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Documentation of Environmental Contamination | Documentation of Health Hazards
Documentation of Environmental Contamination 1. Sessink PJM, Boer KA, Scheefhals APH, et al. Occupational exposure to antineoplastic agents at several departments in a hospital. Int Arch Occup Environ Health (1992) 64:105-112. 25 pharmacy technicians and nurses from four departments of a hospital were analyzed in a study for contamination of Cyclophosphamide (CP), ifosfamide (IF), 5-fluorouracil (5FU), and methotrexate (MTX) . Contamination was detected on the work surfaces in the safety cabinets, on the floors, workbenches, sinks, vial and ampoules. 2. Opiolka M, et al. Umgang mit Zytostatika: Besteht ein ausreichender Personenschutz bei der Zytostatika-Zubereitung? Krankenhaus Technik (1998) 56-58. This study indicates that safety cabinets equipped with high performance HEPA filters can protect against hazardous particles, but not substances in gas form. Variables such as open doors, ventilation air pressure, size of room, etc. can effect the functionality of air-cleaning systems and therefore, result in hazardous vapors entering the preparation room, where they can be inhaled by staff. The study further suggests that staff are not adequately protected against cytostatics in gas form. 3. Sessink PJM, Bos RP. Drugs Hazardous to Healthcare Workers (Evaluation of Methods for Monitoring Occupational Exposure to Cytostatic Drugs) A Review Article. Drug Safety, 1999, Apr: 20 (4) 347-359. This article reviews the literature concerning the possible health risks of individuals occupationally exposed to cytostatic drugs. 4. Minioia C, Turci R, Sotannie C, et al. Application of High Performance Liquid Chromatography/Tandem Mass Spectrometry in the Environmental and Biological Monitoring of Health Care Personnel Occupationally Exposed to Cyclophosphamide and Ifosfamide. Rapid Commun. Mass Spectrom. 12, 1485-1493 (1998). The study reports that environmental contamination of cyclophosphamide and ifosfamide was detected outside of BSCs, under latex and vinyl gloves, and under protective gowns. 5. The Baker Company, Introduction to Laminar Flow Clean Benches. "Regardless of the cabinet class or type, it is essential to remember that the HEPA filter traps particulates only. It is completely porous to gases and vapors." 6. Conner T, Anderson R, Sessink PJM, Broadfield L, Power L. Surface contamination with antineoplastic agents in six cancer centers in Canada and the United States. AJHP Vol 56 Jul 15 1999, 1427-1432. Significant surface contamination of cyclophosphamide, ifosfamide and 5-fluorouracil were found outside Biological Safety Cabinets on floors and cabinets both in preparation areas and administration areas at six cancer treatment centers in the US and Canada. 7. Opiolka S, Molter W, Goldschmidt R, Erich E, Schoppe G. Evaporation of cytostatic drugs during preparation. Gefahrstoffe-Reinhaltung der Luft 58 (1998) Nr. 7/8-July/August. The study establishes the vapor pressure of cyclophosphamide and 5-fluorouracil and concludes that both agents vaporize at room temperature and can escape the Hepa filter and penetrate the environment where health care workers reside. 8. Conner T, Shults M, Fraser M. Determination of the vaporization of solutions of mutagenic antineoplastic agents at 23 and 37°C using a desiccator technique. Hospital Pharmacy, Vol. 34 No. 11, Nov 1999, 85-92. "This study found that vaporization of standard solutions of some antineoplastic agents is possible at room temperature and increases as the temperature increases." Carmustine (BCNU™), cyclophosphamide (Cytoxan™), ifosfamide (Ifex™), thiotepa, and nitrogen mustard (Mustargen™) demonstrated vaporization at 37°C. Carmustine and nitrogen mustard demonstrated significant vaporization at 23°C (room temperature) cyclophosphamide demonstrated a 50% increase in revertants at this temperature. 