Oncologic drug Exposure Risks and Prevention Guidelines 19 June 2014

Transcription

1 Oncologic drug Exposure Risks and Prevention Guidelines 19 June 2014

2 ส งค กคามซ งอาจเป นอ นตรายต อส ขภาพ HAZARD? HAZARD

3 ส งค กคามซ งอาจเป นอ นตรายต อส ขภาพ ENCLOSURE Substitution

4 ส งค กคามซ งอาจเป นอ นตรายต อส ขภาพ ADMINISTRATION

5 Industrial Hygiene Management System Anticipation (การคาดการณ ) Recognition (การตระหน ก) Evaluation (การประเม น) Policy Organization Planning and Implementation Toxicology review Health effects Industrial Hygiene Survey Hazard Inventory & Tracking Prioritize Risk IH Management BEI Exposure assessment Report Health Risk Assessment Prioritize Risk Control (การควบค ม) Evaluation Action for Improvement Engineering control Administration Training Risk Communication - Chem Info System PPE, Respirator Specific hazard, HCP Medical Surveillance

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8 Hazard of Risk factors Understand material use to determine TOXICITY Understand situation of use to estimate EXPOSURE HAZARD = TOXICITY X EXPOSURE

9 Source of Standard values OSHA : Occupational Safety and Health Administration NIOSH : National Institute for Occupational Safety & Health ACGIH : American Conference of Governmental Industrial Hygienists IARC MSDS : International Agency for Research on Cancer : Material Safety Data Sheet Chemical fact Sheets 9

10 Abbreviations TLV TLV-C TWA PEL REL BEI STEL AL IDLH : Threshold Limit Value : Threshold Limit Value-Ceiling : Time-Weighted Average : Permissible Exposure Level : Recommended Exposure Level : Biological Exposure Index : Short Term Exposure Limit (15 min) : Action Level : Immediately Dangerous to Life or Health

11 Characteristics That Define Hazardous Drugs Carcinogenicity Teratogenicity or other developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity Structure & toxicity that mimics existing hazardous drugs Adapted from the National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA), and the American Society of Health-System Pharmacists 11

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13 Antineoplastic Agents That are Classified as Known or Probable Human Carcinogens IARC Group 1 (Human Carcinogens) Arsenic trioxide Azathioprine Chlorambucil Chlornaphazine Cyclophosphamide Myleran Melphalan Semustine Tamoxifen Thiotepa Treosulfan Mustargen-Oncovin-Procarbazine-Prednisone (MOPP) Etoposide-Cisplatin-Bleomycin (ECB) IARC Group 2A (Probable Human Carcinogens) Azacitidine BCNU CCNU Chlorozotocin Cisplatin Doxorubicin HCl N-Ethyl-N-nitrosourea Etoposide Mechlorethamine HCl N-Methyl-nitrosourea Procarbazine HCl Teniposide Adapted from the International Agency for Research on Cancer (IARC). The majority of antineoplastic drugs are nonselective in their action: they exhibit their effects in both cancerous and noncancerous cells in most organs and body tissues. 13

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15 Antineoplastic Agents That are Classified as Pregnancy Category D* or X 16 Drug Pregnancy Category Drug Pregnancy Category Arsenic trioxide D Imatinib mesylate D Azathioprene D Interferon alfa-2b X Bleomycin D Irinotecan HCl D Capecitabine D Leflunomide X Carboplatin D Lomustine D Carmustine D Mechlorethamine HCl D Chlorambucil D Melphalan D Cisplatin D Mercaptopurine D Cladribine D Methotrexate X Cyclophosphamide D Mitoxantrone HCl D Cytarabine D Oxaliplatin D Dactinomycin D Paclitaxel D Daunorubicin HCl D Pipobroman D Docetaxel D Procarbazine D Doxorubicin HCl D Tamoxifin D Epirubicin D Temozolomide D Etoposide D Teniposide D Floxuridine D Thalidomide X Fludarabine D Thioguanine D Fluorouracil D Thiotepa D Gemcitabine D Topotecan D Hydroxyurea D Tositumomab X Ibritumomab tiuxetan D Vinblastine sulfate D Idarubicin D Vincristine sulfate D Ifosfamide D Vinorelbine tartrate D Adapted from the US Food and Drug Administration Center for Drug Evaluation and Research. D = Clear evidence of risk to the human fetus. X = Clear evidence that medication causes abnormalities in the fetus. 15

