USP <800> was created to address the significant risks to health care workers handling hazardous medications. As supplemental engineering controls, closed system drug-transfer devices (CSTDs) provide additional protection when compounding and administering hazardous drugs (HDs). Per USP <800>, CSTD use is recommended for HD compounding and required for administration of antineoplastic HDs, as long as the dosage form allows and the HD is compatible with the CSTD. With over 2 years’ experience using CSTDs at Joe DiMaggio Children’s Hospital (JDCH) in Hollywood, Florida, we have identified the following key tips to ensure the successful implementation and ongoing use of this key safety technology.
Establish the Essential Purchasing Requirements
Because there are no universal performance standards for CSTDs, organizational leaders must determine the essential factors in selecting a CSTD. At JDCH, efficacy, ease of use, and cost were identified as the most critical factors. Efficacy was evaluated via independent research and a review of published literature. We were particularly interested in the published results of product testing that demonstrated the ability of available CSTDs to preserve product sterility while containing vapors, aerosols, and droplets within the system. Ease of use was based on a review of CSTD components, the number of pieces involved, and the strain on the user from repeated use. In addition, we considered the CSTD’s compatibility with medications and other compounding products used by the institution. Lastly, the ability to negotiate a competitive contract with the manufacturer ensures use of the product can be sustained by the organization for years to come. While perhaps not as essential as the aforementioned factors, product availability and manufacturer support were nonetheless considered as part of the selection process. These can become key issues should product malfunctions or purchasing challenges arise at a future date.
Gain Administration’s Buy-in for USP <800> Compliance
Support from hospital administration was crucial to attaining the financial backing necessary for our institution to obtain and implement CSTDs. Pharmacy leaders initiated conversations with both executive leadership and nursing administration that focused on the benefits of CSTD use and the pending regulatory requirements. The increasing availability of published literature revealing the scope and detriment of HD exposure to health care workers provided justification for the added cost of the products. The publication of USP <800> and enforcement of the chapter by regulatory agencies such as The Joint Commission helped to establish a timeline for adopting CSTDs.
The organization created a system wide HD Task Force with multidisciplinary representation. The role of the HD Task Force chairs is to share information with hospital executive administrators, medication safety leaders, and other stakeholders to improve HD handling practices. Thus, it was quite helpful to have members of the HD Task Force as part of the Request for Proposal (RFP) process.
With the support of the supply chain department and a thorough RFP process, a detailed manufacturer assessment was conducted, and ultimately the final vendor selection was accomplished. Simultaneously, pharmacy leadership worked proactively through the hospital’s annual budget process to request funding for the necessary CSTD supplies for preparation and administration of select hazardous medications.
Gain Staff Buy-in for CSTD Use
Obtaining buy-in from impacted hospital staff was essential to the success of the CSTD implementation. Pharmacists, pharmacy technicians, and nurses were provided education to increase awareness regarding the risk of HD exposure to health care providers. The main points of the education initiative encompassed:
The goal was to increase the understanding of risks associated with HDs while also creating a safe handling culture at our institution. Group education sessions were held to inform team members of risks and mitigation strategies, including the importance of products such as CSTDs, which were to be implemented throughout the system to increase safety for the health care provider.
Another strategy used to increase staff buy-in was to involve the impacted staff in the CSTD selection process. Select staff members were invited to participate in the CSTD vendor fair to evaluate the ease of use of each device, assess the components, and identify any workflow changes that would be needed to implement the selected CSTD. Staff involvement, education, and culture shift were necessary to gain support for the implementation.
Provide Thorough Staff Training
To encourage appropriate use of the selected CSTD, staff were educated on the device through a multitiered approach. The first step was the observation of manufacturer recorded video tutorials, which was well-received by the team members. The use of videos allowed staff to visualize the steps for correct handling and increased their comfort level with the product itself. Following the videos, manufacturer representatives provided hands-on training to impacted pharmacy personnel and a small group of nursing super-users who then educated their peers. The train-the-trainer approach was another effective educational tool. Following the train-the-trainer sessions, hospital-wide education was led by all super-users, targeting those who were projected to use the CSTD. Role specific education started with a presentation to explain the purpose of CSTD use, followed by hands-on training, and finally, user competency was validated through direct observation and return demonstration. A competency checklist was created and completed for all employees to document the training. Once the CSTDs were implemented, an annual competency for pharmacy and nursing staff inclusive of CSTD workflow has served as a measure to evaluate proficiency.
Develop a Positive Relationship with your CSTD Vendor
The effectiveness of our CSTD implementation is due in part to the positive relationship between our organization and the vendor. Sustained lines of open communication began prior to the contractual agreement and continue through current day. Real time reporting occurs for any issues or concerns that arise. The reporting is typically initiated by staff who handle the CSTD and then funneled through pharmacy and nursing leaders to the manufacturer. By encouraging the reporting of end user feedback and concerns, we have benefitted from the resultant product revisions undertaken by the CSTD vendor, which further strengthens buy-in from staff. Additionally, a strong relationship with the vendor allows for easy triaging of product availability questions. The CSTD vendor’s openness to feedback as well as the provision of consistent product updates has fueled a strong vendor-buyer relationship, and more importantly, it creates trust in the product among the end users.
The facility wide CSTD implementation was celebrated as an additional safety measure by staff and administration alike. This, coupled with identification of essential requirements, comprehensive training, a constructive relationship with the CSTD vendor, and a culture shift embracing safety in HD handling allowed for both a successful implementation and sustained utilization of this important technology.
Joanie Spiro Stevens, PharmD, BCPS, BCPPS, is a pharmacy clinical manager and the PGY2 pediatric residency program director at Joe DiMaggio Children’s Hospital (JDCH) in Hollywood, Florida. She received her Doctor of Pharmacy degree from the University of Florida College of Pharmacy and completed a PGY1 residency program at Sarasota Memorial Health Care System.
Courtney Trace, MSN, RN, CPHON, is the nurse clinician for inpatient and outpatient pediatric hematology-oncology and clinical grand rounds coordinator at JDCH. She received her Bachelor of Science in nursing from University of Florida College of Nursing, and her Master of Science in nursing education from Grand Canyon University College of Nursing. Her professional interests include the pathophysiology and treatment of sickle cell disease, as well as the promotion of employee and patient safety.
Leyner Martinez, PharmD, MS, MHA, FACHE, is the director of pharmacy services at Baptist Hospital of Miami. Dr. Martinez received his Doctor of Pharmacy degree from the LECOM School of Pharmacy. He completed a PGY1 residency with drug information emphasis at the Poison Control Center/Jackson Memorial Hospital and a combined PGY1/PGY2 residency in Health-Systems Pharmacy Administration at the University of Pittsburgh Medical Center. Dr. Martinez earned a Master of Science degree in pharmacy administration and a Teaching Certificate from the University of Pittsburgh, a Master of Healthcare Administration from Florida Atlantic University, and certifications in Medication Therapy Management and Pharmacy-Based Immunization Delivery. He is a preceptor to residents and students for health-system pharmacy administration and advance hospital/institutional practice rotations. Dr. Martinez is also a Fellow of the American College of Healthcare Executives (ACHE).