In February 2016, the United States Pharmacopeia (USP) released General Chapter <800> to “provide standards for safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare personnel, patients, and the environment.” The rule provided much-needed codification around the handling of hazardous drugs, following research that found improper employee exposure may lead to both acute and long-term health effects. The chapter was released twice for public comment, and has now been finalized with the feedback of hundreds of stakeholders. As USP <800> will soon take effect, it’s critical health care facilities and organizations understand the following about the chapter:
- It applies to many different types of facilities. Even if they don’t frequently use drugs they consider “hazardous,” facilities shouldn’t assume USP <800> doesn’t apply to them. Per USP, the chapter is broadly applicable to “all healthcare personnel who handle HD preparations and all entities that store, prepare, transport, or administer HDs,” which could include “pharmacy and nursing personnel, physicians, operating room personnel, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel.” And for some facilities, the definition of a hazardous drug may be surprising. For example, per the National Institute for Occupational Safety and Health (NIOSH), many drugs not normally associated as being hazardous can require additional safeguards when in certain forms (e.g., crushed in a suspension) – facilities must be sure they know which ones.
- The deadline is less than a year away. USP <800> goes into effect on July 1, 2018, and many facilities have yet to conduct a risk assessment to determine what’s needed for compliance. As soon as possible, health care facilities must develop a list of the NIOSH-classified “hazardous” drugs they use and conduct a gap analysis for each – what are the likely risks the drug poses to patients and employees, what policies are currently in place to minimize those risks, and how must those policies be updated in accordance with USP <800> standards? This is a good exercise anyway to be sure facilities are embracing industry best practices, but it’s also critical for Joint Commission accreditation, and in some cases, to meet CMS’s “conditions for participation.” Boards of pharmacy in some states, such as California, are currently considering rules related to USP <800> compliance.
- Implementation might be expensive. While some facilities may find they’re ahead of the curve when it comes to USP <800> compliance, others may have a long road ahead. Once a facility conducts its gap analysis, it should prioritize necessary actions based on the expense and resources required. For example, some facilities may need to upgrade their HVAC systems to ensure proper air handling, or even change their layout to meet storage guidelines (for example, hazardous drugs used for nonsterile compounding may no longer be stored in sterile compounding areas). For some facilities, these changes may cost up to $500,000, and if they haven’t already accounted for this expense in their annual capital improvement plan, they’ll need to do so quickly to avoid potential financial hardship.
- Compliance will be an ongoing process. Once a facility has conducted its USP <800> gap analysis, and rewritten policies and procedures to ensure compliance, it must train employees on the new guidelines and ensure their ongoing adherence to the rules. It may be helpful to consult with a third party to conduct the initial risk assessment and gap analysis (as, through no fault of their own, facility workers may be “too close” to the subject matter to approach these processes objectively). This person can also provide guidance on the best way to engage employees to understand and enforce the changes. As a final step, facilities may identify a USP <800> “champion” (either as a new role or as a new responsibility for an existing role) to communicate the importance of the new rules to employees and address any questions or concerns.
While for some facilities, USP <800> compliance may seem overwhelming, it may comfort them to know that, in addition to the primary goal of improving worker health and safety, implementation of these best practices may also improve their long-term operational efficiency. For additional information, facilities may review free resources on USP’s website, including the organization’s overview and FAQ sections for the chapter.
Kenneth Maxik is director of patient safety and compliance for CompleteRx. He has more than 20 years of pharmacy operations and management experience and works closely with health organizations across the country to help them stay ahead of current and imminent regulatory standards.