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Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
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Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
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Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
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Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)
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  • Any drugs that exhibit at least one of the characteristics listed. The oncogenic and teratogenic effects of therapeutic doses of many drugs are well established. Mutagenic effects of cytotoxic drugs, immunosuppressant drugs, antiviral agents, and biological response modifiers have been documented.
    Genotoxic: produce gene mutations and damage DNA. Most cancers are a result of multiple gene mutations (estimated 2-7)
    Reproductive risks: Fetal loss, spontaneous abortions, infertility, low birth weight, fetal abnormalities.
    Major organ toxicities: review any chemotherapy drug reference. Hepatotoxicity, etc.
    Carcinogenicity in animals or humans
    Teratogenicity in animals or treated patients
    Organ toxicity at low doses in animals or treated patients
  • Leukemia in nurses (1992) The relative risk (RR) for leukemia among Danish nurses handling antineoplastic drugs was significantly increased (10.65) but based on only two cases. (oncology nurses identified in the Danish cancer registry from 1943 to 1987 (Skov et al. 1992). The same group (Skov et al. 1990) found an increased, but not significant, risk of leukemia in physicians employed for at least six months in a department where patients were treated with antineoplastic agents.
    Based on animal data and the reports of frequency of secondary tumors in patients treated with cyclophosphamide, (WAG), the urinary excretion of cyclophosphamide in healthcare workers was used to estimate the uptake of the drug, which ranged from 3.6-18 g per day.
    Cancer risks were calculated for a healthcare worker with a body weight of 70 kg over 40 years of work at 200 days/year.
    They proposed an increase in the risk of cancer of 1.4-10 additional cases per million workers per year.
    Higher exposure, such as 16-80 g per day, which has been calculated based on urinary excretion of cyclophosphamide in exposed nurses, may represent an increase in cancer risk estimated at 7-50 excess cases per million (Connor et al 1999)
    Hansen & Olsen--The overall standardized incidence ratio [SIR] for cancer was 1.0. An increased risk for non-Hodgkin's lymphoma appeared among long-term pharmacy dispensers (N = 5, SIR 3.7, 95% CI 1.2-8.9).
    More recently, Martin (2005) found that exposed nurses were significantly more likely to report a cancer diagnosis than unexposed nurses (OR = 3.27, p = 0.03). Additionally, in that study, the nurses’ age at initial cancer diagnosis was younger than that reported in the Surveillance, Epidemiology, and End Results [SEER] Data (National Cancer Institute, 1999).
  • Harrison (2001) reviewed fourteen studies that looked at adverse reproductive outcomes of healthcare workers exposed to hazardous drugs. Nine of the studies showed adverse outcomes related to exposure. The outcomes included fetal loss, congenital malformations, and infertility.
    Selevan, Lindbohm, Hornung, and Hemminki (1985) reported an odds ratio of 2.3 for fetal loss among nurses exposed during the first trimester of pregnancy. An odds ratio of 1.7 for spontaneous abortion was found in another study of nurses exposed to antineoplastic drugs (Stucker et al., 1990). Hemminki reported an odds ratio of 4.7 for fetal malformations in nurses who were exposed to hazardous drugs greater than once per week in the first trimester of pregnancy (Hemminki, Kyyronen, & Lindbohm, 1985).
    In a matched case-control study of nurses and pharmacists, a small but significant relationship was found between women who handled antineoplastic agents and infertility. A similar odd ratio was found for men, but was not statistically significant because of the small number of men in the study (Valanis, Volmer, Labuhn & Glass, 1997).
  • The Valanis study is a perfect example of this. She looked at over 7,000 pregnancies in approximately 3,000 pharmacy and nursing personnel who continued to work with antineoplastic agents during their pregnancies. She compared the rates of miscarriages. Low birth weight and congenital malformations to the normal population and the results were striking. Although these types of studies are based on pooled data this is as good as you can do since there is no way you would ever get a double blind study past an ethics review.
