What are the requirements for the reporting of adverse drug events?

In Tennessee, all persons, including medical practitioners, pharmacists and health care facilities, must report adverse drug events (ADEs) to the Tennessee Department of Health. The Tennessee Department of Health requires reporting of all adverse events associated with a drug or device approved by the Food and Drug Administration (FDA). Adverse drug events include injuries, illnesses, and deaths associated with the use of a drug or device. In order to report an ADE, you must provide detailed information regarding the patient’s medical history, the type of drug or device used, the date of use, any adverse reactions experienced, and any other related information pertinent to the incident. The report must be provided within 15 days of an ADE incident. Additionally, the date when the ADE was first suspected by the reporter must be reported. If the reporter is a health care facility, they must also provide information on any tests, procedures, or treatments that were provided in response to the event. Vaccine-related adverse events must also be reported to the Tennessee Department of Health. Any side effects, allergic reactions, or other injuries and illnesses experienced after receiving a vaccine must be reported to the Department within 30 days of the event. The Tennessee Department of Health is required to track all reported ADEs to ensure the safety of both the patient and the public. By monitoring all adverse events related to drugs and devices, the Department can identify any potential health risks or problems and take action to prevent similar incidents from occurring in the future.

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What are the requirements for the reporting of adverse drug events?

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