Safe Handling of Hazardous Drugs

Transcription

1 Safe Handling of Hazardous Drugs 1.5 Contact Hours Commercial Support Provided by: Carmel Pharma, Inc. Question 1 What is your primary practice setting? A. Hospital Pharmacy B. Long Term Care C. Education D. Other 1

2 Question 2 What is your position? A. Pharmacy Director/Management B. Staff Pharmacist C. Pharmacy Technician D. Student. Other Question 3 Are you familiar with the current studies related to closed-system drug transfer devices? A. Yes B. No C. Not Sure 2

3 Question 4 So far A. I ve hit the jackpots. B. I am even. C. I ve lost some money, but haven t given up. D. I don t gamble.. It looks like my friends and family will not be getting any gifts this holiday season! Program Information Target Audience: Pharmacists and Certified Pharmacy Technicians ACPE Nos L04-P L04-T 1.5 Contact Hours Release Date: 12/1/07 Expires: 12/1/10 Statements of Credit will be issued by mail within 2 weeks. STAT Educational Services is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. 3

4 Contact Information STAT Educational Services Phone Fax PO BOX Houston, Texas Presentation Download Available at Learning Objectives 1. Describe the reproductive risks associated with exposure to chemotherapeutic agents. 2. Describe the carcinogenic potential associated with exposure to chemotherapeutic agents. 3. Analyze the findings from current research and studies on closed-system drug transfer devices. 4. Present the NIOSH current recommendations for a medical surveillance program for hazardous drugs. 5. Describe the medical surveillance program for hazardous drugs of a community based pharmacy. 4

5 Jim Jorgenson, RPh, MS, FASHP Administrative Director for Pharmacy Services Associate Dean for Pharmacy University of Utah What Defines a Hazardous Drug 1. Carcinogenicity 2. Teratogenicity or other developmental toxicity 3. Reproductive toxicity 4. Organ toxicity at low doses 5. Genotoxicity 6. Structure & toxicity profile for new drugs that mimics existing hazardous drugs 5

6 Standards & Guidelines Guidelines ASHP ONS ISOPP HOPA European Oncology NIOSH Standards USP 797 OSHA JCAHO Why Do We Care? The same mechanisms that these drugs employ to kill cancer cells also works to damage healthy cells NIOSH Warning Working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects and possibly leukemia or other cancers 6

7 OSHA Preparation, administration, and disposal of hazardous drugs may expose pharmacists, nurses, physicians, and other health care workers to potentially significant workplace levels of these chemicals. 7

8 Recent Concerns Increasing evidence of exposure Increasing numbers of cancer patients More drug combinations Higher doses of drugs More potent drugs Increasing non-cancer use of antineoplastics New treatment settings Source = Thomas Connor, Ph.D., NIOSH Presence of Hazardous Drugs in the Workplace Numerous published studies demonstrating the presence of hazardous medications in the workplace Multiple studies demonstrating that hazardous drugs are present in the urine of healthcare workers including pharmacists and technicians 8

9 Adverse Effects Patients = High doses with limited number of drugs over a defined time period. Healthcare Workers = Low doses of multiple drugs over long periods of time Acute Effects Nausea Vomiting Headache Dizziness Hair Loss Mucosal Sores Liver Damage 9

10 Long Term Effects Reproductive Developmental Genetic End Organ Damage Cancer Reproductive Risks Numerous peer reviewed studies that clearly establish a direct cause and effect relationship between exposure to cytotoxic agents and adverse effects Statistically significant differences between healthcare workers exposed to these agents and the general population in terms of: spontaneous abortions, infertility, premature labor 10

11 Occupational Exposure to Antineoplastic Agents Kaiser Permanente Center for Health Research 7,094 pregnancies of 2,976 pharmacy and nursing staff studied Exposure of mother to handling antineoplastic agents during pregnancy was associated with a significant increased risk for spontaneous abortion and stillbirth Journal of Occupational & Environmental Med Vol.41; 8: Developmental Effects Numerous peer reviewed studies demonstrating a statistically significant difference in low-birth weight infants, birth defects and learning disabilities in offspring of health care workers exposed to hazardous meds during their pregnancy 11

