To ensure that health care workers handle hazardous drugs (HDs) safely and comply with USP <800> requirements, developing standard procedures for HD handling is critical. Access to clear policies and procedures (P&Ps) and standard operating procedures (SOPs) guarantees that hospital staff who handle HDs have the resources necessary to support safe practices, while the existence of comprehensive procedures illustrates leadership’s support for employee safety. Furthermore, developing procedures for HD handling is required by USP <800>; the December 1 deadline for compliance is imminent.
Vanderbilt University Medical Center in Nashville, Tennessee, utilizes SOPs as instruction manuals that elucidate the health system’s plan to protect employees from repeated exposure to HDs. With extensive experience developing robust procedures, pharmacy leaders can support facilities creating or revising their HD handling documents for USP <800> compliance. Consider the following tips:
- Seek the involvement of multiple departments
- Include comprehensive information
- Use applicable language
- Consider adopting SOP management software
- Provide accessibility
- Encourage staff members to use SOPs
- Regularly review SOPs
Seek Input from Multiple Departments
Because SOPs may affect numerous hospital departments, procedures must not be created in isolation; departments with employees who handle HDs should be involved in developing SOPs that impact their duties. It is crucial to include the right staff members and content experts in document development from the very beginning of the project; failure to include all relevant areas may result in noncompliance and/or the need to make document changes at a later date.
Vanderbilt’s SOPs are developed by a team comprising the program director for pharmacy sterile products compliance and representatives from the departments of environmental health and safety, pharmacy, nursing, and environmental services. Completed SOPs are routed through our chain of document approval process, which requires final approval from the hospital’s medical board.
Include Comprehensive Information
Organizations must maintain SOPs for the safe handling of HDs wherever they are handled throughout the facility, from the loading dock through drug disposal. When considering what information to include in SOPs, the overarching question to guide decision-making should be: Do these SOPs outline steps to properly protect employees from HD exposure?
Per USP <800>, SOPs must address the following: hazard communication program; occupational safety program; designation of HD areas; receipt and storage; compounding; use and maintenance of proper engineering controls; hand hygiene and use of PPE; deactivation, decontamination, cleaning, and disinfection; dispensing; transporting; administering; environmental monitoring; disposal; spill control; and medical surveillance. While it is crucial to include comprehensive information in SOPs, avoid duplication of content across documents, as this practice increases the opportunity for error when updates are required.
In addition to developing and maintaining SOPs for all of the sections listed in USP <800>, be sure to include the following specific information:
- Which staff members must follow the SOP
- Relevant definitions necessary to understand the SOP content
- Required equipment and/or supplies to execute the duties outlined in the SOP
- A list of references where additional information is available
- Links to other relevant SOPs that are referenced within the document
Information related to facility design, staff responsibilities, and whether or not the organization will conduct an assessment of risk for HDs used in the facility should also be considered when drafting HD SOPs:
- Design Considerations. Facility design is particularly impactful on an organization’s ability to execute USP <800> compliance. If areas within the facility are not ideally designed for USP <800> compliance, it is necessary to address these situations in SOPs. For example, should the HD storage area not be located directly adjacent to the cleanroom, detail the process for safely transferring HDs from the storage area to the cleanroom.
- Designate Task Responsibilities. Denote which staff members are responsible for various tasks. It is insufficient to state: Surfaces must be properly decontaminated; rather, specify who is responsible for decontamination.
- Perform an Assessment of Risk. One of the central questions in USP <800> is whether an organization chooses to perform an assessment of risk for each HD used at the facility versus treating all drugs as hazardous. Language specifying which approach the organization has adopted should be clearly delineated in SOPs.
Finally, verify that actual practice matches what the SOP requires. In a large pharmacy department, it is not uncommon for staff members to problem-solve on their own, which introduces practice variation. When a gap appears between real practice and the SOP, consider relevant regulations and practical logistics and then evaluate what needs to change: the SOP or the practice.
