2/19/2018. HAZARDOUS DRUG SAFETY and USP <800> HAZARDOUS DRUG DEFINITION NIOSH DRUG LIST EVOLUTION

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1 HAZARDOUS DRUG SAFETY and USP <800> Seth Eisenberg RN, OCN, BMTCN Professional Practice Coordinator, Infusion Services Seattle Cancer Care Alliance Seattle, WA PSONS March 2018 HAZARDOUS DRUG DEFINITION Defined by NIOSH as having any of the following characteristics: Carcinogenicity Teratogenicity or other developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity Structure mimicking existing HD NIOSH DRUG LIST EVOLUTION 2004 Initial list came from 4 different (non-niosh) sources Beginning 2010, a new list is published every other year Allows 2 years to evaluate postapproval toxicities not seen in studies NIOSH uses expert review panel to scrutinize data Publishes draft in Federal Register for public comment 1

2 NIOSH DRUG TABLES Table Comments 1 Antineoplastic chemotherapy 2 Non-antineoplastics 3 Reproductive risk for personnel attempting to conceive or breast feeding NIOSH, 2016 WHAT ABOUT TARGETED THERAPIES? Monoclonal antibodies have been generally excluded from the NIOSH list, despite toxicities satisfying the HD criteria Why? It s all about size WEIGHING IN: MABs Compounds > approximately 500 Daltons cannot be absorbed via transdermal route FDA-approved transdermal (and topical) medications are < 500 Daltons Transdermal Drugs Scopolamine 305 Fentanyl 336 Nitroglycerine 227 Nicotine 162 Molecular Mass (Daltons) Bos & Meinardi,

3 WEIGHING IN: MABs Drug Molecular Mass (Daltons) 5-Fluorouracil (5FU) 130 Cisplatin 300 Cyclophosphamide 279 Carmustine 214 Gemcitabine 263 Rituximab 143,860 Trastuzumab 145,532 Nivolumab 143,597 Obinutuzumab 146,100 Pembrolizumab 146,286 Daratumumab 148,000 Tom Connor, NIOSH; WEIGHING IN: MABs Comparing 143,800 Daltons (rituximab) to 500 Daltons would be like comparing a 25 pound sack of flour to 1½ ounces of sugar WEIGHING IN: MABs Or for size, like trying to put a 10 foot pipe into an iphone headphone jack If the molecule don t fit, we must omit. 3

4 HAZARDOUS BUT NOT EQUAL Different handling precautions may be needed depending on the activity and formulation Example: Unopened, intact tablets and capsules may not pose the same degree of risk as IV medications. Cutting, crushing, or otherwise manipulating tablets and capsules will increase the exposure. NIOSH, 2016 RECENT WIPE TESTING STUDIES SUMMARY OF RECENT STUDIES Author Year n Findings Hon, C-Y. et al Hon, C-Y. et al Hon, C-Y. et al Viegas, S. et al Janes, A. et al Poupeau, C. et al % of wipe tests in pharmacy and administration areas were positive Areas included calculators, chairs, pens, printers keyboards and mouse % of hand wipes (multidisciplinary staff) were positive Highest level was on staff who were not administering HDs % of urine samples were positive for CY Highest concentration in unit clerks and staff who were not administering HDs % of wipe tests in pharmacy and administration areas were positive Areas included infusion pumps, tables and door handles % of wipe tests in 51 Canadian hospitals were positive for CY Contamination found in pharmacy and patient care areas including infusion chairs and on the counter % of wipe tests in 48 Canadian hospitals were positive for CY Contamination found in pharmacy and patient care areas including infusion chairs and on the counter 4

5 SUMMARY OF RECENT STUDIES Bartel, S. et al (2018): 13 NCI-designated cancer centers Wipe testing in pharmacy and infusion chairs (n = 156 samples). 55% of pharmacy samples were positive for CY and/or 5FU. 78% of administration sites (chairs) were positive for CY and/or 5FU. Bartel, S., Tyler, T. & Power, L. (2018). Am J Health-Syst Pharm. 2018; 75: RECENT CHROMOSOMAL DAMAGE STUDIES SUMMARY OF RECENT STUDIES Author Year n Findings McDiarmid, M. et al (3 us Cancer Centers) (46 control) Abnormalities seen for chromosome 5 in exposed versus non-exposed (p=.01) Increased incidence of chromosome 5 abnormalities with increased drug handling Moretti, C. et al. Ladeira, C. et al (77 control) (111 control) Hazard Ratio 8.54 (p=.01) for alkylating agents Signi cant increase in micronuclei (MN) frequency 5.30 ± 2.99 vs 3.29 ± 1.97; (p < ) Chromosomal Aberrations detection 3.30 ± 2.05 vs 1.84 ± 1.67; (p < ) Significant increase in MN frequency 2.08 ±.31 vs ± 2.05; (p <.001) 5

