While most pharmacy directors (54%) currently plan to manage all of their HDs using the containment properties and work practices listed in USP <800>, an increasing number are committing to performing risk assessments for certain HDs in order to handle these products using alternative containment strategies and/or work practices. As facilities continue to focus on their compliance efforts, it is expected that additional facilities will undertake risk assessments for certain HDs, such as oxytocin.
While many facilities have taken the first step and assigned an individual to the required Designated Person role, few have progressed to creating a written job description for this role. Note that assigning a staff member to the this role has an impact on regulatory compliance: Facilities with a Designated Person in place are twice as likely to have achieved full compliance to USP <800>.
Compliant SOP development is underway to address HD handling in most facilities, with the largest facilities having made the most progress in this endeavor to date. Among the smallest facilities, 79% have created HD handling SOPs; that number jumps to 92% for facilities with 400+ beds.
Job Description for a USP <800> Designated Person
Suzanne J. Francart, PharmD, BCPS; and Lindsey B. Amerine, PharmD, MS, BCPS
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