HAZARDOUS MATERIALS 7/7/2016 OR THE RIGHT-TO-KNOW HAZARD COMMUNICATION STANDARD (HCS) DISCLAIMER

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HAZARD COMMUNICATION STANDARD (HCS) HAZARDOUS MATERIALS SAFE HANDLING Passed by Congress in 1988 with feedback from National Institute for Occupational Safety and Health (NIOSH) United States

1 HAZARD COMMUNICATION STANDARD (HCS) HAZARDOUS MATERIALS SAFE HANDLING Passed by Congress in 1988 with feedback from National Institute for Occupational Safety and Health (NIOSH) United States Pharmacopeia (USP) American Society of Health-System Pharmacists (ASHP) Oncology Nursing Society (ONS) Occupational Safety and Health Administration (OSHA) Enforced by Occupational Safety and Health Administration (OSHA) Surveyed under The Joint Commission (TJC), Florida Board of Pharmacy, Environmental Protection Agency (EPA), and others DISCLAIMER I, Kathleen Moorman, do not have (nor does any immediate family member have) a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. HAZARD COMMUNICATION STANDARD OR THE RIGHT-TO-KNOW Requires every employer to develop, implement and maintain a written comprehensive hazard communication program for the workplace 1, 2 The HCS is commonly referred to as the Right-to-Know Law Gives employees the right to know if they are exposed to a hazardous chemicals including drugs in their workplace Ensures that there are measures in place to protect employees from harm from these chemicals OBJECTIVES Understand the components of the Hazard Communication Standard (HCS) Labeling requirements of hazardous of hazardous chemicals and drugs Describe how to handle hazardous drugs (HDs) and chemicals Explain the use of Safety Data Sheets (SDSs) Review the Resource Conservation and Recovery Act (RCRA) and RCRA Waste Summarize guidelines for safe handling of hazardous drugs HAZARD COMMUNICATION STANDARD CONT D In 2011, the HCS was revised to align with the globally harmonized system of Classification and Labeling of Chemicals to provide the following level of standardization Classification of the chemicals according to their hazard Labeling requirements The format of Safety Data Sheets (SDSs) These have replaced Material Safety Data Sheets (MSDS) 1

HAZARD COMMUNICATION PROGRAM P AND U LISTED WASTE Consists of policies and procedures for handling, preventing, and responding to exposure by HDs Includes A means to identify and warn employees of

waste pure and commercial grade formulations of certain unused chemicals that are being disposed Must meet the following three (3) criteria: Waste must contain one of the chemicals listed on the P or

the sole active ingredient in a chemical formulation ITEMS COVERED BY THE HCS Substances determined hazardous by the manufacturer Liquids known to be corrosives, irritants, suspected carcinogens (i.e. phenol, formalin, glacial acetic acid) Liquid medications (i.

2 HAZARD COMMUNICATION PROGRAM P AND U LISTED WASTE Consists of policies and procedures for handling, preventing, and responding to exposure by HDs Includes A means to identify and warn employees of hazardous chemicals, including a list of hazardous chemicals in the workplace and labeling of containers Safety Data Sheet (SDSs) An employee information and training program Designates hazardous waste pure and commercial grade formulations of certain unused chemicals that are being disposed Must meet the following three (3) criteria: Waste must contain one of the chemicals listed on the P or U list Chemical in waste must be unused; and Chemical in waste must be in the form of a commercial chemical product EPA commercial chemical product: chemical is either 100% pure, technical grade or the sole active ingredient in a chemical formulation ITEMS COVERED BY THE HCS Substances determined hazardous by the manufacturer Liquids known to be corrosives, irritants, suspected carcinogens (i.e. phenol, formalin, glacial acetic acid) Liquid medications (i.e. antineoplastic agents) and other medications (i.e. powdered meds) that contain hazardous substances and are intended to be mixed before administration Tablets, capsules, pills, and other solid medications that contain hazardous substances and are intended to be dissolved/crushed before administration P-LISTED HAZARDOUS WASTE Acute hazardous wastes from discarded commercial chemical products Complete P-list can be found at 40 CFR section ITEMS EXEMPT FROM THE HCS U-LISTED HAZARDOUS WASTE Chemicals and medications that do not contain hazardous substances Chemicals and medications in retail establishments that are packaged for sale to consumers Personal food, medications, and cosmetics intended for use or consumption in the workplace Hazardous medication products in a solid form for direct administration Hazardous medication products in a solid form that are on occasion dissolved or crushed for administration Hazardous wastes from discarded commercial chemical products Complete U-list can be found at 40 CFR section

SUMMARY OF EMPLOYEE RIGHTS SAFETY DATA SHEETS (SDSs) Elements of the HCS that relate to the employee s right-to-know include the following requirements imposed on employers that use or store

SDSs for hazardous chemicals used in the workplace If the SDS is not available, employee may refuse to work with the hazardous chemicals without penalty after following appropriate organization

