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National Institute for Occupational Safety U.S. Guidelines for Safe Handling of Hazardous Drugs Antineoplastic and OtherHazardous Drugs „ Teratogenicity or other developmental (American Society of Health-System Pharmacists,1990) „ Any drug identified by at least one of the „ Any drug identified by at least one of the „ Any drug identified by at least one of the „ Teratogenicity or developmental toxicity „ Any drug identified by at least one of the „ Teratogenicity or developmental toxicity „ Any drug identified by at least one of the „ Teratogenicity or developmental toxicity „ Organ toxicity at low doses in humans (<10 „ Any drug identified by at least one of the „ Teratogenicity or developmental toxicity „ Organ toxicity at low doses in humans (<10 „ Any drug identified by at least one of the following „ Teratogenicity or developmental toxicity „ Organ toxicity at low doses in humans (<10 mg/day) or „ New drugs that mimic existing hazardous drugs in „ Not a fixed cut-off dose„ Used only for guidance„ “For example, a daily therapeutic dose of 10 mg/day or a dose of 1 mg/kg/day in laboratory animals that produces serious organ toxicity, developmental toxicity, or reproductive toxicity has been used by the pharmaceutical industry to develop occupational exposure limits of less than 10 µg/m3.” „ FDA Reproductive Category D- Most times „ Indication of cancer in humans, animal data- Yes „ Carcinogenic in one organ/strain animals- No „ Positive in multiple in vivo genetox tests- Yes „ Weight-of-evidence is the process by which multiple measurement endpoints are related to an assessment endpoint to evaluate whether significant risk of harm is posed to the environment.
(Massachusetts Weight-of-Evidence
Workgroup, 1995)
Pharmaceutical Research and Manufacturers of America (PhRMA) Johns Hopkins Hospital, Baltimore, MD (Revised 9/2002).
Pharmaceutical Research and Manufacturers of America (PhRMA) „ Review all new warnings on existing drugs „ Eliminate warnings that do not apply (sterility, etc.) „ Evaluate based on criteria in hazardous drug definition „ Separate into those that meet criteria and those that do „ Utilize external expert and stakeholder input ALKERAN®
(melphalan)
ALKERAN (melphalan) should be administered under the supervision of a qualified physician experienced in the use of cancerchemotherapeutic agents. Severe bone marrow suppression withresulting infection or bleeding may occur. Melphalan is leukemogenicin humans.
Melphalan produces chromosomal aberrations in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans.
Process to Update NIOSH Hazardous Drug List „ Recent update to hazardous drug list (2004-2007) „ 23 Additions submitted to NIOSH Office of Director for „ Solution for IV, IM, SC, topical administration „ Large molecular weights make uptake by oral, inhalation or dermal route unlikely „ Most are target-specific (should only bind to „ BCG preparation should be done using aseptic „ To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG has been prepared „ A separate area for the preparation of BCG suspension is „ All equipment, supplies and receptacles in contact with BCG should be handled and disposed of as biohazardous „ If preparation cannot be performed in a containment device, then respiratory protection, gloves and a gown should be worn to avoid inhalation or contact with BCG organisms „ Coated-Not a concern unless crushed for „ Reports of >600 Cases of birth defects in contraction of uterine smooth muscle and is used to induce labor in pregnant women pregnancy are at risk from handling this drug

Source: http://www.gerpac.eu/IMG/pdf/TConnor-Classification-Hazardous-Drugs-NIOSH.pdf