MiKaela Olsen MS, RN, AOCNS, and Byron G. Peters, BS Pharm, RPh, have no financial relationships with commercial interests to disclose.

Transcription

1 MiKaela Olsen MS, RN, AOCNS Oncology and Hematology Clinical Nurse Specialist Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Hospital Baltimore, Maryland Byron G. Peters, BS Pharm, RPh Director of Pharmacy Alvin J. Siteman Cancer Center, Department of Medicine Division of Medical Oncology Washington University Medical School St. Louis, Missouri Faculty Presenters: MiKaela Olsen MS, RN, AOCNS Oncology and Hematology Clinical Nurse Specialist Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Hospital Baltimore, Maryland Byron G. Peters, BS Pharm, RPh Director of Pharmacy Alvin J. Siteman Cancer Center, Department of Medicine Division of Medical Oncology Washington University Medical School St. Louis, Missouri Moderator: Elena Beyzarov, PharmD Director of Scientific Affairs Pharmacy Times Office of Continuing Professional Education Plainsboro, New Jersey 1

2 MiKaela Olsen MS, RN, AOCNS, and Byron G. Peters, BS Pharm, RPh, have no financial relationships with commercial interests to disclose. Pharmacy Times Office of Continuing Professional Education Planning Staff Judy V. Lum, MPA; Elena Beyzarov, PharmD; and Donna W. Fausak have no financial relationships with commercial interests to disclose. Dannemiller Planning Staff Michelle Montgomery and Gordon Ringler have no financial relationships with commercial interests to disclose. The contents of this webinar may include information regarding the use of products that may be inconsistent with or outside the approved labeling for these products in the United States. Pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult prescribing information for these products. This activity is cosponsored by Pharmacy Times Office of Professional Education and Dannemiller, and is supported by an educational grant from Be cton, Dickinson and Company. 2

3 Pharmacy Times Office of Continuing Professional Education is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 1.0 contact hour (0.1 CEU) under the ACPE universal activity number H04- P. The activity is available for CE credit through April 22, Type of Activity: Knowledge Dannemiller is approved by the California Board of Registered Nursing, Provider Number 4229, for 1.0 contact hour. RNs outside California must verify with their licensing agency for approval of this course. 3

4 Identify new and continuing concerns for health care workers handling hazardous drugs in the health care system Examine current standards and recommendations for minimizing exposure to hazardous drugs Explore the various available safety measures used in preventing occupational exposure to hazardous drugs MiKaela Olsen MS, RN, AOCNS Oncology and Hematology Clinical Nurse Specialist Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Hospital Baltimore, Maryland 4

5 Sue Crump- pharmacist in Seattle 23 years of experience compounding chemotherapy Died in 2010 of pancreatic cancer April 2011: Washington State legislature passes 2 bills designed to protect nurses, pharmacists, pharmacy techs, and other health care workers (HCWs) Requires facilities (hospitals, clinics, physician offices, laboratories, and veterinarians) to handle hazardous drugs (HDs) according to the National Institute for Occupational Safety and Health (NIOSH) guidelines Requires facilities to maintain database of administered HDs and employees who handle them Three-tiered approach with full implementation by 2014 Over 100 articles published on hazards associated with handling chemotherapy and only 1 state mandates NIOSH guidelines Eisenberg S. NIOSH safe handling of hazardous drugs guidelines becomes state law. J Infus Nurs. 2012;35: million HCWs potentially exposed to HDs Pharmacy and nursing staff involved in mixing and administering at highest risk In the United States, an estimated 23 million adult patient visits occur annually for chemotherapy Approximately 19 million (84%) of those visits in ambulatory settings, largely by nurses By 2050, due to the aging US population, the number of cancer cases are expected to double, increasing the use of antineoplastic drugs Increasing use of HDs in nonmalignant conditions Increasing use of higher doses, more combinations Many biologically engineered drugs exist with unknown health risks Currently, exposure monitoring not possible, and no permissible exposure limit Bureau of Labor Statistics, Occupational and employment statistics homepage. May 2011 employment and wage estimates. Washington, D.C. 5

6 Genotoxic Reproductive toxicity Teratogenic Carcinogenic Structure or toxicity similar to drugs classified as hazardous Organ toxicity at low doses Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH, 2004 Universal approach to all HDs o Antineoplastics, antivirals, hormonal agents, immunomodulatory drugs, and others Evaluation of HDs is an ongoing process, as new drugs approved o NIOSH will review newly FDA-approved drugs on regular basis 26 drugs added to list;15 removed Challenge: Drug package inserts not consistent, comprehensive, or standardized Department of Health and Human Services. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings DHHS (NIOSH) Publication No June