12 Teratogenicity Conflicting opinion on exposure during 2 nd and 3 rd trimesters Greatest danger during 1 st trimester Hemminki case control study of Finish oncology nurses actively handling chemotherapy during 1 st trimester Demonstrated statistically significant increase in risk for malformations Odds ratio of 4.7 (p=0.02) Hemminki K, Kyyronen P, Lindbohm ML. J Epidemiol Community Hlth 1985 Cancer Risk No question that given enough exposure these agents can cause cancer IARC designation Sessink cancer risk model for cyclophosfamide 12

13 Carcinogenic Potential IARC Group 1 Human Carcinogens (102 chemical entities) 10 drugs and 2 combination therapies; cyclophosphamide, azothiaprine, busulfan, thiotepa, tamoxifen, etoposide IARC Group 2A Probable Carcinogens (68 chemical entities) 9 drugs; azacitadine, carmustine, CCNU, cisplatin, doxorubicin, nitrogen mustard IARC Group 2B Possible Carcinogens (245 chemical entities) 10 drugs; dacarbazine, daunoribucin, bleomycin, mitomycin, mitoxantrone Cancer Development Numerous case studies Significant increase in leukemia noted among oncology nurses in the Danish cancer registry (Br J Ind Med 49:855-61) 39 YO pharmacist with papillary transitional cell carcinoma (J Nat Can Inst 85(13): ) 39YO vetrinarian with atypcial thyroid cancer 13

14 Genetic Effects Genotoxic effects noted in both patients and healthcare workers DNA single strand breaks Chromosomal aberrations Length of exposure most significant factor Demonstrated Genotoxicity Significant increase (2.5X) in chromosomal aberrations in nurses and pharmacy techs handling chemotherapy compared to healthy subjects not handling chemo (Cavaloa Abstract 2005 Publication pending) Examined two oncology nurse groups, one using PPE and one not vs. a control group. Statistically higher rate of sister chromatid exchange in the unprotected group when compared to both the control and protected group (p<0.001) Brumen Am J Indust Med 30:67071, 1996 Examined lymphocyte DNA damage in oncology nurses compared to controls and demonstrated increased DNA damage secondary to cytotoxic drug handling Yoshida, J Occup Health, 48:517-22,

15 Summary Cancer chemotherapy presents a clear health hazard for healthcare workers Both acute and long term effects of these medications should be considered Clear cut safety precautions based on sound medical evidence should be established in the work place Question 1 The National Institute of Safety and Occupational Health includes all of the following elements in it s definition of a hazardous drug except: A. Carcinogenicity B. Flammability C. Teratogenicity D. Genotoxicity 15

16 Question 2 Which of the following drugs has been classified by the International Agency for Research on Cancer as Group I, a known human carcinogen? A. Mitomycin B. Doxorubicin C. Cyclophosphamide D. Bleomycin Susan M Spivey, DDS,PharmD Ambulatory Treatment Center Pharmacy Manager UT M.D. Anderson Cancer Center sspivey@mdanderson.org 16

17 Routes of Exposure Dermal- direct contact w/drugs or contaminated surfaces Oral Ingestion food, gum, hand to mouth Inhalation - Particulates (droplets, dusts) - Vapors Injection sharps, breakage Surface Contamination Studies 27 Published studies All studies detected measurable levels of at least one drug Contaminated areas included: biological safety cabinets, floors, counters, IV bags, keyboards, gloves, transport containers, patient tables, chairs, waste containers 17

18 Surface Contamination Studies In 1999, Connor et al. demonstrated surface contamination with cyclophosphamide, ifosfamide and fluorouracil in pharmacy and patient treatment areas in three hospitals in the U.S. and three in Canada Surface Contamination Studies 75 % of pharmacy and 65 % of patient treatment areas were contaminated with at least one of the three drugs Drugs were detected in adjacent areas where drugs were not handled (Connor et al, 1999) 18

19 Air Sampling Studies 16 Published studies Particulate collection on paper or glass filters Low percentage of samples contained drugs Drug levels were usually low Fluorescein Study Conventional Needle/ Syringe Technique vs Utilizing PhaSeal (S M Spivey, T H Connor 2003) 19

