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Indian Health Service The Federal Health Program for American Indians and Alaska Natives


     Indian Health Manual
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Part 3 - Professional Services

Chapter 27 - Controlling Occupational Exposure To Hazardous Drugs

Title Section
Introduction 3-27.1
    Purpose 3-27.1A
    Background 3-27.1B
    Hazardous Drugs 3-27.1C
    Risk of Exposure 3-27.1D
    Hazardous Drug List 3-27.1E
    Policy 3-27.1F
Responsibilities 3-27.2
    Headquarters 3-27.2A
    Area Office Chief Medical Officer 3-27.2B
    Area Institutional Environmental Health Officers 3-27.2C
    Area Pharmacy Managers 3-27.2D
    Area Nursing Managers 3-27.2E
    Chief Executive Officer 3-27.2F
    Department Managers 3-27.2G
Definitions 3-27.3
Prevention of Employee Exposure - General Requirements 3-27.4
    Assess the Hazards in the Workplace 3-27.4A
    Hazardous Drug Inventory 3-27.4B
    Handle Drugs Safely 3-27.4C
    Use and Maintain Equipment Properly 3-27.4D
Prevention of Employee Exposure - Personal Protective Equipment 3-27.5
    Personal Protective Equipment 3-27.5A
    Appropriate Personal Protective Equipment 3-27.5B
    Gloves 3-27.5C
    Gowns 3-27.5D
    Respirators 3-27.5E
Prevention of Employee Exposure - Receiving, Storage, and Transportation 3-27.6
    Receiving 3-27.6A
    Storage 3-27.6B
    Transportation 3-27.6C
Prevention of Employee Exposure - Hazardous Drug Preparation 3-27.7
    General 3-27.7A
    Engineering Controls-Biological Safety Cabinets 3-27.7B
    Cleaning, Disinfection, and Decontamination 3-27.7C
    Work Practices 3-27.7D
    Closed-System Drug-Transfer Devices 3-27.7E
Prevention of Employee Exposure - Hazardous Drug Administration 3-27.8
    Intravenous/injection Administration - Before Administration 3-27.8A
    Intravenous/injection Administration - During Administration 3-27.8B
    Intravenous/injection Administration - After Administration 3-27.8C
Prevention of Employee Exposure - Aerosolized Hazardous Drug Administration 3-27.9
    General 3-27.9A
    Precautions When Administering Pentamidine 3-27.9B
    Precautions When Administering Ribavirin 3-27.9C
Prevention of Employee Exposure - Housekeeping and Waste Handling 3-27.10
    Personal Protective Equipment 3-27.10A
    Waste 3-27.10B
    Trace Hazardous Drug Waste Disposal 3-27.10C
    Bulk Hazardous Drug Waste Disposal 3-27.10D
    Excreta 3-27.10E
    Recycling 3-27.10F
    Training 3-27.10G
    Waste Transportation 3-27.10H
Prevention of Employee Exposure - Spill Management and Control 3-27.11
    Spill Kits 3-27.11A
    Spill Kit Contents 3-27.11B
    Responsible Staff 3-27.11C
    Appropriate PPE 3-27.11D
    Spills of Less than 5 ml or 5 gm Outside a BSC 3-27.11E
    Spills of More than 5 ml or 5 gm Outside a BSC 3-27.11F
    Spills on Carpet/Upholstery 3-27.11G
    Spills on Linen 3-27.11H
    Spills in BSCs 3-27.11I
Employee Response to Occupational Exposure 3-27.12
    Skin Exposure 3-27.12A
    Eye Exposure 3-27.12B
    Exposure by Inhalation 3-27.12C
Maintenance Activities 3-27.13
    General 3-27.13A
    Biological Safety Cabinets 3-27.13B
Medical Surveillance 3-27.14
    Elements 3-27.14A
    Medical Evaluation 3-27.14B
    Frequency 3-27.14C
    Reproductive Issues 3-27.14D
    Results 3-27.14E
Handling Hazardous Drugs Training 3-27.15
    Risks of Handling Drugs 3-27.15A
    Personal Protective Equipment 3-27.15B
    Work Practices 3-27.15C
    Transporting Drugs 3-27.15D
    Waste-Disposal Management 3-27.15E
    Management of Acute Exposures 3-27.15F
    Spill Management Plan 3-27.15G
    Recordkeeping 3-27.15H
    Medical Surveillance 3-27.15I
Facility Considerations 3-27.16
    General Recommendations 3-27.16A
    Personal Protective Equipment 3-27.16B
    Receiving, Storage, and Transportation 3-27.16C
    Hazardous Drug Preparation 3-27.16D
    Hazardous Drug Administration 3-27.16E
    Housekeeping and Waste Handling 3-27.16F
    Spill Control 3-27.16G
    Maintenance 3-27.16H
    Medical Surveillance 3-27.16I
    Training 3-27.16J

Manual Exhibits Description
Manual Exhibit 3-27-A, "List of Hazardous Drugs"
Manual Exhibit 3-27-B, "Assessment of Hazardous Drug Handling in the Workplace"
Manual Exhibit 3-72-C, "Personal Protective Equipment Recommendations"
Manual Exhibit 3-27-D, "Community Health Representative Hazardous Drug Handling Fact Sheet"
Manual Exhibit 3-27-E, "Hazardous Drugs and Times for Protective Handling of Patient Excreta"
Manual Exhibit 3-27-F, "Medical Surveillance Form Sample"

3-27.1  INTRODUCTION

  1. Purpose.  This chapter establishes the policy and procedures to reduce occupational exposure to hazardous drugs.
  2. Background.  Hazardous drugs are drugs that are associated with or suspected of causing adverse health effects.  Hazardous drugs may possess any one of the following characteristics:

    1. Carcinogenicity.  The ability to cause cancer in animal models, humans, or both.
    2. Fertility Impairment.  The ability to cause adverse reproductive outcomes in animal models, humans, (men or women), or both.
    3. Genotoxicity.  The ability to cause a change or mutation in genetic material.
    4. Serious Toxicity.  Serious toxicity at low doses in experimental models or treated patients.
    5. Teratogenicity.  The ability to cause defects in fetal development or fetal malformation.
  3. Hazardous Drugs.  Many hazardous drugs are used in the treatment of cancer and human immunodeficiency virus (HIV), but they may also be in the form of anti viral agents, investigational drugs, or drugs used in non malignant treatments (such as rheumatoid arthritis or hepatitis).  Exposure to hazardous drugs is associated with acute health effects, such as skin rashes, chromosomal aberrations, and soft tissue damage, as well as chronic health effects, such as leukemia and adverse reproductive events.  Workers may be exposed to hazardous drugs through inhalation and dermal absorption, and to a lesser degree, through ingestion and injection.
  4. Risk of Exposure.  There are a number of situations that may place workers or employees or staff at risk of exposure to hazardous drugs:

    1. Receiving, Shipping, Storage, or Transportation.  During receiving, shipping, storage, or transportation, workers or employees or staff may be exposed to:

      1. leaks from shipping containers during storage,
      2. contamination on the outside of hazardous drugs packaging,
      3. punctures and spills during receiving, or
      4. leaks and spills during transportation of prepared hazardous drugs to patient care area.
    2. Preparation.  Employees are at highest risk of exposure during the preparation of hazardous drugs because the drugs are at their most concentrated state at these times.  Operations that pose the greatest risk of exposure include:

