Hospital employees face significant risk from handling hazardous medications, and this holds true for every staff member involved with hazardous drugs in any capacity, from receiving through compounding, delivery, and administration. Unfortunately, adverse effects from exposure to these drugs are generally not immediately evident; to find any trends from exposure to hazardous medications, employees must be monitored over the long term, which requires the implementation of a systematic medical surveillance program for affected employees. As few pharmacists have experience developing such programs, creating a surveillance program to cover affected staff throughout your facility may seem a daunting task.
Cox Health is a three hospital, community-based, not-for-profit organization located in Springfield, Missouri. Our three locations encompass a total of 754 licensed beds, with 8,700 employees, including 487 physicians on staff, and provide services to 25 counties in southwest Missouri. The inpatient pharmacy staff comprises 127 employees, including 54 pharmacists. Each month, the pharmacy processes an average of 219,670 orders and dispenses an average of 352,600 doses. In addition, our oncology satellite prepares medications for more than 900 patients per month, averaging 1.8 medications per patient. In 2011, we compounded a total of 19,391 oncology-related medications for nearly 11,000 patients. Given the large volume of hazardous medication handled by our staff, concern began to mount as to the long-term effects of exposure.
Approaching a Medical Surveillance Program
In our commitment to averting staff exposure at Cox Health, we have always had the support to invest in appropriate engineering controls for hazardous drug preparation. Thus, we prepare hazardous products in negative pressure workspaces using biologic safety cabinets, personal protective equipment (PPE), and closed system transfer devices (CSTDs). To further mitigate exposure to our nursing staff, pharmacy established the routine practice of priming the IV tubing for all chemotherapy medications. While we routinely used large transfer spikes to draw medication from multiple-dose vials in the past, we implemented CSTDs in 2006 to bring this activity under greater control. We have found these devices to be very reliable, as failures are rare and are generally the result of improper use. As part of our contract terms, our CSTD supplier covers the cost of periodic wipe tests. The results of these tests have demonstrated that little exposure exists outside of the hood and the immediate surrounding area, which has bolstered pharmacy leadership’s confidence in the competency and technique of our staff. Nonetheless, we have always been aware that proper technique does not fully protect staff from exposure.
While our staff appear to be unaffected by their work with hazardous medications, we have no way of knowing for sure what the true effects are, especially over the long term. In investigating this, a combination of factors conflated to raise our awareness of the potential positive impact surveillance programs can provide. Ultimately, reviewing the AJHP article Guidelines for the Safe Handling of Hazardous Drugs: Consensus Recommendations1 and subsequent case reports on the Internet, along with questions from pharmacy listservs, led pharmacy leadership to consider implementing an employee medical surveillance program. Largely in response to our NIOSH gap analysis and OSHA recommended practices, pharmacy leadership approved the adoption of a surveillance program in late 2010.
Define Scope Through Teamwork
A team consisting of leadership representatives from the ambulatory infusion clinic, oncology nursing, patient safety, regulatory, and pharmacy met with our occupational medicine department to determine the scope of the program. Based on our collective familiarity with the risks inherent in managing hazardous drugs, along with the literature provided by occupational medicine, the team came to unanimous agreement that a medical surveillance program would provide significant support in protecting our staff. Given occupational medicine’s history in providing medical surveillance services to other companies in our area for many years, it was a natural extension for them to manage the medication surveillance program.
In early 2011, our team began a series of meetings to determine the implementation steps and identify which employees should be enrolled in the program. Our first step was to review the oncology department’s existing policies and procedures (P&Ps), which we found to be detailed and thorough in covering nursing staff procedures, although we did update the spill policy to include medical evaluations for any individual (patient, employee, or visitor) exposed during a hazardous medication spill. The pharmacy-specific policies, however, were in need of significant updating; for example, we added policies on cleaning and decontamination for hazardous drugs, as well as policies for PPE use. Furthermore, as part of this update we were tasked with reviewing the physical space allocated for receipt of hazardous pharmaceuticals, as we are space-challenged within our department. We then instituted P&Ps for receiving, delivery to the oncology satellite area, and mixing of hazardous medications. To build these policies, we utilized the NIOSH guidelines, USP General Chapter <797>, OSHA, and ASHP resources. These policies are strictly enforced; we use walking rounds to monitor compliance. During these rounds we complete spot checks and any staff not following procedures are corrected immediately.
