Criteria for Facilities and Personnel for the Administration of Parenteral Systemic Antineoplastic Therapy

Author:

Abstract

The following American Society of Clinical Oncology (ASCO) position statement represents an update to policy first adopted by the Board in 1997 (J Clin Oncol 15:3416-3417, 1997). The primary change to the statement is the addition of language to section 7, Standards for Antineoplastic Therapy, describing safeguards for preparing and administering chemotherapy drugs. As third-party payors consider and follow through with the establishment of new models for chemotherapy drug procurement, distribution, and delivery, ASCO provides guidance to oncologists to help them ensure the safety and integrity of the drugs they administer. Additionally, section 5, Office Operations, also suggests that oncologists consider measures protecting them from liability associated with drugs obtained from or prepared by outside entities.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Reference5 articles.

1. Standards for Accreditation of Managed Care Organizations are issued by the National Committee for Quality Assurance and updated on a yearly basis. Copies of the standards (Item No. 10351-100-04) may be obtained for $85.00 by contacting the Publications Department of NCQA at 2000 L Street, Suite 500, Washington, DC, 20036. To order by telephone, call 888-275-7585. Orders are also taken online at .www.ncqa.org/publications

2. The Americans with Disabilities Act of 1990 (Public Law 101-336) is codified in the United States Code at 42 U.S.C. 12101-12213. Many libraries have a copy of the United States Code. In addition, copies of the law (Stock No. 869-010-00096-1), may be obtained for $2.00 from the US Government Printing Office, ATTN: Superintendent of Documents, PO Box 371954, Pittsburgh, PA 15250-7954. Credit card orders may be placed by calling 202-512-1800 (fax 202-512-2250). The US Code is also available online at .www.gpoaccess.gov/uscode

3. Occupational health and safety standards issued by the Occupational Safety and Health Administration (OSHA) of the US Department of Labor are codified in the Code of Federal Regulations at 29 C.F.R. Part 1910. University and county law libraries have copies of the Code of Federal Regulations. The two volumes of the Code of Federal Regulations that contain the OSHA standards (Parts 1900 to 1910 and Part 1910) (Stock No. 869-048-00104-2 and 869-044-00105-5) may be purchased for $58.00 and $42.00 from the US Government Printing Office as described in ref . The Code of Federal Regulations is also available online at . The OSHA Technical Manual includes Chapter 21, “Controlling Occupational Exposure to Hazardous Drugs.” The OSHA Technical Manual is available online at .2 www.gpoaccess.gov/cfr www.osha-slc.gov/dts/otm/otm_toc.html

4. The Clinical Laboratory Improvements Act (CLIA) is codified in the United States Code at 42 U.S.C.A. 263a. Many libraries have a copy of the United States Code. Regulations issued by the Centers for Medicare & Medicaid Services to implement CLIA are codified in the Code of Federal Regulations at 42 C.F.R. Part 493. University and county law libraries have copies of the Code of Federal Regulations. The volume of the Code of Federal Regulations that contains the CLIA regulations (Title 42, Part 430 to End) (Stock No. 869-048-00168-9) may be purchased for $61.00 from the US Government Printing Office as described in ref . The Code of Federal Regulations is also available online at .2 www.gpoaccess.gov/cfr

5. The Food and Drug Administration (FDA) approved preparation instructions can be found on the package insert that comes with each drug. Package inserts can also be obtained by contacting the FDA in writing at Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857, or in compendia such as the Physicians' Desk Reference.

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