Training and Competencies for USP <800> Compliance

October 2020 - Vol.17 No. 10 - Page #20

Q&A with Caryn Belisle, BS Pharm, RPh, MBA
Director of Pharmacy Regulatory Compliance, Quality, and Safety
Brigham and Women’s Hospital


Pharmacy Purchasing & Products: What is the process for identifying all staff who could potentially be exposed to hazardous drugs?

Caryn Belisle, BS Pharm, RPh, MBA: Whether working in a small hospital or large health-system, identifying which employees might be exposed to hazardous drugs (HDs) can be a bit overwhelming. The obvious employees, such as nurses, pharmacists, and pharmacy technicians, are at risk of exposure through the nature of their work handling or administrating HDs. But it is also important to consider other staff who may be exposed to HDs, such as those that work for environmental, laundry, transport, or food services. In addition, consider per-diem staff or contracted vendors who perform duties in clinical areas. Identifying staff that have exposure risk should be straightforward in the units, clinics, and areas in which it is known that HDs are used, but remember to also consider the paths HDs travel to get to these areas; there could be a potential spill or exposure while HDs are en route. Unless there are areas within the organization where HDs are restricted, all members of the hospital team must be taken into consideration when orchestrating a training and competency program for HD handling and/or exposure.

PP&P: What are the key components of an effective USP <800> staff training program?

Belisle: USP <800> decrees that any staff member handling HDs must be trained on their specific job function, and that training must include the following elements1:

  • An overview of the institution’s HD list and the associated risks
  • A review of relevant standard operating procedures related to HD handling
  • The proper use of personal protective equipment (PPE) and devices
  • HD disposal procedures
  • The management of HD spills
  • How to respond to a known or expected HD exposure

All other staff that do not handle HDs but may encounter them during their daily work can also be trained on these components; however, it is important not to overload these staff members with extraneous information that may dilute the importance of what to do if they were to be exposed to an HD. For example, an employee from environmental services does not need to know how to use a closed system drug-transfer device (CSTD), but they should know that CSTDs are used in the facility and how to identify them.

Elements of training for staff members who do not handle HDs can include defining what components determine if a drug is hazardous—eg, carcinogenicity, teratogenicity—and the definitions of those terms. The training can also include the information that the institution employs policies and procedures (P&Ps) for those that handle HDs, and where to find those P&Ps. In addition, present an overview of exposure controls that focus on both employee and patient safety, such as engineering controls (eg, biosafety cabinets, CSTDs, etc), PPE, container labeling, HD disposal, spill prevention and response procedures, Occupational Health consultations, and department-specific training. Staff should be directed to speak with their supervisors for more information.

PP&P: How should training be documented, and how should an organization ensure new hires receive proper training?

Belisle: All training must be documented and these records should be stored so they are easily accessible; any form of electronic documentation is preferred over paper documentation. A web-based system can support a comprehensive training program, including all training materials and documentation and/or attestation that the employee has received the training. These web-based systems can also be used to ensure any new hires complete the necessary trainings.

The responsibility that all new hires are properly trained on HDs should reside at the department level. For organizations that wish to centralize HD training and competencies, Occupational Health or Environmental Affairs could be the overarching owners of the training.

PP&P: How should an organization create competency testing processes based on employees’ exposure risk?

Belisle: It is imperative that the design of any competency testing is based on the employee’s job function and HD exposure risk. A pharmacist or pharmacy technician competency test should include specifics about receiving, unpacking, storing, spill control, and compounding of HDs, including how to use a CSTD. This type of competency testing typically is delivered via a presentation that includes photos and/or videos.

Another form of competency for compounding personnel is an HD compounding technique test. While akin to an aseptic technique test, the compounding technique test evaluates the user’s capabilities to manipulate HDs without any spillage or HD contamination. Web-based training is also useful for testing competencies for nurses or any providers that administer HDs. It is important to focus on how to identify HDs, how to use CSTDs, and how to respond in the event of a spill.

For those staff who do not handle HDs but might be exposed, a one-size-fits-all training method might be the best approach; capture the relevant elements of the training program such as HD definitions, PPE, spill response, how to identify an HD, and how to locate the Safety Data Sheets (SDSs).

PP&P: How should an organization develop a template for its hazard communication program?

Belisle: Organizations are required to develop a hazard communication program. The components of the plan must include the following1:

  • How the plan will be implemented
  • How to identify HDs
  • How to identify the labels of HDs with appropriate warnings
  • The assertion that SDSs will be readily available for each HD that the facility has on site
  • A statement that education and information will be given to all personnel who might be exposed to HDs when working
  • Personnel of reproductive capability must acknowledge in writing that they understand the risks of handling HDs

The Occupational Safety and Health Administration posted a sample hazard communication plan on their website (available at:
).2 In addition to the required elements in the HD plan, the sample also includes specific information about training and informing employees who do special tasks as well as informing contractors and other employers about HDs.2


  1. USP General Chapter <800>: Hazardous drugs — handling in healthcare settings. In: USP 42-NF 37. Rockville, MD: US Pharmacopeial Convention; 2019.
  2. Sample Hazard Communication Plan. Accessed August 13, 2020.

Caryn Belisle, BS Pharm, RPh, MBA, is the director of pharmacy regulatory compliance, quality, and safety at Brigham and Women’s Hospital in Boston. She has served as president of the Massachusetts Society of Health-System Pharmacists and presently serves on the House of Delegates for the American Society of Health-System Pharmacists.


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