  • When reconstituting powdered drugs
    Expelling air from syringes
    Administering drugs by any route, counting tablets, crushing or breaking tablets or capsules, priming IV sets, handling contaminated bodily fluids
  • 1979 (Falck et al.). In a small but controlled study, mutagenic activity was found in the urine of patients who received chemotherapy and nurses who administered the chemotherapy. The investigators had intended the nurses to be the control group, but instead found evidence of their exposure. There is more recent published evidence of HD exposure in nurses, pharmacists and pharmacy technicians (Harrison, 2001; Pethran et al., 2003; Sessink & Bos, 1999; Wick, Slawson, Jorgenson, & Tyler, 2003), indicating that there has been little improvement in over twenty-five years.Evidence in the literature should wake you up. Studies have demonstrated:
    12 studies since 1992 have reported contamination on the outside of vials[Most recent: Connor et al, March 2005]
    Causes:
    Incomplete cleaning after filling
    Breakage in storage or transport
    Handling with contaminated gloves
    Drug contamination on the outside of drug vials as shipped from the manufacturer. Typically handled w/o gloves, resulting in exposure.
    Connor (MDA, 1999) showed cytotoxic drugs outside the BSC in pharmacies where drugs are prepared, and even in administration areas (ambulatory infusion.)
    Valanis (Cancer Nursing, 1998) florescent lights showed 18/83 drug handlers (more nurses than pharmacists) had spots of doxorubicin on gloved hands or gowns, visible only with light from scanning device.
    Some drugs have ability to vaporize, even at room temperature. HEPA filters in BSC’s & in respirator masks filter out particles, not vapors, so drug can be inhaled. BSC’s provide NO protection. (Manufactured to provide protection from infectious contamination, not drugs.)
    Valanis reports internal exposure to cytotoxic drugs. Measured mutagenic changes in urine of nurses & pharmacists who prepared and/or administered chemo. Exposed HCW who reported skin contact with drug had evidence in urine, but some who were unaware of exposure did, too. These are similar to the original findings in the 70’s that prompted safe handling precautions. Today, our ability to measure exposure is better--we can detect smaller amounts of drug.
  • “Mock” chemo was fluorescein dye. A few drops were intentionally leaked on the outside of the IV bag to “follow” the contamination. The “basket” is what is used in the clinic for transporting chemotherapy from the preparation room to the patient location
  • A plastic-backed pad (chux) is used to protect the surface of the tray next to the patient. The “wand” is the fluorescent light—you cannot see the drips with the naked eye (just like chemo)
  • The nurses’ gloved hands were contaminated. These pictures show how the contamination was transferred from their gloves to other surfaces.
  • Gas chromotography in tandem with mass spectroscopy-mass spectroscopy
    HPLC-high performance liquid chromatography
    Ifosfamide was only analyzed in US since usage in Canada was low
    One of the best studies to date demonstrating the presence of these drugs in the work environment. All of these hospitals are recognized cancer treatment faciliites and all of them could be considered “best practice” examples in terms of safe handling
  • In general-Levels of contamination higher in pharmacy areas
    Contamination with at least one of the 3 agents
  • Recommendations from all organizations, OSHA & the recent NIOSH Alert are similar.
    One of the Employer responsibilities listed by NISOH is to provide workers with proper PPE and ensure that they use PPE properly.
    Because of long-standing practices of some nurses wearing only gloves, adherence to these recommendations is not as it should be. Although gloves are universally recognized as necessary to protect the nurse, some nurses maintain that if they use “good technique” their risk of exposure is limited, and they may not wear a gown. Is the perception of risk lower in more experienced nurses?
    Nurses report that they do not wear gowns because their employers don’t provide them. Reality is that all preparation & administration activities hold risk of exposure.
    Eye protection is not always necessary: intracavitary chemo (via catheter into bladder or peritoneal cavity, such as for ovarian cancer.) Connections not designed to prevent leaking.