20 Fluorescein Study Fluorescent dye Inspected with UV light Evaluated fluorescein release into the work environment Fluorescein Study Evaluated -Drug Reconstitution -Drug Transfer ( vial- IV bag) -Drug Administration/Disconnection 20

21 Drug Reconstitution With Needle and Syringe Drug Preparation with PhaSeal 21

22 Drug Transfer with Needle and Syringe Drug Transfer with PhaSeal 22

23 I.V. Push with Needle and Syringe I.V. Push with PhaSeal 23

24 Needle/Syringe vs PhaSeal Using Fluorescein Release of fluorecein Closed Needle/Syringe System Reconstitution YES NO Drug Transfer YES NO Vial-Bag Administration YES NO I.V. Push YES NO Fluorescein Summary All phases of the conventional needle/syringe technique resulted in release of drug into the environment Most surface contamination was 1-4 mm in diameter, but some were considerably larger. 24

25 Summary Total of 75 manipulations No fluorecein release was detected with PhaSeal Utah Protocol University of Utah Evaluation of Vial Transfer Devices for Containment of Hazardous Drug Vapors (C Au, J A Jorgensen, B Smith 2006) 25

26 Objective Examine commercially available drug transfer devices and determine which products meet the NIOSH definition of a closedsystem drug transfer device (CSTD). NIOSH Definition A closed-system drug transfer device mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drugs or vapor concentration outside the system 26

27 Methods Evaluated five systems B.Braun OnGuard System with Tevadaptor components Vial adaptor Alaris Smart Site Vented Vial Access Device PhaSeal Protector 50 and Injector Luer lock Chemoprotec Spike (Codan) Chemo Mini Spike Plus Dispensing Pin Methods Titanium tetrachloride Simulates the escape of cytotoxic vapors Generates visible smoke when in contact with air Titanium tetrachloride added to each vial (3 ml) and crimp sealed Each vial was spiked with each individual product 27

28 Methods 60 ml syringe with 50 ml air was attached to each device Air was injected over 10 seconds Photographs and videos were taken to record any escape of titanium from each product Filters were tested for potential damage from hydrochloric gas or titanium dioxide Engineering Controls Closed systems drug transfer device Mechanically prevent the transfer of environmental contaminants into the system and the escape of drug or vapor out of the systems. Phaseal Many more competitors in the market Not a substitute for ventilated cabinets 28

29 2006 Utah Protocol Results The PhaSeal System was the only system to prevent the release of titanium smoke from the closed system drug transfer device PhaSeal was the only device that met the NIOSH definition of a closedsystem drug transfer device. 29

30 Parallel Fluoroscein Studies Conducted by U. T. M. D. Anderson Cancer Center and The University of Utah S M Spivey, J A Jorgenson 2007 Objective Evaluate the potential to release fluorescein into the environment in the preparation and administration phases. B.Braun OnGuard System w/tevadaptor components Cardinal/Alaris System PhaSeal System/Carmel Pharma 30

31 Methods Preparation Phase 0.05% Fluorescein dye 15ml/20ml vial 5 mls withdrawn and 1ml reinjected into vial Vial adaptor and syringe components were disengaged, observed and photographed under uv light and touched to a 4 x 4 gauze. Methods Administration Phase Simulation of a 7 ml IV push Observing the syringe adaptors and IV port device for each product 31

32 Alaris Smart Site /Texium (Cardinal Health) Alaris Smart Site /Texium (Cardinal Health) 32

33 Touch Test - Alaris Smart Site /Texium (Cardinal Health) BBraun OnGuard System Tevadaptor Vial Adaptor & Tevadaptor Syringe Adaptor (Teva Medical, Ltd) 33

34 BBraun OnGuard System Tevadaptor Vial Adaptor & Tevadaptor Syringe Adaptor (Teva Medical, Ltd) Touch Test - BBraun OnGuard System Tevadaptor Vial Adaptor & Tevadaptor Syringe Adaptor (Teva Medical, Ltd) 34

