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Walton and Walker Submit Alliance for Clinical Trials in Oncology Application

Tuesday, June 12, 2018

Kudos to AnnMarie Walton and her mentor Julia Walker for the submission of her Alliance for Clinical Trials in Oncology application entitled "Examining the Impact of USP <800> implementation on surface contamination with Hazardous Drugs." This proposal requests funds for a one-year period with a start date of August 15, 2018.

Purpose/specific aims: Over eight million United States healthcare workers practice in environments in which they may be exposed to hazardous drugs (HDs) that are associated with genotoxicity, carcinogenicity, teratogenicity, fertility impairment or reproductive toxicity and/or serious organ toxicity, even with exposure at low doses. United States Pharmacopeia (USP) General Chapter <800>, anticipated to become official on December 1, 2019, is a new standard developed to minimize exposure to HDs for healthcare workers. USP<800> will mandate staff education, personal protective equipment (PPE) use in clinical areas, and the use of closed system transfer devices (CSTDs) during administration of HDs. Of key importance, healthcare facilities will be required to regularly conduct surface wipe sampling for the first time in history.  However, USP<800> lacks data based guidance on which surfaces to sample. Our specific aims are: 1) Determine the extent of HD contamination on select inpatient and outpatient oncology surfaces; 2) Determine the relationship between surface contamination and the extent of implementation of USP <800>; 3) Explore factors that influence protective behavior for healthcare workers in inpatient and outpatient oncology settings.

Significance of study: This study will fill a gap in knowledge about which surfaces to sample in inpatient oncology units. We will determine the extent to which implementation of USP <800> requirements reduce surface contamination, which facets of the requirements influence outcomes most and explore factors that influence employees' protective behavior. Results will inform multi-level interventions to reduce surface contamination with HDs for healthcare workers in inpatient oncology settings.

Conceptual Framework: This study is guided by National Institute for Occupational Safety and Health's Hierarchy of Controls Framework, which illustrates that a multitude of controls are needed but posits that engineering controls (e.g. CSTDs) will have the greatest impact on exposure and individual controls (e.g. use of PPE) the least. Pender's Health Promotion model will also be utilized to understand the factors that influence an individual's use of PPE. We will measure the extent to which each facet of implementation of USP <800> reduces surface contamination as a proxy for exposure.

Main research variables: The research variables are surface contamination with cyclophosphamide and etoposide, extent of implementation of USP <800>, and factors that influence individual level practice of protective behaviors.

Design: We will collect data at eight different healthcare facilities affiliated with Duke that are Alliance members.

Setting: Inpatient and outpatient oncology units that administer cyclophosphamide and etoposide to patients.

Sample: Eight inpatient or outpatient oncology units that are in the Duke Health System or the Duke Cancer Network and thus Alliance member facilities.

Methods: Approximately 60 wipe samples will be collected from patient rooms and shared work areas in each unit, the USP <800> implementation checklist will be completed by study staff, and all employees on the unit will be invited to complete a questionnaire assessing their level of orientation and competency, protective behaviors, and factors that influence their protective behaviors.

Implications for practice: This project will provide evidence for the effectiveness of USP <800> in minimizing surface contamination, uncover barriers to implementation for this Alliance member, and inform targeted interventions to minimize hazardous drug exposure for all healthcare workers and that can be replicated in other Alliance sites.