    Respirators for aerosolized drug (uncommon) & for spill clean up. Surgical masks do NOT provide respiratory protection. MSDSs describe the appropriate type of respirator necessary based on the drug in question.
  • Normal manipulations performed using flourescein dye as surrogate for chemotherapy
  • No evidence of contamination
    Connections are dry
  • Clear evidence of external contaminatinon
  • Teva had clear contamination including one observed droplet of approximately 1mm
  • With the PhaSeal System, no leakage was observed during any of the preparation or administration manipulations.
    Both the Tevadaptor™ System and the Cardinal Health/Alaris System showed visible fluorescein leaks on the outside of each component during all manipulations of drug preparation and administration.
  • Environmental sampling is also suggested both routinely and when exposure is suspected
  • No matter what systems are used, they are only as good as the operators who use them. Any comprehensive system for safe handling must be based on a solid training program
  • Training program should include the above
  • Transcript

    • 1. Proper Handling of Hazardous Drugs: Topics for Oncology Nursing Presented by Kerry Mahar, RN, MSN, AOCN Dana Farber Cancer Institute Norwell, MA 1
    • 2. Disclosure • Kerry Mahar serves as an Advisory Board member for Carmel Pharma. • This program has been supported by an unrestricted educational grant provided by Carmel Pharma. • This program is intended strictly for educational purposes and does not constitute as an endorsement of any product or off-label usage. 2
    • 3. CPE Program Information ANCC Program CNE #: O-AO-12716-04-08 1.5 Contact Hours Expires: April 21, 2010 • Questions: STAT Educational Services phone 888-247-8700 fax 888-247-8706 3
    • 4. Program Learning Objectives At the completion of this program, participants should be able to: 1. Describe the potential health risks of handling hazardous drugs in oncology nursing practice. 2. Identify the appropriate PPE needed for safe handling of hazardous drugs. 3. Review current recommendations and guidelines for safe handling of hazardous drugs. 4. List recommended practices for the safe handling of hazardous drugs during drug administration and disposal of drugs. 5. List recommendations for medical surveillance for nurses who handle hazardous drugs. 6. Describe essential elements of staff education/training related to safe handling of hazardous drugs. 4
    • 5. Exposure Opportunity is Increasing • WHO estimates a 50% increase in cancer patients in the next 20 years • Use of drugs for non-malignant disease (RA, SLE) • Anti-viral agents for HIV treatment and other viral illnesses • Investigational (IND) Drug Development/Clinical Trials 5
    • 6. Definition of Hazardous Drugs • Carcinogenic • Teratogenic • Reproductive toxicity • Organ toxicity at low doses • Genotoxic • Structure or toxicity similar to drugs classified as hazardous (NIOSH, 2004) 6
    • 7. End Organ Damage • By definition a drug is deemed hazardous if it causes harm to organs • Liver damage was reported in the literature on three nurses (working 6, 8 and 16 years) with chemotherapeutic agents • Cardiotoxicity related to the use of anthracyclines Source: Sotaniemi EA, Sutinen S, Arranto AJ et al. Liver damage in nurses handling cytostatic agents. Acta Med Scand. 1983; 214:181-9. 7
    • 8. Cancer Risk in Workers • Leukemia in nurses (Skov et al, 1992) (RR = 10.65) • Cyclophosphamide (Sessink et al, 1993) (1.4-10 excess cases/million) • NHL & skin cancer (Hansen & Olsen, 1994) (SIR = 3.7) • Overall increased cancer risk (Martin, 2005) (OR = 3.27) RR = Relative Risk; SIR = Standardized Incidence Rate; OR = Odds Ratio 8
    • 9. Reproductive Risks in Workers • Fetal abnormalities (Hemminki et al, 1985) • Spontaneous Abortions (Stucker, 1990) • Infertility (Valanis et al, 1997) • Miscarriages (Valanis et al, 1999) • Infertility, premature labor, low-birth weight, learning disabilities in offspring (Martin, 2005) • Infertility (Fransman, 2007) 9