35 PhaSeal Protector (Carmel Pharma) PhaSeal Protector & Injector Luer (Carmel Pharma) 35

36 Touch Test - PhaSeal Protector & Injector Luer (Carmel Pharma) Results Preparation Phase BBraun OnGuard System Cardinal/Alaris System PhaSeal System Vial Adaptor 56% 80% 0% Syringe Adaptor 47% 67% 0% Touch Test 77% 87% 0% 36

37 Results Administration Phase BBraun OnGuard System Cardinal/ Alaris System PhaSeal System Syringe Adaptor 60% 80% 0% IV Port 60% 100% 0% Touch Test 60% 100% 0% Results B.Braun songuard/tevadaptor System and Cardinal Health/Alaris System showed visible fluorescein leaks on each component during drug preparation and administration phases PhaSeal System showed no visible fluorescein leakage during the preparation and administration phases 37

38 2007 Utah Protocol Update University of Utah Evaluation of Vial Transfer Devices for Containment of Hazardous Drug Vapors (C Au, J A Jorgensen, B Smith 2007) Objective Examine commercially available drug transfer devices and determine which products meet the NIOSH definition of a closed-system drug transfer device (CSTD). 38

39 2007 Utah Protocol Update Results The PhaSeal System was the only system to prevent the release of titanium smoke from the closed system drug transfer device PhaSeal was the only device that met the NIOSH definition of a closedsystem drug transfer device. 39

40 Leakproof Connection Integrity Test For Devices Intended for Handling Hazardous Drugs (J A Jorgensen 2007) Objective To determine if the ICU Medical System, B. Braun/Tevadaptor System, Cardinal/Alaris System or PhaSeal System connections are leak proof or have the potential to allow drugs to escape into the environment during the preparation and administration phases of hazardous drug handling. 40

41 Methods Four transfer devices were tested A liquid with low ph was used as a substitute for active drug. Litmus paper was used as ph indicator. Blue litmus paper turns red under acidic conditions. Syringes were filled with fluid and injected into vials attached to the above transfer devices. After aspirating back and disconnecting, the connections of each device were pressed against litmus paper to detect the presence of any fluid. Every component of each device was tested for 10 manipulations. Clave Vial Adaptor & Spiros Male Connector (ICU Medical, Inc.) 41

42 B. Braun/Tevadaptor Vial Adaptor & Syringe Adaptor (Teva Medical Ltd.) Alaris SmartSite Vented Vial Access Device & Texium Male Luer (Cardinal Health) 42

43 PhaSeal Protector & Injector Luer Lock (Carmel Pharma) Results Visible leakage occurred outside of the components on the ICU Medical System Clave and Spiros connections, the B. Braun/Tevadaptor System and the Cardinal Health/Alaris System during all manipulations. No leakage was observed in any of the manipulations with the PhaSeal System. 43

44 Make Sure You Know What You re Getting.ASK If the device uses a filter to equalize the air pressure, it is not a closed system Ask for Clinical Studies, peer reviews, or independent studies (white papers are not acceptable) The device must meet the requirements of closed-system drug transfer device as defined by NIOSH Question 1 What are characteristics of a closedsystem drug transfer device? A. Mechanically prohibits transfer of environmental contaminants into the system B. Does not allow escape of hazardous drugs C. Does not allow the escape of vapors D. All of the above 44

45 Question 2 What is important to know before choosing a closed-system drug transfer device? A. Peer reviews, independent studies, and/or clinical studies exist on the product. B. The product must meet the NIOSH definition of a closed system C. Does the device have filters that let air escape D. All of the above Dr. Paul J.M. Sessink, PhD Exposure Control B.V., Founder The Netherlands 45

46 Toxicity of Antineoplastic Drugs Acute effects Irritation (skin, eyes) Alopecia Nausea Vomiting Diarrhea Organs (liver, kidney, bladder, lung) Bone marrow suppression Delayed effects Reproductive effects Spontaneous abortions Malformations off-spring Low birth weight Prolonged time to pregnancy Menstrual dysfunction Mutagenicity Carcinogenicity Genotoxic/Nongenotoxic IARC classification Genotoxic Carcinogens Mechanism of Action Absence no-adverse-effect level supposed: one molecule is able to induce cancer! Exposure has to be avoided Workers need to be protected Safety guidelines and protective measures Monitoring of the workers 46

