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

In Maryland, there are specific requirements for the reporting of adverse drug events. An adverse drug event (ADE) is an unexpected event that can occur when a patient takes a medicine or receives a medical treatment. The Maryland Pharmacovigilance Act of 2006 requires healthcare providers, pharmacists, and pharmaceutical companies to report adverse events to the Maryland Department of Health. All adverse drug events must be reported within 30 days after the event took place. The healthcare provider must fill out a Maryland Adverse Drug Event Report Form and submit it along with any relevant medical records to the Maryland Department of Health. Pharmacists must report ADEs that they become aware of through dispensing medications or providing pharmaceutical care. Pharmaceutical companies must report ADEs to the department as mandated by US Food and Drug Administration regulations. The reports must include information about the patient, the drug, and the adverse event. Additionally, the Maryland Department of Health may require reports of medication errors, as well as reports that involve drug product issues, such as ineffective drugs, drug interactions, or incorrect labeling. All reports should be made to the Maryland Department of Health using the appropriate form. In Maryland, reporting of adverse drug events is important for patient safety and the protection of public health. By providing accurate and timely reports of ADEs, healthcare providers, pharmacists, and pharmaceutical companies can ensure that Maryland patients remain safe and healthy.

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