    • 10. 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 • Increased risk for miscarriages by 40 - 50% • Increased risk for low birth weight by 17-fold • Increased risk for congenital malformations by 5-fold Source: Journal of Occupational & Environmental Med Vol.41; 8: 632-638 10
    • 11. Teratogenicity • Conflicting opinion on exposure during 2nd and 3rd trimesters • Greatest danger during 1st trimester • Hemminki case control study of Finish oncology nurses actively handling chemotherapy during 1st trimester • Demonstrated statistically significant increase in risk for malformations • Odds ratio of 4.7 (p=0.02) Source: Hemminki K, Kyyronen P, Lindbohm ML. J Epidemiol Community Hlth 1985 11
    • 12. Modes of Contact for Drug Exposure to Healthcare Worker • Dermal* – Direct contact – Contaminated surfaces • Ingestion – Food, gum – Hand-to-mouth • Inhalation – Aerosols – Vapors • Injection – Sharps – Breakage *Most common source of exposure (NIOSH, 2004) 12
    • 13. Evidence of Exposure • Positive florescent scans (Valanis, 1998) • Positive urine tests for drug exposure – 18 Published studies • 16 detected drugs in urine • In 4 studies, drugs were found in the urine of workers with no direct HD contact • Contaminated vials - 12 studies since 1992 • Surface contamination - 14 studies since 1994 13
    • 14. Drug Reconstitution With Needle & Syringe 14
    • 15. Drug Transfer With Needle & Syringe 15
    • 16. Transfer of Contamination from IV Bag Photographs courtesy of L. Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission. 16
    • 17. Chemotherapy on Plastic-Backed Pad Photograph courtesy of L. Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission. 17
    • 18. Where Else? Photographs courtesy of L. Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission. 18
    • 19. On the Floor… Photograph courtesy of Libby Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission. 19
    • 20. Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States Source: AJHP 1999. 56:1427-32. Objective: This study was designed to demonstrate the presence of ctyotoxic drugs in the workplace. Thomas H. Connor, Roger W. Anderson, Paul J. M. Sessink, Larry Broadfield, Luci A. Power 20
    • 21. Evaluation of Surface Contamination Study was conducted at six cancer treatment centers – 3 in the United States and 3 Canadian centers – Wipe samples analyzed for • Cyclophosphamide and ifosfamide by GC-MS-MS • Fluorouracil by reverse-phase HPLC with UV-light detection – All pharmacies used class II Biological Safety Cabinets (BSCs) Source: AJHP 1999. 56:1427-32. 21
    • 22. Evaluation of Surface Contamination • Measurable levels of antineoplastic agents were detected in – 75% of the pharmacy samples • Top area of BSC airfoil • Floor in prep room and in front of BSC • Work surface inside BSC – 65% of the administration samples • Floor around chair and patient bed • Top of preparation area Source: AJHSP 1999. 56:1427-32. 22
    • 23. Personal Protective Equipment to Prevent Exposure in Healthhcare Workers • Gloves: tested with hazardous drugs, powder-free, latex, nitrile, neoprene – Double gloves – 30-min wear time • Gowns: tested with hazardous drugs, disposable, single- use, cuffs, back closure • Eye protection: – when splashing is possible • Respirator/mask: – for aerosols & spill clean-up • Close System Transfer Device (CSTD) 23
    • 24. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents Source: Wick C. AJHP 2003; 60 (15): 2314-2320 This study examined pharmacists, technicians and nurses at the Huntsman Cancer Center in Salt Lake City, Utah. Urine samples were collected separately from each group over a 24-hour time period. Catherine Wick, Matthew Slawson, James Jorgenson, Linda Tyler, Huntsman Cancer Institute, Salt Lake City, Utah 24