      1. reconstituting powdered or lyophilized drugs with further dilution,
      2. expelling air from syringes filled with hazardous drugs,
      3. counting individual uncoated oral doses,
      4. unit dosing uncoated tablets in a unit dose machine,
      5. crushing tablets to make oral liquid doses,
      6. compounding powder into custom dosage capsules,
      7. contacting contaminated areas (work surfaces, vials, floors, etc.),
      8. handling unused hazardous drugs or contaminated waste,
      9. decontaminating drug preparation areas, and
      10. removing or disposing of contaminated personal protective equipment (PPE).
    3. Administering Hazardous Drugs.  While administering hazardous drugs to patients, operations that have a risk of exposure include:

      1. priming at the bedside,
      2. intramuscular, subcutaneous, or intravenous administration,
      3. contacting contaminated areas (beds, armchairs, work surfaces),
      4. aerosols from intravenous-push or intravenous infusion,
      5. handling unused hazardous drugs or contaminated waste,
      6. decontaminating drug administration areas, and
      7. removing or disposing of contaminated PPE.
    4. Waste Handling and Maintenance.  There is also potential exposure to hazardous drugs when handling waste from hazardous drug operations and maintaining equipment that has been contaminated with hazardous drugs.  Exposure risks include:

      1. handling body fluids or body fluid contaminated clothing, dressings, linens, etc.  (Up to 7 days after treatment),
      2. handling waste containers,
      3. removing or disposing of contaminated PPE,
      4. replacing filters in biological safety cabinets (BSC) (bag in/bag out),
      5. performing preventive maintenance on equipment contaminated with hazardous drugs,
      6. plumbing or waste disposal concerns in rooms that accommodate patients receiving hazardous drugs, and
      7. ventilation concerns in rooms that store hazardous drug-contaminated equipment, materials, or clothes.
  5. Hazardous Drugs List.  Manual Exhibit 3-27-A, “List of Hazardous Drugs,” contains a list of drugs that are considered hazardous drugs.  The drugs on this list are considered hazardous drugs regardless of dosage, use, or disposition.  This list is not intended to be all-inclusive as new drugs are continually being developed and are brought to market frequently.  Facilities should determine if new drugs and investigational drugs are hazardous by reviewing:

    1. package inserts of specific products;
    2. “Some Pharmaceutical Drugs,” International Agency for Research on Cancer (IARC) Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 24, World Health Organization - International Agency for Research on Cancer, April 1998;
    3. “Some Antineoplastic and Immunosuppressive Agents,” IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 26, World Health Organization - International Agency for Research on Cancer, April 1998;
    4. “Pharmaceutical Drugs,” IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 50, World Health Organization International Agency for Research on Cancer, November 1997;
    5. “Some Pharmaceutical Drugs,” IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 66, World Health Organization - International Agency for Research on Cancer, May 1997;
    6. “Some Antiviral and Antineoplastic Drugs, and Other Pharmaceutical Agents,” IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 76,World Health Organization - International Agency for Research on Cancer, June 2000;
    7. “Report on Carcinogens,” Eleventh Edition, U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, January 2005; and
    8. material safety data sheets for suspect drugs.
  6. Policy.  The IHS shall limit staff/contractors/patients exposure to hazardous drugs to the lowest possible level.

3-27.2  RESPONSIBILITIES

  1. Headquarters.  The IHS Headquarters’ clinical director, nurse program manager, pharmacy program manager, and institutional environmental health program manager will oversee the IHS hazardous drugs program; provide technical assistance, guidance, and oversight to Area level management officials; and review the IHS Hazardous Drugs program on an annual basis.
  2. Area Office Chief Medical Officer.  The Area-level Chief Medical Officers will serve as technical advisors to facility medical officers who may administer hazardous drugs.  Area Chief Medical Officers will ensure the hazardous drugs program guidelines are understood and implemented by facility medical staff.
  3. Area Institutional Environmental Health Officers.  Area-level Institutional Environmental Health Officers (IEHO) will serve as technical advisors to facility safety officers and assist with implementation of the hazardous drugs program guidelines.
  4. Area Pharmacy Managers.  Area Pharmacy Managers will serve as technical advisors to facility safety officers and pharmacy managers.  They will ensure the guidelines for safe preparation and disposal of hazardous drugs are understood and implemented.
  5. Area Nursing Managers.  Area-level Nursing Managers will serve as technical advisors to facility nurse managers and ensure the administration and disposal guidelines are understood and implemented.
  6. Chief Executive Officer.  The service unit’s Chief Executive Officer is ultimately responsible for ensuring these hazardous drug guidelines are implemented.  Individuals and committees who may be involved in implementing these guidelines at the facility-level include, (but are not limited to), the safety officer, infection control officer, facility engineer, risk manager, pharmacy manager, nursing manager, Pharmacy and Therapeutics Committee, and Safety Committee.
  7. Department Managers.  Department managers are responsible for applying and enforcing implementation of these hazardous drug guidelines at their facility, developing more specific policies and procedures, where appropriate, reviewing hazardous drug handling procedures on a regular basis, providing and enforcing the use of PPE, and monitoring safe work practices.

3-27.3  DEFINITIONS

  1. Air Changes per Hour.  Air Changes per Hour (ACH) is a commonly used air exchange term that is calculated by dividing the airflow in volume units per hour by the room volume.  Theoretically, it indicates how many times the entire volume of air in the room is replaced per hour with supply air.
  2. Biological Safety Cabinet.  A Biological Safety Cabinet (BSC) is a type of ventilated cabinet that uses a combination of high efficiency particulate air (HEPA) filtration, vertical laminar flow, and containment to protection against particulates, aerosols, and in some types of BSC, vapors (only Class II Type B2 BSC) for personnel, product, or environmental purposes.
  3. Closed System Drug Transfer Devices.  Drug transfer devices that mechanically prohibit vapor concentrations from escaping outside of the system.
  4. Decontamination.  The inactive, neutralization, or removal of toxic agents, usually by chemical means.
  5. Doff.  The act of removing personal protective equipment.
  6. Don.  The act of putting on protective equipment.
  7. Glove Box.  See the definition for "isolator."
  8. Hazardous Drugs.  Drugs that are associated with or suspected of causing adverse health effects.  Hazardous Drugs (HD) may be either carcinogenic, genotoxic impairs fertility, is teratogenic, or may be toxic to specific organs.
  9. High Efficiency Particulate Air.  Filtration that removes 99.97 percent of particles 0.3 microns in diameter or larger; HEPA filtration is used in BCSs to remove particles and aerosols from the air stream; HEPA filtration does not filter vapors or gases from the air.
  10. Horizontal Laminar Flow Cabinet.  A type of ventilated cabinet used for sterile preparations; the airflow moves horizontally from the rear of the cabinet towards the worker.
  11. Isolator.  (Also called a glove box.) A device that is sealed or supplied with air through a microbially retentive filtration system (HEPA minimum) and may be reproducibly decontaminated.  An Isolator uses only decontaminated interfaces or rapid transfer ports for materials transfer and may have attached gloves.  It may be unidirectional or turbulent, positive or negative, relative to the ambient environment, and may be recirculated or exhausted to the outside.  An isolator/glove box is not equivalent to a Class III BSC.
  12. Material Safety Data Sheet.  Material Safety Data Sheet (MSDS) are produced by chemical manufacturers and importers.  They contain detailed chemical, physical, and hazard information about specific substances.
  13. Personal Protective Equipment.  Personal Protective Equipment (PPE) includes all clothing and other work accessories designed to create a barrier against workplace hazards, including gloves, goggles, gowns, and respirators.
  14. Powered Air Purifying Respirator.  A Powered Air Purifying Respirator (PAPR) is a type of air purifying respirator that uses a blower to force the ambient air through air purifying elements to an inlet covering.
  15. Regulated Medical Waste.  Liquid or semi liquid blood products or other potentially infectious materials, contaminated items that would release blood or other potentially infectious materials in a liquid or semi liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.
  16. Resource Conservation and Recovery Act.  The Resource Conservation and Recovery Act (RCRA) is a Federal law that allows the Environmental Protection Agency (EPA) to regulate hazardous wastes from generation to transportation to treatment to storage and finally to disposal.  (See 42 United States Code (U.S.C.) 6901 et. seq.)
  17. Respirator.  A filtered mask that protects the lungs against harmful and hazardous substances.
  18. Sharps with Engineered Sharps Inquiry Prevention.  A non needle sharp or a needle device used for withdrawing hazardous drugs and body fluids; accessing a vein or artery; or administering medications or other fluids; with a built in safety feature or mechanism that reduces the risk of an exposure incident.

