APRIL 18, The University of Texas MD Anderson Cancer Center. Houston, Texas PRESENTED BY

Transcription

1 APRIL 18, 2018 The University of Texas MD Anderson Cancer Center Houston, Texas PRESENTED BY

2 Best Practices for Preventing Occupational Exposure to Hazardous Drugs Elizabeth Frenzel, MD, MPH Director, Employee Health & Well being Professor, Infectious Diseases, Infection Control & Employee Health UT MD Anderson Cancer Center April 18, 2018

3 NIOSH Definition: Hazardous Drug Any drug identified by at least one of the following six characteristics: Carcinogenity Teratogenicity or developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxocity Structure and toxicity of new drugs mimic existing hazardous drugs (HD)

4 Groups of Hazardous Drugs Group 1: Antineoplastic drugs Cancer chemotherapeutics cisplatin, gemcitabine, tamoxifen Group 2: Non antineoplastic drugs Antiretrovirals, hormones, immunosuppressive agents Group 3: Primarily adverse reproductive effects Gonadotropins, estrogen

5 Routes of Exposure/Potential Health Effects Routes of exposure Skin and mucosal absorption, inhalation, injection, ingestion Potential health effects Acute: skin rashes/irritation, burns Chronic: adverse reproductive (infertility, miscarriage, congenital abnormalities) possibly leukemia and other cancers

6 Workers at Risk: Broad Scope Direct patient care nursing, physicians Pharmacy Facilities, environmental services housekeeping, laundry, EH&S Research Vet Med research animal care Setting outpatient clinics, home HCWs

7 Types of Exposure Based on Activity Receipt Facilities, Materials Management Dispensing tablets, capsules Compounding and other manipulations Crushing tablets, pouring liquids, constituting powdered HDs, expelling air from syringe, cleaning, equipment maintenance Transport within healthcare setting Spills generation, management, and waste disposal

8 Types of Exposure Based on Activity Administration Generating aerosols (injection, irrigation, oral, inhalation, topical application) Specialized procedures (intraoperative intraperitoneal injection or bladder irrigation) Priming IV administration set Patient care handling body fluids, contaminated linens, etc.

9 Environmental Contamination Numerous studies have demonstrated low level environmental contamination Surface wipe samples used to measure for approx. 10% of drugs used (cyclophosphamide, ifosfamide, 5 fluorouracil, platinum based drugs, doxorubicin, paclitaxel, methotrexate, etoposide) Cleaning/decontamination not 100% effective HD measured on hands of HCW HD measured in urine of HCW Small number of drugs used as marker of exposure (ex.: cyclophosamide, paclitaxel) Chromosomal aberrations noted in some studies clinical significance unclear

10 Best Practices for Preventing Exposure to Hazardous Drugs

11 Hazardous Drug Guidelines USP <797> Pharmaceutical Compounding: Sterile Preparations, (initial). USP <800> Hazardous Drugs Handling in Healthcare Settings, NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. DHHS (NIOSH) Pub. No NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, DHHS (NIOSH) Pub

12 Risk Assessment: USP <800>

13 USP <800>: Assessment of Risk Type of HD and risk profile Antineoplastic, non antineoplastic, reproductive risk only Dosage form Solid, unit dose tablets vs. liquids aerosol generation, spill, injection Risk of exposure Frequency of handling, injection, intraoperative Packaging HD form, external contamination Manipulation Compounding, dust/residue skin, inhalation, environmental contamination

14 Exposure Risk Based on Activity USP 800. Hazardous Drugs: Handling in Healthcare Settings. Feb

15 NIOSH Hierarchy of Controls

16 Facilities and Engineering Controls Designated areas available for: Receipt and unpacking Storage of HDs Nonsterile HD compounding Sterile HD compounding Considerations: Certain areas required to have negative pressure from surrounding areas to contain HDs and minimum risk of exposure

17 Engineering Controls: Containment Containment Primary Engineering Controls (C PEC) Ventilated device to minimize worker and environmental exposure when directly handling HD Containment Secondary Engineering Controls (C SEC) Room in which the C PEC is placed Supplemental Engineering Controls Closed System Transfer Device (CTSD) Adjunct controls for additional level of protection during compounding or administration