    • 25. Agent # positive samples* % Pre-PhaSeal Cyclophosphamide 18/48 38 Ifosfamide 10/47 21 Post-PhaSeal Cyclophosphamide 0/49 0 Ifosfamide 0/49 0 Total Positive Urine Samples • All 3 groups, pharmacists, pharmacy technicians and nurses had positive urine samples Pre-PhaSeal. • All locations were contaminated with 100% of RN’s and RPh’s contaminated and 30% of Pharmacy technicians • After using PhaSeal for 6 months, there were no positive urine samples recorded and surface level contamination was reduced 10X. Source: Wick C. AJHP 2003; 60 (15): 2314-2320 25
    • 26. Contamination Comparison of Transfer Devices Intended for Handling Hazardous Drugs Objective Fluorescein, a fluorescent indicator, was used to determine if the Tevadaptor™ System, Alaris System or PhaSeal System have the potential to allow drugs to escape into the environment during the preparation and administration phases of hazardous drug handling. Presented at ONS Congress, April, 2007, Las Vegas, NV. Susan Spivey, RPh, DDS, PharmD, Pharmacy Manager James A. Jorgenson, RPh, MS, FASHP, Director of Pharmacy University of Texas, MD Anderson Cancer Center and University of Utah Health Care, Salt Lake City, Utah 26
    • 27. Utah & MD Anderson Study Are Connections Really Dry? • Evaluated dry connection of three commercially available systems for chemotherapy preparation • Utilized flourescein dye and transferred from a vial to syringe • Photographed vial and syringe adaptors under UV light • “Tapped” syringe adaptor on gauze to determine any leakage 27
    • 28. PhaSeal® Protector, Injector Luer Lock & Y-site Connector by Carmel Pharma 28
    • 29. Alaris Smartsite® & Texium by Cardinal Health 29
    • 30. B. Braun OnGuard™ Vial Adaptor, Syringe Adaptor & Luer Lock Adaptor by Teva Medical Ltd. 30
    • 31. Results • With the PhaSeal System, no leakage was observed during any of the preparation or administration manipulations. • Both the Tevadaptor™ System and the Cardinal Health/Alaris System showed visible fluorescein leaks on the outside of each component during all manipulations of drug preparation and administration. 31
    • 32. Leakproof Connection Integrity Test For Devices Intended for Handling Hazardous Drugs James A. Jorgenson, RPh, MS, FASHP, Director of Pharmacy University of Utah Health Care, Salt Lake City, Utah 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. 32
    • 33. Methods • 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. 33
    • 34. Clave® Vial Adaptor & Spiros™ Male Connector (ICU Medical, Inc.) B. Braun OnGuard™ Vial Adaptor & Syringe Adaptor (Teva Medical Ltd.) 34
    • 35. Alaris SmartSite® Vented Vial Access Device & Texium™ Male Luer (Cardinal Health) PhaSeal® Protector & Injector Luer Lock (Carmel Pharma, Inc.) 35
    • 36. 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. 36
    • 37. “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” Source: OSHA Technical Manual: Controlling Occupational Exposure to Hazardous Drugs US Department of Labor 1999 Medical Surveillance 37
    • 38. Medical Surveillance For Who & Why… – To develop a standard that applies to all employees that support patient care services  Product preparation  Product administration & infusion  Acquisition transportation  Environmental service/housekeeping  Waste disposal – To identify biologic effects in anticipation that exposure will be reduced or eliminated [before an employee sustains irreversible damage or injury] 38
    • 39. Medical Surveillance • NIOSH recommends (not a mandate) workers handling hazardous drugs be monitored – Medical history – Exposure history – Physical examination – Selected lab tests (complete blood count, reticulocyte count, or occult blood in urine) Source: NIOSH 117 document April 2007;www.cdc.gov/niosh/docs/wp-solutions/2007-117/NIOSH 39
    • 40. Medical Surveillance Elements of a medical surveillance program • Reproductive and health questionnaires at hire and periodically • Laboratory work – Complete blood count, Urinalysis, Reticulocyte count, Transaminases (AST, ALT), Alkaline Phosphatase • 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 40
    • 41. Medical Surveillance • NIOSH also suggests environmental sampling and/or biological monitoring when exposure is suspected • Some organizations considering urine testing for presence of chemotherapeutic agents 41