7 Objective: Evaluate occupational risk of monoclonal antibodies Methods: Systematic literature review Results: Monoclonal antibodies have potential to cause harm All evaluated monoclonal antibodies were toxic to reproduction Some were mutagenic Authors recommended precautions Halsen G, Kramer I. Assessing the risk to health care staff from long-term exposure to anticancer drugs-the case of monoclonal antibodies. J Oncol Pharm Pract. 2011;17(1): Dermal a Direct contact Ingestion Food, gum Hand-to-mouth Inhalation Aerosols Dust Vapors Injection Sharps Breakage a: Most common source of exposure Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH,

8 Conditions for Exposure Widespr ead contamination of wor k envir onment makes skin contact highly pr obably Delivered to health care facility (shipping, receiving, or direct to pharmacy) Pharmacy Prepares drug using BSC +/- a CSTD Pharmacy contamination Drug delivered to nurse for administration (External bag contamination) Environmental contamination with HD increasing risk of dermal exposure to HCW Hazardous Drug From Manufacturer (External contamination) Exposure or inappropriate handling of patient excreta. Contamination in restrooms Exposure during linen and waste disposal Administration is complete- Improper disposal, touch contamination, improper use of PPE Potential for exposure exits if spiking or unspiking, priming tubing, dripping from end of tubing, or connections, handling bag or pump Drug uptake may occur in work areas due to contamination of food, drink located near drug handling areas Drug is double checked, IV pump and tubing prepared for administration. Double gloves, gown, mask with face protection * BS C indicates b i ologic safety c abinet; C ST D, closed sys tem transf er d ev ice; PPE, personal protective eq u ipment. Objective: Evaluation of HCW exposure to HD Methods: Cross-sectional study examined environmental surface wipe samples, task diary, urine and blood samples Results: Environmental surface contamination is widespread Site that utilized a CSTD was the only area with no reported spills Connor TH, DeBord G, Pretty JR, et al. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. J Occup Environ Med. 2010;52(10):

9 Spill: worst case scenario Lack of knowledge exists regarding best way to clean up spill Risk of spreading HD from spill to larger areas Take every precaution to prevent spills If spill occurs, conduct root cause analysisrecord exact location Leur connectionstighten carefully Eliminate glass bottles for HDs Never unspike HD bags Carefully consider tubing/pump setup to maintain closed system Utilize a CSTD Nurse develops rash on 2 different occasions After dumping urine from patients who received doxorubicin and vincristine Nurse developed projectile vomiting, abdominal cramping, and diarrhea After spill that resulted in exposure of skin to carmustine Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH,

10 Sore throat Cough Headache Dizziness Abdominal pain Diarrhea Nausea and vomiting Allergic reaction Nasal sores Contact dermatitis, eczema Partial alopecia (hair thinning) Ocular (burning, irritation) Kyprianou et al. Eur J Oncol Nurs. 2010; 14: Valanis et al. Cancer Nurs. 1993; 16(4): Valanis et al. Am J Health-System Pharm. 1993;50: Harrison et al. (2001).In M.C. Perry (Ed.), The chemotherapy source book. (3 rd Ed., pp ). Philadelphia, PA. Lippincott, Williams, & Wilkins. Increased risk of cancer Leukemia, non-hodgkin lymphoma, cancer of the breast, bladder, or liver Reproductive risks Menstrual cycle changes, infertility, premature delivery, low birth weight, ectopic pregnancy, miscarriages, congenital abnormalities, stillbirths, learning disabilities in offspring Dranitsaris, et al. J Oncol Pharm Practice. 2005;11: Fransman, et al. Epidemiology. 2007; Martin. ONF. 2005;32, 425. Petralia, et al. Am J Ind Med. 1999;36: Saurel-Cubizolies, et al. Lancet.1993;341: Skov et al, BJM. 1992;49: Skov et al. Lancet. 1990;336:1446. Stucker, et al. Scand J Work Environ Health. 1990;16: Valanis et al. Cancer Nurs. 1993;16(4): Walusiak et al. Allergy May;57(5):461 10

