Ch 27 Reporting of Medication Errors and Adverse Drug Reactions doc - cphcs ca 2025

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An error may or may not cause an adverse event. Adverse events are injuries that result from a medical intervention and are responsible for harm to the patient (death, life-threatening illness, disability at the time of discharge, prolongation of the hospital stay, etc.)
A medication error is an error (of commission or omission) at any step along the pathway that begins when a clinician prescribes a medication and ends when the patient actually receives the medication. An adverse drug event (ADE) is defined as harm experienced by a patient as a result of exposure to a medication.
An error was defined as the failure of a planned action to be completed as intended or the use of an incorrect plan for a specific aim. Some adverse events were attributable to errors. In this study, errors resulting in physical injury or potential harm were classified as adverse events.
Upon detection of a reportable adverse event, a hospital is required to report no later than five (5) days, or, if the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, no later than twenty-four (24) hours after the adverse event is detected.
To submit your voluntary report: Complete voluntary Form FDA 3500 online. Call 1-800-FDA-1088 to report by telephone.
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The National Coordinating Council for Medication Error Prevention and Analysis (NCC MERP) defines a medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a healthcare provider, patient, or consumer.
ADRs and medication errors are the most specific terms. Adverse drug reaction refers to any unexpected, unintended, undesired, or excessive response to a medicine. A medication error is any preventable event that has the potential to lead to inappropriate medication use or patient harm.
.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

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