Title: Adverse Drug Events Regulation Reference: Policy Number: Effective Date: Purpose: It is the policy of XXXXX to report and record significant adverse drug reactions. Policy: Personnel affected: Physicians, Advanced Practitioners, and Nursing Adverse Drug Event Definition: An adverse drug event is defined as an event of unexpected nature or severity that is not of therapeutic, diagnostic or prophylactic benefit to the patient. Report significant adverse drug events with emphasis on: a. serious or fatal reactions b. uncommon or unusual reactions c. drug interactions or reactions Procedure: Nursing responsibilities are as follows: 1) Monitor patient, 2) Notify the clinician and 3) Begin treatment per standing orders Documentation: a. Record in Nursing Notes: 1) Nature of the event 5) Time physician notified 2) Onset of reaction 6) Any specific measures taken 3) Severity of reaction 7) Any untoward effect on patient 4) Duration of the reaction outcomes b. Record true allergic drug reaction on patient’s chart when confirmed. This should be recorded on the section designed for allergies. c. When an event occurs that prevents the continuation of therapy or if the patient is dismissed via an ambulance the following must occur: i. The Charge Nurse will send an email to the AP and the physician notifying them of the event, even if they are present ii. The nurses note will be put into the physicians queue for review and approval iii. The patient will be scheduled for a follow-up visit with the physician only iv. The physician will document the discussion of the reaction, treatment options going forward, and the release to continue therapy in the patient’s follow-up visit note Please Note: If there is no documentation of the release of the patient for continuation of therapy the infusion nurse is responsible for calling the physician, reminding them of the reaction, and verbally obtaining this release prior to any further infusions. The nurse will then document the discussion in a note in the patient’s EMR. d. An Occurrence Report is to be completed by clinic staff within 24 hours of the adverse drug event. Please follow proper procedure for reporting occurrences found in policy XXXXX, Occurrence Reporting. Responsibility and Approval Authority: This policy shall be reviewed by the appropriate committees, managers and staff to whom it is relevant, approved by the Executive Committee of the Board, with final signatory authority of the Medical Director. Version Number: Original Approval Reviewed Date: Prepared by: Approved by: Page 1 of 1