One in three U.S. drugs may have safety issues, explains a new Fast Facts policy brief from the Institute for Patient Access. The statistic opens the paper’s exploration of how the United States tracks and traces prescription drug side effects – and why advanced medicine demands that the process be strengthened.
In approving new drugs, the Food and Drug Administration faces two concurrent challenges. The first is approving medications quickly for the patients who need them. The second is maintaining the rigor of an approval process that keeps those same patients safe. Finding the right balance is difficult – but critical.
Yet even the most robust clinical trials for new medications face inherent limitations, the paper explains. Researchers simply cannot account for all the variables that might affect patients. These include factors such as their environment, lifestyle or drug-to-drug interactions. Meanwhile, some side effects are so rare that they do not occur during a clinical trial, but can pose problems once the drug is approved and available to more patients.
Which is precisely why pharmacovigilance is necessary. It’s “the process of detecting, tracking, analyzing, and preventing negative side effects of drugs,” the paper explains. And it entails three basic steps:
- Collecting information on side effects, or adverse events. Patients can report to their physician or directly to the FDA.
- Reviewing clinical data. The FDA monitors data and flags products as necessary using its Adverse Event Reporting System.
- Responding to clinical data. If the FDA has a concern about patient safety, it may evaluate the drug further or take regulatory action such as updating a drug’s label and/or communicating findings to the public. In extreme cases, FDA may consider removing the drug from the market.
The process is crucial to patient safety. So, the paper argues, it’s important that pharmacovigilance procedures evolve to address innovative drugs such as biologic and biosimilars. These similar drugs may produce distinctly different side effects. To aid physicians, patients and regulators in accurately matching drugs to the adverse events they cause, the FDA determined earlier this year that biosimilars needed names that were distinguishable from their biologic counterparts.
Policy that ensures accurate reporting of adverse events for similar but distinct drugs must continue as a means of bolstering pharmacovigilance, the paper explains.
The Fast Facts also acknowledges other challenges, namely public awareness and data coordination. The paper suggests public awareness campaigns such as those undertaken by the World Health Organization to make the public more familiar with adverse event reporting. The paper also suggests a coordinated patient registry that would centralize data for faster, more efficient monitoring.
To learn more, read “Fast Facts: Pharmacovigilance.”