3/22/2017 1 Implementing USP 800 ASHLEY DUTY, PHARMD, MS JOANNA ROBINSON, PHARMD, MS Disclosure •Ashley Duty has no conflicts of interest to disclose •Joanna Robinson has no conflicts of interest to disclose Objectives 1. Understand the purpose of USP 800 2. Describe how to engage key stakeholders and implement the required elements of USP 800 3. Explain what resources are available to implement USP 800 standards
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
3/22/2017
1
Implementing USP 800ASHLEY DUTY, PHARMD, MS
JOANNA ROBINSON, PHARMD, MS
Disclosure•Ashley Duty has no conflicts of interest to disclose
•Joanna Robinson has no conflicts of interest to disclose
Objectives1. Understand the purpose of USP 800
2. Describe how to engage key stakeholders and implement the required elements of USP 800
3. Explain what resources are available to implement USP 800 standards
3/22/2017
2
Overview
•Background
•Basic definitions
•Gap analysis
•Assessment of risk
•Non‐Sterile Compounding
BackgroundAwareness of risk◦ Per the CDC, 8 million healthcare workers are potentially exposed1
◦ Presence of chemotherapy in urine of healthcare workers2
◦ Long‐term repercussions of hazardous drug exposure
Guidance documents previously released: ◦ Oncology Nursing Society (ONS) in 1984
◦ Occupational Safety and Health Administration (OSHA) in 1986
◦ American Society of Health‐System Pharmacists (ASHP) in 1990
1. “Hazardous Drug Exposures in Health Care.” Centers for Disease Control and Prevention. 15 Sept 2016. Web. 20 Feb 2017. 2. Sorsa M, Anderson D. “Monitoring of occupational exposure to cytostatic anticancer agents.” Mutation Research 355 (1996): 253‐61.
BackgroundRelease of the USP 800 chapter is a call to action
Enforceable standard◦ State BOP and other regulatory bodies can require compliance
6
3/22/2017
3
Background‐ Scope of USP 800
7
Receiving Storage Manipulating Administration Disposal
Background‐ USP 800 TimelineMarch 2014
• Chapter first published for public comment
March 2014
• Chapter first published for public comment
December 2014
• Revisions published, round 2 of public comment
December 2014
• Revisions published, round 2 of public comment
February 2016
• Final version published in USP‐NF
February 2016
• Final version published in USP‐NF
July 1, 2018
• Federally enforceable
July 1, 2018
• Federally enforceable
463 Days
Background – USP 800 Chapter OverviewList of Hazardous Medications
Personal Protective Equipment (PPE)
Facilities Design
Handling Hazardous Medications
Cleaning
Medical Surveillance
9
3/22/2017
4
Basic DefinitionsAcronym in USP 800
Definition What it really means
CPEC Containment Primary EngineeringControl
The hood
CSEC Containment SecondaryEngineering Control
The room the hood is in
CSCA Containment SegregatedCompounding Area
Segregated area, no requirement for ISO classification
“Should” Recommendation
“Shall” or “Must” Requirement
CPEC: Types of hoods
Laminar Airflow Workbench (LAFW)
• Horizontal Airflow
• Most common hood found in IV rooms
• Can NOT be used for HD compounding
Biological Safety Cabinet (BSC)
• Vertical Airflow
• Often referred to as a “Chemo hood”
• Classes and Types with % air recirculation
“Glove boxes”
• Compounding Aseptic Isolator (CAI)‐ POSITIVEpressure
• Compounding Aseptic Containment Isolator (CACI)‐NEGATIVE pressure
11
CPEC: Sterile Compounding of HDsMust be performed in a CPEC within a separate room with ISO Class 5 air
Laminar airflow workbench (LAFW) or Compounding Aseptic Isolator (CAI) can NOT be used for compounding HDs
12https://www.terrauniversal.com/laminar‐flow‐hoods/horizontal‐laminar‐flow‐hoods.phphttp://www.nuaire.com/products/pharmacy‐isolators
3/22/2017
5
Changes from <797>Elimination of low‐volume exemption currently in <797>◦ All HDs must be compounded in BSC or CACI in a negative pressure room
Allowance for CSCA
Storage under negative pressure
13
Gap Analysis
14
Conducting a Gap Analysis•Compare the best practices with the processes currently in place in your organization
•Determine the “gaps” between your organization’s practices and the identified best practices
•Select the best practices you will implement in your organization
•Get organized!
