Developing a USP <800> Compliance Gap Analysis

January 2017 - Vol.14 No. 1 - Page #10
Categories: Closed System Drug-Transfer Devices (CSTDs), PPE/Garb & Gloves

In February 2016, the United States Pharmacopeia (USP) published USP <800>, which defines processes for handling hazardous drugs (HDs) in health care settings, with the intention of promoting patient and staff safety and protecting the environment. The scope of USP <800> extends to all personnel who compound and administer HD preparations, including pharmacists and pharmacy technicians, nurses, environmental services, as well as any other areas that receive, store, compound, dispense, administer, and/or dispose of HDs. To become compliant with the new chapter, many—if not most—facilities will need to make updates or change the way they store and prepare hazardous medications, for both sterile and non-sterile compounding, and review physical design and ventilation systems for compliance.

Inova Health System, a multi-facility, 1700+ bed health system in northern Virginia comprising five acute care hospitals, multiple ambulatory facilities, and three outpatient infusion centers, is committed to its mission of improving the health of the diverse community it serves through excellent patient care, education, and research. As such, ensuring safe, compliant HD handling throughout the health system is one of our prime concerns. With the implementation date of July 1, 2018 for USP <800> compliance quickly approaching, Inova set out to develop a USP <800> gap analysis to identify areas of weakness that could be promptly addressed.

Developing a USP <800> Compliance Strategy

The fundamental steps for ensuring USP <800> compliance throughout our health system included:

  1. Establish a task force and a project lead (as defined by the chapter)
  2. Construct a gap analysis tool for compliance
  3. Incorporate the tool into practice
  4. Respond to and/or incorporate longitudinal revisions and clarifications in the regulations

The initial purpose of Inova’s USP <800> team was to explain relevant sections of USP <800> and the NIOSH regulations related to HDs to all stakeholders, and to establish pharmacy’s organizational strategy for the handling, storage, and disposal of HDs.

When developing an HD strategy, gaining buy-in and soliciting leadership support from each operating unit in the health system is just as important as ensuring support from hospital administration. Therefore, it was important for the pharmacy team to facilitate a high level of decentralized leadership. While pharmacy management helps provide the engine for change, staff pharmacists and pharmacy technicians working in areas handling HDs can be instrumental in helping to identify areas that require assistance.

Creating a Gap Analysis Tool

USP <800> requires that each entity have a compounding supervisor who is the designated individual responsible for developing and implementing appropriate procedures. A multidisciplinary team at Inova decided that the best way to understand these detailed regulations was to create a custom tool, specific to the regulations that will be assessed. Consider delineating the document into two sections to cover both suggestions and requirements based on wording in the chapter (eg, should rather than must).

It is strongly advised that organizations that have yet to consider USP <800> begin taking practical steps toward compliance. However, USP <800> compliance is a long-term project—be prepared for a marathon rather than a sprint. As the timeline progresses, inclusion of external stakeholders is critical. Consider teaming up with members from key departments, including employee health and/or safety, nursing, risk, compliance, quality, human resources, materials management, environmental services, facilities/engineering, and senior leadership (for appropriate sponsorship and to facilitate effective communication). Organizations should plan to meet as often as needed to ensure goals are met. Starting early is critical to success, as many efforts may take years to put in place.

Our gap analysis was broken down into six key areas (see TABLE 1): creating an HD list, conducting a hazardous risk assessment, implementing facility design/redesign, refining policies and procedures (P&Ps), establishing a staff training plan, and monitoring staff compliance and health. Key items to include in the gap analysis tool are delineated in TABLE 2.

Establish an HD List (A). One of the most basic, yet most critical, requirements of USP <800> is establishing an HD list. The importance of developing this list changed considerably with the final revision of USP <800>, as the wording for inclusion of the NIOSH list has changed from a suggestion to a requirement. The verbiage now reads: An entity must maintain a list of HDs, which must include any items from the current NIOSH list that the entity handles. The HD list must be reviewed at least every 12 months and whenever a new agent or dosage form is used. Because NIOSH typically updates the list every 2 years, pharmacists should consider preparing a template and a plan for reviewing new items that are either added to the formulary or used in the facility.