9. Baker E, Connor T. Monitoring occupational exposure to cancer chemotherapy drugs. A Review Article. AJHP 53 Nov 15 1996, 2713-2723. This report is a general overview of literature published to support the need for improved handling practices of chemotherapeutic drugs. The report stresses the need for education and compliance with better techniques. "One must conclude intuitively that exposure to even small quantities of mutagenic, teratogenic, or carcinogenic substances should be avoided to the utmost extent." 10. Sessink PJM, Anzion RBM, et al. Detection of Contamination with antineoplastic agents in a hospital pharmacy department. Pharmaceutisch Weekblad Scientific edition 14:16-22 (1992). Study showed contamination of fluorouracil, cyclophosphamide and methotrexate in air samples, vertical laminar airflow safety hood both in front of and below the hood. 11. Sessink PJM, Joost HC, et al. Occupational exposure of animal keepers to cyclophosphamide. Journal of Occupational Medicine 35:47-52 (1993). This study shows environmental contamination was found in facilities that utilize animals for cytotoxic agent (cyclophosphamide ´CP´) experimentation. Air samples, wipe samples and staff urine samples were found to be positive for CP. 12. Sessink PJM, Wittenhorst BCJ, et al. Exposure of pharmacy technicians to antineoplastic agents; reevaluation after additional protective measures. Department of Toxicology, Faculty of Medical Sciences, University of Nijmegen, The Netherlands. Submitted. 1994. The study indicates that after additional measures to protect staff by double gloving, replacement of ampoules with vials, as well as using special masks, contamination still resulted. The reason for continued contamination remains unknown in this study. 13. Sessink PJM, Timmermans JL, et al. Assessment of occupational exposure of pharmaceutical plant workers to 5-fluorouracil. Determination of a-fluoro-b-alanine in urine. Journal of Occupational Medicin 36:79-83 (1994). Pharmaceutical plant workers were studied for contamination of 5-fluorouracil during manufacturing. Contamination was found in air samples, wipe studies and discovery of the main metabolite a-fluoro-b-alanine in the urine of the workers. 14. Sessink PJM, Friemel NSS, Anzion RBM, Bos RP. Biological and environmental monitoring of occupational exposure of pharmaceutical plant workers to methotrexate. International Archives of Occupational and Environmental Health, 65:401-403 (1994). Pharmaceutical plant workers were studied for contamination of methotrexate (MTX). All air samples were positive for MTX as were all urine samples from the workers. Documentation of Health Hazards 1. Valanis B, Vollmer W, Glass A. Acute symptoms associated with antineoplastic drug handling among nurses. Cancer Nursing 16(4): 288-295, 1993. The findings of this study are that skin contact is the best predictor of acute symptoms in nurses working with chemotherapy. Symptoms shown to increase with skin exposure to chemo or patient excreta (those receiving chemotherapy) included loss of appetite, N/V, diarrhea, coughing, shortness of breath, irregular heart beat, increased blood pressure, hair loss, pain during urination, etc. 2. Sotaniemi EA, Sutinen S, Arranto AJ et al. Liver damage in nurses handling cytostatic agents. Acta Med Scand. 1983; 214:181-9. This study describes liver damage in three oncology nurses hypothesized to result from several years’ occupational exposure to cytostatic drugs. 3. Selevan SG, Lindbohm M-L, Hornug RW et al. A study of occupational exposure to antineoplastic drugs and fetal loss in nurses. N Engl J Med. 1985; 313:1173-8. Stucker I, Caillard J-F, Collin R et al. Risk of spontaneous abortion among nurses handling antineoplastic drugs. Scand J Work Environ Health. 1990; 16:102-7. 4. Skov T, Maarup B, Olsen J et al. Leukaemia and reproductive outcome among nurses handling antineoplastic drugs. Br J Ind Med. 1992; 49:855-61. Reports show an increased frequency of leukemia cases in nurses exposed to cytostatic drugs. 5. Valanis BG, Vollmer WM, Labuhn KT et al. