A Comprehensive Approach to USP <800> Compliance

November 2017 - Vol.14 No. 11 - Page #20

Exposure to hazardous drugs (HDs) is prevalent among health care workers and has long been a safety concern. Wipe sampling has identified widespread contamination on multiple work surfaces in health care facilities,1-3 and air sampling studies have confirmed airborne HD contamination.4,5 Facilities with work surface contamination are associated with higher rates of HD exposure among health care staff.1,6-12 Despite clear evidence of adverse health consequences associated with HD exposure (see SIDEBAR13-18), as well as published safety recommendations to prevent exposure, safe HD handling practices have yet to be universally adopted.

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, which establishes the first federally enforceable standards to protect health care workers handling HDs, adopts the National Institute for Occupational Safety and Health’s (NIOSH) list of HDs as a framework from which to base its recommendations.19 The NIOSH list of HDs utilized in the health care setting, which was updated in 2016, divides HDs into three categories based on exposure risk: antineoplastic, non-antineoplastic, and reproductive risk.20 Although USP does not have the regulatory authority to enforce its recommendations, past publications, such as USP Chapter <795> (non-sterile compounding) and USP Chapter <797> (sterile compounding), have been partially or entirely adopted by state boards of pharmacy and accreditation organizations that possess this authority. All US health care facilities that store, transport, prepare, or administer HDs must attain full compliance with USP <800> standards by December 1, 2019.

Ensuring USP <800> Compliance
Sarasota Memorial Hospital (SMH) is an 829-bed regional medical center, one of the largest public health systems in Florida. SMH provides specialized expertise in cardiac, vascular, oncologic, orthopedic, and neuroscience services, and is the only hospital in Sarasota to provide obstetrical and pediatric services, a Level 2 trauma center, and a Level 3 neonatal intensive care unit. In addition, the SMH health system includes a network of outpatient centers, long-term care, and rehabilitation services to patients outside of Sarasota County.

Although HD policies and procedures (P&Ps) have been in place at SMH for some time, we did not yet fully meet USP <800> compliance standards. The objective of our hospital’s quality improvement project was to improve compliance with USP <800>, focusing on those standards related to pharmacy practice. USP <800> compliance efforts included conducting a gap analysis; identifying HD inventory and assessment of risk (AoR) candidates; developing an HD list; revising HD P&Ps; and providing HD staff education.

Gap Analysis
Conducting a gap analysis to identify areas of weakness is the first step in developing a comprehensive strategy to attain compliance with USP <800>. A team comprising nursing and pharmacy staff members performed a gap analysis of current HD handling practices to determine our level of hospital compliance. A Web-based self-assessment tool, developed by Joint Commission Resources, was used to survey nine areas of compliance via 145 questions. SMH scored less than 50% compliant in eight of the nine categories. Areas related to pharmacy practice were identified and targeted as the focus for the USP <800>-compliance project (see FIGURE 1). Questions from the gap analysis were then used to create a spreadsheet to track hospital-wide progress with USP <800> implementation.

HD Inventory
Identifying all HDs in our inventory was a critical first step in implementing compliant strategies for management. Using the NIOSH HD list as a guide, an inventory was taken of all HDs on formulary. All HD dosage forms were included separately, as the risks of exposure can vary by dosage form. A table listing each of the drugs from the NIOSH list that appeared on our formulary was created, along with each dosage form; next, we confirmed that each drug was in stock. The dosage form and manufacturer packaging were noted, and any irregularities were investigated prior to creation of a final inventory list.

Assessment of Risk
USP <800> requires that health care facilities follow full containment strategies for all HDs unless an assessment of risk (AoR) is performed. If current handling practices are determined to be adequate for preventing staff exposure, an AoR allows health care facilities to continue with these practices. However, an AoR cannot be performed on all drugs; parenteral antineoplastic agents that require manipulation prior to administration, as well as active pharmaceutical ingredients (APIs), are ineligible. Therefore, full containment strategies are required for these drugs, including all personal protective equipment (PPE), use of closed system drug-transfer devices (CSTDs), and other strategies for preventing exposure.

AoRs may be conducted on all other HDs utilized in the hospital. The AoR must consider, at a minimum, the drug, dosage form, packaging, manipulation, risk of exposure, and alternative containment strategies. A spreadsheet tool, which provided a step-by-step process for evaluating exposure risk and documenting containment strategies (see FIGURE 2), was used to complete the risk assessments. We used the NIOSH list categories and their recommendations for handling based on drug dosage form to determine handling precautions. For example, oral-solid dosage forms have a low risk of exposure and require the least amount of PPE for handling, whereas intravenous forms can be absorbed through skin or mucous membranes and therefore carry a higher risk of exposure. Crushing, splitting, or otherwise manipulating an oral-solid dosage form increases the risk of exposure due to inhalation; therefore, additional PPE is required.

