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Advisor Live® Webinar:

USP 800 Hazardous Drugs: Overview and

the Road to Readiness

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© 2019. All rights reserved. | Premier Inc. | 2© 2019. All rights reserved. | Premier Inc.

Advisor Live® Webinar:

USP 800 Hazardous Drugs: Overview and

the Road to Readiness

July 17, 2019

Listen to Today’s Audio: 800.926.6349

© 2019. All rights reserved. | Premier Inc. | 3

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Annie Lambert, PharmD

Director, Performance Partners

Chris Jones, RPh

Director, Pharmacy Automation & Technology

Today’s Speakers


Agenda

Overview of USP <800>

Road to Readiness

Challenging Scenarios

Premier Resources to Assist with USP Compliance

Question & Answer

Please Note: This content is provided for informational and discussion purposes

only and is not an official interpretation of the regulation.


USP Compounding Standards

*Source or Footnote = Arial Regular 8pt

USP <795>: Non-sterile compounding

➢ Describes requirements for the compounding process, facilities, equipment, components, documentation quality controls and training to promote patient safety.

USP <797>: Sterile Compounding

➢ Helps to ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. It describes a number of requirements, including responsibilities of compounding personnel, training, environmental monitoring, storage and testing of finished preparations.

USP <800>: Hazardous Drugs

➢ Provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.

USP <825>: Radiopharmaceuticals

➢ Provides the minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and non-sterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities.


Evolution of HD Guidelines and Standards

Organization Title Year/Revision

ONS Chemotherapy & Biotherapy Guidelines and

Recommendations for Practice

1984, 1988, 1996, 1999, 2001, 2005,

2009, 2014

ASHP Technical Assistance Bulletin / Guidelines on

Handling Cytotoxic and Hazardous Drugs

1985, 1990, 2006

OSHA Controlling Occupational Exposure to

Hazardous Drugs

1986, 1995, 1999, 2016

NIOSH Preventing Occupational Exposures to

Antineoplastic & Other Hazardous Drugs in

Health Care Settings

2004, 2010, 2012, 2014, 2016

USP <797> Sterile Compounding 2008, 2019

USP <800> Hazardous Drugs—Handling in Healthcare

Settings

2016

ONS = Oncology Nursing Society; OSHA = Occupational Safety &Health Administration; ASHP = American Society for Health

Systems Pharmacists; NIH = National Institute of Health; NIOSH = National Institute for Occupational Safety & Health; USP = United

States Pharmacopeia

12/1/19


USP <800> Hazardous Drugs

WHAT:

• Safety and quality standards to minimize risk of exposure to hazardous

drugs in health care settings.

• Defines Hazardous Drugs (HD)

– Allows for Assessment of Risk by entity

• Requirements for: facilities, storage and handling, PPE, training,

decontamination, documentation.

• Recommendations for environmental monitoring, medical surveillance.

• Refers to USP <795> and USP <797> for compounding standards

– Compendial applicability of USP <800> based on the extent of <795> and

<797>


USP <800> Hazardous Drugs

WHO:

• “Applies to all healthcare personnel who handle hazardous drug

preparations and all entities which store, prepare, transport, or administer

HDs.”

WHY:

• Over 8 million health care workers are exposed to hazardous drugs

annually.

• Well established risks of exposure to HD, acute and chronic

Intent to promote: Via:

• Patient safety Prevention

• Worker safety Containment

• Environmental protection Reduced exposure


Road to Compliance


Hazardous Drug List

• NIOSH List

– Formulary status

– Other drugs since 2016 list

– HD brought in to facility

• Identification of hazardous drugs

– Receiving and Storage

– Prepared

– Administered

– Disposal


NIOSH Hazardous Drug List


Assessment of Risk (AoR)

Assessment of Risk: required elements

• Type of HD i.e. non-antineoplastic, reproductive risk only

• Dosage form and packaging

– Bulk bottle, unit dose, oral solution, pre-mix IV solution

• Manipulation

– Cut, crush, sprinkle, reconstitute, pour, splash

• Alternative containment strategies…

– Silent Night, dedicated HD equipment, dedicated HD area

• …and work practices

– Additional PPE, decontaminating the product and/or work area

• Start with some broad strategies, then work down to the specific drugs

and dosage forms

• Think about WHY and WHAT processes support compliance


Assessment of Risk


Facilities--Engineering Controls

Focus on Containment

Antineoplastic HDs requiring manipulation other than counting or

repackaging of final dosage forms and any API must be stored in the

following manner:

• Separately from non-HDs

• In an externally ventilated, negative pressure room with at least 12 ACPH

• Refrigerated antineoplastic HDs must be stored in a dedicated

refrigerator in a negative pressure area with at least 12 ACPH

Other HDs e.g. Non-Antineoplastic (NIOSH group 2), reproductive risk only

(NIOSH group 3), and final dosage forms of antineoplastic HDs can be

stored with other inventory if this has been included in the entity’s policy


Facilities--Receiving and Storage

Focus on Containment

• Negative or neutral pressure OK for most HD handling activities

• Store HDs together vs mixed with regular stock

• Bins and shelving to prevent leaking or falling

• Dedicated counting tray and prep area/tools

• Clearly identify HD areas


Policies and Procedures

Pharmacy Times 11/14/18

https://www.pharmacytimes.com/resource-centers/usp-800/highlighting-the-risk-of-occupational-exposure-to-hazardous-drugs-in-the-health-care-setting-


Training

✓ Overview of HD List and risks associated

✓ Overview of SOPs

✓ Proper use of PPE

✓ Proper use of equipment and devices

✓ Response to exposure

✓ Spill management

✓ Disposal of HD and contaminated waste

• Who to include

• Any more job specific training or competency required


Monitoring

Oversight

• Designated person or committee

• Annual review

• Annual training

Recommended

• Medical surveillance

• Wipe sampling


Challenging Scenarios and

Possible Solutions


Methotrexate

Situation: methotrexate for ectopic pregnancy. Low volume, emergent

situation, needed 24/7

Background: anti-neoplastic drug requires compounding and full USP

<800> compliance:

• Negative pressure storage

• Compounding in C-PEC and C-SEC

• CSTD for administration

Options/Risk Assessment:

• Handle with full USP <800> precautions including mix in C-PEC/C-SEC

• Build out compliant pharmacy space

• Transport from another compliant pharmacy space

• Refer to or schedule at another facility

• Proceed with existing capabilities


GnRH/LHRH agonists

Situation: NIOSH Table 1 anti-neoplastic agents e.g. degarelix, goserelin,

leuprolide

Background: anti-neoplastic drug, requires manipulation of self-contained

formulation.

Options:


• Complete AoR to include details on dosage form and packaging; how the

product is manipulated and by whom; and alternative containment

strategies and work practices.

– Double gloves, gown, faceshield

– Consider CSTD use if feasible

– Consider product with least amount of manipulation

See USP <800> FAQs #21

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


BCG

Situation: NIOSH Table 1 anti-neoplastic agent commonly used in urology

offices

Background: products may or may not require reconstitution or

manipulation following the manufacturer’s instructions for use prior to

administration

Options/Risk Assessment:


• On site vs. off site--transport to urology clinic

• Consolidate services to location with compliant facilities

• Stop offering service if compliant options not feasible

• Consider scope and compendial applicability of USP <797> and USP

<800> and enforcement by state agencies or accrediting bodies

See statement from AUA and USP <800> FAQs

https://community.auanet.org/blogs/policy-brief/2019/06/05/usp-releases-updated-guidance-on-compounding-handl


Limited HD

Situation: Small pharmacy only has a few NIOSH HD in stock and not

enough space or funding for a negative pressure storage area.

Background: Many oral solid HD are only available as bulk bottles for

dispensing.

Options:

• Conduct AoR for drugs in stock

• Identify if any non-HD formulary substitutions are available

• Identify if any unit dose NDC are available

• Contact repackaging vendor for alternatives

• Provide dedicated counting tray, PPE and SOPs for handling

• Contain all HD in designated area


Premier Resources

Support Services for USP Compliance


Premier Safety Institute®

http://www.premierinc.com/safety


Cleanroom PPE, Cleaning Supplies, and Consumables

Current Suppliers:

• Acute Care Pharmaceuticals

• Contec, Inc.

• S2S Global (Premier subsidiary)

Includes:

Shoe covers, non-shedding Beard covers

Hair covers/hair bonnets Masks, sterile

Goggles Coats, non-shedding

Coveralls, non-shedding Gloves, sterile

Gloves, chemotherapy, sterile Gowns, non-shedding

Wipes, lint-free Alcohol pads/wipes

70% sterile isopropyl alcohol Sporicidals

Other disinfectant agents

Floor mops, non-shedding Media fill kits

Floor wipers, non-shedding Chemo spill kits


Capital Equipment- Primary Engineering Controls

Current Suppliers:

• The Baker Company

• NuAire, Inc.