3-27.4  PREVENTION OF EMPLOYEE EXPOSURE - GENERAL REQUIREMENTS

The following “General Requirements” should be applied across multiple departments.  These requirements shall be applied in addition to the requirements of the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard, Code of Federal Regulations (CFR), Title 29, Section 1910.1200.

  1. Assess the Hazards in the Workplace.  Before any employee begins working with hazardous drugs, the entire workplace must be assessed to identify any potential hazards.  This includes assessing work processes, from receiving the drugs, to preparation, through administration, and finally to waste disposal.  The facility Safety Officer, with the assistance of the pharmacy manager, nursing manager, employee health, and IEHO, should conduct the hazard assessment.  Manual Exhibit 3-27-B, “Assessment of Hazardous Drug Handling in the Workplace,” can be used to assess potential workplace hazards.  The assessment must include the following:

    1. equipment (BCSs, needleless systems, PPE);
    2. potential conditions for exposure (aerosolization, crushing, open vs. closed settings);
    3. physical layout of work areas;
    4. types, forms, frequency, and volume of drugs to be handled;
    5. equipment maintenance;
    6. decontamination and cleaning;
    7. waste handling/spill response;
    8. waste disposal segregation and containment; and
    9. routine operations.
  2. Hazardous Drug Inventory.  A hazardous drug inventory (which includes any new drugs added to a facility's formulary) must be reviewed by the pharmacy staff to determine if any are listed as hazardous drugs or meet the definition of a hazardous drug.  Work practices and equipment used to handle hazardous drugs should also be reviewed on an annual basis.  Either a facility safety officer or an Area IEHO, or both can assist pharmacy staff in reviewing equipment and practices.  Staff who regularly handle hazardous drugs should provide input on work practices.
  3. Handle Drugs Safely.  Nursing and pharmacy staffs shall have drug handling policies and procedures that address the following:

    1. presence of hazardous drugs;
    2. labeling;
    3. storage;
    4. reproductive issues (pregnant/attempting pregnancy/nursing); and
    5. spill control:

      1. detailed procedures for preparing, administering, and disposing of hazardous drugs;
      2. training for safe handling of hazardous drugs, cleaning up spills, and using all equipment (engineering controls) and PPE; and
      3. general hygiene practices (prohibiting eating or drinking in areas where drugs are handled, restricting drug administration to areas without carpeted floors).
  4. Use and Maintain Equipment Properly.  Facility maintenance, biomedical engineering, nursing, pharmacy, and infection control departments shall develop procedures for using, maintaining, and verifying equipment used to reduce exposure to hazardous drugs (BSCs, needless systems, PPE).  Biological safety cabinets must be field performance tested to the National Science Foundation (NSF)-49 standards every 6 months.

3-27.5  PREVENTION OF EMPLOYEE EXPOSURE - PERSONAL PROTECTIVE EQUIPMENT

  1. Personal Protective Equipment.  Manual Exhibit 3-37-C, “Personal Protective Equipment Recommendations,” summarizes the types of PPE that should be worn during various procedures.
  2. Appropriate PPE.  Appropriate PPE must be worn during all steps of preparation including opening all drug packaging, handling vials, labeling hazardous drug containers, and disposing of waste.
  3. Gloves.

    1. No single glove offers complete protection against all hazardous drugs.  Double gloving offers the best protection and should be done for all activities related to handling hazardous drugs.  The outer glove should extend over the cuff of the gown.  When removing the gloves, the outer glove is removed first, followed by the gown, and then the inner glove.
    2. Powder-free Gloves.  All gloves shall be powder free.
    3. Appropriate Gloves.  Latex, nitrile, or "chemotherapy" gloves are appropriate for use.  Regardless of the thickness of the glove, staff must use double gloves when handling concentrated forms of hazardous drugs.
    4. Inspect Gloves.  Inspect gloves for visible defects prior to donning.
    5. Disposal.  Dispose of gloves after 30 minutes of use or when they become torn, punctured, or contaminated.
    6. Trace Waste.  Gloves are to be treated as trace hazardous drug waste unless heavily contaminated.
    7. Hands.  Wash hands immediately after removing gloves.
  4. Gowns.  Gowns must be made of a polyethylene coated or vinyl-coated material (non linting and non absorbent) and have closed fronts, long sleeves, and elastic or knit closed cuffs.  Cloth laboratory coats are not appropriate to wear when handling hazardous or potentially hazardous drugs because they do not provide any protection against contamination.
    1. Trace Waste.  Gowns are to be treated as trace hazardous drug waste unless heavily contaminated.
  5. Respirators.  Respirators, if used, shall be of the half face or full face type.  Powered air purifying respirators are also appropriate for use.

    1. Wearers of respirators must comply with the OSHA Respiratory Protection Standard (CFR, Title 29, Section 1910.134).
    2. Respirators must be equipped with appropriate filters that are specific to the hazard.  A HEPA or organic vapor filter should be appropriate for most hazardous drugs.
3-27.6  PREVENTION OF EMPLOYEE EXPOSURE - RECEIVING STORAGE, AND TRANSPORTATION

Receiving refers to the delivery of bulk products into a facility from a manufacturer or wholesaler.  Storage refers to practices used in warehouse settings to receive or store bulk containers of hazardous drugs.  Pharmacy storage areas with in use quantities of hazardous drugs are also included.  Transportation refers to practices used to move raw materials from a warehouse or bulk pharmacy storage area to the pharmacy for preparation.  It also includes the movement of finished products from the pharmacy to patient care units or the return of unused prepared drugs from patient care units back to the pharmacy.

  1. Receiving.

    1. All hazardous drugs are required to be shipped to the facility in plastic, leak-proof containers with a secure lid and appropriate labeling.
    2. All staff must wear gloves when opening containers and unpacking hazardous drugs.
    3. All staff must inspect all incoming shipments of hazardous drugs for crushing, leaks, or punctures.  If evidence of any of the above is found, trained staff must don appropriate PPE and inspect the shipment contents; cleaning up any leakage or spilled contents; as necessary.  Hazardous drug waste must be double bagged and disposed of as bulk hazardous drug waste.  (Refer to 3-27-11C(1) for more information).
  2. Storage.

