Moving from USP 797 to USP 800 Patricia Cook RPh, B.S. HACP, GRCP - - PowerPoint PPT Presentation

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Moving from USP 797 to USP 800 Patricia Cook RPh, B.S. HACP, GRCP - - PowerPoint PPT Presentation

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Moving from USP 797 to USP 800 Patricia Cook RPh, B.S. HACP, GRCP 2 USP Chapter 800 Learning Objectives 1. Cite and locate the document that defines the components and expectations of USP Chapter 800 2. Identify 2 major components of USP

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Moving from USP 797 to USP 800

Patricia Cook RPh, B.S. HACP, GRCP

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USP Chapter 800

Learning Objectives

  • 1. Cite and locate the document that defines the components and expectations of

USP Chapter 800

  • 2. Identify 2 major components of USP Chapter 800
  • 3. Recognize the latest timeline for compliance
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Today’s Program

Outline

  • 1. History of the USP
  • 2. Review of the Journey
  • 3. Overview of Evolution: USP 795; 797 and 800
  • 4. Review and Timeline of USP 800‐ Who, What, When Where and Why
  • Key Terminology
  • Key Components
  • Timelines
  • Action Planning
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Who is the USP?

  • The United States Pharmacopeia: An not‐for‐profit

science driven organization dedicated to the establishment of standards designed to ensure the quality, safety, and benefit of medicines and foods.

  • Set the Gold Standards for medicinals, biologicals,

medical equipment, food supplements and food ingredients.

  • Not a Government Agency ‐ but their standards are

recognized and adhered to in over 140 countries including the United States

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The USP Journey

Past and Present

USP 795:

  • sets standards for

compounding of NON‐ STERILE Drugs/Products USP 797

  • sets the standard for the delivery
  • f sterile compounds
  • Designed to deliver quality

preparations that are free from contaminants and are consistent in intended identity, strength and potency. USP 800

  • sets the standard for

Handling of Hazardous Drugs

  • Sets standards for safe

handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.

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  • Introduced around 2013
  • Established Good Compounding Practices for non‐sterile

compounds

  • Oral suspensions, ointments/creams
  • Training Requirements
  • Equipment and Environmental Requirements

USP 795….

Highlights

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  • Developed in 2004. Last revised 2008.
  • Far Reaching – applicable to all settings where the

compounding of sterile preparations occurs.

  • Established Risk levels for compounded products
  • Simple ‐ Moderate ‐ Complex and Immediate Use
  • Birth of Beyond Use Dating

USP 797….

Highlights

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  • Developed in 2013 and 2016
  • Establishes standards for handling hazardous drugs

at every point of the drug distribution process.

  • Focuses on the management of Hazardous Drugs

from both a Worker Safety Perspective and Environmental Perspective.

  • Far reaching applications‐ applicable to all settings

involved in the procurement, compounding, administration and disposal of hazardous drugs.

  • Multiple Go‐Live dates

USP 800

Highlights

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Important to note: USP 800 does not replace USP 795 or USP 797. It continues the spectrum and focuses on the people involved in the medication process involving those medications classified as hazardous or whose classification has not been determined yet.

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Revised Timeline:

  • Revised September 2017
  • Original date: July 2018
  • New Date: December 1, 2019
  • Revised 797 and new 800 requirements

effective December 1, 2019

  • Revisions to 797 will be announced Fall 2018
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USP 800

A Summary Review

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Major Components of USP 800

The Math Inventory + Risk Assessment + Engineering Controls + Training/Competency + Personal Protective Equipment + Work Practices =

Reduced Exposure Risk

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Major Components of USP 800

Reduce Exposure Risk – WHEN?

  • The management cycle:

Receiving Process Transport Process Storage Process Preparation Process Administration Process Disposal Process

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Major Components of USP 800

Reduce Exposure Where?

Organizational Assessment

Pharmacy Receiving Department Oncology Inpatient Unit Outpatient Infusion Physician Practices Emergency Department Ambulatory Locations Other Locations ???

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USP 800 Components

The Inventory and NIOSH

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Inventory

The NIOSH List

  • NIOSH : National Institute for Occupational Safety and Health
  • Component of the CDC
  • USP 800 ‐ Uses the NIOSH List of Hazardous drugs as it’s foundation.
  • List is NOT limited to Anti‐neoplastics drugs. List of criteria for inclusion available
  • n website at https://www.cdc.gov/niosh/docs/2016‐161/default.html
  • Currently about 40 active pharmaceutical ingredients listed
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Inventory

Your List

  • Use the NIOSH list to develop your organization’s

inventory

  • Establish a process to review the inventory annually and

each time a new active pharmaceutical ingredient or formulation is released

  • Maintain this inventory
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USP 800 Components

Risk Assessment & Risk Mitigation

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Always Risk

No Choice

  • All USP 800 containment strategies must be used in the following:
  • Whenever manipulating anti‐neoplastic drugs ( Chemo drugs)
  • When compounding with any NIOSH drug
  • When the results of the risk assessment are not available
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Assessing Risk and Mitigation

Considerations

  • Type of Drug: Antineoplastic, non‐antineoplastic, reproductive risk only
  • Dosage Form: Tablet, Capsule, liquid etc.
  • Risk of Exposure
  • Does the product require repackaging?
  • Does the repackaging require product manipulation?
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When ? When there is RISK

Risk Assessment

  • Based upon Risk Assessment – determine what containment strategies and work

practices will be required. Maintain records of Risk assessment and mitigation strategies.