16 Potential for Worker exposure Throughout its life cycle These workers include receiving personnel, pharmacists and pharmacy technicians, nursing personnel, physicians, operating room personnel, environmental services personnel, and housekeeping workers 16

17 List of Hazardous Drug Handling Activities in Workers Activity Handling drug - contaminated vials Reconstituting powdered or lyophilized drugs and further diluting either the reconstituted powder or concentrated liquid forms of hazardous drugs Expelling air from syringes filled with hazardous drugs Compounding potent powders into custom-dosage capsules Primary Group of Workers Exposed Pharmacists, pharmacy technicians Administering antineoplastic drugs by intramuscular, subcutaneous, or intravenous (IV) routes Generating aerosols during the administration of drugs, either by direct IV push or by IV infusion Priming the IV set with a drug-containing solution at the patient bedside Handling body fluids or body-fluid-contaminated clothing, dressings, linens, and other materials Handling contaminated wastes generated at any step of the preparation or administration process Nursing personnel Counting out individual, uncoated oral doses and tablets from multi-dose bottles Unit-dosing uncoated tablets in a unit-dose machine Crushing tablets to make oral liquid doses Pharmacists, pharmacy technicians, and nursing personnel Adapted from the National Institute for Occupational Safety and Health. 17

18 List of Hazardous Drug Handling Activities in Workers Activity Contacting measurable concentrations of drugs present on drug vial exteriors, work surfaces, floors, and final drug products (bottles, bags, cassettes, and syringes) Handling unused antineoplastic drugs or antineoplastic drug contaminated waste Decontaminating and cleaning drug preparation or clinical areas Performing certain specialized procedures (such as intraoperative, intra-peritoneal chemotherapy) in the operating room Transporting infectious, chemical, or hazardous waste containers Removing and disposing of personal protective equipment after handling hazardous drugs or waste Performing repairs or maintenance on biological safety cabinets or isolators used to prepare antineoplastic drugs Primary Group of Workers Exposed Pharmacists, pharmacy technicians, nursing personnel, housekeeping personnel Physicians, nursing personnel, and operating room personnel Nursing, housekeeping and waste disposal personnel Pharmacists, pharmacy technicians, nursing & housekeeping personnel Maintenance, biological safety cabinets certification personnel Adapted from the National Institute for Occupational Safety and Health. 18

19 CONDITIONS FOR EXPOSURE Both clinical and nonclinical workers may be exposed to hazardous drugs when they create aerosols, generate dust, clean up spills, or touch contaminated surfaces during the preparation, administration, or disposal of hazardous drugs. The following list of activities may result in exposures through inhalation, skin contact, ingestion, or injection: 19

20 Occupational exposures to hazardous drugs can lead to - Acute effects: headache, dizziness, nausea, allergic reaction (asthma & skin rashes). Chronic effects: - increased genotoxic effects - Developmental & reproductive events - possibly cancer (leukemia) 20

21 Recent evidence summarized that Worker exposure to hazardous drugs is a persistent problem. The sampling methods used in the past have come into question and may not be a good indicator of contamination in the workplace. Surface contamination of the workplace is common and widespread. A number of recent studies have documented the excretion of several indicator drugs in the urine of healthcare workers. Results from studies indicate that worker exposure to hazardous drugs in health care facilities may result in adverse health effects. 21

22 Hierarchy of Industrial Hygiene Control Elimination of the hazard or substitution with a less hazardous chemical (this is not feasible in health care) Engineering controls (the use of biological safety cabinets, isolators, or closed systems) Administrative controls (training and education programs; availability of material safety data sheets; established work practices, policies, and surveillance) Personal protective equipment (the use of protective gloves, gowns, respiratory protection, and eye protection) Adapted from Soule RD. Industrial Hygiene Engineering Controls 22

23 NIOSH recommends NIOSH is currently conducting studies to further identify potential sources of exposure and methods to reduce or eliminate worker exposure to these drugs. To minimize these potentially acute (short-term) and chronic (long-term) effects of exposure to hazardous drugs at work, that at a minimum, employers and health care workers to follow. 23

24 Summary of NIOSH Recommended Procedures 1. Assessment the hazards in the workplace. - Evaluate the workplace to identify & assess hazards. - Regular review the current inventory of hazardous drugs, equipment and practices, seeking input from affected workers. - Conduct regular training reviews with all potential exposure workers in workplaces where hazardous drugs are used. 2. Handle drugs safely. - Implement a program for safely handling hazardous drug at work and review this program annually. - Establish procedures & provide training. 3. Use and maintain equipment properly. 24