    1. All containers holding hazardous drugs shall be labeled (in the appropriate languages) to indicate the contents.
    2. Staff shall ensure there is adequate ventilation in the storage area to prevent a buildup of airborne contaminants.  There must be at least 10 air changes per hour (ACH) in the room or storage area.
    3. Depending on the quantity and characteristics of the drugs being stored, an emergency exhaust fan may be required to quickly purge air in the room in the case hazardous fumes are released.
    4. Store hazardous drugs in leak-proof, closed containers to minimize the potential for hazardous drugs release.
    5. Store hazardous drugs separately from other drugs.
  3. Transportation.

    1. Staff shall wear gloves to prevent contamination when transporting a vial or syringe to a work area.
    2. Hazardous drugs must be transported in leak-proof, closed containers to prevent leakage and minimize breakage.
    3. Strict control and possession of hazardous drugs must be maintained while transporting hazardous drugs.  This means hazardous drugs should remain in the possession of and under the supervision of a person trained in the handling and transport of hazardous drugs.  Because of their hazardous nature, must not fall into the possession of someone not familiar with hazardous drugs.
    4. If hazardous drugs are to be transported to a home care setting, they must be sealed in a bag or container and transported in a leak proof container with a lid.
    5. Community Health Representatives (CHR) may occasionally transport hazardous drugs.  Each CHR shall receive a copy of Manual Exhibit 3-27-D, “Community Health Representative Information Sheet,” which summarizes hazardous drugs handling tips and information.
3-27.7  PREVENTION OF EMPLOYEE EXPOSURE - HAZARDOUS DRUG PREPARATION

The highest risk of exposure occurs during the preparation of hazardous drugs because the drugs are at their most concentrated state at that time.  Engineering controls, such as the proper use of BSCs, are the most effective means of reducing employee exposure.  However, if BSCs are not available, see Section 3-27.16, “Facility Considerations,” for guidance.

  1. General.

    1. Minimize manipulations by using liquid drugs, if available.
    2. Workers shall refrain from eating, drinking, smoking, chewing gum, applying make up, or storing food in a hazardous drug preparation area.  Signage should be posted stating these restrictions.
    3. Uncoated tablets must not be counted in an automatic pill counter.
    4. Material Safety Data Sheets shall be readily available to anyone who handles hazardous drugs.
  2. Engineering Controls - Biological Safety Cabinets.

    1. Use and Selection.

      1. Hazardous drug operations that include mixing, counting, crushing, compounding powders, or pouring liquid forms of hazardous drugs shall take place in a BSC.  Uncoated tablets or broken encapsulated tablets must also be handled within a BSC.
      2. Intravenous tubing and syringes shall be primed in a BSC, where available.  Intravenous tubing must never be primed at a patient's bedside.
      3. Hazardous drugs should be prepared in a Class II, Type B2 BSC (preferred) and exhausted to the outside to maintain a sterile field and protect workers.  Class II Type A2 and B1 BSCs can only be used when a drug's volume, toxicity and volatility is low.  Hazardous drugs that are volatile when handled must not be prepared in Type A2 or B1 BSC as they may recirculate air into the room.
      4. At the time of publication, isolators are not recommended for use with hazardous drugs due to the absence of common design criteria and field performance procedures.  If isolators are used for hazardous drug preparation, they must be pressurized negative to the ambient environment to prevent contaminants from leaving the containment.  They should be vented to the outside unless the drugs prepared in them will not volatilize.  If sterile hazardous drugs are prepared in an isolator, the supply air must be HEPA filtered and the air movement laminar.
      5. The BSC should be located in a room that is restricted to authorized personnel.
      6. The following reference can be referred to when choosing a BSC: U.S. Department of Health and Human Services. “Primary Containment of Biohazards: Selection, Installation and Use of Biological Safety Cabinets,” 2nd ed. (Washington:  Government Printing Office, 2000).
      7. Bag in/bag out BSCs are strongly recommended because they use enclosed HEPA filters.  This enclosure allows the removal of the filter with reduced risk of worker exposure.  A diagram of a bag in/bag out filter may be found in Manual Exhibit 3-27-B, “Assessment of Hazardous Drug Handling in the Workplace.”
    2. Operation.

      1. All staff using BSCs shall be trained in its proper use.
      2. Activities not requiring a sterile environment (checking labels, doing calculations, etc.) should be completed prior to accessing the BSC.
      3. To reduce the number of persons entering and exiting the BSC, designate one person to work in the cabinet preparing hazardous drugs each day.
      4. The BSC should remain “on” to enable the blower to operate continuously.  If the BSC is turned “off,” it must first be cleaned and the front opening closed and sealed with plastic and tape to prevent any contaminants from escaping.
      5. Staff must place on work surface only those items for immediate use.  Crowding the interior space of the BSC can result in decreased filter efficiency.
      6. Staff must prepare hazardous drugs on a chemotherapy preparation mat.  The mat should not cover any grills in the BSC.  The mat should be replaced at least daily and after any spills.  It should be disposed as trace hazardous drug waste.  If heavily contaminated, the mat should be disposed as bulk hazardous drug waste.
      7. When moving arms and hands in and out of the BSC, any movement should be perpendicular to the face opening of the BSC and not in a sweeping motion.
      8. Workers should refrain from resting their arms on the table edge at the face opening of a BSC as this can allow potentially contaminated air to flow into the work area.  This can be alleviated by raising the arms from the table surface.
      9. The door to a hazardous drug preparation room must be kept closed at all times.
  3. Cleaning, Disinfection, and Decontamination.  There are distinct differences between cleaning, disinfecting, and decontaminating work surfaces where hazardous drugs are prepared.

    1. Cleaning.  Cleaning is the physical removal of dirt and particles through a mechanical action.  The mechanical action of removing particles using soap (with a pH between 8 and 9) is the best way to clean contaminated work surfaces.
    2. Disinfection.  Disinfection is a chemical process that uses an antimicrobial agent to kill bacteria, viruses, fungi, and other microorganisms.  Surfaces contaminated with hazardous drugs must be cleaned prior to disinfection.

      NOTE:  Sodium hypochlorite has been shown to deactivate some specific hazardous drugs and can be used to both clean and disinfect surfaces for these drugs.  Sodium hypochlorite may also oxidize and damage BSC surfaces.  When used, it should be followed immediately with a sodium thiosulfate solution that decreases the oxidation.  Commercially available two part cleaners combine these chemicals in the correct amount and can be applied in a two step process.
    3. Decontamination.  Decontamination is the inactivation, neutralization, or removal of toxic agents, usually by chemical means.
    4. Procedures.

      1. Clean work surfaces before and after each activity and at the end of each work shift using soap with a pH between 8 and 9 or using an appropriate disinfectant.
      2. Isopropyl alcohol must not be used for cleaning because it does not deactivate all hazardous drugs.
      3. Other surfaces contacted by hazardous drugs (administration carts and trays) should be placed on a cleaning schedule.
      4. Don double gloves and appropriate eye protection for cleaning and decontamination.  Make sure gloves are chemically resistant to the cleaning agent (refer to the MSDS).
      5. Decontaminate the BSC on a regular basis (weekly or monthly based on usage).  During decontamination, lift all removable parts and clean and disinfect them while in the BSC.
  4. Work Practices.

