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Guidelines for Handling Parenteral Antineoplastics FREE

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Report D of the Council on Scientific Affairs, adopted by the House of Delegates of the American Medical Association at the Interim Meeting, December 1984.

This report is not intended to be construed or to serve as a standard of medical care. Standards of medical care are determined on the basis of all of the facts and circumstances involved in an individual case and are subject to change as scientific knowledge and technology advance and patterns of practice evolve. This report reflects the views of scientific experts and reports in the scientific literature as of December 1984.

Reprint requests to Council on Scientific Affairs, Division of Drugs and Technology, American Medical Association, 535 N Dearborn St, Chicago, IL 60610 (John C. Ballin, PhD).


JAMA. 1985;253(11):1590-1592. doi:10.1001/jama.1985.03350350084026
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BACKGROUND  The growing professional concern over the potential carcinogenic hazards associated with the handling of antineoplastic agents has resulted in the publication of studies concerned with the detection of metagenic effects in hospital staff involved with cancer chemotherapy, as well as publication of numerous guidelines to minimize exposure to antineoplastic agents. Although the actual hazards associated with the handling of parenteral antineoplastic drugs have not been established, the issue of ensuring the safety of all health care personnel is becoming a broader public concern.1The objectives of this report are to (1) review the scientific data regarding the risks to physicians and other health care personnel in handling and administering parenteral antineoplastic drugs; (2) study the guidelines recommended by the National Institutes of Health (NIH) and other sources for the safe handling of parenteral antineoplastic drugs; and (3) determine whether the currently available guidelines are adequate to ensure safe

REFERENCES

Brink CJ:  Employee complaints draw OSHA inspection of hospital procedures for handling cytotoxic drugs . Am J Hosp Pharm 1984;;41:591-608.
Anderson RW, Puckett WH Jr, Dana WJ, et al:  Risk of handling injectable antineoplastic agents . Am J Hosp Pharm 1982;;39:1881-1887.
Jagun O, Ryan M, Waldron HA, et al:  Urinary thioether excretion in nurses handling cytotoxic drugs . Lancet 1982;;2:443-444.
Falck K, Gröhn P, Sorsa M, et al:  Mutagenicity in the urine of nurses handling cytostatic agents . Lancet 1979;;1:1250-1251.
Norppa H, Sorsa M, Vainio H, et al:  Increased sister chromatid exchange frequencies in lymphocytes of nurses handling cytostatic agents . Scand J Work Environ Health 1980;; 6:299-301.
Waksvik H, Klepp O, Brøgger A, et al:  Chromosome analyses of nurses handling cytotoxic agents . Cancer Treat Rep 1981;;65:607-610.
Carter SK:  The carcinogenic potential of cytotoxic chemotherapy and its implications for therapeutic decision making . Cancer Chemother Pharmacol 1984;;12:67-69.
Green MH, Boice JD Jr, Greer BE, et al:  Acute non-lymphocytic leukemia after therapy with alkylating agents for ovarian cancer: A study of five randomized clinical trials . N Engl J Med 1982;;307:1416-1421.
Aisenberg A:  Acute nonlymphocyte leukemia after treatment for Hodgkin's disease . Am J Med 1983;;75:449-454.
Boice JD, Greene MH, Keehn RJ, et al:  Late effects of low-dose adjuvant chemotherapy in colorectal cancer . JNCI 1980;;64:501-511.
Boice JD, Greene MH, Killen JY, et al:  Leukemia and preleukemia after adjuvant treatment of gastrointestinal cancer with methyl-CCNU . N Engl J Med 1983;;309:1079-1084.
Harrison BR:  Developing guidelines for working with antineoplastic drugs . Am J Hosp Pharm 1981;;38:1686-1693.
Nicholson HO:  Cytotoxic drugs in pregnancy: Review of reported cases . J Obstet Gynaecol Br Commonw 1968;;75:307-312.
D'Arcy PF:  Reactions and interactions in handling anticancer drugs . Drug Intell Clin Pharm 1983;;17:532-538.
Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs , Dept of Health and Human Services publication (NIH) 83-2621. Bethesda, Md, National Institutes of Health, 1982;.
Recommendations for Handling Cytotoxic Agents . National Study Commission on Cytotoxic Exposure, 1983;.
Jones RB, Frank R, Mass T, et al:  Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center . CA 1983;; 33:258-263.
Procedures for Handling Cytotoxic Drugs . Bethesda, Md, American Society of Hospital Pharmacists, 1983;.
Clinical Oncological Society of Australia:  Guidelines and recommendations for safe handling of antineoplastic agents . Med J Aust 1983;;1:426-428.
Zimmerman PF, Larsen RK, Barkley EW, et al:  Recommendations for the safe handling of injectable antineoplastic drug products . Am J Hosp Pharm 1981;;38:1693-1695.
Neal AD, Wadden RA, Chiou WL:  Exposure of hospital workers to airborne antineoplastic agents . Am J Hosp Pharm 1983;;40:597-601.
National Disease and Therapeutic Index . Ambler, Pa, IMS America Ltd, 1984;.

