Drugs with any of the following characteristics are considered hazardous: genotoxicity (have the ability to alter genetic material); teratogenicity (can cause defects in a developing fetus); reproductive toxicity and fertility impairment; cause serious organ toxicity at low doses and/or possess a chemical structure and toxicity profile that is like that of drugs classified as hazardous. The 2016 list adds 34 drugs and includes a review of the 2004 list. Risk factors for birth defects Certain drugs such as alcohol, some illegal drugs, and some prescription and over-the-counter medications are known to cause birth defects if taken during pregnancy. The area of new drug development is rapidly evolving as unique approaches are being taken to treat cancer and other serious diseases. Defining Hazardous Drugs Hazardous drugs include those used for can-cer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and other miscella - neous drugs. The format for the 2014 list was revised to include three groups of hazardous drugs: (1) Antineoplastic drugs; (2) Non-antineoplastic hazardous drugs; and (3) Drugs with reproductive effects. comments, of whether the drug me ets the NIOSH definition of a hazardous drug. Impacts a developing fetus or embryo; Causes developmental abnormalities; Causes organ damage; Has a similar structure to another drug deemed to be hazardous; Mishandling these drugs could lead to both acute and long-term effects including hair loss, cardiac toxicity, kidney damage… Drugs that meet the definition are proposed for addition to the List, and those that do not meet the definition are not proposed for addition to the List. A teratogen is a substance that interferes with the normal development of a fetus. Overview. In pharmacology, hazardous drugs are drugs that are known to cause harm, which may or may not include genotoxicity (the ability to cause a change or mutation in genetic material). ... gowns needed when compounding hazardous drugs; ... knowledge & competency evaluations. should be performed at first orientation and again at least once a year. Shirangi A, Bower C, Holman CDJ, Preen DB and Bruce N. A study of handling cytotoxic drugs and risk of birth defects in offspring of female veterinarians. It is well known that many drugs, while providing beneficial treatment, also pose a health risk themselves. Selevan SG, Lindbohm M-L, Hornung RW and Hemminki K. A study of occupational exposure to antineoplastic drugs and fetal loss in nurses . ASHP Guidelines on Handling Hazardous Drugs ASHP published its first guidance on hazardous drugs (HDs) in 1983 as part of the 1983–84 ASHP Practice Spotlight: Safe Handling of Cytotoxic Drugs.1,2 This was followed by tech-nical assistance bulletins in 1985 and 1990 and the ASHP Guidelines on Handling Hazardous Drugs in 2006.3-5 The OSHA has identified worker exposure to hazardous drugs as a problem of increasing health concern. Preparation, administration, manufacturing, and disposal of hazardous medications may expose hundreds of thousands of workers, principally in healthcare facilities and the pharmaceutical industry, to potentially significant workplace levels of these chemicals. N Eng J Med. The definition of hazardous drugs term defines hazardous drugs as damaging to the developing fetus. Drugs that can cause birth defects are called ‘teratogens’. Both generic and proprietary drug names are provided fo r ease of determining the drug reviewed. Teratogenicity. The American Society of Health Systems Pharmacists (ASHP) and the National Institute of Occupational Safety and Health (NIOSH) have defined a drug to be “hazardous” if it exhibits one or more of the following characteristics in humans or animals: 1,2 1985; 313:1173-78.
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