Clinic Pharmacy

USP <797> and USP <800> Auditing Assessment

IndustryClinic Pharmacy
ProblemAn oncology clinic’s pharmacy was operating as a physician dispensing site for the preparation of their compounded chemotherapeutic medications. Because physician dispensing sites are not subject to the same requirements as state-licensed pharmacies, the organization’s management was concerned that the pharmacy’s operational practices and physical components, such as compounding hood(s), were not fully compliant with USP <797> and USP <800>.
PHSL SolutionPHSL held preliminary discussions with management, created an audit plan, and reviewed the organization’s existing policies and procedures to better understand current operations before completing an onsite assessment. The onsite audit compared the pharmacy’s current physical layout and operations to USP 797 and USP 800 guidance. PHSL was also able to perform a gap analysis between the P&Ps and actual pharmacy practices. PHSL provided the clinic with a comprehensive report highlighting areas of concern and recommendations to remediate.
ResultsThe audit findings report and subsequent action plan highlighted the pharmacy issues for clinic management, allowing them to focus efforts on improving the pharmacy work environment for employees and potentially avoiding audit or patient safety risks in the future.

Dispensing System Implementation

IndustryClinic Pharmacy
ProblemThe hospital system required external assistance in implementing a new EnterpriseRx pharmacy dispensing system and point of service (POS) in their clinic pharmacy after the departure of the personnel in charge of the project. The dispensing and POS systems needed to be configured to accommodate the available space, pharmacy workflow, and defined business requirements to complete the implementation by the targeted installation date.
PHSL SolutionPHSI participated in the decision making process and worked to configure and set up the systems. PHSI preformed testing on the dispensing system to validate the conversion data. A portion of the project was supported remotely to minimize travel expenses for onsite visits. PHSI revised the physical layout of the pharmacy to improve workflow and engaged the facilities management department to execute the changes. PHSI worked with the robotics vendors to de-install and install the automated dispensing systems. PHSI was part of the system implementation process and assisted with the training process on the new dispensing and POS systems.
ResultsPHSI assisted the client in implementing the new dispensing and POS systems that enabled them to manage their workflow process through PHSI recommended system configurations and changes to the physical layout of the pharmacy. Experience and knowledge of the pharmacy dispensing process and the new EnterpriseRx system allowed PHSI to provide direction and the necessary insights into configuring the systems and to educate users on how to efficiently use them. PHSI’s ability to guide the process led to the successful and timely implementation of the new systems.