Sustainable USP <800> Education and Training

May 2022 - Vol.19 No. 5 - Page #10
Category: USP Training Programs

Creating policies and procedures is a fundamental first step for many facilities when ensuring USP <800> compliance. However, in an ever-changing regulatory landscape, it is necessary to go beyond policy development—education and training are key pillars of a successful hazardous drug program. It is critical to assess every possible point of interaction with hazardous drugs including receiving, compounding, dispensing, packaging, transport, administration, disposal, and spills to identify where education and training are necessary.

Organizations may have various levels of hazardous drug training based on the personnel involved in each step (see TABLE 1), and each organization may have a different approach for determining whether to provide broad or focused education within groups of personnel. For example, some institutions may choose to educate providers (ie, physicians, nurse practitioners, physician assistants) on all elements of USP <800>, while others may focus only on activities imperative to each position within the institution.1 The process can be simple or complex depending on the normal structure of education and training. Regardless of the approach taken, all education and training should begin with an explanation of the cumulative risks of hazardous drug exposure and the purpose of the USP <800> chapter.1

Establish a Workgroup

Once the health system’s policies and procedures are clear, the USP <800> designated person needs to form a workgroup of the key stakeholders that will create and implement education and training.1 Having at least one team member from each personnel group provides an accurate perspective of needs. Larger organizations may have access to an educational department that can help guide the educational process and meetings. This department also typically has access to electronic resources that support the dissemination of information across large groups.

Special education and training needs should be considered for the following groups:

  • Students, residents, fellows, and other rotating learners
  • Traveling nurses, respiratory therapists
  • Non-employee staff
  • Offsite areas with potentially limited resources

Focus on Pharmacy Staff

There are two essential elements for pharmacy staff education:

  • Understanding the risks of hazardous drugs
  • Comprehending the hazardous drug policy and procedures

Personnel must fundamentally understand that the risk of working with hazardous drugs is cumulative over time and some activities pose more risk than others. For example, cleaning spills, working with powders, crushing tablets, and preparing injectable antineoplastic agents carry more risk than handling unit dose tablets. When familiar with these risks, pharmacy staff will more fully comprehend the required policies and procedures.

To create an educational program for pharmacy, three primary areas need to be addressed:

  • Onboarding education
  • Skills testing and validation
  • Annual competencies

Attention to all three of these areas ensures staff will have the knowledge and confidence to act within department policies and procedures and thus maintain compliance with USP <800>.1 Policies and procedures vary greatly from institution to institution depending on whether an assessment of risk has been completed and the decisions made based on that assessment. For example, a facility that has demonstrated incorrect use of personal protective equipment (PPE) during the assessment of risk may implement different classification systems or color coding to confer risk and level of PPE required.

Onboarding

New staff should have dedicated educational time with qualified personnel to discuss hazardous drugs. Technicians and pharmacists should have a clear and measurable plan for ensuring each step in the hazardous drug distribution process is addressed. Documentation of this plan should be completed during the onboarding and training period. Example documentation checklists are provided in TABLE 2.

Toward the end of the onboarding period, staff should not only be able to discuss accepted practices for handling hazardous drugs but also demonstrate proficiency through skills assessments. Assessment days can be scheduled at the end of the training period to demonstrate selected tasks related to hazardous medications.

Ongoing Competencies

Creating a competency testing protocol can aid in establishing the timing and frequency of testing, required resources, and staff responsible for carrying out testing. The protocol should delineate subject material to include in competency testing that reflects USP <800> guidelines, skills for handling hazardous medications, organizational policy, and any specific items wherein the department may be deficient.1 This testing protocol will serve to ensure consistency over time.

Annual written competencies should focus on the proper handling of hazardous drugs. Additional questions should be compiled by subject matter experts in each area with consideration given to medication safety events from the previous year, policy and procedure updates, and compliance guideline updates. Ideally, competency exams are distributed electronically and scored against a pre-determined threshold. Any staff that scores below the threshold must receive documented remediation directed at providing the necessary knowledge and skills to competently follow department policies and procedures. Individual competency question analysis should also be performed to direct departmental education efforts.

Annual observations can be evaluated in person or virtually via live feed cameras. Results of scored observations and opportunities for improvement should be shared with the staff. Individuals not meeting the scoring threshold should promptly receive supplemental remedial education.

A robust way to sharpen skills and promote long-term compliance is to hold skills days. Skills days are events in which specific skills are reviewed in stations with a set time interval. Staff rotate through the stations until all are completed. These events are planned months in advance with coordinating schedules to allow for broad participation. Leadership and educators can both instruct at the stations and cover for others as they rotate through the stations. Resources required to conduct a skills day include time, space, personnel, and supplies.

Considerable time and effort are dedicated to hazardous drug onboarding, annual didactic competencies, and skills observations. To ensure these efforts are demonstrable to surveyors and accrediting bodies, documentation methods should be developed that are both efficient for staff to use and easy to access in the event of an audit. Audits of this information should occur on a departmental level at regular intervals.