    • 42. Environmental and Biological Monitoring Environmental Monitoring (Wipe Testing) • 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 (Urine Testing) • Assessment of uptake of the drug in the body of the worker • Estimation of health-risk for the worker 42
    • 43. USP 797 Recommendation for Environmental Sampling • Suggests routine environmental sampling to detect uncontained hazardous drugs • Initial benchmark and every 6 months or more as needed • Surface wipe sampling of BSC or CACI and adjacent areas including the floor directly under the work area, counter tops, and patient care areas • Common marker drugs include cyclophosphamide, ifosfamide, methotrexate, and fluorouracil 43
    • 44. USP 797 Recommendation for Environmental Sampling • If any measurable contamination is found, practitioners shall make the decision to identify, document and contain the cause • Action may include retraining, thorough cleaning, and improving engineering controls • USP notes that cyclophosphamide levels greater than 1.0 ng/cm2 has been found to cause human uptake 44
    • 45. Sessink Stride Risk Level Model • Based on predictive model for additional cancer cases per million workers based on cyclophosphamide urine levels • Stride risk level is 1 extra cancer case a year per million workers • Prohibitory risk level is 100 extra cancer cases a year per million workers Source: Dr. Paul Sessink Exposure Control; 2008 45
    • 46. Sessink Model Stride Risk Level Prohibitory Risk Level Urine CP (ug/24 hr) < 0.02 0.02 – 0.2 0.2 – 2 > 2 Contamination CP (ng/cm2 ) < 0.1 0.1 – 1 1 – 10 > 10 Action None Yes At short notice Yes Immediately Yes Stop Working Monitoring Periodic Regular Regular Regular 46
    • 47. Training on Handling of Hazardous Medications • ASHP (1990) and OSHA (1995) agencies must have a system for validating staff performance, and this must be documented • USP 797 revisions state all personnel who compound hazardous drugs shall be fully trained in the storage, handling and disposal of these drugs • Training must occur prior to preparing or handling hazardous CSPs & effectiveness must be verified by testing specific hazardous preparation techniques at least annually with results documented • Current MSDSs must be readily available in the areas hazardous drug preparation and administration Source: ASHP;Gullo, 1988:OSHA, 1990, 1995: USP 797 revisions (2007) 47
    • 48. Training on Handling of Hazardous Medications Training must include at least: • Use of engineering controls including correct use of closed-system transfer devices • Use of PPE • Drug preparation • Drug Transport • Drug administration • Disposal of hazardous materials • Management of hazardous drug spills • Management of acute exposure 48
    • 49. Training on Handling of Hazardous Medications 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 vs. chronic – Annual review of critical process and hazardous chemicals – Plan in place to educate on new chemicals 49
    • 50. Training on Handling of Hazardous Medications Storage and Compounding • Evaluation of work environment and 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 – Personal Protective Equipment (PPE) – Closed-system drug transfer device (CSTD) Source: Massoomi, 2007 50
    • 51. Training on Handling of Hazardous Medications Decontamination Procedures • “Decontamination” of cabinets – Surface Safe (15/case) $1.43 each • Step 1: 2% sodium hypochlorite detergent • Step 2: 1% sodium thiosulfate & 0.9% benzyl alcohol • 6% Hypochloride solution – Combination of surface safe & cationic soap solution • “Sterilization” of cabinets – Caution isopropyl alcohol use in Type II-A and II-B3 – Must be in contact for 30 seconds Source: Massoomi, 2007 51
    • 52. Training on Handling of Hazardous Medications Appropriate Personal Protective Equipment (PPE) • Gloves – Use good-quality gloves made of latex, nitrile, polyurethane, neoprene, or other materials that have been tested with hazardous drugs. – Select powder-free gloves. – Inspect gloves for visible defects. – Wear double gloves for drug preparation. – Change gloves every 30 minutes or immediately if damaged or contaminated. • Eye Protection – When splashing is possible Source: Safe handling of cytotoxic drugs: an independent study module. 2nd ed. Pittsburgh (PA): Oncology Nursing Society; 1997. p26 52
