The Xyrem
Journal
Drugs - real world outcomes
ISSN: 2199-1154
Titre abrégé: Drugs Real World Outcomes
Pays: Switzerland
ID NLM: 101658456
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
accepted:
05
12
2020
pubmed:
14
1
2021
medline:
14
1
2021
entrez:
13
1
2021
Statut:
ppublish
Résumé
Sodium oxybate, which is approved for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy, is available in the USA only through the restricted-distribution Xyrem This analysis reports data from the XRP regarding assessment of the risks of serious adverse outcomes that may result from inappropriate prescribing, abuse, misuse, and diversion. Data collected from December 2016 to December 2017 were analyzed. Prescriptions were from enrolled prescribers (n = 4524); 17,037 patients received one or more shipment of sodium oxybate. No patients were shipped sodium oxybate under more than one name/identifier or after being disenrolled; no individual patient had overlapping active prescriptions. Sodium oxybate was dispensed in 146,426 shipments containing 375,173 bottles; of those, 13 shipments (0.009%) and 26 bottles (0.007%) were lost in delivery and not recovered. Notifications regarding potential abuse (n = 31), misuse (n = 343), or diversion (n = 22) were discussed with prescribers. Most patients and prescribers were aware of the main safety risks of sodium oxybate. The XRP maintains controlled access to sodium oxybate; additional prescriber education on safety risks may be warranted.
Sections du résumé
BACKGROUND
BACKGROUND
Sodium oxybate, which is approved for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy, is available in the USA only through the restricted-distribution Xyrem
OBJECTIVE
OBJECTIVE
This analysis reports data from the XRP regarding assessment of the risks of serious adverse outcomes that may result from inappropriate prescribing, abuse, misuse, and diversion.
METHODS
METHODS
Data collected from December 2016 to December 2017 were analyzed.
RESULTS
RESULTS
Prescriptions were from enrolled prescribers (n = 4524); 17,037 patients received one or more shipment of sodium oxybate. No patients were shipped sodium oxybate under more than one name/identifier or after being disenrolled; no individual patient had overlapping active prescriptions. Sodium oxybate was dispensed in 146,426 shipments containing 375,173 bottles; of those, 13 shipments (0.009%) and 26 bottles (0.007%) were lost in delivery and not recovered. Notifications regarding potential abuse (n = 31), misuse (n = 343), or diversion (n = 22) were discussed with prescribers. Most patients and prescribers were aware of the main safety risks of sodium oxybate.
CONCLUSIONS
CONCLUSIONS
The XRP maintains controlled access to sodium oxybate; additional prescriber education on safety risks may be warranted.
Identifiants
pubmed: 33439474
doi: 10.1007/s40801-020-00223-6
pii: 10.1007/s40801-020-00223-6
pmc: PMC7984153
doi:
Types de publication
Journal Article
Langues
eng
Pagination
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