Includes:

Containment Ventilated Enclosure (CVE)

Containment Primary Engineering Control (C-PEC)

Compounding aseptic containment isolators (CACI)

Key Considerations:

• Warranty and service guarantees

• Size configurations

• Accessories


Outsourced Services: Cleanroom Planning & Design

Cleanroom Planning and Design:

• Aseptic Enclosures

• Carter Health


Containment Supplemental Engineering Controls

Closed System Transfer Devices (CSTD’s):

BD CareFusion: PhaSeal

BD CareFusion: Texium

Bbraun: On-Guard

Hospira/ICU Medical: ChemoLock

Hospira/ICU Medical: Sprios


Capital Equipment- Cleanroom Automation

Cleanroom compounding robotic Suppliers:

• Omnicell- i.v. Station- ONCO

• ARxIUM- RIVA cGMP robot- (pending)


Outsourced Services- Oral HD Re-Packaging

Third party Supplier for HD Re-Packaging:

• SafeCor Health

• Meets <795> and <800>

requirements


Disposal

• New EPA requirements for hazardous waste disposal have been finalized

– When: Effective August 21st for most states

– Why: To keep hazardous drugs out of waterways and other environmental

areas

– Who is Impacted: Healthcare facilities that generate, accumulate, or

otherwise handle hazardous waste pharmaceuticals and reverse distributors

engaged in the management of prescription hazardous waste

pharmaceuticals

– What:

• Prohibits disposing of hazardous waste pharmaceuticals down the toilet or drain

(sewering)

• Differentiates between reverse logistics vs reverse distributors and clarifies that

hazardous pharmaceuticals moving through reverse distribution are considered

waste at the healthcare facility level

• Provides greater flexibility at the healthcare facility level regarding small quantities

and residual waste

• Imposes some new restrictions and requirements on healthcare facilities and

reverse distributors, including certain notification, training, container, labeling,

reporting, and recordkeeping requirements

• Exempts OTC nicotine replacement therapies

https://www.federalregister.gov/documents/2019/02/22/2019-01298/management-standards-for-hazardous-waste-pharmaceuticals-and-amendment-to-the-p075-listing-for


Get Ready and Stay Ready with Premier’s Support

General advice and

updates

Subject Matter

Experts

Consulting Services

- Gap analysis or organizational assessment

- Policies and procedures

- Training

- Mock surveys

Preparation Checklists


Resources

Preparation Checklists for USP <795> <797> <800>

GPO Contracts

USP Compliance Services for Non-Acute Sites of Practice

Premier Experts:

• Annie Lambert, PharmD – acute sites of practice

• Jennifer Valentine – non-acute sites of practice

• Chris Jones, RPh – GPO contracts

• Soumi Saha, PharmD, JD – advocacy

General Inquiries: [email protected]

https://www.premierinc.com/newsroom/education/your-2019-usp-preparation-checklist

https://communities.premierinc.com/display/PMR/Contracts

https://www.innovatix.com/usp800/

mailto:[email protected]






Annie Lambert, PharmD

Director, Performance Partners

Premier

253.651.2288

[email protected]

Chris Jones, RPh

Director, Pharmacy Automation & Technology

Premier

704.816.5783

[email protected]

Speakers Contact Information

Additional Resource

Jennifer Valentine - Program Manager, Specialty Pharmacy Management

[email protected]





Resources and References

USP <800> Gap Analysis

https://www.readyfor800.com/

http://797study.criticalpoint.info/

https://www.pppmag.com/article/2021

Assessment of Risk

http://www.ncbop.org/PDF/USP800PacketforNonCompoundingPharmacies

UPDATEDMarch2019.pdf

https://www.calhospital.org/sites/main/files/file-

attachments/ppp_1703_usp800_risk.pdf

https://www.readyfor800.com/

http://797study.criticalpoint.info/

https://www.pppmag.com/article/2021

http://www.ncbop.org/PDF/USP800PacketforNonCompoundingPharmaciesUPDATEDMarch2019.pdf

https://www.calhospital.org/sites/main/files/file-attachments/ppp_1703_usp800_risk.pdf

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