It is critical to understand the NIOSH HD definition when creating the HD list. Drugs are considered hazardous if they exhibit one or more of the following six characteristics in humans or animals:

  • Carcinogenicity
  • Teratogenicity or other developmental toxicity
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity
  • Structure and toxicity profiles of new drugs that mimic existing drugs
    determined hazardous by the above criteria

Conduct a Hazardous Risk Assessment (B). NIOSH and USP acknowledge that not all HDs have an identical risk profile. Drugs defined as hazardous may not pose significant risk of occupational exposure due to their dosage formulation, such as solid, intact unit-dose tablets that do not shed particulates. However, many items present a risk of dust/debris and exposure by skin contact and/or inhalation. An assessment of risk should be performed for these dosage forms to determine alternative containment strategies and/or work practices.

At a minimum, risk assessments must encompass the following:

  • Type of HD (eg, antineoplastic, non-antineoplastic, reproductive risk only)
  • Dosage form
  • Risk of exposure
  • Packaging
  • Manipulation

When conducting the assessment, consider the effects on pharmacy, nursing, environmental services, and any auxiliary staff who may come into contact with hazardous materials in the medication-use process. It is recommended that stakeholders consider both the potential risk and the potential for exposure when developing such an algorithm.

Implement Facility Redesigns/Updates (C). To meet USP <800> requirements for facility design, organizations will be faced with the decision to reorganize health system facilities, which will likely require either distribution consolidation or significant facility redesign based on service provision and distribution models. Pharmacy leadership is encouraged to consider the following issues: physical location of the compounding facility within the overall operation, workload volume for each facility, the relative distance of the compounding area from other viable operating units, and future plans for growth and/or service expansion. In the absence of available opportunities for facility redesign, organizations may choose to consolidate services where possible.

Click here to view TABLE 2.

Create and/or Update P&Ps (D). While many pharmacy leaders will initially focus on facility design, perhaps the most significant undertaking to ensure USP <800> compliance will be developing P&Ps. Prior to the advent of the chapter, many institutions’ P&Ps focused predominantly on safe ordering and administration of chemotherapy. P&Ps must now be expanded to address all hazardous medications and all aspects of the medication-use process. P&Ps should be comprehensive and cover multiple areas: use of personal protective equipment (PPE), personnel/training, environmental quality and control, facility design, as well as more specific areas of medication use—for example, closed system drug-transfer devices (CSTDs). A project of this magnitude should be a multidisciplinary endeavor. Moreover, creating P&Ps will not be a one-time undertaking; rather, P&Ps must be living documents incorporated into daily practice and reviewed at least annually.

It is critical to pay particular attention to specific USP <800> verbiage related to PPE use. For example, staff must wear appropriate PPE that is resistant to the cleaning agents used, including two pairs of ASTM‐-tested chemotherapy gloves and impermeable disposable gowns. A second pair of shoe covers must be donned prior to compounding HDs. While CSTDs are only required for the administration of HDs, USP <800> recommends that CSTDs be utilized during the preparation of compounded HDs.

In addition, USP <800> mandates that all personnel who handle HDs are trained based on their job functions, and that this training is completed before individuals independently handle HDs. Competency must be demonstrated and reassessed at least annually. Staff also should be trained prior to the addition of any applicable new drugs and/or equipment, or when significant changes in policies occur.

Partnering with environmental services and employee health/safety is prudent when creating P&Ps related to environmental quality and control. For example, note the requirement for surface sampling, which must be completed initially and every 6 months thereafter, which complements the requirements for cleaning and decontamination. Institutions are encouraged to standardize any regularly used decontamination and cleaning solutions across pharmacies, and to engage both frontline staff and vendors to provide products in ready-to-use form as often as possible.