    1. Prepare hazardous drugs in limited access areas in order to protect persons not directly involved in preparation.
    2. nitially and annually evaluate the technique of persons who prepare hazardous drugs.  Staff must prepare hazardous drugs in a way that minimizes any potential exposure.
    3. When preparing hazardous drugs, extremes of positive and negative pressure in medication vials should be avoided.  Venting devices such as filter needles or dispensing pins should be used when possible to reduce pressure differentials.
    4. Tap down ampules with dry material before opening to move any material in the top of the ampule to the bottom.  A sterile gauze pad should be wrapped around the ampule neck before breaking the top to prevent aerosolization.
    5. Remove and dispose of gowns worn while preparing hazardous drugs before leaving the immediate hazardous drug preparation area.  The practice of hanging up gowns between uses is prohibited.
    6. When hazardous drug preparation is complete, the final product must be sealed in a plastic bag or other sealable container prior to removal from the BSC.
    7. Remove outer gloves and bag them for disposal while still inside the BSC.
    8. Seal and wipe all waste containers and sharps containers inside the ventilated cabinet before removal.  Bleach (9 parts water to 1 part bleach dilution), hydrogen peroxide, sterile water, or alcohol should be used to wipe down the waste and sharps containers.
  5. Closed-System Drug Transfer Devices.  Closed system drug transfer devices may be used to minimize contamination by limiting the generation of aerosols, but are NOT a substitute for a BSC and should ONLY be used in a BSC.

    1. Gloves and gowns must be worn when using closed system drug transfer devices.
    2. Pharmacies using a Type A2 BSC or Type B1 BSC are strongly encouraged to use closed-system drug transfer devices to reduce the aerosolization of hazardous drugs in the hood.
3-27.8  PREVENTION OF EMPLOYEE EXPOSURE - HAZARDOUS DRUG ADMINISTRATION

  1. Intravenous/Injection Administration.  Before administration:

    1. Protective medical devices (such as needleless systems and sharps engineered for sharps injury prevention SESIP) shall be used when administering hazardous drugs.
    2. Intravenous tubing shall be primed by pharmacy staff within a controlled environment.  If the pharmacy is not equipped with a BSC, intravenous tubing should be primed using a non drug solution.  Intravenous tubing must not be primed at the patient's bedside.
    3. Appropriate PPE (double gloves, goggles, and protective gown) shall be worn during all stages of drug administration (opening the outer bag, assembling the delivery system, delivering the drug to the patient, and disposing of all equipment used to administer the drugs).
  2. Intravenous/Injection Administration.  During administration:

    1. Never remove tubing from an intravenous bag containing a hazardous drug.  Do not disconnect tubing at other points in the system until the tubing has been thoroughly flushed.
    2. Remove the intravenous bag and tubing intact when possible.
    3. Place absorbent pads near the administration site to capture any leaking drugs.  If a leak occurs, follow the spill procedures for contaminated linen.  (Refer to Section 3-27.11H.)
    4. Work below eye level to avoid eye, mouth, or nasal exposure from splashing hazardous drugs.
  3. Intravenous/Injection Administration.  After administration:

    1. Place disposable items directly in a trace hazardous drug waste container and seal the container.  Sharps must be disposed in a puncture proof container (even if the sharp is a SESIP).
    2. Double bag all hazardous drug administration materials.
    3. Double bag the hazardous drug waste before removing the gloves.  Dispose the gloves as regular waste unless they are visibly soiled or/and contaminated.  If gloves are visibly soiled or/and contaminated, dispose as trace hazardous drug waste.
    4. Remove gloves and gown and dispose of them in a trace hazardous drug waste container.
    5. Gowns shall be changed when leaving the patient care area or immediately if contaminated.  The practice of hanging up gowns between uses is prohibited.
    6. Wash hands with soap and water before leaving the drug administration site.  Alcohol based hand sanitizers must NOT be used in place of soap and water.  Alcohol does not inactivate all hazardous drugs.  Only the mechanical action of soap and water will physically remove any hazardous drug residue.
    7. Laboratory samples from patients being treated with hazardous drugs must be labeled as “CYTOTOXIC” in order to alert laboratory personnel of the presence of hazardous drugs.
3-27.9  PREVENTION OF EMPLOYEE EXPOSURE - AEROSOLIZED HAZARDOUS DRUG ADMINISTRATION

  1. General.

    1. Aerosolized hazardous drugs should be administered in a private room that is under negative air pressure.  The door to the room should remain closed during administration of the drug and for 10 minutes after administration has ended.  A warning sign must be posted on the outside of the door to restrict entry to authorized individuals only.
    2. Terminate flow to the nebulizer prior to removal of the nebulizer from the patient's mouth.
    3. Don gloves, gown, eye protection, and respirator/PAPR when handling aerosolized hazardous drugs or interacting with patients who are undergoing treatment with aerosolized hazardous drugs.
    4. Wash hands before and after handling any aerosolized hazardous drug.
  2. Precautions When Administering Pentamidine.  Administer Pentamidine in a negative flow isolation room and/or in a horizontal laminar flow cabinet or booth.

    1. Rooms where Pentamidine is administered must have at least 12 ACH.
    2. Dispose of the nebulizer, tubing, empty vial, and used syringe as trace hazardous drug waste.
    3. Workers and visitors who must enter the room must don a particulate respirator (N 95 or better or PAPR with HEPA filter).
    4. If a patient is unable to finish a treatment session, the nebulizer with any leftover hazardous drug solution should be disposed together.  Do not attempt to retrieve the Pentamidine from the nebulizer.
    5. Nebulizers used for administering Pentamidine must have a scavenging system with filters to minimize the release of aerosol droplets into the air.
  3. Precautions When Administering Ribavirin.

    1. Use Ribavirin in a well ventilated room with at least 6 ACH.
    2. Keep all doors to the room closed during administration.
    3. Use disposable items when possible including dishes, utensils, linen, gowns, etc.
    4. If a Ribavirin solution is used to fill a nebulizer cup outside of the pharmacy, don double gloves, gown, eye protection, and respirator.  Fill the nebulizer cup over a sink.
    5. Workers and visitors who must enter the room where Ribavirin solution is being used must don a particulate respirator (N 95 or better or PAPR with HEPA filter).
    6. Turn off aerosol flow 5 to 10 minutes prior to providing direct patient care.
    7. In addition to administering Ribavirin in a negative air pressure room, patients receiving treatment should be under a tent or wearing a mask.  The purpose of the tent is to allow the aerosol particles to settle from the air before being introduced into the environment.
    8. When administering Ribavirin through a ventilator, place an in line filter on the expiratory valve to capture aerosol particles.
    9. Since Ribavirin administration can take up to 18 hours, administer during times when there will be fewer staff interacting with the patient (during night time, for example).
    10. Return any residual Ribavirin left in the nebulizer cup after administration to the pharmacy.
    11. Pour the residual Ribavirin back into the original pharmacy container over a sink and don double gloves, a gown, eye protection, and a respirator (N 95 or better or PAPR with HEPA filter).
3-27.10  PREVENTION OF EMPLOYEE EXPOSURE - HOUSEKEEPING AND WASTE HANDLING

  1. Personal Protective Equipment.  When handling contaminated linens, feces, or urine from patients who have received hazardous drugs, wear two pairs of appropriate gloves and a disposable gown.  A face shield should be worn if splashing is possible.  Patient excreta should be handled in this manner for at least 48 hours and up to 7 days after a hazardous drug is administered, based on the drug.  See Manual Exhibit 3-27-E, “Hazardous Drugs and Times for Protective Handling of Patient Excreta,” which outlines how long PPE must be worn when handling excreta from patients exposed to hazardous drugs.

