Drug safety issues have caused more than 200,000 patient deaths in the EU. And one in three U.S. drugs may have safety issues, explains a new “Fast Facts” from the Global Alliance for Patient Access. The paper explores how countries track and trace prescription drug side effects – and why advanced medicine demands a stronger approach.
Read Fast Facts: Pharmacovigilance
In approving new drugs, regulators face 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 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.
- Reviewing clinical data.
- Responding to clinical data.
Logistics vary across regions. For example, in the United States patients tend to report adverse events to their doctors. In the EU, patients can self-report to national pharmacovigilance centers. In Latin American countries, processes are less defined.
For all regions, however, pharmacovigilance is crucial to patient safety. The paper argues that it’s important for pharmacovigilance procedures to 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 WHO determined in 2016 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, the paper argues.
The Fast Facts acknowledges other challenges, namely public awareness and data coordination. The paper suggests more 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.”