5-Feb-15 2:00 PM  CST

ISMP Report Shows Drug Manufacturer Data on Drug Side Effects Needs Improvement

The central purpose for the formulation of the Food and Drug Administration was to protect the citizens of the United States from misleading, dangerous, and scrupulous drug manufacturing and sales. Additionally, the FDA has developed a system to track the side effects associated with approved legend and non-legend drugs. While this system has generally been effective, the FDA Adverse Drug Effect Reporting System still seems to have a long way to go. According to a recent report initiated by the Institute of Safe Medication Practices (ISMP) the FDA’s reporting and tracking system for drug side effects is in need of improvements.

ISMP, a non-profit, independent, and respected organization that champions for the improvement of medication safety, and overall medication error awareness found that only half of the adverse drug effect reports submitted to the FDA from drug manufactures contained complete reports. A complete report includes a patient’s age, sex and the date the side effect was witnessed. Although this information is considered to be basic reporting information it is essential and imperative in tracking side effects of medications. ISMP found that while the information the drug manufactures submitted to the FDA’s reporting system was largely incomplete approximately 85% of the reports submitted by the FDA were complete.

ISMP believes this should be a wake up call for improvements to a system that is supposed to not only protect patients, but also help single out potential drug side effects that could lead to serious medication errors. ISMP reports that 97% of adverse drug reports are submitted by drug manufactures making it easy to see why concern over incompleteness of reports has become such a concern. ISMP reviewed more than 800,000 reports over a 1-year period.




Thomas, K., (2015) “Drug makers’ data on side effects called lacking in a report” New York Times, http://www.nytimes.com/2015/02/03/business/drug-makers-data-on-side-effects-is-called-lacking-in-a-report.html?ref=health&_r=0, retrieved 4.February, 2015


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Source: Sandy Andrews  

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