11 Purpose Study of relationship between organizational structures and processes of care in ambulatory setting associated with increased risk of unintentional chemotherapy exposure Measures Sample of oncology nurses (n=1339) Results Overall rate of exposure to skin or eyes in past year: 16.9% When nurses reported adequate staffing/resources and 2 RN dose verifications with chemotherapy: likelihood of exposure decreased Friese, CR, Himes-Ferris L, Frasier MN, McCullagh MC, Griggs JJ. Structures and processes of care in ambulatory oncology settings and nurse-reported exposure to chemotherapy. BMJ Qual Saf. 2012;21(9): Chromosome 5 and 7 Abnormalities in Oncology Personnel Handling Anticancer Drugs O bjective: To determine the frequency of signature chromosomal abnormalities in oncology workers handling anticancer drugs Methods: Peripheral blood from health care personnel (n=109) examined for targets on chromosomes 5, 7, and 11 o Effect of drug-handling frequency on chromosome abnormalities Results: Excess of structural (0.18 vs 0.02; P =.04) and total abnormalities (0.29 vs 0.04; P=0.01) of chromosome 5 observed in high-exposure group, compared with unexposed o Increased incidence rate ratios (IRR) for abnormalities of chromosome 5 (IRR =1.24; P 0.01) and for either chromosome 5 or 7 (IRR =1.20; P 0.01) obtained at 100 handling events o Effect sizes were augmented 2- to 4-fold when alkylating agent handling alone considered Conclusions: Biologically important exposure to genotoxic drugs occurs in oncology work settings, despite reported use of safety practices McDiarmid M, Oliver MS, Roth TS, Rogers, B, Escalante C. Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs. J Occup Environ Med. 2010;52(10):

12 67-year-old male patient with metastatic colorectal cancer and bowel/bladder incontinence taking oral chemotherapy Family caring for patient in home setting Linens and diapers soiled frequently Small children and animals in home What are conditions for exposure to family? What education is being done? Package oral agents in blister packs or foil packs Uncoated tablets: Risk of exposure from dust inhalation or skin contact Utilize gloves when handling oral drugs Utilize full personal protective equipment (PPE) when handling liquid oral drugs Do not crush, break, or compound solutions outside biologic safety cabinet Do not place drugs in automated counting machines Dispose of unused drug as cytotoxic waste Educate patients and caregivers, provide written instructions Goodin S, Griffith N, Chen B, et al. Safe handling of oral chemotherapeutic agents in clinical practice: recommendations from an international pharmacy panel. J Oncol Pract. 2011;7(1):

13 Occupational Safety & Health Administration : Employers subject to the OSH Act have general duty to provide work and workplace that is free from recognized, serious hazards NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings (2004) Safety and health topics (online) HD exposures in health care Occupational exposure to antineoplastic agents Oncology Nursing Society (ONS): Polovich M, Whitford JM, and Olsen M (eds.) Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (3rd ed.) Pittsburgh, PA: Oncology Nursing Society; American Society of Health-System Pharmacists (ASHP). ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63: United States Pharmacopeia (USP) <797>: Guidebook to Pharmaceutical compounding: sterile preparations. Rockville, MD: United States Pharmacopeia; Environmental Protection Agency: 2013 Proposal to Address the Management of Hazardous Waste Pharmaceuticals. pharmaceutica ls.htm. 13

14 Byron G. Peters, BS Pharm, RPh Director of Pharmacy Alvin J. Siteman Cancer Center, Department of Medicine Division of Medical Oncology Washington University Medical School St. Louis, Missouri HD exposure can have negative impact Protective measures critical Protection levels should run from top (Level 1) to bottom (Level 4): Not free to choose Cannot cherry pick levels of protection International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. a ISOPP: International Society of Oncology Pharmacy Practitioners. 14

15 Elimination, substitution, replacement Change the product to another product which is nontoxic or less toxic Rarely possible when treating cancer patients Targeted therapies may make this possible If impossible or insufficient, apply Level 2 International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. Isolation of hazard/source containment Contain the toxic product in it s container or at the source Containment of persons or materials can be prevented if product contained at source Source containment should not be limited to 1 point; continuous throughout process (preparation, administration, etc) CSTD If impossible or insufficient, apply Level 3 International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):