Interdisciplinary collaboration with nursing staff was essential when performing the risk assessments, as nurses provided insight into common reasons for exposure and suggestions for future prevention. The AoR must be documented in writing and updated annually, as required by USP <800>.

Developing an HD List
Following completion of the risk assessments, the institution’s HD list was updated based on our inventory and the most recent NIOSH list. To maintain consistency with our previous HD policy, we continued classifying HDs into A, B, and C categories, where category A drugs pose the lowest risk of exposure and category C drugs pose the highest risk. All drugs in the same category require the same PPE and handling strategies, so knowing a drug’s category is sufficient for determining its handling requirements. The one exception to this is warfarin, which has different disposal requirements than other HDs due to its status under the Resource Conservation and Recovery Act (RCRA).

The primary determinants of handling category at SMH include dosage form and NIOSH category. USP <800> mandates full containment strategies for antineoplastic agents requiring manipulation, so these drugs receive the highest level of precaution as handling category C. Category B includes dosage forms such as oral liquids, topicals, ophthalmics, and certain injectable agents, which carry a higher risk of exposure than oral solids but do not require full containment strategies. Category A, which primarily comprises oral solids, requires the fewest handling precautions, as there is a relatively low exposure risk associated with this dosage form.

Per USP <800>, antineoplastic agents cannot be delivered through pneumatic tube systems, so SMH chose not to store these drugs in ADCs. Subcategories were created to reflect storage and delivery requirements, including A1, A2, B1, and B2. All A2 and B2 drugs (antineoplastics) require hand delivery. In addition, it was necessary to change the HD list to separate pharmacy and nursing handling categories in order to differentiate handling and PPE re­quirements within the same category. For example, it was determined that certain dosage forms, such as ophthalmic drops, should be delivered by pharmacy in sealed manufacturer packaging, as they pose little risk to pharmacy staff, but significantly more risk to the nurses who open and administer this liquid dosage form (see FIGURES 3 and 4. To view SMH’s HD list in its entirety, see online-only FIGURE 3A).

Click here to see FIGURE 3.

Click here to see FIGURE 3A.

Another improvement to the new HD list is the addition of risk information for each drug, such as the NIOSH category, FDA pregnancy category, International Agency for Research on Cancer (IARC) group, National Toxicology Program (NTP) group, black box warnings, and other specific risk information. This data is included to inform staff of potential adverse effects that may result from exposure.

In addition to the list of HDs on formulary, we created a separate list for non-formulary HDs. The non-formulary list, which contains the handling category for each drug, serves as a guide for situations where a non-formulary HD is required.

HD Policy Revision
Once we completed the risk assessments and categorized the HDs, we revised the joint pharmacy/nursing HD policy to reflect these changes. Additional information provided in the policy includes the process for disposal in hazardous waste bins (eg, any remaining drug, packaging, used tubing, etc) and administration instructions for nursing (eg, IV tubing for HDs may not be reused due to the splash potential when removing tubing from IV bags).

Per the revised policy, pharmacy staff is only required to wear PPE when manipulating dosage forms requiring removal from their sealed manufacturer packaging. Similarly, PPE is only required for nursing staff once the drug is removed from its packaging. Splitting, crushing, or otherwise manipulating an oral-solid dosage form may only be performed in a segregated area of the central pharmacy and requires the same handling as a category B2 HD.

Handling and PPE requirements were updated for the repackaging of HDs; oral solids must be repackaged manually by pharmacy staff, rather than via the automated packaging machine, due to the potential for cross-contamination of other drugs. Handling requirements for each category of HD are included in SMH’s HD list for reference (see FIGURE 4).

Click here to see FIGURE 4.

Staff Education
SMH utilized a multimodal approach to educate staff and disseminate new information, including online education modules, live presentations, a reference poster/algorithm, and just-in-time education strategies. In collaboration with nursing leadership, a mandatory online education module outlining the HD list and policy changes was developed and released to pharmacy and nursing staff, including a competency test to assess understanding. Live education sessions were provided to pharmacy staff members, followed by creation of a separate online module for future pharmacy staff education. A reference poster (see FIGURE 5) and talking points were distributed to nursing leaders for discussion during staff huddles, highlighting the most important considerations of these policy changes.

Click here to see FIGURE 5.