6 EXPOSURE ROUTE HIERARCHY Handling Intact Oral Agents Handling Feces Handling Urine Administration Spill Management Compounding 2017 S. Eisenberg HOW EXPOSURE OCCURS Compounding using needles Incorrect BSC and or ventilation Contamination from exterior of vials Courtesy of S. Eisenberg HOW EXPOSURE OCCURS Spiking and unspiking at the bedside Connecting and disconnecting syringes and tubing Priming IV tubing Touching the exterior of the IV bag without wearing proper PPE Wearing improper PPE Handling excreta Spills and leaks Polovich, M., & Olsen, M. 2018, ONS. 6

7 NIOSH HD SURVEY N = 1954 nurses Survey Item % Primed tubing with hazardous drug 6 Crushed tables or opened capsules (n=494) 13 Touched IV pump or bed controls while wearing chemotherapy gloves 61 Used pens or pencils while wearing chemotherapy gloves 26 Touched doorknobs or cabinets while wearing chemotherapy gloves 20 Never used a Closed System Transfer Device (CSTD) 47 Always wear double gloves 20 Always wear recommended gown 58 Reported a spill within prior week 12 Spills not always cleaned up 10 Boiano, Steege & Sweeney, 2014 HD GUIDELINES ASHP ASHP ONS OSHA NIOSH Alert USP 2016* US Pharmacopeial Convention UNITED STATES PHARMACOPEIA (USP) Most nurses have never heard of USP but we ve seen their logo 7

8 UNITED STATES PHARMACOPEIA (USP) The mission of USP is to set standards for the identity, strength, quality, and purity of medicines GUIDELINES VS. STANDARDS Guidelines Recommended practice Evidence-based What should be Example: ONS Chemotherapy Guidelines Standards Expectations for practice Evidence-based What must be Example: The Joint Commission CMS USP CHAPTER 800 (USP <800>) Includes standards for: HD delivery and storage Education Compounding Administration Disposal * ** 8

9 USP <800> Is enforceable by: Each state s Board of Pharmacy Designated agency (e.g., Department Of Health) The FDA CMS (through USP <797>) o CMS currently has COPs with USP for USP <797> *CMS Standard (a) ( USP <800> Compliance date: December 1, 2019 USP <800> REQUIREMENTS 9

10 USP <800> REQUIRED EDUCATION A designated individual must be in charge of the HD program All employees must have access to and understand the organization s HD list Education must be provided for all staff handling HDs before performing any HD-related duties Assessment of competency must be performed annually and documented All staff of reproductive capability must sign an acknowledgement of HD risks PERSONAL PROTECTIVE EQUIPMENT Worn during: Compounding Administration Disposal Spill Cleanup (Handling excreta) PERSONAL PROTECTIVE EQUIPMENT Double-gloves for handling HDs BOTH pair must be chemotherapy tested to ASTM D standards Do not need to be the same brand of glove for the inner and out pair 10

11 PERSONAL PROTECTIVE EQUIPMENT Not all chemotherapy gloves are created equal: Drug Minimum breakthrough time (minutes) Cardinal Cool Blue Cardinal Esteem Carmustine (BCNU) Cisplatin >240 >240 Cyclophosphamide >240 >240 Doxorubicin >240 >240 Etoposide >240 >240 5FU >240 >240 Methotrexate >24 Not Tested Paclitaxel >40 >240 Thiotepa PERSONAL PROTECTIVE EQUIPMENT Chemotherapy-resistant gown Single-use and disposable Solid front and elastic or knit cuffs Shown to resist HD permeability There are no current standards for gowns Ask the manufacturer to provide proof of HD resistance Polovich, M., & Olsen, M. 2018, ONS.; Eisenberg, S SPILL MANAGEMENT Spill training with appropriate respiratory protection for drugs that vaporize at room temperature Carmustine Etoposide Cyclophosphamide Thiotepa Nitrogen Mustard 5-FU Cisplatin Ifosfamide Connor, Shults & Fraser, 2000; Kiffmeyer et al,

12 VAPORS AND AEROSOLS Vapors: small particles (e.g., perfume) Aerosols: larger particles (e.g., Windex ) N95 or N100 are for aerosols and particulates Vapors require a canister respirator or PAPR (Powered Air Purifying Respirator) with organic vapor cartridge DHHS (NIOSH) Publication No ; USP<800> 2016 VAPORS AND AEROSOLS Full Face Respirator with OV canister PAPR (Powered Air Purifying Respirator) with OV cartridge Photos: S. Eisenberg CLOSED SYSTEM TRANSFER DEVICE A Closed System Transfer Device (CSTD) will be required for administration of antineoplastic HDs Designed to restrict hazardous drug liquid or vapor from escaping into the environment. CSTDs are recommended for compounding 12

