OSHA says worker exposure to hazardous drugs is a major health concern for workers in healthcare facilities and the pharmaceutical industry. The preparation, administration, manufacturing, and disposal of hazardous medications are the primary activities that may expose hundreds of thousands of workers to potentially significant workplace levels of these chemicals.
Hazardous drugs can cause serious acute and chronic health effects such as skin rashes, fertility problems, genetic damage, birth defects, organ toxicity, and possibly leukemia and other cancers.
Potentially harmful exposure can occur when you handle or work around hazardous drugs. These drugs include antineoplastic cytotoxic medications, anesthetics, anti-viral drugs, hormones, and others.
The numbers and types of work environments, including pharmacies that contain antineoplastic drugs are expanding as these agents are used increasingly for nonmalignant rheumatologic and immunologic diseases and for chemotherapy in veterinary medicine. The likelihood that a worker will experience adverse effects from antineoplastic and other hazardous drugs increases with the amount and frequency of exposure and the lack of proper work practices. The following case illustrates one example of the health effects reported after exposure to antineoplastic drugs:
A 41-year-old patient-care assistant working on an oncology floor developed an itchy rash approximately 30 minutes after emptying a commode of urine into a toilet. She denied any direct contact with the urine, wore a protective gown and nitrile gloves, and followed hospital policy for the disposal of materials contaminated with antineoplastic drugs. The rash subsided after 1 to 2 days. Three weeks later, she had a similar reaction approximately 1 hour after performing the same procedure for another patient.
Upon investigation, it was found both hospital patients had recently been treated with vincristine and doxorubicin. The patient-care assistant had no other signs or symptoms and reported no changes in lifestyle and no history of allergies or recent infections. After treatment with diphenhydramine (intramuscular) and oral corticosteroids, her symptoms disappeared.
Although the cause could not be definitely confirmed, both vincristine and doxorubicin have been associated with allergic reactions when given to patients. The aerosolization of the drug present in the urine may have provided enough exposure for symptoms to develop.
For more information on antineoplastic drugs see 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs
Exposure occurs during manufacturing and packaging, receiving, preparation and administration, and cleaning and disposal activities. Clinical and non-clinical workers with potential exposure include:
Exposures to hazardous drugs may occur through inhalation, skin contact, skin absorption, ingestion, or injection. Inhalation and skin contact/absorption are the most likely routes of exposure, but unintentional ingestion from hand-to-mouth contact and unintentional injection through a needlestick or sharps injury are also possible.
Employers should implement a written program which meets the requirements of the Hazard Communication Standard (HCS) for employees who are handling or exposed to the chemicals, including drugs that represent a health hazard to employees. Manufacturers are responsible for evaluating their chemical products, and creating the Safety Data Sheet (SDS), which is the most comprehensive written information about that chemical.
The written program must provide for worker training, warning labels, and access to Safety Data Sheets (SDSs). HCS Labeling and SDS best practices include the following actions:
As part of the HCS, a written Hazardous Drug Safety and Health Plan should also be developed. It should be readily available and accessible to all employees, including temporary employees, contractors, and trainees.
OSHA says the plan should include each of the following elements and indicate specific measures that the employer is taking to ensure employee protection:
HCS information and training are a critical part of the hazard communication program. It is through effective information and training that employees will learn to read and understand labels and SDSs, determine how to acquire and use them in the pharmacy, and understand the risks of exposure to the chemical as well as the ways to protect themselves. HCS procedures, for example, purchasing, storage, and handling of these chemicals will improve, and thereby reduce the risks posed to employees exposed to the chemical hazards involved.
Each pharmacy employee who may be "exposed" to hazardous chemicals when working must be provided information and be trained prior to initial assignment to work with a hazardous chemical, and whenever the hazard changes. "Exposure" or "exposed" means that an employee is subjected to a hazardous chemical in the course of employment through any route of entry (inhalation, ingestion, skin contact, or absorption) and includes potential (e.g., accidental or possible) exposure.
Employees must also be informed of the requirements of the Hazard Communication Standard, including:
Departments with employees who handle hazardous drugs on a regular basis must:
Employees who handle hazardous drugs should:
The hazard assessment is conducted to help you identify what tasks have the potential for exposure, which employees may be exposed, and how to control exposure. It will form the foundation of your Hazardous Drug Control Program.
Here are some steps to help you conduct your hazard assessment:
OSHA requires SDSs only for materials that meet OSHA's definition of "hazardous," and are "known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency".
Drugs regulated by the U.S. Food and Drug Administration (FDA) are covered by the HCS. However, section (b)(6)(vii) of the HCS exempts FDA drugs when they are:
Examples of those needing SDS's for drugs would include pill manufacturing facilities and pharmacies (if the drug is compounded, crushed etc.).
There are other exceptions to the standard, such as:
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