|ASAP Announces REMS Standard||| Print ||
The American Society for Automation in Pharmacy (ASAP) has partnered with Cephalon, Inc., on key elements for a new generation of risk evaluation and mitigation strategy (REMS) programs. Specifically, ASAP provided insights on a new communication standard designed to allow a pharmacy management system (PMS) to send required safety data to a REMS database.
The Standard for Real-Time Safety Adjudication for REMS Elements to Assure Safe Use (ETASU) program has been developed based on the current ASAP prescription-monitoring program (PMP) standard that is widely used today. This new communication standard is designed to support the various ETASU requirements of a REMS program and not just those of Cephalon.
Using the ASAP PMP standard as the basis for the REMS application minimizes programming changes needed in pharmacy management systems in order to handle the safety adjudication requirements and should expedite implementation.
In addition to transmission control protocol (TCP) transmissions using segments and data elements, the ASAP standard supports the exchange of XML for real-time safety adjudication enabled by a highly structured, sequential schema. This schema is implemented using the XML schema definition language (XSD) defined by the World Wide Web Consortium.
The REMS standard is available in the bookstore section of the ASAP Web site asapnet.org.