Study: Drug makers fail to meet adverse-event reporting requirements
- According to a study by the Institute for Safe Medication Practices, only half of reports on serious side effects submitted by drug makers are complete.
- While companies such as Amgen, Vertex and Biogen Idec submit high quality-reports, others, such as Par Pharmaceuticals and Cubist have been performing below average.
- The study focused on adherence to the basic standards of completeness, including a patient's age, sex, and the event the date took place.
Adverse-event reporting to the Institute for Safe Medication Practices important, because almost all adverse events that are reported by drug makers are reported into that system. In addition to reporting into that system, drug makers also report directly to the FDA--85% of the information reported through that system was found to be accurate.
The stakes are high, because although product labeling is based on adverse event data from clinical trials, over time, the total picture for a drug emerges as a combination of pivotal trial data, post-marketing surveillance and adverse-event reporting through the Institute for Safe Medication Practices and the FDA. With more than 847,000 case reports submitted between March 2013 and March 2014, clearly there is a great deal of information that needs to be factored into the efficacy and safety files for various medications. For that reason, accuracy and comprehensive submission is necessary. Plus, the entire process is expensive. Reform efforts are underway.