47 Council Directive European Union Carcinogenic Compounds 28 June 1990 STRATEGY (decreasing priority) 1) replacement by a less toxic compound If not possible 2) reduce sources of exposure If not possible 3) ventilation If not possible 4) personal protection Council Directive European Union Carcinogenic Compounds 28 June 1990 STRATEGY FOR ANTINEOPLASTIC DRUGS 1) replacement by a less toxic compound Impossible 2) reduce sources of exposure Closed systems 3) ventilation Clean rooms with BSCs 4) personal protection Gloves, gowns, masks, special clothes, 47

48 Environmental and Biological Monitoring Environmental Monitoring Measures the presence/release of the drug in the environment No information about uptake of the drug in the body of the worker No information about health-risk for the worker Biological Monitoring Assessment of uptake of the drug in the body of the worker Estimation of healthrisk for the worker Monitoring Antineoplastic Drugs Exposure Control B.V. Environmental Monitoring Cyclophosphamide sample 0.1 ng/ml Ifosphamide sample 0.1 ng/ml 5-Fluorouracil sample 20 ng/ml Methotrexate sample 5 ng/ml Platin compounds (cis-platin & carbo-platin) sample 0.2 ng/ml Etoposide sample 50 ng/ml Mitomycine C ng/ml sample 100 Analysis: HPLC, GC-MSMS, Voltammetry 48

49 Monitoring Antineoplastic Drugs Exposure Control B.V. Biological Monitoring (urine) Cyclophosphamide sample 0.1 ng/ml Ifosphamide sample 0.1 ng/ml 5-Fluorouracil (a-fluoro-ß-alanine) sample 20 ng/ml Analysis: GC-MSMS Sources of Contamination and Potential Exposure External vial contamination Spillage during preparation and administration (handling technique) BSC/isolator Patient (urine, sweat, vomit, blood, faeces) Waste Laundry and clothing patient 49

50 Glove Contamination During Preparation of Antineoplastic Drugs Pair of gloves Drug N(pos) Range ( g/pair) 17 Cyclophosphamide Fluorouracil Methotrexate Cyclophosphamide Fluorouracil Methotrexate Contamination BSC Day Before preparation After preparation After alcohol cleaning Drugs analyzed: cyclophosphamide - 5-fluorouracil - methotrexate + one drug detected ++ two drugs detected +++ three drugs detected - no drugs detected Conclusion: contamination and ineffective cleaning procedure 50

51 Surface Contamination with Cyclophosphamide in Preparation Areas (ng/cm 2 ) *Connor et al., Am J Health-Syst Pharm 1999; 56: Description surface Canada* USA* Belgium Sweden Germany Netherlands Table top cyto preparation/bsc Floor under BSC Floor central preparation room Table top not for cyto preparation Floor entrance preparation room Floor entrance preparation room/corridor Surface Contamination with Cyclophosphamide in Administration Areas (ng/cm 2 )* Connor et al., Am J Health-Syst Pharm 1999; 56: Description surface Canada* USA* Netherlands Floor near bed patient (infusion pole) Arm rest chair patient Top patients table Floor toilet patients Arm rest chair visitors patient Floor corridor/away from administration

52 Surface Contamination with Cyclophosphamide in Preparation Areas Reduced with PhaSeal *Sessink et al., submitted to Am J Health-Syst Pharm 22 US Hospital Pharmacies Surface BSC surface N 30 Standard techniques < Cyclophosphamide (ng/cm 2 ) Min-Max PhaSeal < Median Standard techniques PhaSeal 0.02 BSC airfoil 26 < Floor in front of BSC 29 < < Counter 29 < < P < Vapor Pressure Antineoplastic Drugs Kiffmeyer et al., Pharm J 2002; 268:331-7 Antineoplastic Drug Carmustin Mol. Weig ht 214 Vapor pressure (Pa) at 20 C Max. concentration (mg/m 3 ) 1.7 Cisplatin Cyclophosp hamide Etoposide Fluorouracil Conclusions Antineoplastic drugs possess a low vapor pressure Maximum concentrations possible by insufficient ventilation Protective clothes and equipment are not designed to protect workers from vaporized antineoplastic drugs Additional health-risk? 52