Use Appropriate Language
Our health system typically develops a broad, umbrella P&P, and within that structure, multiple specific SOPs. While P&Ps use general language, SOPs are more explicit. For example, the HD handling P&P describes our HD handling philosophy in general terms; the pharmacy-specific HD handling SOP describes processes for handling HDs in the department (eg, compounding, storage, delivery). Other care areas might implement their own, department-specific HD SOPs. The language used in P&Ps describes our intent as an institution (eg, what medications we will treat as hazardous, what PPE will be used), while SOPs are more directive (eg, Don PPE for compounding HDs following these steps; Decontaminate equipment following these steps). SOPs resemble checklists and are designed as tools to guide specific practices. Also, be specific: It is insufficient to state PPE must be worn when handling HDs; rather, specify who needs to wear PPE and during which activities.
Consider Adopting SOP Management Software
To properly manage all of our health system’s procedures, Vanderbilt employs customizable document management software, which has proven useful for organizing, managing, and updating documents. Because document approvals are often required from staff in multiple departments, the review process can quickly become complicated. The software facilitates an electronic approval process, which clearly delineates those staff members who have read and approved the document and those who have not. The software utilizes version control and records when changes are made and by whom. New and updated documents are automatically routed to those employees required to sign off. The SOP management software can be particularly helpful during an audit.
Every staff member who handles HDs must have access to the documents that outline safety procedures. Utilizing online SOPs is recommended to ensure accessibility while also facilitating efficiency in document updates; this approach is particularly helpful when updating SOPs that affect multiple departments. Maintaining SOPs in a centralized repository is critical; discourage the practice of printing out hard copies to keep in the workspace, as this practice virtually guarantees that the paper copies will quickly become outdated.
Promote SOP Use
Pharmacy leadership actively encourages staff to use the electronic SOP service, which is available at every work station. The value of developing and implementing SOPs is only realized when staff members use these resources as intended. Given that we expend significant time crafting and managing SOPs, should staff members not use these tools, our efforts would be for naught.
Vanderbilt employs a multifaceted strategy to promote the utilization of SOPs. SOPs are reviewed at length in staff training sessions and new employee orientations. At this point, each step is read and discussed to verify that all staff members understand the requirements. We actively encourage SOP use by emphasizing that these documents make employees’ jobs easier. In addition, weekly SOP reminder emails are sent. If we sense that certain employees are becoming complacent, targeted SOP reminders are sent to these practitioners. These reminders describe correct practice and include a link to the SOP. Monthly SOP update notifications are another excellent tool. The manager for compliance and process improvement sends a statement to all staff that includes all of the facility-level and pharmacy-specific documents that were newly added or updated over the past month. These notifications include links detailing exactly what has been changed or added.
It is critical to verify staff adherence to HD SOPs. At Vanderbilt, sterile product and USP <800> competencies are built into an electronic training system that guides staff members through a series of slides on important topics, such as aseptic technique and HD spill cleanup. These lessons are required for certain staff on a scheduled basis, usually annually or semi-annually. Each of these topics includes a quiz at the end, on which staff must score at least 80% correct.
Review SOPs Regularly
The HD designated person (as specified in USP <800>) and the SOP author should review SOPs at least every 12 months, and document that the review has occurred. The SOP author collaborates with the HD designated person and the relevant content experts to identify any required changes. Thereafter, depending on the topic and the staff members it affects, the document is routed through a series of committee approvals; the final sign-offs include the CEO and/or the director for the area(s). If the P&P or SOP being reviewed is considered high-level, it also requires sign-offs from upper administration; pharmacy-specific SOPs require sign-offs from all pharmacy department directors. All approvals are recorded and tracked within the SOP management software.
Although creating comprehensive SOPs may not be the most glamorous pharmacy task, dedicating concerted effort to this process can provide much needed resources to employees, ensure a safe, efficient workflow, and encourage consistency in practice. With the December 1, 2019 deadline for USP <800> compliance quickly approaching, organizations should directly address SOP development for HD handling.
Lindsay Ford Adams, PharmD, is the program director for pharmacy sterile products compliance at Vanderbilt University Medical Center in Nashville. She received her pharmacy degree from the Medical University of South Carolina in Charleston.
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