Hazardous drugs, such as those used for chemotherapy, may be used to heal patients, but they can pose a serious hazard to workers. These drugs can get in the air or on work surfaces, clothing, and medical equipment. They can also be found in patient urine or feces. Even with low-level exposures, workers could suffer irreversible effects. For that reason, measures must be taken to provide appropriate protection to workers that handle hazardous or potentially hazardous drugs.
A drug is labeled hazardous when it is:
- Known to be a human mutagen, carcinogen, teratogen, or reproductive toxicant;
- Known to be carcinogenic or teratogenic in animals or mutagenic in multiple bacterial systems or animals;
- Known to be acutely toxic to an organ system;
- Listed as a hazardous, newly Food and Drug-Administration-approved agent; or
- Designated as “Therapeutic Category 10:00 (Antineoplastic Agent)” in the American Hospital Formulary Service Drug Information.
A drug is also labeled as hazardous if the drug maker recommends special isolation or other techniques to handle, administer, or dispose of it.
Scope
According to the National Institute for Occupational Safety and Health (NIOSH), those with the greatest potential for exposure to dangerous drugs are doctors, nurses, pharmacy personnel, operating room personnel, lab researchers, veterinary care workers, environmental services workers, and shipping and receiving personnel. Activities that increase exposure potential include administering drugs to patients, packaging or processing drugs, and drug disposal. Studies reveal that surface areas where hazardous drugs are mixed, stored, administered, and disposed of, as well as where patients are cared for, are typical sources of exposure.
Primary routes of exposure include:
- Inhalation — An example of this exposure route is when drugs vaporize or generate dust during counting or dispensing.
- Absorption — This means ingestion of contaminated food or drink or through mouth contact from contaminated hands, utensils, or smoking devices.
- Accidental injection — This includes accidental injection from needle use or contact with broken glass.
While federal OSHA does not have a comprehensive regulation for hazardous drugs, the agency offers some worker protections as listed in the Regulatory citations list below. Note also that state-plan states may have regulations specific to hazardous drugs, so check your state regulations.
Key definitions
- Administrative controls: Management-prescribed work practices and policies to reduce or prevent exposures to risk factors. Administrative control strategies can include special work procedures, changes in job rules and procedures, rotating workers through hazardous jobs, and training.
- Contamination: making something impure by exposure to or addition of a poisonous or polluting substance.
- Engineering controls: Physical changes made to equipment or the workplace that isolate or remove or reduce worker exposure to risks.
- Exposure: Subjecting a worker to a hazardous drug by any route of entry, such as inhalation, ingestion, skin contact, or absorption. Exposure includes potential (e.g., accidental or possible) exposure.
- Hazardous: The potential for physical or mental harm that, if left uncontrolled, can result in an injury or illness.
- Sterile: A state in which all forms of microbial life (including spores) have been eliminated by physical or chemical means.
Summary of requirements
- Conduct hazard assessments to identify potential exposures to hazardous drugs. Include a list of hazardous drugs present in the workplace.
- Develop and implement a written hazardous drug safety and health plan that includes elements for hazardous drug handling, storage, disposal, spill response, medical surveillance, training, and recordkeeping.
- Establish and implement control measures. This includes engineering and administrative controls, as well as selection of appropriate PPE to protect workers. PPE may include respiratory protection, eye protection, gloves, gowns, head and facial hair covers, and shoe covers.
- Create and communicate procedures and policies for managing and controlling hazardous drug exposures. Include information for ventilation, storage, use, sterile and non-sterile compounding, and disposal of hazardous drugs.
- Train workers on identifying hazard exposures, required protective measures, and proper handling of hazardous drugs.
- Ensure hazardous drugs and containers are properly labeled.
- Ensure safety data sheets (SDSs) for hazardous drugs are readily accessible for workers if the hazardous drugs are not exempted by 29 CFR 1910.1200.