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Specialty pharmacies need to ensure that certain protocols are in place for product shipment and storage.
Specialty pharmacies need to ensure that certain protocols are in place for product shipment and storage.
The Utilization Review Accreditation Commission (URAC) is an independent, nonprofit, standards-setting and quality improvement organization that sets benchmarks for and accredits more than 500 organizations through 17 separate accreditation programs across several areas of health care delivery. These areas include preferred-provider organizations, health technology, worker's compensation, health call centers, and recently, specialty pharmacy.
URAC began standards-setting in the late 1980s when decisions about coverage of plan benefits were nonstandardized and fragmented. By setting standards, URAC helped improve the quality of health utilization management. Standardization through accreditation helps measure changes in quality over time and ultimately improves the quality of service delivery and care.
Two important aspects of care quality recognized by URAC in regard to specialty pharmacy operation are shipping and storage standards.
URAC standards help ensure that shipments are fulfilled accurately to help maintain the integrity and stability of specialty pharmaceutical products. One way this is accomplished is through shipment tracking and mechanisms to notify pharmacists when shipments are delayed.
The URAC guideline notes the importance of 3 main quality-assurance aspects of shipping, including systems for ensuring shipping accuracy, maintaining appropriate institution-specific standards for shipping requirements, and assurance of product integrity and stability. Maintaining adequate temperature controls is an important part of maintaining the last of these requirements—product integrity and stability.
This requirement relates to another set of standards for specialty pharmacies set by URAC regarding product handling, storage, and inventory tracking. Among the requirements for this aspect of pharmacy operations listed in the URAC guidelines are the accountability and security of inventory, systems for controlled substances management, as well as maintenance of products at a proper temperature.
During inspections, URAC reviews product temperatures by examining recent temperature logs and interviewing staff members who are in charge of inventory management. Due to the temperature log requirement, to simplify the accreditation process any specialty pharmacy seeking URAC review now or in the future should have access to and use a continuous tracking temperature tracking logger.
Temperature tracking loggers are an important part of any specialty pharmacy, and in particular any specialty pharmacy seeking future accreditation with URAC. These loggers help protect patients by ensuring product stability and help protect pharmacies from the liability of expensive and unnecessary product losses due to improper storage.
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