Less Than Half Of Adverse Drug Side Effect Reports “Reasonably Complete”: Report

A new report by the Institute for Safe Medication Practices (ISMP) suggests that less than half of all adverse events contain enough information to help federal drug regulators determine if there may be a safety problem with the medication suspected of causing the problems. 

The ISMP released its latest QuarterWatch report (PDF) this week, detailing adverse event reports submitted to the FDA Adverse Event Reporting System (FAERS) throughout 2016. The reports are often seen as an indicator for medications that may have serious adverse health risks that may not have been detected before the drug was approved and put on the market.

The report found that the agency received 1,165,073 adverse event reports for drugs throughout 2016, which represents a nearly two percent decline from 2015. However, ISMP researchers warn that it is estimated that only about 10% of adverse events actually get reported to the FDA.

Researchers found that only 42.5% of the reports submitted by manufacturers can be considered reasonably complete. ISMP indicates that patient age was the most common information left off of the reports.

“In 2016, a majority of serious adverse event reports collected and submitted by drug manufacturers were incomplete,” the report states. “Among 575,912 reports of serious injury submitted by the pharmaceutical industry, 57.5% did not meet four basic standards for completeness: 1) Patient age; 2) Sex; 3) Event date; and 4) At least one medical term to describe what happened.”

Also, the ISMP found that reports submitted directly to the FDA by health care professionals and patients were much more complete, with 85% meeting all four of the basic standards of completeness, and only 5.7% not including patient age.

A number of factors appeared to affect the completeness of the adverse event reports, including the manufacturer and the age of the drug. Some manufacturers were better at filing complete reports than others, and newer brand name drugs were more likely to have detailed reports than older drugs whose safety profiles are believed to be already well known.

Among the best performers, Actelion, Gilead and Aurobindo were the drug manufacturers most likely to submit complete adverse event reports. Among the worst were Cipla and Mylan.

Reports involving newer drugs had about the same chance of being complete as older drugs, initially. However, those reports were more likely to be revised to later include the information that had been missing.

“Since the last time the FDA updated its guidance in 2001, reports into the FAERS system have increased almost 10-fold, from 143,000 to 1.2 million in 2016,” the report states. “A full-scale modernization of the FAERS reporting requirements is needed to build on the new possibilities for better postmarket surveillance created in the modern age of digital information.”


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