Zyprexa® Relprevv™ Patient Care Program

• Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
  

• Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
  
• Potential risk factors of post-injection delirium/sedation syndrome (PDSS). [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
  

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:

1. Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
2. Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and
3. Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.