Post on 30-Mar-2015
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Safe Handling of Hazardous Drugs
Karen Bowman, MN, RN, COHN-S, EHS, WSNA
Jeff Rochon, Chief Executive Officer, WSPA
Alex Truchot, Sr. HSE Manager, CBRE
Presentation on August 30, 2013
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Legislation
SB 5594 Healthcare Settings:
Hazardous Drugs
L&I will adopt rules for the
handling of hazardous drugs
Rulemaking shall consider
stakeholder input
Created WAC 296-62-500 which
was published January, 2012
Law passed – LNI to develop Haz Drug program consistant with NIOSH Guidelines
Seattle Times Articles about cancer after years of exposure
2 Stakeholder meetings and WSHSC panel of experts presentation.
LNI rewrites rule in last 2 weeks of Dec.
Hazardous Drugs Advisory Committee established
LNI presented at WSHSC – painted picture of things to come
New rule published
Request for 1 year extension granted. Rule starts Jan 1, 2015
2013201220112010
LNI Model Programs published and Algorithm created
Timeline
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NIOSH Guidelines
L&I to mandate to create rules consistent with but not exceed provisions adopted by the NIOSH 2004 alert on preventing occupational
exposures
Presents a standard or universal precautions approach to handling drugs safely
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Rule Scope
Applies to all employers in health care facilities regardless of setting with employees with occupational exposure to hazardous drugs
Health Care Facility where a health care provider provides health care to patients
All hospitals Clinics Nursing homes Laboratories Offices or similar places
WAC 296-62-5005
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Hazardous Drugs
Any drug identified by NIOSH or any drug that meets at least one of the following six criteria:
Carcinogenicity
Teratogenicity or developmental toxicity
Reproductive toxicity in humans
Organ toxicity at low doses in humans or
animals
Genotoxicity
New drugs that mimic existing hazardous drugs in structure or toxicity
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Occupational Exposure
Hazardous drug contact as a result of an employee’s duties
Inhalation Skin Ingestion Injection contact
Note: A hazardous drug that is formulated so that exposure will not occur may require less or minimal exposure protection as long as it is not altered (cut, dissolved, crushed, etc.)
Some drugs defined as hazardous may not pose a significant risk of occupational exposure because of their dosage formulation Example: coated tablets or capsules that are administered to patients without modifying the formulation. Note: They may pose a risk if altered if tablets are crushed or dissolved, or if
capsules are pierced or opened
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Occupational Exposure Job Classes
Pharmacists and pharmacy technicians
Physicians and physician assistants Nurses (ARNPs, RNs, LPSs)
Patient care assistive personnel Operating room personnel Home health care workers Veterinarians Janitorial Engineering Shipping and Receiving
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Rule Structure
Hazardous Drugs Control Program Hazard Assessment Engineering Controls Personal Protective Equipment Safe Handling Practices Housekeeping Spill Control Training Implementation Medical Monitoring and Recordkeeping
removed
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Hazardous Drugs Control Program
Written inventory of hazardous drugs in the workplace – NIOSH list is a starting point
Written polices and procedures including Engineering controls Personal protective equipment (PPE) Safe handling practices Cleaning, housekeeping, and waste
handling Spill Control Personnel issues Training
Requires employee involvementWAC 296-62-50015
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Hazard Assessment Conduct an initial and annual
assessment New assessments needed when changes
that affect occupational exposure occur New drug New process Different formulation of a drug
Assessment must include PPE Types of HD handled Volume, frequency, packaging and form of
HD Equipment maintenance Decontamination and cleaning Waste handling Potential HD exposure during work
operations Spill response
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Approach NIOSH recommends a standard or
universal precautions approach to managing occupational exposure to hazardous drugs
Some health care facilities may find it more effective to institute precautions based on exposure risk. For example a tiered approach that matches precautions to the nature of exposure may be used including but not limited to:
Handling Storing Cleaning Preparing Engineering controls
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Engineering Controls
Evaluate and implement appropriate engineering controls to eliminate or minimize employee exposure
Ventilated cabinets
Closed system transfer devices
Safer sharps devices
Safety interlocks
Pharmaceutical waste containers
WAC 296-62-50025
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Ventilated Cabinets Prepare hazardous drugs inside an
appropriate ventilated cabinet Mix Compound Crush Pour liquid
When sterility is not required, a Class I biosafety cabinet or isolator intended for containment applications may be sufficient
Alternate precautions may be used where hazard assessment indicates a low potential for occupational exposure. These may include, but are not limited to:
Temporarily designating a preparation area Use of appropriate personal protective
equipment Instituting cleaning procedures
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Ventilated Cabinets Cont’d Chemotherapy drugs must be
prepared in an appropriate ventilated cabinet with the exception of circumstances where the employer can document evidence of a clinical need. For example:
There is a non routine need to provide chemotherapy treatment
Compounding services aren’t readily available, and it is in the best interest of the patient to provide local care
Use appropriate filtering media as approved by cabinet manufacturer
Maintain properly and display field-certification label on each cabinet
Place fans downstream of the filter so contaminated ducts are maintained under negative pressure
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Ventilated Cabinets Cont’d Do not use a ventilated cabinet that re-circulates air or exhausts air back into
the room environment unless the hazardous drug in use will not volatilize while they are being handled or after they are captured by the filter
Field-certify biosafety cabinet performance, in accordance with National Sanitation Foundation/American National Standards Institute Standard 49:
After installation Relocation Maintenance Repairs to internal components HEPA filter replacement Every six months or as recommended
by the manufacturer
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Personal Protective Equipment - PPE1. When there is reasonably anticipated exposure
to hazardous drugs each health care facility must conduct a PPE assessment and provide and ensure use of appropriate PPE in accordance with:WAC 296-800-160, personal protective equipment (PPE), and chapter 296-842 WAC, Respirators
2. Gloves Use powder-free chemotherapy gloves when
handling chemotherapy drugs or potential contact with chemotherapy contaminated items or surfaces
Provide latex-free gloves to employees with latex sensitivities
Wear two pairs of gloves when there is a significant risk of breakage or contamination or permeation
Change gloves every thirty to sixty minutes or when torn, punctured, or contaminated
WAC 296-62-50030
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Personal Protective Equipment
3. Protective Clothing – Gowns Wear gowns whenever there is a possibility of
a hazardous drug splash or spill
Wear gowns made of polyethylene-coated polypropylene or other nonabsorbent, non linting protective material as determined by the PPE hazard assessment. Make sure the gown has a closed front, long sleeves, and elastic or knit cuffs
Remove and dispose of gowns: At the end of hazardous drug handling activities When leaving the hazardous drug handling area As possible when damaged or contaminated
If no permeation information is available, change gowns every two to three hours or when contaminated after a splash or spill.