    1. Dispose of the gown and gloves after each use or whenever they become contaminated.  Dispose the gloves as regular waste unless they are visibly soiled or/and contaminated.  If gloves are visibly soiled or/and contaminated, dispose as trace hazardous drug waste.
    2. Wash hands with soap and water after removing gloves.
  2. Waste.  Waste from hazardous drug handling is of two types, trace and bulk.

    1. Trace hazardous wastes are waste items that contain less than 3 percent (by weight) of the original quantity of hazardous drugs.  Trace hazardous drug waste includes empty vials and syringes, gloves, gowns, linen, and tubing.
    2. Bulk hazardous drug wastes are waste items that contain more than 3 percent (by weight) of the original quantity of hazardous drugs.  Bulk hazardous drug waste includes spill clean up materials; partially or fully filled vials; expired or unused vials; ampoules; syringes; bags and bottles of hazardous drugs; or solutions with more than trace contamination.
  3. Trace Hazardous Drug Waste Disposal.  Collect soft trace hazardous drug waste (gowns, gloves, linen, tubing, etc.) in thick, leak proof plastic bags, colored differently from other hospital trash bags.  The bags should be labeled.

    1. Empty vials, needles, and other sharps should be disposed of in thick, plastic sharps containers colored differently from other hospital sharps containers.  Do not place these items in red sharps containers as they may be disposed improperly.  Seal containers when three fourths full.
    2. Locate waste containers for trace hazardous drug in areas where drugs are prepared or administered.
    3. Cover waste containers for trace hazardous drugs when not in use and seal and tape when filled.
    4. Trace hazardous drug waste must be incinerated at a regulated medical waste facility or disposed of in a landfill that will accept hazardous drug waste.
    5. Microwaving or autoclaving trace hazardous drug waste does not inactivate the hazardous drugs.  Do not use these methods for final destruction of trace hazardous drug waste.
  4. Bulk Hazardous Drug Waste Disposal.  Bulk hazardous drug waste includes spill clean up materials; partially or fully filled vials; expired or unused vials; ampoules; syringes; bags and bottles of hazardous drugs; or solutions with more than trace contamination.

    1. Seal containers when three fourths full.
    2. A location for collecting bulk hazardous drug waste should be centrally located (pharmacy is a good location).
    3. Hazardous drug waste storage areas shall meet applicable EPA requirements.  All hazardous waste storage areas must be well ventilated.
    4. Bulk hazardous drug waste must be incinerated at a regulated medical waste facility or disposed at a landfill that will accept hazardous drug waste.
    5. Microwaving or autoclaving bulk hazardous drug waste does not inactivate the hazardous drugs.  Do not use these methods for final destruction of bulk hazardous drug waste.
    6. Hazardous Waste.

      1. The following hazardous drugs are considered hazardous waste under the RCRA when disposed as bulk hazardous drug waste:

        1. Arsenic Trioxide (P-listed waste);
        2. Chlorambucil (U-listed waste);
        3. Cyclophosphamide (U-listed waste);
        4. Daunomycin (U-listed waste);
        5. Melphalan (U-listed waste);
        6. Mitomycin C (U-listed waste);
        7. Streptozotocin (U-listed waste); and
        8. Uracil Mustard (U-listed waste).
      2. All RCRA hazardous drug waste must be packaged, labeled, listed on the manifest and then incinerated at an RCRA permitted incinerator (this is different than a medical waste incinerator) or disposed at a licensed hazardous waste landfill.
      3. Facilities must maintain records of names, amounts, weights, types of bulk hazardous drug wastes generated, manifests, and records of destruction in order to verify records of the waste transporter and comply with RCRA requirements.
  5. Excreta.  Patients excrete the majority of drug metabolites in their urine and stool within 48 hours after administration.  However, some drug metabolites are excreted in urine and stool for 7 days after administration.  During these time periods, patient excreta should be handled with care.

    1. Patient excreta can usually be disposed in the sanitary sewer.  Confirm this with your facility safety officer or environmental health officer as some localities may require notification of disposal of contaminated excreta.
    2. Encourage male patients to sit on toilet seats rather than standing during urination to reduce the risk of aerosolization and droplet transfer.
    3. When feasible, encourage the use of toilets rather than urinals and bedpans so that excreta can be disposed of immediately.
    4. When applicable, collect drainage of pleural fluids, ascites, and other body fluids in a closed system that can be disposed of intact.
    5. If possible, use disposable ostomy pouches rather than rinsing and reusing them.
    6. Protect the skin of incontinent patients from their own excreta.  The metabolites of drugs found in the urine or stool may be damaging to the skin.  Following each urination or stool, cleanse the skin with soap and water and apply a moisture barrier to the perineal and perirectal areas.  Apply a clean disposable diaper.
    7. Educate patients receiving hazardous drugs in home care regarding the hazards of their excreta.
    8. Close the lid on the toilet, if available; prior to flushing in order to reduce the risk of aerosolization and droplet transfer.
    9. Diapers and other absorbable material contaminated with patient excreta from patients receiving hazardous drugs should be treated as trace hazardous drug wastes.
  6. Recycling.  Many reverse distribution companies (RDC) offer product return processing, professional waste disposal and customized reporting services.  These companies will pick up hazardous drugs, controlled substances, and other pharmaceuticals and return them to the manufacturer, usually for percentage of the value of the returned pharmaceuticals.  Drugs that can not be returned to the manufacturer should be handled as hazardous waste and disposed.

    1. It is strongly recommended that IEHO or facility safety officers inspect and audit the disposal facilities on an annual basis to ensure that hazardous drugs are properly disposed.  Depending on the findings, this survey may need to be conducted more frequently.  This inspection should be outlined in the contract with the RDC.

      NOTE:  Some RDCs may already conduct this annual audit with the hazardous waste disposal facility.  Documentation of this audit from the RDC may take the place of an actual onsite audit of the disposal facility.
    2. The RDC must not designate any hazardous drug products being returned as "waste" onsite.  This designation will make your facility the generator of hazardous waste.  This designation must be made offsite so that the RDC will be the generator of the hazardous waste.
    3. The RDC must provide a certificate of destruction for all hazardous drugs that are incinerated, deposited in a hazardous waste landfill, or otherwise disposed.
  7. Training.  Personnel who are involved in handling hazardous drug waste must be properly trained.  They should know where to access the spill kit and how to use it.
  8. Waste Transportation.  Transportation of hazardous waste is regulated by the EPA, the Federal Department of Transportation (DOT), and State regulators.

    1. Trace hazardous drugs waste must be sealed and transported in the same manner as regulated medical waste as defined by State and Federal regulations.  Minimally, the waste should be double bagged and labeled.  Other State requirements may apply.
    2. Resource Conservation and Recovery Act hazardous waste (U listed and P listed hulk hazardous drug waste).

