It might be itching, chills, fatigue or sleeplessness. Side effects are common with prescription drugs. So how do regulators, patients and physicians keep tabs on these events and ensure that drugs are safe in everyday use?
There’s a process to report and analyze side effects called “pharmacovigilance.” And a new video from the Alliance for Patient Access, “Understanding Pharmacovigilance,” explains the system and its value to patients.
Despite rigorous clinical trials, “data shows that as many as one out of every three drugs approved in the United States has safety issues,” the video explains.
This can occur because not every type of patient can possibly be represented during testing and some side effects are so rare that they simply do not occur in the course of a clinical trial.
This process follows 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.
But, policies that encourage awareness, accuracy, and efficiency are necessary for pharmacovigilance to work. In addition, similar but distinct drugs such as biologics and biosimilars need unique names, billing codes and labels, the video adds. In the end, it’s patients who benefit from a strong pharmacovigilance system.
To learn more, watch “Understanding Pharmacovigilance.”