According to the Centers for Disease Control and Prevention (CDC), close to 8 million healthcare employees in the U.S. alone are potentially exposed to hazardous drugs every year.
When improperly managed, drugs such as chemotherapy medications, antiviral drugs, hormone agents, and more can cause severe adverse health effects. These can range from skin rashes, infertility, spontaneous abortions, and congenital malformations to cancers and immune disorders. The risks associated with the improper storage and handling of hazardous drugs are well-known, but some previous regulations have failed to provide a comprehensive set of guidelines that covers the spectrum of drugs within the industry.
In 2008, the United States Pharmacopeia (USP) sought to address this need for new storage and handling regulations. According to their website, “USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.”
Efforts by the USP to create a new set of hazardous drug storage and handling guidelines came to fruition in February 2016 as what is now known as USP General Chapter <800>. These guidelines describe requirements including responsibilities of personnel handling hazardous drugs, facility and engineering controls, procedures for deactivating, decontaminating and cleaning, storage, spill control, and documentation. They apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.
Under these new guidelines, pharmacies, hospitals, patient treatment centers, and physician practice facilities are required to meet new, more rigorous environmental and safety criteria to reduce potential risks to healthcare workers and their patients, with a key aspect of the regulations related to the storage of products.
Here are a few key excerpts from the USP<800>:
“Hazardous drugs (HDs) must be stored in a manner that prevents spillage or breakage if the container falls. Do not store HDs on the floor. In areas prone to specific types of natural disasters (e.g., earthquakes), the manner of storage must meet applicable safety precautions, such as secure shelves with raised front lips.
Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD. These HDs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy.
Sterile and non-sterile HDs may be stored together, but HDs used for non-sterile compounding should not be stored in areas designated for sterile compounding to minimize traffic into the sterile compounding area.
Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH [e.g., storage room, buffer room, or containment segregated compounding area (C-SCA)]. If a refrigerator is placed in a negative pressure buffer room, an exhaust located adjacent to the refrigerator’s compressor and behind the refrigerator should be considered.”
It is critical that all facilities faced with the task of storing and handling hazardous drugs begin to assess their current environments. For some, the new requirements could mean major renovations to these areas or other changes that may impact workflow, processes, and purchasing decisions.
As the healthcare industry continues to improve its standard of care, it’s crucial that pharmacies, hospitals, patient treatment centers, and physician practice facilities reevaluate their processes, including how they handle and store hazardous drugs. It is imperative that these facilities invest in new solutions now that will allow them to keep pace with the more stringent regulations of tomorrow.