USP 800 Hazardous Drugs - Handling in Healthcare Settings is a chapter of a book which provides guidance about the handling of hazardous drugs (HDs) in the healthcare setting. It was created by the United States Pharmacopeia Convention. USP 800 was published on February 1, 2016 and originally planned for implementation in December, 2019, but implementation has been delayed. [1]
USP 800 describes practice and quality standards for the handling of HDs involving but not limited to the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non-sterile products. This chapter applies to any personnel who may be exposed to HDs. Personnel likely to be exposed may include pharmacists, pharmacy technicians, nurses, physician assistants, home healthcare workers, veterinarians, and veterinary technicians. [2]
Facilities that handle HDs must follow the standards outlined in USP 800. At minimum the facilities's management system must include:
The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and HDs that are used in healthcare settings. The site must maintain a list of any drugs they use that are on the NIOSH list and it must be updated every 12 months. If the facility begins using a new medication on the NIOSH list it must be added to their HD list.
Each facility must have a designated person who develops, implements, and maintains USP 800 compliance. This person is also responsible for overseeing the training of personnel and reporting hazardous situations to the management team. All personnel who handle HDs must be trained on the fundamental practices and precautions to contain HDs. [4]
HDs must be handled in ways to limit contamination. HD storage areas must be separated from break rooms and refreshment areas. Designated areas must be available for:
Antineoplastic HDs and all HD active pharmaceutical ingredients (APIs) must be unpacked in an area that is neutral/normal or negative pressure. [6]
HDs must be stored properly to prevent spillage or breakage. HDs should not be stored on the floor or areas prone to natural disaster such as earthquakes. Antineoplastic HDs that require further manipulation other than repackaging or counting must be stored separately from non-HDs. Sterile and non-sterile HDs must not be stored together. Refrigerated HDs must be stored in a dedicated refrigerator located in a negative pressure area.
Chemical waste is a waste that is made from harmful chemicals. Chemical waste may fall under regulations such as COSHH in the United Kingdom, or the Clean Water Act and Resource Conservation and Recovery Act in the United States. In the U.S., the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA), as well as state and local regulations also regulate chemical use and disposal. Chemical waste may or may not be classed as hazardous waste. A chemical hazardous waste is a solid, liquid, or gaseous material that displays either a “Hazardous Characteristic” or is specifically “listed” by name as a hazardous waste. There are four characteristics chemical wastes may have to be considered as hazardous. These are Ignitability, Corrosivity, Reactivity, and Toxicity. This type of hazardous waste must be categorized as to its identity, constituents, and hazards so that it may be safely handled and managed. Chemical waste is a broad term and encompasses many types of materials. Consult the Material Safety Data Sheet (MSDS), Product Data Sheet or Label for a list of constituents. These sources should state whether this chemical waste is a waste that needs special disposal.
Sterilization refers to any process that removes, kills, or deactivates all forms of life and other biological agents like prions present in a specific surface, object or fluid, for example food or biological culture media. Sterilization can be achieved through various means, including heat, chemicals, irradiation, high pressure, and filtration. Sterilization is distinct from disinfection, sanitization, and pasteurization, in that those methods reduce rather than eliminate all forms of life and biological agents present. After sterilization, an object is referred to as being sterile or aseptic.
The Resource Conservation and Recovery Act (RCRA), enacted in 1976, is the principal federal law in the United States governing the disposal of solid waste and hazardous waste.
A confined space is a space with limited entry and egress and not suitable for human inhabitants. An example is the interior of a storage tank, occasionally entered by maintenance workers but not intended for human occupancy. Hazards in a confined space often include harmful dust or gases, asphyxiation, submersion in liquids or free-flowing granular solids, electrocution, or entrapment.
The United States Army Chemical Materials Activity (CMA) is a separate reporting activity of the United States Army Materiel Command (AMC). Its role is to enhance national security by securely storing the remaining U.S. chemical warfare materiel stockpiles, while protecting the work force, the public and the environment to the maximum extent.
A needlestick injury is the penetration of the skin by a hypodermic needle or other sharp object that has been in contact with blood, tissue or other body fluids before the exposure. Even though the acute physiological effects of a needlestick injury are generally negligible, these injuries can lead to transmission of blood-borne diseases, placing those exposed at increased risk of infection from disease causing pathogens, such as the hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Among healthcare workers and laboratory personnel worldwide, more than 25 blood-borne virus infections have been reported to have been caused by needlestick injuries. In addition to needlestick injuries, transmission of these viruses can also occur as a result of contamination of the mucous membranes, such as those of the eyes, with blood or body fluids, but needlestick injuries make up more than 80% of all percutaneous exposure incidents in the United States. Various other occupations are also at increased risk of needlestick injury, including law enforcement, laborers, tattoo artists, food preparers, and agricultural workers.
