1. 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

2. 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 which was published January, 2012

3. Timeline Request for 1 year extension granted. Rule starts Jan 1, 2015
2 Stakeholder meetings and WSHSC panel of experts presentation.
Request for 1 year extension granted. Rule starts Jan 1, 2015
Law passed – LNI to develop Haz Drug program consistant with NIOSH Guidelines
New rule published
2010
2011
2012
2013
Seattle Times Articles about cancer after years of exposure
LNI presented at WSHSC – painted picture of things to come
LNI rewrites rule in last 2 weeks of Dec.
Hazardous Drugs Advisory Committee established
LNI Model Programs published and Algorithm created

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. Personal Protective Equipment - PPE
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 , personal protective equipment (PPE), and chapter WAC, Respirators
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

18. Personal Protective Equipment
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.

19. Personal Protective Equipment
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
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
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

20. Safe Handling Practices
Receiving and storage
Preparation and administration
Waste Handling
Personal Hygiene
WAC

21. Receiving and Storage/Preparation & Administration
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
WAC

22. Waste Handling/Personal Hygiene
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

23. 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

24. 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

25. 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

26. Schedule Adoption Effective dates January, 2012
January 1, Hazardous Drugs Control Program
Training completed by 7/1/15
Ventilated cabinets installed by 1/1/16

27. 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

28. 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

29. Establish a Hazardous Drugs Web Page
L&I Hazardous Drugs web page

30. 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

31. 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?

32. Thank YOU!
Questions?