Oregon Administrative Rules|Section 325-015-0025 - Reporting Adverse Events

                                                
Current through Register Vol. 60, No. 12, December 1, 2021
(1) The Commission will provide an Event Report form to be used by Pharmacy Participants for reporting Adverse Events. The Event Report will include a summary description of the event; a description of the Pharmacy Participant's complete, thorough, and credible analysis for that event; information about plans to implement improvements to reduce risk. The meaning of terms "complete," "thorough," and "credible" are explained in OAR 325-015-0035. 
 
(2) Pharmacy Participants must use the Event Report form when reporting Adverse Events to the Commission. 
 
(3) Pharmacy Participants must submit a completed Event Report to the Commission within 45 calendar days of discovery of a Reportable Adverse Event. 
 
(4) If a Pharmacy Participant believes the Commission should immediately issue an alert to all Oregon pharmacies based on a specific Reportable Adverse Event, the Pharmacy Participant should provide an initial report to the Commission within 3 business days of discovery of the event, or sooner. The Pharmacy Participant and Commission will work together to identify information to include in the alert.
 
Or. Admin. R. 325-015-0025
PSC 4-2006, f. 12-18-06, cert. ef. 1-1-07; PSC 2-2015, f. & cert. ef. 7-10-15
Stat. Auth.: ORS442.820
 
Stats. Implemented: ORS 442.819-442.851
This section was updated on 8/6/2015 by overlay.