Operation Red Hat was a U.S. military action taking place in 1971, which involved the movement of chemical warfare munitions from Okinawa, Japan to Johnston Atoll in the North Pacific Ocean.
A health professional may provide health care treatment and advice based on formal training and experience. The field includes those who work as a physician, surgeon, physician assistant, medical assistant, nurse, physiotherapist, dentist, midwife, psychologist, psychiatrist, or pharmacist or who perform services in allied health professions. A health professional may also be a public health or community health practitioner.
Potassium nitrate is an oxidizer so storing it near fire hazards or reducing agents should be avoided to minimise risk in case of a fire.
In pharmacology, hazardous drugs are drugs that are known to cause harm, which may or may not include genotoxicity. Genotoxicity might involve carcinogenicity, the ability to cause cancer in animal models, humans or both; teratogenicity, which is the ability to cause defects on fetal development or fetal malformation; and lastly hazardous drugs are known to have the potential to cause fertility impairment, which is a major concern for most clinicians. These drugs can be classified as antineoplastics, cytotoxic agents, biologic agents, antiviral agents and immunosuppressive agents. This is why safe handling of hazardous drugs is crucial.
Under United States environmental policy, hazardous waste is a waste that has the potential to:
Biomedical waste or hospital waste is any kind of waste containing infectious materials. It may also include waste associated with the generation of biomedical waste that visually appears to be of medical or laboratory origin, as well research laboratory waste containing biomolecules or organisms that are mainly restricted from environmental release. As detailed below, discarded sharps are considered biomedical waste whether they are contaminated or not, due to the possibility of being contaminated with blood and their propensity to cause injury when not properly contained and disposed. Biomedical waste is a type of biowaste.
A closed system drug transfer device or "CSTD" is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system. Open versus closed systems are commonly applied in medical devices to maintain the sterility of a fluid pathway. CSTDs work by preventing the uncontrolled inflow and outflow of contaminants and drugs, preserving the quality of solution to be infused into a patient. Theoretically, CSTDs should enable complete protection to healthcare workers in managing hazardous drugs, but possibly due to improper handling or incomplete product design, contaminants can still be detected despite use of CSTDs.
Pharmacy automation involves the mechanical processes of handling and distributing medications. Any pharmacy task may be involved, including counting small objects ; measuring and mixing powders and liquids for compounding; tracking and updating customer information in databases ; and inventory management. This article focuses on the changes that have taken place in the local, or community pharmacy since the 1960s.
Waste management laws govern the transport, treatment, storage, and disposal of all manner of waste, including municipal solid waste, hazardous waste, and nuclear waste, among many other types. Waste laws are generally designed to minimize or eliminate the uncontrolled dispersal of waste materials into the environment in a manner that may cause ecological or biological harm, and include laws designed to reduce the generation of waste and promote or mandate waste recycling. Regulatory efforts include identifying and categorizing waste types and mandating transport, treatment, storage, and disposal practices.
An automated dispensing cabinet (ADC) is a computerized medicine cabinet for hospitals and healthcare settings. ADCs allow medications to be stored and dispensed near the point of care while controlling and tracking drug distribution. They also are called unit-based cabinets (UBCs), automated dispensing devices (ADDs), automated distribution cabinets, automated dispensing machines (ADMs) or pyxis.
Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized.
The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization and other actions on medical devices, equipment and consumables; for subsequent use by health workers in the operating theatre of the hospital and also for other aseptic procedures, e.g. catheterization, wound stitching and bandaging in a medical, surgical, maternity or paediatric ward.
Engineering controls are strategies designed to protect workers from hazardous conditions by placing a barrier between the worker and the hazard or by removing a hazardous substance through air ventilation. Engineering controls involve a physical change to the workplace itself, rather than relying on workers' behavior or requiring workers to wear protective clothing.
Drug disposal is the discarding of drugs. Individuals commonly dispose of unused drugs that remain after the end of medical treatment. Health care organizations dispose of drugs on a larger scale for a range of reasons, including having leftover drugs after treating patients and discarding of expired drugs. Failure to properly dispose of drugs creates opportunities for others to take them inappropriately. Inappropriate disposal of drugs can also cause drug pollution.