Record of training dates should be kept Comprehensive information sheets kept on each hazardous drug or chemical Provide information regarding proper handling procedures, accident and fire

3 SUMMARY OF EMPLOYEE RIGHTS SAFETY DATA SHEETS (SDSs) Elements of the HCS that relate to the employee s right-to-know include the following requirements imposed on employers that use or store hazardous chemicals and drugs Employers must post a notice of employee rights (provided by the Department of Labor) Employers must maintain and make readily accessible to employees, the most current SDSs for hazardous chemicals used in the workplace If the SDS is not available, employee may refuse to work with the hazardous chemicals without penalty after following appropriate organization procedure Appropriate labels must be maintained on containers Employers must provide education and training regarding hazardous chemicals to employees. Record of training dates should be kept Comprehensive information sheets kept on each hazardous drug or chemical Provide information regarding proper handling procedures, accident and fire prevention, potential hazardous effects, and emergency procedures for chemicals used in the work area The HCS requires SDSs to include certain information in a specific order and format SUMMARY OF EMPLOYEE RIGHTS THE RESOURCE CONSERVATION AND RECOVERY ACT (RCRA) Employers must inform employees of exposure to hazardous chemicals, identify areas where hazardous chemicals are stored/handled, provide access to the hazardous chemicals list and SDSs, and provide copies of SDSs upon request Employers must provide personal protective equipment and materials for cleanup and disposal of hazardous chemicals Employers may not retaliate against employees for exercising rights under the act Employers may not force employees to waive any right under the act as a condition of employment Enacted by the EPA in 1976 to provide a way for tracking hazardous waste from the point of generation to final disposal Focus is on environmental and human health issues surrounding the handling and disposal of hazardous waste Applies to medications and chemicals discarded by healthcare organizations and other commercial entities Waste defined as hazardous under the RCRA must be collected separately from other waste, labeled properly and disposed of per specific procedures Hazardous waste cannot be discarded into waste water systems (i.e. drains, sewers) or landfills PICTOGRAMS APPROVED FOR USE BY HCS RCRA CONT D Chemicals considered hazardous under the RCRA (meet 1 of the following characteristics) Ignitability Toxicity Corrosivity Reactivity RCRA includes lists of specific agents classified as hazardous EPA assigns each hazardous chemical a hazardous waste number 3

RCRA WASTE STORAGE RCRA allows empty containers to be exempt from hazardous waste regulations Residue in container not more than 3% by weight of total capacity of the container Examples: empty vials,

Unused/partial containers of hazardous chemicals Unused/partially used containers and IV preps of hazardous drugs Empty containers of P-listed agents Materials from spill cleanups Stored separately

4 RCRA WASTE STORAGE RCRA allows empty containers to be exempt from hazardous waste regulations Residue in container not more than 3% by weight of total capacity of the container Examples: empty vials, ampules, syringes, needles, IV sets, gloves, gowns, prep pads Does not apply to empty containers of P-listed agents or residues from hazardous spill cleanups Must be managed as RCRA hazardous waste Unused/partial containers of hazardous chemicals Unused/partially used containers and IV preps of hazardous drugs Empty containers of P-listed agents Materials from spill cleanups Stored separately from other medications Stored in a well ventilated area with limited unauthorized access Stored on shelves and in bins with front barriers to decrease likelihood of falls and breakages HDs stored in refrigerators should be placed in separate bins designed to prevent breakages Storage containers should be clearly labeled Chemotherapy gloves should be worn when stocking/inventorying and selecting/gathering HDs for preparation and dispensing HANDLING HAZARDOUS DRUGS (HDs) COMPOUNDING & PREPARATION Receiving Storage Compounding and Preparation Final Product Labeling Medication Transport and Delivery Cleaning, Decontamination, and Housekeeping Waste Disposal Accidental Exposures and Spills Medical Surveillance Quality Assurance Documentation Preparation should be limited to a designated area by authorized personnel Compounding should be performed under negative pressure in a BSC (biological safety cabinet), isolator, or by a robotic device designed for such a purpose Exhaust air from the cabinet must be ventilated to an outside area Use of supplemental equipment (i.e. closed-system drug-transfer devices or needless systems) to decrease contamination BCS, isolator, and robotic devices used to prepare HDs should not be used to prepare non-hds Personnel must wear PPE during compounding and preparation activities RECEIVING FINAL PRODUCT LABELING Cartons and containers should be inspected for leaks or breakages Containers should be opened in an isolated, well-ventilated area wearing PPE If there is a chance of aerosolization from broken HDs containers, it is recommended that a NIOSH-certified respirator be worn A distinct warning label with appropriate cautions must be placed on all HDs containers Solutions of vinca alkaloids must be labeled with the statement: For IV use only-fatal if given by other routes Syringes or IV containers of vincristine and vinblastine must be dispensed in a labeled over-wrap with the statement: Do not remove covering until the moment of injection. For IV use only- Fatal if given by other routes 4

