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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 296-800-160, personal protective equipment (PPE), and chapter 296-842 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 296-62-50030

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.

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

Safe Handling Practices Receiving and storage Preparation and administration Waste Handling Personal Hygiene WAC 296-62-50035

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 296-800-170

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

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

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

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

Schedule Adoption Effective dates January, 2012 January 1, 2015 - Hazardous Drugs Control Program Training completed by 7/1/15 Ventilated cabinets installed by 1/1/16

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

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

Establish a Hazardous Drugs Web Page L&I Hazardous Drugs web page http://www.lni.wa.gov/Safety/Topics/AtoZ/HazardousDrugs/default.asp

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

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?