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

In Washington, pharmaceutical companies are required to report all adverse drug events that occur after a drug has been released to the public. These events must be reported to the Food and Drug Administration (FDA) or the appropriate state agency within 15 days after they are discovered. The reporting process begins by sending a written report to the FDA detailing the incident. The report must include the brand name, strength, and dosage form of the drug; the name and address of the manufacturer and marketer; the lot number; the condition of the packaged product; and any special precautions taken or codes used. Any physician or health care provider who has knowledge of an adverse drug event occurring must also report it. The reports must include a description of the adverse drug reaction, any other treatments given, the date the drug was given, the date the reaction occurred, the treatment given, and any follow-up actions taken. Pharmaceutical companies are also expected to train their personnel in the proper procedures for handling adverse drug events and the importance of reporting them. Companies must also have a designated reporting system in place so that adverse events can be reported quickly and accurately. All reports of adverse drug events must be carefully reviewed and evaluated by the FDA to ensure that the correct procedure was followed and all necessary information was obtained. The FDA will then assess the reports to determine if any actions need to be taken to address the reported event.

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