53 Cyclophosphamide (CP) in Urine of Dutch Technicians Preparing Antineoplastic Drugs Technician Number of days Number of urine samples Number of positive samples Mean CP ( g/day) Cyclophosphamide (CP) in Urine of Dutch Nurses Administrating Antineoplastic Drugs Nurse Number of days Number of urine samples Number of positive samples Mean CP ( g/day)

54 Additional Cancer Risk Exposure to Cyclophosphamide Technicians 0.18 g CP in urine/day extra cancer cases a million workers a year Nurses 0.80 g CP in urine/day extra cancer cases a million workers a year Prohibitory risk level 100 extra cancer cases a million workers a year Strive risk level 1 extra cancer case a million workers a year Conclusion strive risk level not achieved too high exposure levels Cancer Risk Level in Relation to Environmental Contamination with Cyclophosphamide Strive risk level Prohibitory risk level Urine CP ( g/24 hr) < > 2 Contamination CP (ng/cm 2 ) < > 10 Action No Yes At short notice Yes Immediately Yes Stop working Monitoring Now and then Yes Yes Yes 54

55 Conclusions Antineoplastic drugs are spread in the environment during preparation, administration, patient care and waste handling Healthcare workers are exposed to antineoplastic drugs The main exposure routes are: Dermal uptake contact with contaminated surfaces Inhalation particles (vapors?) Additional cancer risk for hospital workers handling antineoplastic drugs (nurses > technicians) Vials are mostly contaminated Gloves are always contaminated Avoid open connections Do not disconnect systems Question 1 Based on the current knowledge what is considered to be the most important exposure route of antineoplastic drugs for hospital workers? A. Inhalation B. Ingestion C. Skin Permeation 55

56 Question 2 Protective gloves used for preparation of antineoplastic drugs should be changed: A. Once a day B. After each shift C. Every 2 hours D. Every 30 minutes Firouzan Fred Massoomi, Pharm.D., FASHP Pharmacy Operations Coordinator Nebraska Methodist Hospital Omaha, Nebraska fred.massoomi@nmhs.org 56

57 Nebraska Methodist Hospital Department of Pharmacy Services Scope of Department In-patient Pharmacy Services Home Infusion Anesthesia Support Services Cancer Center Infusion Ambulatory Anticoagulation Service Fully automated dispensing Pyxis, AutoMed, BAXA, McKesson, Cerner Bedside barcode scanning, 100% USP <797> & NIOSH compliant work space Cleanroom 400 sqft; IV Workroom 380 sqft; HD room 160sqft 51 FTE s, equating to 90 team members 40 RPhs, 26 PharmTechs, 10 Interns, 4 RN s, 3 Anesthesia Techs, 2 LPN s Formal decentralized clinical services Centralized services M-F; 7am to 10pm; 24/ 7 Nebraska Methodist Hospital Department of Pharmacy Services Dispensing Statistics 2006 Automated Dispensing 1,004,967 Oral doses 235,742 IV Push, topicals (etc.) 2006 Sterile Compounding 285,548 Large volumes 301,902 Sterile Products Low and medium risk 10,392 Hazardous drugs 57

58 Workers may be exposed to a hazardous drug at many points during its manufacturer, transport, distribution, receipt, storage, preparation, and administration..exposure to these drugs in the workplace has been associated with acute and short-term reactions, as well as long-term effects ASHP Guidelines on Handling Hazardous Drugs Am J Hosp Pharm 2006 Studies have associated workplace exposures to Hazardous Drugs with health effects such as skin rashes and adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations) and possibly leukemia and other cancers NIOSH Alert: Preventing Occupational Antineoplastic and Other Hazardous Drugs in Health Care Settings CDC

