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

In Oregon, pharmaceutical law requires individuals and organizations to report adverse drug events (ADEs). Adverse drug events are harmful reactions to a drug, including injuries, illness, or death. Pharmaceutical companies must submit reports to the Oregon Board of Pharmacy whenever an ADE is reported to them. The Oregon Board of Pharmacy also requires healthcare professionals to report ADEs to them. This includes physicians, pharmacists, podiatrists, optometrists, nurses, and other healthcare professionals. Reports must include patient information, medication history, and specific details of the ADE. To ensure that reports are submitted quickly, Oregon has created an electronic reporting system. Additionally, in Oregon, all pharmacies must report incidents of medication errors or adverse reactions in which a patient was harmed. Reports must include a description of the error or reaction, the medication and dose, and what steps were taken to correct the problem. These reports must be sent to the board within 48 hours of the incident. Finally, medical device manufacturers must report any injury or death associated with a medical device use. They must include information regarding the device, specific details of the event, and what steps were taken to correct the problem. By requiring reporting of these adverse drug events, Oregon hopes to reduce them and ensure that medications are safe for public use.

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