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Report Finds Flaws in FDA’s System for Reporting Adverse Drug Events

A new report identifies major flaws in the U.S. Food and Drug Administration’s system for reporting pharmaceutical drug-related adverse events, including deaths. However, there are ways to fix those problems, the report’s authors say.

The Institute for Safe Medication Practices (ISMP), a non-profit group that tracks drug safety issues, published the report in late January. It features an analysis of the 847,039 adverse event cases reported to the FDA’s Adverse Event Report System (FAERS) over a 12-month period ending in March 2014.

Those adverse events can be reported to the FDA in one of two ways: First, doctors and patients can voluntarily submit reports through the MedWatch program. Second, drug companies must submit reports of any adverse events they learn about from patients, doctors or other sources such as medical journals.

The FDA receives the overwhelming majority of reports the second way, the ISMP states. In fact, drug companies account for 96.6 percent of adverse event reports.

“Thus the performance of the drug manufacturers, combined with FDA regulations and compliance activity, determines the quality, coverage and completeness of this surveillance system,” the ISMP states.

The problem: Most manufacturer reports are lacking, as the ISMP found.

Majority of Manufacturer Reports are Incomplete

According to the ISMP, a report is “reasonably complete” when it includes a patient’s age, gender and the date when the adverse event occurred.

The ISMP reports that 81.3 percent of reports voluntarily submitted to the FDA by patients and doctors met this reasonably complete standard. When the case involved a “serious” adverse event – one caused by a side effect for which there was no label warning and/or resulting in hospitalization, disability or death – 85 percent of the voluntary reports were reasonably complete.

In contrast, the ISMP found that only 46 percent of the reports provided by drug companies were reasonably complete. Thirty-six percent of those reports lacked the patient’s age, while 44 percent lacked an event date.

The ISMP also found several other problems with the manufacturer reports, including:

  • A small percentage of reports come from generic drug manufacturers – despite the fact that 86 percent of outpatient prescriptions in the U.S. are for generics.
  • Even though children comprise roughly a quarter of the U.S. population and account for 7.3 percent of dispensed prescriptions, only 3 percent of adverse events involved children. (Birth defects may also be underreported.)

What Can Be Done to Fix the FDA’s System?

As the ISMP points out, the FDA uses the information collected through FAERS to discover new drug risks and issue warnings to the public about dangerous side effects. This is why it is important to shore up this reporting system.

The ISMP recommends that the FDA address three top priorities:

  • Use a “simple computer-driven assessment” to provide greater feedback to drug companies about reports. This can help to improve the quality of the reports. As the ISMP notes, the fact that 85 percent of voluntary reports are “reasonably complete” shows that it is feasible for companies to do a better job. The FDA should focus, in particular, on better reporting of child injuries and birth defects, the ISMP states.
  • Due to changes in marketing and federal regulations, drug companies now interact directly with patients and doctors more than ever before. The FDA should establish protocols that will allow the drug makers to get better information when they make those contacts. In particular, when manufacturers learn of patient deaths, they should be doing more to find out if the death is believed to be drug-related.
  • Finally, the FDA must create new programs aimed at improving reports from generic drug manufacturers, including possibly expanding its direct, on-line reporting system, the ISMP states.

Additionally, the ISMP suggests making it easier to collect adverse event data through electronic health records that are now required in the U.S.

If you believe that you or a loved one has suffered an adverse event due to a brand-name or generic drug, you should report it not only to the FDA’s MedWatch program but also contact an attorney in order to protect your legal rights and explore your options for seeking justice.