    • 53. Training on Handling of Hazardous Medications Appropriate Personal Protective Equipment (PPE) - continued • Gowns – Wear gowns that are disposable, made of a lint-free, low- permeability fabric. – They should have a solid front (back closure) and knit or elastic cuffs. – Laboratory coats and other cloth fabrics absorb fluids, so they provide an inadequate barrier to hazardous drugs and are not recommended. – The existing guidelines do not contain a recommendation for the maximum length of time that a gown should be worn. Because no recommendations are stated in the literature, at a minimum, change the gown every time it is contaminated or gloves are changed. • Respirator/masks – For aerosols & spill clean-up Source: Safe handling of cytotoxic drugs: an independent study module. 2nd ed. Pittsburgh (PA): Oncology Nursing Society; 1997. p26 53
    • 54. Staff Education & Training • Educator/CNS Role & Accountability – Competence • Theory • Principle – Validation • Practical application • Skill – Documentation • Initial • Annual • PRN 54
    • 55. Staff Education & Training – Continuous Assessment – Inservices – Products  Studies  Modification/revision  Defect  Incidence report 55
    • 56. Factors to be considered when selecting a closed-system drug transfer device system. 56
    • 57. ISOPP* Standards of Practice • Know Your Risk • Staff Training • Levels of Protection • Closed-System – Definition – Clinical Evidence *ISOPP =International Society of Oncology Pharmacy Practice J Onc Pharm Pract 2007; 13 Suppl. 57
    • 58. What is the Risk? • Hazardous drug exposure – Skin rashes – Infertility – Miscarriages – Birth defects – Malignancy • Leukemia • Other cancers 58
    • 59. Staff Training • Aseptic technique • Safe handling of hazardous drugs • Ongoing feedback – Annual competency training – Assessment/review on a regular basis • Multi-disciplinary approach 59
    • 60. Levels of Protection • Level 1 – Elimination/substitution/replacement • Level 2 – Isolation of the hazard/source containment • Level 3 – Engineering controls/Proper ventilation • Level 3b – Administrative controls/ Organization measures • Level 4 – Personal protective equipment (PPE) 60
    • 61. What is a Closed-System? “A closed system drug transfer device mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system” NIOSH* * National Institute for Occupational Safety & Health 61
    • 62. What is the Clinical Evidence? 62
    • 63. 63
    • 64. Questions to ask when evaluating a drug transfer device 1. Does the device have independent, peer-reviewed clinical evidence that proves the efficacy in reducing surface contamination? 2. Does the device have more than one piece of clinical evidence? 3. Does the device have any published data that shows that healthcare workers will not excrete chemotherapy in their urine if the product is used? 4. Does the device integrate with all phases of preparation, administration, and disposal? 5. Can you reconstitute powdered medications with the device? 64
    • 65. Questions to ask when evaluating a drug transfer device (cont) 6. Does the system have universal capability 7. Does the product remain closed throughout multiple manipulations in preparation and administration as defined in the NIOSH and ISOPP guidelines as the standard? 8. Does the device protect over a full spectrum of hazardous drugs? 9. Was the device beta tested by a third party for this product? 10. Does the company offer ongoing clinical support and safe handling training/education for all staff? 65
    • 66. Plan of attack….. • Cytotoxic Drug Handling • NIOSH Official Statement • ISOPP Standard of Practice • Overview of our “testing” of the product. – Explanation – Data overview – Cost 66

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