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
1
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
2
Timeline
Law passed –
LNI to develop
Haz Drug
program
consistant with
NIOSH
Guidelines
2010
Seattle
Times
Articles
about cancer
after years of
exposure
2 Stakeholder
meetings and
WSHSC panel of
experts
presentation.
2011
LNI
presented at
WSHSC –
painted
picture of
things to
come
New rule
published
Request for
1 year
extension
granted.
Rule starts
Jan 1, 2015
2013
2012
LNI rewrites
rule in last 2
weeks of
Dec.
Hazardous
Drugs
Advisory
Committee
established
LNI Model
Programs
published
and
Algorithm
created
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
4
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
5
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
6
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
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capsules are pierced or opened
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
8
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
9
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 involvement
WAC 296-62-50015
10
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
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Spill response
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
12
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
13
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
14
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
15
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
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the manufacturer
Personal Protective Equipment PPE
1.
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
17
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.
18
Personal Protective Equipment
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:


5.
Respiratory Protection


6.
Cleaning a spill
Performing a procedure such as bladder instillation
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
Disposable PPE

Must be discarded into appropriate containers
immediately after use or soon after contamination.
Reusable PPE must be properly cleaned &
decontaminated after use19 or contamination
Safe Handling Practices




Receiving and storage
Preparation and administration
Waste Handling
Personal Hygiene
WAC 296-62-50035
20
Receiving and Storage/Preparation &
Administration
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
WAC 296-800-170
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
21
them for disposal while inside
the cabinet
Waste Handling/Personal Hygiene
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 hands22are contaminated
Cleaning and Housekeeping



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
WAC 296-62-50040
23
Spill Control

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
WAC 296-62-50045
24
Training

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).
WAC 296-62-50050
25
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
26
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
27
forms
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
28
Establish a Hazardous Drugs Web
Page


L&I Hazardous Drugs web page
http://www.lni.wa.gov/Safety/Topics/AtoZ/Ha
zardousDrugs/default.asp
29
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
30
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?
31
Thank YOU!
Questions?
32