USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, which was created to promote patient and worker safety, as well as environmental protection, states that each entity must have a designated person who is qualified and trained to be responsible for compliance with handling hazardous drugs (HDs). It is important to note that the scope of handling includes the entire spectrum of the HD life cycle, from receiving through disposal. Further, the standard is not specific to the pharmacy department alone; rather, it encompasses any and all personnel who handle HDs. In multihospital health systems, this creates a unique opportunity to determine the optimal approach to USP <800> compliance with the designated person promoting safe, efficient, and standardized processes.
Designated Person Requirement
USP <800> outlines specific responsibilities for the designated person (see the SIDEBAR). The designated person is a single person managing HDs for the entity; this is not a shared responsibility. However, one individual could be responsible for multiple sites within the organization. An entity encompasses any site where HDs are handled. The chapter does not specify a requirement for the position to be a pharmacist, technician, or an administrative role. However, there is no specification for responsibility of oversight of HD handling as the sole job responsibility of the designated person. These factors create flexibility for organizations to determine how best to implement this requirement for a designated person.
Centralized Role in a Multihospital Health System
Multihospital health systems are commonly formed with the goal of improving the service benefits and economics of hospital operations through shared resources, economies of scale, and improved access to capital. This structure creates a unique opportunity to develop a centralized HD designated person to serve as a key HD resource and expert within the health system and to ensure system-wide compliance with USP <800>.
Within a multihospital health system, there may be a multitude of entities where HDs are handled, such as ambulatory clinics, community hospitals, stand-alone emergency rooms, surgical centers, and large academic medical centers. In general, staff in smaller sized hospitals often are expected to have a hybrid skillset that can serve many functions, while specialized, dedicated roles are more typical in larger hospitals. Considering the complexities of USP <800>, it may not be economically feasible or practical to assign an individual designated person at each entity and expect that each person will be sufficiently qualified and properly trained. Depending on the size, scope, and geographic footprint of the health system, having a single, dedicated, centralized HD designated person may promote a higher level of expertise, standardization, and compliance with HD handling. A single leader can connect efforts across the wide variety of areas and departments where HDs are handled and promote effective communication streams for optimal safety and compliance (see TABLE 1).
USP <800> requires the HD designated person be qualified. However, the chapter does not define the experience, training, or background that would deem someone qualified, focusing instead on the responsibilities of the individual in the designated person position. Further, the chapter does not outline how the position should be structured to ensure optimal compliance.
Formalized training and certificate programs for the designated person are available, such as the Hazardous Drug Designated Person Certification by the Pharmacy Compounding Accreditation Board (see: https://achcu.com/hdhdp). Such programs should be offered to the designated person to ensure the breadth and depth of knowledge required to perform the job responsibilities are realized. It is prudent to consider several variables in structuring the position, such as having a single/centralized designated person or multiple designated person(s), the individual’s background (pharmacist, pharmacy technician, medication safety officer, nurse, etc), whether the task is a dedicated role or added job responsibility, and the term for which the HD designated person is staffed (eg, short term vs long term, full time vs part time) (see TABLE 2).
Survey of Multihospital Health Systems
To identify how organizations are choosing to structure their HD designated person position, a survey was created and sent to multihospital health systems across the nation through an ASHP Connect blog posting within The Section of Pharmacy Practice Leaders. As demonstrated by the survey, multihospital health systems have taken the undefined structure of the position and interpreted it in a multitude of ways. Many multihospital health systems have elected to have a pharmacist as the HD designated person (80%) and to add the job responsibility to an existing position (86.7%). In contrast, 6.7% of health systems have designated a pharmacy technician, while a safety officer, quality and safety individual, and facilities manager were each designated for 3.3% of the health systems surveyed. Full survey results are presented in TABLE 3.
Based on the national survey results, 82% of newly added designated person positions were justified on the sole regulatory requirement for compliance with USP <800> within their state. Further value can be demonstrated through the significant cost avoidance potential based on how the position is structured. TABLE 4 contains examples of how value may be demonstrated for the designated person to seek organizational support and approval for the position.
An Approach to Consider
The following approach, developed through an in-depth evaluation of the needs of multihospital health systems, meets regulatory requirements while maximizing the value of the position to an organization.
Single Dedicated Person for the Health System
Strategies and questions shared from other multihospital health systems indicate the utility and desire for one person who would act as the point person to drive compliance with USP <800> system-wide, emphasizing that for larger health systems, the designated person responsibilities are a full-time job that cannot simply be an added job responsibility.
Pharmacy Technician Leader
The HD designated person must be granted decision rights to effectively collaborate with impacted departments and make decisions in a timely manner. Consideration should be given to a pharmacy technician leader to ensure a level of responsibility over system-wide decisions. A pharmacy technician was chosen over a pharmacist, as the job responsibilities require minimal to no clinical knowledge or decision making, and a highly qualified and trained pharmacy technician could be successful in the role. Note that the survey revealed that at least one state requires the designated person to be a pharmacist.
Full Time, Long Term, Health System Wide
In investigating the long-term feasibility of having a full-time position as the HD designated person, a list was created of short-term and long-term job duties; it was determined that these compliance needs are truly a full-time, long-term need (see TABLE 5). For a multihospital health system to have an appropriate level of compliance with USP <800>, the HD designated person must have the time and investment from the organization to visit each department in each entity that is handling HDs. They must have hours allocated to their position to have timely follow-up just as they need long-term staffing to ensure compliance is maintained each year.
Flexibility exists for multihospital health systems to implement the required designated person role in a multitude of ways. Careful consideration of the approach to the role can prove beneficial for organizations’ journeys to compliance with handling HDs across the health system. A pharmacy technician leader serving as a centralized HD designated person within a health system is a unique role that will elevate the profession and promote national expertise within HD handling. Further, collaboration of centralized HD designated persons across the nation could lead to sharing of best practices, resources, and ultimately enhanced containment of HDs to protect workers, patients, and the environment.
Emma Sullivan is a fourth-year pharmacy student from the University of North Carolina Eshelman School of Pharmacy.
Kevin N. Hansen, PharmD, MS, BCPS, BCSCP, the assistant director of pharmacy at Moses H. Cone Memorial Hospital, provides oversight and leadership for pharmaceutical compounding and perioperative services pharmacy. He graduated from the Lake Erie College of Osteopathic Medicine with a Doctor of Pharmacy degree and received an MS in Pharmaceutical Sciences from the University of North Carolina Eshelman School of Pharmacy.
USP <800> Excerpt: Responsibilities of Personnel Handling HDs1
“Each entity must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures; overseeing entity compliance with this chapter and other applicable laws, regulations, and standards; ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas. The designated person must thoroughly understand the rationale for risk-prevention policies, risks to themselves and others, risks of noncompliance that may compromise safety, and the responsibility to report potentially hazardous situations to the management team. The designated person must also be responsible for the oversight of monitoring the facility and maintaining reports of testing/sampling performed in facilities and acting on the results.”
Overview of USP <800> Designated Person Responsibilities