16 Engineering controls/ventilation Apply local and general ventilation or extraction in order to dilute the toxic product Any form of dilution reduces the concentration of toxin/hd Any form of extraction reduces the amount of toxin/hd BSCs and isolators are Level 3 Contamination can still occur inside BSC or isolator International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. Administrative controls/organizational measures Organize work to reduce duration of exposure Organize work to reduce number of exposed employees Maintain adequate number of trained employees Use rotational schedule for potentially exposed staff If not possible or insufficient, apply Level 4 International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):

17 PPE Individual protection by using personal tools Temporary barrier between operator and contamination, created by use of gloves, gowns, masks, goggles or face shields, or other equipment Employ proven resistant materials for PPE International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. Gloves Eye and Face Protection Gowns Wear double gloves for all handling activities (eg, preparation, administration, handling of contaminated waste) Disposable, powder-free gloves, tested for use with HDs Inspect gloves for visible defects prior to use Change gloves every 30 minutes or immediately if damaged or contaminated; DO NOT reuse gloves Wash hands with soap and water after removing gloves Combination of mask and face shield when possibility of splashing exists Disposable, lint-free, low-permeability fabric Solid front with back closure, long sleeves, tight cuffs Cloth fabrics, including lab coats, should not be used Inner glove under gown, outer glove over gown Discard if visibly contaminated, after handling drug, and before leaving area where drug is handled Gowns are for single use only -DO NOT reapply Polovich M. (Ed.) Safe Handling of Hazardous Drugs (2nd Ed). Pittsburgh, PA: Oncology Nursing Society; Polovich M, Whitford JM, and Olsen M (eds.) Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (3rd Ed.) Pittsburgh, PA: Oncology Nursing Society;

18 In a self-reported survey of 330 oncology nurses: 96% reported usually wearing gloves during HD administration 98% reported usually wearing gloves while handling excreta 18% reported using double gloves during HD administration 52% reported usually wearing a chemotherapy gown during administration Gown use was less common when disposing of HDassociated equipment (eg, tubing, bags) and when handling patient excreta Polovich M, Martin S. Nurses use of hazardous drug-handling precautions and awareness of national safety guidelines. Oncol Nurs Forum. 2001;38(6): A survey of 165 oncology nurses and a telephone interview of managers perspectives on safe handling demonstrated: Organization s safety climate has an impact on safe handling Higher number of patients/day/nurse associated with lower use of HD precautions Availability of PPE is a barrier to HD precautions Safe practice is a shared responsibility between employers and nurses Polovich M and Clark PC. Factors influencing oncology nurses use of hazardous drug safe-handling precautions. Oncol Nurs Forum. 2012;39:E299-E

19 Use of BSC (Class II or Class III) Use of Compounding Aseptic Containment Isolators (CACI) CSTD Administrative controls PPE (Pharmacy) PPE (Nursing) International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. Eliminate/reduce worker exposure to hazards (eg, chemical, biologic) Ventilated cabinets: designed for worker protection Cytotoxic agents should never be prepared using horizontal laminar airflow (LAF) hood Equipment: BSCs and isolators BSC: Class I (not aseptic conditions), Class II, Class III International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):

20 Open front with inward airflow: personnel protection Downward high-efficiency particulate air (HEPA)-filtered LAF: product protection HEPA-filtered exhausted air: protect environment Does not prevent generation of contamination inside cabinet ISO Class 5 (Class 100), work surface 4 sub classification: A1, A2, B1, B2 (related to exhaust) International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. Class II A1: Not recommended for volatile/toxic chemicals Class II A2: Only minute quantity of toxic/volatile chemicals Class II A: 30%-70% of air recirculated in BSC Class II A: Exhaust-contaminated air back into workroom Class II B: Offers alternative to Type-A International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):

21 Class II B1: Inflow air partially recirculated Class II B2: Total exhaust (preferred) Both suitable for cytotoxic drug preparation Do not recirculate air in hood or return air to workroom Environment meets standards for aseptic preparations Vaporization of some chemotherapy (eg, Cytoxan), not prevented Contamination may still occur in BSC International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. Totally enclosed, vented cabinet; leak-tight construction Operator uses fixed-glove access Maintained with negative pressure through HEPA filter Exhaust air exists via double HEPA filter Products use double door pass-through box Advantage: barrier between toxic product and operator Use: highly toxic or infectious material (seldom used) International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):

