BMJ 2015;350:h651 doi: 10.1136/bmj.h651 (Published 4 February 2015)
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NEWS Drug makers’ adverse event reports are often incomplete, US report finds Michael McCarthy Seattle
Drug manufacturers’ reports of adverse drug events are often incomplete, lacking such basic information as the patient’s age or gender or the date of the event, a US investigation by an independent drug safety group has found.
Researchers from the Institute for Safe Medication Practices looked at the quality of reports made to the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) over one year to the first quarter of 2014.1 During that period 847 039 reports were made to the system, including reports of 45 688 patient deaths from US sources and 41 884 deaths from foreign sources.
FAERS reports come from two main sources: from consumers or healthcare providers, who voluntarily submit reports either directly to the Food and Drug Administration (FDA) or to the drug makers; or from the drug makers, who are required by law to submit reports of any adverse events they learn about to the FDA. Reports from drug makers account for 96.6% of the FAERS reports. The reports contain a narrative describing the adverse event and its severity. The severity is coded by FDA regulations as resulting in one or more of the following outcomes: death, disability, a birth defect, hospitalization, required intervention to prevent harm, threat to life, or other medically serious consequences.
The investigators found that, while 85% of the reports submitted directly to the FDA from consumers and healthcare providers were “reasonably complete”—which the researchers defined as containing at least the patient’s age and gender and the date of the event—only 49.4% of the reports from drug makers included all of this basic information. In 36% of cases, for example, the patient’s age was not reported, and in 44% the date of the event was omitted. The quality of drug makers’ reports of serious adverse events varied widely, the investigators found, and the weakest performance was seen in four companies that submitted reasonably complete reports in only 15% or less of cases. Not one manufacturer matched the 85% completeness seen in the reports filed directly to the FDA, and only five of the 74 manufacturers (7%) whose reports were analyzed had reported at least the age and gender in 90% or more of their reports of serious adverse events. “Manufacturers overall did a poor job
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collecting basic patient and event data regardless of the severity of the event,” the researchers concluded. Drug makers must also report to the FDA when they learn that a patient has died, which happens more frequently now that many patients receive high risk drugs that are available only through closely monitored, restricted distribution programs. However, 24 939 (28.5%) of the manufacturers’ 87 572 reports on patient deaths “had no useful information about the cause of death or possible drug role,” the researchers wrote.
Despite its shortcomings FAERS does have its strengths, the researchers said, as its standardized, electronic reporting system now gives it a global reach. “With coverage of hundreds of millions of patients around the world, it successfully identifies rare but catastrophic side effects not clearly evident in small pre-market clinical trials,” they wrote. The system also captures events rapidly, they said, as 88.5% of serious, unexpected events reach the FDA within 15 days of the manufacturer learning of the event, as is required by FDA regulations. Nonetheless, FAERS needs an update, the researchers concluded, saying that “it seems clear that this drug safety monitoring system is in need of modernization. It suffers from a flood of low quality reports from drug manufacturers and has not yet been updated for the changing environment in which drugs are marketed to health professionals and consumers.” In particular, they noted that the increasing number of drugs being made available only through restricted distribution schemes, as well as an increase in the number of very expensive specialty drugs targeting a small number of patients, mean that many manufacturers maintain close contact with patients and with prescribing doctors.
“The digital tools and marketing practices that now enable extensive contacts between manufacturers, health professionals, and consumers can be extended to provide enhanced post-market surveillance,” the researchers wrote. “A pilot program is needed to learn how to make physician adverse event reporting easily accessible from the now required electronic health records.” 1
Institute for Safe Medication Practices. A critique of a key drug safety reporting system. QuarterWatch 28 Jan 2015. www.ismp.org/quarterwatch/pdfs/2014Q1.pdf.
Cite this as: BMJ 2015;350:h651 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
Page 1 of 1
News
NEWS Drug makers’ adverse event reports are often incomplete, US report finds Michael McCarthy Seattle
Drug manufacturers’ reports of adverse drug events are often incomplete, lacking such basic information as the patient’s age or gender or the date of the event, a US investigation by an independent drug safety group has found.
Researchers from the Institute for Safe Medication Practices looked at the quality of reports made to the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) over one year to the first quarter of 2014.1 During that period 847 039 reports were made to the system, including reports of 45 688 patient deaths from US sources and 41 884 deaths from foreign sources.
FAERS reports come from two main sources: from consumers or healthcare providers, who voluntarily submit reports either directly to the Food and Drug Administration (FDA) or to the drug makers; or from the drug makers, who are required by law to submit reports of any adverse events they learn about to the FDA. Reports from drug makers account for 96.6% of the FAERS reports. The reports contain a narrative describing the adverse event and its severity. The severity is coded by FDA regulations as resulting in one or more of the following outcomes: death, disability, a birth defect, hospitalization, required intervention to prevent harm, threat to life, or other medically serious consequences.
The investigators found that, while 85% of the reports submitted directly to the FDA from consumers and healthcare providers were “reasonably complete”—which the researchers defined as containing at least the patient’s age and gender and the date of the event—only 49.4% of the reports from drug makers included all of this basic information. In 36% of cases, for example, the patient’s age was not reported, and in 44% the date of the event was omitted. The quality of drug makers’ reports of serious adverse events varied widely, the investigators found, and the weakest performance was seen in four companies that submitted reasonably complete reports in only 15% or less of cases. Not one manufacturer matched the 85% completeness seen in the reports filed directly to the FDA, and only five of the 74 manufacturers (7%) whose reports were analyzed had reported at least the age and gender in 90% or more of their reports of serious adverse events. “Manufacturers overall did a poor job
For personal use only: See rights and reprints http://www.bmj.com/permissions
collecting basic patient and event data regardless of the severity of the event,” the researchers concluded. Drug makers must also report to the FDA when they learn that a patient has died, which happens more frequently now that many patients receive high risk drugs that are available only through closely monitored, restricted distribution programs. However, 24 939 (28.5%) of the manufacturers’ 87 572 reports on patient deaths “had no useful information about the cause of death or possible drug role,” the researchers wrote.
Despite its shortcomings FAERS does have its strengths, the researchers said, as its standardized, electronic reporting system now gives it a global reach. “With coverage of hundreds of millions of patients around the world, it successfully identifies rare but catastrophic side effects not clearly evident in small pre-market clinical trials,” they wrote. The system also captures events rapidly, they said, as 88.5% of serious, unexpected events reach the FDA within 15 days of the manufacturer learning of the event, as is required by FDA regulations. Nonetheless, FAERS needs an update, the researchers concluded, saying that “it seems clear that this drug safety monitoring system is in need of modernization. It suffers from a flood of low quality reports from drug manufacturers and has not yet been updated for the changing environment in which drugs are marketed to health professionals and consumers.” In particular, they noted that the increasing number of drugs being made available only through restricted distribution schemes, as well as an increase in the number of very expensive specialty drugs targeting a small number of patients, mean that many manufacturers maintain close contact with patients and with prescribing doctors.
“The digital tools and marketing practices that now enable extensive contacts between manufacturers, health professionals, and consumers can be extended to provide enhanced post-market surveillance,” the researchers wrote. “A pilot program is needed to learn how to make physician adverse event reporting easily accessible from the now required electronic health records.” 1
Institute for Safe Medication Practices. A critique of a key drug safety reporting system. QuarterWatch 28 Jan 2015. www.ismp.org/quarterwatch/pdfs/2014Q1.pdf.
Cite this as: BMJ 2015;350:h651 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
