9/30/2018 1 9/30/2018 USP <800>: A Guide for Community and - - PDF document

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NCPA 2018 Annual Convention

USP <800>: A Guide for Community and Long-Term Care Pharmacy

Brenda Jensen CPhT, CNMT, MBA Compounding Consultants, LLC

Disclosure

Brenda Jensen is an owner of Compounding Consultants, LLC. The conflict of interest was resolved by peer review of the content. The views and opinions expressed are those of the speaker and are not endorsed by or affiliated with USP.

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Learning Objectives

• 1. Review important updates to USP standards and the

impact on community pharmacy, particularly in the LTC space.

• 2. Identify common medications most likely impacted by USP

<800> standards.

• 3. Discuss best practices for preparing your practice site for

implementation.

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Timeline associated for the proposed revisions to <795> and <797> and

• pportunities to engage with USP and provide input.

http://www.usp.org/compounding/updates-on-standards

Who Does USP <800> Apply To?

All facilities where hazardous drugs are handled.

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Facility Requirements

• Designated areas must be available for:
• Receipt and unpacking
• Storage of HDs
• Nonsterile HD compounding (if performed)
• Sterile HD compounding (if performed)
• Certain areas are required to have negative pressure from

surrounding areas to contain HDs and minimize risk of exposure.

Facility Requirements

• Access to areas where HDs are handled must be restricted

to authorized personnel to protect persons not involved in HD handling.

• HD handling areas must be located away from breakrooms

and refreshment areas for personnel, patients, or visitors to reduce risk of exposure.

• Signs designating the hazard must be prominently displayed

before the entrance to the HD handling areas.

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Engineering Controls

• Containment primary engineering control (C-PEC) is a

ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs. Examples: BSC, CACI.

• Containment secondary engineering control (C-SEC) is the

room in which the C-PEC is placed.

• Supplemental engineering controls [e.g., closed-system

drug-transfer device (CSTD)] are adjunct controls to offer additional levels of protection.

Engineering Controls – HD Storage

• C-SEC requires fixed walls, external venting, minimum of 12

ACPH and negative pressure between 0.01 and 0.03 inches

• f water column relative to all adjacent areas.
• Refrigerated antineoplastic HDs must be stored in a

dedicated refrigerator in a negative pressure area with at least 12 ACPH.

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Engineering Controls – Nonsterile Compounding

• C-PEC must be located in a C-SEC with fixed walls.
• C-PEC used for compounding nonsterile HDs must be

externally vented or have redundant HEPA filters in series.

• C-SEC requires external venting, minimum of 12 ACPH and

negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas.

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Designated Person

• Develops and implements appropriate procedures.
• Oversees compliance.
• Ensures competency of personnel.
• Ensures environmental control of HD areas.
• Understands the rationale for risk-prevention policies.
• Oversees monitoring of facility.

List of Hazardous Drugs (HDs)

• An entity must maintain a list of HDs, which must include

any items on the current NIOSH list that it handles.

• The list must be reviewed at least every 12 months.
• Whenever a new agent or dosage form is used, it should be

reviewed against the entity's list.

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Common Hazardous Drugs (HDs)

• Table 1

Anastrazole, Letrozole, Methotrexate, Tamoxifen

• Table 2

Carbemazepine, Azathioprine, Phenytoin, Spironolactone, Tacrolimus

• Table 3

Clonazepam, Fluconazole, Paroxetine, Temazepam, Topiramate, Warfarin

<800> Hazardous Drug SOPs

• Receipt
• Storage
• Compounding
• Dispensing
• Administration
• Disposal and Spill Management
• Transport

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<800> Hazardous Drug SOPs

For each hazardous drug handling activity include:

• Location and environmental monitoring requirements.
• Who is permitted to perform the activity (and what

training and competency is needed).

• PPE and hand-hygiene requirements.
• HD handling procedure.
• Cleaning procedure.

<800> Hazardous Drug SOPs - Receipt

In addition to the above

• Use of tiered approach, starting with visual examination of

the shipping container.

• Handling of damaged packages.
• Spill kit must be accessible in the receiving area.
• Must not be done in positive pressure environment.

