OAR 325-015-0025
Reporting Adverse Events
(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 (Commission Review of Reports).(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.
Source:
Rule 325-015-0025 — Reporting Adverse Events, https://secure.sos.state.or.us/oard/view.action?ruleNumber=325-015-0025.