The hospital assumes that practitioners are doing their very best and that errors and ADEs are not the result of incompetence or misconduct. The reporting program is coordinated through the Pharmacy and Therapeutics Committee, as part of the hospital's performance improvement and peer review function, with participation by Nursing and Pharmacy departments and the medical staff. Pharmacists report ADRs to the FDA if they are serious, associated with a new drug, or not mentioned in the drug's labeling. Staff members identifying an ADE in category 6 or 7 or classified as a sentinel event report the event, contact the Administrator on call and follow the steps outlined in the Sentinel Event Policy and Procedure. Identifying an ADE 5.1.1 Staff who suspect an ADE notify prescriber immediately if the event is significant or may alter the patient's plan of care.
Staff assess the patient.
5.1.3 Staff collaborate with clinical and supervisory resource personnel if unsure how to proceed 5.1.4 Staff implement adjustments in patient's treatment as ordered. 5.1.5 Staff document the factual description of the ADE, notification of physician and subsequent monitoring in the progress record. 5.2 Reporting an ADE 5.2.1 Staff calls the ADE hotline, completes the ADE reporting form or enters an ADE clinical intervention in the Meditech Pharmacy-module within 24 hours of the ADE identification. ADE forms are mailed, confidentially, to the Saf-Med Committee in the Pharmacy or put in an ADE drop box. Pharmacy staff take ADE reports off Hotline 7 days a week and complete ADE Report forms.