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Will New FDA System Reduce Medication Errors?

The U.S. Food and Drug Administration (FDA) recently launched a new search tool that improves access to data on adverse drug events. According to the agency, the user-friendly tool is designed to make it easier for consumers, providers, and researchers to access information collected by the FDA Adverse Event Reporting System (FAERS).

Tracking Adverse Drug Events

Adverse drug events (ADEs), which are defined as harm experienced by a patient as a result of exposure to a medication, are among the most common medical mistakes. In total, ADEs account for nearly 700,000 emergency department visits and 100,000 hospitalizations every year. Nearly five percent of hospitalized patients experience an ADE, making them one of the most frequent types of inpatient errors.

The FDA uses FAERS to collect and analyze information on adverse event and medication error reports submitted to the agency. The database is part of the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. Pharmaceutical companies are required to submit adverse event reports. However, reporting by health professionals and patients is voluntary.

The FDA’s new dashboard allows users to search for and organize data by specified search parameters, such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe. "Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA," said FDA Commissioner Scott Gottlieb, M.D. "The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in."

The FDA’s adverse event reporting database provides valuable information and is often used by the agency to detect safety issues. However, it is important to highlight that FAERS does have limitations. Notably, because the FDA does not require that a causal relationship between a product and event be proven, there is no conclusive proof that the product caused the alleged harm to the patient. In addition, the agency does not receive reports for every adverse event or medication error that occurs with a product.

While the added transparency is a good first step, we are hopeful that the FDA also enhances its procedures for post-market surveillance. To protect patients, it is imperative to track a drug’s safety record once it is released to the market and make that information available to the public.

If you or someone you love has suffered serious harm due to a defective medical device or medication, don’t hesitate to contact a San Diego product liability lawyer at the Law Offices of Robert Vaage for a free consultation.