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4. Face Protection Wear a full-face shield or a mask and eye protection
as appropriate when splashes to the eyes, nose, or mouth may occur.Examples include:
Cleaning a spill Performing a procedure such as bladder instillation
5. Respiratory Protection Use N95 or equivalent respiratory protection during
spill clean up & whenever there is a significant risk of inhalation exposure to hazardous drug particulates
Use appropriate chemical cartridge-type respirator for events such as large spills of volatile hazardous drugs
6. Disposable PPE Must be discarded into appropriate containers
immediately after use or soon after contamination. Reusable PPE must be properly cleaned & decontaminated after use or contamination
Personal Protective Equipment
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Receiving and storage Preparation and administration Waste Handling Personal Hygiene
Safe Handling Practices
WAC 296-62-50035
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Receiving and Storage Label HD containers as required by Hazard
Communications (Global Harmonization) policy Store and transport in a manner that minimizes
the risk of breakage
Preparation & Administration Provide designated areas and limit access during
preparation Coordinate tasks to minimize occupational exposure. Spike and prime IV tubing and syringes in a manner
to limit occupational exposure Do not remove tubing from IV bags that held HD Seal final product in a bag when prepared in a hood Remove all outer gloves and sleeve covers and bag
them for disposal while inside the cabinet
Receiving and Storage/Preparation & Administration
WAC 296-800-170
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Waste Handling Dispose of pharmaceutical waste in
accordance with applicable state and federal regulations
Place disposable items in designated containers
Personal Hygiene Prohibit eating and drinking in areas
where HD are handled Wash hands with soap and water
before donning gloves, immediately after removal, and whenever hands are contaminated
Waste Handling/Personal Hygiene
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Establish procedures for cleaning and decontamination of areas and equipment
Do not clean contaminated equipment in unventilated areas
Clean work surfaces before and after each continuous activity and at the end of the work shift
Cleaning and Housekeeping
WAC 296-62-50040
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Develop written spill response procedures which include at minimum:
Description of who is authorized to respond and under what circumstances
PPE for various hazardous drugs and spill sizes.
Location and use of spill kits or clean-up materials
Possible spreading of contamination, and area containment and signage
Reporting and evaluating the circumstances surrounding spills and releases
Restricted access to hazardous drug spills Waste disposal
Spill Control
WAC 296-62-50045
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Training
WAC 296-62-50050
Provide training
The time of initial job assignment
On a regular basis thereafter
Whenever changes in the workplace
occur that may affect occupational
exposure (Implied).
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Schedule
Adoption January, 2012
Effective dates January 1, 2015 - Hazardous Drugs
Control Program Training completed by 7/1/15 Ventilated cabinets installed by 1/1/16
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Implementation
The department will work with stakeholders to implement this chapter by doing the following:
Establish a Hazardous Drugs (HD) Advisory Committee
Develop model programs for implementation of these rules in a variety of health care facilities and settings
Provide education, training and consultation services to ensure that these model programs are widely distributed and can be effectively utilized.
Establish a hazardous drugs web page, and post relevant resources, sample programs and forms
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HD Advisory Committee Associations nominated Employer representatives:
WSMA WSHA WSPA WSVMA WHCA
Associations and Labor nominated Employee Representatives:
Virginia Mason: Registered Nurse (Oncology) WSNA: Registered Nurse (Occupational Health) Seattle Cancer Care Alliance: RN (Oncology) Nursing Home Facility: RN (Geriatrics) Bartell Drugs (Pharmacy Technician A)
DSHS representatives from Western State and Rainier School
DOH
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Establish a Hazardous Drugs Web Page L&I Hazardous Drugs web page http://www.lni.wa.gov/Safety/Topics/Ato
Z/HazardousDrugs/default.asp
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Model Programs and Training Develop model programs for
implementation of these rules in a variety of health care facilities and settings
Provide education, training and consultation services to ensure that these model programs are widely distributed and can be effectively utilized
This is subcommittee work
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Next Steps Subcommittee work on Model
Programs and Intention of NIOSH’s list
Continue efforts with WSHA, WSMA and other stakeholders
Work with ASHP, APhA, AHA to encourage dialog with NIOSH on their guidelines
Work with L&I on education of inspectors about pharmacies
Legislative fixes?
Thank YOU!
Questions?
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