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. AJHP. 1993; 50:455-62. The findings of this study are that skin contact is the best predictor of acute symptoms in nurses working with chemotherapy. Symptoms shown to increase with skin exposure to chemo or patient excreta (those receiving chemotherapy) included loss of appetite, N/V, diarrhea, coughing, shortness of breath, irregular heart beat, increased blood pressure, hair loss, pain during urination, etc. 6. Sessink PJM, Kroese ED, van Kranen HJ, Bos RP. Cancer risk assessment for health care workers occupationally exposed to cyclophosphamide. Int Arch Occup Environ Health, 1995, 67:317-323. This study establishes a minimal level of acceptable extra cancer risks per one million. The Netherlands propose that a target of 1 extra cancer case per million is acceptable and >100 per million is totally unacceptable. Any risk between 1 and 100 should be dealt with aggressively. Increased cancer risks of healthcare staff exposed to cyclophosphamide are theoretically shown to be 17-100 extra cases per million employees, with regard to leukemia in women. Cases of bladder cancer in men and women exposed to CP increased to 15-76 extra cases per million. 7. Valanis B, Vollmer WM, Steele P. Occupational Exporsure to Antineoplastic Agents: Self-Reported Miscarriages and Stillbirths Among Nurses and Pharmacists. J Occu Envir Med Vol 41 No. 8, AUG 1999, 632-638. The study suggests a statistically significant increase in the risk of miscarriage in women handling cytostatic agents prior to or during pregnancy. 8. Sessink PJM, Bos RP. Drugs Hazardous to Healthcare Workers (Evaluation of Methods for Monitoring Occupational Exposure to Cytostatic Drugs) A Review Article. Drug Safety, 1999, Apr: 20 (4) 347-359. This paper reviews the literature concerning possible health risks for individuals occupationally exposed to cytostatic drugs. 9. Hansen J, Olsen JH. Cancer morbidity among Danish Female pharmacy technicians. Scand J Work Environ Health, 1994; 20:22-6. The study evaluated the increased risk of cancer in 9,499 active and retired female pharmacy staff licensed as of January 1, 1970 or later. The study indicated an increased risk of non-Hodgkin’s lymphoma among the long-term pharmacy staff. In addition, there was a 53% significantly higher risk for non-melanoma skin cancer than amongst the general population. 10. Peelen S, Roeleveld N, et al. Toxic effects on reproduction in hospital personnel. (Translation by Interverbum, Gothenburg Sweden from original Dutch) The study suggests an increased risk of spontaneous abortion and low birth weight in children, associated with exposure to cytostatic agents. 11. Labuhn K, Valanis B, Loveday K, et al. Nurses´ and Pharmacists´ exposure to Antineoplastic Drugs: Findings from Industrial Hygiene Scans and Urine Mutagenicity Tests. Cancer Nursing, 1998, 21(2), 79-89. These findings indicate that biological intake (positive urine mutagenicity tests) can occur among healthcare workers who handle cytostatic drugs. 12. Sessink PJM, Scholtes MM, Anzion RBM, Bos RP. Determination of cyclophosphamide in urine by gas chromatography-mass spectometry. Journal of Chromatography Biomedical Applications 616:333-337 (1993) The paper describes the mass spectrometry method of testing urine for traces of cyclophosphamide. The method is deemed appropriate for the routine analysis of urine for antineoplastic agents in healthcare workers. 13. Sessink PJM, Cerna M, Rossner P, et al. Urinary cyclophosphamide excretion and chromosomal aberrations in peripheral blood lymphocytes after occupational exposure to antineoplastic agents. Mutation Research 309:193-199 (1994). This study involved a group of Dutch and Czech healthcare workers handling antineoplastic drugs. The study compared the results from a method detecting cyclophosphamide in urine with the results from an analysis of chromosomal aberrations in peripheral blood lymphocytes. |
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