Antineoplastics and Other Hazardous Drugs

Slide26

Your Options

Handle all drugs and dosage forms with all containment and work practices listed in <800>

Perform an Assessment of Risk to determine alternative containment strategies and work practices

Slide27

What Drugs Can Be Handled Differently?

All <800>

Precautions

Apply

Can Be

Included in

Assessment of Risk

API of any HD on the list

Antineoplastics that only need to be counted or packaged

Antineoplastics that need to be manipulated

Table

2 drugs

Items that don’t fit the Assessment of

Risk

Table 3 drugs

Slide28

Active Pharmaceutical Ingredient

Any substance or mixture of substances intended to be used in the compounding of a drug preparation

“Raw chemical”

NOT finished dosage forms

Slide29

Compliance with All <800> Elements

Facilities

Containment Primary Engineering Control (C-PEC)

Containment Secondary Engineering Control (C-SEC)

Personal Protective Equipment (PPE)

Work practices

Policies and procedures

Containment from receiving to dispensing

Decontamination of work surfaces

Slide30

OK to Consider for Assessment of Risk

Antineoplastics that only need to be counted or packaged

Non-antineoplastic meds (Table 2)

Reproductive-only hazards (Table 3)

Slide31

OK to Consider forAssessment of Risk

Situation

Yes

No

Dispense methotrexate tablets

Pour

megestrol

suspension into bottle

Dispense conventionally-manufactured

fluorouracil cream

Mix

fosphenytoin

in the IV room

ICU

nurse mixes

fosphenytoin

IV

Dispense premixed oxytocin

infusion

Slide32

OK to Consider forAssessment of Risk

Situation

Yes

No

Dispense methotrexate tablets

Pour

megestrol

suspension into bottle

Dispense conventionally-manufactured

fluorouracil cream

Mix

fosphenytoin

in the IV room

ICU

nurse mixes

fosphenytoin

IV

Dispense premixed oxytocin

infusion

Slide33

Alternative Strategy Examples

Purchase unit-dose or unit-of-use

Store in lidded bins

Use closed system drug-transfer devices (CSTDs)

Handle with chemo gloves

Designate tackle boxes for transport

Slide34

“Must” vs “Should”

Must or shall = requirement

Should = recommendation

Use of CSTDs for compounding

Wipe samples for environmental sampling

Medical surveillance

Photo courtesy of USP

Slide35

Receiving and Storage

HDs can be received in the same area as other drugs

Should have a designated area

Can be neutral/normal or negative pressure

Cannot be positive pressure

HDs (unless entity-exempt through the Assessment of Risk)

Must be stored with proper containment

Slide36

Containment Primary Engineering Controls

C-PEC = PEC

Nonsterile compounding

Containment ventilated enclosure (CVE)

Sterile compounding

Biological safety cabinet (BSC)

Compounding aseptic containment isolator (CACI)

Slide37

Minimum Room Requirements

Contains hazard

Removes hazard

Slide38

What’s Allowed – What’s Not

Configuration

Allowed in <797>

Allowed in <800>

Cleanroom suite: ISO 7 positive anteroom opening into ISO 7 negative buffer room (30 ACPH)

Yes, with negative

pressure of at least 0.01” negative to adjacent space

Yes, with pressure range of 0.01 to 0.03” negative to adjacent

space

Low use exemption

Yes

No

Containment Segregated Compounding Area

Not addressed in <797>

Yes if externally vented and pressure range of 0.01 to 0.03” negative to adjacent

space, but limited to 12 hour BUD

CACI in negative room with 12 ACPH

Yes, optimally vented

BSC outside of cleanroom

No

Slide39

Containment Segregated Compounding Area

Four minimum characteristics

Does not need to be ISO classified

No requirement for HEPA-filtered ceiling air

But … limited to 12 hour beyond-use time

Slide40

Closed System Drug-Transfer Devices (CSTDs)

CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor

Required for administration when the dosage form allows

Recommended for use when compounding

Photo courtesy of BD

Slide41

Personal Protective Equipment

Mask (to protect the preparation)

Hair covers

Shoe covers

Gloves tested to ASTM D6978

Gowns that are impervious, close in back, knit or elastic sleeves

Respirator (to protect the compounder)

Eye protection

Disposable PPE

cannot be

re-used

Slide42

Work Practices

Policies and procedures

Containment

Outside of container once compound completed

Waiting for patient pickup or transfer to administration area

PPE

Two pairs of shoe covers in negative space

Outer pair removed prior to entering anteroom

Decontamination procedures

Slide43

Cleaning Process for HDs

Slide44

Cleaning Steps

Function

Agent

Deactivate and decontaminate

Properly-diluted

EPA-approved oxidizer intended for use with HDs

Clean

Germicidal

detergent

Disinfect

70%

isopropyl alcohol (sterile for sterile compounding)

Slide45

Decontamination

Under work tray of BSC or CAI

Counting trays and spatulas

Outside of containers

Photo courtesy of

Contec

, Inc.

Slide46

Resources for <797>

USP website

www.usp.org

ASHP Sterile Compounding Resource Center

Slide47

Resources for <800>

USP <800> FAQs

http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

www.readyfor800.com

One hour panel discussion (physician, nurse, pharmacist

Short (~5 minute) videos targeted to specific audiences

Ready for 800 checklist

Perform an Assessment of Risk to Comply with USP <800>

Pharmacy Purchasing and Products (

www.pppmag.com

), March 2017

Slide48

References for <800>

www.ashp.org

www.hazmedsafety.com

www.ons.org

Slide49


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