Following another review of the policies to date, we then focused on identifying who should be enrolled in the medical surveillance program. The decision was straightforward for nursing services, as they determined that all staff would be enrolled. In the pharmacy, it was clear that all staff members working in the oncology unit would be enrolled, but beyond the oncology unit, where hazardous medications rarely are administered, the decision was less obvious.
Given that our staffing model is built around team-based coverage by patient care areas with customized training programs, we chose to enroll only those staff who worked in the sterile products areas or who were members of the oncology team. This initial enrollment accounted for approximately 25% of the pharmacy staff. We have since expanded the enrollment to staff routinely working in our pre-packaging area. While we did consider including the entire pharmacy staff, the team decided that the most efficient enrollment criteria would be to include only staff members who handled any hazardous medication at any point within our facility. Human resources supported this decision, going so far as to make enrollment in the program requisite for working in any area where hazardous medications are handled or administered. New or existing employees identified to begin training in our sterile products areas are automatically enrolled into the medical surveillance program as part of the orientation process.
Defining Program Parameters
Due largely to their past experience, occupational medicine designed the structure of the surveillance program for us. They posited that the ideal program would begin with a baseline evaluation, then follow up periodically with all at-risk workers handling hazardous material (program enrollees). However, given that the program includes some individuals who have been practicing at our institution for more than 25 years, a baseline evaluation for every employee was not possible. Our occupational medicine medical director has recommended annual or biannual follow-up evaluations, although the optimal period for follow up has yet to be determined.
It is clear that building the program in conjunction with the occupational medicine department was key to its success. They bring expertise to the surveillance component and are available on-site for discussion with pharmacy leadership and staff. In addition, occupational medicine created an education program for the initial enrollment period during which participation is required. In fact, the medical director of occupational medicine completed the majority of this education in person.
Employees identified for enrollment in the program are provided with a questionnaire, also designed by the occupational medicine department. The questionnaire is quite extensive and covers many aspects of an employee’s health, including a comprehensive medical, social, and family history, along with an exposure and reproductive history (see Figure 1). The employee also receives a requisition for blood and urine samples to be collected by our laboratory. Once the medical staff in occupational medicine receives the results, they schedule a time to meet with each employee and review the findings. The results are shared only with the employee—a key element of the program, as when the program was launched, many employees expressed concern that their personal health information would be shared with their department leaders or with human resources. During the initial enrollment phase, when the respective department leader explains how the program works, they emphasize that the employee’s personal medical information will not be shared outside of the medical staff in occupational medicine. However, employees are encouraged to share any relative results with their primary care physician.
Program Goals and Results
There is an innate challenge to the success of all medical surveillance programs in that employees often move on to other organizations, making long-term analysis of trends difficult. To address this situation, our goal is to provide each employee with sufficient information for future monitoring. Employees leaving the organization are requested to complete a post-employment screening similar to the initial screen. This information is again provided to the individual who may in turn provide it to their next employer.
The occupational medicine department provides feedback to the team leaders regarding the initial outcomes of the surveillance results. This information is provided in aggregate, without identifying individual employees. While there have been no alarming results, they did identify a few non-urgent health care needs for which the employee was referred to their primary care physician. For example, two employees were identified as having diabetes or being in need of further determination of their blood sugars. Otherwise, the results have been within the normal range. The individual patient files are maintained in the occupational medicine department. Overall the medical surveillance process has been well received by our leadership, as well as by human resources and our staff. Leadership sees the program as an excellent method for detecting trends, while individual employees see the benefit to their general health and are confident in the privacy we maintain. After initially implementing this program within our nursing and pharmacy areas, we have since expanded to include staff from radiology, endoscopy, sterile processing, and some of our clinic entities. The program is offered to any department or employee deemed to have contact with hazardous medications. From a financial perspective, the lab work costs approximately $400 per employee and the MD appointment is approximately $100.
Jennifer Reeves, RPh, has served as assistant director of pharmacy at Cox Health in Springfield, Missouri since 2005, where she focuses on pharmacy operations and regulatory readiness. Prior to this role, she served as the site supervisor for two facilities in the Cox Health System following a role as a clinical pharmacist in the NICU. Jennifer received her BS in pharmacy from the University of Kansas in 1993.