The average consumer assumes if a drug is on the market, and especially if it is prescribed by his or her physician, that drug is safe. Unfortunately, all too often the user realizes there are side effects, often severe ones, and the drug was indeed not safe at all. How does this happen and why are dangerous drugs prescribed to patients on a regular basis by their doctors?
Part of the problem lies within the system that governs reporting post-market issues with drugs. The US Food and Drug Administration is supposed to ensure drugs are relatively safe before they are approved for the market, but the FDA also relies on the drug manufacturer to be open and honest with information related to problems with drugs after they are in use. And research is now revealing that far too many drug manufacturers fail to provide a complete picture of the safety of a drug once side effects are discovered by consumers.
Flawed Reporting System
According to new information published in the Pharmacoepidemiology and Drug Safety journal, many drug manufacturers are reporting incomplete and patchy reports for their drugs. The main problem relates to the Adverse Event Reporting System, put in place by the FDA to keep tabs on medical data related to problems with drugs and medical devices.
Doctors and consumers can voluntarily report problems to the FDA or the drug maker, and drug companies are then required to investigate any reports they receive and report their findings to the FDA.
Recent investigations have found many drug makers fail to report key data that could be used in follow-up FDA investigations.
The report found:
• In 2014 the FDA received more than 525,000 new reports related to serious or fatal side effects. Nearly 5% were filed with the agency by doctors or consumers and of those, 86% included the four data points of patient age, gender, date the side effect occurred, and the specific medical term to describe the problem.
• That same year, drug manufacturers filed the remaining 95% of side effect reports, but the majority did not include all four data points. Forty percent of the reports filed with 15 days of learning of the side effect were incomplete and 51% of the reports filed within 90 days were just as incomplete.
• Approximately 38% of the reports filed by drug manufacturers lacked information about the patient's gender and age. Nearly half did not have the date of the problem.
• Reports related to fatalities had the least amount of information.
• An analysis of reports filed by two drug manufacturer's showed that less than 25% of reports filed were complete with information about all four data points.
The lack of complete information is especially troubling with the latest trend to rush drugs to market with fewer clinical tests. Thomas Moore, a senior scientist from the Institute for Safe Medicine Practices, a nonprofit that tracks drug safety issues is calling on the FDA and the medical community to modernize its system for monitoring drug safety. The latest upgrade to the system occurred in 2001 and has not kept pace with drug marketing.
The FDA has acknowledged the shortcomings of the current system and admitted that improving the quality of information is an FDA priority, but it comes with challenges because reporting is voluntary.