Report Criticizes FDA’s Drug Safety Tracking

When drug manufacturers are responsible for reporting the potential side effects of the products they develop, is it any surprise that the record is less than complete?

Last week the Institute of Safe Medication Practices (ISMP) issued a report critical of the FDA’s Adverse Event Reporting System (FAERS) because of incomplete information about injuries and harmful effects of prescription drugs. As characterized by the Wall Street Journal’s Pharmalot blog, the database consists of “haphazard reports filed by drug makers.”

The FAERS, a resource within the MedWatch program, is primarily how information is collected about potential side effects of prescription medicines. Consumers and medical providers may report problems to the FDA or a drug maker voluntarily, and the pharmaceutical companies are supposed to investigate and report about side effects their products might cause or be associated with.

But drug makers contribute most of the reports. During a recent 12-month period, the pharmaceutical industry filed more than 9 in 10 of the FDA reports, according to ISMP, a nonprofit organization that follows drug safety issues. That led the watchdog to conclude that, according to Pharmalot, “the integrity of the reporting system rests largely with drug makers, but that drug makers too often file incomplete reports.”

In more than 1 in 3 industry reports, patient age was not determined, and more than 4 in 10 lacked the date of the adverse event. The ISMP said that patient age, gender and event date must be included for a report to be considered reasonably complete. Not even half of reports filed by drug makers with serious events were reasonably complete; of those filed by consumers and doctors, 85% were reasonably complete.

Four drug makers submitted reasonably complete reports only 15% of the time or less. And NO drug maker matched the 85% completeness achievement that the average person did.

The ISMP said the number of death reports associated with drugs were “questionable.” Almost 3 in 10 reported patient deaths by drug makers lacked useful information about the cause of death or the possible role of a medicine in it. The ISMP said that fewer than 7 in 10 such reports were of “limited value,” because they contained only the word “death,” or because they lacked complete information about it.

“It makes no sense for drug manufacturers to be required to spend millions collecting and submitting adverse drug event reports promptly,” according to the report, “when so many reports contribute little to the assessment of drug safety. The FAERS system, for all its flaws, nevertheless remains the primary source for detecting new, serious adverse effects in approved drugs and identifying other risks to patients.”

Thomas Moore, one of the scientists involved in the ISMP report, told Pharmalot, “… if we don’t know how many people are being injured and which drugs are most responsible, how do we go about reducing the number of people who may be harmed every year?”

Moore attributed part of the problem to the way pharmaceutical marketing has changed since 2001. That’s the last time the FDA updated the adverse event reporting system. Consumers, providers and drug makers have so many ways of interacting these days that reports about side effects might not be based on spontaneous complaints about a drug. And that can compromise the quality of the information.

An example, said Moore, is an FDA program called REMS (See our blog, “Doctors Don’t Know Dangers of Narcotics and the FDA Leaves Drug Makers in the Driver’s Seat.”) It requires drug makers to take certain steps to minimize risk, such as restricting distribution. But a patient mentioning a possible side effect during a doctor-patient interaction might end up as incomplete database information if the FDA receives it without the drug maker determining whether the medicine caused it.

“The [FDA] regulations are outdated and haven’t kept up with how drugs are marketed today. The system is being flooded with low-quality adverse events reports and, as a result, we don’t know which drug may be suspected of causing the health problem that was reported,” Moore told Pharmalot. He suggested that the FDA should develop a better way to track contact with patients to make side effect information more definitive.

The FDA told Pharmalot that its ability to gather complete information is limited, but that the feds use “modern data-mining techniques” to identify reports of greatest value and that its Sentinel Initiative is being developed to monitor safety.

That program to collect electronic health data was authorized in 2007, and a few years ago we wondered what the delay was; it’s still not fully engaged?

According to the ISMP report, certain drug makers are regular laggards in reporting side effects of their wares. They include Par Pharmaceutical, a generic drug maker whose products include a generic version of Wellbutrin (for depression) and the stimulant Provigil; it filed complete reports less than 1% of the time, and more than 8 in 10 of those were minimally complete, which it blamed on the fact that most of its reports come from the American Association of Poison Control Centers’ annual report, which doesn’t include event dates.

Pfizer submitted the most reports (more than 35,400), nearly half of which were deemed to be reasonably complete and nearly 7 in 10 of which were minimally complete.