Establish a Staff Training Plan (E). Consider the onboarding process and how HD handling factors into current training and standards, both for staff members who compound regularly and those who occasionally handle HDs within and outside of the pharmacy. For example, determine what training is appropriate for environmental services. Some facilities use an onboarding checklist that includes training standards. ASHP offers sterile compounding training and is releasing a USP <800> training module, which can be licensed for health system training. Evaluating staff competency on a regular basis is just as important as setting standards; competency evaluation intervals and requirements should be agreed upon and specified in the project management plan.

Monitor Staff Compliance and Health (F). Pharmacy leaders are responsible for monitoring staff compliance, environmental status, and for conducting medical surveillance of appropriate staff. Environmental wipe sampling for HD surface residue should be performed as a benchmark, and at least every 6 months thereafter, in areas where compounding occurs. Furthermore, additional surface wipe sampling should be performed to document the effectiveness of any agent used in practice. Third-party products are available to perform wipe testing; be sure to plan for these products in your budget. It may be convenient to perform wipe testing at the same time hoods are certified for air quality. It is important to note that USP <800> does not establish any standard for acceptable limits in HD surface contamination or define follow up in the event of contamination. This underscores the importance of conducting employee medical surveillance to monitor staff for potential or actual exposure.

USP <800> states that workers who may be exposed to chemical hazards should be monitored in a medical surveillance program, with the intention of preventing occupational injury and disease. Personnel of reproductive capability (both men and women) must confirm in writing that they understand the risks of handling HDs prior to working in affected areas. In addition, provide a baseline employee assessment, which should be supplemented by lab reviews at regular intervals, and include an exit interview when an employee leaves the organization.

Conducting an Effective Gap Analysis

The Inova USP <800> committee addressed the results of our compliance analysis with department representatives focusing on the needs of their individual operating units, while the system committee was tasked with identifying resources required and prioritizing tasks.

A key responsibility of the committee was to interpret the USP standards. The committee agreed that it was critical to identify areas of compliance and noncompliance from the system perspective in order to prioritize tasks for completion. For example, some pharmacies in the health system had been recently renovated, while others required significantly more attention. Representatives from each operating unit then began the journey to compliance by addressing the gaps that had been identified. Prioritizing the most challenging and high-cost tasks first is recommended, as these will require capital requests or will span months to years for full implementation (eg, external ventilation of all hoods where HDs are prepared and stored).

USP <800>’s delayed implementation date of July 1, 2018 allows entities additional time to achieve compliance with the standard. However, even when taking this extension into account, adherence to a strict timeline is necessary to meet the deadline. Consider any state board of pharmacy regulations that coincide with the chapter, as some states have become proactive with setting in motion requirements that may be similar to or different from the text so they can be addressed simultaneously. Organizations must create a multi-year plan, a prioritization schedule, and a timeline for meeting the standards. Moving forward, prepare to continually evaluate P&Ps as new medications come to market and are added to formulary, and as new standards are required.


Ensuring compliance with USP <800> requires a thorough understanding of the chapter and a wide range of expertise. The journey toward full compliance is not a one-time project; a sustained effort is required to address all elements of the chapter. A significant element of success will be undertaking one gap at a time until all tasks have been completed.

David Aguero, PharmD, is the manager of pharmacy operations and technology at St. Jude Children’s Research Hospital, and was formerly a pharmacy supervisor for Inova Health System Alexandria Hospital. He specializes in the coordination, communication, and support of pharmacy services and the medication-use process, with experience spanning multiple electronic health record and medication distribution platforms in multi-facility systems, academic, and research
hospital settings.

Kristin Marge, PharmD, BCPS, is the PGY1 residency program director at Inova Health System Mount Vernon Hospital; she previously served as the hospital’s pharmacy manager. Kristin is a graduate of the University of Rhode Island College of Pharmacy and completed a PGY1 residency at Inova Health System Fairfax Hospital. She focuses on quality initiatives and process improvement, and is an active participant in several hospital multidisciplinary committees, including sepsis, stroke, medication safety, and readmission prevention.


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