25 1. Assess the hazards in the workplace. Evaluate the workplace to identify and assess hazards. - Total working environment - Equipment (ventilated cabinets, closed-system drug transfer devices, glovebags, needleless systems & PPE) - Physical layout of work areas - Types of drugs being handled - Volume, frequency & form of drugs handled (tablets, coated/uncoated, powder versus liquid) - Equipment maintenance - Decontamination and cleaning - Waste handling - Potential exposures during work, including hazardous drugs, bloodborne pathogens, and chemicals used to deactivate hazardous drugs or clean drugcontaminated surfaces - Routine operations - Spill response - Waste segregation, containment, and disposal 25

26 1. Assess the hazards in the workplace Regularly review the current inventory of hazardous drugs, equipment, and practices, seeking input from affected workers. Conduct regular training reviews with all potentially exposed workers in workplaces where hazardous drugs are used. Seek ongoing input from workers and use this input from workers to provide the safest possible equipment and conditions for minimizing exposures. 26

27 2. Handle drugs safely. Implement a program for safely handling hazardous drugs at work and review this program annually on the basis of the workplace evaluation. Establish work policies and procedures specific to the handling of hazardous drugs. These policies and procedures should address and define the following: Presence of hazardous drugs Labeling Storage Personnel issues (such as exposure of pregnant workers) Spill control Detailed procedures for preparing, administering & disposing of hazardous drugs 27

28 2. Handle drugs safely. Establish procedures and provide training for handling hazardous drugs safely, cleaning up spills, and using all equipment and PPE properly. Inform workers about the location and proper use of spill kits. In addition, establish procedures for cleaning and decontaminating work areas and for proper waste handling and disposal of all contaminated materials, including patient waste. Establish work practices related to both drug manipulation techniques and to general hygiene practices - such as not permitting eating or drinking in areas where drugs are handled (the pharmacy or clinic). 28

29 3. Use and maintain equipment properly. Develop workplace procedures for using and maintaining all equipment that functions to reduce exposure - such as ventilated cabinets, closed-system drug-transfer devices, needleless systems, and PPE. 29

30 Wear PPE while reconstituting and admixing drugs: - The gloves are labeled as chemotherapy gloves. - Consider latex-sensitive workers and a number of glove materials are suitable for protecting workers from antineoplastic drugs. - Consider using chemotherapy gloves for other hazardous drugs or for which no information is available. - Use double gloving for all activities involving hazardous drugs. Make sure that the outer glove extends over the cuff of the gown. - Inspect gloves for physical defects before use. - Prefer gloves with minimal or no powder.

31 Wear PPE while reconstituting and admixing drugs: - Wash hands with soap and water before donning protective gloves and immediately after removal. - Change gloves every 30 minutes or when torn, punctured, or contaminated. Discard them immediately in a yellow chemotherapy waste container. - Use disposable gowns made of polyethylene-coated polypropylene. Make sure gowns have closed fronts, long sleeves, and elastic or knit closed cuffs. - Dispose of protective gowns after each use. - Use disposable sleeve covers to protect the wrist area and remove the covers after the task is complete. 31

32 NIOSH Recommendations for Safe Handling of Antineoplastic and Other Hazardous Drugs Activity Receiving and storage of drugs Preparation and administration of drugs Recommendations - Wear PPE* suitable for task being performed - Properly label all hazardous drugs - Store and transport drugs in proper containers - Evaluate drug preparation and administration policies - Wear suitable PPE, including double gloves for task being performed - Limit access to areas where drugs are prepared - Use proper engineering controls when preparing drugs - Wash hands with soap & water before donning and after removing gloves - Prime intravenous tubing in a ventilated cabinet - Use needleless or closed systems when preparing & administering drugs - Do not disconnect tubing from an intravenous bag containing a hazardous drug - Dispose of used materials in the appropriate container Ventilated cabinets - Perform all preparations with hazardous drugs in a ventilated cabinet designed to reduce worker exposure - Do not use supplemental engineering controls as a substitute for a ventilated cabinet - When asepsis is required, select a cabinet designed for both hazardous drugs containment and aseptic processing - Horizontal laminar-flow clean benches should not be used for preparation of hazardous drugs - Properly maintain engineering controls as required by the manufacturer 32

