USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings1 provides standards for the safe handling of hazardous drugs (HDs) to reduce the risk of exposure to health care personnel, patients, their families, and the health care environment. Focusing on staff safety, USP <800> is based on well-established, replicated data. The chapter does not represent new thinking; rather, it establishes reasonable and long overdue requirements to protect staff who handle these substances in the care of their patients. Though initially published in 2016, USP delayed the chapter’s official enforcement date until December 1, 2019, to provide healthcare organizations sufficient time to make the necessary changes.
For the second year in a row, CriticalPoint’s USP Compliance Study has sampled hospital practice in the US through the lens of various data points from USP <800>, including informational elements (non-scored gap analysis items), required elements (the “musts”), and best practice recommendations (the “shoulds”). Unsurprisingly, hospital compliance findings demonstrate little change over the past year. In 2017, of the locations that completed 90% or more of the applicable survey questions, 549 hospitals reported performing HD compounding. The following pages detail overall compliance rates as well as specific findings for hospitals handling HDs. From this data, it is clear that work remains to be done. Regardless of whether your state pharmacy board (or department of health regulators) will require compliance with USP <800>, there is a moral imperative to comply with these standards. Employees handling HDs deserve a safe workplace, and other persons (visitors, general employees, and non-HD-receiving patients) also have a right to expect a safe environment free from incidental exposure to HDs. Employers have been put on notice and must move toward these long overdue improvements to ensure protection for all.
Since it is less than 2 years from the December 1, 2019 enforcement date for USP <800>, organizations must focus on creating an executable framework for compliance. CriticalPoint’s Initial Roadmap to USP <800> Compliance selects five specific Key Performance Elements (KPEs) that come directly from USP <800> and can guide an organization’s pursuit of staff and workplace safety (see TABLE 1).
KPE1: Oversee HD Handling
USP <800> requires a sound first step: Organizations must appoint a project manager to serve as the point person for overseeing HD handling. Given the importance of filling this position, it is somewhat concerning that compliance is only at 55% (see FIGURE 1). Perhaps this is because the designated person must be “qualified and trained.” Ensuring a staff member is comprehensively trained is fairly straightforward; however, there is no defined path to proving an individual “qualified.” Comprehensive, self-directed learning programs that integrate post-testing are available, as are a variety of live training programs, yet no certification is available in this area. Rather, regulators will want to see that the individual designated to perform this function has received and successfully completed some type of formal education beyond what is offered in the pharmacy. USP <800> does provide specific guidance about the HD leader’s responsibilities, which are outlined in TABLE 3.
To begin, identify a person in your organization who is interested in taking on this responsibility and provide them with the tools they need to do the job by investing in their education. Suitable training programs must present information that is consistent with USP <800> while also providing sufficient details and practical steps to help participants learn how to comply with the chapter. If no one in your organization is willing or suited to assume this role, then invest in recruiting a qualified, formally trained person. Compliance with USP <800> requires widespread organizational changes in attitude, the physical plant, and work practices. This change is not difficult, but it is complex and requires a point person to orchestrate and monitor the organization’s efforts.
KPE 2: Create HD List
Once the HD Leader is in place, the next step is to review the current NIOSH HD list to identify the HDs (and each dosage form) handled by your organization (see TABLE 4). Given the 76% compliance rate for this KPE, it is likely that most hospitals have already addressed this issue (see FIGURE 2). Nevertheless, it is important to check whether the current hospital HD list requires revision, as many lists historically comprised antineoplastic agents only. The 2016 NIOSH HD List establishes three HD categories (see TABLE 5). Each drug handled from these categories (and all dosage forms) must be identified and included on the organization’s HD list.
After compiling the HD list, mechanisms must be put in place to: 1) Guarantee the list is reviewed at least annually; and 2) Identify new HDs that enter the market and are handled in the organization. Tap into existing operational metrics to review new drugs brought into the institution. If your organization has yet to designate an HD leader, you can still compile the organizational HD list and create a mechanism to keep it up to date. Without a detailed, disciplined process in place to create and maintain the list, subsequent steps cannot be implemented effectively.
KPE 3: HD Risk Assessment
Three types of drugs/dosage forms are eligible to be handled using alternative containment strategies and work practices from those that are identified in USP <800>, but only if an Assessment of Risk (AoR) is performed according to the criteria set forth in the chapter. Of the 457 hospitals that indicate they handle HD dosage forms, 396 (87%) confirm that they handle drugs and dosage forms that are eligible for the use of alternative containment strategies and work practices from those identified in USP <800>. However, only 39% (155 of 396) of those hospitals are performing an AoR for these dosage forms. Furthermore, among those facilities that have performed an AoR on one, some, or all of the eligible drugs and dosage forms, only 60% (93 of 155) indicate that their AoRs each contain all of the elements required by USP <800> (see FIGURE 3).
There seems to be significant confusion about how to perform an AoR, which may account for the low number of facilities utilizing alternative handling methods. Performing an AoR to properly exempt certain dosage forms from the complete gamut of required containment and work strategies is a worthwhile undertaking (see TABLE 6).
Certainly no organization is required to perform an AoR on eligible drugs and dosage forms; however, if an organization chooses not to perform AoRs, then it must handle all HDs in a uniform manner, using all the containment strategies and work practices listed in <800>. It is possible that organizations are unclear on how to perform and AoR, and thus, are not planning to utilize them. We strongly recommend that organizations educate themselves on how to conduct an AoR, as it leads to time and cost savings.
