Drug manufacturers are required to report serious adverse events – those involving “death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect” – to the U.S. Food and Drug Administration within 15 calendar days after such cases are reported to the company.
That’s so wholesalers can recall the drug as soon as possible and alert pharmacists to call patients taking that medication. “Whether we should have this regulation or how should we change it”, Massachusetts said.
Consumers and physicians also can take matters into their own hands and report adverse reports directly to the FDA, rather than going through the drug company, Redberg added.
“A larger fraction of these serious and unexpected events that involved a patient death were delayed – about 12 percent of events with patient death, compared to 9 percent of events without patient death”, Karaca-Mandic said. Among them, 160,383 were reported beyond the mandatory 15-day window – including 40,464 reports that involved a patient death.
The researchers categorized reports as occurring within the 15-day requisite window, and by from time frames after the patient’s healthcare provider reported the event to the drug maker, 16-90 days, 91 to 180 days, or more than 180 days.
This is according to the analysis of 1.6 million side effects that the FDA has reported between 2004 and 2014.
“Strikingly, AEs (adverse events) with patient death were more likely to be delayed”, the study’s authors said.
A correlation between patient death and delayed reporting was found in a multivariable analysis.
The FDA needs to step up its enforcement of reporting requirements to ensure patient safety.
While the delays aren’t surprising, the focus on the 15-day time limit doesn’t account for the labor-intensive process manufacturers face in verifying adverse events before submitting reports to the FDA, said Kenneth Getz, a researcher at the Center for the Study of Drug Development at Tufts University School of Medicine.
The FDA has the ability to suspend drug sales or withdraw approval for unsafe medications, a tool that might also be deployed when companies fail to report serious side effects in a timely fashion, Dr. Rita Redberg, editor of JAMA Internal Medicine, wrote in an editorial.
“Our findings are likely an underestimate of overall under-reporting or misreporting, given the anecdotal evidence of FDA warning letters to manufacturers alleging downward misclassification of serious AEs”.