  • Each mitigation strategy should consider each of the risk reduction

interventions:

  • Use a Biocontainment Safety Cabinet ( a/k/a Hood) ?
  • Use Personal Protective Equipment? What kind?
  • Impervious Gown? Chemo rated gloves? Double vinyl gloves?
  • Review and reassess your risk assessments every 12 months.
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USP 800 Components

Physical Facility & Engineering Controls

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Physical Plant Requirements

Non‐Negotiables Compounding Environment:

  • Primary Engineering Control‐ Containment Ventilated Enclosure – a/k/a HOOD
  • Must create an set type of environment
  • Vented to the outside
  • Hood must never be turned off.
  • Secondary Engineering Control – the room that contains the PEC ( Hood)
  • Must be a Separate Room with Fixed Walls
  • Constant Negative Pressure Environment
  • Vented to the outside
  • Set # of air exchanges per hour
  • Air flow must continuously circulate
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Physical Plant Requirements

Drug Storage

  • Separate dedicated storage and preparation spaces
  • Eliminates the current exception that allows compounding of small amounts of HD

products in non‐HD designed spaces

  • ALL Hazardous Drugs must be stored in a Negative Pressure Environment
  • Even those requiring refrigeration
  • Repackaging of oral products requires use of a primary engineering control device
  • Cannot compound IV’s and Oral products at the same time.
  • Once repackaged, can be stored in individual plastic dosage bags ( to limit risk of

exposure) and stored in a clearly identifiable bin in your normal storage location.

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USP 800 Components

Training & Competency

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Training and Competency

Each Task – Each discipline involved

  • Develop based upon Overall Facility Scope Assessment Results
  • Each person assigned to conduct a task or duty involving a hazardous drug

needs training and competency.

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Personal Protective Equipment

Each Task – Each discipline involved

  • Personal protective equipment (PPE) refers to protective clothing, helmets,

goggles, gloves, face shields, eye protections, masks or other garments or equipment designed to protect the wearer's body from injury or infection

  • Each PPE product has various specifications.
  • Align the PPE requirements with the task. Goal: Sufficient coverage without over

burdening the user.

  • Include details of the PPE requirements on the risk assessment. BE SPECIFIC!
  • Ensure staff are trained and competent on how to DON and DOFF PPE.
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USP 800 Components

Work Practices

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Work Practices – Policy & Procedure

Accountability

  • Reduce the results of your risk assessments and mitigation strategies into POLICY.
  • Convert policy into easy to understand Staff Education Resources
  • Easily Accessible to Staff in Easy to Use Format
  • Wall Poster
  • Index Card System
  • Teach the to the WHY, then the HOW.
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USP 800 Components

Quality Control & Surveillance

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Environmental Quality Controls

Performance Improvement and Quality Assurance

  • USP 800 sets forth specific Environmental monitoring.
  • Also sets forth specific Assessment and Reassessment activities for medical surveillance
  • f staff involved in these processes.
  • Ensure an operational reporting process for reporting all exposures.
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Tips for Success

Summary

  • Partnering with your Pharmacy Leadership team is essential.
  • Ensure that the key stakeholders assume
  • the lead in the development of the action plan and required processes
  • Serve as subject matter experts
  • Represent the key disciplines involved in this body of work
  • Hardwire this team into your PI/Quality Reporting process
  • Periodic status updates
  • Ongoing monitoring results
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Tips for Success

Summary

  • Many free resources are available
  • Look for resources from Professional Organization such as
  • USP
  • ASHP ( American Society of Health System Pharmacists)
  • Access the C&A Readiness Compliance Strategy tool
  • Rely on your Pharmacy Experts to facilitate a multi‐disciplinary, Interdisciplinary

team to take on this work.

  • Embed this work into your Formulary Management Process
  • Ensure Organization –wide communication
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Questions?

Good Luck !

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References

And Important Links

  • USP General Chapter 800 Hazardous Drugs – Handling in Healthcare Settings; United States Pharmacopeial Organization.

www.usp.org Retrieved September 12, 2017

  • FAQs: USP 800 Hazardous Drugs—Handling in Healthcare Settings Update of September 29, 2017.

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

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