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<800> Hazardous Drug SOPs - Storage

In addition

• HDs must be stored in a manner that prevents spillage or

breakage if the container falls. In areas prone to natural disasters the manner of storage must meet applicable safety precautions.

• Do not store HDs on the floor.
• Need AOR for storage outside of containment secondary

engineering control (C-SEC).

<800> Hazardous Drug SOPs - Compounding

In addition

• Comply with the appropriate USP standards for

compounding.

• Equipment must be dedicated for use with HDs.
• Equipment use, maintenance and cleaning.
• Need AOR for compounding outside of containment

primary or secondary engineering control (C-PEC or C-SEC).

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<800> Hazardous Drug SOPs - Dispensing

In addition

• Counting and repackaging equipment should be dedicated

for use with HDs and should be decontaminated after every use.

• Antineoplastic HDs must not be placed in automated

counting or packaging machines.

• Pneumatic tubes must not be used to transport any liquid

HDs or any antineoplastic HDs.

<800> Hazardous Drug SOPs - Administration

In addition

• Use of protective medical devices and techniques.
• Use of CSTD with antineoplastic HDs if dosage form allows.
• Use of techniques/devices that minimize risk of open

systems.

• Avoid manipulating HDs (e.g. crushing tablets or opening

capsules). If not possible, don appropriate PPE and use a plastic pouch to contain any dust or particles generated.

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<800> Hazardous Drug SOPs - Disposal

In addition

• Consider all PPE worn when handling HDs to be

contaminated with, at minimum, trace quantities of HDs.

• Place waste in an appropriate waste container and further

disposed of per jurisdictional regulations.

• Refer to SDS Section 13 for disposal considerations that

meet federal requirements. Refer to state/local law for additional requirements.

<800> Hazardous Drug SOPs – Spill Management

In addition

• Include clean-up of spills (address the size and scope), use
• f spill kit, location of spill kits and clean-up materials, PPE

requirements, and specify who is responsible for spill management.

• Prevention of accidental exposures or spills.
• Use of Safety Data Sheets (SDS).
• Response to known or suspected HD exposure.

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<800> Hazardous Drug SOPs – Transport

In addition

• Address appropriate shipping containers and packaging

materials.

• Ensure labels include storage instructions, disposal

instructions, and HD category information in a format consistent with the carrier's policies.

• Refer to SDS Section 14 for transport information.
• Address use of exposure-reducing strategies.

<800> Hazardous Drug SOPs – Recommended

• Hazard communication program (required by federal law)
• Occupational safety program (required by federal law)
• Hand hygiene for each HD handling scenario.
• Washing of contaminated non-disposable clothing.
• Environmental monitoring

(e.g., wipe sampling) – If performed.

• Medical surveillance – If performed.

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Summary of Training Requirements

• All personnel who handle HDs or who perform custodial

waste removal or cleaning activities must be trained based

• n job functions.
• Training must occur before independently handling HDs.
• Personnel must be trained prior to the introduction of a new

HD, new equipment, or change in process or SOP.

• Effectiveness of training must be demonstrated and

competency must be reassessed at least annually.

Summary of Training Requirements

• Overview of HDs in use and their risks
• Use of Safety Data Sheets
• Storage
• Review of SOPs related to handling of HDs
• Use of equipment and devices.
• Use of PPE including use of NIOSH-certified respirators

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Summary of Training Requirements

• Prevention of HD contamination
• Labeling
• Transport
• Disposal of HDs and trace-contaminated materials
• Spill management and use of a spill kit
• Response to known or suspected HD exposure

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Assessment of Risk (AOR)

• If AOR is not performed, all HDs must be handled with all

containment strategies defined in this chapter.

• AOR must, at a minimum, consider: type of HD, dosage

form, risk of exposure, packaging, and manipulation.

• Document alternative containment strategies and/or work

practices being employed for specific dosage forms to minimize occupational exposure.

• Review at least every 12 months and document review.

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Resources

• USP <800> FAQ

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

• USP <800> HazRx Mobile App

https://www.usp.org/hazrx-app

• The Chapter <800> Answer Book by Patricia Kienle

https://store.ashp.org

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Brenda Jensen

CPhT, CNMT, MBA Compounding Consultants, LLC brenda@compoundconsults.com

Questions?