According to USP Chapter <800>, “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 [the] chapter and other applicable laws, regulations, and standards; ensuring competency of personnel and ensuring environmental control of the storage and compounding areas.”1 The scope of USP <800> encompasses the entire health care continuum and applies to all health care personnel who handle hazardous drugs anywhere they are received, stored, compounded, dispensed, administered, and disposed.

While USP chapters on compounding often fall to pharmacy to implement, hazardous drug safe handling warrants an interdisciplinary approach. At University of Michigan Health (UMH) (see the SIDEBAR), we formed an Oversight Committee (HDOC) to act as a body of designated persons to oversee USP <800> implementation and ongoing compliance. The committee formed in 2019 with an initial directive of evaluating surface sample results of hazardous drug (HazD) residue. [Note that at UMH, the HDOC nursing members requested we abbreviate hazardous drugs as HazD to avoid confusion with hemodialysis abbreviations.] The group’s scope quickly expanded as our organization sought to achieve full adherence to USP <800> standards. The success of the committee resulted from clearly defining the committee’s charge, scope, reporting structure, membership, subcommittees, impact, and challenges.

Committee Charge and Scope

The HDOC is charged with providing institutional oversight for HazD handling activities and compliance. HDOC responsibilities and workflow are depicted in FIGURE 1. Broad categories of responsibility include: policy and procedure ownership, HazD classification, general program oversight, program monitoring, process improvement, and reporting.

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Reporting Structure

The HDOC has dual reporting relationships as a formal subcommittee of both the Pharmacy and Therapeutics Committee (P&T) and the Environment of Care Committee (EOC). At a high level, HDOC activity oversight is divided in the following manner:

• P&T focuses on the activities related to the classification of HazDs
• EOC focuses on activities related to processes ensuring employee safe handling of HazDs

A more detailed explanation of the delineation of oversight can be found in TABLE 1 and FIGURE 2. Admittedly, dual reporting can create additional layers of complexity for policy and reference list approvals, but in our experience, a single body could not effectively assume oversight of both the clinical drug evaluation and the staff safety facets of HazD safe handling. Because of the significant staff safety implications related to HazD safe handling, we also consult with other institutional committees for endorsement of policy elements including our Medication Safety and Nursing Evidence Based Standards committees. Final approval of the organization’s policy on Safe Handling of HazDs is completed by the Board of Directors Compliance Subcommittee and the health system president.

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Membership

The HDOC comprises 22 voting members. The membership demographics encompass: 10 pharmacy representatives, 7 nursing representatives (including 1 front line nurse), 1 provider, 1 environmental health and safety representative, 1 occupational health representative, 1 accreditation team representative, and 1 infection preventionist. The infection preventionist was added to the group when our scope was expanded to include biosafety medication safe handling oversight and classifications. In the future, we may consider adding a pharmacy technician representative to the group.

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Subcommittee on HazD Classification

Due to the need to conduct routine reviews of new and existing HazDs for the purpose of classification and assessment of risk evaluations, it was determined that a group outside of the HDOC should be assembled. The HazD Classification Review Panel acts as a subgroup of the HDOC. Due to the clinical nature of the work, a subset of clinicians from the HDOC was recruited to join the review panel. This multidisciplinary group is charged with reviewing the HazD classifications assigned by the pharmacy area teams that review new medications for use within the organization and new-to-market drugs that may be utilized as part of a nonformulary utilization pathway. The review panel meets monthly and provides a forum to debate or discuss HazD classifications with ambiguous supportive clinical evidence. The review panel also evaluates the operational impact of HazD list changes and assists with implementation planning. Changes in HazD status for existing formulary items often requires ad hoc meetings and the involvement of additional subject matter experts.

Review Panel Duties

Members of the review panel are responsible for the following tasks:

• Review the initial drug categorization assignments conducted by Medication Use Policy (MUP) or Research Pharmacy (RP) using an internally developed, standardized categorization template according to the organization’s HazD classification policy
  • Initial categorization reviews with straightforward HazD classification are reviewed by the chair of the review panel and then prepared for consent agenda approval at the following month’s HDOC committee meeting
  • Initial categorization reviews with ambiguous or reviewer questioned results are discussed by the review panel, with the final classification being sent to the next monthly HDOC committee meeting for approval (with discussion as needed)
• Review and maintain the institutional HazD list and associated assessments of risk, which are then approved by HDOC and P&T
• Conduct a quarterly review of drugs that are new to market and perform a proactive HazD classification review to ensure any nonformulary drug utilization includes appropriate HazD safe handling precautions
• Inform UMHS employees of changes to the HazD list through the monthly P&T newsletter

Review Panel Membership

The review panel is composed of 9 voting members. The broad membership demographics include: 5 pharmacy representatives, 2 nursing representatives, 1 electronic health record (EHR) pharmacist and 1 infection preventionist. Inclusion of the EHR pharmacist has been key to maintaining timely updates to prescription order sets and optimizing HazD classification status across various facets of the application (eg, creation of medication administration record graphical displays, assessment of risk links, and story board alerts for body substance handling). The infection preventionist was again added to the group when the scope was expanded to include biosafety medication safe handling oversight and classifications. The smaller percentage of nursing representatives on the review panel is compensated by requiring a nursing representative vote on any HazD classification decisions.

HDOC Impact

Since its formation in 2019, the HDOC has instituted significant organizational advancements and initiatives for the safe handling of HazDs including:

• Establish a committee charter that outlines the committee’s charge, scope, and oversight. Also formally recognizes the committee as the USP <800> designated person for the organization (2019)
• Assume responsibility for routine and ongoing review of the institutional HazD Safe Handling Policy (2019)
• Develop a formal policy for the classification of HazDs based on the NIOSH 2018 Draft Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other HazDs in Healthcare Settings2 (2020)
• Direct the evaluation of and classification of all HazDs through the HDOC Review Panel, with an average of 15 reviews conducted per month (5 deemed hazardous, 10 non-hazardous) (2020)
• Develop a formal policy for the classification of biosafety HazDs based on our HazD classification workflow and a review of federal safety standards on biological agent safe handling3 (2021)
• Create a 5-year strategic plan (2021-2026) to advance the safe handling of HazDs within the organization, including key goals (see TABLE 2)