Strategies to Prepare for USP

9/27/2016 Disclosure Patricia Kienle is an employee and stockholder of Cardinal Health She is an elected member and Vice Chair of the USP Compounding...
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9/27/2016

Disclosure Patricia Kienle is an employee and stockholder of Cardinal Health She is an elected member and Vice Chair of the USP Compounding Expert Committee, but this talk is not endorsed by or affiliated with USP

Strategies to Prepare for USP

She authored the ASHP upcoming publication The 800 Answer Book and is a contributor to Competence Assessment Tools for HealthSystem Pharmacies

PAT R ICIA C. KIE NLE , R PH , M PA, FASH P DIR E CTOR , ACCR E DITAT ION AND M E DICAT ION SAFE T Y CAR DINAL H E ALT H INNOVAT IVE DE LIVE R Y SOLUT IONS

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Objectives

Patti’s Wish

Identify the three categories of hazardous drugs

Identify three things that you can improve the next day you are at work

Describe elements of an Assessment of Risk State the garbing requirements when compounding hazardous drugs Identify the steps in the cleaning process when handling hazardous drugs

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What’s All the Fuss?

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Why ? To promote patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs) Addresses, but is not limited to ◦ Receipt ◦ Storage ◦ Compounding

• Dispensing • Administration • Disposal

Applies to all healthcare personnel who handle hazardous drugs Applies to all healthcare entities that store, prepare, transport, or administer hazardous drugs

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USP

How Close to Compliant is Your Facility?

USP becomes federally enforceable on July 1, 2018 It is a required standard (not a guideline)

25%

50%

75%

100%

Courtesy of United States Pharmacopeial Convention

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Hazardous Drugs in Your Facility

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Major Components of USP Facilities Assessment of Risk Other Elements

Receiving

Storing

Mixing

Administering

◦ Personnel acknowledgement ◦ Medical surveillance ◦ Education and training ◦ Personal Protective Equipment ◦ Use of closed-system drug transfer devices (CSTDs) ◦ Environmental monitoring

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Genesis of USP

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NIOSH List of Hazardous Drugs Antineoplastic Non-antineoplastic Reproductive hazards

Hazardous to personnel ◦ Different from EPA hazards www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf 11

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Your Hazardous Drug List

Your Handling Options

Review the NIOSH list of hazardous drugs Identify the drugs and dosage forms you handle

Treat all Hazardous Drugs with all containment strategies in

Document review of this list annually

Perform an Assessment of Risk 13

Your List All containment strategies in

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Assessment of Risk Drug Dosage form Risk of exposure

Alternative containment strategies

API of any Hazardous Drugs on the list

Antineoplastics you only need to count or package

Antineoplastics you have to manipulate

Non-antineoplastics

Packaging Manipulation Documentation of alternative containment strategies and/or work practices Review annually and document

Items that don’t fit your Reproductive hazards Assessment of Risk approach 15

Receipt of Hazardous Drugs Supplier should mark containers Can be received in either a neutral/normal or negative pressure area (NOT in positive pressure) Receiving personnel need to assess the integrity of the container You must provide:

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PEC

CPEC

Positive Pressure

Negative Pressure

◦ Chemotherapy gloves ◦ Chemotherapy spill kit

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Hazardous Drug Storage and Compounding

Engineering Controls

Contain the hazard

Primary ◦ Biological Safety Cabinet (BSC) ◦ Compounding Aseptic Containment Isolator (CACI)

◦ Separate room with fixed walls ◦ Negative pressure

Secondary

Remove and dilute the hazard

◦ The room in which the PEC is placed

◦ Vented to the outside ◦ Appropriate number of air changes per hour (ACPH)

Supplemental ◦ Closed system drug-transfer devices

These are the minimum requirements

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Design for NonSterile Compounding

Two Options for Sterile Compounding

Primary Engineering Control

Cleanroom suite ◦ Positive pressure ISO 7 anteroom opening into negative pressure ISO 7 buffer room with biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI)

◦ Containment Ventilated Enclosure (“powder hood”)

Secondary Engineering Control ◦ Room that is separate from non-hazardous drugs, and is under negative pressure, vented to the outside, and has the appropriate number of air changes per hour (ACPH) Occasional nonsterile compounding can be done in the sterile compounding area; details are in USP

Containment Segregated Compounding Area ◦ Separate space with BSC or CACI ◦ Limited to 12 hour beyond-use date (BUD) ◦ NOTE: Not currently allowed by

Low volume exemption is no longer allowed

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Personnel

Work Practices

Acknowledgement of risk of handling hazardous drugs

Policies and Procedures ◦ Master Formulation Records

Training ◦ USP for nonsterile compounding ◦ USP for sterile compounding ◦ State Board regulations

Technique ◦ Negative pressure technique

Personal Protective Equipment

Monitoring

Closed-System Drug Transfer Devices

◦ Media fill test ◦ Gloved fingertip test

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Personal Protective Equipment Requirements in

Gloves for Handling Hazardous Drugs

Gloves

Chemotherapy gloves tested to ASTM D6978

Gowns

Two pairs of non-powdered gloves

Hair covers

Gloves must be sterile when compounding sterile preparations

Shoe covers Face protection Respirators

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Gowns for Handling Hazardous Drugs

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PPPMag – January 2015

Tested and shown to resist permeability by hazardous drugs Disposable Polyethylene-coated polypropylene or other laminate

Close in back (no open front) Long-sleeved Elastic or knit closed cuffs No seams or closures that could allow hazardous drugs to pass through

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Other Garb Issues

Closed System Drug-Transfer Devices

Eye protection

CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system

◦ BSC/CACI provide eye protection ◦ Use goggles when working outside a PEC

Respirators

NIOSH has published a proposed performance protocol

◦ Use when outside a PEC

All garb is required when using a CACI Photo courtesy of BD 29

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How Close to Compliant is Your Facility? What solutions do you use to clean your chemo hood?

25%

50%

75%

100%

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Three Steps Step Deactivate Decontaminate Clean Disinfect

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Monitoring Agent Properly-diluted EPAapproved oxidizer intended for use with hazardous drugs Germicidal detergent Sterile isopropyl alcohol

Personnel

Safe Workplace

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Medical Surveillance

Environment

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Occupational Exposure

Recommended by Requirement to follow organizational policies Consider ◦ Health questionnaire ◦ History of exposure to HDs ◦ Record of acute exposure (spills) ◦ CBC with diff

http://www.cdc.gov/niosh/docs/wp-solutions/2013-103/pdfs/2013103.pdf

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Environmental Monitoring

How Close to Compliant is Your Facility?

requires EM to detect microbial contamination recommends wipe samples to detect rogue hazardous drug contamination

25%

50%

75%

100%

Screenshot courtesy of ChemoGlo 37

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Timeframe for Compliance Where do I start?

USP will be federally enforceable on July 1, 2018

1970s

1985

2004

2008

2016

2018

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Resources Gap analysis ◦ Critical Point ◦ www.797gaptool.com ◦ www.800gaptool.com ◦ Joint Commission Resources ◦ www.hazmedsafety.com

Assessment of Risk Facility changes Policies and Procedures

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