FDA Proposes Changes to System For Monitoring Drug Safety Issues

Over the past year and a half the Food and Drug Administration (FDA) has come under fire from medical experts. In articles published in several medical journals, experts have questioned the agency’s response to and reporting of medication errors, adverse drug events, and other medicine safety concerns.

The FDA maintains a database of medicine issues and drug mistakes known as the Document Archiving, Reporting and Regulatory Tracking System (DARRTS). This database is meant to archive “Tracked Safety Issues” (TSIs) which are problems related to various medicines. By tracking issues, officials can potentially uncover previously unknown information about drug dangers.

However, healthcare experts argue FDA officials use the database inefficiently. Researchers published a study in January’s issue of Medical Care that indicated the FDA was inconsistent in reporting risks to the public and to healthcare professionals.PM Live.com reports similar conclusions were published in other health journals. As a result, information about medication safety issues are often not communicated in a timely and effective way, putting patients at risk of medicine mistakes and bad drug reactions.

In an effort to improve their procedures for handling medicine issues, the FDA has proposed new guidelines for how to handle reports of drug errors. It categorizes issues into three levels: priority, standard and emergency. Those deemed to be of priority or emergency level would be monitored and timelines for decision making and action would be followed to ensure information is made public in a timely manner. When categorizing these drug safety concerns, FDA officials will examine what kind of event was reported, how many people were exposed, and how likely it is that people will be harmed.

The FDA has published their proposed changes in a draft available to the public. Citizens are welcome to submit their comments on the draft to the FDA.


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