59 Timeline of Significant Studies and Guidelines for Hazardous Drugs Advent of Modern day chemotherapy Loius Goodman and Alfred Gillmon use nitrogen mustard to treat non-hodgkin s Lymphoma First case report of occupational exposure risk with HDs Mutagenicity in the urine of nurses handling cytostatic agents Risk defined for occupational exposure to HDs Risk of handling injectable antineoplastic agents American Society of Hospital Pharmacists Technical advisory bulletin (TAB) on handling cytotoxic and hazardous drugs OSHA Technical Manual Update: Controlling occupational exposure to HDs OSHA instruction TED A Section VI. Chapter 2 NIOSH Alert Preventing occupational exposure to antineoplastic and other HDs in healthcare settings USP <797> Pharmaceutical compounding-sterile preparations First review of carcinogenic potential of anticancer drugs The carcinogencity of anticancer drugs: A Hazard in Man First published guidelines for handling HDs Developing guidelines for working with antineoplastic drugs American Medical Association guidelines for HDs Guidelines for handling parenteral antineoplastics OSHA Technical Manual: Controlling occupational exposure to HDs Chapter 21. (OSHA instruction CPL B CH4) First US evaluation of PhaSeal Evaluation of the PhaSeal hazardous drug containment system American Society of Health-System Pharmacists Guidelines on handling hazardous drugs DHHS NIOSH Medical Surveillance for health care workers exposed to HDs Guidelines for Hazardous Drugs Source Year ASHP 1985, 1990, 2006 NIOSH Alert 2004, 2007 OSHA 1986, 1996, 1999 Oncology Nursing Society 1988, 2003 AMA Council on Scientific Affairs

60 OSHA and NIOSH Standards Occupational Safety and Health Administration (OSHA) Author Agency: US Department of Labor US Labor Laws OSHA Technical Manual: Controlling Occupational Exposure to Hazardous Drugs 1999 National Institute for Occupational Safety & Health (NIOSH) Authoring Agency: Centers for Disease Control US Practice Standards NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings August 2004 NMH Approach to Handling Hazardous Drugs Sub-committee of Hazardous Material Committee formed in early 2005 Representation by Nursing, Pharmacy, Human Resources, Safety, Surgery, Radiology, Performance Improvement, Employee health, House Keeping Goals Address national compliance standards to daily practices to ensure patient and employee safety Compare practices to nationally approved labor laws and practice standards Conduct a Gap Analysis of policy to practice Formally present findings Implementation strategies 60

61 Process of Gap Analysis Initial knowledge level of key stakeholders: low Formal education through presentations Required reading of OSHA & NIOSH Preparation of Gap Analysis Grid to assess compliance Supporting documentation through policies to practice Practice in most cases dictated compliance Analysis of sites outside of Methodist Hospital Grid may be used as a tool for compliance to clinics Site visits to two outside clinics demonstrated lack of compliance to OSHA and EPA regulations Hazardous Drugs Pharmaceutical agents are classified as hazardous drugs if studies in animals or humans indicate their potential to cause cancer, developmental or reproductive toxicity, or harm to organs When it occurs at low doses ASHP 1990; OSHA 1995, 1999 Appendix A of NIOSH Alert antineoplastics; Immunosuppressive agents; Estrogens; Oxytocics; Contraceptives; 5-alpha reductase inhibitors; Androgens; Antivirals; Gonadotropins; Anti-infectives; Estrogen agonistantagonists; Skin mitotic inhibitors; Cell stimulants and proliferants All forms of drugs How do we tell if it is Hazardous? No Universal symbol to designate 61

62 Exposure & Risk Sources of Exposure Drug vials Drug preparation Spills Vapor Drug administration Patients Waste & laundry RX Waste Workers at risk Shipping/receiving Pharmacy personnel Nursing personnel Physicians OR personnel Environmental services Laundry services Waste management Work Environment Traditional Biological Cabinet Isolator Glove Box NuAir, ChemoShield Not exempt from garbing requirements 62

63 Storage and Compounding Evaluation of work environment & equipment Policy & Procedures delineation of hazardous materials develop list with Safety departments Labeling, storage, personnel issues, spill control Education, preparation, administration, disposal Evaluation of workspace Ventilated cabinets Use of equipment or devices to minimize exposure Needle-less Personal Protective Equipment Closed-system devices Decontamination Decontamination of cabinets Surface-safe (15/case) $1.43/ea step 1: 2% sodium hypochlorite detergent step 2: 1% sodium thiosulfate & 0.9% benzyl alcohol 6% Hypochloride solution azathioprine, bleomycin, daunorubicin, etoposide, fluorouracil, etoposide, mitomycin, vinblastine, vincristine cyclophosphamide, melphalan, ifosfamide, methotrexate Sterilization of cabinets Caution Isopropyl alcohol use in Type II-A and II-B3 Must be in contact for 30 seconds 63