The just-in-time education strategies include the following:

    • Auxiliary labels for each handling category affixed to every HD dispensed from pharmacy, listing the required PPE and precautions (see FIGURE 6)
    • Alerts when removing HDs from ADCs, identifying the handling category and requirements

  • Handling instructions in the electronic medication administration record (eMAR) during drug administration
  • Reference posters distributed to nursing units
  • An algorithm for handling procedures (see FIGURE 7)

3D Handling Labels - Click here to see FIGURE 6.

HD Handling Algorithm Chart - Click here to see FIGURE 7.

Overcoming Challenges
A significant challenge of this compliance project was the lack of specific guidance offered by the chapter. USP <800> allows health care facilities to determine the HD handling strategies that best fit their specific operation. Since our USP <800>-compliance project was completed prior to the required adoption date, little guidance was available from other health care organizations, as few had begun the implementation process. Researching best practices and determining our own HD handling requirements proved challenging. Additional USP guidance would prove useful as more health care organizations seek to improve their compliance with <800>.

Another foreseeable challenge with hospital-wide implementation of USP <800> is effective interdisciplinary collaboration. USP <800> impacts operations for every hospital department that handles HDs, and involvement from multiple disciplines is critical for successful implementation. Due to the focus of this project, significant collaboration was only required between nursing and pharmacy staff. However, even coordination between two departments proved challenging at times due to conflicting schedules and differing opinions.

Finally, USP <800> requires that health care facilities appoint a single individual to lead implementation efforts. Our experience highlights the importance of establishing this position in order to improve coordination and hasten decision-making.

Our USP <800> initiative brought the organization significantly closer to the goal of full compliance. Updating SMH’s HD list ensured that all drugs identified as hazardous by NIOSH are handled in a manner that maximizes staff safety by reducing the risk of exposure. In addition, staff is provided with specific risk information for each HD on formulary, which increases awareness of the dangers they pose.

Staff education was well received, with employees finding just-in-time education particularly helpful. Auxiliary labels, ADC alerts, and messages in the eMAR guide staff toward appropriate PPE, handling, and disposal procedures. Reference posters and algorithms provide additional resources to assist staff in patient care areas. Collaboration with nursing was critical during development of this education, providing pharmacy with insight into the needs of nursing staff and helping to shape the format of these tools to optimize utilization.

Future Directions
Regulations for HD handling by health care personnel have been lacking for decades, leading to harmful consequences among countless workers. A stepwise strategy for attaining pharmacy compliance with USP <800> has ensured that our organization will be compliant by the enforcement date. A separate USP <800> steering committee will oversee future hospital-wide implementation initiatives to attain full compliance with the chapter.

Gary Houchard, PharmD, completed his PGY1 residency training at Sarasota Memorial Hospital (SMH). He is currently completing a PGY2 residency at The Ohio State University, specializing in pain management and palliative care. Gary received his pharmacy education at The University of Michigan. His professional interests include palliative care, hospice, pain management, and opioid stewardship.

Pam Lewis, RPh, is a pharmaceutical care specialist in medication safety at SMH. She received her pharmacy degree from the University of Toledo in Ohio. Her professional interests include medication safety, human factors engineering, and investigational drugs.

Lisa Hymel, PharmD, MBA, BCOP, is a senior manager for pharmacy clinical and educational services at SMH. She received her pharmacy education at Florida A&M University in Tallahassee. Her professional interests include oncology, pharmacy leadership, and teaching.

Sandra Prenosil, PharmD, MBA, is pharmacy manager in process operations at SMH. She received her pharmacy degree from Drake University in Des Moines, Iowa. Her professional interests include quality process improvements, sterile compounding, inventory management, and staff development and engagement.

Rebecca Kisgen, PharmD, BCPS, is a clinical pharmacist at SMH. She received her pharmacy education at the University of Florida. Her professional interests include outpatient infusion clinic, oncology, and adult medicine.

Risks of HD Exposure
The severe teratogenic effects of certain drugs
were first realized following the use of thalidomide in pregnant women in the 1950s and 1960s, leading to numerous birth defects, including blindness, deafness, cleft palate, disfigurement, and phocomelia. Some antineoplastic medications, such as azathioprine and cyclophosphamide, have the potential to cause secondary malignancies and genetic damage in humans.13-17 Although these effects occur primarily in patients receiving active treatment, they can also occur as a result of unintentional exposure.

Adverse effects, including nausea and vomiting, alopecia, skin rashes, and organ damage, have also been documented from non-antineoplastic medications.18 Studies have found a greater incidence of congenital malformations, spontaneous abortions, and other adverse pregnancy outcomes in oncology nurses, presumably due to inadvertent exposure to drugs that pose a reproductive risk.


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  19. USP-NF. General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. http://www.uspnf.com/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed September 18, 2017.
  20. Centers for Disease Control and Prevention/National Institute of Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. https://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Accessed September 18, 2017.


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