Handling and preparing hazardous chemotherapeutic agents has been a documented occupational risk for health care workers since the 1970s. Exposure to hazardous drugs may cause chromosomal aberrations, congenital malformations, miscarriages, and possibly leukemia and other cancers.1-6 Although safe handling procedures—such as use of personal protective equipment, engineering controls, and HEPA ventilation—are effective, they cannot prevent the generation of contaminants. The efficacy of any safety measure depends on the skill of the person using it. Perhaps more concerning, studies have shown that even when these safety measures are fully employed, contaminants still may be found around safety hoods, on gloves, and on hospital room floors.7-10 Thus, the importance of developing and implementing a robust hazardous drug training program for pharmacists cannot be overstated.
North Fulton Hospital (NFH) in Roswell, Georgia is a 202-bed, acute-care hospital and a state-designated level II trauma center. The hospital’s cancer program is fully accredited by the American College of Surgeons’ Commission on Cancer. As a small hospital that prepares chemotherapy infrequently—on average, about three or four times per month—ensuring that pharmacists are properly trained in hazardous drug preparation is vitally important to prevent skill decay over time. In November 2013, NFH implemented a process to ensure safe chemotherapy preparation using a robust pharmacist-training program, which includes use of a closed-system drug transfer device (CSTD) for preparation and administration of hazardous drugs.
Developing a Standardized Chemotherapy Preparation Program
A thorough training program is an essential component of a comprehensive hazardous drug management strategy. At NFH, pharmacy technicians prepare the pre-medications required for chemotherapy and pharmacists check the technicians’ work and prepare the chemotherapy. Prior to the implementation of the pharmacist-training program at NFH, only three pharmacists prepared chemotherapy, thus limiting the times during which patients could receive these drugs. In addition, coverage was a challenge when a pharmacist was unable to prepare chemotherapy, such as when trying to conceive a child or during a pregnancy. To make certain chemotherapy would be available to patients at all times, the decision was made to train all pharmacists in a standardized approach to chemotherapy preparation.
Ensuring each element of the hazardous drug-training program was standardized to the greatest extent possible was a primary concern. For example, it was vital to create standardized process for handling hazardous drugs safely, as well as for proper CSTD use.
To begin, two clinical pharmacists studied videos and received training on proper CSTD use from the manufacturer. Thereafter, several tools were developed to ensure chemotherapy preparation occurs in a uniform manner, regardless of which pharmacist prepares the medication; these tools formed the basis for our hazardous drug safety–training program for pharmacists.
A checklist for preparing chemotherapy was developed, based on guidelines from ASHP, USP Chapter <797>, NIOSH, and an article from Pharmacy Purchasing & Products that detailed a staff competency program for chemotherapy preparation (available at www.pppmag.com/staffcompetencyprogram). The chemotherapy preparation checklist for pharmacists is available at www.pppmag.com/HDChecklist. In addition, a step-by-step policy and procedure was created for pharmacists to use when checking chemotherapy orders. Finally, a chart was developed that included stability data and specific administration directions for the chemotherapy medications on formulary.
Integrating CSTD Use
The pharmacy director, clinical manager, a clinical pharmacist, and the clinical pharmacist specialist in oncology participated in the development of the hazardous drug–training program. The pharmacy director worked closely with management to explain the benefits of using a CSTD to ensure the safety of pharmacists and nurses, as well as the risks associated with not using a device; management agreed and funded the CSTD purchase. After reviewing the literature and evaluating the available CSTDs, we met with two CSTD manufacturers and selected the device that was best suited for pharmacy and nursing use based on safety, ease of use, clinical study results, and overall cost.
CSTD Training Process
Training was conducted with each pharmacist individually. The pharmacist began by watching the training videos and reviewed the diagrams available on the CSTD manufacturer’s Web site prior to the training. This was followed by hands-on practice. The clinical pharmacist specialist in oncology demonstrated the procedure, preparing a mock chemotherapy drug using normal saline and sodium chloride vials, and then the trainee followed the checklist to demonstrate competency by producing the mock chemotherapy. Ten pharmacists were trained in a one-week period during the annual staff competency tests for pharmacists. At the end of the week, all checklists were added to each pharmacist’s annual competency file to document that training occurred.
A Collaborative ProcessThe involvement of the pharmacy director, clinical manager, a clinical pharmacist, and an oncology specialist were crucial to the success of the training process. The pharmacy director participated in meetings with the CSTD manufacturers and facilitated the approval of the chemotherapy-training program, while the clinical manager assisted with scheduling the training and providing the necessary materials, such as saline bags and mock chemotherapy drug vials. The clinical pharmacist and oncology specialist were responsible for researching the CSTD, assisting in the development the chemotherapy-training program, and training the pharmacists.
Evaluating the Effectiveness of the Program
To evaluate the effectiveness of the tools developed to ensure safe chemotherapy preparation, a pharmacist with no chemotherapy preparation experience followed the checklist and demonstrated that she could make the product using the instructions provided. A pre- and post-training chemotherapy preparation questionnaire was developed to measure the effectiveness of the chemotherapy-training program (see Figure 1); the results demonstrated that pharmacists’ chemotherapy preparation knowledge improved significantly after completion of the training. Once the pharmacy director and clinical manager approved the training process, it was added as a component of pharmacists’ required annual competencies.
Ensuring Continued Adherence to Safe Practices
To ensure ongoing adherence to proper procedures for preparing chemotherapy, the chemotherapy procedures were placed in plastic covers next to the vertical flow hood for easy reference. Because our hospital administers a low volume of inpatient chemotherapy, pharmacists rarely have the opportunity to prepare chemotherapy, making the preparation checklist extremely useful.
In addition, pharmacists undergo annual training, during which they must demonstrate their ability to prepare chemotherapy according to the procedure. A chemotherapy competency test also was created and is administered to each pharmacist during the annual training process to ensure proficiency in chemotherapy calculations and protocols.
Several measures have illustrated the success of the hazardous drug–training program. Pre- and post-tests completed by each pharmacist show that their comfort level in preparing chemotherapy has increased. Staff satisfaction is high, although the pharmacists would like to have more frequent opportunities to practice chemotherapy preparation. To address this, we are considering conducting ongoing training every six months rather than annually. In addition, we are considering scheduling time each month for pharmacists to practice preparing mock chemotherapy.
Regular review of guidelines for hazardous drug preparation is required to ensure that our procedures remain current and that we continue to use the most effective technologies for minimizing contamination. If the volume of inpatient chemotherapy increases in the future, NFH may consider training and certifying the pharmacy technicians to prepare chemotherapy, which would be checked by a pharmacist.
The development of a hazardous drug–training program for pharmacists at NFH has improved patient safety and increased staff knowledge of proper chemotherapy preparation. The training program has been well received by staff, and the reference materials developed ensure ongoing adherence to the standardized procedure. In the future, we look forward to continually identifying opportunities to further improve the quality and reach of our pharmacist hazardous drug–training program.
Sonia Patel, PharmD, is a clinical pharmacist at North Fulton Hospital in Roswell, Georgia. She received her pharmacy degree from South University School of Pharmacy in Savannah, Georgia. Sonia’s professional interests include medical and hematology oncology.
The author would like to acknowledge Christopher Pitts for his assistance with this article.
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