MEDICATION TRANSPORT & DELIVERY All HDs must be transported in appropriately labeled, clear, sealable bag or container to prevent breakage and container leakage Pneumatic tubes system or other

5 MEDICATION TRANSPORT & DELIVERY All HDs must be transported in appropriately labeled, clear, sealable bag or container to prevent breakage and container leakage Pneumatic tubes system or other methods that produce mechanical stress on containers should not be used to transport HDs because containers may break or leak All antineoplastic agents delivered to patient care units should be placed in areas designated for these preparations ACCIDENTAL EXPOSURES & SPILLS Spills/breakages should be cleaned up immediately Only personnel trained in HDs may clean up HDs spills, while wearing PPE Chemotherapy spill kit locations must be known to staff Clean up materials must be disposed of in waste containers that meet local, state, and federal laws and regulations Personnel accidentally exposed to HDs must seek official medical assistance immediately as outlined by established policies and each incident must be documented In areas where HDs are handled eyewash fountains are preferred over manually operated bottles of flush solutions CLEANING, DECONTAMINATION, HOUSEKEEPING Personnel must wear appropriate PPE Surfaces within the BSC/compounding isolator should be decontaminated before and after each activity and shift per the HDs manufacturer's recommendation Work areas must be disinfected with 70% isopropyl alcohol prior to compounding sterile preparations The BSC/isolator should be decontaminated after any spill during compounding and the outside of the BSC front opening and the floor in front of the BSC should be cleaned daily Contaminated equipment used in compounding should be wiped with sterile water, decontaminated, then rinsed with sterile water Materials used in cleaning must be disposed of properly and staff must wash hands before and after donning their PPE MEDICAL SURVEILLANCE Personnel who are pregnant, breastfeeding, or trying to conceive a child should not handle HDs or associated waste Personnel handling HDs should be monitored in an ongoing medical surveillance program that includes a medical and exposure history, physical examination, and appropriate laboratory tests WASTE DISPOSAL HDs waste must be placed in the designated containers at the facility Contaminated sharps must be placed in sharps containers designed for HDs located inside the BSC or compounding isolator to minimize aerosolization Contaminated soft materials should be placed inside a sealable bag in BSC or isolator and then discarded in the designated waste containers All HDs prepared or dispensed, but not administered, should be placed in a sealed bag and discarded in a container for bulk HDs and documented per policy HDs waste containers should be labeled with appropriate warnings as required by policies, laws, and regulations. HDs waste should be picked up for disposal by designated personnel only QUALITY ASSURANCE DOCUMENTATION Patient profiles must be maintained for all patients receiving injectable hazardous drugs and the pharmacist compounding the HDs These profiles should be permanently maintained for future medication therapy reference and serve as a record of drug exposure for personnel Daily/Monthly HDs usage reports should be kept BCS and compounding isolator cleaning/filter changes and other cleaning/decontamination of areas where HDs are handled should be documented in appropriate records Accidental exposures/spills must be documented in accordance with policies, laws, and regulations 5

6 CHEMOTHERAPY: ADMINISTRATIVE CONTROLS Policies and procedures CHEMOTHERAPY SAFE HANDLING Additional training Duty-specific training Medical surveillance program Establish janitorial policies with cleaning contractor Clean BSC with a deactivating agent Sample work surfaces periodically for HD Prohibit food/drink consumption in work area Encourage employees to report health concerns to their supervisor SAFETY WITH CHEMOTHERAPY Engineering Controls Administrative Controls Personal Protective Equipment (PPE) CHEMOTHERAPY: PERSONAL PROTECTIVE EQUIPMENT (PPE) Ensure appropriate PPE is readily available Gloves should be ASTM certified Change every 30 minutes or if torn/punctured Double glove Follow OSHA standards for respiratory protection Ensure proper storage of respiratory equipment Replace when they become visibly clogged or difficult to breath through CHEMOTHERAPY: ENGINEERING CONTROLS Reduce Exposures by: Creating a barrier Removing HD from the process REFERENCES Transport chemotherapy bags and equipment in plastic bins to minimize exposure Clean the bins after each use Biologic Safety Cabinet (BSC) sash height The sash height is the opening into the BSC. Ensure at least 100 ft/min air flow Many thanks to Jennifer Kim and James Powers, University of South Florida Pharmacy Candidates Class of

USP <800> A practical approach to compliance. Ryan W. Naseman, PharmD, MS, BCPS Michael Storey, PharmD, MS, BCPS

USP <800> A practical approach to compliance. Ryan W. Naseman, PharmD, MS, BCPS Michael Storey, PharmD, MS, BCPS USP A practical approach to compliance Ryan W. Naseman, PharmD, MS, BCPS Michael Storey, PharmD, MS, BCPS Learning Objectives Explain the need for USP from an employee safety standpoint Describe