An AoR must include all of the information outlined in TABLE 7, which can then be kept in a database, on a spreadsheet, or in separate paper or electronic forms for each drug dosage form. Whichever storage approach you choose, the data must be simple to update when changes occur, and it must be reviewed at least every 12 months. Ample free information is readily available outlining how to perform an AoR (see TABLE 8).
Consider oxytocin as an example. This drug is listed in Table 3 of the 2016 NIOSH HD List as a non-antineoplastic drug that is hazardous only for women in their third trimester of pregnancy. It is routinely compounded in the sterile pharmacy controlled environment at a standard diluent and drug amount to allow for easy titration on the Labor and Delivery unit. As such, there is little reason to routinely handle oxytocin in a negative pressure BSC or CACI. Furthermore, why would we want to require nurses who routinely administer this drug (but not other HDs) to take full HD handling precautions, including the donning of PPE? This is a clear example of a drug that would benefit from a systematic AoR.
KPE 4: SOPs
The HD leader and other stakeholders must develop evidence-based standard operating procedures (SOPs) that are compliant with <800> but also meet the specific needs of their organization (see TABLE 9). Although there are some fine commercial SOP templates available, a template is only a starting point. SOPs must be comprehensively written to stand alone without additional explanation and with a clear articulation of the following:
- Identify the need for the SOP
- Delineate to whom and under what circumstances the SOP applies
- Include references that support the evidence-based underpinning and rationale of the SOP
- Cross-reference other relevant SOPs
- List or provide information on any applicable equipment, components, or supplies
- Specify step-by-step procedures that require no verbal explanation
- Include guidelines for any required documentation relevant to the SOP
The group’s time and effort spent developing, validating, and implementing these SOPs is well worth it. Clearly written, thoughtful SOPs serve as a springboard for the development of specific staff training tools and ensure consistency and quality. Given that just 45% of hospitals report that they have developed safe handling SOPs for their HDs, many hospitals have a long way to go (see FIGURE 4). But this can be accomplished. Finding the time and discipline to focus on the development of detailed SOPs may seem difficult, but this is an exceedingly critical task. The right thing does not happen just because we want it to; detailed SOPs are required to drive compliance forward in a meaningful, efficient way.
KPE 5: Training
Only 45% of hospitals report being in compliance with KPE 5, the requirement for staff training (see FIGURE 5). USP <800> clarifies that staff are defined as handling HDs if they receive, store, compound, repackage, dispense, or administer HDs, or discard HD waste. Any staff handling HDs must receive training that is specific to their job. Furthermore, staff members must complete training before they handle HDs, before they handle new HDs or operate new equipment in concert with HDs, and any time there is a new or significantly changed SOP. All of this training must be documented (see TABLE 10).
General HD handling training forms the foundation upon which staff then fully integrate their understanding of SOPs. Yet all too often, training on specific SOPs is insufficient, either because evidence-based SOPs have not been developed or SOPs are not detailed enough to provide guidance on specific steps or procedures. If staff learn only by watching and imitating the practice of others, who themselves are not guided by detailed, evidence-based, facility-specific SOPs, each procedure will vary based on differing beliefs of what constitutes correct practice.
The Association of Talent Development’s (ATD’s) 2016 State of the Industry publication3 reports that businesses spend an average of 33.5 hours per year training employees. According to the report, businesses invest the most time on managerial and supervisory training at 12.4%, with mandatory and compliance training (safety and security training) representing 11.1%. Training related to processes, procedures, and business practices ranked third, representing 9.8% of the total hours devoted to training. Thus, the average employee spends 3 hours and 17 minutes on training specific to SOPs over the course of a year. Though ATD did not look at health care organizations separately, we recommend that hospitals consider devoting more time to specific SOP training, since it is a chief determinant of patient safety.
Without meaningful SOPs, it is difficult to train staff on proper procedure. Involving all staff in the development of SOPs, based on their knowledge and talents, results in a more cross-functional team. An added benefit is that the learning curve for those involved in the SOP development process is less significant. Once SOPs are developed, training can then be based on the specifics therein.
USP <800> is not yet enforceable, and the deadline has been extended. Nonetheless, it is safe to assume that the 30 states currently enforcing chapter <797> are also likely to enforce USP <800>. CriticalPoint’s State Regulatory Map will soon be updated to reflect each state’s enforcement plan for USP <800> (pppmag.com/statemap). We hope the information herein helps to raise awareness of the coming requirements and that the KPEs defined in this article provide a helpful framework for your compliance efforts.
Compliance with USP <800> requires an investment of time, money, human capital, and focus. As we have learned from USP <797>, compliance is a journey, not a destination.
CriticalPoint gratefully acknowledges the assistance of two colleagues: Nick Kastango, whose proficiency with Tableau facilitated our ability to obtain and analyze the study data in a robust and efficient manner, and Patricia Kienle, who lent her expertise to a thoughtful review and critique of this manuscript.
Kate Douglass, MS, RN, CRNI, is the vice president of CriticalPoint, LLC, and serves as the codirector of the annual USP Compliance Survey.
Eric S. Kastango, MBA, RPh, FASHP, is the president, CEO, and principal of Clinical IQ, LLC, and CriticalPoint, LLC. He also serves as the co-director for the annual USP Compliance Survey.Peter Cantor, who serves as the COO and managing partner of CriticalPoint, LLC, is the study coordinator.
Address any questions to Kate Douglass at firstname.lastname@example.org
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. Accessed August 29, 2017.
- NIOSH, NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBor DG, Trout DB, O’Callaghan JP. Cincinnati, OH: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138). Accessed August 30, 2017. www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf.
- Association for Talent Development. 2016 State of the Industry. December 2016. E-ISBN: 978-1-60728—085-9.