22 Barrier isolator for aseptic preparations Ventilated, controlled environment with fixed walls (floor and ceiling) Supply air drawn in through HEPA filter Exhaust air is HEPA filtered to outside of facility Work area accessed using gloves, sleeves, air locks, etc Does not prevent generation of contamination inside International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. A drug transfer device which mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system ISOPP and NIOSH definition of CSTD System cannot be considered semi-closed; it is either closed or it is not (ISOPP) Definition applies to preparation and administration of HD Department of Health and Human Services. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. DHHS (NIOSH) Publication No September International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):

23 Must indicate: if some steps not covered/properties retained If properties retained for more than 1 vial If studies demonstrated reduction in contamination If containment guaranteed for which administration routes If all steps in administration process covered or not International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63: Air venting devices with filters (0.22 micron diameter) and HEPA filter do not retain vapor of cytotoxic products Filters with active carbon absorb vapors on temporary basis Data needed from manufacturers to indicate maximum load for filter, working conditions, and filter capacity International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63:

24 Numerous national and international guidelines have addressed CSTD in HD handling Association of Pediatric Hematology/Oncology Nurses : When reconstituting drugs in vials, avoid pressure build-up because it can lead to aerosolization. Use a closed-system device (eg, PhaSeal) if available. ONS: Using a closed-system eliminates the exposure risk associated with spiking and priming tubing. ASHP: As products become available, they should meet the definition of a CSTD established by NIOSH and should be required to demonstrate effectiveness in independent studies. Kline NE (Ed). The Pediatric Chemotherapy and Biotherapy Curriculum (2nd Ed). Glenview, IL: Association of Pediatric Hematology/Oncology Nurses; Polovich M. (Ed.) Safe Handling of Hazardous Drugs (2nd Ed). Pittsburgh, PA: Oncology Nursing Society; American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63: ISOPP: Only airtight and leak-proof devices prevent chemical contamination. To be a closed-system, a device must meet this. Thus, vented, filtered devices are not closed. NIOSH: Evidence documents a decrease in drug contamination when a CSTD is used. USP 797: The use of a CSTD is preferred because of their inherent closed-system process (ie, vial transfer systems that allow no venting or exposure of hazardous substances to the environment). International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. Department of Health and Human Services. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. DHHS (NIOSH) Publication No September USP Chapter <797>. Guidebook to Pharmaceutical Compounding: Sterile Preparations. Rockville, MD: United States Pharmacopeia;

25 New specific product code created by FDA (1/2013) ONB: Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System ONB: requires data to prove system is closed for HD use ONB: requires data to demonstrate reduction in exposure to healthcare workers ONB: clarifies misconceptions about chemotherapy devices FDA: 21 Code of Federal regulations (CFR) Three criteria needed to meet the requirement of ONB Code: Nothing out : No escape of HD or vapor concentration (leakproof and airtight) Noting in : No transfer of environmental contaminants Prevention of microbial ingress BD PhaSeal: First and only CSTD cleared under FDA s new ONB code (for devices indicated to reduce exposure to HDs) FDA: 21 CFR BD Medical; Franklin Lakes, NJ; January

26 Comparison of surface contamination with cyclophosphamide and fluorouracil using CSTD versus standard preparation techniques Multicenter, randomized, blinded trial (independent analysis) 36-week study (12-week baseline; 12 weeks with CSTD (PhaSeal) and 12 weeks without CSTD 342 wipe samples collected Significant reduction in positive wipe samples when CSTD used (P =.0002) Conclusion: use of a CSTD reduced surface contamination Harrison BR, Peters BG, Bing MR. Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques. Am J Health Syst Pharm. 2006;63(18): Policies and procedures should be in place for all situations and all areas Develop a comprehensive safety program to address all aspects of handling HDs Safety program must be collaborative (all key disciplines) Material safety data sheets must be readily available Comprehensive training programs are needed (all staff) Monitoring and medical surveillance (a necessary component) PPE must be addressed American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63:

27 PPE must be worn by personnel during the handling and preparation of HDs Intended to protect operator (temporary barrier) Ensure sterility of compounded products HD contamination identified: on vials, counters, floors, BSC PPE needed during all aspects of preparation/handling PPE includes: gloves; gowns; masks or respirators; eye and face protection; sleeve, hair, and shoe covers (in pharmacy) American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63: Widespread contamination of work environment makes skin contact highly probably Organizations need to encourage safety and enforce safe handling guidelines Appropriate use of containment equipment (eg, BSC, CACI), can reduce exposure to HDs Use of a true CSTD may reduce exposure to HDs 27

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