33 Ventilated Cabinets Use of cabinets Mix, prepare, and otherwise manipulate, count, crush, compound powders, or pour liquid hazardous drugs inside a ventilated cabinet designed to prevent hazardous drugs from being released into the work environment. Do not use supplemental engineering or process controls (such as needleless systems, glove bags, and closedsystem drug transfer devices) as a substitution for ventilated cabinets. 33

34 Selection a ventilated cabinet Depending on the need for aseptic processing - When asepsis is not required, a Class I BSC or an isolator intended for containment applications may be sufficient. - When aseptic technique is required, use one of the following ventilated cabinets: a) Class II BSC (Type B2 is preferred) b) Class III BSC c) Isolators intended for asepsis and containment 34

35 Types of Biological Safety Cabinets (BSC) All types have downward airflow and HEPA filters BSC The amount of re-circulated air within the cabinet Exhaust to Contaminated duct pressure room outside negative positive Type A 70% 30% - - P Class II Type B1 30% - 70% P - Type B % P - Type B3 70% - 30% P - Class III Class I - Totally enclosed with gas tight construction. - The entire cabinet is under negative pressure - Similar a chemical fume hood, but usually has a limited fixed work access opening and the exhaust air must be HEPA filtered, to protect the environment. 35

36 Air flow and exhaust

37 Class I: BSC Class II: BSC Class III: BSC 37

38 Air flow and exhaust To confirm adequate air flow before each use. Use a HEPA filter for the exhaust from these controls and exhaust 100% of the filtered air to the outside. Install the outside exhaust so that the exhausted air is not pulled back into the building by HVAC systems or by the windows, doors. Place fans downstream of the HEPA filter so that contaminated ducts are maintained under negative pressure. Do not use a ventilated cabinet that recirculates air inside the cabinet or exhausts air back into the room environment. Seek additional information about placement of the cabinet, exhaust system, and stack design from NSF/ANSI [NSF/ANSI 2002]. 38

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40 NIOSH Recommendations for Safe Handling of Antineoplastic and Other Hazardous Drugs Activity Routine cleaning, decontamination, housekeeping, and waste disposal Spill control Medical surveillance Recommendations - Use suitable PPE for the task being performed - Establish periodic cleaning routines for all work surfaces and equipment used where hazardous drugs are prepared or administered - Consider used linen and patient waste to be contaminated with the drugs and/or their metabolites - Separate wastes according to institutional, state, and federal guidelines and regulations - Manage spills according to written policies and procedures - Locate spill kits in areas where exposures may occur - Adhere to Occupational Safety & Health Administration (OSHA) respiratory protection program - Dispose of spill material in a hazardous chemical container - Participate in medical surveillance programs at work, or see your private health care provider if one does not exist - Medical surveillance should include the following: Reproductive and general health questionnaires Complete blood count and urinalysis Physical examination at time of employment and annual health status questionnaire review Follow up for workers who have shown health changes 40

41 1. Assess the hazards in the workplace. 41

42 Housekeeping Wear protective double gloves and a disposable gown if you must handle linens, feces, or urine from patients who have received hazardous drugs within the last 48 hours or in some cases, within the last 7 days. Dispose of the gown after each use or whenever it becomes contaminated. Wear face shields if splashing is possible. Remove the outer gloves and the gown by turning them inside out & placing them into the chemotherapy waste container. Repeat the procedure for the inner gloves. Wash hands with soap & water after removing the gloves. 42

43 Spill Control Established written policies and procedures. The size of the spill - authorized person to conduct the cleanup & decontamination and how the cleanup is managed. PPE required for various spill sizes, spreading of material, restricted access to hazardous drug spills, and signs to be posted. Cleanup of a large spill is handled by workers who are trained. Locate spill kits & other cleanup materials in the immediate area where exposures may occur. Surgical masks do not provide adequate protection. Dispose of all spill cleanup materials in a hazardous chemical waste container, not in a chemotherapy waste container. 43

44 The ASHP recommends that kits include: chemical splash goggles, two pairs of gloves, utility gloves, a low-permeability gown, 2 sheets (12" 12") of absorbent material, 250-ml and 1-liter spill control pillows, a "sharps" container, a small scoop to collect glass fragments, and two large HD waste-disposal bags. 44

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