13 7 CSTD SYSTEMS AVAILABLE Halo (Corvida) Phaseal (BD) Equashield (Equashield Medical) OnGuard (B Braun) ChemoLock (ICU Medical) ChemoClave (ICU Medical) Chemo Safety System [Texium] (CareFusion/BD) CSTDs For administering drugs in a syringe (IVP, SC, IM) On all IV chemotherapy bags if attaching at bedside or disconnecting bag from tubing Used at the end tubing (secondary tubing and/or primary) Eisenberg, S GENERAL CSTD COMPARISON Manufacturer Device Luer / Membrane Notes BD Phaseal Membrane First to market (1999) BD ChemoSafety [Texium] Luer Designed to work with CareFusion Smartsite valve B Braun OnGuard Membrane Dual layer microfilters on vial adapter Corvida Halo Membrane New; limited availability Equashield Equashield II Membrane Dual-chamber syringes ICU Medical ChemoClave Luer Universal luer compatibility ICU Medical ChemoLock Membrane Needless 13

14 CSTD OPTIONS Direct Spikes: Allows for direct connection to HD bag using CSTD on tubing Dry Spikes: Allows for spiking of tubing at the bedside without risk of puncturing the IV bag CSTD EFFECTIVENESS Still no standardized test for effectiveness NIOSH is working on a second draft protocol for testing Products that passed 1 st protocol: ChemoLock Phaseal Equashield OnGuard PREPARING FOR USP <800> 14

15 DETERMINE WHO S IN CHARGE All aspects of HD safety must be overseen by an individual responsible for development of any additional HD policies and procedures monitoring for compliance with USP <800> and state and Federal regulations Should work with members of an interdisciplinary team IDENTIFY AREAS OF VULNERABILITY Perform a gap analysis between USP <800> and current policies and practice Several free tools available HazMedSafety.com (Joint Commission Resources) 800gaptool.com (Critical Point) Compounding Today.com USP <800> Gap Analysis Tool.5 Eisenberg, S. 2016; Walton, A IDENTIFY AREAS OF VULNERABILITY Must have SOPs covering: Gloves meeting the ASTM 6978 standard Hazard communication and occupational safety programs Designation of HD areas Receipt and storage of HDs Compounding and dispensing of HDs Use and maintenance of proper engineering controls (e.g., C-PECs, C-SECs, and CSTDs) Eisenberg, S

16 IDENTIFY AREAS OF VULNERABILITY Must have SOPs covering: Hand hygiene and use of PPE based on activity (e.g., receipt, transport, compounding, administration, spill, and disposal) Deactivation, decontamination, cleaning, and disinfection HD Transport HD Administration HD disposal and spill control Eisenberg, S IDENTIFY AREAS OF VULNERABILITY Determine if: Gloves meet the ASTM 6978 standard Gowns meet the USP <800> requirements Disposal meets USP <800> requirements Eisenberg, S. 2016; Walton, A IDENTIFY AREAS OF VULNERABILITY Education meets the requirements: Occurs prior to HD handling Documented Performed annually Eisenberg, S. 2016; Walton, A

17 IDENTIFY AREAS OF VULNERABILITY Spill Management Staff trained to manage a spill Staff are available whenever HDs are administered Staff have the requisite respiratory protection for drugs that vaporize Staff treat every spill as if it was MRSA or Ebola Eisenberg, S. 2016; Walton, A IDENTIFY AREAS OF VULNERABILITY CSTD are in place for antineoplastic HD administration Documentation that staff have been trained Verify that staff are using the device Eisenberg, S. 2016; Walton, A IDENTIFY BARRIERS FOR SAFETY COMPLIANCE Poor staffing (workload) Lack of education about HD dangers PPE not meeting staff needs (e.g., gowns or gloves that do not fit) Workplace culture does not support HD safety Callahan 2016; Polovich & Clark

18 CHANGE WORKPLACE CULTURE Find Hazardous Drug champions! Staff nurses Advanced Practice Nurses Clinical educators Department manager Pharmacy manager Department medical director Risk manager Eisenberg, S CHANGE WORKPLACE CULTURE Adopt a zero-tolerance approach to preventing exposure within the workplace Increase nursing awareness of the risks associated with hazardous drugs through multiple mediums and methods Staff meetings Local chapter presentations Newsletters Eisenberg, S ADDITIONAL RESOURCES