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© 2019. All rights reserved. | Premier Inc. | 1© 2019. All rights reserved. | Premier Inc.
Welcome
Advisor Live® Webinar:
USP 800 Hazardous Drugs: Overview and
the Road to Readiness
Our Presentation Will Begin Shortly
Listen to Today’s Audio: 800.926.6349
Download today’s slides at www.premierinc.com/events
© 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
Logistics
AUDIODial in to our operator assisted call 800.926.6349
QUESTIONSUse the “Questions and Answers”
RECORDINGThis webinar is being recorded.
View it later on-demand at premierinc.com/events.
NOTESDownload today’s slides from the event post at premierinc.com/events.
© 2019. All rights reserved. | Premier Inc. | 4
Annie Lambert, PharmD
Director, Performance Partners
Chris Jones, RPh
Director, Pharmacy Automation & Technology
Today’s Speakers
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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.
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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.
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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
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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>
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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
© 2019. All rights reserved. | Premier Inc. | 10© 2018 | Premier Inc. | 10© 2019 | Premier Inc. | 10
The Road to USP <800> Readiness
Focus areas for compliance
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Road to Compliance
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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
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NIOSH Hazardous Drug List
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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
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Assessment of Risk
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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
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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
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Policies and Procedures
Pharmacy Times 11/14/18
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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
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Monitoring
Oversight
• Designated person or committee
• Annual review
• Annual training
Recommended
• Medical surveillance
• Wipe sampling
© 2019. All rights reserved. | Premier Inc. | 21© 2018 | Premier Inc. | 21© 2019 | Premier Inc. | 21
Challenging Scenarios and
Possible Solutions
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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
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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:
• Handle with full USP <800> precautions including mix in C-PEC/C-SEC
• 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
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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:
• Handle with full USP <800> precautions including mix in C-PEC/C-SEC
• 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
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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
© 2019. All rights reserved. | Premier Inc. | 26© 2018 | Premier Inc. | 26© 2019 | Premier Inc. | 26
Premier Resources
Support Services for USP Compliance
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Premier Safety Institute®
http://www.premierinc.com/safety
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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
© 2019. All rights reserved. | Premier Inc. | 29
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
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Outsourced Services: Cleanroom Planning & Design
Cleanroom Planning and Design:
• Aseptic Enclosures
• Carter Health
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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
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Capital Equipment- Cleanroom Automation
Cleanroom compounding robotic Suppliers:
• Omnicell- i.v. Station- ONCO
• ARxIUM- RIVA cGMP robot- (pending)
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Outsourced Services- Oral HD Re-Packaging
Third party Supplier for HD Re-Packaging:
• SafeCor Health
• Meets <795> and <800>
requirements
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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
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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
© 2019. All rights reserved. | Premier Inc. | 36© 2018 | Premier Inc. | 36
Questions?
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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: solutioncenter@premierinc.com
© 2019. All rights reserved. | Premier Inc. | 38
Annie Lambert, PharmD
Director, Performance Partners
Premier
253.651.2288
Annie_Lambert@Premierinc.com
Chris Jones, RPh
Director, Pharmacy Automation & Technology
Premier
704.816.5783
Christopher_Jones@Premierinc.com
Speakers Contact Information
Additional Resource
Jennifer Valentine - Program Manager, Specialty Pharmacy Management
jennifer_valentine@innovatix.com212.901.1328
© 2019. All rights reserved. | Premier Inc. | 39
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
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