June 2019, Volume XXXIiI, No 3
Are You USP <800> Compliant?
New guidelines for handling hazardous drugs
ealth care facilities have until December 1, 2019, to comply with new, federally enforceable rules and regulations issued by the U.S. Pharmacopeial Convention under USP <800>. The primary objective of the rules and regulations is to promote patient safety, staff safety, and environmental protection from hazardous drugs.
USP <800> requires health care facilities to maintain a list of hazardous drugs used in the facility. The National Institute for Occupational Safety and Health (NIOSH) provides a list of hazardous drugs. The facility must address any agent listed as hazardous by NIOSH. However, facilities may add other items that are not on the NIOSH list. The three groups of hazardous drugs to be considered are antineoplastic drugs, non-antineoplastic drugs that meet one or more of the NIOSH criteria for hazardous drugs, and drugs that primarily pose a reproductive risk. Safe-handling precautions may vary based on activity and formulation of the drug. For some facilities, these precautions may require architectural redesigns and rebuilding.
In 2004, NIOSH published an alert intended to increase awareness about the health risks posed by working with hazardous drugs. Exposure to hazardous drugs may occur from skin contact, inhalation, ingestion, or injection from a wide array of activities, and the results in health effects can include skin rashes, adverse reproductive outcomes, and possibly leukemia and other cancers. USP <800> clearly states that there is no acceptable level of personnel exposure to hazardous drugs, and it is intended to provide containment of hazardous drugs to as low a limit as reasonably achievable.
In addition to NIOSH, other organizations, such as the Occupational Safety and Health Administration (OSHA), the American Society of Health-System Pharmacists (ASHP), and the Oncology Nursing Society (ONS), have provided documents and/or best practices addressing hazardous drug handling. Where conflicts exist, the most stringent requirements prevail.
USP <800> provides safe practice requirements for receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, counting, crushing, and pouring hazardous drugs. The standard impacts sterile and non-sterile hazardous drugs. It applies to any health care setting, including pharmacies, hospitals, clinics, physician offices, veterinarian offices, and other locations and facilities where hazardous drugs are stored, transported, and administered. While a key component is focused on primary and secondary engineering controls, USP <800> covers everything from organizational planning to spill control and environmental monitoring.
There is no acceptable level of personnel exposure to hazardous drugs.
Seeking outside help
After the assessment of risk has been completed, it is a good idea to hire a third-party organization that specializes in pharmacy LEAN design and understands the required changes, such as developing evidence-based standard operating procedures that are compliant with USP <800> but also meet the specific needs of their organization, workflows, HVAC (heating, ventilation, and air conditioning) improvements for proper air exchanges, adjustments to the facility’s footprint to comply with storage guidelines, temporary construction phasing if renovating in place, and cost of construction.
Once capital improvements are made, and new procedures are rolled out, personnel training and education is a key component of the compliance process. It’s not a one‐time event, but more a continuing cycle of training, assessment, and improvement, all of which keeps patients safe, themselves safe, and our environment safe.
Aside from primary and secondary engineering controls, adequate work practices with donning and doffing of personal protective equipment (PPE) are important to protect the worker and the work environment from contamination with hazardous drugs. Highly reliable cleaning procedures can prevent worker exposure and environmental contamination. Personnel performing cleaning activities need to be protected from inadvertent exposure to hazardous drugs. USP <800> provides comprehensive requirements and best practice recommendations for PPE and cleaning procedures.
USP <800> recommends environmental quality and control monitoring. To evaluate hazardous drug practices, wipe sampling is recommended at baseline and every six months. Wipe sampling can help to identify work practices or environmental controls that need to be altered to prevent worker and environmental contamination.
Knowing that USP <800> will become official on December 1, 2019, most facilities need to take USP <800> into account so that any newly built or renovated facility does not become obsolete in terms of conformance to standards after the deadline. To cover all bases, it is recommended that any facility contemplating this decision contact its State Board of Pharmacy to verify its position on this matter.
Health care facilities may need to redesign and rebuild their physical space.
Redesigns and upgrades
Hospitals and clinics are constantly changing, so rearranging existing space is usually necessary to integrate modern equipment and technology into these buildings. Facilities that are 30–60 years old can present many challenges. New medical equipment is often needed. For example, a new pharmacy chemo hood requires larger or reconfigured rooms in which to operate due to changing workflow, equipment layout, and clearances. As new medical equipment is added to support the new spaces, the existing mechanical and electrical infrastructure may need to be modified and/or upgraded to support the new spaces. When installing new handling units, for example, additional structural support may be required. The key to a successful retrofit project is to select a design and construction team that has worked together and is qualified and knowledgeable working in a health care environment. Bringing these professionals on early in the process of considering a retrofit can save the owner money caused by unforeseen delays.
Common redesign and rebuilding measures to ensure compliance with USP <800>
While individual needs will vary, some health care facilities have found it necessary to:
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