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Brink CJ:  Employee complaints draw OSHA inspection of hospital procedures for handling cytotoxic drugs . Am J Hosp Pharm 1984;;41:591-608.
Anderson RW, Puckett WH Jr, Dana WJ, et al:  Risk of handling injectable antineoplastic agents . Am J Hosp Pharm 1982;;39:1881-1887.
Jagun O, Ryan M, Waldron HA, et al:  Urinary thioether excretion in nurses handling cytotoxic drugs . Lancet 1982;;2:443-444.
Falck K, Gröhn P, Sorsa M, et al:  Mutagenicity in the urine of nurses handling cytostatic agents . Lancet 1979;;1:1250-1251.
Norppa H, Sorsa M, Vainio H, et al:  Increased sister chromatid exchange frequencies in lymphocytes of nurses handling cytostatic agents . Scand J Work Environ Health 1980;; 6:299-301.
Waksvik H, Klepp O, Brøgger A, et al:  Chromosome analyses of nurses handling cytotoxic agents . Cancer Treat Rep 1981;;65:607-610.
Carter SK:  The carcinogenic potential of cytotoxic chemotherapy and its implications for therapeutic decision making . Cancer Chemother Pharmacol 1984;;12:67-69.
Green MH, Boice JD Jr, Greer BE, et al:  Acute non-lymphocytic leukemia after therapy with alkylating agents for ovarian cancer: A study of five randomized clinical trials . N Engl J Med 1982;;307:1416-1421.
Aisenberg A:  Acute nonlymphocyte leukemia after treatment for Hodgkin's disease . Am J Med 1983;;75:449-454.
Boice JD, Greene MH, Keehn RJ, et al:  Late effects of low-dose adjuvant chemotherapy in colorectal cancer . JNCI 1980;;64:501-511.
Boice JD, Greene MH, Killen JY, et al:  Leukemia and preleukemia after adjuvant treatment of gastrointestinal cancer with methyl-CCNU . N Engl J Med 1983;;309:1079-1084.
Harrison BR:  Developing guidelines for working with antineoplastic drugs . Am J Hosp Pharm 1981;;38:1686-1693.
Nicholson HO:  Cytotoxic drugs in pregnancy: Review of reported cases . J Obstet Gynaecol Br Commonw 1968;;75:307-312.
D'Arcy PF:  Reactions and interactions in handling anticancer drugs . Drug Intell Clin Pharm 1983;;17:532-538.
Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs , Dept of Health and Human Services publication (NIH) 83-2621. Bethesda, Md, National Institutes of Health, 1982;.
Recommendations for Handling Cytotoxic Agents . National Study Commission on Cytotoxic Exposure, 1983;.
Jones RB, Frank R, Mass T, et al:  Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center . CA 1983;; 33:258-263.
Procedures for Handling Cytotoxic Drugs . Bethesda, Md, American Society of Hospital Pharmacists, 1983;.
Clinical Oncological Society of Australia:  Guidelines and recommendations for safe handling of antineoplastic agents . Med J Aust 1983;;1:426-428.
Zimmerman PF, Larsen RK, Barkley EW, et al:  Recommendations for the safe handling of injectable antineoplastic drug products . Am J Hosp Pharm 1981;;38:1693-1695.
Neal AD, Wadden RA, Chiou WL:  Exposure of hospital workers to airborne antineoplastic agents . Am J Hosp Pharm 1983;;40:597-601.
National Disease and Therapeutic Index . Ambler, Pa, IMS America Ltd, 1984;.
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