SUMMARY: Per the Times, “what if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbohydrates and calories in an Oreo cookie?”. Drug facts boxes are needed, but the FDA disagrees.
According to the AMA one of the key reasons for non-adherence is that patients may be frightened of potential side effects. Additionally, patients report not taking their medication because they may have witnessed side effects experienced by a friend or family member who was taking the same or similar medication. From seeing those side effects experienced by someone else, it may have led them to believe the medication caused those problems.
There is no doubt that drug side effects are key reasons patients don’t fill prescriptions, and the FDA has not made it easy. Fair balance does communicate potential side effects, but they lack context. People want to know what their chances are of experiencing a listed side effect.
A Drug Facts Box?
A “drug-facts box”—is a one-page sheet that would appear on prescription drugs and drug websites. They would provide clear, simple language, and the box would describe exactly what the drug is for, how much it helps people, what the side effects are, and how often they occur. It other words it would easily communicate drug side effects to patients.
Researchers presented the fact-box idea to the FDA in 2009, but the agency decided not to create the boxes, determining “that the inclusion of such quantitative information in a standardized format cannot be readily applied to many drugs.” What?!
The drug facts box could probably not be applied to all prescription drugs, but it beats the fair balance statements by a lot and is patient-friendly.
A drug facts box could certainly be applied to drugs that patients use every day with a low risk of side effects. The reason the FDA is not on board is that they are scientists who are trying to apply science to irrational patient decisions.
I’ve listened to research as patients talk about fair balance statements. To say they are not patient-friendly would be a huge understatement. Many people ignore fair balance on TV commercials unless certain keywords, like deaths, catch their attention.
Americans rely too much on prescription drugs, and it’s time to simplify their side effects because patients are consumers of healthcare.