18 Engineering Controls: Sterile HD Compounding Configuration C PEC (Containment Primary Engineering Controls) C SEC (Containment Secondary Engineering Controls) ISO Class 7 buffer room with ISO Class 7 ante room Unclassified C SCA (Containment Segregated Compounding Area) Externally vented Examples: Class II BSC (partial barrier systems) CACI (compounding aseptic containment isolator) Externally vented Examples: Class II BSC or CACI Externally vented 30 ACPH (air changes/hour) Negative pressure between in H2O column relative to adjacent areas Externally vented 12 ACPH (air changes/hour) Negative pressure between in H2O column relative to adjacent areas USP 800. Hazardous Drugs: Handling in Healthcare Settings. Feb. 2017

19 Best Practices for Preventing Occupational Exposure to Hazardous Drugs Supplemental Engineering Controls: Closed System Transfer Devices (CSTD)

20 Personal Protective Equipment (PPE) SOPs for PPE based on risk of exposure and activities performed Appropriate PPE worn when handling HDs during: Receipt, storage, transport Compounding Administration Cleaning, spill control, waste disposal

21 Personal Protective Equipment Gloves 2 pairs of ASTM chemo Change every 30 minutes Gowns Polyethylene coated polypropylene or laminates Eye and face if risk of spills or splashes, googles with face shield Respiratory N95 airborne, aerosols full face, chemical cartridge type or PAPR for large spill cleanup, airborne powders/vapors Head, hair, and shoe covers

22 HD Administration Protective devices and techniques Needleless and closed systems Spiking/priming IV tubing with non HD solution in C PEC CSTD used for antineoplastic HD when dosage forms allows Administration into certain organs or body cavities (bladder, eye, peritoneal or chest cavity) equipment may not have locking connectors CAUTION Avoid manipulating HD (crushing tablets, opening capsules) If so, PPE and use of plastic pouch to contain dust/particles

23 Waste Management: Proper Disposal, Spill Cleanup

24 Cleaning/Spill Control SOP required for HD spill prevention and cleanup Size and scope of spill Spill management responsibility (decontamination, deactivation, cleaning) may depend on: Size and type of spill, spill kit capacity Type of PPE full facepiece, chemical cartridge type respirator if exceeds spill kit capacity or potential airborne vapors or gases All spills disposed of as hazardous waste

25 Environmental Monitoring: Assessing Control Measures Surface wipe samples every 6 months Pharmacy, patient administration areas Currently no standard for acceptable limits for HD surface contamination Cyclophosphamide, methotrexate, fluorouracil, ifosfamide, platinum containing drugs If any measurable contamination, Perform thorough decontamination, cleaning Reassess work practices, engineering controls, personnel re training Repeat wipe samples

26 HD Workplace Safety and Compliance

27 HD Workplace Safety Regulations and Compliance OSHA HazCom Standard (29 CFR ) CDC/NIOSH EPA Resource Conservation and Recovery Act (RCRA) DOT USP (US Pharmacoepial Convention) Board of Pharmacy

28 Hazard Communication Program: Personnel Training Training based on job functions Review of SOPs related to handling of HDs Safety Data Sheets (SDS) Proper use of PPE Proper use of equipment & devices (engineering controls) Response to known or suspected exposure Accident reporting and followup Spill management Proper waste disposal Personnel of reproductive capacity Written confirmation understand risks

29 HD Exposure Prevention: An Integrated Approach HD Containment + Prevention of Contamination= HD Exposure Prevention Policies, Programs, and Practices Focus on Process Safety Facilities and Engineering Controls, PPE Continuous assessment of engineering controls and PPE for new HDs Participation and Collaboration Key Stakeholders from all levels of organization Provide input, key to successful implementation Adherence and Compliance Leadership Commitment Drive accountability, provide resources and environment

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31 Contact Information Elizabeth Frenzel, MD, MPH Director, Employee Health & Well being Professor, Infectious Diseases, Infection Control and Employee Health

32 Operational Application for General Facilities Mike Jones

33 Getting Started Stakeholder Team Process, procedure and policy Employee Health PPE Exposure Control Education

34 Keeping it going Expected Opportunities Stakeholder Team Process, procedure and policy Employee Health PPE Exposure Control Education