1088 Supporting Safety for Patients Diagnosed with Narcolepsy by Restricting Distribution of Sodium Oxybate to a Central Pharmacy Using a Central Database and Longitudinal Monitoring

• Published in: Sleep (New York, N.Y.) N.Y.), 2018-04, Vol.41 (suppl_1), p.A404-A404
• Main Authors: Strunc, M J, Black, J, Lillaney, P, Profant, J, Lilienfeld, D, Appio, G, Mills, S, Bujanover, S, Thorpy, M J
• Format: Article
• Language: English
• Subjects: Pharmacy; Prescriptions; Shipments; Sleep disorders
• ISSN: 0161-8105; 1550-9109
• DOI: 10.1093/sleep/zsy061.1087

Abstract Introduction In the US, sodium oxybate (SXB) is used to treat cataplexy and excessive daytime sleepiness in narcolepsy in adults. Because of the risks of central nervous system depression, abuse, and misuse, SXB is available only through an FDA-mandated structured distribution program - the Xyrem® Risk Evaluation and Mitigation Strategy (REMS) Program. The program goal is to mitigate the risks of serious adverse outcomes that may result from inappropriate prescribing, misuse, abuse, and diversion of SXB. Methods This REMS program includes Elements to Assure Safe Use (ETASU), which specifies that clinicians who prescribe SXB and the central pharmacy that dispenses SXB are certified, and that SXB is dispensed and shipped only to patients enrolled in the REMS, with documentation of safe use conditions. Enrollments, prescriptions, shipments, and adverse events associated with SXB use are tracked via a central database. Risk management reports are generated if there is suspicion of abuse, misuse, or diversion. Data collected from the central database over a 16-month period were analyzed and reported. Results From August 2015 to December 2016, 18,161 patients received ≥1 shipment of SXB. A total of 185,816 shipments were dispensed, of which 12 (0.0065%) were lost in delivery and not recovered. No patients had overlapping active prescriptions, no duplicate patients were shipped drug under more than one name or identifier, no patient was shipped the drug after being disenrolled, and no prescriptions were filled from a prescriber not enrolled in the program. All patients received counseling prior to receiving their first shipment of SXB. A total of 446 notifications regarding potential abuse, misuse, or diversion were discussed with prescribers. Conclusion These data demonstrate that the REMS Program is meeting its goal of mitigating inappropriate prescribing, abuse, misuse, and diversion of SXB, while maintaining access to the drug for appropriate patients with narcolepsy. This approach to risk mitigation may inform risk management of other prescription controlled substances. Support (If Any) Jazz Pharmaceuticals.