      1. At a minimum, hazardous drug waste leaving the facility must be listed on a manifest, labeled appropriately, and shipped to a regulated treatment storage disposal facility (TSDF).
      2. Since the generator of the hazardous drug waste (the facility) is ultimately responsible for the disposition of the waste, the waste hauler must be reputable, competent, and certified to haul hazardous waste.
      3. It is strongly recommended that the IEHO or facility safety officer(s) inspect the hazardous waste hauler's policies and procedures on an annual basis to ensure that hazardous drugs are properly transported.  Depending on the findings, this survey may need to be conducted more frequently.  This inspection should be outlined in the contract with the hazardous waste hauler.
3-27.11  PREVENTION OF EMPLOYEE EXPOSURE - SPILL MANAGEMENT AND CONTROL

  1. Spill Kits.  Spill kits should be located in the immediate area where exposures may occur.
  2. Spill Kit Contents.  Each spill kit should contain the following items (commercial chemotherapy spill kits may also be used):

    1. absorbent pads with impermeable backing,
    2. isposable dust pan and scoop,
    3. eye protection,
    4. gloves (2 pairs),
    5. hazardous drug disposal bags (2),
    6. protective lint free gown with cuffs and back closure, and
    7. shoe covers.
  3. Responsible Staff.  Due to their specialized training and experience working with hazardous drugs, pharmacy and nursing staff should be responsible for cleaning up hazardous drug spills.  Only individual staff who have received formal spill response training are permitted to clean up spills of hazardous drugs.

  4. Appropriate PPE.  Wear appropriate PPE (gloves, gown, respirator) for cleaning up spills.
  5. Spills of Less than 5 ml or 5 gm Outside a BSC.  Spills of less than 5 ml or 5 gm outside a BSC should be cleaned up immediately by trained personnel wearing gowns, double gloves (latex, nitrile, or chemotherapy), and eye protection (if splashing is possible).

    1. Immediately notify other employees in the area that a hazardous drug spill has occurred and prevent anyone from entering the area of the spill.
    2. Liquids should be wiped up with an absorbent gauze pad with an impermeable backing; solids should be wiped up with wet absorbent gauze with an impermeable backing.  The spill area(s) must be cleaned using a detergent solution with a pH between 8 and 9 followed by clean water.  Repeat this cleaning two or more times.
    3. Any broken glass fragments shall be picked up using a small scoop (never the hands) and placed in a hazardous drug sharps container.
    4. Contaminated reusable items, such as glassware and scoops, shall be washed twice with detergent by a trained employee wearing double gloves and a disposable gown.  This PPE shall be disposed as trace hazardous drug waste.
    5. Place all contaminated absorbent pads and other materials in a bulk hazardous drug waste container.
    6. After removing PPE, wash hands, arms, and face.
    7. Reusable protective goggles should be cleaned with mild detergent and water after each use.
  6. Spills of More than 5 ml or 5 Outside a BSC.  For spills of amounts larger than 5 ml or 5 gm, the area should be isolated and aerosol generation avoided.

    NOTE:  Staff who are required to wear respirators must meet other requirements under Title 29, CFR, Section 1910.134 including annual medical evaluations, fit testing, and training.

    1. Immediately notify other employees in the area that a spill has occurred.  Prevent anyone from entering the area of the spill so that it is not tracked to other areas.
    2. Use a chemotherapy spill kit to clean up hazardous drug spills.
    3. Don a gown, double gloves (one glove under the cuff and one glove over the cuff of the gown), eye protection, shoe covers, and appropriate respiratory protection.
    4. Limit liquid spread by covering the hazardous drug spill with absorbent sheets or spill control pads or pillows.  If a powder is involved, damp cloths or towels should be used.
    5. Pick up any broken glass fragments using a small scoop (never the hands) and place in a sharps container.  Dispose of the sharps container and all hazardous drug clean up material (absorbent pads, PPE, etc.) as bulk hazardous drug waste.
    6. Thoroughly clean all contaminated surfaces no less than three times with detergent and water.
    7. Place all contaminated absorbent pads and other materials in a bulk hazardous drug waste container.
    8. Wash hands, arms, and face.
    9. Protective goggles and respirators must be cleaned with mild detergent and water after each use.
  7. Spills on Carpet/Upholstery.  Secure the area and use an absorbent powder to absorb the hazardous drug spill.  Use a vacuum cleaner that is designated solely for hazardous drug cleanup to remove the powder.  Notify your facility safety officer as soon as possible that a hazardous drug spill has occurred and has been cleaned up.
  8. Spills on Linen.  Linen contaminated with hazardous drugs should be immediately removed from service and washed separately from other linen.  Workers handling contaminated linen should wear gloves, a gown, and eye protection.  If minimally contaminated, linen can be disposed of as trace hazardous drug waste.  For inpatients receiving hazardous drug treatment, disposable linen should be used where possible.
  9. Spills in Biological Safety Cabinets.

    1. Extensive spills within a BSC necessitate decontamination of all interior BSC surfaces after completion of the spill clean up.
    2. If the HEPA filter of a BSC is contaminated, the unit must be labeled and sealed in plastic until the filter can be changed and disposed of properly by trained personnel wearing appropriate PPE.
3-27.12  EMERGENCY RESPONSE TO OCCUPATIONAL EXPOSURES

  1. Skin Exposure.

    1. Remove contaminated clothing and PPE.
    2. Wash affected area thoroughly with soap and water.
    3. Consult the MSDS for drug specific instructions.
    4. Report to an employee health professional for medical review.  Physicians shall perform a medical exam concentrating on the site of contamination and target organs of the hazardous drug(s) in question.
    5. Report a hazardous drug event using WebCident or other Agency approved reporting system.
  2. Eye Exposure.

    1. Flush the eye(s) with water for 15 minutes.
    2. Consult the MSDS for drug specific instructions.
    3. Report to an employee health professional for medical review.  Physicians shall perform a medical exam concentrating on the site of contamination and target organs of the hazardous drug(s) in question.
    4. Report the event using WebCident or other Agency-approved reporting system.
  3. Exposure by Inhalation.

    1. Acute symptoms may require emergency intervention.
    2. Consult the MSDS for drug specific instructions.
    3. Report to an employee health professional for medical review.  Providers shall perform a medical exam concentrating on the site of contamination and target organs of the hazardous drug(s) in question.
    4. Report the event using WebCident or other Agency-approved reporting system.
3-27.13  MAINTENANCE ACTIVITIES

  1. General.

    1. Develop a written safety plan for all routine maintenance activities performed on equipment that could be contaminated with hazardous drugs.
    2. Workers performing maintenance on any utility that may be contaminated with hazardous drugs must be familiar with applicable safety standards, warned about hazards, and trained in the appropriate work techniques and PPE needed to minimize exposure.
  2. Biological Safety Cabinets.

    1. The facility safety officer or IEHO must review, in advance, all maintenance activities performed on the BSC and exhaust systems associated with hazardous drugs use.  This review should assess PPE recommendations and work practices.
    2. The BSC shall be certified by the National Sanitation Foundation (NSF).
    3. The BSC shall be field-certified as outlined in NSF/ANSI 49 2004 upon installation (prior to first use), after relocation, after any repair to internal components, after HEPA filter replacement, and every 6 months.  The current field certification must be prominently displayed on the BSC.
    4. Only qualified technicians can certify a BSC.
    5. Locate all BSCs away from doors, aisles, open windows, air supply registers, or equipment that creates air movement.
    6. Exhausted air from the BSC must be located no closer than 30 feet from outdoor air intakes and operable windows, skylights, or doors.
    7. Exhausted air from the BSC should not be recirculated.
    8. Remove all hazardous drugs and decontaminate the BSC prior to beginning maintenance.  As outlined in Title 29, CFR, Section 1910.147, Control of Hazardous Energy, lockout or tag out the BSC prior to beginning maintenance.
    9. Decontaminate and bag BSC equipment and parts removed for replacement before they are taken from the containment area.
    10. Used filters must be bagged immediately upon removal from the BSC and handled as hazardous waste.
    11. Each BSC should be equipped with a continuous monitoring device to confirm adequate air flow before use.
3-27.14  MEDICAL SURVEILLANCE

Pharmacists, pharmacy technicians, and nurses who handle hazardous drugs must be included in a medical surveillance program to determine if exposure to hazardous drugs has caused health effects.  Medical surveillance is comprised of a detailed work history focusing on the target organs of concern, a physical examination, and laboratory tests.  Special biological monitoring for specific agents may also be used to determine exposure.  Each facility should determine if other workers, who are potentially exposed to hazardous drugs, should be included in medical surveillance.  Other workers that may be considered include environmental services workers, maintenance staff, materiel management staff, and other nursing staff.