http://www.buzzanalysis.com/2016/07/31/gap‐analysis‐what‐and‐how‐all‐you‐need‐to‐know/ 15
3/22/2017
6
Conducting a Gap AnalysisExample◦ Current State◦ 65% of hospitalized patients have received the influenza vaccine for 2016‐2017
◦ Desired State◦ 100% of hospitalized patients have received the influenza vaccine for 2016‐2017
◦ Identified Gap◦ 35% of hospitalized patients need to receive the influenza vaccine for 2016‐20173
◦ Barriers to Implementation◦ Misconceptions about vaccination
◦ Appropriate documentation about vaccination history
◦ Vaccine supply issues
16
https://archive.ahrq.gov/professionals/systems/hospital/qitoolkit/d5‐gapanalysis.pdf 17
Hazmedsafety.com
18
3/22/2017
7
19Hazmedsafety.com
Hazmedsafety.com 20
21Hazmedsafety.com
3/22/2017
8
22Hazmedsafety.com
800gaptool.com
23
800gaptool.com 24
3/22/2017
9
25800gaptool.com
26800gaptool.com
Gap Analysis at Children’s MercyAnalyzed USP <800> by section to identify actionable items
Created spreadsheet for each item with notes on◦ Necessary changes◦ Responsible individuals◦ Policies that need updated◦ Status
Update frequently based on new information and item completion
27
3/22/2017
10
Gap Analysis at Children’s Mercy
28
What a Gap Analysis Cannot Do•Show all complexities of the problem that may exist
•Implementation work
•Education to staff
•Minimize barriers to compliance
29
Completing an Assessment of Risk
30
3/22/2017
11
NIOSH List• National Institute for Occupational Safety and Health
•Updated every two years
•Three classificationsoAntineoplasticoNon‐antineoplasticoReproductive only
https://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous‐drugs‐list_2016‐161.pdf 31
http://blog.rmi.org/blog_2015_07_01_the_grid_is_at_a_fork_in_the_road 32
Everything must follow all USP 800 rules
Complete an assessment of risk
Consider…Colchicine
Fluconazole
Paroxetine
https://www.laurieayers.com/consider‐all‐options/ 33
3/22/2017
12
What Qualifies?NIOSH TABLE 1: ANTINEOPLASTIC
Requires manipulation◦ Ex: crushing methotrexate tablets
◦ Must follow all USP 800 precautions
Final dosage form with no manipulation◦ Ex: counting methotrexate tablets
◦ Perform assessment of risk for these agents
NIOSH TABLE 2 AND 3: NON‐ANTINEOPLASTIC AND REPRODUCTIVE ONLY
Can perform an assessment of risk for all items◦ Unless using active pharmaceutical ingredients (API)
http://qctimes.com/counting‐pills/image_b52bc2d6‐1964‐11de‐96db‐001cc4c002e0.html 34
Performing an Assessment of Risk
Use NIOSH list to create a facility list of hazardous drugs
Separate into two categories
• API or antineoplasticsrequiring manipulation
• Everything else
Determine strategies to minimize exposure to employees
Create a form to evaluate each dosage form in the “everything else” list and perform assessment
Evaluate current policies to ensure congruence
Incorporate into hazardous drug policy and get approval through organization’s policy process
Review at least annually
Improving Safe Handling Practices for Hazardous Drugs. Joint Commission Resources. 2016. 35
Consider These ActionsReceipt from wholesaler
Transport to storage
Storage
Transport to and from◦ Compounding areas (sterile and non‐sterile)
◦ Dispensing area◦ Prepacking area◦ Administration area◦ Offsite area
Deactivating, decontaminating, and disinfecting compounding and administration areas◦ Including spills
Administration
Disposal
Education of staff
Improving Safe Handling Practices for Hazardous Drugs. Joint Commission Resources. 2016. 36
3/22/2017
13
Children’s Mercy Assessment of RiskNIOSH list evaluated by pharmacists
Two classification of drugs◦ Cytotoxic
◦ Hazardous
Upgrades◦ Asparaginase
◦ Isotretinoin
Historical items◦ Alemtuzumab
◦ Rituximab
◦ Pentamidine
Update list in Handling Cytotoxic and Hazardous Agents policy◦ Nursing Practice Council
◦ P&T Committee
◦ Hospital executives
37
Children’s Mercy Assessment of Risk•Collaboration with Children’s Hospital Association members◦ Creation of Access database
•Meet with Nursing and Environmental Services to discuss proposed handling rules
38
39
3/22/2017
14
Tips•Prioritize your concerns and implement those first
•Respectfully remind other departments that USP 800 is not a pharmacy issue
•Be reasonable when deciding how to handle items on Table 2 and Table 3
40
Non‐Sterile HD Compounding
41
Non‐Sterile HD Compounding Definition of Compounding:
42United States Pharmacopeia Chapter 800‐ Hazardous Drugs‐ Handling in Healthcare Settings. 2016
3/22/2017
15
Repackaging•USP 800 eliminates the ability to repackage tablets in packaging machines◦ Risk of crushing and exposure
◦ Cytotoxic vs. hazardous
•Assessment of risk
•Buy unit dose
•Blister packaging
http://shop.gohcl.com/default.aspx?page=item%20detail&itemcode=7079 43
It’s not just cleaning anymore…•Deactivate◦ Renders the compound inert or inactive
•Decontaminate◦ Inactivating, neutralizing, or physically removing hazardous residue
•Cleaning◦ Process to remove contaminants from objects and surfaces using water, detergents, surfactants, solvents
•Disinfect◦ Inhibiting or destroying microorganisms
44
Closing Thoughts•USP 800 is a minimum requirement
•It is a supplement to USP 795 and 797 and does not replace it
•Sensitivity of messaging
45
3/22/2017
16
Questions
46
Related Documents
