Category: Professional Posters
Purpose: Handling of hazardous drugs (HD) comes with inherent risk and USP discusses practices and standards to promote safety and protection for both patients and workers. The chapter states that environmental monitoring (EM) should be conducted to detect HD residue initially as a baseline and at least every 6 months. The pharmacy department at NewYork-Presbyterian/Queens developed an environmental monitoring plan using a point-of-care lateral flow technology hand-held device that delivers qualitative results for select marker HD (methotrexate and doxorubicin).
Methods: An EM plan was developed by examining the life of an HD drug throughout the pharmacy. An assessment was conducted to determine every point an HD may come in contact with the environment. The overall risk of each site was stratified according to three categories: likelihood of occurrence (dependent on volume and manipulation of HDs), severity of occurrence (accessibility and exposure to others), and mitigation controls (engineering controls, administrative controls, and personal protective equipment in place). Each category was scored from one to three and collectively tallied to determine if a site was low (3-4), medium (5-6), or high (7-9). The risk level was then used to determine a frequency of testing where low would be tested semiannually, medium would be tested quarterly, and high would be tested monthly.
This technology allows for rapid detection with actionable results, so a procedure for mitigation, remediation and further investigation of positive HD surface contamination results was created. When a site was positive testing was expanded to evaluate if HD contamination had spread. After sample collection, the positive site was deactivated, decontamination, cleaned and re-tested. An analysis of the site was used to determine if the HD contamination was due to work practices, personnel practices, or environmental controls. In addition to the routine monitoring, random testing was then conducted as a follow up to the plan of correction.
Results: After evaluating potential sites in the pharmacy department, it was determined that 30 sites would compose the baseline. Out of the baseline sample, 2 out of 30 sites were positive for methotrexate: a tote from the distributor and the edge of a containment primary engineering control (CPEC). Adjacent sites were further tested both before and after deactivation, decontamination, and cleaning which showed no positive results.
The corrective action plan for the distributor tote was to re-educate staff to unpack totes with chemotherapy rated gloves and to decontaminate and deactivate the receiving table at the end of every workday. The distributor was notified that the tote had been received with trace HD residue on the inside. The correction action plan for the edge of the CPEC was to re-educate and re-train staff about proper manipulation of HDs and deactivation, decontamination, and cleaning.
Conclusion: Although the point-of-care lateral flow technology is currently limited in the number of HD marker drugs for contamination detection, the cost-effective and rapid testing allowed for the development of a robust EM plan for the pharmacy department. This technology enables routine and random surface contamination testing to take place. In addition, the technology can be used as a tracer for when a marker drug is compounded. Even though the results are qualitative, the fact that the results are obtained within 10 minutes permits immediate mitigation and remediation that cannot be obtained with other current wipe-sampling analysis.