  1. Elements.  All of these staff routinely handle hazardous drugs:  Pharmacists, pharmacy technicians, and nurses who handle hazardous drugs must be included in a medical surveillance program.  Each facility should determine if other workers who are potentially exposed to hazardous drugs should also be included in medical surveillance  Other workers who may be considered include environmental services workers, maintenance staff, materiel management staff, and other nursing staff.
  2. Medical Evaluation.  The medical evaluation should contain the following components.

    1. Detailed Work History.  Previous and current work experience shall be reviewed.  The work history should focus on symptoms relating to the target organs and systems associated with exposure to hazardous drugs (hematopoietic, renal/urinary, hepatic, and reproductive).  Female workers should be queried regarding reproductive history.  (Manual Exhibit 3-27-F, “Medical Surveillance Form Sample,” can be used as a template to collect the appropriate data).
    2. Physical Examination.  The physical examination is most useful following an employee hazardous drug exposure, or as indicated by laboratory tests (low white blood cell count).  Post exposure physical examinations shall focus on the specific area of exposure and target organs affected by the agent.
    3. Laboratory Testing.  A complete blood count with differential and a reticulocyte count should be taken.  A complete blood cell count may be helpful as an indicator of bone marrow reserve.  Urine should be monitored (either by a urine dipstick or microscopic examination of the urine for blood) as several antineoplastic agents can cause bladder damage.
    4. Special Biological Monitoring.  For some agents there are specific gentoxic endpoints or indicators of hazardous drug exposure.  When available and indicated, these markers can be used to determine exposure.
  3. Frequency.  Employees who handle hazardous drugs must receive a medical evaluation prior to handling any hazardous drugs (serves as a baseline), after an exposure to a hazardous drug, post-employment, and periodically (no less than every 2 years).
  4. Reproductive Issues.  Adherence to the medical surveillance engineering controls, administrative controls, and PPE recommendations in this chapter should minimize potential hazardous drug exposures.  Staff who are pregnant, attempting pregnancy (male and female), or who are nursing, may provide written voluntary disclosure to their supervisor.  When feasible, supervisors should reassign these staff so that their job duties do not include the direct handling and manipulation of hazardous drugs.
  5. Results.  If a review of the results of medical surveillance indicates any exposure or risk of exposure for an employee, the facility Safety Officer or IEHO shall be notified to investigate the workplace and work practices of that employee.

3-27.15  HANDLING HAZARDOUS DRUGS TRAINING

The following 9 topics should be included in any curriculum developed for training staff on handling hazardous drugs.

  1. Risks of Handling Drugs.  Staff must be educated on the risks of handling hazardous drugs including the definition of a hazardous drug, characteristics and forms of hazardous drugs, exposure routes, acute and chronic adverse health effects of exposure, and reproductive issues.
  2. Personal Protective Equipment.  Staff must be trained on the proper donning and doffing of PPE.  The circumstances under which it should be worn, how long it should be worn, and limitations of PPE.  Respiratory protection PPE will require additional training and respirator fit testing.
  3. Work Practices.  Staff must be trained on work practices that reduce potential exposures including proper maintenance and use of BSCs (if available), use of closed system devices (if available), priming, and use of luer-lock connections.  Those who prepare or administer hazardous drugs should be tested annually regarding their work practices.
  4. Transporting Drugs.  Staff must be trained on how drugs are transported in bulk form (prior to pharmacy processing), final form (for delivery to the patient), and used drugs (after partial administration to a patient, for example).
  5. Waste Disposal Management.  Staff should understand the difference between trace and bulk hazardous drugs waste and how each type is handled.  Staff should be aware of appropriate disposal methods for the type of hazardous waste generated.
  6. Management of Acute Exposures.  Staff must be trained on immediate responses to acute exposures and the process of reporting the exposures.
  7. Spill Management Plan.  Staff expected to clean up hazardous drug spills must be trained and proficient in the use of a spill kit.  This includes familiarity with spill kit contents, how it is used, and how to evaluate spill size and determine staff response(s).
  8. Recordkeeping.  Staff must report all hazardous drug spills and exposure and unintentional exposures and (or both) potential exposures to their immediate supervisor.  Where available, hazardous drug spills and exposures should be documented using WebCident software.  Occupational exposures should be reported on the facility's OSHA 300 log.
  9. Medical Surveillance.  The medical surveillance program must be outlined including the frequency of medical surveillance, the need for medical surveillance, and how the records will be maintained.

3-27.16  FACILITY CONSIDERATIONS

Facilities that may dispense hazardous drugs infrequently or on a limited basis may follow these exceptions to the guidelines.  It is important to note that hazardous drugs, whether dispensed for chemotherapy treatment or for other treatments, are dangerous.  All hazardous drugs should always be handled appropriately regardless of dosage or treatment regime.

  1. General Recommendations.  No exceptions.
  2. Personal Protective Equipment.  No exceptions.
  3. Receiving, Storage, and Transportation.

    1. (2)b Storage.  Ensure there is adequate ventilation in the storage area to prevent the buildup of airborne contaminants.  There should be at least 4 ACH.
  4. Hazardous Drug Preparation.

    1. (2)a(i) Use and Selection.  If a BSC is not available, facilities should attempt to outsource hazardous drugs preparation by ordering prepared hazardous drugs from other facilities equipped with a BSC.  If this is not possible, staff preparing hazardous drugs shall don appropriate PPE including double gloves, face protection, gown, and half face or full face respirator.  Hazardous drugs should be prepared on a disposable chemotherapy mat which should be disposed immediately after preparation.  The work area should be cleaned as indicated in 6D(4).  Staff who wear respirators must also comply with all components of the OSHA Respiratory Protection Program standard (1910.134) including medical evaluation and fit testing.
    2. (2)a(ii) Use and Selection.  Facilities not equipped with a BSC that are considering purchasing a new BSC should consider purchasing a Type B1 at a minimum.  The cost difference between a Type A and Type B hood is minimal.
  5. Hazardous Drug Administration.  No exceptions.
  6. Housekeeping and Waste Handling.  No exceptions.
  7. Spill Control.

    1. General.  Spill kits may be located in central locations and not necessarily in every location where exposures may occur.  If the areas of potential exposure are located in separate buildings, there should be a spill kit in each building.
  8. Maintenance.  No exceptions.
  9. Medical Surveillance.

    1. Elements.  Pharmacists and nurses who are primarily handling hazardous drugs will need to be included in medical surveillance but those who contact them in rare circumstances may not be included.  Those who are occupationally exposed through spills, body fluid exposure, etc., should always be medically evaluated.
  10. Training.  No exceptions.

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