Resource Sharing

Measures should be taken to ensure clear and consistent information is available electronically for all staff members. Internal websites are a great way to share information. The pharmacy department should maintain resources specific to internal medication practices, such as policies and procedures, a hazardous drug handling handbook, closed system transfer device instructions, and position onboarding presentations. For departments outside of pharmacy, it is helpful to maintain a landing webpage for hazardous drugs which contains information and links to policies and procedures, external resources, PPE charts, FAQs, and various departmental onboarding presentations. Both the institutional resources and the pharmacy department’s resources should be audited at regular intervals and compared across departments for consistency. Likewise, these resources should be regularly compared against published guidance and best practice documents.

Managing Spills

While preparing for the expected is important, it is perhaps even more important to prepare for the unexpected. Pharmacy should partner with the safety or risk management departments to develop an appropriate response to minimize the risk of hazardous drug spills to patients, visitors, and employees. Examples of emergent situations can include hazardous drug spills, IV tubing disconnections, or broken packaging in hazardous drug deliveries. Dedicated emergent situation response staff should be trained on the PPE and safety data sheet (SDS) in order to deactivate, decontaminate, clean, and dispose of hazardous drugs and materials. Personnel that handle hazardous drugs should be trained to clean spills using a spill kit. Spill kits should be stored near all hazardous medication storage areas and other convenient areas identified by management. If the kit contains an N95 respirator, fit testing may be necessary. Organization and department policies must define which staff members need to be educated and demonstrate competency for cleaning spills.

Creating a spill team is an effective method to address the organization’s responsibility for managing emergent hazardous drug situations. The team should be onsite or on-call 24 hours a day to assist with large spills. Spill teams may not be required in every hazardous drug spill; however, quantifying a spill volume can be challenging for employees in a stressful situation. A good rule of thumb is to require a spill team response when more than two spill kits are required to clean a hazardous drug spill. Spill team members should cover all shifts, weekends, and holidays through a combination of leaders, charge nurses, educators, safety, pharmacists, and pharmacy technicians. The spill team must have the necessary resources and authority to ensure an emergent situation can be resolved. The responsible person coordinating the spill team needs to be aware of legally required communication with any government entities to report emergent situations. Finally, security services may also be necessary to ensure patients, staff, and visitors are not exposed to areas contaminated with hazardous drugs or materials.

Compliance technicians or pharmacists and a safety director can conduct mock spill drills in areas that handle, store, or administer hazardous medications to prepare staff for handling emergent situations. A scoring tool should be used to measure competency (see FIGURE). The drill results and feedback should be shared with the department leader and staff, along with any necessary education that is identified during the drill.

Long-term Compliance

With many competing priorities, ensuring long-term compliance can be challenging. Scheduling recurring quarterly or twice annual multidisciplinary hazardous drug leadership meetings serves to hold the organization accountable. Meetings to review data help ensure the completion of onboarding education within applicable roles throughout the organization. Results from ongoing written and observed competencies as well as spill drill scores should also be reviewed. Documentation of these meeting minutes and any action items will be helpful during regulatory surveys.

Some organizations may find that annual efforts are burdensome to approach all at once. Splitting competencies into smaller parts may prove less intimidating. One approach is to address smaller competencies during the first 5 to 10 minutes of a staff member’s shift so that they are not absent from patient care for an extended period.

Documentation

Documentation of any education, training, or competency assessment is required. Education through presentations should be recorded or acknowledged electronically. Institutions frequently create paper checklists for personnel to use during their onboarding period. These checklists should be scanned or converted to electronic documentation in the organization’s learning management system or electronic human resources file. Any annual or other ongoing competencies and assessments should follow similar processes.

Conclusion

To create effective hazardous drug education and training, organizations must invest both time and resources. Creating policies and procedures is typically the first step in each institution’s effort to ensure compliance with USP <800>, but without personnel knowledge and proficiency, policies and procedures alone will fail to protect employees from the risks of hazardous drugs.

References

  1. United States Pharmacopeia (USP). USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare.

Ashley Duty, PharmD, MS, BCSCP, is the director of inpatient pharmacy operations at Nationwide Children’s Hospital. Ashley earned a doctor of pharmacy from Ohio Northern University and a master of science in health-system pharmacy administration from Northeast Ohio Medical University.

T. Patrick Collins, PharmD, is an inpatient operations manager at Nationwide Children’s Hospital. Patrick previously served as the pharmacy educator at Nationwide Children’s. Patrick earned his doctor of pharmacy at The Ohio State University.

Troy Kienzle, PharmD, MS, is an inpatient pharmacy manager at Nationwide Children’s Hospital. Troy received a doctor of pharmacy from the University of Wisconsin and a master of science in health-system pharmacy administration from The Ohio State University.

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