64 Administration and Cleaning Administration Skills assessed for administration All personnel including MD s Policy on tubing sets not removed from original bags Housekeeping and Decontamination All waste placed appropriate waste containers & labeled Routine cleaning of work environments and rooms?? PPE for Environmental Services?? Blood and Urine specimens???? in the pneumatic tubes? Linen management All linen bagged in yellow bags peri and post chemo Linen personnel to don appropriate garb Hazardous Pharmaceutical Waste Streams Biohazard Infectious Waste (Regulated Medical Waste) Blood products, sharps, items contaminated with liquid blood, etc. Trace Chemo Waste Containers RCRA empty chemotherapy vials, syringes, IVs, tubing, gowns, gloves, etc. RCRA Hazardous Waste Containers Bulk chemo in vials, unused IV s, P, U. toxic & ignitable D Overtly contaminated gowns, glove, chemo spill clean up materials 64

65 Staff Education Program Education Plan Orientation to hazardous chemicals - Key contacts within the organization - Location of policies Encourage employees to notify their physician of their possible occupational exposure to hazardous drugs Educate employees of signs and symptoms - Based on the agents - Acute versus chronic - Annual review of critical process and hazardous chemicals - Plan in place to education on new chemicals Medical Surveillance Recommendations since 1985 NIOSH 117 document April Recommendations, NOT a mandate Elements of a medical surveillance program - Reproductive and health questionnaires - at hire and periodically - Laboratory work - Complete blood count & Urinalysis - Physical examination at hire and thereafter for abnormal findings on health questionnaire - Follow-up for those workers who have health changes or significant exposures - Tracking trends with questionnaires and sick-call 65

66 Agencies That Could Be Involved with Hazardous Drug Exposures Occupational Safety and Health Association (OSHA) Centers for Medicare and Medicaid Services The Joint Commission United States Environmental Protection Agency (USEPA) State Boards of Health (Nursing, Pharmacy, etc.) The Joint Commission Visit November 27 to 30, 2007 Tracer on a Oncology patient Started from admission to point of administration of November 28, 2007 Cyclophosphamide dose Visited pharmacy to observe compounding Use of NuAire Isolator Use of full garb with the Isolator Use of PhaSeal Use of Black delivery bags & RCRA waste containers Interviewed compounding pharmacist Stated Nice to not have to worry about being exposed Surveyor commented in exit interview Very impressive system from patient care unit to the pharmacy utilizing an isolator and the PhaSeal system 66

67 NMH Process Changes Education of Hazards Plan New employee orientation & annual review Team meetings: pharmacy, housekeeping, nursing Garbing Requirements Shipping/receiving, housekeeping, contractors, laundry Segregation of regulated waste Defined red, yellow and black (RCRA) waste Signage for Hazardous Drug Use Signage in pharmacy where HDs are stored Magnets on doors of patients receiving treatment Medical Surveillance Analysis of sick-call for high risk team members - follow-up call for all at-risk members Compounding personnel only, new for 2008 Workers who are potentially exposed to chemical hazards should be monitored in systematic program of medical surveillance to prevent occupational injury and disease.the purpose of surveillance is to identify the earliest reversible biological effects so that exposure can be reduced or eliminated before the employee sustains irreversible damage OSHA Technical Manual: Controlling Occupational Exposure to Hazardous Drugs US Department of Labor

68 Question 1 A comprehensive safety program for managing hazardous drugs should include: A. Gap analysis of current processes to standards B. Education and Medical surveillance of high risk personnel C. Incorporation of engineering controls to protect personnel D. All of the above Question 2 Medical surveillance is mandated under the Occupational Safety and Health Association (OSHA)? A. True B. False 68

69 Questions Question 1 Were you previously informed of the studies/research presented today? A. Yes B. No 69

70 Question 2 Will you change your approach to practice as a result of this program? A. Yes B. No C. Undecided Thank You! Commercial Support Provided By Carmel Pharma, Inc. 70